A ,
: UNITED STATES ENVIRONMENTAL PROTECTION AGE.NCV
WASHINGTON. O .C. 20460
OFFICE 3F
A MO TOXIC SUBSTANCE1
MEMORANDUM
SUBJECT: Compliance/Enforcement Strategy for the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA)
'TO: Al vi n L. Aim
14 Deputy Administrator
Attached is the Compliance/Enforcement Strategy for the
Federal Insecticide, Fungicide, and Rodenticide Act. The
strategy was developed by a work group composed of Headquarters,
Regional, and State pesticides personnel, and reflects the vi-ews
of al1 parti cipants.
*
The pesticides program is a well established program that has
evolved over the years in which States have a major enforcement
rol e.
The strategy is based on the assumption that adequate resources
would be available to support a balanced credible program. Because
of actual resource constraints, however, our primary goals through
FY85 are 1) to maintain th-e present monitoring/compliance level in
States with cooperative enforcement agreements, 2) to negotiate
cooperative agreements with the remaining States, 3) to refine
the program management and oversight activities and 4) to further
develop and expand the data audit/Good Laboratory Practices inspection
program. To meet these goals, we will perform the following activities
through FY85:
o Write FY35 Cooperative Agreement Guidance.
o Develop a formal procedure for and provide support to the Office
of Pesticide Programs for most new regulations and suspensions/
cancellations to ensure that the documents are enforceable. CMS
plans to prepare a draft document on the formal procedure by
the end of the second quarter of FY84. Input and agreement from
the Office of Pesticide Programs on the procedure is anticipated
by the end of the third quarter of FY84 and should be operational
immediately thereafter.
o Develop compliance monitoring strategies and enforcement
response policies for most new regulations and suspensions, as
appropriate.
Finalize strategy for conducting data audit
Practices (GLP's) Inspections.
and Good Laboratory
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o Finalize enforcement response policy for data auaits/GL? inspd
ti ons.
o Ensure that all States and Regions conducting Federal enforce-
ment programs have fully implemented the most effective/flexi-
ble system for allocating resources to priority pesticide
problems.
o Provide technical and legal support to States.
o Provide training for State inspectors and chemists.
o Prepare additional policies for the FTFRA Policy Compendiu-m, as
needed.
o Promulgate a final FIFRA §4 rule requiring dealers' to keep
records- of their restricted use pesticide sales and clarifying
where commercial applicators must keep their records on their
applications of restricted use pesticides.
o Conduct Certification Programs in States without approved certi-
fication plans.
o Along with States, ensure that applicators are made aware of
changing technology.
o Along with States, continue to certify new applicators.
o Prepare guidance to encourage States to address- major use problems
in Certification and Training materials.
o Prepare guidance which ensures that State Certification and
Training materials meet Federal standards, as appropriate.
As soon as we receive your approval to pursue these activities.
they will be incorporated into the Administrator's Management System
with projected completion schedules. Due to anticipated resource
limitations, we will be unable to undertake the following activities
through FY85:
o Expand FATES data to Include State data and ensure that FATES
data 1s complete and current. (CMS plans to request funding
to Initiate this- activity In FY86.)
o Provide guidance and training to the Regions for data audits/
laboratory Inspections and case preparation.
o Support all ruleaaking by the Office of Pesticide Programs.
o Develop compliance monitoring strategies and enforcement response
policies for all new regulations.
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o Update the Pesticides Inspection Manual.
o Consolidate FIFRA Enforcement Response Policies.
«
o Revise FIFRA §7 establishment registration rule and reporting
form to improve the usefulness of data in the system.
o Conduct periodic surveys of pesticide use to improve the priority
setting system.
Please let me know if you have questions or would like to further
discuss our plans for implementing the FIFRA Strategy.
Don R. Clay"
Acting Assistant Administrator
for Pesticides and
Toxic Substances
Attachment
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FIFRA COMPLIANCE /£:ir ORC&MEN7 3T3A7TG:
Introduction 1
FIFRA Compliance Program Overview 1
Previous Compl i ance/Enf orcemerrt Strategies 3
Present State of Compliance 12
Goals and Priorities 13
Plans for Achieving Program Goals 15
Compliance Monitoring Plan 16
Compliance Promotion Plan 21
Noncomp1iance Response Plan 23
Heaaq-uart ers /Regi cnal Coordination 29
Federal/State Relationship 29
Cooperative Certification ani 7r ai i-i .-•:
Program . 31
Cross Program elements 3-r
Program Evaluation 3.6
Future Guidance 38
Appendix 39
Figure I - FIFRA Case Flow
Table I - Enforcement Actions Resulting
from Grant Inspections FY81
Table II -'Enforcement Actions Resulting
from Grant Inspections FY82
Table III - Federal Pesticide Compliance
Inspections
Table IV - Federal Pesticide Enforcement Actions
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FIF3A Compliance/Enforcement Strategy
I nt roduct *, on
This document contains EPA's strategy for acn^eving and main-
taining compliance witn tne requirements of the Feaeral Insectici;e,
Fungicide, and Rodenticide Act (FIF3A) as anendea and implementing
regulations. The document provides an overview of tne FIFXA com-
pliance/enforcement program, a summary of prior strategies, tne
existing state of compliance, the current goals and priorities of
the program, recommended strategies for attaining these goals, a
discussion of the roles of the Federal and State governments in
implementing strategy elements, a discussion of cross program
elements, and a description of the system for program evaluation.
The major elements in this strategy are reflected in existing
guidance documents unless otherwise indicated.
It should be noted at the outset that this strategy tak'es a
comprehensive look at the program and indicates a number of actions
which should be taken to implement an effective program. Sased'on
resource constraints, the actions which will be taken are limited
to those indicated in the priorities for FY85.
FIF3A Compliance Program Overv •Jew
S t a t u t o ry 7 R e g u 1 atory Requi rements
FIFRA, as auienaea, cjrrently haj a variety o f .ndc>. ar,; J.T.S to rrz~
tect health and the environment from unreasonable risks from pesticides
It contains the following requirements:
o Federal registration of pesticides.
o Submission of data to EPA by the registrant/applicant for registra-
tion in support of registration, which shows that the product,
when used as directed will not injure man, animals, crops, or
the environment and will not result in illegal residues on food
OP feed.
o Federal classification of pesticides for general or restricted use.
o Specific labeling of pesticides, including the product's classifica-
tion and proper use directions.
o Ch-ild Resistant Packaging if a product meets certain toxicity
criteria and its label allows for residential use.
o Submission of a Notice of Arrival for all importations of
pesticides or- devices.
o Certain labeling for all exported pesticides a-nd notification of
EPA when unregistered pesticides are exported.
o Establishment by EPA of residue tolerance levels for products
used on a food or feed crop.
o Experimental Use Penults (EUP's) for limited field testing prior
to registration.
o FIFRA §18 Emergency Use Exemptions by the Administrator upon
application from a State 1f certain criteria are met.
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o FIF3A §24 (c) State registration for additional uses •: " i
pesticide within a State to
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The 1972 amendments to FIFRA require the certification of
applicators to apply or super visa trie application o~ p es:; ;•: ties
classified for restricted use. Congress expected States to certify
applicators and authorized funding support. The State -oooeracive'
Extension Servicas were to be utilized for the train i-g of pesti-
cide applicators with EPA funding support.
As of October 1983, all but 4 States have funded cooperative
enforcement agreements; all but 3 States have been granted use
enforcement primacy; and all but Z States have approved certification
plans. As th-ese figures indicate, most FIFRA enforcement and certi-
fication and training responsibilities rest with the States. EPA
activities include oversight of States with agreements, taking
enforcement action for cases referred by the States, conducting
enforcement and certification and training activities in States
without cooperative agreements, and conducting national compliance/
enforcement programs in areas where States have limited jurisdiction
or capability such as data audits/laboratory inspections, import
and export surveillance, and rodenticide/device testing, and regulation
development support.
Previous Compliance/ Enforcement Strategies
Pre-1980 Program Reassessment
General Enforcement of FIFRA
While the FIF3A anforcement pro^-am ^as located i i t.: = 'J.-.:t=j
States Department of Agriculture (USDA), the enforcement program was
centralized witn all activities., inspections, case preparation ana
policy development conducted by Headquarters personnel. After EPA
was formed, a Regional program was adopted. Inspections and case
preparation were conducted by Regional personnel. Concurrence from
Headquarters w.as required for all civil actions. Headquarters
provided guidance and made policy decisions regarding the program.
Prior to 1972,. the strategy for the Federal program was to
enforce product-related violations, I.e., mislabeling, inefficacy,
chemical deficiencies, nonregistration. There was no authority to
take enforcement action against improper use. Criminal action was
-the only available- response against violators.
The 1972 amendments to FIFRA 1) provided for administrative
civil penalties as well as criminal action, 2) made use incon-
sistent with the label a violation, 3) provided for cooperative
enforcement agreements with the States, and 4) required classi-
fication of p-est1ddes along with provisions for certification
and training (C & T) of pesticide applicators. As. a result, the
Federal program shifted to Include enforcement of the label use
directions. The use of dv1l penalties became the backbone of
the enforcement effort. States were responsible for developing
CAT programs based on EPA regulations and obtaining approval for
programs frtJiB €PA.
f
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Federal presence in those States with agreements.
. The Feaeral enforcement program became more secantra1i222 i?
February 1375 when Headquarters announced a program to waive con-
currence for routine civil cases, excluding use cases. 3y November
1978, all Regions were granted 1) full relaxation of the requirement
for Headquarters concurrence in actions related to stop sales
and civil cases other than misuse cases, and 2) partial relaxation
o*f HeaTtquarters coTrcurrance rn tire enforcement of misuse cases.
The 1973 amendments, under certain circumstances, gave primary
responsibility for use enforcement (primacy) to States. As mere
State programs became operational under cooperative agreements
and received primacy, Federal activities shifted to enforcement
programs in States without cooperative agreements and primacy,
program oversight, training of Stats personnel, disinfectant/device
tasting, import/export surveillance, and data audits.
Guidance for the cooperative agreement program was issued
annually. until 1930, strategies empnasizea a gradual shifc from
activities related to product compliance t-o t.iosa monitoring use.
Guidance documents assigned percentages to various a c t i /: t i * s
including agricultural, n o n i -. r i c u 1 t u r i 1 2 n •: ey. ? e - i -^ e n t:'. 1-2
inspections; producer establishment, marketplace, import, certified
dppiicdtcr r d c o r ii .$ insp^ctijna, a n u rsscr'iwCsu use p £ 3 c i c i ^ e w c a , c r
inspections. The percentages correlated to the amount of total •
worlcyears EPA expected the States to spend on the various activities
Percentages were assigned based on prior violation trends and new
regulatory requirements.
Federal and State Certification and Training
Prior to FY81 , the C 4 T program was operated by the Office
of Pesticide Prograas (OPP) independently of the compliance program.
1980 Program Reassessment
In June 1380, ths pesticides compliance/enforcement program
was reassessed. The resultant strategy document. "Reassessment of
the Federal/State Pesticides Enforcement Program", has guided the
Federal/State cooperative pesticides program in recent years. The
document was the basis for major changes in the compliance/enforce-
ment program and contained the following goals and priorities:
o Improve management of all State and Federal pesticides enforcement
program elements by: a) developing a priority setting system; and
b) improving program evaluation through a better information
retrieval system, uniform evaluation standards, periodic program
evaluations, and appropriate program modifications.
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o Ensure tnat eligisie States receive primacy and aceq-.,itely
the public. This goal was to se acniaved by: a) promu' :iting an
interpretive rule on prirnacy standards; b) promulgating a regula-
tion governing hearings for re-scission of privacy; c) issuing
guidance on incentives and sanctions to encourage adequate State
programs; and d) evaluating all State use enforcement programs.
o Ensure effective compliance monitoring and enforcement activities
by assessing training programs and revising training inacarials,
o Ensure adequacy of the certification and training program by: a)
reviewing State plans and certi f i.ca±ion and recert i f i cat i on proce-
dures and Extension Service program materials; and b) revising
training materials as appropriate.
o Increase public understanding of and participation in pesticides
enforcement activities. This goal was to be achieved by preparing
materials and sponsoring training activities designed to help users
minimize pesticide risks and to help persons exposed to pesticides
in documenting misuse violations.
Implementation of Strategies
The Compliance Monitoring Staff designed and began implementing
strategies for achieving t'lesa goa's in 1?31. A summary of ::i?53
strategies f ol 1 cws •.
Improve Man a gement
P ri ori ty Setti ng. The largest portion of the Agency's pesticides
compliance and enforcement resources are directed at pesticide
product and use activities. These resources are used primarily by
the States through the cooperative agreement program but also by
the Regions 1n conducting FIFRA compliance programs in Colorado,
Nebraska, Wyomin-g, and Ohio and handling referrals from the States.
In the past.. EPA Headquarters directed that resources in both
the State and Federal programs be allocated to compliance activities
based solely on general national priorities. As a result of the
reassessment 1n 1980, EPA required both the States and the Agency's
compliance program to Identify priority pesticide problems and to
allocate resources to activities wftlch most effectively deal with
these problems. To assist the States 1n this activity, the Compliance
Monitoring Staff (CMS), 1n conjunction with the Office of Planning
and Resource Management (OPRM), developed a flexible priority setting
model designed to ensure that resources in both Federal and State
FIFRA compliance programs would be applied in a manner which would
most effectively address major pesticide use problems arising in
individual States. This model was included in the FY82 guidance for
Cooperative Enforcement Agreements and was referenced in the Guidance
for F-ederal. Programs 1n States without Cooperative Agreements.
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Application of the model results in four products:
A list 3f pesticide use problems ranked by their .-^a:-
contribution to harm from pesticide use/misuse
i nci :2~t 3
2. A- listing of pesticides ranked by their relative con: ri out '• •:-
to ham from pesticide use/misuse incidents.
3. A list of program activities to be carried out to deal witi
each of the identified problems, including both traditional
compliance monitoring and enforcement efforts as well as
other activities such as increased education,
4-. An allocation of program resources that maximizes potential
program effectiveness by considering 1) the relative priority
of rhe use problem addressed; and 2) the likely effectiveness
of the proposed activities in dealing with that problem.
All States have begun implementing this model or a related
method for identifying priority pesticide use proolems and
effectively allocating available resources.
The FY82 Cooperative Agreement guidance g~ave general directions
for setting non-use priorities but contained no specific model.
Upon request of the States, such a model was developed for the
r Y 3 4 guidance. Because narm is 1 i < e 1 y to oe greater for use-ralatea
activities and the compliance rate is generally hign for non-use
related activities, t " e ranking procedure suggests that 25* of
available inspection .- 3 s 7 >j .- c a s 33 allocated to .-. o r: - u s a r a 1 a t a j
activities. Under the ranking procedures suggested for non-use
pr'uP't'sj, cc ."ujj i i a 1*1 c e iii j ~t 1 1 J i* '• 'i £ priori ty i j d^^ijnej i r> u .1 ^
following order to establishments within a State which produce
restricted use pesticides (RUP), pesticides subject to the Label
Improvement Program (LIP), and pesticides likely to be subject to the
Child Resistant Packaging (CRP) requirements:
1. Violators 1n the State
a) Establishments with major violations.
b) Establishments with multiple violations.
c) Establishments with minor violations.
2. Establishments not previously inspected.
3. Establishments previously inspected with no violations detected.
Information System, A strategy for improving data storage and
retri eval for both the pesticides and toxic substances compliance
enforcement programs was initiated in 1979. Prior to 1981, the
Compliance Monitoring Staff had two ADP systems: 1) the Pesticide
Enforcement Management System (PEMS) which contained inspection,
sampling and case development data, and 2) tne Establishment Regis-
tration Support System (EUSS) which contained FTFRA §7 establishment
registration data. In 1979, a strategy was developed for consoli-
dating expanding, and improving these systems into a new automate^
data system FATES (FIFHA and TSCA Enforcement System). FATES con-
sists of five subsystems which operate independently with cross
reference capaij-f H±-!*T:
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o Pesticide establishment registration and production -200;-ting
o Inspections and sampling
o Case management
o Grants information
o Contract inspect ions
After a feasibility study in 1979, a system design phase was
initiates in 1930. Development and Implementation was b-egun in
early 1931, and by October 1981 FATES was operational. Regional
system installation .and user training was accomplished in 1982,
and system validation was completed in 1983. However, major FATES
data base system updates and enhancements are required to maintain
data for new program activities such as the FIFRA Child Resistant
Packaging and Label Improvement programs, and to provide compretieTi-
sive information for the Administrator's Management Accountability
System. Additional ADP contract, resources are required to provide
these system enhancements and to maintain the additional data the
new programs generate. When fully operational, FATES should facili-
tate priority setting.
Uni form Standards. In 1982, an evaluation protocol was included in
the FY83 cooperative agreement guidance. The protocol was developed
1) to ensure that all State cooperative enforcement and C 4 T programs
would be evai uated. annual !y by the Regions according to uniform stan-
dards; and 2) to ensure that appropriate pesticide usa problems would
ba addressed in State pesticide applicator training and certification
mat'a rials. T'nis protocol was developed for d 5 a in ~ Y 3 3 an.} will 36
modified as appropriate based on experience with its use.
Information from program evaluation is particularly important,
since it is to be used by the States to update priorities for the
next year and to determine specific areas needing additional
regulation (for example, through OPP's label improvement program).
This use of priority setting and evaluation gives the program an
element of flexibility which allows resources to be allocated each
year to those areas where they are most needed and can be most
effectively used.
Primacy
At the request of the States, EPA developed a rule Interpreting
several key provisions in §25 and §27 of FIFRA. The Interpretive
Rule promulgated on January 5, 1933 addressed 1) when a State will
be deemed to have adequate pesticide use laws and enforcement proce-
dures, 2) criteria used by EPA to determine whether a State is
adequately carrying out primacy. 3) EPA procedures for referring
misuse allegations to tne State and tracking State responses. 4)
the meaning of appropriate enforcement action, and 5) factors con-
stituting an emergency and circumstances under which EPA will defer
to the State for enforcement. Generally, tne Agency determines
whether a State should be granted primacy or whether its use program
Is adequate based on a review of the State's entire program rather
than a case by case review. EPA evaluates a State's primacy program
during the end of the year grant review for those States with coopera-
tive enforcement programs,
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On May 11, 1981 EPA promulgated a rule (45 FR 25353' govarni
procedures to be followed by the Administrator in rescinding
primacy. Under these procedures, whenever the Administrator ma
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Certification and
Training Program
In FY81, OMB transferred trie program to tne corns';
enforcement program. This transfer provided an opportunity to
better coordinate the two programs.
FIFSA provides that certification of pesticide applicators
be accomplished under State Certification Plans approved by
EPA with training provided by the State Cooperatw-e Extension
Services (SCES's). This objective has been largely accomplished.
Only Colorado and Nebraska lack approved certification plans and
only the Colorado* SHE.S fails to provide applicator training. In
each of these States, EPA has established programs in the absence
of State activity.
Three Federal agencies, the Department of Defense (ODD),
the Department of Interior (DOI), and USOA, have established pro-
grams to certify their own employees. These programs are authorized
by EPA to allow Federal agencies to certify their employees to apply
pesticides anywhere in the performance of their official duties.
Federal employees can still be certified by States, but their certi-
fication has the same geographic limitations as other applicators
certified by the Stite.
Based on operational experience, there has been a need for 5:r>e
changes, and certification plans have been amende-! in res pens a 12
these needs.
Certification plans were required to contain a provision Keeping
applicators abreast of changing technology. This requirement is
generally met by recertif1cation either at specified intervals or
when deemed appropriate by the State. Most States have completed at
least, one recertlfication cycle.
EPA has worked with USDA to develop training material. There
1s need to periodically update the material in order to incorporate
Information on new technology, existing training material is
cataloged at the USDA Beltsville library.
Additional Activities - Federal Program
iTvput f-nto Developing-nt of New Regulations
To ensure that new regulations are enforceable, CMS participates
and assists 1n the development of regulations or other regulatory
actions such as suspension/cancel!ation orders for which the Office
of Pesticide Programs (OPP) has the lead role.
*Colorado has 1n.d1c.ated an Interest In establishing a program,
which w1^l initially cover only commercial applicators.
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General
As mentioned previously, the Federal ro^e sni*t22, as nc~2
States received grants, to the oversight of the ccooerative program,
enforcement response for State referrals, en f orcement programs in
States without cooperat-ive programs or primacy, ana a compliance
monitoring and enforcement program consisting of data audits,
import and export surveillance and efficacy testing. With the
exception of the data audit program, which is managed at Headquarters,
the Regions have primary responsibility for the Federal Program.
CMS provides guidance documents, policy interpretations, technical
support, and oversight for Regional activities.
Data Audits
The data audit program for studies submitted in support of
pesticide registration was instituted in 1975 after the Food and
Drug Administration (FDA) found that studies submitted to it had
serious deficiencies. The strategy has been to audit studies at
pro.blem laboratories, audit studies of special significance to"
regulatory decisions, and conduct routine audits at all pesticide
laboratories. Under an Interagency Agreement originating in 1973
F3A conducts inspections at laboratories whiz in conduct healtn
effect studies. £°A inspectors primarily conduct audits of environ
mental studies. EPA scientists participate on audits as aoorsp
A Sat a Audit P-anel within Office of Pesticides and Toxic Su'ostat
(OPTS) targets inspections, reviews reports, and recom-
FIFRA Imoort Surveillance
Compliance monitoring of the import provisions of FIFRA is
performed In cooperation with the U.S. Customs Service. Customs
inspectors screen imported pesticides and allow only products
which are in compliance with FIFRA to enter the United States.
If a pesticide appears to be 1n violation of FIFRA, the Customs
inspector stops the entry of the pesticide into the Customs
Territory of tfte United Staes and refers the matter to the appro-
priate EPA Regional Office for resolution or enforcement action.
In addition, a Notice of Arrival form is required to be submitted
to" EPA for all importations of pesticides and devices. An annual
average of 4375 Notices of Arrival hat« been received and 670
inspections of imported products have been conducted for the past
few years.
Efficacy Testing
Disinfectant Testing
The Federal program for disinfectant testing, which is no
longer active, involved eff1.ca.cy testing of hospital disinfectan
Sucti testing is important considering that failure of hospital
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disinfectants can contribute to the incidence of in-'-tions aiong
vulnerable patients and result in unnecessary and j -•;-.: -^ •!? g e.ocs'j-e
of nosoital staff to pathogenic organisms. 0?3's Seltsville
laboratory formerly performed efficacy testing on aoout 200 sables
per year. The failure rate ranged from 4 5 X of 111 s a -a 1e s in 1930
to 72% of 40 samples in 1982. T.'ne Beltsville laboratory suspencea
testing of disinfectants, sanitizers, sterilizers, ana germicides
in October 7S32 due to competing higher-priority needs, altnougn
the capability to perform such tests remains. CMS proposed an"
efficacy testing program for FY85; however, it was not included in
the priority listing of .OPTS programs.
Ultrasonic Device Testing Program
Under an Interagency Agreement between the FDA's Winchester
Engineering Analytical Center and EPA's CMS, the FDA tested the
acoustical properties of a dozen different ultrasonic pest control
devices being manufactured in the United States. This information
was used to select "representative" devices for testing the principl
of ultrasound on rodent control. The efficacy testing is being
conducted under a separate Interagency Agreement with the Denver
Wildlife Research Center, Fish and Wildlife Service and CMS.m A
final report on the first of six devices was recently received,
and the other tests and reports will be completed by February
1984. CMS and OPP will use this information in the regulation of
ultrasonic device labelling claims which are overstated.
Electromagnetic Device Testing Program
A program similar to the ultrasonic program was conducted
for devices which purport to control pests utilizing the principle
of electromagnetism. The Bureau of Standards, through an Interagenc
Agreement with CMS, conducted the electronic analysis of eighteen
different devices. University and USDA personnel conducted efficacy
tests on rodents and insects for CMS and determined that electro-
magnetic devices were ineffective for these pests. Appropriate
regulatory actions were taken by CMS which resulted in the ban of
these types of devices from the consumer marlcetpl ace.
Rodenticide Efficacy Testing
The Office of Pesticide Programs funded an Interagency Agree-
ment with the Denver Wildlife Research Center in FY83 to conduct
a national program to test rodenticides for efficacy. CMS is
participating in this program by coordinating the sampling,
chemistry testing, efficacy reviews, and enforcement response, if
any, for the rodenticides.
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M on i 13 ri n g of Federal Srray Programs
The EPA tnrough tne Federal enforcement program or t.-.e
cooperative State programs routinely monitors spray pr^ra.os
funded by Federal agencies. For instance, applicators'::;/
for-hirs applicators during the Grasshopper Control Program nave
been monitored by the States of New Mexico, Texas, and Oklahoma,
and by EPA in Nebraska and Colorado. The EPA and tne States
may also conduct use investigations for smaller scale programs
including aquatic weed control, forest p-est control, and pre-
dator control programs.
Present State of Compliance
Regulated Community
The following is a list of known members of the regulated community:
o Number of Rsgistsrsd Establishments 1-1,000
o Number of Applicators Trained and Certified
Private 1,500,000
Commercial - 495,000
o Number of Laboratories Conducting FIFKA Studies -03
o Number of Notice of Arrivals Received in 1982 (imports) 5,014
o Number of Export Notices received annually (approximate) 75
o Number of Experimental J;a Permits Issued in 1982 441
o Number of §18 Exemptions issued in 1932 " 373
o Number of Restricted Use Pesticide Dealers 23,706
(This number does not include dealers in Colorado,
Montana, or North Dakota. It 1s estimated that
these States have approximately 300 RUP dealers.)
This 11st does not Include Information on the total number of
pesticide users or pesticide dealers of unrestricted pesticid-es.
Many users of pesticides only use general use pesticides and there-
fore are not certified. This is especially true of homeowners who
are not commercial applicators OP farmers. Although the unknown
categories represent a large number of persons, the overall impact
of violations by this group which go undetected is much less than
the effect of violations by members of the known regulated community
Violations by the known community may Involve more highly toxic
pesticides OP product type violations which impact a large number
of .people if left undetertsd. Violations by private users who
uncertified generally affect a more limited population. In add
violations by users *h1cn result 1n serious harm ape likely to be
reported to the Agency.
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Inspections and Actions
The shift from a Federal to a State program has res
increased number of inspections and increased field presence. A
complete data oase on enforcement actions wnich induces State
activities only exists for FY31 and FY82. In FY31 , a total of
50,104 State inspections was conducted. The percent of inspections
resulting in action was 17.4. In FY32, a total of 59,317 State
inspections was conducted. The percent insoections resulting in
actions was 13.1. Violations figures for specific types of
inspections indicate a higher rate of noncompliar.ee *':r use related
requirements than for non-use related requirements.
The number of Federal inspections for FY81 and FY82 was 225
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Priorities for the FIFRA compliance/enforcement program through
FY85 fall into the following management, compliance monitoring
enforcement response and certification areas:
Manaaement
o Write FY85 Cooperative Agreement Guidance.
o Develop formal procedure for and provide support to OP? for most
new regulations, suspensions/cancellations and other actions to1
ensure that the documents ara enforceable. In order' to do this
effectively, it is mandatory that compliance/enforcement program
staff be involved early in the development of such documents.
This has oeen a problem in the past. Therefore, a formal syste
of communication between OPP, Office of General Counsel, anc C.MS
should be developed.
o Finalize strategy for conducting data audits and Good Laboratory
Practices (GLP) inspections.
o Finalize enforcement response policy for data audits/GLP
inspections.
o Develop compliance monitoring strategies and enforcement response
policies for most new regulations and suspensions, as appropriate.
o Ensure that all States and Regions conducting Federal
enforcement programs have fully implemented the most effec-
tive/flexible system for allocating resources to priority
pesticide problems.
o Provide technical and legal support to Strata*
o Provide training for State Inspectors and chemists.
o Prepare additional policies for the FIFRA Policy Compendium, as
needed.
o Promulgate final FTFRA §4 rule requiring dealers to keep records
of their restricted use pesticide sales and clarifying where
commercial applicators must keep their records on their applica-
tions of restricted use pesticides.
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Compliance .Monitoring
-15-
Program guidance indicates tn at generally 75" 3- :~::e:~^:r:
resourcas should be directed at use probla-ns and 25" at :-oc-jct
relatad priority problems. The priority setting gui^a^ce '3 iesignec
to be flexible, allowing a shift in inspection targets -rom year to
year based on shifts in State specific problems ana new r!-RA
regu1 at i ons .
In addition, the Federal program will emphasize tne data
audit/laboratory inspection program.
Enforcement Response
States will set their own enforcement priorities with major
emphasis being given to priority use problems which they have agreed
upon with EPA.
The Agency attaches the highest priority to responding to the
following instances of noncomp1iance:
o Violations relatad to those priority use problems which
EPA and the State have agreed to track under primacy and
for which the State does not take appropriate action.
o Violations related to other priority use probla-s established
by the States or EPA.
o Submission of falsa data to EPA in conjunction with ?esti::.:a
regi strati on .
o Sale of Restricted Use Pestic'ides to uncertified applicators in
Statas with Fadara' Programs.
o Label or formulation violations likely to result in harm to
health or the environment.
o Violations of Child Resistant Packaging regulation.
o Pesticide enforcement registration and reporting violations.
Certification
o EPA will conduct Certification Programs in States without
approved certification plans.
o EPA and States will ensure that applicators are made aware of
c&anqing technology.
o EPA and States will continue to certify new applicators.
o EPA will prepare guidance to encourage States to address major use
problems 1n C X T materials.
o EPA will prepare guidance which ensures that State CAT materials
meet Federal standards, as appropriate.
Plans for Achieving Program Goals
This section discusses the compliance monitoring plan, the
compliance promotion plan, plans for responding to noncompl iance,
certification and training, Headquarters/Regional coordination,
Federal/State relationship, and cross program effects.
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Como "Nance Moni tori no Plan
Object!ves
The basic objectives of the compliance monitoring r'an are:
1) to provide a visible enforcem-ant presence which wil: encourage
voluntary compliance; 2) to collect evidence to support enforcement
actions; 3) to expand the data base for determining compliance oy
the regulated community (FATES) and to use this information to
identify persons likely to be in noncompl iance; and 4) to discover
problem areas requiring resolution through re-gulatory initiatives
by OPP.
Compliance Monitoring Tools
Tools available to EPA and the States for monitoring compliance
with FIFRA include data review, letters, and on-site inspections.
EPA can determine by reviewing available data whether an
establishment has met its §7 reporting requirements or wnetter
there is some questionable registration data.
Letters are used to determine which specific industries are*
actually subject to FIFRA requirements when a full scale on-site
inspection is not co-st -effective. They are generally usaa wnen
purposeful noncompliance is not suspected and the likelihood of
response is good.
On-site inspections are the major method through which EPA
monitors compliance with TTrSA. T>.<=SS i -spaztl z~- zr* co."--cts-
in response to complaints and on the basis of target selection
under a neutral administrative inspection scheme (NAIS).
Inspections Based on Referrals/Complaints
Both the Agency and the States place a hi gh priority on
response to complaints or referrals regarding violations.
Referrals, tips, and complaints are particularly important to
EPA compliance monitoring for misuse. This is because FIFRA §9
gives "EPA inspectors authority to enter only establishments where
p-esticides are held for distribution in commerce. It does not
clearly give EPA authority to enter places where pesticides are
being used. Therefore, the Agency can enter such places only with
T) consent of the owner or his agent, or 2) with a warrant based
on probable cause that a violation has occurred, or 1s occurring.
Probable cause can be based upon a detailed allegation from a
reliable source 11 Hiring specific action with a specific misuse.
Some State statutes give their Inspectors broader entry
authority to detect misuse.
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Misuse is difficult to detect unless an inspect;-" : 3 2 - •» 5 e n t
during actual use or soon a.Ttar tne use of the pest i c: .; = . "^ere-
fore, use inspections are conducted in resoonsa to a cr~c',i:nt
referral or during trie actual application of trie p.^sf'c'^e. -29''-
timate complaints/referrals regarding pasticiie r. is use ^ay 22
ineffective if tney are not made and investigated oromotly oecause
the evidence, especially in the case of highly toxic organopnosonates
will no longer be there at the time of the investigation.
Even if there were no limitations on entry authority, evidence
of pesticide misuse may be difficult to detect during a planned use
observation. Because inspectors would not generally otherwise know
when and where a ctmnnercial or private applicator is going to tr.a' "«,-
States to determine whether the requirement is being met. In
addition States can follow-up the records and inspect the applicator
to determine whether he is certified. Based on records which
commercial applicators are required to keep, it-is often possible
for the States to determine whether the RUP was used'in accordance
with its label instructions.
EPA does not have regulations requiring dealers in States
without cooperative agreements/primacy to keep records regarding
their sales of RUP's. As a result, it has been difficult for EPA
to determine whether dealers in these States have sold RUP's
to uncertified applicators. Although Federal regulations exist
requiring commercial applicators to keep records regarding their
RUP applications, the regulations were unclear about where these
records had to be kept. However, EPA expects to remedy these
problem* by promulgating a final rule under FIFRA §4 requiring
dealers to keep records of their RUP sales and clarifying where
certified commercial applicators must keep their records on their
applications of RUP's. This rule should appear 1n the Federal
Register early 1n FY84.
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Ta rge 11 i n g
As indicated on page 6, EPA and the States use the priority
setting system for pesticide use/misuse to determine specific
categori.es of persons who should be targetted for inspection.
Selection of specific p-ersons within each category is based on an
NAIS. The system is flexible and may vary from year to year based
on major existing or anticipated problems. Each neutral scheme
includes a set of criteria designed to help the Agency and States
achieve the best cost/benefit ratio between the use of compliance
monitoring resources and detection of violations. The criteria
applied to all facilities under a neutral scheme vary based on
individual priorities but generally include the following: viola-
tion history, production volume, amount of specific pesticides
used, inspection history, and location. Inspection targets are
selected at random based on available resources from the facilities
identified through application of the NAIS criteria.
The current use/misuse priority setting system is based -
primarily on data in case files and incident files. It thus
yields priorities which are responsive to previously existing
problems which posed actual harm. This system should be com-
plemented by one aimed at predicting potential for harm based
on trends in the quantities and types of pesticides used. Such
a system would require periodic surveys of pesticide use by the
States and/or EPA. To date, resource limitations have prevented
further exploration of .this option.
The priority setting system for product/faci1ity related
inspections (see page 7) results in the targetting of specific
persons and products for inspection. Again priority is based on
a number of factors including violation history, production of
products most likely to result in human or environmental harm
if violative, and the need to show a government presence for
important new regulations. Since States and Regions will use
this system for the first time in FY84, EPA may need to make
adjustments in FY85.
To assist in targetting use inspections, the Agency needs to
encourage the successful generation and transmittal of referrals,
tips, and complaints in both misuse and use areas. Therefore, EPA
should undertake the following activities:
Expand Formal Referral Systems
Within the Agency
A system for data audit/laboratory inspection referrals exists
between the Office of Toxic Substances (OTS), OPP, and CMS. Also,
OPP provides referrals regarding products not in compliance with
the Child Resistant Packaging Regulations. A formal system for
referrals for other requirements should be developed. EPA should
encourage States to develop similar referral systems within each
State.
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- 1 9 -
Expand Referral Systems
With Other Agencies
While trie Agency has referral systems for specific tyoes of
products or violations witn FDA, Consumer Product Safety Comnissio-
(CPSC), Occupational Safety and Health Administration (OSHA), ana
Federal Trade Commission (FTC), it should expand the systems. EPA
should encourage States to set up similar systens.
Improve Referral System
Between the Regions and States
FIFRA §27 requires EPA to refer all significant allegations
of pesticide misuse to the States. The Interpretive rule provides
specific procedures for the referral and tracking of such cases.
Although all Regions have implemented informal referral and trackin
systems, some systems are better developed than others. All the
Regions need to implement a formal system.
Expand Work with the Press
and Special Interest Groups
Botn EPA and the States periodically encourage the national
and local trade press to write articles on new and existing pesti-
cide control requi rsments.
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away from requiring a specific frequency in its guidance. I
t n e Agency suggests that frequency be estaolisnea 11 ^ c u : -i tie
priority setting system. This is trua for ^lisusa 33 •*-''. a;
establishment inspect ions. '
Laboratories are exoected fo oe inspected under -.12 data aucit/
laboratory inspection program every 2-3 years.
Inspections at device producing establishments should be oart
of the routine inspections of establishments manufacturing general
use pesticides. When the Agency is conducting a major testing
program for specific devices, samples are collected at Headquarters'
request or in response to complaints. Types of devices for which
t-esting has b-een/is being conducted are water purifiers and elec-
tromagnetic, supersonic, and ultrasonic devices with rodenticide or
insecticide claims.
Disinfectants are collected as part 'of a State's routine
inspections. Since the Agency no longer conducts efficacy testing,
there is no separate program for disinfectants.
Rodenticides are collected as a result of sample requests
prepared by CMS. Samples are requested based on an OPP prepared
list of products which OPP believes should be tested.
Follow-uc Insoections
Follow-up inspections are conducted when inore information
is needed for a possible enforcement case or when violations
^ 2 v e bean f c 'j ~ d 2nd t h a R3rtio*v'St2ta d a ta TI ^ ? ° s * *^ * * ' n o * h a **
inspection is necessary in order to assure compliance. The
frequency is determined on a case-by-case basis depending on
the need for a follow-up Inspection to assure compliance.
Inspection Quality
To ensure inspection quality and the evidentiary value of com-
pliance monitoring information collected by the States, EPA will
continue to provide training for State pesticide inspectors and
State pesticide chemists. The types of training provided by EPA
are described under the training section on page 9. Aside from
training, basic guidance on the conduct of pesticide inspections
1s contained in the Pesticides Inspection Manual. This manual
«m be up-dated and revised 1f resources for this activity are
available 1n the future.
In addition to providing training and basic guidance, EPA
reviews State Inspection reports to ensure that inspections are
conducted properly, appropriate inspection procedures are followed,
and sufficient evidence is collected to support enforcement actions.
This review 1s normally conducted as part of EPA's routine oversight
of the cooperative prog-ram durl-n-g mid-year and end-of-year reviews.
This r-evvew activity -*i 11 continue.
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In accordance with the Agency's Quality Assurance ' - ^ ,' require
ments, States receiving grant money through tne coooe r-a c i ve enforce
ment program must develop QA Plarcs covering botrt compliance mcnitop
and sample analysis. These QA Plans must be submit-ec to tne Regio
Quality Assurance Officers annually for review and aporoval. Tne
Compliance Monitoring Staff, with the approval of tne EPA Quality
Assurance Management Staff of ORD, has provided guidance to the
£-egions and States on the development of QA Plans.
Compliance Promotion Plans
Objecti ve
Compliance promotion is an important component of any
successful compliance program. The objective of compliance pro-
motion 1s to ensure that the regulated community is aware of
the requirements of FIFRA and related Scate pesticide laws and
understands what it must d.o to comply.
Since neither EPA nor the States have sufficent resources ts
Inspect every member of the community regulated under FIFRA, both
must depend largely on voluntary compliance.
ool s
EPA and the States promote voluntary compliance witn
through the following mechanisms.
Educational Proarams
Certification and Training. Perhaps the most widespread compliance
promotion tool is the pestici de applicator training and certifi-
cation program. This program is conducted by EPA in two States
and in other States by the States themselves. It ensures that both
private (farmers) and commercial applicators (all others) are not
only aware of pesticide use requirements and generally competent
to apply pesticides but competent in particular to apply restricted
use pesticides. Training materials are frequently revised, and
EPA will issue further guidance in FY85 directing that information
from the priority setting process be incorporated into certification
and training materials and examinations as appropriate. Implemen-
tation of this guidance will be dependent on availa-ble resources.
Other education programs. These programs are designed to promote
safe pesticide use. An example is Project SAF£. which is sponsored
by the National Aerial Applicators Association and the Extension
Service and is supported In part through cooperative agreement funds
During the first phase of project SAFE, trainers were trained to
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- 22 -
conduct fly-ins* to teacn aerial applicators better ca • : : -at: :--
tecnniques to minimize pesticide drift and to obtain estiva* sest
control with the niinltnu^i amount of pesticide- The~= -,275 tee^
three trainer fly-ins which involved approximately -3 States.
During the next phase of the program, these trained specia 1i5*3,
mostly cooperative extension staff, will be conducting fly-ins for
aerial applicators in their States to help the applicators calibrate
and apply pesticides in the most environmentally effective manner.
Farmworkers Program
Several jr*«r« ^ago, tfrve Agency initiated a .pro-gram to ev.al-u.at-e
the specific problems of pesticide misuse related to farmworkers,
especially the migrant farmworker.
In 1974, the Agency promulgated 40 CFR 170 Worker Protection
Standards, which addressed four basic protections to persons
engaged in agricultural hand labor in the field: 1) protection
from being sprayed, 2) reentry periods (one general and 12 specific),
3) protective clothing, and 4) warnings. The worker protection -rule
found in 40 CFR 170 are implemented through the labeling of agricul-
tural pesticides. The regulation is enforced at the registrant '
level by requiring sp-ecific label language. The regulation is
en-forced at the user label in that it -is illegal to use a pesticide
in a manner inconsistent with its labeling. A .vor:
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fended and Cancelled 3asf!cidas booklet. T n -; 3 boo <'.--.
area oy CMS in 197/. It was conpiiad to sunna'^a i": t'ar*
Tncy actions on pasticiias which nave bean suspense c, :^-,ca"'ec,
or otherwise restricted. It was designed as a qu:c< ~='a~a^ca gu':;
for use by pesticide inspectors but is available to t.~a cuol't.
*
Publication of Results of flajor Testing Programs. - "i 0 c t o o e r 1 9 3 C ,
CMS issued a puolication called ihe_Invest 1 gat ion of Efficacy a?c
Enforcement Activities Re"! a fine to elect re ^ic^atr: P'est'Contro'
Devi cesl fhe results of tne ultrasonic testing program wilt a '> so
be published in the future. These types of puolications ara useful
to other Federal regulatory agencies, consumer groups, foreign
countries, prospective producers of such devices, and to the public
Notices of Judgment. Under Section 15(d) of FTF3A, EPA publisnes
enforcement actions tanen against violators. It is believed that
the Notices of Judgment have some deterrent effect.
Press Sel eases. TK. 933 ara ganarally issued when major violations
occur or if public attantic-n has besn focusad on a-case.
Personal Contacts
Compliance Inspections. Discussions of regulatory requirements
during inspections a'io provide a system for educating tne regulates
unity concerning specific FIFRA requirements and tne nee-: to
Public Presentations. EPA personnel give presentations and
parti ci pat a in pane ! i: £ cut- i :r. 2 at : -.iust -y zzr, f srar.ces , :=.r,; -i,-3 ,
and other public meetings.
Noncomol i ance Response Plan
The objectives of a program for responding to instances of
noticorapl i ance are 1) to ensure that violations and resulting pro-
blems are promptly corrected; 2) to quickly and effectively take
equitable enforcement action against violators; and 3) to deter
similar noncompl i ance in the future.
A broad range of enforcement responses is available under
FIFRA, including advertisement letters (i.e., letters to registrants
regarding advertising claims), warning letters, stop sale, use and
removal orders, request for voluntary recalls, seizure, injunctions,
administrative civil penalties, criminal penalties, suspension or
revocation of certification, refusal to accept data from labs
refusing inspection, suspension/cancellation of the registration,
and revocation of the establishment number.
Detailed guidance for selecting the appropriate response is
«ailable to the Regions and States in the 1983 FIFRA Compliance/
forcetnent Suidance Manual and in the Civil Pmalty Policies
sted on page 25 under the Administrative Civil Actions Section.
Inspections will continue to be conducted with increased frequency
at those estabHshaenls with a violation history.
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3 a ^'j sal to Ac cast Data f*om Laboratories Refusing '. n;c:?:"'3^s
This policy is stated in the final FIFRA Good Laboratory
Practice Regulations (GLP's) which are to be pronu 1 gacaa in FY3-i.
Suspension/Cancellation of Ragistration
This is an action whien may be considered if the statemen-
of compliance or noncompliance with the GLP's that is to be
submitted along with any data under FIFRA §3 is falsified. This
action is discussed in the final FIFRA GLP's.
Termination of Establishment Registration
The regulations on the registration of pesticide-producing
establishments (40 CFR §167.3) state than an establishment
registration will remain in effect so long as the establishment
continues to submit annual pesticides reports. If an establish-
ment does not submit an annual pesticides report within 20 days
after receipt of a Notice of Warning or civil penalty for failure
to submit the report, EPA will initiate procedures to terminate .
the establishment registration.
Facilities
Generally, if Faiaral Agencies are fcuni in vis lav en of =;.",-,
the EPA does not issue penalties. This is in accordance with Exec-tiv*
Drier 12088, Federal Comolianca With Pollution Control Standaras,
which established a government wide program for ensuring Federal
facility compliance with pol luti on ''control requirements. Instead of
assessing penalties, EPA tries to resolve the problem. First, a
Notice of Warning is issued to notify facility managers of violations, -
and the EPA works with the violative agency to establish a remedial
plan. If the problem cannot be resolved between agencies, the matter
Is referred to OMB.
With regard to criminal action, the Department of Justice
has indicated it would not allow EPA to file suit against another '*
Executive Agency. In FY 1983, EPA issued a warning letter to the
Fish and Wildlife Service for failure to comply with the pro-
visions of an EUP.
The EPA Office of Federal Activities has developed a Federal
Facilities Compliance Program Strategy which outlines how EPA
Headquarters and Regional offices will handle Federal facility
compliance activities. This strategy covers:
cal Assistance - to ensure cost effective and timely
ompliance.
o Compliance Monitoring - to -monitor actual compliance.
*
o Fiscal Planning Assistance - to assist OMB 1n evaluating budget
'5^^P^^^^^>^rr*^rT?™^Tr7STri ,. ...4*t»
A IMI « 4*«««*j u w t»Oiu^ < j w i • ..
monitor use of funds.
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Cooperative Enforcement Program
As tne cooperative enforcement program has eve ;/?•:, t'?e S: = tas
with agreements have accepted increasing rssponsiblity ana now snare
fully in all phases of the program with E ? A .
Co mo 1 i ance/E nf orcement Activities
The States with cooperative agreements conduct all FIFRA
compliance monitoring activities related to pesticide production
sale and use. Federal inspections are limited to those related to
data audit, imports, and assistance upon State request in major
sp"ray progr-aws in the Stat«. (Th-es-e major spray programs are
usually funded by Federal agencies.) In addition, EPA through
NEIC provides technical assistance including:
o pesticide use investigation workshops
o state-of-the-art techniques for monitoring pesticide drift
o conducting state chemists training courses
o evaluating State pesticide laboratories and providing check
sample analyses
Under the terms of the cooperative agreements, States will
take all enforcement actions on violations of only State law and
will re"?er all -rl ol ati on-s of only Federal law product and establish-
ment registration requirements to EPA for en fa reamsnt action.
Where * n e r e is a violation of both State ana Federal law, a State
may take enforcement action itself or refer the case to EPA if it
is unvn'lling or -jr.able to do so.
All States with cooperative agreements also have primary
use enforcement responsibility (primacy). Under the terms of FIFRA
§§26 and 27 and the final rule interpret!ng these sections, EPA
may not take enforcement action on a significant case referred to
the State unless the State does not take adequate and timely enforce-
ment action.
Stats Program Oversight
EPA has primary respon-sibi 1 ity for cooperative enforcement
programs oversight; however, the States are closely involved in
this process.
Program Guidance and
Compli ance/Enforcement Pri orities
The States through SPIRES (State FIFRA Issues. Research and
Evaluation Group) participate in the development of annual program
guidance. Although the guidance contains national priorities,
these are only for consideration by the States as they develop
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tneir own annual program priorities. Specific outputs ' ; - zz~-
pliance/ enforcement activities ar» negotiated on t-e ::: j • 3 or" ti
State priorities and productivity factors in t'ne guiaa^ce.
Proaram Evaluation
Major elements of the Regional evaluation of State programs
i nclude :
o Semiannual reports by the States of their accomp 11 sh-ments compared
to the types and numbers of inspections projected in the grant
agreement.
o Midyear and end of year on-site evaluation based on a uniform
evaluation protocol which contains both quantitative and qualita-
tive evaluation factors. The States are given an opportunity to
review evaluation reports before they become final.
o Training and close informal review of the quality of State •
acti vities.
The effectiveness of a State program is judged primarily on .
the quality of its priority setting system, its adherence to
negotiated number of outputs, the quality of its inspections and
the adequacy of its enforcement responses.
Feceral Program in Non-Cooperative Agreement • States
In Colorado, Nebraska, and Wyoming, EPA conducts the entire
Federal enforcement program. The Regions use the same priority
setting mechanism used by States with cooperative agreements to
allocate resources, conduct all inspections and take enforcement
acti ons.
EPA will continue its efforts to persuade these States to
participate in the Cooperative Program.
Cooperative Certification and Training Program
Certification and Training Activities
Currently all States but two have approved and operating State
pesticide applicator certification plans. All States with the
exception of Colorado have applicator training programs administered
by their State Cooperative Extension Service in accordance with
FIFRA §23. Ten Indian tribes have received EPA funds to develop
Certification Programs, Under rh« C 4 T prograa. over 1.6 million
private applicators and 496,000 commercial applicators have been
certified and trained. As of September 1982. there were over
600.000 private applicators and over 266,000 commercial applicators
recertified.
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EPA will continue to conduct certification prc:-^~3 • ? Statesi
w i t h o u t c e ~ t i • i c a t i o n plans. 3 c t h E ? A and States •„ ; c i : = : - a i n -; -: •-
material and Information to ensure mat applicators a — 3.-
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- 33 -
U a j a t a of Materials
w
The core manual and various category manuals
updated to reflect changing needs and technology. Corses of the
manuals will ae printed by che State Cooperative Extension Services
(SCES). These and other training materials will 2-2 cataloged at
the U.SDA 3eltsville library using EPA funding. T'->e problem continues
to be future availability of copies. Neither the Government Printing
Office or the Department of Commerce will maintain copies of these
publications for distribution and sale. Therefore, while copies
can be reviewed at the Beltsville library, a user can only print
his own copies from a camera ready copy, or if the timing is correct,
order from a SCES which is a.bo.ut tJ3 make a printing run. SCES's
do not usually maintain an inventory of copies for sale. Therefore,
the problem is not so much updating training material, but making
it available when requested to groups other than the SCES's.
Indi an Tri be s
Ten Indian tribes have received EPA funding assistance to
develop certification plans and some draft Indian plans are nojw
being reviewed. Therefore, while some tribes will probably ha've
approved plans, others will not. EPA must then urge these tribes
to enter into an arrangement with States to perform certification
on the reservations or EPA must establish Indian certification
programs. There is also the possibility of some split options,
such as, States issuing certificates and E3A enforcing misuse and
denial, suspension or revocation of certification.
Re view Plans
A more complex and long-term proposal is ttre review of all
existing certification plans for adherence to current standards.
Currently limited resources preclude such an evaluation.
Colorado and Nebraska
Efforts will continue to be made to have thase States
develop and submit certification plans. Colorado has recently
indicated its Interest in developing a program which will initially
address only commercial applicators. The Nebraska State Cooperative
Extension Service has provided training since the program began,
and this should prove an asset in the effort to have the Nebraska
Department of Agriculture develop a certification program.
Federal Facilities
Federal agencies can have their employees certified under
State or EPA administered certification programs. Most Federal
agencies chose this option, even though it imposes geographic
limitations cm wtere tfce applicator can apply pesticides, I.e.,
th« State Issuing the certificate or States with reciprocal
agreements. However, because some Federal applicators must work
1 it sever*! States, ofte-n on sliort notice. EPA allows Federal
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agencies to develop certification plans for tneir e-oo/ees.
Applicators certified under Federal agency plans cai aro'y
pesticides anywhare, but this certification is limits': to of fid a
auty functions. To date, three Federal agencies, DOG, USDA anc
DOI, have approved Federal agency certification plans.
Cross Program Elements
The pesticide program impacts regulations and enforcement of
other State and Federal envi ro-rrmental statutes. There is a need
to 1) establish a better and more formal referral program, and 2)
to develop a mechanism to educate inspectors on the various pro-
gram requirements in order for them to effectively ma
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Pesticides are a major constituent of the .vaszes at a large
number of hazardous waste sites and information on registrants
ana producers is needed for clean-up cost recovery and associates
enforcement actions. Information on oesticide manufacturers 133
been provided to the Office of Waste Programs £n-"o r cement as part
of the Agency's dioxin monitoring arogram.
For pesticides listed as hazardous wastes under Resource
Conservation and Recovery Act (RCRA), disposal of the pesticide
and/or empty container is directly regulated under RCRA, Investi-
gations and cases involving illegal disposal of RCRA regulated
pesticides identified under FIFRA or associated State enforcement
programs requires close cooperation with State and Federal RCRA
personnel. Pesticide investigations may also provide information
on disposal practices which point to the need for regulation under
RCRA.
Water Program
Use of pesticides resulting in drift into water is primarily
a FIFRA and State pesticide enforcement function having a direct
interface with Water Quality Criteria established by the Wat*"
Programs. Pesticide contamination of groundwatsr resulting from
pesticide use also requires coordination between tne pesticides
and water programs.
InterAaencv
Data Audits/Good laboratory
Practice Inspections
As discussed on page 10, FDA conducts inspections for EPA
at laboratories which conduct health effects studies.
Soray Programs
As discussed on page 28 under Federal Facilities. EPA/States
have monitored spray programs conducted by USDA and the 001.
Efficacy Testing
As discussed on page 11, EPA has coordinated with FDA, USDA,
DOI, and the Bureau of Standards to have testing conducted on
ultrasonic devices, electromagnetic devices, and rodenticides.
-------
- JO -
C & T
£?A w o r K s with other "ederal Agencies o" tne:- - e -j u e s t i i
the development and implementation of C i 7 procrans. Cjrre.itly
DOD, USDA, and DOI's Bureau of-Land Management •-, a •/ e a o p r o •/ e d C 3 ~
programs.
Food C:.-?t3^1 nation
USDA an-d FDA monitor pesticide residues in food. Botn
agencies forward reports on food contamination by pesticides
to EPA for followup investigation, if appropriate.
Referrals and Information Exchange
EPA coordinates with USDA, FDA, DOI, FTC, CPSC, and the
U.S. Postal Service on several specific types of products/devices
that are of mutual interest.
Program tva1uation
A system for evaluating the effectiveness of the FIFRA com-
pliance/enforcement program must define specific areas for evaluatio,
measures of program success and mechanisms for performing the
evaluation. The Agency can best measure its success in achiev
compliance *nen it has developed 1) an aaequate aata oase for
identifying members of the regulated community and 2) predict:
models designed to select those -nenbers most 1i
-------
Compliance by ttve Regulated Co-nreu rv ty
The extant of conp" i an ca for tie "egulatec ::•"":-"!:•/ -iay oe
measured to a limited degree by tie fallowing factors:
o Number of applicators trained and certified.
o Proportionate number of estaolisnments known to oe in compliance.
o Proportionate nunoer of applicators known to oe in compliance.
o Proportionate number of laboratories known to oe in compliance.
o Trends in major types of violations.
evaluation Mechanisms
Th-e major mechanisms to txe u.sed in program evaluation are
the f ol1owi ng:
o FATES. The FIFRA and TSCA Enforcement System contains data on
inspections and sampling, case development, grants and contract
inspections. This data will be analyzed to determine whetner
program commitments were met. The FATES system should be modified
to include State data and to generate descriptive information
which could be used to better target inspection areas based* on an
analysis of major types of violations and violation trends., How-
ever such a modification cannot be implemented without additional
resources. In FY86, CMS plans to request funding to incorporate
State data into FATES.
o *4 id -year and enrf of year State program reviews. As discussed
on page 31, these reviews/evaluations are based on a uniform
evaluation protocol wnic." contains iot.i quantitative anc.
qualitative evaluation factors.
o Regional Reviews. A team of Headquarters and Regional personnel
visits each Region avary two years to conduct a thorough program
review. The review concentrates on Regional program organization;
performance of outputs; adherence to national guidance in th«
performance of inspections and development of cases; and the
need for improved/expanded Headquarters support of Regional
activities in specific areas.
Approximately four weeks after the on-site review, Head-
quarters submits a written report to the Region covering all
program elements that were part of the review. The report notes
bot-h posltlv-e and negative aspects of the Region's pesticides
compliance/enforcement program and includes recommendations for
changes to be Implemented by the Region and Headquarters. The
Director of the Compliance Monitoring Staff conducts a follow-up
visit with the Regional Administrator to go over any issues raised
by the review which require further discussion.
o Periodic review of overall program based on review of FATES data
and State and Regional reviews. In order to effectively evaluate
the program, 1t 1s necessary to review the program in its entirety
-------
- 33 -
Program Modification
EPA uses aata from FATES, State Program 3av:-»w3, 3 e ;•'ona :
reviews and the overall program review, to mod:*;' t">e ZOTC1'2 ice '
enforcement program as necesary and to give input to OP° cofcerr'ic
regulatory cnang«s necessary to facilitate comoliance monitoring,
enforcement, or compliance.
F u t U r e 3 u i 3.a n c a
The following is a list of guidance documents currently under
development or consideration.*
o -FY85 Cooperative Agre-ement Guidance. This document will modify
C 4 T al1ocations, specific instructions on transferring enforce-
ment priorities to the CAT programs, evaluation of the CAT
program plans and training materials, and improved productivity
factors for negotiating grant outputs.
o FIFRA Compliance Program Policy Compendium further defines the
requirements of FIFRA regulations. Currently there are twenty
such policies in the compendium and three under review by the
Regions, the States (through SFIREG), and the progra'm office.
o FIFRA Inspection Manual provides information on conducting insoec-
t i o n s , col 1 acti ngsamp"es, thain-of-custody procedures, p~ep.|jfcpg
suoport documents, and other information necessary to conduc^^
FIFRA inspections.. This document snould be revised if resources
are avai Table.
o C!~RA Enforce Trent Response Policy. Several additions tT tne
originalpenalty policy have been developed over the years to
reflect amendments to the law. These will all be combined into
one comprehensive document.
a FTFRA Compliance Strategies. The FIFRA Compliance Strategies are
developed for all rules promulgated under FIFRA. A compliance
strategy identifies the (a) requirements of the regulation, (b)
the type of actions which are appropriate for the violation, (c)
the inspection scheme (from which the regulated community is
targetted), and (d) allocation of responsibilities between Head-
quarters and the Regions.
o Quality Assurance Plan Development Guidance When manuals are
updated, and as resources are available, CMS will coordinate
with the Office of Research and Development's Quality Assurance
Management Staff and tne N€IC in developing a mod«l Quality
Assurance Plan- for use by the States 1n developing individual
Quality Assurance Plans. States receiving Federal funds for
compliance monitoring must submit Quality Assurance Plans to EPA
annually.
A comprehensive list of existing compliance/enforcement guidance
docyments 1s Included 1n tne Appendix trf tne FIFRA Cowpliasca/
Enforcement Guidance.
-------
- 39 -
APPENDIX
-------
FLOW
NEUTRAL
IFOR CAUSE]
NO
ACTION
J.
•
-{COMPLIANCE]
( 30 days to deteynl ne coinpl Jance/nuncompl lance)
~~
(60 days to prepare action)
| ADMINISTRATIVE ACTIONS")
| JUDICIAL..ACTIONS)
.
[1C
EOF
t™
NdTlC
HARN
t
E OF
INfl_
ADVERTISING (TERMINATION
. LETTER 1 lESTAIL, REQ.J
"1 T
ACTION IAKEN
ON APPLICATOR
CERTIFICATE
I
IRITAILS]
STOP SALE
USE OK
REMOVAL
ORDER
1
CIVIL ADM.
PENALTIES
[mill/If 11 SFlZURFl
1
1 k .'
/
J
--«•".»— M
CRIMINAL
I PROCEED ING
REMEDIAL
ACT
OH
CAGE Hi! r
(IMPlAjflj
ftKS. ATTORNEY |
UEPT. OF
JUST 1C F
ArflOtjJ
(DEFAULT)
NO
ACTION
DEFAULT
ORDER
[ALJ
CrilllSENlT]
1,1/11 ni Nil
— _-,_.__^_l
HEARING]
-4 , ,
u.s. i)isT7~cou»Tf—>|NOT GUILTY)
INITIAL
DECISION
FINAL
ORDER
(NOT!
I CUIlTYf
I
[ UPHELDk—
APPEAL TO
ADMINISTRATOR
| UPHELD
Jf—Tu.s.
SUPREME
COURT
iUII-
•^REINSPEci^—
^Determinations of complIance/noncanplIancei are dependent upon receipt of all documentation and cmnpletlon of all
Sample Analyses. Action preparation Is dependent upon ((.'solution of any new policy issues iirt;si:iih>
-------
t'
5 nTsi
Ml [
ENFOHCFMI w AI noir, TTTsui TING FROM GRANT INSPECTIONS
I till ACCOfU'llSIIMENTS
HKilDII National
ENFORCEMENT
ACCOMPLI SIUC NTS
i
)_._.. __„_. j
.
Inspections
i
Civil Actions
Criminal Actions
Administrative
Hear Inns
LIconso/Cort 1 1 Icata
Suspension '
License/Certificate
Revocation
License/Cert II lea to
Conditioning or
Modification
Ntimbor oi Cases
Issued Warnings
Ston-^Sale, Seizure,
Quarantine or Embaryo
Cases Forwariled to
EPA for Action
Other Enforcement
Actions ,
«BBaasaaMaa*aaacssaaua=a
Total Numbor of
Actionable Inspections
Percent of inspections
Result Inn In Action
Petcont of total
Actions (8712)
Nufnbqr of Casos
Assessed Finos
AGrtlCU
Use
2,923
19
2
16
1
M
8
366
24
II
\
0
lascaaai
451
19.4
5.2
laoscaqi
12
TURAL
Misuse
3,675
70
47
76
33
126
17
366
17
22
43
i a an aatMt
017
22.2
9.4
laKMSBdC
59
imNAGRICIiUmAI
IJ,o
4,631
7
20
21
II
10
24
694
62
4
25
870
IB. 9
10. 1
;aao;assa
9
Ml SUM)
IA00/
IMi
II
(>'.
li
(t
'1
412
21
2'»
til
(I'K,
4(>.U
«J.7
E a S- a 3 :.;;::.
„...'/?
ixr ur,r
INSP
M)4
20
0
0
0
()
0
16
3
3
0
4?
10.9
0.5
M
PRODUCE
ISIAIl
2j6'J3
30
5
25
0
3
2
402
77
119
""" H7
750
20.3
O.l)
- '30
MARKET-
PLACE
12,522
142
1
57
3
0
3
620
1032
163
970
2991
23.9
34.4
,J
IM-
PORTS
523
6
0
2
0
0
0
1
0
0
10
19
3.6
0.2
. =: casrss a
»l
CEHTIFIEIl
API 'LICK
RECORDS
IIJ75
159
90
67
502
/
70<
7
2
1561
13.9
17.9
»
RES1K4CIID
IISI PI SI
DIAIIRS
9,1111
44
0
14
2
1
0
219
50
0
9
VI /
>.'•
'1.0
22
101 AI
50,104
665
242
343
565
106
i
57
3002
J30I
354
1197
07 1 2
| 7. 4
100
424
-------
ENFORCEMENT ACTIONS
FV02
lAfllE «•
lit MIL 11 H<; HIOM GRANT INSPECTIONS
ACCOMl'l |SIIIII NFS
HA i KIIIAI
ENFORCEMENT
ACCOMPLISHMENTS
Inspection*
Civil Actions
Criminal Actions
Administrative
w tarings
reuse/Certificate
*>j sponsion
License/Certificate
Evocation
License/Certificate
"ontht lout tig or
lidhtcatton
iniliof of Cases
Issuud Marftlngs
Stop-Sale, Seizure,
l^iarantlne or Embargo
r.ases Forwarded to
[PA for Action
Jllicr Enforcement
Vet Ions
total Number of
let 1 enable Inspections
'erctht of Inspections
^suiting In Action
Vrcinl of Total
V lions (J764)
liimhi-r of^fees
Visessed M»
AGRICULTURAL
Use '
4,841
22
2
20
1
n
123
in
9
51
tammmmxti
254
5.2
3.3
10
Misbse
2,401
26
15
59
29
5
13
471
12
10
17
657
27.4
0.5
25
TiffllATlRl
Use
4,962
20
41
43
7
in
3
666
30
10
173
laasaaai
1,027
20.7
13,2
-uaxmst
5
CUTURAL
Misuse
1,792
27
152
175
21
35
3
406
54
5
5?
IKCHr BBC i
t
930
51.9
12.0
maaaa sz:
105
rxFiisi
IHSI'
313
1
311
31
9.-J
n.4
fitohiicr
1 SI All
2,339
2
1
14
237
116
69
14
4/3
20.2
6.1
n
HABIT
PLACE
15,932
10
5
57
1
505
1 ,024
04
940
2,706
17.0
^4.11
6
TMT-
POIUS
174
3
1
4
: - a a a 3 s :
0
4.6
O.I
0
CERTIFIED
APPLICR
HECORDS
14,700
7
5
27
140
'I
2
742
5
2
102
1,011
7.1
13.4
ItTSlRllUI)
USE I'EST
DEALEKS
11,779
5
11
11
210
119
.;;
491
4.2
6.3
II
* ,
76
1
i
17
124
1
3
:~.~£:=L.a«
Iff.
l
1.9
;j u u » to ft. «-
0
TOTRT
59,317
120
221
406
216
60
30
3,469
1,531
224
1,479
i v a u « x: s
7,764
13.1
1(10
*.i»irn*.
I'JO
« I
-------
FEDERAL PESTICIDE COMPLIANCE INSPECTIONS
Producer Establishment
I nspect i ons
Use Investigations
Marketplace Inspections
Import Inspections
Dealer Inspections
Laboratory Audits/
Inspecti ons
TOTALS
CV79
443
482
1115
332
359
17
2803
rv3C -'a- r,£2 rv=3 -
•
234 257 235 151
559 435 414 124
320 291 233 210
494 241 306 301
955 945 719 0
8 413 25
2621 2254 2021 821
2nc Quarter r'icZ Tczais
-------
TOE3AL PESTICIDE ENFORCEMENT ACTIONS
Civil Co^oTaints
Initiated
Criminal ^5~2rrals
Initiates
Stop Sale, Use, Removal
Orders
Notices of Warning
Inport Detantions
TOTALS
r v 7 3
.
252
2
479 2J
507
91
1332
r v 3 o - v .3 '
i 75 151
a 0
113 105
831 429
70 71
1194 755
• ^ 2.1
2 '
50 42
855 1270
53 11
1137 1545
I/ Second Quarter FY83 Totals
T/ An additional 24,000 Stop Sale Orders were issued to firms t£
held susoended 2,4,5-T and Silvex products.
-------
o*C
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 30460
JAN 151985
OFFICE OF
PESTICIDES AND TOXIC SUBSTANCES
MEMORANDUM
SUBJECT: Final GLP Compliance Strategy
FROM: A. E. Conroy II, Director
Office of Compliance Monitoring£fEN-342 )
TO: Addressees
Attached for your information is the final compliance
strategy for the Good Laboratory Practice (GLP) regulations (also .
attached) published on November 29, 1983 (48 FR_ 53922). The
rules became effective on December 29, 1983 for the Toxic
Substances Control Act (TSCA) and on May 2, 1984 for the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Office
of Compliance Monitoring (OCM) is now evaluating comments on the
TSCA GLP enforcement response policy (ERP) and the final ERP is
expected to be completed during the second quarter of FY 85.
We appreciate the time and effort spent by the various program
offices and regions in reviewing this document. OCM received
several editorial comments regarding the compliance strategy
which has helped to clarify portions of the final policy. While
all the comments received were reviewed, all comments were not
incorporated into the final policy. Responses to the most
significant comments are provided below.
Comment 1- For large commercial laboratories and/or complex
studies, two days notice prior to inspection is unrealistic.
Recommend two weeks. Without adequate notice... personnel and
key data... (may not be) readily availaole.
Response- The GLP regulations have provided adequate notice to
all persons, 1n the section for storage and retrieval of records
and data, that there shall be archives for orderly storage and
expedient retrieval of all raw data and documentation. Persons
will be in violation of the GLP regulations when not complying
with this provision. Two days has generally been accepted as
adequate notification by the other commentors and OCM staff.
-------
-2-
Comment 2- OTS has noted that "some data submitted with PMNs
have stated that studies were done according to GLPs (usually
OECD GLPs). However, protocols are often missing, test
substances are inadequately defined, and there are other
deviations from any known GLPs. OTS recommends that claims that
data were in accordance with GLPs not be allowed unless the data
reports are sufficiently detailed to support the claim. As a GLP
compliance issue, this recommendation should be considered by
OCM."
Response- OCM does not have the authority to restrict persons
from making claims such as described above. OTS could remedy
this by amending the PMN rule requiring submitters to 1) provide
statements with PMNs indicating whether the submitted studies
adhere to the GLPs and 2) support such claims with sufficiently
detailed reports. When OTS has concerns with specific data and
compliance with the GLPs, OTS should provide OCM a list of
studies supporting PMNs and the names of the labs. OCM can then
schedule inspections/audits at the laboratory.
Comment 3- OPP recommends that the "quality assurance unit
establish written procedures which it would follow in conducting
inspections." OPP justifies this request by stating that section
160.35(d) of the FIFRA GLP regulations does not clearly identify
who is responsible for writing the procedures.
Response- OCM agrees that such language is needed. However,
OCM does not have the authority to require this in the GLP
strategy unless it first appears in the GLP regulation. OCM
suggests that OPP propose an amendment to the regulation
regarding this subject.
Comment 4- OPP recommends that the GLP strategy indicate that
management communicate deviations from the regulations "in
writing" to EPA because the GLP regulations do not specify the
means of communication.
Response- Same response as for comment 3.
If you have any questions concerning this memorandum, please
call Richard Green of my staff at (202) 382-7845.
Attachments
Addressees
Marcia Willia-ns Air and Waste Management Division Directors
Don Clay Environmental Services Division Directors
Steven Schatzow Regional Toxics and Pesticides Branch Chiefs
Terrell Hunt Office of Regional Counsel
Ruth Bel 1
Jim McCormick
-------
Strategy for the Enforcement of the Good Laboratory Practice
Regulations Under TSCA and FIFRA
0vervi ew
On November 29, 1983, the Environmental Protection Agency
(EPA) published final rules establishing Good Laboratory Prac-
tice (GLP) standards for the conduct of laboratory studies that
are used to obtain data for hazard evaluations under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Federal
Food, Drug, and Cosmetic Act (FFDCA) , and the Toxic Substances
Control Act (TSCA). The GLP regulations became effective on
December 29, 1983 for TSCA and on May 2, 1984 for FIFRA. They
were the result of investigations by the Food and Drug Adminis-
tration (FDA) and EPA which showed that some studies submitted
in support of the safety of regulated products and pesticides
had not been conducted in accordance with acceptable practice,
and that, accordingly, the quality and integrity of such studies
were not always adequate. In conjunction with EPA's new data
audit efforts, the regulations are intended to ensure the high
quality of laboratory test data required to evaluate the health
and environmental effects of regulated chemical substances and
pesti cides.
The Assistant Administrator for Pesticides and Toxic Sub-
stances has established a Laboratory Data Integrity Program
(LDIP) within the Office of Compliance Monitoring (OCM) which
combines the GLP inspection program with EPA's data audit program
OCM, the Office of Pesticide Programs (OPP), and the Office of
Toxic Substances (OTS) are charged with cooperating in the
development and conduct of an effective laboratory inspection
and data audit program.
Requirements of the Rule
Appli cabi1ity
The GLP regulations apply to any study conducted, initiated,
or supported on or after the effective dates of the rules that
relate to health effects, *»nvi ronmental effects, and chemical
fate testing under TSCA arid studies (as defined by section
160.3(m) of the FIFRA GLPs) that support or are intended to
support applications for research or marketing permits for
pesticide products regulated by EPA. By their terms the rules
apply to studies related to TSCA Section 4 Test Rules, under
FIFRA to Section 3 'applications for registration), Section 5
(experimental use permits), Section 18 (emergency exemptions),
and Section 24(c) (registrations for special local needs), and
under FFDCA to Section 408 (tolerances for pesticide residues on
raw agricultural commodities) and Section 409 (food additive
regulations) .
-------
-2-
In addition, under TSCA the Agency will require sponsors to
utilize the GLP standards When conducting testing under negotiated
testing agreements. Agency policy also requires that all data
developed as a result of regulations or orders under Section 5
of TSCA must be in accordance with GLP standards. Any failure
to adhere to GLP standards in generating data under negotiated
testing agreements or under Section 5 of TSCA may result in the
Agency's electing to consider such data insufficient to evaluate
the health effects, environmental effects, and fate of the chemical
Specific Requirements of the GLP Regulations
The requirements of the GLP regulations are contained in
40 CFR Part 160 (48 F_R 53946, November 29, 1983) and 40 CFR
Part 792 (48 F_R 53922, November 29, 1983). Generally, the rules
contain provi sTo nsrelatingto:
(1) General Provisions;
(2) Organization and Personnel;
(3) Facilities;
(4) Equipment;
(5) Testing Facilities Operation;
(6) Test and Control Substances;
(7) Study Protocols; and
(8) Records and Reports.
(1) General Provisions (Subpart A).
Subpart A contains a number of key provisions that are
designed to promote an awareness of GLP requirements on the
part of all persons involved in the testing process. First, the
rules require that a sponsor must notify of the GLP regulations'
applicability any laboratory that performs all or part of a
study that is subject to the regulations.
Second, any person who submits data from a study in connec-
tion with a TSCA Section 4 test rule or an application for a
research or marketing permit must include in the submission a
statement signed by the applicant, the sponsor, and the study
director, of one of the following types:
(a) A statement that the study was conducted in accordance
with the GLP regulations;
(b) A statement describing in detail all differences between
the practices itsed n the study and those required by the GLP
regulations; or
(c) A statement that the person was not a sponsor of the
study, did not conduct the study, and does not know whether
the study was conducted in accordance with the GLP regulations.
-------
-3-
Finally, Subpart A details the sanctions available to the
Agency that are in addition to the imposition of civil and crimi-
nal penalties. For example, EPA may choose not to consider
reliable for purposes of showing that a chemical does not present
a risk of injury to health or the environment any study which •
was not conducted in accordance with GLP requirements. Any
determination that a study will not be considered reliable will
not relieve the sponsor of a required test of the obligation
under any applicable statute or regulation to submit the results
of the study to EPA. EPA may also require the sponsor of data
submitted under a TSCA Section 4 test rule to develop data in
accordance with GLP requirements where he or she failed to do so
inaprevioussubmission.
(2) Organization and Personnel (Subpart B).
(a) Personnel (Sections 160.29 and 792.29).
While specific qualifications are not required of laboratory
personnel, the rules generally require facilities to document
that each individual engaged in the conduct of a study has educa-
tion, training, and experience to enable that individual to
perform his or her assigned 'functions .
Personnel are also required to take necessary personal
sanitation and health precautions to avoid contamination of test
and control substances and test systems.
(b) Testing Facility Management (Sections 160.31 and
792.31).
For each study, testing facility management is required to
designate as study director a scientist or other professional of
appropriate education, training, and experience. The study
director has overall responsibility for the technical conduct of
the study, as well as for the interpretation, analysis, documen-
tation, and reporting of results, and represents the single
point of study control.
Testing facility management is required to establish a
quality assurance unit responsible for monitoring each study to
ensure that the facilities, equipment, personnel, methods,
practices, records, and controls are in conformance with the
GLP regulations. For any given study the quality assurance unit
must be entirely separate from and independent of the personnel
engaged in the direction and conduct of that study.
Management is also required to ensure that test and control
substances have been properly tested for identity, strength,
-------
-4-
facilities, equipment, materials and methodologies are available'
as scheduled. Finally, management must ensure that any deviations
from the regulations reported by the quality assurance unit are
communicated, preferably in writing, to the study director and
that corrective actions are taken and documented.
(3) Facilities (Subpart C).
Each testing facility is required to be of suitable size,
construction, and location for the proper conduct of studies.
It must be designed so that activities are sufficiently separ-
ate to prevent any adverse impacts on the study. More detailed
requirements ensure proper facilities for:
(a) Animal care and supplies;
(b) Handling test and control substances;
(c) Laboratory operation;
(d) Specimen and data storage; and
(e) Administration and personnel.
(4) Equipment (Subpart D).
Any automatic, mechanical, or electronic equipment used
in the generation, measurement, or assessment of data, and
equipment used for facility environmental control is required
to be of appropriate design and adequate capacity to function
according to the protocol and must be operated, inspected,
cleaned, and maintained in a suitable location. Equipment
used for the generation, measurement, or assessment of data
must be adequately tested, calibrated, and standardized.
(5) Testing Facilities Operation (Subpart E).
A testing facility is required to have standard operating
procedures (SOPs) in writing that set forth study methods
adequate to ensure the quality and integrity of the data generated
in the course of a study. Any deviations must be authorized and
documented. SOPs are required for most facets of a study.
(6) Test and Control Substances (Subpart F).
The identity, strength, purity, and composition, and any
other characteristics which will appropriately define the test
or control substance, must be determined for each batch and be
documented before the study is initiated. The sponsor or testing
facility must document all methods of synthesis, fabrication,
derivation of the test and control substances and must
-------
-5-
that they are stable, properly labeled, stored, and handled in
such a way as to prevent contamination, deterioration, or damage.
The receipt and distribution of each batch must be documented
and reserve samples retained.
For each test or control substance that is mixed with a
carrier, tests must be conducted to determine the mixture's
uniformity, concentration, and stability. The expiration date
of any components of the mixture must be shown clearly on the
contai ner.
(7) Study Protocol (Subpart G).
Each study is required to be conducted in accordance with
an approved protocol that clearly indicates the objectives and
all methods for the conduct of the study. Any changes in an
approved protocol must be explained, documented, signed and
dated by the study director, and maintained with the protocol.
(8) Records and Reports (Subpart J).
A final report must be prepared for each study, signed
and dated by the study director, and maintained by the sponsor
and the testing facility. In addition, all raw data, documen-
tation, records, protocols, specimens, and final reports generated
as a result of a study must be retained and archived for orderly
storage and expedient retrieval. This includes correspondence
and other documents relating to the conduct, interpretation, and
evaluation of data.
(9) Environmental Testing (Subpart L - TSCA only).
The TSCA 6LP regulations contain special provisions that
adapt the regulations to environmental studies. The FIFRA GLP
regulations contain no corresponding subpart.
Regulated Community
The regulated community consists of those who sponsor and
submit tests that are subject to the GLP regulations and the
laboratories that conduct such tests (see Appli cabi1ity, above)
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E nforcement
Objecti ve
The objective of this strategy is to maximize compliance
with the GLP regulations in order to promote the high quality of
laboratory test data necessary to evaluate the health and environ-
mental effects of regulated chemical substances under TSCA and
pesticides under FIFRA.
Vi olati ons
Generally, the failure to comply with any requirement of the
GLP regulations is a violation of those regulations (see Speci fi c
Requirements of the GLP Regulations, above). However, violations
are actionable in a different manner under FIFRA than under
TSCA, since, unlike TSCA, FIFRA does not provide that it is
unlawful to violate a regulation promulgated under its authority.
Accordingly, a violation of the GLP regulations is not necessarily
a violation of FIFRA. Exceptions are where falsification is
committed knowingly within the meaning of Section 12(a)(2)(m) of
FIFRA, and where records are not maintained as required by FIFRA
The FIFRA GLP regulations provide further that EPA may refuse
to consider reliable for purposes of supporting an application
for a research or marketing permit any data from a study which
was not conducted in accordance with the GLP regulations.
In addition, the submission of a false statement under the
certification provisions of the GLP regulations may form the
basis for cancellation, suspension, or modification of a research
or marketing permit, or denial or disapproval of an application
for such a permit under Sections 3, 5, 6, 13, or 24 of FIFRA or
Sections 408 or 409 of FFDCA, for criminal prosecution under
18 U.S.C. 2 or 1001 or Section 14 of FIFRA, or for imposition of
civil penalties under Section 14 of FIFRA.
Similar sanctions are contained in the TSCA GLP regulations,
except that the failure to comply with the TSCA GLP regulations
is a violation of Section 15 of TSCA. Violations are therefore
subject to the sanctions contained in that section.
Inspection Scheme
EPA, with t'»e assistance of the Food and Drug Administration
(FDA) and the National Toxicology Program (NTP), will use a
Neutral Administrative Inspection Scheme (NAIS) for laboratories
that have conducted or are conducting health effects studies
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that are subject to the GLP regulations. The responsibilities
of FDA and NTP are set forth in two interagency agreements.
Laboratories conducting environmental effects studies will be
addressed similarly, but only EPA will be involved in these
since FDA and NTP do not review studies of this type.
The GLP regulations require testing facilities to permit
EPA inspections at reasonable times and in a reasonable manner.
EPA believes that the possibility of unannounced inspections
motivates compliance and efficiently uses resources. Generally,
however, EPA will notify laboratories up to two days before
an inspection in order to ensure the availability of appropriate
personnel and records. Once EPA notifies a laboratory, it will
not change the date of the inspection unless the laboratory
demonstrates unusual circumstances and good cause. EPA will
coordinate with FDA and NTP to avoid multiple inspections at
the same faci1i ty.
The NAIS will consist of two major categories of inspections:
GLP inspections and data audits. Inspections within both of
these categories normally will be conducted on the basis of
objective criteria or random selection. However, inspections
may be targeted for cause at certain facilities where: 1) major
problems were discovered during a previous inspection that might
affect the validity of unaudited studies; 2) EPA receives tips
(i.e., phone calls and letters from various sources, and
information provided by OPP or OTS based on their ongoing reviews
which OCM will review for validity and significance to determine
the level of priority for enforcement action), complaints, or
other information indicating that a particular laboratory is in
violation of the GLP regulations; or 3) a particular study is
assigned a high priority because it is expected to form the
basis for major regulatory action.
GLP inspections are laboratory-oriented and will focus on
a facility's compliance with the GLP regulations. They will
usually include partial audits of at least two ongoing studies.
GLP inspections will be scheduled by OCM and carried out by
Regional inspectors and FDA. NTP, at OCM's request, will provide
assistance when OCM personnel lack specific expertise.
A data audit is stu-jy-ori ented and is the process by which
EPA verifies that the data from a completed laboratory study are
consistent with the final report that was submitted to the Agency.
This is accomplished by examining raw data and other records
generated during the study and comparing them with results provided
in the study report. Data audits will be scheduled and carried
out by OCM, with necessary assistance provided by FDA, NTP,
Program Offices, and the Regions.
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Ideally, EPA should inspect regularly every laboratory that
conducts EPA-related studies and should audit every study that
has been (or will be) submitted to EPA in support of the safety
of regulated substances. However, in the event that EPA's re-
sources do not permit such complete coverage of the regulated
community, EPA will apply the following criteria to the conduct
of inspections:
GLP Inspections/Partial Study Audits: EPA will assign
priority to the estimated 90-100 laboratories that conduct
90 percent of EPA-related testing. EPA plans to conduct
inspections on a periodic basis at every laboratory
conducting testing under TSCA and FIFRA. Priority will be
assigned to testing laboratories with greatest number of
studies performed under TSCA and FIFRA and those who
initiate testing under TSCA or FIFRA for the first time.
The frequency of these inspections will depend upon
available resources and will be geared towards visiting labs
to inspect the full gamut of studies (acute, subchronic and
chronic), if possible.
Data Audits: EPA will assign priority to studies based
upon the known need of the specific program to form the
basis for major regulatory action. EPA will also assign
priority to studies known to be or suspected of being in
violation of FIFRA or TSCA. High priority studies often
will be the subject of both a GLP inspection/partial study
audit while they are ongoing and an audit after completion.
Studies that were not required to be conducted in accordance
with the GLP regulations normally will be targeted for
audit by the Program Offices.
Within both of these categories, EPA will assign the highest
priority to responding to tips, complaints, and other information
indicating that violations of the GLP regulations exist.
Violation Detection Priorities
The requirements of the GLP regulations may be separated
into two categories: (1) those directly related to the actual
conduct of a study; and (2) laboratory housekeeping requirements.
EPA will assign a higher priority to violations in the former
category. However, some overlap between these categories may
be expected. Wnere this occurs, the guiding consideration becomes
the degree to which a given violation may compromise the validity
of a study. For example, a violation of the recordkeeping require-
ments would ostensibly fall within the housekeeping category.
Nevertheless, the lack of records may prevent EPA from determining
that a study's results are valid and would therefore be given a
higher priority.
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Adnrinlstrative Considerations
The attached Memorandum of Agreement (MOA) between OCM,
OTS, and OPP will govern the administration of LDIP. Generally,
the MOA establishes the LDIP Panel which will be chaired by OCM
and will include members from OPP and OTS. The Panel will serve
as a clearinghouse for the flow of information among participating
Offices and will periodically review LDIP policies, procedures,
and operations and recommend program changes to the Director,
OCM, who has full responsibility for implementing the program.
The Panel will serve as a steering committee to ensure that
Agency commitments and objectives are fully implemented and met.
OCM will have the lead in directing the program by (1)
coordinating all laboratory inspections and data audits with
OPP, OTS, and the Regions, and by (2) acting as a liaison with
other agencies, such as FDA and NTP, which cooperate with EPA in
conducting laboratory inspections and data audits. OCM will be
the Agency contact for scheduling FDA and EPA laboratory inspec-
tions and study audits, as well as for receiving and disseminating
audit and inspection reports to both OPP and OTS. OCM will
monitor the status of each inspection andaudit.
The Regional Offices will provide support for inspection
and enforcement activities as needed. Regional responsibilities
will include the conduct of and case development for most GLP
inspections.
OTS and OPP will provide the scientific and regulatory
review of laboratory GLP inspection reports and data audit
reports within their respective program areas. Program Office
scientists will recommend studies for audit and will participate
in inspections and study audits at laboratories, consistent
with resource allocations. They will also serve as expert
witnesses in support of Agency litigation efforts.
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INTERAGENCY AGREEMENT
BETWEEN
THE U.S. ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDES AND TOXIC SUBSTANCES
. ' AND
THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL TOXICOLOGY PROGRAM
1. PURPOSE
This agreement provides for cooperation between the National
Toxicology Program (NTP) and the Environmental Protection Agency
(EPA) in the areas of inspector training, inspection operations,
data audits and information exchange. This cooperation will
enhance the EPA's mandated activities designed to determine
whether laboratory testing was performed properly and in compliance
with Good Laboratory Practice (GLP) regulations and whether the
test report can be fully validated through audits of the raw data
generated during the testing phase.
The primary purpose of this cooperation is to utlize NTP's
experience in conducting and reporting laboratory GLP inspections
and data audits to enhance the training and capabilities of EPA
personnel in these activities.
2. SCOPE OF WORK
The Environmental Protection Agency (EPA) is responsible
for setting tolerances for pesticide residues in or on raw
agricultural commodities and processed food under the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 346 and 348) and for
registering pesticides under the Federal Insecticide, Fungicide,
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and Rodenficide Act (FIFRA)(7 U.S.C. 136 et sec). In addition, '
EPA has- the mandated task under the Toxic Substances Control Act
(TSCA) (15 U.S.C. 2601) to assure that no chemical wi11 present
an unreasonable risk of injury to health or the environment.
EPA regulatory decisions on such matters are based in part on the
results of toxicological testing performed by or for registration
applicants, tolerance petitioners, and chemical manufacturers
or processors.
This agreement, which provides for cooperation in the
training of EPA laboratory inspectors and auditors, in providing
specific scientific expertise as required for laboratory inspec-
tions and data audit as well as in the sharing of information on
laboratory GLP compliance monitoring will enable EPA to
determine (1) whether the testing was performed in accordance
with specified methodology, (2) whether any reported deviations
may have affected the reliability of the test results, (3) whether
the test results as reported can be fully supported by the raw
data generated during the study and (4) whether the testing was
carried out in compliance with EPA's GLP regulations. The
authority for FIFRA GLP regulations is 4U CFR Part 160 and for
TSCA is 40 CFR 792. For studies conducted prior to this, "GLP
regulations" refers to the Food and Drug Administration's GLP
Regulations (43 FR 59986).
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Laboratories inspected may be facilities in which both EPA
and NTP have common interests or they may be.faci1ities carrying
out studies applicable only to the EPA but that the EPA finds it
cannot inspect due the to the lack of specific expertise.
While EPA may have an interest in an NTP-sponsored study,
EPA will not audit an NTP-sponsored study without the express
approval of NTP management. Studies to be audited may be either
in progress or completed.
3. EXCHANGE OF INFORMATION
Each agency will exchange information concerning active
inspections and audits of interest to the.other agency.
Each agency will inform the other of legal or administrative
action being considered or taken against any laboratory covered
under this agreement. This section is concerned with legal or
administrative penalties and not with such infractions or
deviations as can be corrected easily and judged to have had
little or no significant impact on the validity of the study.
4. NTP'S RESPONSIBILITIES
a. Study Audits - NTP will provide EPA's Compliance
Monitoring Staff (CMS) with a copy of the final NTP audit report
of chemicals of interest to EPA; such chemicals may have been
originally nominated or co-nominated by EPA for study or EPA may
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have developed an interest in the chemical during thetesting
phase. NTP will provide CMS on a quarterly basis with the
schedule of NTP audits of completed studies to be conducted in
the next quarter.
b. GLP Compliance Monitoring - NTP will supply CMS on a
quarterly basis with an advance schedule of site visits to be
conducted by NTP in the next quarter. At the request of CMS,
NTP will provide EPA with a copy of the report of a site visit
of interest to CMS. EPA will not institute any enforcement
action against an NTP-inspected laboratory based solely on
an NTP inspection report.
c. Training - NTP, within constraints of personnel and
schedules, will detail experienced NTP personnel who will act
as instructors in EPA-sponsored courses or workshops on GLP
compliance monitoring, data audits and related topics. Schedules
and topics will be worked out cooperatively to ensure adequate
time for course preparation and review. Such details of personnel
will be at no expense to NTP other than salary.
d. Expert Inspections - NTP, at the request of CMS, and
within the constraints of personnel and schedules, will detail
expert personnel to accompany a CMS inspector or EPA audit team
when EPA is unable to inspect a testing laboratory or complete a
data audit because of the lack of specific expertise. CMS will
provide the -equef.ted scheduling in advance to NTP along with
all non-confidential information on the laboratory and study(ies)
necessary to prepare for a compliance inspection.
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NTP personnel in this situation will be advisory to the CMS
inspector, who has the responsibility for conducting the
inspection or audit and preparing the report of the inspection
or audit. The NTP personnel's advisory report of findings will
be incorporated into the EPA inspector's report. Wherever
possible such inspections will be at no cost to NTP other than
s a 1 a ry .
e. Confi denti ality - Under various provisions of FIFRA
and TSCA, toxicology data submitted to EPA may be considered
trade secrets entitled to protection from unauthorized public
disclosure. Such information will not be furnished .to NTP
personnel in advance of a laboratory inspection or a study audit.
Any requests for further disclosure of such information received
by the NTP under the Freedom of Information Act will be referred
to the EPA for processing. NTP personnel will not prepare any
reports utilizing data which may be confidential.
5. EPA'S RESPONSIBILITIES
a. List of Laboratories for Coverage - EPA will provide NTP
with a quarterly listing of labortories to be visited. This
listing is to be provided to NTP at least 30 days in advance of
a given quarter and will include the name(s) of the faci1ity(ies )
to be inspected, the dates of the inspections and the EPA
scientific personnel who will participate in the inspection
or audit. This information will be classified as "For Official
Use Only" and shcjld not be disclosed except on a need-to-know
basis.
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EPA will identify for NTP those inspections where assistance
is requested from.NTP and provide NTP with a clear definition of
the assistance needed.
In advance of a laboratory inspection EPA will provide NTP
with a list of EPA studies in progress as well as test protocols,
EPA test guidelines as available and FDA test guidelines as
appropri ate.
b. Reporti ng Format - A mutually agreed format will be
used by NTP in reporting its advisory portions of EPA inspections
c. Studies to be Audited - EPA will provide NTP with copies
of the test protocol, guidelines and toxicology test reports
including any special instructions which might be appropriate to
the study to be audited. None of the material so provided will
be classified as Confidential Business Information.
d. Confidenti a!ity - EPA is required, under both FIFRA and
TSCA, to maintain confidentiality of certain test-related infor-
mation. EPA will not provide NTP any material classified as
FIFRA or TSCA "Confidential Business Information." EPA may
furnish NTP with material classified as "For Official Use Only"
which is not to be disclosed by recipient NTP personnel to others
except on a need-to-know basis.
e. NTP Requests - EPA will respond to all requests for
information received by NTP under the Freedom of Information Act
which relate to visits performed for EPA by NTP.
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f. Delegation of Authority - As necessary EPA will provide
to NTP personnel a letter containing appropriate delegation of
authority. This letter will then be furnished to the management
of the laboratory at the beginning of the visit.
g. Notification of Sponsor - Contracts may exist between
laboratory and sponsor prohibiting disclosure of raw data by the
laboratory without the permission of the sponsor. In order to
ensure that raw data are available to EPA and NTP personnel
conducting a data audit, EPA's Compliance Monitoring Staff will
notify the sponsor of the study of the intent to audit one or two
working days preceding the scheduled visit. CMS will exercise its
own discretion regarding advance notification to the laboratory
of the scheduled visit.
h. Evaluation of Reports - EPA will determine whether
discrepancies listed in the compliance inspection reports submitted
by NTP personnel or study audit reports impact on the validity of
studies. Any administrative or regulatory actions resulting from
these reports will be the responsibility of EPA.
i. Trai ni ng Schedules - CMS will consult with NTP on the
content and scheduling of training courses and workshops and will
jointly determine the faculty for such courses and workshops.
Both EPA and NTP staff will be invited to attend such courses and
workships as appropriate.
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6. DURATION OF AGREEMENT
This agreement will .become effective on the date of the last
signature and shall continue in effect until September 3U, 1984,
unless modified by mutual written consent of both parties or
terminated by either party upon a ninety (90) day advance written
notice to the other. This agreement may be reviewed by written
consent of both parties on a fiscal year basis.
7. PROJECT OFFICERS
For EPA: Dr. Dexter S. Goldman (EN 342)
Head, Laboratory Data Integrity Program
Compliance Monitoring Staff
Environmental Protection Agency
401 M Street, S. W.
Washington, DC 20460
For NTP: Dr. Bernard A. Schwetz
Chief, Systemic Toxicology Branch
National Toxicology Program
National Institute of Environmental Health Sciences
P.O. Box 12233
Research Triangle Park, NC 27709
8. FUNDING
No transfer of funrio is necessary under this agreement. Each
agency will fund its part of cooperative actions. EPA will fund
travel and travel associated expenses of NTP personnel requested
to participate in EPA activities described above.
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9. AUTHORITY
APPROVED AND ACCEPTED FOR
THE ENVIRONMENTAL PROTECTION
AGENCY
BY
77"
'hn A. Moore, DVM
TITLE: Assistant Administrator
for Pesticides and
Toxic Substances
APPROVED AND ACCEPTED FOK'
T.HE NATIONAL TOXICOLOGY
PROGRAM
BY:
David P. Rail, MD, Ph.D
TITLE: Director
DATE:
-o
DATE:
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MEMORANDUM OF AGREEMENT
BETWEEN
THE COMPLIANCE MONITORING STAFF
THE OFFICE OF TOXIC SUBSTANCES AND
THE OFFICE OF PESTICIDE PROGRAMS
IN THE OFFICE OF PESTICIDES AND TOXIC SUBSTANCES
FOR A MANAGEMENT FRAMEWORK
FOR THE CONDUCT OF
LABORATORY INSPECTIONS AND DATA AUDITS
1. PURPOSE AND PRINCIPLES
A Laboratory Data Integrity Program (LDIP) has been estab-
lished within the Compliance Monitoring Staff (CMS) of the Office
of Pesticides and Toxic Substances (OPTS). LDIP is specifically
charged with developing and conducting laboratory inspection
and data audit programs to assure the reliability and validity
of data reported to EPA under both the Federal Insecticide,
Fungicide and Rodenticide Act (FIFRA) and the Toxic Substances
Control Act (TSCA) Sections 4 and 5. This Agreement establishes
the matrix management framework under which CMS, the Office of
Pesticide Programs (OPP) and the Office of Toxic Substances
(OTS) will work cooperati•-sly to assure an effective laboratory
inspect ion and data audit program.
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2. PROGRAM ABSTRACT
CMS will establish and chair the .Laboratory Data Integrity
Program Panel (the Panel) which will also include members from
OPP and OTS. The Panel will serve as the conduit for the flow
of information between participating Offices and will periodically
review LOIP policies, procedures, and operations and advise the
Director, CMS, who has full responsibility for implementing the
program, of recommended program improvement and changes. The Panel
will serve as a steering committee to ensure that Agency commit-
ments and objectives of the LDIP are fully implemented and
met.
The CMS will have the lead in directing the program by (1)
coordinating all FIFRA- and TSCA-related laboratory inspections
and study audit activities with OPP and OTS as well as by (2)
liaison with other agencies, such as the Food and Drug Administra-
tion (FDA) and the National Toxicology Program (NTP), which
cooperate with the EPA in laboratory inspections and data auditing.
LDIP will be the Agency contact for scheduling FDA and EPA labora-
tory inspections and study audit activities, as well as for receiv-
ing and disseminating audit and inspection reports to both OPP and
OTS. LDIP will monitor the status of each inspection and audit.
It is the goal of LDIP to (1) ensure full compliance with
FIFRA and TSCA Good Laboratory Practice (GLP) regulations, as
applicable, a: all testing facilities performing studies to be
presented to the EPA to meet requirements of both FIFRA and
TSCA and (2) to audit fully all data supporting the results of
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these studies. Both the CMS and the OPTS Program Offices are
responsible for recommending studies for audit and laboratories
for i nspecti on.
The OPTS Program Offices will provide the scientific review
of laboratory GLP inspection reports and data audit reports of
studies within their respective program areas to LDIP. Program
Office scientists will participate in inspections and study
audits at laboratories, as appropriate and as resources permit.
A detailed description of the responsibilities of CMS, LDIP,
OPP, OTS and the Panel is given in Section 3 of this document.
A detailed definition of terms used in this document is given
in Section 5 of this document.
3. DIVISION OF RESPONSIBILITIES
a. Compliance Monitoring Staff
(1) Appoints the Chairperson of the Panel.
(2) Establishes inspection procedures and specific audit
procedures, with necessary technical input and review from OPP
and OTS.
(3) Establishes neutral administrative inspection schemes
for routine selection of laboratories for inspection and, based
on recommendations from PPP and OTS, specific criteria for "for
cause" and follow-up inspections, where necessary.
(4) In conjunction with the Regional Offices, supports
appropriate enforcement actions based on the information provided
in reports, audits, reviews and impact assessments. Notifies
OPP and OTS of the progress and disposition of compliance procedings
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(5) Responds to FOIA requests for Information on and
availability of completed -compliance inspection reports-(GLP
Inspections or data audits).
(6) Reports program activities to the Assistant Admini-
nistrator for Pesticides and Toxic Substances and to the Admini-
strator through the Management Accountability System.
b. Laboratory Data Integrity Program
(1) Closely coordinates activities with FDA and NTP to
avoid duplicative efforts and to achieve maximum efficiency in
auditing studies used for government decision making.
(2) Trains EPA inspectors and auditors in the conduct of
laboratory inspections and audits with technical assistance from
OPP, OTS, FDA, NTP and contractors as needed.
(3) Establishes and maintains an accessible data file o
studies submitted to or required by the EPA under TSCA Section 4
Test Rule or Negotiated Testing Agreement, TSCA Section 5 Signifi-
cant New Use Rule, Section 5(e) Order, FIFRA Sections 3, 5, 8, 18
and 24(c) as well as FFDCA Sections 408 and 409. This data file
will be maintained and updated by LDIP staff and will permit the
tracking of both CMS-directed activities on studies as well as
OPP- or OTS-negotiated study milestone dates starting with the
date of agreement betwe'.-n OPP or OTS and Sponsor and ending with
the final study data audit report.
(4) Receives copies of notices of deliverabies sent by test
/
Sponsors to EPA Product Managers and enters dates of deliverables
into the data file. The deliverables themselves are directed
to OPP or OTS by the Sponsor.
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(5) Notifies OPP or OTS Product Managers of 'schedule devia-
tions and refers to CMS evaluations -by OPP or OTS scientists of
deviations as well as recommendations for action.
(6) Receives notices of sponsor-requested protocol changes
and refers these requests to the OPP or OTS Product Manager for
evaluation and recommendations. Refers these evaluations and
recommendations to CMS for communication to the Sponsor.
(7) Maintains security as needed on all reports, schedules
and data files under its control.
(8) Within the constraints of available resources selects
laboratories for inspection and studies for audit based on the
neutral administrative schemes and selection criteria of CMS along
with target lists and selection criteria supplied by OPP and OTS.
(9) Schedules data audits and laboratory GLP inspections
for health effects, for ecological effects and chemical fate
studies. Coordinates the audit and inspection schedule with
FDA, EPA Regional Offices and with OPP or OTS scientific support
staff as necessa'ry.
(10) Receives inspection and audit reports from FDA and
EPA inspectors after the audit or inspection is completed.
(11) Develops and utilizes procedures for clarifying ques-
tions and resolving conflicts raised in data audit reports with
the testing laboratory and/or the test sponsor prior to issuing
a final report of a data audit to ensure that the audit can be
properly evaluated.
(12) Prepares GLP compliance reports and final data integ-
rity statements based on inspection reports as well as reviews
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of the raw data and final study report.
c. O'ffice of Toxic Substances and the Office of Pesticide
Programs
(1) Appoint a representative to the Panel. This repre-
sentative will also be the focal point for all information exchange
between OPP, OTS and CMS and will serve as technical program repre-
sentative.
(2) Provide LDIP with information needed to track studies
submitted to or required by the EPA under TSCA Section 4 Test
Rule or Negotiated Testing Agreement, TSCA Section 5 Signifi-
cant New Use Rule, Section 5(e) Order, FIFRA Sections 3, 5, 8, 18
and 24(c) as well as FFDCA Sections 408 and 409.
(3) Maintain a current awareness of LDIP-set laboratory
GLP inspection and study audit schedules from the LDIP data file.
Recommend to LDIP changes in these schedules when problems are
noted that may jeopardize a study. Such requests will contain
an assessment of the need for the inspection or audit based on
OPP or OTS review, pending regulatory decisions and other estab-
lishedcriteria.
(4) Provide LDIP with copies of the study protocols and
revisions , FIFRA or TSCA testing guidelines for each type of
test, available EPA scientific reviews, and all study interim
and/or final reports as well as other pertinent test information
from both the rponior and the testing laboratory before inspections
and audits are undertaken.
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(5) Within resource constraints designate appropriate
scientific staff to accompany FDA and EPA inspectors on GLP
inspections and study audits as requested by LDIP. Staff scien-
tists may participate in routine inspections and audits as recom-
mended by LDIP, and will participate in inspections and audits
where violations are suspected by CMS.
(6) Provide LDIP in a timely fashion with review and
assessment of Sponsor-initiated protocol changes, test laboratory
schedule changes and any other study-related information from
either the Sponsor or the testing laboratory.
(7) Provide LDIP in a timely fashion with regulatory
significance reviews of GLP inspection and data or study audit
reports including an assessment of the impact of inspectional
or audit findings on the study itself.
(8) Recommend, to CMS and LDIP, specific criteria for
"for-cause" or "priority" GLP inspections or study data audits.
(9) Regulatory decisions (registrations, cancellation,
suspension, rule-making, etc.) are the responsibilities of the
program offices; enforcement responses (stop-sale, civil complaints,
etc.) are the responsibility of CMS.
d. The Laboratory Data Integrity Panel:
(1) Serves as a steering committee to ensure that EPA
committments and objectives on LDIP are implemented and met.
(2) Serves as a steering committee to oversee the manner
in which LDIP tract's studies under FIFRA and under TSCA Sections
4 and 5.
(3) Assists CMS in evaluating the effectiveness of the
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audit and inspection programs through periodic program reviews.
(4) Advises the Assistant Administrator for Pesticides
and Toxic Substances through the Director, CMS, of recommended
improvements and changes in LDIP.
(5) Reviews, at the request of LDIP, criteria for labora-
tory' inspection and study audit priorities to ensure that needed
changes in inspection or audit schedules are made promptly and
in a manner consistent with OTS requirements.
4. IMPLEMENTATION
The Director, OTS and the Director, OPP shall select that
Office's representative for the Panel within 30 days of concurrence
in this Memorandum of Agreement by the Assistant Administrator.
The Panel members' names shall be provided to the Director, CMS.
5. DEFINITIONS
a. Data Audit - The data audit is the process by which the
Agency determines the validity of the results of any ongoing or
completed laboratory study. Validation is accomplished by
examining raw data and other records generated during the study
with results provided in the study report. A data audit is not
a scientific review of the conclusions of the study. Data audits
may be partial or full.
(1) Partial data audits are associated with:
i
(a) In-life studies where data are still being
generated and the audit provides confidence that the data in
general are being generated according to protocol requirements '
and time frames and properly recorded.
-------
-9-
(b) Completed studies where selective percentages
of available data a re examined.
(2) Full data audits are those audits where, insofar as
possible, all raw data from all segments of a completed study are
audited. Full data audits are usually associated with ruleor
regulation processes where full prior validation of the
results is considered necessary.
b. Study Audit - A study audit compares the actual conduct
of a study with the approved study protocol. A study audit con-
tains elements of a data audit and a Good Laboratory Practices
inspection and may be partial or full.
c. Good Laboratory Practices (GLP) Inspection - The authority
for GLP inspections is contained in 40 CFR Part 792 (TSCA) and 40
CFR Part 160 (FIFRA). A GLP inspection is an inspection of a test
facility or laboratory where EPA-related test data are generated.
The purpose of such an inspection is to ensure full compliance with
GLP's (as regulations). GLP inspections may be carried out by EPA
inspectors or by inspectors or other designees of other government
agencies under interagency agreements. At present such an inter-
agency agreement exists between EPA and FDA.
Other definitions pertaining to studies and to GLP are con-
tained within the GLP regulations.
-------
-10-
6. CONCURRENCES
/
Moore, D.V.M.
Assistant Administrator
for Pesticides
and Toxic Substances
Date
ictxTr
Don R. Clay, Direi
Office of Toxic Substances
Date
Edwin L. Johnson, Director
Office of Pesticide Programs
Date
go
A. E. Conroy/11 ,| Di rector
Compliance Mbnitbring Staff
Office of PestiVides and Toxic
Substances
Date
-------
United States Pesticides and
Environmental Protection Toxic Substances Washington, DC
Agency Enforcement Division 20460
Federal Insecticide, Fungicide,
and Rodenticide Act
Compliance/Enforcement
Guidance Manual
Policy Compendium
Volume 3: FIFRA Compliance
Monitoring Strategies
-------
Table of Contents
The revised FIFRA Compliance Enforcement Guidance Manual Policy Compendium has been designed
as a series of volumes to accommodate expansion as new guidances are added. Volume 3 of the
Compendium contains compliance monitoring strategies issued by the Office of Compliance Monitoring,
with other pertinent guidances issued by other EPA offices. The Appendix in Volume 1 provides the
Table of Contents for each volume of the Compendium, a list of FIFRA miscellaneous sources, and a
list of obsolete documents. A detailed, cross-referenced Index is provided to help locate specific material
throughout each volume of the Compendium.
Any questions or comments concerning these documents should be addressed to:
Director, Policy and Grants Division
Office of Compliance Monitoring (EN-342)
Office of Pesticides and Toxic Substances
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460
Volume 3: FIFRA Compliance Monitoring Strategies
TITLE DATE
Enforcement Facts and Strategy; Compliance Monitoring Procedures; Water 10/80
Water Purification Devices
Strategy for the Enforcement of the Child Resistant Packaging Regulation 06/08/81
Under FIFRA
General Compliance Strategy for Products Subject to the FIFRA Label Improvement 04/21/83
Program
Compliance/Enforcement Strategy for the Federal Insecticide, Fungicide, and 11/22/83
Rodenticide Act (FIFRA)
Strategy for the Enforcement of the Good Laboratory Practice Regulations Under TSCA 01/15/85
and FIFRA
FIFRA Compliance/Enforcement Guidance Manual
Policy Compendium i November 1990
-------
Volume 3
Table of Contents
Volume 3: FIFRA Compliance Monitoring Strategies (continued)
Compliance Strategy for FIFRA §3(c)(2)(B) Suspensions
Compliance Monitoring Strategy for Enforcement of Pesticide Registration
Cancellations Due to Non-Payment Fees
Alar (see Daminozide)
DATE
09/03/85
08/21/90
Aldicarb
Aldicarb Compliance Monitoring Strategy
04/30/90
Aldrin and Dieldrin
Continuing State Registration of Products Containing Aldrin and Dieldrin for Which
Uses Have Been Suspended
01/10/75
Arsenicals
Compliance Strategy for the Cancellation of Non-Wood Uses of the Inorganic
Arsenicals
06/06/89
Bromoxynil
Compliance Strategy for the Conditional Registration and Cancellation of Certain
Bromoxynil Products
07/06/89
Carbon Tetrachloride
Compliance Strategy for the Cancellation of Carbon Tetrachloride
07/13/87
FIFRA Compliance/Enforcement
Policy Compendium
11
Guidance Manual
November 1990
-------
Volume 3
Table of Contents
Volume 3: F1FRA Compliance Monitoring Strategies (continued)
TITLE
DATE
Chlordane-Heptachlor
Enforcement of Administrator's Decision and Order Suspending Most Uses of
Heptachlor and Chlordane
Clarification of Heptachlor/Chlordane Suspension Order
Status Report on the Heptachlor/Chlordane Suspension
Heptachlor/Chlordane Suspension Order Enforcement Strategy
Heptachlor/Chlordane Suspension Order Enforcement Strategy-CORN USE
Continued Enforcement of the Suspension of Registration for Certain Products
Containing Chlordane and Heptachlor
Revised Compliance Strategy for the Cancellation and Suspension of Chlordane
and Heptachlor Termiticides
Chlordimeform
Chlordimeform Strategy
Final Compliance Strategy for the Cancellation of Chlordimeform
Compound 1080
Compliance Monitoring Strategy for Compound 1080 Livestock Protection Collars
01/15/76
01/22/76
02/19/76
03/23/76
08/27/76
11/23/76
04/13/88
02/09/89
06/19/89
07/25/86
FIFRA Compliance/Enforcement
Policy Compendium
in
Guidance Manual
November 1990
-------
Volume 3
Table of Contents
Volume 3: FIFRA Compliance Monitoring Strategies (continued)
TITLE DATE
Daminozide (Alar)
Final Compliance Monitoring Strategy for Daminozide (Alar) 10/20/86
Compliance Strategy for the Agreement to Voluntarily Halt Sales of Food-Use 06/14/89
Pesticides Containing Daminozide
DBCP
DBCP Suspension Order Enforcement Strategy 11/07/79
Dinoseb
Compliance Strategy for the Emergency Suspension of Dinoseb 10/07/86
Amendment to the Compliance Strategy for the Emergency Suspension of Dinoseb 04/02/87
OCM Memorandum: Dinoseb 04/17/87
OCM Memorandum: FIFRA Section 18 for Dinoseb 03/14/88
OCM Memorandum: Dinoseb Stipulated Order 03/28/88
Compliance Monitoring Strategy for Final Cancellation of Dinoseb 06/15/88
Compliance Monitoring Strategy of the June 9, 1988 Dionseb Cancellation Order 03/03/89
for the 1989 Growing Season
Compliance Strategy for the Cancellation and Registration Amendments for Pesticide
Products Containing Ethylene Bisdithiocarbamate (EBDC)
03/12/90
FIFRA Compliance/Enforcement
Policy Compendium
IV
Guidance Manual
November 1990
-------
Volume 3
Table of Contents
Volume 3: FIFRA Compliance Monitoring Strategies (continued)
EPS
Memorandum: "Indemnification Claims for Suspended EDB Products"
EDB Facts - EPA Decision
Memorandum: "Emergency Suspension of Products Registered for Use as a Grain
Fumigant or Spot Fumigant of Grain Milling Machinery"
Strategy for Compliance/Enforcement of the Emergency Suspension of Ethylene
Dibromide (EDB)
DATE
10/06/83
02/03/84
02/06/84(a)
02/06/84(b)
Lindane
Compliance Monitoring Strategy for Cancelled Lindane Products
Memorandum from A.E. Conroy to Region VII: "Lindane Notice of Intent to Cancel
vs. Registration Standard"
04/25/85
07/10/86
Mercury
Conclusion of Mercury Cancellation Proceeding
Enforcement of Mercury Settlement
10/28/76
01/06/77
2.4.5-T and Silvex
Enforcement of Administrator's Emergency Orders Suspending 2,4,5-T and Silvex
Registrations
Further Guidance Concerning Enforcement of the Administator's Emergency Orders
Suspending 2,4,5-T and Silvex Registrations
Further Guidance on the Cancellation and Suspension of 2,4,5-T and Silvex
03/07/79
04/05/79
08/20/79
FIFRA Compliance/Enforcement
Policy Compendium
Guidance Manual
November 1990
-------
Volume 3 Table of Contents
Volume 3: F1FRA Compliance Monitoring Strategies (continued)
TITLE DATE
Toxaphene
Toxaphene Cancellation Compliance Strategy 01/01/83
Wood Preservatives
Compliance Monitoring Strategy for the Wood Preservative Uses of Creosote, 10/23/86
Pentachlorophenol, Inorganic Arsenicals
Page
Index 1-1
FIFRA Compliance/Enforcement Guidance Manual
Policy Compendium vi November 1990
-------
ENFORCEMENT FACTS
AND STRATEGY
**************** *****
COMPLIANCE
MONITORING PROCEDURES
WATER PURIFICATION DEVICES
October 1930
Pesticides & Toxic Substances
Enforcement Division
Office of Enforcement
U. 3. Environmental Protection Agency
Washington, D. C. 20460
-------
STRATEGY OVERVIEW 1
BACKGROUND 2
?.i:-VLATSD INDUSTRY 3
APPLICATION OF FIFRA 4
Requirements of FIFRA
FIFRA Enforcement Authorities
REMEDIES- -----------------------6
General
Misbrand ing Purifier Claims
Ineffective Water Purifiers
Recall
Other Violations of FIFRA
Criminal Citations
COMPLIANCE MONITORING - 9
Program Development Overview
Guidelines for Selection of Devices To Be Tested
Inspection
Post Inspection
Testing
Pesticide Enforcement Management System (PSMS)
Outreach
CASE DEVELOPMENT 14
ALLOCATION OF RESPONSIBILITIES ,-15
ENFORCEMENT FACTS AND STRATEGY- --19
-------
trategy Over view _ __ _
Water purifiers are products which are intended to render
er sa'fe to drink by removing pests (microorganisms ) through
chemical or physical means. Water purification devices
el.ate peats (microorganisms) from water by using a physical
method such as ultraviolet light, filtration, or other non-chemical
means. To qualify as a "purifier", the product must remove all"
disease causing microorganisms from the water, including bacteria,
viruses, and cysts. Since devices are not subject to the regis-
tration requirements under FIFRA, regulation of them falls entirely
on the Office of Enforcement, which must determine if they comply
with the other requirements of the Federal Insecticide, Fungicide,
and Rodenticide Act to which they are subject. The key to the
compliance determination will be verification of label claims
through a program of product testing.
___________ T_he .jtejstinjg program_will examine the purifier claim used by
many products. If a product cTalms "'"to 'be""a pur i"fTer b"ut""it 'does "
not remove test organisms in the efficacy test, the product is
deemed to be misbranded and subject to enforcement action under
FIFRA, including Stop Sale Orders to remove the product from the
marketplace. The testing scheme designed for this program consists
of two phases. Phase I tests the ability of the products to .
remove environmental coliforms. Phase II tests specific bacterial,
viral and protozoan pathogens likely to be found in water such
as Pseudomonas aerogenosa, Poliovirus and Giardia lamblia. To
substantiate a purifier claim, a product must pass both phases.
if it fails Phase I, enforcement actions will be taken,
spending time and money on the Phase II tests.
The goal of the program is to remove from the market those
pro-ducts which do not purify water to protect the health of persons
who might rely on the products for safe drinking water.
-------
Background
Water purifiers are a class-of products which are intended
to render unprocessed water safe for drinking. They nay be used
in horses which obtain water from wells, by backpackers to treat la
and stream water, by persons whose community water supply nay be
temporarily contaminated, and by vacationers who may encounter water
of questionable quality. Consequently, failure of a product to
adequately purify water may present a serious public health hazard.
Because purification of water involves the killing of micro-
organisms, which are defined as pests in Section 2 of PIFRA, these
products are regulated by the Environmental Protection Agency.
There are two kinds of water purifiers: Those which employ a chemical
means to purify water, and those which use a physical method. While
both types are subject to the provisions of FIFRA, including but not
limited'to, Sections 7, 8, and 12 as well as Section 2(p) and (q),
only purifiers utilizing a chemical must obtain product registration
~a¥""p~r"e"scrIb"el""b"y""Sec"!t'io"a "3 ~o"f the" Act. Under- Section- 25-("C-K4-)—o-£-
FIFP.A the Administrator is authorized to declare a device subject to
the Act. Water Purification devices are among those devices subject
to the Act (see Fed. Reg. Vol. 41, No. 225, page 5*065, November 19,
1976).
The registration process for chemical purifiers is central to
the Agency's ability to evaluate the risks and benefits presented
by the product. If data submitted to the Agency does not support
the label claims made for the chemical purifier, the Agency will
not register the product. Enforcement of the labeling-an-d misbrand-
ing provisions of ?I?RA is very straightforward for chemical-based
water purifiers. If a manufacturer makes claims on a label that do
not appear on the label accepted by the Agency at the time of regis-
tration, then the manufacturer has violated PIPRA by "making claims
in excess of those accepted at the time of registration," which is
a misbranding violation.
"vater purifiers which use a physical means of microorganism
elimination are devices, and are therefore subject to the same
requirements of FIFRA as the chemical water purifiers except that
they are exempt from product registration requirements. Conse-
quently, since a premarket label review based on test data
was not performed, products may appear on the market with
label claims which falsely exaggerate the capabilities of the
product. If the claims.,-are found to be "false or misleading," the
product is misbranded as defined in PIFRA Section 2(q) and subject
to enforcement action.
The EPA cannot require the manufacturer to substantiate the
claims made for the product, so to evaluate the performance of such
devices, EPA must sample and test the devices. The results of labo-
ratory analysis will document or call into question claims made
on the labeling. The test results will also form the basis for
enforcement actions brought against a manufacturer making false or
sis", e ad ing claims.
-------
Water purification device producers are generally small
"businesses, although a few large companies are also in the market.
There are approximately 50 purification devices now on the market.
Producers must register their establishments, but there.may be some
producers who have not done this.
Almost any available physical method that might kill a micro-
organism is employed in at least one product. The most popular are
ultraviolet (UV) light, micropore filtration, chlorine generators,
and ozone generators. Ultrasound, reverse osmosis, electrolysis,
and distillation are other known methods used by purification
devices (See Appendix I). These types of devices are called "point-
of-use" treatment products, since the water is treated immediately
before use. "Small systems" treatment products treat water intended
-for., u-s-e i-r..-3.mal.l. c^amu.ni±ia3_..-_-g5Ji5.C3.1,ly_..^e.y^,Jial, .tajps_jmd_a_Jlistj_i-
cution network are part of the system. "Small systems" treatment"
units are 'also regulated under FIFRA but the quality of the water
produced is regulated by the Safe Drinking Water Act. Since the
public is protected under another Act and the resources of the Office
of Enforcement are limited, these products will not be tested as part.
of this program. However, if such products are found to be ineffective,
they may be subject to enforcement actions under FIFRA.
-3-
-------
Abdication of FI7RA
?I?HA and its implementing regulations clearly apply to devices
The requirements of those regulations are outlined below. State
laws are often ambiguous where devices are concerned.
Since it is desirable that Stop Sale Use or Removal Orders
have nation-wide applicability, this policy is to be administered
as a federal program. State inspectors who may collect evidence
will turn that evidence over to the appropriate Regional office
for enforcement actions.
Requirements of FIFRA
Producers of water purification devices are regulated under
--"??. A-r'-th-e- a-i>pli-c-abl-e- -se-ct i-ons--inc-lu4e- but- are.-not l-im-it
-------
FIFRA Enforcement Authorities
Failure to adhere to any of the above requirements jof FIFRA may
be an unlawful act under §12 of FIFRA as follows:
"Failure to register the establishment [Section 12(a)(2)(K)]
"Failure to keep books and records or to perrait inspection of
books and records [Section 12 (a)(2)(B)]
"Misbrar.ding [Section 12 (a)d)(F)]
"Failure to file production reports [Section 12 (a)(O(N)]
-o-
-------
.-.e~ei i es
C-er.eral
FIFRA provides several remedies for violations of-.its provi-
sions. If the purifier efficacy claims are found to lie false, a
serious public health hazard can exist, and a Stop Sale, Use, or
Removal Order will be issued immediately to limit the availability
of the product. Penalties for other violations are to be determined
through*application of the general FIFRA penalty policy and matrix
(39 Federal Register 2771, July 31, 1974). Civil penalties for
-isbranding violations, which are applied in addition to Stop Sale
friers, are to be determined by consulting the penalty matrix for
Ineffective Water Purifiers, below. If there are severely misleading
claims, particularly in advertising material, the case may be
referred to the Federal Trade Commission through headquarters.
"isbranding Purifier Claims
Water Purification Devices which fail the purifier efficacy test
are misbranded. A Stop Sale, Use or Removal Order will be issued to th
manufacturer of any product which fails the efficacy test. The.Stop
Sale is issued because of the health hazard 'presented by the continued
sale or use of the product, and will not be lifted until the product
coses into compliance with the Act.
In addition to the Stop Sale Order, a civil penalty will be
assessed as described below". The Civil Penalty,must be assessed
within fourteen days of the Stop Sale Order. _'
(This is consistent with the penalties for similar violations in the
current FIFRA Penalty Matrix.)
Ineffective Water Purifiers
I II III IV V
1. Category A 5000 5000 5000 5000 5000
2. Category B 1000 1750 2500 3200 4500
\ See A. 3. Cor.roy's Memorandum of September 12, 1930, "Interim
Final Regulation Section 13, FIFRA."
-6-
-------
Category A - Products in this category failed Phase I of the testing
"**protocol (see Strategy Overview page 1). Phase I tests
the ability of the product to remove a known group of
pathogens which commonly occur in water, so products
which fail are presenting the consumer with a potentially
severe health hazard.
Category B - Products in this category passed Phase I "but failed
Phase II. Since viruses and cysts are pathogens as
well as bacteria, a health hazard is also presented
by these products, although the hazard is somewhat
reduced by the removal of the coliform bacteria.
Some products in this category nearly passed
the efficacy test. It may be that a slight change to
__ either the label instructions or the product itself
..... -.^-^ -v^i^g the pf 6Iuct""into-"coffi?rtaTTcre-"wi^h--^h-e"-A-ct-."'2-/---
A Stop Sale Order would be issued in such cases, but it
may be lifted when the manufacturer agrees that he will
immediately incorporate those changes which appear to
have a reasonable likelihood of remedying the problem.
The "modified'1 device is, of course, subject to testing.
Recall
Another remedy that is used either as an alternative to a civil
proceeding or in addition to one is a recall action. Recalls may
be voluntary or compulsory. If this remedy is employed, the guidance
in Section 12 of the Case proceeding Manual should be followed.
2/ For example, UV light kills viruses and bacteria but may
permit G. Iambiia cysts to persist in water. Since the cysts are
relatively large, a pre-filter on the system could predictably
remove them. Another example would be a chlorine generator whose
directions do not explicitly indicate the concentration and contact
time that are necessary for chlorine to effectively disinfect water
-7-
-------
Other Violations of FI??.A
«As described in the section on the Application of FI7RA,
the Agency has authority to take enforcement action when
provisions of FIFr.A are violated. Violations which do not
Involve the purification claim (e.g. violation of Sect.ipns 2(p)
and (q), 7 and 8) are also to be handled in the regions-according
to current enforcement policy.
If enforcement actions based on violations of FIFRA which
do not include the efficacy of the product are taken before the
efficacy tests are complete, the complaint or warning should
clearly state that additional action nay be taken if the results
of the efficacy test should prove to be unsatisfactory. We recom-
mend that all civil actions be.initiated at the same time.
Willful violations of FIFRA may justify the filing of
criminal charges against a manufacturer. PTSED concurrence
would be required for criminal actions.
-3-
-------
•Gfven below are procedures for the compliance monitoring aspects of the
ogram with description of responsibilities ar.i data flow
T-ulielir.es for Selection of Devices To Be Tested
8 CM3-PT3ZD will select the devices to be tested and determine the
order cf testing based on criteria noted below.
0 Only "point-of-use'1 devices will be tested. These devices consist
of those intended for use in a single family household, camper,
boat, etc.
0 Tvo categories will be established to help determine the order
- of-tes-tir.2,. . . . . ." .
- The first category, which will be given the highest
priority, will contain those products for -which
there is reason to believe that a violation
has occured. This will be determined by consumer
or competitor ccnplaints, scientific judgement based
on the study cf product design, and failure of the
device in similar tests.
- The second category will contain all other products.
The order of testing for this category will be determined
by such neutral criteria as the number produced and dis-
tributed, and the availability of testing space. If
production data is not available for all -devices, the
order of testing will be determined by random selection.
e CM3-PTS3) will prepare the sample request forms and forward
them to the appropriate Region for collection.
Inspection
At the opening conference:
- The inspector should request efficacy data from the
manufacturer pertaining to his/her device(s). The
manufacturer cannot however, be required to submit
this data.
- The inspector should advise the mainfacturer that
his/her product Is not being singled out for attention.
The collection cf his/her device is part of a nationwide
effort to test water our if i cat ion devices.
-9-
-------
Inspection cf boots ard records will be performed in accordance
with the Pesticides Inspection Manual for the purpose of deter-
mining compliance with the record keeping requirements (§3).
An o
fficial sample of the device will be collected at the producer
establishment according to the Pesticides Inspection Manual. The
official samole will include labeling (including instructions 'for
installation) and all other documentation as required (Notice of
Inspection, Receipt for Samples, etc.).
- "Optional Equipment", such as a pre-filter, which
is required for the qualify of water the laboratory
will be using should also be collected. Specific
guidance will be provided on the sample request
fora.
- Because many of these devices are very expensive, the .
....... jj33pector.-shmLd_c2ke.,an.^ ....... ______
donate the device, ''any manufacturers have already
indicated a desire to have their devices tested, and
a willingness to donate them for this purpose.
- If the manufacturer refuses to donate the
device, the inspector should offer to purchase it.
- Two samples of the device will be collected unless
the cost of the device exceeds S700.
If the manufacturer requests to install the device himself,
arrangements with the testing laboratory should be made
If entry is denied:
- The inspector should follow established procedures
for denied entry. £/
- If a distributor of the product can be located
through reviewing -the ad vertising or contacting a
local trade association, then a marketplace sample
can be obtained.
£/ Barlow's Decision: Guidance to Re.ti.onal Personnel: Conduct
:f Inspections after the Barlow's Decision Upril 11, 1979)
-10-
-------
- If a product sample obtained from the marketplace
fails the efficacy tests, a warrant to conduct an
in-depth bocks ani records inspection nay be
obtained. This will be necessary if production
and distribution data is needed.
When the requested.sample has been collected, the "PRD
Acknowledgment" copy of the sample request form will be
forwarded to CX3-PTSED with the "Sample Identification"
section completed.
All non-confidential information obtained by the inspector
will ba placed in the enforcement jacket and forxarded
to the testing laboratory along with the device(s).
- A second copy of the device's labeling is to be assembled
by the inspector and forwarded to CM3-PTSED for contract
management purposes.
Testing
" Efficacy testing will be performed by the State of New York,
Department of Health, Division of Laboratories and Research.
0 Each device will be examined when received by the laboratory
for arr,r possible defects resulting from shipment.
0 Chain of custody procedures will be followed for all official
samples.
0 The device will be subjected to a series of rnicrobial challenges
until it fails or exhausts the series.
- All failures will be confirmed by a second test
0 A second device will be tested if the first one fails.
- Enforcement action will not be initiated unless both
samples fail
0 The testing laboratory '.-,111 be subjected to a Quality Assurance
(QA) Performance Audit and a QA Systems Audit. These audits
will be initiated by ?TS3.
* The testing laboratory will submit to CME-PTSH) a QA Program
and Project Plan.
-11-
-------
• CM3-PTSID is to be kept informed of the testing status of the device.
This information is to include:
- date the official sample was received
- date testing was initiated and ccapleted
* When testing is completed, the laboratory will review the test
results and determine if the device has failed efficacy testing.
All test results -will be placed in the device's enforcement jacket.
- All enforcement jackets win go directly to the appropriate
Region frm the testing laboratory for review to determine
violations, and to initiate enforcement action.
- A copy of the test results will be forwarded to CM3-PT5JD
from the testing laboratory to monitor the contract.
* The testing laboratory will retain all devices for which
violations exist until enforcement action is completed
or the case is placed in permanent abeyance.
V. Pesticide Znfcrcement "anagement System (?5M
The Regions will keep PIS2D informed as to the enforcement status of
the device by entering relevant information, such as the date they issued
a particular order or penalty, the results of the enforcement action, etc.
to the PS-S Co-puter system.
71. Oat reach
vany manufacturers of water purification devices do not appear to be
avare cf Section 7 establishment registration requirements. To help notify
ir^ustry of these requirements, a letter to potential manufacturers and
their trade associations has been prepared (Appendix III^&
The responses free this letter will allow the Agency to compile an
accurate list of manufacturers, their products, and production and distri-
bution data.
A press release has also been prepared announcing the program to the
public and notifying industry of the establishment registration requirements
(Appendix
As a result of this cut reach program, it is anticipated that the
public and the industry will report the existence of various companies
which they suspect are not in compliance with the Act (establishments not
registered, products are ineffective, etc.). All information obtained by
the Regions should be forwarded to CMB-PTSID, Comp" iance Monitoring
Coordinator.
-12-
-------
Microbiological data generated by this prograa will be submitted tc. the
Journal of Applied and Environmental Microbiology for publication after the
enforcement cases are completed. The results of the tests may also be
Presented at the 1932 Annual Meetings of the American Society for Microbiology.
possible that presentations
n **„««. ^^^.*,.j ,_,
will be nade to these groups.
Regions nay release information concerning individual cases in the sane
manner that such information is handled in other civil proceedings.
-------
PTSED
o reviews test results and
labeling
o maintains a file of test
results, labeling, and action
taken
PTSED
o requests samples
o monitors program
sample
request
notification of
action taken
• Region
o-reviews lab's report, labeling
and any records collected to"
determine possible violations
o determines er.forcer.ent response
and initiates action
o maintains official enforcement
file en devices
Region
o sets up enforcement jacket
o collects samples, performs
inspections
o sends PRD Acknowledgment to
CMB-PTSED
o sends copy of labeling to
CMB-PTSED ;
sample &
enforcement jacket
tsst results &
Testing
Laboracory
performs efficacy tests
enforcement jacket
on devices
o reviews test results
Determine product
failure
to.
test results
-13-a-
-------
j.aoel review win oe aone Dy tne KegisTration Division using
the product performance criteria developed for evaluating "both
chemical and physical water purifiers and the data on produtt
performance fron the efficacy test.
Please note that a civil complaint should be issued along with
the Stop Sale, Use or Removal Order when the product fails the
efficacy tests.
-------
Tnis cr.art is a guide to the resporiaibilities for the different tasks in the water
purification device enforcement program.
Headquarters (PTSZD)
Regions
1. Identification of Purifier Devices
* Information sources: ZRSS,
consular queries, competitor
complaints, advertising, other.
1. Identification of Purifier Devices
* Regions submit info mat ion on
netf products they bee one aware
of to Compliance Monitoring
Branch
2. Selection of Devices to be Tested
0 Compliance Monitoring Branch
updates' list of known devices
and selects devices.
* Policy & Strategy Branch will
evaluate ITeatral Inspection
Scheme. All known devices
will be tested.
Allocation of Inspections
0 Compliance Monitoring Branch deter-
mines nazies and locations of device
producer establishments; assigns
inspections to appropriate Regions;
prepares sample request forms and
sends then to Regions.
4. Inspections and Sample Collection
0 Regions assign inspectors to
conduct establishesnt and/or
bocks and records inspections
and product sample and docu-
mentary material collection.
(Inspections may be made by
Federal or State inspectors.)
0 Inspector performs inspection
according to FETRA procedures
and guiciance; special instruc-
tions may appear on the sample
request fora.
-15-
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Headquarters (?T~ID)
Region
Inspector ships sample(s) and
one set of documentary ma
to testing laboratory, ser
copy of documentary sample
headquarters^
Testing of Devices
" Laboratory (Environmental Health
Center, State of New York, Depart-
oent of Health, Albany, N.Y.)*
performs efficacy test according
to ITS 3) approved protocol; furnishes
results etc. to PISH) and the
Segisn-.- -(See -*I,3.— below-.) The ...lab
will keep the device until litigation
is corn-Dieted.
Determination of Violations
0 The testing laboratory indicates
whether the product passed or
failed the efficacy test.
Determination of Violations
0 Region review's inspection data
and its set of documentary
material to determine existence
of violations under PIFRA
Sections 7, 8, or 1 2 as we
as well as Section 2(q)
branding violations.
0 The regions are strongly
advised, particularly early —
in the program to send the
jacket to headquarters for a
pesticide Enforcensnt Review.
The reviewers compare testing
results against label and
advertising claims to deter-
mine if purifier claims are
false and .misleading (misbrand-
ing violation). N.B. The
enforcement jacket accompanies
the sample to the laboratory.
The laboratory inserts the data
from the testing program and
forwards the jacket to Regions
•which may forward them to head-
quarters for Enforcement Review;
the jacket and the review will
then be sent back to the appro-
priate Region.
-16-
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Regions
Based on the laboratory's
determination, the Regions
may initiate action on the
purifier plain. This should
not preclude discussion of
the case with headquarters.
7. Determination of Appropriate
Enforcement: Response
* If aisbrarding violation'based on
the purifier clain has occurred,
headquarters niay provide additional
info mat ion "based on historical files.
A>p-rcpri-ate- records and- reconnendatians..__
will be forwarded to the Regions. If
advertising is seriously misleading, a
referral to the Federal Trade Commission
will also be made.
7. Determination of Appropriate
Enforcement Response
" A Stop Sale, Use or Removal
Order (SSURO) will be issued
for all products which fail
efficacy test. A civil penalty
is. ..also_as3e_ssed_.
Region applies general FI?RA
civil penalty policy and
matrix to determine appropria.-'•
level of actions for ail .
violations.
8. Znforce_ent Actions, Litigation,
Set-clerent
0 PTS2D :=ay, under exceptional
circumstances, initiate
enforcement, actions.
8 Sections of the agreer^nts
which involve label or product
inprover.ents to bring the product
into compliance are to be sent to
PTS-D for concurrence.
Enforcement Actions. Litigation,
Settlement
8 Regions will initiate
enforcensnt actions
(warning letters, civil
ccnplaints, SSURO's).
8 Region may obtain expert
testincny fro~ headquarters
reviewers or laboratory
scientists.
9. Ccm-pleted Case Files
8 PTS3D will maintain a file
of all test data results and
copies of Final Orders for use
in dccu.r..enting the possible need
for regulatory or legislative
changes.
Completed Case Files
8 The Region should retain
completed case files, in-
cluding all relevant
documents.
8 A copy of the Final Order
should be sent to PTSED.
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Eea-itruarters (FTSZD)
Regions
10. Publicity
10. Publicity
1 Start of Program
- Press Release
- Letters to manufacturers and
trade associations.
Release of data generated by
testing program. (Laboratory and
Compliance Monitoring Branch;
- Publication of Scientific data
in appropriate journals
- Presentation in proper forums.
1 Consumer Information determined as
. ..._a..result. .of_.thfi_whole_..prQgrgm.»
- nuriber distributed
- type of use/risk factor
- conclusion to be drawn from the
program.
Release of information abc
individual cases in the ss
manner as" other pesticide civil
cases.
-18-
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grLforcezent Facts and Strategy
^
•pendix I: Types of Porifier Products 20
^pendix II: Legal Definitions, "Purifier" ani "Device" 22
Appendix III: Publicity and Outreach 33
-19-
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Appendix I
Wa^er purification devices employ a variety of techniques to purify water.
The most common techniques are:
8 Ultraviolet light - Light of wavelengths around 260nm damages the DI1A
of exposed, organisms, "if the exposure time is sufficient, the organisms
are no longer viable. Light may also be absorbed by the bonds of certain
complex organic molecules -which could result in photolysis of those mole-
cules. Efficacy of this method depends heavily on the engineering of the
whole system. The protocols used by the Canadians are the basis of the
screening phase of the US EPA Water Purification Device Testing Protocol.
Duplicative verification of results on the same types of products used
to develop the protocol is useful to the U.S. and Canadian Enforcement
Programs.
8 Submicron Filtration - Some products filter water through "sieves" whose
pores are about 0.4 micron. Since a typical bacterium is 1 micron in
•diameter, these products frequently make purifier claims. Unfortunately,
a very large virus would be only 0.1 micron in diameter and some bacteria
are capable of changing shape. The filter would consequently not work.
0 Ultrasound - High frequency sound causes pulse waves to form in water. The
rapid changes in water pressure result in "shearing forces" which- cause
bacterial cell walls to break. This technique is used in a research setting
to avoid chemical denaturing of mac r molecules and cellular orgar.elles.
'whether it would be efficent on the scale necessary to purify water is un-
known.
0 Chlorine generators - These devices electrolyse salt (NaCl) to form chlorine.
The chlorine ac'3 as a disinfectant to purify water. Tnese products are devices
and not chemical pesticides because the product which enters channels of trade
is not a chemical. The consumer generates the pesticide at the site of use
for his own use and not for sale or distribution. Unfortunately, since there
has been virtually no regulation of these products, the label directions may
not be sufficiently explicit to ensure efficacy of the product. Chlorine
levels can be tested using a simple test kit and the presence of adequate
levels of free chlorine for a minimum contact time would ensure a reasonably
pure water.
0 Ozone generators - Oxygen from air is electrically ionized to form ozone, a
powerful oxidizing a^nt and disinfectant. Unlike chlorine, ozone- 'does not
persist (it rapidly decomposes to oxygen) and cannot be easily measured. It
is difficult for consumers to know if the device is actually working or if
some minor product failure has resulted in lower levels of ozone production.
Installation is complex - often done by the seller - and cheaper products
may be unsafe electrically.
" Electric current - Presumably the microorganisms are electrocuted by the
passa^ of an electric current through a water reservoir.
0 Distillers - These products condense stesm from boiled water.
-20-
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Microorganisms are killed by boiling. Distillation can concentrate
certain organic compounds.
* Reverse Osr.osis - High quality organic polymer membranes
selectively filter water. This product is similar in principle
to a kidney dialysis machine. It is a pctentialy workable means
of purifying water since the pores of the membrane act as a
molecular sieve. Complex organic molecules are prevented from
crossing over to the "pure water" side of the membrane. Viruses,
bacteria and protozoans would also be retained on the "impure
side". Maintenance of these products is important. A damaged
ce-brane would not purify water. There is sose indication that
old membranes may themselves be colonzied by some forms of bacteria
which use the organic polymer as a food source.
Two types of products which are labeled as water purifers will not be
tested:
e Potable water "rurifers" - These products use the term purifier on
their labeling "out are clearly intended for use on water that
is already potable (i.e., faucet "purifiers" for use on municipally
treated water). *•'.?.mfacturers of these products should be warned
that use of the term "purifier" is for products which process
untreated water. (See 41 Federal Register 32778, August 5, 1976)
Other enforcement actions may also be necessary.
0 larse rurifiers which treat water for groups of tventv-five persons
or more. These products are regulated by PIJHA. However, the quality
of the water is requlated by the Safe Drinking Water Act. Since
the public is protected by another act and the resources of the Office
of Enforcement are limited, these products will not be included in this
program. (These are also known as "snail systems" purifiers.)
-21-
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Appendix II
Legal Definitions, "Purifier" and "Device
Since the enforcement strategy and penalty policy rests on the
definitions of "water purifer" and "devices," the following material
is attached to support the definitions used in this document:
A. Purifier:
1. FTC ruling in the matter of Sibco Products Company Inc., Et Al.
(63 FTC (1965) pg. 917).
" " * 2'." ' Guideli nes' for Registering - Pesticide-Products -in -the United 'States - ••
Section G: Product Performance Standards for Water Purification
Devices.
3. ZPA ruling In re Contact Industries, Inc., I.F. & R. Docket No. II-?S6
(1973) pg. r.
3. Devices
Pest Ccntol Devices and Device Producers: Consolidation and Clarification
of Requirements. Federal Register, vol. 41, no. 225 (11/19/1976).
-22-
-------
st
IN THE MATTER or •
•-SIBCO PRODUCTS COMPANY, IXC., ET. AL.
ORDEBr OPLVIOX, ETC., IN BECABD TO THE ALLEGED VIOLATION OP TH2
%FEDEEAL TRADE COMMISSION ACT '
?•". ^ .* ?**" 552S- Complaint. June 8, ISe-t^-Decuion^oo. 22.1965-
'Orde? requiring a"N*w Jersey manufacturer" of' water Yiltaton to ceaw
£ja= th«j effectives ar.d capability of its water filtration
decepbvely guaranteeing the perfonnanca of aoch unita. .
' 8X6IBCO TEO3UCTS-CO.,aNC.,7rr.-AL:Vf • -317
i {Opinion
- .2. Imptie'd ..Represer.tsiiorw -Respecting -~MicTo-*organis7ns-"and""
•Viruses
' Complaint counsel charges that by the use of such words as"ptire,^
"purify" and "clean" and the phrase "pure drinking and cooking
• water are vital to the health of your family * ~ •" in connection with
the unit, respondents are implicitly representing that disease-carry-
ing water will be mace safe for drinking through the use of the Sibco
"Purifier." • •
Respondents 'admit that the unit will not kill micro-organisms
but maintain that the words quoted above -do -not -constitute -an
implicit representation to this effect., .Moreover, respondents .air.
leged in their answer that the literature accompanying the unit
contains a specific disclaimer that it does not kill bacteria.
We conclude from the evidence that respondents' water purifier
does not in 'fact remos'e water-borne micro-organisms or viruses
• capable of causing diseases. Moreover, we hold that the statements
in respondents' advertisements and form letters — that their unit
will /'purify and filter" water, will ensure "clean" water, will cor-
rect "bad" water, will give "pure drinking and cooking water"
which is "vital to the health of your family" and will filter "im-
purities" found in the consumer's water supply— constitute repre-
sentations that respondents' unit will remove bacteria and other
disease-causing germs. \Ve find that a potential purchaser who
'has or believes he has or may have contaminated water could
easily be led ,by statements of the type quoted above to believe
that respondents' unit will make his water potable. Gian^Foods_,
Inc. v, F.r.C. 332 F. 2d 977 (1963). . - " •"" -. ~
With respect to the disclaimer used by respondents in one bro-
chure, we have no way of knowing from the evidence whether all-
of respondents' prospective customers actually received this pam-
phlet. Furthermore, this ciiscL-.irr.er was not inserted until respond-
ents' precornplaint negotiations with complaint counsel. Finally, the
presence of this disclaimer '.-. ::s of respondents' brochures does
not negate the cor.tr.iry ::r.v 'i-.-n ir. the r.ffirmativc representa-
tions contained in their au%i • . -. — or.ts and sales literature as to
the purifying qualities of their unit.
-------
c:r. jrart cr iucoar- u: Guidelines for Recistratien -of Pesticides r
a S;a:2s: rrccuct Perfor. inca Stancards (pg* 14.5-146). (Full tsxt
frr.T, .U.ecdquurt5rs.} ' .:.
elements: representative levels of organic-and inorganic soil
contamination; various wacer temperatures; Che specific dosage
* .
and exposure period recocmended for the proposed produce; a
variety of test aicroorganises representative of the target pests
rt
to be controlled; and quantitative determination of the level of
oicrobial contaainacion of the vater before and after treatment.
(ii) Performance standard. The treatment oust eliminate all
tect cicroorganiszis frca the vater.
(3) Vater treatment units, (i) Vater purifier units. Any unit
intended for the treacaenc of rav water to elininate the potential
' health hazard posed by nicroorganisas is identified as a water
purifier. The unit aay rely on physical filtration* (pesticidal
device), or chesical treatment (pesticide), or a coabinaticn thereof,
to achieve the intended purpose of purifying aicrobiologically ncn-
potable vater by eliminating watar-bome pathogens in the water
itself. Those units, such as subaicron aeabranes and absolute filters,
•
which rely solely en a physical aeans for reaoval of aicroorganisas
fron vater, are identified under the Act as devices, and are subject
to regulation but not registration. The test requirenents indicated
below are for the units containing an antinicrobial agent.
(A) Test standard. Controlled siaulated-use studies for the
water purifier ur.it aust be conducted under conditions representing
actual use employing a defined raw water source containing a high
level of aicrabiological pollution. The test design wil vary
145
-------
vieh different types of units and patterns of use, buC oust include
auch basic elements as: representative levels of organic and in-
* •
organic soil contamination; various water temperatures; docuaen-
tation of the antimicrobial concentration found is the test system;
and quantitative determinations of the oicrobial contaaination
level of the water before and after passage through the unit. The
duration of effectiveness or effective capacity of the unit before
a replacement is necessary oust be documented.
(B) Performance standard. The treatment oust elisinate the
aicrobial pollution in the rav vater.
(li) Potable vater'treatment unit. Any unit intended for physy
ical and/or chemical treatment of aicrobiologicaliy potable vater
from a municipal treatment facility to remove undesirable tastes
odors, cheaicals, or other aesthetically objectionable properties
is Identified as a potable vater treatment unit. A substrate such
as activated charcoal (with- or without a bacteripstatic agent) is
incorporated into the unit for this terminal processing treatment
of potable vater prior to consumption. Since the requirements of
the Safe Drinking Vater Ait do permit aunicipally-treated drinking
vater to contain a liaited number of harmless "saprophytic" bacteria
vaich are cozaonly recognized contaminants of vater, an antimicrobial
agenc is sometimes incorporated in a potable vater treatment unit
to provide bactariosnatic activity against these contaminants. Only
potable vater treatment units containing a bacteriostatic agent are
urder the purview of the Act.
146'
-------
Exerpt fror. In re Contact Industries. Inc. (pg. 6-8). (Full text of document
available from headquarters.)
ENViROn:-:r.:ttAL PROTECTION AGENCY
BEFORE THE REGIONAL ADMINISTRATOR
In re ) ' '
• Contact Industries, Inc., ) l.F. & R. Docket No. II-1S6C
Respondent ) Initial Decision
The term purifier connotes a product which eliminates impurities
and polluting natter. V.'e are in agreement with the conclusion of
Complainant's expert witness that the "word ourifier is suffir.ini--'Hv
broad to induce ridding the air of oh.icctionables, includinq roirro-
orgc-nisr.is as they would exist." An air purifier would therefore
cleanse the air of air-borne b?.cteria, virus, and fungi particles. If
Respondent had intended for the product to be understood to be merely
an air freshener or deodorizer, the label could have contained the
term air freshener (cf. Respondent's Ex. 7) or been limited to the
-claim that the product was an industrial odor absorbent and nbt also
a glycolized air purifier. In fact, the latter phrase would be
somewhat redundant in the context in which it is employed on the
label if all that was intended thereby was to inform the consumer
that the product functions as an air freshener. As indicated by
Complainant's expert witness, the term air purifier especially when
-------
. - 7 -
taken together with the word "Sanicidc" on the label would indicate
that thti pro-Jjcl is intended to rid the air of genus, that is,
bacteria or viruses.
m
"Sanicide" is printed in bold-face, conspicuous type on the front
of the label. The word also appears at the top of the back of the
label in type which is in larger and bolder print than all other words
on that side of the label. It is clear that the word "Sanicide" is
meant to provide the most conspicuous reference to the product.
"Sanicide" implies both a sanitizing and a killing action or, at
the least, a killing action. Sanitize means to free from dirt, geras,
etc., as by cleaning or sterilizing. The suffix -cide means killer
or killing. Ses Lobster's Third Mew International Dictionary (19G5).
A consumer would, we believe, recognize the meaning of the suffix
-cide as is evidenced by the corunon usage of words such as homicide,
pesticide, and insecticide.
In interpreting broad remedial legislation, the consumer is not
assumed to be an expert or one possessing special knowledge or
ability, and includes "the ignorant, the unthinking, and the credulous."
Unite:! States v. An Article. . .Consisting of 216 Ortonsd Cottles,
supra at p. 740 and cases cited therein; United States v. An Article
of Drug. . .47 Shipping Cartons. . .. 331 F.Supp. 912, 917 (D. Md.
1971). Her can we assume that the buying public will exercise great
selectivity and caution in what they choose to believe: of what they
-------
- Li -
re?.d. Unitiu Str.tes v. Articlcr. of Drug. Etc.. 263 F.Supp. 212 (D.
Neb. 1CG7). Cf. Hclhros Watch Co-.rp.inv v. Federal Trade Cc:rm'r,sicn.
310 F.2d 863, , 859 (D.C. Cir. 195?.), cert, denied 372 t>.S. 976
*
(1552), rehearing denied 374 U.S. 857 (19G3), and coses cited therein.
A consumer would be justified in believing that the product he purchased
had the capability of both cleansing the area sprayed (sanitizing) and
killing microorganisms present in the area sprayed. This is especially
so when the term "Sanicide" is read in conjunction with representations
that the product is an air purifier or a glycolized air purifier.
Certainly, the use of the prefix sani- with the suffix -cide has
greater significance than the use of that prefix in other contexts
disclosed in the record.
Antimicrobial agents are specifically included as one of the
classes.of sanitizers or pesticides subject to registration under the
»/~t (a crtrH^r, 1 r? ")f-?#l «* + ^~ r«^..i - <-~ -. - - '40 /•«-" •; <•; If^f^V,
MWU. ^ «*•*.«- «*i. W «» I wi t • vb- . w I • * j w* .^*lt. tV_^UIUCIVJM.3 ^*TOv^l l\ IUC.^^1 t J J J •
The claim that the product Superior Sanicide Air Purifier is an air
purifier when read in conjunction with the word "Sanicide" would indi-
cate that the product is indeed an antimicrobial agent "intended to
reduce the number of living bacteria or viable virus particles on
inanimate surfaces, in water, or in air", in this case. See 40 CFR
y
162.3(ff)(2)(i)(B) (Emphasis supplied). Thus, representations rcao'e
I,/ Microorg;'.:)-;t:iij, including but not limited to algae, fungi,
and bacteria, and viruses have been declared by the Ao cnvirot::;!int (Sec 40 CFR 162.14(b)(4) and (5.)).
-------
.^f^\ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
? WASHINGTON. D.C. 20450
JUN 8 198!
OFFICE OF ENFORCEMENT
MEMORANDUM
SUBJECT: Child Resistant Packaging Requirements for Pesticides
- Enforcement Strategy and Penalty Policy
%
TO: Enforcement Division Directors
Pesticide Branch Chiefs
On March 9, 1979, the Agency published a final rule which
requires certain pesticides labeled for residential use to be
packaged in Child Resistant Packaging (CRP) if released for
shipment on or after March 9, 1981.
The CRP enforcement strategy document, which is attached,
stipulates that states operating under grants will be responsible
for conducting inspections to determine compliance with the CRP
requirements. This activity should be incorporated into their
routine establishment inspection program. The regions will be
responsible for coordinating the program and initiating enforce-
ment actions for CRP violations with PTSED's concurrence. The
reasons for this are: 1) violations of the CRP requirements
are not violations of pesticide statutes in many states, and
2) a need for close coordination with the Office of Pesticide
Programs during the initial stages of the program.
The strategy document should be distributed to states with
a cover letter from the appropriate office within your region
explaining the specifics of the program.
If you have comments or questions on the strategy document,
please contact Phyllis Flaherty (755-0970) of my staff.
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- 2 -
I am also attaching an amendment to the Guidelines for
Assessing Civil Penalties pursuant to FIFRA. This amendment
adds violations of the CRP regulation to the Civil Penalty
Matrix and provides guidance on appropriate enforcement
actions for CRP violations.
Comments or questions on the amendment should be addressed
to Patricia Mott (755-9404) of my staff.
Also attached are copies of the applicable Federal Register
notices.
A. E. Conroy II,I D4rector
Pesticides and Toxi^/Substances
Enforcement Division
Attachments
-------
STRATEGY FOR THE ENFORCEMENT
OF THE CHILD RESISTANT PACKAGING
REGULATION UNDER FIFRA
OVERVIEW
REQUIREMENTS OF THE RULE
Applicabi1ity
Exceptions
Exemptions
Specific Requirements
REGULATED INDUSTRY
ENFORCEMENT
Objecti ves
Voluntary Compliance
Viol at ions
Inspection Scheme
Violation Detection Priorities
ADMINISTRATIVE CONS IDE-RAT IONS
Program Management and Allocation of Responsibilities
Program Integration
-------
t_r-a.tJL9jy_ f ° r—t h e _Ejrf p r_ce m e nt ^_o_f t^h e_ C h 1 l_d_R_e_s_1 s t a n t
aCJK.a_gi_1_nj^je g uTa~t i^n"U n dTr' "" """"
Overview
On March 9. 1979, the Environmental Protection Agency
published a final rule at 44 FederjJ Register 13019 (40
CFR 162.16) which requires chlfd res'istant packaging (CRP)
of certain pesticides labeled for residential use. The
intent of the rule 1s to reduce the number of accidental
exposures by children to pesticides.
The regulation requires child resistant packaging for
any pesticide product released for shipment after March 9, 1981,
if (1) its labeling allows for^residential use. (2) it .has not
fceen classified for restricted use, and (3) it meets certain
toxicity criteria. Exemptions may be granted for products
for which special packaging is not technically feasible or
where the toxicity criteria are not Indicative of hazard to
humans .
The rule also requires affected registrants to submit
applications for amended registration and maintain records on
child resistant test data.
Possible violations include misbranding, failure to keep
records, failure to file reports, and falsification of data.
It is anticipated that states operating under grants will
have major responsibility for conducting inspections concerning
the CRP requirements. The Regions will handle the casework since
these types of violations would not be in violation of many
State statutes. Concurrence from PTSEO is required for enforce-
ment actions resulting from violations of the CRP regulation.
Headquarters support will be available for data review and to
answer questions on whether or not a product meets the criteria
that trigger the requirement for child resistant packaging.
In addition, PTSED will provide inspection targeting information.
Requirements of the Rule
Applicability
As indicated in the overview, child resistant packaging is
required for any pesticide product released for shipment after
March 9, 1981, if (1) its labeling allows for residential use,
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-2-
(2) it has not been classified for restricted use, and (3) it
meets certain toxicity criteria. In addition, registrants with
products subject to the rule must amend their registrations to
reflect changes 1n packaging and certify that the packaging
complies with the CRP regulation.
For your Information certain terms used 1n the Strategy have
been defined below:
0 "Released for shipment" is defined as that point in time
when it is the intent of the producer to introduce the
product Into commerce. Intent exists in any of the
following situations:
(1) a producer asserts that what is being sampled is
representative of what is actually sold;
(2) a product is stored in an area where finished
products are held for shipment in the ordinary
course of business (warehouses, loading docks,
etc.);
(3) the custom of the pesticide chemical industry
indicates that similarly situated products are
intended for release; or
(4) the custom of the particular producer indicates that
similarly situated products have been intended for
release in the past.
0 "Residential use" - A pesticide meets this criterion if
it is applied (other than by a commercial applicator)
directly to humans or pets or is applied in, on or
around all structures, vehicles, or areas associated with
the household or homelife or noncommercial areas where
children spend time, including, but not limited to gardens,
houses, yards, patios, mobile homes, campers and
recreational vehicles, noncommercial campsites, home
swimming pools, educational, lounging, and recreational
areas of preschools, nurseries, and day camps, etc.
Furthermore, residential use is determined by whether
a product has a use on the label which is within the
meaning of residential use. A registrant may have a
product that Is not really Intended for residential
use, but the labeling is either vague concerning use
areas, or use areas are actually omitted. Such a
product is subject to the child resistant requirements
unless its registration and label are amended to indicate
a strictly non-residential or agricultural application.
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-3-
0 "Toxlcity criteria" are defined in 44 Federal Regi ster
13019 (March 9, 1979) and at 40 CFR 162.16(C)(2).
Exceptions to CRP
0 "Dormant" Product Registration
A dormant product registration is defined as a product
which is not currently in production but retains valid
EPA registration. For a product not in production and
which is not scheduled to be released for shipment on
or after March 9, 1981, an amended registration,
special packaging certification and other related
forms need not be submitted at this time. However, at
any time after March 9, 1981, if the product is put back
into production, an amended registration, child resistant
certification, etc., must be submitted before the
product is released for shipment if it meets the
criteria for special packaging.
Toxicity Data
If the toxicity of a product is not known to the level of
specificity necessary to determine whether or not the
toxicity criteria are met (e.g., the information on file
with EPA is extrapolated data), the registrant may perform
additional testing. If testing indicates that the toxicity
criteria are not met, the product is not required to
have child resistant packaging. However, if the regis-
trant does not conduct further testing when the toxicity
is not known to the necessary level of specificity,
child resistant packaging is required.
0 Products for Residential Use by a Serviceperson
The Agency has decided to remove from the scope of CRP
requirements certain products which meet the criteria
for special packaging but are not normally stored in
areas where children could likely have access to them.
Examples include products used by janitors in nurseries
or daycare centers and products used by exterminators or
lawncare servicepersons. To accomplish this, EPA will
allow products such as those listed above to be sold and
distributed without child resistant packaging if such
products bear a statement restricting the sale, use, and
S-Loraae to_s_fi_rv icejjerSOILS^
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-4-
This provision has been communicated to producers
through a Federal Register Notice Issued March 3, 1981;
it will also appear in proposed revisions to Section 3
Registration regulations. Until it appears in final
regulations, EPA will use .prosecutorial discretion and
not take enforcement action if a subject product is
not specially packaged but is labeled or sticker-labeled
with a statement restricting the product's sale, use,
and storage to servicepersons, e.g., "Only-for Sale
to, Use, and Storage by Servicepersons." The statement
must appear in type size at least as large as the
child hazard warning statement. Labels need not be
submitted to the Agency for approval but must be submitted
for the official label file used to determine compliance
with FIFRA.
0 A registrant may amend his/her registration so that
the new label does not allow for residential uses.
In such a case the product bearing the new approved
label would no longer be subject to the special packag-
ing requirement.
Exemptions to CRP
Exemptions may be granted by the Director of the Regis-
tration Division for products for which special packaging is
not technically feasible or where the toxicity criteria are
not indicative of hazard to humans.
Note that only the Agency may grant an exemption. It is
not up to the registrant to decide if he or she is exempt
or not, based on the two factors listed in the above paragraph.
Specific Requirements for Registrants of
Products Subject to the Special Packaging Requirement
0 Develop and test special packaging
"Special packaging" refers to packaging that is designed
and constructed to be significantly difficult for
children under five years old to open or obtain a
toxic or harmful amount of the substance contained
therein within a reasonable time. In addition, it
should not be difficult for normal adults to use pro-
perly. Effectiveness testing procedures which must
be used are those specified by the Consumer Product
Safety Commission (CPSC) at 16 CFR 1700.20(a), (b),
and (c). Effectiveness specifications and standards
for special packaging are delineated in 40 CFR 162.16.
0 Amend registration - Certification
Prior to changing a product's packaging, the registrant
must submit an application for an amended registration
and have it approved by EPA. Instead of submitting
-------
-5-
detailed information demonstrating that the packaging
meets the requirements, the registrant shall Include
with his application a certification that the package
meets the standards of §162.16(d). An applicant for
a new registration shall also submit a certification
statement that the package meets the standards.
UtJLlize special packaging
Products subject to the requirement must be in child
resistant packaging if released for shipment after
March 9, 1981.
Recordkeeoinq.
Certain records must be retained by the applicant or
registrant for as long as the registration is valid.
These records shall be available, upon request, for
inspection and copying purposes or for submission
to EPA. The records which must be kept are:
(1) A full description of the package including:
(i) A full description of the container including
(A) Its dimensions, and
(B) Its composition; and
(ii) A full description of the closure or special
package, if appropriate, including:
(A) The name of its manufacturer,
(B) The manufacturer's designation (title)
for the special packaging closure or
the physical working of the special
packaging mechanism, and
(C) The explicit directions for proper use
of the closure or special packaging
and the placement of these directions
on the package;
(2) A complete copy of the data resulting from the
tests conducted in accordance with §162.16(d);
and
(3) Data demonstrating the compatibility of the
pesticide formulation with the entire package to
determine that the chemical and physical charac_-___
teristics of the substance will not interfere
with the safety and efficacy of the pesticide
and functioning of the special package.
-------
-6-
Note: The registrant may not have actual data
company did not perform the testing but
on verification from others such as the
produces the packaging. The registrant
letter or literature verifying that the
been tested and met the CRP standards.
Regulated Industry
on file if the
, instead, relied
company which
should have a
packaging has
The regulated community consists of registrants of those
products subject to these regulations. Estimates suggest that
approximately 9000 products may be involved.
The Registration Division of EPA has prepared a pre-
liminary list of types of products which are expected to be
covered by the CRP regulations if used and stored in and around
residential areas. (See attachment.) A second, more complete
list will be developed and forwarded as soon as it is available.
A company may remove its product from these requirements by
amending the label to remove residential uses, stickering or
amending the label so that sale, use and storage is restricted
to a serviceperson, or by receiving an exemption.
Enforcement
Objectives
The objective is
so as to minimize or
poisonous pesticides
Outreach
to assure compliance with this regulation
eliminate accidental exposures to highly
used in and around residential areas.
Registrants should be aware of the
publication in the Federal Register.
Packaging Institute prepared and
concurrence, a pamphlet entitled,
Packaging." Personnel in the
regulation through its
In addition, the Glass
dTstributed, with EPA's
"Pesticides and Protective
Registration Division are generally
available to answer any questions and clarify the requirements
for registrants.
Violations
Mjsbranding - §12(a)(l)(E) of FIFRA
As defined in §2(q)(l)(B) of FIFRA, a pesticide 1s
misbranded if "it is contained in a package or other
container or wrapping which does not conform to the
standards established by the Administrator pursuant
-------
-7-
to § 2 5(c ) (3 )." Failure to have special packaging
for those products released for shipment after March
9, 1981, would make the product misbranded if it is
subject to the special packaging requirement.
There are three variations of this violation:
(1) No special packaging, although required.
(2) Company's new toxicity test data indicate
that such packaging is not required, but
the Agency does not agree that the
toxicity data support their conclusion
(e.g., improperly conducted toxicity
tests or incorrect toxicity tests
utilized).
(3) Company changes packaging, but it does
not meet the child resistant requirements
because tests were incorrectly done or the
tests were conducted on the incorrect
container size.
Failure to File Reports Required - §12(a)(2)(N) of FIFRA
It is unlawful for a person who is a registrant to
fail to file reports required by this Act. Prior to
changing a pesticide's packaging, the registrant
must submit an application for amended registration to
EPA. Failure to do so prior to distributing the product
in new packaging would be in violation of this section.
In addition, the registrant is required to
submit a certification statement with the amended
registration application.
^Failure to Maintain Reports Rpqnirpri - §12(a)(2)(B) of FIFRA
It is unlawful for a registrant to fail to maintain
reports required by FIFRA. The regulation requires
the registrant to submit a certification that the
product is in compliance as opposed to detailed data
supporting this. However, it is required that the
detailed data be maintained and be subject to Agency
inspection or request for submission. The registrant
is not required to have such data on file if the firm
relied on testing conducted by others such as the package
supplier. In lieu of such data he or she must have
some verification on file that the product is in compliance.
-------
-8-
In some cases, the company may claim that the parent
company/company headquarters has the data. This should
be noted on the inspection report and sent to the
appropriate region. The regional office should forward
this to PTSED so that a request for the data can be sent to
the company's headquarters by OPP.
of Application/Report or of Records
taintainednjr of Exemption Request - §12(a)(2)(M) of
FIFRA or Title 18 of the U.S. Code.
It is unlawful to falsify all or part of any appli-
cation for registration, any records required to be
maintained pursuant to §8, or any report filed under
this Act. Thus, falsification of an application for
amended registration, the certification, or data such as
test protocol and results would be in violation of FIFRA.
Title 18 of the U.S. Code also makes this type of activity
i1 legal.
INSPECTION SCHEME
Inspections to determine compliance with these special packaging
requirements should be incorporated into a state/region's existing
inspection program, which should be based on a Neutral Administra-
tive Inspection Scheme. Generally, only producer establishments
will be inspected for compliance with the CRP regulation. Prior
to inspecting a pesticide producing establishment, the appropriate
personnel (inspector or whomever is designated to do this)
should determine if the company produces any of the products
on the attached list prepared by the Registration Division.
If so, the inspector should check for compliance with
the child resistant requirements.
Reports from inspections involving possible violations of
these requirements should be forwarded to the regional office
for case review and appropriate enforcement action.
Violation Detection Priorities
During an inspection, it is helpful to establish priorities
for detecting violations. The fol1 owing tab!e gives the general
priority ranking for violation detection. The following is
meant only as a guide to decision making and is not a rigid OE
p o1 icy.
Priority 1 - Misbranding
Failure to utilize Child Resistant Packaging where required.
This will probably be the most common violation found initially.
-------
-9-
Priority 2 - Failure to Maintain Records
Such records may be necessary to verify compliance with the
regulations. This includes test data which either (a) show the
package meets the child resistant requirement (CPSC test results)
or (b) show the product's actual toxicity does not meet the
criteria.
Priority 3 - Failure to File Reports
This refers to a company's failure to amend the registration
prior to a packaging change. This should not be a frequent viola-
tion but is easy to determine.
Priority 4 - Falsification of Data
While this is one of the most serious violations, it should
not be encountered frequently. Child Resistant Tests are
expensive (approximately $8000) and may be conducted under
contract if a company's test results are suspect.
ADMINISTRATIVE CONSIDERATIONS
PROGRAM MANAGEMENT AND ALLOCATION OF RESPONSIBILITIES
State and regional personnel if appropriate will be responsi-
le for conducting inspections and documenting cases.
With regard to actual casework, issuing penalties, notices of
warning, etc., the regions will have primary responsibility but
must request and receive concurrence from PTSED.
This is necessary for 3 reasons:
1) A violation of the child resistant requirement
is not a violation of many state laws.
2) Some companies may have received exemptions or
the product may not be subject based on toxicity data
on file with EPA.
3) The Registration Division may consider cancellation
action for those products which remain in violation.
PTSED's Case Development and Legal Branch will be respon-
sible for resolving questionable cases, i.e., those for
which there is some doubt or question as to the product's
-------
-lo-
st a t u s or the v a 1 1 d 1 t..' of the fl a t a , ^ n < I r r? v i ow i n n concurrence
requests.
Program In t e_g ration
The Case Development and Legal Branch, PTSEO, will coordinate
with the Regions and the Registration Division to resolve any
questions regarding the child resistant packaging requirement
and the status of products covered.
The Regions will coordinate with the States regarding the
enforcement of the special packaging requirements.
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
MEMORANDUM PESTICIDES AND TOXIC SUBSTANCES
SUBJECT: Enforcement Strategy Concerning Child-Resistant Packaging of
Pesticide Products.
TO: Jack Neylan
Pesticide Toxic Substances
Enforcement Division (EN-342)
As a follow-up to our recent meeting concerning an enforcement strategy
on compliance with CRP regulations we are providing to you a list of
generic products for which an unqualified assumption can be made that
they need to be in CRP if used and stored in the household. This is con-
sidered phase I of the strategy. Phase II will consist of a more refined
list which will be based on the actual CRP amendments we receive.
^ 1. Disinfectants
Product Concentration Use
1. Calcium
hypochlorite 65% swimming pool
2. Lithium
hyprochlorite 35% "
3. Sodium dichloro
s- triazine trione
and Trichloro-s
triazine trione 98-100% " "
4. Mono (Trichloro
tetra (monopotassium
dichloro) penta-s-
triazinetrione 99% Swimming pool
5. Hydrochloric acid 8% Toilet bowl
6. Phosphroric acid 17%
7. Chlorophenolics 6% Disinfectant
8. Sulfamic Acid 20% Toilet bowl
9. Quaternary Ammonium
Compounds 105 General disinfectant
10. Paraforcaldehyde 95% " "
11. Formaldehyde 37% " "
-------
2. Ips^c^cide and Rpdep^icide
Pesticide Chemical % At and Above Requiring CRP
1. Carbophenothion 1.4
2. Chlordane
3. Chlorpyrifos (Dursban)
4. Cryolite
5. Diazinon
6. Dimethoate (Cygon)
7. Disulfoton (Disystox)
8. Dyfonate
9. Ethion
lO.Imidan
ll.Lindane
12. Metaldenyde
13. Mexacarbate (Zectran)
14. Naled
15. Propoxur (Baygon)
16. Phosphorus (white)
28.0
9.0
15.0
7.0
17.0
0.4
1.2
3.5
10.0
6.5
20.0
2.0
18.0
6.2
1.1
Remarks
Some lawn use
products
Termite control
products
Sprays for outdoor
Ornamentals
Plant dusts
Many plants and garden
sprays; encapsulated
diazinon does not require CRP
Systemic insecticides
for indoor and outdoors
plants
Some combinations with
lawn fertilizer
Borer sprays, dog
dips
Slug and snail
control
Insect, slug and
Snail control
Rodenticide
-------
3*
Chemical Formulation / % A.I.
Bis (tributyltin) oxide Above 0.5%
Paraquat any %
Pentachlorophenol above 88%
Chlorothalonil above 40%
Copper-8-quinolinolate above 5%
bo Engler, (finief/y
Disinfectants Branch
Registration Division (TS-767)
cc: D. Campt
R. Gross
J. Jenkins
H. Harrison
J. Akerman
Use
Wood Presenvative
Homeowner herbicide
Wood preservative
Homeowner fungicide
Wood preservative
-------
General Compliance Strategy for Products Subject to the FIFRA
Label Improvement Program
0 ve rvlew
On June 5, 1980 EPA published in the Federal Register (45 FR
37884) a notice initiating a program to improve pesticide labeling.
The Label Improvement Program (LIP) was initiated to upgrade pro-
duct labeling in an attempt to better protect health and the environ-
ment as well as further defining legal use of a product, this program
was designed to work in conjunction with currently existing registra-
tion programs and to respond rapidly to labeling needs identified by
the Agency. To date, four major label improvement program notices
have been issued and are in effect. Two additional label improveme'nt
program notices have been recently issued but are not yet in effect.
Regulated Industry
Some label improvement rules affe.ct all registrants, while
others affect only registrants of certain products.
Requirements of the Rule
Submission of Applications
The Office of Pesticide Programs (OPP), Registration Division
(RD) will notify each registrant of an affected product by certified
letter or a certified mail copy of a PR Notice that his product is
subject to specific requirements under that label improvement program
revision. For each affected product, the registrant is required to
submit' the following to EPA:
1) An application for amended registration (E.PA Form 8570-11).
2) Five copies of draft labeling incorporating required changes.
-------
3) If necessary, a Statement of Confidential Formula (EPA Form
8570-4).
Registrants must normally submit applications within 60
calendar days of receipt of the LIP Notice. The Agencj will state
any deviation from this deadline in the LIP Notice.
Products for which the Agency has not received an application
for amended registration within the stated deadline will be subject
to cancellation. The Agency will issue a Notice of Intent to Cancel
for any such product, effective 30 days from its receipt, unless
within that time the registrant or an interested party with the
consent of the registrant, either applies for amended registration
or requests a hearing under section 6 of FIFRA.
Exemption from Compensation Requirements
In many cases an amended registration to meet the requirements
of a Label Improvement Program Notice will not- be subject to com-
pensation requirements. If this is the case, the Offer to Pay or
Certification Statement will not be required to be submitted to RD
and approval of labeling submitted will not convert registrations
to conditional status. Each notice will address the compensation
status of applications submitted in response to the LIP Notice.
Processing of Applications
Generally, the Registration Division will review labels
for compliance witji the requirements of the LIP Notice. A regis-
tration amendment submitted in response to a LIP Notice is not
complete until the amended labeling is submitted and accepted by
RD. If draft labeling is not acceptable, RD will notify the
registrant of the deficiencies by letter and give the registrant
75 calendar days to submit amended labeling. Amended labeling
-------
- 3 -
must be limited to changes required by the letter in order to
maintain the exemption from compensation requirements.
Combined Application in Response to Multiple Label Improvement
Noti ces
Applicants receiving multiple notices requiring LIP labeling
amendments for the same product may combine responses into one
application for amended registration provided the relevant LIP
Notices are clearly referenced. Applications that are non-compen-
sable under FIFRA section 3(c)(l)(D) may not be combined with
X
applications that are compensable. The submission deadline for
combined applications for amended registration is the later of
the deadlines established in the LIP Notices.
Time Frames for Compliance
Any product released for shipment 180 calendar days after the
registrant receives RO's acceptance of amended labeling must bear
that accepted label. Registrants are responsible for compliance
by their sub-registrants (distributors).
Products that have been released for shipment and are in
retail channels of trade prior to the 180 day deadline may continue
to be distributed in commerce, sold and used until supplies are
exhausted.
Enforcement Objectives
The objective of LIP compliance program is to ensure that
product labeling is in compliance with the requirements of the
various Label Improvement Program Notices. This will be accom-
plished through producer establishment inspections.
-------
- 4 -
Typesof Violations
Producers not complying with the requirements of .the notices
*
issued under the Label Improvement Program are in violation of
of FIFRA section 12(a)(l)(E) in that their products are misbranded
under sections 2(q)(1)(F) and (G). Products being sold in violation
of a cancellation order are in violation of FIFRA section 12(a)(2)(L)
and subject to the penalties thereunder. -
x
Administrative Considerations
The Office of Pesticide Programs has issued four major label
improvement notices (See Attachments) which are currently in effect
with two more LIP Notices issued but not yet in effect. The four
existing LIP Notices are listed below in order of inspectional
targetting priority according to their potential hazard.
1) Fumigants - Issued 12-4-80 - This LIP Notice requires
registrants of products containing certain active ingredients to
add additional precautionary labeling, misuse statements and storage
and disposal statements.
2) Termiti ci des - Issued 11-7-81 - This LIP Notice requires
registrants of termiticide products containing one of the active
ingredients listed in the LIP Notice to revise use directions of
their product, use the appropriate storage and disposal statements,
add a misuse statement, and reformat their labels.
3) Antlfoul Ing Pai nts - Issued 3-9-82 - This LIP Notice required
registrants of all antifouling paints to make extensive revision
of their product's labeling.
-------
4) Salt Water Emesi s - Issued 11-30-80 - This LIP Notice
»
requires all registrants to delete salt water emesis statements
from their labeling. Since the revision was a simple del etion,
«
registrants were not required to submit amended labeling for review,
Two more LIP Notices have been recently issued dealing with
worker reentry Intervals and disposal requirements. As they become
effective they will be included for targetting in the inspectional
program.
Targetting Inspections ^
• *
The Registration Division, OPP is responsible for compiling
lists for each LIP Notice consisting of:
1) The name and address of each registrant affected;
2) The name and registration number of each product affected;
3) The registration status of each product affected, i.e.,
compliance, pending, or subject to cancellation; and
4) The date of acceptance of the amended labeling if the
product is in compliance.
These lists, which the Compliance Monitoring Staff will forward to
the Regions, will be a basis for the States' or Regions' inspection
targetting.
States should target inspections* based on the priority as-
signed to each LIP Notice in this document and on the current
registration status of products regulated under each Notice.
To identify inspection targets, States should first list under
each LIP Notice the registrants andthe number of their products
whose: a) product labels are subject to cancellation for failure
Only producer establishments should be targetted for inspection
under this guidance. Marketplace inspections are not appropriate
for determining compliance with this rule. Products in the channels
of trade prior to the date when amended final printed labeling
must appear on a product may continue to be sold. Therefore, it
would not be an effective use of resources to determine the existence
of violations based on marketplace samples.
-------
- u -
to respond to the.LIP Notice; and b) label amendments RO has
approved. Inspection priorities will not include registrants
whose products have label amendments pending with RD. Priority
«
for inspection should then be as'signed on the following basis:
1) Registrants of products subject to cancellation for failure
to respond to the LIP Notice. These registrants should
be ranked based on the number of their products subject to
the LIP Notices in the following order: Fumigants, Termi-
ticides, Antifouling Paints and Salt Water Emesis.
2) Registrants with the .^ost number of products with accepted
amended labels subjec* to any LIP Notices in the following
order: "Fumigants, Termi ti'cTd'e'sy "Ant i foul "irrg Paints and
Salt Water Emesis.
After determining inspections! priorities for the LIP, the
States should integrate these priorities with the criteria listed
in the FY 84 Cooperative Agreement Guidance for scheduling
producer establishment inspections (past violative history, products
subject to Label Improvement Program, products subject to Child
Resistant Packaging (CRP) regulations, and Restricted Use Pesticides)
The highest priority in scheduling inspections should be given to
those producers which meet the largest number of these criteria.
Inspections
Inspectors will examine products released for shipment at
the producer establishment to determine compliance with the terms
of the LIP Notice. Registrants have 180 calendar days following
acceptance of amended.1abeling to bring the product into compliance.
Any product released for shipment after this 180 calendar day period
must bear accepted amended labeling.
Registrants with products not in compliance with any LIP
Notice will be issued a Stop Sale Use or Removal Order (SSURO) by
-------
- 7 -
the State or EPA in addition to any enforcement action taken by
\
the State or EPA. The SSURO will be removed only "after the registrant
brings th-e product into compliance. SSURO's will not be lifted for
cancelled products sold in violation of a cancellation order.
Issuance of a SSURO is an appropriate response to non-compliance
as the LIP is designed to mitigate the risks of handling pesticides
through labeling changes and the registrant is given ample time
to make and incorporate these changes on the label.
Allocation of Responsibilities
Headquarters Responsibility
a) Provide Regions with a compliance strategy for Label
Improvement Program,
b) Provide Regions with copies of each LIP Notice,
c) Provide list of registrants affected by a Notice,
status of the products affected and date of accep-
tance of final printed labeling for each product
i n compli ance.
Regional Responsibility
a) Provide copies of all pertinent materials to the States.
b) Provide guidance and assistance for State enforcement
efforts.
c) Assist in issuance of SSURO's.
State Responsibility
a) Schedule and conduct inspections of affected registrants.
b) Issue SSURO's to non-complying registrants.
c) Take enforcement actions where appropriate.
-------
General Compliance Strategy for Products Subject to the FIFRA
Label Improvement Program
Q ve rvi ew
On June 5, 1980 EPA published in the Federal Register (45 FR
37884) a notice initiating a program to improve pesticide labeling.
The Label Improvement Program (LIP) was initiated to upgrade pro-
duct labeling in an attempt to better protect health and the environ-
ment as well as further defining legal use of a product, this program
was designed to work in conjunction with currently existing registra-
tion programs and to respond rapidly to labeling needs identified by
the Agency. To date, four major label improvement program notices
have been issued and are in effect. Two additional label improvement
program notices have been recently issued but are not yet in effect.
Regulated Industry ""
Some label improvement rules affe.ct all registrants, while
others affect only registrants of certain products.
Requirements.of.theRule
Submission of Applications
The Office of Pesticide Programs (OPP), Registration Division
(RD) will notify each registrant of an affected product by certified
letter or a certified mail copy of a PR Notice that his product is
subject to specific requirements under that label improvement program
revision. For each affected product, the registrant is required to
submit the following to EPA:
1) An application for amended registration (E.PA Form 8570-11).
2) Five copies of draft labeling incorporating required changes.
-------
3) If necessary, a Statement of Confidential Formula (EPA Form
8570-4).
Registrants must normally submit applications within 60
calendar days of receipt of the LIP Notice. The Agency will state
any deviation from this deadline in the LIP Notice.
Products for which the Agency has not received an application
for amended registration within the stated deadline will be subject
to cancellation. The Agency will issue a Notice of Intent to Cancel
for any such product, effective 30 days from its receipt, unless
within that time the registrant or an interested party with the
consent of the registrant, either applies for amended registration
or requests a hearing under section 6 of FIFRA.
Exemption from Compensation Requirements
In many cases an amended registration to meet the requirements
of a Label Improvement Program Notice will not- be subject to com-
pensation requirements. If this is the case, the Offer to Pay or
Certification Statement will not be required to be submitted to RD
and approval of labeling submitted will not convert registrations
to conditional status. Each notice will address the compensation
status of applications submitted in response to the LIP Notice.
Processing of Applications
Generally, the Registration Division will review labels
for compliance witji the requirements of the LIP Notice. A regis-
tration amendment submitted in response to a LIP Notice is not
complete until the amended labeling is submitted and accepted by
RD. If draft labeling is not acceptable, RD will notify the
registrant of the deficiencies by letter and give the registrant
75 calendar days to submit amended labeling. Amended labeling
-------
- 3 -
nust be limited to changes required by the letter in order to
maintain the exemption from compensation requirements.
Combined Application in Response to Multiple Label Improvement
Noti ces
Applicants receiving multiple notices requiring LIP labeling
amendments for the same product may combine responses into one
application for amended registration provided the relevant LIP
Notices are clearly referenced. Applications that are non-compen-
sable under FIFRA section 3(c)(l)(0) may not be combined with
/
applications that arecompensable. The submission deadline for
combined applications for amended registration is the later of
the deadlines established in the LIP Notices.
Time Frames for Compliance
Any product released for shipment 180 calendar days after the
registrant receives RD's acceptance of amended labeling must bear
that accepted label. Registrants are responsible for compliance
by their sub-registrants (distributors).
Products that have been released for shipment and are in
retail channels of trade prior to the 180 day deadline may continue
to be distributed in commerce, sold and used until supplies are
exhausted.
Enforcement Objectives
The objective of LIP compliance program is to ensure that
product labeling is in compliance with the requirements of the
various Label Improvement Program Notices. This will be accom-
plished through producer establishment inspections.
-------
- 4 -
Types of Violations^
Producers not complying with the requirements of .the notices
4
issued under the Label Improvement Program are in violation of
of FIFRA section 12(a)(l)(E) in that their products are misbranded
under sections 2(q)(l)(F) and (G). Products being sold in violation
of a cancellation order are in violation of FIFRA section 12(a)(2)(L)
and subject to the penalties thereunder. -
x
Administrative Considerations
The Office of Pesticide Programs has issued four major label
improvement notices (See Attachments) which are currently in effect
with two more LIP Notices issued but not yet in effect. The four
existing LIP Notices are listed below in order of inspectional
targetting priority according to their potential hazard.
1) Fumi gants - Issued 12-4-80 - This LIP Notice requires
registrants of products containing certain active ingredients to
add additional precautionary labeling, misuse statements and storage
and disposal statements.
2) Termiti ci des - Issued 11-7-81 - This LIP Notice requires
registrants of termiticide products containing one of the active
ingredients listed in the LIP Notice to revise use directions of
their product, use the appropriate storage and disposal statements,
add a misuse statement, and reformat their labels.
3) Antifouling Paints - Issued 3-9-82 - This LIP Notice required
registrants of all antifouling paints to make extensive revision
oftheirproduct'slabeling.
-------
4) Salt Water Emesi s - Issued 11-30-80 - This LIP Notice
s
requires all registrants to delete salt water emesis statements
from their labeling. Since the revision was a simple deletion,
*
registrants were not required to submit amended labeling for review
Two more LIP Notices have been recently issued dealing with
worker reentry Intervals and disposal requirements. As they become
effective they will be included for targetting in the inspectional
program.
Targetting Inspections ^
• v
The Registration Division, OPP is responsible for compiling
lists for each LIP Notice consisting of:
1) The name and address of each registrant affected;
2) The name and registration number of each product affected;
3) The registration status of each product affected, i.e.,
compliance, pending, or subject to cancellation; and
4) The date of acceptance of the amended labeling if the
product is in compliance.
These lists, which the Compliance Monitoring Staff will forward to
the Regions, will be a basis for the States' or Regions' inspection
targetting.
States should target inspections* based on the priority as-
signed to each LIP Notice in this document and on the current
registration status of products regulated under each Notice.
To identify inspection targets, States should first list under
each LIP Notice the registrants andthe number of their products
whose: a) product labels are subject to cancellation for failure
T0n lyproducer establishments should b~etargetted for inspection
under this guidance. Marketplace inspections are not appropriate
for determining compliance with this rule. Products in the channels
of trade prior to the date when amended final printed labeling
must appear on a product may continue to be sold. Therefore, it
would not be an effective use of resources to determine the existence
of violations based on marketplace samples.
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to respond to the.LIP Notice; and b) label amendments RO has
approved. Inspection priorities will not include registrants
whose products have label amendments pending with RD. Priority
«
for inspection should then be as'signed on the following basis:
1) Registrants of products subject to cancellation for failure
to respond to the LIP Notice. These registrants should
be ranked based on the number of their products subject to
the LIP Notices in the following order: Fumigants, Termi-
ticides, Antifouling Paints and Salt Water Emesis.
2) Registrants with the most number of products with accepted
amended labels subject to any LIP Notices in the following
order: -Fumigants, Termi ti'cTdesy "Anti fouTi rrg Paints and
Salt Water Ernes i s.
After determining inspectional priorities for the LIP, the
States should integrate these priorities with the criteria listed
in the FY 84 Cooperative Agreement Guidance for scheduling
producer establishment inspections (past violative history, products
subject to Label Improvement Program, products subject to Child
Resistant Packaging (CRP) regulations, and Restricted Use Pesticides)
The highest priority in scheduling inspections should be given to
those producers which meet the largest number of these criteria.
Inspections
Inspectors will examine products released for shipment at
the producer establishment to determine compliance with the terms
of the LIP Notice. Registrants have 180 calendar days following
acceptance of amended labeling to bring the product into compliance.
Any product released for shipment after this 180 calendar day period
must bear accepted amended labeling.
Registrants with products not in compliance with any LIP
Notice will be issued a Stop Sale Use or Removal Order (SSURO) by
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- 7 -
the State or EPA in addition to any enforcement action taken by
*
the State or EPA. The SSURO will be removed only 'after the registrant
brings the product into compliance. SSURO's will not be lifted for
cancelled products sold in violation of a cancellation order.
Issuance of a SSURO is an appropriate response to non-compliance
as the LIP is designed to mitigate the risks of handling pesticides
through labeling changes and the registrant is given ample time
to make and incorporate these changes on the label.
Allocation of Responsibilities
Headquarters Respons i bi1ity
a) Provide Regions with a compliance strategy for Label
Improvement Program,
b) Provide Regions with copies of each LIP Notice,
c) Provide list of registrants affected by a Notice,
status of the products affected and date of accep-
tance of final printed labeling for each product
i n compli ance.
Regional Responsibility
a) Provide copies of all pertinent materials to the States.
b) Provide guidance and assistance for State enforcement
efforts.
c) Assist in issuance of SSURO's.
State Responsi bi 1 i t.y
a) Schedule and conduct inspections of affected registrants.
b) Issue SSURO's to non-complying registrants.
c) Take enforcement actions where appropriate.
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MEMORANDUM
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
SEP 3 1985
OFFICE OF
PESTICIDES AND TOXIC SUBSTANCES
SUBJECT: Compliance Strategy for FIFRA §3(c)(2)(B)
Suspensions
FROM: A. E. Conroy II, Director
Office of Compliance Monitoring
TO: Addressees
Attached is the Compliance Strategy for FIFRA Section
3(c)(2)(B) Suspensions. This strategy sets forth the
responsibilities of the Office of Pesticide Programs (OPP),
OCM and the Regions in implementing a program to assure com-
pliance with suspensions issued under section 3(c)(2)(B) of
FIFRA.
Section 3(c)(2)(B) of FIFRA authorizes the Administrator
to require registrants to develop and submit data to fill gaps
in the data base for registered pesticides. Failure to respond
to a section 3(c)(2)(B) data call-in or to properly develop
data results in suspension of the product for which the data
was requested.
Comments on the draft compliance strategy and OCM's
responses are as follows:
0 One Region requested that the three month period for
conducting inspections for compliance with the Stop
Sale, Use or Removal Order (SSURO) not begin until the
States receive the information on the issuance of the
SSURO. The strategy has been amended to reflect this
comment.
0 One Region noted that each time a State is requested to
conduct a Section 3(c)(2)(B) inspection, the grant will
have to be renegotiated and outputs will have to be
adjusted. An amendment to the FIFRA Enforcement Grant
Guidance was issued on July 31, 1985 to address this
problem.
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-2-
0 Several Regions questioned the need to search FATES to
provide a list of inspection targets to the States.
The list provided by OCM lists only the registrants
affected. The FATES data will provide the States with
any establishments that may have produced the suspended
products.
0 One Region commented on the fact that the policy does not
address contract manufacturers or supplemental registrants
who may have produced suspended products. By the Regions
providing States with information from FATES on those
establishments which have in the past produced suspended
products, the States should be able to reach those distrib-
utors who have produced a product which has been suspended
In the case of contract manufacturing, the registrant
should immediately instruct the contract manufacturer to
cease production. The SSURO sent to registrants covers
those products produced under contract as well as pro-
ducts supplementally registered. States can confirm
that distribution has been halted by visiting those
establi shments.
0 One Region commented that the Regional offices needed the
certified receipt cards for the NOITS and SSURO to support
enforcement cases. OCM will not routinely send the certi-
fied receipt cards to the Regions. Please note that OCM
may have one green card, verifying that the registrant
received the SSURO, which applies to several establish-
ments located in different Regions. If a Region needs
a certified receipt to support a specific enforcement
action, OCM will provide it on request.
0 The Office of Pesticide Programs suggested that OCM in-
clude a copy of the OPP Standard Operating Procedure
Number 3049.1 - Suspension of Pesticide Registrations in
the package. OCM has attached the SOP to this package.
Thank you for your cooperation in reviewing the draft
strategy. If you or your staff have questions, please contact
David Stangel of my staff at FTS 382-7845.
Attachments
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SEP 3665
COMPLIANCE STRATEGY FOR FIFRA §3(c)(2)(B) SUSPENSIONS
OVERVIEW
Section 3(c)(2)(B) of the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA) authorizes the Administrator to
require registrants to develop and submit data to fill in gaps
in the data base for registered pesticides. Failure to respond
to a FIFRA §3(c)(2)(B) data call-in appropriately or failure to
develop data as agreed to in the FIFRA §3(c)(2)(B) response will
result in suspension of the product for which the data was
requested. In those cases the Office of Pesticide Programs
(OPP) will issue a Notice of Intent to Suspend (NOITS). The
suspension becomes effective thirty days after its receipt unless
the company complies with the requirements of the data call-in
notice, requests a hearing, or requests a voluntary cancellation.
Generally, there will be no existing stocks provisions for products
in the registrant's possession unless registrants request a
voluntary cancellation.
In order to enforce a suspension under FIFRA §3(c)(2)(B),
it is necessary to issue a Stop Sale, Use, or Removal Order
(SSURO) and to conduct followup inspections. A registrant whose
product is suspended under FIFRA §3(c)(2)(B) may comply with the
data call-in requirements at any time. OPP will lift the suspen-
sion and OCM the SSURO provided all FIFRA §3(c)(2)(B) data
requirements have been met for that product.
REGULATED INDUSTRY
The regulated industry consists of all registrants which
receive a FIFRA §3(c)(2)(B) data call-in notice. There are
several types of data gaps for which data call-in notices may be
i ssued :
0 chronic toxicological data gaps,
0 registration standards data gaps,
0 special review data gaps, and
0 others such as product chemistry data gaps, confidential
statements of formula, or ground water data gaps.
REQUIREMENTS ~
Section 3(c)(2)(B) of FIFRA:
0 Authorizes the Administrator to require additional data
on a chemical to further evaluate the chemical and to
support existing registrations.
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o
-2-
Requires each registrant to provide evidence within
ninety days after notification that he is taking appro-
priate steps to secure the additional data.
Grants EPA the authority to issue a Notice of Intent
to Suspend if a registrant fails to take steps to secure
the required data. (This includes failing to respond to
the data call-in notice, responding inadequately such as
maintaining that testing is not necessary, or failing
to submit data in the timeframe to which the registrant
committed or which OPP established.)
Allows a registrant and other parties adversely affected by
the NOTTS to request a hearing within thirty days of
receipt of the NOTTS by the registrant regarding whether:
(1) the registrant diligently took one of the listed
steps to develop the data, or whether (2) the Agency's
decision on the disposition of existing stocks is consistent
with the Act. If a registrant requests a hearing, the
suspension on his product does not take effect until
after the conclusion of the hearing.
Each registrant originally is given the following options
for complying with the data request:
0 develop or supply the required data himself or jointly
with other registrants;
0 certify that the product is exempt, e.g., because it is an
end-use product formulated from a registered, non-suspended
manufacturing use product and was therefore not subject
to the data call-in for safety data;
0 delete uses that require the data requested;
0 request and receive a waiver of some or all of the data
requi rements; or
0 voluntarily request cancellation.
Failure to exercise one of these options within certain
specified time periods will result in the suspension of the
registrant's product. When a product is suspended under FIFRA
§3(c)(2)(B), there will generally be no existing stocks provisions
for products in the registrant's possession. More information
on how OPP suspends a product and the conditions of the suspension
can be found in OPP's Standard Operating Procedure for FIFRA
§3(c)(2)(B) Suspensions.
ENFORCEMENT OBJECTIVES ~
The aim of the compliance strategy is to enforce the F
§3(c)(2)(B) suspension via a SSURO.
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-3-
TYPES OF VIOLATIONS
Section 12(a)(2)(J) of the Act prohibits the violation of a
suspension order under FIFRA §6. There is, however, no specific
unlawful act under section 12 for the violation of a section
3(c)(2)(B) suspension order. Under section 13 of FIFRA, the
Administrator may issue a SSURO when a product is suspended. By
issuing a SSURO, EPA is able to enforce the suspension. Any person
violating a SSURO would be in violation of section 12(a)(2)(I) and
would be subject to the penalties thereunder. It is essential that
each registrant of a suspended product be issued a SSURO in order
for the section 3(c)(2)(B) suspension to have the force of law.
NEUTRAL ADMINISTRATIVE INSPECTION SCHEME
The Regions should work with the States to schedule inspec-
tions of producing establishments of suspended products within
three months after the State receives notification of the SSURO.
Once it is determined that a producing establishment is in compli-
ance, no additional special targetting is necessary. However,
continued compliance should be checked during the next routine
i nspecti on.
ADMINISTRATIVE CONSIDERATIONS ~
Program Management
OPP is responsible for tracking data requests up until the
point at which a commitment to test is made. At that point,
the Office of Compliance Monitoring (OCM) is responsible for
tracking the test schedule. OPP is responsible for issuing
the NOITS and tracking the registrants' responses. When a pro-
duct is suspended (thirty days after receipt of the NOITS unless
the registrant requests a hearing or complies with the data
request), OPP notifies OCM and forwards a copy of the NOITS to
OCM. At that time, OCM will issue a SSURO to the registrant of
the suspended product. Previously, OPP had allowed a specified
amount of time for continued production of the product and sale
of all existing stocks. The current OPP Standard Operating
Procedure indicates that there will be no distribution of stocks
by the registrant allowed after the effective date of the suspen-
sion, i.e., thirty days after receipt by the registrant. If
there are any existing stocks provisions allowed, OPP will forward
this information to OCM at the same time OPP notifies OCM of the
effective suspension. Normally, there will be no prohibition on
sale of suspended products in the channels of trade.
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-4-
At the time that OCM issues the SSURO, it will send a sample
copy of the SSURO, a sample NOITS, a list of registrants to whom
SSURO's were issued and products affected, and any other relevant
supporting documents to the Regions. The Regions will notify
States of the suspension and the SSURO and provide them with
copies of all the information which the Region has received from
OCM. The SSURO may only be vacated by OCM. This will only be
done when OPP is lifting the suspension because the company has
come into compliance with the data call-in request. The Regions
will be notified immediately that OPP has lifted the suspension
and OCM has vacated the SSURO. Regions and States may issue
SSURO's for any products which have been distributed in violation
of a SSURO issued by OCM.
ALLOCATION OF RESPONSIBILITIES
OPP
Issues data call-in notices and tracks responses.
Issues NOITS as appropriate and tracks responses.
Notifies OCM of products suspended and provides copies of
NOITS at that time along with other relevant documents.
Lifts suspensions when registrant fully complies.
Prepares letters lifting the suspensions and the SSURO's for
OPP and OCM signature.
OCM
Tracks testing once commitment to test is made and notifies
OPP of failures by registrants to meet commitments.
Issues a SSURO to the registrant after being notified that
a suspension is effective.
Sends the Regions a list of registration numbers for suspended
products and the names and addresses of registrants which
received SSURO's within 5 days of mailing the SSURO's. OCM
will also send a sample SSURO and NOITS. Upon request by a
Region, OCM will provide the actual SSURO and NOITS for a
specific product as well as the certified receipt.
Vacates a SSURO at the same time OPP lifts the suspension for a
registrant, which fully complies with the data call-in, and sends
the Region information on the vacation of the SSURO.
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-5-
s working with OPP to develop and implement a system for tracking
;uspensions and SSURO's.
legions
legions forward information on the suspensions and SSURO's to
:he States within a week of receipt and work with the States
in monitoring compliance. The Regions will provide to the
States a list of producing establishments which have produced
the products subject to the suspension and SSURO. This informa-
tion should be obtained from FATES.
In those States without State Cooperative Enforcement Agreements,
the Regions monitor compliance with the SSURO's within three
months of their receipt of the information on the issuance of
the SSURO.
Regions negotiate with the States to assure that States conduct
inspections at producing establishments to verify compliance
within three months of the date the State receives the information
on the SSURO and that States check for compliance during
future routine producing establishment inspections.
Regions will handle any cases arising from violations of the
SSURO's issued by OCM.
States
States will conduct follow-up inspections to ensure compliance
with the SSURO's and forward results of the inspections to the
Regions. For situations involving a violation of the SSURO, the
State will forward the case file to the Region for appropriate
enforcement action.
PENALTIES
Violation of a SSURO is a violation under section 12(a)(2)(I)
and subject to the penalties found under section 14(a)(l) and
section 14(b)(l). Violation of a SSURO will generally result in
an administrative civil complaint. The FIFRA penalty policy
provides guidance on calculating the administrative civil
penalty for this violation. Repeated or continued violations of
SSURO's will be considered for criminal referral.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20-160
OFFICE OF
PESTICIDES AND TOXIC SUBSTANCl
MEMORANDUM
SUBJECT: Compliance Monitoring Strategy for Pesticide
Registration Cancellations Due to Nonpayment of Fees
FROM: John J. Neylan III, Director
Policy and Grants Division
Office of Compliance Monitoring
TO: Addressees
Attached is: (1) the Compliance Strategy for Pesticide
Registration Cancellations Due to Nonpayment of Fees; and (2) the
Notice of Cancellation which was published in the Federal
Register on October 18, 1989 (54 FR 42936). Thank you for your
comments on the February 12, 1990 draft. A summary of those
comments and our responses is also attached.
The effective date of cancellation for the first fee period
was October 10, 1989, the date of the letter informing
registrants of the Cancellation Order. However, registrants
could continue to sell and distribute existing stocks until March
1, 1990. The attached Strategy calls for routine producer
establishment inspections to ensure that the 20,000 pesticide
products are not sold in violation of FIFRA. Last October, the
Office of Pesticide Programs (OPP) sent the States and Regions
copies of the list of approximately 20,000 products, which were
cancelled for nonpayment of fees under FIFRA section 3 and
section 24(c). On March 9, 1990, the Office of Compliance
Monitoring (OCM) sent the Regions a list of the registrants and
producing establishments, which have produced since 1984 any of
the pesticide products cancelled for nonpayment of fees.
Please provide copies to the State pesticide control
officials in your Region as soon as possible. If you have any
questions regarding the Strategy, please contact Beverly Updike
Of my Staff at FTS 475-9438 (EN-342).
Attachments
Pr.mad on Recyd:-J Pa^g?
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ADDRESSEES
I Louis F. Gitto, Director
Air, Pest. & Toxics Mangt. Div.
II Barbara Metzger, Director
Environmental Services Div.
Ill Thomas J. Mas1any, Director
Air, Toxics and Radiation Mangt. Div.
IV Winston A. Smith, Director
Air, Pest. & Toxics Mangt. Div.
V William H. Sanders III, Director
Environmental Services Div.
VI Bob Hanneschlager, Acting Director
Air, Pesticides & Toxic Div.
VII William A. Spratlin. Director
Air and Toxics Div.
VIII Irwin L. Dickstein, Director
Air and Toxics Div.
IX David P. Howekamp, Director
Air Management Div.
X Lynn McKee, Acting Director
Air and Toxics Div.
cc: Valerie Jewett (TS-788)
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ADDRESSEES
(TS-766C)
(TS-767C)
(TS-767C)
(H-7506C)
(LE-134P)
(LE-132A)
(EN-342)
it
Douglas D. Campt
Edwin F. Tinsworth
Anne Lindsay
Steve Johnson
Michael Walker
Mark Greenwood
A. E. Conroy II
Connie Musgrove
David Dull
Mike Wood
Phyllis Flaherty
Jerry Stubbs
Maureen Lydon
Ken Kanagalingam
Bob Zisa
Sherry Sterling
Jan Bearden
Jake Mackenzie
Western Regional Compliance Director
II
Marvin Rosenstein. Chief
Air, Pest. & Toxics Mangt. Div.
Pest. & Toxic Substances Br.
Ernest Regna, Chief
Environmental Services Div.
Pest. & Toxic Substances Br.
Ill Larry Miller, Chief
Hazardous Waste Managt. Div.
Toxic & Pest. Br.
IV Richard D. Stonebraker, Chief
Air, Pest. & Toxics Mangt. Di.
Pest. & Toxic Substances Br.
V Phyllis Reed, Chief
Environmental Services Div.
Pest. & Toxic Substances Br.
VI Robert Murphy, Chief
Air, Pest. & Toxic Div.
Pest. & Toxic Substances Br.
VII Leo Alderman, Chief
Air and Toxics Div.
Pest. & Toxic Substances Br.
VII Martha Nicodemus, Act. Chief
Air and Toxics Div.
Toxic Substances Br.
IX Davis Bernstein, Chief
Air Management Div.
Pest. & Toxics Br.
X Kenneth Feigner, chief
Air and Toxics Div.
Pest. & Toxic Substances Br.
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RESPONSE TO COMMENTS ON PESTICIDE CANCELLATION STRATEGY
All of the following comments submitted by the Regions are
appreciated and have been considered. The Compliance Strategy
incorporates many of these comments.
/
Existing Stocks
COMMENT 1
One commenter wanted the following language used in the Strategy
to be added to the Summary:
Due to the face that the Cancellation Order allows stocks at
the dealer and user level to be used until exhausted,
inspections beyond those at producing establishments are not
being requested.
RESPONSE 1
We have incorporated that statement into the Summary.
COMMENT 2
A commenter reported that the proposed existing stocks provision
presents a problem for those States in which pesticide products
must have a current EPA registration to be offered for sale.
RESPONSE 2
State inspectors should take their direction from the State laws
in those States which have more stringent laws regarding the
distribution and sale of existing stocks of pesticide products no
longer registered by the EPA.
Enforcement Response
COMMENT 3
One commenter asked what would be the appropriate enforcement
action if the inspectors discovered pesticides on the
cancellation list in the marketplace.
RESPONSE 3
If an inspector finds existing stocks at the user and dealer
level which have been produced, packaged or labeled after October
10, 1989 (effective date of cancellation), those stocks are in
violation of the Cancellation Order. Registrants had until March
1, 1990, to dispose of existing stocks of cancelled products. A
Stop Sale, Use or Removal Order (SSURO) should be issued for
violative acts and penalties assessed as needed.
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Cancellation Information
COMMENT 4
One conmenter requested that the list of registrants and producer
establishments which produced since 1984 any of those pesticide
products included among the 20,000 cancellations be sorted by
registrants with product names.
RESPONSE 4
The information was developed in this format and mailed out by
OCM.
COMMENT 5
One commenter cited a need for a list of current cancellations
and SSUROs.
RESPONSE 5
This Strategy deals only with the cancellations related to
nonpayment of the registration maintenance fees. OCM will send
out periodic updates amending the list of products cancelled for
nonpayment of the fees. In addition, in April, the Compliance
Division of OCM published a booklet, "Suspended, Cancelled, and
Restricted Pesticides", which summarizes the Agency's actions on
such pesticides.
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SUMMARY
COMPLIANCE MONITORING STRATEGY FOR PESTICIDE
REGISTRATION CANCELLATIONS DUB TO NONPAYMENT OF FEES
The due date for-the EPA required payment of the maintenance
fee to maintain registration was March 1, 1989.
On October 10, 1989, EPA notified registrants of 20,000
products by letter that their registrations were being
cancelled due to nonpayment of maintenance fees. A Notice
of Cancellation was published in the Federal Register on
October 18, 1989. The effective date of cancellation was
October 10, 1989, the date of the letter informing
registrants of the Cancellation Order.
Registrants could continue to sell and distribute existing
stocks until March 1, 1990. Existing stocks are defined as
those stocks produced, packaged and labeled on or before the
effective date of cancellation.
Compliance inspections to assure compliance with these
cancellations will be conducted by States and EPA (where
there is no Cooperative Enforcement Agreement) as part of
their routine pesticide producing establishment inspections.
Due to the fact that the cancellation order allows stocks at
the dealer and user level to be used until they are
exhausted, inspections beyond those at producing
establishments are not needed.
All imports are to be checked against the cancellation list
prior to Regions signing off on the Notice of Arrival.
Exports are subject to FIFRA section 17(a) after
October 10, 1989 and should be checked as part of routine
inspections.
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COMPLIANCE STRATEGY FOR PESTICIDE
REGISTRATION CANCELLATIONS DUE TO NONPAYMENT OF FEES
OVERVIEW ;
Section 4(1)(5) of the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) requires the payment of annual pesticide
registration maintenance fees by March 1 of each year to keep
registrations in effect. During the first fee collection period
ending March 1, 1989, there were approximately 20,000 registered
products for which registrants did not pay the required fee.
Section 4(i)(5)(D) of FIFRA states that the Administrator may
cancel the unpaid registrations without a hearing. Accordingly,
Cancellation Orders were issued to cancel the majority of the
unpaid registrations. This group includes approximately 13,500
products registered under section 3 of FIFRA and about 6,000
under section 24(c) of FIFRA. The Notice of Cancellation was
published in the Federal Register on October 18, 1989 (54 FR
42936). However, the effective date of cancellation was October
10, 1989, the date of the cancellation letter. As new
cancellations go into effect for subsequent fee periods, OCM will
provide an amendment to Appendix II which will inform the Regions
of the products cancelled, the date of the cancellation, and any
existing stock provisions.
The Federal Register Notice of October 18, 1989, deferred
for 30 days the cancellations of 189 pesticide products
(containing 77 different active ingredients) for which the
registration maintenance fee was not paid. These were products
which have been in production at least one year since 1984.
Additionally, unlike the majority of the other cancelled
registrations, the records for these 189 products show that there
are no other registered products containing these active
ingredients. The deferral period allowed potentially affected
users of these pesticides an opportunity to develop strategies to
maintain the continued registration of any products important to
their needs. Only four of the registrants producing the 189
pesticide products have now complied with the provisions of the
maintenance fee requirements. See Appendix I for the list of
product registration numbers and names of the registrants.
This Compliance Monitoring Strategy provides for compliance
checks during routine producer establishment inspections to
assure compliance with the Cancellation Orders issued for
nonpayment of maintenance fees and to assure compliance with
FIFRA section 17 export requirements. Note that registrants of
cancelled products for the first fee period could continue to
sell and distribute existing stocks until March 1, 1990. Due to
the fact that the Cancellation Order allows stocks at the dealer
and user level to be used until they are exhausted, inspections
-------
beyond those at producing establishments are not needed. As the
Strategy is amended for future cancellations. Appendix II will be
updated to include Federal Register information on existing
stocks, dates of effective cancellation, etc.
REQUIREMENTS
The Cancellation Order of October 18, 1989, allowed
registrants to continue to sell and distribute existing stocks of
the cancelled products until March 1, 1990, the due date for the
next annual registration fee. Existing stocks are defined as
those stocks produced, packaged, and labeled on or before the
effective date of cancellation. Existing stocks already in the
hands of dealers or users can be sold and used until they are
exhausted. The exceptions to these provisions are cases where
more stringent restrictions on sale, distribution, or use of the
products have already been imposed through separate Agency
actions. Dates regarding existing stocks provisions for products
cancelled after subsequent fee periods can be found in
Appendix II. ?
c
Exports R
In the case of exports, any products exported after the r
effective date of cancellation must comply with section 17 of §
FIFRA, which includes citations for other applicable FIFRA I
requirements. Under section 17, prior to export, a foreign £
purchaser must sign a purchaser acknowledgement statement and a ^
copy of that statement must be submitted by the exporter to EPA. £
In addition, note that unregistered pesticides intended for ^
export must conform with labeling requirements pursuant to £
section 17, including section 2(q)(l)(H) (i.e., the label must 5^
say in a conspicuous manner "Not Registered for Use in the United §
States of America"). ^
K
COMPLIANCE MONITORING §
i
C
H-
CO
Compliance inspections are to be conducted by the States and *"
EPA (in States without Cooperative Enforcement Agreements) during ?f
routine producer establishment inspections to monitor compliance P
with the cancellations and the section 17 export provisions for %
such products. If inspectors find cancelled products at the £
producing establishment after March 1, 1990, Stop Sale, Use or §
Removal Orders (SSUROs) should be issued. Prior to establishment $
inspections, States should check the list of producing
establishments to determine if an establishment has produced one
or more of the products since 1984. Appropriate enforcement is
also to be taken for violative products.
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ALLOCATION OF RESPONSIBILITIES
The following is a summary of the allocation of
responsibilities between OPP, OCX, Regions and the States.
Office of Pesticide Programs (OPP)
Will provide the Regions and States with a hard copy and disks of
the list of products and registrants cancelled because of
nonpayment of maintenance fees for section 3 and section 24(c)
registrations.
Will provide periodic updates of deletions or additions to the
cancellation list will be provided to OCM.
Office of Compliance Monitoring (OCM)
Will provide the Regions with a list of registrants and producer
establishments which have recently produced (since 1984) any of
those pesticide products included among the approximately 20,000
cancelled for nonpayment of maintenance fees.
Will prepare the Compliance Monitoring Strategy for Pesticide
Cancellations Due to Nonpayment of Maintenance Fees and will send
periodic updates of additional cancellations or deletions to the
cancellation lists.
As new cancellations go into effect for other maintenance fee
periods, OCM will update the Compliance Strategy to include
information on the number and type of product cancellations.
Appendix II will be updated to include Federal Register
information on existing stocks, dates of effective cancellations,
etc*
Regions
T "
Will provide the States with the Strategy.
Will conduct compliance inspections as part of routine producer
establishment inspections in States without Cooperative
Enforcement Agreements to assure compliance with the October 18,
1989 Cancellation Order and section 17 export requirements.
Will distribute the list of cancelled products; the names of
registrants whose products have been cancelled; and information
on producing establishments to the States, including updates on
newly cancelled products or products whose cancellations have
been rescinded.
Will check all Notices of Arrival for imports against the list of
cancelled products before releasing such products.
Will take enforcement action and issue Stop Sale, Use or Removal
Orders (SSUROs), as appropriate.
-------
States
Will conduct compliance inspections as part of routine
establishment inspections to assure compliance with the October
10, 1989 Cancellation Order and export requirements.
Will take enforcement action and issue Stop Sale, Use or Removal
Orders (SSUROs), as appropriate.
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APPENDIX Z
The following registrants for the pesticide products listed
below, which were previously included among the 189 deferred
products, are now in compliance with the 1989 maintenance fee
requirements of FIFRA.
Reg.No.
Registrant &
Product No.
Product Name
#47319
#11275
Savanah Co.
047319-00001
047319-00002
047319-00004
Guth Corp.
011275-00002
Sevana Bird Repellent
Sevana Bird Repellent
Agrigard Insect Repellent
Lithate 2,4 D - Broadleaf Weed Killer
Non-Volatile
#01457 Hexcel Corp.
001457-00015
#08730 Hercon Environ-
mental Co.
008730=00035
Bromat
Lure N Kill Roach and Ant Killer
Insecticidal Baits With Sex Lure
CO
Ul
U>
CO
I
OJ
NJ
I"
U1
S-
-------
APPENDIX II
SUMMARY OF CANCELLATIONS
FEDERAL
REGISTER
NOTICE
MAINTENANCE
FEE PERIOD,
MARCH 1
NUMBER OF
PRODUCTS
CANCELLED
EFFECTIVE
DATE OF
CANCELLATION
EXISTING STOCKS AT
REGISTRANT, DEALER 6
USER LEVEL
10-18-89
J-89
13,500 sec. 3
6,000 sec. 24(c)
10-10-89
Registrant can continue to sell and
distribute stocks until 3-1-90. Dealer
and user can use existing stocks until
exhausted. Existing stocks are defined
as those products produced, packaged or
labeled by 10-10-89.
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APR 30 1990
** T • • : ; -. i .. • ~j ~ : *.'.'.
MEMORANDUM
SUBJECT: Strategy for Aldicarb -+*?
FROM: John J. Neylan ill. Director Sfy^&At^//?//fy/"1
Policy and Grants Division '
Office of Compliance Monitoring (EN-342)
TO: Addressees
Attached is the Compliance Monitoring Strategy for the
Voluntary Action by Rhone-Poulenc for Aldicarb.
On April 11, 1990 Rhone-Poulenc announced that it would
voluntarily stop sale aldicarb labeled for potato use and recall
stocks of aldicarb in areas where potatoes are grown, for
modification of the labels. In addition the Environmental
Protection Agency, Food and Drug Administration and the U.S.
Department of Agriculture also issued a statement on this action.
This.is a voluntary action by the company while further studies
are completed. Rhone-Poulenc has not amended its registration to
delete use on potatoes, and they have not voluntarily cancelled
the use.
No specific inspections need to be targeted as a result of
the voluntary action by Rhone-Poulenc. In keeping with the
voluntary stop sale by Rhone-Poulenc for these pesticides, the
attached strategy calls for Regions and states to notify
distributors/dealers/retailers of the action if aldicarb stocks
are found during routine inspections and to monitor compliance
with the revised label as part of any routine or for-cause
inspections.
Please transmit the strategy to the States within your
Region. If you have any questions on the attached aldicarb
strategy, please contact Virginia Lathrop at FTS 475-8418.
Attachments
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Addresses:
Douglas Campt (TS-766C)
Edwin F. Tinsworth (TS-767C)
Anne Lindsay (TS-767C)
Fredrick Stiel (LE-134A)
Mark Greenwood (LE-132A)
A.E. Conroy II (EN-342)
Connie Musgrove "
David Dull "
Mike Wood "
Jerry Stubbs "
Maureen Lydon "
Ken Kanagalingam "
Bob Zisa "
Sherry Sterling "
Jan Bearden "
Michael Walker (LE-134P)
Valerie Jewitt (TS-788)
John Tice (TS-769C)
Artie .Williams (H-7508C)
Phil Ross (LE-132A)
REGIONS, DIVISIONS:
Jake Mackenzie
Western Regional Coordinator
Louis Gitto, Director
Air Management Division, Region I
Barbara Metzger, Director
Environmental Services Division, Region II
Thomas J. Maslany, Director
Air, Toxics and Radiation Management Division
Region III
Winston A. Smith, Director
Air, Pesticides & Toxics Management Division
Region IV
&
William H. Sanders III, Director
Environmental Sciences Division, Region V
Bob Hanneschlager, Acting Director
Air, Pesticides and Toxics Division, Region VI
William A. Spratlin, Director
Air and Toxics Division, Region VII
-------
Irwin L Diskstein, Director
Air and Toxics Division, Region VIII
David P. Howekamp, Director
Air and Toxics Division, Region IX
Gary O'Neal, Director
Air and Toxics Division, Region X
BRANCH CHIEFS:
Marvin Rosenstein, Chief
Pesticides & Toxic Substances Branch
Region I
Ernest Regna, Chief
Pesticides & Toxic Substances Branch
Region II
Larry Miller, Chief
Toxic & Pesticides Branch
Region III
Richard Stonebraker, Chief
Pesticides & Toxic Substances Branch
Region IV
Phyllis Reed, Chief
Pesticides & Toxic Substances Branch
Region V
Robert Murphy, Chief
Pesticides & Toxic Substances Branch
Region VI
Leo Alderman, Chief
Pesticides & Toxic Substances Branch
Region VII
Alvin Yorke, Chief
Toxic Substances Branch
Region VIII
Davis Bernstein, Chief
Pesticides & Toxic Substances Branch
Region IX
Kenneth Feigner, Chief
Pesticides & Toxic Substances Branch
Region X
-------
Attachment
ALDICARB COMPLIANCE MONITORING STRATEGY
BACKGROUND
On Wednesday, April 11, 1990, Rhone-Poulenc announced that
it would voluntarily stop the sale of aldicarb for potato use and
recall the stocks of aldicarb labeled for use on potatoes in
areas where potatoes are grown. The recalled stocks will be
relabeled to delete the potato use. This is a voluntary action
by the company while further studies are completed. Rhone-
Poulenc has not amended its registration to delete use on
potatoes nor has the Company voluntarily cancelled the use.
COMPLIANCE ACTIVITIES '
Given that this is a voluntary action by the registrant,
sale, distribution and use of Rhone-Poulenc aldicarb for use on
potatoes remains legal. However, once a user has a product with
the potato use deleted, he may not use the product for potatoes.
Although no inspections are being specifically targeted,
routine or for-cause pesticide inspections may involve aldicarb.
During these inspections, two actions should be taken:
o When aldicarb products are found at the distributor/
retailer/user level in States where potatoes are grown,
the inspector should inform the distributer/retailer/
user of the voluntary stop sale and recommend that the
person Contact Rhone-Poulenc at 1-800-334-9745. It may be
useful to provide copies of the attached statement when
aldicarb stocks are found (See Attachment).
o If a user applies aldicarb bearing a label which no longer
has potatoes on it, appropriate enforcement action should
be taken for use inconsistent with the label.
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- 2 -
AFFECTED PRODUCTS
Aldicarb products with potato use on label:
EPA Registration No. Brand Name
264-319 Temik Brand TSX Granular Aldicarb
Pesticide (1)
264-417 Temik Brand 15G Aldicarb Pesticide (2)
264-331 Temik Brand 10% Granular Aldicarb
Pesticide (3)
(1) This is the most common aldicarb product sold in 1986 to
1988.
(2) Sold primarily in 1988.
(3) Only sold for export in 1987.
-------
Environmental News
.
(TIIUnCDAY, APRIL 11, 1990)
The following joint statement is being issued as the result of
action taken yesterday by Rhone-Poulenc Ag Co. to voluntarily stop sales
and recall the stocks of the pesticide aldicarb for use on potatoes. The
Company has informed EPA that it found the allowable residue level of
aldicarb was exceeded on a few potatoes in one field among 26 fields
tested. Aldicarb has been registered since 1970 to control insects,
mites and nematodes. Since aldicarb was registered, there have been no
reported illnesses from eating potatoes. For more information, contact
Al Heier at (202) 382-4374.
JOINT SATEMENT BY
ENVIRONMENTAL PROTECTION AGENCY
FOOD AND DRUG ADMINISTRATION
AND
U.S. DEPARTMENT OF AGRICULTURE
The Environmental Protection Agency (EPA), the Food and Drug
Administration (FDA) and the U.S. Department of Agriculture (USDA)
commend Rhone-Poulenc Ag Company for voluntarily ceasing the sale and
recalling the stocks of the pesticide aldicarb for use on potatoes due to
recent data which indicate that the allowable residue level was exceeded
on potatoes in isolated cases. The action taken yesterday is a cautious
measure to ensure the safety of our food supply.
Consumers should not be alarmed and they should continue their
normal consumption of potatoes. The company is taking this action after
recently finding that the allowable residue level was exceeded in ten
individual potatoes among approximately three hundred that were tested
following a request for data from the EPA.
In the seventeen years aldicarb has been used, there are no reports
of illness from eating aldicarb-treated potatoes. At the highest levels
found in a few potatoes, aldicarb could cause flu-like symptoms such as
nausea, headache and blurred vision which disappear quickly.
EPA will continue to review and nonitor this situation and t.ike
further action if necessary.
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x.// i" UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
- ••'•**
,,,. >y WASHINGTON. D.C. 2CM60
JAM 1 Q 1975
To: Regional— !Ulministrators
istrator" iorw
From: AssTj^aninTnistrator" iorwater
and Hazardous. Materials (WH-556)
Assistant Administrator for Enforcement,^
and General Counsel (EG-329) U
Subject: Continuing Slate Registration of Products Containing
Alclrin and Dieldrin for Which Uses Have Been Suspended
Late inDeccmbar, 1974, the Agency became aware of the existence of
activity in the above referenced matter, first in the State of California,
and subsequently in several other States in other Regions0 Preliminary
investigation into the magnitude of the problem suggests that there may
bo significant continuing activity on a national scale, that there is con-
fusion as to the ex tent of Federal jurisdiction over such activity by States,
and that the economic, political and regulatory considerations involved
require ad rational action by the Agency,
Accordingly, our joint stuffs are preparing a Federal Register notice,
v/hlch, upon publication, v/ill formally assort Fed~3".i~a.f~jurisciiction over
nop.-Fooe rally registered products containing A^rin and Dieldrin by
implLT/.cnting Section 3. of the Federal InseoTicirie, Funj^ctd'-e and
Rcder.tLcide Act (F1FRA), as amended (7 U.S. C. 136 et seo.). Attached
is a strategy pap^r v/hica explains the background of this matter in greater
detail and provides an explanation of how those Ald.-in and Dieldrin pro-
•ducts should be treated upon the activation of Section 3. In add-.tion,
proposed enforcement activities b}- the Agency, anticipated in cooperation
with involved States, is discussed,,
We shall expedite publication of this notice in the Federal Register.
Pending formal publication, you should proceed v/ith confidence in t!ie
proposed substance of the notice as outlined above and in the attached
paper to inform affected States in your Region of these developmer'-s,
Further, \vetrustyou \vill encourage their support and cooperation in our
effort to achieve orderly and equitable disposition of existing State-reg-
istered products together \vith even-handed aud coinpreheiisivc enforce-
ment of the Aldrin-Dieldrin cancellation and s*.: sponsion orders. The
Enforcement Division of each region \vili be contacted by the Pesticides
Enforcement Division in Washington v/hi.ch \vill provide additional dot ails
and support, v.-hcrc needed, to achieve Federal-State cooperalic-.i in pro-
viding notice of these developments and in proceeding \vit.h enforcement
of the Administrator's orders relating to cancellation and suspension of
Aldrin and Dieldrin,,
Enclosure:
-------
; UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
'«« «,o*0%P WASHINGTON. D.C. 20460
Strategy Paper:
State Registration of Products Containing Aldrin and'Dieldrin
for Which Uses Have Been Suspended
Background;
Late in December, 1974 Headquarters was informed by Region DC
and the State of California that products containing Aldrin and Dieldrin
were being.registered by the State in possible contravention of the intent
of the Administrator's Order of December 7, 1972 (37 F.R. 26463, 26465).
That order provided that henceforth all technical Aldrin and Dieldrin
must bear the label restriction: "For use only in formulating prodvicts
bearing EPA-approved FIFRA registrations." It was thought that such a
restriction on use of the technical material, which is available only
through import and therefore subject to Federal jurisdiction, would pre-
clude further formulation of finished products for State registration
and thereby provide ds facto Federal control of all products containing
Aldrin or Dieldrin, Investigations by California and Region IX (confirmed
now by several other Regions and State.-;) have revealed that many State-
rc-ffistaved Alck-Ln-Dieldrin products wore: 1) formulated from technical
material held prior to December 7, 1972 and therefore not subject to the
restrictive labeling requirement, 2) formulated from so-called "end-
use" or finished Aldrin-Diclclrin products bearing State or Federal
registi-ations and lacking any stated restrictions concerning refor-
mulation, 3) formulatod from technical meterial sold after December 2,
1972 which failed to bear the required restriction, 4) formulated from
technical material restrict!vely labeled and ignored by the formulator.
Stales, having lately become aware, of the intent of the Decemoer, 1972
order, are faced with a dilemma: pressure to reregister for continued
shipment, sale and use products formerly approved by them and the
likelihood that such registration contravenes at least the spirit, and- in
some cases possibly the letter, of a Federal cancellation order,
Action;
In order to clarify existing ambiguities concerning the legal status of
these non-Federally registered products with respect to Federal ju:-i^ac-
tion over their production, shipment, sale, and use, and to insure -jvon-
handod enforcement of the Aldrin and Dieldrin cancellation and sus;;ti-|Pion
orders, ihe Agency will formally implement Section 3 of the Federal Inso.c-
ticide, Fungicide, and Rodculicide Act, as amcndod (7 U, S. C. 13G ct seq.)
by notice in the Federal Register. This notice will contain an exemption,
-------
-2-
pursuant to the provisions of Sections 6(a)(l) and 15(b)(2) of the Act, allow-
ing States to register fox* orderly disposition through shipment, sale and
use in that State, existing stocks of products containing Aidrin and
Dieldrin produced on or before the date of signature by the Administrator
of the order implementing Section 3 of the Act as to these State-registered
products. Effective the day follov/ing signature of the order implementing
Section 3 of the Act, production of products containing Aldrin and Dieldrin
must cease, and States rmist cease to register for shipment, sale and use
any but existing stocks of such products.
Regional offices should arrange to advise appropriate authorities in
States in that Region, in advance, of the planned activation of Section 3
and its attendant prohibitions, and should request State authorities to
noti'y all State registrants and any other potentially affected parties of
the activation of Section 3 and of the effective date of related prohibitions.
States are to be asked to provide to the appropriate Regional OCficcs lists
of State registrants or persons -.vith registration applications pending for
products containing Aldrin or Dieldrin, Information relating to location
and relative amounts of these State-registered products also is to be
sought.
The Agency's pesticides enforcement personnel \vill enlist Slate coope-
ration in continuing its on-goiny investigation of the formulation since
December 7, 1972, 01" products containing Aldrin or Dieldrin for State
registration. Should it be the case that Federal registrants of technical
Ald'rin orDiclcU'in have not r^ir.belc^ their products in coni'ormance v/ith
the Administrator's Order of December 7, 1072, or that posticicJ•;- pro-
ducers have formulated products containing Alcirin or Dieldrin in con-
travention of labeling prohibitions against use in non-Federally rc'gisrcred
products, such violations \vill be prosecuted in accordance v/ith the appro-
priate provisions of the Act.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
To: [Enforcement Division Directors]
From: A. E. Conroy II, Director // ,*[ (,T
Pesticides Enforcement Division /* • "
Subject: Non -Federally Registered Products Containing Aldrin or Dieldrin
Background;
In his memorandum of December 10, 1974, Point #4, the Director
advised that production of non-Fed-arally registered products containing
Aldrin and Dieldrin contravened the December 7, 1972 Order of the
Administrator (37 F.R. 25463, 26465). The intent of that ord«*r was to
restrict use of technical Aldrin and Dieldrin to use in EPA-registered
products only. The Director's memorandum continued that production
of non-Fedcrally registered products containing Aldrin and Dieldrin
could subject such products to stop sale and their producers to liability
under Sections 12(a)(2)(G) and (K) of the Act.
Subsequent to the Director's memorandum, it has come to the
Agency's stcention that numerous products containing Aldrin anu Dieldrin
r-'.a*' have be~n produced since December 7. 1972 and rpaistproH v»y .«;roT^ =
under circumstances not strictly contravening the December, 1972 Order.
Details concerning this production and questions relating to the scone of
Federal jurisdiction over such production under the December, 1972
Ord**** are elaborated in the attached memorandum and strategy paper,
which »vere sent to all Regional Administrators on January 10, 1975.
Action;
For purposes of I- ederal enforcement activity, the following develop-
ments are important:
1) The Agency has determined to implement Section 3 of the
Act with respect to products containing Aldrin and Dield: in
intended for intrastate shipment. States will be permitted
to register and allow shipment, sale and use in that State
of stocks of products containing Aldrtn or Dieldrin in 3:
-------
-2-
and States must cease to permit registration or to allow
shipment, sale or use of any but existing stocks. Viola-
tions of the Act will be subject to prosecution 60 days
after Federal Register publication of the Administrator's
order. (This of course will not apply to- those products
registered Federally and by States for uses which have
not been suspended: 1) subsurface ground insertion for
termite control; 2) dipping of non-food roots and tops; 3)
moth-proofing in a closed system.)
2) It is the obligation of each Region to notify, in advance,
appropriate State authorities of this development and its
attendant prohibitions and to enlist their aid in notifying
registrants and other affected persons in their State.
Attached is a sample letter which States may wish to
employ as a guide in the notification process.
3) Immediately upon signature, of the Section 3 order. Head-
quarters staff will notify Regional officials who should con-
tact the State authorities directly.
4) Cooperation and aid of State authorities is to be enlisted in
obtaining for Federal use:
- lists of State registrants or persons with applications
pending for Aldrin-Dieldrin product registration;
- information on location an<^ relative am/Mints or" such
ducts within the Slate;
- assistance of State enforcement authority to achieve com-
pliance with the production, registration, and shipment,
sale and use cut-off.
5) EPA regional personnel are to continue their investigations
of production since December 7, 1972 of products contain-
ing Aldrin and Dieldrin for Siato registration. Should it be
determined -;ha*. Federal registrants of technical Aldrin or
Dieldrin have not relabeled their products in conformance
with the Administrator's Order of December 7, 1972, or
that pesticide producers have formulated products confin-
ing Aldrin or Dieldrin in contravention of labeling prohi-
bitions against use in non-Federally registered products,
such violations are to be prosecuted in accordance with the
appropriate provisions of the Act.
Shorld you have questions or encounter difficulty with regarr, to any
of these matters, please notify the appropriate Regional Coordinator.
Attachments:
-------
Attachment I
Aldrin - Dieldrin Strategy
1. R.C. 's phone Region in advance of order - inform of "strategy
2. R.C. 's send Director's enforcement package to Regions
3. Regions inform States of pending action and request names of
State registrants
4. PEP sends Administrator's order to Regions
5. HDQ sends Administrator's order to States
6. States or Regions notify State registrants of order
(See Attachment ii).
7. Regions follow-up at each State registrant.
-------
Attachment II SAMPLE LETTER
State Registrant
(Address)
Gentlemen:
On (date), the Administrator of the United States Environmental
Protection Agency issued an Order asserting Federal jurisdiction over
all non-Fedcrally registered Aldrin-Dieldrin products in intrastate
commerce by invoking Section 3 of the Federal Insecticide Fungicide,
and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136 ct seq. ).
As a result of this Order, the shipment, sale, and use of non-Feder-
ally registered Aldrin-Dieldrin products, produced after the effective
--d-ate-of-the-Grd-cr-wiit-be-prohibited-- AtrcorxiiTiglyT^he-St^crnjf-frraTm^
can register or continue registrations only of non-Federally registered
Aldrin-Dieldrin products v/hich were produced on or before the date
of the Order. Such registrations are being permitted to allow the
orderly disposition of non-Federally registered products through
shipment, sale, and use in the registering State.
Any further questions regarding the Order should be directed to
Mr. , EPA, Region , street _,
city, , State , telephone number
Sincerely,
-------
Attachment III
Types of Violations Involving Non-Federally Registered products
containing Aldrin or Dieldrin
1. Failure of a Federal registrant to place a statement such as "For
use only in formulating products bearing EPA-approved FIFRA
registrations" on manufacturing use only labels.
Violation: Misbranded, inadequate directions
Section 12(a)(l)(E)
Action: Civil/Criminal/Stop Sale
2. Use of a "manufacturing use only" product bearing a statement such
as "For use only in formulating products bearing EPA-approved
FIFRA registrations" on the label in a non-Federally registered
Aldrin - Dieldrin product.
Violation: Misuse Section 12(a)(2XG)
Action: Civil/Criminal/Stop Use
3. Sale of a non-Federally registered Aldr-in - Dieldrin product pro-
duced after the effective date of the Order, but before violations
are actionable (GO clays after publication in the Federal Register).
Action: Slop SaL^
4. Sale of a non-Federally registered Aldrin-Dieldrin product pro-
duced after the effective date of the Administrator's Order (day
after signature) and after the date violations become enforceable
(60 days after publication in the Federal Register).
Violation: Ken registration Sec. 12(a)(l)(A)
Action: Civil /Criminal /Stop Sale
-------
J*
^ V
g UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
V
* Vj^S^-
Policy and Grants Division r\~\^ Jf^^
Office of Compliance MonltorlngJ f\ <£)
TO: Addressees
Attached Is the Compliance Strategy for the Cancellation
of the Non-wood Uses of the Inorganic Arsenlcals. On June 30,
1988, the Agency published "Inorganic Arsenlcals; Intent to
Cancel Registrations for Pesticide Products Registered for Non-
Wood Preservative Use; Conclusion of Special Review" in the
FEDERAL REGISTER (53 FR 24787). This notice, which Is also
attached, cancelled all minor uses of Inorganic arsenlcals with
the exception of the Insecticide use of arsenic trloxide in a
solid formulation and packaged In a sealed metal container, and
the solid formulation of arsenic trioxide for the control of
moles, gophers and pocket gophers. Also attached is a summary
of the action for your convenience.
The turf herblctdal use of the flowable formulation of
calcium arsenate, the grapefruit growth regulator use of lead
arsenate, the grape fungicidal use of sodium arsenlte, and the
desiccant uses of arsenic acid on cotton and okra grown for
seed, I.e., the major uses, are still under special review
awaiting food crop residue data from registrants as requested
under FIFRA §3
-------
-2-
The cancellation has been appealed and a list of those
persons appealing the cancellation Is attached. If you have
any questions concerning this action please contact David
Stangel of my staff at 382-3477.
Attachments
-------
ADDRESSEES
Douglas D. Campt (TS-766C)
Edwin F. Tinsworth (TS-767C)
Anne Lindsay (TS-767C)
Frederick F. Stiehl (LE-134A)
Mark Greenwood (LE-132A)
A. E. Conroy I I (EN-342)
Connie Musgrove w
John J. Neylan I 11 "
David DulI "
Mike Wood
PhylI is Flaherty
Jerry Stubbs
Maureen Lydon
Ken Kanagalingam
Bob Zisa
Sherry SterlIng
it
it
it
it
it
n
ii
Jake Mackenzie
Western Regional Compliance Director
I Louis F. Gitto, Director
Air Management Division
LJ Barbara Metzger, Director
Environmental Services Division
III Stephen R. Wassersug, Director
Hazardous Waste Management Div
IV Winston A. Smith, Director
Air, Pest. & Toxics Mangt. Div
V William H. Sanders III, Director
Environmental Services Division
VI William B. Hathaway, Director
Air, Pesticides & Toxic Division
VII William A. Spratlln, Director
Air and Toxics Division
VIII Irwln L. DIcksteIn, Director
Air and Toxics Division
IX David P. Howekamp, Director
Air Management Division
X Gary O'Neal, Director
Air and Toxics Division
Marvin Rosenstein, Chief
Pesticides 4 Toxic Substances Br
Ernest Regna, Chief
Pesticides 4 Toxic Substances Br
Larry Mi Iler, Chief
Toxic 4 Pesticides Branch
Richard DuBcse, Chief
Pesticides 4 Toxic Substances Br
PhylI Is Reed, Chief
Pesticides 4 Toxic Substances Br
Robert Murphy, Chief
Pesticides 4 Toxic Substances Br
Carl Walters, Acting Chief
Pesticides 4 Toxic Substances Br
Alvln Yorke, Chief
Toxic Substances Branch
Davis Bernstein, Chief
Pesticides 4 Toxics Branch
Kenneth Feigner, Chief
Pesticides 4 Toxic Substances Br
cc: Michael Walker (LE-134P)
Jim Roeloffs (TS-788)
John Tlce (TS-769C)
-------
COMPLIANCE STRATEGY FOR THE CANCELLATION OF
NONWOOD USES OF THE INORGANIC ARSENICALS
OVERVIEW
On June 30, 1988, the Agency published "Inorganic
Arsenicals; Intent to Cancel Registrations for Pesticide
Products Registered for Non-Wood Preservative Use; Conclusion
of Special Review" in the FEDERAL REGISTER (53 FR 24787),
which cancelled all minor uses of Inorganic arsenicals with the
exception of the Insecticide use of arsenic trioxide in a solid
formulation and packaged In a sealed metal container, and the
solid formulation of arsenic trioxide for the control of moles,
gophers and pocket gophers.
The turf herblcidal use of the flowable formulation of
calcium arsenate, the grapefruit growth regulator use of lead
arsenate, the grape funglcldal use of sodium arsenlte, and the
desiccant uses of arsenic acid on cotton and okra grown for
seed, i.e., the major uses, are still under special review
awaiting food crop residue data from registrants requested
under FIFRA §3(c)(2)(B). A reassessment of the carcinogenic
potency of Inorganic arsenic as it relates to dietary and
dermal exposures will be conducted when this data Is received.
REQUIREMENTS OF THE RULE
All minor uses of inorganic arsenicals with the exception
of the Insecticide use of arsenic trioxide in a solid
formulation and packaged in a sealed metal container, and the
solid formulation of arsenic trioxide for the control of moles,
gophers and pocket gophers are cancelled effective August 8,
1988. Manufacturers of cancelled products are required to
notify their distributors of the time limits on distribution
and sale of cancelled products in the possession of the
distributor by July 25, 1988, and to keep records of the date
of contact with the distributor.
Regulated Industry
All registrants, producers, distributors, and users of the
minor use products of Inorganic arsenlcals with the exception
of arsenic trioxide products registered as an insecticide for
use In a solid formulation and packaged in a sealed metal
container or as a solid formulation for the control of moles
gophers and pocket gophers. This action affects 45 registrants
producing 60 products.
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-2-
Ex I st I ng Stocks
As of August 8, 1988, no existing stock of any cancelled
product may be distributed, sold, offered for sale, held for
sale, shipped, delivered for shipment, or received and (having
so received) delivered or offered to deliver, or used. This
includes products voluntarily cancelled which would otherwise
still be allowed to be sold under the terms of the voluntary
cancellation. Persons holding existing stocks of cancelled
products must dispose of them In accordance with the applicable
requirements of the Resource Conservation and Recovery Act
(RCRA). NoncompI Iance with the cancellation order is a
violation of FIFRA §§ 1 2(a)(1 )(A) and 12(a)(2)(K).
COMPLIANCE MONITORING
Compliance with the NOIC will be determined by inspection
of registrants and producers of cancelled products to determine
If production and sale for distribution within the U.S. has
ceased and that distributors have been notified of the action
as required by the Notice. These Inspections are to be carried
out within 6 months of receipt of this compliance strategy.
During routine inspections of dealers and users. Inspectors
should ensure that cancelled products are no longer being sold
or used. Tips and complaints are to be investigated as
rece ived .
Neutral Administrative Inspection Scheme
Since the issuance of the Cancellation Order Is an
administrative action which cancels all minor non-wood
preservative uses of the inorganic arsenicals with the
exception of the two previously mentioned uses of arsenic
trioxide, Inspections for violations of this cancellation order
will take place within the existing compliance monitoring
framework.
ALLOCATION OF RESPONSIBILITIES
Office of Pesticide Programs
Will develop and provide OCM with a list of products affected
by this Notice and their registration status.
Office of Compliance Monitoring
WIN develop and transmit the Compliance Monitoring Strategy to
the Regions.
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-3-
WMI transmit the list of those products which have been
cancelled to the Regions.
Will transmit the list of registrants and producing
establishments of Inorganic arsenicals to the Regions.
Reg ions
Will provide copies of the Compliance Monitoring Strategy to
the States.
Will distribute a list of products, registrants and producing
establishments affected by this Notice to the States.
Will conduct Inspections in States without Cooperative
Enforcement Agreements as part of their routine Inspectional
schedule.
Will take enforcement actions as appropriate.
States
Will conduct Inspections of registrants within 6 months of
receipt of the compliance strategy.
Will conduct inspections of dealers as part of their routine
inspectional schedule.
Will take enforcement actions as appropriate.
Will report to the Regions on actions taken under this Notice
-------
INORGANIC ARSENICALS NON-WOOD PRESERVATIVE USES
NOTICE OF INTENT TO CANCEL
All non-wood preservative uses of inorganic arsenical pesticide
products are cancelled effective August 8, 1988, with the
exception of the following uses.
The following registrations will be retained without change;
1. Arsenic trioxide insecticide use (solid formulation
manufactured in a sealed metal container only) for:
Domestic outdoor - domestic dwellings
Domestic indoor - domestic dwellings
2. Arsenic trioxide mole, gopher, and pocket gopher killer use
(solid formulation only) for:
Domestic outdoor - domestic dwellings
Terrestrial non-food crops - golf courses, ornamental
plants and lawns, non-crop areas
Registrations not considered in this action;
1. Lead arsenate plant growth regulator use on grapefruit.
2. Sodium arsenite fungicide use on grapes.
3. The desiccant uses of arsenic acid on okra (grown for seed)
and cotton.
4. The flowable formulation of calcium arsenate for use on
turf.
Decisions on these uses are deferred pending the Agency's Risk
Assessment Council's reassessment of the carcinogenic potency
of inorganic arsenic for dermal exposure and the receipt of
dietary exposure data the Agency has requested.
Effective Dates
As of August 8, 1988, no existing stock of any cancelled
product may be distributed, sold, offered for sale, held for
sale, shipped, delivered for shipment, or received and (having
so received) delivered or offered to deliver, or used. This
includes products voluntarily cancelled which would otherwise
still be allowed to be sold under the terms of the voluntary
cancellation.
Registrants were required to notify their distributors of
cancelled inorganic arsenical products by July 25, 1988, to
inform them of the time limitations on distribution and sale of
existing stocks in the hands of the distributor.
-------
PARTIES REQUESTING A HEARING
Jones Products Company
Box 204
Middleton, WI 53562
Jones Ant Killer EPA Reg. No. 29-4
Senoret Chemical Company
566 Leffingwell Ave.
Kirkwood, MO 63122
Terro Ant Killer EPA Reg. No. 149-2
General Pest Service Co.
1819 Goldfield Street tB
North Las Vegas, NV 89030
Jit Jex Redwood Ant Stakes EPA Reg. No. 3324-3
Protexall Products, Inc.
1109-11 Hwy 427 N.
Longwood, FL 32750
Protexall "Ant-Kil" EPA Reg. No. 4972-8
-------
,,€0
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
JUL 6
OFFICE OF
PBSTICIDCS AND TOXIC SUOSTX
MEMORANDUM
SUBJECT
FROM:
TO:
Compliance Strategy for the Conditional Registration
and" Cancellation of Certairf\$romoWni
John J. Neylan III, Director
Policy and Grants Division
Office .of Compl iance Monitori
Addressees
On May 5, 1989 the Agency approved an Agreement with Rhone-
Poulenc to conditionally amend the-registrations of three
bromoxynil pesticide products (buctril, bronate, and buctril +
atrazine), pursuant to FIFRA section 3(c)(7)(A).
On June 5, 1989 the Director of the Office of Pesticide
Programs, Office of Pesticides and Toxic Substances, signed a
FEDERAL REGISTER .Notice entitled: "Order Cancelling Registrations
For Pesticide Products Containing Bromoxynil Butyrate." The
registrant requested voluntarily cancellation of bromoxynil
butyrate products and proposed to conduct a recall of the
cancelled products down to the user level.
Attached are the Final Compliance Monitoring Strategy, a
summary of the Strategy, a copy of the Agreement between the
registrant and EPA, and the Cancellation Order. Please transmit
a copy of the Strategy and other attachments to the States.
Please note that because of the nature of this action, this
Compliance Strategy is immediately effective. If you have any
questions or comments regarding the Strategy, contact Steve Howie
(E-mail EPA 7201, FTS 475-7786) of my staff.
Thank you for your cooperation.
Attachments
-------
ADDRESSEES
I I
IV
VI
Douglas D. Campt (H7501C)
Edwin F. TInsworth (H7505C)
Anne Lindsay (H7505C)
Frederick F. Stlehl (LE-134A)
(LE-132A)
(EN-342)
Mark Greenwood
A. E. Conroy I I
Connie Musgrove
Mike Wood
Jerry Stubbs
Sherry SterI ing
David Dui l
Ken Kanagalingam
Bob Zisa
John J. Neylan III
PhylI is E. Flaherty
Maureen Lydon
Jake Mackenzie
Western Regional Compliance Director
H
If
II
If
II
It
tf
It
Louis F. Gltto., Director
Air Management Division
Barbara Metzger, Director '
Environmental Services Division
Stephen R. Wassersug, Director
Hazardous Waste Management Dlv
Winston A. Smith, Director
Air, Pest. 4 Toxics Mangt. Div
William H. Sanders III, Director
Environmental Services Division
WlI I iam B. Hathaway, Director
Marvin Rosensteln, Chief
Pesticides 4 Toxic Substances Br
Ernest Regna, Chief
Pesticides 4 Toxic Substances Br
Larry Ml Iler, Chief
Toxic 4 Pesticides Branch
Richard DuBose, Chief
Pesticides 4 Toxic Substances Br
PhylI is Reed, Chief
Pesticides 4 Toxic Substances Br
Robert Murphy, Chief
Air, Pesticides 4 Toxic Division. Pesticides 4 Toxic Substances Br
VII William A. Spratlln, Director
Air and Toxics Division
VIM Irwin L. Dlcksteln, Director
Air and Toxics Division
IX David P. Howekamp, Director
Air Management Division
X Gary O'Neal, Director
Air and Toxics Division
Car.l Walter, Acting Chief
Pesticides 4 Toxic Substances Br
Alvln Yorke, Chief '
Toxic Substances Branch
Davis Bernstein, Chief
Pesticides 4 Toxics Branch
Kenneth Feigner, Chief
Pesticides 4 Toxic Substances Br
cc: Michael Walker (LE-134P)
Jim Roeloffs (TS-788)
John TIce (TS-769C)
Al Heier (A-107)
-------
BROMOXYNIL CONDITIONAL REGISTRATION AND VOLUNTARY CANCELLATION
COMPLIANCE MONITORING STRATEGY SUMMARY SHEET
1. Conditional Registration of products containing Buctril,
Bronate, and Buctril + Atrazine.
TARGET DATE FOR
INSPECTION
CONDITIONS OF REGISTRATION TO BE MONITORED BY
INSPECTION
LEY
by 8/7/89
by 9/6/89*
Restickering of products released for shipment
after 5/5/89; Stickers sent to dealers for
relabeling by 5/15/89.
Restickering of dealer stocks carried out by
Registr
Produce
Distrifc
by 9/6/89*
between 10/1/89
and 11/1/89
between 10/1/89
and Spring, 1990
growing season
5/25/89; Point-of-purchase communication carried
out by registrant per schedule in conditions of
registration.
Used only by certified applicators according to User
conditions of registration.
Revised Labelling on all products by 10/1/89; all - Registr
bulk containers have correct transfer mechanism by Produce
10/1/89.
Compliance with EPA-approved user training plan. Registry
Plan must be implemented prior to 1990 Spring User
growing season. • Interfac
2.
Vp] untary Cajicel lation of Broiaoxynil Butyrate Products**
LEVEL
TARGET DATE FOR
INSPECTION
ACTIVITY TO BE MONITORED BY INSPECTION,
PER TARGET DATE
by 8/7/89
by 9/6/89*
by 9/6/89*
No shipments intended for sale/use after 6/12/89
No sale after 6/12/89
No use after 6/12/89
Registrar
Producer
Distribui
User
* As part of routine inspections.
** Includes the following products: Dragonmate, ME 4 Bromfnal, Torch Twin Pak, 3+3
Brominal, Bromoxynil Butyrate Technical, Certrol, and Buctril 4 EC.
-------
COMPLIANCE STRATEGY FOR THE CONDITIONAL REGISTRATION
AND CANCELLATION OF CERTAIN BROMOXYNIL PRODUCTS
OVERVIEW :
Bromoxynil is 'a selective, postemergence herbicide used to
control broadleaf weeds primarily in field corn, wheat, garlic,
barley, oats, rye, sorghum, onions and flax. Most use occurs
between February and June on small grains and corn.
On May 5, 1989 the Agency approved an Agreement with Rhone-
Pou,lenc to conditionally amend the registrations of three
bromoxynil pesticide products (buctril, bronate, and buctril +
atrazine), pursuant to FIFRA section 3(c)(7)(A).
On June 5, 1989 the Director of the Office of Pesticide
Programs, Office of Pesticides and Toxic Substances, signed a
FEDERAL REGISTER Notice entitled: "Order Cancelling Registrations
For Pesticide Products Containing Bromoxynil Butyrate." The
registrant requested voluntarily cancellation of bromoxynil
butyrate products and proposed to condu'ct a recall of the
cancelled products down to the user level.
REGULATED COMMUNITY
Rhone-Poulenc, the only registrant, producers,
distributors, and users of bromoxynil are affected by the
Agreement and the Cancellation Order, although responsibility
for meeting the terms of the conditional registration Agreement
is on the registrant. At the time of the Agreement and
Cancellation Order there were 8 registrations and 6 producer
establishments. A list of these can be found in the Appendix.
REQUIREMENTS QF CONDITIONAL REGISTRATION
Under FIFRA Section 3(c)(7)(A), EPA.has imposed certain
conditions for the continued registration of three bromoxynil
octanoate products (buctril, bronate, and buctril + atrazine).
These conditions include adding warning statements to the
product labels stating that exposure during pregnancy causes
birth defects in laboratory animals, restricting its use to
certified .applicators, and requiring additional protective
clothing for mixers, loaders and applicators.
The registrant is also required to conduct an extensive
notification and educational program for bromoxynil users to
inform them of the potential birth defect risks for mixing,
loading and applying bromoxynil as well as the importance of
following the new risk reduction measures.
The registrant is also required to provide extensive
data within specified time frames and interim reports to enable
-------
-2-
the Agency to better estimate the magnitude of risk to exposed
workers.
Stocks of Products with Amended Sticker ina/Labelincr
By May 6, 1989 the registrant was required to halt shipment
of all bromoxynil products until approved amended stickers are
affixed to each container within the company's possession.
By May 15, 1989, the registrant was required to provide
each distributor holding inventory of bromoxynil products
sufficient stickers for such inventory.
By" May 25, 1989 the registrant was required to provide each
reseller and retailer holding inventory of bromoxynil products
sufficient stickers for such inventory.
>
The registrant was also required to provide each
distributor, reseller, and retailer with instructions concerning
the manner in which the sticker must be affixed to each
container, and to implement the attached labeling communication
plan by the dates described therein.
The registrant is also required to assume responsibility
for insuring that each distributor, reseller or retailer
attaches the sticker to each container which is sold or
distributed by the distributor, reseller or retailer after the
date the stickers are received.
After October 1, 1989, revised labeling, which deletes all
claims, references, and use directions pertaining to the
.previously permissible uses for turf and non-crop areas, and
which includes all new label provisions as required by the
agreement, must be attached to the containers of all bromoxynil •
products released for shipment by the registrant.
Additional Requirements
By October 1, 1989, the registrant must develop and submit
to EPA a proposed program to provide additional training to
users of bromoxynil products prior to the 1990 spring use season
and will implement the program once it has been approved by EPA.
By October 1, 1989, the registrant is also required to
establish a. program to provide assistance to users who do not
own a mechanical transfer system which terminates in a drop-
free hard coupling and who wish to obtain such a system or to
modify their present system.
After October l, 1989, the registrant is required to insure
that all bulk containers released for shipment include a
mechanical transfer mechanism which terminates in a drip-free
hard coupling which may be used only with a spray or mix tank
which has been fitted with a compatible coupling.
-------
-3-
By January 1, 1990, the registrant is required to have
investigated and reported to EPA, the feasibility of packaging
bromoxynil products in containers which are smaller than 30
gallons and which include a hard coupling designed for use with
a specific closed mixing and loading system.
By specified dates, the registrant is required to develop
and submit rabbit dermal teratology, male reproduction effects
and worker exposure studies to EPA. The agreement requires the
registrant to submit one- line, status reports on each required
study on at least a quarterly basis to EPA.
CONDITIONS OF CANCELLATION
All pesticide products containing bromoxynil butyrate were
automatically canceled, effective the day following publication
of the Cancellation Order in the Federal Register.
Recall _ : _
In their request for voluntarily cancellation, the Company
stated that it would institute a plan to recover remaining
stocks of these products from distributors, dealers, and users.
Existing Stocks _
Sale, distribution and use of existing stocks of bromoxynil
butyrate product now in the possession of distributors, retailers
and end-users is not permitted after the date of publication of
the Cancellation Order in the Federal Register. The registrant
also .indicated that they will accept for disposal any stocks of
bromoxynil butyrate products turned in by distributors, dealers
and end-users. Persons holding existing stocks of cancelled
bromoxynil butyrate products must dispose of them in accordance
with the applicable requirements of the Resource Conservation and
Recovery Act (RCRA) . Noncompliance with the cancellation order
or its terms is a violation of FIFRA sections 12(a)(l)(A) and/or
COMPLIANCE MONITORING
Regional/State Activities
Inspections will.be conducted by the States and EPA (in
non-grant states) to monitor complitance with the Conditional
Registration" Agreement and the Canc'e Hat ion 'Order. This will be
accomplished through registrant; producer establishment, and
marketplace inspections. Enforcement actions regarding the
Cancellation Order will be taken, as appropriate, by the States
and Regions, with reports of such actions and/or potential
violations made to EPA headquarters. States and Regions will
also report to EPA headquarters all violations or potential
-------
-4-
and Regions, with reports of such actions and/or potential
violations made to EPA headquarters. States and Regions win
also report to EPA headquarters all violations or potential
violations of the conditions of registration of bromoxynil
octanoate products.
Registrant/Producer Level
Within 30 days of the date of this strategy, the
Regions/States will schedule and conduct inspections of Rhone-
Poulenc's producer establishments to obtain assurance that the
company has complied with the requirements of the May 5, 1989
Agreement "by not having released products for shipment without
the amended stickers, and the June 5, 1989 Cancellation Order
to determine if production and sale for distribution of
cancelled bromoxynil products within the U.S. has ceased.
Information obtained during inspections of registrants records
regarding disposition of stocks of conditionally registered and
cancelled products should be forwarded to other Regions for
their use in scheduling inspections.
After October 1, 1989 inspections at producer
establishments will assure that all products released for
shipment by the registrant have the required revised labelling,
and that all bulk containers released for shipment include the
required mechanical transfer mechanism with a drip-free hard
coupling.
After October 1, 1989, and before the Spring 1990 planting
season, inspections will be conducted to determine registrant
compliance with the EPA-apprbved plan for user training and
assistance. This plan will be sent to the States and Regions
following its approval. The inspections will be appropriately
directed at the registrant-user interface and may, for example,
include monitoring or inspection of training sessions/materials
by Regions or States.
within 60 days of the date of this strategy, the
Regions/States will follow-up and track the recall of the
cancelled bromoxynil butyrate products, that the registrant is
undertaking, following the outlines in section 14 of the
Pesticides Inspection Manual.
Distributor/Reseller/Retail Level
Within 60 days of the date of this strategy, the
Regions/States will inspect, during routine scheduled
inspections, distributors, resellers, and retailers to assure
that the registrant has adhered to the time frames and
requirements listed above under "Requirements of Conditional
Registration," and the June 5, 1989 Cancellation Order to
determine if sale and distribution of cancelled bromoxynil
butyrate products within the U.S. has ceased.
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-5- . .
User Level
Within 60 days of the date of this strategy, inspectors
will assure, during routine scheduled inspections, that non-
cancelled bromoxyni.l products are being used only by certified
applicators and in accordance with the use directions and
protective clothing requirements on the amended sticker/label,
and that cancelled bromoxynil butyrate products are not being
used.
ALLOCATION OF RESPONSIBILITIES
of Pesticide
Will develop and provide OCM with a list of all products
affected by the Conditional Registration Agreement and the
Cancellation Order.
Office of Compliance Monitoring _ • _
Will develop and transmit the Compliance Monitoring Strategy to
the Regions.
Will receive quarterly reports from Regions for one year
following the date of this Strategy.
Will transmit to the Regions a list of those affected products
and a list of producing establishments.
Will transmit to OPP any information regarding violation of the
conditions of registration.
Regions
Will provide copies of the Compliance Monitoring Strategy to
States.
Will report quarterly to the Director of the Compliance
Division, OCM detailing State inspection activities per their
quarterly reports, for one year following the date of trhis
Strategy.
Will distribute a list of products, and producing establishments
to the States.
Will conduct inspections in States without Cooperative
Enforcement Agreements as specified in this Strategy.
Will take enforcement action as appropriate.
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-6-
noncompliance with the requirements of the Agreement,.including
information on tips and complaints received.
Will report to the Director of the Compliance Division, OCM
regarding violations of the conditions of registrations
immediately upon receiving such information.
Spates '.
Will conduct inspections as specified in this Strategy.
Will make quarterly reports to.the Regions detailing the number
and dates-of inspections related to this Strategy, for one year
after the date of this Strategy.
Will take enforcement action as appropriate provided they have
the authority.
Will report to the Regions on potential violations of the
bromoxynil conditional registration agreement, including
whether training and assistance activities are conducted, and
enforcement actions for violations of'the Cancellation Order.
Reports will be submitted within two weeks of knowledge of
violation or enforcement action.
Will investigate tips and complaints as received. If States
receive information which indicates possible noncdmpiiance with
the .Agreement ,• they should-investigate to ensure compliance.
-------
APPENDIX
BRQMOXYNIL REGISTRANT, PRODUCTS, AND PRODUCING ESTABLISHMENTS (1985-87)
Rhone-Poulenc AG Company
P.O. Box 12014 2 T.W. Alexander Drive
Research Triangle Park, NC 27709
Product Name
Buctril*
EPA Reg. No.
264-437
Broot 15GX (Bronate)* 264-438
il II
Buctril + Atrazine*
ME 4 Brominal
(Buctril ME 4)**
(Also produced as
3+3 Brominal
and Torch Twin Pack)
264-477
264-340
Estab. No.
264-OR-001
264-OR-001
264-IA-001
Estab. Address
Rhone-Poulenc AG Company
6200 W St. Helens Rd.
Portland, OR 97210
Rhone-Poulenc AG Co
2100 S 21st St.
Clinton, IA 52732
No USA Production Records for 1985-88
264-MO-001
Rhone-Poulenc
PO Box 367
317 West Florence Rd
St. Joseph, MO 64502
Buctril 4 EC'**
Certrol**
264-474
264-421
264-NC-001
55259-IL-001
2393-IL-003
Rhone-Poulenc AG Company
T.W. Alexander Dr
Research Triangle Pk, NC 27709
Bradford Ag Service Inc.
401 Phoenix Ave
Bradford, IL 61421
Hopkins Agri. Chemical Co.
303 SU Arch St.
Atlanta, IL 61723
No USA Production Records for 1965-88
264-MO-001 Rhone-Poulenc AG Company
PO Box 367
317 West Florence Road
St. Joseph, MO 64502
2393-IL-003 Hopkins Agricultural Chemical Co
303 SW Arch St.
Atlanta, IL 61723
-------
-2-
Dragormate Broadleaf 264-339
Herbicide**
264-MO-001
Rhone-Poulenc
PO Box 367
317 West Florence Rd
St. Joseph, MO 64502
* conditionally registered products.
** Registrant has requested voluntary cancellation of these registered products and they are
cancelled by the cancellation order published in the FEDERAL REGISTER (54 FR 24948).
-------
Federal Register / Vol. =14. No. Ill / Monday. June 12. 1989 / Notices
24949
Name o4 aoohcarM
Locauon
Protect dcscnnon
Reviewing agency
Dmeot imel
action
Long latand lighting Co. > ' Weet Babylon. NY.
Naaaau Ciatnet Energy Cars.., unondale. NY
Karrane Cirthage Cogenera- ' driftage. NY
don Co . Inc. I
Momll Press Co I Fultan, NY
Kam.re Sou* Glens Fi.a Soctn Glens FaJa.
Co5en«rat.'cn Co., Inc. . NY
inaeck-vertm energy Sarv- • Tjnawarwa. MY- ....
cea. Inc
Hoise Cascade Corp ; 3ee-ei ri.'s, NY
La Pocfe Inc Betvidero. NJ
c ; PaCT!. NJ ..- —
Long island Ugntmp Co Snor.in.irn. NY
Ufe Severs. lr-c ! Las Piedrms. Pa
Aooon Laboratories _... Sarcetoneta, PB..
Mec^n-^acine. Assesses. ' Carson. NY
inc. :
United Development Gtotav j Niagara Faiia. NY..
Niagara, inc. i
Town of Norm Kempstead • Por: V/asrvngton.
Solid waste Management] NY.
Autncrr/. \
L4J Energy Systems. Inc howw;*. NY
Pennsautien Solid W.«te PeV«:i- an 11 station rotograwe press and
modrtcaton of an a stamen rotogravure press.
CornruOJOn at a 50 NW gas tureme/ steam gener-
S'-X.
Co'-Jtrjctjon of a S3 MW jas turome.'steam gcner-
a;or.
Rec-accrr«nt of an existing oiMired 6o*ar «mn a
now oil-fired ooiter.
Revision ol me mregsn oude errussnn tout piew
permitted tor a 23.3 MW coganeraticn
item.
ol tne sarocusae maner emawen (bin
perrmned tar trvaw ooaHved DoMra.
ol a 220 MW gas turbine gcneraeon
facdtyS
' ConstrucaVn of a new stesm bpaar and • new
> gtmermiorV^nd cenoeisMn of an emng generav
! tor and boner to standoy operaoon.
: Re'.,s:on ol tn\PM emission Omit previously permrt-
; ted lor a 20 ?"WW cogeneratci laolrty.
, Construction ol «\19 MW gas turom*/steam gener-
ator.
: Construction ol a cdy fired cogeneration system—.
Construction of a 990 i
resources recovery I
Construction ol a 49 MW (
ator.
Corstruction ol fio 250
3.M waste niui.aaxis.
i per day municipal waste
i airdme/steam janer-
per day muntopai
NYSCeC
NYSCEC
.NYSOEC
NYSDEC
NYSDEC.
NYSDEC .
NYSDEC .
SPA region II....
EPAImonU....
NYSCECs
\
EPA region 11 —
\
EPA region H ...
NYSDEC
NYSDEC
uvencr*
NYSCEC
NJOEP
•V"
««..J
PSO pern*
do
do
do
do
Ml
PSO norv
epptocabtifty
determination.
PSO perm* re»i*on...
do ___. '.
PSD penurt
approval. |
PSOnorv ,
applicability {
deterrranaoon. {
PSO perm HKUMI..J
PSOperrart
\ approval.
\oo ,..
\
aporov*\
go .\..'
7/18/88
10/07/88
10/19/88
'2/05/88
12/09/88
t/09/89
1/11/99
1/17/89
I/17;89
1/23/89
3/01/89
3/06/89
3/06,89
3/10/39
3/1S/89
3/20/89
4/20/89
>ssues were rsv>^ea during an >ssu envvonmerral
tecticn This ?*:mt ni'M "ave beccn'v «'toc!ve on M.rcn 13. '9i9 rt no pes'jon for aomsmsirasve review was filed wnft tne EPA Adrmrtisffaior ?n Waspinaion.
CC. Hcxwver. a oetmon tor revww «rjs ••*<« ?» TT>e Tawrinip 51 Cinnarr.mson, tfe Sorougn at Palmyra, and tne Borougn ot Rivenon on Marcn 7. 1989. On AwH 20.
1989. "19 EPA AarruTHstratar o«acEC a".ei ca.-e^i revie» of tfe appeal not to grant fu.-r^r revic\ c-t tt>o oetmon. Therefore, me PSWMS PSO permn s erlec^ei «s
ol.AD.il 20. 198J.
us notico lists oniy the sources that
i received finai PSD dete^ninatior.-s.
Anyone who wishes to review these
ions and related materials
should Contact tl.s following offices:
EPA Actions
I'nitod Stat>js.Env:ror.rr.entai Protection
Agency, r -^on II Oi::^e. Permits
AJ:nin:stra;ion Branch—tvocrri 505. 26
Fsr.-.Tdl P;..2d.\'ew Yoik. New York
li.'2'3.
NYSDEC Acuons
N'ew York State Dppnr^rient of
Environmkiita'i Ccrseryatton. Division
of Air Resources. £ourc\Rev:aw and
Re-.vuni»l Support Section\5n Wolf
• Road. AIL-jny. New York '\23J-OOCn.
NID'EP Actions
.'•'ei% Jersey n-.-p^rrment of
Er.vjronrr.i ntul Protection. D.v.iiJyi of
^n\ironme!:.di QiM::;y. D'.ireju of
F:r.i.-:neer;n^ A Technoii ;y 401 Er:st>
jtate Street Trenton. New Jersey
825.
Available pursuant to the
ConsolidatEd Permit Regulations (40
CFR P\rt 124). j'ldicial review of these
cletermiKations under section 307(b)(l)
of the Clefcn Air Act (the Act) aiay be
souaht or.ly\by the f:;:r.g of a peti'ion for
review in thai'nited States Court cf
Appeals for ths. appropriate circuit
within 60 days Item the date on which
these de'erminatrdns are published in
the Federal Register. Under section
307(b)(2) of ihe Act. Jhcae
determinations shall nSt be subject to
later judicial review in cvv:l or i:ri."ir.al
proceedings for cr.fo
Dated: [une 1.1969.
William |. Mu«i}-nskJ,
;:H Doc. 3^-1.1349 Filed 6-9-38: 8 4S .i-.f
8XLIKG C=CE ISCO-SO-M
IOPP-66131; FW.-3600-4J
Order Canceling Registration for
Pesticide Product* Containing
Bromoxynil Butyrate
AGENCY: En^rynmental Protection
Agency (EPA).
ACTION: Cancellation notice and order.
CUMMAKY: This no ace announces EPA's
decision to cancel all registrations
i-.-sued under the Federal Insecticide.
Fungicide, and Rodenticicie Act (F1FRA)
for pesticide products containing the
butyric acid ester of bromoxynil (3.3-
dibromo-i-hydroxybenzontLrile). The
Mgistrmt Rhone-Poulenc AC Company
has requested voluntary cancellation of
these products. Because of the
ucvclcpmental risks associated wiih
exposure to these products, EPA will noi
permit and the cancellation order will
explicitly prohibit the sale, distribution.
a,id use of existing stocks of affected
products.
-------
24-J.-0
Federal Register
Mor.ci.i
inrt'.i . \\
DATE: The carccildtion order
incorporated in this notice will become
effective June 13. 1989.
FOR FURTHER INFORMATION CONTACT:
|u»i<.' Andreasen. Special Review/
Rnrcjjistration Division {H"08Q.
Office of Pesticide Progr.ims.
!•!.:•. :mr.rp(?ntal Protection Awcncy. -Jiil
M S(r-L't SW.. Washington. DC 20400
Office location and telephone number
F.~. lOOtjF CM =:. 1CU1 Jefferson
D.iv:s Hijjh'.vriy. Arlington. VA. ("0"!
5j--ll"0.
SUPPLEMENTARY INFORMATION:
I. Request for Voluntary Cancellation
On May 1.1989. js a result of
discussfon between EPA and Rhone-
PG.:! JP.C AC Company concerning
measures to minimize potential risk of
developmental toxicity associated with
exposure to bromoxynil. Rhone-Poulcnc
requested voluntary cancellation of its
registered pesticide products containing
bromoxynil butyrate (the butyric acid
ester of 3.5-dibromo-4-
hydroxybenzonitrile). Rhone-Poulenc
stated in its request that it would
institute a plan to recover remaining
stocks of these products from
distributors, dealers, and users. Under
this plan. Rhone-Poulenc will replace
these products with an equal quantity of
a corresponding product containing
bromoxynil octanoate. and will pay
shipping and handling costs.
Distributors and dealers holding stocks
of affected products should contact
Rhjne-Poulenc customer service. Users
holding stocks of affected products
should return them to the dealer.
Rhone-Poulenc had previously
requested voluntary cancellation of a
number of registered bromoxynil
products, including some but not all of
its products containing bromoxynil
butyrate. on October 27.1988. EPA
canceled certain bromoxynil products
pursuant to this request, but was
unwilling to accept the remaining
requests for voluntary cancellation
because those requests were made
contingent on the Agency's permission
to sell and use existing stocks of
affected products. Given the unresolved
concerns regarding the developmental
toxicity of bromoxyiuL EPA considered
it inappropriate to issue an existing
stocks order for such products.
n. Existing Stock*
In its May 1.1988 letter. Rhone-
Poulenc did not request that EPA permit
the sale, distribution, or use of existing
stocks of canceled products containing
bromoxynil butyrate. EPA has
determined that continued use of
products containing bromoxynil
butyriite would present d.n un;icci'pt.:i'ii;
r:sk of developmental toxicity :n persons
handhra sur.h products. Acccrdinyly.
EPA will nnt permit the continued s.ile.
distribution or tr.e of any cancc!r>J
product cnnt.-i:r:nt: h-orr.otyr.i! ru-tyr^L1.
EPA enrouraui'S ail pers.-r.s holding
stocks of c.-injelt-'d prod--ic;s cont.i;;::na
bromoxynii nutvrate to p;i:-.n;:pjte in the
recovery prog-am e?t.-,l>iishcd by Rhcne-
Pouler.c.
III. Cancellation Order
Effective June 1.1. :?fi9. the
registrations for jl! pesticide products
containing the butyr-c aci J ester cf
bromoxynil (3.5-Jibromo-4-
hydroxyber.zonitrile) are canceled
pursuant to section 6(f)[l) of FIFRA, 7
U.S.C. 136d(f](l). Effective June 13. 1989.
it shall be unlawful under FIFRA section
12fa)(l)(A) and/or FiFRA section
12(a)(;)fK). 7 U.S.C 136j(a)(l)(A).
i36j(a)(2)(K). for any person to distribute
or sell, or to use for any pesticidal
purpose, any of the following canceled
products containing the butyric acid
ester of bromoxynil:
EPA 1 . Previous I
registration I registration ! Product
No. ; NO. !
264-339 : ' Oragonmat*
264-340 ( ME 4 arcminal.
264-340 ' Torcn Twin Pa*.
264-340 j 3-3 Srominal
264-3JM I ; Bromovntf Bulyrale
I
Technical
264.421 Certrot
264.474 3£3-7!6 Suctnl 4 EC.
This Order docs not prohibit any
shipments of canceled products
containing the butyric acid ester of
bromoxynil which are associated with
the program to recover stocks of such
products established by Rhone-Poulcnc
AC Company, or which are otherwise
necessary to facilitate proper storage or
disposal of such products.
Dated: June S. 1989.
Douglas O. Campt
Director. Office of Pesticide Progress.
(FR Doc 89-13646 Filed 6-9-89: 8:45 air.J
MLUNO COOC IMO-W-M
RAL MARITIME COMMISSION
AgreernfeqUs) Filed
The FederaXMaritime Commission
hereby gives nomeof the filing of the
following agreements! pursuant to
section 5 of the Shippiflg^ct of 1984.
Interested parties may ih«oect and
obtain a copy of each agreement at the
Washington. DC Office of the Federal
Maritime Commission. 1100 L Stree
\\w . Kn,j!:i ;ir,25 ;.-.:,•-.-MLJ :•
i;iy submit ci'T.jvi.-r-.ts c'.'i r."-~.
^roomer.: -1' ^A(" ?' ' '''••••''• F, ..
(3. tviihin 10 d.iys ^f'er 'he
udcrul Register :.-. «•-.:. ^ "
appe\fs. The rerju.-r-'rnLT/s fcr
'j ;ire four.J in 5 ".;.• •
»r, of th\« Code of Fi-ioral R. •
Iiiierts.oCi persons --houiii c-..:.--
i ciiR:rr...i"!i;i'!.r j •••>
.'!"'• Firti:."!^ d pfrc'~:
Ti.-ft.: Su;:ln\
Conference ("t
e I' S.A.
Achille Lauro
Compania TrasA;!an::ca Esrar.
S.A.
Ccsta Container L\ne (a Du is:
Contship Contairierlines Lir-
d'Amico Societa di .Nav:gaz:cr.
S.P.A. \
Evergreen Marine Corporation
(Taiwan) Ltd. \
Farrell Lines. Inc. \
"Italia" di N'avigazione S/p.A.
Jogolinija \
Jugooceanija \
Lykes Lines (Lykes Bros. Steam
Co.. Ltd.)
A.P. Mcller-Maersk Line
Nedlloyd Lir.es (N'edlloyd Lijr.c.
Sea-Land Service. Inc.
P 4 O Containers (TrLl Ltd.
Zim Israel Navigation Co Tip-any
\nopsis: The proposed moc:fic
would permit any member to
disassociate itself from any Cor.fe;
actionVi a rate or service item tha
would rqsult in a reduction in the c
cost per oargo unit to the shipper b
giving written notice to the other
members pmir to the time the rate
service item lias been filed with th<
FMC and become effective.
Agreement No.: 217-010738-003.
Title: Barber Blue Sea/Open dull
Carriers Chartering Agreement.
Parties:
Wilhelmsen LinesV-t/S
Open Bulk CarrienSLimited
Synopsis: The proposed modifies
would authorize the pariies to disci.
and agree upon rates, charges and c
competitive matters regarding
intermodal movements. It would als
permit the parties to agree upon sai.
schedules, service frequency. »nd p<
to be served by each party. It would
further make other non-substantvve
administrative changes. \
Agreement No.: 232-Olll84-002.\
Title: Evergreen Marine Corpora:i
(Taiwan) Ltd. Italia di Navigaziortc .'
-------
<>.
\ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
"i
' WASHINGTON. D.C. 20460
e or
-- - ' 'CSTICIOBS ANO TOXIC SUBST/
Mr.- Nick Somma.
Rhone-Poulenc Ag. Company ... _
P.O.- BOX 12014
2 T.w. Alexander Drive
Research -Triangle Park, NC 27709
Dear Mr. Somma:
Subject: Application for Conditional Amendment - Revised
.Labeling/Restricted Use Classification/Data
Requirements/Additional Conditions .
Buctril Herbicide
EPA Registration No. 264-437
Bronate Herbicide '
EPA Registration No. 264-438
Buctril + Atrazine Herbicide
EPA Registration No. 264-477
Your Submission Dated May 1, 1989
Your application dated May 1, 1989 to conditionally amend the
subject pesticide registrations to incorporate revised labeling,
a new classification for restricted use, additional claims-,— and
specific conditions for continued registration is granted,
effective immediately. -Continued registration of these
pesticides win be contingent on satisfaction of each of the
conditions set forth in the approved amendment. Please submit
for each of the subject registrations five (5) copies of the
final printed stickers incorporating this amendment. A stamper
copy of the approved text for these stickers is enclosed for your
records.
Sincerely yours,
Taylor
Product Manager (25.)
Fungicide-Herbicide Branch
Registration Division (H7505C1
-------
« /fl/*y I _ ~li°& SENDER'
PLEASE ADVISE BY FACSIMILE OR PHONE IF MESSAGE IS NOT LEGIBLE OR ALL PAGES
ARE NOT RECEIVED.
FACSIMILE NO, ISi
DIRECT LINE TO TELECOMMUNICATIONS OPERATOR IS« 919-5
-------
RHONE-POULENC
BHdNE-POULENC AQ COMPANY
May 1. 1989
Robert Taylor .
Environmental Protection Agency
Office of Pesticide Programs
Crystal Mall, Building 2
Arlington, Virginia 22202
Dear Mr. Taylor:
SUBJECT. Buctril (264-437), Bronatc (264-438)
Buctnl + Atrazine (264-477)
Rh6ne-Poulenc Ag Company hereby applies to conditionally
amend pursuant to FIFRA §3 (c) (7) (a) the pesticide product
referenced above to incorporate the revised labeling, new
classification for restricted use, additional claims, and specific
conditions for continued registration set forth below. Rh6ne Poulcnc
hereby claims in connection with this application for a-nencc.
registration that it will .conform to the following conditions as cart of
its distribution and sale of these products.
The text for stickers which incorporates new language adding a
classification for restricted use, a new label warning concerning. .
developmental toxicity, and specific use directions requiring
additional protective clothing and equipment and new use practices
is appended to this Application as Attachment A. . Rhone Poulcnc
agrees as a condition of registration that it will 'attach the stickers
appended to this Application as Attachment A to- all containers of
these products that are released for shipment by Rhone-Poulenc
after the date of approval of this amendment by EPA. Rhdne
Poulenc further agrees as a condition of registration that it will
97700
•NTEW*»TiO*Al. TELEX NUMBEB B*CX *PC IOC
-------
CONDITIONAL REGISTRATION
I.Revised Labeling
A. Wh a t
1. Classification
2.Warning Label
3.New use pracices
B.How
1.Stickers
a.All stocks leaving RP after 5/5/89
b.All stocks leaving distributors after 5/15/89
(1) ins-tructions
'(2)enough for all inventory by 5/25/89
2.New permanent labels
a.Plan by 5/22/89
b.On products by 10/1/89
c.states:
(l)deletes claims for turf and non-crop uses
(2)all restickering provisions
(3)equipment needs
11.User Training
A.Training of users
1.prior to 1990 spring use
2.pending EPA approval
8.Hard-coup!ing transfer systems
1.program to assist users not owning such system
2.plan by 10/1/89
III .Repackagi ng
A.Hard-coupling for all bulk (>30 gal) by 10/1/89
B.Feasibi1ity study for small containers by 1/1/90
IV.Safety assessment data
A.Rabbit dermal Tox--5/l/90
B.Male repro--6/l/90
C.Worker exposure--12/31/90
-------
RHONE-POULENC
RH6NE-POULENC AQ COMPANY
provide to each distributor holding inventory of these products
quantities of these stickers sufficient for such inventory within ten
days after the date of approval of this amendment by EPA, and that
Rhdne Poulenc will assume responsibility for insuring that each
distributor attaches the sticker to each container of these products
which are sold or distributed by the distributor after the date the
stickers are received. Rhdne Poulenc further agrees as a condition of
registration that it will provide to each reseller and retailer holding
inventory of these products quantities of this sticker sufficient for
such inventory within twenty days after the date of approval of this
amendment by EPA, and that Rhdne Poulenc will assume
responsibility for insuring that each such reseller or retailer attaches
the slicker to each container which is sold or distributed by the
reseller or retailer after the date the stickers are received. Rhone
Poulenc further agrees as a condition of registration that it will
provide to each distributor, reseller, and retailer along with such
stickers the information package and the instructions concerning the
manner in which the sticker must be affixed to each container of
these products which are appended to this application as Attachment
B. Rhdne Poulenc further agrees as a condition of registration that it
will implement the communication plan appended to this application
as Attachment C in the manner and by the dates described therein.
Rhone-Poulenc further agrees as a condition of registration that
it will submit by May 22, 1989 a complete copy of revised labeling
for subject products which (1) deletes all claims, references, and use
directions pertaining to the previously permissible uses for turf and
nOn-crop areas, (2) includes all the new label provisions included in
the sticker which is appended to this application as Attachment A,
and (3) incorporates the additiona! revised labeling concerning the
equipment. which must be used for mixing and loading as set forth in
Attachment D. . Rhone-Poulenc -agrees as a condition of registration
that, after review and approval by EPA of the complete revised
labeling to be submitted by May 22, 1989, such revised labeling will
be attached to each container of these products which are released
for shipment by Rhone-Poulenc after October 1, 1989.
Rhdne Poulenc further agrees as a condition of registration that
it will develop and submit to EPA by October 1, 1989 a proposed
S«0 2030
- TELE* NUMB^M 4W937H-
IO*. 9««VIC£S TClCX NJMOCD «9W3»- AMCWCP3ACK APC IDS
-------
ff RHONE-POULENC
RH6NE POULENC AO COMPANY
program to provide additional training to users of bromoxynil
products prior to the-1990 spring use season, and will upon approval
by EPA implement such a training program. Rhone-Poulcnc further
agrees us a condition of registration thai it will by October 1, 1989
establish a program to provide assistance to users who do not own a
mechanical transfer system which terminates in a drip-free hard
coupling (the type required for 30 gallon drums in the labeling which
must appear on containers after October 1, 1989) and who wish
either to obtain such a system or to modify their present system.
Rhone-Poulenc further agrees as a condition of registration that it
will thoroughly investigate the feasibility of packaging these
products in containers which are smaller than 30 gallons and which
include a hard coupling designed for use with a specific closed mixing
and loading system, and will provide to EPA a detailed report of its
findings and conclusions no later than January 1, 1990. For products
sold in bulk containers: Rhone-Poulenc hereby applies to amend its
registration for these products to provide, and agrees as a condition
of registration, that all bulk containers of these products which are
released for shipment by Rhone-Poulenc after October 1. 1989 will
include a. mechanical transfer mechanism which terminates in a drip-
free hard coupling which may be used only with a spray or mix tank
which has been fitted with a compatible coupling.
For each of the specific data requirements described below,
Rhdne Poulenc agrees as a condition of registration that it will
develop and submit' the specified data according to the specified
schedule. Rhdne Poulenc agrees that failure to submit the required
data, or to adhere to any element of the specified schedule for
development and submission of the data, will constitute grounds for
cancellation of this registration under FIFRA $ 6(e), unless Rhdne
Poulenc demonstrates that it has undertaken in good faith and in a
timely manner all steps necessary to develop and submit the data
according to Uie specified schedule and that its failure to submit the
data or to adhere to the schedule was due to factors that could not
reasonably have been within its control.
Rabbit Dermal Teratology Study
*O BO* 1JOM J *
aiSIABCMlRH
(010) 540-333S
. TG.EXN
K.CS 9ERVICC3
-------
f[ RH6NE-POULENC
RH6NE-POULENC AQ COMPANY
Pilot:
Submit Protocol-May 8, 1989
EPA Approval of Protocol by--May 23, 1989
Study Initiation—May 31, 1989
Study Completed-September 1, 1989
Final Report-October 16, 1989
Full:
Submit Protocol-June 1, 1989 (without dose selection)
EPA Approval of Protocol by-July 15, 1989
Discussion of Dose Selection-October 2, 1989
EPA Approval of Dose Selection by-October 23, 1989
Study Initiation—November 1, 1989
Study Completed-March I, 1990 '
Final Report -May 1. 1990
Male Reproduction Effects Study
Pilot:
Submit Protocol -June 15, 1989
EPA Approval of Protocol "by-July 3, 1989
Study Initiation-July 14, 1989
Study Completed-September 1, 1989
Final Report-October 2, 1989
Full:
Submit Protocol-July 3, 1989 (without dose selection)
EPA Approval of Protocol by-August 4, 1989
Discussion of Dose Selection-October 2, 1989
EPA Approval of Dose Selection-October 14, 1989
Study Initiation--November 1, 1989
In-Life Completed—February 1, 1990
Final report-June I. 1990
Worker Exposure Study
Submit Protocol—June 15, 1989
RESE *«O TB.ANGie BkAK MC 27700
INTERNATIONAL UL«* NUM8f» C IDS
-------
ff RHONE-POULENC
RHONE-POUtiNC AQ COMPANY
(Protocol is to be based on scope of study as presented in Attachment
E)
EPA Approval of Protocol -August 18, 1989
Draft Report (Non- QA'd.)--November 15, 1990
Final Report-December 31. 1990
The schedules given above are based on Rhone Poulenc's expectation
that EPA will respond to the protocols and dose selection in a timely
manner. If EPA does not provide a full response to a proposed
protocol or proposed dose selection by the date specified for EPA
approval, the agreed schedule may be adjusted to permit an equal
delay in completion of subsequent steps. However, if EPA responds
in a timely manner but is unable to approve a proposed protocol or
proposed dose selection by the specified date due to substantive
concerns regarding the content of the proposal, Rhonc-Poulcnc agrees
that it will adhere to the established schedule unless EPA approves
an extension.
Rhone-Poulenc will submit one-line status reports on each of the
required studies on at least'a quarterly basis. The proposed protocol
for the Worker Exposure Study- will also describe and require
submission of appropriate interim reports. In addition to submission
of these reports, Rhone-Poulenc will immediately notify EPA if any
problems arise which might prevent the timely completion or
submission of any of the required studies.
Rhone Poulenc acknowledges that this ..pplic .tion fir
conditional amendment is based on the Agency's assessment of the
data concerning the risks and benefits of bromoxynil use available to
EPA as of the dale of this application. Rhone Poulenc declares that it
is Rhdne Poulenc's present intention not to request additional
amendments of this registration during the time required to develop
and submit the data described above. Rhdne Poulenc specifically
agrees that EPA may deny without hearing any additional application
to amend this registration which Rhdne Poulenc may submit during
the time required to develop and submit the data required above, if:
(1) EPA determines that Rhone-Poulenc has not submitted
substantial new evidence which materially changes the Agency's
cs:*nCM TRIANGLE WX NC 37709
(9l9lS4«?000
IONAL TELEX NUM3CB 40M3?I ANSWERBACK »PC OTP
OTH-OUTJON SCrtVlCCS T6k£* NjMBtBaOOOS.'J-AKBlMiMQtt.* »"C IOC
-------
•//?r RHONE-POULENC
RHdNE-POULENC AO COMPANY
assessment of the risks and benefits of use of bromoxynil and which
was not available to cither EPA or Rhone-Poulcnc at the time this
application was submitted and (2) EPA provides a written
explanation of the basis for its determination.
Sincerely,.
Nick Somma
Registration Manager
COPY; Mr. Edwin Tinswonh
AE6CABCMTOlANGl.rataK.NC 27700
<9t«l5«9-?000
INTe^NATlONAC O'STBlS JTION SC^VlCCS ?t..C* NJMOCP *VHV> ANSWCnOATK APC O3
-------
Unu»c $(*•••
9lOO-«rr>» (TS
OC 204«0
Application for P«sticid0: U Registration
Kr LxAmendment
102852
t Company/Product Number
364-477
12. Daw
Section
May 1. 1989
Product M«nag*r
Robert Taylor
4. PropOMO Qtll <•£«
.«..* FT!,'
S N*m* artI Aa<3<»M of
Rhone-Poulenc Ag Company
P. 0. Box 12014. 2 T. W. Alexander Drive
Researcn Triangle Park. NC 27709
K »U It
Bucirll * Atrazlne Herbicide
Section K • Amtnflmtnt Infarmatlgn
In ftiBBHM to
0«t*
May 1. 1989
Label modification to include Restricted Use. Classification and additional
label restrictions.
ttctlon HI
in
1. Location of N»l Cont»nt» WO"n«uon
Umt
• wyt No.
Ptekagi w*!0ht No. p»r eenUJntr
M»UI
PlMtie
Lowoon of
OUMt
On m«i«f<«l «coomp«ny
-------
RHONE-f»OUL,ENC AG COMPANY
BROMOXYKIL SPECIAL LABELING COMMUNICATION PLAN
09:20;38A
Nay 1, 1989
COMMUNICATION
MEDIA
FAX
DIRECT MAIL
PERSONAL CONTACTS
STICKER PBRSONAL
DELIVERY
DATA-LINE
RADIO
POINT OP PURCHASE
INFORMATION
DI 66 EMI MATED
RESTRICTIONS/
USE DIRECTIONS
RESTRICTIONS/
USE DIRECTIONS
V
RESTRICTIONS/
USE DIRECTIONS
V
PACKAGE STICKERS
RESTRICTIONS/
USB DIRECTIONS
RESTRICTIONS
(SEE DEALER FOR
FURTHER INFORMATION)
RESTRICTIONS/
USB DIRECTIONS
TARGET
AUDIENCE
DISTRIBUTORS/
RPAC SALES/FD
DISTRIBUTORS
RESELLER/CUST APPLTR
UNIVERSITY EXTENSION
GROWERS { RESELLER HAIL)
UNIVERSITY EXTENSION -
NEED SCIENTISTS
RESELLERS
CONSULTANTS/FARM NGRS
DISTRIBUTORS
RESELLERS
GRONERS
GROWERS
GROWERS (VI A RESELLERS
PLACE OF BUSINESS)
ESTIMATED NO.
INDIVIDUALS
160
169
50
6,000
4,000
5,000
100
3,000
100
160
2,000
35,000
143,000
40,000
DELIVERY
TINE FRANK
DAY 2
DAY 5
1
V
WEEK 3
WEEK 1
WEEK 1 - 1,500
WEEK 2 - 1,500
WEEK 2
WEBK 1-2
WEEK 2-3
WEEK 3
WEEK 3
WEBK 2-3
TOTAL NUMBER CONTACTS: 238,739
-------
-it*. B,3|.C:.= - ,
WaahinglO". DC
Application for Pesticide:
_ Registration
£J Amendment
10283
i Cofipany/*odu0i
Z64-438
2 Oatt
flaeilon
May 1, 1989
S Nam* ana JkJO'tw o< Applicant (ineiuot Z/f Cew»;
'Product Managar
Robert Taylor
j i
| | Qh»
Rhone-Poulenc Ag Company
P. 0. Box 12014. Z T. W. Alexander Drive
Research Triangle Park. NC 27709
Bronate Herbiddt
Section II - Am«ndm«nt Information
May 1. 1?89
LaDel modification to Include Restricted Use Classification and additional
label restrictions.
S.dlon III
i . Malarial Tnii Product win 0a Pac*a0ed in
C'u'd-Aoaiiiani Packaging, unit Packaging
riv*. 'PINO
(JJve, QNO »V«.-
Unit pariiaj* wgt No. per oantaJnar
Watai -Soluble Pacoaging
riv*. riNo
• tea.'
Paohag* w*»flhi NO. per eontainar
J Location of Nat Content* lrfo
-------
o> P*»tie.d« Pr
WaaMngion.
i Ptot»c*'On
'«Ti» (TS 767
2O*«0
__ —^—^ _
1^ FR/X Application for Pesticide: Registration
.T LB! r\ KK ULJ Amendment
102850
1 Company/Product NumOor
264-437
2 Daw
May 1. 1989
jLaaifln
iy_
37<
Piodud Man«g»t
Robert Taylor
4rzT"c
5 Nam* and Addcw of Applicant (Inch** ZIP GOd*J
Rhont-Poulenc Ag Company
P. 0. Box 12014, 2 T. W. Alexander Drive
Research Triangle Park. NC 27709
it • n«w
Sod Ion II - AfT^ondfnant fln^qfrpatlon
8wbj*et
i Aamna*
f"™| Final pHntod lab«l
1 llnraiDani* uTAaa
nev IMMr
Data of v*mr
Mav 1. 1989
Label modification to Include Restricted Use Classification and additional
label restrictions.
Section ML
v Mat»naiTni» Product win 90 Pae»afl*d m
Location of Not Conttnt* mformation
Unit Paokaglng
HToa.*
UnH paokago «gi No. p*> oontalnoi
Watof*8o(«(s) of ftoUH enuinar
2. Typo of Contain*!
Motal
Qiaa*
Papor
Oth* (Specify)
. Location of Ub«i
6 Mannor In \n*«teh lab*! to Affixed To Product
_ ,
J
~
| On mat»rlal •oaomp«ny1ng product
f^J'*
J ] dM
ftaailan IV
N1ck Somma
Registration Manager
Taiapnona No. (toclvd* A/o« Cod*/'
919-549-2372
I oartffy that the Maiamentt I ha*o mad* en tni» form and an •naehmonta tftoroto an true, aoaura
oempioto. I aoknowiodge tftti any knowingly falaa or misleading Matamonl may b* pwnlthabi* by
Imprlaonmant o» both undo' applicable law
Una or
9. Tltto
4. T
/- / '
Nick Somna
Registration Manager
. Oat* Signod
May 1. 1989
Dai*
PA f **m
-------
ATTACHMENT A
-------
»-» CJ '
RESTRICTED USE PESTICIDE
for r*jul Mfe to «nd UM anty by
wo scc«»'vc,on and on»y far thos* U
S*» precautionary tm»"n«nu tor ta*tofu tfm product • cUst/iad Racrtaad Uta
BUCTRIL* HERBICIDE
Or
tar e( brereayn
NERTNQFED&JTBc. ........ ...... .
dte
hyt
.33.4%
80.8%
•Bramexynll actenoat* *jqu>v«tooi to 22£% of bromoiynll or not b)M than
ID pounds ef bramorynll p*r gallon.
KEEP OUT OF REACH OF CHILDREN
AVISO WARNING
PRECAUTION AL U5UAHIO: S u»t«a no
, no u«* •*• pfoqucte n»
•» »Uqu>u tx»y« »Mo •xpltexx> •rnp»>m»)nt+
C.F.A. H*>q. No. 264-437
I*HB*,II*« c«i i .jce in •?«•.
«*m*tl*n OILY Oil t« Miu'V A 0«y 1-4O
»M(CAUT10MA«T
TO NUMANt AMO OOMtiTJO
WAIIMHQ . •IITNCttO utl
AMMAU
OUKIHO AIWAL
•*•** H«»tU«B
• •••Ml
A«MM
i M*te>«t MANOXINQ Twic oowcs ixm»rt MUSI otatnvt
•M IMC Th* oBonoHi «MI la ••" on
(•VO*. * «K«^I»«I '••(Afl «>•• |*«
oowvrmgt. or eooa » iwv yM • *«C«I*IMI ••(•lot
!••><• *KM «W icng atnt Wow OMW«
im.il *>IM*M »>«• •*••
lor rt mttJna, on* loM«|
• M B'M.a k ii«*»»ai« In • 30 9*0* *vr* a> • >«» nM» • MUI *f M fMtov •> -•« •>
m*i wtxf 1 "•er^rie*' imltt if»t»m. ao net •
AU. »C*»ONft A^^irMQ THia M*OOUCT. OH ••••IMINC OB CUAMINQ
USC3 WITH TUB PflOOuCT. UU«I OVKA
CIMT i* I*
•ft* 9f P*W*WB ^*)flp*^*j ^ 4
n«rafi *ii.ina «• CJP i
(K.)
rt «• »ro»feM« JTW.. in •nOo.»o
!•• « i«»ra*nil«i «M( i».g . norm*
OCNUUk
TAjm MI
v •»«»>•, t »•* •«•
in** '»» auuii* e<
0* Ml
*en u»*
rwT 0* MAOKOAl TUCAfMtMt
If ••rAllOWOi Oft MMHAi M*nu*« O* «•» UM>
dilUaMi 0* Na g*>» «vMn
W ON MM: W*>n ••> pftjrty al ••* in* •«** 0*1 rrvdUu «n*ri«x> I Mrwn p*n»u
V III ffTtt: Ru*« •M ••• W It mm/N» a* m**K«l MUflMH
t«VI«OHM«MTAl MAT A HO*
TMi pBMCJO* • VIC • •««»•• tM fB" CM* ••* OB)* Ml*x •BfXfl >« MM* l'*8u»"t»« Of
•HMD* •> MlMaj"! 10 »f7 D0*> * ••»'. DO HOI «pn; 9I»«* W **•' PO net (BBIp •*•"
**Mff«i aandUan* )**• <«1 (>«m tfrg*i •/••* Oe nei ORH umnal* w«i*< Or o»»ninj a
M4VSICAI 1MO CMtHCAL NAZAWt
0* *•> MM •> •!•• «••> N**l o> on*n Itan*
roa utc -te* imciMtf ••••MI
IT IS A MOIATIOH 0» nOHAt CAW TO U»» IMS rPJOOUCT IM A MAHHCR
MCOMI«1(NT WITH IT» UkHUNC.
•mi ••• «*jf «r «•*••
<• to don* by <••<
IOHAOE AND
Do *a
<•*» bv dortg* or
W*1M* 'Munnf Mm tta «• «IMi tntfua ma to ««oo«*« al *n ••• •>
• •»• •»«•»• alia
. 1 T W N*»M»*
-------
RESTRICTED USE PESTICIDE
BUCTRIL** Atrazine Herbicide
POSTEMERCENT HERBICIDE FOR CONTROL OF CERTAIN BROADLEAF WEEDS IN CORN AND
90RGHUM.
ACTIVE INO«ED1B*T
OoUnob «otd
gallon.
"Pradua oorttJnt ZO pounofc of oftsina par gafan
erT«*y^
T5.74%
Si.er*.
..62.04%
KEEP OUT OF REACH OF CHILDREN
CAUTION
SHAKE WELL BEFORE USING
EPA H«g. No.
No.
ror PRODUCT uoe inwrmaiwn ecu i r«a
EMf RC€NCY totomMtton ONLY Ckll 24 Hour* A Dcy 140O494-7577
•TATfM»Mr»
HAJAMO* TO MUMAM AMD oont«nc AMMAL*
WAHMMO • MSTftCTtO Utt
U»» •« M« WMliM! m«r 0» Mt»>4*tf> M
lloo OMB IKOOT lo
OUMIHO AXMAI.
o»l*«t* Mi lofcoroiory tn
I* M*
W»i
OCMCMAI. MOUMfM(NT« fOd AU UM
If Ml
Awl
UMn • »>• o/o*wc< AM
AMMK
Mute
(Mggh «ln or
10
•AW UAO 0> IMi
com* «•» •». «r«* cr
WONR.
ji cio•? •(
«Mr
TMi
• tOBC I*
* *» 0>Wuei •
*• praouci pv
m * a gwon «um • f »«w
"wtt UM
• «ul « »
4M •*» OM •«•> Of* •**>
0* "•" *M>r di>*a% u> •«•. 0« »«' . IMM
I A MMC HAH A I
10 1M
MAMMA twa
«M)lnf tram A
MMUMkOVI
m m mm* MJABJ»III A>
to A «o. To om« COTAI
MM1» Of AMh; IM» *M«ci «Ah •*• 4A*r " *•*»"• «W« *• •»»»"•"« H> «V •*•
•«tN
HAW at* (irnxn Wm* ••"I1 H
ill •)•«•• '
•TOIU01
0*«• ow» ••»'ooiilon •>ooo*. •*• « IOJTWOJOUMO o»i»o l?"r. * «o^o»oa 10 ('•otmg
I01HJOIOXOA. «N« l*fl«l>«MO> «aM AS* ' (• « hOUtl • VMi<
rtvncmt oit»OMi
torn •• WM ot Mi
Moiol
* AM «OOM*
o> I AIBIM* or 6u» **> Local «wihoil«»
JO Mf
KlM)0»
.»Tw
•I
» A
NMk CAMAM
-------
RESTRICTED USE PESTICIDE"
Por r«uJ
iUlemots fc-
tnos* u»*s covoroo by
'UaiJ Us*.
B RON ATE" Herbicide
rOH CONTROL Or CEHTAJN oMvjAUUbAr
ACTIVE INGREDIENT
Oewnole «c*d «*ur of bromoiynll* O.S-dlbromo I hydf
booctyl***
INERT NQREOIENTS;
aton> « ?1 9% of taemcuynl or *oc IMC ih*n 2.0 pound* d
VQ% 2-rn«tf>U*Bj«iaJ»«i ij«> aortic acd o> ntf laaajtw 2 3om.ndB MCPA add p*
KEEP OUT OF REACH OF CHILDREN
WARNING
EPA Rag. No.
fePA Ut NO.
POT PHOOUCT USE information c«ii
EOT BmgftCENCY Information Qf^L,Y Call 2* Hours A Day 1 -800-334.7877
•T4TCIMMT*
AMMftlt
HAZAMOI TO MUUAMt AMD w_..... _^._v> ».,..„«
WABMIMB . •CITBICTtQ UM OVIWIHa
U« .. «. •rc.uci m.; »• ".«^.». IB ,— HBBltt.. CWBIU^ t. M. p^luc. ±^T J^t •S±IrJLf "I?,""1 ""*' *" '•" * **"*•' *•" w •
tttt kB«n »»»«B I* (BUB* Bl«»i •BICCU Ml M»B'*IB'T »nlin»l». WBIHBA •« •»<•••.HBIBW». t"BB»«( •)••». B»I
••• **•«« »• p»MI«vl»nr «»»»»wl •*•» !>« 0* A* <••« V '• ••• MXU>^^*)«« f'9>
i •«i«i tA«i «•<*> IA* *'0i*cii>« aotning
•TATCHIKT Of MACnCAL TOC4TMCHT
If (WAUOWCO: 4*i •»•"«•' •»•!»»•(. 0* «•' !•<••«
•^ul*w Oe na |k« 4«y to v KMcftoaeu* pw
V ON tWI*: *»«»i win ouniv » •«•» •«• •••' 0» "WOC* tncnian i nii«iian
If I" ITU: *V»» «•» ••• !•>
m§ aradua px Mf. r»u
• .• r». KWMM • nut oi 10 |«ion» •> rrmn «
Ui» oix CM*
Oa >w «e*r «"»«
!«««> dfll' (torn urgpi vMi OB "*
*>•>*> 14Mb
TMIJ ••OOUCT
UUI O»«durl Iram •
0*
minnnin •
• Mr. T»
i to tram •»>*" «*«« «• e* >•
r (Ml
ITOBAQI AND WI'OIAL
•TOMOt
OB *• dM
f. iBMMI
tew e>
«••• r
fB*j«Hg Dem o* UBB el Mi oratfwa mey «• »«* * en *«• o> • in
i •»«
COMTAIMH Ol«»0»Al
tat ** •< «
0» Owning •
i •» •*•»• By «••• i
MM«B»MMk> I K«M
-------
ATTACHMENT §
-------
BROHOXYNIL CONTAINER RCLABCL'NG SCHCDULL
FOLLOWING IS A DETAILED PLAN DESIGNED 70 APPROPRIATELY RELABEL ALL BROMOXYNIL
PRODUCT CONTAINERS EXISTING WITHIN THE CHANNELS Op TRADE. INCLUDING
RHONE-POULENC, DISTRIBUTOR- AND DEALER INVENTORIES, IN A TIMCFRAME CONSISTENT
WITH THE APPLICATION FOR AMENDED REGISTRATION. UPON FINAL EPA APPROVAL
THESE STEPS WILL IMMEDIATELY BE IMPLEMENTED:
DAY 1 FOLLOWING. EPA AMENDED REGISTRATION APPROVAL
RHONE-POULENC WILL INITIATE THE PRINTING OF APPROVED AMENDED LABELS
FOR BUCTRIL*. BUCTRIL* * ATRAZINE AND BRONATE* HERBICIDES IN SUFFICIENT
QUANTITIES TO RELABEL ALL EXISTING BROMOXYNIL CONTAINERS HELD BY RPAC,
DISTRIBUTORS AND RETAILERS, .AS HELL AS FUTURE PRODUCTION QUANTITIES
SCHEDULED FOR THE REMAINDER OF 1969 USE SEASON.
RPAC HILL IMMEDIATELY HALT SHIPMENT OF ALL BROMOXYNIL PRODUCTS UNTIL
APPROVED AMENDED LABELS CAN BE PRINTED AND AFFIXED TO EACH CONTAINER
HITHIN RPAC POSSESSION/IN A MANNER CONSISTENT HITH THE "RELABELING
PROCEDURES" OUTLINED IK ATTACHMENT A.
DAY 4-10 FOLLOWING EPA AMENDED REGISTRATION APPROVAL
REVISED LABELS HILL BE DELIVERED AND STICKERING OF RPAC INVENTORIES
AT PLANTS AND WAREHOUSES HILL BEGIN. NEWLY L .* E 11 IKIU ' W II BE
RELEASED FOR SHIPMENT TO DISTRIBUTORS.
ADEQUATE QUANTITIES OF EACH APPROPRIATE LABEL, ACCOMPANIED HITH "RELABELING
PROCEDURES", WILL BE SHIPPED TO RPAC FIELD SALES REPRESENTATIVES FOR
IMMEDIATE DELIVERY TO DISTRIBUTOR WAREHOUSE LOCATIONS WHERE BROMOXYNIL
INVENTORIES EXIST OR HILL BE DIRECTLY MAILED TO DISTRIBUTOR LOCATIONS.
APPROPRIATE COMPENSATION FEES HILL BE PAID TO DISTRIBUTOR FOR RELABELING.
AND VERIFICATION OF LABEL DELIVERY WILL BE MADE BY DISTRIBUTOR SIGNING
THE "RP LABELING COMPENSATION" FORM. MONITORING BY RPAC FIELD REPS
HILL BE PERFORMED TO INSURE COMPLIANCE. DISTRIBUTORS WILL BE INFORMED
THAT NO BROMOXYNIL PRODUCTS MAY BE SHIPPED PRIOR TO RELABELLING ONCE
LABELS ARE RECEIVED.
-------
BRONATE*/BUCTRIL*/BUCTRIL* * ATRAZ1NE
RELABELING COMPENSATION PROGRAM
THIS PROGRAM IS DESIGNED TO COMPENSATE THE DISTRIBUTOR AND RESELLER
FOR RELABELING' HIS CURRENT INVENTORIES OF BRONATE*, BUCTRIL* AND/OR
BUCTRJL** ATRAZINE BROADLEAF HERBICIDES TO COMPLY WITH EPA REQUIREMENT!
TO PERFORM THIS TASK IN ACCORDANCE WITH SPECIFIED 'RELABELING DIRECTIONS,
DISTRIBUTOR/RESELLER WILL BE COMPENSATED AT A RATE OF $0.50 PER
CARTON, 30-GALLON DRUM, OR 110-GALLON fllN-I-BULK CONTAINER.
CURRENT PHYSICAL INVENTORY AS OF
(DATE)
BRONATE'* BUCTRIL* BUCTRlL* * ATRA7JNE
CASES
DRUMS
MINI'S
I HEREIN CITIFY THAT AS OF DATE SPECIFIED ABOVE, WE HAD IN OUR
INVENTORY THE QUANTITIES OF RHONE-POULENC BROMOXYNIL PRODUCTS
AS LISTED Au'OVE, AND HAVE RECEIVED ADEQUATE QUANTITIES OF REVISED
LABELS FOR RELABELING ABOVE INVENTORIES.
BUSINESS NAME:
STREET ADDRESS:
CITY: COUNTY: _____ STATE: ZIP
OWNER/MANAGER: PHONE:
tSJoNAlURfc)
RHONE-POULENC REPRESENTATIVE:
(SIGNATURE; TtRR
-------
DAY 11-20 FOLLOWING EPA AMENDED REGISTRATION APPROVAL
FIELD REPRESENTATIVES WILL INITIATE DELIVERY OF APPROPRIATE LABELS TO
EACH ACTIVELY SELLING BROMOXYNIL RESELLER. BEGINNING FIRST WITH PRIORITY
ACCOUNTS WHERE LARGE INVENTORIES ARE KNOWN TO EXIST. INSTRUCTIONS FOR
PROPER RELABELING WILL BE" PROVIDED AND COMPENSATION MADE TO INSURE COMPLIANCE,
RESEl-uRS WILL BE INFORMED THAT NO BROMOXYNIL MAYBE SOLD PRIOR TO RELABELLING
ONCE uABELS ARE RECEIVED. RETAILERS WILL BE SUPPLIED WITH ADEQUATE
NUMBER OF LABELS TO PROVIDE TO GROWERS. VERIFICATION OF LABEL DELIVERY
WILL BE MADE BY RESELLER SIGNING THE "RELABELING COMPENSATION" FORM.
EFFORTS TO HAND DELIVER NEW LABELS TO ALL RETAILERS WITH BROMOXYNIL
INVENTORIES WILL BE MADE. HOWEVER. MAILINGS TO MINOR BUSINESSES MAY
OCCUR TO INSURE DELIVERY IN TIMELY MANNER. THESE MAILINGS WILL BE DONE
USING REGISTERED MAIL TO VERIFY LABEL DELIVERY.
DAT 20 FOLLOWING EPA AMENDED REGISTRATION APPROVAL
LABEL DELIVERY FOR BROMOXYNIL FIELD INVENTORIES WILL BE COMPLETE AND
MONITORING BY RPAC FIELD REPRESENTATIVES WILL CONTINUE, TO.INSURE ALL
CONTAINERS PROPERLY LABELED FOR SALE.
-------
ATTACHMENT A
BUCTRIL*. BUCTRIL* « ATRAZ1NE. BROHATE*
RE LAB CLING PRXLDURE
2*-6ALLOH JUG
1. DEPALLETIZE CARTONS (36 PER PALLET).
2. USING THIN. FLAT METAL BAR. OPEN THE CARTON BY SLIDING BAR UNDER
TOP FLAPS FROM MIDDLE OF CARTON TOWARDS END OF CARTON. USE BAR
TO BREAK CLUE SEALANT ON BOTH FLAPS BEING CARFUL NOT TO DAMAGE FLAPS.
3. REMOVE HI TRUE GLOVES AND SET ASIDE.
4. REMOVE BOTH JUGS FROM CARTON.
5. REMOVE THE PRODUCT BOOKLET FROM THE LABEL ON SIDE OF JUG. ROLL BOOKLET
AND PLACE INTO HANDLE HOLE OF JUG.
6. PEEL BACKING FROM NEW PRODUCT LABEL AND PLACE NEW LABEL COMPLETELY
OVER EXISTING LABEL ON THE JUG.
7. RETURN JUGS TO CARTON AND REPLACE GLOVES ON TOP OF JUGS.
6. FOLD DOWN THE TWO SMALL FLAPS OF CARTON AND FOLLOW WITH TWO LARGE
i-LAPS.
9. TAPE CARTON CLOSED WITH COLORED PACKING TAPE CENTERING ALONG THE
CARTON OPENING AND EXTENDED DOWN BOTH SIDES 2-3 INCHES.
10. REPALLET1ZE CARTONS IF NECESSARY INCLUDING RESTRETCH WRAPPING IF
AVAILABLE.
30-6ALLOM DRUM AMD 110-GALLOH MINI-BULK
PEEL BACKING FROM NEW PRODUCT LABEL AND POSITION NEW LABEL OVER THE
EXISTING LABEL ON EITHER THE 30-GALLON DRUM OR 110 MINI-BULK CONTAINER.
-------
ATTACHMENT C
-------
ff RH<5NE-POULENC
«HdNi.P»OULENC AO COMPANY
OFFICE MEMORANDUM
TO: Nick Somma DATE: M*y J. i9B9
FROM: Dave Downing
Please find attached the Bromoxynll Label Amendment Communication
Plan. Our goal'1s to reach all persons who sell* apply or recommend
bromoxynll products within the agricultural community In an orderly,
logical and timely manner. With this In mind, we plan to first communicate
new restrictions the day following EPA approval to all RPAC Field and
Office Personnel involved with the sale, promotion, development, field
testing and distribution of bromoxynll products. By the second day
all bromoxynll product distributors will be contacted with this Information
via overnight mall. All resellers, university extension personnel and
weed scientists will have bromoxynll label restrictions direct mailed
to them within the first week following EPA approval of copy.
In addition to written communication, distributors, resellers, university
extension personnel and weed scientists will be personally contacted
by our field representatives within 2 weeks of EPA approval. Resellers
will be contacted on a priority basis according to their past sales
volumes as recorded by RhSne-Poulenc.
Following these written and personal contacts, with those who will
be called upon to provide Information, mass communication to growers,
crop consultants and farm managers will begin via radio spots, data-line
Information system, and point of purchase posters.. Informing them of
the new "Restricted Use" classification for bromoxynil products and
to contact their local reseller for detailed information.
Rhone-Poulenc feels that this coranunication plan will serve the
Intended need to alert the agricultural Industry of the proper manner
to handle and apply bromoxynil products with minimal risk during the
1989 use season.
DPD:vwg
Attachment
cc: J.N. Harton
S.A. Schmotzer
-------
BROHOXYNIL LABEL AMENDMENT COMMUNICATION PLAN
UPON RECEIVING FINAL APPR'OVAL FROM THE EPA OF 1989 LABEL AMENDMENTS
FOR COMMERCIAL BROMOXYNJL OCTANOATE FORMULATIONS, AND APPROVED COPY
OF INTENDED INDUSTRY COMMUNICATIONS. RPAC WILL IMMEDIATELY INITIATE
A COMPREHENSIVE PLAN TO DISSEMINATE NEW PRODUCT PRECAUTIONS AND RESTRICTIONS
TO APPROPRIATE AUDIENCES WITHIN THE PESTICIDE CUSTOMER/USER NETWORK.
FOLLOWING IS A DETAILED DESCRIPTION AND TIMETABLE OF HOW THAT PLAN WILL
UNFOLD:
PAY 1 FOLLOWING CPA APPROVAL OP COPY
COMPLETE LABEL AMENDMENTS, WITH A COVER LETTER HIGHLIGHTING EACH PRECAUTION
AND RESTRICTION OF THE BROMOXYNIL LABEL. AS WELL AS A DESCRIPTION OF
THE PRODUCT RELABELING PLAN, WILL BE TELEFAXED TO EACH DISTRICT AND
REGIONAL OFFICE. WITHIN RHONf-POULENC AG COMPANY.
OVERNIGHT MAIL, INCLUSIVE OF IDENTICAL INFORMATION, WILL BE SENT TO
EACH FIELD REPRESENTATIVE WITHIN THE COMPANY, AS WELL AS APPROPRIATE
RPAC ADMINISTRATIVE AND PLANT PERSONNEL.
DAY 2 FOLLOWING EPA APPROVAL OF COPY
ANNOUNCEMENT OF THE BROMOXYNIL LABEL CHANGES AND THE PRODUCT RELABELING
PLAN WILL BE SENT. VIA OVERNIGHT MAIL TO ALL BROMOXYNIL DISTRIBUTORS.
RPAC FIELD SALES PERSONNEL WILL BEGIN MAKING PERSONAL CONTACT CALLS
ON BROMOXYNIL DISTRIBUTORS AND RESELLERS GIVING CONTACT PRIORITY TO
THOSE RETAILERS REPRESENTING THE MAJORITY OF BROMOXYNIL SALES TO GROWERS.
IN ADDITION RPAC FIELD DEVELOPMENT REPRESENTATIVES WILL BEGIN CONTACTING
UNIVERSITY EXTENSION PERSONNEL AND WEED SCIENTISTS. AN ESTIMATED 3,000
TOTAL CONTACTS CAN BE MADE WITHIN TWO WEEKS.
-------
DAY 5 FOLLOWING EPA APPROVAL OF COPY
DIRECT MAIL LETTERS OUTLINING THE LABEL AMENDMENTS AND NEW RESTRICTIONS
WILL BE SENT TO DISTRIBUTORS. DEALERS. CUSTOM APPLICATORS AND UNIVERSITY
EXTENSION PERSONNEL - AN ESTIMATED 12.000 INDIVIDUALS. THIS WILL REINFORCE
PERSONAL CONTACTS BY RPAC FIELD PERSONNEL.
DAY 14 FOLLOWING EPA APPROVAL OF COPY
"RESTRICTED-USE" CLASSIFICATION OF BROMOXYNIL HERBICIDES WILL BE COMMUNICATED
TO SOME 35.000 GROWERS THROUGHOUT HIGH INTENSITY USE-AREAS. VIA DATA-LINE.
A COMPUTERIZED INFORMATIONAL SYSTEM, WITH COPY THAT INSTRUCTS GROWER
TO SEEK DETAILED LABEL USE AND HANDLING PRECAUTIONARY INFORMATION THROUGH
THEIR AG CHEMICAL SUPPLIER.
DIRECT MAIL LETTERS OUTLINING THE LABEL AMENDMENTS AND NEW RESTRICTIONS
WILL BE SENT TO FARM MANAGERS AND CROP CONSULTANTS.
PRINTING OF POINT-OF-PURCHASE POSTERS WILL BE COMPLETED AND SENT TO
RESELLERS. TO BE DISPLAYED AT THE RETAILER LOCATION TO ALERT GROWERS
WHO'PURCHASE BUCTRIL*. BUCTRIL* + ATRAZINE OR BRONATE* HERBICIDES OF
THEIR "RESTRICTED USE" CLASSIFICATION.
A RADIO CAMPAIGN, TARGETED AT GROWERS WITHIN BROMOXYNIL USE-AREAS WILL
KICK-OFF ON DAY 14 TO COMMUNICATE THE "RESTRICTED-USE" CLASSIFICATION
OP BUCTRIL*. BUCTRIL* + ATRAZINE AND BRONATE* AND 0 Ni'.Ut
-------
DEALER/DISTRIBUTOR LETTER
ATTEXTIO* - LABEL CHANGES FOR BRONATE*. BUCTRIL* AND BUCTRIL* * ATRAT1NE
This Is to Inform you that BRONATE*. BUCTRJl* ana BUCTRIL* * Atrazlne
broadleaf herbicides have recently been reclasslfled as "RESTRICTED USE
PESTICIDES" and that the labels have been amended to Include new
precautionary statements, additional protective clothing requirements, and
new handling and application restrictions.
These changes have been Implemented because recent tests have shown that
exposure to the active Ingredient 1n these products has caused birth
defects 1n laboratory animals. The new label amendments have been added to
substantially reduce the exposure to these products when handling or
applying. . •
Enclosed you will .find copies of each new label for your review. Please
take time to become'familiar with this Information 1n order that you are 1n
fu*l compliance with each Important amendment. Significant additions
Include: 1} New warning statements; 2) Specific use directions requiring
additional protective clothing and clean-up procedures; 3) The requirement
of mechanical transfer systems when handling 30 gallons or more product 1n
a single day; 4) Use of enclosed cabs when applying 180 or more acres In a
single day; and 5) New chemlgatlon and aerial application restrictions.
In an effort to assure .that all Inventories of BRONATE*. BUCTRIL* and
BUCTRII* + Atrazlne are stlckered with these changes, a relabelling-program
Is being Implemented by Rh5ne-Pou1enc and within the next several days your
RP Field Representative will be delivering adequate quantities of
self-adhesive labels with Instructions for relabelling your current
Inventories. To perform this task Rhdne-Poulenc will compensate your
efforts at a rate of JO.SO/case. 30-gallon drum or UO-gallon mini-bulk
unit, and will verify your participation with an enrollment form at time of
label delivery. In addition, your RPAC Field Rep will provide Resellers
with a polnt-of-purchase poster for hanging, and grower handouts, both
alerting him to the label changes of which he mist comply.
Once you have received revised labels, no product may be shipped or sold
until stlckered with the new label. If for any reason distributors.don't
receive labels within 7 days of receipt of this letter (14 days for
Retailers), pleast call the toll free Rh6ne-Poulence Hot-Line at
1-800-334-9745, and labels will be Immediately shipped to you.
Thank you for your continued support and help 1n communicating this
information. Please contact your RPAC Field Representative 1f you have
questions or specific Issues relating to this matter that you would like to
discuss.
Sincerely,
-------
UNIVERSITY/CROP CONSULTANT LETTER
ATTENTION - LABEL CHANGES FOR BRONATE*. BUCTRIL* AND BUCTRIL* * ATRA2INE
TMt Is to Inform you that BRONATE*. BUCTRJl* tnd BUCTRIl* » Atrazine
broadleaf herbicides htve recently been reclasslfied as "RE5TRJCTED USE
PESTICIDES" end tha-t the Ubels have b«en amended to Include new
precautionary statements, additional protective clothing requirements, and
new handling and application restrictions.
These changes have been Implemented because recent tests have shown that
exposure to the active ingredient in these products has caused birth
defects In laboratory animals. The new label amendments have been added to
substantially reduce the exposure to these products when Handling or
tpplylng.
Enclosed you will find copies of each new label for your review. Please
take time to become familiar with this Information In order that you are In
full compliance with each Important amendment. Significant additions
Include: 1) Mew warning statements; 2) Specific use directions requiring
additional protective clothing and clean-up procedures; 3) The requirement
of mechanical transfer systems when handling 30 gallons or more product 1n
a single day; 4} Use of enclosed cabs when applying 180 or more acres 1n a
single day; and 5) New chemigation and aerial application restrictions.
Thank you for your continued support and help 1n communicating this
Information. Please contact your RPAC field Representative If you have
questions or specific Issues relating to this matter that you would like to
discuss.
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*
f RH6NE-POULENC
GROWER LETTER TO BE AVAILABLE AT RESELLER LOCATION
RHONE-POOLING AO COMPANY
TO: BUCTRIL»/BUCTRIL« * Atrazlne/BRONATE* Users
BUCTRIL*. BUCTRIL* * Atrazine and BRONATE* herbicides have been
reclassified "Restricted Use Pesticides", and additional label
restrictions and precautions have been added to minimize user
exposure.
Please note when review the revised product labels the following
changes have been made:
* Warning Statement: This product has been shown to cause birth
defects in laboratory animals. Women of chlldbearlng age
should be particularly careful when handling this product to
avoid ingestion and skin contact.
* Protective clothing requirements such as nitrile gloves,
cotton coveralls, chemical resistant shoes, and chemical
resistant apron for mixer/loaders have been added. Please
review the label for full details.
* Mechanical transfer systems are required to be used 'for
loading-of 30 or more gallons of product are used per day.
* Enclosed cabs are required for ground applications If 180 or
more acres are treated per day.
* New chemigatlon and aerial application restrictions have been
added. Please review the label for details.
Please thoroughly familiarize yourself with and strictly adhere to the
label requirements because the safety of you, the user, is our
foremost concern. Please contact your local chemical supplier if you
have questions or require further Information.
BUCTRIL and BRONATC are registered .trademarks of RhSne-Poulenc Ag
Company.
?T«« A^
«U«AOe««T*lAW6».ES»«"
BdTMiBUliC«SEAv:CES TELE* NUMOC& «M93". A>4CWCnQACH *°C IDS
-------
RADIO/DATA-LINE COPY
ATTENTION 6ROWERS!
BUCTR1L*/ BUCTRIL* * ATRAZINE AND BRONATE* HERBICIDES/
USED FOR PO£T-EMCRGENCE BROADLEAF WEED CONTROL/ HAVE
*
BEEN HE-CLASSIFIED AS RESTRICTED USE PESTICIDES.
FOR COMPLETE DETAILS AND INFORMATION/ CONTACT YOUR FARM
CHEMICALS SUPPLIER. AND REMEMBER ... YOUR SAFETY IS OUR
TOP PRIORITY. SO/ AS WITH ANY CROP PROTECTION
CHEMICALS. ALWAYS READ AND FOLLOW INSTRUCTIONS ON THE
LABEL.
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POSTER FOR RESELLER
BUCTRIL •
BRONATE •
l
BUCTRIL* •+ ATRAZINE
ARE NOW
RESTRICTED USE PESTICIDES
ASK HERE FOR COMPLETE
DETAILS AND INFORMATION,
RHONE-POULENC AQ COMPANY
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ATTACHMENT D
In lieu of the sentence which states, "If this product is
packaged in a 30 gallon drum or you will har.-iie a total of 30
gallons or more of this product per day/ you must use a
mechanical transfer system for all mixing arid loading
operations," the complete revised labeling will state, "If you
will handle a total of 3C gallons OL more of this product per
day, you must use a mechanical transfer system for all mixing and
loading operations. If t-his product is packaged in a 30 gallon
drum, you must use a mechanical transfer system which terminates
in a drip-free hard coupling which may be used only with a spray
or mix tank which has beon.fitted with a compatible coupling. If
you do not presently own or have access to a mechanical transfer-
system with this type of coupling, contact your dealer for
information on how.to obtain such a system or to modify your
present system."
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ATTACHMENT B
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APR 2 5
DRAFT PROPOSED PROTOCOL: DROMOXYNJL tXPOSURZ STUDY
1.0 INTRODUCTION
A passive doeiaetry study shall be conducted to ••»••• the
dermal and inhalation exposure occurring during routina uaa of
broooxynil. The study shall ba designed so that the
Environmental Protection Agency aay be able to: (1) quantify the
exposure occurring during nixing/loading, application, and clean-
up when bromoxynil is applied by ground boon to field crops
employing rigs where boon lengths typically exceed 30'; (2)
quantify the exposure occurring during nixing/loading,
application, and clean-up when bromoxynil is applied by ground
boon to crops where rigs of 20' to 40* predominate; (3) within
each subgroup estimate the total potential dermal exposure and
the actual deposition to the skin under the clothing worn by each
study participant. As an additional objective, this study or a
seperate study will quantify the potential dermal exposure and
•Kin deposition occurring during open pour aixing and loading
with the new Rhone-Poulenc 2.5 gallon container and a
conventional 2.5 gallon container*
2.0 MATERIALS AND METHODS
2.1 Sits Selection
The study will address two sain crop groupings. The first
grouping shall be crops to which daily treataents of 150 acres or
nore art typical and boom sices ef 50' or gr'eater are the norm.
The usual application speed i* expected to be approximately 0.5
acres/minute. The second grouping shall be crops to which daily
treatment of 50 to 120 acres is standard and boom sizes average
20* to 40*. The usual application speed is expected to be
approximately 0.25 to 0.35 acres/ainute.
within each grouping tha sites shall be selected based on
routine use ef bromoxynil or other early post'emergent herbicides
in that arsa. A minimum, of tan sites are to ba used within each
grouping.
2.2 Cooper at or felection . . . . ...
Cooperators used in the study are to be individuals
intending to apply a pott emergent herbicide independent ef
possible participation in the study. The candidates are te be
•alactad in a manner identical to that employed in the May 4
Baker Canada/Rhone-Poulenc Study with the exception that a
minimum number ef participants with enclosed tractor cabs shall
ba required. The questionnaire used should be similar to that
used in the Canadian study. Selected cooperators will receive
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• 2 -
broaoxynil in a manner identical to * non-cooparator who would be
obtaining breaoxynil for bia/her uae exeapt that bromoxynil may
;« providad in a non-atandard containar aa necaasary to
.effectuate tha study. Rhone-Poulane may provida elaan coveralls
and nitrila glovas to study partieipanta. Tha study participants
will initially be inatructad to follow label diractions. Should
tha participant attempt to handla bromoxynil with lass than tha
labal required protective clothing, Rhona-Poulanc will racord
such deviation froa the label diractions and then require the
participant to utilize ell required clothing. The normal and
typical wcrfc routines of the participants are not to be altered
once the-study participant has begun handling bro&oxynil during
the aonitoring portion of the study.
2.3 Application Detail*
Information collected for each application of broaoxynil
shall include target crop, data involving cultivar, growth stage,
date of planting, and row spacing. Equipment information shall
include sprayer model and sake, tractor aodel and make, procedure
and tine required to aix and load the -sprayer and the date and
method of sprayer calibration. Alterations to the equipment such
as shielding of booas and opening of windows in closed cab
tractors will be recorded. Application rate and amount of active
ingredient handled shall be recorded as will the actual tiae of
application.
Field conditions including wind speed and direction,
relative humidity, rainfall, temperature, and cloud cover shall
be recorded at each aonitoring site for the duration of each
aonitoring period. A description of each test site will be
recorded.
2.4 Dermal Exposure
Dermal exposure to all bcdy araaa with the exception of the
hands vill be aonitored in a Banner that will permit the
estiaation of potential dermal exposure and dermal exposure to
the skin. Potential dermal exposure vill be 'monitored by the
Our ham-Wolfe patch aathod (Measurement of Exposure of Workers to
Pesticides, Bull. Wld Kith Org., 1962, 26:75-91). Patches shall
be placed in a manner specified in Subdivision U of the Agency's
Pesticide Assessment Guidelines on the outside of the
cooperator's clothing. Dermal exposure to body areas covered by
clothing shall be monitored using either whole body dosimeters
composed of a long sleeve cotton T-shirt and long legged cotton
underpants or by a fluorescent tracer technique. The whole body
dosiaeters, if selected, will be provided to each cooperator by
Rhone-Poulenc at least one day prior to the study and shall be
placed on each cooperator, by the cooperator, at the time that
tha cooperator gets dressed to perform the day's worX routine.
Tha whole body dosimeters are to be worn under all clothing
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- 3 -
normally worn by the eoeperators. racial exposure may be
monitored by the use of facial swabbing in liau of doaiaeter*.
Hand exposure will be monitored by u*« of hand rinses.
The monitoring paried vill oonsist of the handling of not
less than IS Iba ac.tive ingredient with the exception that
external patches will be changed and hand rinses will be
conducted at the end of each mix/load cycle and each application
cycle.
2.5 Inhalation Exposure
Inhalation exposure will be monitored by use of personal
air samplers. The air saaplers will be turned off during each
break in the work routine likely to exceed 30 minutes. The
duration of the sampling period should be the entire day's work
routine; however* caution must be taken to prevent breakthrough
from saturation of the collection oedia. The duration of
sampling and calibration of air flov vill be conducted for each
eaaple period.
3.6 REPLICATIONS
A replicate is defined as one monitoring period consisting
of the handling of at least IS Ibs active ingredient. The
residue levels of external patches for each body area and hand
rinses will be combined in the calculation of total potential
dally exposure for each job function and the combined nixing,
loading, and application functions. For each crop grouping a
minimus of ten sites are to be selected. For each crop grouping
a -minimum of 20 replicates shall be monitored. For each set of
20 replicates, a minimum of 7, but no more than 13 replicates,
•hall involve application from enclosed tractor cab*. A total of
at least 40 mixer/loader/applicator replications will be
conducted for the study. Monitoring of the exposure resulting
from the ure of the new 2.5 gallon container may be conducted
either as an ancillary portion of the study or as a separate
study and must consist of a minimum of 15 replications of the new
2.5 gallon container .and IS replications involving a conventional
2.5 gallon container. lach set of 15 replications vill involve a
minimum of five individuals at three different sites. A
replicate for this portion of the study is defined as one
mix/load cycle, in. vhicft a spray tank is filled to capacity.
2.7 QUALITY ASSURANCE
All quality assurance as defined in Subdivision U of the
SFA's Pesticide Assessment Guidelines will be required.
3.0 DATA ANALYSIS
The purposes of this study are to quantify the exposure
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- 4 -
received during the use of broaoxynil end the identification of
regulatory option* that aay be required to reduce exposure.
The data will be presented as a mean exposure and • range.
The standard deviation will also be determined. Non-parametric
or other appropriate statistics may be ecployed to determine the
statistical significance of different variables in determining
exposure. Major emphasis will be placed on tractor type, boom
size, and tank site. Post priori analyses nay be conducted on
other variables depending on observed patterns in the data. A
priori statistical tests will.be defined in the protocol by the
Agency.
A priori statistical aethods will test the following null
hypotheses: 1) Exposure during mixing/loading with standard 2.5
gallon containers is the same as with the new 2.5 gallon
containers; 2) Exposure during application involving snail rigs
is the saae as those involving large rigs; and 3) Exposure during
application froa open tractors is the sane as from enclosed
tractor cabs. Any post priori statistical analysis will be
determined upon receipt and assessaenfof the data. The Agency
fully recognizes the fact that exposure data is inherently highly
variable (C.v. > 100%) and that identification of variables
having statistical significance at p < 0.05 aay not occur without
requiring an even greater nuaber of replications. Such an
undertaking would be prohibitive in cost. Trend analysis of the
data aay be conducted in the absence of statistical significance
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
^
*/„
* WASHINGTON, D.C. 20460
OFFICE OF
PESTICIDES AND TOXIC SUBSTANCES
JUL I 3 1987
MEMORANDUM
SUBJECT: Compliance Strategy for the Cancellatio
of Carbon Tetrachloride
FROM: John J. Neylan III, Director
Policy and Grants Division
Office of Compliance Monitorin
TO: Addressees
Attached is the Compliance Strategy for the Cancellation
of Carbon Tetrachloride. The attached strategy provides
guidance for the enforcement of the November 12, 1986 order
which cancelled all pesticide products containing carbon
tetrachloride, except those registered for use on encased
museum specimens.
This strategy is effective immediately and calls for
compliance monitoring of the cancellation order through
inspections of registrants, producers, dealers and users of
cancelled products. Inspections will be conducted by States
with Cooperative Enforcement Agreements, and EPA in States
without Cooperative Enforcement Agreements, as part of their
current routine inspections.
We appreciate.the comments offered on the May 5, 1987
draft of this strategy.- Most of the comments were editorial
and have been incorporated into the final document. However,
one commenter suggested that the strategy should also
address the disposal of any carbon tetrachl oride products.
OCM does not believe that this issue should be addressed
in the strategy. OCM recommends that the disposal of any
remaining stocks of carbon tetrachloride should be in
accordance with the label directions.
If you have any questions concerning the attached strategy,
please contact Dan Helfgott of my staff at FTS 382-7825.
Attachments
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ADDRESSEES
Douglas D. Campt (TS-766C)
Frederick F. Stiehl (LE-134A)
Stanley Abramson (LE-132A)
Peg Anthony (EN-342)
Ken Shiroishi
Davi d Hannemann "
John Martin
John J. Neylan III
Jerry Stubbs "
Mike Wood
Dexter Goldman "
Jake Mackenzie
Western Regional Compliance Director
A. Charles Li ncoln
Eastern Regional Compliance Director
I Louis F. Gitto, Director
Air Management Division
II Barbara Metzger, Director
Environmental Services Div.
Ill Stephen R. Wassersug, Director
Hazardous Waste Management Div.
IV Winston A. Smith, Director
Air, Pest. & Toxic Mgmt Div.
V William H. Sanders III, Director
Environmental Services Div.
VI William B. Hathaway, Director
Air, Pesticides & Toxics Div.
VII William A. Spratlin, Director
Air & Toxics Division
VIII Irwin L. Dickstein, Director
Air & Toxic Subs. Division
IX Jeffrey Zelikson, Acting Director
Toxics & Waste Management Oiv.
X Gary 0'Meal, Di rector
Air & Toxic Hivision
Gerald M. Levy, Chief
Office of Pesticides & Toxic Sub
Ernest Regna, Chief
Pesticides & Toxics Sub. Br
Larry Miller, Chief
Toxic & Pesticides Branch
H. Kirk Lucius, Chief
Pesticides & Toxic Subs. Branch
Phyllis Reed, Chief
Pesticides & Toxic Subs. Branch
Norman E. Dyer, Chief
Pesticides & Toxics Subs. Branch
Leo Alderman, Chief
Toxics & Pesticides Branch
Alvin Yorke, Chief
Toxic Substances Branch
Richard Vaille, Chief
Pesticides & Toxics Branch
Anita Frankel, Chief
Pesticides & Toxic Subs. Branch
cc: Jim Lamb
(TS-788)
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. COMPLIANCE STRATEGY FOR THE
CANCELLATION OF CARBON TETRACHLORIDE
OVERVIEW
In 1984, the Agency suspended all registrations of
pesticide products containing carbon tetrachloride, except
those products registered for use on encased museum specimens,
after registrants failed to respond to a FIFRA §3(c)(2)(B) Data
Call-In. On July 23, 1985, the Agency issued a Stop Sale, Use,
or Removal Order (SSURO) to all registrants covered by the
suspension order. This SSURO stated that registrants may not
legally distribute, sell, offer for sale, hold for sale, ship,
deliver for shipment, or receive and (having so received)
deliver or offer to deliver pesticide products containing
carbon tetrachloride after the date of receipt of the SSURO.
Registrants who later agreed to voluntarily cancel their
registrations, as well as all persons who sell or distribute
pesticide products containing carbon tetrachloride, were
allowed to distribute, sell, offer for sale, hold for sale,
ship, deliver for shipment, or receive and (having so received)
deliver or offer to deliver carbon tetrachloride until December
31, 1985. Stocks were allowed to be used until June 30, 1986.
On November 12, 1986 (51 FR 41004), the Agency issued a
Notice of Intent to Cancel (NOIC) for all remaining suspended
registrations of pesticide products containing carbon tetra-
chloride except those products registered for use on encased
museum specimens.
Carbon tetrachloride was present as an active ingredient
in pesticide products registered for use as fumigants on stored
grain, in flour milling and grain processing plants, as well as
on encased museum specimens in storage. All registrations for
pesticide products containing carbon tetrachloride as an active
ingredient, except for use on encased museum specimens, have
now been cancelled.
Carbon tetrachloride poses significant toxicological
risks, and may contribute to the breakdown of the atmosphere's
ozone layer. The use on encased museum specimens will be
allowed to continue because the current label instructions are
sufficient to reduce applicator exposure so that the benefits
outweigh the risks.
Compliance with the Cancellation Order will be determined
through inspections of registrants, producers, dealers, and
users of cancelled products. Inspections will be conducted by
States with Cooperative Enforcement Agreements, and EPA in
States without Cooperative Enforcement Agreements, as part of
their current routine inspections.
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-2-
REQUIREMENTS OF THE RULE
All pesticide products containing carbon tetrachloride,
except for use on encased museum specimens, were cancelled
thirty days after publication of the NOIC or the date of
receipt of the Notice by the registrant, whichever date was
later.
Regulated Industry
All registrants, producers, distributors, and users of
carbon tetrachloride other than those with products registered
for use on encased museum specimens. At the time of the ori-
ginal Data Call-in, there were 52 registrants and 114 registra-
tions. Vulcan Formula 72 (EPA Registration Number 5382-2) is
the only product registered for use on encased museum specimens.
Carbon tetrachloride is also known as perchloromethane
and tetrachloromethane.
Existing Stocks
Previous regulatory action has already prohibited regis-
trants and retailers from distributing, selling, offering for
sale, holding for sale, shipping, delivering shipment, or
receiving and (having so received) delivering or offering to
deliver carbon tetrachl oride after December 31, 1985.
Additionally, all provisions for use, except use on encased
museum specimens, have been prohibited since June 30, 1986.
Therefore, the November 12, 1986 NOIC provides for no additional
existing stocks or use provisions. Noncompliance with the
carbon tetrachloride cancellation order is a violation of FIFRA
§§12(a)(l)(A) and 12(a)(2)(K).
COMPLIANCE MONITORING
Compliance with the Cancellation Order will be determined
by inspection of registrants and producers of cancelled products,
inspections of dealers and users, and investigation of tips and
complaints.
Neutral Administrative Inspection Scheme
Since the issuance of the Cancellation Order is an admini-
strative action which cancels all carbon tetrachloride pesticide
products suspended for noncompliance with the FIFRA §3(c)(2)(B)
Data Call-In, inspections for violations of this cancellation
order will take place within the existing compliance monitoring
framework.
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-3-
ALLOCATION OF RESPONSIBILITIES
Office of Pesticide Programs
0 Will develop and provide OCM with a list of those products
which have been cancelled.
Office of Compliance Monitoring
0 Will develop and transmit the Compliance Monitoring Strategy
to the Regions.
0 Will transmit the list of those products which have been
cancelled to the Regions.
0 Will transmit the list of registrants and producing establish-
ments of carbon tetrachloride.
Regions
0 Will provide copies of the Compliance Monitoring Strategy to
States.
°"Will distribute a list of products, registrants and producing.
establishments to the States.
0 Will conduct inspections in States without Cooperative
Enforcement Agreements as part of their routine inspectional
schedule.
0 Will take enforcement action as appropriate.
States
0 Will conduct inspections as part of their routine inspectional
schedule.
0 Will take enfocement action as appropriate provided they have
the authority.
0 Will report to the Regions on actions taken under the carbon
tetrachloride cancellation.
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ATTACHMENT
CARBON TETRACHLORIDE REGISTRANTS AND PRODUCTS
REGION I (1)
Uniroyal Chem. Co.
74 Ami ty Rd.
Bethany, CT 06525
EPA Reg. No. : 400-192,-193,-197 ,-200 ,-203 ,-268
REGION II (3)
Rochester Midland
Box 1515
Rochester, NY 14603
EPA Reg. No. : 527-11
Prentiss Drug & Chem. Co.
21 Vernon St. C.B. 2000
Floral Park, NY 11001
EPA Reg. No. : 655-624
Bernard Sirotta Co., Inc.
67 35th St.
Brooklyn, NY 11232
EPA Reg. No. : 2826-1
REGION III (0)
REGION IV (11)
Lester Labs
2370 Lawrence St.
Atlanta, GA 30344
EPA Reg. No. : 337-16
Hill Manufacturing, Inc.
1500 Jonesboro Rd., SE
Atlanta, GA 30315
EPA Reg No. : 402-54
Quinn Drug & Chem. Co.
Box 847
Greenwood, MS 38930
EPA Reg. No. : 416-48
Selig Chem. Industries, The
840 Selig Dr., SW
Atlanta, GA 30373
EPA Reg. No. : 491-2,-47,-82,-154,-190
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-2-
Southland Pearson and Co..
Drexel Chem. Co.
Box 9306
Memphis, TN 38109
EPA Reg. No. : 723-19
Peach County Property Inc.
Sureco
E. Main St. Box 938
Fort Valley, GA 31030
EPA Reg. No. : 769-70
Oxford Chemicals
P. 0. Box 80202
Atlanta, GA 30366
EPA Reg. No. : 3635-136
Stephenson Chem. Co. Inc.
Box 87188
College Park, GA 30337
EPA Reg. No. : 4887-57,-127
Vulcan Materials Co. Chem. Div.
P. 0. Box 7689
Birmingham, AL 35253
EPA Reg. No. : 5382-1,-2,-4,-6 ,-7 ,-9,-11,-31,DC38000100
Big F Insecticides, Inc.
Box 3346
Jackson, TN 38303
EPA Reg. No. : 33161-2
Mid America Chem. Co.
P. 0. Box 490
Montrose, AL 36559
EPA Reg. No. : 36480-47,-48,-49,-50,-51
REGION V (5)
Riverdale Chem. Co.
220 E. 17th St.
Chic. Heights, IL 60411
EPA Reg. No. : 228-8
Dow Chemical USA
P. 0. Box 1706
Midland, MI 48640
EPA Reg. No. : 464-32,-34,-97,-171,-181,-188,-193 ,-216,-227
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-3-
Walter Haertel Co.
8719 Lyndale Ave So.
Minneapolis, MN 55420
EPA Reg. No. : 821-2
E. H. Leitte Co.
Box 180
Lake Elmo, MN 55042
EPA Reg. No. : 939-25
Universal Cooperatives Inc
7801 Metro Parkway P. 0. Box 460
Minneapolis, MN 55440
EPA Reg. No. : 1386-463
REGION VI (6)
Main Pro. Inc.
P. 0. Box 153249
Irving, TX 75015
EPA Reg. No. : 1325-22,-51
Staffel
ESCO Distributor Inc.
301 1/2 Staples St.
Corpus Christi, TX 78411
EPA Reg. No. : 3286-8098
Voluntary Purchasing Group, Inc.
P. 0. Box 460
Bonham, TX 75418
EPA Reg. No. : 7401-82
Grain Conditioners , Inc.
2622 Poydras St.
New Orleans, LA 70119
EPA Reg. No. : 10203-1
Soweco, Inc.
411 So. Parker'St.
Amarillo, TX 79106
EPA Reg. No. : 21327-8145
J. Chem. a division of Fumigators Inc.
P. 0. Box 5421
Houston, TX 77012
EPA Reg. No. : 36301-5
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-4-
REGION VII (17)
Bartels and Shore Chem. Co.
1400-02 St. Loui s Ave.
Kansas City, MO 63110
EPA Reg. No. : 413-51
Industrial Fumigant Co.
601 E. 159th St.
Olathe, KS 66061
EPA Reg. No. : 485-7,-9,-13,-15 ,-16,-17
MFA Oil CO.
Box 423
Shenandoah, IA 51601
EPA Reg. No. : 746-93
Douglas Chem. Co.
P. 0. Box 297
Liberty, MO 64068
EPA Reg. No. : 1015-10,-20,-22,-27,-29,-33,-36 ,-53
Warren Dougas Chem Co., Inc.
3002 F St.
Omaha, NE 68107
EPA Reg. No. 1616-4
Weevil-Cide Co. a subs, of Research Products Co.
411 N. 7th St.- Box 1057
Salina, KS 67401
EPA Reg. No. : 1629-1
Knox Chem. Co.
7625 Page Blvd.
St. Louis, MO 63133
EPA Reg. No. : 1645-12
Farmland Industries Inc.
P. 0. Box 7305
Kansas City, MO 64116
EPA Reg. No. : 1990-116,-184,-392,KS-83000400
Patterson Green-Up Co. Div of Curry Cartwright, Inc.
1400 Union Ave.
Kansas City, MO 64101
EPA Reg. No. : 2169-92
PBI/Gordon Corporation
1217 W. 12th St.- P. 0. Box 4090
Kansas City, MO 64101
EPA Reg. No. : 2217-108
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-5-
The Huge Company, Inc.
7625 Page Ave.
St. Louis, MO 63133
EPA Reg. No. : 2270-5
Research Products Co.
Box 1057
Salina, KS 67401
EPA Reg. No. : 2548-3,-13,-22,-30,-48
Chemi. Sol Chem. and Sales Co.
P. 0. Box 1485
Hutchison, KS
EPA Reg. No. : 2618-2
Brayton Chem. Inc.
P. 0. Box 437
West Burlington, IA 52655
EPA Reg. No. : 2993-7,-14,-23
Ferguson Fumigants, Inc.
93 Ford Lane
Hazlewood, MO 63042
EPA Reg. No. : 3886-13,-18,-136
Stewart Sanitary Supply Co., Ltd
P. 0. Box 15061
St. Louis, MO 63110
EPA Reg. No. : 43954-6
Kaw Val1ey, Inc.
1801 S. 2nd St.
Leavenworth, KS 66048
EPA Reg. No. : 44215-58,-59,-60,-61,-62
REGION VIII (3)
Lystad Inc.
Box 1718
Grand Forks, ND 58201
EPA Reg. No. : 2881-21
Falls Chemi cals Inc.
P. 0. Box 2345
Great Falls, MT 59403
EPA Reg. No. : 40831-21
Morgro Chem. and Energy Corp.
145 W. Central Ave.- P. 0. Box 151048
Salt Lake City, UT 84115
EPA Reg. No. : 42057-98
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-6-
REGION IX (5)
Stauffer Chem. Co.
1200 S. 47th St.
Richmond, CA 94804
EPA Reg. No. : 476-537,-1112,-1113,-1543
Hockwald Chem., Div. of Oxford Chem.
275 Valley Dr.
Bri sbane, CA 94005
EPA Re-g. No. : 1111-132
Coyne Chem. Co.
999 Anderson Dr., Suite 140
San Rafael , CA 94901
EPA Reg. No. : 3050-23
Cardinal Chem. Co.
'Green and Sansome Streets
San Francisco, CA 94111
EPA Reg. No. : 5440-6,-20,-22
Siskiyou County Dept. of Agriculture
525 S. Foothill Dr.
Yreka, CA 96097
EPA Reg. No. : CA79027400
REGION X (1)
Atomic Chem. Co.
Box 1111
Spokane, WA 91210
EPA Reg. No. : 6152-5,-6
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±i ii ;j
3 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
JAN 15 1976
OFFICE OF ENFORCEMENT
SUBJECT: Enforcement of Administrator's Decision and
Order Suspending Most Uses of Heptachlor and
Chlordane '
TO: Enforcement Division Directors
Pesticide Branch Chiefs
FROM: A. E. Conroy U.. Director
Pesticides Enforcement Division (EN-342)
I. LEGAL DEVELOPMENTS
istrator on the Suspension of Heptachlor-Chlordane (In re Velsicol
Chemical Corporation, et al. , FEFRA Docket No. 384) ordered the
suspension 01 "registrations of all pesticide products containing hepta-
chlor or chlordane for use on corn, household, garden, lav/n, and
turf pests, use against ticks and chiggers, and use as a'conslituent
in shelf paper. This Final Order reversed the December 12, 1975,
"Recommended Decision" of Chief Administrative Law Judge Herbert L.
Perlman dismissing the Administrator's July 29, 1975, "Notice of
Intent to Suspend. "*
On January 8, 1976, the Agency filed a "Suggestion for Clarifcation"
(attached) requesting the Administrator to adopt the Agencyrs interpre-
tation of the meaning and limitations of the Final Order. The Admin-
istrator has requested briefs on the issue of the appropriateness of a
clarification.
Finally, appeals have been filed by the Environmental Defense
Fund (in the Court of Appeals for the District of Columbia Circuit)
and by Velsicol (in the Court of Appeals for the Sixth Circuit). The
Velsicol appeal of the District Court's denial of its motion for pre-
liminary injunction against the Administrator's issuance of the July
" Copies of the Administrator's "Conclusions" and the "Order" are
attached.
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-2-
29. 1975, "Notice of Intent to Suspend" remains in abeyance in the
Sixth Circuit as well.
II. CURRENT AGENCY ACTIVITY
The office of the Hearing Clerk is preparing to serve by :
certified mail copies of the Final Order on all parties to the suspen-
sion proceeding. In addition, the Registration Division is preparing ,
to notify all registrants by letter of their status under the Order and
of what label amendments, if any, are necessary for them to continue
the registration of their products in accordance with the Order.
HI. ENFORCEMENT
The Pesticides Enforcement Division is preparing a general
strategy to enforce the Administrator's Order. This strategy will
provide status of registrants vis a vis the cancellation and suspension
proceedings, lists of formulatorjand distributors of chlordane and
heptachlor products, and status of product uses as clarified by any
'subsequent Orders.
Pending the completion of this strategy, regions should pro-
ceed with normal surveillance and inspection activities relating to
chlordane and heptachlor products. Enforcement actions should await
official notice of ^suspension to subject registrants.
Until that time you may find it helpful to deal with general
inquiries as follows.
1) So far as PED is able to determine at this time, stoc
which were formulated after
are illegal for further gh-jr^o.-* ^-i^ ~r ,IC_A.
2) Persons desiring to dispose of illegal stocks may arrange
with involved regions to ship the products for assorted disposal, includ-
ing for return to a supplier, for export, or in accordance vith directions
provided by the Office of Solid Waste Management. Disposal" questions
may be referred to Ray Kreuger in Washington at (202) 755-8050. Regional
offices should cooperate in every way possible with responsible efforts to
dispose of suspended chlordane /heptachlor stocks.
3) Questions relating to label status should be referred to
Tim Gardner of the Registration Division, Washington. (202) 426-9425.
As soon as firm policy exists as to this issue you will be informed of
its substance.
Should you have questions concerning any facet of the
chlordane /heptachlor suspension, please contact the appropriate regional
coordinator.
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'>,
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
JA?J r
OFFICE OF ENFORCEMENT
SUBJECT: Cltr-icr.tl^r. of Heptachlor/Chlordane
Suspension Order
TO: Enforcement Division Directors
Pesticide Branch Chiefs
FROM: A. E. Conroyll, Director
Pesticides Enforcement Division (EN-342)
Please find attached a copy of the Administrator's "Clarification
of Order of December 24, 1975 (In re Velsicol Chemical Corporation
et al., FIFRA Docket No. 384), " dateci January 19, iy75.Although -
the Administrator did not adopt per se Respondent EPA's proposed
order and table for clarification (see my January 15th memorandum
and enclosures), this document makes patent that all registrations
(Federal and State) of pesticide products containing heptachlor and
chlordane for uses not specifically continued (as set forth in paragraph
4 of the Conclusion to the December 24th Decision) were suspended.
For purposes of enforcement, "Attachment A" will be used as the
list of uses not suspended.
Should questions arise concerning the Clarification, or any other
matter relating to the heptachlor/chlordane proceedings, please con-
tact the appropriate regional coordinator.
-------
UNITED STATES OF Af.rRICA
niVlRO.'WENTAL PROTECTION AGENCY
BEFORE THE ADMINISTRATOR
i«uui>1 Chemical Corporation
.FIFRA Docket Mo. 384
Reqistrants.
CLARIFICATION- OF .
ORDER OF DECEMBER 24, 1975
C* January 7, 197S, Respondent EPA filed-a Suggestion for
purification of the Order of December 24, 1975, in the above-
• * " f «
<*?*. irr.cd proceeding, seeking clarification of the uses of
•r-r-i.-cts containing heptachlor and chlordane for which
TjJ'.lratior.s are not suspended by the December 24 Decision
«*,: Crdcr. Respondent also submitted a Proposed Order, including
*A 4*.uctopnt setting forth a proposed list of uses not suspended,
••i-;.?:f.cr with certain explanatory notes. . '
. On January 13, 1976, I "issued a notice of the filing of
>*-.;>:ftJent's Suggestion for Clarification and Proposed Order
••••' fasted written • comments. from the parties, thereby
•touting my intention to consider the possible need for
«:*'iJ»c*lion of the December 24. Decision and Order.* On
*«v»*ry 15, 1 976 ,' written comments were received from counsel for
fon v.vre submitted by counsel for Vclsicol Chemica
••-c'-'rc' r"»?n Oanua>'y 1J^. 19?6, but not sufficiently in adv
• .uraiiori of the January 13 notice to be considered th
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2
Agriculture of the State of Hawaii; counsel for some 300
registrants of various products containing hsptachlor or chlordane;
•
the Environmental Defense Fund; the U.S. Department of Agriculture;
and Respondent EPA. All of the foregoing parties, except the
Environmental Defense Fund, oppose Respondent's suggested
clarification of the December 24 Order, both on grounds that the
•
Administrator lacks jurisdiction or authority to clarify, modify,
• •" •
or al ter the .Order .and ..that. the. Order.-is_f inal.^and .cannot. nov/_be. - -
chanced .ir. the manner proposed by Respondent.
Even though not expressly provided for in the Rules of
Practice governing expedited hearings under the FIFRA, I have
.determined that authority does exist to clarify the December 24
Order and that some clarification is warranted, in view of the
apparent possibility that its provisions may be unclear. In my
view., the December 24 Decision and Order are clear and specific
in their terms and should not require any further elaboration.
Implicit in Respondent's suggested clarification, however, is the
notion that proper administration of the Decision and Order by
the Agency and explicit understanding thereof by all the parties
require a clear statement of the uses of products containing
heptachlor and chlordane for which registrations have not been
•
suspended. In an abundance of caution and concern,"therefore,
I believe proper administration of the Decision and Order wflV.be
served and facilitated by the following clarification of the..
•-•.•*
December 24 Order.
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3
In reviewing the Decision and Order and the possible need .
»
for clarification. I have not considered any new evi-JciiCt or
• /
argumentation. I have sought only to discern any possible source
i*
or sources of any lack of clarity in the expression of my
intentions at the tims I issued the Decision and Order. Cc-r.nnsnts
received from the parties have been roost helpful- in determining
• *•
•whether or not my intentions were clearly expressed. The sole
. . '• •
purpose of this clarification is to add clarity to the expression
of my intentions at ths time I issued tha Decaniber 24 Decision . •'
and Order.
The December 24 Order, by its terms, provides that all
* • •
. pesticide products containing heptachlor or chlordane for use
• • •
(1) on corn pests, (2) on household, garden, lav/n, and turf pests
(both by private homeowners and by pesticide control operators),
(3) against ticks and chiggers, and (4) as a constituent in
shelf paper, are suspended [the suspension of products for use on
corn having a post-effective date of August 1, 1976]. The Order
further provides that any stocks of technical grade heptachlor
or chlordane formulated into products intended for such uses
[after July 29, 19753 nay not be placed in commerce, sold, or used •
for such purposes or any other purpose not specifically
:exempted [in the Novemberv.18; 1974, cancellation order] or_
' * ' *"' • '.• *•' f
specifically permitted in'accordance with the Decision of the
Administrator attached thereto. .
-------
Ths uses specifically permitted or continued by the
Desision accompanying the December 24 Ordar include or.ly those set
forth in paragraph 4 of the Conclusions contained in the Decision*
• • • •
and, therefore, these uses (together with the exempted uses for
subsurface ground injection for termite control and dipping of
roots or tops of nonfood plants) are the only uses not suspended
by the December 24 Decision and Order. All other registrations
" • •
for uses "of products ^containing heptachlor or chlordasie are •
•*
suspended. Because th-2 x*ords "intended for such uses" in line 12
of the Order might be interpreted as limiting the suspended, uses
to the four uses enumerated in the first sentence of the Order,
the words "intended for such uses" are hereby deleted from the
December 24 Order.
The reasons for the specific enumeration of four uses •
'suspended in the first sentence of the Order, while suspending uses
for "any other purpose" in blanket form in the second sentence, are
twofold: (1) other than an occasional reference to certain
fruits and vegetables and other miscellaneous crops, the record
(including the Recommended Decision.of the Administrative Law
• •
Judge) does not adequately address many other (presumably minor)
uses of heptachlor and-chlordarie, as to-which-little or-'no benefits
evidence was presented at the hearing, and, indeed, because'the
record was so inadequate in this regard, the Administrative Law
Judge reconunendcd that such other uses not be continued, and
*uccision of the Administrator, p. 76
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5
(2) the four uses enumerated specifically in the December 24 .
Order nro ainon; t';" vses as to v;hich sufficient benefits evidence
•
was presented at the haariny to permit a risk-benefit assessment.
. • *
• . • •
Ulanket suspension of uses as to which there was little or no
evidence on benefits was necessary because the* evidence on
care*nogenicity risk v/as applicable to all uses. In view of the
risk so established, and in the absence of.sufficient benefits
evidence.as to uses for "any other purpose," it was'of course*
necessary to suspend such other uses, even though (for the reasons
• ' • • . '
indicated above) they could not bs enumerated specifically in the
Order. .
As to the grouping of uses on "certain fruits and vegetables
and other miscellaneous crops" [referred to in paragraph 5 of the
Conclusions in the Decision], it was my intention, that the
• • • •
provision in the Order applicable to uses for "any other purpose"
apply as well to this grouping of uses. In stating that "the
record in this proceeding is not sufficient to reach a conclusion"
regarding this grouping of uses,* I stated only that the evidence
on benefits was insufficient to permit the kind of discussion of
«... "
the risk-benefit assessment which I had used for better documented
• . •
• . «w». "
wsos. Therefore, with respect to this grouping of uses, I reached
' " * "
same ultimate conclusion as d.iscussed above concerning uses for
^-
f"?eision of the Administrator* p. 76.
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6
"any other purpose" generally, i.e. that, in vicv/ of'the
evidence on carcinogenic!ty risk, and in the absence of sufficient
benefits evidence, these uses are suspended, evsn though they"
• • •
could not be enumerated specifically in the Order. Thus, there is
no inconsistency between paragraph 5 of the Conclusions in the
•
Decision and the provisions of the,Order.
* * • • •
In view of the foregoing, I do not find it necessary to
•
either --adopt or-pcject -the .Proposed-
Russel E. Train
' .".'•'
Dated: January 19, 1976 "
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ATTACHMENT A
1
SPECIFIC usns or cm.onnANi* *. ILKPTACTILOII
NOT SUSPENDED 1»Y ADMINISTUATOJI'S OUDUU OF 12/24/75
COMPOUNDS) USE(a) * -STATUS OF USC(s)
ehlordane &
heptachlor •
ehlordane &
heptachlor
ehlordane &
' 4
heptachlor
• 4
heptachlor
heptachlor
heptachlor
ehlordane
eldordane
ehlordane
.'• ehlordane
i
Subsurface ground insertion for termite control
Dipping of roots or tops of non food plants
Control of cutworms on corn (both pfe and post
emergence)
Control of narcissus bulb fly
• " *
Seed treatment
.
Ant control to achieve pineapple mealy bug
control in Hawaii '• '
la Federal /Slate quarantine programs for
6 .5.6
Japanese Beetle and Imported fire ant
Control of black vine weevil on Japanese Yew
in Michigan
Control of Texas harvester ant in Oklahoma '
Control of inn ported fire ant by private ^
5.7 - *• .f
individuals
continued
continued
continued until
8 H /7G only
continued
• continued
continued ""
• . ;
continued • ,
• " • ?
continued
continued
continued
ehlordane
Control of white fringed beetle attacking food
8
crops in 8 S.E. States (AL.FL.GA.LA.MS.NC,
SC. TN)
continued
ehlordane
Control of soil insects attacking Florida citrus
continued
"ehlordane
Control of strawberry root pests by pro-plant continued
treatments
ehlordane
Control of white grubs in Michican
continued
1. All registrations (r edcrai and biaio) 01 pesuciae products containing hcpiacnlor ana
ehlordane for uses not specifically continued are suspended by the Administrator's
Decision and Order on the Suspension of Hcptachlor-Chlordanc.. The effect of the
Order is1 to further prohibit the manufacture, formulation or reformulation of products
:'. containing Heptachlor or Chlordane for any purpose other than for those registered
• uses which have been exempted in the Order and for manufacturing uses as an
. interim step in the. ultimate.formulaUon for.such registered uses. Sale and use of .
'. existing stocks-ofrcgistcrcd''products which were formulated prior to July 30, 1975
are permitted'for both continued and suspended uses. ' '~~ :' "~~~~-
•2«* PR No lice.74-11 (39 FR 41298) exempted thisiuse from cancellation. Such use
was similarly exempted from the Notice of Intention to Suspend. 40 FR 34456
(7/29/75). '•-.-•• '. -. .
3. Clarified at 40 FR 30522 (7/21/75) to apply to Ute use of emulsifiable or oil
concentrate formulations for controlling subterranean termites on.structural
.sites such as buildings, houses, barns, and sheds, using current control
practices. t . *
4. Velsicol has represented that it would voluntarily suspend domestic shipments
of heptachlor for this use ponding resolution of the cancellation proceedings.
5. On tlic assumption that Mirc.x is not available. •'
0. To include treatments required to certify to pest.free conditions as well as for
- . use in suppression and control programs. .- • -^ .
7. To include use on both public and private property by either owner, agent,
employee..or contractor. . ; . . • ;'-•;•' '"., • •' •
8. Not intended to preclude use on cotton. However; uco oh'tobacco is suspended.
9. Restricted to citrus root weevils. • .•:.!•'• "•" .
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5p7 ? UNITED STATES ENVIRONMENTAL PROTECTION AGENCY -
-------
f &&
'I \j§7
~'
ilTED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C, 20460
CERTIFIED MAIL
Gentlemen:
Subject : Notice of Suspension for:
On December 24, 1975, the Administrator issued his Decision and Order
on--the. suspension of Heptachlor and Chlordane. Most federal and state
registrations of Heptachlor and Chlordane were suspended although
certain uses were specifically exempted, (Refer to the enclosure). Any
registration v/hich included a suspended use was suspended effective
December 24, 1975. This letter is to notify you that your above
registration contained a use suspended-by the Order and therefore has
been suspended effective December 24, 1975.
* • .
• « •
If you wish to be permitted to continue your registration, you have two
'alternatives. First, you may dimply discontinue the use of CMordane
or Heptachlor in the formulation of your product. If.you select this
approach you will not be required to submit -a petition for an amendment
if your product contains no other insecticides and all insecticide claims
are eliminated. If other insecticides are contained you must apply for
an amended label which in certain instances jnay require new efficacy
data. If you wish to continue to formulate your product with either
Heptachlor or Chlordane you may continue to do s,o only for uses not
'suspended and only after you have submitted a petition for a label
amendment in v/hich all references to suspended uses have been deleted.
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*'*•"«*,
tj
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
/ WASHINGTON. O.C. 20460
CERTIFIED HAIL
Gentlemen:
Subject : Notice of Suspension for:
-On December 24, 1975, the Administrator issued his Decision and Order
on the suspension of Heptachlor and Chlordane. Most federal and state
registrations of Heptachlor and Chlordane were suspended although
certain uses were specifically exempted (Refer to the enclosure). -Any
registration which included-a suspended use was suspended effective
December 24, 1975. This letter is to notify you that your subject
registration contained a use suspended by the Order and therefore has.
been suspended effective December 24, 1975.
If you wish to be permitted to continue to formulate and/or sell Hepta-
chlor and/or Chlordane for uses not suspended, you will be required to
petition for a provisional amandment of registration. Such petition •
should request the "elimination fro'm-your labels of any reference to
suspended uses. It is sufficient to. send a cover-letter with an amended
label or label in which the suspended uses including any claims referring
to these^uses haveibeen>blocked^out^ The "granting by-the Agency of such
a petition will peroit.-youj^ and/or sale of Hepta-
chlor and/or Chlofdane'-for^ex^mpfed us.esV" Petitions for a provisional
labeling amendment/in accordance.with the enclosure must be received
within 30 days of receipt of this letter at the following address:
-------
5 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
\ l&* WASHINGTON. D.C. 20450
'«»•no**-0
' CERTIFIED
Gentlemen:
Subject : Notice of Suspension for:
This is to notify you that on December 24, 1975, the Administrator
issued his- Decision and Order on the suspension of Chlordane and
Heptachlor.
This document provides that all uses of Chlordane and Heptachlor are
suspended except those set Yorth on the enclosure. Your subject regis-
tration was suspended effective December 24, 1975.
As stipulated in the Administrator's Notice of Intent to Suspend, issued
on July 29, 1975, the product under this registration may not be formu-
lated, shipped, sold or .used after July_ 29; 1975..
The'Administrator's Decision and Order yriU be published'in the Federal
Register..in/the^riear'future^ * ''"' ''" '
Sincerely'yours,
John B. Pitch, Jr.
Director
Registration Division (WH-567)
Enclosure
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-2-
It is sufficient to send a cover letter with an airsr.ded label or
'1n which the suspended uses including any claims referring to these
uses have been blocked out. The granting by the Agency of such a
petition will permit you to continue formulation and/pr sale of Hepta-
chlor and/or Chlordane for exempted uses. Petitions for a provisional
labeling amendment in accordance v/ith the enclosure mubt be received
within 30 days of receipt of this letter at the following address: .
Mr: Timothy A. Gardner
Product Manager (15)
Registration Division (WH-567)
Environmental Protection Agency
Washington, O.C. 20460.
The amendment_ wi.ll_not. aferaga.te_yaur-..cighi-to-def end-beth- suspended -or • •--
"nonsuspended uses in the continuing cancellation proceeding.
Existing stocks of EPA registered pesticides containing Heptachlor or
Chlordane may be distributed and sold for suspended uses only if the
stocks were formulated prior to July 30, 1975. This date was stipulated
in the Administrator's Notice of Intent to Suspend, issued on July 29,
1975. Stocks of Heptachlor or Chlordane formulated after July 29, 1975,
may only be distributed and sold for those exempted uses included in ths
enclosure and under labels containing no suspended uses. Stocks which
you may presently have on hand, if-manufactured or formulated after
July 29, 1975, may not be shipped or sold until you receive EPA appr1
of your amended label.
*
The Administrator's Decision and Order will be published in the Federal
Register in the near future. . ' -
Sincerely yours,
John B. Ritch, Jr.
Director
Registration Division (WH-567T
Enclosure •
-------
srr.ciFic USES or CHL.ORDANK t- i;r:rTAan.orc
NpTSUSJ'tlf.'DED BY ADMINISTRATOR'S O;:i.»i:;i OF 12/2-1/75
COMPC)UND(s)
chlordane &
heptachlor
chlordane U
heptachlor
chlordane &
4
heptachlor
4
heptachlor
heptachlor
heptaehlor
US£(s)
Subsurface ground insertion for termite control
Dipping of roots or tops of non food plants
Control of cutworms on corn (both pre and post
emergence)
Control of narcissus bulb fly
Seed treatment* *
Ant control to achieve pineapple mealy bug
S
control in Hawaii
STATUS OF USE(s)
continued
continued
. continued until
8/1/76 only
continued
continued
continued
^ * « •
chlordace
In Federal/State quarantine programs for
6 5.6
Japanese Beetle and imported fire ant
continued
chlordane
Control of black vine weevil on Japanese Yew
in Michigan
continued
chlordane
'Control of Texas harvester ant in Oklahoma
continued
chlordane
Control of imported fire ant by private
5.7
individuals
continued
chlordane
Control of white fringed beetle attacking food
8 •
crops in 8 S.E. States CAL.FL,,GA.LA.MS.NC.
SC. TN)
continued
chlordiuie
Control of soil insects attacking Florida citrus
continued
chlordane
Control of strawberry root pests by pre-plant . continued
treatments
chlordane
Control of white erubs'in Michigan
continued
j. All registrations U'cocrai anc state) 01 pesucioe products containing ncpt^cmor and
chlordane for uses not specifically continued arc suspended by the Administrator's
Decision and Order on the Suspension of Heptachlor-Chlordane. The effect of the
Order is to further prohibit the manufacture, formulation or reformulation of products
containing Heptachlor or Chlordane for any purpose other than for those registered
~ uses which have been exempted in the Order and for manufacturing uses as an
• interim step in the ultimate formulation for such registered uses. Sale and use of
existing stocks of registered products which were formulated prior to July 30. 1975
*. are permitted for both continued and suspended uses. ' •
•3. PR Notice 74-11 (39 FR 4127?) exempted this use from cancellation. Such use'
..was similarly exempted from the Notice of Intention to Suspend. 40 FR 34456
(7/29/75).." •---• :••.--•• . " '
3.: Clarified at 40 FR 30522 (7/21/75) to apply to the use of emulsifiable or oil
concentrate formulations for controlling Mibtcrrancan termites on structural
/ sites such as buildings, houses, barns, and sheds, using current control
. practices. '.
4. Velaicol has represented that ft would voluntarily suspend domestic shipments
of heptachlor for this use. pending resolution of .the cancellation proceedings.
5. On the assumption that Aiircx is not available. ' . •
6. To include treatments required to certify to pest free conditions as well as for
use in suppression and control programs. '*
7. To Include use on bath public and private property by cither owner, agent.
employee, or contractor.'
8. • Not intended to preclude use on cotton. However, use on tobacco is suspended. •
9. Jtcstrictcd tojcitrus root weevils. «
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-2-
• • Mr. Timothy A. Gardner
Product Manager (15)
Registration Division (WH-567)
Environmental Protection Agency
Washington, D.C. 20460.
The amendment will not abrogate your right to defend both suspended or
nonsuspendec! uses in the continuing cancellation proceeding.
Existing stocks of EPA registered pesticides containing Heptachlor or
£hlordane_may. .b£_ dis trj bul^d,£nd^sjD.ld--£ai^^uspgndedaise^-on3jM4-.4Ae
stocks- v/ere formulated prior to July 30, 1975. This date v/as stipulated
1n the Administrator's Notice of Intent to Suspend, issued on July 29,
1975. Stocks of Heptachlor or Chlordane formulated after July 29, 1975,
foay only be distributed and sold for those exempted uses included in the
enclosure and under labels containing no suspended uses. Stocks which
you may presently have on hand, if manufactured or formulated after
July-29, 1975, may not be shipped or sold until you receive EPA approval
of your amended label. . . ' "
The Administrator's Decision and Order will be published in the Federal
Register in the near future. .. -•
Sincerely yours,
John B. Ritch, Jr.
Director
Registration Division (WH-567)
Enclosure
-------
8 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
f • WASHINGTON. D.C. 20460
2 3 MAR 1976
OFFICE OF ENFORCEMENT
SUBJECT: Heptachlor/Chlordane Suspension Order
Enforcement Strategy
TO:. , ., Enforcement Division-Dir.ector.s-—~
Pesticide Branch Chiefs ^~\
FROM: A. E. Conroy II, Director
Pesticides Enforcement Division
In my memorandum of February 19, 1976 regarding the status
of Agency activity jon_the Administrator's December 24th Order sus-
pending most heptachlor and chlordane product registrations, I alerted
the appropriate Regional personnel that a more specific strategy for
ensuring compliance would be forthcoming. This memorandum pre-
sents EPA's enforcement strategy concerning the three categories
of these products: (A) Federally registered products, all uses of which
have been suspended} (B) Federally registered products, some uses
of which were suspended, but which may continue to be sold and dis-
tributed for continued uses upon amendment of the product's registration
and labeling to delete any suspended uses; and (C) intrastate products
afforded the opportunity to continue in intrastate commerce until the
completion of the cancellation proceedings.
I. SUSPENSION ORDER PROVISIONS - .__._-
In previous memoranda, the terms of the Administrator's Sus-
pension Order have been discussed. To recap, the December 24th Order
and January 19th Clarification provide the following:
(1) All registrations of pesticide/products containing
heptachlor and chlordane for uses not specifically
continued [see "Attachment A — Specific Uses of
Chlordane and Heptachlor Not Suspended by Admin-
istrator's Order of 12/24/75TT"for the list of uses
exempted] were suspended as of December 24, 1975.
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-2-
(2) By invoking the "Special Rule" provision of section
15(b)(2), the Administrator has provided that stocks of
EPA registered pesticides containing heptachlor or
chlordane formulated prior to July 30, 1975, maybe sold,
distributed, or used for suspended uses.
(3) Stocks of heptncMor or chlordane products formulated
after July 20, 1975 may be sold, distributed, or used
only for exempted uses, as per "Attachment Al:.
H. CATEGORIES OF HEPTACHLOR/CHLORDANE PRODUCTS ' _ r~vj
As stated above, there are three categories of heptachlor/chlor- .. .
dane products:
(A) Federally registered products, all uses of which have been -~
susp'e'ndeHI The Registration Di vision /Office 01" Pesticide Programs
has notified, by certified mail, all affected registrants that their prod-
ucts have been finally suspended by the December 24th Order. 1 / An
example of a product in this category would be a product regisieced —•- -
for use only on ticks and chiggers. There are approximately 644 prod-
ucts registered by over 300 registrants which have been so suspended. .
You will find attached to this memorandum a list of suspended product
registration numbers, product names, registrant names, and the names
and addresses where such heptachlor/chlordane products have been pro- .
duced.
*
(B) Federally registered products, some uses of which have been
suspended^ As noted in the introduction and in previous memoranda, r
there is a large category of registered products whose uses were sus-
pended in part by the December 24th Order, but whose sale and distri-
bution may continue upon [ "provisional"J amendment of the produces
registration and labeling to delete all suspended uses. A typical product
in this category would be one registered and labeled for indoor roach con-
trol and for subterranean termite uses (the former being a suspended use,
while the latter is a permitted use). Pending the decisions by the regis- •
trants to amend or not [such decision- must be made within 30 days of -
receipt of the notice of suspension], it is not-possible to determine
the registration status of products in this category. Upon RD's comple--
tion of the necessary registration, review, a region specific list will
be forwarded to you noting the.status of individual products in this category.
(C) Intrastate products. Although this third category is comprised
of products similarly situated to those in above categories (A) and (B),
for purposes of this enforcement strategy, "intrastate products" are
.being-treated separately. The Registration Division has notified the
I/ see myjf eoruary 19. 1976 memorandum entitled "Status Report on the
fieptachlor/Chlordane Suspension. " and its attachments.
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-3-
registrants of 140 "intrastate" products as to the impact of the
December 24th Order on their heptachlor/chlordane products.
These products were being sold only in intrastate commerce when
they became subject to the FEPCA registration requirements by
the accelerated activation of section 3 in November 1974. Sub- •
sequently, all applications for Federal registration were denied
and the applicants who timely requested a hearing were made
parties to the cancellation proceeding and the subsequent suspen-
sion hearings. Accordingly; these products were equally affected
by the December 24th Order in that to continue marketing them.
registrants must delete suspended uses from their labeling. Please
note the attached three Registration Division form letters used to
sppn s e~ thli 9
You will find an attached list of forty-eight-products in this cate-
gory whose sale, distribution, and use was prohibited as of Decem-
ber 24. 1975. for formulations made after July 29. 1975. As soon as
the suspension status of the remaining products in this category is
. available, you will be advised. ......... .
HI. ENFORCEMENT POLICY -
The Agency intends to ensure that-the-Administrator's Order
of December 24th -is strictly complied with by all affected persons,
including manufacturers, formulators, registrants, wholesalers,
retailers, and users. The Administrator, in his December 24th
Order, provided that products formulated prior to July 29, 1975,
should be permitted distribution and use through normal channels
of trade until the stocks are exhaused. Affected persons were
informed of the consequences of formulating after July 29th — those
that chose to continue formulation despite the Notice of Intent
to Suspend did so at their own risk. The Agency wants to ensure
that the pesticide producing industry does not interpret a Notice
of Intent to Suspend as a signal to increase production of the subject
product during the pendency of the suspension proceeding.
It has been the general policy of the Agency to request national
recall where product registrations have been suspended in order
to prevent an imminent hazard to man or. his environment. That
policy will be applied in the instant case;.r As the initial step in ....
implementing this policy, EPA has requested the recall, down to
and including the retail level, of all heptachlor/chlordane products
for which all uses were suspended and which were formulated
after July 29, 1975 [category A products]. In addition, the Agency
intends to request the recall — in some instances for1 relabeling — of
all heptachlor/chlordane products formulated after July 29, 1975
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-4-
whose labels contain both suspended and non-suspended uses [category
B products]. "Intrastate" products [category C products] will be treated
in a manner consistent with similarily situated Federally registered
products.
IV. ENFORCEMENT ACTIONS.
As has been the established policy in such matters, enforcement
actions will be taken, in accordance with normal procedures and at
levels consistent _with those provided for in the Pesticides Enforcement
Division Case Proceedings Manual,"against all persons found in viola-
tion of the heptachlor/chlordane suspension order. "• •••
•• There exist a number of enforcement action options available .to . :.~i
ensure compliance with the Administrator's Suspension Order. As - -^
previously stated, the Agency has determined that a national recall
of violative products would be the most effective and efficient means " • -
.of ensuring compliance with the suspension-order. Because of. the ..._._
-extra-ordinary number of products and-firms which are affected by~~-'
the December 24th Order and the commensurate amount of Agency -•?-•
resources which would be involved in-conducting a formal recall, -the- •••
Agency feels that the procedures outlined in the Case Proceedings
Manual, Chapter 12, for informal recalls would be more appropriate
in this matter. Information and guidance with respect to specific en-
forcement related actions which may be directed toward each of the
aforementioned categories of heptachlor/chlordane products follows: .:.;•
(A) Federally registered products, all uses of which were sus-
pended and which were formulated after July 29, 1975. As per recall'"
initiation procedures, the Pesticide Enforcement Division has notified
by certified mail those registrants who had all uses of their heptachlor/
chlordane product(s) suspended by the December 24th Order, that EPA
is requesting that all subject products formulated after July 29; 1975>.
•be recalled immediately. This letter,- A.copy of which is attached to
this memorandum, refers the addressee, to the Registration Division
suspension letter informing the registrant of the registration status of
his product(s), and continues by specifically requesting that (a) the
company initiate procedures to determine the locations of all quantities-
of their finally suspended product and the amount of such product at
each such product location, (b) that the product be returned to the
registrant from all locations, and (c) that the named regional contact
person be informed of all actions taken in connection with the recall.
•
In your follow-up to determine compliance with the recall request, you
should:
(1) be assured that the registrant has recalled the product
from the retail level, and either
(i) disposed of the product.
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-5-
(ii) exported product in accordance with section 17, or 2/
(iii) sought new registration for continued uses;
(3) stop sale any such product found in consumer channels
under section 13; and
(4) where appropriate, initiate enforcement action under
section 14. 3/ ........
mmm^ *
(B) Federally registered products with both suspended and con-
ti'nue'd uses and which were lormuiated alter July 29, IS7a. As soon
as these products can be identified as to their registration status, FED
•wgl request •eacfa-regigtrarnt'to'trontacL all kauwu distributors; wholg-
salers, and retailers that the subject product should not be sold or
otherwise distributed. Registrants will be instructed that they should .
recall from retail level as set forth above for category A products.
When following-up to determine compliance with the recall of these pro-
ducts, you should:
• (1) be assured that the registrant has recalled the product
from the retail level, and either
(i) disposed of product if amendment to labeling is not
made,
(ii) exported product in accordance with section 17,
(iii) relabeled product with amended label deleting sus-
pended uses, or *• .
(iv) in accordance with EPA approved instructions,
overlaid product with approved sticker labels.
masked out suspended uses, or used other means to
-._ delete suspended uses from the labels;
21 Registrants: should be informed tfaafthe Agency would interpose
no objection to the export of products affected .by. the suspension order,
but wishes to caution, registrants concerning the recent stipulation
signed by the Department of State concerning the utilization of US funds
for USAID procurements of such products. See USAID regulation entitled
"Pest Management Program, Interim Pesticide Procedures," published
in the Federal Register on January 7, 1976.
3/ Those persons who distribute or sell a suspended heptachlor/
chlordane product in violation of the terms of the December 24th
Suspension Order will be in violation of section 12(a)(l)(A) for non-
registration, as well as section 12(a)(2)(J) for violation of a section
6 suspension,order. . " "~
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-6-
(2) stop sale any such product found in consumer channels
under section 13; and
(3) where appropriate, will initiate enforcement action under
section 14. 3/
*
(C) Intrastate products. The policies outlined above will also
apply, as appropriate, to intrastate products as they become identified.
At present, the 48 products thus far identified will be treated the same-
^
[category A products].
Now that all parties affected by-the Administrator's Decision and
Order in the heptachlor/chlordane suspension proceedings have been - - •
duly notified of this action and of their obligations attendant thereto,
the Agency places the highest priority- on assuring full and immediate -'
compliance. The initiation and follow-up of the heptachlor/chlordane
recall herein authorized will represent a significant addition to" exist-
ing regional enforcement burdens. It is anticipated that regions will
exercise initiative and energy in performing,, in addition to program---;. .
med outputs, the surveillance^ inspections,- -enforcement actions, -and
routine follow-up necessary to implement this recall.
The region should report the. following information to the appro-
priate regional coordinator as soon as available:
(1) the number of firms subject to-recall; -
(2) the amount of each product recalled; and
(3) the methods of actual or planned disposal
of recalled material.
V. DISPOSAL OF HEPTACHLOR/CHLORDANE PRODUCTS
Persons desiring to dispose of stocks of heptachlor/chlordane
should be apprised that they may arrange with the appropriate regions
•to ship the product ;for disposal, including return to a supplier, for
export, or in accordance with directions provided by. the Office of
Solid Waste Management. Disposal questions may be referred to
Mr. Ray Kreugeri Operations Divison, Office of Pesticide' Programs
[(202) 755-8050], Regional offices are encouraged to cooperate in every
way possible with responsible efforts to dispose of suspended heptachlor/
chlordane stocks.
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r 7 -
VI. INDEMNITIES
The Office of Enforcement has been advised by th? Office of
General Counsel that the registrants of heptachlor/chlordane products
suspended by the December 24th Order are not eligible for indemni-
fication under section 15 of the amended FIFRA.
VH. INQUIRES
Should you have any questions concerning any facet of this memor-
andum and the heptachlor/chlordane suspension order, please contact .
the appropriate regional coordinator. -Questions relating to registration
and label status should be referred to Mr. Tim Gardner, Registration -
ATTACHMENTS _____ .-._..-.•
Please find attached the following:
(1) "Attachment A — Specific Uses of Chlordane and
-.Heptachlor Not Suspended by Administrator's Order
of 12/24 /VS."""" .
(2) Copies of recall request-letters sent-to registrants by
PED.
(3) Three form letters sent by RD/OPP to "intrastate"
.: heptachlor/chlordane registrants.
(4) 41 FR 7552 (February 19. 1976) — "Velsicol Chemical
--------- Co. et al. , Consolidated Heptachlor/Chlordane Hearing. ".
(5) List of Federally registered heptachlor/chlordane pro-
ducts, all uses of which have. been suspended [category
--A products] was mailed by PED to the regional pesticide .
. branch chiefs under separate cover March 17, 1976.
(6) List of the 48 "intrastate". heptachlor/chlordane products,
.all use of which were suspended [category C products].
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, o.c. 20460
27AUG1976
OFFICE OF ENFORCEMENT
TO: Enforcement Division Directors
Pesticides Branch Chiefs
FROM: A. E. Conroy II. Director
Pesticides and Toxic Substances
Enforcement Division (EN-342)
RE: Heptachlor/Chlordane Suspension Or\der
Enforcement Strategy — CORN USE
Some confusion has arisen concerning the enforcement response
to certain heptachlor/chlordane product* now on the market which are
labeled for use on corn pests. The Administrator concluded in In re
Velsicol Chemical Corporation, et al. (Expedited Hearing On Heptachlor-
Chlordane;, 41 Fed. Reg. 7552 (February 19, 1976) that
the benefits of continued use of heptachlor and chlordane to
control cutworms on corn crops during the time which may
be required to reach a final decision in the cancellation
proceeding are not sufficient to outweigh the human health
risks identified; provided, however that particularly in view
of the difficult transition require? to implement alternative
cutworm control methods, the use of heptachlor and chlordane
to control cutworm on corn crops should be permitted during
the 1976 corn growing season. Accordingly, I have concluded
that the registration for use of heptachlor and chlordane to
control cutworms on corn crops should be suspended effective
August 1, 1976. */
As you are aware, the Administrator's heptachlor/chlordane orders
provide the following concerning the legal status of the various products:
*/ See also, "Clarification of Order of December 24, 1975, " 41
Fed.TTeg. 7552 (February 19. 1976).
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1. With the exception of the corn use. all registrations of pesticide
products containing heptachlor and chlordane for uses not specifically
continued (e. g. . chlordane to control black vine weevil on Japanese yew
in Michigan), were suspended as of December 24, 1975. **/
2. By invoking the "Special Rule" provision of FIFRA section 15(b)
(2). the Administrator has provided that stocks of EPA registered pesti-
cides containing heptachlor/chlordane formulated prior to July 30, 1975,
may be sold, distributed, or used for suspended uses, including use on
corn.
3. Stocks of heptachlor or chlordane products formulated after
July 29, 1975, may be sold, distributed, or used only for exempted uses
£see "Attachment A," enclosed]. Thus, for example, a chlordane product
whose sole registered use was for cutworm control on corn could legally be
produced, distributed, sold, and used without violatingthe December 24
suspension order until this product became finally suspended on August 1,
1976.
You will remember that prior to our request for the recall of violative
heptachlor/chlordane products, Registration Division, Office of Pesticide
Programs advised affected registrants that if amended labeling which deleted
all reference to suspended uses was submitted and approved by EPA, the
relabeled product could continue in commerce. To accomodate those pro-
ducers of agricultural products listing corn uses, a decision was made to
allow the registrant to continue to display the directions for use on corn,
provided the following disclaimer was inserted immediately after the crop
designation: "USE SUSPENDED EFFECTIVE AUGUST 1, 1976. " Ten com-
panies exercised their option to relabel accordingly; the 19 products areas
follows:
279-2656 NIAGARA CHLORDANE 5 COATED GRANULES
279-2904 CHLOR KIL 10 DUST INSECTICIDE
449-123 SURE DEATH BRAND HEPTACHLOR 3E
449-74 SURE DEATH BRAND HEPTACHLOR 2E
876-55 VELSICOL CHLORDANE 72EC SOIL INSECTICIDE
876-89 VELSICOL BELT 72 ECF
876-99 VELSICOL BELT 33. 3 G AGRICULTURAL INSECTICIDE
GRANULARS FOR SOIL INSECT CONTROL
876-102 VELSICOL BELT 72 EC AGRICULTURAL INSECTICIDE .
876-172 BELT 40% WP AGRICULTURAL INSECTICIDE'
148-139 CHLORDANE E-8
226-178 TASCO BRAND CHLORDANE 20 GRANULAR
226-219 TOBACCO STATES 50% CHLORDANE WETTABLE POWDER
228-92 RIVERDALE 25% CHLORDANE GRANULES
. ^*7 To arrive.at a result consistent with the Administrator's intent to
suspend all use of chlordane/heptachioj; on corn, regardless of target pest,
the use of these pesticides to control the white fringed beetle attacking corn
crops in eight southeastern states (AL, FL, GA, LA. MS, NC, SC, and TN)
and to control white grubs on corn in Michigan is also precluded.
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1029-77 AIHGX CrlLORDANt: 8E
2&35-131 RiiD TOP CHLORDANE 8 SPRAY
9C59-51 CIILORDANE 10 GRANULAR
9859-53 CHLORDANE 5 GRANULAR
9859-55 CHLORDANE 25 GRANULAR
'14775 CHLORDANE-TOXAPHENE BAIT NO. 11 (Florida "intrastate"
—Asgrow Florida Company, P. O. Drawer D. Plant City, FL)
Therefore, after December 24, 1975, no product produced after July 29,
1975 for corn use could be legally distributed or sold without the above men-
tioned disclaimer. The detection of such violative product will continue to
receive Agency response in the form of a FIFRA section 13(a) Stop Sale, Use
or Removal Order and section 14 action, as appropriate. It is the Office of
Enforcement view that enforcement action, including SSURO's, should not be
taken against the sale and distribution after August 1, 1976 of products bearing
the disclaimer. The use of such product on corn after August 1, 1976 is in vio-
lation of the suspension order [§12(a)(2)(J)j, as well as a misuse [§12(a)(2)(G)].
' To summarize: (1) products formulated prior to July 30, 1975, includ-
ing those with directions for use on corn, may continue to be sold, distributed,
and used; (2) products formulated after July 29, 1975, m?/ ne sold, distri-
buted, and used only with labeling amended to include only continued uses;
and (3) products formulated after July 29, 1975, with directions for use on
corn, must bear the following disclaimer immediately after the corn use
directions: "USE SUSPENDED EFFECTIVE AUGUST 1. 1976."
The Agency is not contemplating at this time 'the recall of the above
products for relabeling to delete reference to corn uses. At the conclusion
of the cancellation proceeding, heptachlor/chlordane labels will be revised
to conform with the Administrator's final order.
All inquiries in this matter should be referred to the appropriate regional
coordinator.
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.-.t" •••:..
ur;r: .\j STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20*60
25NGV W8
OFFICE OF ENFORCEMENT
To: Enforceine.it Division Directors
and Pesticide Branch Chiefs
From: A. E. Conroy n. Director
Pesticides and Toxic Substances.
Enforcement Division
Re: Continued Enforcement of the Suspension of Registration
for Certain Products Containing Chlordane and Heptachlor
On August 1, 1976, the suspension of existing registrations of
heptachlor/chlordane products for use on corn was effective as to
all products formulated-after July 29, 1975. Thus, the Admini-
strator's suspension order of December .24, 1975-became completely
effective as to all subject products formulated after August 29, 1975
and not already cancelled. The recall of subject products initiated in
March 1C76 is now essentially coinplete and a final report should be
submitted to PTSED for inclusion in the heptachlor/chlordane file.
Therefore, each region should prepare a Recall Final Report (Exhibit
14-E, Pesticides Inspection Manual) for each product subject to our
recall request which was produced after July 29, 1975. This report
should be submitted to the appropriate Regional Coordinator no later
than December 31, 1976.
Recently the Court of Appeals for the D. C. Circuit sxistained the
Administrator's decision to suspend certain uses of chlordane and
heptachlor in all but one important respect. (Environmental Defense
Fund v. EPA, No. 76-1247 (D.C. Cir., decided Nov. 10, 197ti)). With
respect to the Administrator's decision to allow use of existing stocks,
the court remanded for reconsideration of sxich issues as amounts of
existing stocks and the problems involved in their return or disposal.
How the Agency will proceed in meeting the requirements of the
remand has not been determined.
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Future surveillance for compliance with the Administrator's
order should bo routine except in the c^rsc of firms refusing to roc nil.
Additional visits to producers and/or distributors miry Je necessary
to assure compliance in these situations. Regarding enforcement
actions, pending a final outcome on the issue of the remand, the fol-
lowing should be pursued. Any suspended hcptachlor/chlordane pro-
duct produced after July 29. 1975, and remaining in commerce should
be stop saled. Additionally, since all but retail distributors should ,
have been notified to. return the violative products, any suspended
products found in channels of trade above the retail level should be
sampled and civil penalty actions issued to the distributor and/or the
producer, as appropriate. Civil penalty actions should also be.issued
for any violative samples previously collected above the retail level.
Beyond stop sale,-decisions on-the Ievel>*of'action'to"berapplied~a1rthe'^
retail level are left-to regional discretion, though any repetition of
violation or evidence of bad faith should warrant civil penalty action.
This policy is reiterated now because a period of grace was previously
allowed for return or disposal of violative stocks. Now that the recall
is complete and the suspension order close to a year old, such leniency
is no longer appropriate.
Finally, in several instances recently, questions have aris'en con-
cerning indemnities. The Agency's position has been that such requests
pursuant to section 15 of the Act are inappropriate in the absence-of a
final order of cancellation. (See letter attached).
Enclosures: ^
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UNITED STATES ENVir.OriAflSNTAL PROTECTION /•.•".: :.;
/ • /
120CT 1976
Mr. Kalpii Lii.i& 1' , '
executive Director
Chemical 3p.-?ciii'i.ti2C r-ia
Association; Incorporated
1001 Connecticut Avenue, N.«::.
Suite 1120 ••£
Washington, £. C. '20036
Doer Mr. Cr.qel:
Your letter of -August 30, 19"/G, hsc boon reCerras to
this office vor re^ly.. because of. ttic .\irr.lnistrator' s
OMooin-.T rwle in tlie chlordan-r/heytacnlor prccesrtimis, it ,
would }:2 ' inproocr under the Agency's rules of practice
for i'iinj to respond to your inquiry.
• " • " *" . 9 ••
*' »
•f Your letter asks that'ths Ad^iniutratof invokR the '. .
"special rult"/unjter 515(b)(2), in order to allow inv-an-
tcries of chlor3ane products forsiulatoci between July 29,-. ;
1975, ana Dvscemi»er 2^, 19?r>, end currently on dealer
shelves, to be sold until such. fctoc'«s: ore exhausted.
• v •.
." Vour request would-necessitate KO.Jificaticn o£ the •
order issued by the Administrator'on Oocewoer 24> 1975.
Requests tor such modifications must be wads in cont'orsancc
v/ith the roles of practice set forth in 40 CFR Part 164.
be?* especially 40 CFr< Io4.6(b), concerning 'enlargement of
filing perioilsj 40 \CFU 164.31, concerninq intervention?
cnJi 40 CTK IG/r.llO,' concernin-T po.ticns for reconsideration^
'of orders. ' • .
CONCURRENCES
id £r
S.7NAM1 J>
turn {>
/i r>2-
1/7^/-)K
/A-*)^1-
t > ^/
ror^
^^ / 1 1*** i •
»•
-,
.
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- 2 -
finally, candor requires that I inform you that -the
Aqsncy statf woulci oppose any suc:> .notion to modify tue* .
suspension order, snould one in fact.be filetf. Essentially,
this is because the suspension order is a temporary order,
which ultimately will be sneerceded, l.-y an order at the
termination of the cancellation proceeding. .The question
of the extent' to which distriouticn 01! existing stocks ot
c.h .soi'a a no or octets should be allowed can and should be
a'Jcrsssed in th« cancellation procjetii'nc;, and resolved in
the order at tns conclusion of that proceeding. Sound
considerations of procedure! man&qen'jnt militate against
interruption of the cancellation proceeding to consider •
this question at this time. t
G. '.fillLam Prick
General 'Counsel (A-130)
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CHEMICAL SPECIALTIES MANUFACTURERS ASSOCIATION. INCORPORATED
.t O'i C'..~ • SIT.'C M2J • »OCI COHNtCTlCUTAVE.. N.W.. WASHINGTON. D.C.2003C • (?02) 172-0110
August 30, 197€
lir. RUE sell E. Train
Administrator, EPA
•401 M Street, S.W. , Room W1200
Washington, D.C. 20460
Dear Mr. Train:
On August 16, CSMA counsel Robert Ackerly and Roger
Copland of my staff met with several Agency officials,
including those from the Enforcement Division and the
Office of General Counsel, to discuss the situation
pertaining to products containing chlordane.
Pursuant to that meeting,-I hereby request that you"
invoke the Special Rule of §15(b)(2) and allow inven-
tories of chiordane products formulated between July 29,.1975
and December 24, 1975 and currently- on dealer shelves to
be sold until- such stocks are exhausted.
There are several reasons for this request:
1) Recall is in most cases a practical impossibility
and constitutes an economic hardship, particularly
to smaller forraulators. There are literally thou-
sands of small retailers who may have a few units
of chlordane products in stock. It is not always
possible for the formulator to ascertain where
such products are being sold. If stocks are dis-
covered, compliance with-' Department of Transpor-
tation regulations governing the shipment of
hazardous materials becomes a major problem,
especially in view of the fact that substantial
numbers of retailers will have only a few units
of various brands.
2) Invocation of the Special Rule will not create a
health hazard. Use .of the products as directed
may be the safest way of disposing of remaining
stocks. The remaining supply of chlordnne pro-
ducts does not, in relative terms, constitute a
large amount. We estimate that between 1,800,000
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-2-
to.3,600,000 units remain on the shelves of some
75,000 retail dealers. While the recall or stop-
sale of these units would have an adverse economic
impact on many formulators, their normal, generally
outdoor use would not significantly exacerbate a
situation that has been ongoing for some 26 years.
Furthermore, we have heard that some dealers are.'
simply flushing unmarketable units away, thereby
possibly creating a potential hazard more pro-
nounced than that created by accepted uses before
suspension. Indeed, safe disposal remains a pro-
blem for the formulator.
3) There has been some ambiguity concerning the sale
of chlordane that has left a number of formulators
confused and uncertain. On July 29, 1975 you, in
your Notice of Intent to Suspend, announced that
you were invoking the Special Rule for those pro-
ducts formulated as of the date of the notice.
We believe that this action should have been, taken
when the registrations of chlordane for most uses
was suspended on December 24, 1975. Had you is-
sued an emergency'suspension order on July 29th,
the Special Rule could ha~ve been" invoked. By
letter dated September 23, 1975, the Office of
General Counsel indicated that the sale of pro-
ducts formulated after July 29th was legal until
final suspension decision was made. On December 24,
you suspended most registrations and stated that
products formulated after July 29th could not be
sold. On March 23, 1976 the Enforcement Division
requested formulators to undertake a voluntary
recall of products formulated after July 29th.
The net effect of these actions has been to en-
gender confusion-in many people over the mandatory
nature of a ban on sales. While perhaps not de-
cisive, xve believe this factor should in good faith
be considered. ..-'. •
4) Harassment of dealers by some Enforcement officials,
especially in the Northeast, has fostered resent-
ment of the Agency as a- whole and, in some cases,
strained relations along the distribution chain.
The orderly sale of remaining inventories would-.
reverse these counterproductive tensions.
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Of course, should you invoke the Special Rule, it would
alleviate indemnification problems that will "arj.se with
respect to products formulated prior to the Suspension
Order. •
I look forward to hearing from you concerning this impor^
tant matter.•
Executive Director
KEtkas
cc: A.E. Conroy
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
PESTICIDES AND TOXIC SUBSTANCES
MEMORANDUM
SUBJECT: Revised Compliance Strategy for the Cancellation and
Suspension of Chlordane and Heptachlor lern^ticides
FROM: John J. Neylan III, Director
Policy and Grants Division
Office of Compliance Monitoring
TO: Addressees
On February 23, 1987, in the case of the National Coalition
Against the Misuse of Pesticides vs. EPA, the U.S. District Court
ruled that the Agency's allowance of the continued sale and use
of al1 cancelled chlordane and heptachlor products was void,
and ordered EPA to take "whatever action is necessary ... so
that on and after April 15, 1988, sales, commercial use, and
commercial application of existing stocks of chlordane and
heptachlor which have been the subject of voluntary cancellation
shall cease..." Since sale, distribution, and use of Velsicol's
chlordane and heptachlor products are already prohibited after
April 15, 1988, the District Court Decision effectively only
applies to the non-Velsicol chlordane and heptachlor products
which have been voluntarily cancelled.
In order to Implement that Court Decision, on April 5, 1988,
EPA issued a "Chi ordane/Heptachl or Termi tiddes; Notification
of Cancellation and Amendment of Existing Stocks Determination."
That Notice informed the public that the registrations of the
products listed 1n that Notice are cancelled (see Appendix C for
this list), and that It is a violation of the cancellation order
for any person to distribute, sell, offer for sale, hold for sale
deliver for shipment, receive (and having so received) deliver
or offer to deliver to any person, or to make commercial use or
commercial application of those products after April 14, 1988.
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In the spirit of the February 23, 1988 U.S. District
Court Order, on April 5, 1988, EPA also issued a "Chlordene/
Heptachlor Termiticides; Notice of Intent to Suspend Registrations
and to Place Limitations on Sale and Use of Existing Stocks".
All of the chl ordane/heptachl or termiticides affected by this
April 5, 1988 Suspension Notice were previously suspended and
issued Stop Sale, Use, or Removal Orders (SSUROs) for failure
to respond to the FIFRA §3(c)(2)(B) Data Call-in. However, the
limitations on sale and distribution of the previous suspension
and SSUROs only affected the registrants. The recent April 5,
1988 Suspension Notice includes prohibitions on the sale,
distribution, and use of existing stocks of the suspended products
which are similar to those imposed by the U.S. District Court
Order and the resulting Notification of Cancellation described
above. That is, after the April 5, 1988 Notice of Intent to
Suspend becomes final and effective, no person may distribute,
sell, offer for sale, hold for s.-. 1 e, deliver for shipment,
receive (and having so received) deliver or offer to deliver
to any person, or to make commercial use or commercial application
of suspended chlordane or heptachlor products (see Appendix D).
Please note that all persons adversely affected by the April i
1988 Suspension Notice may request a hearing within 30 days of
publication of the notice. The existing stocks provisions of
this suspension notice which affect persons other than registrants
will only take effect 30 days after the date of publication in
the Federal Reg i ster, or after completion of the suspension
hea rings, whi chever i s later. OCM will inform the Regions when
the April 5, 1988 chl ordane/heptachl or suspension notice becomes
effect i ve.
As stated in the April 5, 1988 Cancellation and Suspension
Notices, the prohibition on sale, commercial use and commercial
application applies to sales of chlordane and heptachlor
termiticides in any situation, and to all use and application
of such products in any situation, and to all use and applications
of such products with the exception of use and application in
accordance with label directions by individuals (as opposed
to organizations, government agencies, corporations, etc.) on
property owned by tnose individuals. However, this exception for
individuals shall not apply to use or application by individuals
on property which is owned by them but which is rented or leased
to others and is occupied or intended to be occupied by human
beings, nor will it apply to new structures under construction
for sale or lease. Effectively, this means that the only
non-Velsicol chlordane and heptachlor termiticides that may be
used after April 14, 1988 are homeowner products used on property
owned and occupied by the individual user.
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The attached Revised Compliance Monitoring Strategy for the
Cancellation and Suspension of Chiordane/Heptachlor Termiticides
is identical to the January 29, 1988 strategy in regard to the
Velsicol products. However, this revised strategy calls for
inspections of producing establishments, distributors/dealers/
retailers, and commercial users to assure that non-Velsicol
chlordane and heptachlor termiticides (i.e., both suspended and
cancelled) are not sold, distributed, or used in violation of
the April 5, 1988 Cancellation Notice and Suspension Order.
Inspections of distributors, dealers, retailers, and commercial
users to assure compliance with the chlordane/heptachlor suspension
and cancellation will be conducted by States with Cooperative
Enforcement Agreements, and by EPA 1n States without Cooperative
Enforcement Agreements, as part of their routine inspections.
The attached revised strategy also calls for a books and
records inspection of registrants of the suspended chlordane and
heptachlor termiticides to determine the first-line distributors
of those products. The books and records inspection are to be
conducted by States, or Regions in States without Cooperative
Enforcement Agreements, within 60 days of the date of this strategy.
States conducting the books and records Inspections are to transmit
information on the first-line distributors to the Regions where
Stop Sale, Use, or Removal Orders (SSUROs) are to be issued to
those persons. Regions are to transmit information on first-line
distributors located in other Regions to those Regions. Additionally
States and Regions are to Issue SSUROs to distributors, dealers,
retailers, and users of suspended chlordane/heptachlor products
as it is found during the course of routine inspections. Please
note, registrants of the suspended products have already received
SSUROs in response to the previous FIFRA §3(c)(2)(B) suspension
action. Therefore, sale and distribution of these products by
the registrant would be a violation of FIFRA §12(a)(2) (I). Sale,
distribution, commercial use and commercial application of cancelled
chlordane and heptachlor termiticides is a violation of FIFRA
§12(a)(2)(K).
The attached revised strategy is effective Immediately and
replaces the January 29, 1988 strategy. Please transmit a copy
of this strategy to the States within your Region immediately.
If you have any questions regarding the revised strategy, please
contact Dan Helfgott of my staff at FTS 382-7825.
Attachments
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ADORES
Douglas D. Campt
Edwin F. Tinsworth
Frederick F. Stiehl
Mark Greenwood
A.E. Conroy II
Connie Musgrove
Ken Shiroishi
Phyllis Flaherty
John J. Neylan III
Mike Wood
Jerry Stubbs
Dexter Goldman
(TS-766C)
(TS-767C)
(LE-134A)
(LE-132A)
(EN-342)
Jake Mackenzie
Western Regional Compliance Director
I Louis F. Gitto, Director
Air Management Division
II Barbara Metzger, Director
Environmental Services Div
III Stephen R. Wassersug, Director
Hazardous Waste Management Div
IV Winston A. Smith, Director
Air, Pest. & Toxics Mangt. Div
V William H. Sanders III, Dir
Environmental Services Div
VI William B. Hathaway, Dir
Air, Pesticides & toxic Div
VII William A. Spratlin, Director
Air and Toxics Division
VIII Irwin L. Dickstein, Director
Air and Toxics Division
IX Jeffrey Zelickson, Director
cc:
Marvin Rosenstein, Chief
Pesticides & Toxic Substances Br
Ernest Regna, Chief
Pesticides & Toxic Substances Br
Larry Miller, Chief
Toxic & Pesticides Branch
Richard DuBose, Chief
Pesticides & Toxic Substances Br
Phyllis Reed, Chief
Pesticides & Toxic Substances Br
Robert Murphy, Acting Chief
Pesticides & Toxic Substances Br
Leo Alderman, Chief
Pesticides & Toxic Substances Br
Alvin Yorke, Chief
Toxic Substances Branch
Davis Bernstein, Chief
Toxics and Waste Management Div Pesticides & Toxics Branch
Gary O'Neal, Director
Air and Toxics Division
Anita Frankel, Chief
Pesticides & Toxic Substances Br
Michael Walker
Jane Hopkins
Margaret Rostker
Phil Gray
(LE-134P)
(TS-788)
(TS-788)
(TS-766C)
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3 ;g&£
REVISED
COMPLIANCE STRATEGY FOR THE CANCELLATION AND SUSPENSION 3
OF CHLORDANE/HEPTACHLOR TERMITICIDES
OVERVIEW
This Strategy calls for monitoring compliance with the
August 11, 1987 Memorandum of Understanding (MOU) between the
agency and Velslcol Chemical Corporation, the October 1, 1987
cancellation of Velsicol's chlordane and heptachlor termiticides,
the April 5, 1988 "Chiordane/Heptachlor Termiticides; Notification
of Cancellation and Amendment of Existing Stocks Determination",
and the April 5, 1988 "Chiordane/Heptachlor Termiticides; Notice
of Intent to Suspend Registrations and to Place Limitations on
the Sale and Use of Existing Stocks."
Inspections will be conducted by States with Cooperative
Enforcement Agreements, and by EPA Regions in States without
these agreements, at the registrant, distributor/dealer/retailer,
and user level in accordance with the neutral administrative
inspection scheme outlined in this Strategy. Stop Sale, Use, or
Removal Orders (SSUROs) are to be issued to any person who sells,
distributes, or makes commercial use or commercial application
of suspended chlordane or heptachlor products after the effective
date of the April 5, 1988 suspension notice (see Appendix D for
the list of these products). Civil penalties are to be assessed
against registrants, who have already received a SSURO, and who
sell or distribute suspended chlordane/heptachlor products (see
Appendix E for the 11st of registrants who have received SSUROs).
Finally, SSUROs will be Issued, and civil penalties will be
assessed to any person who sells, distributes, or makes commercial
use or commercial application of any chlordane/heptachlor termiticide
in violation of the October 1, 1987 or April 5, 1988 cancellation
orders (see Appendix C for 11st of cancelled products).
BACKGROUND
On August 11, 1987, the EPA and Velslcol Chemical Corporation
entered into a Memorandum of Understanding (MOU) in which Velsicol
agreed to Immediately discontinue the sale and distribution of all
of its termiticide products containing chlordane or heptachlor.
Persons other than Velslcol were not affected by this agreement, and
were therefore not prohibited from sale, distribution, or use of
existing stocks of Velslcol's termitlddes under existing labeling.
Under the terms of the MOU, EPA also granted Yelslcol a
conditional registration for certain uses of some of Velsicol's
chlordane and heptachlor products. Velslcol may only distribute
these conditionally registered chlordane/heptachlor pesticide
products as Restricted Use Pesticides 1f air monitoring tests
reveal zero exposure from each use, an"3~provi ded certain uses,
such as use Inside the home and high pressure injection, remain
deleted from the label ("deleted uses", see Appendix A for deleted
and retained uses). Regions and States will be notified if and
when Yelsicol has met the terms of the conditional registration,
and therefore, when Velslcol may resume Its sale of chlordane
and heptachlor products.
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-2-
On October 1, 1987, Velsicol agreed to voluntarily cancel
its chl ordane/heptachlor termiticide products which were not
conditionally registered pursuant to the MOU. The October 1, 198
Cancellation Order was published in the Federal R *i stej" o n
November 3, 1987 (52 FR 42145). Under the Cancel .tion Order,
Velsicol was still prohibited from the SG e and distribution of
its chlordane/heptachlor termiticides; hooever, existing stocks
provisions were established which phased cut sale, distribution,
and use of Velsicol's chlordane/heptachlor termiticides by persons
other than Velsicol. Between December 1, 1387 and April 15, 1988,
stocks of Velsicol's chlordane/heptachlor termiticides may be
;,ld, distributed, and used by persons other than Velsicol as a
Restricted Use Pesticide (RUP), and only in accordance with
the use directions found in the Cancellation Order. No sale,
distribution, or use is to be permitted after April 15, 1988.
On April 5, 1988, EPA issued a "Chlordane/Heptachlor
Termiticides; Notification of Cancellation and Amendment of
Existing Stocks Determination". That notice informed the public
that, after April 14, 1988, no person may distribute, sell, offer
for sale, hold for sale, deliver for shipment, receive (and having
so received) deliver or offer to deliver to any person, or to
make commercial use or commercial application any non-Velsicol
chlordane or heptachlor product which has been cancelled (see
Appendix C for a list of these products).
Also on April 5, 1988, EPA issued a "Chlordane/Heptachl or
Termiticides; Notice of Intent to Suspend Registrations and to
Place Limitations on Sale and Use of Existing Stocks". All of
the chlordane/heptachlor termiticides affected by that Notice were
previously suspended and issued Stop Sale, Use, or Removal Orders
(SSUROs) for failure to respond to the FIFRA section 3(c)(2)(B)
Data Call-In. However, the limitations on sale and distribution
of the previous suspension and SSUROs only affected the registrants.
The April 5, 1988 Suspension Notice includes prohibitions on the
sale, distribution, and use of existing stocks of the suspended
products which are similar to those imposed by the U.S. District
Court Order and resulting Notification of Cancellation described
above. That 1s, after the April 5, 1988 Suspension Notice becomes
final and effective, no person may distribute, sell, offer for
sale, hold for sale, deliver for shipment, receive (and having
so received) deliver or offer to deliver to any person, or to
make commercial use or commercial application of suspended chlordane
or heptachlor products (see Appendix D).
Please note that while the original Suspension Orders which
affected only registrants remains in effect, all persons adversely
affected by the April 5, 1988 suspension notice may request a
hearing within 30 days of publication of that notice. The xisting
stocks provisions of the April 5, 1988 Suspension Notice wh ^h
affect persons other than registrants will only take affect 30
days after the date of publication 1n the Federal Register, or
after completion of the suspension hearings, whichever is later.
OCM will inform the Regions when the April 5, 1988 chlordane/
heptachlor Suspension Notice becomes effective.
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REGULATtD INDUSTRY
The sole producer of technical chlordane and heptachlor in the
United States 1s Velsicol Chemical Corporation. The October 1, 1987
cancellation order affects registrants [i.e., Velsicol and its
supplemental registrants (see FIFRA Compliance Program Policy
No. 3.9)], distributors/dealers/retailers, and users of Velsicol's
chlordane/heptachlor. The October 1, 1987 cancellation order
does not affect non-Velsicol chlordane and heptachlor termiticides.
The April 5, 1988 chlordane/heptachlor cancellation notice
affects registrants (effectively, only the non-Velsicol registrants
of chlordane and heptachlor termiticides), distributors/dealers/
retailers, and commercial users and commercial applicators of
cancelled chlordane and heptachlor products (see Appendix C).
The April 5, 1988 chl ordane/heptachl or suspension notice affects
all registrants (again, the non-Velsicol registrants), distributors/
dealers/retailers, commercial users and commercial applicators
of chlordane and heptachlor products which have already been
previously suspended because the registrant failed to submit
data to the Agency pursuant to the FIFRA section 3(c)(2)(B) Data
Call-In (see Appendix D).
Please note that for purposes of the April 5, 1988 chlordane
and heptachlor suspension and cancellation notices, the prohibition
on sale, commercial use and commercial application applies to
sales of chlordane and heptachlor termiticides in any situation,
and to all use and application of such products with the exception
of use and application in accordance with label directions by
individuals (as opposed to organizations, government agencies,
corporations, etc.) on property owned by those individuals.
However, this exception for individuals shall not apply to use
or application by individuals on property which is owned by them
but which is rented or leased to others and is occupied or intended
to be occupied by human beings, nor will it apply to new structures
under construction for sale or lease. In short, this means that
the only non-Velsicol chlordane and heptachlor termiticides that
may be used after April 14, 1988, are homeowner products used on
property owned and occupied by the individual user.
REQUIREMENTS OF THE AUGUST 11, 1987 MEMORANDUM OF UNDERSTANDING
As per the August 11, 1987 MOU, Velsicol may not sell or
distribute any of its chlordane/heptachlor termiticides after
August 11, 1987. Products that remain conditionally registered
may only be sold and distributed by Velsicol when the terms of
the conditional registration are met (OCM will Inform the Regions
when this occurs). Other persons (i.e., distributors/dealers/
retailers, users, and non-Velsicol registrants) were not affected
by this agreement.
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::^ IH
Register / Voi 52 No. 2:2 ' Tupsd.i>. N'ov.'-.!>pr 3. 196? / Noiir.rs
-: - •-• • •• T.t :!-.„! the en;..:
•.• - :'•-:.• s :
— ' : ; .. ' -<•<,: all bi- mncc \\ith
;•••••.•' y .•«••, ti..i:-. 50 p s ; at the
:'- .'•'.'• .i« -.2 i rca-sf spray nozzle
• •' • : '•'.•u*,i;.,'-.r.;; horizontal b.irruvs
—'.: i ' '.rrt v sij^s cannot be poured
t!J;.-.2 'he ..utr.io. jM'vrruivr.
USP low pri *VJ:P (ii s.5 I"-..-IT: Tj p s.i L!
the ncrrit!
—Trenches nerd not lip \vi ier tri..n f>
inches nor below thi- foot.rg Thn
emulsion should be mixed w;th thr
soil as it is being repluced in the
trench. Cover the treated soil with
approximate^ 2 inches of untreated
soil.
—A complete termite barrier may
require treatment with another EPA-
registered product to the inside
perimeter of the foundations and to
other in:.»nor critical areas.
Basement Fourdjlions
Horizontal Darners
After exterior grading is completed
and prior to the pouring of concrete
slabs, horzor.u! barriers may be
estaLlibhed or. soil whic.'i will be
covered by concrete entrance platforms.
and in othr: exterior critical areas
which w-.'n be covered by concrete slabs.
To produce a .-.onzontal barrier, apply
the emulsion at the rate of 1 gal!" per
10 square fee! to fill dirt. If fill is washed
pruvcl or other coarse me'.crial. apply at
1'/: gallons per 10 square feet.
—It is irrpr -tj.-.t that the emulsion
renchcs :L.c son
—Applications shall be made (w.'.h
pressures less than 50 p.s.i. c! the
nozzle) us;n; a course spray nczzic
when establishing horizontal barriers.
—If concrete slabs cannot be poured
over soil the same day it has been
treated, a water-proof cover, such as
polyethylene sheeting, should be
placed over the soil to prevent
erosion.
—Do not apply to any area inside the
foundation wall.
Vertical Barriers
After the final exterior grading is
completed, vertical barriers nav be
created in back-filled soil against
foundation walls. To produce a vertical
barrier, apply the emulsion by low
pressure roddmg or trenching at the rate
of 4 gallons per linear feet per foot of
depth from grade to the top of the
footing.
—Low pressure rodding and/or
trenching applications should not be
made below the top of the footing
except when the footing is exposed at
or above grade. Special care should
be taken to avoid soil washout around
the footing
—When rodding. use low pressure (less
thnn 25 p.si at the nozzle). It is
important th«t enulson roaches the
footing. Rod holes should be sp;it.nd to
provide a continuous bhrrier.
— Trenches need nc! be w.Jcr than C
inches.
— Emulsion should bo m:\cd w:;h, :!-c
soil as it is b^ing repinccd in thr
trench. Cover treated se;l wiih
approx.nidtcly 2 inches of
soil.
Dilution Instruction fcr Gold Crest
Termale
Use a .75rt xvater emulsion for
subterranean termites other than
Cop'.aterrr.cs spp. Mix 1 gallon of Gold
Crest Tcrmide in 99 gallons of water to
produce at 0.75"i water emulsion. Uce a
0.75-1.5% water emulsion for
Coptoterrr.es spp. where necessary. Mix
1-2 gallons of Gold Crest Terrnide in 90
gallons of water to produce a 0.75-1.5%
water emulsion.
Dilution Instructions for Gold Crest ClOO
and Chlordane 8EC/Termite
Use a 1% water emulsion for
subterranean termites other than
Coptc'.emes spp. Mix l gallon of
product in 95 gallons of water to
produce a 1% water emulsion. Use a 1-
21 water emulsion for Coptote.-mes spp.
where necessary. Mix 1-2 gallons of
product in 95 gallons to produce a 1-2%
emulsion.
Dilution Instruction for Gold Crest H-60
Use a .5" water emulsion for
subterranean termites other than
Crptotermes spp. Mix 1 gallon of
product in 59 gallons of water to
prodcue a .5% water emulsion. Use a 1%
water emulsion for Coptoterrr.es spp.
where necessary. Mix 2 gallons of
product in 59 gallons of water to
produce a 1% water emulsion
Dilution Instruction for Gold Crest C-50
Use a 1% water emulsion for
subterranean termites other than
Coptotermes spp. Mix 1 gallon of
product in 47 gallons of water to
produce a 1% water emulsion. Use a 2%
water emulsion for Coptotermes spp.
where necessary. Mix 2 gallons of
product in 47 gallons of water to
produce a 2% water emulsion.
Do not apply this produce into hollow
masonry voids.
Do not apply this product to soil
beneath the interior of the structure. Do
not apply to the soil beneath a plenum
air space.
Do not apply emulsion until location
of pipes, water and sewer lines and
electrical conduits arc known and
identified.
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Vn!. 52
Tt;.
421-1 <"!
.i:*!:i.-rl,.>n
V.f. .,: l..ir::rr:, rr..v. V' , vi.,1.1.,11, J
.ii.ii;a :r>i' o'.ijidf of Ihc fi'.ni.ljlion bv
I iv» (jri-s .•;:••• ruUiiniR Jiul/or irr.nchin,;
.it ihi- rjii- of 4 g.iilon-. of emulsion per
in urn .1: fprl I .cm press, no rncljir.^
.".iv,;!J nut cxicnd beyond Sin.- Icpr. nf
I.M- f,...-:r.cs
— V, i. en loddmg. use on!> low pressure
(Irss ;nan 25 p.s.i at the nurzie).
— IJriil holes m ou'.s:de slabs (patios.
sidc-\\a!ks. etc ) nbout 12 to 30 inchns
up.iri iu prov :eie a continuous
<:hcm-< ,\', bnrncr.
— ! 'or sr.iiiow foundations. 1 fool or
less. d:p a narrow trench
;:pp.-cx:mate!y six inches wide along
the outside of the foundation walls.
Do not trench brlow the bottom of the
foundation The emulsion should be
Jipp'ieJ to the Irene!, and t!ie soil at 4
gallons per TO linear feet as the soil is
replaced in the trench. Cover the
trc.it-d soil with approximately 2
inches of untreated soil.
— For foundations deeper than 1 foot
npply 4 gallons per 10 linear feet per
foot of depth.
U.:. be applied only
by triT.chir.B or the exravation
technique below ct a rn!e of 4 gallons of
r.-p.u'sion per 10 hnt^r feet per foot of
depth to he treated. Where exterior
s,.,!is arc odjacent to the foundation
wall, drill through the slab along the
outside of the wall at a spacing that
provides application of a continuous
b.irrrr and apply the emulsion just
under the slab. After drilling, emulsion
may be applied. Apply only at the
lowest pressure that will start the flow
of emulsion from an unobstructed rod.
Apply up to 4 gallons of emulsion per 10
linear feet.
A ccrr.plete termite barrier may
require application of another EPA-
registered product under interior slabs.
through hollow masonry voids to the
footing, and to other interior critical
areas.
Excavation Technique
If treatment is to be made in difficult
situations such as near weJls or cisterns.
along faulty foundation walls, and
around pipes and utility lines which lead
downward from the structure.
application must be made in the
following manner to avoid intrusion of
termiticidc into water supplies or the
interior of the structure.
— Trench and remove the scil to be
treated only heavy plastic sheeting or
similar liner.
— Treat the soil at the rate of 4 gallons
of emulsion per 10 linear feet per foot
of ilc;';h :if |S- tr^n'-i;. Mix l!ic
C'J'iiUmii •imrT.ijjHy irvo ;he *•"•!
l.iK.:'i. i .ite '.. ; • i v i:nt li^LiiJ f..»in
rnr.:-..:-.!; ,,-ff i; • lir.i r.
—After i'ii' '.riM'.Ld so:: hjs ciru d
.iJotjii.ili-';.. ri'cljo- li.t .ml ,n ll.r
triT.i.h and tuver w;:h ;ipi'roMn..ii:ly
2 :nchrs of ontrcalcd soil.
fiL-t.-catmrn: Restrictions
Retreatmcnt for subterranean termites
should onk be made when there is
evidence of reinfcstation suh.scqvient to
thu initial treatment, or thcrp has been
disruption of the chemical barru.-r in the
soi! due to construction, excavation.
landscaping, etc. Keireatment should be
made as a spot appiicntion tc these
areas.
Re'.rentmcnts may be made to critical
ureas in accordance with the application
techniques described above. This
application should be made as a spot
treatment to these areas. Do not
annually retreat entire premises.
Copies of the August 11.1987.
agreement and the October 1.198".
supplementary agreement between EPA
and Vclsicol. can bo obtained from the
person listed under FOR MORE
INFORMATION CONTACT:
Dated: Ociuber 23. 1SGT.
Douglas D. Campl.
Director. Or?:Ce ofF?slicnlrPrvgrcm:.
|FR Doc. 8r-25383 Fiic-d n-2-8T. 6.45 amj
•ILUHC COOC IMO-90-U
IOPP-180747; FRL-3286-S)
California Department of Food and
Agriculture; Receipt of Application for
Emergency Exemption To Use
Hydrogen Cyanamlde; Solicitation of
Public Comment
AGENCY: Environmental Protection
Agency (EPA).
ACTION: Notice.
SUMMARY: EPA has received a request
for an emergency exemption from the
California Department of Food and
Agriculture (hereafter referred to as the
"Applicant") to use the active ingredient
hydrogen cyanamide ("Dormex") to
promote uniform bud break in 18.800
acres of table grapes grown in the
Coachella Valley in Riverside County.
California. Dormex contains an
unregistered active ingredient and.
therefore, in acordance with 40 CFR
166.24. EPA is soliciting comment before
making ' "e decision whether or not to
grant the exemption.
DATE: Comments must be received on or
before November 10.198?.
ADDRESSES: Three copies of written
comments, bearing the identification
ni-l.i!:,.: OIT. 1 111-4-. •' o. • .:.!
Mi!. Pi.;-. ,! .;\ r;.i . :. I: : ••:• i-
S.TV.. . , S. >.: ..... I'r.if ... M .-
unJ S,.; ; -i\\ U.\ :.i.ir i lv>-"d"v.
of IVMn ..... l»ri..-i_n-.> K..\I:.-I.
W.is!;;!i'.-.-.i.. H.C ^
In pci»on. bnrig corrirr.i-i'.ts lJ. R:n l.io
Cr\st.il Mai! =2. 19C1 jpffcr^in U..MS
Hiyhwdy. Arlington. VA.
Inform. ition submitted in ;i.-.y
commnnt TDncerning ilns notice r.-..iy i'C
rluimed confidential by m;irking any
part or all of that informal ;on as
"Confidential Business l.-.farrr.utio^
(CBI)." Information so marked wiii r.oi
be disclosed except in accordance v.::h
procedures set forth in 40 CFR Part "„. A
copy of the comment thnt dors contain
CBI mus! bo subn-.i!!ed for ::%.cLs;o:: ~.
the public record. Information not
marked confidential may be disclosed
publicly by EPA without prior nc:;co tc;
the submitter. All written comments w:ll
be available for inspection in Rm. 230 d'.
the address given above from 8 a.m. to 4
p.m.. Monday through Friday, excluding
lega! holidays.
FOR FURTHER INFORMATION CONTACT:
By mail: Litiuy Pemberton. Rig:stratior.
Division (TS-767C). Office of Pesticide
Programs. Environmental Protccticr.
Agency. 401 M Street. SW.. VVashinpio.-..
DC 20460.
Office location end telephone P.LT.I
Rm. 716. Crystal Mull ~2. 192:
Davis Highway. Arlington. VA.
557-1806). "
SUPPLEMENTARY INFORMATION: Pur.-.uar.t
to section 18 of the Federal Insectir.Je.
Fungicide, and Rodcnt:cide Act (FIFRAJ
(7 U.S.C. 136p). the Administrator may.
at his discretion, exempt a State agency
from any provisions of F1FRA if he
determines that emergency conditions
exist which require such exemption.
The Applicant has requested the
Administrator to issue a specific
exemption to permit the use of an
unregistered plant regulator, hydrogen
cyanamide (CAS 420-04-2).
manufactured as Dormex. by SK'.V
Trostberg Aktiengesellschaft. tc prsrncte
uniform bud-break in table grapes
grown in the Coachella Valley in
Riverside County. California.
Information in accordance with 40 CFR
Part 166 was submitted as part of this
request.
Approximately 18.800 acres of tobie
grupes. Vitts spp.. are grown in the
Coachella Valley. The Applicant
indicates thai California growers rf '
early market table grapes are f:ic:r;
economic losses due to increasing
competition from fore:pn irrpcrts.
particularly from Me.vco. The
-------
-4-
REQUIREMENTS OF THE OCTOBER 1. 1987 CANCELLATION ORDER
The registrations of Gold Crest Termide, Gold Crest C100,
and Chlordane SEC Termite were amended by splitting each registration
into two separate registrations. A new EPA registration number
was assigned for each of the above End Use products for the uses
described in Appendix A as "retained uses". The remaining uses
for each of the above products maintained their current EPA
registration numbers of 876-233, 876-63, and 876-104 respectively.
The registrations of Gold Crest Termide, Gold Crest C100,
and Chlordane 8EC Termite, which have maintained their current
EPA registration numbers of 876-233, 876-63, and 876-104 have
been voluntarily cancelled effective September 30, 1987 along
with the following Velsicol products: Gold Crest C-50 (876-86),
Gold Crest H-60 (876-85), California SLN for crawlspace perimeter
spray (Termide) (CA-810012), California SLN for crawlspace
perimeter spray (C-100) (CA-810012), and Hawaii SLN for crawl-
space perimeter spray (C-100) (HI-850003). The cancellation
order also affects Velsicol 's supplementally distributed products
(the list of supplemental registrations are in Appendix B).
The Gold Crest Termide, Gold Crest C100, and Chlordane
SEC Termite products which bear the "retained uses" and have
been assigned new EPA registration numbers are not cancelled.
These products continue to be conditionally registered with
EPA but may not be sold and distributed by Velsicol until the
terms of the conditional registration, as outlined in the
August 11, 1987 MOU, are met. Additionally, the cancellation
does not affect the following Velsicol Chlordane and heptachlor
products: Technical Chlordane/ Export (876-280); Technical
Heptachlor/Export (876-288); and Technical Heptachlor/Formulation
of Fire Ant Granular for Cable Closure Only (876-330). Please
note, as per the MOU, except for the Technical Heptachlor/Formulation
of Fire Ant Granular for Cable Closure, none of the above products
may be sold or distributed by Velsicol in the United States even
though they have not been cancelled.
Existing Stocks for Velsicol 's Chiordane/Heptachlor Termiticides
As per the October 1, 1987 cancellation order, persons
other than Velsicol [and its supplemental registrants(see 40 CFR
162.6(b)(4)(1 i 1)] may sell, distribute, and use existing stocks
of Velsicol's Chlordane and heptachlor products in any manner
consistent with the existing labeling until November 30, 1987.
From December 1, 1987 until April 15, 1988, Velsicol's Chlordane
and heptachlor termiticide products will be restricted use pesticides
for retail sale to and use only by certified applicators or
persons under their direct supervision. Between December 1, 1987
and April 15, 1988, certified applicators, or persons under
their direct supervision, are required to use Velsicol's Chlordane
and heptachlor products in accordance with the use directions
found in the cancellation order (52 FR 42145; November 3, 1987).
Sale, distribution, and use of such Chlordane and heptachlor
products will not be permitted after April 15, 1988.
-------
-5-
Please note, the directions for use found in the cancellation
order cannot be considered "labeling" unless they accompany the
product. There 1s no requirement in the cancellation order that
these directions for use accompany the product. Therefore, between
December 1, 1987 and April 15, 1988, unless the directions for
use found in the cancellation order accompanied the product at
the time of sale, use of Velsicol's chlordane and heptachlor
products not in accordance with the revised use directions must
be considered a violation of the cancellation order and not
"misuse." Additionally, unless Velsicol's chlordane and heptachlor
products have been sold with the revised use directions, sale to
or use by uncertified persons will be a violation of the cancellation
order and not a violation of FIFRA §12(a)(2 ) (F ).
REQUIREMENTS OF THE APRIL 5, 1988 NOTIFICATION OF CANCELLATION
The April 5, 1988 Notice of Cancellation announces the
cancellation of the chlordane and heptachlor products listed
in Appendix C, and establishes limitations on the sale and use
of existing stocks of these products. Please note, the products
affected by this notice were previously voluntarily cancelled at
the request of the registrant.
Existing Stocks
It is unlawful for any person to distribute, sell, offer
for sale, hold for sale, deliver for shipment, or receive (and
having so received) deliver or offer to deliver to any person,
or to make commercial use or commercial application, cancelled
chlordane and heptachlor termiticides after April 14, 1988.
REQUIREMENTS OF THE APRIL 5, 1988 NOTICE OF INTENT TO SUSPEND
The April 5, 1988 Notice of Intent to Suspend will suspend
the products listed 1n Appendix D of this strategy for continued
failure to submit data within the time periods required by the
chlordane and heptachlor Data Call-In, as contained in the December
31, 1986 Chlordane and Heptachlor Registration Standards. All
products affected by this Notice have previously been suspended
for failure to commit to comply with the terms of that Data Call-In.
However, the previous chlordane/heptachlor suspensions did not
place prohibitions of the sale or use of existing stocks of
suspended products by persons other than the registrant. Any
suspensions resulting from the April 5, 1988 Notice of Intent to
Suspend will include prohibitions on the sale and use of existing
stocks of suspended chlordane and heptachlor termiticides.
-------
-6-
Exi sting Stocks
When the April 5, 1988 Notice of Intent to Suspend becomes
final and effective for a particular product listed in Appendix D
(either 30 days after publication in the Federal Register or
upon completion of a suspension hearing) no personmaydTstribute,
sell, offer for sale, hold for sale, deliver for shipment, or
receive (and having so received) deliver or offer to deliver to
any person, or to make commercial use or commercial application,
suspended chlordane and heptachlor termiticides.
COMPLIANCE MONITORING
Conformance with the August 11, 1987 MOU will be determined
through inspections of Velsicol's establishments to determine
whether any stocks of chlordane or heptachlor were sold or
distributed after August 11, 1987. Please note, there is no
violation under FIFRA for not conforming with the terms of an
MOU, however, the Agency would like assurance that the terms of
the MOU have been met.
Compliance with the October 1, 1987 Cancellation Order
and the April 5, 1988 Notice of Cancellation and Notice of
Intent to Suspend will be determined through inspections of
producing establishments, distributors/dealers/retallers, and
users of chlordane and heptachlor termiticides. Noncompliance
with the October 1, 1987 Cancellation Order or the April 5, 1988
Notice of Cancellation is a violation of FIFRA sections 12(a)(l)(A)
and 12(a)(2)(K).
The Agency, and States with authority, are to issue Stop Sale,
Use, or Removal Orders (SSURO) to any person who distributes, sells
offers for sale, holds for sale, ships, delivers for shipment, or
receives and (having so received) delivers or offers to deliver
chlordane and heptachlor termiticides other than in accordance
with the October 1, 1987 Cancellation Order and the April 5, 1988
Notice of Cancellation and Notice of Intent to Suspend.
Neutral Administrative Inspection Scheme (NAIS)
Except for the Initial inspections of Velsicol's establish-
ments, all Inspections for violations of the October 1, 1987
Cancellation Order will take place as part of the Regions' and
States' routine Inspections. Inspections of Velsicol's producing
establisments to assure conformance with the MOU and compliance
with the October 1, 1988 Cancellation Order are to take place by
April 29, 1988.
-------
-7-
Inspections of distributors/dealers/retailers, and commercial
users to assure compliance with the April 5, 1988 Notice of Intent
to Suspend will also take place as part of the Regions and States
routine inspections. However, within 60 days of the date of
this strategy, States, or Regions in States without Cooperative
Enforcement Agreements, are to also conduct a books and records
inspection of registrants of the suspended chlordane and heptachlor
termiticides to determine the first-line distributors of those
products. States conducting the books and records inspections are
to transmit information regarding the first-line distributors to
the Regions. Upon receipt of this information, Regions are to
issue SSUROs to those persons identified as first-line distributors
in their Region. Regions are to transmit information on first-line
distributors located in other Regions to those Regions, where the
SSUROs are to be issued. Additionally, States and Regions are to
issue SSUROs to distributors, dealers, retailers, and commercial
users of suspended chlordane/heptachlor products as they are
found during the course of routine inspections. Compliance with
the SSUROs will be monitored in accordance with the Pesticides
Inspector's Manual .
as
Regions/States will also investigate all tips and complaints,
appropriate.
Please note, registrants of the suspended products have already
received SSURO's in response to the previous FIFRA S3(c)(2)(B)
suspension action. Therefore, sale and distribution of these
products by the registrant would be a violation of FIFRA §12(a)(2)(I)
Sale, distribution, commercial use and coir.mercial application of
cancelled chlordane and heptachlor termiticides is a violation
of FIFRA §12(a)(2)(K).
Registrant/Producer Level
By April 29, 1988, the Agency/States will schedule and
conduct Inspections of Velsicol's establishments to obtain
assurance that Velsicol has complied with the October 1, 1987
Cancellation Order by not having released products for shipment
after October 1, 1987. At this inspection the Agency/States
will also obtain assurance that Velsicol has abided by the
terms of the August 11, 1987 MOU by not having released the
affected products for shipment after August 11, 1987.
Within 60 days of the date of this strategy, the Agency/
States will conduct a books and records Inspection of the non-
Velsicol chlordane/heptachlor registrants to determine the first-
line distributors of those products.
During the course of routine inspections, the Agency/States
will obtain assurance that non-Velsicol registrants/producers
have not sold or distributed their chlordane/heptachlor products
in violation of the cancellation orders, suspension orders, or
SSUROs.
-------
-8-
Di:tributor/Dealer/Retall Level
After November 30, 1987, when conducting routine inspections
at the distributor/dealer/retail level, inspectors will check to
determine whether Velsicol's chlordane and heptachlor termiticide
proc :ts are being sold and distributed in accordance with the
Octooer 1, 1987 Cancellation Order.
After April 15, 1988, when Agency/States conduct routine
inspections at the distributor/dealer/retail level, they will
assure that remaining stocks of cancelled chlordane and heptachlor
termitic ides are not being sold.
After the effective date of the suspension order, the Agency/
States will conduct routine inspections at the distributor/dealer/
re-ailer level to assure that remaining stocks of suspended chlordane
ana heptachlor termiticides have not been moved and are not being
sold.
User Level
During routine use inspections prior to April 15, 1988,
inspectors will assure that Velsfcol's chlordane and heptachlor
is being used only by certified applicators and in accordance
with the use directions found 1n the Cancellation Order.
After April 15, 1988, during routine inspections at the
user level, Agency/States will assure that any remaining stocks
of Velsicol chlordane and heptachlor are not being used, and
remaining stocks of non-Velslcol cancelled chlordane and heptachlor
products are not being used for purposes of commercial use or
commercial application.
After the effective date of the suspension order, and during
routine inspections at the user level, the Agency/States will
assure that remaining stocks of suspended chlordane and heptachlor
are not being used for commercial use or commercial appUca: on.
ALLOCATION OF RESPONSIBILITIES
Office of Pesticide Programs
Will develop and provide OCM with a list of those products
which have been cancelled/suspended.
Will notify OCM when registrants of suspended chlordane :nd
heptachlor products agree to voluntarily cancel their , oducts.
Will notify OCM 1f and when Velsicol has met the terms of the
conditional registrations of Gold Crest Termite, Gold Crest C100,
and Chlordane *EC Termite, and therefore when these products
may be sold and distributed.
-------
-9-
Office of Compliance Monitoring
0 Will develop and transmit the Compliance Monitoring Strategy
to the Regions.
0 Will issue SSUROs for non-Velsicol chlordane/heptachlor
termiticides suspended under FIFRA §3(c)(2)(B).
0 Will transmit to the Regions the list of those products
which have been cancelled pursuant to the October 1, 1987
Cancellation Order, cancelled as specified in the April 5,
1988 notification, or suspended pursuant to the April 5,
1988 Notice of Intent to Suspend.
0 Will transmit a list of establishments producing Velsicol's
chlordane and heptachlor termiticides to the Regions.
0 Will notify the Regions if and when Velsicol has met the terms
of the conditional registrations of Gold Crest Termite, Gold
Crest C100, and Chlordane SEC Termite, and therefore when these
products may be sold and distributed.
0 Will notify Regions of the effective date of the April 5, 1988
Notice of Intent to Suspend Chlordane and Heptachlor Termiticides
Regions
0 Will provide copies of the Compliance Monitoring Strategy to
States.
8 Will distribute lists of products to the States.
0 Will conduct distrlbutor/dealer/retailer and user inspections
in States without Cooperative Enforcement Agreements as part
of their routine inspectional program.
0 Will conduct a books and records inspection, in States without
Cooperative Enforcement Agreements, of non-Velsicol chlordane/
heptachlor registrants to determine the first-line distributors
of those products.
0 Will issue SSUROs to first-line distributors, of non-Yelsicol
chlordane and heptachlor products, located in their Region.
0 Will transmit Information on first-line distributors located
in other Regions to those Regions.
0 Will monitor SSUROs as per the Pesticides Inspectors' Manual.
0 Will take enforcement action, including issuing SSUROs, as
appropri ate.
-------
-10-
Will report to OCM quarterly for one year on any enforcement
actions taken within their Region, including State actions,
under the cancellation and suspension actions. This report
should include any occurrence of non-con^ormance with the
terms of the MOU by Velsicol. As stipulated in the January 29,
1988 Chi ordane/Heptachlor Compliance Monitoring Strategy, the
first report is due April 15, 1988.
Will notify the States when Velsicol has met the terms of
the conditional registration, and therefore when Velsicol
may sell the conditionally registered products.
Will notify the States of the effective date of the chlordane/
heptachlor suspension.
States
0 Will conduct inspections by April 29, 1988, of Velsicol's
establishments that produced chlordane and heptachlor within
the past 2 years.
0 Will inspect for compliance during routine distributor/dealer/
retailer and user inspections.
o
o
o
Will conduct a books and records inspection of non-Velsicol
chl ordane/heptachlor registrants to determine the first-line
distributors of those products.
Upon identification from the books and records inspections,
States will transmit information on the identity of first-line
distributors to the Regions.
Will take enforcement action, Including issuing SSUROs, as
appropriate, provided they have the authority.
Will report to the Regions quarterly for one year on enforcement
actions taken for violations of the cancellation order. This
report should include any occurrence of nonconformance with the
terms of the MOU by Velsicol. As stlpultaed in the January 29,
1988 Chl ordane/Heptachlor Compliance Monitoring Strategy, the
first report 1s due April 7, 1988.
-------
Establishments Producing Velsicol's Chlordane and
Heptachlor Termiticides
00876-IL-001
Velsicol Chemical Corporation
Box 39A II 1 i noi s HWY 1
Ma rshal1 , IL 62441
00876-TN-001
Velsicol Chemical Corporation
1199 Warford Street
Memphi s , TN 38108
-------
APPENDIX A
Retained ana Deleted Uses of
V e1s i c ol's Cnloraane/Heptacnlor Products
Velsicol classified che following uses of
ics end-use termiticiae products as
"deleted uses":
a. post-construction application of
material trom within a structure
frequented by humans ("structure");
b. post-construction application of
material from outside a structure
to inside or underneath a structure;
c. the use of pressure rodding for post-
construction application of material
to a baseraenc-type or crawl-space type
structure;
d. pre- or postrconstruction treatment
of the area underneath crawl-space
and post and pier type structures;
e. treatment of voids and spaces in
masonry or block walls or areas
behind veneers;
f. applications by non-certified
applicators;
g. soil-injection pressure rodding at
pressures greater than 25 psi.
The agreement further classified the
following uses of end-use terroiticide
products as "retained uses":
a. application to the outside
perimeter of any structure by
trenching, or drilling ,through
sidewalks, patios, gr other
unenclosed slabs, and applying
material to the soil without
pressure (e.g. , How or gravity
feed);
-------
-2-
APPENDIX A
•
b. applications by the excavation
technique to the exterior of any
structure (i.e. . by removing soil
next to che foundation, placing
on a tarp, creacing wich
cerraicicide, and placing back in
trench after soil dries);
c. pre-construction low-pressure
(maximum "!5 psi) vertical rodding
(with the application rod equipped
with a pressure control device co
prevenc higher pressures) of che
perimecer oucside any scruccure;
d. post-construction low-pressure
(maximum 25 psi) vertical rodding
(with the application rod equipped
with a pressure control device to
prevent higher pressures) outside
slab and post and pier type
structures;
e. pre-construction coarse spray
surface treatment (maximum 50 psi)
and low-pressure (maximum 25 psi)
vertical rodding (with the
applicacion rod equipped wich a
pressure control device co prevenc
higher pressures) under the slab of
slab type structures.
The agreement classified one use, the
procecclon of underground cables, as an
"unaffected use".
In addition to this classification of
che uses of Veisicol's cermiticide products.
the agreement included, later" alia, the
rollowing provisions:
0 The retained uses were converted to
restricted uses as provided for in
Sections 3(d) and 4 of F1FRA;
-------
A?=END IX A
The registrations or the retained
uses were amended to conditional
registrations, with no sale or
distribution by Velsicol allowed
until certain conditions set forth
in the Conditions of Registration
are met.
No further sale or distribution by
Velsicol of end-use products labeled
for deleted uses was allowed.
Velsicol amended the label of its
manufacturing-use produces to provide
that such products could not be used to
manufacture any end-use product (other
than Velsicol products) for sale and
distribution in the United States that
is labeled for use as a subterranean
termiticide.
-------
APPENDIX B
Supplengntal Registrants of Velsicol's
Chlordane/Heptachlor Termiticides
(375-03053-000192)
(376-00053-000430)
(376
(376
(376
376
276
376
(376
(876
(876
(376
(876
(876
-00053-
-00063-
-00063-
-00063-
-00053-
-00063-
-00035-
-00086-
-00086-
-00086-
-00036-
-00086-
002935}
005887)
010370)
025030)
034704)
043227)
035034)
000016)
000192)
004376)
005887)
OC;387)
876-00036-005887)
876-
876-
376'
375-
00085
00086
00036
00036
•006723)
•010370)
•012000)
•012000)
(375-00036-034704)
(376-00100-000192 )
(376-00104-000430)
(376-00104-001812)
(376-J0104-004876)
(876-00104-006723)
(376-00104-025030)
(376-00104-042761)
(376-00233-001927)
(876-00233-006754)
Drexol Chlordane 721 Termite Spray for
Professional Termite Use
Durham's Chlordane Emulsifiaole Consentrate
Insecticide for Use Only By Professionals
Red-Top Chlordane 8 Spray
Black Leaf 72X Chlordane Emulsifiable Concentrate
Ford's Chlordane SEC
Red Panther Chlordane SEC
Pro-Chlordane 8-E
Chloro-800 Emulsifiable Consentrate Insecticide
Diversey 2.5 H
Dragon 451 Chlordane Spray
Dexol Chlordane 45% Termite Spray (Prof,
AG Chlordane 4-EC Termite Control
Black Leaf 45X Chlordane Termite Killer
Black Leaf 45% Chlordane
Around Buildings
Black Leaf 451 Chlordane
Insect i cide
Red Wing Chlordane 4 EC
Ford ' s Chiordane 4 EC
K Mart 45* Chlordane Termite
K Mart 45t Chlordane Termite
Build1! ngs
Pro-Chlordane 4-E
Dexol Chlordane Termite Spray
Durham's Chlordane SEC Emulsifiable Concentrate
Pee Gee 8 1bs. per gallon Chlordane Emulsifiaole
Concentrate
Chlordane-8 Termite Control
Red Wi ng Chiordane SEC
Red Panther Chlordane
Red Panther Chlordane SEC
Termi nix C-H
Orkil 2X
/Termite Use
1
Killer
Termite Killer For Use
Emulsifiable Consentrate
Killer
Killer
for Use Around
-------
Pio* I:.
01/06/18
ST;? SALES iss:i: >.s :v
of Products Containing
rdane and Heptachlor
COSPA5!
.*•.
CEiSICAL
ss iss
WVA! CEEKICAL CCEP. 548: 223
4100 iAST HASEINGTCI BLVD
LOS AS-'-LES CA 90023
AKVAC C-iHICiL CCS?. 546. 226
415C EAST HASEU'/OJi SIV:
LOS W;:L£S CA 50223
WT;AC CSIIUCAL CORP. 5481 H5
4 ICC EAST WSEIHrOS BT.V?
LOS ASGiLES CA 9CJ23
AHVAC c?£j«:c!.: :?s?. 5461 so
4K: Ef.SI »ASi:!S;*jli rlVD
LOS MGELES CA 90C2J
A3 C-'SICM C3E?.
1514 ELEViSTK "
POETSC.G3TE OE 45662
CHLCSDASE
CELORDASE
CELOHDASE
7122 121
AS CE-KICAL COST. 7122 !
!5:4 ElIVESTr ST
PrH'S^;":: OE 45662
A- CHZ!«::A: cos?. ?;:.' 34
1514 L1EVESTE ST
FCETS»0;*S QE 456:2
Ol/Ob/BB / / OS CA
01/06/88 / / 09 CA
01/06/88 / / OS CA
01/05/88 / / 09 CA
01/06/88 / / 05 OE
01/06/58 / / ' 0! OE
Ol/Os/58 ' / 05 OE
B & G CCHFABK
10539 SAl-BASS DH BOX 20372
DALLAS ?X 75220
86:2 66
CHW3DAS:
BLAC? LEA? PSODrCTS CO. 5i8? 127
667 D STATE ST CELOF.DASE
ELGI5 11 6012;
BLACK LEAP ?80D5CTS CO. 58!? 67
667 I STATE ST C8LORMJE
8LGIN II 60120
BORBIB CEEf.iCAL CO., IK. 4 274
2 mi AVE. C--.Q5DASE
IOESV.LLE HK 13495
BOFDI! CH-«ICAL CD., ISC. 4 21?
I mi AVE. CHLC'Sl.'.SE
JOP.'VILLE *1 13495
EOS:! » CSEf.ICAL CO., INC.
i M.'SZ AVE.
KO-ltVlLLE SY 1*495
01/06/88 / / 16 TX
01/06/88 / / cs
01/Ob.'8B
01/06/88 / / C2 SY
•11/06-'BE / ' ..' S:
(.1
CELORIANE
-------
APPENDIX B
Supplemental Registrants of Velsicol's
Chiordane/Heptachlor Termi tic ides
(876-00063-000192)
(876-00063-000430)
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(876-
00063
00063
00063
00063
00063
00063
00085
00086
00086
00086
00086
00086
•002935)
•005887)
•010370)
•025030)
•034704)
-043227)
•035034)
•000016)
•000192)
-004876
•005887)
-005887)
(876-00086-005887)
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(876-
(875-
•00086
on o.s 6
•00086
00086
00086.
00100
00104.
•00104
•00104
00104.
00104.
00104.
00233-
00233.
-006723)
-010370)
-012000)
•012000)
-034704)
-000192)
•000430)
•001812)
-004876)
•006723)
•025030)
•042761)
•001927)
•006754)
Orexol Chlordane 72% Termite Spray for
Professional Termite Use
Durham's Chlordane Emulsifiable Consentrate
Insecticide for Use Only By Professionals
Red-Top Chlordane 8 Spray
Black Leaf 72% Chlordane Emulsifiable Concentrate
Ford's Chlordane SEC
Red Panther Chlordane SEC
Pro-Chlordane 8-E
Chloro-800 Emulsifiable Consentrate Insecticide
Diversey 2.5 H
Dragon 45% Chlordane Spray
Dexol Chlordane 45% Termite Spray (Prof./Termite Use)
AG Chlordane 4-EC Termite Control
Black Leaf 45% Chlordane Termite Killer
Black Leaf 45% Chlordane Termite Killer For Use
Around Bui 1di ngs
Black Leaf 45% Chlordane Emulsifiable Consentrate
Insecti ci de
Red Wing Chlordane 4 EC
Ford ' s Chiordane 4 EC
K Mart 45% Chlordane Termite Killer
K Mart 45% Chlordane Termite Killer
B u i 1 d i ngs
Pro-Chlordane 4-E
Dexol Chlordane Termite Spray
Durham's Chlordane 8E3 Emulsifiable
Pee Gee 8 1bs. per gallon Chlordane
Concentrate
Chlordane-8 Termite Control
Red Wing Chlordane SEC
Red Panther Chlordane
Red Panther Chlordane SEC
Terminix C-H
Orkil 2X
for Use Around
Concent rat e
Emu!s i fi able
-------
APPENDIX C
CHLORDANE CANCELLATIONS
COHPM7Y EPA REGISTRATION NO. EFFECTIVE I
Bonide Chemical 4-96 3/17/83
4-218 3/17/88
4-274 3/17/88
4-275 3/17/88
4-287 3/17/88
Dragon Chemical
Corporation 16-96 4/27/87
16-116 4/27/87
16-122 4/27/87
16-124 4/27/87
Rigo Company
Incorporated 70-119 4/27/87
Thompson-Hayward
Chemical Company 148-27 6/01/87
-------
Industries
Tobacco States Chemical
Company
Chevron Chemical
Company
FI-'C Corporation
191-42
192-43
192-132
192-133
226-177
226-184
239-478
239-1232
279-383
279-538
C.J. Martin Company 299-171
Res id-ex Corporation . 373-26
3/20.- 83
3 / 3 0 / 8 S
3/30/88
4/27/87
4/27/S7
3/25/87
3/25/87
3/07/87
11/01/86
3/25/87
3/25/87
Imperial Incorporated
Boyle-Hidvay Inc.
Rockland Chemical
Company Incorporated
Haviiand Agricultural
Chemical Compajiy
Federal Chemical
Company Incorporated
Prentiss Drug &
Chemical Company
Perk Products '&
Chemical Company
Southland Pearson &
Company
407-269
407-400
475-192
572-65
595-129
595-321
654-12
654-19
654-67
654-110
655-516
690-53
728-45
728-47
3/25/87
3/25/87
3/25/87
3/25/S7
3/25/87
3/25/87
6/01/87
7/01/87
7/01/87
6/01/87
3/25/87
7/01/87
3/24/88
3/24/88
-------
MFA Oil Corr.par.y
Security Lav.Ti and
Garden Products Co.
Faesy i Besthoff
Incorporated
Cl~.as. H. Lilly Co.
Green Light Company
Velsicol Cher.ical Co
Miller Che-ical &
Fertilizer Corporation
Cre-O-Tox Chemical
Products Company
Seacoast Labortories
Incorporated
Cotton States Chemical
Company
Land 0'Lakes
Universal Cooperatives
Incorporated
746-53
746-76
746-119
769-90
769-511
779-82
802-71
3 15
315
3
3/25/87
3/25/87
6/02/87
9. il/£7
869-14
869-188
876-63
876-86
876-100
876-104
876-233
876-281
876-303
876-304
876-305
876-306
876-308
876-309
876-310
904-135
904-223
1066-26
1066-28
1066-29
1159-102
1159-178
1339-74
1339-87
1381-51
1381-83
3/25/87
3/25/87
11/04/87
3/25/37
3/25/87
11/04/87
11/04/87
9/28/87
9/28/87
9/28/87
9/28/87
9/28/87
9/28/87
4/28/87
4/27/87
3/25/87
3/25/87
7/01/87
7/01/87
3/19/88
7/01/87
7/01/87
8/20/87
8/20/87
3/25/87
3/25/87
1386-26
3/25/87
-------
•7"
u<-.-: tiebach Chemical
Co: porat i on
PCX, Incorporated
Griffin Corporation
1336-324
1386-353
1421-23
1598-145
1598-244
1812-242
1812-243
d ,. 2 0 . 8 -
8/20,67
3/21. SS
4/27/37
4/27/87
7/01,-'8 7
7/01 /87
Triangle Chemical
Cor.par.y
1S42-41
1842-42
5/14/87
Terir.inix Division
cf Cook Industries
Incorporated
ELCO I'!anuiacturir.c Co
Farmland Industries
Incorporated
v;.R. Grace & Company
PEI-Gordon
Corporation
Hopkins Agricultural
Chemical
Colonial Products
Incorporated
LaRocne Industries
Earl May Seed & Nursery
L.P.
Stephenson Chemical
Company Incorporate
1927-5
1927-20
1927-21
1927-49
1941-66
1990-178
1990-179
2124-742
2217-34
2217-98
2393-350
3314-73
3314-74
3442-747
3442-816
3442-846
3442-847
3772-8
4887-19
4887-48
4887-183
2/19/87
2/19/87
2/19/87
2/19/87
7/01/87
3/25/87
3/25/87
3/28/88
5/01/87
5/01/87
3/25/87
7/01/87
7/01/87
3/25/87
3/25/87
3/25/87
3/25/87
3/25/87
3/22/88
3/22/88
3/22/88
-------
:-•=:!wood Chemical,
Incorporated
Coastal Chemical
Corporation
Chacon Chemical
Corporation
GRO Chemical
Company
Helena Chep.ical
Company
Octagon Process
Incorported
rn Corporation
4931-5
Forshav Chemical
Company
Voluntary Puchasing
Group, Inc.
B & G Company
Sunniland Corporation
Nationwide Chemical
Products, Inc.
Ross-Daniels, Inc.
Cornbelt Chemical
Company
5549-41
5719-24
5778-33
5905-97
5905-102
5830-15
7122-3
7122-34
7122-121
7234-5
7234-6
7234-10
7234-100
7234-101
7234-20
7401-78
7401-348
8612-86
9404-6
9591-6
9591-7
9649-2
10107-7
10107-8
6/29, 8'
6/29/3'
3/17/88
7/01/87
6/11/87
3/25/87
3/25/87
7/01/87
3/17/88
3/17/38
3/17/88
3/17/83
3/17/88
3/18/88
3/17/E8
3/17/88
3/18/88
6/18/87
6/18/87
3/21/88
3/23/88
10/01/87
10/01/87
6/12/87
3/21/88
3/21/8E
-------
:-;rd's Cae-iral i,
Service Incorporated
Hacienda Enterprises
?u.~a Chemical Company
Lrexel Chemical Ccrcanv
Flatte Chemical
Cc-pany
Falls Chemical
Kaw Valley, Inc.
Wilson Laboratories
Caterer. I-:. Bairc
r-'icro-Flo Company
Garden Care by
Farmingdale, Ltd.
10370-40
1 0 3 T 0 - 11 6
10370-144
10370-145
11037-7
11611-4
19713-214
19713-215
34704-1
40831-5
40631-24
44215-7
44215-20
50383-20
50383-29
50415-27
51036-30
51036-31
53127-1
53127-10
3,28-83
3.- 2 b 35
3/23/83
3/ 23,53
4/27/S7
7/17/8 7
3/24.. SS
3/24/38
4/27/87
3/24/88
3/24/88
9/08/87
12/12/87
3/24/88
3/24/88
7/01/87
11/13/87
11/13/87
3/22/88
3/22/88
HEPTACHLOR
COMPANY
Thompson-Hayward
Chemical Co.
Velsicol Cnemical
Corporation
EPA REGISTRATION NO.
148-964
876-101
876-85
876-233
876-308
876-309
876-310
EFFECTIVE DATE
6/01/87
4/27/87
9/28/87
11/04/87
9/28/87
4/27/87
4/27/87
-------
-7-
Cre-O-Tox Chemical
Products Company
Griffin Corporation
Triangle Che-deal Co.
Terr.inix Division of
Cook Industries, Inc.
Stephenson Chemical
Company Incorporate
Rocv:ood Chemical, Inc.
Red V,Ting Chenicai
Icrpany
•
;-.r;~heir; Corporaticr.
Forsh£.w Chemical Company
Chem-Nut, Inc.
Farmco Industries
Incorporated
Micro-Flo Company
1066-28
1066-29
1066-30
1812-77
1342-183
1927-50
4887-59
4387-85
4981-17
6723-8
7122-6
7234-27
7234-31
7234-89
37686-27
46778-1
51036-50
7/01/87
3/19/88
7/01/87
7/01/87
5/14/87
4/21/87
3/22/88
3/22/88
7/08/63
6/07/84
3/17/8 8
3/13/83
3/18/88
3/18/88
5/08/87
5/12/87
4/27/87
-------
APPENDIX D
CHLOR n7Ji?>
i .? ION 5
EPA_P F.G.I_STRAT
Var. Wdt.ers & Rogers, Inc.
Cl'.apr.an Cheir.ical
Con.pany
Vaccinol Chemical Company
Incorported
A-'-r.T^C Cher.ical Corporation
550-106
550-107
1022-502
1353-4
5481-223
5461-226
5461-50
5481-315
EFFECTTJVE DATE
7/18/87
7/18/87
7/15/87
7/15/87
7/17/87
7/17/87
7/17/87
7/17/87
Carolina Cher.ical
Corporar ion
EIa:>: Leaf Products
Cor.pany
S-ut-hern Kill Creek
Products
Dettlebach Pesticide
Corporation
Mystic Chemical Products
5797-88
5857-67
5587-127
U.S. Marketing Distributors 6409-13
6720-2
6720-71
6720-133
6720-176
6720-260
6720-361
6720-363
6754-9
6754-11
5754-40
6754-64
36272-3
7/15/37
7/16/87
7/16/67
10/21/87
7/15/87
7/15/87
7/15/67
7/15/87
7/15/87
7/15/87
7/15/87
7/15/37
7/15/87
7/15/87
7/15/87
7/15/87
COMPANY
Southern Mill Creek
Products Cor.pany
Pett ] er-acri Pesticide
Corporal ion
REPTACHLOR SUSPENSIONS
EPA REGISTRATION NO.
6720-279
6754-5
6754-40
6754-54
6754-64
EFFECTIVE DATE
7/12/87
7/15/37
7/15/67
7/15/87
7/15/87
-------
P»9« *c- • ] of Products Containing
01/06/88 I rdanc and Heptachlor
STOP SALK ISS:ZD AS :i . • : ci s»:t:o»
^ isi.-.. »:EI HFIA
COTPAIT
f?A ?.:'.-.I PSOXCT i CEL1ICAL
ss
AKVAC CHEMICAL CORP.
4100 UST HASIIIGTOI BLVD
LOS ANGELES Ci 9002]
AC.VAC CEMICAL C08P.
4100 EAST VASEIKTOS SIVJ
LOS ASGELES CA 9CC23
AKVAC CB1M1CAL COIP.
4100 EAST WSIU7TOI VM
LOS AUGELES CA 90023
AHVAC C5EHICAL COEP.
4100 EAST MASHl)i::oii !ITO
LOS AJGEU5 CA 9002)
A! C»S!C!C COB?.
1514 ELSVEITE ST
01 45f62
Al CE!*.ICAL COS?.
1514 ElEVHTH ST
POBTSXOOTH 01 4S662
A3 CSZR1CAL COSP.
1514 ELJVEIT! S7
rCBTSROOTI 0! «5f62
BIGCOVAI!
10539 UlWl N BOI 20372
MllM -- H 75220-
BUC! UIP PtDMCK CO.
667 I STATE ST
ELCI1 IL 10120
ma uu PIOOOCTS co.
667 1 nm ST
ncn — i
BOWII cmicu co., lie.
2 NU m.
ntimu n IM^
KPDIE CE2MCAL CO., 1 1C.
2 Mil ATE.
TOtmiLE II 13495
BWOIB C1BICAL CO.. »C.
2 M-'li AV!.
TOftlVILLE IT 1)4*5
54bi 223
5461 226
5481 J15
5481 50
7122 121
7122 3
7122 34-
CHLOBDAHE
CELORDASE
CILOBDAI!
CSL«R?A!»S
CBLCRLASH
CllOSDAJE
0(12 If
5887 127
5817 67
4 274
4 275
CIUlDAi!
C1IABDAIE
CBLOBDAJE
CHIOSDU!
CHIOS!***
C1/06/6B / / OS CA
01/06/88 / / 09
01/06/88 / / 09 CA
01/06/88 / / 09 CA
01/C6/U / / 05 OE
81/06/88 / / ' 05 OE
01/06/8( / / 05 05
01/K/N / / 06 T!
61/06/n / / 05 ::
01/06/88 / / OS I
01/06/88 / / 02
01/06/88 / ' 02 !i
01/06/88 / / vi .>•
-------
Pio* lo. 2
••»
STOP SALES ISSUED AS TB! RESULT OS SECTIOI KcH2)t3>
F»!is::'55 ISSUE? r-Mi? F:F?.»
m sE'.-.i ?F.::UC' i •:?:••.:•:AL
?? :SS?EJ LIPTDATS ••::•;
mill CSMICAL CO.. IK. 4 287
I fr.-RL MS. CEWSDASE
02
or.iE CH»«.:CAI co.. :s:. 4
BON::- :=.WICA: co., me. 4
•:A?.OIISA CEEHICAL cos?. 5"?i 86
SC 2?S^
E2
CSLOSDMe
CSMEDASE
C-13RD.W:
Ot, JO/85 / / !!4 DO
/ .' 64 TS
COAST'.'. CH!*I'?.l.l CO?.?.
•.'.'. >J »5t
•3r--SV::i: SC i?i)4
":-..'« BELT THE SI ?A1 CO.
?•.•:. -:x <:•'.
SCCJOX S! *9GC1
CCi!< ?Eir CESRICIL CO.
':.:. g.JS- 410
?.:::-0!! SE 69fl!:i
5549 41
1:107 /
1010? 8
C:LOHDi»E
CBE-O-TOI CEZSICAI, PSOD. CO. 1066 29
BOX 12598
KSHP8IS TS M112
C52-0-TOI CIBICAi PSOD. CO. 10t6 29
BOI 12598
HSPHIS T« 38112
D!TTE1 SACS PESTICIDE CORP. 6754 11
P.O. BOI 9986
AT:»«I:A GA 30119
D:TT:L ?ACE PESTICIDE COSP. 6714 40
r.:. BOX 99-:r
iTliSTA GA 3031?
DETTsi £AC? ?EST:CIDL CORP. 67?« 40
P.O. ri'X 998*
AL7ASTA GA 3';319
CEL43DANE
CELOEDAHE
5EPT4CEI05
CELOKAS!
CHLORDAHE
SEPTACELOF.
Oi/Ct/SS / / 04 SC
Cl/56/88 / / 07
01/St/!8 / / 07 SS
01/06/88 / / 04 T5
01/C6/88 / / C4 T«
01/06/58 / / C4 GA
')..'06/88 / / Q4 :-A
'4
-------
Pi« lo. 3
STOP SALES ISS--ED AS TEE 1ESILT OS SSCTIOI
?:SPEISI01IS ISS?»: MDES FIP8A
:e*.?A«Y
ErA !K.I PSOMCT i CEERICAI,
ss issvED LI?TDA:E RE^
DETTE', 5*C1: PESTICIDE COB?
?.0. -OX 99i»?
?TTTE' EA.Cii ?E5?IIIDi CORP.
i'.O. sOS ?9e
i::js:i '-A K-JI*
rETT:" B.'.CE PESTICIDE COSP.
?.c. BCX wet
ATLASTA GA 30319
:ir.-.; nr- PESTICIDE ccap.
:... •'.} -•«
A'.TASTA « Jv.!19
%••?» sice :pe»-("*,r "»?3
.«.>.. ..!.» .•^••^•••to . %... .
?.C. :C!f *•«
AT1ASTA 3A J331J
DETTELEA.CF. CS2SICA1S COSP.
,'*7t APP1: VALLEK SE.
ATLANTA GA JCii9
6754 5
'.7!4 54
DETTSL SACS PESTICIDE CORP. b754 54
ALTASTA GA W19
6754 64
t'54 64
:45i a. 22bT:: ST.
T:?.?.ASCS CA 9t5ti
MIC! I^STEIES
i45i «. 223TH ST.
TCiiUCE CA 90501
:-KL IIDOSTSIES
145v K. 22m R.
T3RRAHCE CA 905G1
PEXCl ISDDSTRIES
1450 N. 228TS ST.
TCP.JASCE CA 9C501
DRSIEL CaiSICAL CORPASY
i4J7 PJSSS1LMIA ST. ?J! H
*.i*?HIS TS J8;v5
D?.!X»L CHSHICIL COBIW
i4S' JESSSYIASIA ST. 50! 9}0b
!•.•*.? HIS TS i^li'6
1*^1 2J
:?2 132
192 133
192 42
192 43
;?7i3 214
19713 215
•KPTACSLOH
CELC-BDASE
EEPTACB108
CtieMLM
EZPTACHLOS
CELCiDASE
CEWS3AS!
CHLCSDASE
CHMEDA5E
CHW5W.SB
CHLOBDME
CHLOBDASE
CHIORDASE
.' / (4
01/06/86 / / '4
fll/Ot/S8
01/06/88 / / G4 GA
01/06/88 / / :< '.-A
01/06/83 / ' 04
01/05/88 ; / ro CA
U1/C6/B8
/ /
CA
-------
»C* !K 4
STOP SAHS us:*: AS ?•• RESULT rs SE:TIOI
si'SrEisiois us!-'- *:-•? ?:•?.»
!?A »•.-.» ?-OJ!;C? 4 CsS'ICAL
5« SVED
FALLS •.•••"ICALS. IRC.
i-.C. SOJ *S45
.:?.EAT -A1L5 *T' '»4v
CEL02M.SZ
-•;.::? -rsEsiCsLs. :sc.
i.v. -;T ^:4^
:?.E?.7 -ALL? *
:•:?.:•? :::-«:cfeL » SERVICE IK. iuiic ::«
J.T ?I.>A.:-SI 5LVL'.
;A5A:iSS TX "502
?:-?.:s c-isicuL » SZP.VICE INC. 103?: .44
'OPTS "ii'ICAL i SE-VICE I!EC. .C:T .4;
*Tj? FA5AJESA Sl'vT. 'J-LO-rASE
PAS.O-SA TI 775C2
•"•?.:? rHiSTCAL i 5E-.VKE ISC. 10?/? 40
."jy PASADENA SVv'L. •T-'.vP.DASE
:'.-.j-Aii :H-y.CIAl CO. :<43 ^*
•Jr: STATE STr.:ET EE-TACEL::
r'RSEASi CHEftCiAL CO. 7243 3:
»E". STATE STREET E:?"J.CELC-
CHARLOTTE 5C 28208
FCRSEA* CHMCIAL- CO. T24J *«
t-5i STATE STREET 5EPTAC5LOH
CHARLOTTE 5C 282?!<
FORSEAK CHffllCAL CO. 7234 ISO
t5fl STATE S11MT CHLORjASE
CHARMTTE 1C 28208
F'TiSEAK CHttlCAL CO. 7234 101
?:i STATS STREET CELOBDASi
wiAr._-...; SC 2KJG8
FC:.S-AW C-HJ'.ICAL CO. "224 5
?:•. ?"ATE STP.EE" CELOP.DASE
CHA.'ICTTE SC 2S21.'?
"E. STATE STREET CHLORDAN!
•':!?.?!:TTE HC iOJL'S
::/Ob/et / / 56
£1/66/88 / / 06 TI
Oi/fl{;/»b / / C4 .-.'c
1)1/06/58 / / C4
01/06/88 / .' C4 SC
01/06/38
01/06/88 / / 04 NT
.' / £4 S-T
' .'
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STC? 5AL2S IJSVi: AS Trit SiSvLT OS 5ZC?IO!i j.r;
srsr'ssioss :??'.£! .?•:•? -ir-A
£.-». ?•;.! ;•;>:? * c-2r.::Ai
* t-' -:' I »^ " ' i S **"-'
':.';. ?.! l(r«-r::4 S *•:!•• :£?7A.~£LC?
Tr.'lrA FL !':-ru
5'"'.'T'-E.:S "ILL CEEi.' ?8C'?:. CO. •i'lO ^80
?.C. BOX lc« 5:14 S stTii C?.jjEDAS£
?"i»i?.!i BILL C5£i;S P5.CD. CO. *''t\> ti'.
P,C. 301 1096 5514 li 5»?E CEIO-DME
TA«A FL 3W01
SC'JTHEHS SILL •?.:£• PS?!). CO. 6720 J63
I-.;. JCX ICVt ??.4 S 5t::: CELOR3AS£
•>".?*. Fl 'jbCl
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Cl'Ct'B?
C4
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CO.
45
-------
ST.; 5A.'.-? iss'-i •? *•; ••? '.' '• fi.i;.
SCJriSf". >.c l?f :. •>.:.- ''.:':
ST-'rH'?"?:!* Cr.1*. CC.. IS1?. 48:" '.-
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c::::-:- ?»?? :A •:;;"
r:?::1*?'.!! C5:.".. CC'., ISC. 4::" »:
BOX 5'ic: C:-:LI?.:.
COLLEG- PftR? GA JOJi1
?T-?HiS=:S I":!1. TO.. ISC. 4S:'1 :*
!0i' v'.:* HE??.V!
CC::E-:E -A?r •;?. . :;"
?TI?:ESMS CHi*. "I.. IM. 4::" ::
?I'NSI1A!»I' COr.PIrATIIR -4.4
;.-• AV;:,.: ?.I.E?!? ."•"
VACCIS:L CH£»I:AL co.. INC. i-s: 4
1:2?- SI": HII-:-:iAS--
VAN WTZ8S i P.OGEP.S 550
225t JDHCTMS AVES'JE
SA* JOSE CA 95:51
VAN MATERS & BOGEP.S 550
2256 JMCTIOJ AVESI!
SAS JOS! CA 95131
M ?. C-SAC! i CORPARY 2124
P.0.30! 27? 10? H RAM ST.
HES?s:S TS 3B10.'
HI".SOS 1A-S. INC.
;.:. MJ ;!:"
5?rISC-:A'.E "T
«I15I!i 1AE5, IS?. 5G;;:-
-------
Federal RexiMor / Vol. 5U. No. 212 / Tuosilny. November 3. ll»8" / Notice*
42
h«',iiln-:.iriiTS litnlititiK id 4111 V Slrtvl
S\\ . V. '.ifchmstnn. L)C.
The purpose of the mrvimg is In
n \ icw (ho first Jraft of the Risk
l»eiJi.i;tion Croup's stralcKN on
i-nv ii<::in:c:i::il risk reduction
Tl«. meeting is opt:n to the public. Any
mcir.ber of thf public wishing to attend.
n:jke brief or4il comments, or submit
written comments to the Croup should
notify Mrs Kathleen Conv.-ay. Executive
Secretary, or Mrs. Dorothy Clark. Staff
Secretary. (A101-F) Sciencn Advisory
Board, by the close- of business on
Friday. November 20.1987. The
telephone number is {202} 382-2552
Terry F. Yosie.
Director. Science Advisory Board.
D.ile October 23. 19,".
|FR Doc. 87-25383 Filod 11-2-67: 8 45 nm)
BILLING CODE eSGO-SO-U
tFPL-3266-1)
Science Advisory Board Research
Strategy Subcommittee Sources,
Transport and Fate Group; Open
Meeting
Under Pub. L S2-463. notice is hereby
Riven that the Sources. Transport and
Fate Subgroup of the Science Advisory
Board's Rescarrh Strategies
Subcommittee will met I from 9:00 a.m.
to 4:00 p.m. on December 8th at the
Hyatt Regency Hotel. International
Parkway (inside the Dallas Fort Worth
Airport), in the Conference Room. The
purpose of the Research Strategies
Subcommittee is to advise the
Administrator of the Environmental
Protection Agency on the dex-elopment
of research strategies needed to enhance
the Agency's ability to acquire scientific
and technical information to support
regulatory decision making, and to
identify emerging environmental issues.
The Sources. Transport and Fate
Subgroup will evaluate environmental
contaminants from both a media-
specific and a multi-media basis.
The meeting M open to the public. Any
member of the public wishing to attend
or submit written comment* should
notify Dr. Terry F. Yosie. Director.
Science Advisory Board, at 202-382-
4126 or Joanna Foellmer by December 4.
1907.
Dale: October 23.1987.
Terry F.Yoiie.
Director. Science Advisory Board.
(FR Doc. 87-25391 Filed 11-2-67; 8:45 «m|
coot MW-SO-N
IOPP-60011; FRL-3286-a I
Chlordane and Heptachlor
Termiticides; Cancellation Order
AGENCY: Environmental Protection
Aponcy (EPA).
ACTION; Order.
SUMMARY: Or. October i. 19B7. EPA
issued an Order accepting the voluntary
cancellation of certain chlorcane and
hcptachlor tcrmiticide registrations held
by Velsicol Chemical Corporation, and
limiting the use of existing stocks of
Velsicol's chlordane and heptachlor
termiticide products outside the
company's control on August 11.1987.
Under the terms of the Order, such
stocks may be sold, distributed or used
according to their current labels until
November 30.1987. Frcm December 1.
19C7 until April 15.19ft6. such stocks
may onl> be sold, distributed or used in
accordance with the Directions for Use
accompanying the Order. No sale.
distribution or use of such stocks will be
permitted after April IS. 1988.
FOR FURTHER INFORMATION CONTACT:
By mail: George LaRocr.a. Registration
Division (TS-767C). Office of Pesticide
Programs. Environmental Protection
Agency. 401 M Street SW..
Washington. DC 20480.
Office location and telephone number:
Rm. 204. Crystal Mail Building *2.
1921 Jefferson Davis Highway.
Arlington. VA. (703) 557-2400.
SUPPLEMENTARY INFORMATION: On
August 11.1987. EPA and ' 'elsicol
Chemical Corporation (Velsicol) entered
into an agreement affecting Velsicol's
registrations of chlordane and
heptachlor termiticide products [except
for a registration involving underground
cable treatments). Under the terms of
the agreement, certain uses of Velsicol's
tcrmiticide products were deleted from
the label and the remainder of the
registrations were converted into
conditional registrations. Under the
terms of the conditional registrations, no
further tale or distribution by Velsicol of
its affected chlordane and heptachior
termiticide products was allowed unless
and until Velsicol satisfied air
monitoring requirements specified in the
conditional registrations. The August
llth agreement did not affect existing
stocks of Velsicol's termiticide products
outside of Veisicol's control on or faatore
that date (which EPA estimated at the
time to be a volume equal to
approximately 2 months average use. or
about 110.000 gallons).
Portions of the August llth agreement
were challenged by a number of
environmental groups \o a fedend court
action.
Tl"p (.I'irt in !iiH< .i. nun r\|ir •>>• .!
i:iiiii.-Tn iti.it Ki'.\ ".'.^nl n.iv
»!nt|i-rc
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42141,
Fod.Tjl Register / Vol. 52. No. 2\2 ; Ttifsd.iy. \n
\ci:i!.r 3. inn? /
us.- 'i T.:1.. :iii; pr:.tU:irii(in ;ir>;>lic;jtlon of
m ;. -; i. f^nn. vvi'h:r. .1 strm.lure
fr- . ;• :i!i-;j !,\ humans (' structure"):
I- l':i\: c;jr.s:r;:ction ap^iica(:on of
rr. ;• r:j; frorr. outbid1.1 n structure IO
ir.s.Jc n; underneath a structure:
c The use of pressure roddine for
post-construction application of mjterial
tn ;i boseri.^nt-type or crax-. l-space type
stn.'Cturr:
ri. Pre- or post-ccnstrvictior. treatment
of :hc area underneath crawi-space and
post und pier type structures:
e. Tren'rr.cnt of voids and spaces in
masonry cr block wal:s or areas behind
venders:
f Applications by non-certified
applicators;
;> Soil-injection pressure roddir.g at
prrssuros greater than 25 psi.
Yhr agreement further classified the
following USPS of end-use termiticide
products as "retained uses":
a. Application to the outside perimeter
of any structure by trenching, or drilling
through sidewalks, patios, or other
ur'T.f!o>
VelsiLul of cnd-u:»e products l.i!» h-d fui
deleted usi:s w.is jiiowrd
• Velsicol amended the label uf its
manufacturing-use products to provide
that such products could not be used to
manufacture any end-use product (ether
than Velsicol products) for sale and
distribution in the United States that is
labeled for use as a sublerrancnn
termiticide.
The agreement became effective
immediately on August 11.7987. In
return for the conditions accepted by
Velsicol. EPA agreed, inter alia, that it
would take no action against existing
stocks of Velsicol's products then in the
hands of applicators and distributors.
EPA estimated that a volume equal to
approximately two-months average use
of chlordane and hep'.achlor termiticides
(or approximately 110.COO gallons) was
in the hands of applicators and
distributors as ct August llth.
Portions of the agreement between
Velsicol and EPA have been challenged
in a federal court action brought by a
number of environmental groups
[NCAMP v. EPA. Civil Action No. 87-
1089-LFO. D.D.C.) The court in that
action has expressed concerns '.hat EPA
may have substantially underestimated
the amount of existing stocks as of
August llth or that some individuals
may have large stockpiles of chlordane
products. While EPA continues Io
believe that its earlier estimate of
existing stock was an accurate one. Er \
contacted Velsicol (as well as the
plaintiffs in the federal litigation) to
discuss possible amendments to the
August 11 agreement in order to resolve
the court's corrern. Velsicol agreed to
amend the agreement, and on October 1.
1987. Velsicol and EAP ratified a
Supplement to the Memorandum of
Understanding (a copy of which is
attached hereto}.
Under the terms of this Supplement.
Velaicol's chloradane termiticide
registrations have been split into
product registrations containing the
deleted uses and product registrations
containing the retained uses. Velsicol
and EPA have agreed to the voluntary
cancellation of certain product
registrations, including those containing
the deleted uses (but not those
containing the retained uses), and have
further agreed to the placement of a
two-tiered cap on the use of existing
stocks of Velsicol's products outside of
its control before August 11. These
existing stocks may be sold, distributed.
and used in any manner consistent wild
their labeling until November 30.1987.
l'rn:n Dcfnil'.-r 1. TOP" unlil April 15.
1'iiill. Ihcsf s>tiicks r.Niy lit- so!;l.
distributed, ar.il i...i-d only in lire J.imr
.\ ilh ihc n>nH:!-."r.N rf use prr-sr:. --J in
Appendix A o! this Or-.irr. No use will
be prrmittcd after April 15. 19U8.
FI'A believes the ti;rms of this
Supplement will allow fur an orderly
and efficient phase-out of chloridane
use. The Supplement provides sufficient
lime for the use of the volume of existing
stocks estimated by EPA to exist in
August of 1907. but will prevent
unlimited use of such slocks if EPA was
substantially incorrect in its estimate or
if individuals possess large stor*piles.
EPA favors a two-tiered appro ..n
because it cncouragne 'he use of
application methods that are believed to
pose less potential for misapplication
and are believed less likely to result in
indoor exposure than the USPS that will
be discontinued a fur November 30.
13C7.
EPA finds '.hat implementation of this
Supplement is consistent with the
purposes of FIFRA and will not have
unreasonable adverse effects on the
environment. EPA has previously
determined that the agreement entered
into on August 11.198". which contained
no limitations on the use of existing
stocks, was consistent with the purposes
of the Act. The limitations contained in
this Order will not permit any greater
use of stocks than that w • the
Agency has already foun,. -> be
acceptable.
The Agency considers the dates set
forth herein, which were the product of
an agreement between Velsicol and
EPA. to be appropriate for several
reasons. First, the Agency believes the
dates chosen satisfy the concerns that
the Agency may have substantially
underestimated the amour stocks in
the possession of applicatir ind
distributors as of August 11.1987 or that
individuals may have large stockpiles.
by establishing a cap on use that would
prevent the use of significantly larger
quantities than the amount estimated to
exist by EPA. Second, these dates allow
for an orderly transition away from the
deleted uses (with such uses not being
permitted after November 30,1937). and
eventually from all other uses (after
April 15,1988). In particular, they
provide EPA, Velsicol. and the National
Pest Control Association with an
adequate opportunity to notify
applicators and state enforcement
agencies of the terms of this Order, the
dates will not encourage a hurried use of
existing stocks which could lead to
misapplication and greater indoor
exposures: and they will allow far the
ccrtifu.jtion of applicators (use of the
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Federal Register / Vnl 52. No. 212 / Tui""! -y. Novr-mbiT 3. TOfT /
-12 UT
rx Mine slocks will be B restricted USP
H<: set Ir.r'.h in FIFRA sections 3!d) and 4
.if'-T November 30. 1987). Finally, the
d.itcs reflect iin'urmation provided to
KPA tKit. even though there may well
h.uc I), , n only 110.000 gallons of
i-vis'ir.e Mucks m the hands of
up;.hectors und distributors on August
11 1907. the rr.te of chlordane use has
decreased sinre Ihdl date, and will of
necessity decrease even further after
November 30.1907 when certain uses
will no longer be permitted.
Based on all thp foregoing, pursuant to
riKRA section 6(a)(l):
1. The following registrations of
Velsicol's End Use Products arc hereby
cancelled:
A. The F.nd Use Product described in
Section I1.A.2 of the attached
Supplement (that product currently
assigned EPA Registration Number 876-
233 bearing all uses of Gold Crest
Termide other than the retained uses}.
B. The End Use Product described in
Section II.E.2 of the attached
Supplement (that product currently
assigned EPA Registration Number 076-
63 bearing all uses of Cold Crest C-100
othrr than the reta.ned uses).
C. The End Use Product described in
Section I1.C.2 of the attached
Supplement (thai product currently
assigned EPA Registration Number 876-
104 bearing all uses of Chlordane SEC
Termite other than the retained uses).
D. Cold Crest C-50 (EPA Reg. No. 878-
G6).
E. Cold Crest H-60 (EPA Reg. No. 876-
65).
F. California SLN for crawlspace
perimeter spray (Temide) (CA-810012).
C. California SLN for crawlspace
perimeter spray (C-100) (CA-810011).
H. Hawaii SLN for crawlspace
perimeter spray (C-100) (HI-850003).
2. The sale, distribution, and use of
existing stocks of any products in the
possession of persons other than
Velsicol on or after August 11.1987
bearing Registration Numbers 876-63.
876-85. 876-86. 876-104. 876-233. CA-
810011. CA-810012, or HI-650003 is
subject to the following conditions:
A. Such products may be sold.
distributed, and used in any manner
consistent with their labeling until
November 30.1987.
B. Such products may be sold.
distributed, and used from December 1.
1967 until April 15.1988 only in
accordance with the provisions
contained in Appendix 1 to this Order.
C. Such products may not be sold.
distributed, or used after April 15,1988.
D. Any such products that have not
been u?.ed on or before April 15. I960
must be disposed of in accordance with
applicable federal, state and local laws.
It is s<< ordered this 1st rf.iy of
Octnl>er. W.
l)u:ic!.is 0 Cimpt.
D.re: tur. O;f«.e o/'•''•''•'""-» >p|.
where npr.rss.iry Mix 1-J c./i.ir.s .if
product in 93 potions (if wafer to
produce a 1-2'^ water enuU.on.
Dilution Instructions for CoU! Cri->t 11-
00
Use a .5% water emulsion for
subterranean termites other tlinn
Coptotermes spp. Mix 1 gallon of
product in 59 gallons of water to
produce a .5% water emulsion. Use a l"'-
water emulsion for Copto/vrmi-* spp.
where necessary. Mix 2 gallons ot
product in 59 pailons of water to
produce a lc-o water emulsion.
Dilution Instructions for Cold Crost C-5U
Use a 1% w.iter emulsion for
subterranean termites other than
Coptotermes spp. Mix 1 gallon of
product in 47 gallons of water to
produce a 1% water emulsion. Use a 2aJ
water emulsion for Coptotermes spp.
where necessary. Mix 2 gallons of
product in 47 gallons of water to
produce a 2% water emulsion.
Do not apply to soil beneath
structures which will contain subslab or
intra-s!ab air ducts. Do not apply to any
area intended as a plenum air space.
Check with builder or contractor or
determine if the design of the structure
includes these ducts or a plenum.
Do not apply to any area inside the
foundation wall which will not be
covered by a concrete slab (e.p . bath
traps, inside surfaces of concrete or
block walls above the level of the sldb).
Cover these areas during application
with polyethylene or similar material.
Do not treat into or through hollow
masonry voids.
Slab Construction
Horizontal Barriers
Before footings are poured, horizontal
barriers may be established in footing
trenches. Treatment of the footings
through hollow masonry voids is
prohibited. Then, after interior grading is
completed and prior to the pouring of
concrete slabs, horizontal barriers may
be established on soil which will be
covered by concrete floor, entrance
platforms, and in other critical areas
which will be covered by concrete slabs.
In the case of a single-pour.
monolithic slab which does not have a
separate foundation or footing, an
overall horizontal barrier would be
created before the concrete is poured.
To produce a horizontal barrier, apply
the emulsion at the rate of 1 gallon per
10 square fent to fill dirt. If fill is washed
gravel or other coarse materinl. apply at
l'/i gallons per 10 square feet.
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1 UNITED STATES ENVIRONMENTAi
/ WASHINGTON. D.C.
OFFICE OF
ur- I- i<_t u>-
CCD Q JODO PESTICIDES ANO TOXIC SUBSTANCES
MEMORANDUM
SUBJECT: Chlordimef orm - Stocks at Dealer/Distributor Level
FROM: Phyllis E. Flaherty
Acting Director
Policy and Grants Division
Office of Compliance Monitoring
TO: Addressees
Recently, I received a question regarding chlordimeform.
The question was: "Would a dealer/distributor be in violation
of the Cancellation Order for Chlordimeform if a farmer pays
for chlordimeform prior to February 19 but does not physically
receive the product until after February 19, 1989?"
Based on discussions with the Office of General Counsel
ind the Office of Pesticide Programs, this action would be a
violation of the Cancellation Order. The Cancellation Order
states that no one may sell or distribute chlordimeform after
February 19. Under the FIFRA 88 amendments, the definition of
the term "sell or distribute" includes "deliver". In addition,
the intent of the Order was to require the recall of all stocks
in the possession of distributors and retailers.
Please forward a copy of this memorandum to States within
your Region in order to make sure everyone understands that
this is the Aaencv's position.
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