I ,
1.
I UNITED STATES ENVIRONMENTAL PROTECTION AGE.NCV
v> ... WASHINGTON. 3.C. 20460
«(
22"SS3
t AMD TOXIC XUBCTAMCCS
^SUBJECT: Compliance/Enforcement Strategy far the Federal
';'^ Insecticide, Fungicide, and Rodenticiie Act (F IF 3 A )
.TO: Al vi n L . Aim
Deputy Administrator
KV
Attached is the Comp1iance/Enforcenent Strategy for the
,, Federal Insecticide, Fungicide, and Sodenticide Act. The
^strategy was developed by a woric group composed of Headquarters,
Regional, and State pesticides personnel, and reflects tne views
of al1 parti cipants.
The pesticides program is a well established program that has
evolved over the years in which States have a .Tiajor enforcement
rol e.
The strategy is based on trie assumption that adequate resources
would be available to support a balanced crediale 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 FY8S:
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 snould be operational
immediately thereafter.
o Develop compliance monitoring strategies and enforcement
response policies for most new regulations and suspensions, as
appropriate.
o Finalize strategy for conducting data audit and Good Laboratory
55 Practices (GLP's) Inspections.
o>
o HEADQUARTERS LIBRARY
ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
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o Finalize enforcement response policy far data auii t s.'GL? insoe
tions.
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.
0 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 Veep 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
1n 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 Hanagement 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 1f you have questions or would liice 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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Introduction 1
FIFRA Compliance Program Overview 1
Previous Compl i ance/Enforcamerrt Strategies 3
Present State of Compliance 12
Goals and Priorities 13
Plans for Achieving Program Goals 15
Compliance Monitoring Plan 16
Cowoliance Promotion Plan 21
Noncomp1iance Response ?1an 23
Heaaquarters/^egicnal Coordination 2?
Federal/State Rel ati onsr;i p 29
Cosperativa Certification ani "ra: "• .--
Program . 31
Cross i5rogram Elernencs 2-r
Program Evaluation S6
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
Inspectioos
Table IV - Federal Pesticide Enforcement Actions
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FIF3A Comoliance/£nforcament
I nt raauct *• on
and ma:i-
nsecti ci :
Tills document contains EPA's strategy for acn-evi
taining compliance wltn tne requirements of the F»aeral
Fungicide, an* Rodent i ci de Act (FIF3A) as a^enaed
regulations. The document provides an overview of cne FIFRA ccm-
pl 1 ance/enforcem«nt program, a summary of prior strategies, the
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
comprehensive look at the program atid indicates
which should be taken to implement an effective
resource constraints, the actions which will be
to those indicated in the priorities for FY85.
strategy tak'es a
a numb-er of actions
program. Based'on
taken are limited
IF3A C jmp 1 •! a i ca J roc ran
Statu t o ry / 3 s c u 1 a t ary 3 ecu i r s m e n ~ 5
FIFRA, as a»ienaea, currently hai a varis^y o .r .r.e-.-.
tect health and the environment from unreasonable risks
It contains the following requirements:
from
pesti ci des
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.
a Ctrllti Reststant Packaging if a product meets certain toxicity
criteria and Its lab«l allows for residential us«.
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 Penrtts (EUP's) for limited field testing prior
to registration.
o FIFRA §18 Emergency Use Exemptions by the Administrator upon
applicition from a State if certain criteria are met.
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or a a a i t: o n a
special 1o c a
of
*n
use:
n a a ;
:cn
,nce or oooi
ted
las
the
us
sif
di
3 pestle
i ed
rect
for
sup
s.?-ie-1 s
«•» f*
'des
er-
o FIF3A §2A(c) State registration
pesticide witnin a Stata to
o Cancellation/suspension Dy £?*
ao le adverse effects.
o 'ederal registration of pesticide or device pro'
0 Submisson of annual reports to E?A and maintena>
records oy each registered estao1isnment
o EstaDlishment inspections.
o Certification and training for users of restrict
by the States with plans or EPA. (Pesticides c
restricted use may only be applied by or under
vision of a certified applicator.)
o Use in accordance with the label.
o Efficacy requirement for pesticides.
o Prohibitions of statements or graphic representations on the label
which are false or misleading.
Impl 5!sentati on
FIFRA was first enacted as the Federal Insecticide Art in 1.910.
Since then, 1t has undergone major revisions which have resulted in
changes in the compliance/enforcement program.
Traditionally, primary responsioi1ity for enforcing trie reqatra
ne.its of FIFSA has resided with the r*±*r\\ government. "*
"•vow «ver, Congress oavsd trie way to snift r»so ons i o* \ i ty ~2 ~,
by amending FIFRA to provide for radars'; / St 2t a cocparst: v« .:
governing pesticides enforcement and applicator training ana
fixation. Congress furtner strengtnenea :ne reipons i o i". i ;y
States in the 1978 FIFRA amendments which establish the pres
that States, under certain circumstances,, shall have primary
sibility for bringing enforcement actions against violators
pesticide use requirements (primacy).
oer- i -
umpt i on
respon-
of
Most States Mho enter into a cooperative enforcement agreement
with EPA und.er §23 automatically obtain primacy as do States which
have an approved pesticide applicator certification plan (§4)
wnlcti also meets the- criteria under §26{a) for adequate pesticide
use laws and Implementing* procedures. A State which has neither a
cooperative agreement nor an approved plan can also obtain primacy
1f it has adequate laws and procedures governing pesticide misuse as
required by §26(a).
Section 27 of FIFRA provides for: 1) an EPA response to a
complaint alleging a significant violation of the pesticide use
provisions when a State does not commence appropriate enforcement
action within 30 days of a referral from £?A; 2) rescission of primacy
If the Adninistrator drtem1n«s that a State 1s not carrying out its
enforcement responsibility; and 3) action by EPA during emergency
condlti otis.
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The 1972 a/Tiendnients to FIF3A require the cart i fi ~i". • :r of
aps'Mcato'-s to apply or supervise tie application o - ~*z~~z*~*s
classified for restricted use. Congress exaectaa States to certify
applicators ana authorized funding support. The State -cooarative
Extension Services were to oe utilized for trie t r a: T • g of pasti-
cice apolicators *itn EPA funding sjooort.
As of October 1983, all but 4 States have funded coooerative
enforcement agreements; all out 3 States have been granted use
enforcement primacy; and all but 2 States have approved certification
plans. As ttvese figures indicate, most FIFRA enforcement and certi-
fication and training responsibilities rest with the States. EPA
activities include oversight of States with agreements, talcing
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 regulatio:
development support.
Previous jomp1iance/ Enforcement Strategies
Pre-1 980 Program Reassessment
General Enforcement of FIFRA
While trie FIF3A an forcaine-t prSg.-im *as 'Dcatai : i :.:= 'J-.:ts:
States Department of Agriculture (USDA), the enforcement o^ogram 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 was 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-es-tlddes 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 civil penalties became the backbone of
the enforcement effort. States were responsible for developing
CAT programs based on EPA regulations and obtaining approval for
fron €PA.
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. .
-:-j" e^
In 1374, £?A entered into pilot cooperative a :-2
5 States. Prior to this ti.Tie, ine States ana tna Fa-i
had separata programs witn little interaction. ~-* "
of the cooperative program *as joint an'orcanent vt- cortinuec
Fedaral prasenca in those States with agreements.
The Feaeral enforcement program became none aecentral i 233 : -
February 1375 when Headquarters announced a program to waive con-
currence for routine civil cases, excluding use cases. 3y NovemDer
1978, all Regions were granted 1) full relaxation of the requi rene.i
for Headquarters concurrence in actions related to stop sales
and civil cases other than misuse cases, and 2) partial relaxation
tj-f HeaTiquartars CDTrcuTTBnce tn t-h-e enforcement of misuse cases.
The 1978 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 State personnel, disinfectant/device
testing, import/export surveillance, and data audits.
Suidan
annually.
activities
Guidance cto
i^clLidiic a
inspections
dppiicdtcr
inspections
workyears E
Percentages
regulatory
ce for the cooperative agreement program was issued
Until 1930, strategies emphasized a graauai shi
related to product conpliince to t.tosa non : to<":
cuments assignee! oa"cantagas to various acti/'t
gricultural, noni^r'C'jl". ^rj" a?-: ?».;•»-•; -lent »" .
; producer establishment, marketplace, import,
recoruj \ nsp^ct i *cia> ; anu rascr.Cwcu a^c pejcici
. The percentages correlated to the amount of
PA expected the States to spend on the various
were assigned based on prior violation trends
requirements.
r; rrsm
.1: usi
certified
total
activiti
and new
es
Federal and State Certification and Training
Prior to FY81 , the C i
of Pesticide Programs (OPP)
1980 Program Reassessment
T program was
Independently
operated by the Office
of the compliance program
In June 1980. th.e 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, p«r1od1c
evaluations, and appropriate program modifications.
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ana acsq
by: a
1 0 ~•„
tnsure tnat eligisie States receive primacy
tne puolic. This goal *as to se achieved
interpretive rule on privacy standards; b) p-o^ulca ^ .
tion governing hearings for r-sciss'on of pr-i^acy; c) i s s
guidance on incentives and sanctions to encourage adequate
s ! y 2 ~ ~ t 2 C t
,7 •» r a -'
g
itate
orograms; and d'i evaluating a1.! State use enforcement programs.
o Ensure effective compliance monitoring and enforcement activities
by assessing tr-aitn'Tig programs and revising training rcacerials.
o Ensure adequacy of the certification and training program by: a)
reviewing State plans and certi f i.ca±ion and recerti f i cat i on proce-
dures and Extension Service program materials; and b) revising
training materials as appropriate.
Increase public understanding
enforcement activities. This
materials and sponsoring training activities
minimize pesticide risks and to help persons
in documenting misuse violations.
Implementation of Strategies
of and participation in pesticides
goal was to be achieved by preparing
desi gned
exposed i
:o help users
o pesticides
stra
The Compliance Monitoring S:aff designed and began i-no'amen:i
tegie
strat 2gi 2S
for
achie
f 3! 1 c-"S :
ng t-s^s* ;c
r o v e i-i ana jam e n t
Priority Setting. 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 tn conducting FIFRA compliance programs in Colorado,
Nebraska, tfyomin-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 which most effectively deal with
these problems. To assist the States in this activity, the Compliance
Monitoring Staff (CMS), in 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
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Application of the model results in four products:
1. A list sf pesticide use problems ran*ad by tnei • -»*2t've
ccatriaution to fiaru froa pesticide use/misuse iic*:ar:ts.
2. A- listing of pesticides .-aniced by their relative zznz ri ajt ^ :~
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 ooth traditional
compliance monitoring and enforcement efforts as well as
other activities such as increased education,
4. An allocation of program resources that maximizes potential
prosram effectiveness by considering 1) the relative priority
of tne 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
"Y34 guidance. Because narm is li c c »«o >"i \ t J * • ii 3 priori cy ~> j a £ * '< y n — o < >i c •i
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0
3
3
0
0
?3Sti;1da estas 1 i s^ent ragistrati an and product•sn -
"nspections ano sampling
ase nanagenent
rants information
on tract inspections
After a feasibility study in 1979, a system design
initiates in 19£j, 3<*v»! apment and implementation
early 1981, and by October 1931 FATES was operational.
system installation and user training was accomplished
and system validation was completed in 1983. However,
data base system updates and enhancements are required
data for new program activities such as the FIFRA Child
Packaging and Label Improvement programs, and to provide
sive information for the Administrator's Management Accountability
System. Additional AOP 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.
pnasa was
was begun in
Regi onal
in 1932,
major FATES
to maintain
Resistant
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 oe evaluated, annually by tha Regions according to u.Tlfarn stan-
dards; and 2) to en-sure that appropriate pesticide usa problems woul 1
is addressed ii State pesticids appHcatO'* tra'niig and cer-i f 1 cat: o*
materials. This ,: r 3 1 o c c 1 * 3 3 aeveloDed for a 5 a ii ~ Y 3 3 s.:: i ,v
modified as appropriate based on experience with
"Y33 z::
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 th£ program an
element of flexibility which allows resources to be allocated each
year to those areas where they are most needed and can be aost
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 1s
adequately carrying out primacy, 3) EPA procedures for referring
misuse allegations to t-he 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* the 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
tiv« enforcement programs.
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On May 11, 1981 EPA promu1gated a rule (io PR 25352V gvsern
procedures to be followed by the Aami ni strator in rescinding
primacy. Under these procedures, whenever the Adrsi n 1 st-ator ma*as
a detenni nati on that a State is^not adequately aiscnarglrsg its
use enforcement responsi ai 1 i ti ss'r ne nust send a notice to trie
State specifying the deficiencies in the State's usa enforcement
program. If after ninety days from receipt of a notice by a State,
the Administrator finds tnat the Jtate has not corrected the
deficiencies set forth in the notice, the Administrator may rescind,
in whole or in part, the State's primary enforcement responsibility
for pesticide use violations. In practice, if someone complains or
deficiencies are discovered during an evaluation, the Regional
office will contact the State and try To r*so1»« the problem prior
to formal rescission procedures. Generally, few problems have arisen,
and those were satisifactori1y resolved.
Training/Guidance
Throughout the development of the cooperative agreement- pro-
gram, EPA has placed a major emphasis on training state pesticide
Inspectors. State inspector training has been accomplished primarily
by the Regional offices through formal training sessions and througn
having experienced EPA oesticide insoectors assist State inspectors
in the field. In addition the National Enforcement Investigations
Canter (NEIC), in cooperation with the Co~a1i3nca Monitoring Staff
(CMS) and the Regions, conducts 'js»/Tn S'jse ' i •/•st'* catl on *o"< s^oo, "
fGf State pesticide inspectors. Tnase -vcrxsnops cover s:a:a a*
the art pesticide drift monitoring techniques and basic use/misuse
investigation techniques. Tne worksnops include ootn classroom
and field training. EPA Intends to continue both these training
programs in the future.
In addition to inspector training, EPA has emphasized the
improvement of State pesticide laboratories and training of State
chemists to ensure the quality of State pesticide analytical data.
Under a Memorandum of Agreement between CMS and NEIC, the NEIC con-
ducts chemists training workshops, provides advice to the States on
analytical techniques, conducts on-s1te reviews of State pesticide
laboratories to evaluate sufficiency and recommend improvements,
and conducts a ctieck sample quality control program. Th«se
activities will continue 1n the future.
To «n$qr« tlrat compliance/enforcement activities were properly
carried out, an inspection manual and case preparation manual
Including a FIFRA civil penalty policy was Issued to the States.
Additional strategies and penalty policies were developed for
new regulations. In addition, guidance has been issued to the
Regions/States governing response to cancellations/suspensions.
CMS and th« Office of Legal Enforcement Policy recently released a
revision of the Pesticide Case Preparation Manual as the FIFRA
Compliance/Enforcement Guidance Manual.
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Cert". ficatTon and
Tra-i n: na ^ro
n FY31, OMB transferred tne program to
enforcement program. This transfer
better coordinate the two programs.
provided
trie con: ,
an opPoft.
to
if pesticide applicators
Plans an proved by
FIFSA provides that certification
be accomplished under State Certi *•' c»t i on
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* SCE.S fail
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General _____ _____
As mentioned previously, the Federal ro'e sii'te^, as Tic"a
States received grants, to the oversight of tne coooer»tive proa-*?.,
enforcement response for State referrals, enforcement programs in
States without coooerative programs or primacy, aic 3 compliance
monitoring and enforcement program consisting*of data audits,
import ana export surveillance and efficacy testing. With tne
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 (FOA) found that studies submitted to it had
serious deficiencies. The strategy has been to audit studies at
problem laboratories, audit studies of special significance to"
regulatory decisions, and conduct routine audits at all pesticide
laboratories. Under an Interagency Agreement originating in 1973, I
FGA conducts inspections at laboratories wnlcii conduct iiaaltn I
effect studies. E°A inspectors primarily conduct audits of environ-
mental studies. E?A scientists participate on audits as aoor'
A Data Audit Panel within Office of Pesticides and Toxic S-jbS'
(OPTS) targets inspections, reviews reports, and r'ecom-
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 the 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 hav« been received and 670
Inspections of Imported products hav« been conducted for the past
few years.
Efficacy Testing
Disinfectant Testing
The Federal program for disinfectant testing, which 1s no
longer active, involved afftcary testing of hospital dlsinfectan
Sucti testing 1s Important considering that failure of hospital
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a o*
v a in
0?a's
ng on
of 1 1
a la;
i I a r 5
r i t y
"M
i
wa
a -•,-:,
Be':;
1 sa-3
, ana
needs ,
S prop
s not
200
las i
y sjs
garmi
altn
oseci
i nclu
Sams'!as
n 1530
3 a n c e c
ci aas
ou CT
an
aed 11
d: s i D fact ants can contribute to the incidanc
vultarab'a p at i ants and '•esj't i •: jn.-ecassa
of nosnital staff to pathogenic organisms.
laboratory formerly performed efficacy tasti
Der year. The failure rata ranged from 45%
to 721 of 40 samples in 1982. I'ne Beltsvili
tasting of disinfectants, sanitisers, atari!
in Octcoer 7932 due to competing higner-prio
the capability to perform such tests remains
efficacy testing program for FYS5; however,
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., A
final report on the first of six devices was recently received,
and the other tests and reports will be completed by February
1934. CMS and OPP will use this information in the regulation
ultrasonic device labelling claims which are overstated.
E 1 act roma anat i c Device Tasting 3nc-a-i
on of
A orogram similar to tha ultrasonic program was conducted
for devices which purport to control pests utilizing tne principle
of electromagnetism. The Bureau of Standards, through an Interagenc
Agreement with CMS, conducted tne 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 o*f devices from the consumer marketplace.
Rodenticide Efficacy Testing
The Office of Pesticide Programs funded an Interage-ncy Agree-
ment with the Denver Wildlife Research Center in FY83 to conduct
a national prograa to test rodenticides for efficacy. CMS is
participating 1n this program by coordinating the sampling,
chemistry testing, efficacy reviews, and enforcement response,
any, for the rodenticides.
if
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- 12 -
Monitoring of Federal S_s_ray Programs
The EPA tnrougn tne Federal enforcement program ^- v. 2
cooperativ-e State programs routinely monitors spray pr^raas
funded by Federal agancias. For instance, app"! i ca-* its sy
for-hire applicators during the Grasshopper Control Program nave
been monitored by tne States of New Mexico, Texas, ana Oklahoma,
and oy EPA in Nebraska and Colorado. The EPA ana tne States
may also conduct use investigations far 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 co-muni'ty:
o Number of Rsgistarad Establishments 11,000
o Number of Applicators Trained and Certified
Private 1,500,000
Commercial • 436,000
o Numser of laboratories Conducting FI"*A Studies -33
o Number of Notice of Arrivals Received in 1982 (imoorts) 5,01^
o Number of Export Notices received annually (approximate) 75
o Number of Experimental Jsa 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 list does not Include information on the total number of
pertlcltle users or pesticide d«*lers of unrestricted pesticld-es.
Many users of pesticides only use general use pesticides and there-
fore are not certified. This 1s especially true of homeowners who
a.re not commercial applicators or 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 nembers of the known regulated coimnunity
Violations by the known community may Involve more highly toxic
pesticides or product type violations which impact a large number
of people if left undetected. Violations by private users who *r"
uncertified generally affect a more United population. In addi"
violations by users whlcft result 1n serious hann are likely to to-
rt ported to tti« Agency.
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-13-
SDe c
Actions
T^e shift from a Federal to 3 State p'-ocra
increased numoer 3* inspections and increased f
complete aaca oase on enforcement actions wnicn
activities only exists far FY31 and FY82. In ~
50,104- 3tate inspections was conducted. The oe
resulting in action was 17.4. In FYS2, a total
inspections was conducted. The percent insoect
actions was 13.1. Violations figures for sped
inspections indicate a nigher rate of noncompli
requirements than for non-use related requi reme
•n has
i e 1 d
i ncl
731 ,
rca 'it
of 5
i ons
f i c t
anca
its.
uce
2 t
0*
9,3
ras
y?e
se~ 12 .
s S:ate
o t a I of
i isoec
17 Scat
u 11 i n g
s of
use re
ti ans
a
1 n
latad
The numoer of Federal inspections for FY81 and FY82 was 225^
and 2021 respectively. In FY81 , the number of enforcement actions
was 755 and in FYS2 the number was 1139. These figures induce
actions oased on referrals from tne States. A detailed breakdown
of the numbers of inspections and actions can be found in Tables I,
II, III, and IV. (See Appendix.)
Sotn. EPA and the States ara collecting a large body of data
related to specific types of violations. The Agency will inc'luaa
this data in the FATES system and then use the system to better .
define major violations and specific causes of violations if
funding is available for system modification.
boa ! s a " a
Long Term
J r •! o r i t i a s
Goals
Long term goals for the FIF3A Compli anca /Enforcement Program
are listed in order of priority below:
of
o
o.
o
o
o
o
o
o
Expand FATES to include State data and assure completeness
Develop a predictive model to set priorities.
Ensure fhat all States participate in cooperative enforcement
agreements and the C & T Program.
Improve EPA-State communlcation systems through the use of state
the art technology, e»g.f use of electronic mail.
Provide guidance and training to the Regions for data audits/
laboratory inspections and case preparation.
Conduct periodic surveys of pesticide use to improve priority
setting system.
Cotrtlnue reflnemetrt of program management for the cooperative
enforcement program, the C 1 T program and Federal program.
Improve program evaluation.
Ensure the adequacy of the C & T program.
Review certification and training materials.
Ensure adequacy of Federal Compliance/Enforcement Program.
Promote programs to prevent violations of FIFRA.
Provide technical and legal support to States.
Continue to provide training for State inspectors and chemists.
Continue cooperative relationship with States.
data
of
-------
o Develop compliance monitoring strategies and enforcement
response policies for new regulations ani sjssans^ons
cancellations as appropriate.
o Update the Pesticides Inspection Manua1.
o Consolidate FIF3A enforcement reoonse oolicies.
o Revise FIF3A §7 estaolishment "registration ru 1 a ana reporting fc--
to improve tne usefulness of data in tne system.
o Expand formal referral systems within the Agency.
o Expand formal referral systems *itn other Agencies.
o Improve referral system between the Regions and States.
o Expand work with the press and special interns* groups.
o Continue Integration of inspections.
Near Term Priorities
Priorities for the FIFRA compliance/enforcement program' throws;:
FY8S fall into the following management, compliance monitoring
enforcement response and certification areas:
Hanaoement
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 to
ensure that the documents are enforceable. In o"der to io 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. Tnerefare, a formal syst
of communication between GPP, Office of General Counsel, anc CMS
vld
o Finalize strategy for conducting data audits and Good Laboratory
Practices (GLP) inspections. I
o Finalize enforcement response policy for data audits/GLP |
1nspections.
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 St-ats.
o Provide training for Stats inspectors and chemists.
Promulgate final FIFRA §4 rule requiring dealers to keep records |
of their restricted use pesticide sales and clarifying where
comnercial applicators must keep their records on their applica-
tions of restricted use pesticides.
o Prepare additional policies for the FIFRA Policy Compendium, as
needed.
-------
i aica ^on*tori no
rogram gulaance
i: c a t a s t nat
75",
resources should be directed at use
genera ; \j
problems and 25*
related priority problems. The priority setting g'ji:2"t? '3 -ec
to be flexible, allowing a snift in inspection targa-s --o^ yea
year based 2,-. shifts i r, State specific problems ais ^-j1^ -Ir3A
regulati ons.
to
a t n e data
In addition, the Federal program will emphas'i
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 related to those priority use problems which
EPA and the State have agreed to track under primacy ana
for which the State does not take appropriate action.
o Violations related to other priority use probla-s established
by the States or EPA.
3 Submission of false data to i?A in conjunction witn pes:i :': 3
regi strati on.
o Sale of Restricted Use Pesticides to uncertified applicators in
Statas with Fsdera": 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 1n States without
approved certification plans.
o EPA and States will ensure that applicators are made aware
ciw-n-gin-g technology.
o EPA and States will continue to certify new applicators.
o EPA will prepare guidance to encourage States to address
problems 1n C S T materials,
o EPA will prepare guidance which ensures
meet Federal standards, as appropriate.
of
major use
that State C 4 T materials
Plans for Achieving Program Goals
This section discusses the compliance monitoring plan, the
compliance promotion plan, plans for responding to noncompl i ance ,
certification and training, Headquarters/Regional coordination,
federal/State relationship, and cross program effects.
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-10-
Conoliance HonitorinoPlan
Objectlves
The basic objectives of ttie compliance monito-i 15 ^'jn »-«:
1) to provide a visible enforcement presence which wi ' ; encourage
voluntary compliance; 2) to collect evidence to support enforcement
actions; 3) to expand the data base for determining comoliance ay
the regulated community (FATES) and to use this information to
identify persons lilcely to be in noncompl i ance; and 4) to discover
problem areas requiring resolution fhnsugh re-gulatory initiatives
i_ . nnn
by OPP.
C omp Hance Hon 11or 1 ng Too 1 s
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.
On-site inspections are the major method through which E?A
monitors coitipl i a.ica with FI?3A. T'.-.ass \ r.spsrfi :*; i.-a ic.-.i-ctsJ
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 g-h 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 t?A inspectors authority to enter only establishments where
pesticides 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
1) consent of the owner or hts agent, or 2) with a warrant based
on probable cause that a violation has occurred, or is occurring.
Probable cause can be based upon a detailed allegation from a
reliable source Unking specific action with a specific misuse.
Some State statutes give their Inspectors broader entry
authority to detect misuse.
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- 17 -
Misuse is difficult to detect jn'ass an inspect:" -3 ;
during actual use or soon a.rtar c.ie use of tne aest ;::: = .
fore, use inspections are conducted in --esoonsa to 2 ::~:".j;i-
referral or during tne actual aoolication of tne 3-;s.; c'-2 . '-25'-
tlmate complaints/referrals regarding pesticide -.'sjse -:ay 02
ineffective if tney are not made and investigated oronot1./ sec a use
the evidence, especially in the case of *vgnly toxic organoanoso^ates
will no longer be there at the tiTie 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 commercial or private applicator is going to make
a pesticide application, they make appointments to conduct the
observations. It is, therefore, not as likely that instances of
knowing and willful misuse will be detected on a planned inspection,
as on an investigation conducted in response to a complaint.
Routine Inspecti ons
EPA and the States can use on-site inspection to determine"
with relative ease and at reasonable cost whether an establishment
has met its establishment registration or reporting requirements,
whether a product is appropriately lao-el«a, or wnether scientific
S2ta submitted in support of a pesticide "e^1'st rj^i on correct':'
reflects the testing wnicn *as condu
Since most States have regulations requiring dealers of
RiiP's to keep records or t.ieir ad^es, i; ii peict;«c1> ejjj ."j,-
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 1s 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
problems by promulgating a final rule under FIFRA §4 requiring
dealers to keep records of their RUP sales and clarifying where
certified commercial applicators aust keep their records on their
applications of RUP's. This rule should appear 1n the Federal
Register early 1n FY84.
-------
Ta rge tt i n g
As indicated on page 6, EPA and the States use the priority
setting system for pesticide use/misuse to cetermine specific
categories of persons who should be targetted for inspection.
Selection of specific persons within each category is based on an
NAIS. The system is flexible and may vary from year to year sased
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 p roduct/f aci 1 i ty 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
Wi thi n 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.
-------
T
Expand Referral Systems
'•A1t h 01 n t r A g e n c 1 a 5
e tne Agency nas -5*2
or violations "~~ ""
a' systems * -
Consumer
r
srgauCfcS or vioidiigns witn I-JM, ugnsumer .* r o C "j C t Safety Camr
(CPSC), Occupational Safety ana Healtn Administration (OSnA),
Federal Trade Commission (FTC), it should expand tne systems.
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 imolemented 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 Soecial Interest Grouos
Botn EPA and the States perioaically encourage tne national
and local trade oress to *ri'e articles on new and existing pesti-
cide control '•equi renents. Knowledge of FIF3A ana 5:2te pesv'iiis
1 jws .nave co"sistantly results^ in discovery of v'olatijns of oot?
laws. Because evidence of pesticide misuse'may rapidly disappear,
ic is particularly import an: trtdt EPA ana :ne Screes expan,
efforts to work with such groups as farmworkers to educate them
about basic evidentiary requirements and the 'need to contact tne
government as soon as possible after occurrence of the alleged
misuse. Efforts made 1n this area continue to be restricted by
resource levels. CflS has Issued a Complaint Form, which was
sent out is an update to the FIFRA Inspection Manual, to facilitate
tti« reporting of cotnplalnts or referrals.
Integration of Inspections
To make the
States currently
proximity of the
most effective use of resources, both EPA and the
conduct inspections based in part on geographic
targets. Both will continue this approach
EPft will also continue Its program of Integrating FIFRA and
TSCA data audit/laboratory inspections.
Inspection Frequency
the past EPA and the States were to Inspect establishments
urlng general use pesticides every 5 years and those manu-
In the past EPA and the States were t
manufacturing general use pesticides every
facturlng RUP's every 3 years. In practic
on the number of establishments existing 1
5 .
ce, this has
n a State.
varied based
EPA has moved
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- 20 -
away f-om requiring a specific frequency in its cuHance. I-sta
tne Agency suggests that frequency fie astaailsiea f-c-:" :^s
priority setting system. This is trua far jnisusa as «3*' is
astao li snrsent inspections.
Laboratories are axoectad t*3 oe inspected an 33- t^e lata au:it.
laboratory inspection program every 2-3 years.
Inspections at device producing establishments snould 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
testing 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 separata 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-uo Insoections
rollaw-up insoections are conducted when more information
is needed for a possible enforcement case or when violations
hive ba°n fc'j~- i?j the ^3"io-'State iete***^'"as t^it jio*1?*"
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.
I nsipecti on Qua 1 ity
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
will be up-dated and revised 1f resources for this activity are
available in the future. I
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-rain durtn-g urid-year and end-of-year reviews.
Ttti-s review activity** 11 continue.
-------
In accordance with tne Agency's Quality Ass-ranc* I-' -
ments, States receiving grant money througn trie coooe -2 : * ve e
ment program flust develop QA Plans covering botn CD^Silatca m
and sample analysis
hese QA Plans must be
ne
Quality Assurance Officers annually for review aid ajcrova1.
Compliance Monitoring Staff, with tne approval of v^e H?A Cui
Assurance Management Staff of QRO, has provided guidance to the
Regions and States on the development of QA Plans.
Compliance Promotion Plans
Qbjecti ve
'arcs -
i e 3 i 2 n;
"is
ty
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 do to comply.
Since neither EPA nor the States have sufficent resources to
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 wi
through the following mechanisms.
Educational Proarams
;.-^A
Certi fi cati on and Trai ni ng. Perhaps the most widespread compliance
promotion rool is the pesticide applicator training and certifi-
cation program. This program is conducted by EPA in two States
and in other States by tne States themselves. It ensures that both
private (farmers) and commercial applicators (all other*) 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 Bate Mais and «xani nations as appropriate. Implemen-
tation of this guidance will be dependent on available resources.
Other education programs. These programs are designed to promote
safe pesticide use. An example is Project SAFE, which is sponsored
by the National Aerial Applicators Association and the Extension
Service and is supported 1n 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 taacn aeria' applicators setter cj'::->:
techniques to minimize pesticide drift ani to ootai^ ::-.:-2'
control with the minimum amount of pesticide, The-* is := see^
three trainer fly-ins which involved aporoximately 3 States.
During the next phase of the program, these trainee specialists,
mostly cooperative extension staff, will be conducting fly-ins -"or
aerial applicators in tne'r States to help trie applicators calisrata
and apply pesticides in the most environmentally effective manner""'
Farmworkers Program
Several y*-ar« *go, the Agency initiated a .pro-gram to evaluate
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 specific laoel language. The regulation is
enforced at the user label in tnat it is illegal to use a oesti :i *e
in a manner inconsistent with its labeling. A ,vor
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to
- 23 -
Laboratories
TV! s policy is stated in tne final FIF3A 3occ Laboratory
Practice Regulations (GLP's) which are to oe p rc~-j * gi ;a a in FY5-.
Sjjsaensi on/Cancel lati on of Registration
This is an action whicn may De considered if tne statement
of compliance or noncompliance with the GLP's tnat 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 (£0 CFR §157.3} 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.
aci 11 ties
Senerally , i f Fed
the EPA does not issue
Drier 12038, Faderal C
wnich established a go
facility compliance wi
assessing penalties, E
Noti ce of Warning i s 1
and the EPA works with
plan. If the problem
is referred to OMB.
sral Agencies ar» fcu^.i : " v1:lit"
penalties. This is in accordance
omoliance With Pollution Control S
vernment wide program for ensuring
th polluti on'control requirements.
PA tries to resolve the problem.
ssued to notify facility managers
the violative agency to establish
cannot be resolved between agenda
- z * r i i
, < * . ~
•» . - n te
tandars
Federa
Inste
Fi rst,
of vi ol
a re me
s, the
of
s,
1
ad
a
ati ons,
dial
matter
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-
vi si ons 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:
Technical Assistance - to ensure cost effective and timely
ompliance.
Compliance Monitoring - to -monitor actual compliance.
Fiscal'Planning Assistance - to assist OMB 1n evaluating budget
ie
US« Of funds.
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- 30 -
Cooperative Enforcement
As the cooperative enforcement program has a •/•: '/*
wt agreements have accepted increasing raspons i 51 it/
fully in ail pnasas of the program wi-.h £?A.
now snare
Cornp' i anca/Hnf o reagent Acti vi t i es
The States with cooperative agreements conduct all FIFSA
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
spray programs in tiie State. (Th-es-e major spray programs are
usually funded by Federal agencies.) In addition, EPA through
NEIC proviaes 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
all
enforcement actions on violations of only State
re-far all ylolrtiorvs of only Federal law product anc
i* <
aw
taica
will
ne.nt registration requ i regents -0 i?A for enforcement acti
Where tnere is a violation of oo*h 3~ate ana Feceral law, a
may take enforcement action itself or refar the case to Z?A
is unv/i'ling 2r urable to io so.
it
All States with cooperative agreements also have primary
use enforcement responsibility (primacy). Under the terms of FIFRA
§§25 and 27 and the final rule interpreting 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.
Stare Program Oversight
cooperati ve
are closely
enforcement
involved in
EPA has primary r«spon-sibi 1 ity for
programs oversight; however, the States
this process.
Program Guidance and
Compliance/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
-------
-------
own annual program priorities
Specific outputs
pijnra/ an'orceiient activities ar> negotiates on t*2 ?i:*s if fe
Stats priorities and productivity factors in the guica^ce.
Prog ram • va 1 uat i on
*ajor elements of tne .Regional evaluation o* StJta pro grans
include:
o Semiannual reports by the States of their accomplishments comoar
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
review evaluation reports before they become final.
to
o Training and close informal
acti vi ties.
review of the quality of State
The effectiveness of a State program is judged primarily on .
the quality of its priority setting system, its adherence to
negotiated n unite r of outputs, the quality of its inspections aid
the adequacy of its enforcement responses.
Fa serai Program in Npn-Coooerative Agreement "States
In Colorado, N
-------
- 32 -
EPA will continue to conduct car*'*icat*-3n ^r---j-;
dit^cut cs-ti-• cati on plans. 3cth E?; an: State's -:ci-.s
material and : of orinati on to ensure tnat a?p", i ca" 3-5 i-= 2,
-------
- 33 -
U p c a t e of
The core manual and various category manuals *e-»
updated to reflect cnanging neads ana tecnnolocj. Ccr'es of trie
manuals *ill oa orintsd by the State Cooperative Exts^s'on Sarv-css
(SCES). "nese and other training materials will :* cataloged a:
tne USDA Seltsville library using EPA funding. ">» Droalem csnt'-iua
to be future availability of copies. Neither t.ie Government ?ri.?fi-.
Office or the Department of Commerce will maintain copies of :-?ese
publications for distribution and sale. Therefore, wnile 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 t£ 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 matcing
it available when requested to groups other than the SCES's.
Indian Tribes
EPA funding assistance to
draft Indian plans are no.w
some tribes will probably ha've
EPA must then urge these tribes
Ten Indian tribes have received
develop certification plans and some
being reviewed. Therefore, while
appro ved plans, others will not. u.-n must, m^n u. d= unc^c ^ < > w*
to enter into an arrangement with States to perform certification
on the reservations or £?A must establish Indian certification
programs. There is also the possibility of sorce split options,
such as, States issuing certificates and E?A enforcing misuse anc
denial, suspension or revocation of certification.
Review 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 these States
develop and submit certification plans. Colorado has recently
indicated its iat*r±st 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 «rt1f1 cation programs. Most Federal
agencies chose this option, even though it imposes geographic
limitations on wlrer* tte applicator can apply pesticides* I.e.,
the State Issuing the certificate or States with reciprocal
agreements. However, because some Federal applicators must work
1ft sever*! States, often on sfcort notice, EPA allows Federal
-------
agencies to devsloo certification plans for tneir e"'v"5
Applicators carti'^ed under Federal agency plans C*"1 irvy
pesticides anywhere, but tnis certification is limit*-: to* 0'
duty functions. To data, three Federal agencies, DC3, USDA
00
have approved Federal agency certification plans
Cross Program £ laments
The pesticide program impacts regulations and enforcement of
other State and Federal environmental 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 1n order for them to effectively ma
-------
- 35 -
'Vasta •>""3crn
Pesticides are a major constituent of trie .vasras at a ;a-
number of Hazardous waste sites ana information c? regi st ran- s
ana producers is needed for clean-uo cost recsve"/ and associa
enf orca-rtent actions. Information on oesticide ,ianu f act j rars 1
aeen orovi iad to the Office r>f Waste Programs £ T'T r ta
of the Agency's dioxin monitoring orogram.
as par
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 RCSA regulated
pesticides identified under FIFRA or associated Stata enforcement
programs requires close cooperation with State and Federal RCRA
personnel
on disposal
RCRA.
Pesticide
practices
i nvesti gati ons may
which point to tha
also provide information
need for regulation under
Water Program
Use of pesticides resulting in drift into water
a FIFRA and State pesticide enforcement function havi
interface with Water Quality Criteria established t>y
Programs. Pesticide contamination of grounawatsr "ss
pesticiae usa also requires coordination between t"*
and watar 3rggrjms.
InterAgency
Data Audits/Good Laboratory
Practice Inspections
is
ng
rimari ly
direct
t * n
pes:
As discussed on page 10, FDA conducts inspections for EPA
at laboratories which conduct health effects studies.
Spray Programs
As discussed on page 28 under Federal
have monitored spray programs conducted by
Efficacy Testing
Facilities. EPA/States
U50A and the DO I.
As discussed on page 11, EPA has coordinated with FDA, USOA,
DQI, and the Bureau of Standards to have testing conducted on
ultrasonic devices, electromagnetic devices, and rodenticides.
-------
EPA worses *:" t n otne" r e d e " a 1 Ageic'35 3 f '
tne development and i r,z 1 ementat: an of C S 7 2":
300, USDA, and 001's Sursau of-Land Management
programs.
Food C:rrt2rn1 naff an
-save
USOA arvd FDA monitor pesticide residues in food. 3otr.
agencies forward reports on food contamination by pesticides
to EPA for followup investigation, if appropriate.
Referrals and Information Exchange
EPA coordinates with USOA, FOA, DOI, FTC, CPSC, and the
U.S. Postal Service on several specific types of products/devices
that are of mutual interest.
Program evaluation
pHa
me as
eval
mode
At t
131
-,* c
A system for evaluating the effectiveness of the F1FRA com-
nee/enforcement program must define specific areas for evaluatio
ures of program success and mechanisms for performing the
uation. The Agency can best measure its success in achie*
lianca *han it nas dsvelopea I) an a aequate sat a oase for
t i f y i n g me?noe.'"S of the regulatad csnmuiity and 2} areilt"'
Is designed ta select those -rra^oefs most l: ca-s*3er ^ts program a succass '- on';
of tnose persons inspected under a neutral scneme are violators
Evaluation Areas
Areas for evaluation Include 1) adherence by EPA and tne
States to quantitative and qualitative performance commitments; and
2) the extent of compliance with FIFRA by the regulated community.
Measures of Success
Adherence to Commitment
The adherence by E?A and the States to performance cowmlfments
can be measured by the following factors:
o Implementation of a priority setting scheme.
o Adherence to output commitments as measured by the Administrator's
Management Accountability System.
o Adherence to Inspection procedures required In guidance.
o Number, promptness, success and adequacy of enforcement act1ons_.
o Accuracy and timeliness of compliance data entry a-nd retrievaf
These factors will allow a quantitative and qualitative
evaluation of the syste*.
-------
C o mo ! i a n c s by the Regulated
ty
'he extant of conD1 :" aice fi~ t'
'«d to a limited degree sy tie
•agu " a tec : :
]ow•ng "5 :~
o Number af applicators trained and certified.
o ? rooort i ona t e numoer of estaDl i snrnents
-------
- 33 -
?-3gram Modification.
a a t a from " A 7 £ 5 , S s 2 1 2 3 - 3 g " 2 :i
3 v
t?A uses
-27'ews and r^e overall program rav*ew, 13 nosi*.' ••'•s C2""3
enforcement program as necasa^y and to g^v? iiput to O30 c:
"•gulatory cnang«5 necessary
enforcement, or compliance.
acilitate comaHance monitoring,
.- utura ju ' 33nee
The following is a list of guidance documents curren1
development or consideration.*
>y under
o FY85 Cooperative Agreement Suidance. This document will modify
C i T allocations, specific instructions on transferring enforce-
ment priorities to the C 4 T programs, evaluation of the C it T
program plans and training materials, and improved productivity
factors for negotiating grant outputs.
o FIFRA Compllance Program Pol 1cy Compendium further defines the
requirements of F1FRA regulations.Currently there are twenty
such policies in the compendium and three under review by the
Regions, the States (through SFIREG), and the program office.
o FIFR_A Inspection Manual provides information
cnai i-of-:ust3iy
ions, coil acting samples,
suooort documents,
Flr^A inspections.
are aval 1aole.
and other :'n*3rr:at:on necessary to
This document snould se revised i
on conducting insseC'
•scedurss, rra
i-'O'l* 11 *j
orig i ha 1 pena 1ty p o1i cy ha ve been developed over the years
reflect amendments to the law. These will all be combined
one comprehensive document.
to
into
o. FIFRA COfflp_1 iance Strategies, The FIFRA Compliance Strategies are
developedfor al1 rules promulgated under FIFRA. A compliance
strategy Identifies the (a) requirements of the regulation, (b)
the typ« of act-Tons 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 model 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 E?A
annually.
A comprehensive 11st of existing compliance/enforcement guidance
docyiaents 1s Included 1n the Appendix vf tne FIFRA Cowpliascs/
Enforcement Suidance.
-------
- 39 -
APPENDIX
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•* V ""» "*
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Producer Estaolisn
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Usa Investigations
.Marketplace Inspections
Import Inspections
Sealer Inspections
Laboratory Audits/
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TOTALS
•143
•182
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-------
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Orders
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Inport Detentions
TOTALS
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91 70 71
1332 1194 755
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I/ Second Quarter FY83 Totals
An additional 24,000 Stop Sa:e Orders were issued to firms t£
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-------
-------
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
JW 151985
OFFICE OF
PESTICIDES AND TOXIC SUBSTANCES
MEMORANDUM
SUBJECT: Final GLP Compliance Strategy
FROM:
TO:
A. E. Conroy II, Director _. .
Office of Compliance Monitoring(/EM-342)
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 £R_ 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 available.
Response- The GLP regulations have provided adequate notice to
all persons, 1n the sectior 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 or 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.
-------
Comment 2-
have stated
OECD GLPs).
substances
devi ations
data were i
reports are
compllance
OCM."
-2-
OTS has noted that "some data submi'tted with PMNs
that studies were done according to GLPs (usually
However, protocols are often missing, test
are inadequately defined, and there are other
from any known GLPs. OTS recommends that claims that
n accordance with GLPs not be allowed unless the data
sufficiently detailed to support the claim. As a GLP
issue, this recommendation should be considered by
Response- OCM does not
from making claims such
this by amending the PMN
statements with PMNs ind
adhere to the GLPs and 2
detailed reports. When
compliance with the GLPs
studies supporting PMNs
schedule inspections/aud
have the authority to
as described above.
rule requiring submi
icating whether the s
) support such claims
OTS has concerns with
, OTS should provide
and the names of the
its at the laboratory
restrict persons
OTS could remedy
tters to 1) provide
ubmitted studies
with sufficiently
specific data and
OCM a list of
labs. OCM can then
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 Williams
Don Clay
Steven Schatzow
Terrell Hunt
Ruth Bel 1
Jim McCormick
Air and Waste Management Division Directors
Environmental Services Division Directors
Regional Toxics and Pesticides Branch Chiefs
Office of Regional Counsel
-------
Strategy for the Enforcement of the Good Laboratory Practice
Regulations Under T5CA and FIFRA
Overview
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
pesticides.
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
Applicability
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, pnvironmental effects, and chemical
fate testing under TSCA a*id 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 rrgulated 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 FIR 53922, November 29, 1983). Generally, the rules
contain proviTTons relating to:
(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
with the GLP regulations;
the study was conducted in accordance
(b) A statement describing in detail all differences between
the practices iised 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
in a previous submission.
(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,
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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,
in the generation, measurement,
equipment used for
or electronic equipment used
or assessment of data, and
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 1s 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, or
derivation of the test and control substances and must determin
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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 GLP 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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Enforcement
Objective
The objective of this strategy is to maximize compliance
with the 6LP 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.
Violations
Generally, the failure to comply with any requirement of the
6LP regulations is a violation of those regulations (see Speci fie
Requirements of the GLP Regulations, above). However, violations
are actionable Tna di fTerent manurer 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 J
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
or marketing permit, or denial or disapproval of an
for such a permit under Sections 3, 5, 6, 13, or 24
a research
application
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.
Inspectio n 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 6LP 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 facility.
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.?y-oriented 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 accomplisherl by examining raw data and other records
generated dur-ng tf*e 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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Administrative Considerati o n s
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 and audit.
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 1aborato-iest consistent
with resource allocations. They will also serve as expert
witnesses in support of Agency litigation efforts.
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INTEKAGENCY 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 Rodentlcide 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 will 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 6LP 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 ';he 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 the testing
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. Trai ning - 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 ? -spect a testing laboratory or complete a
data audit because of the lack of specific expertise. CMS will
provide the -equerted 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 La boratpries 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 da*ss of the inspections and the EPA
scientific personnel who will participate in the inspection
or audit. Tris information will be classified as "For Official
Use Only" and shcjld not be disclosed except on a need-to-know
basi s.
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EPA will identify for NTP those inspections where assistanc
is requested from.NTP and provide NTP with a clear definition b
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. Reporting 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 ality - 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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r
-7-
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- Training Schedules - CMS will consult with NTP on tne
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 30, 19B4,
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 fun^i 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-
9. AUTHORITY
APPROVED AND ACCEPTED FOR
THE ENVIRONMENTAL PROTECTION
AGENCY
BY:
77
ih)hn A. Moore, DVM
TITLE: Assistant Administrator
for Pesticides and
Toxic Substances
1
APPROVED AND ACCEPTED FOK
THE NATIONAL TOXICOLOGY
PROGRAM
David P. Rail , MD, Ph.D
TITLE: Director
DATE:
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 - 3ly to assure an effective laboratory
inspection 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 LDIP 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 inspection.
The OPTS Program Offices will provide the scientific review
of laboratory 6LP 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. Comp1iance Monitoring Staff
(!) 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 OPP 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 dupllcative 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 o1
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 deliverables 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 FOA 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. Office 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 LOIP 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 LOIP 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-
lished criteria.
(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 foon^or and the testing laboratory before inspections
and audits are undertaken.
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-7-
(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) Serve? as a steering committee to oversee the manner
in which LDIP tracks studies under FIFRA and under TSCA Sections
4 and 5.
(3) Assists CMS in evaluating the effectiveness of the
-------
-8-
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:
(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.
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-9-
(b) Completed studies where selective percentages
of available data are 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 rule or
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 (F1FRA). 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 FOA.
Other definitions pertaining to studies and to GLP are con-
tained within the GLP regulations.
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-10-
6. CONCURRENCES
V
.V * V
^-A.
Moore, D.V.M.
Assistant Administrator
for Pesticides
and Toxic Substances
Date
O
Don R. Clay, Dired
Office of Toxic Substances
Date
Edwin L. Johnson, Director
Office of Pesticide Programs
Date
go
A. E. Conroy/I I ,| Di rector
Compliance Mbnitbring Staff
Office of Pesticides and Toxic
Substances
Date
-------
-------
-------
United States Pesticides and
Environmental Protection Toxic Substances Washington, DC
Agency Enforcement Division 20460
Fecjera| 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
Policy Compendium
Guidance Manual
November 1990
-------
Volume 3
Table of Contents
Volume 3: FIFRA Compliance Monitoring Strategies (continued)
TITLE
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)
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
Guidance Manual
November 1990
-------
Volume 3
Table of Contents
Volume 3: FfFRA 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
Chlordimeforra 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: F1FRA Compliance Monitoring Strategies (continued)
TITLE
Daminozide (Alar)
Final Compliance Monitoring Strategy for Daminozide (Alar)
Compliance Strategy for the Agreement to Voluntarily Halt Sales of Food-Use
Pesticides Containing Daminozide
DBCP
DBCP Suspension Order Enforcement Strategy
Dinoseb
Compliance Strategy for the Emergency Suspension of Dinoseb
Amendment to the Compliance Strategy for the Emergency Suspension of Dinoseb
OCM Memorandum: Dinoseb
OCM Memorandum: FJFRA Section 18 for Dinoseb
OCM Memorandum: Dinoseb Stipulated Order
Compliance Monitoring Strategy for Final Cancellation of Dinoseb
Compliance Monitoring Strategy of the June 9, 1988 Dionseb Cancellation Order
for the 1989 Growing Season
DATE
10/20/86
06/14/89
11/07/79
10/07/86
04/02/87
04/17/87
03/14/88
03/28/88
06/15/88
03/03/89
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: F1FRA Compliance Monitoring Strategies (continued)
TITLE
EDB
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)
Toxaphene
Toxaphene Cancellation Compliance Strategy
DATE
01/01/83
Wood Preservatives
Compliance Monitoring Strategy for the Wood Preservative Uses of Creosote,
Pentachlorophenol, Inorganic Arsenicals
10/23/86
Index
Page
M
FIFRA Compliance/Enforcement
Policy Compendium
VI
Guidance Manual
November 1990
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ENFORCEMENT ?AGTS
AKD STRATEGY
COMPLIANCE
MONITORING PROCEDURES
WATER PURIFICATION DEVICES
October 1930
Pesticides & Tcxic Sucstances
Enforcement Division
Office of Enforcement
U. 3. Environmental Protection Agency
Washington, D. C. 20460
-------
STRATEGY OVERVIEW - 1
BACKGROUND 2
?.I:-V1ATSD INDUSTRY ; 3
APPLICATION OF FIFRA 4
Requirements of FIFRA
FIFRA Snforoenent Authorities
?.2"EDIES 6
General
Mi soranding Purifier Claims
Ineffective Water Purifiers
Recall
Other Violations of ?IFRA
Crininal Citations
COMPLIANCE MONITORING 9
Program Development Overview
Guidelines for Selection of Devices To Be Tested
Inspection
Post Inspection
Testing
Pesticide Enforcement "anagement System (PSMS)
Outreach
CASE DEVELOPMENT U
ALLOCATION OF RESPONSIBILITIES ,-15
ENFORCEMENT FACTS AND STRATEGY 19
c
-------
S tr?.r?*y Over view
_..,.•„-•> 4
iis
vir
tra
on •
wit
and
ter purifiers are products which are intended to render
er s-ife to drink by removing pests (microorganisms) through
chemical or physical means. Water purification devices
te peats (microorganisms) from water by using a physical
such as ultraviolet light, filtration, or other non-chemical
To qualify as a "purifier", the product oust remove all*
causing microorganisms from the water, including bacteria,
and cysts. Since devices are not subject to the regis-
*"» a
..3 •
ease
uses,
ion requirements under PIFRA, regulation of them falls entirely
he Office of Enforcement, which must determine if they comply
h th
Rod
plia
e other requirements of the Federal Insecticide, Fungicide,
enticide Act to which they are subject. The key to the
nce determination will be verification of label claims
a program of product testing.
_T_he ..testing program_will examine the purifier claim used by
~ar.r products. If a product claims to be""a purifier b'uf'it does ~" "
not remove test organisms in the efficacy test, the product is
iee-ed to be misbranded and subject to enforcement action under
7I??.A, 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
Th-"5, if it fails Phase I, enforcement actions
spent ing time and money on the Phase
pass both phases.
will be taken,
II tests.
The goal of the program is to
prciucta which do not purify water
who night rely on tli
- ** r- .3 i
remove from the market those
to protect the health of persons
products for safe drinking water.
0
-------
racks rouncT
Water purifiers are a class-of products which are intended
to render unprocessed water safe for drinking. They nay be used
in homes which obtain water from wells, by backpackers to treat la
and stream water, by persons whose community water supply may 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 PIPRA, 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 tyTjes are subject to the provisions of PI7RA, including but not
limited'to, Sections 7, 8, and 12 as well as Section 2(p) and (q),"
only ourifiers utilizing a chemical must obtain product registration
a3"tTi'scribel" by "SectioS J Of the Act."- 'Jnder- S«tlofl-25-ferU-)~of-
?Ir?.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 red. Reg. Vol. 41, No. 225, page 51065, 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-and misbrand-
ing provisions of'PIPRA is very straightforward for chemical-based
water purifiers. If a manufacturer makes claims on a label that do
not aopear on the label accepted by the Agency at the tine 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.
Yater purifiers which use a physical means of microorganism
elimination are devices, and are therefore subject to the same
requirements of PI?RA as the chemical water purifiers except that
theyareexempt 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 FIFRA Section 2(q) and subject
to enforcement action.
The 2? A cannot require the manufacturer to substantiate tha
claims mad-2 for the product, so to evaluate the performance of such
devices, SPA 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
mis".eaci ng clainis.
-2-
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*
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 eight kill a micro-
organism ia employed in at least one product. The most popular are
ultraviolet (*JV) light, aicropore 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.3-3 lr.-sma.ll. cjD.mmu,niJtj.fi.3-..--^2ji3.C3.;,ly_.^eyre,r_al taps__andr a_ dist_ri—
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.
cf this program. However, if such products are found to be ineffective,
they may be subject
€n •fc->^'^o«^^»'
• » ** W * \f v •— v «
actions under FIFRA.
-3-
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• r...-I
FIFHA and its implementing regulations clearly apply to devices!
The requirements of those regulations are outlined below. State
laws are often aabiguous 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 prograa. State inspectors who nay 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
•~FI??.A-r":th
-------
For greater detail, consult 41 Pede. *1 Register 51055,
"oveaber 19, 1975. nil requirenents of device producers described
in that document apply to producers of water purification devices.
*
FIFHA Enforcement Authoritieg
Failure to adhere to any of the above requi renents .of FIFRA may
be an unlawful act under §12 of FIFHA as follows:
'Failure to register the establishment [Section 12(a)(2)(X)]
"Failure to keep books and records or to nernit inspection of
books and records ("Section 12 (a)(2)(B)]
••Usbranding [Section 12 (a)(l)(F)]
'Failure to file production reports [Section 12 (a)d)(H)]
-------
C-gr.eral
FITHA provides several remedies for violations of..its provi-
sions. If the purifier efficacy claims are found to b.e 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 PIFRA penalty policy and matrix
(39 Federal Register 2771, July 31, 1974). Civil penalties for
-isbranding violations, which are applied in addition to Stop Sale
Orders, 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 ?ederal Trade Commission through headquarters.
"isbranding Purifier Claims
Water Purification Devices which fail the purifier efficacy test
are cisbranded. 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 continue'3
sale or use of the product, and will not be lifted until the product
comes into compliance with the Act.
in addition to the Stop Sale Order, a civil penalty will be
assessed as described below*. The Civil Penaltv^must be assessed
within fourteen days of the Stop Sale Order. _
(This is consistent with the penalties for similar violations in the
current ?I?RA Penalty Matrix.)
Ineffective Water Purifiers
I II III IV 7
1. Category A 5000 5000 5000 5000 5000
2. Category 3 1000 1750 2500 3200 4500
See A. S. Cor.roy's Memorandum of September 12, 1930, "Interim
'inal Regulation Section 13, ?I?HA."
c
-------
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 hasard 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
" would "bring the product"-ia'tO''c'Ott?l-laTnrer*trl-feh-™th«'-ATit-.
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 "modified11 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
sermit G. Iambiia cysts to persist in water. Since the cysts are
relatively large, a ore-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-
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Cther Violations of ?I??.A
.As described in the section on the Application of PI?RA,
the Agency has authority to take enforcement action when
provisions of FIFFvA are violated. Violations which do not
involve the purification claim (e.g. violation of Sections 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 FIPRA 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 sane time.
Crisi-flal— G-l-te-tion-g- -------- •-- ........ -- -- ....... ....... - ..........
Willful violations of ?IFRA nay justify the filing of
original charges against a nanufacturer. PTSED concurrence
would be required for criminal actions.
c
-3-
-------
•/fven. below are procedures for the compliance monitoring aspects of ths
jgram with description of responsibilities and data flew
7—: delir.es for Selection of Devices To Be Tested
*
M3-?T3iD will select the devices to be tested and determine the
order cf testing based on criteria noted below.
Only "point-of-use" devices will be tested. These devices consist
of those intended for use in a single family household, camper,
boat, etc.
Two categories will be established to helo determine the order
of tsstirj:.
- The first category, vfcich will be given the highest
priority, will contain those products for vhich
there is reason to believe that a violation,
has occured. This will be determined by consumer
or competitor complaints, scientific judgment 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 deterained by random selection.
C-3-PTS3) will prepare the sample request forms and forward
then to the appropriate Region" for collection.
inspection
At the opening conference:
- The inspector should request efficacy data fron the
manufacturer pertaining to his/her device(3). The
manufacturer canr.ct however, be required to submit
this data.
- The inspector should advise the raarufacturer 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 rsurificatior. devices.
c
-------
* Inspection of boots and records will be perforasd in accordance
with the Pesticides Inspection Manual for the purpose of deter-
aining compliance with the record keeping requirenents (§3).
*
( * An official sample of the device will be collected at the producer
establishment according to the Pesticides Inspection Maruai. The
official sa-ole 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 quality 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 expansive, the .
- inspector... sliould.naks.,an.. a£tessrt;._.tP._.have. Jjie..mamf acturer
donate the device, y.any manufacturers have already
indicated a desire to have their devices tested, and
a willingness to donate then for this purpose.
- If the zarufacturer 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 T^irufacturer requests to install the device himself,
arrangements with the testing laboratory should be cade
through CT-S-rTSE).
" 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 advertising or contacting a
local trade association, then a marketplace sanple
can be obtained.
£/ Barlow's Decision: Guidance to Re-*ional Personnel: Conduct
:f Inspsstiors after the Sarlcw's Decision (April 11, 1979)
C
-10-
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If a product spjsple obtained froa the zarketplace
fails the efficacy tests, a warrant to conduct an
in-depth bocks and records inspection may be
obtained. This will be necsssary if production
and distribution data is needed,
III. Pest Inspection
When the requested.aaaple has been collected, the "PRD
Ackr.owledgnent" copy of the saaple request form will be
forwarded to CI-3-PTSHD with the "Sample Identification"
section completed.
All non-confidential information obtained by the inspector
will be placed in the enforcement jacket and fonarded
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-PTS33 for contract
raanage^ent purposes.
Testing
0 Efficacy testing will be performed by the State of New York,
Department of Health, Division of Laboratories and Research.
" Zach device will be examined when received by the laboratory
for arr,' possible defects resulting from shipment.
0 Chain cf custody procedures will be followed for all official
samples.
* The device will be subjected to a series of microbial challenges
until it fails or exhausts the series.
- All failures will be confirmed by a second test
9 A second device will be tested if the first one fails.
- Enforcement action will not be initiated unless both
samples fail
' The testing laboratory will be subjected to a Quality Assurance
(QA) Performance Audit and a OA Systems Audit. These audits
will be initiated by ??S3D.
* The testing laboratory will submit to O3-PTSID a QA Prcgraa
and Project Plan.
-11-
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* CM3-PTS3) is to be kept informed of the testing status of the device.
This information is to include:
f """ i
< - date the official sample was received
- date testir.g was initiated and completed
* V,"nen 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 jaclets will go directly to the appropriate
Region frcm the testing laboratory for review to determine
violations, and to initiate enforcenent action.
* - A copy of the test results will be forwarded to CM3-PTSH)
fron the testing laboratory to monitor the contract.
* The testing laboratory will retain all devices for which
violatiors exist until enforcement action is completed
or the case is placed in permanent abeyance.
V. Pesticide Zr-fcrceaer.t Management System (PS
The Regions will keep PTS3D informed as to the enforcement statas 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 PEM3 Cccputer system.
^ ~
Outreach
v^rr/ .manufacturers of water purification devices do not appear to be
aware of Section 7 establishment registration requirements. To help notify
industry of these requirements, a letter to potential manufacturers and j
their trade associatior^ has been prepared (Appendix IH-)C> v
Ths responses free this letter will allow the Agsncy to cccpile an
accurate list of carufacturers, their products, and production and distri-
bution data.
A press release has also been prepared announcing the program to the ./
c and notifying industry of the establishment registration requireisnts "
(Appendix ^A
As a result of this oatresch pro^raa, 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 CT-S-PTS33, Cocp" lance Monitoring
Coordinator.
c
-12-
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Microbiological data generated by this prograa will be submitted tc the
Journal of Applied and Environmental Microbiology for pjblication after the
enforcement cases are ccnpletei. The results of the tests may also be
-^resented at the \¥*2. Annual Meetings of the American Society for Microbiology,
The results of this program are also of interest to the National
Sanitation Foundation and D-19. Cocaittee on Water Microbiology of the
American Society for Testing Materials. It is possible that presentations
will be nade to these groups.
Regions nay release information concerning individual cases in the saae
manner that such information is handled in other civil proceedings.
c
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\
PTSED
and
o reviews test results
labeling
o maintains a file of test
results, labeling, and action
taken
PTSED
o requests samples
o monitors program
sample
request
r.otification of
action taken
Region
o reviews lab's report, labeling
and any records collected to"
determine possible violations
o cerercir.es er.forcer.ent response
and initiates action
o maintains official enforcement
file en devices
Region
o sets up enforceaent jacket
o collects samples, performs
inspections
o sends PSD Acknowledgment to
CMB-PTSED
o sends copy of labeling to
CMB-PTSED :
sample &
enforcement jacket
test results
enforcement jacket
test results
-13-a-
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Case development will proceed in accordance with the Case
- ?rcc?-?di«ngs Manual. The Regions are aivised to avail themselves
;" the option of Enforcement Review through headcuarters. The
*abel review will be done by the Registration Division using
the product performance criteria developed for evaluating b'oth
chemical and physical water purifiers and the data on produtt
performance from the efficacy test.
Please note that
the Stop Sale, Use or
efficacy tests.
a civil complaint should be issued along with
Removal Order when the product fails the
-------
rr.is_cr.art _is a_gaiie to the responsibilities _i or the different tasks ln_ta_e_vater_
rurification device enforcement rroffras.
Heajauarters (PTSZD)
Regions
Identification of Purifier Devices
* Information sources: ERSS,
consumer queries, competitor
complaints, advertising, other.
Identification of Purifier Devices
* Regions suinit inforcation on
ne*r products they bee one aware
of to Compliance Monitoring
Branch
2. Selection of Devices to be Tested
' Compliance t^onitoring Branch
updates list of taown devices
and selects devices.
" Policy &. Strategy Branch will
evaluate Neatral Inspection
Scheme. All known devices
vill be tested.
Allocation of Inspections
* Caspliance Monitoring Branch deter-
mines nazes and locations of device
producer establishments: assigns
Inspections to appropriate Regions;
prepares sazple request for^s and
sends then to Regions.
G
4. Inspections and Saarile Collection
0 Regions assign inspectors to
conduct establishes.it and/or
bocks and records inspections
and product sample and docu-
mentary material collection.
(inspections aay be aade by
Federal or State inspectors.)
e Inspector performs inspection
according to PIFRA procedures
and guidance; special instruc-
tions aay appear on the sanple
request fora.
-15-
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Headrjiarte rs (FT3ZD)
Region
r
Inspector ships saaple(s) and
one set of documentary ca
to testing laboratory, ser
copy of documentary sszple
headquarters,;
Testing of Devices
' Laboratory (Snvironnental Health
Center, State of Mew York, Depart-
ment of Health, Albany, N.Y.)
performs efficacy test according
to PTS2) approved protocol; furnishes
results etc. to PTS2D and the
™ SvegiOT-. (See *U3.-below..) The .lab
will keep the device until litigation
is
Determination of Violations
" The testing laboratory indicates
whether the product passed or
failed the efficacy test.
Determination of Violations
" Region reviews inspection data
and its set of documentary
material to determine existence
of violations under PIFRA
Sections 7, 8, or 12 as well
as well as Section 2(q)
branding violations.
* The regions are strongly
advised, particularly early —
in the program: to send the
jacket to headquarters for a
pesticide Snforcersent Review.
The reviewers ccopare testing
results agiinst label and
advertising claims to deter-
mine if purifier claims are
false and misleading (misbrand-
ing violation). N.B. The
enforceaent jacket acconcpanies
the sample to the laboratory.
The laboratory inserts the data
from the testing program and
forwards the jacket to P.egions
•which nsy for/ard then 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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Healriartgrs (PT5ZD)
Regions
Based on the laboratory's
determination, the Regions
cay initiate action on the
purifier claim. This should
not preclude discussion of
the case With headquarters.
Determination of Appropriate
Zr.forcemer.t Response
* If misbranding violation based on
the purifier claim lias occurred,
headquarters may provide additional
information based on historical files.
A-r~rcpriate- records and recoursendations
will be forwarded to the Regions. If
advertising is seriously misleading, a
referral to the Federal Trade Coamisaion
will also be made.
7. Deteraination of Appropriate
Enforcement Response
* A Stop Sale, Use or Removal
Order (SSUHO) will be issued
for all products -which fail
efficacy test. A civil penalty
is. alspj
Region applies general ?I?EA
civil penally policy and
satrix to deteraine appropria':
level of actions for ail .
violations.
Zriforcerer.t Actiorys, Litigation,
FT SID ^,-( ur.de r exceptional
circumstances, initiate
enforcement actions.
Sections of the agreements
which irr/olve label or product
improvements to bring the product
into conpliance are to be sent to
PT3-D for concurrence.
S. Enforcement Actions. Litigation,
Settlement
Regions will initiate
enforcecsnt actions
(warning letters, civil
complaints, SSURO's).
Region may obtain expert
testimony fro~ headquarters
reviewers or laboratory
scientists.
Completed Case Files
* PTS3D will caintain a file
of all test data results and
copies of 7inal Orders for use
in dcc-a.tr,-?ntir.g the possible need
for regulatory or legislative
changes.
9. Conpleted Case Piles
* The Region should retain
completed case files, in-
cluding all relevant
documents.
* A copy of the Final Order
should be sent to PTSED.
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Eeaisuarters
Regions
10. Publicity.
r
10. Publicity
Sta
of Program
- Press Release
- Letters to raanufacturers and
trade associations.
Release of data generated "by
testing prograi. (Laboratory and
Compliance Monitoring Branch)
- Publication of Scientific data
in appropriate journals
- Presentation in proper foruas.
Consumer Information detenained as
._a ..result af_..ths-.wbale_..prQSPsp» __________
- number distributed
- type of use/risk factor
- conclusion to be drawn from the
program.
Release of information
individual cases in the
manner as' other pesticide civil
cases. *
-18-
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reesent Facts and Strategy
*
^^..•dix I: Types of Purifier Products
•ppendLx II: Legal Definitions, "Purifier" and "Device"
niix III: Pub licit? and Outreach
20
22
33
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Aendix I
Water purification devices employ a variety of techniques to purify water.
ost cccasn techniques are:
* Ultraviolet light - Light of wavelengths around 260tn danases the KIA
of exposes organisms. ~If the exposure tine is sufficient, the orsnisrs
are no longer viable. Light may also be absorbed by the bonds of certain.
complex organic molecules which could result in photolysis of those role-
coles. Zfficacy of this cethod depends heavily on the engineering of the
whole system. The protocols used by the Canadians are the basis of the
screening phase of the TJS SPA Water Purification Device Testing Protocol.
Duplicate ve verification of results on the saz& types of products used
to develop the protocol is useful to the U.S. and Canadian Enforcement
Programs.
3ub-icron 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 zake purifier claims. Unfortunately,
a very large virus would be only 0.1 micron in diaaeter and soas bacteria
are capable of changing shape. The filter would consequently not work.
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 macrcnolecules and cellular orsanelles.
Whether it would be eff icent on the scale necessary to purify water is un-
known. A
Chlorine generators - These devices electrolyse salt (NaCl) to fors chlorine.
The chlorine acts as a disinfectant to purify water. Tnese products are devices
and not chssical pesticides because the product which enters channels of trade
is not a chenical". The consumer generates the pesticide at the site of use
for his OV.T* use ani not for sale or distribution. Unfortunately, since there
has been virtually no regulation of these products, the label directions say
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 miniaua contact time would ensure a reasonably-
pure water.
Csone generators - Oxygen from air is electrically ionized to fora ozone, a
powerful oxidizing a^nt and disinfectant. Unlike chlorine, ozone* does not
persist (it rapidly decomposes to oxygen) and cannot be easily ceasured. It
is difficult for consuosrs to know if the device is actually working or if
sorse sinor product failure has resulted in lower levels of ozone production.
Installation is complex - often done by the seller - and cheaper products
-ay be unsafe electrically.
ZLectric current - Presumably the raic reorganises are electrocuted by the
-a^ of an electric current throu.^. a water reservoir.
Distillers - These products ccnder.se stesm from boiled water.
-20-
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Microorganisms are killed by boiling. Distillation can concentrate
certain organic compounds.
Reverse Osmosis - High quality organic polymer membranes
selectively filter water. This product is similar in principle
to a kidney dialysis machine. It is a potentialy workable means
of purifying water since the pores of the membrane act as a
molecular sieve. Cccplex 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
~embrane would not purify water. There is some indication that
old membranes mcf themselves be colonzied by some forms of bacteria
which use the organic polymer as a food source.
Two tyres of products which are labeled as water nurifers will not be
tested:
* Potable v*t°r "rurifers" - Theso 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), "ariifacturers of these products should be warned
that use of the term "purifier" is for products which process
untreated water. (See 4.1 Federal Register 32778, August 5, 1S75)
Other enforcement actions may also be necessary.
* large Jgurifiers which treat water for groups of twenty-five persons_
or sore. These products are regulated by FI7EA. However, the quality
of the water is requlatei 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 "small systems" purifiers.)
I.
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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 oibco Products Cczrany Inc., Et Al«
(63 FTC (1965) pg. 917).
" '" 2. Guidelines for Registering •'Pesticide-Products-i-n-the United -States- -••
Section 3: Product Performance Standards for Water P-urification
Devices.
3. EPA ruling In re Contact Industries, Inc., I.P. & H. Docket tlo. II-?36
(1973) pg. r.
3. Devices
Pest Ccntol Devices and Device Producers; Consolidation and Clarification
of Reouirersnts. rederal Register,~ vol..' 41, no. 225 Ul/19/1976).
-22-
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1 ; -v. J
•
««••«
.at a 7. (Fun zszz available
IN THE "MATTER OF •
•SIECO PRODUCTS COMPANY) ixc., ET. AL.
GROSS, OPINION, ETC., IN BECABD TO THE ALL£C£0 VIOLATION OE
^ FEDERAL TBADE COMMISSION ACT ' "
*'•"„ ^ * •?oe*el 5WS- Complaint. Juni d. «f ^/fccuio/vATw. 22. IMS'
.Order requirir.y a" N*w Jersey manufacturer' df" water" Yilba tor* to
X,*.xm?repre?enfc3S the e««tiv«r-«» a-'d capability of itj water filtration
i—.- uutJ aad deceptively guiranuetag the perfonaajica of «di unitt .
f . -317
i -tOpiaion
Implied ..Representeiiona -Respecting ~~Micro--organisins"*and—
• Complaint counsel charges that by the use of such words as'"ptfre,"
"purify" ajid "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 cade 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 at-
Jeged in their answer that the literature accompanying the unit
contains a specific disclaimer thit it does not kill bacteria.
We conclude from the evidence that respondents' water purifier
does not in fact remove 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" tvater, 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. We find that a potential purchaser who
"has" or believes he has or may have contaminated water could
easily be led Jby statements of the type quoted above to believe
that respondents' unit will make his water potable. _G/a/:_t_Foqa's,
Inc. v. F.T.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 difc!.-.:.T.er was not inserted until respond-
ents' precoraplaint negotiations with complaint counsel. Finally, the
presence of this riiaciaitEcr '•. ::o of respondents' brochures does
not negate the cor.::nry irr.r •:-:\ ir. the affirmative representa-
tions con wined in choir auv> . .'Jior.to and sales literature as to
the purifying qualities of tlu:': unit.
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-.-5
" -avai
Guidelines fcr Registration -of Pesticides •;•
Ur,i:as 2:2:25: rrccuci Perron snca Stancartis (pg» 145-146). (Full text
elements: representative levels of organic1 and Inorganic soil
contaaination; various water tesrperaturas; the specific dcsage
* *
aad exposure period recocaended for the proposed produce; a
variety of test oicroorganlsss representative of Che Cargec pests
,t
to be controlled; aad quantitative detersisation of the level of
microbial contssination of the vater before aad after treacaent.
(li) Performance stasdard. The treataeac oust eliminate all
test cicroorgaaiscs frcs the water.
(3) Vater treatreat usit_s« (i) Water curifisr usits. Asy unit
intended for the treataent of raw water to elinicate the potential
' health hazard posed by oicroorganisas is identified as a eater
purifier. The unit nay rely on physical filtration,* (pesticidal
device), or cheslcal treac=eat (pesticida), or a coobinatica thereof,
to achieve the intended purpose of purifying nicrobiologically ncn-
potable vater by elininating vatar-borre pathogens in the water
itself. Those units, such as subaiczon nesbranas and absolute filters,
•
which rely solely en a phjsical neans for resoval of =icreorganises
fron vater, are identified under the Act as devices, and ara subject
to regulation but not registration. The test rei^uireaents indicated
below are for the units containing an antimicrobial agent.
(A) Test standard. Controlled si=ulatsd-use studies for the
water purifier ur.it cust be conducted under conditions representing
actual use ezploylug a defined raw water source containing a high
level of aicrabialogical pollution. The tast design wil vary
145
-------
C
with different types of units and patterns of use, but oust include
•uch basic elesenta as: representative levels of organic an4 is*
* •
organic soil contamination; various water tesperatures; docisen-
tatioa of the antimicrobial concentration found in the test system;
and quantitative deterainations of the oicrobial eoataaination
level of the vater before and after passage through the unit. The
duration of effectiveness or effective capacity of the unit before
a replacement is necessary aust be doct=aented •
(B) Performance standard. The treataest oust elisiaate the
cicrobial pollution in the rav vater.
(ii) ?etable vater'treatment unit. Any unit intended for ?hys7
ical and/or chesical traacnent of sicrobiologically potable vater
fron a cusicipal treacsest facility to resove undesirable tastes
odors, cheaicals, or other aesthetically objectionable properties
id Identified as a potable vater treatment unit* A substrate such
as activated charcoal (vith or without a bacteripstatic agent) is
incorporated into the unit for this terminal processing treatment
of potable water prior to consumption. Since the requirements of
the Safe Drinking Vater Act do perait ausici?ally-treated drinking
vater to contain a liaited nusber of harmless "saprophytic" bacteria
vhich are cosaonly recognized coccaaisants of vater, an antimicrobial
a^enc is scaetines incorporated in a potable vater treatment unit
to provide bactarioscatic activity against these contaninants. Only
potable vater treacsect units containing a bacterlostatic agent are
urder the purviav of the Act.
146*
-------
."Exerpt fror, In re Contact Industries. Inc. (pg. 6-8). (Full text of document
.available from headquerters.)
ENViRO;j::r.;nAi. PROTECTION AGEKCY
BEFORE THE: REGIONAL ADMINISTRATOR
In re
Contact Industries, Inc.,
Respondent
I.F. & R. Docket No. II-1S6C
' . Initial Decision
The term purifier connotes a product which eliminates impurities
and polluting ratter. We are in agreement with the conclusion of
Complainant's export witness that the "word purifier is sufficici'-'Hv
broad to include ridding the air of nb.icctionables, including nirrn-
orgsnisr.15 as they would exist." An air purifier would therefore
clesnse the air of air-borne b?.cteria, virus, and fungi particles. If
Respondent had intended for the product to b3 understood to be merely
an air freshener or deodorizer, the label could have contained the
terni air freshener (cf. Respondent's Ex. 7) or been limited to the
claim that the product was an industrial odor aLisorbant and nbt also
a glycolized air purifier. In fact, the latter phrase would bs
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 en air freshener. As indicated by
Complainant's expert witness, the term air purifier especially when
-------
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. - 7 -
taken toother vvith the word "Sanicidc" on the label would indicate
that thu» prc-Jjci is intended to rid the
-------
- ti -
rc?.d. Unit.Ld States v. Articles of Drug. Etc.. 263 F.Supp. 212 (0.
Neb. 1?G7). Cf. He 1 hros totr|;i_ Co^p.iny v. Federal Trade Cnrrrnr.sicn,
310 F.2d 863, , 869 (D.C. Cir. 1952), cert, denied 372 IKS. 976
*
(1552), rehearing denied 374 U.S. 857 (1363), and cases cited therein.
A consumer would be justified in believing that the product he purchased
had .ths capability of both cleansing tha area sprayed (sanitizing) and
killing nicrcorgani^ms 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 glycolizecl air purifier.
Certainly, the use cf 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
act. (See section !C2.3(ff) cf the regulations (4G.C!Tv lC1.3(ff}}).
The claim that the product Superior Saincide 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 ths number of living bacteria or viable virus particles on
inanimate surfaces, in water, or in air", in this case. See 40 CFR
J/
162.3{ff)(2)(i)(B) (Er.iphasis supplied). Thus, representations made
_!/ i'-Mcroorg«'.:n::ii:, inch-ding but not limited to a1g:.c, fungi,
and bacteria, and viruses have bc«n declared by the Ad.iinis'Lratur to
be posts \;!;cn tl-.cy •'.•::ist under circumstances that Make tiiOii doletorious
to man or the cnvircracut (See 40 CKU 162.14(b)(4) and (5)).
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
' WASHINGTON. D.C. 20450
JUN 8I9S!
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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- Z .
I am also attaching an amendment to the Guidelines for
Assessing C1v11 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,! Wrector
Pesticides and Toxi^/Substances
Enforcement Division
Attachments
-------
STRATEGY FOR THE ENFORCEMENT
OF THE CHILD RESISTANT PACKAGING
REGULATION UNDER FIFRA
OVERVIEW
REQUIREMENTS OF THE RULE
Applicability
Exceptions
Exemptions
Specific Requirements
REGULATED INDUSTRY
ENFORCEMENT
Objectives
Voluntary Compliance
Violations
Inspection Scheme
Violation Detection Priorities
ADMINISTRATIVE CONSIDERATIONS
Program Management and Allocation of Responsibilities
Program Integration
-------
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f o r_Jt n ? --
lacjc a g t n g' Teg uTaTI on"Un d^ r' TTFfTA"
Overview
c n * dRes
On March 9, 1979, the Environmental Protection Agency
published a final rule at 44 federal Register 13019 (40
CFR 162.16) which requires chifd reTistantT packaging (CRP)
of certain pesticides labeled for residential use. The
intent of the rule is 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 Jias not
been classified for restricted use. a,nd (3) it meets certain
loxicity 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
;ecords, 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.
Requi rements 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 in packaging and certify that the packaging
complies with the CRP regulation.
For your Information certain terms used in the Strategy have
been defined below:
0 "Released for shipment11 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 1s 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.
• "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 "Toxicity criteria" are defined in 44 Federal Register
13019 (March 9, 1979) and at 40 CFR 162.16(C)(2).
Exceptions toCRP
"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.
Products for Residential Use by a Serv iceperson
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 serv i cepersons . 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,
t n
n r a a e
ser v iceoersons ._
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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 Jirosecutorial 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.
e 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 t^est 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.
p Amend reoistratinn - Cep^: 1 f i r a t i on
»
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
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-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.
Utilize special packaging
Products subject to
resistant packaging
March 9, 1981.
Becordkeeoina
the requirement
if released for
must be in child
shipment after
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
registration is
inese records snail be available, upon request, r
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.
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-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
eliminate accidental exposures
used in and around residential
regulation
to highly
areas.
Registrants should be aware of the regulation through its
publication in the Federal Register. In addition, the Glass
Packaging Institute prepared and distributed, with EPA's
concurrence, a pamphlet entitled, "Pesticides and Protective
Packaging." Personnel in the Registration Division are generally
available to answer any questions and clarify the requirements
for registrants.
Violations
Misbranding - §12(a)(l)(E) of FIFRA
As defined in §2(q}(l)(B) of FIFRA, a pesticide is
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
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to §25{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.
Jiailure to Maintain Reports Rp
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-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.
^j si f icatijon of Application/Report or of Records
aintained^or 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
illegal.
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 following"table 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 o 1 i cy.
Priority 1 - Misbranding
Failure to utilize Child Resistant Packaging where required.
This will probably be the most common violation found initially.
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-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-
ble 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
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-10-
status or the validit " of tho dat-i. dml r<>vifwin<] concurrent0
requests.
Program Integration
The Case Development and Legal Branch, PTSF.D, 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 requ i percent s .
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
MEMORANDUM
OFFICE OF
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 CR? 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
1. Calcium
hypochlorite
Concentration
65%
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%
5. Hydrochloric acid 8%
6. Phosphroric acid 17%
Chlorophenolics 61
Sulfamic Acid 20%
7.
8.
9.
Quaternary Ammonium
Compounds
10. Parafomaldehyde 95%
11. Formaldehyde 37%
Use
swimming pool
Swimming pool
Toilet bowl
R n
Disinfectant
Toilet bowl
General disinfectant
-------
2.
and Rodenticide
Pesticide Chemical
1. Carbophenothion
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)
% At and Above Requiring CRP
1.4
23.0
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. Hejbieides and Fungisidfis
Che_mic_al Formulation / % A.I.
Bis (tributyltin) oxide Above 0.5%
Paraquat any %
Pentachlorophenol above 88%
Chlorothalonil above 40%
Copper-8-quinolinolate above 5%
Use
Wood Preservative
Homeowner herbicide
Wood preservative
Homeowner fungicide
Hood preservative
to Engler,
Disinfectants Branch
Registration Division (TS-767)
cc: D. Campt
R. Gross
J. Jenkins
H. Harrison
J. Akerman
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Mi
General Compliance Strategy for Products Subject to the FIFRA
Label Improvement Program
0 ver vi 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 IndusYry J
Some label improvement rules affe.ct all registrants, while
others affect only registrants of certain products.
Requi rements7jg/Jlt_lie Ru 1 e '
S u b n i s s j_o_n_o_f_ Ajs p 1 i c a t i p_n_s
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 (EPA 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 ^P
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 witli 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
mai'ntain the exemption from compensation requirements.
Combined Application in Response to MultlpieLabel Improvement
Notices
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
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 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.
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Types of Violations
Producers not complying with the requirements of .the notices
tf
issued under the Label Improvement Program are in violation of
of FIFRA section 12.(a)(1)(E) 1n 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 l2(a)(2)(L)
and subject to the penalties thereunder. - -
Ajjminisjtrat_1 ve 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) Termiticides - 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} Antifoulinq Paints - Issued 3-9-82 - This LIP Notice required
registrants of all antifouling paints to make extensive revision
of their product's labeling.
c
-------
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 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 ^
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
targetti ng.
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 and the number of their products
whose: a) product labels are subject to cancellation for failure
4
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.
-------
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 RO. Priority
d
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 t fcTd'es"," "Anti fouTi rrg Paints and
Salt Water Emesis.
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 Pesti ci des^T.
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
.t
-------
- 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 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.
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-------
General Compliance Strategy for Products Subject to the FIFRA
Label Improvement Program
Dverview '_ ...."" ''". ~
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 affect all registrants, while
others affect only registrants of certain products.
Requirements of the Rule' .._._
Subm'ssion 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 nail 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 (EPA Form 8570-11).
2) Five copies of draft labeling incorporating required changes.
-------
- 2 -
3) If necessary, a Statement of Confidential Formula (EPA Form
8570-4).
• ^^k
Registrants must normally submit applications within 60 ^r
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 RO
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 with 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 App11cation in Response to Multiple label Improvement
Notices
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 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.
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. 4 -
Type so f Viol at 1o n s
Producers not complying with the requirements of .the notices
tf
Issued under the Label Improvement Program are in violation of
of FIFRA section 12(a)(l)(E) 1n 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) Termiticides - 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) Anti fouling Paints - Issued 3-9-82 - This LIP Notice required
registrants of all antifouling paints to make extensive revision
of their product's labeling.
c
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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 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 ^
•*
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
targetti ng.
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 and the 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.
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to respond to the.LIP Notice; and b) label amendments RD has
approved. Inspection priorities will not include registrants ^B
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: Futnigants, Terml ti~cTd~esy 'Anti fouTi n"g Paints and
Salt Water Emesis.
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.
Inspecti ons
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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./-I
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 Respons i b iJities
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
in compliance.
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.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
SEP 3 1935
MEMORANDUM
OFFICE OF
PESTICIDES AND TOXIC SUBSTANCE*
SUBJECT: Compliance Strategy for FIFRA §3(c)(2)(B)
Suspenslons
FROM: A. E. Conroy II, Director
Office of Compliance Monitoring
TO: Addressees
N,
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
responses are
the draft compliance strategy and OCM's
f n 1 1 nui« •
on
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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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 3666
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
issued:
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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0 Requires each registrant to provide evidence within
ninety days after notification that he is taking appro-
priate steps to secure the additional data.
0 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.)
0 Allows a registrant and other parties adversely affected by
the NOITS to request a hearing within thirty days of
receipt of the NOITS 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
requirements; 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 FIFRA
§3(c)(2)(B) suspension via a SSURO.
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TYPES OF VIOLATIONS
Section 12(a)(2)(J) of the Act prohibits the
suspension order under FIFRA §6. There is, howeve
unlawful act under section 12 for the violation of
3(c)(2)(B) suspension order. Under section 13 of
Administrator may issue a SSURO when a product is
issuing a SSURO, EPA is able to enforce the suspen
violating a SSURO would be in violation of section
would be subject to the penalties thereunder. It
each registrant of a suspended product be issued a
for the section 3(c)(2){B) suspension to have the
violati on of a
r , no speci fi c
a section
FIFRA, the
suspended. By
sion. Any person
12{a)(2)(I) and
is essential that
SSURO in order
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 nspection.
"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-
Is working with OPP to develop and implement a system for tracking
suspensions and SSURO's.
Regions
Regions forward information on the suspensions and SSURO's to
the 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.
cases arising from violations of the
Regions will handle any
SSURO1s 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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UNJTED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 2CM60
OFFICE OF
PESTICIDES AND TOXIC SUBSTANCl
MEMORANDUM
SUBJECT: Compliance Monitoring Strategy for Pesticide
Registration Cancellations Due to Nonpayment of Fees
FROM
TO:
John J. Neylan III, Director
Policy and Grants Division
Office of Compliance Monitoring
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
Pnntadon flecvdsJ Paper
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ADDRESSEES
l' 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. Howefcamp, Director
Air Management Div.
X Lynn McKee, Acting Director
Air and Toxics Div.
cc: Valerie Jewett (TS-788)
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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
ADDRESSEES
(TS-766C)
(TS-767C)
(TS-767C)
(H-7506C)
(LE-134P)
(LE-132A)
(EN-342)
H
H
It
II
H
It
II
II
H
Jake Mackenzie
Western Regional Compliance Director
II
IV
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.
Richard D. Stonebraker, Chief
Air, Pest. & Toxics Mangt. Di.
Pest. & Toxic Substances Br.
Phyllis Reed, Chief
Environmental Services Div.
Pest. & Toxic Substances Br.
VI
VII
VII
IX
Robert Murphy, Chief
Air, Pest. & Toxic Div.
Pest. & Toxic Substances Br.
Leo Alderman, Chief
Air and Toxics Div.
Pest. & Toxic Substances Br.
Martha Nicodemus, Act. Chief
Air and Toxics Div.
Toxic Substances Br.
Davis Bernstein, Chief
Air Management Div.
Pest. & Toxics Br.
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.
4
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 commenter 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 S
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.
L
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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
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beyond those at producing establishments are not needed. As the
Strategy is amended for future cancellations, Appendix It 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.
Exports
In the case of exports, any products exported after the
effective date of cancellation must comply with section 17 of
FIFRA, which includes citations for other applicable FIFRA
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
say in a conspicuous manner "Hot Registered for Use in the United
States of America").
COMPLIANCE MONITORING
Compliance inspections are to be conducted by the States and
EPA (in States without Cooperative Enforcement Agreements) during
routine producer establishment inspections to monitor compliance
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, OCM, 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 fOCM)
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 Federa1 Register
information on existing stocks, dates of effective cancellations,
etc.
Regions
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.
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States
Will conduct compliance inspections as part of routine
establishment inspections to assure compliance with the October
10, 1989 Cancellation Order and export requirements.
take enforcement action and issue Stop Sale, Use or Removal
Orders (SSUROs) , as appropriate.
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APPENDIX I
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. '
Rea.No.
#47319
#11275
#01457
#08730
Registrant &
Product No.
Savanah Co.
047319-00001
047319-00002
047319-00004
Guth Corp.
011275-00002
Hexcel Corp.
001457-00015
Hercon Environ-
mental Co.
008730-00035
ProductName
Sevana Bird Repellent
Sevana Bird Repellent
Agrigard Insect Repellent
Lithate 2,4 D - Broadleaf Weed Killer
Non-Volatile
Bromat
Lure N Kill Roach and Ant Killer
Insecticidal Baits With Sex Lure
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8
u
CO
00
ff
Ul
U)
CD
bJ
*.
NJ
I
S-
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APR 30 1990
.:..= ., - : *.._ SUBST
MEMORANDUM
SUBJECT: Strategy for Aldicarb
FROM: John J. Neylan III, Director ^f^^t^J//?
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, 199& 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
f
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
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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
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Atracr.r>er.c
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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AFFECTED PRODUCTS
Aldicarb products with potato use pn label:
EPA Registration No. Brand Name
264-319
264-417
264-331
Temik Brand TSX Granular Aldicarb
Pesticide (1)
Temik Brand 15G Aldicarb Pesticide (2)
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.
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&EPA Environmental News
Y, 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 monitor this situation and t.ike
further action if necessary.
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(J
To:
From:
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20-160
-JAN i Q 1975
Regip!i2,UL<.lministrators
^-«.«^<. X^-t^L, 4
vuinimstrator" lor water
and Hazardous.Materials (WH-556)
Assistant Administrator for Enf'orcemeny^'
and General Counsel (EG-329)
Subject: Continuing Slate Registration of Products Containing
Aldrin and DJeldrin for Which Uses Have Been Suspended
Late in December, 1974, the Agency became av/arc of the existence of
activity in the above referenced matter, first in the State of California,
and subsequently in several other States in other Regions,. Prelim:.nary
investigation into the magnitude of the problem suggests that thore may
bo significant continuing activity on a national scale, that there is con-
fusion as;toT.h-3 extent of Federal jxirisdiction over such activity by States,
and that the economic, political and regulatory considerations involved
require additional action by the Agency.
Accordingly, our joint sUcfs are preparing a Federal Roister notice,
v.'hich, upon publication, vail formally assort Fed~3.ral juris diet ion over
nop-Fc:cici'aUy registered products cor.taining Atclrin and Dieldrin by
impZoiv.cr/.iug See* Ion 3 of the Federal Insecticide, Fung^eid-? and
l-1ccler.llci-.ie Ac: (FIFRA), as amended (7 U.S.C. 136 et seo.). Attached
is a strategy pc-p^r \vhich explains the background of this matter in greater
detail and provides an explanation of ho-.v thos-3 Aldrin and Dieldrin pro-
•ducts shovdd be treated upon the activation of Section 3. In add-.tion,
proposed enforcement activities by
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S'<2 • UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
'
WASHINGTON. D.C. 20460
Strategy Paper:
State Registration of Products Containing Aldrin and1 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 products
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 de facto Federal control of all products containing
Aldrin or Dieldrin. Investigations by California and Region IX (confirmed
now by several other Regions and S'tnte.-:) have revealed that many. State-
rc-£isti->;-ed Akii-In-Dieldrin products were: 1) formulated from tfic.hnical
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 AldVin-Dicldrin products bearing State or Federal
registrations and lacking any stated restrictions concerning refor-
mulation, 3) formulated from technical mete rial sold after December 2,
1072 which failed to bear the required restriction, 4) formulated from
technical material restrictively labeled and ignored by the formulator.
States, having lately become aware, of the intent of the December, 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 jurisdic-
tion over their production, shipment, sale, and use, and to insure uven-
hancbd enforcement of the Aldrin and Dtcldrin cancellation and suspt->?ion
orders, vhc Agency will formally implement Section 3 of the Federal Insec-
ticide, Fungicide, "and Rodculicide Act, as amctubd {7 U. S. C. 130 et scq.)
by notice in the Federal Register. This notice will contain an exemption,
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nursuant to the provisions of Sections 6{a)(l) and 15(b)(2) of the Act. allow-
inc States to register for orderly disposition through shipment, sale and
use in that State, existing stocks of products containing Aldrm 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 following signature of the order implementing
Section 3 of the Act, production of products containing Aldrm and Dieldrin
must cease, and States must cease to register for shipment, sale and use
any but existing stocks of such products.
Regional offices should arrange to advise appropriate authorities in
Stat<^; in that Region, in advance, of the planned activation 01 Section 3
and its attendant prohibitions, and should request State authorities to _
noti'v all State registrants and any other potentially affected parties 01
the uctivalion of Section 3 and of the effective date of related prohibitions.
Stai-s are to be asked to provide to the appropriate Regional O:nces lists
of Sta'-G registrants or persons with registration applications pending for
products containing Alcirln or Dieldrin. Information relating .o .ocaaon
and relative amounts of these State-registered products also is to be
sought.
The -\*encv's pest*c:c!cs enforcement personnel will enlist Slate coope-
ration in contir.-Jir.? its on-goir.:,- investigation of the formulation since
Dcc'-ir,b-r 7, 1972^ o: products cor.laimng Aldrin or Diclorin fo^ oCR-.e
rc'rislra«ioi. Should it be the case th:.t Federal registrants o: tecniuca.
^1-i^-i o-D^l'-^n u^vc not r^l."bc-lcH their nroducts in coni'ormancc \vitii
tlie Ad-r'nistr^.or's Order of December 7, 1072, or that posticids ?ro-
ducc»s have fcrmulatec: products eontaiiung Aldrin or Dieldrin in con-
travention of labeling prohibitions against use in non-Federally registcvcc.
products, such Eolations vnll bo prosecuted in accordance with the appro-
priate pro\asicr.s of tlie Act.
c
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
.<•* WASHINGTON. D.C. 20460
. JAN U J23
To: [Enforcement Division Directors]
From: A. E. Conroyll, Director
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-Federally 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 Dieidrin
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 Etce^tion that numerous products containing Aldrin s.nu Dieldrin
r-'3^' have be~n produced since December 7. J972 and rpaistproH v,y .Qroi.a*
under circumstances not svrictly 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
Ordi"* are elaborated in the attached memorandum and strategy paper,
which »vere sent to all Regional Administrators on January 10, 1975.
Action;
For purposes of £ ederal enforcement activity, the following develop-
ments are important:
1) The Agency has determined to implement Section 3 of the
Act v/ith 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 Slate
of stocks of products containing Aldrin or Dieldrin in 3-ds-
tence on the date of the signature by the Administratev of
the order activating Section 3. After that date, all tj'-od: c-
tion of products containing Aldrin or Dieldrin must cease.
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and States must cease to permit registration or to allo\v
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-proof ing 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
ducts within the State;
relative
such
- 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 end DLeldrin for State; 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.
Shovld you have questions or encounter difficulty with rcgaro to any
of these matters, please notify the appropriate Regional Coordinator.
Attachments:
c
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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- FED 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*
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o
Attachment II SAMPLE LETTER
State Registrant
(Address)
Gentlemen:
On (date), the Administrator of the United States Environmental
Protection~"Agcncy 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 et seq.).
As a result of this Order, the shipment, sale, and use of non-Feder-
ally registered Aldrin-Dieldrin products, produced after the effective
-date-of-t^e-Ord-er-wiH-be-prohib-itedr A-ctx?rdingly7~the-5tatc--af---(Tra.Tni;)
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,
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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 !2{a)U)(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)(2MG)
Action: Civil/Criminal/Stop Use
3. Sale of a non-Federally registered Aldr-in - Dieldrin product pro-
duced after the efieciive dale of the Order, but before violations
are actionable (60 days after publication in the Federal Register).
Action: Sf.op Sal./
4. Sale cf a non-Federally registered Aldrin-Dieldrin product pro-
\ duced after the effective date of the Administrator's Order (day
j after signature) and alter the date violations become enforceable
i (60 days after publication in the Fejeral Register).
j Violation: Non registration Sec. 12(a)U)(A)
I Action: Civil/Criminal/Stop Sale
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. DC 20460
JUN 6 1989
OFFCEC*
PESTCJDeS *ND
TOXIC SUBSTANCES
MEMORANDUM
SUBJECT: Compliance Strategy for the Cancellation
Uses of the Inorganic Arsenlcal's
FROM: John J. Neylan III, Director
Policy and Grants Division
Office of Compliance Monltorln
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 herbicidal use of the flowable formulation of
calcium arsenate, the grapefruit growth regulator use of lead
arsenate, the grape fungicidal use of sodium arsentte, 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 f3(c)(2)(B).
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. Inspections of dealers and users
wilt be conducted to ensure that cancelled products are no
longer being sold or used. Tips and complaints are to be
investigated as received.
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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
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ADDRESSEES
Doug I as D. Campt
Edwin F. TJnsworth
Anne Lindsay
Frederick F. Stiehl
Mark Greenwood
A. E. Conroy 11
Connie Musgrove
John J. Neylan Ml
David Dull
Mike Wood
PhylI is Flaherty
Jerry Stgbbs
Maureen Lydon
Ken Kanagalingam
Bob Zisa
Sherry SterlIng
Jake Mackenzie
Western Regional Compliance Director
(TS-766C)
-------
-------
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 arsenlcals with the
exception of the Insecticide use of arsenic trfoxfde in a solid
formulation and packaged In a sealed metal container, and the
solid formulation of arsenic trioxlde 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 trioxlde 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,
1968. 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
AM registrants, producers, distributors, and users of the
minor use products of Inorganic arsenicals with the exception
of arsenic trioxlde 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-
Exfstlng 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. Thfs
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 (n accordance with the applicable
requirements of the Resource Conservation and Recovery Act
(RCRA). NoncompI lance with the cancellation order Is a
violation of FIFRA §§12(a)(1)(A) and 12Ca)(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!ved .
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 piece 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
Mill develop and transmit the Compliance Monitoring Strategy to
the Regions.
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-3-
WIM 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.
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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
t 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
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-------
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'
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
JU. 6
reiTiciois ANO TOXIC SU>STA
MEMORANDUM
SUBJECT: Compliance Strategy for the Conditional Registration
and- Cancellation of CertaitfNlrom
FROM: John J. Neylan III, Director
Policy and Grants Division
Office .of Compl iance Monitori
TO: 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
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-------
ADDRESSEES
VI
VI
Douglas 0. Campt
Edwin F. Tlnsworth
Anne Lindsay
Frederick F. Stlehl
Mark Greenwood
A. E. Conroy I I
Connie Musgrove
Mike Wood
Jerry Stubbs
Sherry SterI ing
Davi d Duli
Ken Kanagal ingam
Bob Zisa
John J. 'Neylan I I I
Phyl Ms E. Flaherty
Maureen Lydon
(H7501C)
(H7505C)
CH7505C)
CLE-134A)
(LE-132A)
(EN-342)
tt
tt
it
tt
tt
tt
tt
n
tt
tt
Jake Mackenzie
Western Regional Compliance Director
IX
Loufs F. GItto, Director
Air Management Division
Barbara Metzger, Director •
Environmental Services Division
Stephen R. Wassersug, Director
Hazardous Waste Management DFv
Winston A. Smith, Director
Air, Pest, 4 Toxics Mangt. Dlv
William H. Sanders III, Director
Environmental Services Division
W!iIiam 3. Hathaway, Director
Air, Pesticides 4 Toxic Division
William A. Spratlln, Director
Air and Toxics Division
Irwfn L. DIcksteIn, Director
Air and Toxics Division
David P. Howekamp, Director
Aic Management Division
Gary 0'NeaI, D i rector
Air and Toxics Division '
Marvin Rosensteln, Chief
Pesticides 4 Toxic Substances Br
Ernest Regna, Chief
Pesticides 4 Toxic Substances Br
Larry Miller, 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
Pesticides 4 Toxic Substances Br
Carj 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 Roefoffs (TS-788)
John Tlce (TS-769C)
Al Hefer (A-107)
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-------
8ROMOXYNIL CONDITIONAL REGISTRATION AMD 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
LEV
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
Registf
Produce
Oistrifc
by 9/6/89*
between 10/1/89
and 11/1/89
between 10/1/89
and Spring, 1990
growing season
5/25/89; Ppint-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.
Voluntary Cancellation of Broiiroxym'l. 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
Distribul
User
* As part of routine inspections.
** Includes the following products: Dragonmate, ME 4 Brorainal, Torch Twin Pak, 3+3
Brominal, Broraoxynil Butyrate Technical, Certrol, and Buctril 4 EC.
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-------
COMPLIANCE STRATEGY FOR THE CONDITIONAL REGISTRATION
AND CANCELLATION OF CERTAIN BROMOXYNIL PRODUCTS
OVERVIEW :
Bromoxynil is 'a selective, post emergence 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,ienc 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 OF 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 Stickerina/Lahelinq
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.
•i»
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 1, 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.
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-3-
By January l, 1990, the registrant is required to have
investigated and reported to EPA, the feasibility of packaging
bromoxynil produces 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 MOMITQRING
Regional /State Activities
Inspections wili.be conducted by the States and EPA (in
non-grant states) to monitor compliance with the Conditional
Registration' Agreement and the Cancellation '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
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-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 bromoxynii
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 bromoxynii 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 bromoxynii butyrate products, that the registrant is
undertaking, following the outlines in section 14 of the
Pesticides Inspection Manual.
pis, tr ibutpryftqsel J.er /Ret;a j. 1 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 bromoxynii
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
Office of Pesticide Programs
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 this
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, includingI
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.
States
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 win 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 noncdmpliance with
the Agreement,- they should-investigate to ensure compliance.
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APPENDIX
BROMOXYNIL REGISTRANT, PRODUCTS, AND PRODUCING ESTABLISHMENTS (1985-87)
Rhone-Poulenc AG Company
P.O. Box 12)14 2 T.W. Alexander Drive
Research Triangle Park, NC 27709
Product Name
Buctril*
EPA Reg. No.
264-437
Broot 15GX (Bronate)* 264-438
ii H
Buctril + Atrazine*
ME 4 Brominal
{Buctril ME 4)**
(Also produced as
3+3 Brcminal
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 NW 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 Rhone-Poulenc AG Company
T.W. Alexander Dr
Research Triangle Pk, NC 27709
55259-IL-001 Bradford Ag Service Inc.
401 Phoenix Ave
Bradford, IL 61421
2393-IL-003 Hopkins Agri. Chemical Co.
303 SW Arch St.
Atlanta, IL 61723
No USA Production Records for 1985-88
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
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-2-
Dragomate Broadleaf
Herbicide**
264*339
264-MO-001
Rhone-Poulenc
PO Box 367
317 West Florence Rd
St. Joseph, MO 64502
uoncntionany 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. 54. No. Ill / Monday. |une 12. 1989 / Notices
24*49
name ol applicant
locauon
tans M"W lighting Co. ' ' we* taBytan. NY ....; Conduction of a 220 MW a** utra generation | NVSC6C j PSD pun*
NMMU Catnet Energy Coo .., unondlM. NY
Kamne Carthage Cogenera- ' Carthage, NY
wjn Co . Inc.
.
ConnjctJon * • 57 MW cogenennon faoMy ' NYSCEC
! Conwucaon ol • 50 MW jaa tunna. siMrn gener-
! itor.
Momli P'esi Co i Fultan, NY Construction of an 11 ttanon rotaqravm
_....do
do - -.-
NYSDEC ............... — I — HO
Sou* Glens e jus Satin Stens Film.
.. :nc NY
energy £«v- : TsnawerWa. !fY- ...
CM. Inc.
SOIM Ciicad* Con? ............ 3«r.« Fi.-f. NY
(j «ccf.« tnc 3«tv«3env MJ
"
o'
aior
of • 50 NW gee wem»,tiM>n flener- i NYSCEC ------------ _
a 53 MW ]*1 furDine.'Steam gener- NYSDEC ................... | ..... Ml
|
-wtnt ot en •aaang a^fircd txM*r witn • NYSMC ...... -------- ..... | PSO no»*
vision of tne nitrogen oude emisaon lirml pawn- Xf* region II....
permmed tor a 23.3 MW eogenenucn \
Inc ............. . . . ;
island Ughnng Co .........
'.. NJ _..
NY
of int
r permuted tor
Aooon
inc.
United C«MiO6oer £5. 1988 Pc~s»»_, o.-..sf_jn notice on f*»n PSD tci"!"! oecauw »Jv«»Vusf»floBy!fln ;'ant n ciruiderte trecave aa of «uiv T«. 1988.
s T-:e Panrsauiiai SK'.v YJI*. New York
NYSDEC Actions
New York Sla!° Dop-jr^ieat of
En-, :ronmciitnl Ccrser\a?ion. Division
Of Air Resources, sourc\Rev:ew and
Re-.vunal Support SfcttonVSO V.'oif
. Road. Albany. New York. r^:33-0'jm.
N|DEP Actions
.'-'ew J-rsey IV f^r'ment of
Er.'ronrr.i n!ai Protection. D,\ .aiNn of
^n\iranmer.i.: A Technoii cv 401 E"5t>
jtate Street. Trenlon. New Jersey
B25.
L avail able pursuant to the
Consolidated Permit Regulations (40
CFR Part 124). jndicial review of these
urs under sectian 307(b)(lJ
of the Clewi Air Act .the Act) 3iay be
s^vaht or.ljKby the fiiiri! of a peti'ion for
review ;n th^i'ni.'ed States Court cf
Appeals for tM. appropriate circuit
within 80 days hem the date on which
these de'erminahtas are published in
the Federal Register. Under sect'on
307(b](2}of.heAct.f».c?e
determinations shall iw be sui.pct to
Liter judicial review ir. cii"l or or
prcceedingj for
Dated: June l. IS&J.
WilUam). M
IOPP-4C1M; FRL-3600-4]
Ontor Canc«Ung Registration for
Pmttaet*) Products Containing
Bromoxynil Butyratt*
AGEKCY: Environmental Protection
Agency [EPA).
: Cancellation notice and order.
;:n Doc. !')-l.ia;9 Filed fr-9-flfl 8 « .in]
BILLIKC CCCC 5SCO-SO-tl
CUWMASY: This noace announces EPA '«
decision to cancel all registrations
i'-sued under the Federal Insecticide.
I'ur.gicide. and Rodenticide Act (F1FRA)
fur pesticide products containing the
L ut\ Tic acid esMr of bromonynil (13-
(Jibrorro-4-hydroxybenzonitri!e|. The
r.'gtsirint Rhone-Poulenc AC Compnny
has requested voluntary cancellation of
these products. Because cf the
u-:velcpr?.ental risks asior.tate J wiih
c.vposure to these product*. EPA will nut
permit and the cnncellauon order will
explicitly prohibit the sale, distribution.
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241^0
Fedurjl Register
Mor.t;,iv.
DATE: The cancellation order
incorporated in this notice will become
effective fune 13.1989.
FOB FURTHER INFORMATION CONTACT:
fuJi; Andreasen. Special Re\. lew/
Rr-egistration Division (H7j08C),
Ofhce of Pesticide Programs.
r-'..v. :mr.TTicntal Protection Agency. -4U1
M Sir-ret SW.. Washington. DC 20400
Office location and telephone number
F,-;. lOOhF CM =:. 10:1 Jfrffprscm
n.)v:s Highway, Arlington. VA. (70"!
jj'-nro."
SUPPLEMENTARY INFORMATION:
I. Request for Voluntary Cancellation
On Mjy l'. 1989. ^s a result of
discussion between EPA and Rhone-
Pc.:::-nc AC Company concerning
measures to minimize potential risk of
developmental toxicity associated w.th
exposure to hromoxynil. Rhone-Pouienc
requested voluntary cancellation of its
registered pesticide products containing
bromoxynil butyrale (the butyric acid
ester of 3.5-dibromo-4-
hydroxybenzanitrile). 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
Ihsse 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
Rhone-Poulenc customer sen-ice. Users
holij.ng 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
i's products containing bromoxynil
butyrate. on October 27,1968. EPA
canceled certain bromoxynil products
pursuant to this request, but wa«
unwilling to accept the remaining
requests for voluntary cancellation
because those request* were made
contingent on the Agency's permission
to sell and use existing stocks of
affected product*. Given the unresolved
concerns regarding the developmental
toxicity of bromoxynil EPA considered
it inappropriate to issue an existing
stocks order for such products.
n. Existing Stock*
In its May 1.1989 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
bt;tyr;ite Aouid present art una
nsk of development;*! toxicity :n
handling sur.h products. Accordingly.
EPA will not perm:! the continued s.ilc.-,
distribution or ine of jr,y canrcltfJ
product contains h'orruxyr;;! hutyr'i'-v
EPA encour.i^t-s aiJ pers..'-s holdi-g
Mocks o[c.-t~jdt,>d produces cont.iu'.jns
bromoxynii bu'\rd!e to p.-i;p:ic'.pj!e in the
rcrovrry prog-am established b> Rhone-
Po-jlenc.
111. Cancellation Order
Efiectivs June 1.1. !9fi9. tlie
registrations for j!l pesticide products
containing thfi t'jtyr-c aci j e;-ter of
bromoxynii (3.5-Jib-omo-4-
KyJroxybenzonitrilt) are canceled
pursuant to section 6ff)(l) of FIFRA, r
U.S.C. 136d(f)[l). Effective June 13. 1989.
it shall be unlawful under FIFRA section
:2f;i)(D(A) and/or FIFRA section
12faj(2)fK). 7 U.S.C. 136j(a)(l)(A).
136j(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 I
registration i registration
No. ; NO.
Product
284-339 :
264-3« ! M6 4 BrcmiinJ.
264-340 ' Torch Twin Pak
264-340 j 3*3 Sronnrw
264-3S4 I • Sromovn* 9o«y»ie
'
264474
Ctnroi
Sustn(4£C.
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-Poulenc
AC Company, or which are otherwise
necessary to facilitate proper storage or
disposal of such products.
Dated: June 5.1989.
Douglas 0. Caaipt,
Director, Office of Pesticide Fragrant.
[FR Doc. 89-13Wfl Filed 6-»-89:8:45 am)
gRAL MARITIME COMMISSION
: F. ,.
205TX vviihir, 10 days
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T4 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
ornei or
— - - " ^esTicioes AND TOXIC zucsr/
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 will 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
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(INCLUDING COVER PACE).
FAX NO
ATmS.FACS'WLE " PHON£ IF "*•« « T U..KE « AU PAG£S
FACSIMILE NO,
DIRECT LINE TO TELECOMMUNICATIONS OPERATOR ISi 919-509-2395
UPre»»*»
MESSAGg
TO; Edwfn Tinsworth
EPA
,.. Attached 1s the Apjjjjcation for Amended Registration of bromoxynil products.
3 'It should contain all the revisions discussed. A copy is also being sent ove
mafl. If there are any questions, please let me know
overnight
Sincerely,
Nick Sonrna
'513A
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RHpNE-POULENC
KHdNE-POULCNC AO COMPANY
May I, 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)
Buctril + Atrazine (264-477)
Rh6ne-Pouienc Ag Compony 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 u-nencc..
registration that it will.conform to the following conditions as oart 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 uie 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 Rhonc-Poulenc
after the date of approval of this amendment by EPA. Rhdne
Poulenc further agrees as a condition of registration that it will
AN«WC«W*CK U*C RTP
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CONDITIONAL REGISTRATION
Revised Labeling
A. Wh a t
1.Classification
2.Warning Label
3.New use pracices
B.How
1.Stickers
a.All stocks leaving
b.All stocks leaving
(1)instruetions
'(2)enough for all
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
(2)all restickering provisions
(3)equipment needs
RP after 5/5/89
distributors after 5/15/89
inventory by 5/25/89
non-crop uses
11.User Training
A.Training of users
1.prior to 1990 spring use
2.pending EPA approval
B.Hard-coupling transfer systems
1.program to assist users not owning such system
2.plan by 10/1/89
III.Repackaging
A.Hard-coupling for all
B.Feasibility study for
bulk (>30 ga! ) by 10/1/89
small containers by 1/1/90
IV.Safety assessment data
A.Rabbit dermal Tox--5/l/90
B.Male repro —6/1/90
C.Worker exposure--12/31/90
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ilk
RHONE-POULENC
RHONE-POUUENC AQ COMPANY
provide to each distributor holding inventory of these products
quantities of these slickers sufficient for such inventory within ten
days after the date of approval of this amendment by EPA, and that
Rh6ne 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 sucker to each container which is sold or distributed by the
reseller or retailer after the date the stickers are received. Rhdne
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 additional revised labeling concerning the
equipment.which must be used for mixing and loading as set forth in
Attachment P. . 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
PO COX I »« 2 TW « F KAN.Y II ONifE
Tticx suMiftx 49993?*.
(NTf ftNtf.ONAt. D<9TM<«g<
.* A«C BIS-
AUCWtn34Cl< APC IDS
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if RHONE-POULENC
r ••^•••••^•'•••••••^•••I'^^g^"
MH6NI POUU6NC 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 as a condition of registration that 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 mining
and loading system, and will provide to EPA a detailed report of iis
findings and conclusions no later than January I, 1990. For products
sold in bulk containers: Rhone-Poulenc hereby applies to amend its
registration for these products lo provide, and agrees as a condition
of registration, (hat 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 • compatible coupling.
For each of the specific data requirements described below,
Rhdne Poulenc agrees as a condition of registration (hat it wilt
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 Uiis registration under F1FRA $ 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 10 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 99* WM. > • w »U «*««<• PO've
•fSIAKHIAlANw.kMtlM HC 1»\ft
. .
mTCftMTiONA.. D'STfl SU7.C* SEftVCCS TUCK N'JWOCn *W83"-*MCWCna»C« ACT iQS
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(ff RHQNE-POULENC
WHdNf-POULENC AQ COMPANY
Pilot:
Full:
Submit Protocol--May 8, 1989
EPA Approval of Protocol by--May 23, 1989
Study Initiation—May 31. 1989
Study Completed-Septembcr I, 1989
Final Report-October 16, 1989
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 1. 1990 •
Final Report -May 1. 1990
Male Reproduction Effects Study
Pilot:
Full:
Submit Protocol -June IS, 1989
EPA Approval of Protocol'by-July 3, 1989
Study Initiation-July 14, 1989
Study Completed-September 1, 1989
Final Report-October 2, 1989
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 1. 1990
Worker Exposure Study
Submit Protocol-June 15, 1989
«S€A*OT«.ANGl€WAK
_
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tf RHQNE-POULENC
RH6NE-POULINC 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, Rhone-Poulenc agrees
that it will adhere to ihe 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 .lion ft.r
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 date 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 Rh6ne 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
Cioc
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RH&NE-POULENC
RH6N6-POULENC Ad COMPANY
assessment of the risks and benefits of use of bromoxynil and which
was not available to either EPA or Rhone-Poulenc 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 Tins worth
"O iOX 19014 9 TW *vCx«M06B MVE
NC
OS
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j&EPA
264-477
i N«m« and AOO'tM Of *tf pl-ci
QMicNt $f "v*t>e»i4* ^fOflff^i n"9 ^8^1
Vt%4/\lngto«, 00 JSCM4KS
Application for Pwtlcida: P Registration
(JsAmcndment
102852
- --„. _ , SacHon
13. Di» ftaft ) FrMwet Mvi«gtr "^
j May 1. 1989 Robert Taylor
4 PropOUC Cl«tt '•£«• ;^
f\i(inekA*Vt 355*7 " ' ' " " — '
Rhont -Poultnc Ag Company
P. 0. Box 12014, 2 T. W. Alexander Drive
Research Triangle Park, NC 27709
Nam*
Buctrll * Atrazlne Herbicide
0«tt of Utter
1. 1989
Label modification to Include Restricted Use Classification and additional
laoel restrictions.
Bectton HI
m TH**
n 9* P«e
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Offic* o< *«ti>c>dt PfoQ'*m
^^ ^HV M^fc ^B WMftinglen. DC 80*
Vy ERrX Application for Pesticide:
264-438
2 Oil* 3 A
May 1, 1989
irS-f^l")
I] Registration 10285i
JL1 Amendment
08«eiM»n«f»r « >ro'pO»»8 t«M «C.
Robert Taylor /"let-** fP-^
S *am» •n4'"'Ad0'tM e( Applicant (Wio* Z* COtf»; " ' ' "* '
Rhone* Poulenc Ag Company
P. 0. Box UOJ4. 2 T. W. Alexander Drive
Research Triangle Park, NC 27709
Bronate Herbicide
i Swb^Mf
ofi
iuMMM ui *;»»«, tofttr
lnt»<>
0«i« of un«'
May 1.
LaOel modification to Include Restricted Use Classification and additional
label restrictions.
••etlgn III
M«t»n»i
^»i*a H««i»ni PMfcaQin0
W QND
in
L0«*Uon p« N»> ContffnM M«/(«iaiion
MMk«e* «MtOM »M. »*r MMUiAM
Tnwcf
~n»*ui
Olhm ffpwiy;
«. Mtnntr M Which UM' • A«..»0 To Product
ft*eilfln IV
N4?
aa^i^ii^ tr~*».m~ m, ^^e,,, »/, ^.a.yfr.qj
Nick Somma
Registration Manager
9W-549-2372
' artwio'wodp* tfwt M^y
inwnl w ootri und»f WDNM
riMd* on Ate fenn «nd «0 i
by CM 0r
rTyp^rttW
Nick
ssTSnpMrcHnfsswTsnr^'iSHi* •*«•«• •»• oo*w*i*"
Registration Manager
Hay 1. 1989
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$1*1*1
Propr
. OC
axoo
Application for Feticide: Registration
KK H Amendment
QOO
102850
NumMr
264-437
I OM*
Hay 1. 1989
Robert Taylor
4 Propo**a
*'''C'
n~ fvT**»!'
Q>n»-«< [X |,,a
Rhone~Poulenc Ag Company
P. 0. Box 12014, 2 T. W. Alexander Drive
Research Triangle Park, NC 27709
I™"] CM* w mit n • n«w *0dr«u
.
Buctrll Herbicide
Swojaot
Saeilan II . Amandmant Information
anal printed label
ftiPPfiil B net
lMtqjg>lW*ttl>r_
Data pf uafltr
**y i- i9S9
Label modi ff cation to Include Restricted Use Classification and additional
label restrictions. ' -
t»Ct<00»L
Maiaftai THIJ Pfoflxa vwi fa Pacxaaao
Location ef Ubai Otraationa
ND. pw
1 IYM !""|NB
Paekaea wlgM No. p«
(*t P vUl ontainir
Haaue
OIM*
Othai
3
i±i
• *
i OantaatPoini
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ATTACHMENT A
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IICTED USE PESTICIDE
for ratal *** ts and u»» only by G»fl*tad Appfaflora ot p»Tons diwsty urvhx ttwi M^nmon and only tor *ca» UMS QDVWWJ by
BUCTRIL* HERBICIDE
WH IHk UUMWd Bf CEfl»AlN tfHCADLEAF WEEDS IN SMALL OIUJMS. SEEOUHq ALFALFA. OOPH SORCHUM. PLAX. SAHUC
ONK5KAWUSSANO>iNT. - '
ACTIVE IMCftED4EWT. " "
.33.4%
•Qremexynll eet»na*te •qwbclwfl to (24% e( bremorynll or not tow Ihwt
KEEP OUT OF REACH OF CHILDREN
AVISO WARNING
. no um •*• proaucto t>»»6 qu»
NAJAHOf TO MUHAW *NO DOU(«T10 AM
UM
»••<«••
OCNUtat MOtHMMturi torn au UN
*• «!»>•<»« *l •!• •«< »r
M> tftt^f ••»• IMP in« MW. Q* Ml M* «r i*->M
Mf» VM«ll>«IVMva
n»0oywnc AflConMT
M«tei« MAMM.IM tx oonc(«im*Ti MUSI attt«vt n« FOUOWMQ
Ww <*•» W !•' «WM| OTrttttl »U OMV « MX!
•MlM! Til, CBW*« l*»l t» ••
trATtHTMt Of MA6HOAI tniATUIMT
NF tOAllOWfOi Ow mmrnttl Mvww 0* *• iMn** nwniMf WMftfii o••«•«»
- • o»««(
"•"• "T-1*t
0 IK ITU; PUait HWI v^v
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For r«UI Mb to vd
"RESTRICTED USE PESTICIDE
BUCTRIL** Atrazine Herbicide
*6stlMEflGENT HERSICIOE FOR CONTROL OF CERTAIN BROAOLEAF WEEDS IN CORN AND
SOBGMUM.
ACTIVE INQflEDOJT
Oetirtolo *oM »**r of bromonynl
gtien.
"Pwdus certain* ZO poem* of
KEEP OUT OP REACH OF CHILDREN
CAUTION
SHAKE WELL BEFORE USING
EPA Hifl. NO. Z>»477
Pbc BMCRGCNCY totomvtten ONLY QiH 24 H»wr« A toy t^OCK»4.7577
•T*TfM»MT»
TO MVMAN* *
VMMMMO . HfSTMCTtO UM
Uw •< M( vWvW M*r
MM *••• (hem l« «*«•• »tf« «*<•««• I"
»(• *li*«M to MrtUwlvif wife* •*•»
«Ul MMML
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•*«•>•« • •••r> fxm •«•
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(Ml **t*f • •«*•• «O 1M W MM* •»• ta • *«T. T« «
««»•» f i*v«i mm *• k*t «••• m* «ML IM IMM H «*n «•>•> «"n( ft* c* i«
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-------
T> e
i T ~ r sc arrr.
RESTRICTED USE PESTICIDE
For r«ul MM to and u*t only By O»r»«d Af«*o«o» or p«.-*am d»«cfly vrn»»r ih»» »«lpVrv»on and only ptaOmJ B aU»r'«d R*4»'U«J \Jyu
BRONATE* Herbicide
FOR CONTROL OF CERTAIN B"U*UUe.Ar
ACTIVE INGREDIENT
(3,
INERT NORICXINTS;
no«»«
V9% 2i
34.0*.
1M.V*.
d orngi i>a» mar 2 0 pp«ndi MCPA aod p»t
KEEP OUT OF REACH OF CHILDREN
WARNING
EPA tit. No.
POT PRODUCT USE Information CAN 1*OO-3S4-9745
gor IMgftCEHCY information fitlUC C*" 2* Hour< A P>y i <0v *nMwl«. WVMMI •<
•NIA**>«H( *f« ***** »•
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-------
ATTACHMINT S
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6ROMOXYNIL CONTAINER RELABELING SCHEDULE
FOLLOWING IS A DETAILED PLAN DESIGNED TO APPROPRIATELY RELABEL ALL BROMOXYNIL
PRODUCT CONTAINERS EXISTING WITHIN THE CHANNELS Or TRADE, INCLUDING
RHONE-POULENC, DISTRIBUTOR-AND DEALER INVENTORIES, IN A TIMtFRAME CONSISTENT
WITH THE APPLICATION FOR AMENDED REGISTRATION. UPON FINAL EPA APPROVAL
THESE STEPS WILL IMMEDIATELY BE IMPLEMENTED:
DAY I 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 WELL AS FUTURE PRODUCTION QUANTITIES
SCHEDULED FOR THE REMAINDER OF 1969 USE SEASON.
RPAC WILL IMMEDIATELY HALT SHIPMENT OF ALL BROMOXYNIL PRODUCTS UNTIL
APPROVED AMENDED LABELS CAN 8E PRINTED AND AFFIXED TO EACH CONTAINER
WITHIN RPAC POSSESSION, IN A MANNER CONSISTENT WITH THE "RELABELING
PROCEDURES" OUTLINED IK ATTACHMENT A.
DAY 4-10 FOLLOWING EPA AMENDED REGISTRATION APPROVAL
REVISED LABELS WILL BE DELIVERED AND STICKERING OF RPAC INVENTORIES
AT PLANTS AND WAREHOUSES WILL BEGIN. NEWLY L J E M II. I U ' W LL BE
RELEASED FOR SHIPMENT TO DISTRIBUTORS.
ADEQUATE QUANTITIES OF EACH APPROPRIATE LABEL, ACCOMPANIED WITH "RELABELING
PROCEDURES", HILL BE SHIPPED TO RPAC FIELD SALES REPRESENTATIVES FOR
IMMEDIATE DELIVERY TO DISTRIBUTOR WAREHOUSE LOCATIONS WHERE BROMOXYNIL
INVENTORIES EXIST OR MILL BE DIRECTLY MAILED TO DISTRIBUTOR LOCATIONS.
APPROPRIATE COMPENSATION FEES WILL BE PAID TO DISTRIBUTOR FOR RELABELING.
AND VERIFICATION OF LABEL DELIVERY WILL BE MADE BY DISTRIBUTOR SIGNING
THE "ftP LABELING COMPENSATION" FORM. MONITORING BY RPAC FIELD REPS
WILL BE PERFORMED TO INSURE COMPLIANCE. DISTRIBUTORS WILL BE INFORMED
THAT NO BROMOXYNIL PRODUCTS MAY BE SHIPPED PRIOR TO RELABELLING ONCE
LABELS ARE RECEIVED.
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BRONATE*/BUCTRIL*/BUCTR1L* * ATRAZ1NE
RELABELING COMPENSATION PROGRAM
THIS PROGRAM IS DESIGNED TO COMPENSATE THE DISTRIBUTOR AND RESELLER
FOR RELABELING' HIS CURRENT INVENTORIES OF BRONA1E*, BUCTRIL* AND/OR
BUCTR1L** ATRA2INE BROADLEAF HERBICIDES TO COMPLY KITH EPA REQUIREMENTS
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 J10-GALLON MIN-I-BULK CONTAINER.
CURRENT PHYSICAL INVENTORY AS OF
CASES
DRUMS
MINI'S
TDATD
BUC7R1L* BUCTR1L* * ATRAZJNE
1 HEREIN CITIFY THAT AS OF DATE SPECIFIED ABOVE, WE HAD IN OUR
INVENTORY THE QUANTITIES OF RHONE-POULENC BROMOXYNR PRODUCTS
AS LIsTEiJ AiiOVE, AND HAVE RECEIVED ADEQUATE QUANTITIES OF REVISED
LABELS FOR RELABELING ABOVE INVENTORIES.
BUSINESS NAME:
STREET ADDRESS:
CJTYs
COUNTY:
STATE:
ZIP
OWNER/MANAGER:
PHONE:
(SIGNATURE)
RHONE-POULENC REPRESENTATIVE:
ItKK. 9
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DAY I1-20 FOLLOWING EPA AMENDED REGISTRATION APPROVAL
FIELD REPRESENTATIVES WILL INITIATE DELIVERY OF APPROPRIATE LABELS TO
EACH ACTIVELY SELLING BROMOXYNlL 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.
RESELLS WILL BE INFORMED THAT NO BROMOXYNlL MAYBE SOLD PRIOR TO RELABELLING
ONCE lABELS ARE RECEIVED. RETAILERS WILL BE SUPPLIED WITH ADEQUATE
NUMBER OF LABELS TO PROVIDE TO GROWERS. VERIFICATION OF LABEL DELIVERY
HILL BE MADE BY RESELLER SIGNING THE "RELABELING COMPENSATION" FORM,
EFFORTS TO HAND DELIVER NEW LABELS TO ALL RETAILERS WITH BROMOXYNlL
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 BROMOXYNlL FIELD INVENTORIES WILL BE COMPLETE AND
MONITORING BY RPAC FIELD REPRESENTATIVES WILL CONTINUE, TO INSURE ALL
CONTAINERS PROPERLY LABELED FOR SALE.
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ATTACHMENT A
BUCTRIL*. BUCTRIL* « ATRAZINE. BRONATE*
•EUBELINC PROCEDURE
2I-6ALLON 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 NITRILE 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.
«. PEEL BACKING FROM NEW PRODUCT LABEL AND PLACE NEW LABEL COMPLETELY
OVER EXISTING LABEL ON THE JUG. . ' •
o
7. RETURN JUGS TO CARTON AND REPLACE GLOVES ON TOP OF JUGS.
8. 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.
». REPALLET1ZE CARTONS IF NECESSARY INCLUDING RESTRETCH WRAPPING IF
AVAILABLE.
6
30-CAUON DRUM AMD 110-CALLON MINI-BULK
PEIL BACKING FROM NEW PRODUCT LABEL AND POSITION NEW LABEL OVER THE
EXISTING LABEL ON EITHER THE 30-GALLOW DRUM OR 110 MINI-BULK CONTAINER.
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ATTACHMENT C
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RH&NE-POULENC
ftMdNI-POULCNC AO COMPANY
OFFICE MEMORANDUM
TO: Nick Sowna
FROM; Dave Downing
OAT£: May J, 1989
Please find attached the Sromoxynil label Amendment Communication
Plan. Our goal 1s to reach all persons who sell, apply or recommend
brorooxynil 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 bromoxynil products. By the second day
all bromoxynil product distributors will be contacted with this Informal(on
via overnight mall. All resellers, university extension personnel and
weed scientists will have bromoxynil 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 CPA approval. Resellers
will be contacted on a priority basis according to their past sales
volumes as recorded by fth£ne-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.
Rh6ne-Poulenc feels that this communication 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.
OPOrvwg
Attachment
cc: J.N. Harton
S.A. Schmotzer
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BROHOXYNIL LABU AMENDMENT COMMUNICATION PLAN
UPON RECEIVING FINAL APPROVAL FROM THE EPA OF 1989 LABEL AMENDMENTS
FOR COMMERCIAL BROMOXYNIL OCTANOATE FORMULATIONS, AND APPROVED COPY
OF INTENDED INDUSTRY COMMUNICATIONS. RPAC HILL IMMEDIATELY INITIATE
A COMPREHENSIVE PUN 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 MILL
UNFOLD:
DAY 1 FOLLOWING EPA APPROVAL OF COPY
COMPLETE LABEL AMENDMENTS, WITH A COVER LETTER HIGHLIGHTING EACH PRECAUTION
AND RESTRICTION OF THE BROMOXYNIL LABEL, AS HELL AS A DESCRIPTION OF
THE PRODUCT RELABELING PLAN, WILL BE TCLEFAXED TO EACH DISTRICT AND
REGIONAL OFFICE. WITHIN RHONE-POULtNC 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 HILL 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 OP BROMOXYNIL SALES TO GROWERS.
IN ADDITION RPAC FIELD DEVELOPMENT REPRESENTATIVES WILL BEGIN CONTACTING
UNIVERSITY EXTENSION PERSONNEL AND HEED SCIENTISTS. AN ESTIMATED 3,000
TOTAL CONTACTS CAN BE MADE WITHIN TWO WEEKS.
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PAY S FOLLOWIMC EPA APPROVAL Of COPY
DIRECT MAIL LETTERS OUTLINING THt LABEL AMENDMENTS AND NEW RESTRICTIONS
HILL 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.
OAT 14 rOLLOWING 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
OF BUCTRIL*. BUCTRIL* + ATRAZINC AND BRONATE* AND 0 Ni*. Ul < M W
TO SEEK DETAILED LABEL AND PRECAUTIONARY INFORMATION THROUGH THiIR AG
CHEMICAL SUPPLIER. APPROXIMATELY 143.000 GROWERS ARE EXPECTED TO BE
REACHED OVER A SEVEN DAY PERIOD WITH 30-SECOND RADIO SPOTS RUNNING TWICE
A DAY.
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DEALER/DISTRIBUTOR LETTER
ATTWTIOK - LABEL CHANGES FOR 0RONATE*. BUCTRIL* AND 8UCTRIL» * ATRAZINE
ThU 1» to Inform you that BRONATE*. BUCTRIL* and BUCTRJL* * Atrazine
broadleaf herbicides have recently been reclassifled is "RESTRICTED USE
PESTICIDES" end that the labels have been emended to Include fie*
precautionary statements, additional protective clothing requirements, and
new handling and application restriction*.
These changes have been Implemented because recent tests have shown that
exposure to the active Ingredient 1n these products has caused birth
defects In laboratory animals. The new label amendments have been added to
substantially reduce the exposure to these product* 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 in order that you are In
full compliance with tech Important amendment. Significant additions
Include: 1) New warning statement*; 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 chemtgetion and aerial application restrictions.
In an effort to assure that all Inventories of BRONATf.*. BUCTRIL* and
BUCTRlL* + Atrazlne are stlckered with these changes, a relabelling program
Is being implemented by Rhfine-Poulenc 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 Rhflne-Poulenc will compensate your
efforts at a rate of $0.50/case, 30-gallon drum or no-gatlon mini-bulk
unit, and will verify your participation with an enrollment form at time of
label delivery. In addition, your RPAC Field Rep will provide Resellers
with a point-of-purchase poster for hanging, and grower handouts, both
alerting him to the label changes of which he must comply.
Onee you have received revised labels, no product may be shipped or sold
until stlckered with the new label. If for any reason distributors.don't
receive labels within 7 days of receipt of this Utter (14 days for
Retailers), please call the toll free Rhfine-Poulence Hot-Una at
i-tOO-334-i?4$. and labels will be Immediately shipped to you.
Thank you for your continued support and help In 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.
Sincerely.
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UNIVERSITY/CROP CONSULTANT LETTER
ATTEXT10X - LABEL CHANGES FOR BRONATE*. 8UCTRJL* AND BUCTRlL* * ATRAZ1NE
TMs Is to Inform you that BRONATt*. 0UCTRIL* and BUCTRII* * Alrailne
broedleaf herbicides have recently been reclassified as 'RESTRICTED USE
PESTICIDES" and that the labels htvt 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 In laboratory animals. The new label amendments have been added to
substantially reduce the exposure to these products when handling or
tpplylnf.
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
full compliance with tech Important amendment. Significant additions
Include: 2} New warning statements; 2) Specific use directions requiring
additional protective clothing and clean-up procedures; 3) The requirement
of nechanical transfer systems when handling 30 gallons or tore product In
a single day; 4) Use of enclosed cabs when applying 180 or more acres 1n a
single day; and 5) New chemlgation and aerial application restrictions.
Thank you for your continued support and help In 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.
Sincerely,
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GROWER LETTER TO BE AVAlLAQlC AT REStllCR LOCATION
RH6NE-POULENC
f a^^^BBBiiiiiii^^
RHdNE-AOULINC AQ COMPANY
TO: BUCTRR»/BUCTRIL» * Atrazlne/BRONATC* Users
BUCTRIL*. BUCTRIl* * Atraiine 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 childbearing 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 chemigation 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 Rh6ne-Pou1enc Ag
Company.
.AM8*CnQAC« *"C IDS
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RADIO/DATA-LINE COPY
ATTENTION GROWERS!
BUCTR1L** BUCTR1L* * ATRAZINE AND BRONATE* HERBICIDES,
USED FOR POST-EMERGENCE BROADLEAF WEED CONTROL* HAVE
•
BEEN RE-CLASSIFIED AS RESTRICTED USE PESTICIDES.
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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HOSIER FOR RESELLER
BUCTRIL*
BRONATE •
BUCTRIL* + ATRAZINE
ARE NOW
RESTRICTED USE PESTICIDES
ASK HERE FOR COMPLETE
DETAILS AND INFORMATION.
RHONE-POULENC AG COMPANY
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ATTACHMENT 0
In lieu of the sentence which states/ "If this product is
packaged in a 30 gallon drum or you will har.-ile a total of 30
gallons or more of this product per day, you must use a
mechanical transfer system for all mixing and loading
operations," the complete revised labeling will state, "If you
will handle a total of 3C gallons 01 mor« of this product per
day, you must use a mechanical transfer system for all mixing and
loading operations. If this 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 been fitted with a coir^atible 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 ot to modify youi
present sy«tem."
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ATTACHMENT I
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5
DRAFT PROPOSED PROTOCOL: BROMOXYKXi, EXPOSURE STUDY
1.0 INTRODUCTION '
A paasiva doaiaatry study shall ba conducted to *•»••• tha
daraal and inhalation axpoaurs occurring during routina u»a of
broaoxynil. Tha atudy shall ba dasignad so that tha
Bnvironaantal Protaction Agancy aay ba aJala to: (1) quantify the
•xposurs occurring during aixing/loading, application, and claan-
up whan brovoxynil ia appliad by ground booa to fiald crops
•vploy ing rigs whsrs booa langths typically axcaad 30'; (2)
quantify tha axposura occurring during mixing/loading,
application, and claan-up whan broaoxynil ia appliad by ground
boom to crops whara rig* of 20* to 40f pradoainata ; (3) within
aach subgroup astiaata tha total potantial daraal axpoaura and
tha actual dspositien ta tha akin undar tha clothing worn by aaeh
•tudy participant. A* an additional objsctiva, this study or a
•aparata study will quantify tha potantial damal axpeaura and
sKin dapoaitien occurring during opar pour aixing and loading
with tha naw Rhona-Poulanc 2.5 gallon containar and a
convantional 2.5 gallon eontainar.
3.0 MATERIALS AHD METHODS
2.1 Sit* Sal act ion
Tha study will address two sain crop groupings. Tha first
grouping shall ba crops to which daily traataants of ISO acras or
nora art typical and boon sizas of 50' or gr'aatar ara tha norm.
Tha usual application apaad is axpactad to ba approxiaataly 0.5
acras/ainuta . Tha sacond grouping shall ba crops to which daily
traataant of SO to 120 aeras is standard and boom sizas avaraga
20* to 40'. Tha usual application spaad is axpactad to ba
approxinataly 0.25 to 0.95 acraa/ainuta .
Within aach grouping tha sitas shall ba salactad basad on
routina us a of broaoxynil or othar aarly post ' aaargant harbicidas
in that araa. A ainiaua of tan a it as ara to ba uaad within tach
grouping.
2.2 Cooparator f alaetion . . . _______________ ._
Cooparators usad in tha study ara to b* individuals
intanding to apply a post anargant harbicida indapandant of
possible participation in tha study. Tha candidatss ara to ba
salactad in • aannar idantieal to that aaployad in tha May &
BaXar Canada/Rhona-Poulanc Study with tha axoaption that «
Biniaua nuabar of participants with anclosad tractor eabs shall
ba raquirad. Tha quastionnaira usad should ba siailar to that
usad in tha Canadian atudy. Ssltctad eooptrators will racaiva
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. 2 -
bromoxynil in a manner idantical to a non-cooparator who would t
obtaining bromoxynil for hia/har uaa axeapt that breaoxynil »«y
ba providad in a non-atandard containar aa nacaaaary to
affactuata tha study. Rhona-Poulane may provida claan coveralls
and nitrila glovas to study participanta. Tha atudy participant*
will initially ba inatnictad to follow Iabal diraetions. Should
tha participant atteapt to handla bronoxynii with laas than tha
Iabal raquirad protactiva clothing, Rhona-Poulanc will racord
such daviation from tha Iabal diraetions and than raquire tha
participant to utiliza all raquirad clothing. Tha normal and
typical work routinaa of tha participanta ara not to ba altarad
onca tha-study participant has bagun handling broaoxynil during
tha monitoring portion of tha study*
2.3 Application Dataila
Information collactad for aach application of broaoxynil
shall includa targat crop, data involving cultivar, growth staga,
data of planting, and row spacing. Equipmant information shall
includa sprayar modal and maka, tractor modal and maka, procadura
and tima raquirad to mix and load tha -aprayar and tha data and
mathod of sprayar calibration. Altaratiens to tha aquipmant aueh
as ahialding of booms and opaning of windows in closad cab
tractors will ba racordad. Application rate and amount of active
ingradiant handlad shall ba racordad as will tha actual tima of
application.
Fiald conditions including wind spaad and diraetion,
ralativa humidity, rainfall, tamparatura, and cloud eovar aha11
ba racordad at aach monitoring sits for tha duration of aach
monitoring pariod. A description of aach tast aita will ba
racordad. A
2.4 Darmal Exposure
Darmal axposura to all bcdy araaa with tha axeaption of tha
hands will ba monitorad in a mannar that will parait tha
estimation of potantial darmal axposura and darmal axposura to
tha skin. Potantial darmal axposura will ba monitorad by tha
Durham-Wolfe patch method (Measurement of Exposura of Workers to
Pasticidas, Bull. Hid 81th Org., 19«2, 26:75-91). Patches shall
ba placad in a mannar specified in Subdivision U of the Agency'a
Pesticide Assessment Guidelines on tha outside of tha
eooparator's clothing. Darmal axposura to body araas covered by
clothing shall ba monitorad using either vhola body dosimeters
composed of a long slaava cotton T-shirt and long lagged cotton
underpants or by a fluorascant tracer technique. The vhola body
dosimeters, if selected, will ba provided to aach cooparator by
Rhona-Poulanc at laast ona day prior to tha study and shall ba
placad on aach eooperator, by tha cooperator, at tha time that
tha cooperator gats dressed to perform tha day's work routina.
Tha vhois body dosimeters ara to ba worn under all clothing
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• 3 •
normally worn by the eoeperatox-s. Facial exposure may be
nonitored by the uee of facial swabbing in liau of doai&eterf.
Hand exposure will ba monitored by uaa of hand rinaaa.
Tha monitoring pariod will oonaiat of tha handling of not
laaa than 13 Iba ac.tiva ingradiant vith tha excaption that
external patches will be changed and hand rinaaa will ba
conducted at the end of each six/load cycla and each application
cycle.
2.5 Inhalation Exposure
Inhalation exposure will be monitored by uaa of parsonal
air samplers. Tha air samplers will b* turnad off during aach
break in the vorX routine likely to axcaad 30 minutes. The
duration of tha sampling period should be the entire day's work
routine; however, caution must be taken to prevent breakthrough
from saturation of the collection media. The duration of
stapling end calibration of air flov will be conducted for each
eaaple period.
3.6 REPLICATIONS
A replicate is defined as one monitoring period consisting
of the handling of at least 13 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 tor each job function and the combined mixing,
loading, and application functions. For each crop grouping a
Biniaua of ten sites are to be selected. For each crop grouping
a miniaun of 30 replicates shall be monitored. For each set of
20 replicates, a miniaun of 7, but no more than 13 replicates,
•hall involve application from enclosed tractor cabs. A total of
at least 40 mixer/loader/appllcator replications will be
conducted for the study. Monitoring of the exposure resulting
from the use of the new 2.5 gallon container nay be conducted
either as an ancillary portion of the study or as a seperate
study and Bust consist of a minimum of 15 replications of the new
2.5 gallon container .and 15 replications involving a conventional
2.5 gallon container. Zach set of 15 replications vill involve a
minimum of five individuels at three different sites. A
replicate for this portion of the study is defined as one
mix/load cycle in which a spray tank is filled to capacity.
3.7 QUALITY ASSURANCE
All quality assurance as defined in Subdivision U of the
EFA's Pesticide Assessment Guidelines will be required.
3.0 DATA ANALYSIS
The purposes of this study ere to quantify the exposure
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- 4 -
received during the use of bromoxynil and the identification of
otion* that may be required to reduce exposure.
regulatory option* that may
The data will b« pr»»entad as a »«an »xpo*ur« and a ran?*.
Th« standard deviation -ill aUo b« datanain.d. Non-parametric
er otft.r Ippropriatt ttati.tic. «*y b« wployad to dateline tha
Statistical .ignitleanc. ot diffarant variabl.a in datannining
!«a«uri Major aophasU -ill »>• placed on tractor typa, be.oo
!??! IJd tanX 5iia. Po.t priori analy.e. «ay ba conducted on
SiSIr ISJiaSla. Standing o? observed patterns in the data. A
priori Jta?ii"c.l test. *ill.be defined in the protocol by the
statistical »ethods will test the following null
-
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•: '•'.' '''••^f^^'4f~-' ~^- • ; • • - " • •
;. "•••^g^?-"'^yJc^. .3,^..'>;.>;.' ...;^..v->^ "-ttf
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I XJB2 ? 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 I
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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I
II
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 Lincoln
Eastern Regional Compliance Director
Louis F. Qitto, Director
Air Management Division
Barbara Metzger, Director
Environmental Services Div.
Gerald M. Levy, Chief
Office of Pesticides & Toxic Sub
Ernest Regna, Chief
Pesticides & Toxics Sub. Bran
III 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 3 Toxics Div.
VII William A. Spratlin, Director
Ai r & Toxics Di vi sion
VIII Irwin L. Dickstein, Director
Air & Toxic Subs. Division
IX Jeffrey Zelikson, Acting Director
Toxics & Waste Management Div.
X Gary O'Neal, Director
Air & Toxic Oivision
Larry Miller, Chief
Toxic & Pesticides Branch
n^i
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
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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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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
1ater.
Regu1ated Indu s t ry
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,
and
Carbon tetrachloride is also known as perch!oromethane
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 tetrachloride 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).
ANCE 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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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 Compl iance Mom'tori ng
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.
Regi ons
0 Will provide copies of the Compliance Monitoring Strategy to
States.
0 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 Amity Rd.
Bethany, CT Q6525
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.8. 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 30378
EPA Reg. No. : 491-2,-47,-82,-154,-190
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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,-l1,-31,DC3800010Q
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.
Minneapoli s, 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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REGION VII (17)
Bartels and Shore Chem. Co.
1400-02 St. Louis 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
Weevll-Cide Co. a subs, of Research Products Co.
411 N. 7th St.- Box 1057
Sallna, 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. Oiv 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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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 Valley, 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 Chemicals 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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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.
Brisbane, CA 94005
EPA Reg. 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
it
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
I/
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 H, Director
Pesticides Enforcement Division (EN-342)
I. LEGAL DEVELOPMENTS
istrator on the Suspension of Heptachlor-Chlordane (In re Velsicol
Chemical Corporation, et al. , FIFRA Docket No. 384J ordered the
suspension 01 registrations of all pesticide products containing hepta-
chlor or chlordane for use on corn, household, garden, lawn, and
turf pests, use against ticks and chiggers, and use as a:'consii'cuent
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 Agency*s 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
V,-
* Copies of the Administrator's "Conclusions" and the "Order" are
attached.
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29. 1975, "Notice of Intent to Suspend" remains in abeyance in the
Sixth Circuit as well.
•
H. 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 formulatorj and 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 heptachior products. Enforcement actions should await
official notice of ^uspension to subject registrants.
Until that tirr.e you may find it helpful to deal with general
inquiries as follows.
of
1) So far as FED is able to determine at this time,
*,vhich were formulated
"""* "^ "r "CLP-
975. are illegal for
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 \d,th 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
coordinator.
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* UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
.< WASHINGTON. D.C. 20460
'
JAN
•
OFFICE OF ENFORCEMENT
SUBJECT: Clfci'-iciJiir. of Ecptachlor/Chlordane
Suspension Order
TO: Enforcement Division Directors
Pesticide Branch Chiefs
FROM: A. E. Conroy n. Director ' Jtf/ L
Pesticides Enforcement Division (EN-342) /S <*
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), " dateu January 19, ia7b. 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.
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UNITED STATES OF AMERICA
niVIROKMEIITAL PROTECTION ACEfJCY
UEFORE THE ADMINISTRATOR
•
col Chemical Corporation
Registrants. \
, .FIFRA Docket Mo. 384
CLARIFICATION OF .
ORDER OF DECEMBER 24, 1975
C* January 7, 1975, Respondent EPA filed--a Suggestion for —
{Unification of the Order of December 24, 1975, in the above-
• • * . «
<*/-'.ur.od proceeding, seeking clarification of the uses of
jr^.-cts containing heptachlor and chlordane for which
*r iterations are not suspended by the December 24 Decision
»*•: Cr-Jcr. Respondent also submitted a Proposed Order, including
4^ 4*.uctacnt setting forth a proposed list of uses not suspended,
'i-;?:/.cr with certain explanatory notes. . •
On January 13, 1976» I'issued a notice of the filing of
''••WftJent's Suggestion for Clarification and Proposed Order
written consents from the parties, thereby
intention to consider the possible need for
«:*'t«ic«fqn of the December 24. Decision and Order.* On '. "
»«s4*ry lst 1976,'written comments were received from counsel for
*«Hft9l Chciaical Corporation; counsel for the Pineapple Growers
of Hawaii and the Attorney General and Department of
-7
-;.r.«^ ?-coraonts ^n response to Respondent's suggested
'-"- "r[t"t. v>vre submitted by counsel for Velsicol Chemical
''" Oanuai%y 12« 19?6» but not sufficiently in advance of
of the January 13 notice to be considered therein.
r
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Agriculture of the State of Hawaii; counsel for some 300
registrants of various products containing heptachlor or chlordane;
the Environmental Defense Fund; the U.S. Department of Agriculture;
and Respondent EPA. All of the foregoing parties, except the
Environajental 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 alter the .Order.and that.the. OrderJ s_ final...and .caiwot.nov/,.he. - -
• - .
* ' •'"•.'
changed .in 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 will'be
served and facilitated by the following clarification of the..
December 24 Order. •. -^
I
f.
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3 .
In revievnng the Decision and Order and the possible need .
»
for clarification, I have not considered any new evftiuuc* or " . v
argumentation. I have sought only to discern any possible source'
* . " * * ,*
or sources of any lack of clarity In the expression of my .. - '
# • *
intentions at the tims I issued the Dscisibn and Order. Cc-ransnts
received from the parties have been most 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 the time I issued the December 24 Bccisieii •'
and Order. . • • - ' .. *•.'•*••".. "" '
• • • . • •• *.-*
The December 24 Order, by its terns, provides that all
• . * ^ •.•••«•
pesticide products containing heptachlor or chlordane for use
(1) on corn pests, (2) on household, garden, lawn, 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 . ,.
. ' . • • i
corn having a post-effective date of August 1, 1976]. The Order ;
further provides that any stocks of technical grade heptachlor ... .- (
• ' • • - '--I
or chlordane formulated into products intended for such uses [
, * . * • *
[after July 29, 1975] nay not be placed in commerce, sold, or used " |
for such purposes or any other purpose not specifically • . |
.exempted [in the ttovejnber/i.lSr 1974, cancellation order] or_ ' :* ' ; >
.-:. , '-,.• •:-•--:.;•••'•.;, • -•• • j
specifically permitted in1Accordance with the Decision of the • |
•
Administrator attached thereto. . . < . t
. '- • - 'V
••:- . • . ....'..-, . . '• . • • J
. •' .. ' ' • * • «
. t
.. r
. i
•if- r——
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c
.Ths uses specifIcaUy permitted or continued by the
Decision accoiupanying the December 24 Order 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 t \
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 hcplachlor or chlordans are •
•**•
suspended. Because the words "intended for such uses" in line 12
of the Order might be interpreted as Halting 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, • ' r
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 "\
* . I
Judge) does not adequately address many other (presumably minor)
uses of heptachlor and chlordane, 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 recommended that such other uses not be continued, and
*•» • .
?Decision of the Administrator, p. 76
t
*•• .
* * • •- "*: ;.*•-
-------
• s • -.-...
(2) the four uses enumerated specifically in the December 24
Order are arco:ir tl- vses as to which sufficient benefits evidence
*
IMS presented at the haariny to permit a risk-benefit assessment.
• «
Ulanket suspension of uses as to which there v/as little or no
evidence on benefits was necessary because the" evidence on
carcinogenic*Ity 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 v/as 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
• * "
•••
. Therefore, with respect to this grouping of uses, I reached
tame ultimate conclusion as discussed above concerning uses for
• * Vision of the Administrator, p. 76.
i .
•*•»*•
-------
"any other purpose" generally, jje..tliat, in view of the
.evidence on carcinogen!city risk, and in the absence of sufficient
benefits evidence, these uses are suspended, even though they "
could not be enumerated specifically in the Order. Thus, there is
no inconsistency between paragraph 5 of the Conclusions in the
•
* • .
•Dscision and the provisions of the,Order. . .
In view of the foregoing,'! do not find it necessary to '
- either-nadopt oP-^cject-th« -Proposed.JOwUai
Russell E. Train
Datetl: January 19, 1976
r
1..
'. •••
t
• I
C
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4 ?
•V
"
* . •
• •
*
*
COMPOUNDS)
chlordane It
heptaehlor •
chlordane &
heptaehlor
chlordane &
' 4
heptaehlor
- 4
heptaehlor
heptaehlor
heptaehlor
• * '
chlordane
cMordane
.•
ehlordane
/ ATTACHMENT A -I
SPECIFIC USES OF Cm.OnDANI* f. m:PTACm.Oll - -.1
NOT SUSPENOOJ UV ALV.'IKlSTllATOU'S OUDEIl OF 12/24/75 j
1
US£(S) -STATUS OF USE(s) [ 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 .'""
5
control in Hawaii
In 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 '
continued . k
continued ' .;
continued until ••'
8/1/70 only . " '
continued
• continued
continued
•« '
. «
•
continued • ,
. .i
•
continued
continued
•*
t'
".
W
:
•
i
chlordane
Control of imported fire ant by private
5.'
individuals
continued
chlordane
Control of white fringed beetle attacking food
i crops InSS.E. States (AL.FL.GA.LA.MS.NC,
SC, TN)
continued
chlordane
Control of soil insects attacking Florida citrus
continued
'chlordane
Control of strawberry root pests by prc-plant continued
treatments '
chlordane
Control of white crubs in Michigan
continued
r .
l« All registrations (Federal and s;ate) 01 pcsucioe products containing ticpiadilor ana
chlordane for uses not specifically continued are suspended by the Administrator's
Decision and Order on the Suspension of Hcptaehlor-Chlordano.. The effect of the
Order is' to further prohibit the manufacture* formulation or reformulation of products
; ' . containing Heptaehlor 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 registcrcd''products which were formulated prior to July 30, 1975
are permitted' for both continued and suspended uses. ...... ------ ™ r" " ~~.
•2.' PR No lice. 74 -11 (39 FR 4 r298) exempted thisiuse from cancellation. Such use
was similarly exempted front 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 tmulsifiable or oil
concentrate formulations for controlling subterranean termites on-structural
.sites such as buildings, houses, barns, and sheds, using current control
practices. > . •*
4* Velsicol has represented that it would voluntarily suspend domestic shipments
of hcptaclUor for this use ponding resolution of the cancellation proceedings.
&. On Urc assumption that f.Mrc.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 oii both public and private property by cither owner* agent.
employee,. or contractor. . " - • .". v' '"., • .
8* Not Intended to preclude use on cotton* However; uce oh 'tobacco is suspended. ' .•
9. Restricted to citrus root weevils* ":>' ''"•',' '*
b
"
I !
I ;
I.
ir
I
. \'
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY -
WASHINGTON. D.C. 20460
-619 1976
ENFORCEMENT
SUBJECT: St&Hts Report on the Hcptachlor/Chlordane Suspension
TO: Enforcement Division Directors
Pesticides Branch Chiefs
FROM: A. E. Conroy n. Director
Pesticides Enforcement Division
The purpose of this informational memorandum is to keep you
abreast of Agency activity relating to the Administrator's suspension
of most heptachlor/chlordane registrations. • • •
- The Office of the Hearing Clerk has completed an uncertified mail
service of the final order and the clarification in the heptachlor/chlor-
dane proceeding to the approximately 425 parties involved....The Agency
has sent to the Federal Register the "Notice of Intent to Suspend, the
"Initial Decision, " the "Administrator's Decision and Order, " and the
"Clarification" for publication. An expedited publication is expected.
The Registration Division is currently in the process of serving
by certified mail a notice of suspension to all affected registrants of
heptachlor/chlordane products. Please find attached three form letters
being used to notify registrants of their products' status under the
December 24 Order. These letters will apprise the particular registrant
that it's products.registration (1) has been finally suspended, (2) was
suspended, but by discontinuing the use of heptachlor and chlordane in
the product's formulation, continued registration is permitted, or (3)
was suspended, but may continue to_bc sold and distributed if the reg-
istration is provisionally amended. ~ - ' ~
You will be receiving shortly a region specific.list of all suspended
registrations on the basis of which you may begin surveillance and
enforcement activities" to "ensure compliance with the Administrator's
order. ;. •
"•' -i";" ' 's " •
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r
UNITED 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. Host 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 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 fimply discontinue the use of Cfclordane
* 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 which all references to suspended uses have been deleted.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
' ' WASHINGTON. D.C. 20460
CERTIFIED MAIL
" • '••"*:.. *
.:. • 'i.. • -X';- : ;
"* ,. "• ', '• ."•- ."..'« ' . ; »• •
. • • .- ' . • '••• .»' •..'...
'; i •
.• •... -f- '. • • . .-.
.1 . ....... ... .. .
••• .. -.-. -.-.v,.*-.-•-•.;....i
• % •* - t * ,•" •* * *.»"••*
Gentlemen: ' • .••••'• '.. • :-• *.'•• •'• -
Subject : Notice of Suspension for:
.'"'. \
\ *..,-. -w.i .- w-^.
c •+•*••. *•
< ' •*•
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 amendment of registration. Such petition •
should request the "elimination from-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 have;.been ^blocked'outv': The granting by-the Agency of such
a petition will permit.ypujtp;c&ntinue.formulation and/or sale of Hepta-
chlor and/or Chlofdane*'"forrexfeinptted uses: " 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:
'_ *m •
•
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»-•" — ' ••-'•:— C
.'I • ' • . . ' ' V-
\
7- • \SX\bL* UNITED STATES ENVIRONMENTAL PROTCCTiON AGENCY
WASHINGTON. D.C. 204SO ' .' "'
«• - • *
•' • ' .*'••.•' • ' . ."•'..
CERTIFIED MAIL " • "" ' • • " . .! . . • '* -'• -
:. Gentlemen: . • .
"• Subject : Notice of Suspension for:
• • . •
This is to notify you that on Decenier 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 forth 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, jwed after July 29; 1975.. • *
.» ' * . — • * • ^
* * • • • .,"••',"• *
The Admin1strat6r:.'s Decision and Order wi 13 be pub!ished'1n the Federal
/(tegister^in/the^riear^futur^ f ' ^ . ';
Sincerely'yours,"• ': / ••• '""• '-'•"'"''*''•'**"'.- ''''•:- '^3-';-^.j. !-.."l-;:_.
"" "'
John B. RitcK; Jr. •'"/.''••
Director • "
Registration Division (tm-567) "
Enclosure
-------
„__ • . .2-
* *
___;__ It is sufficient to send a cover letter with an amended label or
( "" in 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 with the enclosure nrust 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.
• ' " p
. . The amendment. wij.l_not .abTO^a.tc_yiujr^jdght_to~dofend--beth-5U5peflded-'-or—
" nohsuspended 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
s ' July 29, 1975, may not be shipped or sold until you receive EPA
of your amended label. .
\ • m .
The Administrator's Decision and Order will be published in the Federal
Register in the near future. . . .
* " - * *
Sincerely yours, "•'-,*
John B. Ritch, Jr.
Director
7 Registration Division (WH-5677
Enclosure ' •
/• • •
' i
c
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siT.anc USES or CIILORDANK t- nnr-
\ NOT SUSJ'EN'DEO BY AD.\UN(STKATOK':: O;'.iJi:il OF 12/24/75
X
c
COMPOUND(s)
ehlordane &
hepfachlor
chlordane &
heptachlor
chlortiane &
4
heptachlor
4
heptachlor
heptachlor
oeptachlor
USE(s)
Subsurface ground insertion for termite control
2
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
5
control In Hawaii
STATUS OK USE(s)
2.3
continued
continued
. continued until
e/I/76only
continued
continued
continued
f < *
chlordane
In Federal/State quarantine programs for
6 5.6
Japanese Beetle and imported fire ant
continued
chlordaoe
chlordane
chlordanc
Control of black vine weevil on Japanese Yew
in Michigan
'Control of Texas harvester ant fn Oklahoma
Control ol imported fire ant by private
5,7
individuals
continued
continued
continued
chlordane
Control of white fringed beetle attacking food
• 8 .
crops in & S.E. States (AL..FL,,GA.LA,MS.NC.
SC, TN)
continued
chlordano
Control of soil insects attacking Florida citrus
continued
chlordane
Control of strawberry root pests by pre-plant
treatments
continued
*. ehlordane
*•
Control of white crubs in Michigan _ continued
u cocral anc ataieJ ot pesucioc products containing ncpucnlor and
4.
5.
6.
7.
8.-
9.
Ail registration
chlordane for uses not specifically continued arc suspended by the Administrator's
Decision and Order on the Suspension of HepUchlor-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
axe permitted for both continued and suspended uses. ' .
PR Notice 74-11 (39 TR 4I2?3) exempted this use from cancellation. Such use
was similarly exempted from the Notice of Intention to Suspend. 40 FJl 34456
(7/29/75). -v. •'.-.- -
Clarified at 40 FR 30522 (7/21/75) to apply to the use of emulsifiabte or on
concentrate formulations for controlling .subterranean termites on structural
Bltco such as buildings, houses, barns, and sheds, using current control
practices. •
Velsicol has. represented tliat it would voluntarily suspend domestic shipments
of heptachlor for this use pending resolution of the cancellation proceedings.
On the assumption that Mir ex is not available. ' ' .
To include treatments required to certify to pest free conditions as welt as for
use in suppression and control programs. ''
To include use on both public and private property by cither owner, ancnt.
employee, or contractor.' . - '
Not intended to preclude use on cotton. However, use on tobacco is suspended. - *
Jtcstrictctl tojcitnis root weevils. «. . . :
* *^ .•••'.: ' - .•• • '
-------
J> .
'/ • " • • Mr. Timothy A. Gardner ".•'"•.
. . ; . - Product Manager (15) ' •", '•'.-"'
.; Registration Division (WH-567) ' • . .'
.• " '• Envirorcnental Protection Agency
V,'£iMngton, D.C. 20460.
The amendment will not abrogate your right to defend both suspended or
nonsuspended uses in the continuing cancellation proceeding.
Existing stocks of EPA registered pesticides containing Heptachlor or
1 .£blordane jnay, .bfi_ <
stocks-were formulated prior to July 30, 1975. This date v/as 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,
toay 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 1n the Federal
Register in the near future. . • .
Sincerely yours,
John B. Ritch, Jr. • . .
Director . '.''.'"'
.Registration Division (WH-567)
. .
_ , ..•"...
Enclosure »•..•• .
.-^ •
. . .
. «... tv... .-. ••» --." v . ;:-'-•*-•.'. . •• •.. :•,.• - ..-'.•
• .. . • . . | .. ; • i. • ' •< - • . i •• :. f. ' j.~* . - . « •- • • • • . • • *••* ,,
' , '• .! -. .. -«.-i;'-.'i ;;••:" V--.' -^ & ' •-••• ; '• "' '•' ' • •*' ' * - •* '
'''' '
...
*. !- •'•'.'. '' ;»*i:-V .•*"•:
•."-.."' . •'•'•>. -•'.';'!' ^j-7'-^ • .. i •-••.••..".••'•;.•.•-. ^'»•-•;:.'.•/'• '.. ;--.
•• ':- ".;:..'; ^'il-.''"••" . . "-J. '-^Ift-:'. '.''..'."' *::'>'^''':.'"•"..• _.r..uJ
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(* *ffc \
m
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
23 MAR 1976
OFFICE OF ENFORCEMENT
SUBJECT: Heptachlor/Chlordane Suspension Order
Enforcement Strategy
TO:, ,_ Enforcement Division-Uir^ctocs .... .
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 on .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 12/24/7T1"for the list of uses
exempted] were suspended as of December 24, 1975.
-------
-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, may be sold,
distributed, or used for suspended uses.
(3) Stocks of heptcicMor or chlordane products formulated
rlter July 29, 1975 may be sold, distributed, or used
only for exempted uses, as per "Attachment At!.
H. CATEGORIES OF HEPTACHLOR/CHLORDANE PRODUCTS _ -.-
As stated above, there are three categories of heptachlor/chlor-
dane products:
(A) Federally registered products, all uses of which have been -
suspended. The Registration Pi vision/Office of Pesticide Programs
has notified, by certified mail, all affected registrants that their prod-
ucts have been finally suspended by the December 24th Order. I / An
example of a product in this category would be a product regisfeced
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, ~
to ere 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"] amendment of the product's
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
if see my* eoruary 19, 1976 memorandum entitled "Status Report on the
"Heptachlor/Chlordane Suspension. " and its attachments.
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registrants of 140 "intrastate'1 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
apprise-this category uf-rgg'isU ants as to "thair* products' "status:
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.
m. 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.- 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 similarity situated F ederally 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 - -*.-
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 wmca were formulated alter July 29, ^75. 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, 1975v
• be recalled immediately. This letter.-5t 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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(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 /
t
(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 vthat 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 Kreuger, 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.
1 n.
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. . -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 -
BtvistotrrOffice- of-Pesticlde-Pr ogr3ffls^t202} --SZ&z&ttSf. ------
VIE. ATTACHMENTS
Please find attached the following:
(1) "Attachment A — Specific Uses of Chlordane and
-.Heptachlor Not Suspended by Administrator's Order — -•—
of 12/24/75.~TT~" .
(2) Copies of recall request-letters senfrto registrants by
FED.
(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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1
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
27AU61976
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\ier
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."Keg. 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 15Cb)
(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 . A
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 violating the 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
To arrive, at a result consistent with the Administrator's intent to
suspend all use of chlordane/heptachib^.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 AinEX CrlLORDANE BE
2&o5-l 31 RiiD TCP CHLORDANE 8 SPPvAY
9859-51 CriLOnDANE 10 GRANULAR
9850-53 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, aiter 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 I3(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)]( 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?/ r>e sold, distri-
buted, and used only with labeling amended to include only continued uses;
and (3) products formulated after July 29, 1975, with directions fdr 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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.-,1".•..-„.
•*' . '••>
r
i'^Ni/? -r ur;'": "^ STATES ENVIRONMENTAL PROTECTION AGENCY
%*."" '",>" WASHINGTON. D.C. 20*60
OFFICE OF ENFORCEMENT
To: Enforcement 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 1976 is no\v essentially complete 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 sustained the
Administrator's decision to suspend certain uses of chlordane and
heptachlor in all but one important respect. (Environmental Def ens c
Fund v. EPA, ISo. 76-1247 (D.C. Cir., decided Nov. 10, 1976)). With"
respect to the Administrator's decision to allow use of existing stocks,
the court remanded for reconsideration of such 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 be routine cxcc_pt_ in the c.-rsr: of firms refusing to rr.-cill.
Additional visits to producers and/or distributors may .Se 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 en-t-he level-of jaction'to"berapplieti-at-the
retail level are leftio 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 ENVIRONMENTAL PROTECTION /•-•". i;
120CT 1976
'•• ' «T ' •' .. ., '. *•
Mr. Kalp'i Ln.-jal " , ' •• '
executive Director \ •
•'> Chentical Sp.^ciiiltiac r-ianuCACturors - ' *
Asaocicticn; Incornor&ted
s- 1001 Connecticut Avenue, ^.'.:.
. Suite 1120 * •; » - •• .
• Washington, 5. C. 20036 ': '. .
Deer Hr. Unoels -. *
Vour latter of August 30, 197C, hsc boon referrad. to
v this office icr re^ly-- Because of. tus Administrator' f:
onnoin-3 rvle in the ctilc-rdanir/hev'-£cnlor proceedinas, it
would »:2'inoroper unoer the Agency's rules of practic-a
for dini to respond to your inquiry.
•f Your letter asks tliat'tha Adiciniotrotor invokes tha
"special Tult"/umier slO(h)(?.), in orcier to allow invan-
tcries of chlordane products foraiulstod between July 29,. ;
1^75, end December 2^, 197T>, «nci currently on asaler
shelve;:, to be eold until such f>tochs: ore exhausted.
. Vour request would -necessitate' co.iiticiticn o£ the v
order isaueu by the Administrator "on Doceipoer 24-, 1975.
Rec/U'ists tor such Modifications must be r.ioda in confornancc
with the rules of practice set forth in 40 CPR Part 164.
se?j especially 40 CFK Io4.£(b), concerning 'enlarcieit-.cnt oH
'lilino oeriotisj 40'.CFU 1G4.31, corvcsrninq intervention?
.anj 40 CTt\ lC/i',110," conccrnir.-y KV cicns for raconsidaration
•"of
201
SUIHMU
JL
OFFICIAL. i-ILE COF
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g
«.
finally, candor requires that I inform you that the
Arjency statt would oppose any sucu Aotio.i to modify tne* .
suspension order, snould one in fact.be filed. Essentially,
this is because the suspension order is a tennerary order,
which ultimately will be sncercoJed Uy en order at the
termination of the cancellation nroccaclinq. .The question
of Urn extent' to which distriDUti.cn of existing stocks oi
c.hjarafinc j>roi»-.:cts should be allowed csn and should be
aUrrossed in the cancellation procoeui'ncj, and resolved in
the order at tha conclusion of that proceeding. Sound .
considerations of proceaurcl ntanecjenint ;nilitate egainst
interruption of the cancellation proceeding to consider •
this question nt this time. *
* *
•'."•' f" ' . •' •• - - . • '
' • Sincere
erely,^
b/&c<
G. Will Urn Frick
General 'Counsel (A-130)
C,
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•/•
CHEMICAL SPfCIALTIES MANUFACTURERS ASSOCIATION. INCORPORATED
* c«c.o!r.» «,n c'.r-« SU-.IE nw . icciccxrucTicuiAv^.Nw,wAS)«"
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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 sonic 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, we 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 invoice the Special Rule, it would
alleviate indemnification problems that will'arj.so with
.respect to products formulated prior to the Suspension
Order.
* • *
I look forward to hearing from you concerning this impor*
tant matter. -
RalphX/Gngel
Executive Director
RErkas
cc: A.E. Conroy
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X
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, O.C. 20460
APR | 3
orricc OF
PESTICIDES AND TOXIC SUBSTANCES
MEMORANDUM
SUBJECT
Revised Compliance Strategy for
Suspension of Chlordane and Hep
FROM: John J. Neylan III, Director
Policy and Grants Division
Office of Compliance Monitoring
TO: Addressees
ion and
tic ides
On February 23, 1987, 1n the case of
Against the Misuse of Pesticides vs. EPA.
ruled that the Agency's allowance of the
of aV[ cancelled chlordane and heptachlor
and ordered EPA to take "whatever action
that on and after April 15, 1988, sales,
commercial application of existing stocks
heptachlor which have been the subject of
shall cease..." Since sale, distribution
chlordane and heptachlor products are air
April 15, 1988, the District Court Decisl
applies to the non-Vels1col chlordane and
which have been voluntarily cancelled.
the
the
National Coalition
U.S. District Court
continued sale and use
products was void,
is necessary ... so
commercial use, and
of chlordane and
voluntary cancellation
and use of Velsicol's
eady prohibited after
on effectively only
heptachlor products
In order to Implement that Court Decision, on April 5, 1988,
EPA issued a "Chlordane/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 in that Notice are cancelled (see Appendix C for
this 11st), and that 1t 1s 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 chlordane/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 le, deliver for shipment,
receive (and having so received) deliver or offer to de"Mver
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 5,
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 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
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 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. 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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-3-
The attached Revised Compliance Monitoring Strategy for the
Cancellation and Suspension of Chi ordane/Heptachl or Tertni ticides
is identical to the January 29, 1988 strategy in regard to the
Velsico] 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 in 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 termlticides 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 termlticides 1s 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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-------
II
III
IV
VI
Douglas D. Campt (TS-766C)
Edwin F. Tinsworth (TS-767C)
Frederick F. Stiehl (LE-134A)
Mark Greenwood (LE-132A)
A.E. Conroy II (EN-342)
Connie Musgrove "
Ken Shiroishi "
Phyllis Flaherty
John J. Neylan III "
Mike Wood "
Jerry Stubbs "
Dexter Goldman "
Jake Mackenzie
Western Regional Compliance Director
Louis F. Gitto, Director
Air Management Division
Barbara Metzger, Director
Environmental Services Div
Marvin Rosenstein, Chief
Pesticides & Toxic Substances Br
Ernest Regna, Chief
Pesticides & Toxic Substances Br
Stephen R. Wassersug, Director Larry Miller, Chief
Hazardous Waste Management Div Toxic & Pesticides Branch
Winston A. Smith, Director Richard DuBose, Chief
Air, Pest. & Toxics Mangt. Div Pesticides & Toxic Substances Br
William H. Sanders III, Dir
Environmental Services Div
William B. Hathaway, Dir
Air, Pesticides & toxic Div
Phyllis Reed, Chief
Pesticides & Toxic Substances Br
Robert Murphy, Acting Chief
Pesticides & Toxic Substances Br
VII William A. Spratlin, Director Leo Alderman, Chief
Air and Toxics Division
VIII Irwin L. Dickstein, Director
Air and Toxics Division
IX Jeffrey Zelickson, Director
Pesticides & Toxic Substances Br
Alvin Yorke, Chief
Toxic Substances Branch
Davis Bernstein, Chief
Toxics and Waste Management Div Pesticides & Toxics Branch
X Gary O'Neal, Director
Air and Toxics Division
cc: Michael Walker (LE-134P)
Jane Hopkins (TS-788)
Margaret Rostker (TS-788)
Phil Gray (TS-766C)
Anita Frankel, Chief
Pesticides & Toxic Substances Br
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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 "Chlordane/Heptachlor Termiticides; Notification
of Cancellation and Amendment of Existing Stocks Determination",
and the April 5, 1988 "Chlordane/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 list 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 list 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 Velsicol's termiticides under existing labeling.
Under the terms of the MOU, EPA also granted Velslcol 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 if air monitoring tests
reveal zero exposure from each use, anT~provided 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 Velsicol has met the terms of the conditional registration,
and therefore, when Velsicol may resume its sale of chlordane
and heptachlor products.
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•2-
On October 1, 1987, Velsicol agreed to voluntarily cancel
its chlordane/heptachlor termiticide products which were not
conditionally registered pursuant to the MOU. The October 1, 198'
Cancellation Order was published in the Federal R ri ster on
November 3, 1987 (52 FR 42145).
Under the Cancel .tion
Velsicol was still prohibited from the sale and distribution of
its chlordane/heptachlor termiticides; however, existing stocks
provisions were established which phased out sale, distribution,
and use of Velsicol's chl ordane/heptachl or termitlddes by persons
other than Velsicol. Between December 1, 1987 and April 15, 1988,
stocks of Velsicol's chlordane/heptachlor termiticides may be
sold, 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/Heptachlor
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 Votice 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 is, 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 existing
stocks provisions of the April 5, 1988 Suspension Notice which
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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-3-
REGULATED INDUSTRY
The sole producer of technical chlordane and heptachlor in the
United States is 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 chlordane/heptachlor 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 1s 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 1?F THE AtTGUST 11. 1987 MEMORANDUM OF UNDERSTANDING
As per the August 11, 1987 NOU, 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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Ri-yister / Vo! 52 No 2",2 ' Tunsd.iv. N'ow-.'.pr 3. 196? / Notir.rs
ii; c;r
-re cJ
' •«• s: jjl b< nntjc v%iih
-•:.. <•» !(..i:-. 5H p S ; u! the
•« ".; i rt,j"Sf- spray nozzle
••> •«:.!,. -.?-. nj horizontal b.irni'is
-( v sld-^s cannot be poured
/ ; IM- «..irr.e J^y ii has been
: ,i \\utrr-proof cover, such as
.;icnt' shec-ung. should be
0-. t-r the soil to prevent
r-ci.rn Tn ^ is not necessary if
fi.uTd.iticn wails have been insuiied
..rr.jnd Ihe treated sc.il.
Vi-r'.jc .ii Barriers
Afi.-r ihp fo'jrri.it.on wn!!s Have been
pujrrj cr buiii but before slabs are
poured, vertical barriers may be
es' iM.ihrd ir. so;! which will be under
ihe perimeters of floating or supported
sij.i? around utilities which will
PF-:-.L ':•):•: the slab and in other crMit^l
,ir. ,:s '.-.rich w.JI be covered by
r . r.' T'.-.r After the final exterior grading
iv i^rrpte:cd. vertical barriers may be
crtuifd in back-fi)!?d soil against
foundation wails or against the outside
of ncnulith.c slab. To produce a vortical
harper applv !he emdiion at the rd'e of
4 Ccli.-r.s per linear fret per foot of depth
{••nr-. cMtk- to the top of the foorir.s For
-' •• •:. i:!hir s; i:-; apply to :he bottom of
— I ,-vv prrssurr rr
.ric
-. .i;ji!:rat!-jr.s should nc' be
.< b-, 'L>W rhe lop of ;hc fcc:;r.j;
c^r' Khrn the footing ;s e\pos?d j:
or ul:".r c'aiJe. Speci^.! care shct'J
tr tdktn 10 avoid soil washout around
;S fn&nrij
—When reeding, use cn!y lew presyu.'e
(less t.hdr. C5 p s i. ai the nozzit) 1; is
iiriporiant that emulsion reaches the
foctir.p Rod holes should be spaced to
prcvide a continuous barner.
— Trenches need not be wider ihdn G
inchas.
— E^yision should be mixed with the
soil as it is being replaced in the
trench Cover treated soil with
approximately 2 inches of untreated
soil.
C.-c:>/' Space Foundations
For craw] space foundations, vertical
barriers ma> be established in the soil
on the outside perimeter of the
foundation using a rate of 4 gallons of
emulsion per 10 linear feet per foot of
depth from grade to the top of the
footing Application may be made by
low pressure redding and/or trenching
to the footing. If the footing is exposed
at or above grade, application should be
nude with specid! care to avoid w;i«h-
O':i around the footing
— Do not trciit the footing thru ugh
hollow masonry voids.
— Rod h lie-. sK uld L.1 'Ourui to prir.itir
.1 coniin-jous tKnir,i| barrirr
—V.'hpn r't!J:r.z i.kf ..iririj. pi---ru:ii-r.
u^r low jin
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Vn! 3;
\,
5 ••• C •<•«?. ~'it--T
.li.tt.ij irti- j'.tjiilf of the fiMu.J jtion bv
i >v» prv*.,';r' rodtlmg Jiui/or irrnthir,;
.ii ih< r jn- uf 4 g.illons of emulsion pt>r
in nni .1: frft Low press,if rmldir.y
:;o-_!J ni;' c»icnd beyond *h« Inf. uf
— V. i.pn lodJing. use on!> low pressure
{Irss ;har) 25 p si at the nicziu)-
—U,-,.J h be applied only
by t;c r.chir.R or the exravation
te,hr.:quc below ct a r*'.e of 4 gallons of
rrru'sion per 10 hntvr feel per foot of
depth to be treated. Where exterior
s..i!is arc adjacent to the foundation
wall, drill throuph the sUb along the
outside of the wdil at a spacing that
provides application of a continuous
b.i.-r-i-r and apply the emulsion just
i:rdpr the slab. After drilling, emulsion
may be applied. Apply only at the
lowest pressure that will start the flow
of emulsion from en unobstructed rod.
Apply up to 4 gallons of emulsion per 10
linear feet.
A complete termite barrier may
require application of another EPA-
registered product under interior slabs.
through hollow masonry voids to the
fooling, and to other interior critical
areas.
E\cavation Technique
If treatment la to be made in difficult
situations such •• near well* or citterns,
along faulty foundation walls, and
around pipes and utility lines which lead
downward front tha atructure.
application must be made in the
following manner to avoid intrusion of
termiticide 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
r.f •!i-;i:h .if I1'- tn-n*'; Mm t!ic
C'!'uUi"is •n'w.ujHy rrr'i \h\. -.n-l
l.i* :•,. i .ire !. ; -i n.Til li^t.tj .'i.un
nir::-..:-^ ^ff I: • lir.i r
— Aficr i*u src.ittd so;: lus urud
.idv^ii.iir'x. ri-;'Lrr lit .ml .n il.f
trtT.i. h and tover wi:h .ipi.'rt>Mr'i,.ii.ity
2 :ncr>r$ of uniruatcri soil
net. i*:i.:
S.-r^ i
ofV.Vi'i
Pruti-i.:
• OIT
' '• -> r
; , .111 U-
(....« !*:<
as; A^f
1 ni-
n-t^r
HI \
• - •- wi . • i
. \i : "•• >' '
.1^" . .. ,»* i ' .i/
,r t|>>"-v ^
,, r...,,.-.'fl
4u: N:S.. •. '^
Retreatmcnt for subterranean lerrr.iics
should onlv be made when there is
(nidenci- of reir.festation subsequent to
the initial treatment, or thcrf has been
disruption of the chemical barrier in the
soil due to construction, excavation.
liir.dscapmg. etc. Kctreatment shojld be
rrade as a spot appiicntion tc these
areas.
Resentments may be made to critical
ureas m 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, 1987.
supplementary agreement between EPA
and Vclsicol. can bo obtained from the
person listed under FOR HOME
INFORMATION CONTACT:
Daitfd October :i ISfCr.
Dou(la» D Carrpl.
Director. Orf.Cf otf-?s:iCitJrPiv$ivm:.
|FR Doc 8r-!3J83 Fiicd ll-2-6r. 6 45 nmj
•ILUNC COOC «J4«-»-U
IOPP-1B0747; FRL-32S6-5I
California Department of Food and
Agriculture; Receipt of Application for
Emergency Exemption To Us*
Hydrogen Cyanamlde; SollelUtion of
Public Comment
AGINCY: 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") lo use the active ingredient
hydrogen cyanemide ("Dormex") to
promote uniform bud break in 16.800
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 lo
grant Uu exemption.
OATt: Comments must be received on or
before November 10. 198".
AOONCSSES: Three copies of written
comments, bearing the identification
\\.ishiiv.-..i. JVC :u
In pt:i»on. bring commtr.ti u. R:n I>u
Crssl.il Mall *2. 1921 Jefferson D.i\is
Highway. Arlington. VA.
lnforni.it ion submit led in .ir,\
commpr.t roncerninp this nonce n:.iy te '
rlaimed cnr.fiderttial hy marking jny
part or all of that informal.on as
"Confidential Business InformJMC^
(CBI)." Information so marked wui ro(
be disclosed except in .icccrdjncc v.;'h
procedures set forth m 40 CFR Port z. A
copy of the comment th.it docs ccr.tjm
GDI mus! be submtsted for -icLsiOr. .r.
the public record. Information nut
marked confidential may be disriusci!
pubiicK by EPA wilhou! prior notice HJ
the subrr.itter. All written comments w::l
be available for inspection in Rm. 230 <*:
the address given above from S a.m to 4
p.m.. Monday through Friday, excluding
legal hohdays.
FOR FURTHER INFORMATION CONTACT:
By mail; b'.'by Pemberton. Rig:stration
Division (TS-rerC). Office of Pesticide
Programs. Environmental Pro!cct;cr.
Agency. 401 M Street. SW.. Wasrunp-.o.-..
DC 20460
Office location end telephone i
Rm. 716. Crystal Mo!! =2 19:: ||
Davis Highway. Arlington. VA.
557-1606}
SUPPLEMENTARY INFORMATION: P'jr.ruar.t
to section 16 of the Federal Insrr.iir. Je.
Fungicide, and Rodenticide Act (FIFRA)
[7 U.S.C. 136p). the Administrator may.
at his discretion, exempt a State agency
from any provisions of FIFRA if he
determines that emergency condition?
exist which require such exerrpticr..
The Applicant has requested the
Administrator to issue a specific
exemption to permit the use of an
unregistered plant regulator, hyijrogcn
cyanamide (CAS 420-04-2).
manufactured as Dormex. by SK'.V
Trostberg Aktiengesellschaft. to promote
uniform bud-break in table grapes
grown in the Coachella Valley m
Riverside County. California.
Information in accordance with 40 CFR
Part 166 was submitted as part of this
request.
Approximately 18.800 acres of labic
grupes. Vitis spp.. are grown m the
Coachella Valley. The Applicant
indicates thut California growers rf
early market table gnpes arc frir-.ra
economic losses due to increas:rc
competition from fore:?- impcris.
particularly from Mcvco. The Ar
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-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 registrati
into two separate registrations. A new EPA registration number
was assigned for each of the above End Use products for the uses
Appendix A as "retained uses". The remaining uses
above products maintained their current EPA
on
two
i s s i <,
described in
for each of the
registration numbers of 876-233, 876-63, and 876-104 respectively.
The regi
and Chi ordane
EPA registrat
been vo1untar
wi th the fo11
Gold Crest H-
spray (Termid
perimeter spr
space perimet
order also af
(the list of
strations of Gold Crest Termide, Gold Crest C100,
SEC Termite, which have maintained their current
ion numbers of 876-233, 876-63, and 876-104 have
ily cancelled effective September 30, 1987 along
owing Velsicol products: Gold Crest C-50 (876-86),
60 (876-85), California SLN for crawlspace perimeter
e) (CA-810012), California SLN for crawlspace
ay (C-100) (CA-810012), and Hawaii SLN for crawl-
er spray (C-100) (HI-850003). The cancellation
fects Velsicol 's supplementally distributed products
supplemental registrations are in Appendix B).
The Gold Crest Termide, Sold 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 MOD, are met. Additionally, the cancellation
does not affect the following Velsicol chlordane and heptachlor
products: Technical Chlordane/ Export (876-280); Technical
Neptachlor/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)(111)] 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.
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r
-5-
Please note, the directions for use found in the cancellation
order cannot be considered "labeling" unless they accompany the
product. There is 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 in 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.
chlordane/heptachlor suspensions did not
the sale or use of existing stocks of
persons other than the registrant. Any
from the April 5, 1988 Notice of Intent to
prohibitions on the sale and use of existing
However, the previous
place prohibitions of
suspended products by
suspensions resulting
Suspend will Include
stocks of suspended chlordane and heptachlor termi ticides.
-------
-6-
Existing 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 person maydistribute,
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/retailers, and
users of chlordane and heptachlor termiticides. Noncompliance
with the October 1, 1987 Cancellation Order or the April 5, 1988
Notice of Cancellation 1s a violation of FIFRA sections 12(a)(l)(A)
and 12(a)(2HK).
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 di stn'bu tors/deal ers/retail ers, 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.
Regi ons/States wil1
as appropriate.
also investigate all tips and complaints,
Please note, registrants of the suspended products have already
received SSURO's 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 S12(a)(2)(I)
Sale, distribution, commercial use and con.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 Velslcol 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-
D Is £ r 1 b u t o r / D e a 1 e r / R e t a 11 L e v e 1
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 termiffcide
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 Velsicol's chlordane and heptachlor
is being used only by certified applicators and in accordance
with the use directions found in the Cancellation Order.
After April 15, 1988, during routine inspections at
user level, Agency/States will assure that any remaining
of Velsicol chlordane and heptachlor are not being used,
remaining stocks of non-Velsicol cancelled chlordane and
products are not being used for purposes of commercial use or
commercial application.
the
stocks
and
heptachlor
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 applica* on.
ALLOCATION OP KtSPONSTBTLTTlES
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 chlordan? nd
heptachlor products agree to voluntarily cancel their oducts.
Will notify OCM if 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.
8 Will transmit a list of establishments producing Velsicol's
chlordane and heptachlor termiticides to the Regions.
e 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.
* Will distribute lists of products to the States.
* Will conduct distributor/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.
e Will issue SSUROs to first-line distributors, of non-Velsicol
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-
0 Hill 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-cor*ormance with the
terms of the MOU by Velsicol. As stipulated in the January 29,
1988 Chiordane/Heptachlor Compliance Monitoring Strategy, the
first report is due April 15, 1988.
0 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.
Will conduct a books and records
chlordane/heptachlor registrants
distributors of those products.
inspection of non-Velsicol
to determine the first-line
0 Upon identification from the books and records inspections,
States will transmit information on the identity of first-line
distributors to the Regions.
e Will take enforcement action, Including Issuing SSUROs, as
appropriate, provided they have the authority.
e 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 Chlordane/Heptachlor Compliance Monitoring Strategy, the
first report 1s due April 7, 1988.
-------
Establishments Producing Velsicol's Chlordane and
Heptachlor Termi t i ci des
00876-11-001
Velsicol Chemical Corporation
Box 39A II 1 i noi s HWY 1
Marshal 1 , IL 62441
00876-TN-001
Velsicol Chemical Corporation
1199 Warford Street
Memphis, TN 38108
-------
-------
APPENDIX A
Retained and Deleted uses of
Velsicol's C il oMa ie 'Hept ach 1 or Products
Velsicol classified the following uses of
its end-use termiticiae products as
"deleted uses":
a. post-construction application of
material *rotn 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 redding for post-
construction application of material
to a basement-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 ot voids and spaces in
masonry or block walls or areas
behind veneers;
f. applications by non-certified
g
applicators;
soil-injection pressure rodding at
pressures greater than 25 psi.
The agreement further classified the
following uses of end-use termiticide
products as "retained uses":
*. application to the outside
perimeter of any structure by
trenching, or drilling .through
sidewalks, patios, gr <5ther
unenclosed slabs, and applying
material to the soil without
pressure (e.g., flow or gravity
feed);
-------
d.
-2-
APPENDIX A
b. applications by cne excavation
technique co the exterior of any
structure (i.e. , by removing soil
next to the foundation, placing
on a tarp, treating with
terraiticide. and placing back in
trench after soil dries);
c. pre-construct ion low-pressure
(maximum 15 psi) vertical rodding
(with the application rod equipped
with a pressure control device to
prevent higher pressures) of the
perimeter outside any structure;
pose-construction low-pressure
(maximum 25 psi) vertical rodding
(with the application rod equipped
with a pressure control device to
prevent higher pressures) outside
slab ana post and pier type
structures ;
e. pre-construction coarse spray
surface treatment (maximum 50 psi)
and low-pressure (maximum 25 psi)
vertical rodding (with Che
application rod equipped with a
pressure control device to prevent
higher pressures) under the slab of
slab type structures.
The agreement classified one use, the
protection of underground cables, as an
"unaffected use".
In addition to this classification of
the uses of Veisicol's termiticide products.
the agreement included, inter' alia, the
rollowing provisions:
0 The retained uses were converted to
restricted uses as provided tor in
Sections 3(d) and 4 of FIFRA;
-------
A?=ENDIX
The registrations of Che 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 net.
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 products to provide
that such products could noc 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
temiticide.
,11
-------
-------
APPENDIX B
Supplenental Registrants of Velsicol's
Chlordane ,'Heptacnlor Termiticides
(d?S-C3053-000192)
(875-00053-000430)
(376-
(376.
(376-
(376-
(375-
(376-
(376-
(876-
(876-
(376-
(876-
(876-
00063
00063
00063
00063-
00063
00063-
00035
00086
00086-
00086
00036-
00086-
•002935}
•005887)
-010370)
•025030)
-034704)
•043227)
•035034)
•000016)
•000192)
•004876)
•005887)
•00.387)
(376-00036-005887)
(876-00086-006723)
(876-00086-010370)
(376-00036-012000)
(375-00036-012000)
(375-00036-034704)
(376-00100-OU0192)
(876-00104-000430)
(376-00104-001812)
(376-UQ104-004876)
(876-00104-006723)
(376-00104-025030)
(876-00104-042761)
(376-00233-001927)
(876-00233-006754)
Drexol Chlordane 72* Termite Spray for
Professional Termite Use
Durham's Cnlordane Emulsifiaole 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
Di versey 2.5 H
Dragon 451 Chlordane Spray
Dexol Chlordane 45X Termite Spray (Prof./Termite Use
AG Chlordane 4-EC Termite Control
Black Leaf 451 Chlordane Termite Killer
Termite Killer For Use
Emulsifiable Consentrate
for Use Around
Black Leaf 451 Chlordane
Around Buildings
Black Leaf 451 Chlordane
Insect icide
Red Wing Chlordane 4 EC
Ford ' s Chiordane 4 EC
K Mart 45X Chlordane Termite Killer
K Mart 451 Chlordane Termite Killer
Bu i1d^ ngs
Pro-Chlordane 4-E
Dexol Chlordane Termite Spray
Durham's Chlordane SEC Emulsifiable Concentrate
Pee Gee 8 IDs. per gallon Chlordane Emulsifiable
Concentrate
Chlordane-8 Termite Control
Red Wing Chlordane SEC
Red Panther Chlordane
Red Panther Chlordane SEC
Terminix C-H
Orkil 2X
-------
-------
G,
C.
FIB* I:. \ '
01/Ci/H :
st;? SAL'S ISJTK AS :
of Products Containing
rdane and Heptachlor
COWAM
WVA: CEMICAL COEP.
41C3 MS: WSSIIISTCI BLVD
105 A$::IES H 90023
A«VAC c-*«::iL ccs?.
4100 !»S: MieHr/H EX
LOS 4S'!L!S C». 50:23
MT;AC CRMCJIL COB?.
41 :c EAST KASiisros BT.V:
MS ASGiLES CA W.I}
IK; KST iAS-isr'jii «:vr-
LOS AS;£L!S CA 90I2i
Ai CH™::*: *3E?,
iSH ELEVtSTt ST
NZTSWtti OE 45662
AP CE-V.CA: ::=?.
15:4 EL!V!!lrf ST
?'-TS«.;::: OE 45e<;
A= CH*::A: co-j.
'li< i,".5Vt8r: 57
JCETS«;:7E CH 456*2
B 4 G K«Mt
1D539 •A«5A!C!'. M B5H iC'<
DALLAS ?! 1522C
8LAC? L!A? PSODrCTS CO.
6«7 I STATE ST
II 6C12:
EUCI l!»F PRODUCTS CO.
fca7 I STHE ST
ELGIN II 60:20
80SCIE CBEHICAl CO., 1«.
2 KUSl AVE.
MEJV.L1! SK 13495
80SDI! CH-SIC4L CO., ISC.
i K«Z AVE.
KCP.rviUE I! 11*^5
E0«i:!» CH»*!CAL CO., ISC.
2 n:s; AVE.
10-FVi;:! UK !J4»5
5*b: 223
545. 226
5481 31
5461 50
7122 121
V ^ 1
/** A
CSLC2DARE
CHLOS:ASS
CSIOBDAH
.->;;
SiS" 127
i«: 6?
4 274
4 21?
CEWF.DASE
CHLOSDASE
CSiLOSIAS:
ss iss:-: L!?::A:- H:::" •"*
Ol/Jfc/BB / / OS CA
01/C6/I8 /
CA
01/06/88 / / 05 CA
01/06/88 / / 09 Ci
01/fl6/86 / / C5 OH
51/06'$$ / t ' K OE
!6 TI
01/06/88 ,' / r:5 IL
01/03/8B • ' i.; I!
01/06/86 / / C2
-------
-------
APPENDIX B
Supplemental Registrants of Velsicol's
Chlordane/Heptachlor Termiticides
(876-00053-000192)
(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)
(876-00086-006723)
(876-00036-010370)
(876-00036-012000)
(876-00086-012000)
(876-00086-034704)
(876-00100-000192)
(876-00104-000430)
(876-00104-001812)
(876-00104-004876)
(876-00104-006723)
(876-00104-025030)
(876-00104-042761)
(876-00233-001927
(876-00233-006754
Drexol 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
Oexol 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 1 di ngs
Black Leaf 45% Chlordane Emulsifiable Consentrate
I nsecti ci de
Red Wing Chlordane 4 EC
Ford ' s Chlordane 4 EC
K Mart 45% Chlordane Termite Killer
K Mart 45% Chlordane Termite Killer
Bu i 1 di ngs
Pro-Chlordane 4-E
Dexol Chlordane Termite Spray
for Use Around
Durham's Chiordane
Pee Gee 8 Ibs. per
Concentrate
Chlordane-8 Termite Control
Red Wing Chlordane SEC
Red Panther Chlordane
Red Panther Chlordane SEC
Terminix C-H
Orkil 2X
8EC Emulsi fi able
gallon Chlordane
Concentrat e
Emulsifiable
-------
-------
COMPEJT?
Bonide Chemical
Dragon Che-deal
Corporation
Rico Company
Incorporated
Thompson-Hayvard
Chemical Company
APPENDIX C
CHLORDANE CANCELLATIONS
EPA REGISTRATION NO.
4-96
4-218
4-274
4-275
4-287
16-96
16-116
16-122
16-124
70-119
148-27
EFFECTTVF 1
3/17/88
3/17/88
3/17/88
3/17/88
3/17/88
4/27/87
4/27/87
4/27/87
4/27/87
4/27/87
6/01/8'
-------
-------
Litxt. 1 Industries
Tobacco Stages Chemical
Company
Chevron Chemical
Cor.pany
FMC Corporation
C.J. Martin Conpany
Residex Corporation
191-42
192-43
192-132
192-133
226-177
226-184
239-478
239-1232
279-383
279-538
299-171
373-26
3/20 • 8S
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
.poritl Incorporated
Boy1e-Mi dvay Inc.
Rockland Cheinical
Company Incorporated
Kaviland Agricultural
Chemical Company
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
3/25/87
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
-------
-------
• -o
• MFA Ci 1 Cor.par.y
__ Security Lawn and
""" Garden Products Co.
Faesy i Besthcff
Incorporated
1 Chas. H. Lilly Co.
Green Light Ccmpany
Velsicol Chemical Co.
•
Miller Cherr.icai &
Fertilizer Corporation
Cre-0-Tox Chemical
Products Company
Seacoast Labortories
Incorporated
Cotton States Chemical
Company
Land 0' Lakes
746-53
746-76
746-119
769-90
769-511
779-82
802-71
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 15 ':
3 25 £ '
3 1 5 ,. £ 7
3/25/87
3/25/87 .
6/OZ/87
9, 11/ET
3/25/87
3/25/87
11/04/87
.-,,'25/87
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
3/19/86
7/01/87
7/01/87
8/20/87
8/20/87
3/25/87
3/25/87
Universal Cooperatives
Incorporated
1386-26
3/25/8"
-------
-------
Or.--, tiebach Chemical
Co: porat ior.
FCX, Incorporated
Griffin Corporation
Tria:.gle Chemical
Teririnix Division
cf Ccok Industries
Incorporated
r.LCO "ar.uf act'-ring Co
Farmland Industries
Incorporated
r.-:.R. Grace & Coir.pajiy
PSI-C-ordon
Corporation
Hopkins Agricultural
Chemical
Colonial Products
Incorporated
La£oche Industries
Earl May Seed & Nursery
L.P.
Stephenson Chemical
Company Incorporate
1386-353
1421-23
1598-145
1598-244
1812-242
1812-243
1S42-41
1842-42
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
8, 2J - o~
3/21 S3
4/27/37
4/27/87
7/01/87
7/0 i .'87
I< / ~ 4 , £ /
5/14/87
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
-------
-------
Cherr.ical
Incorporated
Coastal Chemical
Corporation
Chacon Chemical
Corporation
GRO Chemical
C crip any
Helena Cher.icai
Coir.pany
Octagon Process
Incorported
n Corporation
Forshav Chemical
Company
Voluntary Puchasing
Group, Inc.
B & G Company
Sunniland Corporation
Nationwide Chemical
Products, Inc.
Ross-Daniels, Inc.
Cornbelt Chemical
Company
4931-5
4 9 £1 - 6
5549-41
5719-2-
5778-33
5905-97
5905-102
6830-15
7122-3
7122-34
7122-121
7234-5
7234-6
7234-10
7234-100
7234-101
723-1-20
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 / S 7
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
-------
? ::" d ' s C; ic * i r a 1 c.
Hr.cier.aa Enterprises
rur.a Chemical Company
Lrexel Chemical Ccr.par.y
?:atte Chenzcal
Ccr.pany
Falls Chemical
Raw Valley, ir.c.
V.'ilscr. Lairoratories
Car.ercr. H. Bairc
r-'icro-Flo company
Garden Care by
Farmingdale, Ltd.
10370-4C
10370-116
10370-144
10370-145
11037-7
11611-4
19713-214
19713-215
34704-1
COMPANY
TIiompson-Hayvard
Chemical Co.
velsicol Chemical
Corporation
EPA REGISTRATION NO.
148-964
876-101
876-85
876-233
876-308
876-309
876-310
3,2S- 8S
3.- 2 b i c
3/2S, 63
3/ 28, 63
4/27/87
7/17/87
3/24, SS
3/24/33
4/27/87
40831-5
40631-24
. 44215-7
44215-20
50383-20
50383-29
50415-27
51036-30
51036-31
53127-1
53127-10
HEPrfyCHLQR CANC.FJ-T.I
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
^TIONS
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-Q-Tox Chemical
Products Company
Griffin Corporation
7r i angle Che-ical Cc .
r&rr.inix Divisicri of
Cock Industries, Inc.
Stepi-.enson Cher.ical
Ccr.pany Incorporate
Roiv.-ood CnciTiical, Inc.
Pe± v;ing Chenical
*
.".rvher; Corpcraticr.
Forshaw cne-dcal Company
1066-28
1066-29
1066-30
1812-77
1342-183
1927-50
4887-59
43S7-85
4981-17
Cnerri-Nut , Inc .
Farmco Industries
Incorporated
Micro-Flo Company
37686-27
46778-1
51036-50
7/01/87
3,19/88
7/01/87
7/01/37
5/14/8"
4/21/87
3/22/88
3/22/88
7/08/63
6723-8
7122-6
7234-27
7234-31
7234-89
6/07/84
3/17/68
3/18/88
3/18/88
3/18/88
5/08/87
5/12/87
4/27/87
-------
-------
APPEND:/: D
S rs
COMPAJfY
Var. Writers & Rogers, Inc.
Chap-an Cheir.ical
Company
550-106
550-107
1022-502
Vaccine! Chemical Company
Incorported 1353-4
AMVAC Chemical Corporation 5481-223
54B1-226
5481-50
5481-315
7/18/67
7/18/87
7/15/87
7/15/B7
7/17/87
7/17/87
7/17/87
7/17/87
Carolina Chemical
Corporation
Black Leaf Products
Ccr.par.y
Sr--jthcrr. Mill Cree):
Fro^jcts Cor.par.y
Dettle±;ach Pesticide
Corporation
Mystic Cher.ical Products
5797-8B
5857-67
5687-127
U.S. Marketing Distributors 6409-13
6720-2
6720-71
6720-133
6720-176
6720-260
6720-361
6720-363
6754-9
6754-11
6754-40
6754-64
36272-3
7/15/37
7/16/87
7/16/87
10/21/87
7/15/87
7/15/67
7/15/87
7/15/87
7/15/87
7/15/87
7/15/87
7/15/S7
7/15/87
7/15/87
7/15/87
7/15/87
COMPANY
Southerr. Mi 11 Creek
Prcfucts Cor.pa.iy
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-------
Federal Reuister / Vol. 52. No. 212 / TursilrfV. Novrrnl>or 3. 1l»H*
42141
t
h'M fust Uraft of the Ki»k
Kir.ii.uiion Croup s sl rali:u\ on
i-nvii.:an;< n:.il risk reduction
Thi mi-ciing is open to the public. Any
men,her of lh*» public wishing to attend.
rv.jke brief or.il comments, or submit
written comments to the Croup should
notify Mrs Kathleen Conv/ay. Executive
Setrot.iry. or Mrs. Dorothy Clark. Staff
Scoffidry. (A101-F) Sciencr Advisnry
Daard. by the close of business on
Friday. November 20.1987. The
telephone number is {202} 382-2552
Terry F. Yocie.
Dirc-.'.or. Snera Advisor}- Board
U-.lc Oc:ol-Lf TS 19.""
JFR Doc. 87-:5383 Filed ll-:-e.*; 8 45 urn]
•IUJMC cooc
Science Advisory Board Research
Strategy Subcommittee Sources,
Transport and Fate Group; Open
Meeting
Under Pub. L B2-463. notice is hereby
given that the Sources. Transport and
Koic Subgroup of the Science Advisory
Bo.ird's Research Strategies
Subcommittee wif) met I from 9:00 a.m
to 4 00 p.m. on December 81h at the
Hyati 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 development
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 it open to the public. Any
member of the public wishing to attend
or submit written comments should
notify Dr. Terry F. Yosie, Director.
Science Advisory Board, at 202-382-
4126 or Joanna Foellmcr by December 4.
1907,
Date October 2fl. 1087.
Terry F.Voi IB.
Director. Science Advisory Board,
|FR Doc. 87-25391 Filed 11-2-67; 8:45 «m|
•ILL1NO COM MW-M-N
IOPP-*0011;FRL-3JB6-SI
Chlordane and Heptachlor
Termiticides; Cancellation Order
AGENCY: tnvironir.cnl.il I'jo'-clion
Agency (LI'A)
ACTION: Order.
SUMMARY: On October 1.1987. El'A
issued an Order accepting the voluntary
cancellation of certain chlordane and
hcptachlor lermiticide registrations held
by Velsicol Chemical Corporation, and
hmilinf: the use of existing slocks of
Velsicol's chlordane and heptachlor
termiticide products oulside the
company's control on August 11.15*87.
Under the terms of (he Order, such
stocks may be sold, distributed or used
according to their current labels until
November 30.198". From December 1.
19E7 until April 15.1988, such stocks
may only 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 Apnl IS. 1988.
FOR FVRTMEft 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 11,1967, EPA and ''elsicol
Chemical Corporation (Velsicol) entered
into an agreement affecting Vetsicol'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
termiticide products were deleted from
the label and the remainder of the
registrations were convertad into
conditional registrations. Under the
terms of the conditional registrations, no
further sale or distribution by Velsicol of
its affected chlordane and heptachlor
termiticide products was allowed unless
and until Velsicol satisfied air
monitoring requirements specified in the
conditional registrations. The August
11 Ih agreement did not affect existing
stocks of Velstcot's termiticide products
outside of Velsicol's control on or faelore
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 io a federal court
action.
Tit.- (."irt iti !im< ,i. linn r\|ir ->-i .!
i.mil •Tr ih il t.i' \ ;- :^n| n.n r
<:Mi'fL'iti'r..!i-r! Mir .11;; v.iiv t ! rv > ;:.:
sUie.ks in llut >!«>• if :i'i i \iSi.fk; •.:•>. ».•«
niiph! rxTtdnui- t:.Ji insitrJy VVhi.r \'.\'\
ninlinjr-s ly bfi.i:vc Ti-it US rs!:n-, i'c
v..is nn jLcur.itL- one. Li'A nr.J \ i-isicoi
.lyetil lo suppli-ment Ihe Auirust 11 sh
av;i rcniur! in orciur lo Hlii-vi.iie tht-
court's coru cms.
Under the terrr.s of the S^pplnmcr.!.
i.itififd on OcUfier 1. lytr. Vebicol s
chlr.rrlnne ar.d heptnchlor tcrrniticidi:
rcpistriiticns worn split ir.tn produr?
ri'^istrdiionb cor.tjiring the dcSeied uses
ard product registrations containing the
retained uses. Those registrations
containing the deleted uses were
voluntarily canceled EPA issuer! .in
Order on October 1.1957. accepting thu
voluntary cancellation and placing j
two-licred cap on the use of existing
stocks of Velsicol's chlordane and
heptachlor termiticide products outside
of Velsico! s control on August 11.190".
These stocks may be sold, distributed
and used in any manner consistent with
thtir labeling until November 30.198-
From December 1.1HK7 until Apnl 15.
1988. these slocks may be sold,
distributed and used only in accordance
with the specific directions for use
attached to the October 1st Order. No
use of existing stocks uiil be permi;;cd
af'.tfr April 15. I960
The text of the October Isi Order and
the attached Directions for Use arc set
forth below:
Ir the Mutter of The Vnluntsry
Cancellation of Certain Pestic;dt Procjct
Regis'.ritioni Held by the Vctsicol Chcrr.,cd!
Corporation
Order Accepting Voluntary Cancellation
and Authorizing Use of Existing Stocks
With Limitations
As explained more fully below, this
order accepts the voluntary cancellation
of the registrations of certain pesticide
products registered by the Velsicol
Chemical Corporation ("Velsicol") and
imposes limitations on the continued
sale, distribution, and use of existing
Stocks of such products. This Order is
issued pursuant to the authority in
section 6(a)(l) of the Federal insecticide.
Fungicide and Rodenticide Act.
On August 11.198'. Velsicol and EPA
entered into an agreement affecting
Velsicol's registrations of chlordane and
heptachlor products. The agreement is
memorialized in a Memorandum of
Understanding and accompanying
Conditions of Registration and
Monitoring Protocol. Under the terms of
the August 11 agreement. Velsicoi
classified the following use* of its end-
-------
42141.
rVri.-rjl Register / Vol. 52. No 212 / Tiii'sil.iy \ovi
r 3. TOOT
\f>t'l CS
"d^ie'rj
on ;ip;>!ici»tion of
bv VrNitC'l :il!:>ut?d iir.lii crrl.nn
rondiliuns set forth in thr Conu.iimis uf
n. :. * i f'nn \v'h.r. .1
!:•• • :>!••.! i,v htfTirtr.s (' structure"):
I. t'us! construction up^ii(:Al:on of
rr. .• :;j', from outbid'. » structure lo
ir.s.kic o; underneath a siruclurc;
c The use of pressure roddire for
pusJ-ronstruction application of muterial
to ;i baseri.-nt-type or cran l-spocc lype
ri. Prp- or post-ccnsirjction treatment
of :he urea underneath crawi-spuce and
post and pier type structures:
e Tro.VT.cm of voids end spaces in
masonry cr block walls or areas behind
venders:
f Applications by non-certified
i> Soil-injection pressure redding at
pn-^surrs greaier lhar. 25 psi.
The agreement fur'her classified the
folldwmg USPS of end-use termiiic-.de
products as "retained uses";
a. Application to the outside perimeter
of any structure bj trenching, or drilling
through sidewalks pat;os. or other
u"'T.do«rfi slabs. ard applying material
in :iu' so.! without pressure (t?.£.. flow or
g'.iv.ty fri'ili,
b Applications bv the excavation
technique !« the cxter or nf any
"•truri'.irr \i e . by re .TV". :np soil next lt>
."e foundation. placing 01 a tarp.
t:t. i.nj; w:th lerrrutii.idp. aril piacinc
(j,!t^ ;r. trench after soil dries);
c Pn-ror.i! ruction lev, -pressure
jrr,;M~v:rr 25 psi) vertical roddmp (with
the dpp!.;j!;on rod equipped with a
pressure control device to prevent
hiphur pressures) of the perimeter
outside any structure;
(2 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. Post-construction coarse spray
surface treatment (maximum 50 psi) and
low-pressure (maximum 25 psi) vertical
rodding (with the application rod
equipped with a pressure control device
to prevent higher pressures) under the
slab of slab type structures.
The agreement classified one use. the
protection of underground cables, as an
"unaffected use".
In addition to this classification of the
uses of Velsicot's termitinde products.
the agreement included, inter die. the
following provisions;
• The retained uses were converted to
restricted uses as provided for in
sections 3(dl and 4 of F1FRA:
• The registrations of the retained
usi-s wure amended to conditional
regulations. with no sole or distribution
• Nn fi'-jhi-r ia!t. ::: di'lr>l:i,ii'»-, In
Vi.-isii.al of ctid-uii; products lii!» l.-d f»i
deleted usi:» was jiuwrd
• Vclsico! amended the !dl>6H. thrsf »toi.ks :::iiy he so',)
rt'Mrilnitrd. ;tr,.l i. .cd oniy in lire J.im r
witri il;c (.mul.vr.s rf use pw;. -'J in
Appendix A u! this OnU'r. No ust will
be permitted 4fier April 15.1908.
EI'A believes tht tt;rms of this
Surpiomer.i will iillow for an orderly
and efficinni phase-out of chlor.Jane
use. The Supplement provides sufficient
time for the use uf the volume of existing
siocks estimated by EPA to exist in
Aucust of WC7. but will prevent
unlimited use of such stocks if EPA was
substantially incorrect in its estimate or
if individuals possess large stor*piles.
EPA favors a two-tiered appro...h
because it encourap"' the use of
application methods that are believed to
pose less potential for misapplication
and are beheved less likely to result in
indoor exposure than the USPS that will
be discontinued afur November 30.
19C7.
EPA finds that implementation of this
Supplement is consistent with the
purposes of F1FRA and will not have
unreasonable adverse effects on the
environment. EPA has previously
determined that the agrfeme.it entered
into on August 11.198". which contained
no limitations on the use of existing
slocks, was consistent w;th the purposes
of the Act. The limitations contained in
this Order will not permit any greater
use of stocks lh;in that w • O.P
Agency has already four.., ^ 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 subst; ^tially
underestimated the amoun stocks in
the possession of applicatc- 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 dotes 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 lo 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 for the
ccrt!.rn,jtion of appliLjtors {use of liie
4
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Federal Roister / Vol 52. No. 212 / Tui-"'-y November 3. 19 fT / NVlccs
4214:
i» utirse stocks will be « restricted \jsr-
«* scl fr.nh in FITRA sections 3/d) and 4
.if'.-r \o\«mb»>r 30. 1987J. Finally, the
d.itus reflect iniurmjtpon provided to
KK\ iKii even though there may well
h,u r b< • n only 1 50,000 g.illons of
txis'ir.s «,U)cks in the hands of
ur'',-nc.j!i)rs and distributor* on August
11 190". the rate of cKlordane use has
decreased sinrft that date, and will of
necessity decrease) even further after
NIM ember 30.1907 when certain uses
w-ii'i no longer be permitted.
Dasrd on all the foregoing, pursuant to
riVRA section 6(a](l):
1. The following registrations of
Velsicol's End Use Products arc hereby
cancelled:
A The End Use Product described in
Section I1.A.2 of the attnched
Supplement (that product currently
assigned EPA Registration Number 876-
233 bearing all uses of Gold Crest
Termide other than the retained uses).
D. The End Use Product described in
Section II.B.2 of the attached
Supplement [that product currently
assigned EPA Registration Number 076-
63 bearing alt uses of Cold Crest C-100
other than the reta.aed uses).
C. The End Use Product described in
Section II C.2 of the attached
Supplement (thai product currently
•issipned EPA Registration Number 876-
1U4 bearing all uses of Chlordane 8EC
Termite other than the retained uses)
D. Cold Crest C-50 (EPA Reg. No. 876-
135)
E Cold Crest H-60 (EPA Reg. No. 876-
135)
F. California SLN for crawlspace
perimeter spray (Termtde) (CA-810012).
G. California SLN for crawlspace
perimeter spray (C-100) (CA-810011).
H. Hawaii SLN for crawlspace
perimeter spray (C-100) (Hl-650003).
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 Number* 875-63,
1376-65, 676-86. 876-104, 876-233. CA-
310011. CA-810012, or Hl-650003 is
iubject to the following conditions:
A. Such products may be sold.
distributed, and ustd In any manner
Consistent with their labeling until
November 30.1987.
B. Such products may be sold.
distributed, and used from December 1.
1987 until April 15.1968 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 IS. 1988.
D Any such products that have not
been uf.ed on or before April IS, I960
must be disposed of in accordance with
applicable federal, state and local laws.
It is sc ordered trm 1st ri.iy of
("kinder. 198?.
I)'>;ic!.i5 U Cimrii.
/) re: l>jr. O;'fn.e ofPi-nln idc Fr^,-?ii;ii
Appendix I— Voluntarily Cancelled
Subterranean Termite Control Products
Directions (or Use Between December 1.
1987. and April IS, 1980
Restricted use Pesticide
For Retail Sale to and use Only by
Certified Applicators or Persons Under
Their Direct Supervision
It is a violation of Federal law to use
this product in a manner inconsistent
with these Directions. This product may
not be used against any pests not named
in these Directions. Apply only to
establish subsurface termite control
barriers specified in these Directions.
Contamination of public and private
water supplies must be avoided by
following these precautions: Use anti-
backflow equipment or procedures to
prevent siphonage of pesticide back into
water supplies. Do not treat soil beneath
structures that contain cisterns or wells.
Do not treat soil that is water saturated
or frozen. Consult state and local
specifications for recommended
distances of treatment areas from wells.
and refer to Federal Housing
Administration Specifications on new
construction for further guidance.
Preconstruction Subterranean Temile
Treatment
Effective preconstruction
subterranean termite control »equire»
the establishment of an unbroken
vertical and/or horizontal chemical
barner between wood in the structure
and the potential or existing termite
colonies in the toil. To meet FHA
termite proofing requirements, follow
the latest edition of the Housing and
Urban Development (HUD) Minimum
Property Standards.
Dilution Instructions for Cold Crest
Termide
Use a .75% water emulsion for
subterranean termites other than
Coptotermes spp. Mix 1 gallon of Cold
Crest Termide in 99 gallons of water to
produce a 0.75% water emulsion. Usa a
0.75-1.5% water emulsion for
Coptotermes spp. where necessary. Mix
1-2 gallons of Gold Crest Termide in 99
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
Coptotermes spp. Mix 1 gallon of
product in 95 gallons of water to
produce a \~ nv.cr *nn:Ui'T. '.'.».• i 1-
2 a water emulsmo fur ('. v" ••''•rij: .-«. >,pj
VkhlTi' nPrr^i.Tfy Mix 1-J c.i. :•'!•.« .if
product in 93 £
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T>
\ UNITED STATES ENVIRONMENTAi
WASHINGTON, D.C
OFFICE OF
Q IQPO PESTICIDES AND TOXIC SUBSTANCES
MEMORANDUM
SUBJECT: Chlordimeform - Stocks at Dealer/Distributor Level
FROM: Phyllis E. Flaherty WVfWo
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
nd 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 Agency's position.
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