-------
JUL 3 I IScO
3UBJECT: Request tn Stop Collection of 3oa?le
Requests for T«i3tir.^ at iJeltsville
lOt Snforceaent Division Directors
Pesticide Sranch Chicfa
.t*c arc in f.ne prr»c*;s3 of evaluatini the A^»:ncy's Disinfectant
lonitocin^ ?rr»^ra«. Tne objective of our review is to establish an
c!Ct-ctivc monitor iny system for t;ie purpose of irrorovin^ teat pro-
ccJur'.-j and data flow bctwcun Ucacquarturs, tn«* notions, an.1
3clt3villc.
Until further notice, appropriatr; 3»!3sure3 should fc«.«
stn-j collection of all octstanding s-a.-n?!*^ requ^ats int«-.n-.ied
ttr-wtinq at the Che.-aica! a.nJ Siolo.-jirai Invtstijations Jronch,
j^ltsvillo, .-!J.
cooperation in tais matter is aooreciatr-3.
A. 2. Conroy II? director
Pesticides anJ Touic 3ubs
Znforcca»»nt Division
-------
Tuesday
March 3, 1931
Part III
Environmental
Protection Agency
Pesticide Registration, Reregistration, and
Classification Procedures; Clarification of
Policies on Special Packaging
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.5104
Fcdrr=I Register / Vol. 46. No. 41 / Tuesday. Mnrcn 3. 1981 / Rules ana Kesuiaucns
:NVIRCNVENTAL PROTECTION
;G£.\CY .
OC-rRPart 1E2
2500118]
,ide Registration, Registration,
nd Classification Procedure;
:iarific2tion of Pciicy Issues en
:pec:al Packaging
.SSNCY: Environmental Protection
vje.-.cy (EPA).
,CTION: Rule rsiated notice.
.•JMMARY: This interpretation of the
hiiu-resistant packaging regulation (-JO
15?. 152.15) provides clarification on
everal aspects of the regulation. This
nterpretation becarr.e necessary
•ecause the pesticide industry had
uised a number of questions which the
cency fasis can best be resolved by
-is publication. It is intended that
hrcu§h these clarifications the affected
esticide registrants will be in a better
osition to comply with the regulation
y March 9, 1981. when it becomes
ffective.
Oft RJRTHSa INFORMATION CONTACT:
'.csaii.-.a L Gross. Registration Division
TS-rerQ. Office of-Pesticide Programs.
Ir.vironmental Protection Agency. Rra.
C7. CM=2. 1321 Jefferson Davis
Highway. Arlington, VA 22202. (703-
5- ••'51).
MENTAL INFORMATION: On
•f.-j...; 9. 1379. the Environmental
roteciion Agency (EPA) issued final
^sulaticns which require certain toxic
esticides to be in special, i.e., child-
2s;stsnt. packaging aftar March 9, 1931.
"he regulations are now contained in 40
IFR 162.15. Because so many registrants
.ave had questions about the
T.piemer.iaticn of these regulations,
!?A has decided to publish this Notice.
c answer those questions and to clarify
he regulations in areas where they
night be unclear. These clarifications
•an be used immediately in order to
.mer.d registrations with respect to
:hi!d-resis£ant packaging. Where EPA
:roposes to amend the regulations.
hose amendments will of course-
-eceme effective after full notice and
^eminent ralemaking.
\. Eye and Skin Im'atioa Criteria
Mar.y questions were received
:oncerning the conduct and
r.terpretation of eye and skin irritation
.f-idies. As indicated in the preamble to
he final regulations (-M FR 13021),
estina for a pesticide's eye and skin
rritation effects should be done in
• c' -nee with the National Academy
of Science/National Research Council
Publication 1133 protocols.
B. "Inherently Child-Resistant" Products
A number of registrants have
questioned whether their products need
to be tested for child-resistant
effectiveness, contending that they are
"inherently" child-resistant. These
products fail into two main categories:
(1) those where it is claimed that the
package is intrinsically ur.oper.able by
children, and therefore "inherently"
child-resistant, and (2) those where it is
admitted that the product is toxic and
accessible to children, but where it is
contended that it would not be possible
for a child to consume or be exposed to
a sufficiently large amount of the toxic
pesticide to cause him harm.
It is the agency's position that neither
of these classes of products is
"inherently child-resistant." In the first
case, where product design is the basis
for the "inherently child-resistant "
claim, it will be necessary for that
package to be tested, like all other
pesticide packages, in accordance with
the Consumer Product Safety
Commission protocols, as discussed in
' the regulations and clarified below. In
the second case, it is open to the
registrant to attempt to show that its
product fails within the exemption
category of 40 CFR 162.16(c)(3). on the
ground that despite the pesticide's
meeting of one or more of the loxicity
criteria, it is not hazardous to man. The
registrant must show that a child could
not be exposed to a toxic or harmful
amount of the pesticide. The fact that a
pesticide has not been implicated in a
large number of accidents involving
children is not in itself sufficient-
grounds for exemption. Product specific
test data and an appropriate scientific
rationale must be submitted in support
of an exemption request.
C. Distinction Between "Exempt From
Special Packaging" and "Not Being
Subject to Special Packaging"
Many registrants are requesting
exemptions for products, when in
actuality they are asking if their product
is subject to the regulation. An exempt
ia only appropriate for a product which
is subject to the regulation.
A product whose label does not allow
for residential use. is classified for
restricted use. or does not meet the
toxicity criteria, is generally not subject
to the special packaging regulations. A
product "allows for residential use" if its
label either directly recommends
residential use or reasonably can be
interpreted to permit residential use.
Determining the potential for
residential use from the label directions
may be difficult. Many ornamental
plants and garden vegetables, for
example, arc grown by the individual
homeowner and. there!"jre. a label
which lists them can be interpreted 23
permitting residential use. Residential
use thus may not be automatically
excluded for a relatively large number of
products. In fact. th'e'sa.T.e formuiaticn
may be used, for example, by the
commercial vegetable grower as well as
the home gardener raising the same
crop. The registrant of a product is best
aware of the actual use area/user group
of the pesticide. The registrant is
therefore in a position to either choose
proper labeling (see I below) for those
products not intended to be used by the
homeowner or to choose child-resistant
packaging for those products used and
stored in residential areas. For those
products which will not enter the
residential area even by use of a
serviceperson (see I below) the agency
will continue to follow its customary
distinction between pesticides products
entering the home market and those
which are intended for commercial
production of food crops and
ornamental plants. This distinction has
over the years been accomplished by a
number of means, for example", use
directions and size limitations. On a .
case-by-case basis, and in case of
'uncertainties, the agency has also '
allowed or requested label language
such as "for agricultural use orJy." or
"not for use in or around the home."
The regulations provide for
exemptions under two circumstarrces:
(1) technical infeasibility or (2) where a
product's meeting of the toxicity criteria
is not indicative of a genuine hazard to
man.
Technically feasible means that the
technology exists to produce special
• packaging for a particular pesticide. The
agency is not required to find either that
the packing is readily available or that it
will lend itself conveniently Jo the
existing packages or packaging •
equipment of the registrant. EPA
considers practicability and
appropriateness to be components of
technical feasibility. In EPA'a view.
packaging is practicable if it is
susceptible to modern mass production
and assembly line techniques and
. appropriate if it is chemically
compatible with the pesticide contained
in the package.1
This definition is consistent with thai of the
Consumer Product Safety Commission (CPSC).
published in the Federal Register 01 February-15k
19,-: (37 FR 1427).
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Federal Register / Vol. 46. No. 41 / Tuesday, March 3. 1S31 / Rules and Regulations ISlC-i
•D. "Dormant" Pesticide Registrations
A pesticide whose registration is '
"dorrr.ar.t" is cni which is vniicly
registered with EPA but is net currently
in production. Obviously, the registrant
of a "dormant" product subject to the
chi'd-resistar.t packaging regulations
must ccmpiy'with these regulations
when it either begins cr renews
production after March 9.1931.
E. Voluntary Child-Resistant Packaging
• A auaber of registrants whose
products are not required to be in child-
resistant packaging have asked whether
they may nonetheless use it. The anwer
'is yes. However, once a registrant
chooses to use child-resistant packaging.
the registrant must comply in all
respects with the child-resistant
packaging regulations. It would be
misleading to the public to have two
types of child-resistant packaging—
voluntary and compulsory—which were
nat of equal safety or effectiveness.
F. Product To.xicity and Child-Resistant
Packaging
A pesticide product's toxicity places it
in one of three categories in regard to
child-resistant packaging. These are:
1. Those products which clearly meet
or exceed the toxidty criteria in 40 CFR
162.16(c)(2). These products must be in
child-resistant packaging unless the-
registrant can demonstrate grounds for
an exemption under 40 CFR 162.16(cj(3).
2. Those products for which the
existing toxicity data are not precise
enough to indicate whether the product
.meets or exceeds the tcxidty criteria of
40 CFR 162.:S(c](2). The registrants of
these products may either do further
testing to determine the precise toxicity
of their products, cr they may concede
that their products are sufficiently toxic
to be Li child-resistant packaging, and
ccmp'.y with the chiid-resistar.t
packaging regulations. This second
situation does not constitute voluntary
child-resistant packaging. There are
three notable situations where this may
occur.
(i) For purposes of precautionary
labeling the agency may have
considered oraUoxicity data sufficient
to show that the" product was in toxicity
category III (LD»« of from 500 through
5,000 mg/kg). but not specific enough to
determine whether the product has an
LD»of 1.5 g/kg or less.
(ii) Eye irritation studies may have
been submitted which showed corneal
effects past day 7. and the study may
have been terminated without
determining whether the effects were
reversible in 21 days. Such a study was
sufficient for purposes of precautionary
Inbeiin? (category 1) but is no longer
adequate to determine whether or not
child-resistant packaging (CH?) is
needed.
(iii) The third situation applies to skin
irritation studies using an exposure
period of 24 hours. These studies would
not necessarily allow a conclusion.as to
whether the criteria for CRP have been
exceeded.
3. Those products which clearly do
not meet the toxicity criteria in 40 CFR
162.16(c](2). These products are not '
required to be in child-resistant
packaging, although a registrant may
choose to use child-resistant packaging
voluntarily, in accordance with £ above.
G. Released for Shipment
The phrase "released for shipment" is
defined as follows: "A product is
released for shipment by a producing
establishment when it is the intent of the
producer to introduce the product into
commerce." Products at the distributor
and retail levels are considered to have
been previously released for shipment
by the producing establishment
H. Testing Procedure for ChUd-Resistant
Packaging Which Requires a Tool for
Opening
As the regulations indicate, the
protocol testing procedures of the
Consumer Product Safety Commission '
(CPSC) 16 CFR 1700.20) are to be '
followed in testing the child-resistant
packaging of pesticides. The CPSC
policy for testing child-resistant
packaging which requires a tool to open
the packaging, published in the Federal
Register of October 13.1972 (37 FR
21632). will also be followed The test
policy is that
1. children need not be given the tool
during the test unless the tool and
product are marketed together, and
2. adults will be given the tool for
testing.
L Limited Exception for Products Sold
to, and Used by, Servicepersons
EPA has determined, based on
comments submitted by various industry
groups, that pesticides which are used in
residential areas by janitors,
professional pest control applicators,
exterminators, swimming pool
operators, lawncare and landscaping
personnel, and other similar people need
not be in child-resistant packaging. This
is because the storage and usage
patterns generally employed by these
people are such that a significant hazard
to young children is not apparent.
Therefore. EPA plans to propose to .
amend the present child-resistant
packaging regulations to provide that
pesticides applied and used by
Servicepersons. as defined below, will
not be within the scope of the
regulations. EPA's proposed
amendments to the regulations •.•.•::! b?
published shortly, and will be subject to
public comment. In the meantime. EPA
will exercise its prosecutional discre:::.-
not to enforca the child-resistant
packaging regulations against these
manufacturers who comply with these
restrictive measures enumerated beio-.v.
EPA now plans to propose
amendments which are substantially as
follows:
1. Serviceperscn. As used in the child-
resistant packaging regulations, a
serviceperson is defined as one who
provides a sen-ice cf controlling pests
without delivering any unapplied'
pesticide to any person so served. The
term "serviceperscn" includes, but is no
limited to, a janitor, pest control
operator, maintenance person, la%vncare
and landscaping personnel
"Serviceperson" does not include a
household servant such as maid.
housekeeper, or private gardener.
2. A pesticide which meets the criteria
for child-resistant packaging and is
distributed only to Servicepersons cay
be marketed without child-resistant
packaging if the registrant labels its
product (either by conventional or
sticker label), "Cr.ly for Sale to. Use.
and Storage by Servicepersons." This
statement must be in type at least as
large as the child hazard warning
statement. Sale or other distribution of a
pesticide labeled in this way to a person
other than a serviceperscn will violate
FTFRA section 12(a)(2)(F), once the
restriction is imposed by regulation. Use
of a pesticide labeled in this way by
anyone other than a serviceperson will
be a violation of FIFRA section
J. Testing Each Size of a Design
The regulations provide that.
"Standards for special packaging shall
be evaluated for each size of a design
used' pursuant to the Consumer Product
Safety Commission protocols specified
in 16 CFR 1700.20 ..... 40 CFR
162.16(d](3). In explaining the necessity
for testing each size of a design, the
Preamble to the final regulations stated
that:
Tests do not have to be run on each
pesticide product, only en each special
packaging design f * *. However, in
5 102.16(d)(3) a requirement has been added
to test- each size of a closure disitn used. !n
discussions with the Consumer Product
Safely Commission. EPA was advised that
changing the size of a design often reduces
the child-resistant effectiveness. RequiriT'j
each closure sizs to be tested wi:i «ii— .::::; :c
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13105
Federal Register / Vol. 46. No. 41 / Tuesday. March 3. 1921 / Rules and Reflations
:r.e pos$:«:-.!v of an ineffective packase being
-s.-^e'.ed ,-i-i rS ::o:3).
E.-A reccgr.izss that this preambia
lanausr-e is somewhat arr.bisuous.
brssuse it refers both to the testing of
:'• " -*t;r8 special packaging design and
testing of the closure size aione.
,. .i it was the intent cf the drafters of
the resuiaticr.s to require that the entire
special package be tested for its child-
resistant effectiveness.5 the preamble
'.a.-.ruage apparently prompted same
ret:srants to test only the closure size
which thsy intended to use on their
pesticide product.
In view of the closeness cf the March
9. 193*. deadlir.e for compliance with the
special packaging regulations. EPA is
now prepared to resolve this possible
ambiguity by permitting pesticide
registrants to certify that their pesticides
packages are in compliance with the
regulations based solely on the testing
of each closure size. EPA will then
propose amended regulations, to be
open for public comment, which will
-ake it clear that the phrase "each size
of a design" means the entire package.
The entire package will be denned to
consist of the following elements:
belonging to a specific AS7M (American
Sociery for Testing and Materials)
classification of packages; being made
by a particular packaging manufacturer.
having a specific trade name: being a
specific model/style number; having a
p?—'— ilar shape; having a particular size
{ ; capacity) container/package;
h. J a particular size closure (if
applicable): having a specific liner (if •
applicable); and having the container/
closure or package being constructed of
a particular material.
EPA recognizes that the time and
expense necessary to test each specific
package cf each product requiring
regis'-ration would be considerable.
Accordingly, to lessen the impact which
wculd occur if such testing were
required. EPA will offer manufacturers
an alternative method by which the
packaging of products can be certified.'
1: is ceiievad that this scheme provides
a reasonable degree of assurance that a
package not tested -will still meet the
effectiveness specifications for special
packaging.
: As eariy as the 1377 proposed regulations. EPA
s'3!td that. "lUJr.cer 'J-.:3 regulation it is intended
'--.a: '.he entire package be tested. Containers which.
'.cf exa.T.cie. use sat'e'.y ciosures which are not
corr.pa!-.;:« with the container body are not
acceptable" (*Z TH i323S).
1 However, should a pesticide package be tested
arc four.d not to estr.?!y with the child-resistant
e.'fK-.iveresi standards of 16 CFR 1700.23. it will not
I* a defer.!* !h«ii the similar product on which the
rc::s'.-ar.t rsi:ed d.d meet :huw standards.
L'.:.-.i.:ely. each spec:al paciage must be evalaaled
03 ' raer.t*.
EPA's proposal is set forth 'below, in
the hope that some manufacturers will
voluntarily comply with it before it
becomes effective.
Proposed Tsstirg Scheme
If a registrant uses a package other
than she exact package system for which
the protocol test data are available. EPA
will accept certification if the package
used meets the following criteria:
(1) Package shape: The package for
which protocol data are available must
be a conventional shape, e.g.,
cylindrical, rectangular, square, and the
package for which certification is
sought, even if different from the shape
of the package tested, must also be
conventional in shape. If an "F* style
metal can or a conical metal can are
involved, the shape used must be the
same as the shape tested. Ail
npnconventional package shapes, e.g.,
hourglass configuration, triangular
packages, must be tested individually.
(2) Container/package material: The
material of the package/container for
which certification is sought'must be
genetically equivalent and have the
same physical/chemical properties (e.g.,
bursting strength, tear strength, etc.) as
the material of the package for which
protocol data are available. Different
materials include polypropylene, low
density polyethylene (LDFE), high
density polyethylene (HOPE), glass, tin
plate (steel), aluminum, etc. If data are •
available for a glass package and an
LDPE package is used, it must be tested.
(3) Volume of the package: For
certification on the basis of data • '
involving a package other than the exact
one used by the registrant, the protocol
test data must demonstrate that the
package tested has a child-resistant
effectiveness of 38 percent of more after
demonstration. The size of the package
used must fall within the limits set forth"
below. The 88 percent figure was
chosen, based on statistical analysis, to
ensure that a package similar but not .
identical to the one tested would mset
the 30 percent and 35 percent
effectiveness testing requirements of the
CPSC protocols. See 16 CFR 1700.20. If a
registrant wants to certify that its
package is child-resistant on the basis of
testing the package actually used, a
minimum of 30 percent child-resistant
effectiveness after a demonstration is
proper.
1. To use test data from a package
which contains 0 to 8 fL oz~,4 the
• Volumes measured in cubic inches can be
converted to P.yid ounces ustna the rule that 1 fl.
oz. = 1.3 cu. in. Numbers should be rounded to the
sext highest whole number.
registrant's package must be the exact
size of the package Vested.
2. To use test data from a package
which contains 3-54 fl. oz.,4 the
registrant's package can be equal to or
as much as twice the size of the package
test. For example, if an 3 fl. oz. package
has been tested, its data (assuming that
all other factors were equal) cculd be
used for a package frora 3 to 16 fi. oz.
3. To use data from a package which
is larger than 54 fl. oz..4 the registrant's
package can be equal to or as much as
1.5 times the volume of the package
tested.
4. Closure/package: The closure/
package used must be the same ASTM
classification, the same model/style, the
same model/style number.
manufacturer, and trade name as the
package tested.
5. Closure size: For certification on the
basis of data involving a closure other
than the exact one used by the
registrant, the protocol test data must
demonstrate that the closure tested has
a child-resistant effectiveness of 38
percent or more after demonstration
(see (3) above)/The size of the closure
used must fall within the limits set forth
below:
a. To use data from a closure with a
diameter less than 20 mm or greater
than 45 mm, the registrant's closure
must be the exact size of the closure
tested
b. If the registrant wishes to rely on
data from one other closure, which is
between 20 and 45 mm in diameter.
inclusive, he may do so, provided that
the diameter of the registrant's closure is
in the size range between 20 and 45 nun
inclusive and is between 1 and 1.15
times that of the closure tested.
(Numbers should be.rounded to the next
highest whole number). For example, a
registrant with a 28 sim closure could
rely on test data for a 24 mm closure.
c. If the registrant wishes to rely on
test data for two closures, which are
between 20 and 45 mm in diameter,
inclusive, and within 10 mm of each
other, he may rely on that data for any
closure which fails between the two
tested. For example, if a 24 mm and a 33..
mm closure of the same design were
tested, the registrant could certify to the
child-resistant effectiveness of its
similar closures which were 28. 28. and
30 mm in diameter. . -
6. Closure material: The material of
the closure used must be genetically
equivalent and have the same physical/
chemical properties, i.e., bursting
strength, tear strength, etc.. as the
closure material for which protocol data
are available.
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Federal Resister / Vol. 46. Xc. 41 / Tuesdav. March 3, 1981 / Rules and Reflations
131C
7. Liners: The materials cf the
registrant's liner and the Sir.er on whose
test data the resistrar.t wishes to rely
must be identical. This is because, in :h3
experience of the Consumer Product
Safety Commission, the cicsure liner is
an integral cart of the child-resistant
package, ar.d char.str.g the liner may
impair or eliminate ths child-resistant
. effectiveness of a closure or packaging
design.' In the situation where test data
exist for a closure-liner system that
differs from the cicsure-liner system
used or.ly in terms of closure diameter
(>20 mm and <45 mm) certification is
permissible if:
a. closure diameter used is greater .
than the diameter tested but is within
the permissible range (size used is equal
to or greater than the size tested and
equal to or less than 1.15 times the size.
tested), then the closure to be used need
not be tested if scientific data exist to
demonstrate that the mechanical
properties of the closure-liner system
used ars comparable to that tested. An
. example is if a 24 mm closure with a
PVC liner is tested, then its data maybe
used for certification of a 28 nun version
of the same closure with a PVC liner,
provided there is scientific evidence that
the 23 mm closure-liner system has
mechanical properties similar to the 24
mm closure-liner system or
b. test data exist for two closure sizes
with a difference equal to or 'ess thaa 10
mm. .the liner used in the two closure
sizes for which data exist must be the
same as the liner in the size used, then
the closure to be used need not be
tested. An example would be the test'
data for a 24 mm and 23 mm cicsure.
both with a vinyl pulp backed liner.
These data can be used for the
certification cf a 23 mm closure with a
vinyl pulp backed liner.
The agency acknowledges that only a
limited amount of data are available on
large size packages. Consequently,
exceptions will be considered in those
cases where a registrant has submitted
appropriate sciar.tific and technical
data.
X. Label Language
The particular wording of the label
giving directions for child-resistant
packaging opening and closing
instructions is at the discretion of the
registrant, so long as it clearly explains
to the adult user how to use the
package.
'This is why evan an 3??a:s:i:!y minor
mndificjiian in the liner, such as idJirt an insert
for promotional purposes, may r«?uire retcsti.-.q !o
«nsii« ihar ihe chili-,-?sis:ani e:'fec:ivere« of she
cicju.t or pocxa-je ha» noi b«n imp.nred.
L Certification of Child-Resistant
Effectiveness
Ac=sri'.-.g '.o 40 C7R ;52.15{e). the
arr.cr.iJrtvj.-.ti fsr child-resistant
packaging shall include a certification
by the registrant that the package meets
the standards of § 152.15fd).
The registrant is furthermore required
to maintain records concerning the
package (§ 152.1S(fj) which include a.
complete copy of the data resulting from
the tests conducted in accordance with
§ 152.l6(d). As indicated under J, above.
the agency realizes that it was net made
entirely clear whether certification as to
the child-resistant effectiveness of a
particular package should be based on
protocol tests carried out on the entire
package or merely the closure.
Therefore, by March 9,1S81, the agency
is allowing two types of certifications,
both of which will equally serve to
comply with the regulation. After the
agency has formally proposed and
published a final regulation concerning
the testing of package designs (see J,
above) certain packages may have to be
retested and recertified.
(a) Certification of effectiveness
based on testing.scheme listed under J
above. If the protocol test data in the
registrant's files show that either the
exact package or a package meeting the
criteria enumerated under J, above, has
been tested, the registrant shall certify
that the package meets the effectiveness
criteria for child-resistance. The
certification statement must include the
registration number of ths product, the
registered product name, the registrant's
name and address, date, the name, tide,
and signature of the company official.
The certification, which should be
submitted in triplicate, should include at
a minimum the following statement
1 hereby certify that the special package*
for this product and all applicable
supplementary registered distributor
products have been tested and found to meet
the requirements of 40 CFR 162.:6(d).
Standards cf Special Packaging.
I understand that 1 am recviired !o retain
the records described in 40 C5R l£2.:5(f](i).
(2), and (3) for as long as the registration is
valid. These records shall be available upon
request, for inspection or copying purposes or
for submission to EPA. funhermore. I certify
that should the scecai packaging for £is
product be changed, I will update this
certification statement.
Additionally, if the product is sold in
several sizes of packages all the size?
which this certification applies must be-
listed.
(b) Certification of effectiveness
based on testing the package closure
only. If the protocol test data in the
registrant's files show that the closure
used has been tested for effectiveness
but it was actually tested on a ccr.tair.r.:
(package) other than the one used or
outside the limitations of '.he scheme
listed under J, above, he shsl! certify :hs
effectiveness on the basis of th= exact
size closure. The certification staterr.sr.:.
which should be submitted in triplicate,
shall include the information listed
under (a) above and snail include af a
minimum the following statement:
I hereby certify that the exact c:csu:2 us si
on ths package of this product ar.d d'.i
applicable suppie.T.entaily rsw's:e.'=:i
distributor-products have beer. ;=s:2d ar.d
found to tneet the requirements of 40 C7R
162.IG(d). Standards for Special Packaging.
I understand that I am required :o retain
the records described in 40 CFR ;C-;.:5ii];:J.
(2), and (3) for as long as the registration is
valid. Thess records shall be available upon
request, for inspection and copying purposes
or for submission to EPA. Furtherr.ore. I
certify that should the special packaging for
this product be changed. I will update this
certification statement
If a product is sold in a line of several
size packages, some of these packages
may be certifiable under method (a) and
some under (b). In, this case two
certification statements are required.
one for those packages meeting the
specifications of (a) and one for those
which meet the specifications of (b).
(c) Information concerning the
package/closure used. The child-
resistant packaging regulation does not
_require the registrant to submit
"information concerning the type and
make of child-resistant packaging used.
_ although this information is part cf these
records which must be kept, and which
must be available for inspection and
submission upon request by EPA. The
agency at this time, however/requests
the cooperation of registrants to supply
this information voluntarily as an
addendum to the certification statement
This request is made for purposes of
gathering in/cr.r.u'.:;.- on the variety of
packages and/or closures which have
undergone extensive testing to allow
certification by (a) above, for example.
The agency feels that this information
will be extremely helpful in providing
data which may permit it to propose a
more liberal testing scheme than the cnc
listed under J. The information
requested is as follows: Product sizest
name of special packaging
manufacturer, name of special
packaging and model/style: (ASTM
classification); closure sizes, and liners
used.
M. Amended Product Registrations for
Child-Resistant Packaging (CRP)
There are basically three types of
amended registration applications that
may be submitted in conjunction with
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Federal
Register / Vcl. 45. No. 41 / Tuesc.iy. March 3, 1931 / Rules and
:?. 5^cc.ji ?uckdg:r.'i; Rcgulaticns. An
mer.d.T.erfl may be filed to indicate the
se c: special packaging and :o submit
•5 asjc.c'.stac certification statement:
.-: amendment may be filed to revise
" '''-n? to remove a package from the
':: the special packaging
j::;.-.s: cr an amendment may be
'.ed ;.o change the product formulation
: submit new :o.x:c;ty data to remove a
esticide frcm :he sccpe o: the special •
ackagir.g regulations. The registrant
-.us: ind:cate the use of special
ackagi." en Form 8570-11 and must
esigr.ate CR Package ia Box 5 under
type of amendment."
1. Amendments for child-resistant
ackaging certification: The registrant
:ust submit the required certification
:atement (original and two copies)
long with the amended application. If
hilc-resistar.t packaging instructions
:r opening and resecuring such
ackaging appear on the product label
: on an accompanying circular, then
-.e label or circular must be submitted.
:' uie instructions are on the container
r closure, only a copy of the
is ructions should be submitted.
' 2. Labeling amendments: Registrants '
-.us: file an amended application to
3v:;e ;'neir labeling to indicate specific
.onresidential use areas, or restricted
:se. i.e.. the elected restriction of
•urchasa. storage, and use only by a
erviceperson; see section I. Registrants
xish lo amend their registrations to
.fferent labels for the same
:.,_-ct may do so. The same product
.-.ay be packaged in child-resistant
acsag:ns and non-child-resistant
ackaging in accordance with sections
'•. through L of this Notice. The revised
ibeling must be submitted to and
eviewed by EPA to determine if it
:orr.p!ies with the special packaging
sg'jia'.icns. If sticker labels are used on
.n interim basis che sticker must be
ubrnitted with the amendment.
3. Revisions to registrations to submit
;e\v toxicity data and/or to change
crmulaticns: A product may be less
oxic than is currently indicated by its
sgistration and precautionary labeling.
:ome registrants may subject their
.voduct to additional testing to
ieterrr.ine its prscise toxicity. or they
nay reformulate their products so that
hey do not meet the toxicity criteria
incer 40 CFR 162.16{cj(2) (see F. 2
above). If a product is reformulated an
3pp!ica!ion for amended or new
•°2istration must be filed as for any
other formulation change. If the
registrant's retesting indicates that the
rrcdvjct is more toxic than previously
.ndicated. the registrant must submit
'> ew test data to EPA. pursuant to
F1FRA section 6(a](:). If this toxicity
testing also indicates that the
registrant's product should be placed in
a new (either higher or lower) toxicity
category for labeling prupcsss under 40
CFR~lG2.10(h)(l). the registrant must file
an application for amended registration.
If the new toxicity testing indicates that
the registrant's product is less tcxic than
previously known, so that child-resistant
packaging is not required but does not
require that the product be placed into a
different category, the registrant is not
required, to bring this information to
EPA's attention. However, it would be
helpful for him to do so, in order to-
avoid unnecessary enforcement actions
in regard to the child-resistant
packaging regulations.
NT. Child-Resistant Packaging
Certification for Registration of a New
Pesticide Product Which Meets the
Criteria
1. Fsrsts. An applicant for the
registration of a new pesticide product
must indicate the use of special
packaging on Form 3570-01 but a sample
of the packaging need not be submitted.
The applicant must submit the required
certification statement (original and two
copies).
2. When csrtificciion Is required.
Applicants may initiate registration
procedures for new products before they
• obtain the child-resistant packaging
'data for certification. However, the
child-resistant effectiveness certification
must be submitted before any new
product registration is issued after
March 9,1SS1.
3. Labeling. Instructions for opening
and resecuring child-resistant packaging
may appear en either the product label.
accompanying labeling or circular, the
container itself, or the closure.
Instructions for special packaging on the
label or circular will normally be
submitted, as labeling is required for a
new registration. If such instructions
appear on the container or closure, then
a copy of the instructions should be
submitted. The container or closure
should not be submitted.
O. Requesting Exemptions
The Special Packaging Regulations
allow for exemption from chiid-resistant
packaging of those products which meet
the criteria for required special
packaging only on the basis of technical
infeasibiiity or on the basis .that the
hazards indicated by the toxicity criteria
are not indicative of hazard to man.
An exemption should be mailed or
delivered to Ms. D. Jean Jenkins. Special
Packaging Coordinator. Registration .
Division (TS-767). Office of Pesticide
Programs. Environmental Protection
Acency. Rm. E-317, 401 M St. SW.,
Washington. D.C. 20460. (202-7S3-3930).
The regulation states that in order fur
an exemption to be jrantcd it must be
based on sufficient data which
accompany the request, to support the
decision. Additionally, it provides that
any such decision snail be published in
the Federal Register-and shall be
applicable to any product with identical
or substantially similar composition and
intended uses.
Initially, the procedures and data
necessary to consider an exemption
request will be determined en an
individual basis. However, this
document recommends certain
procedures and data to help the agency
in its consideration of requests for
exemption. The agency requests but
does not require that an exemption:
1. Be written in the English language.
2. Contain the name, address, and
telephone number of the registrant
3. Contain the Pesticide Registration
Number and name of the Pesticide
Product Manager.
4. Contain an explicit request for
exemption from special packaging
requirements. • "
5. Identify the particular product for
which the exemption is sought
6. Describe the package size of the
product for which the .exemption is
sought
7. Be typewritten. •
8. Be accompanied by at least two
copies of the request
9. Explain the reason for the
• exemption based on one or more of the
following grounds:
a. If the justification is based on the
hazard indicated by the toxicity criteria
in 40 CFR 162.16(c)(2) not being
indicative of the risk to man. the
justification shall state how the lack of.
human exposure, certain
pharmacological mechanisms, or other
human experience evidence6 for the
product clearly support granting of the
exemption.
b. If the exemption is requested
because special packaging is not
technologically feasible (which includes
compatible, practicable, or appropriate
for the product), the justification shall
explain why. '
c. Where the exemption request is
based upon an allegation that special
packaging is incompatible with the
particular product or would seriously
and adversely compromise the utility or
stability of a product, the registrant shall
'Human experience data, indicating the lack of
acc:der.:s, are considered helpful but not primary
evidence for an e.vompnon.
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Federal Register / Vol. 46. No. 41 / Tuesday. Nfarch 3. 1931 / Rules and Reauistions
. submit adequate evidence :o support the
allegation.
d. If the allegation of incompatibility ' "' .
is based upon "the fact that the shelf-life
of the product Units package choice, the
exemption shall outline the particular
limitation and snail include a time
schedule /or the registrant to reestablish
sheif-iifs data.
Granting exemptions: Where the " •
agency deternir.es that reasonable
grounds for an exemption are presented.
the acer.cy shall publish that decision in "
the Federal Register, and it shall be
applicable to any product with identical
or substantially similar composition and
intended uses. _ •
"Reasonable grounds" for granting an •
exemption are information and data
sufficient to support the.conclusion that: ' '
(a) The hazard indicated by the .
toxicity criteria in 40 CFR 162.16(c)(2] •" .. " .
are not indicative of the risk to man. . '•
(b) Special packaging is not
technically feasible, which includes - •
compatible, practicable, or appropriate '
for the product
Denying exemptions: Where the '
agency determines that reasonable
grounds for an exemption are not
presented, the exemption shall be
denied, and the registrant notified in
writing of the denial, including a brief
statement of the reasons therefor.
Effect of filing an exemption: The . . . .
filing of an exemption shall not have the •' • ' . '
effect of staying the regulation from
which the exemption is sought
Therefore, products subject to special
packaging shall be considered to be in
violation of the law unless packaged in
special packaging during the agency's • • -
consideration of the exemption request
after March 9.1S31.P. . '
Data Compensation . -
In accordance with the data
compensation regulations contained in
.40 CFR 162.9-1. and particularly
paragraph (b)(17) thereof, all
amendments to registration which are
made solely to achieve compliance with
the special packaging regulations and
which do not require EPA to review
scientific data before deciding whether
to permit the amended registration, will
not be subject to the data compensation
provisions of FIFRA sections 3(c)(l)(D]
and 3(c)(2)(B).
(Sec. 25(c](3) as amended (Pub. L 92-316. 88
Slat. 983: P-jb. L 94-140. 39 Stat. 735: Pub. L
95-396. 9: Stat. 619: 7 U.S.C. 136 et aeq.))
Dated: Jjnuary ZS. 1981.
Edwin L Johnson.
Deputy Assi'aaat Administrator for Pesticide
Programs.
iFS Due. 81-6718 F-.k-J 3-J-rt: 143 jm|
EILUNO CCOE ISoO-H-U
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STRATEGY FOR THE ENFORCEMENT
OF THE CHILD RESISTANT PACKAGING
REGULATION UNDER FIFRA
OVERVIEW
REQUIREMENTS OF THE RULE
Appli cabi1i ty
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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S t r a t_* g_y_ fqr_the Enforc em_e n t of the Child R_e s i s t a n t
fV? k\gj 'n g_R~e g uT_aYi^n^l)~ri"d_e r~ JFTF_R_A^ " " " ~
Overvi ew
On March 9, 1979, the Environmental Protection Agency
published a final rule at 44 Federal Rsgjster 13019 (40
CFR 152.15) which requires c h~i 1 d "re's i VtYn t 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.
resistant packaging for
The rule also requires affected registrants to submit
applications for amended registration and maintain records on_
child resistant test data.
Possible violations include misbranding, failure to keep
records, failure to file reports, and falsification of data.
It is anticipated that states operating under grants will
have major responsibility for conducting inspections concerning
the CRP requirements. The Regions will handle the casework since
these types of violations would not be in violation of many
State statutes. Concurrence from PTSED is required for enforce-
ment actions resulting from violations of the CRP regulation.
Headquarters support will be available for data review and to
answer questions on whether or not a product meets the criteria
that trigger the requirement for child resistant packaging.
In addition, PTSED will provide inspection targeting information.
Requirements of the Rule
App1i cabi1i ty
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) 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:
3 "Released for shipment" is defined as that point in time
when it is the intent of the producer to introduce the
product into commerce. Intent exists in any of the
fol1owi ng situations:
(1) a producer asserts that what is being sampled is
representative of what is actually sold;
(2) a product is stored in an area where finished
products are held for shipment in the ordinary
course of business (warehouses, loadino docks,
etc.);
(3) the custom of the pesticide chemical industry
indicates that similarly situated products are
intendedforrelease;or
(4) the custom of the particular producer indicates that
similarly situated products have been intended for
release in the past.
0 "Residential use" - A pesticide meets this criterion if
it is applied (other than by a commercial applicator)
directly to humans or pets or is applied in, on or
around all structures, vehicles, or areas associated with
the household or homelife or noncommercial areas where
children spend time, including, but not limited to gardens,
houses, yards, patios, mobile homes, campers and
recreational vehicles, noncommercial campsites, home
swimming pools, educational, lounging, and recreational
areas of preschools, nurseries, and day camps, etc.
Furthermore, residential use is determined by whether
a product has a use on the label which is within the
meaning of residential use. A registrant may have a
product that is not really intended for residential
use, but the labeling is either vague concerning use
areas, or use areas are actually omitted. Such a
product is subject to the child resistant requirements
unless its registration and label are amended to indicate
a strictly non-residential or agricultural application.
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"Toxicity criteria" are defined in 44 Federal Register
13019 (March 9, 1979) and at 40 CFR 1 62. i 6 (C) ( ?•)•.
Exceptions to CRP
"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 Serviceperson
The Agency has decided to remove from the scope of CRP
requirements certain products which meet the criteria
for special packaging but are not normally stored in
areas where children could likely have access to them.
Examples include products used by janitors in nurseries
or daycare centers and products used by exterminators or
lawncare servicepersons . To accomplish this, EPA will
allow products such as those listed above to be sold and
distributed without child resistant packaging if such
products bear a statement restricting the sale, use, and
storage to servicepersons.
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T'nis provision has been communicated to producers
through a Federal Register Notice issued March 3, 1931;
it will also appear in proposed revisions to Section 3
Registration regulations. Until it appears in final
regulations, EPA will use prosecutorial discretion and
not take enforcement action if a. subject product is
• not specially packaged but is labeled or sticker-labeled
with a statement restricting the product's sale, use,
and storage to servicepersons, e.g., "Only for Sale
to, Use, and Storage by Servicepersons." The statement
must appear in type size at least as large as the
child hazard warning statement. Labels need not be
submitted to the Agency for approval but must be submitted
for the official label file used to determine compliance
with FIFRA.
0 A registrant may amend his/her registration so that
the new label does not allow for residential uses.
In such a case the product bearing the new approved
label would no longer be subject to the special packag-
i ng requ i rement.
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.
Nota that only the- Agency may grant an exemption. It is
not up to the registrant to decide if he or she is exempt
or— not, based on the two factors listed in the above paragraph.
Specific Requirements for Registrants of
Products Subject to the Special Packaging Requirement
0 Develop and test special packaging
"Special packaging" refers to packaging that is designed
and constructed to be significantly difficult for
children under five years old to open or obtain a
toxic or harmful amount of the substance contained
therein within a reasonable time. In addition, it
should not be difficult for normal adults to use pro-
perly. Effectiveness testing procedures which must
be used are those specified by the Consumer Product
Safety Commission (CPSC) at 16 CFR 1700.20(a), (b),
and (-c). Effectiveness specifications and standards
for special packaging are delineated in 40 CFR 162.16.
0 Amend registration - Certification
Prior to changing a product's packaging, the registrant
must submit an application for an amended registration
and have it approved by EPA. Instead of submitting
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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 the requirement must be in child
resistant packaging if released for shipment after
March 9, 1981 .
Recordkeeping
Certain records must be retained by the applicant or
registrant for as long as the registration is valid.
These records shall be available, upon request, for
inspection and copying purposes or for submission
to EPA. The records which must be kept are:
(1) A full description of the package including:
(i) A full description of the container including
(A) Itsdimensions,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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Note: The registrant may not have actual data on file if the
company did not perform the testing but, instead, relied
en verification from others such as the company which
produces the packaging. The registrant should hav's a
letter or literature verifying that the packaging has
been tested and met the CRP standards.
Regulated Industry
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 to-assure compliance with this regulation
so as to minimize or eliminate accidental exposures to highly
poisonous pesticides used in and around residential areas.
Outreach
Registrants should be aware of the regulation through its
publication in the Federal Regi ster. 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)(1)(E) of FIFRA
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to §25(c){3)." Failure to h a v a 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
uti1i zed).
(3) Company changes packaging, but it does
not meet the child resistant requirements
because tests were incorrectly done or the
tests were conducted on the incorrect
container size.
Failure to File Reports Required - §12(a)(2)(N) of FIFRA
It is unlawful for a person who is a registrant to
fail to file reports required by this Act. Prior to
changing a pesticide's packaging, the registrant
must submit an application for amended registration to
EPA. Failure to do so prior to distributing the product
in new packaging would be in violation of this section.
In addition, the registrant is required to
submit a certification statement with the amended
registration application.
Failure to Maintain Reports Required - §12(a)(2)(3) of FIFRA
It is unlawful for a registrant to fail to maintain
reports required, by FIFRA. The regulation requires
the registrant to submit a certification that the
product is in compliance as opposed to detailed data
supporting this. However, it is required that the
detailed data be maintained and be subject to Agency
inspection or request for submission. The registrant
is not required to have such data on file if the firm
relied on testing conducted by others such as the package
supplier. In lieu of such data he or she must have
some verification on file that the product is in compliance.
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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 ca-n. be sent to
the company's headquarters by OPP.
' Falsification of Application/Report or of Records
Maintained or of Exemption Request - §12(a)(2)(M) of
FIFRA or Title 13 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 13 of the U.S. Code also makes this type of activity
i11egal .
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
poli 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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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 $3000) 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
onfilewithEPA.
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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-ID-
status or the validity of the data, and reviewing concurrence
requests .
Program In t_e_g_r a t i on
The Case Development and Legal Branch, PTSEO, will coordinate
with the Regions and the Registration Division to resolve any
questions regarding the child resistant packaging requirement •
and the status of products covered.
The Regions will coordinate with the States regarding the
enforcement of the special packaging requirements.
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;;!!TED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
«• --*«V-
PESTICIDES AN 3 ToVTc
SU3JECT: Enforcement Strategy Concerning C'.iild-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 cccr.pliance with CRP regulations we are providing to you a list of
generic products for which an unqualified assumption can be made that
they need to be in CRP if used and stored in the household. This is con-
sidered phase I of the strategy. Phase II will consist of a more refined
list which will be based on the actual CRP amendments we receive.
1. Disinfectants
Product
1. Calcium
hypochlorite
Concentration
65%
2.
6.
7.
3.
9.
Lithium
hyprochlorite 35%
Sodium dichloro
s- triazine trione
and Trichloro-s
triazine trione 98-1001
Mono (Trichloro
tetra (monopotassium
dichloro) penta-s-
triazinetrione 99*
Hydrochloric acid 3%
Phosphroric acid 17%
Chlorophenolics 6!>
Sulfamic Acid 20%
Quaternary Ammonium
Compounds 10 S
10.. Parafomaldehyde 953
11. Formaldehyde 37%
Use
swimming pool
Swimming pool
Toilet bowl
n M
Disinfectant
Toilet bowl
General disinfectant
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2. Insecticide and Rodenticide
Pesticide Chs~ical
1. Carbophenothion
2. Chlordane
3. Chlorpyrifos (Dursba'n)
4. Cryolite
5. Diazinon
6. Dimethoate (Cygon)
7. Disulfoton (Disystox)
8. Dyfonate
9. Ethion
10.Imidan
11.Lindane
12. Metaidenyde
13. Mexacarbate (Zectran)
14. Naled
15. Propoxur (Baygon)
16. Phosphorus (white)
At and Above Requiring CR?
1.4
2S.O
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 CR?
Systemic insecticides
for indoor and outdoors
plants
Some combinations with
lawn fertilizer
Borer sprays, dog
di-ps
Slug and snail
control
Insect, slug and
Snail control
Rodenticide
-------
3. Herbicides and Funcicides
Chemical Formulation / % A.I,
Bis (tributyltir.) oxide Above 0.5%
Paraquat
Pentachlorophenol
Chlorothaionil
Copper-8-quinolinolate
any %
above 88%
above 40%
above 5%
I/-/
Refco Engler, Gnief//
Disinfectants Branch
Registration Division (TS-767)
cc: D. Campt
R. Gross
J. Jenkins
H. Harrison
J. Akerman
Use
V.'ood Presenva'tive
Homeowner herbicide
Wood preservative
Homeowner fungicide
Wood preservative
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General Compliance Strategy for Products Subject to the FIFRA
Label Improvement Program
0 vervi ew
On June 5, 1980 EPA published in the Federal Register (45 FR
37884) a notice initiating a program to improve pesticide labeling.
The Label Improvement Program (LIP) was initiated to upgrade pro-
duct labeling in an attempt to better protect health and the environ-
ment as well as further defining legal use of a product. This program
was designed to work in conjunction with currently existing registra-
tion programs and to respond rapidly to labeling needs identified by
the Agency. To date, four major label improvement program notices
have been issued and are in effect. Two additional label improvement
program notices have been recently issued but are not yet in effect.
Regulated Industry
Some label improvement rules affect all registrants, while
others affect only registrants of certain products.
Requirements of the Rule
Submission of Applications
The Office of Pesticide Programs (OPP), Registration.Oivisi on
(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.
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- 2 -
3) If necessary, a Statement of Confidential Formula (EPA Form
8570-4).
Registrants must normally submit applications within 60
calendar days of receipt of the LIP Notice. The Agency will state
any deviation from this deadline in the LIP Notice.
Products for which the Agency has not received an application
for amended registration within the stated deadline will be subject
to cancellation. The Agency will issue a Notice of Intent to Cancel
for any such product, effective 30 days from its receipt, unless
within that time the registrant or an interested party with the
consent of the registrant, either applies for amended registration
or requests a hearing under section 6 of FIFRA.
Exemption from Compensation Requirements
• In many cases an amended registration to meet the requirements
of a Label Improvement Program Notice will not be subject to com-
pensation requirements. If this is the case, the Offer to Pay or
Certification Statement will not be required.to be submitted to 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
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- 3 -
must be limited to changes required by the letter in order to
maintain the exemption from compensation requirements.
Combined Application in Response to Multiple Label Improvement
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)(1)(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 -
Types of Violations
Producers not complying with the requirements of..the notices
issued under the Label Improvement Program are in violation of
of FIFRA section 12(a)(l)(E) in that their products are misbranded
under sections 2(q)(l)(F) and (G). Products being sold in violation
of a cancellation order are in violation of FIFRA section 12(a)(2)(L)
and subject to the penalties thereunder. "
X
Administrative Considerations
The Office of Pesticide Programs has issued four major label
improvement notices (See Attachments) which are currently in effect
with two more LIP Notices issued but not yet in.effect. The four
existing LIP Notices are listed below in order of inspectional
targetting priority according to their potential hazard.
1) Fumigants - Issued 12-4-80 - This LIP Notice requires
registrants of products containing certain active ingredients to
add additional precautionary. 1abeling , misuse statements and storage
anddisposalstatements.
2) Termiti ci des - Issued 11-7-81 - This LIP Notice requires
registrants of termiticide products containing one of the active
ingredients listed in the LIP Notice to revise use directions of
their product, use the appropriate storage and disposal statements,
add a misuse statement, and reformat their labels.
\
3) Anti foul ing Paints - Issued 3-9-82 - This LIP Notice required
registrants of all antifouling paints to make extensive revision
of their product's labeling.
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- 3 -
4) Salt Water Ernes is - 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
targetting.
States should target inspections* based on the priority as-
signed to each LIP Notice in this document and on the current
registration status of products regulated under each Notice. .
To identify inspection targets, States should first list under
each LIP Notice the registrants and the number of their products
whose: a) product labels are subject to cancellation for failure
A0nlyproducer establishmentsshouldbe targettedforinspection
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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-u-
to respond to the.LIP Notice; and b) label amendments RO has
approved. Inspection priorities will not include registrants
whose products have label amendments pending with RO. -Priority
for inspection should then be as'signed on the following basis:
1) Registrants of products subject to cancellation for failure
to respond to the LIP Notice. These registrants should
be ranked based on the number of their products subject to
the LIP Notices in the following order: Fumigants, Termi-
ticides, Antifouling Paints and Salt Water Emesis.
2) Registrants with the most number of products with accepted
amended labels subject to any LIP Notices in the following
order: Fumigants, Termiticides, Antifouling 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.
Inspections
Inspectors will examine products released for shipment at
the producer establishment to determine compliance with the terms
of the LIP Notice. Registrants have 180 calendar days following
acceptance of amended labeling to bring the product into compliance .
Any product released for shipment after this 180 calendar day period
must bear accepted amended labeling.
Registrants with products not in compliance with any LIP
Notice will be issued a Stop Sale Use or Removal Order (SSURO) by
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-• 7 -
the State or EPA in addition to any enforcement action taken by
the State or EPA. The SSURO will be removed only "after the registrant
brings the product into compliance. SSURO's will not'be lifted for
cancelled products sold in violation of a cancellation order.
Issuance of a SSURO is an appropriate response to non-compliance
as the LIP is designed to mitigate the risks of handling pesticides
through labeling changes and the registrant is given ample time
to make and incorporate these changes on the label.
Allocation of Responsibilities
Headquarters 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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I t\r/7 ? UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
3TON. D.C. 2
JAM 12/3
V ..ej? WASHINGTON. D.C. 20460
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-2-
A. Primary Enforcement Responsibility -
1. ' What is it? .. .. ..; ' ' . ; .
When a governiiEnt entity, be it EPA or State, has prinary
enforcement responsibility, it has the first (or primary) option
for investigating and taking appropriate enforcement action
against pesticide'use violations.
2. How does a State get it?
In brief, there are three ways by which a State shall have
primary responsibility for pesticide use enforcement:
a. A State will have the primary responsibility for pesticide
use enforcement if, upon request by the State, EPA has
determined .that 1) the State has adequate pesticide use
laws and regulations, 2) the State has adequate procedures
for implementing these laws and regulations, and 3) the
State will keep records and make reports shaving conpliance
with 1) and 2) above.
b. Notwithstanding this, any State with a cooperative agreement
with EPA to cooperate in the enforcement of FIFRA, pursuant
to Section 23, shall immediately upon imp lensntation of that
agreement, have primary responsibility for pesticide use .
enforcement within its borders.
c. A State may also receive primary responsibility for use en-
forcers nt if EPA determines that the State has an approved
plan under section 4 for certifying applicators and the plan
• msets the criteria of a. above.
If at any tins after September 30, 1978, a State asks for and
receives a determination that it meets the test of adequate laws,
regulations, and procedures under a. above, implements a coopera-
tive enforcement agreement with EPA or, upon final approval of its
section 4 Plan, receives a determination that the plan meets the
criteria of a. above, that State shall have primary enforcement
responsibility for use violations within that State.
x
If a State with a cooperative enforcement agreement chooses to
withdraw from that agreement, the State will lose- their primary
enforcement responsibility upon the date of termination of the co-
operative agreement. Should that same'state have an approved State
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-3-
Plan under section b, EPA will review that plan for enforcement ade-.
quacy as soon as practical to determine whether the State can regairj
use enforcement prinacy.
3. Who has it?
The following States, as of the date of this memorandum, have
primary enforcement responsibility for pesticide use violations:
Region I Region IV Region VIII
Connecticut Kentucky Montana
Ne.tf Hampshire Mississippi North Dakota
Vermont North Carolina South Dakota
Tennessee
Region II Region V Region IX
\J
New Jersey Indiana ' Arizona
New York Michigan California
Puerto Rico ' Minnesota Guam
Virgin Islands Hawaii
Region III Region VI Region X
D. C. _, Arkansas Idaho
Dela/are Louisiana Oregon
Maryland lies Mexico Washington
Pennsylvania Oklahoma
Virginia Texas
West Virginia
Region VTI
Iowa
Kansas
I/
Arizona divides responsibility for use' enforcement between the
structural Pest Control Board and the Arizona Board of Pesticide
Control (Agriculture). EPA has a cooperative enforcernant agree-
ment with the former, not the latter. Therefore, Arizona has
primary use enforcement responsibility for pesticide use viola-
tions that come within the jurisdiction of the Structural Pest
Control Board; EPA has responsibility for all other use enforce-
ment activities. If there are other instances of very distin-
guishable separation of use enforcemsnt authority within a State
and EPA has a cooperative enforcement agreement with only one of
the authorities, the region should bring this to the attention
of PTSED.
-------
Who does not have it?
The following States, as of the date of this..memorandum, do
not have prirrsry enforcenEnt responsibility for pesticide use
violations; EPA continues to have primary responsibility.
Pegion I Region VII Region X
Maine* Missouri* , Alaska*
Massachusetts Nebraska
Rhode Island*
Region IV . Region VIII
Alabama* Colorado*
Florida* Utah*
Georgia Wyoming*
South Carolina*
Region V Region IX
Illinois* Trust Territories
Ohio* Samoa
Wisconsin*
* EPA will be conducting a rapid evaluation (to be conpleted
within 6 months of the date of enactment of this law) of
these State's §4 Plans in order to determine the enforce-
ment adequacy of the State's pesticide use laws, regulations,
and procedures.
5. What is EPA's role in pesticide use enforcensnt?
In States that do not have primary use enforcement responsi-
bility, EPA will have the prinHry responsibility. In those States
where EPA has the primary responsibility for pesticide use enforce-
ment, Congress has affirmatively provided that the Agency my
inspect the books and records and work establishments of commer-
cial applicators and "for hire" applicators. Also, saaples nny
be taken of pesticides or use dilutions of pesticides held by
those applicators. "For hire" applicators are those applicators
that are in the business of applying pesticides. Exsroies of
"for hire" applicators, for whom controlling pests is all or part
of their occupation, are structural pest control operators, aerial
applicators, arborists, lawn maintenance workers, and janitorial
service workers. Nothing in this Act precludes the Agency from '
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-5-
continuing routine use surveillance, (i.e. use observations where
there is no prior evidence of misuse) whether or not that surveil-
lance takes place in a State that has primary use enforcement
responsibility. However, in those States having primary use
enforcement responsibility, the Agency nay not include within that
routine surveillance visits to commercial or "for hire" applicator
establishments for purposes of sampling or reviewing bodes and
records. In those States, routine use surveillance shall be con-
fined to application sites where entry has been gained by consent
of the owner. Any information or evidence that points to a signi-
ficant violation of FIFRA (i.e. one which we would deem worthy of
further investigation) shall be referred to the State if that State
State has primary enforcement responsibility.
6. How will the referral of complaints or infcreation indicating
use violations of FIFRA work?
Section 27(a) of the amended FIFRA requires that EPA refer
any complaints or other information alleging or indicating a
significant violation of the pesticide use provisions of FIFRA
to the appropriate State officials for their investigation. Of
course, such referral need only be made when the State has pri- •
raary use enforcement responsibility. Further, if the State dees
not commence appropriate enforcement action within thirty 'days,
EPA may act upon the complaint or information.
If any information or complaint, indicating or alleging a
significant violation of FIFRA, is received after September 30,
1978, and the alleged violation took place in a State with pri-
mary use enforcement responsibility, such information or com-
plaint shall imcnediately be referred to the appropriate official
in that State. Any such information or complaint received in
EPA headquarters shall be referred to the State via the appropri-
ate regional office. Regions will be responsible for immediately
establishing working relationships with States for the orderly
flow of information on enforcement activities and for determining
who the appropriate State officials for handling such information
are. The State will have thirty days to initiate appropriate
enforcement action upon making a determination that a possible
violation of either FIFRA or the State pesticide law has occurred.
It is expected that appropriate enforcement action will be t • .en
by the State under that State's pesticide law in cases where the -
evidence indicates either, a violation of only the-State law or
both the State law and FIFRA.
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-6-
At the conclusion of the thirty day time period, the regional
office shall request information on the status of the particular
investigation. Obviously, in some cases States may.be unable to
investigate and commence appropriate enforcement action, particular-
ly in complicated cases, within the thirty day tine frane referred
to in the amended FIFRA. Regions should use their discretion when *•
determining whether to extend the time period for a State to com-
mence appropriate enforcement action or to request return of the
case file. It is expected that States will forward all evidence
obtained in an investigation to the EPA regional office: 1) where
no enforcement proceedings have been initiated within thirty days
of a determination of a possible violation of State law and FIFRA,
2) where the investigation determines that a possible violation
of only FIFRA occurred, (not State law), or 3) where EPA deter-
mines that the enforcement action taken by the State is not
appropriate to the alleged violation. Until regulations are
in place for rescinding primary enforcement responsibility
for failure by the State to assure enforcement of State ;
pesticide use regulations, a region shall request concurrence '
from their PTSED regional coordinator before overriding any
State enforcement action.
Complete and thorough documentation must be kept of all
referrals to States of complaints or information on alleged
use violations and subsequent follow-up actions by States. A
draft complaint referral form is attached for use by those
regions without any current referral form (Appendix B). Two
copies of this form, with additional attached information,
where appropriate, shall be completed and forwarded to the
appropriate State official immediately upon receipt of any
complaint or information about a use violation. Within thirty
days (or longer, if extended), the State should be instructed
to return one copy of the State form with a brief description
of the disposition of the case, i.e. either a notation of the
kind of enforcement action taken (e.g. 2 month suspension of
applicator's license) or an explanation as to why no enforce-
ment action was taken (e.g. not-a violation of State la/). If
no report on the disposition of a case is received within a
suitable period of tine, the region shall follow-up with either
a written or telephonic request for such information. Such
records will be necessary for future determinations as to
whether States are properly discharging their enforcement res- -
ponsibilities in the pesticide use area.
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-7-
7. Hew should emergencies arising cut of the use of pesticides be
handled?
When the region becomes aware of emergency conditions arising
out of the use of pesticides, they should immediately inform the
appropriate State officials. State officials are to be requested
to respond to the emergency; the region should offer whatever
assistance they can. If State officials indicate that they are
unwilling or unable to adequately respond to the emergency, the
region should respond to the fullest extent possible.
Should you have any questions concerning this interim policy, please
contact your PTSED regional coordinator or Jack Ne/lan (755-0997).
A. E. Conroy II, (Director
Pesticides and ToxicNauis tances
Enforcement Division
Attachments
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•SEC. :s. STATE PRIMARY ENFORCEMENT RESPONSIBILITY.
"(a) For the purposes of thi.i Act. a State ihall have primary en-
forcement responsibility for pt-iticide use violations during any period
for which the Administrator determines that such State—
"(J) has adopted adequate pesticide use laics and regulations.:
Provided, That the Administrator may not require, a State to have
pesticide use laws that are mor<> stringent than this Act}
u(5) has adopted and ii implementing adeuuate procedures for
the enforcement of such State laics and regulations,' and
u(3) wilt keep -ruch records and make such reports showing
compliance with paragraphs (1) and (2} of this subsection as the
Administrator may require by regulation,
"(b) Notwithstanding the provisions of subsection (a) of this sec'
tion, any State that enters into a cooperative agreement \oith, the Ad-
minis trat or under -section 23 of this Act for the enforcement of vesti'
cide use restrictions shall have the primary enforcement responsibility
for pesticide use violations. Any State thai has a, plan approved by the
Administrator in accordance with the requirements of section 4 of this
Act that the Administrator determines meets the criteria set out in sub-
section (a) of this section shall have the primary enforcement respon-
sibility for pesticide use violations. The^Administrator^hail make, such
determinations i.cith respect to State plan-i under section 4 of this Act
in effect on the d-zte of enactment of the Federal Pesticide Act of 1978
not Inter than -rix month,* after that date.
"(c) The Administrator'thall have primary enforcement responsi-
bility for those. State* that do not have primary enforcement rf.sponsi-
bilify under thin Act. Notwithstanding the provisions of section -2(e\
(J)'(if this Act* during any period when the Administrator ha-1 such.
enforcement responsibility, section X(b] of this Act shall apply to the
suc.
the
boohs and records of commercial applied-tors and to any applicator who
holds or applies -pes'timd**. or use dilutio-ru of pesticides, only to provide
a. service of controlling pests without delivering any unapplied pesti-
- -
cide- to any -person so served, and section 0(a} of thii Act shall apply to
the p.stabli-ihmenf. or other place where pesticide* or devices are held for
application by such persons with, respect to pesticide or devices held
for such, application^
' "SEC. 17. FAILURE BY THE STATE TO ASSURE ENFORCEMENT OF
STATE PESTICIDE USE REGULATIONS.
" (a) Upon -receipt of any complaint or other information alleging or
indicating a sigrdncznt violation of the pesticide ^se provisions of this
Act. the Administrator shall refer the matter to the ippro-priate 'State
Officials for their investigation of the matter co^n-iistent icith the rv-
quirements of thin Act. If. icithin thirty days, the State hns not com.-
menced appropriate enforcement action, the Administrator may act
upon the complaint or information to the extent authorized under thin
• Act.
"(5) Whenever the Admini.ttnzf.or determines that a. Stale having
<• primary enforcement responsibility for pesticide u*e it'oMtiona i-s not .
camiing out^ (or cannot carry out due to the lack of adequate legal au-
thority) such. re.rpor).ribilit.y. the Administrator shall notify the State.
Such notice shall specify those aspects of the administration of the'
• State program that are determined to be inadequate. The State shall
have ninety days after receipt of the notice to correct any deficiencies.
If after that time the Administrator determines that the State program.
remain* inadeiruuite, the Administrator m
-------
.>.REFERRAL FORM
Date Rec'd
inscription of Alleged Corrplaint or Information
(Disposition
Referred to:
Referred by:
For further information, contact
Date referred
Date response du
-------
. /
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-2-
Basically the Stats plans will be measured against the standards
sat forth in sections 26(a)(l) and (2) of the amended FIFPA. They
require that the State:
(1) has adopted adequate pesticide use laws and
regulations; Provided, 'that the Administrator may
not require a State to have pesticide use laws
that are more stringent than this Act; [and]
(2) has adopted and is implementing adequate pro-
cedures for the enforcement of such State laws and
regulations;...
tthile there is a presumption that States with approved applicator
certification plans have adopted adequate laws for violations involv-
ing restricted use pesticides, it will still be necessary to make
certain that their laws and regulations are also adequate for viola-
tions involving general use pesticides. It is clear, however, that the
focus of the review will be on the question whether each State has, in
fact, established adequate procedures for enforcing against use viola-
tions and whether the/ are implementing those procedures adequately.
Some of the procedural aspects that will be examined include: 1. Are
sufficient State resources committed to the investigation and" actual
enforcement of use violations; 2. Are complaints of pesticide misuse
follcwed-up promptly and concluded in a timely manner; 3. Are State
personnel properly trained to handle investigations and enforcement
actions involving allegations of pesticide misuse; 4. Do substantive
complaints of misuse actually result in State enforcement action; and
5. is the State enforcenent action appropriate in light of the viola-
tion and the enforcement options open to the State enforcement Agency?
Since EPA regional representatives are the most knowledgable about
the status of pesticide enforcement in the States in their regions, it
will be essential to the success of the review of each State's plan and
operating procedures to have strong regional participation on March 23rd.
Although the Regions' views can either be presented in writing in
advance of the irseting or in person on March 23rd (or both), if a Region
is of the opinion that a particular State should not be granted primary
use enforcement responsibility/ it should plan to send a representative
to the March meeting to discuss that position with the Headquarters
personnel. For States where the regional office thinks there is little
question about the appropriateness of granting State primary use enforce-
ment, it would be sufficient to submit such a recommendation in writing
before March 23rd. Once a decision has been made about the status of
each of the thirteen States, letters will be prepared for Mr. Costle's
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-3-
signature notifying the various State lead agencies about EPA's deci- .
sion. In addition, each State being granted primary use enforcement
responsibility in accordance with the new section 26 will be asked to
meet certain minimal reporting requirements concerning pesticide use
enforcement until final regulations implementing sections 26 and 27
are implemented.
I would appreciate it if each of the seven Regions that have State
plans to be reviewed at the March meeting would notify Mr. Ulfelder
whether or not they plan to be represented at that meeting. If you have
any questions about the. review of the thirteen State plans, please direc
your questions to Mr. Ulfelder at 472-3701.
7——
A. E. Conroy II,^Direct
Pesticides and Toxiq Substc
Enforcement Division
Attachments
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ATTACHMENT A
List of States With Approved Section 4 Plans, But .Without CEAS
REGION I: Maine
RE3ION 17: Alabama
Florida
Georgia
South Carolina "
RE3ION V: Illinois
Ohio
Wisconsin
REGION VII: Missouri
R33ION VIII: 'Utah
Wyoming
REGION IX: Arizona (Agricultural Use Only)
REION X: Alaska -
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ATTACHMENT B
Friday, Kerch 23, 1979
Location: EPA Headquarters
Washington, D.C.
3rd Floor Conf. Pro., East Tower
Room Mo. 344
I. 9:00 a.m. - 12:00 noon
The following States will be reviewed:
Region I: Maine
Region IV: Alabama
Florida
Georgia
South Carolina
Region V: Illinois
Ohio
Wisconsin-
II. 1:30 p.m. - 4:30 p.m.
The following States will be reviewed:
Region VII: Missouri
Region VIII: Utah
Wyoming
Region K: Arizona
Region X: Alaska
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
V.'ASHINGTCN. D.C. 20460
r..,-...
:
OFFICE'Or ENFORCEMENT
MEMORANDUM
i
SUBJECT: Clarification of Primary Use Enforcement Responsibility Guidance
TO: Regional Pesticide Branch Chiefs
Regional Enforcement Division Directors
On January 4 of last year, the Pesticides and Toxic Substances
Enforcement Division (PTSED) sent cut an interim policy statement
describing procedures for EPA/State cooperation in the area of primary
responsibility for enforcing pesticide use violations. This memorandum
supplements the January 4 guidance by expanding upon the proper Agency -
response to receipt of a State file which indicates a pesticide use
violations.
Since the amended FIrRA, per sections 26 and 27, directs the Agency
to allow the States to have first option for bringing enforcement actions
against violators of pesticide use requirements, EPA should take no
action except in emergencies as described under section 27(c), based on
any otate file until thi appropriate Region consults with the State on
the investigatory or enforcement status of the case. After the State
has been allowed time to conduct its inquiry, the Region should request
a statement indicating the proposed enforcement action chosen by the
State. If the State's action is not "appropriate" (see section 27(a))
in light of the gravity of the alleged violation, the Region should
after obtaining concurrence from the Office of Enforcement's Pesticides
and Toxic Substances Enforcement Division, send a notice to the State
(1) ccinmunicating its disagreement with the selected action, (2) re-
commending the type of State action which the Agency would consider to
be "appropriate", and (3) notifying the State that it has 50 days to
commence an appropriate action. -
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- 2 - • '
As a general operating principle, the Regions should avoid using •
already-scarce Federal resources merely to reinforce state enforcement
actions taken in response to minor violations of the pesticide..laws.
Rather the Regional Offices, in accordance with stated Agency goals of
protecting public health and safety and preserving sensitive ecosystems,
should be careful to focus their efforts and resources on those situations
which significantly endanger public health or the environment and which
are not otherwise appropriately addressed by state actions.
Lchard D. Wilson
Deputy Assistant Administrator
for General Enforcement
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Utilicu iiATES t.SYiKONMuNTAL PROTECTION AGENCY
18690
MEMORANDUM
SUBJECT: Appropriate Documents to be Presented by State
Inspectors Conducting Pesticide Use Inspections in
States Having Primacy
TO: Enforcement Division Directors
Air 6 Hazardous Materials Division Directors
Pesticide Branch Chiefs
At present most State inspectors conducting pesticide
use inspections present credentials headed: "United States
Environmental Protection Agency". The credential later
identifies the inspector as "an employee of the State of
." This credential has been supplied by the Agency
as a convenience to States which have cooperative enforcement
agreements with EPA. (EPA Form 3540-28 (Rev. 4-78))
•
These credentials were designed before primacy when
States conducted use inspections for violations of FIFRA
under the auspices of a cooperative agreement. Pursuant to
Section 26, most States now exercise primary enforcement
responsibility for all use violations. Use inspections are,
therefore, primarily a State activity. Consequently, use
inspections in States with primacy are undertaken under the
authority of State law, (this is true even where the use
inspections are Federally funded).
*
Therefore, during use inspections, it is appropriate
for State inspectors to present credentials which indicate
that the inspectors are acting under authority of State law.
The existing Federally supplied credentinla are misleading
since they are headed "United States Environmental Protection
Agency." In the fu£urjL«_State inspectors conducting pesticide
use inspections fihsatasaprasent credentials that are issued
by their, State employers. If State credentials do not
already exist, the State is responsible for designing
providing such credentials to their inspectors*
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It. iii additionally nccossary .Cor Statas to cease using
the rcderully supplied "I^ou-icu of Ia:;,ycction" forr.-., (EPA
Fcr:.i 3540-2 (Itev. 3-75)). The present foru erroneously
identifies use inspections as beinc,- authorised under the
authority of the "U.S. Environmental Protection Agency". The
es are responsible for drafting nev.' Notice of Inspection
The States must design their Notice of Inspection
forn in a manner which parallels tho liPA form. A consistent
format will greatly aid the indexing of the information in
the Agency computer. The State Notice of Inspection form
should indicate the relevant State statutes which authorize
the inspection. While States await the printing of the nev;
forms, they may use the Federally supplied forms if all
indicia of Federal authority are obscured.
It should also be noted that State inspectors conducting
use inspections cannot rely upon FIFRA for authority to take
affidavits. Consequently the Agency affidavit forsi (EPA Form
3540-11 (Rev. 9-75)) may not be used by States during use
inspections. If State law grants this power, of course, the
inspector nay take an affidavit according to State pro-
cedures.
I hope that the Regions will implement these guidelines
during the next 60 days. Please contact John Martin of ny
staff at 755-1075 if you have any questions.
A. E. Conroy II, Director
Pesticides and Toxic Substances
Enforcement Division
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404 Federal Register / VoL 4& No. 3 / Wednesday. January 5. 1983 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFfl Part 173
(OP* 00159; PH-fFL 2215-3]
Federal Insecticide, Fungicide, and
Rodenticide Act, State Primary
Enforcement Responsibilities
AGiMCV: Environmental Protection
Agency (EPA).
ACTION: Final interpretive rule.
SUMMABY: This rule states EPA's
interpretation of several of the key
provisions In sections 28 and 27 of the
Federal Insecticide. Fungicide, and
Rodenticide Act (FTFRA). but does not
impose substantive requirements on the
State*. Sections 29 and 27 established a
standard and procedure for according
States the primary enforcement
responsibility for pesticide use
violations {primacy). The rule also
provides operational substance to the
criteria used by EPA for primacy related
decisionmakiag, and ensures that such
decsionmakicg is consistent throughout
the regions.
smcnvz DATK This role will not takes
effect before the end of 60 calendar days
of continuous session of Congress after
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the date of publication. EPA will publish
• notice of ine actual effective date of
this rule. See SUPPIEMIMTAMY
INFORMATION fur further detail*.
ro* narrow INFOMMATIOM CONTACT:
Laura Campbell. Pea'Jcidei and Toxic
Substances Enforoer»eat Division (£,V»
342). Office of Pesticides and Toxic
Substances, Environmental Protection
Agency. Rm. M-2a24£, 401 M SU SW,
Washington. OC. 20480, (2J2-382-S56G).
MFORUATIOfe
Back
In 1978. Congress enacted Pub. L 85-
338 which contained numerous revision*
to the Federal Inaecticide. Fungicide.
and Rodenticide Act (7 U.S.C. 136 e<
*et/. J. One of the changes added two
new sections to FIFRA. section* 28 and
27. U.SJ1 138w-l and 138W-Z. wfaxh
together established • standard and
procedure for according States the
primary enforcement n^mniAitt+y for
pesticide tae rJolabon* (primacy}.
Section 28 provides three saeibccb by
winch a State can obtain prnaecy.
Section 2S(a) requires a State to be
accorded primacy if the AdoinistraJoT
finds that the State has (l) adopted
adequate uee laws. (2) adopted
adequate procedures for hap]eru?r..fa3
those laws, asd (3) agreed to fcrep such
records aad gvakf each reports as the
Administrator may require by
regulation. Section 26(b) allow* a Stale
to obtain primacy if the State has aa
approved tecc'oa 4 certificatian plan
thai meets ths criteria set fcrth in
section 26{aJ. or if a State enters isio a
cscperative a green eat for the
enforsessat of pesticide CM restrictions
under secScn 23.
Secties 27 authorizes die
Adzunistratar ts override or rescind a
grant of primacy in certain situations.
Section 2T(a) requires the Administrator
to refer cg=£icar:t allegories* cf
pesticide s*e violations to the States. If
a State dees not commence appropriate
enforcement actioa within 20 days of
such referral, EPA may bring ils own
enforcement nctlna.
Section 2Tjb] audsoriaej me
Administrator to rescind the primary
enforcement responsibility of a Slate if
she finds that the State is not carrying
out such responsibility. Tie
Administrator initiates a rescission
proceeding by notifying the State of
those aspects of the Slate's pesticide use
en forcemeat program which the
Administrator haa foend to be
inadequate, if the State does not correct
the deficiencies in its programs within 90
days, the Administrator may rescind the
States'* primary enforcement
responsibility in whole or in part. EPA
hus promulgated procedures which
govern !::£ conduct of a proceeding to
reicint! Sti^e prjnacv. These procedures
wure publi.shed in lh» Federal Register
of May 11. 19fll (46 FR 28058). {« CFR
Part 17JJ.
S-c:ion 2Tfr) authorizes the
Aftairijitrator lo take immediate action
to abate an emergency situation where
the State is ooabie or unwilling to
respond to the cri&is.
As in evident from die above
description, several of the operative
term* in sections 23 and 27 require
further definition. This rule clarifies the
meaning, of such words «s "adequate"
and "appropriate" which FIFRA seta
forth as the criteria for rao*t of die
decisions which will be r>»^f 'i**H*r
these two ««rti/»t»«. The rale also seta
guidelines to be T**^ by EPA in mjltlna
*^^^*m^ afio> essures
that such
by limits^, arthsvgh riot ^
Agency discretion in the orimacy area.
Specifically, this rale addresses Xhe
UATtsTtCj? X3XQCS*
I. Procedares EPA «nU follov whea
femng »flg«afin-M ,at so State
with mare strfejent pesticide cse laws
than the Federal law should be granted
primacy. Although EPA cannot require a
Stare to enact a pestidde use law that Ls
mere stricg^cl than rTFHA. there is no
prohibition against granting primacy to a
State whose pesticde use law is more-'
stringent.
One. comment so£**3ted a chaste in
the requirement that State laboratories
conducting sample analysis perticipate
in EPA's check umple program. The
comment stated that the National
Enforcement Investigation Center
(NGQ check sample program should be
coordinated wnh me American
Association of Peat Control Officials
(AAPCO). The NE1C check sample
program is currently coordinated with
the AAPCO check sample program. The
rule has been changed to reflect this
comment
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Further tnfaraution on Effective Oat* of
ThisRuls)
On December 17. 1800. the Federal
Insecticide. Fungicide, iad Rodenticida
Act extension bill (Pub. L »-W9) '
•ame law. This bill amended several
ions of FIFRA. hctmHng section 25
.. rulemaking. Section 4 of the
Extension Act adds a new paragraph,
section 25(e). to FIFRA which requires
EPA to submit final regulation* to
Congress for revlaw before tha
regulation* become effective. Copies of
this rule have been transmitted to
appropriate office* in both Houses of
Congress, .• _
Under section 4 of the 1380 FIFRA
Extension Act this rule will r.ot take
effect before tha end of GO calendar days
of continuous session of Congress after
tho date of publication of this rule. Since
the actual length of this waiting period
cay be affected by Congressional
action. It is not possible, at this time, to
specify a date on which this regulation
will become effective. Therefore, at the
appropriate time EPA will publish a
notice acr.cuacing the end of the
legislative-review period and notifying
the publlcrjf the actual effective date cf
-this regulation.
Cotnpliaaca With the- Regulatory
Flexibility Ad
I hereby certify that this rule will not
have a significant economic Impact on
small entities. The role affects only
r '• pesticide control agencies, which
3t scall entitles under the
.iatcrjr Flexibility Act S U.S.C. 601
et seq.
Compliance With Executive Order
Under-Executive Order 12231. EPA
rsust fudge whether a regulation is
"Major" and therefore subject to the
requireceat of a Regulatory Impact
Analysis. This regulation la not Major
since it is Interpretive in nature and
docs not contain new substantive
requirements. The regulation:
1. Does not have an annual effect on
the economy of SI 00 million or more.
2. Will not substantially increase
costs to consumers, indusiry. or
government.
3. Will not have a significant adverse
effect on competition, employment,
Investment, productivity, or innovation.
This regulation was submitted to the
Office of Management and Budget for
review as required by Executive Order
32291. (Sec. 2S(a](l) (7 U.S.C. 136w)).
[Note: This rule will not appear in the
Code of Federal Regulations.)
L Appropriate Enforcement Action
A, Procedures Governing Referrals. \.
General. Section 27(a) requires EPA to
refer to the States any Information it
receives indicating a significant
violation of pesticide use laws. If a State
has not commenced appropriate
enforcement action within 30 days. EPA
may act on the information.
Given current resource limitations,
EPA Is not In a position to monitor State
responses to every allegation of
pastldda misuse referred by the Agency.
Rather, tha Agency will focu* its ,
oversight activities on evaluating the
overall success of State pesticide
enforcement programs, aad will track.
on a case-by-case basis, only those
allegations involving particularly serious
violations. Such "significant" allegations
will be formally referred to the Slates
and tracked by EPA, while other less
serious complaint* will be forwarded to
the States for information purposes only.
2. Cfitsria for tt'snificant cases. To
determine which alleged violations are
sufficiently significant to warrant formal
referral and tracking, the regions will go
through a two step process. First tha
regions. In consultation with each State.
will identify priority areas for referral
These priority areas will consist of those
pesticide activities in tha State which
present the greatest potential for harm
to health or tha environment (e.g. the
application of a pesticide by a certain
method to a particular crop, such as
ground application of endria to apple
trees). Tha selection of these priority
areas will depend primarily en the
results of pesticide enforcement program
evaluations conducted by the States and
the regions. The priority areas will be
revised on an annual basis based upon
the effectiveness of tha program in
reducing, the harm associated with
pesticide use.
Thereafter SPA will determine on a
case-by'Csse basis which allegations in
these priority areas involve sufficiently
"significant" violations to be formally
referred to tha State and Cracked. If a
complaint received by EPA alleges a
minor infraction which clearly presents
little or no danger to health or the
environment or if the information
contains patently spurious allegations.
tuch as those from sources which have
repeatedly proved unreliable, the matter
will be forwarded to the State for
information purposes only.
3. The 30-day time period. The Agency
interprets the term "commence
appropriate enforcement action" In
section 27{a) to require States to initiate
a judicial or administrative action in the
nature of an enforcement proceeding, if
one is warranted. Starting an
investigation of the matter would not be
sufficient. If (he State does not
commence an appropriate
administrative, civil, or criminal
- enforcement response. EPA would then
be permitted, although not required, to
bring it* owa enforcement action,
Although section 27(a) permits EPA to
act If the State ha* not commenced an
enforcement action wiUtfinO days, the
Agency recognize* that States may not
be able to complete .their Investigation
of many formal referrals in so short a
time. The time needed to Investigate a
possible use violation will vary widely.
depending upon the nature of the
referral A referral which simply
conveys an unsubstantiated allegation
will usually require more investigation
than a referral which partially or fully
documents a pesticide use violation.
Consequently, the Agency wishes to.
develop a flexible approach towards the
tracking of referrals.
To accomplish this objective. EPA i*
adopting a system in. which the referral
process is broken down into two stages.
investigation and prosecution.
4. The investigsUan stage. Following
the formal written referral of an
allegation of a significant pesticide use
violation, the appropriate regional
pesticide official will contact the State
to learn the result* of the Investigation
and the State's intended enforcement
response to the violation. If the State
has not conducted aa adequate
Investigation of the alleged violation, the
region may choose to pursue its own
investigation or enforcement action after
notice to the State. As a general rule.
however, the regional office will attempt
to correct any deficiencies in the
investigation through informal
communication with the State.
An investigation will b« considered
adequate if the State has (1) followed
proper sampling and other evidence-
gathering techniques. (2) responded
expeditiously to the referral, so that
evidence is preserved to the extent
possible, and (3) documented all
inculpatory or exculpatory events or
information.
5. Tho prosecution stage. After
completion of the Investigation, the
State will have 30 days, the prosecution
stage, to commence the enforcement
action, if one Is warranted. An
appropriate enforcement response may
consist of required training in proper
pesticide use. Issuance of a warning
letter, assessment of an administrative
civil penalty, referral of the case to a
pesticide control board or State's
Attorney for action, or other similar
enforcement remedy available under
State law. The 30-day period may be
extended when necessitated by the
procedural characteristics of a State's '
regulatory structure (se« Unit V.A.
Hypothetical 1).
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Federal Register / Vul. 48, No. 3 / Wednesday. January 5. 19flJ / Rules and Reuuianons .^ 4U7
If. after consultation with the Slute.
EPA determines that the Slate's
intended enforcement response la the
violation is Inappropriate (see
•ubdjvision B). EPA may bring its own
action after notice to the State. Regional
attorney* will not, however, initiate an
enforcement proceeding looner than 30
days after the matter wai referred to the
State.
At times, a State may find that the
particular enforcement remedy it views
as the appropriate response to a use
violation is not available under the
State's pesticide control laws. Therefore
the State may. at any time, request EPA
to act upon a violation utilizing remedies
available under FIFRA. In these
Instances, of course, EPA will
Immediately pursue its own action, if
one is'warranted.
To illustrate better the proposed
referral system, two hypothetical
situations are described in Unit V. A.
B. Appropriate Enforcement Action. 1.
General: After the Agency learns of the
enforcement action. \i any. the State
proposes to bring against the violator.
the EPA regional pesticide cfHce will
consider, in consultation with the State.
whether the proposed action is
"appropriate", relative to the remedies
available to the State under its pesticide
control legislation. EPA interprets the
modifier "appropriate" In section 27(a)
of FIFRA to require that the severity of
the proposed enforcement action
correlate to the gravity of the violation.
It is not possible in this Interpretive
Rule to prescribe the specific
enforcement action which will constitute
an appropriate response to a particular
violation. There an too many variables
which will influence the treatment of a
use violation, including the disparity
between the types of enforcement
remedies available under the various
Slate pesticide control statutes. Thia
document can. however, establish
criteria to be employed in evaluating the
appropriateness of a proposed State
enforcement action. More detailed
guidance on evaluating relative gravity
is contained in EPA'a "Guidelines for
the Assessment of Civil Penalties under
Section 14(a) of the Federal Insecticide.
Fungicide, and Rodenticide Act as
amended", published in the Federal
Regster of July 31.1974 (39 FR 27711).
The Guidelines establish dollar amounts
to be applied under the Federal statute
to use violations in civil penalty
proceedings. Regional personnel can use
these figures as a guide in evaluating the
gravity of a particular violation. The
Agency will not require that a State
response to a violation have a monetary
impact equivalent to that of a dvtl
penalty which EPA would Impose under
the Guidelines. Rather, the dollar
amounts contained In the penalty
matrices can be used by regional
personnel to define the relative gravity
of a violation by comparing the figures
applicable to different violations.
2. Gravity of the violation. The
Agency believes that the gravity of a
pesticide use violation Is dependent
upon the risk the violation poses to
human health and the environment. The
factors which determine the degree of
risk presented by a use violation can be
divided Into two categories: factors
related to the particular action which
constituted the violation and factors
related to the pesticide involved in the
incident.
a. Risk associated with the violativa
action. The circumstances surrounding
the violative action partially determine
the risk the violation presents to human
health or the environment. To assess the
degree of such risk. State and regional
personnel should ask such questions as:
L Did the violation occur in a highly
populated area, or near residences.
schools, churches, shopping centers.
public parks or public roads, so that
health was endangered?
11. Did the violation occur near an
environmentally sensitive area, such aa
a lake or stream which provides
drinking water to the surrounding
community, a wildlife sanctuary, a
commercial fishery, or other natural
areas?
iii. Did a structural application
threaten to contaminate food cr food
service equipment?
iv. Did the violation have the potential
to affect a large cr a small area?
T. What was the actual ham which
resulted from the violation?
vi. Was the nature of the violation
such that serious consequences wera
likely to result?
This lest question is designed to take
Into account the variation in the
inherent risk associated with different
categories of use violations. For
example, a drift violation resulting from
improper aerial application generally
presents a greater risk of harm than a
storage violation, since the latter
infraction does net necessarily involve
the improper exposure of the pesticide
to the environment
b. Risk associated with the pesticide.
The factors which will be crucial in
evaluating the risk associated with the
pesticide itself Include:
L The acute toxidty of the pesticide or
pesticides involved in the incident The
toxidty of a pesticide will be indicated
by the "human hazard signal word" on
the la'uels (see 40 CFR 162.10). "Danger"
or "Poison" are indicators of a highly
toxic pestidde while "Warning- and
"Caution" signify successively less toxic
substances.
ii. The chronic effects associated with
the pestidde. if known.
ill. The amouJUrTihe pesticide
involved in the Inddent relative to the
manner of application (e.g., aerial versus
structural).
iv. Other data concerning the harm a
pestidde may causa to human health or
the environment such as data
concerning persistence or residue
capability.
An analysis of the interrelationship
between these two categories of risk
factors should yield a notion of the
relative gravity of the violation and the
severity of the action which should be
taken in response.
3. Category of applicator, size of
business, and history of prior violation.
Gravity is not the only factor which EPA
will take into account in evaluating the
propriety of an enforcement action.
Secticn 14 of FIFRA requires that
distinctions in the severity of an
enforcement response be made between
the categories of persons who commit
usa violations. The Intent of Congress,
as expressed In section 14. is that
commercial pestidde-applicatora who
violate use requirements will be subject
to more stringent penalties that other
persons who violate use restrictions.
Congress also envisioned that the size of
the violator's business will be a factor in
determining the severity of the penalty.
In addition, section 14 distinguishes
between violators who have committed
previous infractions and those who &n .
first offenders. Thus,' the issuance of a
warning letter by a State to a person or
firm who has been repeatedly warned in
the past about a certain violation would
not generally be considered an
appropriate response to the violation.
4. Knowins violations: criminal
penalties. The state of mind of the
violator is another important'
consideration. In extreme circumstances
where the civil penalty remedy is
inappropriate, it is the Agency's policy
to pursue a criminal action against
persons who knowingly violate a
provision of FIFRA. EPA will be
particularly interested in pursuing
criminal prosecution for those violations
which involve a death or serious bodily
injury or la which the violator has
demonstrated a reckless or wanton
disregard for human safety.
environmental values or the terras of the
statute. To be appropriate, a State's
response to a knowing violation under
the circumstances indicated above must
be similarly severe.
5. Deterrence. It should be noted that
the appropriateness of an enforcement
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408
Federal Remitter / Vol. 48. No. 3 / Wednesday. January 5. 1983 / RuJes and Kegulations
action it • dynamic, rather thin • static.
concept Because it U dynamic.
penalties must be periodically
evaluated. If a certain violation U
occurring more frequently, the leniency
of tha remediea which have been
applied to this infraction in the pa»t
should ba questioned Consequently,
what is appropriate ifl ona year may be
viewed as an inadequate response in the
next.
The factors described above, together
with the aforementioned Guideline*.
should help to clarify the Agency's
definition o/"appropriate enforcement
action.** To understand belter how the
criteria described above can be tued to
evaluate whether • proposed State
enforcement action is appropriate, the
reader la referred to the hypothetical
fact situations in Appendix B.
0. Criteria Governing Grants of Primacy
Section 29 of FIFRA sets forth the
general criteria which apply to EPA'i
decision whether to grant primacy to a
State:'
"(a) For ih* purpose* of ihh Aci. s Smeihall have primary enforcement
responsibility lot pesticide use violations durteg any period for »hich (he Ad'
miruurator determines thai such Slate—
•*(1) has adopted adequate pesticide use unr» and regulations; Pro-
vided. That the Administrator may not require a State (o ha»e pesticide
u'jg laws ihai are more stringent than this Ac:;
"(2) has adopted and is implementing adequate procedure* for the
enforcement of such State laws and regulations; and
"(3) »iil keep such records and mike such repofiv vhouing com-
pliance wiin paragraphs (|) and (2) of (his subseviion as the Ad-
ministrate* may require by regulation.
"(b) Notwithstanding the provisions of subjection (a) of (his section, any
State ifut emert into a cooperative agreement with the Adrnmisir«or under
section 23 of this Act for the enforcement cf pesticide use restrictions shall
have th« primary enforcement responsibility for pesticide use violations. Any
State that has a plan approved by the Administrator in accordance *uh the re-
quirernern* of section 4 of this Act that the Administrator determines meets
the crnerii set out is subieciion (a) of (h»s section $ha!l have !he primary en-
forcer*™ responsibility fat pesticide use violations. Th* Administrator Oiall
make such determinations »ith respewt 10 State plan* under Section 4 of this
Act m effect on September 30. 1978 not later than March Jl. H7».
Thus, a Stata nay obtain primacy bi
vo ways; (1) by demonstrating that the
.•rents of its use enforcement
.cgram. cr of its-approved certification
program, satisfy the rwo nain criteria in
section ZS(a). (adequate laws and
adequate procedures implementing
these laws}, or (2) by entering into a '
cooperative agreement for the
enfcrcesent of use restrictions.
provided the tenss of the agreement do
not specify otherwise. The Agency will
also evaluate lha adequacy of a State's
LIB enforcement program before
conferring primacy by this latter
method.
A. Adequate Lam and Regulation*.
To be considered adequate, a Stale's
pesticide control legislation must
address at least the following areas:
1. Use restrictions. State pesticide
control legislation will be considered
adequate for purposes of assuming full
primat) if State law prohibits those acts
which *.-r; proscribed ur.der FIFRA and
which -».iie to pesticide use. The
activi!i»i presently proscribed under
FIFRA . .-.ude:.
a. L!si .' * registered pesticide in a
martn". •. '.nsistent with its label
!HFRA«~';onl2(a)(2)(C)).
b. Us* of a pesticide which is under
an exparimental use permit contrary to
the provisions of the permit (section
c. Use cf a pesticide in tests on
humans contrary to the provisions of
section igaj{2)fP).
d. Violation of the provision in section
3(d](1)(c) requiring pesticides to be
applied for any restricted ose only by or
under the direct supervision of a
certified applicator. Violations of
suspension or cancellation. orders are
not considered use violations for*
purposes of the primacy program.
States may be granted partial primacy
If they regulate leas than all categories
of use violations. For example. EPA may
in the future decide to issue "other
regulatory restrictions" on use under
section 3(d)(l)(C}(ii), (such as a
requirement to notify area residents
before pesticide spraying). If such a
restriction were issued, (and not
reflected on pesticide product labels).
each State would automatically have
partial primacy extending to all cf the
categories Hs'ed abov» which are
proscribed by State law. unless the
Slate already has authority to enforce
such restrictions. A State with partial
prmacy would obtain full primary by
enacting a prohibition tracking the
lection 3fd)(l)(C](U) re.friction.
2. Authority to enter. To carry out
effectively their use enforcement ,
responsibilities. State officials should be
able to enter, through consent, warrant.
or other authority, premises or facilities
when pesticide use violation! may
occur. States should also have
concomitant authority to take pesticide
samples as part of the use inspection
process.
3. Flexible remedies. Finally, State
legislation must provide for a
sufficiently diverse and flexible array of
enforcement remedies. The State should
be able to select from among the
available alternatives an enforcement
remedy that is particularly suited to the
gravity of the violation. Without such
flexibility, a State may frequently be
forced to underpenalize violators, and
thereby fail significantly to deter future
use violations. Thus, in order to satisfy
the "adequate laws" criterion. Stales
should demonstrate that they are able
to:
a. Issue Warning Letters or Notices of
N'oncompliaace;
b. Pursue administrative or civil
actions resulting in an adverse economic
impact upon the violator. e.g., license or
certifica-tioa suspensions or civil penalty
assessments: and
c. Pursue criminal sanctions for
knowing violations.
B. Adequate Pncedurey for Enforcing
the Lam. In order to obtain primacy.
States must not only demonstrate
adequate regulatory authority, but must
also show that they have adopted
procedures to Implement the authority.
These procedures must facilitate the
quick and effective prevention.
discovery, end prosecution of pesticide
use violations.
1. Training. One step towards this
objective is the training of enforcement
personnel At a minimum. States, in
cooperation with EPA. should
implement procedures to train
inspection personnel in such areasjes
violation discovery, obtaining consent.
preservation of evidence, and sampling
procedures. Enforcement personnel
should be adequately versed in case
development procedures and the
maintenance of proper case files.
Instruction in these techniques should
take the form of both on-ihe-job (raining
and the use of prepared training
materials. The Agency also considers a
continuing education program to be a
crucial training procedure, so that
enforcement personnel can be kept
abreast of legal developments and
technological advances.
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Federal Register / Vol. 43. No. 3 / Wednesday. January 5. 1983 / Rules and Regulations
409
2. Samp/ing techniques and
laboratory capability. Requests for
primacy thould also »how thai the Stale
it technologically capable of conducting
a use enforcement program. States mutt
have ready access to the equipment
necessary to perform sampling and
laboratory analysis, and should
implement a quality assurance program
to train laboratory personnel and
protect the integrity of analytical data.
Laboratories conducting sample
analyses must also agree to participate
in EPA (NEIC) Check Sample programs
which are designed to ensure minimum
standards of analytical capability. (Such
a program is already operational for
formulation samples, and a residue
sample program is also under
consideration). The EPA Check Sample
program Is coordinated with the
Association of American Pesticide
Control Officials (AAPCO) to reduce
unnecessary duplication of effort. The
EPA will be guided in evaluating the
adequacy of State analytical procedures
by official compilations of approved
analytical methods, such as the Food
asd Drug Administration's (FDA)
Pesticide Analytical Manual, the CEPAC
(Collaborative Interr-alicnal Pesticides
Analytical Council] Handbook, the EPA
Manual of Chemical Methods for
Pesticides, and Official Analytical
Chemists Analytical Procedures. For
additional guidance on adequate
samplirg techniques. States should
cor.suit EPA's FIFRA Inspectors Manual
or contact the appropriate regional
office.
3. Processing ccmplaints. SIcca a
significant portion of pesticida use
violations are identified through reports
from outside E?A or the State lead
agency, the State must implement a
system for quickly processing and
reacting to complaints or other
information Indicating a violation. An
adequate referral system should contain:
a. A method for funneling complaints
to a central organizational unit for
review.
b. A logging system to record th*
receipt of the complaint and to track the
stages of the follow-up investigation.
c. A mechanism for referring the
complaint to the appropriate
investigative personnel
d. A system for allowing a rapid
determination of the status of the case.
e. A procedure for notifying citizens of
the ultimate disposition of their
complaints.
4. Compliance monitoring and
enforcement. Along with the abova
described enforcement procedures.
Slates must provide assurance that
sufficient manpower and financial
resources are available to conduct a
compliance monitoring program, i.e.,
either planned or responsive use
Inspections. In addition. States must
Implement procedures to pursue
enforcement actions expeditiously
against violators identified through
compliance monitoring activities.
The Agency also believes that
program planning and the establishment
of enforcement priorities is an integral
part of an adequate enforcement
program. Such planning, taking into
account the national program priorities
as manifested through the grant
negotiation process, as well as the
priorities specific to the Individual State,
will help assure that compliance
monitoring and enforcement resources
•re properly allocated.
5. Education. Slates should implement
a program to inform their constituencies
of applicable pesticide use restrictions
and responsibilities. Examples of
education methods Include
disseminating compliance information
through cooperative extension services.
seminars, publications similar to the
Federal Register, newspapers, and
public assistance offices where persons
can call to ask questions or report
violations. Such an educational program
will promote voluntary compliance and
Is essential to effective enforcement.
States should also develop procedures
for soliciting input from the public
regarding the administration of the
pesticide use enforcement program.
ITT. Criteria Governing Rescission of
Primacy Under Section 27(b)
Section 27(b) authorizes the
Administrator to rescind primacy from a
State in certain situations:
"(b) Whenever the Administrator determines that a State having primary
enforcement reiponsibiiity for pesticide use violations is not carrying out (or
cannot carry out due :o the lack cf adequate legal authority) such responsibili-
ty, the Administrator shall notify the State. Such notice shall specify those
sspecn of the administration of the State program that are determined to be
inadequate. The State shall have ninety days after receipt of the notice to cor--
reel any deficiencies. If after that time the Adminisiraior determines thai the
State program remains inadequate, the Administrator m«y rncind, in »ncle
or in pan, the State's primary enforcement, responsibility for pesticide use
violations.
In deciding whether a State is not
carrying out or cannot carry out. its use
enforcement responsibilities, the
Administrator will apply the criteria for
an adequate program set forth in Unit 0
to the performance of the State during
the time the State had primacy.
A. Adequate Laws. The legal authority
can conduct an adequate use
enforcement program is a criterion
which affects both the decision to grant
primacy and the decision to rescind it.
Within the context of rescission, the
Administrator will assess the impact of
any amendments or supplements to the
State's pesticide use laws and
regulations. If legislative changes have
adversely affected the State's ability to
collect information or bring enforcement
actions, the State may be subject to a
rescission action on grounds of
Inadequate laws.
E Adequate Procedures. In
determining whether a State which has
adequate legal tools is carrying out its
use enforcement obligations, the Agency
will examine the efficacy of the
procedures adopted by the State to
Implement its pesticide laws. The
Agency will be particularly interested in
the remedies the State has actually
applied to the various use violations.
The lack of sufficient correlation
between the gravity of a use violation
and the severity of the enforcement
response would be evidence that the
State's arsenal of remedies is not being
applied in a flexible manner.
In addition. EPA will evaluate each
program element listed in Unit ILfl.. in
light of the performance of the Slate
during the period the State had primary
use enforcement responsibility.
I. Training. The Administrator will
note whether any difficulties
encountered by the Slate in enforcing
pesticide use restrictions have resulted
from a lack of adequate training of State
enforcement personnel.
2. Sampling techniques and
laboratory capability. The
Administrator will consider whether the
State's sampling techniques end
-------
analytical capabilities are enhancing or
hindering the State'i ability to unearth
and prosecute snccessfuDy persona who
miiasa penticides. Another Important
consideration will be the degree to
hich State laboratory and umpling
icedurej have kept pace with
-velcpmenU in analytical technology.
3. Pncsatiag comp/a/nac The
Administrator will examine whether
complaints have been processed quickly
and efficiently. The degree to which
citizens alleging a MM violation seek
redreu from EPA after first directing
their complain! to the Slate will be
considered. In addition. the
Administrator will take Into account the
performance cf the State in responding
to allegations referred to the State by
EPA under section 27(a) of FTFRA.
4. Compliance mon/torrng and
enforcement. Under this element, the
Administrator will compare the State'*
level of compliance monitoring activities
with that of other comparable States.
The EPA will review State case files to
determine whether tho State has
aggressively Investigated a case bsfsra
deciding on the disposition of the
natter. The ETA will also nrvestjgita
whether a State'i Attorney General'*
office or other presecutcrial authorities
have dascsstrated a wiSirgness to
pursue cases referred by the State's
pesticide control lead agency. '
The Agency will examine whether
Stats ec/crceineat resources have been
c'.ed towards the more significant
rcemeat problem areas, and
.. Aether enforcement priorities have
keen Devaluated as the demands of an
adequate program change over time.
S. Education. The Administrator will
evaluate whether the State's education
program is encouraging voluntary
compliance with pesticide ate
restrictions. As part of this process, the
Administrator will note those use
violations which are at least partially
attributable to the violator's lack of
familiarity with applicable laws and
regulations. The Administrator will also
review State procedures for facilitating
public participation in the enforcement
program.
These criteria are indices of the
adequacy of a State's use enforcement
program, but they do not cunclusiveiy
determine whether a Stale is dist barging
its primacy responsibilities. Since the
Agency's goal is to protect the public
from the risks associated with
pesticides, one of EPA'k central inquin.'s
will be whether the State's primacy
program assures compliance with
pesiicide use restrictions. F.PA. in
e\aluating State program adequacy, will
consider both the deficiencies of the
program and the success of the program
In achieving compliance.
IV. Emergancy Respoas*
Notwitajtaadin* other provisions of
sections 28 and 27. the Administrator
may, after notification to the State, take
Immediate action to abate emergency
situations if tha Stale is "unwilling or
unable adequately to respond to the
emergency."
FTFRA does not define "emergency
conditions." Other EPA-admiaisteied
statute*, however, characterize
emergencies in fairly consistent terms.
The consensus of these statutes is that
an emergency presents a risk of harm to
human health or the environment that is
both serious and imminent, and that
requires immediate abatement action,
p»amn!»« of a£e-reUted emergency
situations ore:
1. Contamination of a building by a
highly toxic pesticide.
2. Hospitaiiza lions, deaths, or other
severe health effects resulting from use
of a pesticide.
X A geographically specific pattern of
use or misuse which presents
unreasonable risk of advene effects to
health or sensitive natural areas. This
situation may occur, for example, if a
hazardous pesticide is consistently
misHsed in a particular area so that the
net effect is the creation of substantial
endangerment to the environment, such
as runoff into a water supply.
A. -UavnUiog'. When EPA learns cf '
aa emergency situation. Agency
representatives eust notify tha affected
State. These representatives will try to
obtaia a coaaitmeni from the State as
to (a) what the Sute is capable of doing
In response to the situs tioa, and (b)
when the State intends to respond to the
crisis.
Emergencies, by nature, require the
quickest possible response. In most
cases, due to proximity, the Slate will
have the opportunity to be first on the
scene. If the State manifests an
unwillingness to respond rapidly to the
situation, or if the State cannot give
assurances that it will respond more
quickly than EPA could respond.'Agsncy
emergency response teams will be
activated.
B. "Unable". The EPA will
immediately take action to abate an
emc'aoncy if Ihs Slate is unable t<> rin
so. The Agency interprets "unable" to
mean thai other the State dot s not have
the authority to adequately respond or
lh.it the State Is incapable of solving the
problem due to tt^e lack of tethnolr^y or
resources.
1. Authority. The EPA c;in utilize its
autOority in section 16(c> of KIFRA to
seek, in conjunction with the
Department of Justice, a district court
order preventing or restraining misuse of
a pesticide. States should also bo able to
address • use-related emergency In this
manner or by the rapid Issuance of an
enforceable stop-use order or other
similar means. If the State lacks this
authority and the emergency conditions
warrant a legal response in the nature of
specific enforcement or equitable relief,
EPA may Initiate its own action after
notice to the State.
2. Technical capability. Some
emergency situations may present
problems which the States are
technologically incapable of solving. In
these instances, if EPA possesses the
requisite technology or equipment the
Agency will immediately respond to the
crisis. For example, where a dissolved
organic pesticide has contaminated a
surface water system. EPA would
activate its portable advanced waste
treatment unit, a resource that is not
generally available to the States.
The EPA will also take action if the
State cannot rapidly commit the
necessary manpower to the emergency
situation. In most cases EPA will not.
however, initiate a response oa this
basis if the State has developed an
emergency response plan detailing the
procedures to be followed in •
counteracting a pesticide emergency.
V. Hypothetical Situations
In reading the hypothetical* in Units
A and B. asruxne that the cases
discussed fall usder priority referral
areas discussed In Unit LA-2.
A. Action by Citizen. Hypothetical 1.
EPA refers to the State a citizen's
allegation fiiat an aerial applicator has
allowed pesticides to drift over his
property. After 22 days, the EPA Region
obtains the results of State's
investigation and learns that the State
plans to issue a warning letter to the
applicator. The EPA advocates a more
firm response and. after discussion, the
State agrees to suspend the applicator's
certification. The Stale certification
board does not meet, however, until two
months later. In this instance, the Region
may decide to extend the normal 30 day
prosecution stage to accommodate the
schedule cf the board.
Hypothetical 2. A citizen calls EPA
vtith information concerning a fish kill
wh.ch occurred m a stream near his
residenre. The citizen claims that he
reported his information to the Stcte. but
State officials have not responded to his
cor.plairt. The TP.Ys Regional official
calN the State, and learns that the State
did indeed kr.ow of the problem, but has
not yet had the opportunity to
investigate (ho allegation. The Regional
-------
official, believing the allegation to b«
lignificant. formally refers the complaint
o tht State, and the Stale agrees that
he matter ihould bt investigated within
da^t. After 20 dayt. the Region learns
Jtste has not yet beaun its
____ Slion. ID this case, the Region
jegin it< own inquiry into the
natter, and may commence its own
•nforcement action, after notice to the
>!ate. provided that 30 days have
japsed from the date of the referral.
B. Action by State. In both of (hesa
lypolheticals, usuae that the State has
hosen a Warning Letter a* the
ppropriata enforcement response.
Hypothetical I. Mr. Smith operates a
ae-man crop dusting company. Smith i*
ired to spray Herbicide A over a power
or.p«..y's lengthy right-of-way. The
•ght-of-way Is bounded on one Bide by
residential development and on th»
ther by a wooded area. Smith performs
:e aer.al applicaticn aoidii high
wiriin3 wtndj la contravention of tha
istroctio^s on the herbicide'* label. A
.gnificast pcrticn of the herbicide drift*
=10 ihe weeded area. Herbicide A.
hich ccntauis ths hazard ward
jaeger" on its lacd. is a highly toxic
r.d persistent restricted use peatkids.
.r.ith has no reccrd of prior pesticide-
:!atcd violations with gavemacci
uticida ccstrcl cfDc=a.
Th* Agency would consider tha
acanca of a warning letter to be an
.apaiJEriate response to this violation.
* ^^^crscc/3i?tf with the violotirt
^^^Rrtiiately fn this instance, tha
.e did not mult Li damage to
ii..;:s or sensitive enviroruseaJaJ
MS, But at tha time (he violation was
.•oir-itted, the risk that kara would
suit L-cm the misuse was quite
jmficar.t. given tha high swirling
inds and the proximity of a residential
.'ighbcrhood. Only chance prevented
e herbicide from drifting Into anN
habited area. The risk of hann waa
so increased by the fact that a yreat
al of land was subject to drift given
» length of the target area.
b. Risk associated with the pesticide.
.>rb:cids A is labelled "danger" end is
:refcr» an acatcly toxic Catenary i
sticide ander |.o.<«>d cooking
racks were to b«s used.
c. Other factors. Under FIFRA. the
Issuance of a Notice of Warning is the
maximum enforcement response to a use
violation commi'ted.by a private
applicator with no history of prior
violations. Thus, the Agency would, of
course, view the proposed State
enforcement action as appropriate. If the
violation were repeated, a more
stringent enforcement action would be
warranted.
Dated- f>c«mUr 12. 18S2.
Icfcn W. ttenuodci. [r.
Actirj AdmLntttrator.
(TB Dot f*4 KM I 4 «>
aaiMCOCt tsso
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'• UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
APR 2 1 1983
OFFICE Of
PESTICIDES AND TOXIC SUBSTANCES
EM08AMDUM
S!''UECT: Final F IT'S 4 Cooperative Agreenent Prog ran Guidance
TO: Air and Waste Management Division Directors
Environnental Service Division Directors
Pesticide Branch Chiefs
Attached is tne final guidance for the FY^4 FIFtfA cooperative
agreement program. This document combines guidance for both the
pesticides enforcement and the applicator certification and train-
ing programs. For your convenience, the sections entitled FY 1984
FIF-iA Cooperative Agreenent Program Guidance and FIF.^A Cooperative
Agreenent Program Guidance are included in their entirety. Thesy
sections replace the FY 1 kJ33 Cooperative Agreenent Pro?ran Guidance
and the FIFRA Cooperative Agreement Program Guidance sections in
the FY33 guidance. Also, nany of the Appendices in the FYo3 cjM-
an c a hove either been an ended, revised or r •» placed ana five new
^"oendic^s have been added.
This final guidance has been modified in response to nost
comments on the earlier draft. Specifically, the following areas
have been changed:
o Bas e Al1otment
o Product/Faci1ity Related Priority Setting Model
(Appendix I, addendum)
o Nonfunded Priority Program
o §26 and §27 Interpretive Rule Procedures
o LIP and CRP Inspection Strategies
/'
For FY84, the enforcement cooperative agreement base funding
level has been increased from $45,000 to 560,000. The weighted
factors used to distribute the funds remaining after each State's
base allotments were subtracted from the total program allotment
have also been revised to reflect new data on the numbers of private
and commercial applicators reported for FY32.
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2-
Comi'ie-i tors aske-i if a State couH conduct, as part of its
rst quarter outputs, the product/facility priority setting.
ates who are 'unable to complete their product/faci1ity priority
setting prior to the awarding of their FY84 cooperative agreement
may include that portion of their priority setting as part of
their first quarter outputs. Part III, Award Conditions of the EPA
Notification of Assistance Award Action for such States must include
* condition requiring States to conduct product/facility priority
setting by no later than the end of the first quarter.
The section on nonfunded priority problems has been clar-
ified. Some States' current pesticide programs may already
address pesticide problems identified through priority setting.
In such cases, States are requested to provide this information
as a supplement tn their cooperative agreement applications so
that EPA will have a complete picture of how a State is addres-
sing all its pesticide problems. This information will aid the
Regions in evaluating the State's cooperative agreement application.
All States must update their previous years use priority
sotting and include it in t^eir FY84 cooperative agreement
applications.
The final guidance document summarizes and expands the
procedures to be followed by the Regions in reviewing State
investigations and enforcement actions un^or the Interpretive
|'e for FIFRA §§25 and 27. The Regional offices and the States
il annually define significant cases to ne tracked by £'JH
. fter referral to the State. The uji/1a."!c~ outlines the orocedures
yMch the Regions must follow 1) in revi f.-;-* PC the adequacy of
State investigations or enforcement *ctio" s and ?. ) before cu""1u:t-
i n g a Federal investigation or taking F e '1 H r a 1 enforcement action.
Finally, inspection strategies for the LIP and^CRP programs
are included in Appendix XI and Appendix XII. The Office of
Pesticide Programs, Registration Division will provide the
required data as outlined in the inspection strategies.
If you have any questions, please contact John Martin,
of my staff, at (202) 382-5572. • - .
•*• '
M. a. Conroy/'jn, Director
Compliance Monitoring Staff
Office of Pesticidesa'nd Toxic Substances
'\
Attachment
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TABLE UF CONTENTS
FY 1984 FIFRA COOPERATIVE AGREEMENT PROGRAM GUIDANCE
ENFORCEMENT 1
A11otment of Funds 1
InitialAl1otment 1
Adjustments to Initial Allotment 2
Final Allotment 2
Alternati ve Funding 2
National Priorities 3
APPLICATOR CERTIFICATION AND TRAINING
Allot "lent of Funds 5
InitialAl1otment 5
Final Allot ment 6
Attachments: Allotment Schedules
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FY 1984 FIFRA COOPERATIVE AGREEMENT PROGRAM GUIDANCE
^
This annual guidance outlines Regional funding allotments and
discusses national priorities to be followed by the Regions in
implementing FY84 cooperative agreements for pesticides enforce-
ment and applicator certification and training. The Compliance
Monitoring Staff (CMS) of the Office of Pesticides and Toxic
Substances Compliance Monitoring Staff (OPTS) expects to receive
56,913,400 to fund State and Indian Tribe cooperative enforcement
programs and has received 52,000,000 for funding cooperative
applicator certification and training programs.
i
ENFORCEMENT
Allotment of Funds
The President's annual budget submission to the Congress requests
an overall program appropriation for pesticides enforcement
cooperative agreements. Individual State allotments for financial
assistance are initially determined by application of a two s'tep
formula. States are to use these initial allotments to develop,
w i t n their respective Regional offices, work programs that meet
both State and Agency needs. [40 CFR Part 35.115(h)] Final allot-
ments will be based on the States' initial allotments and a
redistribution of surplus funds.
Initial Allotment
Because of a proposed reduction in the amount of pesticides
enforcement cooperative agreement funds available for FY84, EPA
Headquarters' initial financial assistance allotments will con-
sider only those States, Territories and Indian Tribes presently
participating in the pesticides cooperative agreement program.
Any non-participating State (Ohio, Nebraska, Colorado, Wyoming,
and Alaska) or Indian Tribe which wishes to. be included in the
final allotment, must send EPA a written commitment to submit
an application and participate in the program prior June 15, 1983.
For FY84, £PA Headquarters will first determine the initial
Regional allotments for pesticides enforcement cooperative
agreements by adding the following: 560,000 for each participating
State, Puerto Rico and the District of Columbia (-17); 525,000
for the Virgin Islands; and 510,000 for each participating Ter-
ritory (•*) which comprise a base level of funding. The initial
Regional allotment also includes 10% of the available funds (1*
per Region) as pesticides enforcement incentive funds; and
5200,000 for cooperative agreements with Indian Tribes (7).
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-2-
Then, Headquarters will distribute the funds remaining after the
base funds, pesticides enforcement incentive funds and Indian
Tribe funds are subtracted from the proposed budget ap-propriation
according to the following factors and weightings:
1981 July 1, 1981, Provisional Estimates of Popula- 20%
tion, U.S. Bureau of the Census - April 1982.
1982 Number of Pesticide Producing Establishments 20%
per State - FIFRA and TSCA Enforcement System
(FATES) printout, December 23, 1982, CMS.
(Numbers do not include Custom Blenders).
1982 Number of Certified Private Applicators per 10%
State, September 30, 1982, CMS.
1982 Number of Certified Commercial Applicators per 20%
State, September 30, 1982, CMS.
(Individual categories were counted separately).
1932 Estimated Number of Farms Per State - Crop 20%
Reporting Board, (SRS) U.S. Department of
Agriculture (USDA) Farm'Numbers,. August 1982.
1982 Estimated Farm Acreage Per State - Crop 10%
Reporting Board, SRS, USDA Farm Numbers,
August 1982.
Each Region's initial allotment is obtained by adding the appro-
priate base amount for each of its States, Territories or Indian
Tribes, the proportioned amount determined by the above factors
and weightings and the pesticides enforcement incentive funds.
Each State's initial allotment is obtained by adding the appro-
priate base amount and the proportioned amount determined by the
above factors and .weightings. The pesticides enforcement incentive
funds will be used by the Regional Administrator to reward innovative
or exceptional pesticides enforcement programs. (Regional and
State allotments are attached.)
Adjustments to Initial Allotment
Regions should not award funds based solely on a State's initial
allotment but rather based on the negotiated need of the State.
The Regional Administrator may modify any State allotment as
necessary as long as total funding for all States does not exceed
the Regional allotment. 40 CFR Part 35.115(d) states that the
Administrator or the Regional Administrator 'may use funds not
awarded or committed to an applicant to supplement awards to
ot^er applicants for pesticides enforcement.
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-3-
A11otment
ne Regional office must furnish the following information i'n
riting to Headquarters no later than July 1, 1983:
1. ' The names of States and Indian Tribes that will be
participating in Fiscal Year 1984.
2. The anticipated financial assistance funding level
for each participating State and Indian Tribe.
ne EPA Headquarters will make the final allotment of cooperative
greement funds and notify the Regional offices in writing by
•jly 15, 1983. This final allotment will include a reallotment
f funds from Regions whose States do not need their entire
n'tial allotments to Regions whose States demonstrate a need
or additional funding. The final Regional allotment consists
f the sum of each participating State's final allotment and
2 s t i c i d e enforcement incentive funds and will be included in
a c h Region's FY84 operating budget.
ne Regions will base the distribution of cooperative agree-
2 n t funds on both the allotment schedule and the thorougnness
f the State's own priority setting process. The States should
•jpntify priority enforcement problem areas by a method similar
at outlined in the Priority Setting section of the State
•cation Standards and Evaluation Procedures, Appendix I ana
: s addendum, so that resource allotment decisions will be
sad on objective measures. The Region will sase final State
•rjing allotment decisions for State applications on the initial
lotrnent, the demonstrated pesticide enforcement priorities
the State and the exceptional nature of a program justifying
vard of a portion of the pesticide enforcement incentive funds.
'ternative Fundina
i e Regional Administrator may use current year funds remaining
•tar the initial State awards to 1) supplement existing awards
• 2) award new partially funded cooperative agreements for
ie next year. A partially funded cooperative agreement is a
?w agreement that would begin immediately after the current
^operative agreement hacl ended and is funded, partially, witn
j r r e n t year funds.
srtially funded cooperative agreements offer States a method
'" maintaining program continuity during EPA's transition
•om fiscal year to fiscal year. All funds must be obligated
i accordance with the legislative restrictions that limit
ie anount of funds that can be obligated in the fourth quarter.
lese funds shall not be used to extend budget or project
? ' ds of existing cooperative agreements.
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-4-
Nati ona1 Priorities
Each year, Headquarters formulates national pesticide enforcement
priorities based on major recurring areas of concern identified
by the States through their priority setting systems and on related
information from other sources.
Based on the available data and priorities established by States
that conducted priority setting in their FY83 cooperative agree-
ment applications, Headquarters has identified the following
general areas of concern as National Priorities for FY84.
1) Drift from pesticide application;
2) Misuse by pest control operators during structural
applications;
3) Disposal of pesticides and pesticide containers;
and
4) Pesticide use problems associated with major spray
programs, i.e. gypsy moth, forest service (conifer
release), and mosquito control. ' •
5) Worker exposure to pesticides before, during and
after appl i cati on.
The EPA has designated these areas of concern as national
priorities to guide the States in their priority setting process.
Although these areas may not be of apparent concern in all States,
the States should consider these areas as they develop data for
use in setting their individual priorities. After considering
pertinent data, a State may find that some or all of these areas
are not priority problems in the State. In that case, the State
should, of course, direct its enforcement resources to those
areas which do present major pesticide problems..
-------
-5-
APPLICATOR CERTIFICATION AND TRAINING
A 11otment of Funds
The President's annual budget submission to the Congress requests
an overall financial assistance program appropriation for pesticide
applicator certification and training cooperative agreements.
Individual State allotments for financial assistance are initally
determined by application of a two step formula including certain
factors and weightings described below. States are to use these
initial allotments to develop, with their respective Regional
offices, work programs that meet both State and Agency needs.
[40 CFR Part 35.115(i)]
Initial Allotment
In FY34 financial assistance funds for the pesticides applicator
certification programs with States will be alloted from FY33
fjnds .!
?or FY34, EPA Headquarters will first determine the initial
Regional allotment for pesticide applicator certification and
training cooperative agreements by adding $10,000 for each parti-
cipating State which comprises a base level of funding. Each.
.Regional allotment will also include an amount for cooperative
.agreements with Indian Tribes that are approved and operating
before the issuance of this guidance document.
Then, Headquarters will distribute the funds remaining after the
oase funds and Indian Tribe funds are subtracted fro
-------
-6-
Regional discretionary allotment for 10%
pesticide applicator certification and
training programs.
Each Region's initial allotment is obtained by adding for
each of its States the base funding amount, the proportioned
amount determined by the above factors and weightings and the
Regional discretionary allotment for pesticide applicator
certification and training.
Each State's initial allotment is obtained by adding the base
funding amount and the proportioned amount determined by the above
factors and weightings. The Regional discretionary allotment for
pesticide applicator certification and training programs will
be used by the Regional Administrator to reward exceptional
programs. (Regional and State initial allotments attached).
Final Allotment
The irritial allotment will become the State's final allotment.
However, if a State cannot use its entire initial allotment
the unused funds will be redistributed by the Regional Adminis-
trator to other States, within the Region requiring additional
assistance. Prior to awarding unused funds to another State the
Regions must inform CMS where these unused funds will be used.
-------
UNITED STATES.ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
April 11, 1983
OPFICE OF
PESTICIDES AND TOXIC SUBSTANCES
ME MO SAND I'M .
TO: Addressees
: I
SUBJECT: Revised State and Regional Initial Allotments
for Pesticide Enforcement Cooperative Agreements '
Attached is a copy of t n e revised State and Regional Initial
Allotments for Pesticides Enforcement Cooperative Agreements for
FY.?» and the supporting allotment formul-a data. This allotment
schedule incorporates tv/o najor changes:
t
•° Utilizes the numbers of private and commercial certified
applicators on September 30, \'}-i2 , instead of the 1931
n u "i fc e r s . ~he 1 ? 8 2 numbers were unavailable when the
previous allocation was ;nade on January 11, 1933.
0
Base funding level was increased from $-15,000 to $50,000
per state. This change was recommended by the Association
of Ame r i can Pes t i c i de Control Officials and the State-
r'lFRA Issues Research and Evaluation Group.
This allotment schedule is based on the President's FY84
budget request of $5,918,400 for pesticide enforcement cooperative
agreements. These allotments should be used in planning the FY84
pesticide enforcement program with the States in your Region. As
indicated in the Draft FY84 Cooperative Agreement Program Guidance
the Initial Allotment Schedule may be revised to provide funding
for any non-participating State (Ohio, Nebraska, Colorado, Wyoming
and Alaska) making a written commitment, prior to June 15, 1983, to
apply for a grant. The. final allotment schedule will be issued by
July 15, 1933.
Conroy if,; Director
Compliance M o n i tW ing Staff
Office of Pesticides and Toxic Substances
. 1 1 achment
-------
State and Regional Initial Allotments for Pesticide
Enforcement Cooperative Agreements for FY84
\
Reg. I
CT
ME
HA
r«H
RI
VT
Regional Incentive
•-' Regional Totals
Reg. II
NJ
NY •
PR
V!
Regional Incentive
Regional Totals
Reg-, ill
DC
CE
MO
PA
VA
* VA
Regional Incentive
Formul
Percent
.627
.383
1.155
.214
.226
.232
2.837
2.275
4.912
1 .243
-
8.430
.112
.227
1.010
2.981
1.779
.677
la Funding
Amounts
19,708
12.038
36,303
6,726
7,104
7,292
89,171
71,507
154,392
39,069
'
264,968
• 3,520
7,135
31,746
93,697
55,917
21,279
Base
Funding "
60,000
60,000
60,000
60,000
60,000
60,000
69,000
429,000
60,000
50,000
60,000
25,000
69,000
274,000
60,000
60,000
60,000
60,000
60,000
60,000
69,000
Total
Funding
79,708
72,038
96,303
66,726
67,104
67,292
69,000
518,171
131,507
214,392
99,069
25,000
69,000
538,963
63,520
67,135
91,746
153,697
115,917
81,279
69,000
Regional Totals 6.78b213,294429,000642,294
-------
-2-
Reg. IV
AL
FL
GA
KY
MS
NC
SC
TN
Regional Incentive
Regional Totals
Reg. V
r '
i '<
1 1 *
• '. i
MN
OH
WI
Regional Incentive
Regional Totals
Reg. VI
AR
lA
i\M
CK
TX
Regional Incentive
Formula
Percent
1.665
4.376
3.154
3.060
1 .369
3.103
1.189
2.910
20.826
A. 636
2.517
2.533
2.661
-
2.731
15.128
1 .487
1 .362
.921
2.107
10.331
Funding
Amount
52,333
137,544
99,135
96,180
43,030
97,532
37,372
91,466
654,592
147,238
79,113
79,616
83,639
-
85,840
475,496
46,739
58,525
28, 9^8
66,226
324,719
Base
Funding
60,000
60,000
60,000
60,000
60,000
60,000
60,000
60,000
69,000
549,000
60,000
60,000
60,000
60,000
-
60,000
69,000
369,000
60, COO
50,000
60,000
60,000
60,000
69,000
Total
Funding
•
1V2.333
197,544
159,135
156,180
103,030
157,532
97,372
151,466
69,000
1,203,592
207,288
139,113
139,616
143,639
-
145,840
69,000
344,496
106,739
118,525
88,948
126,226
334,719
69,000
Totals
••'Oil
-------
-3-
Reg. VII
IA
KS
MO
NB
Regional Incentive
Regional Totals
Reg. VIII
CO
MT
NO
SD
7
WY
Indian Tribes(6)
Regional Incentive
Regional Totals
Reg. IX
AZ
CA
HI
NV
An Sarcod
Gua.T.
Mariana Is.
~"ust Terr-.
• indian Tribes(2)
Regional Incentive
Formula
Percent
2.848
2.097
3.172
-
8.117
-
1.201
1.422
1.310
.615
-
-
4.548
1.481 .
9.322
.369
.427
-
-
-
-
-
Funding
Amount
89,517
65,912
99,700
-'
255,129
-
37,749
44,696
41,175
19,330
-
-
142,950
46,550
293,005
11,598;
13,421
- •
-
-
-
-
Base
Funding
60,000
60,000
60,000
-
69,000
249,000
-
60,000
60,000
60,000
60,000
-
100,000
69,000
409,000
60,000
60,000
60,000
60,000
10,000
10,000
10,000
10,000
100,000
69,000
Total
Funding
149,517
125,912
159,700
-
69,000
504,129
-
97,749
104,696
101,175
79,330
-
100.000
69,000
551 ,950
106,550
353,005
71,598
73,421
10,000
10,000
10,000
10,000
100,000
69,000
-------
-4-
Formula
Percent
Reg. X
AK
ID 1.254
OR 1.656
WA 2.119
Regional Incentive
Funding Base ....
Amount Funding
-
39,415 60,000
.-*
52,051 60,000
66,603 60,000
69,000
Total
Funding
-
99,415
112,051
126,603
69,000
Regional Totals 5.029158,069249,000407,069
Total to Regions 100.008 3,143,400 3,775,000 6-.918.400
-------
FY84 FIFRA ENFORCEMENT GRANT
Allotment Formula Data
March 21. 1983
The attached table shows the statlsical data used in developing
the formula for the allotment of the FY84 Pesticides Enforcement
Grants. Only data from the 45 states participating in the program
plus Puerto Rico and the District of Columbia are Included. The
other territories and the Indian Tribes do not receive any formula
funds. The statistics used in the formula were amended to include
the 1982 certified applicator numbers and include the following:
Popu1ati on
July 1, 1981 Provisional Estimates of the Population -
Bureau of Census, April 1982. i
Farm Numbers and Acreage
1982 Preliminary estimates - Crop Reporting Board, SRS, USDA,
August 1982..
Producer Establ i shmen't s ' "
FATES Data System - December 23, 1982 printout. Numbers used
do not include Custom Blenders.
Private Applicators
Number of Private Applicators certified on September 30, 1982.
Commercial Applicators
Number of Commercial Applicators certified on September'30,
1982. Individual categories were counted separably.
-------
Rey. 1
CT
ME
MA
NH
Rl
VI
Keg. Total
Retj. II
NJ
NY
PR
Reg. Total
Reg. Ill
DC
DE
MD
PA
VA
W VA
Reg. Total
Pop nl at Ion
Stdt.«
(jooo)
3.134
1.133
5,773
936
y53
516
12.415
7 , 41)4
17.602
3.186
TH.15?
631
59cJ
4,263
11.871
5.430
1.952
74-774-5-
%
.290
.105
.534
.OB7
.08B
.048
1.152
.685
1.628
.295
776118
.058
.055
.394
1.098
.502
.181
2.288
Farms
State
4 ,.300
7,900
5,300
3,200
750
7,500
28,950
9,500
50,000
31.837
9T7:nT
0
3,400
18,000
60,000
60,000
20,600
TOTffffff
i
.03H
.071
.047
.029
.007
.067
.259
.085
.446
.284
.8T5"
0
.030
.161
.536
.536
.184
1.447
F iirin Acroiii]o.
Sf.iiti;
(1UOO)
4'Jl)
1.560
630
. 540
80
1 , 700
5,000
1,030
9,500
1.750
1 2.2110"
0
660
2.750
8.800
9,800
4.300
[767370
1'i-st. . Pro'lticers
"1- ' ,t U>
. UOb
Ml
.OO/
.006
.001
.019
.055
.011
.105
.019
.135
0
.007
.030
.097
.108
.048
.290
52
19
113
14
23
5
266
271
280
53
' "fil-l
6
16
78
233
66
22
4"2T
%
.150
.055
.327
.040
.066
.014
.652
.783
.809
.153
T7W
.017
.046
.225
.673
^91
.064
1.216
Private Aj>plic.
State
2,074
2.975
1,879
803
338
2,565
10.634
3,270
15,507
16,260
"3T.03T
0
2,260
8.288
32,780
15.687
14,129
T37i"4T
1
.021
.031
.019
.008
.004
.027
.110
.034
.160
.1'68
.362
0
.023
.086
.338
.1162
.146
.755
Cnimn A
State
2.005
1.698
3.622
725
981
928
9.959
11,073
28,846
5,296
45,215
601
1,089
1.865
3,903
4.577
.880
12,915
plic.
1
.123
.104
.221
.044
.060
.057
.609
.677
1.764
.324
2.765
.037
.066
.114
.239
.280
.054
.790
' \l \. I.* | M
Fonmila
Fun
.627
.383
1.155
.214
.226
.232
2.837
2.275
4.912
1.243
8.430
.112
.227
.1.010
2.981
1.779
.677
6.786
-------
Reg. IV
AL
FL
GA
KY
MS
NC
sc
TN
Heg. Total
Reg. -V
II.
IN
MI
MM
OH
Ml
Reg. Total
Population
State
(1000)
3,917
10.183
5,574
3,662
2,531
5,953
3,167
4.612
39,599
11,462
5,468
9,204
4.094
-
4,742
3T.W
1
.362
.942
.515
.339
.234
.551
.293
.427
3.663
1.060
.506
.851
.379
0
.439
17?rc
Farms
State
57,000
41,000
58,000
101.000
53,000
88,000
33.000
95.000
526,000
104,000
89,000
65,000
103,000
-
92,000
•45TTOW
%
.522
.366
.518
.902
.473
.786
.295
.848
4.710
.928
.794
.580
.919
0
.821
~4~7042
Farm Ac
State
(1000|_
12,300
13,000
15,200
14,500
1 4 , 500
11,100
6,100
13,400
100,100
28,700
17,000
11,500
30,400
-
18,500
10 6", 100
rt'dijt!
1
.136
.144
.168
.160
.160
.123
.067
.148
1.106"
.317
.188
.127
.336
0
.205
1.173
Post. Producers
Stati;
129
864
281
89
64
182
79
140
1,828
418
166
184
152
-
152
1.072
1
.373
2.497
.812
- .257
.185
.526
.228
.405
5.283
1.208
.480
.532
.439
0
.439
Private Applic.
State
9,977
17,308
34,865
86,257
8,632
52,292
12,391
79,441
301,163
53,808
15,000
6,041
20,000
-
28.737
I
3.0981123,586
%
.103
.179
.360
.890
.089
.540
.128
.820
3.109
.556
.155
.062
.206
0
.297
1.276
Zomm A
State
2,757
4.059
12.771
8.376
3,733
9.432
2,914
4,292
48,334
10,087
6.443
6,226
6,247
-
8,677
37,680
plic.
1
.169
.248
.781
.512
.228
.577
.178
.262
2.955
.617
.394
.381
.382
0
.530
2.304
< ~ _dl %
Formula '
Funds
1.665
4.376
3.154
3.060
1.369
3.103
1.189
2.910
20.826
4.686
2.517
2.533
2.661
.000
2.731
15.128
-------
Reg. VI
AR
LA
NH
OK
TX
Reg. Total
Reg. VII
IA
KS
MO
NR
Reg. Total
Key. VIII
CO
MT
NO
SO
'JT
WY
Reg. Total
Popul at ion
St,ite
(1000)
2,296
4,308
1.328
3,!00
14,766
757/W
2,899
2,383
4,941
Tff,27J
-
793
658
686
1,518
-
3,655
%
.212
.398
.123
.287
1.366
TT556
.268
.220
.457
0
.945
0
.073
.061
.063
.140
0
.337
F a rms
State
57,000
37,500
13,500
71,000
185,000
1547(100"
117,000
76,000
117,000
Tio'.oW
-
24,000
38,000
37,000
12,900
-
111,900
%
.509
.335
.121
.634
1.651
•J.TB7I
1.044
.678
1.044
0
TJ66
0
.214
.339
.330
.115
.0
.998
F.jn;i Ac
Stat.?
(100U)
16,400
10,200
47,400
34,300
138,400
74T,701T
33,800
48.500
31,400
TfJ.ffio
-
62,100
41,700
44,500
12,300
-
160,600
r.
'i.
.18]
.113
.524
.379
1.531
7.V?8
.374
.536
.347
0
f.T57
0
.687
.461
.492
.136
0
1.776]
Post. Producers
State
52
146
19
b8
508
783
220
100
204
"52'4T
-
25
38
56
22
-
HI
*
.150
.422
.055
.168
1.468
"fT2~6I
.636
.289
.590
0
iTSlT
0
.072
.110
.162
.064
0
.408
Private Appl ic.
State
20,807
38,316
3,004
26,856
118,493
207,476
19,609
16,054
52,886
-
88,549
-
7,828
17.527
14.930
5,562
-
45,847
%
.215
.396
.031
.277
1.223
2.R?
.202
.166
.546
0
.914
0
'.081
.181
.154
.057
0
.473
Corrcn A
State
3,596
3,237
1,104
5,929
50,567
64,433
5,305
3,397
3,079
-
11,781
-
1,214
4.426
1,782
1,679
-
9,101
pile.
I
.220
.198
.067
.362
3.092
3.939
.324
.208
.188
0
.720
0
.074
.270
.109
.103
0
.556
X) «
> .ula
Funds
1.487
1.862
.921
-2.107
10.331
16.708
2.848
2.097
3.172
.000
T.I 17
.000
1.201
1.422
1.310
.615
.000
4.54^
-------
IX
AZ
CA
HI
NV
Reg. Total
LMJ. X
AK
II)
OR
WA
Reg. Total
National Totals
Populat
State
(1000)
2,794
24,196
981
845
28,816
-
959
2.651
4,217
7.827
216,266
ion
f
.258
2.238
.091
.078
2". 665"
0
.089
.245
.390
.724
20.003
Farms
State
7 , 200
80,000
4,300
2,900
94,400
-
24.000
36,000
39,000
99,000
2.240.587
.064
.714
.038
.026
.842
0
.214
.321
.348
.883
20.012
Farm Ac
State
(1000)
39,000
33.700
1.960
8,900
83,560
-
15,100
18,300
16,300
49,700
904,050
-r»;
.431
.3/3
.022
.098
.924
0
.167
.202
.180
.549
9.993
I'est. F
State
94
rt»6
37
29
1,046
-
45
92
139
276
6.921
•reducers
%
.272
2.560
.107
.084
3.023
0
.130
.266
.402
.798
20.001
Private
State
992
40.000
4,640
773
46,405
-
9.572
11.467
15.677
36,716
968.557
Applic.
I
.010
.413
.048
.008
.479
0
.099
.118
.162
.379
9.999
Coinm App
State
7,286
49,466
1,032
2,179
59.963
-
9,077
8.245
10.426
27,748
372.129
.lie. .
.446
3.024
.063
.133
3.666
0
.555
.504
.637
1.696
20.000
'al X
Formula '
Funds
i
1.481'
9.3^';
.369|
.427|
11.599
.000
1.254
1.656
2.111?
5.02^'
100.00:1
(45 States
plus DC & PR)
-------
FfeB 24 t9S3
FT 03 State Certification Breakout - S in Thousands
(Funds to support act f
\
Reojon I
Regional
Connecticut
Maine
Massachusetts
ftew Hampshire
Rhode Island
Vernont
TOTAL
P A rj i 3 r | J
Regional
New Jersey
ftew York;
Puerto Rico
Virgin Islands
TOTAL
Region 1 11
Regional
Delaware
01 strict of Columbia
Maryland
Pennsylvania
Virginia
Vfcst Virginia
3.3
11.5
u.a
12.4
in.fi
in.*
11.1
71.3
3.i
16.7
21.0
17.3
in. 2
76.7
/
4.6
10. *
10.5
16.7
22.6
19.8
ja.S
vities in FY 84)
Reqion IV
Regional
Alabama
Florida
feorgla
Kentucky
Mi ssisslppl
North Carol ina
South Carol 1na
Tennessee
-C7AL
^fc;on V
=eOonal
[1 1 inoi S
tnrli ana
Michigan
Minnesota
Ohio
W1 sconsln
TOTAL
..-
8.0
lfi.9
22.3
23.^
2.2
16.fi
lfl.9
11. S
2*.Q
172.9
6.7
26.9
19.1
19.1
22.4
29.5
22.1
145.8
-------
FEB 24 !9SJ
-2-
legion VI
Regional
Arkansas
Louisiana
riew Mexico
Oklahorj
Texas
TOTAL
en VII
Iowa
« - m A . •• «
' S , . -T •
(fed. Program)
•»f\f«i
i j i ">.
13.3
22.1
11.5
19.5
18.2
ft*. 7
3.1
22.2
13.2
II. ~>
57.7
Region X
Regional
Alaska
Idaho
Oregon
Washington
2.4
10.3
11.1
17.3
11.7
Region VIII
Regional ...2.8
Colorado
(Fed. Program)
Montana 13.1
North Dakota 17.7
South Dakota 15.n
Utah 12.1
Wyoming (no fed. S
TOTAL
Reaicn !X
50.7
1.5
Ca'i'c.-r.ia 37.4
H>wa:i 11.3
Nevada (NO
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TABLE OF CONTENTS
FIFRA COOPERATIVE AGREEMENT PROGRAM GUIDANCE
REQUIRED APPLICATION ELEMENTS
Ability to Implement the Program
State Certifying Statements
Authority to Conduct the Proposed Program
Authority to Accept Federal Funds
Designation of Lead Agency
Discussion of Performance
Enforcement Management Plan Development
Defining State Program Objectives
Setting Priorities
Enforcement Work Program
Act ion Plan
Nonfunded Priority Program
Proposed Budget
Enforcement Conditions of the Coonerative Agreement
Quality Assurance 5 Procedures
Case Preparation and Enforcement
State Records and Reports
solicitor Certification, and Training Management
Plan Devel opment
Defining State Program Objectives
Aoolicator Certification and Training Work Program
Action Plan
Program Budget
Applicator Certification and Training
Conditions of the Cooperative Agreement
State Reports
2
2
2
2
2
3
4
4
4
7
7
8
9
10
10
12
14
15
15
15
15
16
16
16
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tPA APPLICATION AND AWARD PROCEDURES
Summary of EPA Role 18
Headquarters responsi bi1 ity ' 18
Regional responsibility Id
Application Submission 19
Appl i cation Revi ew 19
Techni ca1 and Program Review 19
Admin istrative Review 21
PROGRAM MANAGEMENT AND ACCOUNTABILITY
Accountability Under the Cooperative Agreement 22
Training 22
Regional Reporting 22
Program Evaluation 23
Mid-year Evaluation 23
End-of-year Evaluation 24
Evaluation Report , 24
Modification, Suspension, or Termination 24
Appendices: I through XV
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Introducti on
Section 23 of the Federal Insecticide, Fungicide, and Rodenticide
Act authorizes, the U.S. Environmental Protection Agency to enter
into cooperative agreements with the States and Indian...Tribes
for pesticides enforcement and for applicator certification and
training. Regulations governing financial assistance to parti-
cipants in the cooperative pesticides enforcement and applicator
certification and training programs are found at 40 CFR Part
35.001 to 35.605. This guidance document, developed by the
Compliance Monitoring Staff (CMS) of the Office of Pesticides
and Toxic Substances (OPTS), supplements those regulations by
setting forth in detail the required elements of cooperative
agreement applications, the process of awarding financial assist-
ance and requirements for program management.
Financial assistance in the form of cooperative agreements for the
pesticides enforcement program is designed to support (a) improved
coordination of a cooperative Federa1/State pesticides enforcement
program, (b) more efficient allocation of resources through
improved planning and management, and (c) program review and
evaluation. The program which a State conducts under the cooper-
ative agreement should provide for pesticides enforcement that
satisfies both State and Federal pesticide laws. Areas of mutual
pesticides enforcement include use/misuse investigations, producer
establishment inspections, experimental use permit inspections,
Tarketplace inspections, restricted use pesticide surveillance,
and applicator certification enforcement inspections.
Financial assistance ir, the form of cooperative agreements for
the pesticide applicator certification and training program is
d e s i gned to support fTl the pesticide applicator cert i f i c a t i o n
and training program, (b.) more efficient allocation of resources
through improved program planning and management and (c) improved
program review and evaluation. The program conducted by the
State should provide pesticide applicator certification and
training to all persons who wish to use restricted use pesticides.
State work programs conducted under the cooperative agreement
will include an estimate of ,the number of applicators to be
certified or recertified b/' the State, the number of training
sessions to be monitored and the number or frequency of .the
certification test ing sessions.
In FY84 States are encouraged to consolidate their pesticides
enforcement and applicator certification and training cooperative
agreement applications. The consolidated cooperative agreement
process is voluntary. A State which chooses to follow this process
may develop a single application for separate financial assistance
programs that are administered by the same agency within the
State. Consolidating cooperative agreement applications does
not alter existing statutory requirements governing eligibility,
matching funds or maintainence of effort. Consolidating coopera-
tive agreement applications does eliminate, duplicating similar
procedures in each individual assistance application. The single
consolidated application will reduce excessive paperwork and
administrative costs.
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REQUIRED APPLICATION ELEMENTS
The formal application for assistance will consist of an
"Application for Federal Assistance", EPA Form No. 5700-33,
and shall include all elements outlined in this section. This
form contains a section entitled "Part IV Narrative Statement"
which the new 40 CFR Part 35.130 simplifies and replaces.
In addition to meeting the requirements contained in 40 CFR
.Part 30, a complete assistance application must contain the
fol 1 owi ng elements:
- o Ability to Implement the Program including certifying
statements that the State program is consistent with
EPA-approved strategies and there are no impediments to
the State's ability to carry out the program; designation
of a lead agency; and a discussion of the State's per-
formance to date under the existing award.
o State Program Management Plan detailing a list of program
ODjectives and priorities; and a description of the process
through which the State identifies priorities.
o Work Program specifying the work years and amount and
source of funding estimated to be needed for each program
element including any outputs required; a schedule for
accomplishment of outputs; and an identification of the
agency responsible for each of the elements and outputs.
o Conditions of the Cooperative Agreement containing a
statement that the State agrees toToTTow the quality
assurance, and case preparation and enforcement or
certification and training requirements.
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Ability to Implement the Program ""
State Certifying Statements
Each applicant must certify that there are no impediments to the
State's ability to carry out its proposed program or programs.
Applicants with continuing cooperative agreement programs are
not required to annually certify their ability to carry out the
proposed programs unless one or more of the areas described below
has changed. The applicant should address the areas described
below as well as any others which might pose problems.
Authority to Conduct the Proposed Program
A State must have enacted legislation which empowers it to:
o Enter into a cooperative agreement with EPA, and
o Conduct specific activities proposed under the
cooperative agreement or consolidated agreement.
Authority to Accept Federal Funds '
A State which can only implement a program under a cooperative
agreement with prior authorization by its legislature to spend
Federal funds must include a statement indicating the date on
which such authorization will be obtained. Commitment of EPA
funds will be contingent upon such authorization by the State
legislature.
Designation of Lead Agency
Although several State agencies may be responsible for regulating
various aspects of pesticide manufacture, handling, and use, EPA
will enter into only one cooperative agreement with a State
for pesticide enforcement and only one cooperative agreement for
pesticide applicator certification and training.
The Governor of the State, through a letter to the Regional
office, should designate a separate lead agency which will be
responsible for each of the cooperative agreement programs or
a single lead Agency responsible for both programs under a
consolidated agreement. The designated lead agency(ies) must
have the authority to enter into contracts or interagency -agree-
ments with other agencies for the performance of all necessary
activities.
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Discussion of Performance
Each State 1s required to provide a discussion of progress under
its current cooperative agreement. In this di scussi on ,• the State
shall examine the appropriateness of its established priorities
as well as the quality and effectiveness of its compliance moni-
toring and enforcement activities. For the applicator certifi-
cation and training program, the State shall disucss the number
of training programs in which the State participated; the
number of training sessions monitored; the number of individuals
examined for certification, for recertification; the number of
certification sessions conducted, recertification sessions
conducted; and any changes made to training materials.
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Enforcement Management Plan Development
0 e f i n i ng State Prog ram Objectives
Each State should define objectives which support the achievement
of the national priorities, adjusted for the particular needs of
the State. Identification of specific State pesticide problem
areas is central to the task of developing the State objectives
(see Priority Setting, below).
State objectives may include management oriented objectives such
as improving planning of the enforcement program, achieving
greater compliance through increased compliance monitoring in
certain areas or improving the quality or availability of
compliance information.
Priority Setti ng
To attain its objectivr.s; the State should establish enforcement
priorities that permit L."se most efficient use of resources and
personnel. The priority setting process will enable a State to
concentrate its training, compliance monitoring, and enforcement
programs on specific pesticide manufacturing, distribution, and
use activities which pose a risk to health or the environment.
Use or Product Related Priorities
As part of the process of setting general objectives for its
pesticides enforcement program, the State should identify specific
problem areas related to pesticide use, production, distribution
and disposal. To identify priority pesticide problems, the
State should develop a mechanism which analyzes information from
.a variety of sources. The result of the State's analysis should
be a list of specific pesticide problems in the State. Following
is a discussion of basic elements which should be involved in
the priority setting process.
Review of Information Sources
In establishing priorities, the States should consult as many
information sources as are reasonably accessible. The most
accessible Information source is likely to be a State's enforcement
and complaint files. These records should indicate trends In
certain use and non-use violations, and recurrence of violations
involving specific pesticide producing or distribution establish-
ments, pesticides or practices, as well as potential associations
between a pesticide or application practice and nealth or
environmental incidents.
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-5-
Infornation related to potential areas of priority concern would
be found in State records on local pesticide production and dis-
•i but ion establishments, or pesticides and pesticide practices
ommonly used in the State. The State may wish to consider
information concerning chemicals which pose more serious health
and environmental risks such as restricted use pesticides, emer-
gency or experimental use pesticides, and special local use
registrations as well as application methods most likely to
result in harm if improperly carried out.
Finally, the State should identify and consider the concerns of
persons in the State who may be exposed to pesticides or otherwise
affected by the pesticides enforcement program. The EPA considers
a State effort to gain public participation in the planning
process to be an important element of the .program. Each State
may use a variety of means to identify the concerns of the public
and involve them in the State planning process. The States, in
.formulating their policy, may wish to use EPA's Public Participa-
tion Policy, January 19, 1981, 46 Fed. Reg. 5736, as a guide.
Establishing Priority Setting Criteria
Since States may have a large body of information to review and
analyze, each State should develop a set of criteria for use in.
ranking problem areas. For use-related problems, these criteria
nay reflect such factors as the degree of actual or potential
harm to health or the environment and the degree of public concern.
'r product/facility related problems, violation history and.
equency of past establishment inspections may be pertinent
criteria.
Ranking of Specific Problems
Once the information has been reviewed and criteria have been
established for setting priorities, each State shoul'd develop
its list of priority problems. Using the selected criteria, the
State can develop a hierarchy of areas of priority concern. The
level of priority will provide a basis for the allocation of
resources in the State's Action Plan.
The above mentioned elements are general guidelines to be followed
by the States in developing priorities. .-The Compliance Monitoring
Staff (CMS) of the Office of Pesticides and Toxic Substances
(OPTS) has also developed documents outlining a step by step
approach for setting use and product/facility related priorities.
(See Appendix I and addendum) Each State is free to follow these
models, to modify them, or to establish its own similarly objective
priority setting methodology.
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-6-
In any case, however, the State should include in its application
not only a listing of its general program objectives and specific
areas of priority concern, but also a discussion of the methodology
used to develop' and rank its priorities. All State priorities
should be as specific as possible, but must either be'placed into
one of the following (fixed) broad types of pesticides problem
areas under each activity for use-related priorities (See also
Appendix I p.29) or one of the 5 broad types of pesticide problems
areas under each activity for product;/faci 1 i ty-rel ated priorities
(See also Addendum to Appendix I).
Use-related Priorities
Home/Yard Incidents ;
- Involving PCO1s
- Involving homeowner's personal use of pesticides
Other Urban Incidents
Agricultural Incidents
- Involving Aerial Application
- Involving Ground Application
- Not Involving Application
;lon-Urban, Right-of-Way Incidents
- Involving Aerial Application :
- Involving Ground Application
Woodland Incidents
Incidents at Other Sites
Product/Facility-related Priorities
Violators within the State
Establishments not visited within the State
Inspected Establishments with no violations detected
Others (from Action Plan activity categories)
Educational Activity
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-7-
Enforcement Work Program
.'he Work Program must specify the workyears and the source of
funding for each program element, including any outputs and an
identification of the agency responsible for each of the elements
and outputs. (40 CFR Part 35.130)
Acti on Plan
Once the State has developed its list of priorities for both use-
related and product/facility-related priorities, it "should describe
its plan for carrying out a balanced program that addresses each
of these areas during the agreement period. Outputs the State
proposes to accomplish during the agreement period mu st be ai med
primarily at solving and dealing with pesticide problems identified
by the priority settinq process. However, the plan may also
include any other activities not identified by priority setting
such as responding to non-priority complaints provided these
activities relate to violations of FIFRA.
A pesticides enforcement program that consists of elements from
both State pesticide statutes and FIFRA should contain outputs
for the activity categories which are defined as follows:
Use/Misuse Inspection is a FIFRA or State inspection. FIFRA
use/misuse inspections are conducted to discover violations
'escribed in FIFRA Sections 12(a)(2)(F,& G). State use/misuse
nspections would be conducted under State statutes. A State or
Federal use inspection is an inspection identified under a neutral
or routine inspection scheme to monitor or observe the use of
pesticides. A State .of Federal mi suse inspection is an inspection
identified as a "for.cause" inspection such as a follow-up to a
complaint, referral or tip.
Monitoring the Certification Program is a FIFRA or State
T)inspection at pesticide dealers to determine if Restricted
Use Pesticides are being sold in violation of FIFRA Section
12(a)(2)(F) or State statute; 2) Inspection of applicators
to determine if they are properly licensed and maintaining
records.
Producer Establishment Inspection is a FIFRA inspection of an
establishment where pesticides or devices are held for distri-
bution or sale for the purpose of inspecting and obtaining
samples. While conducting pesticide producer establishment
inspections States should review product labels for compliance
with the Label Improvement Program (LIP). The Office of Pesti-
cide Programs (OPP) has issued guidelines for the upgrading of
pesticide product labels for several classes of pesticides as
well as replacing or modifying certain labeling requirements.
(See Appendix XI) The States should also inspect pesticide pro-
ducts that are subject to the Child Resistant Packaging (CRP)
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-8-
regulatlons issued by OPP.l CRP inspections should be conducted
in accordance with enforcement strategy (See Appendix XII) and
the inspection guidelines previously issued by CMS.^
Marketplace Inspection is a FIFRA or State inspection at the
retail sale, distribution or wholesale level for determination
of product registration, labeling violations, or product decom-
position. Marketplace inspection samples must b:e samples of
unregistered products, products with violative labeling, pro-
ducts subject to decomposition, or products unavailable at
producer establishment inspections. States should give market-
place inspections a low level of priority unless product violation
rates and compliance ratios show that such inspections will
prevent significant harm. '
Other Inspection is a FIFRA or State inspection. Under FIFRA
this would include custom blender and import inspections,
section 18 and 24(c) inspections etc. Under the State program,
this might include bulk tank sampling at repackaging establish-
ments, inspection of the calibration of application equipment,
etc.
Experimental Use Inspection is a FIFRA or State 'inspection to
monitor experimental use permits. Samples should only be
collected if a violation is suspected. Inspections must be
conducted on site; telephone inspections or mon i.tor i n gs will not.
be credited under the cooperative
agreement.
Educational Activity is a State outreach or related activity
directed towards educating or providing additional informa-
tion to consumers of pesticides or pesticide services designed
to increase compliance with State pesticide laws and FIFRA.
Npnfunded Priority Program
The Agency is aware that not all States' pesticide priority
problems are addressed in the Federal cooperative agreement.
Some States' current pesticide programs may already address
pesticide problems identified through priority setting. In
such cases, States are requested to provide this information as
a supplement to their cooperative agreement applications so that
EPA will have a complete picture of how a State is addressing
all its pesticide problems. 'This will aid the Regions in
evaluating the State's application.
1 40 CFR Part 162.16Final Rule for Child Resistant Packaging,
March 19, 1979, FR Notice pages 13019 through 13024.
2 CRP Inspection Guidelines issued by A. E. Conroy II, dated
March 29, 1982.
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-9-
Proposed Budget
Each application must contain the State's proposed budget for
the program. Expenditures for personnel, fringe benefrts, travel,
equipment, and supplies must be supported by itemized statements
or fact sheets detailing their necessity.
When funding activities under this agreement, EPA will give
priority to ongoing operating expenses that are directly related
to the enforcement of pesticide law, e.g., inspections, invest-
igations, sample analyses, and travel.
EPA's share of the "total project cost" should not exceed 85» of
the total award. The State's share may be paid in direct or
allowable indirect or in-kind contributions.
The application must also contain a summary of work hours or
work years devoted to each of the following activity categories:
Administration, Supervisory, Inspectional (non-priority and
priority, broken down by specific use-related and product/faci1ity^
related activities as identified under priority setting for the
State), Analytical, Analytical Support, Clerical and Legal.
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-10-
Enforcement Conditions of the Cooperative Agreement
Pesticides enforcement cooperative agreement awards are subject
to the regulations found at 40 CFR Part 35.001 through 35.605,
entitled "State and Local Assistance", as well as the "EPA General
Grant Regulations and Procedures" (40 CFR Part 30). In addition,
the applicant must agree to the conditions described below before
obtaining an award.
Quality Assurance & Procedures
Quality Assurance Plan
For FY84 States are required by the EPA Grants Administration
Division (GAD) to include quality assurance plans for analytical
laboratories under the cooperative agreement: All analytical
laboratories involved in environmental monitoring must have
submitted a quality assurance plan within 90 days of award of the
FY84 cooperative agreements. To assist States in complying with
this requirement, CMS has developed model quality assurance
guidelines. The States may use these guidelines or develop
their own. Each Region has an individual assigned as quality
assurance officer and that person will be available to assist"
the State in development of a quality assurance program.
(see Appendi x XIII)
FIF-vA Forms and Procedures. During all inspections and sample
collections performed under the authority of FIFRA, inspectors
shall use standard forms and procedures as outlined in the EPA
Pesticides Inspection Manual. To assure sample integrity, EPA
chain-of-custody procedures shall be adopted during sampling,
handling, shipping, storage, and analysis of pesticides collected
under Federal law.
State Forms and Procedures. During all inspections, observations,
and sample collections performed under authority of State law,
State procedures and forms should be used. During sampling,'
handling, shipping, storage and analysis of pesticides collected
under State law, State chain-of-custody procedures should be
fol1 owed.
Referral and Inspection Procedures under FIFRA 526. Under the
Final Interpretive Rule governing FIFRA Sections 26 and 27 (40
CFR Part 173), EPA and each State will annually define significant
cases to be tracked by EPA after referral to the State.
(FIFRA State Primary Enforcement Responsibilities, Final Inter-
pretive Rule, January 5, 1983, 48 FR Notice pages 404-411)
After EPA formally refers a significant case to a State, the Agency
will contact the State to learn the results of the investigation.
The Region should determine whether the State has conducted an
adequate investigation. An investigation should be considered
adequate if the State has 1) followed proper sampling and other
evidence gathering techniques, 2)responded expeditiously to the
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-11-
referral, and 3)documented all inculpatory or exculpatory events
or information. If the Region cannot negotiate an adequate
"vestigation with the State, the Region may pursue its own
vestigation after notice to the State. That notice should
summarize the facts relating to the State investigation, discuss
the reasons for EPA's determination that the action is inadequate,
and state that the EPA will initiate its own investigation.
Analyti cal Methods. Pesticide samples collected shall be analyzed
by the State1aboratory, or other laboratories specified in the
agreement, using the EPA Manual of Chemical Methods for Pesticides,
Association Of Analytical Chemists (AOAC), The State laboratory
may use the Collaborative International Pesticides Analytical
Council Limited (CIPAC) Handbook, the FDA Pesticide Analytical
Manual (PAM), or other approved analytical methods for sample
analysis. All violative samples shall be verified by a check
analysis performed by a second chemist.
Cross Contamination Screening. States shall establish a cross
contamination screening program in accordance with EPA Cross
Contamination Guidelines. (See revised Appendix III.)
Check Sample. The State shall participate in the EPA (NEIC)
Chec'< Sample Program. Under this program, EPA submits known
pesticide samples to State laboratories for analysis and cross
contamination screening. The States will submit a report
indicating the methodology used and results of the analysis to
^°A. EPA will review the report and inform the States regarding
* accuracy of their analysis and the methodology selected. If
- State failed to obtain the correct results, EPA will assess
the problem and provide assistance to the State laboratory, if
requested*. This program also assists in determining if the States
are screening pesticides for cross contamination, since the
check sample may be contaminated with another pesticide.
Check Analysis Procedure. The State shall participate in the
Sample Check Analysis Procedure. A check analysis is a second
analysis of a sample originally analyzed by a State laboratory.
It i s usually done when:
o A State which is unsure of the results of an analysis
requests an impartial or second analysis before
initiating an enforcement action.
o A State requests that EPA take the enforcement action
and EPA desires to check the State's analysis.
Samples in these instances would be sent to either another State
laboratory or EPA for a check analysis.
Training of Analytical Chemists. EPA will provide knowledgeable
personnelfor the training of analytical chemists. The States
should avail themselves of EPA courses offering training to
^mists on proper analytical procedures, instrumentation, and
, hodology. Personnel from EPA are available, if requested, to
"review State laboratories and discuss areas of improvement.
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-12-
States are also encouraged to participate on their own in profes-
sional association meetings such as those held by AO'AC, as well
as other professional training courses.
Provision of Analysis Results. The State shall send a copy of
the results of anysample.analysis made under the authority of
FIFRA to the person from whom the sample was collected.
Submission/Retentionof Reports. Copies of all inspectional and
analyti cal reports shal1 be retained by the State for examination
by EPA or forwarded to the Regional office.
Training of Case Preparation Officers and Inspectors. EPA will
provide for the training of State case preparation officers,
attorneys and inspectors.
Special Projects. The EPA/National Environmental Investigation
Center (N EIC) will provide, on a limited basis, investigation
and laboratory support for special State pesticide problems
s u c h a s :
o Af f i riTiat'l .3 compliance monitoring of major pesticide
spray programs; and
o Response to pesticide incidents for which States did
not include resources in the cooperative agreement
appli cati on .2
Case Preparation and Enforcement '
The State shall review the quality and adequacy of evidence
gathered in the course of all investigatory activities performed
under the cooperative agreement. For misuse cases, the States
could establish a committee to review inspectors' findings and
determine if any violations of State or Federal law exist. This
committee would provide the States with an objective enforcement
framework for all misuse cases.
State Cases
The State must review the quality and sufficiency of evidence
gathered in the course of all investigative activities performed
under the cooperative agreement.
If the evidence reveals a violation of only the State's pesticide
laws, the State shall pursue an appropriate remedy provided by
State law.
All special projects assistance requests shall be submitted
to the appropriate Regional Office as soon as the State
determines a need for such assistance. EPA Headquarters in
conjunction with the Regions will evaluate each request based
on the seriousness of the problem and the amount of EPA resources
avai1 able.
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•13-
If evidence reveals a violation of both State and Federal law,
the state may bring appropriate enforcement action under State
law or refer the case to EPA for action under FIFRA. In the event
that a case is referred to EPA for action, the Agency-case
preparation officer should review the case file to ensure that
the State inspection procedures adhere to basic constitutional
guarantees. If the State evidence gathered by State inspectors
was legally obtained and is within the scope of admissible evidence,
EPA should proceed with the case.
Since States with cooperative agreements have primary enforcement
responsibility for pesticide use violations, the Regions and States
should follow the Final Interpretive Rule governing Sections 26
and 27.(48FR pages 404-411, January 5, 1983)
Under the Final Interpretive Rule [governing FIFRA Sections 26 and
27 (40 CFR Part 173)], EPA and each State will annually define
significant cases to be tracked by EPA after referral to the State.
The State must commence appropriate enforcement action for cases
tracked under the Interpretive Rule within 30 days after completion
of the investigation. The Region may, after negotiation with
the State, extend this period if required by the procedural
characteristics of the State's regulatory structure.
If the Region determines that the State's intended enforcement
response to the violation is inappropriate, EPA should first
attempt to negotiate an appropriate State enforcement response.
If a State is unwilling or unable to alter its original enforce-
ment response, EPA may bring its own action after notice to the
State. That notice should summarize the facts relating to the
State's enforcement response, discuss reasons for EPA's determin-*"
ation that the enforcement action is inadequate and state that
EPA will initiate its own enforcement action. (See the Final
Interpretive Rule governing Sections 26 and 27, 48FR pages 404-411,
January 5, 1983, Section 58 for criteria) Regional attorneys
should not, however, initiate an enforcement action sooner than
30 days after the matter was referred to the State.
For all pesticide cases, if a State feels that the most appropriate
enforcement action is not available under State law, it may
refer the case to EPA for enforcement under FIFRA.
Federal Cases
Where evidence reveals a possible violation of Federal law only,
the State shall immediately forward the information to the EPA
Regional office and prepare testimony and provide witnesses as
necessary.
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-14-
State Records and Reports
Semi-Annual Reports
The State should submit semi-annual reports to the Regional Office
within 15 working days after the end of the second and fourth
quarters. Each report should compare actual accomplishments
with the projections as specified in the cooperative agreement.
Records of Enforcement Actions
The State should maintain records regarding enforcement actions.
These records should include the type of violation, who was
involved (e.g. applicator, producer, homeowner), certification
status of the applicator, name of the pesticide, application
site and method, compliance history of the violator, and the
type of enforcement action taken. This information will be
used in developing the State's future enforcement priorities.
EPA Report of Enforcement Actions
EPA shall furnish the State with copies of all enforcement actions
taken as a result of inspections conducted by the State and -
referred to EPA for action. This information will be useful to
the State in future priority setting.
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Applicator Certification and Training Management Plan Development
Defining State Program Objectives
The States should define objectives which support the achievement
of the national goal of training applicators in the safe handling
and use of pesticides, especially restricted use pesticides.
State objectives may include management oriented objectives such
as: 1) improving planning of the certification program; and 2)
recommending areas of additional training because of use problems
encountered through the pesticides enforcement cooperative agree-
ment or to provide applicators with information regarding the
impact of other Federal statutes on applicators.
Applicator Certification and Training Work Program
The work program must specify the work years and amount and
source of funding estimated to be needed for each program element
including any outputs required, a schedule for accomplishment of
outputs and an identification of the agency responsible for each
of the elements and outputs (40 CFR Part 35.130).
Action Plan
Once the State' has identified its program objectives, it must
describe its plan for carrying out a balanced program that addresses
each of the program objectives under the agreement.
A pesticide applicator certification and training program that
meets the requirements of both State pesticide statutes and
FIFRA should contain at least the following elements/outputs.
o Number of training sessions in which the State will
part i ci pate. 4
o Number of training sessions which the State will monitor.
o Number of individuals to be examined for certification.
o Number of applicators to be examined for recertification.
o Number of certification sessions the State will conduct.
o Number of recertification sessions the State will conduct.
o Any changes the State will make to training materials.
EPA Regi on VI I has developed a training slide and tape presentation
on how disposal of pesticide wastes and used pesticide containers
by applicators is regulated under the Resource Conservation and
Recovery Act (RCRA). This presentation can be obtained for State
training sessions by contacting Roger Gold, Ph.d., University of
•Nebraska, Institute of Agriculture and Natural Resources, 101 Former
Vet Science Building, East Campus, Lincoln, Nebraska 68583.
Additional training slide and tape presentations can be obtained
for State training sessions by contacting Dr. James Parochetti,
Program Leader -- Pesticides, Applicator Training and Weed Science,
U. S. Department of Agriculture, Extension Service, Washington,
D. C. 20250
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These outputs should be listed separately for private applicators
and for commercial applicators. For commercial applicators, the
outputs should be broken down by certification category as well.
Proposed Budget
Each application must contain the State's proposed budget for
the program. Expenditures for personnel, fringe benefits, travel,
equipment, and supplies must be supported by itemized statements
or fact sheets detailing their necessity.
The EPA's share of the "total project cost" shall not exceed,'
50% of the total award. The State's share may be paid in direct
or allowable indirect or in-kind contributions.
Applicator Certification and Training
Conditions of the Cooperative '
_ ._.-.- ^
ive Agreement
Pesticide applicator certification and training cooperative
agreement awards are subject to the regulations found at ".0 CFR
Part 35.001 through 35.605, entitled State and Local Assistance,
as will as the EPA General Grant -Regulations and Procedu-cs (40
CFR Part 30). In addition the applicant must agree to the
conditions described below before obtaining an award.
State Reports
The States will submit a semi-annual report corresponding to
the project and budget period of the cooperative agreement.
This semi-annual report must be submitted within 30 days after
the end of the second and fourth quarters of the Cooperative
Agreement outputs and will include:
1. The total number of applicators, private and commercial,
by category, currently certified.
2. The number of applicators, private and commercial, by
category, certified during the last reporting period.
3. The number of applicators, private and commercial, by
category, recertified during the last reporting period.
The States are required to submit an annual report corresponding
to the project and budget period of the cooperative agreement.
This annual report for both the State plan and Cooperative
Agreement outputs will include:
1. The total number of applicators, private and commercial,
by category, currently certified.
2. The number of applicators, private and commercial, by
category, certified during the last reporting period.
3. The number of applicators, private and commercial, by
category, recertified during the last reporting period.
4. Any changes in commercial applicator subcategories.
Certification and Training Program Directive #81-2 issued by
A. E. Conrov II, dated 9-10-81.
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A summary of enforcement activities related to use of
restricted use pesticides during the last reporting period
Any significant proposed changes in required standards of
competency.
Proposed changes in plans and procedures for enforcement
activities related to use of restricted use pesticides for
the next reporting period.
Any other proposed changes from the State plan that would
significantly affect the State certification program.^
The States nay combine the Annual FIFRA §4 State
and the final report of outputs accomplished und
agreement, since the first three reported items under th
Plan annual report are identical to the outputs reported
the cooperative agreement.
Plan report
der the cooperative
under the State
under
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EPA APPLICATION AND AWARD PROCEDURES
Summary of EPA Role
EPA Headquarters has the primary responsibility for:
o Developing national priorities and strategies for
the pesticides enforcement program and applicator
certification and training program;
o Preparing guidance for implementing and managing
the programs;
o Making funds available to the Regions for
disbursement to the States;
o Providing a special review of applications
upon written request from the Regional offices; and
o Developing laboratory support for State personnel.
EPA Regi onal Offi ces have primary responsibility for:
o Providing applicants with annual guidance and
application criteria to be used in awarding
cooperative agreements;
o Notifying eligible State agencies of the availability
of funds ;
o Working closely with the States to develop a •
complementary Federal/State program which considers
State as well as EPA priorities and resources;
o Negotiating outputs with applicants;
o Reviewing and approving applications;
o Developing training for State personnel; and
o Conducting Mid-year and End-of-year.program
evaluatlons.
Each participating Region should establish a cooperative agreement
Review Panel to review and evaluate all pesticides enforcement and
applicator certification and training cooperative agreement
applications. This panel should consist of at least one member
from each of the following offices:
o Regional Air and Waste Management Division/or
Waste Management Division
o Regional Grants Administration Office, and
o CMS (Grants and Evaluation Group).
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AppHcatlon Submission
To apply for a cooperative agreement under FIFRA, a State must
submit an'"Application for Federal Assistance", EPA Form No.
5700-33 complete with all elements required by the guidance.
(See Appendix V)
Applications must be submitted at least 60 days prior to the
beginning of the budget period. (40 CFR Part 35.140)
Application Review
The Regional Administrator will review each completed cooperative
agreement application and should approve, conditionally approve,
or disapprove the application within 60 days of receipt. (40 CFR
Part 35.141)
The Agency will allocate funding for cooperative agreements on
the basis of the appropriateness of the State's program plan
when compared to the criteria set forth in the Required Application
Elements section of this guidance and the State and Local Assistance
regulations. (40 CFR Part 35.001 through 35.605)
Each application will be subject to two reviews:
o Technical and Program Review; and
o Administrative Review.
Technical and Program Review
A technical and program review will be made by the Cooperative
Agreement Review Panel to determine the merit of the proposed
outputs in view of the objectives and priorities of the cooperative
pesticides enforcement program and applicator certification and
training program. For the pesticides enforcement cooperative
agreement applications, CMS has developed a form for use by the
review panel in determining answers to basic evaluation questions.
(See Appendi x VI.)
CMS has also developed Output Time Factors for use in evaluating
pesticides enforcement cooperative agreement applications for
financial assistance. The following time factors were obtained
by averaging figures submitted to CMS by the States:
Work Hours to
Acti vi ty ' Complete Acti vi ty
Agricultural Use Inspection 20
Non-agricultural Use Inspection 20
Experimental Use Inspection 15
Producer Establishment Inspection 15
Marketplace Inspection , 5
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Work Hours to
Act i vi ty Complete Activi ty
Import Tnspecti on 10
Dealer Record Inspection 5
Applicator License and Record Inspection 5
Sample Collection and Preparation 5
Sample Analysis (Formulation and Residue) 11
These figures take into account all inspectional or analytical
time spent to complete an activity, including supervisory time,
travel time, document preparation, sample shipment, etc. The
work hours given also include the prorated time for administrative
activities of inspectors and chemists. Additional time for
administrative, case preparation, legal, clerical, and program
planning activities time may be charged if the State can show
that such activities are prerequisites to conducting the program.
The Regional office should compare each State's proposed outputs
and the personnel requested in the pesticides enforcement cooper-
ative agreement application with the work years computed by
using the output time factors amounts shown above. The purpose
of these romyutations is to determine if the State's requested
work hour levels (or work years) for inspectional and analytical
outputs are consistent with the work hours computed for each
activity using the above output time factors. An Output Time
Factors Computations Worksheet has been developed to assist the
Regions in this comparison. (See Appendix VII.)
he Regions should use these time factors as a guide in negotiating
and evaluating pesticides enforcement cooperative agreement
applications. The number of inspections, samples, and analyses
multiplied by the appropriate time factors should equal the
approximate number of work hours which each State requested to
complete the projected outputs under the cooperative agreement.
To ensure equal treatment of all States, CMS has identified a
normal work year as consisting of 1800 hours after allowing for
1 eave and hoii days .
Deviations from these time factors can be expected due to differ-
ences.in travel time, local procedures, etc. However, the Regions
should not permit work hours grossly in excess of these computed
levels. Significant differences between the amount requested
and the amount computed must be justified, e.g., the need for
extensive travel time. If an applicant's commitments are in
excess of those indicated by the computations, the Regional
Office must assure itself that the quality of work is not suf-
fering at the expense of the quantity of outputs.
The Review Panel will evaluate both pesticides enforcement and
applicator certification and training cooperative agreement
applications to determine whether:
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o The application contains all elements outlined in
the Required Application Elements section of this
gui dance;
o The applicant's priority-setting process is adequate;
(for pesticides enforcement agreements only)
o The outputs are appropriate based on the priorities
or objectives set by the State;
o The applicant's objectives and expected results are
consistent and compatible with EPA priorities
and policies; and
o It is feasibile to achieve such objectives in view of
the State's existing problems, program authority, and
resources.
Administrative Review
The Regional Grants Administration Office will perform an
administrative evaluation to determine whether the application
meets the requirements of the EPA General Grant Regulations (40
CFR Part 30) and regulations for State and Local Assistance (40
CFR Part 35.001 through 35.605 Appendix VIII). At each stage of
the evaluation, the State may be required to provide further
information or to amend the application to satisfy the concerns
of the Agency.
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•PROGRAM MANAGEMENT AND ACCOUNTABILITY
After award of the cooperative agreements, both States and the
Regions will have program management responsibilities in the
areas of accountability, training, reporting, evaluation and
agreement modification.
Accountability under the Cooperat1ve Agreement
States must maintain accounting records for funds awarded under
each agreement (including receipts,•State matching contributions,
and expenditures) in accordance with all applicable EPA grant
regulations and with generally accepted accounting principles.
Headquarters suggests that the Regional Grants Administration
Office review State accounting practices and procedures prior to
award of funding to assure t;,e State's ability to maintain
appropriate records.
State expenditures under the agreement must follow cost categories
(i.e., budget line item or program elements) established in the
original agreement. Deviations may be made by the State from the
proposed budget as long as they are in accordance with the general
grant regulations or approved by the EPA Regional project officer.
Training
Training under the pesticides enforcement program will be conducted
by the EPA Regional Office with support from EPA Headquarters.
Training will consist of instruction in inspectional and sample
collection techniques, sample analysis, and case preparation, in
both classroom and on-the-job form. The cooperative agreement
should contain a schedule for conducting training activities
agreed upon by EPA Regions, Headquarters or NEIC and the State.
Regi onal Reporti ng
The Regions must forward copies of all agreement applications
and all mid-year, and/or annual reports to CMS for review.
CMS should also be kept informed of any problem areas or
serious deficiencies that develop within a State program.
The Regions must also enter into the FIFRA And TSCA Enforcement
System (FATES) all State enforcement and certification and
training projections from the completed cooperative agreement
applications, as well as mid-year, if appropriate, and end-of-year
accomplishments. The Regions must enter this data into FATES
within 30 working days after the award of the cooperative agreement
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and within 30 working days of the end of the second and fourth
quarters. For certification and training cooperative agreements
data must be entered within 30 working days after the award of
the agreement and within 30 working days of the end of the forth
quarter. (See attachment X)
The Regions are responsible for reporting to the Administrator
data from the State applications and reports for the following:
(See attachment XIV)
o Indicators for Environmental Results
o Administrators Accountability System
o Environmental Management Report
ProgramEvaluation
Program evaluati on
The Compliance Monitoring Staff (CMS)
and Toxic Substances (OPTS) developed
use by the Regi
the protocol
Stats programs
al1 State
The Regions shall use the evaluation protocol
FRA enforcement and pesticide applicator certi-
ining cooperative agreement end-of-year evalua-
dix IX.)
t ions. (See Append
Mid"year Evaluations
At mid-year, the Regions shall conduct a general review of each
State's outputs and accounting procedures. During the general
review, evaluators should, where appropriate:
o Compare actual accomplishments with output commitments;
o Review selected sample collection documents, inspection,
reports, investigation reports, and results of sample
analyses for accuracy and quality, and review
appropriateness of enforcement actions;
o Review, with State accounting personnel, the following
accounting information:
a. Employee time and attendance reports;
b. Records for one-time non-expendable property
expenditures;
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c. Estimate, (excluding one-time non-expendable
property expenditures), of the amount of funds
x expected to be remaining at the end of budget
period.
If the review indicates areas for improvement or change, the
Region is expected to offer the State suggestions and guidance
in those areas.
End-of-year Evaluations
The scope of the program evaluation conducted by the Region at
the end of the year will differ from that of the mid-year evalua-
tion. The end-of-year evaluation will be an in-depth qualitative
review of the Federal/State cooperative enforcement program and
the pesticide applicator certification training program.
The Regions shall use the evaluation protocol, found in Appendix
IX, to conduct all cooperative agreement program end-of-year
evaluations.
When conducting an evaluation using the protocol, the Kegions
shall answer all questions. The Regions can fill out certain
parts of the protocol in advance from the application and. quarterly
reports; other parts must be completed during the on-site visit
in the State. The Regions should plan on a minimum of three
days to conduct the on-site evaluation in the State.
Evaluation Reports
The Regional office shall prepare a written report of each evaluation
and send a copy to the State within 20 working days of completion
of the on-site evaluation. If the evaluation protocol is completed
properly, it could serve as the basis of the evalution report.
The report should include a discussion of suggested program
improvements. The State shall be allowed 15 working days from
the date of receipt of the report to comment on the findings
contained in the evaluation report. The Regions shall send a '
copy of the Regional evaluation report and the State's response
to Headquarters.
Evaluations of both the pesticides enforcement and the applicator
certification and training agreements are especially important
in FY84 because State applications for continuing assistance must
contain a discussion of their performance under the existing award.
(40 CFR Part 35.140) Funding levels for the next cooperative
agreement project period could be affected if a State's performance
is less than satisfactory.
Modification, Suspension, or Termination of the Agreement
The provisions and funding of the agreement must be modified by
EPA and the State if it is found -that actual accomplishments
differ significantly from the planned accomplishments. These
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changes may Include, but are not limited to, changes in the
outputs, changes in the date of performance for specific outputs,
or changes in the budget for the period of the agreement. Changes
in the agreement are effective only upon the execution of a
written amendment. If performance by the State does not improve
after modification of the agreement, steps may be taken by EPA
to suspend or terminate the agreement.
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TABLE OF CONTENTS
APPENDICES
Appendix I Ranking Procedure to Establish Pesticide Enforcement
Priorities And Allocate Enforcement Resources
(revised 1/83)
Appendix II Deleted
Appendix III Contaminant Screening Guidelines (revised / )
Appendix IV Deleted
Appendix V EPA Application for Federal Assistance - EPA Form
. 5700-33 (Revised 1783..to include 'examples for
completing form to apply for a consolidated
cooperative agreement.)
Appendix VI Pesticides Enforcement Cooperative Agreement
Application Technical Review Form
Appendix VII Output Time Factors Computations Worksheet
(Revised 1/83)
Appendix VIII Revised 40 CFR Part 35.001 - 35.605 Subpart A,
EPA regulations governing State and Local Assistance
(Replaces 40 CFR Part 35.750 - 35.786)
Appendix IX Evaluation Protocol
Appendix X Pesticides Enforcement Cooperative Agreement and
Applicator Certification and Training Output
Projections and Accomplishments Forms, for input
into FATES (Revised 1/83)
Appendix XI Label Improvement Program (LIP):
Dec. 4, 1980 letter from H. Harrison re: LIP
with attachments: PR Notice 80-1, Storage
and Disposal Statements and Sample Label.
PR Notice 80-2 re. deletion of Salt Water Emesls
Termiticides Label Improvement Program
Anti-fouling Paints Label Improvement Program
Funigants Label Improvement Program
Appendix XII CMS Strategy for the Enforcement of CRP from
A. E. Conroy II dated June 8, 1981 and the
OPP listing of product types subject to CRP from
Reto Engler, Chief Disinfectants Branch dated 2-26-81
Appendix XIII Model Quality Assurance Project Plan for State
Pesticide Laboratories from A.E. Conroy II,
dated 12/14/82.
Appendix XIV Developing Indicators for Environmental Results
memorandum from T.E. Hunt dated 9/28/82.
Appendix XV Final Interpretive Rule governing FIFRA §26 A 27
(48 FEDERAL REGISTER, Pages 404-411, Jan. 5, 1983)
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CJ
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V.<> i' UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
w.\.<>' WASHINGTON. D.C. 20460
JAN 1 0 1975
To: Regional—Administrators
•v T*-*-^- v *
From: Asststa.ni Administrator' lor water
and Hazardous Materials (WH-556)
Assistant Administrator for Enforcemen
and General Counsel (EG-32S)
Subject: Continuing State Registration of Products Containing
Aldrin and Dieldrin for Which Uses Have Been Suspended
Late in December, 1974, the Agency became aware of the existence of
activity in the above referenced matter, first in the State of California,
and subsequently in several other States in other Regions,. Preliminary
investigation into the magnitude of the problem suggests that there may
be significant continuing activity on a national scale, that there is con-
fusion as to the extent of Federal jurisdiction over such activity by States,
and that the economic, political and regulatory considerations involved
require additional action by the Agency „
Accordingly, our joint staffs are preparing a Federal Register notice,
v/hich, upon publication, will formally assert Federal jurisdiction over
non-Federally registered products containing Aldrin and Dieldrin by
impl^r.icnting Section 3 of the Federal Insecticide,. Funrjlcid-'? and
Rodsnlicide Act (FIFRA), as amended (7 U.S.C. 136 e"t seq.). Attached
is a strategy paper v/hich explains the background cf this matter in greater
detail and provides an explanation of how these Aldrin and Dieldrin pro-
•ducts should be treated upon the activation of Section 3. In add-'.tion,
proposed enforcement activities by Hie Agency, anticipated in cooperation
with involved States, is discussed*
We shall expedite publication of this notice in the Federal Register.
Pending formal publication, you should proceed v.-ith confidence in the
proposed substance of the notice as outlined above and in the attached
paper to inform affected States in your Region of these developments.
Further, we trust you will encourage their support and cooperation in our
effort to achieve orderly and equitable disposition of existing State-reg-
istered products together with even-handsd and comprehensive enforce-
ment of the Aldrin-Dieldrin cancellation and suspension orders. The
Enforcement Division of each region will be contacted by the Pesticides
Enforcement Division in Washington which will provide additional details
and support, where needed, to achieve Federal-State cooperation in pro-
viding notice of these developments and in proceeding with enforcement
of the Administrator's orders relating to cancellation and suspension of
Aldrin and Dieldrin,,
Enclosure:
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
• WASHINGTON. D.C. 20460
Strategy Paper:
State Registration of Products Containing Aldrin and Dieldrin
for Which Uses Have Been Suspended
Background;
Late in December, 1974 Headquarters was informed by Region IX
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, 26-165).
That order provided that henceforth all technical Aldrin and Dieldrin
must bear the label restriction: "For use only in formulating products
bearing EPA-appro ved 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 State.-;) have revealed that many State-
ro^ist-'ved Aldrin-Dieldrin products wore: 1) formulated from technical
material held prior to December 7, 1972 and therefore not subject to the
restrictive labeling requirement, 2) formulated from so-called "end-
use" or finished Aldrin-Dicldrin products bearing State or Federal
registrations and lacking any stated restrictions concerning refor-
mulation, 3) formulated from technical melerial sold after December 2,
1972 which failed to bear the required restriction, 4) formulated from
technical material restrictively labeled and ignored by the formulator.
Stales, 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 the.ni 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 juri 7'He-
ll on over their production, shipment, sale, and use, and to insure •JVCTI-
Jiand^d enforcement ol" the Aldrin and Dieldrin cancellation and susot-v^ion
orders, xhe Agency will formally implement Section 3 of the Federal Insec-
ticide, Fungicide, and Flodenlicide Act, as amc'.idad (7 U. S. C. 136 ct scq.)
by notice in the Federal Register. This notice will contain an exemption,
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pursuant to the provisions of Sections 6{a)(l) and 15(b)(2) of the Act, allow-
ing States to register for orderly disposition through shipment, sale and
use in that State, existing stocks of products containing Aldrin 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 Aldrin 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
States in that Region, in advance, of the planned activation of Section; 3
and its attendant prohibitions, and should request State authorities to
notiry all State registrants and any other potentially affected parties of
the Activation of Section 3 and of the effective date of related prohibitions,.
States are to be asked to provide to the appropriate Regional Offices lists
of State registrants or persons with registration applications pending for
products containing Aldrin or Dieldrin8 Information relating to location
and relative amounts of these State-registered products also is to be
sought.
The Agency's pesticides enforcement personnel will enlist State coope-
ration in continuing its on-going investigation of the formulation since
December 7, 1972, o: products containing Aldrin or Dieldrin for State
registration, _ Should it be the case th::t Federal registrants of technics.!
Aldrin or Dieldrin have not r^lp.bele^ their products in coni'ormancc with
the Administrator's Order of December 7, 1972, or that pesticide pro-
ducers have formulated products containing Aldrin or Dieldrin in con-
travention of labeling prohibitions against use in non-Fcderally registered
products, such violations will bo prosecuted in accordance with the appro-
priate provisions of the Act,
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^ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
\^*S> . WASHINGTON. D.C. 20460
To: [Enforcement Division Directors]
From: A. E. Conroyll, Director // £ (*s*~^J~^/'> * ~(
Pesticides Enforcement Division /+ • ' X^
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 order was to
restrict use of technical Aldrin and Dieldrin to use in EPA-registered
products only. The Director's memorandum continued that production
of non-Fedcrally registered products containing Aldrin and Dieldrin
could subject such products to stop sale and their producers to liability
under Sections 12(a)(2)(G) and (K) of the Act.
Subsequent to the Director's memorandum, it has come to the
Agency's attention that numerous products ccntaining Ald.rin and Dieldrin
r--.3^'have be-n produced since December 7. 1972 and ppaisTproH 'ny <;^T^ =
under circumsibices not strictly contravening the December, 1972 Order.
Details concerning this production and questions relating to the scoi^e 01
Federal jurisdiction over such production under the December, 1972
Ord<3»~ are elaborated in-the attached memorandum and strategy paper, •
which >vere sent to all Regional Administrators on January 10, 1975.
Action:
For purposes of t ederal enforcement activity, the following develop-
ments are important:
1) The Agency has determined to implement Section 3 of the
Act with respect, to products containing Aldrin and Dield: in
intended for intrastate shipment. States will be permitted
to register and allow shipment, sale and use in that State
of stocks of products containing Aldrin or Dieldrin in 2\is-
tence on the date of the signature by the Administrate nf .
the order activating Section 3. After that date, all tjrod:c-
tion of products containing Aldrin or Dieldrin must cease,
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and States must cease to permit registration or to allow
shipment, sale or use of any but existing stocks. Viola-
tions of the Act will be subject to prosecution 60 days
after Federal Register publication of the Administrator's
order. (This of course will not apply to- those products
registered Federally and by States for uses which have
not been suspended: 1) subsurface ground insertion for
termite control; 2) dipping of non-food roots and tops; 3)
moth-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 i*>
obtaining for Federal use:
- lists of State registrants or persons with applications
pending for Aldrin-Dieldrin product registration;
- information nn location anH relative smmintc ot" such pro
ducts within the State;
- assistance of State enforcement authority to achieve com-
pliance with the production, registration, and shipment,
sale and use cut-off.
5) EPA regional personnel are to continue their investigations
of production since December 7, 1972 of products contain-
ing Aldrin and Dieldrin for Stat^ 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 contain-
ing Aldrin or Dieldrin in contravention of labeling prohi-
bitions against use in non-Federally registered products,
such violations are to be prosecuted in accordance with the .
appropriate provisions of the Act.
Shorld you have questions or encounter difficulty with regara 4.o any
of these matters, please notify the appropriate Regional Coordinator.
Attachments:
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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. PEP sends Administrator's order to Regions
5. HDQ sends Administrator's order to States
6. States or Regions notify State registrants of order
(See Attachment ii).
7. Regions follow-up at each State registrant.
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Attachment II SAMPLE LETTER
State Registrant
(Address)
Gentlemen:
On (date), the Administrator of the United States Environmental
Protection Agency issued an Order asserting Federal jurisdiction over
all non-Fedcrally registered Aldrin-Dieldrin products in intrastate
commerce by invoking Section 3 of the Federal Insecticide Fungicide,
and Rodenticide Act (FIFRA), as amended (7 U.S.C. 136 ct seq. ).
As a result of this Order, the shipment, sale, and use of non-Feder-
ally registered Aldrin-Dieldrin products, produced after the effective
date of the Order will be prohibited. Accordingly, the State of (name)
can register or continue registrations only of non-Federally registered
Aldrin-Dieldrin products which 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 F1FRA
registrations" on manufacturing use only labels.
Violation: Misbranded, inadequate directions
Section 12(a)(l)(E)
Action: Civil/Criminal/Stop Sale
2. Use of a "manufacturing use only" product bearing a statement such
as "For use only in formulating products bearing EPA-approved
FIFRA registrations" on the label in a non-Federally registered
Aldrin - Dieldrin product.
Violation: Misuse Section 12(a)(2)(G)
Action: Civil/Criminal/Stop Use
3. Sale of a non-Federally registered Aldrin - Dieldrin product pro-
duced after the effective date of the Order, but before violations
are actionable (GO days after publication in the Federal Register).
Action: Stop Sal^
4. Sale cf a non-Federally registered Aldrin-Dieldrin product pro-
duced after the effective date of the Administrator's Order (day
after signature) and after the date violations become enforceable
(GO days after publication in the Federal Register).
Violation: Non registration Sec. 12(a)(l)(A)
Action: Civil/Criminal/Stop Sale
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
JAN 15 1976
OFFICE OF ENFORCEMENT '
SUBJECT:
TO:
FROM:
Enforcement of Administrator's Decision and
Order Suspending Most Uses of Heptachlor and
Chlordane
Enforcement Division Directors
Pesticide Branch Chiefs
A. E. Conroy II, Director
Pesticides Enforcement Division (EN-342)
I. LEGAL DEVELOPMENTS
istrator on the Suspension of Heptachlor-Chlordane (In re Velsicol
Chemical Corporation, et al. , FEFRA Docket No. 384) ordered the
suspension' of "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 constituent
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
^ Copies of the Administrator's "Conclusions" and the "Order" are
attached.
-------
-2-
29, 1975, "Notice of Intent to Suspend" remains in abeyance in the
Sixth Circuit as well.
II. CURRENT AGENCY ACTIVITY
The office of the Hearing Clerk is preparing to serve by
certified mail copies of the Final Order on all parties to the suspen-
sion proceeding. In addition, the Registration Division is preparing
to notify all registrants by letter of their status under the Order and
of what label amendments, if any, are necessary for them to continue
the registration of their products in accordance with the Order.
El. ENFORCEMENT
The Pesticides Enforcement Division is preparing a general
strategy to enforce the Administrator's Order. This strategy will
provide status of registrants vis a vis the cancellation and suspension
proceedings, lists of formulatorjand distributors of chlordane and
heptachlor products, and status of product uses as clarified by any
'subsequent Orders.
Pending the completion of this strategy, regions should pro-
ceed with normal surveillance and inspection activities relating to
chlordane and heptachlor products. Enforcement actions should await
official notice of suspension to subject registrants.
Until that time you may find it helpful to deal with general
inquiries as follows.
1) So far as PED is able to determine at this time, stocks
of Dro^]T^tc intpn^r? for gMT^npnHpH ngge; v/hich were formulated after
July 29. 1975. are illegal for further fih'T^^'"''- T"10 ^ ll'jf
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 vath directions
provided by the Office of Solid Waste Management. Disposal questions
may be referred to Ray Kreuger in Washington at (202) 755-8050. Regional
offices should cooperate in every way possible with responsible efforts to
dispose of suspended chlordane/heptachlor stocks.
3) Questions relating to label status should be referred to
Tim Gardner of the Registration Division, Washington, (202) 426-9425.
As soon as firm policy exists as to this issue you will be informed of
its substance.
Should you have questions concerning any facet of the
chlordane/heptachlor suspension, please contact the appropriate regional
coordinator.
-------
°,
? UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
* WASHINGTON. D.C. 20460
JAN ?T 1976
OFFICE OF ENFORCEMENT
SUBJECT: Clarl'-lcrJ,:.-.:: of Heptachlor/Chlordane
Suspension Order
TO: Enforcement Division Directors
Pesticide Branch Chiefs
FROM: A. E. Conroy E, Director
Pesticides Enforcement Division (EN-342)
Please find attached a copy of the Administrator's "Clarification
of Order of December 24, 1975 (In re Velsicol Chemical Corporation
et al. , FEFRA Docket No. 384), " aated January 19, 1975. Although .
the Administrator did not adopt per se Respondent EPA's proposed
order and table for clarification (see my January 15th memorandum
and enclosures), this document makes patent that all registrations
(Federal and State) of pesticide products containing heptachlor and
chlordane for uses not specifically continued (as set forth in paragraph
4 of the Conclusion to the December 24th Decision) were suspended.
For purposes of enforcement, "Attachment A" will be used as the
list of uses not suspended.
Should questions arise concerning the Clarification, or any other
matter relating to the heptachlor/chlordane proceedings, please con-
tact the appropriate regional coordinator.
-------
; UNITED STATES OF AMERICA
rNVIRONMEIITAL PROTECTION AGENCY
BEFORE THE ADMINISTRATOR
>uol Chemical Corporation ) . .FIFRA Docket No. 384
L—' ; ) -, '
Registrants. ) . .
CLARIFICATION OF .
ORDER OF DECEMBER 24, 1975
C* January 7, 1975, Respondent EPA filed a Suggestion for
far itication of the Order of December 24, 1975, in the above-
• * »
?j?!irr.ed proceeding, seeking clarification of the uses of
•i-r^'.-cts containing heptachlor and chlordane for which
f-;'.'.'ratioiiS are not suspended by the December 24 Decision
tX'i Cr-Jcr. Respondent also submitted a Proposed Order, including
t"v «*.uchr,ent setting forth a proposed list of uses not suspended,
!i-;.r;/.er with certain explanatory notes.' . . '
On January 13, 1976, I issued.a notice of the filing of
Suggestion for Clarification and Proposed Order
written- consents from the parties, thereby
l*Jtesting my intention to consider the possible need for
< :if;f>cition of the December 24.Decision and Order.* On . "
•'ivury }fjt 1976,'.written comments v.-ere received from counsel for
f1'/;ll°'i v.vra subsnitted by counsel for Vclsicoi Cl-.emical
lvc''->ri-'lK'nf?n Januapy 1?« 1576, but not sufficiently in advance of
» oration of the January 13 notice to be considered therein.
-------
2
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
Environmental Defense Fund, oppose Respondent's suggested
clarification of the December 24 Order, both on grounds that the
Administrator lacks jurisdiction or authority to clarify, modify,
* . *
or alter the .Order and that the Order is final and cannot now .be
changed .in the nunner 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 wfiV.be-•
. served and facilitated by the following clarification of the..
December 24 Order. . . • -^,.. '
-------
3
In reviev/ing the Decision and Order and the possible need
for'clarification, I have not considered any new eviu'iiiici o.r " •
* * ' ' ' i
argumentation. I have sought only to discern any possible source
i
or sources of any lack of clarity in tiie expression of my
intentions at the time I issued the Decision and Order. Comments
received froa the parties have been most helpful- in determining
* . *•
••whether or not my intentions were clearly expressed. The sole
• •
. purpose of tin's clarification is to add clarity to the expression ;
of my intentions at the time I issued the December 24 [iccisic'i . •
and Order. • . • •
The December 24 Order, by its terms, provides that all
. pestici-de 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
corn having a post-effective date of August 1, 1976]. The Order
further provides that any stocks of technical grade heptachlor . . ..
or* chlordane formulated into products intended for such uses
[after July 29, 1975] may not be placed in commerce, sold, or used •
* '
for such purposes or any other purpose not specifically
exempted [in the November-.18,. 1974, cancellation order] or_
specifically permitted•in'accordance, with the Decision of the •
Administrator attached thereto. . . -.
-------
4 ' - '
. Th3 uses specificall.y permitted or continued by the
Decision accompanying the December 24 Order include only those set
forth in paragraph 4 of the Conclusions contained in the Decision*
and, therefore, these uses (together with the exempted uses for
subsurface ground injection for termite control and dipping of
roots or tops of nonfood plants) are the only uses not suspended
by the December 24 Decision and Order. All other registrations
• ' •
for uses "of products ^containing heptachlor or chlorda:i£ are •
suspended. Because ch-2 words "intended For such uses" in lino 12
of t!::! Order might be interpreted as limiting the suspended, uses
'to thp four uses enumerated in the first sentence of the Order,
the words "intended for such uses" are hereby deleted from the
December 24 Order. • ' . •
The reasons for the specific enumeration of four uses
'suspended in the first sentence of the Order, while suspending uses
for "any .other purpose" in blanket form in the second sentence, are
twofold: (1) other than an occasional reference to certain
fruits and vegetables and other miscellaneous crops, the record
(including the Recommended Decision.of the Administrative Law
Judge) does not adequately address many other (presumably minor)-
uses of heptachlor and .chlordan'e, 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
-------
.5
(2) the four uses enumerated specifically in the December 24
(Vclcr .'••-«-• •--.' <:• • •".•• K- •;"
•". - '
("ici'sion of the Administrator, p. 76.
-------
. 6
"any other purpose" generally, i.e. that, in view of the ^
evidence on carcinogenicity 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 betv/een paragraph 5 of the Conclusions in the
*
•Decision and the provisions of the,Order.
In view of the foregoing, I do not find it necessary to
either adopt or reject the Proposed Order subniitted by Respondent.
Russell li. [rain
• -i
Dated: January 19, 1976 '. • '-.'•..
-------
. chlordane
ATTACHMENT A • .
• •' ' 1
SPECIFIC USF.S OF CIlLORnANE U II.EPTACIII.Oll
NOT SUSPENDED BY ADMINISTUATOU'S OKUlill OF 12/21/75
COMPOUND(s)
chlordane &
hcptachlor •
chlordanc &
hcplachlor
chlordanc &
1 4
hcptachlor
4
heptachlor
hcptachlor
heptachlor
» '
chlordane
clilordanc
r
9
chlordanc
chlordanc
USE(a)
2.
Subsurface ground insertion for termite control
2
Dipping of roots or lops 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
In Federal /Slate quarantine programs for
6 5,6
Japanese Beetle and imported fire ant
Control of black vine v/eevil on Japanese Yew
in Michigan
Control of Texas harvester ant in Oklalioma
Control of imported fire ant by private
5.7
individuals
•STATUS OF US£(s)
3
continued
continued •
continued until ^
8/1 /7G only
continued • ' •
• continued
continued
*'•
continued • ,
•
. * . . 1
*
continued
' continued
continued
Control of white fringed beetle attacking food
' O * "
8 .
crops in 8 S. E. States (AL.FL.GA.LA.MS.NC,
SC, TN)
continued
chlordanc
Control of soil insects attacking Florida citrus
continued
'chlordane
Control of strawberry root pests by pro-plant
treatments
continued
chlordanc
Control of white
-------
I UNITED STATES ENVIRONMENTAL PROTECTION AGENCY -
^ WASHINGTON. D.C. 2
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20450 ' •
CERTIFIED MAIL
Gentlemen: ' •
Subject : Notice of Suspension for:
This is to notify you that on December 24, 1975, the Administrator
issued his-Decision and Order on the suspension of Chlordane and
Heptachlor. ' •• . ,. ••'-...".'
This document provides that all uses of Chlordane and Heptachlor are
suspended except those set ;forth on the enclosure. Your subject regis-
tratipn v/as suspended effective December 24, 1975.
As stipulated in the Administrator's Notice of Intent to Suspend, issued
on July 2?, 1975, the product under this registration may not be formu-
Uted, shipped, sold or_used after July 29, 1975. •
The Administrator's Decision and Orderv wilj be published'in-the Federal
Regi ster.Jn: they near'future -";' . •.;'••'] ^-. ".
Sihcerely;yours, : ': : •::'•"'•'•;;;•-•"•• ;^-;^:V;.:\:(.':^•'..-•^'V ..
John B. Ritch, Or. ..= ..*' •
Director ...
Registration Division (WH-567).
Enclosure ; :
-------
^S& * UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
' " V/ASHINGTON. 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 s'imply discontinue the use of Chlordane
' 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 ,may require new efficacy
data. If you wish to continue to formulate your product with either •
Heptachlor or Chlordane you may continue to do s,o only for uses not
'suspended and only after you have submitted a petition for a label
amendment in v/hich all references to suspended uses have been deleted.
-------
-2- • .
It is sufficient to send a cover letter with an stranded label or labs!
1n which the suspended uses including any claims referring to these
uses have been blocked out. The granting by the Agency of such a
petition will permit you to continue formulation and/or sale of Hepta-
chlor and/or Chlordane for exempted uses. Petitions for a provisional
labeling arriendment in accordance with the enclosure must be received
within 30 days of receipt of this letter at the follov/ing address: .
Mr: Timothy A. Gardner
Product Manager (15) ' • .
Registration Division (WH-567)
. Environmental Protection Agency • •
Washington, O.C. 20460.
The amendment will not abrogate your right to defend both suspended or
nonsuspendad 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 for-.ivlited 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 Hsptachlor or Chlordane formulated after July 29, 1975,
may 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 t
July 29, 1975, may not be shipped or sold until you receive EPA approve"
of your amended label.
The .Administrator's Decision and Order will be published in the Federal
Register in the near future. . .
• •»
* * •
Sincerely yours; ' . , • " •
John B. Ritch, Jr. ' -
Director _
Registration Division (WH-567)
Enclosure
-------
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. 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 vnll 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^beenNblockedx-outv^ The'granting by-the Agency of such
a petition will .permit:-"yQU-Jtp|c&ntihue-:;fprmulation and/or sale of Hepta-
chlor and/or ChVof.dahe'-forrexeinp;ted 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:
-------
"li . -.
' _,..
-Mr. Timothy A. Gardner
Product Manager (15)
Registration Division (WH-567)
Enviror,T:sntal Protection Agency
D.C. 20460. •
The amendrnGnt v/ill not abrogate your right to defend both suspended or
nonsuspendecl uses. in the continuing cancellation proceeding.
Existing stocks of EPA registered pesti-cides 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 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,
'may only be distributed and sold for those exempted uses included in the
enclosure and under labels containing no suspended «ses. Stocks v/hich
you may presently have on hand, if manufactured or formulated after
•.July -29, 1S75, may not be shipped or sold until you receive EPA approval
of your amended label. .. ... ' ~ .: ------- *-
The Administrator's Decision and Order v/ill be published in the Federal
. Register in the near future. . • • . • .
Sincerely yours, ' '
John B. Ritch, Jr.
Director . ' .' ' •
.Registration Division (WH-567)
Enclosure '-"'.•'
-------
SPF.C1FIC USES OF CJILORDAN'K / H"rTACIIl.OK
\' NOT SUGl'E.NDEU DY ADMIN1STKATOKT, OliiJL'H OF 12/2-1/75
COMPOUNDS)
USE(s)
STATUS OK USE(s)
chlordane
heptachlor
Subsurface ground insertion for termite control continued
chlordane
heptachlor
Dipping of roots or tops of non food plants
continued
chlordane i
heptachlor
Control of cutworms on corn (both pre and post
emergence) '_
continued until
8/l/7Gonly
heptachlor
Control of narcissus bulb fly
continued
heptachlor
Seed treatment'
continued
beptaehJor
Ant control to achieve pineapple mealy bug
5
control in Hawaii
continued
chlordace
In Federal/State quarantine programs for
6 5.6
Japanese Beetle and imported fire ant
continued
chlordane
Control of black vine weevil on Japanese Yew continued
in Michigan
chlordane
'Control of Texas harvester ant in Oklahoma
continued
chlordane
Control of imported fire ant by private
5,7
Individuals
continued
chlordane
Control of white fringed beetle attacking food
8 '
crops in & S. 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 pre-plant continued
treatments
• chlordane Control of white trrubs'in Michigan continued
* "IT Ail registrations U-'caeral and state) 01 pesticide products containing heptachlor and
chlordane for uses not specifically continued are suspended by the Administrator's.
Decision and Order on the Suspension of Heptachlor-Chlordane. The effect of the
Order is to further prohibit the manufacture, formulation or reformulation of products
containing Heptachlor or Chlordane for any purpose other than for those registered
~" uses which have been exempted in the Order and for manufacturing uses as an
interim step in the ultimate formulation for such registered uses. Sale and use of
existing stocks of registered products v/hich were formulated prior to July 30, 1975
'. are permitted for both continued and suspended uses. ' •
•3. PR Notice 74-11 (33 FR 412?3) exempted this use from cancellation. Such use
was similarly exempted from the Notice of Intention to Suspend, 40 FU 34456
(7/29/75). --• :
S.: Clarified at 40 FR 30522 (7/21/7S) to apply to the use of cmulsifiable or oil
concentrate formulations for controlling subterranean termites on structural
_• sit CD such as buildings, houses, barns, and sheds, using current control
t '. practices.
' 4. Velsicol has represented thit it would voluntarily suspend domestic shipments
of hcptaehlor for this use. pending resolution of the cancellation proceedings.
5. On the assumption that Mircx is not available. ' ••. •-
6. To include treatments required to certify to pest free conditions as well as for
use in suppression and control pr-o^rams. ''
7, To include use on both public a.nd private property by cither owner, agent,
employee, or contractor.' . .
8. • Not intended to.preclude use on couon. However, use on tobacco is suspended.- •
D. Restricted to_citrus root weevils. ..
-------
* UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
V ./ .,- WASHINGTON. D.C. 20460
• v
2 3 MAR 1976
OFFICE OF ENFORCEMENT
SUBJECT: Heptachlor/Chlordane Suspension Order
Enforcement Strategy
TO: Enforcement Division Directors
Pesticide Branch Chiefs ^~^
FROM: A. E..ConroyII, 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 12/24/7FrT"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 stb'cks 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 heptcichlor or chlordane products formulated
f-fter July 20, 1975 may be sold, distributed, or used
only for exempted uses, as per "Attachment A".
n. 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 ----_
susp'ehdecnThe Registration Division/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. 1 / An
example of a product in this category would be a product regisfered -----
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, "
there is a large category of registered products whose uses were sus-
pended in part by the December 24th Order, but whose sale and distri-
bution may continue upon ["provisional"] amendment of the produces . .
registration and labeling to delete all suspended uses. A typical product
in this category would be one registered and labeled for indoor roach con-
trol and for subterranean termite uses (the former being a suspended use,.
while the latter is a permitted use). • Pending the decisions by the regis-- •
trants to amend or not [such decision must be made within 30 days of ••'-••
receipt of the notice of suspension], it is not .possible to determine
the registration status of products in this category. Upon RD's comple-;-:
tion of the necessary registration.review, a region specific list will
be forwarded to you noting the.status of individual products in this category.
(C) Intrastate products. Although this third category is comprised
of products similarly situated to those in above categories (A) and (B),
for purposes of this enforcement strategy, "intrastate products" are
.being-treated separately. The Registration Division has notified the
*•' '• ••
I/ see my ^edruary 19, 1976 memorandum entitled "Status Report on the •
TTeptachlor/Chlordane Suspension, " and its attachments. ' .
-------
-3-
registrants of 140 "intrastate" products as to the impact of the
December 24th Order on their heptachlor/chlordane products.
These products were being sold only in intrastate commerce when
they became subject to the FEPCA registration requirements by
the accelerated activation of section 3 in November 1974. Sub-
sequently, all applications for Federal registration were denied
and the applicants who timely requested a hearing were made
parties to the cancellation proceeding and the subsequent suspen-
sion hearings. Accordingly; these products were equally affected
by the December 24th Order in that to continue marketing them.
registrants must delete suspended uses from their labeling. Please
note the attached three Registration Division form letters used to
apprise this category of registrants as to their 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.r As the initial step in ....
implementing this policy, EPA has requested the recall, down to
and including the retail level, of all heptachlor/chlordane products
for which all uses were suspended and which were formulated
after July 29, 1975 [category A products]. In addition, the Agency
intends to request the recall—in some instances for1 relabeling--of
all heptachlor/chlordane products formulated after. July 29, 1975
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-4-
whose labels contain both suspended and non-suspended uses [category
B products], "Intrastate" products [category C products] will be treated
in a manner consistent with similarity situated Federally registered
products.
IV. ENFORCEMENT ACTIONS.
As has been the established policy in such matters, enforcement " .
actions will be taken, in accordance with normal procedures and at -"•::•
levels consistent with those provided for in the Pesticides Enforcement-':-J
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 . :.L-.;^-~
ensure compliance with the Administrator's Suspension Order. As - -i-^-i-
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 .:._._...-i-.
--extra-ordinary number of products and'firms which are affecte'd by~~-'
the December 24th Order and the commensurate amount of Agency •--•-— -
resources which would be involved in-conducting a formal-recall, -the-----'---/
Agency feels that the procedures outlined in the Case Proceedings
Manual, Chapter 12, for informal recalls would be more appropriate
in this matter. Information and guidance with respect to specific en-
forcement related actions which may be directed toward each of the
aforementioned categories of heptachlor/chlordane products follows: -.•;.-." •
(A) Federally registered products, all uses of which were sus- •
pended and which were formulated alter July 29, 1975. . As per recall'" "
initiation procedures, the Pesticide Enforcement Division has notified
by certified mail those registrants who had all uses of their heptachlor/
chlordane product(s) suspended by the December 24th Order, that EPA
is requesting that all subject products formulated after July 29; 1975;.. •
•be recalled immediately. This letter .-..a. copy of which is attached to- . -
this memorandum, refers the addressee, to the Registration Division
suspension letter informing the registrant of the registration status of
his product(s), and continues by specifically requesting that (a) the ~.
company initiate, procedures to determine the locations of all quantities-
of their finally suspended product and the amount of such product at
each such product location, (b) that the product be returned to the
registrant from all locations, and (c) that the named regional contact
person be informed of all actions taken in connectiqn with the.recall.
In your follow-up to determine compliance with the recall request, you
should:
(1) be assured that the registrant has recalled the product
from the retail level, and either
(i) .disposed of the product,
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-5-
(ii) exported product in accordance with section 17, or 2/
(iii) sought new registration for continued uses;
(3) stop sale any such product found in consumer channels
under section 13; and
(4) where appropriate, initiate enforcement action under
section 14. 3/ ........
•—M> f
(B) Federally registered products with both suspended and con-
tinued uses and which were formulated alter July 2V, i^To"!As soon
as. these products can be identified as to their registration status, PED
will request each registrant to contact all known, distributors, whole-
salers, and retailers that the subject product should not be sold or
otherwise distributed. Registrants will be instructed that they should..
recall from retail level as set forth above for category A products.
When following-up to determine compliance with the recall of these pro-
ducts, you should:
•••- (I) be assured that the registrant has recalled the product
• from the retail level, and either
(i) disposed of product if amendment to labeling is not
made,
(ii) exported product in accordance with section 17,
(iii) relabeled product with amended label deleting sus-
pended uses, or •- , ..
(iv) in accordance with EPA approved instructions,
overlaid product with approved sticker labels,
masked out suspended uses, or used other means to
delete suspended uses from the labels;
_T/ Registrants: should be inforxned-thatfthe Agency would interpose
no objection to the export of; products affected .by. the suspension order,
but wishes to caution, registr.ants concerning the recent stipulation
signed by the Department of. State concerning the.utUization-.bf US funds
for USAID-procurements of such products. See.USAID regulation entitled
"Pest Management Program, Interim Pesticide Procedures, " published
in the Federal Register on January 7, 1976.
3/ Those persons who distribute or sell a suspended heptachlor/
chlordane product in violation of the terms of the December 24th
Suspension Order will be in violation of section 12(a)(l)(A) for non- •••
registration, as well as section 12(a)(2)(J) for violation of a section
6 suspension,order. . :' " '
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-6-
(2) stop sale any such product found in consumer channels
under section 13; and
(3) where appropriate, will initiate enforcement action under
section 14. 3/
/
(C) Intrastate products. The policies outlined above will also
apply/as appropriate, to intrastate products as they become identified.
At present, the 48 products thus far'identified will be treated the same-
as Federally registered products, all uses of which have been suspended
[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 prior ily -^n-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 apprisedithat 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. - .
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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 -
Division, Office of Pesticide Programs [(202> 426-9425]. -.-• - .?
ATTACHMENTS -._..- -
Please find attached the following:
(1) "Attachment A —Specific Uses of Chlordane and
' -;Heptachlor Not Suspended by Administrator's Order — —-—
of 12 724/75:T7"
(2) Copies of recall request letters sent to 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 pf the 48 "intrastate" heptachlor/chlordane products,"
-all use of which were suspended [category C products]. ^---
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u
? UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. O.C. 20460
27AUG1976
OFFICE OF ENFORCEMENT
TO: Enforcement Division Directors
Pesticides Branch Chiefs ^ f\ .1^' N/.
FROM: A. E. Conroy II. Director
Pesticides and Toxic Substances
Enforcement Division (EN-342)
RE: Heptachlor/Chlordane Suspension OrVler
Enforcement Strategy — CORN USE
e confusion has arisen concerning the enforcement response
to certain heptachlor/chlordane products 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 required to implement alternative
cutworm control methods, the use of heptachlor and chlordane
to control cutworm on corn crops should be permitted during
the 1976 corn growing season. Accordingly, I have concluded
that the registration for use of heptachlor and chlordane to
control cutworms on corn crops should be suspended effective
August 1, 1976. _*/
As you are aware, the Administrator's heptachlor/chlordane orders
provide the following concerning the legal status of the various products:
*/ See also, "Clarification of Order of December 24, 1975, " 41
Fed.TTeg. 7552 (February 19, 1976).
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-2-
1. With the exception of the corn use, all registrations of pesticide
products containing heptachlor and chlordane for uses not specifically
continued (e. g., chlordane to control black vine weevil on.Japanese yew
in Michigan), were suspended as of December 24, 1975. *»/
2. By invoking the "Special Rule" provision of FIFRA section 15(b)
(2), the Administrator has provided that stocks of EPA registered pesti-
cides containing heptachlor/chlordane formulated prior to July 30, 1975,
may be sold, distributed, or used for suspended uses, including use on
corn.
3. Stocks of heptachlor or chlordane products formulated after
July 29,1975, may be sold, distributed, or used only for exempted uses
[see "Attachment A," enclosed]. Thus, for example, a chlordane product
whose sole registered use was for cutworm control on corn could legally be
produced, distributed, sold, and used without violatingthe December 24
suspension order until this product became finally suspended on August 1,
1976.
You will remember that prior to our request for the recall of violative
heptachlor/chlordane products, R ^"tration Division, Office of Pesticide
Programs advised affected registrants that if amended labeling which deletec
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 VELS1COL 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% CHLORDAKE GRANULES
• _**/. To arrive-at a result consistent with the Administrator's intent to
suspend all use of chlordane/heptachlor. 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.
-------
1029-77 AT.HEX CflLORDANE 8E
2&35-151 RED TCP CHLORDANE 8 SPRAY
9859-51 CIILORDANE 10 GRANULAR
9859-53 CHLORDANE 5 GRANULAR
9859-55 CHLORDANE 25 GRANULAR
'14775 CHLORDANE-TOXAPHENE BAIT NO. 11 (Florida "intrastate"
—Asgrow Florida Company, P. O. Drawer D, Plant City, FL)
Therefore, at'ter December 24, 1975, no product produced after July 29,
1975 for corn use could be legally distributed or sold without the above men-
tioned disclaimer. The detection of such violative product will continue to
receive Agency response in the form of a FIFRA section 13(a) Stop Sale, Use
or Removal Order and section 14 action, as appropriate. It is the Office of
Enforcement view that enforcement action, including SSURO's, should not be
taken against the sale and distribution after August 1, 1976 of products bearing
the disclaimer. The use of such product on corn after August 1, 1976 is in vio-
lation of the suspension order [§12(a)(2)(J)J, as well as a misuse [§12(a)(2)(G)J.
' 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, may be sold, distri-
buted, and used only with labeling amended to include only continued uses;
and (3) products formulated after July 29, 1975, with directions for use on
corn, must bear the following disclaimer immediately after the corn use
directions: "USE SUSPENDED EFFECTIVE AUGUST 1, 1976. "
The Agency is not contemplating at this time "the recall of the above
products for relabeling to delete reference to corn uses. At the conclusion
of the cancellation proceeding, heptachlor/chlordane labels will be revised
to conform with the Administrator's final order.
All inquiries in this matter should be referred to the appropriate regional
coordinator.
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<;.-,£"••"•••«...
\ \\ff ^ U!'" ' J STATES ENVIRONMENTAL PROTECTION AGENCY
\.,""'"'>: WASHINGTON. D.C. 20-160
23NGV W3
OFFICE OF ENFORCEMENT
To: Enforcement Division Directors
and Pesticide Branch Chiefs
From: A. E. 'Conroy II, 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 1276 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 Defense
Fund v. EPA, No. 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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-2-
Future surveillance for compliance with the Administrator's
order should be routine except in the c.?~c of firms refusing to recall.
Additional visits to produccrs~and/or distributors may je necessary
to assure compliance in these situations. Regarding enforcement
actions, pending a final outcome on the issue of the remand, the fol-
lowing should be pursued. Any suspended hcptachlor/chlordane pro-
duct produced after July 29, 1975, and remaining in commerce should
be stop saled. Additionally, since all but retail distributors should
have been notified to return the violative products, any suspended
products found in channels of trade above the retail level should be
sampled and civil penalty actions issued to the distributor and/or the
producer, as appropriate. Civil penalty actions should also be issued
for any violative samples previously collected above the retail level.
Beyond stop sale, decisions on the level of action to be applied at the
retail level are left Jo 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 arisen 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 /•.".. ;-;OY
t«-
120CT 1276
Mr. Kalph Lnq'il' ' ,
Executive Director
Chemical Spscialtisc r-iaT
• 'Association; Incorporated
1001 Connecticut. Avsnuo, u.
Suite 1120
Washington, r;. C. 20035
Dear Mr. l£p.:jel:
Your letter of August 30, 1970, has boon referrad to
this office ior rev-ly... •-•CCO.USG of.- tuo Administrator':~
ongoing vole in tfte ch.lc-rdan •-/hev'-^ciilor prccesdir.vo, it /
would >:3 ' improper under the Agency's rules of practice
for i'iim to resoond to your inquiry.
' . ' " • - ' " ' '" • , • * •" ' • '
•f Your letter asks that tl;c A-d:r.iniutr.3tor invoke the ". .
"scccicil rul'i"/uniior 5l'j(b)(2), in order tc allow inven-
tories of chlor3anG. products formulated bctv;c-.?n vluly 29,. ;•
1<;75, ana Decemijsr 2^., li>7r>, and currently on dsalor
shelves, to be sold until such. Btocks: ore oxhausted.
. Your rec/uest would -necessitate r.:o..'.ii'icatioo of the
order issuea by the Administrator on !)occip.oer 2n> 1975.
Requests tor cuch Modifications must be made in coni'oririance
with the rules o£ practice set forth in 40 Cl-'R Part 164.
be"j especially 40 ClfU lo>1.6(b), concern ing 'enlargement of
'filing periotis; 40 >FR 164.31, concsrninq intervention;-
en-.! 40 CTi\ IG-^'.llO,' concernin-i ino.cicnc for reconsideration
'of orders.
OATt
FORM 1333'!
OFFICIAL KILE COF
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finally, condor requires that I inform you that the
Aqency statt would oppose any socii motion to modify tae ,
:suspensicn order, should one in fact .be filcc'l. Essentially,
.this is because the suspension order in a temporary or dor,
which ultimately will be sncerceded. by an ordor at the
termination of the. cancellation prccooclinq. The question
of thfi extonf to v/hich distr iouticn o£ existinq stocks oi
c.hjtovaano protv.-.cts ci-.ould be ailov/ed can and ;?liould be
• a'dc.r^ssed in tho cancellation procvjeui'nq, and resolved in
the order at ttia conclusion of that proceeding. Sound
^considerations of oroceaursl nian&ciom.'jnt militate against
interruption of the cancellation proceeding to consider •
this question at this time. ,;
G. William Frick
Genural 'Counsel (A-130)
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/• i
(J
^J
A&J
CHEMICAL SPECIALTIES MANUFACTURERS ASSOCIATION. INCORPORATED
CXCCUil'.l •:•''.' • RUIfE M2U » 1CCI CONNtCTICVjT AVc.. M.W.. WAStliNGTON. O.C. 2003G • (?02| fl?2-01IO
August 30, 1976
Mr. Russell E. Train . • • ' •
Administrator, EPA . • •• .
•401 M Street, S.W., Room V71200 .
Washington, D.C. 20460 . .
Dear Mr. Train: •
On August 16, CSMA counsel Robert Ackerly and Roger
Copland of my staff met with several Agency officials,
including those from the Enforcement Division and the
Office of General Counsel, to discuss the situation
pertaining to products containing chlordane.
Pursuant to that meeting, I hereby request that you"
invoke the Special Rule of §15 (b) (2) and allow inven-
tories of chlordane products formulated between July 29,.1975
and December 24, 1975 and currently on dealer shelves to
be sold until such stocks are exhausted.
• • * * *
There are several reasons for this request:
1) Recall is in most cases a practical impossibility
and constitutes an economic hardship, particularly
to smaller formulators. There are literally thou-
sands of small retailers who may have a few units
of chlordane products in stock. It is not always
possible for the formulator to ascertain where
such products are being sold* I.f stocks are dis-
covered, compliance with- Department of Transpor-
tation regulations governing the shipment of
hazardous materials becomes a major problem,
especially in view of the fact that substantial
numbers of retailers will have only a few units
of various brands.
2) Invocation of the Special Rule will not create a
health hazard. Use of the products as directed
may be the safest way of disposing of remaining
stocks. The remaining supply of chlorclnne pro-
ducts does not, in relative terms, constitute a
large amount. We estimate that between 1,800,000
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-2-
to.3,600,000 units remain on the shelves of some
75,000 retail dealers. While the recall or stop-
sale of these units would have an adverse economic
impact on many formulators, their normal, generally
outdoor use v/ould not significantly exacerbate a
situation that has been ongoing for some 26 years.
Furthermore, v/e 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 formul'itM as of the date of the notice.
. . We believe that this action should have beea 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 have 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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-3-
Of course, should you invoke the Special Rule, it would
alleviate indemnification problems that will "arise wi.th
.respect to products formulated prior to the Suspension
Order.
I look forward to hearing from you concerning this impori
tant matter. .
Ralp
Exec
RErkas
cc: A.E. Conroy
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
280CT1976
OFFICE OF ENFORCEMENT
TO: Enforcement Division Directors
Pesticide Branch Chiefs
FROM: A. E. Conroy II, Director
Pesticides and Toxic Substances __ .
Enforcement Divison / \)
RE: Conclusion of the Mercury Cancellation Proceeding
On August 19, 1976, the Administrator concluded,the four year old
mercurial pesticide product cancellation case by approving a settlement
in In re Chapman C he mi zzl Company, et al. between the registrants
and EPA. The purpose 01 this memorandum is to briefly review back-
ground events, to explain the terms and conditions of the settlement
order, and to provide you with a revised mercury cancellation enforce-
ment strategy.
I. BACKGROUND .' •
The mercury hearings were initiated on March 22, 1972, when EPA
Administrator Ruckelshaus issued PR Notice 72-5 announcing the Agency's
intent to cancel the registrations of all mercurial pesticide products, and
the immediate suspension of all alkyl mercury compound registrations
and of all nonalkyl products registered for use on rice seed, in laundries,
and in marine antifouling paint. In March of 1972, there were twenty
registrants with thirty-seven alkyl mercury products registered, and
four hundred eighty-four registered non-alkyl mercury products held by
one hundred sixty-five registrants. None of the registrants of the sus-
pended mercury pesticides opposed the Administrator's order and the
products were therefore suspended and finally cancelled. Twenty-three
registrants sought administrative review of the notice of intent to cancel;
these registrants contested-the cancellation of mercury as a bactericide/
fungicide for use on turf, in paints and coatings, as a seed treatment, in
dry formulations, in fabrics, on .wood, and as a treatment for the control
of the Dutch elm disease.
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-2-
The formal adjudicatory hearings were held between October 1974 and
September 1975. On December 12, 1975, Administrative Law Judge Ber-
nard D. Levinson issued an initial decision, concluding that the follow-
ing pesticides containing mercury should be cancelled because they create
an unreasonable adverse effect on the environment:
(1) all uses in paints and coatings, except as an in-can preservative
in water-based paints and coatings and as a fungicide in water-
based paints and coatings used for exterior applications;
(2) all uses as a-fungicide on golf courses, .except as used on greens,
tees, and aprons for the control of fungi of the snow mold complex;
(3) all uses for seed treatment;
(4) as a treatment for control of the Dutch elm disease; and
(5) all uses for any material that could be used in wearing apparel
and other uses for textiles and fabrics, except as a fungicide in
the treatment of textiles and fabrics for out-of-door use.
On February 17, 1976, the Administrator issued his decision and order
in the consolidated mercury hearings (In re Chapman Chemical Company
et al., FIFRA Docket No. 246, et al.).The Administrator found that the
benefits from the continued use of mercurial pesticides for use as bacteri-
cides or fungicides "(1) in paints and coatings, (2) on turf, including golf
course greens and all other areas of golf courses, (3) for seed treatment,
and (4) for any other use not specifically identified and permitted" by the
decision did not sufficiently outweigh the risks to man and the environment
and were, therefore, cancelled. The decision and order cancelled the
registrations for all remaining mercurial products, except for use
(1) as fungicides in the treatment of textiles and fabrics intended
for continuous outdoor use;
(2) to control brown mold on freshly sawn lumber; and
(3) as a treatment for the control of Dutch elm disease.
As to the existing stocks issue, the Administrator provided that the
sale and use of cancelled mercury products which were formulated
on or before February 17, 1976, were permitted.
Several mercury registrants sought review in the United States
Federal Court of the Administrator's cancellation of the seed treatment
and the turf fungicide uses of their products. On March 2, 1976, the
Administrator ordered that the effectiveness of the February 17th
Cancellation Order be temporarily stayed pending judicial review in
several United States Courts of Appeals. This order applied to all
existing mercurial registrations and the stay was to continue through
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-3-
June 30, 1976, or the conclusion of judicial review proceedings, which
ever occurred first. An important feature of the March 2nd Order was
that it prohibited the parties to the cancellation proceeding from increas-
ing production of subject products or from stockpiling.
J
On March 26, 1976, the Administrator granted registrants' petition
for reconsideration of the decision and order to cancel the registrations
of mercurial pesticides for use in water-based paints and coatings.
The Administrator modified the February 17 cancellation order on
May 27, 1976, to reinstate the registrations for certain.mercurial water-
based paints and coatings; and, he extended the stay of the effective
date of the cancellation until November 30, 1976 (or until the conclusion
of judicial review; if earlier).
On August 19, 1976, the Administrator approved a settlement in
In re Chapman Chemical Company, et al. between respondent-EPA
and registrant-appellants Parsons Chemical Works, Inc.; Troy
Chemical Corporation; Gustafson, Inc. ; Mallinckrodt, Inc.; W. A. Cleary
Corporation; and O. M. Scott & Sons Company concerning certain contested
uses awaiting review in the Eighth Circuit, U. S. C^urt of Appeals, as the
result of an appeal filed following the February 17 cancellation order. In
brief, the settlement will terminate the mercury case contingent upon the
completion of necessary regulatory activities by the Registration Division,
Office of Pesticide Programs, according to the following terms:
(1) Registrations for mercurial seed disinfectants and for
mercurial turf fungicides for use against summer turf
diseases will be finally cancelled on or before August
31, 1978. Production of these products in the interim
is limited to prevent stockpiling; total permitted pro-
duction will not exceed the equivalent of two years of
production, as determined by production data for recent
years. These uses involve 20, 000-25, 000 pounds of
production of technical mercury annually.
(2) The cancellation of registrations for mercurial fungicides
for use against winter turf diseases (10, 000-15, 000 pounds
production of technical mercury annually) is vacated. Use
of these products within 25 feet of water bodies where fish
are taken for human consumption is prohibited. --The pro-
ducts may be applied only by or "under the direct supervi-
sion of" golf course superintendents. The registrants will
request that these products be classified as restricted use
pesticides.
(3) Mercury products produced before the effective date of final
cancellation (August 31, 1978 or the date on which maximum
allowed quanitity is reached) will become "existing stocks, "
the sale, distribution, and use of which will be permitted.
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. • -4-
The Administrator has concluded that the terms and conditions of settle-
ment agreed to by the parties to the cancellation proceeding satisfy
appplicable statutory standards under FIFRA and that the.settlement is
in the public interest. See attached "Chapman Chemical Company, et
al., Consolidated Mercury Cancellation Hearing, Settlement and Order
T4TFed. Reg. 36068. August 26, 1976) [hereinafter, Settlement and
Order]."
Until such time as RD/OPP notifies the registrants of cancelled
mercurial pesticide registrations of the status of these products under
FIFRA §3, PTSED cannot be confident in the accuracy of any list of
continued mercury registrations that this office might construct. At.
this juncture, it appears that all uses of mercury were cancelled on
August 31, 1976, except as follows:
(a) for seed treatment (cancellation stayed by August 19
Settlement and Order),
(b) for control of summer turf disease (cancellation stayed
by August 19 Settlement and Order),
(c) in the treatment of textiles and fabrics intended for
continuous outdoor use,
(d) as a treatment for control of the Dutch Elm disease,
(e) as an in-can preservative in water-based paints and
coatings,
(f) as a fungicide in water-based paints and coatings used
for exterior application,
(g) as a fungicide for use against winter turf diseases, and
(h) to control brown mold on freshly sawn lumber.
II. ENFORCEMENT STRATEGY.
A. ENFORCEMENT OF THE STAY ORDER -- STATUS.
In my memorandum to you of May 14, 1976, entitled "Consolidated
Mercury Hearing—March 2 Stay of the Febraury 17 Cancellation Order, "
I outlined the Agency's enforcement strategy concerning the manufacture
of mercurial pesticides during the pendency of the stay of the cancella-
tion's effective date. The order staying the final cancellation could have
been dissolved if the Administrator found that a party to the proceeding
was increasing production and/or stockpiling mercurials during the pen-
dency of the stay. Affected regions (II, III, IV, and V) were requested
to initiate section 8 books and records inspections at all producer estab-
lishments, twenty in all, to determine the level of compliance with the
Administrator's order. Your cooperation in ensuring that the terms
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-5-r
of the Administrator's orders — particularly, the "average monthly amount"
restriction — were complied with by affected registrants is appreciated.
The further need to monitor and to advise the Administrator as to the level
of compliance by the registrants with the conditions of the- stay order has
been mooted tjy the issuance of his most recent order announcing the con-
clusion of the mercury proceedings.
•! ' B. TERMS OF THE "SETTLEMENT AND ORDER. "
1. Registration Status of Mercury Products. The Administrator's
gs
76,
August 31, 1976, Settlement and Order provides the following:
(a) the cancellation order provision cancelling the
registrations of the following mercurial seed
treatment products is stayed until August 31,
1978, or until the registrant has produced the
maximum allowed quantity of the product under
. the conditions of the particular settlement agree-
ment, whichever occurs first:
(i) Parsons Chemical Works (1969-MI-01) —
1969-57 PARSONS SLURRY CONCENTRATE "60"
1969-58 PARSONS LIQUID SEED SAVER
1969-91 PARSONS SEED SAVER DUST
(ii) Gustafson, Inc. (2079-NJ-01; 36209-NJ-01) —
7501-2 MIST-O-MATIC LIQUID SEED DISINFECTANT
7501-5 MIST-O-MATIC DRILL BOX TREATMENT
(iii) Troy Chemical Corporation (5383-NJ-01) —
605-37 GALLOTOX LIQUID SEED DISINFECTANT
(b) the cancellation order provision cancelling the registrations
of the following mercurial fungicide products for use against
summer turf diseases is stayed until August 31, 1978, or
until the registrant has produced the maximum allowed
quantity of the product under conditions of the particular
settlement agreement, whichever occurs first I/:
T/ As part of the settlement agreement, O. M. Scott, and W. A. Cleary
have agreed to apply to the Registration Division, Office of Pesticides Pro-
grams on or before September 1, 197G, to amend the registrations of subject
products to establish separate registrar1*?:-.;-; ;'or (i.) products for use against
summer turf diseases and (ii) product? U;Y n^o against.winter turf diseases.
You will be notified and supplied with the necessary information as soon as
PTSED is apprised of the completion of this action by RD/OPP.
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- 6 -
(i) O. M. Scott & Sons Company (538-OH-01) —
538-27 PRO-TURF BROAD SPECTRUM FUNGICIDE
538-36 PRO-TURF FERTILIZER PLUS FUNGICIDE
538-56 CALIFORNIA FERTILIZER PLUS FUNGICIDE
J (ii) W. A. Cleary Corporation (1001-NJ-01) —
1001-4 PMAS CRABGRASS KILLER AND FUNGICIDE
(c) the cancellation order provision cancelling the registrations
of the following Mallinckrodt, Inc. (372-PA-01; 372-NJ-01)
mercurial fungicide products for -use-against 'V/inter turf dis-
eases 2_l is vacated in accordance with the terms of the
settlement agreement and production, sale, and distribution
may resume unimpeded 3/:
372-5 CALO-CLOR
372-33 CALO-GRAN
(d) the order of March 2, 1976, staying the cancellation
order •••-' February 17, 1976, is dissolved effective.
August oi, 1976.
2. Enforcement Responsibilities Under Settlement and Order. Pur-
suant to the terms of the settlement agreements, registrant-appellants must
fulfill certain substantive requirements to be afforded a stay of the effective
date of the cancellation of the seed treatment and summer turf disease pro-
duct registrations. The conditions impacting on the Office of Enforcement
include;
(a) During the pendency of the stay, the registrants must limit
production of the subject mercurials for use against summer
turf disease to the amount determined by multiplying the
average monthly production rate during the base period (in
most cases, April 1, 1972 to September 1, 1976) times the
number of months the cancellation is stayed (24). If this
total production figure is reached prior to August 31, 1978,
the subject product's registration become immediately
77 "Winter turf diseases" consist of Fusarium nivale (pink snow mold,
pink patch, or fusarium patch), Typhula incarna, Typhula ishikariensis, and
Sclerotinia borealis.
_3_/ As part of the settlement agreement, Mallinckrodt has agreed to
amend the subject products' labeling to include the caution "Do not apply
•within twenty-five (25) feet of any body of v.-ater where fish are taken for
human consumption" and the direction ihrt the product may be used ". . .
only by or under the direct supervision en .•;••.>!:.' course superintendents. "
These label additions will also be made to the O. M. Scott and W. A. Cleary
products for use against winter turf diseases (see footnote I/, supra).
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-7-
cancelled, and the registrants must notify the Director
of the Pesticides and Toxic Substances Division of such
fact immediately.
(b) On or before September 1, 1976, the registrants were to
provide PTSED with (a) production figures by product
for the base period, (b) the total existing inventories
of subject products as of September 1, 1976, and (c) a
list of immediate customers likely to purchase the
subject products. As of now, these data have not
been fully submitted. PTSED is corresponding with
the subject registrants, noting their delinquency and
the necessity for delivery of the required information.
(c) Beginning on September 30, 1976, the registrants must
submit quarterly production reports on subject regis-
tered products to PTSED (plus other reports and/or
additional information necessary to effecutate the
intended purpose of the agreement). As of now, these
data are also incomplete.
C. ENFORCEMENT ACTIVITIES.
The Agency's enforcement strategy concerning mercurial pesticide
products will-have two,g.eneral .areas .of .emphasis: (1) the monitoring of
the production limitation provisions of the settlement agreements for
compliance by all affected registrants, and (2) the exercise of standard
enforcement actions against persons who are discovered violating the
terms of the mercury cancellation order.
1. Monitoring. The monitoring of settlement agreement com-
pliance will be the joint enterprise of regional personnel with pesticide
enforcement responsibilities and the Pesticide and Toxic Substances
Enforcement Division. Initially, PTSED will review data submitted by
the mercury registrants subject to the Settlement and Order, and will
independently calculate and corroborate the figures submitted by subject
companies as the "maximum allowed quantity1 for each product to the
final August 31, 1978 cancellation deadline. The official figures will be
transmitted to the regions who will then be able to determine whether
and when inspection of mercury producing establishments is warranted
under the particular circumstances of each case. Deviations from the
Administrator's Settlement and Order will be dealt with as appropriate.
2. Enforcement'actions. As soon as PTSED is provided with an
official list of those mercury products cancelled and those mercury regis-
trations surviving the cancellation proceedings, you will be so advised.
Additionally, as soon as there is a change in the registration status of
those products whose effective dates of cancellation have been stayed by
'the Settlement and Order, regions will bo notified. Violations of the
cancellation order will be handled as rouri^c enforcement matters. As.
the Administrator has provided for the use of existing stocks of products
subject to the August 19 order, there will be no recall program initiated.
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-8r
HI. INQUIRIES.
Inquires concerning any facet of the mercury cancellation proceedings
and the Agency's enforcement strategy should be referred to-the appropriate
regional coordinator.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
JAM 6 1377
OFFICE OF ENFORCEMENT
TO: Enfor-'^nt rivisi.cn Directors
Pesticides Branch Chiefs
FROM: A. E. Conroy II, Director f\
Pesticides and Toxic Substances
Enforcement Division
RE: Enforcement of Mercury Settlement
In a memorandum of October 28, 1976, entitled "Conclusion of the
Mercury Cancellation Proceeding" (attached), I outlined the background
and conclusion cf In Re Chapman Chemical Company, et_al., including,
at pp 5-7, the terns of the settlement and order and the Agency's pro-
jected enforcement thereof. Review of the compliance with the order by
the six registrants affected indicates that there exist degrees of com-
pliance activities, varying from none to complete.
On December 24, 1976, five registrants (not including Mallinckroct)
were advised by registered letter (copies attached) of the Agency's record
of their compliance, of those activities required to be completed, of a
general deadline of January 14, 1977, for initial compliance, and of EPA's
intention to immediately enforce against non-compliance.
As a follow-up to these letters, you are requested to make plans
to inspect, between January 19 and 21, 1977 those manufacturing facilities
in your region where section 7 records indicate subject products are pro-
duced for the purpose of placing stop sales against those products whose
registrations are no longer valid in that information was not submitted
as required by the "Settlement and Order". Attached is a list of affected
products, labels, producing establishments and addresses. On the afternoon
of January 18, 1977, your Regional Coordinator will contact you to indicate
which producers and products have attained an acceptable level of compliance
and which ones have not.
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-2-
You may use the revised stop sale form provided at p. 13 in the
new section 13 (10-76) of the Case Proceedings Manual. In the paragraph
specifiying the violation, it is suggested you insert the following:
. . . there is reason to believe that (product
name) is in violation of section 12(a)(2)(K)
of the Act in that the registration of said
product was continued subject to the terms of
the "Settlement and Order" signed August 19,
1976, in Re Chapman Chemical Company, et_al.,
and said registration is no longer valid in
that [base period production reports, calcu-
lation of total allowable production, customer
lists, existing inventories, and quarterly
production reports] were not submitted as
required by the Settlement.
This is the first of several so-called "phased cancellations" which
the Agency is handling. It is of great importance that we enforce
compliance firmly and swiftly in this intial order to build an awareness
of and appreciation for the Agency's intentions to enforce similar .
cases in the future. Should you have questions, please contact the
appropriate Regional Coordinator.
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TO: Enfcrccrr-iHt Division Cirectcrc
Pesticides Branch Chiefs
FPC«: A. E. Conroy II, Director
Pesticides and Toxic Substances
Enforcement Division
RE: Enforcement of Mercury Settlement
In a memorandum of October 28, 1976, entitled "Conclusion of the
Mercury Cancellation Proceeding" (attached), I outlined the background
and conclusion of In Pe Chepman Chemical Corcany, et al., including,
at pp 5-7, the tersis of the settlement and order and the Agency's pro-
jected enforcement thereof. Review of the corpliance with the order.by
the six registrants affected indicates that there exist degrees of com-
pliance activities, varying from none to complete.
Cn December 24, 1976, five registrants (not including Mallinckroct)
were advised by registered letter (copies attached) of the Agency's record
of their corrpliance, of those activities required to be cotrpleted, of a
general deadline of January 14, 1977, for initial cotrpliance, and of EPA's
intention to itrr.ediately enforce against non-ccirpliance.
As a follow-up to these letters.- you are requested to make plans
to inspect, between January 19 and 21, 1977 those manufacturing facilities
in your region where section 7 records indicate subject products are pro-
duced for the purpose of placing stop sales against those products whose
registrations are no longer valid in that information was not submitted
as retired by the "Settlement and Order". Attached is a list of affected
products, labels, producing establishments and addresses. On the afternoon
of January 18, 1977, your Regional Coordinator will contact you to indicate
which producers and products have attained an acceptable level of compliance
and which ones have not.
-------
You rrsy use the revised step sale forr provided at ^ 12 in tho
new section 13 (10-76) of the Caso Proceedings .".anusl. In the i^rcgraph
epecifiying the violation, it is suggested you insert the following:
... there is reason to believe that (product
name) is in violation of section 12(a)(2)(K)
of th;.1 Act in cnac the registration of said
product was continued subject to the terns of
the "Settlement and Crder" signed August 19,
1976, in He Checnvan Chemical Cofppany, et al,,
and said registration is no longer valid in
that [base period production reports, calcu-
lation of total allowable production, customer
lists, existing inventories, and quarterly
production reports] were net submitted as
required by the Settlezr,ent.
This is the first of several so-called "phased cancellations" which
the Agency is handling. It is of great importance that we enforce
ccnpliance finrly and swiftly in this intial order to build an awareness
of and appreciation for the Agency's intentions to enforce similar
cases in the future. Should you have questions, please contact the
appropriate Regional Coordinator.
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Region V Pesticide Products and
Company Addresses Involved In
The Mercury Settlement
1 0 M *>^*?- r ",••.'- r^
'• ** • I'* -«'-••' U '„ '. •••!,.' \/>.;|l
a. Corresponding Address:
Mr. John P. Kennedy, General Counsel
0. M. Scott u Sons
Ma r> •-,v i i";
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- 2 -
sons Seed Saver Dust; EPA Reg. No. 1969-91
arsons Seed Saver Dust was included in the settlement
jreement, but a search of EPA records has revealed that
t was never registered. It carries the file symbol
). ISGS-kR.
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RONMENTAL PflOTtlCYION AC-EMCV
rlr. ilofin P. Kennedy, General .Counsel
0. I!. Scott u. Sou:;" . . .'••,.
Karysville, Ohio 43040 ' :'
Dear Mr. Kennedy: ' ' / '
• - " '
Thank you for your timely submission of tlio quarterly report for
the period of July 1. 1976 through Sspteabcr 30, 1S7G.
V'e are attaching for your convenience, a schedule showing when the
next quarterly reports arc due in this office. The reports should be
sent by certified nail and addressed as follov;s:
A. E. Conroy II, Director ;
Pesticides and Tor.ic Substances . ;
Cnforc-oi:«rr.t Division (f.i'KM2)
U.S. Cnvirorner.tal Protection Agency . "
401 M Street, S.iJ. • . .
Washington,' D.C. 2C460 . . . ...
The data you suunit uill b-2 treated as confidential, unless yea"
advise otherwise. " •
V.;e appreciate tfta ptxj^ptr.ass with which you have responded to the .
requirements ov the SottloPssnt Order end !;ope th.it you v/'ill continue to
Deet the coruiifions and rcqiriregents -in:posed upon you, iiov/evc-r, v.-e
should tr:ipi:ai:i;.e ti>at failure to submit •the; reports in a tir.aly inar.ncr
will result in the initiation of step cc-le f.nd seizure actions as well
as ths i;:?•:£.liij-.o en-col iatioii of rcyistraticrss for Lija prcducts involved
in the Settja.-.c-nt Ordnr.
Sinccvaly yours,
A. E. Cor.my II, Director
sstiev'cs 1 " ~
! .L ....1
cor;
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" •ENVIRONMENTAL PROTECTION AGENCY
J'.E ro: so;:,:;ici.io;, or ULTCP.TS.
Period
• Oct. 1 - Doc. 31, 1:276
Jr-n. 1 - tor. 3'i, 1277
April. ]'- Jusio 30, IS77
Jul. 1 - Sept. 30, 1977
"Oct. 1 - Dec. 31, 1577
Jan. 1 .- Mar. 31, 1973
Apr. 1 - June 30, 1978
July. 1 - Aug. 31, 1978
DUG To PTSED
Jan. 15, 1977
Apr. 15. 1977
July 13, 1577
Oct. 17, 1977
Jan. 17, 1973
Apr. 17, 1978
July IS, 1978
Sept. 18, 1978
i •» i :
:'<-.-! • "'7v
ILL" C'JTV
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DEC 27 1S7G
Mr. C.«n. Parsons, President
Parsons Chemical Works, Inc.
P. 0. Box 146
Grand Ledge, Michigan 48S37
Dear Mr. Parsons:
This letter is to acknowledge receipt of your September 10, 1976,
conwi.'nica'cion containing the signed settlement agreement and order
pursuit to the Adrnnistrator's'Crdor and Sattltr.snt of August 19, 1976,
(41 FR 3GG68), 1n In re _Chap~an Chemical ___Co.7i?:my, ot al., the mercury
pesticide cancellation case.
As you are well aware, the settlement to which you agreed specified,
in part, that Parsons Chemical K'orks, Inc. v-.'oulo' provide th2 Director of
the Pesticide-; and Toxic Substances Enforcement Division (PTSED) with
(a) certain production records on your mercurial products, Parsons
Slurry Concentrate "CO" (EPA Reg. !,'o. 1259-57), Parsons Liquid Seed
Savor (EPA Rag. ficu 1SG9-53). and Parsons Seed Saver Dust (EPA Ren. No.
1959-91), (b) a computation of the total maximum amounts of production
of these proc'ucts that arc. allowed under the terms of the settlement
agreement, (c) a list of ir^eoiate customers, end (d) an inventory of
the quantities of these products on hand. PuTSSD has not yet received
this Infornstion. In addition, your first quarterly report, due on
September 30, 1576, has not yet arrived. Ws would also remind you that
the next quarterly Report covering the period through December 31, 1976,
is also due to be submitted.
The above information and the quarterly reports for Scptsr^r and
Decfv~Ler c-'j't be suto.ittrd i-y vJon'.-T.r/ 14, lL"177. Thr c.»o ivv:~-k poriod
betv.'con Occc-.-.-iic-r 31st r.:'.;i Januzi-v !'ftl; should silo/; enple t.;;.yj to com-
plete the proci:jctiorj rrr:/rt: for chc Dccanbcr fjuar^r and still provide
sufficierri tir.io for r;aiMng the infotr^tic1;:. If thijre is no production
ciurinq reporting periods, then zero production figures-should be re- "
portc '
-------
The inforr.iation should be sent by certified mail and addressed as
follows:
' . 'A. E. Conroy II, Director
Pesticides and Toxic Substances
Enforcement Division (EH-342)
U. S. environmental Protection Agency
401 H Street, S.W.
Washington, 0. C. 20s60
You way rest assured that the data you submit will be treated as
confidential, unless you advise otherwise.
Attached for your convenience is a schedule showing when the various
reports are due. There will be no further reminders fron this Agency.
The conditions and requirements imposed upon you by the August 19; 1976,
Settlement and Order are salf-exocutinn. Your strict compliance with
these terms is not only anticipated, but required. Failure to submit
the required reports in a ttoly manner will result in t:ha initiation sf
stop sale and seizure action on all products affected by this Order and
the inwediate cancellation of the registrations for these products.
We are disc attaching a cop/ of the Settlement Order entitled
"Proposed Teras of Settl&ncr.t of Certain Portion of FIFRA Docket flos.
246 et al.: llercury Pesticide Cancellation Case", sicncd by you on
September 10, HVii. K'e sucjyest you review tho docufr.c-nt.
Sincerely yours,
A. E. Conroy II, Director
Pesticides and Toxic Substances
Enforcement Division
cc: Col burn T. Cherney
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PARSONS CHEMICAL 'r/ORKS, IJ.'C.
?
SCHEDULE FOR SUBMISSION OF REPORTS.
i
PERIOD ' DUE TO PSTSED
t fomultited each month
during period between April 1,
1972 and July 3'! , 1376.
Computation or total m-^iiiiujsi " Jan. 14, 1577
amount of production.
Inventory of quantity of
product en licnd as of .
Sept. 1, 127G.
Lfst of ioediato customers
July 1 - Sept. 30, 1976 Jan. 14, 1977
Oct. 1 - Dec. 31. 1976 Jan. 14, 1977
Jan. 1 -Mar. 31, 1977 Apr. 15, 1977
Apr. 1 - Jun. 30, 1977 Jul'. 18, 1977
Jul. 1 - Sept. 30, 1977 Oct. 17, 1977
Oct. 1 - Dae. 31, 1977 . Jen. 17, 1970
Jan. 1 -tor. 31, 1975 Apr. 17. 1D7S
Apr. 1 - Jun. 30, 1570 Jul. IS, 1978
Jul. 1 - Aug. 31, 1P7S Sept. 18, 197G
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ilZ^ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
V' WASHINGTON. D.C. 20450
280CT1976
OFFICE OF ENFORCEMENT
TO:. Enforcement Division Directors
Pesticide Branch Chiefs .
..FROM: A. E. Conroy II, Director
Pesticides -and Toxic Substances
Enforcement Divison
RE: ; Conclusion of the Mercury Cancellation Proceeding
On August 19, 1976, the Administrator concluded the f'.»i;r year old
mercurial pesticide product cancellation case by approving a settlement
in In re Chapman Chemical Company, et al. between the registrants.
and EPA. The purpose 01 this rnernoranoum is to briefly review back-
ground events, to explain the terms and conditions of the settlement
order, and to provide you with a revised mercury cancellation enforce-
ment strategy.
I. BACKGROUND ."..-. ..'•''
The mercury hearings were initiated on March 22, 1972, when EPA
Administrator RucUelshaus issued PR Notice 72-5 announcing the Agency's
intent to cancel the registrations of all mercurial pesticide products, and
the immediate suspension of all alkyl mercury compound registrations
and of all nonalkyl products registered for use on rice seed, in laundries,
and in marine antifouling paint. In March of 1972, there were twenty
registrants with thirty-seven alkyl mercury products registered, and
four hundred eighty-four registered non-?.ikyl mercury products held by
one hundred si:rty-five registrants. None of the registrants of the sus-
pended mercury pesticides opposed th": .Administrator's order -and the
products v.'crc therefore si'.socncerl -And finally ':a:acoUcd. Twenty-three
registrants sought ach:iini:::r~:iv? r?vi-:v.* of the nc:icc o: ir.ts::c :o cancel;
these registrants coutcsctd the cancellation of mercury as a bnctoricide/
fungicide for use on turf, in paints and coatings, as a seed treatment, in
.dry formulations, in fabrics, on wood, and as a treatment for the control
of the Dutch elm disease.
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-2-
The formal adjudicatory hearings v/cre held between October 1974 and
September 1975. On December 12, 1975, Administrative Lav/ Jud;_fc Ber-
nard D. Levinson issued an. initial decision, concluding that the follow-
ing pesticides containing mercury should be cancelled because they create
an unreasonable adverse effect on the environment:
.Y- (1) all uses in paints and coatings, except as an in-can preservative
•''••':'•> in water-based paints and coatings and as a fungicide in water-
based p-ainta and coatings used for exterior applications;
• -(2) all uses as a fungicide on golf courses, .except as used.on;greens,
tees, and aprons for the control of fungi of the snow mold 'complex;
all uses for seed treatment; ;
(4) as a treatment for control of the Dutch elm disease; and
(5) all uses for any material that could be used in wearing apparel
jnd other uses for textiles and fabrics, except as a fungicide in
the.- treatment of textiles and fabrics for out-of-door use. :
On February 17, 1976, the Administrator issued his decision and order
in the consolidated mercury hearings (In re Chapman Chemical Company
et al., FIFRA Docket No. 246, et al. ). The Administrator found "thai: me
benefit's from the continued use 01 mercurial pesticides for use as bacteri-
cides or fungicides "(1) in paints and coatings, (2) on turf, including golf
course greens and all other areas of golf courses, (3) for seed treatment,
and (4) for any other use not specifically identified and permitted" by the
decision did not sufficiently outweigh the risks to man and the environment
and were, therefore, cancelled. The decision and order cancelled the
registrations for all remaining mercurial products, except for use
.(1) as fungicides in the treatment of textiles and fabrics intended
for continuous outdoor use;
(2) to. control brov.ii mold on freshly sawn lumber; and
(3) as a treatment for the control of Dutch elm disease.
/
As to ths 5xi£ tins' stocks iss^s, rh-:- Airr-inistrw-Tor provided that th?
sale and use cf cancelled mercury products which were formulated
on or before February 17, 1576, \Wre pen-ait ted.
Several mercury registrants sought review in the United States
Federal Court of the Aci rain is* rate? r'c -tar. collation of the seed treatrr.ent
and the :ur: fungicide u.cos 01 ;ho:r prouuc:s. On Marc:'. 2, 1976, the
Administrator ordered thai t:."/ c;!:':-rtv"v:O£:s of th:? F?bru?.rv 17t!:
Creiceliation Orcier hi.- v»-v:ipor?ri'.y -r.::y.; ,: .v-tT.iinij judicial rc\ic:v,- fn
several UniLi-a .SiotoK Courts oi A;.:o<.--.:iL-. :.'.':•• order applied to c\l
existing mcrr.urial rc^/stration.s i-.'Kl tjj;e ;-:'.:'y -vVii.s to continu.'.* through
-------
-3-
June 30, 1970, or Ihe conclusion of judicial review proceedings, which
over occu/n -j i'iu;'. A:i iinporltsi:- feature of the March 2nd Order was
that it prohibited the parties to the cancellation proceeding from increas-
ing production of subject products or from stockpiling.
j
On March 2G, 197G, the Administrator granted registrants' petition
for rcconrudcrai;:--- of -• •-. c!ec.icir;n and ordr-r to cancel the registrations
of rn^rcur:'-.! v.:-stic:itie:.-! for use in water-based paints and coatings.
»
The Administrator modified the February 17 cancellation order on
-May 27, l&YG, ..to reinstate the registrations for certain mercurial water-
based paints and coatings; and, he erf ended the stay of the effective
date of the cancellation until November 30, 1976 (or until the conclusion
of judicial review; if earlier).
On August 19, 1976, the Administrator approved a settlement in
In re Chapman Chemical Company, et al. between respondent-EPA
and registrant-appellants Parsons Chemical Works, Inc.; Troy
Chemical Corporation; Gustafson, Inc. ; Mallinckrodt, Inc.; W. A. Cleary
Corporation; and O. M. Scott &. Sons Company concerning certain contested.
uses awaiting review in the Eighth Circuit, U. S. Court of Appeals, as the
result of an appeal filed following the February 17 cancellation order. In
brief, the settlement will terminate the mercury case contingent upon the
completion of necessary regulatory activities .by the Registration Division,
Office of Pesticide Programs, according to the following terms:
(1) Registrations for mercurial seed disinfectants and for
•mercurial turf fungicides for use against summer turf
diseases will be finally cancelled on or before August
31, 1978. Production of these products in the interim
is limited to prevent stockpiling; total permitted pro-
duction will not exceed the equivalent of two years of
production, as determined by production data for recent
years. These uses involve 2"o,' 000-25, 000 pounds of
production of technical mercury annually.
(2) The cancellation of registrations foi' mercurial fungicides
for use against v.-inter turf diseases (10, 000-15, COO pounds
production of teclmica: mercury aivr.Vt-oily) is vacated. Use
of these prc'-iucts vi:hirL-5 •feet of v.-^rsr bodies wh^re -ish
are taken for human consumption is prohibited. The pro-
ducts mny be applied only by or r'iu:cier the direcc supervi-
sion of" golf course superintendents. The registrants will
request that these products be classified as restricted use
pcstici.ies.
(3) Mercury product.? pred-.-cod r>o"o*-e *.'.:«- effective d:\tc os fin.?.!.
' ca.McoJ].';iicu (Ai.;yji!f.t j.j, ii'.-T..' ..>.• \'^-.- -r.cic on which maximum
aliou'ct! iji;;:i!ii!..:i:y is roi'.o.'i-.ru) v/i'i :.- .-c:no ':cxit;i;iny j:ioc!;s, "
tiic oCilo, distribution, auu i;:'e ;•.!' ,v;\.;i.ii v/ill be pci-miLtod.
-------
-4-
The Administrator has concluded that the terms and conditions of settle-
ment agreed to by the parties to the cancellation proceeding satisfy
appplicable statutory standards under F1FRA and that the scltlcmen' is
in the public interest. See attached "Chapman Chemical Cornpnny. rl
al., Consolidated Mercury Cancellation Hearing, Settlement and Ordc-.
(41 Fed. Reg. 36068, August 26, 1076} [hereinafter, SettlcznenJ. and
Order]." -
Until such time as RD/OPP notifies the registrants of cancelled
mercurial pesticide registrations of the status of these,products under
FIFRA S3, PTSISD cannot be confident in the accuracy of any .list of
continued mercury registrations that this office might construct. At
this juncture, it appears that all uses of mercury were cancelled on
August 31, 1976, except as follows: . " ' '
(a) for seed treatment (cancellation stayed by August 19
.. . Settlement and Order),
(b) for control of summer turf disease (cancellation stayed
by August 19 Settlement <*nd Order),
(c) in the treatment of textiles and fabrics intended for
continuous outdoor use,
(d) as a treatment for control of-the Dutch Elm disease,
(e) as an in-can preservative in water-based paints and
coatings, . " '
(f) as a fungicide in water-based paints and coatings used
for exterior application,
(g) as a fungicide for use against winter turf diseases, and
(b) to control brown mold on freshly sawn lumber.
ii. ENFORCK^HLMT STRATEGY. / •
• A. ENFORCEMENT OF ThZ STAY ORDER -- STATUS.
clcncy of the ^i-.y. AiTooteJ rv;Ti3i!:.: {:!,' HI. "l7, and V) were rvJqusWo;!
to initiate scciiou u iiook? :md rccoi-'Js inyp'-'Clioiis ;il all produci1'- c.::."h-
liGljinonts, lv/on!y in r.ll, to dOinnn;.nc lii.c I-.'.-voi of oonij>]!.r.:;«jo '.VKI'I i!>-.-
Admiirislrn.ior'ii of-cici-. Yotu- cooi5Oi-;;{io:i if: ensuring tJjat ll-.o <."r>:;:.;
-------
-5-
of the A..iinini.Ur;uor!s orders—particularly, the "average monthly amount"
rertrirtio"!" ••'.-.-, .•:•'.• (.-o;,i.-.0f xl v/ith by affected registrants is appreciated.
The fui\i;-_-r nui.d to inonKor and to advise the Administrator as to the level
of compliance by the registrants with the conditions of the stay order has
been mooted by the issuance of his most recent order announcing the con-
clusion of the mercury proceedings.
B. TIi.Ti?v!S OF 'JU.JG ".-ij^TTLEP.lSNT AND ORDER. "
*• jRg/Ti.3tr?:-tio;-i Sfr.tv.s of Mercury Products. The Administrator's
August 31, i'J i'G, "bcrtTemcTnt and Grdc/r provider ihe following:
(a) the cancellation order provision cancelling the
registrations of the following mercurial seed
treatment products is stayed until August 31,
•" " 1978, or until the registrant has produced the • •
. ' maximum allov/ed quantity of the product under
... . . the conditions of the particular settlement agree-
ment, whichever occurs first:
(i) Parsons Chemical Works (1969-MI-01) —
1969-57 PARSONS SLURRY CONCENTRATE "60"
1969-53 PARSONS LIQUID SEED SAVER
1969-91 PARSONS SEED.SAVER DUST
(ii) Gustafson, Inc. (2079-NJ-01; 3S209-NJ-01) — .
•7501-2 MIST-O-MA.TIC LIQUID SEED-DISINFECTANT
7501-5 MIST-O-MATTC DRILL BOX TREATMENT
(iii) Troy Chemical Corporation (53S3-NJ-01) —
605-37 GALLOTOX LIQUID SEED DISINFECTANT
(b) the canceLlotion order provision cancelling the registrations
of the follcv/ir.g mercurial fungicide products for use against
summer turf diseases, is stayed until August 31, 1978, or
until the registrant h&s produced the maximum allowed
• quantity of the product under coaciiticns of tiie particular
settlement agrcerri-j.nc, whichever occurs first I,-':
T/ As par: of the settlement sgrccme-nt, O. M. Scott, and W. A. Cleary
have agvred ~c a~~iy :o :he .^•••g:~:.-u:v.:n DiT.-is:cn, Office of Pesticides Pro-
grams on or before September I, 1976, to arriond tho re-gisti*:'t:onj ">f s\:;v'«...-.:
p:'^-.::.;0.::i to v^:. .L'ili:; .v.-.K-.rmo *•.i;t.-j;:- v;...:::^: loc (J) products J'cr i:^>- r.;.;-::-riSt
runinx'r turf '!:.--;ai-os :i?".i (ii) p'.-oi:!1.:-^:;; f-.^'1 uro ru":;i:ist \viufor ti:rf u::;La;';c-;.
You \vJll be no!.•'.;';cu and ;-jnnpried \viih tho ncccjjiirti'y inforniau'on as i;.;^:i ;.ps
PTSED is appri.-.od of the completion of thic nct^on by RD/OTI'.
-------
- c -
(i) O. M. Scott & Sons Company (533-OI-I-01) —
538-27 PRO- TURF BROAD SPECTRUM FUNGICIDE
538-36 PRO- TURF FERTILIZER PLUS FUNGICIDE
533-56 CALIFORNIA FERTILIZER PLUS FUNGICIDE
(ii) W. A. deary Corporation (1001-NJ-01) —
1001-4
PMAS CRABGRASS KILLER AND FUNGICIDE
(c) the cancellation order provision cancelling the registrations
of the following Mallinckrodt, Inc. (372-PA-01; 372-NJ-01)
•mercurial filicide -products for use -against v.inter turf dis-
eases £/ is vacated in accordance with the terms of the
settlement agreement and production, sale, and distribution
. may resume unimpeded _3_/: . .
372-5
372-33
CALO-CLOR
CALO-GRAN
(d) the order of March 2, 1976, staying the cancellation
order of February 17, 1976, is dissolved effective
August 31, 1976. ' .
2. Enforcement Responsibilities Under Settlement and Order. Pur-
su="->t to the terms 01 tne semc-meni agreerhc-nts, rc-gistrant-upp^iiauts must
f? certain substantive requirements to be afforded a stay of the effective
dc., of the cancellation of the seed treatment ana summer turf disease pro-
duct registrations. The conditions impacting on the Office of Enforcement
include:
• (a) During the pendency of the stay, the registrants must limit
production of the subject mercurials for use against summer
turf disease to the amount determined by multiplying the
average monthly production rate during the base period (in
most cases, April 1, 1572 to September 1, 1976) times the
number of mouths the cancellation i? stayed (24). If this
total production fieri;re is reached prior to August 31, 1973,
the subject product's registration become immediately
X
<[/rrv.'1_-::er ;ur: :.:±,-:.z ,1 7_.-.3;=: :: Jusarlun: .-:ivale \p_r.k snow mole,
pink p~.tcb, or fusariuni pate:-.), Typliulr. uicarna, Typliula igl'fkr.riensis, s.nd
_. As part of the settlement, agreement, M.illinckrodt has agreed to
amend the subject n--:di!o:s: :.^^':~: -.-• include :;:..- ?2u::cn "Do noc apply
.vithin tv/enry-i'ive (25) fcot o: any body ot water \vhcre fisii are taken for
Jnly by or »:;ic!or tJcO '.!ii'c.'ct S'.tpc-rvi^-.' .•:. ' :"..-ii' L\>U!T,-C yuperinfetKior.ts. "
Hics;^ lobe; a«Jclitio:i3 \vill zl.i-o bo ::i:;d^ '.-.< i:u.- O. Ai. Scott a:id \V. A. Clcary
)rb> 3 for use against, whiter turf disc:;sos (see footnotc_l_/, £11!
- — ^
-------
-7-
.'.•• cu.-torncrs likely to purchase the
svbjcx-i j); i;;-j-r:i5. As of now, these- data have not
beeii fully .submitted. PTSED is corresponding v/ith
the subject rerlotrants, noting their 'delinquency and
the necessity for delivery of the required information.
(c) Beginning on September 30, 1975, fee registrants must
submit quarterly production reports on subject regis-
. . tered products to PTSED (plus other reports and/or
additional information necessary to effecutate the
intended purpose of the agreement). As of now, these
data are also incomplete.
C. ENFORCEMENT ACTIVITIES. ' .' ;
The Agency's enforcement strategy concerning mercurial pesticide
products will.have tv/o general, areas of emphasis: (1)..the .monitoring of
the production limitation provisions of the settlement agreements for
compliance by all affected registrants, and (2) the exercise of standard
enforcement actions against persons v/ho are discovered violating the
terms of the mercury cancellation order.
*• • Monitoring. The monitoring of settlement agreement com-
pliance will be "me joint enterprise of regional personnel with pesticide
enforcement responsibilities and the Pesticide and Toxic Substances
Enforcement Division. Initially, PTSED will review data submitted by
the mercury registrants subject to the Settlement and Order, and will
independently calculate and corroborate the figures submitted by subject
companies ?.s the "maximum allov/ed quantity11 for each product to the
final August 31, 1078 cancellation deadline. The official figures will be
transmitted to the regions who will then be able to determine whether
and \vhen inspection of mercury producing establishments is v/arrantcd
'under the pariicvlc.r circumstances of c^ch cu.se. D-vviations from the
AcuTiinisirator:s Settlerr.en: anc Crier v.-iil be dealt with as approf-ric.ee.
2. J;M''oycc-ryrr^ actions.^ As soon as PTSrJD is provided viih ar,
official list of those mercury products cancelled and those mercury ro-is
tralions surviving the cancellation proceedings, you will be so advised.
Additionally, ^.s scon zs -.hors i.-; i .chzn-e in :he rogistration status ot'
_those products -.v::osc ei'fective cr.tcs of cancellation have been stayed by
'the ScttlciT-^nt and O:-dor, reri^-v; u-;.;: :.... notified. Violations of the
car.cc.-llcvf.ion o-,-<'.":r "-i]I ro hanri'lod a~: vo; !i;;o on'c.-r-cement mciitcr-. .\i:
the /uimi;u:j!..--::':r.r h::.;'; ]!:-o\'idc>(i for i.'u"1. ">.••"' of '..-:-;i=.tinr? stocks of pro-nets
subject to the August ID order, there v/i.ll bo no recaU program i nit b. fed.
-------
-8r
III. INQUIRIES.
Inquires concerning any facet of the mercury cancellation proceedings
and the Agency's enforcement strategy should be referred to the appropriate
regional coordinator.
-------
O.H. Sect* & Sons Company
ATTTi: Gary ii. Clc.ri:
: Marysvllle, OH 43C40 ' ' : ' '
• » - - .....
Gentlemen: • •" *
: Subject: PROTURF BROOD SPECTRE* FUNGICIDE . ' . :
\ (For Use on Winter Turf Diseases)
} EPA Reg. No. 333-27 " '
•I Letter of Hoveaber 12; 1976
* * ^
The labeling referred to above; 'sufcr.itted in connection with registration
under the Federal Insecticide, Fungicide, and Rodanticide Act, as amended,
is acceptable, and a starcped copy is er.closed for your records.
Oohn H. Lee . ' " * •
Product Manager (2.2.)
Fungicide Herbicide. Branch . *
Registration Division ' '
^ % . . . « .
Enclosure * ;
HH-567:FKB:JHLee:nlo:acs:63S-6767":ll/29/76
-------
SGOTTS
TMO LAWN PEO.-UC Q f
MorysviHe, Ohio >:3040
(513) 042-801 '5
November 12, 1976
EPA Registration Division (WH-567)
Office of Pesticide Programs
Environmental Protection Agency
Washington, D.C. 20460
.Attn: Mr. John Lee, PM-22
Subject: ProTurf Broad Spectrum Fungicide
EPA Keg. No. 538-27 :
Resubnission
Gentlenen:
t
Enclosed are fivercopies of finished labeling for subject
product including the following revisions:
' ' 1) "EPA Est. 538-OH-l" has been added to the
front panel below the ingredient statement.
2) "EPA Rag. No. 538-27-AA" has been changed to
."EPA Reg. No. 538-27".
If you have sny questions concerning this matter, please
give me a call at 513/644-0011, extension 2104.
Respectfully yours,
N./Cl/rk
Federal, Regulatory Specialist ,' ;','
I
ca
enc.
r c t «
• t
-------
/
FH
®
«.,-•% u
NET IVfUG'nV 26 IBS m* KSI
p-"^ \ . __
-'f '
r
n
: . , ,-
vji'u^iiH in!!«;
i-jj^vH/i
^3. n B n
r 'hn n r^ f^ n /';.:\ n r^-. \ ,<
•- n 1I; ; ; ;'7 • 1 •..•• ^ ' ii;' ,•
FOR USE ON
WINTER TURF DISEASES
«ffijy, fffimf^gy^^^y
FOR PROFESSIONAL USE ONLY
DEO i -,Q7P
... a i \;...i-M-:> •'• A-'-
;'o;/'f
Hjfr:^.:;1'.^':^?-) i.;.t< •;••::;-£•; c:^:j;t»'.?i:..n ;: g?:v; ^nts «•,•< i.^r.^^clio
;s:!'C". »'.tt<5ii.'i t' fvsm.M1. ^ .;?; ~rt.;;i ?;:cr,-:r 3rc-r"y. A':rr LJ;.-.-. •« j?n zil
eip::r-J ;i i; jij.'ii-i.'^'j-j^^-.Ciii''
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.;>.- ';
w .... ,
[•• >u fv.:/'r' :':'*j'-iTi"'
[.rv ^~:^b-'LJ
. . .
!(.-i i! nT£
Scotts (Drop Typ°) 3 mph" overlap wheels 7 S'/>
Candy 8 ft A Series Medal 4.5 mph overlap wheels 26 36
42 In Model : 2.5 mph overlcp v/heels 37 46
•FOR USE ON GREENS. TEES, AND APRONS
Use before riissasa appears cr when symptoms ars first
noticed. Revest as r.oc&s*2ry. To arrc-.n severe infsction
L-iadoubJo rale.
Foliage may be- e-ilher moisi or dry when making
application. On golf greens, rinse surface lightly after
cpplicatlor? tc cvcitl pickup en shoes, so'f bails'or main-
Ur.arc'-ecq^'.-.v.iri:
PfcTurf Division, C .M Scoti £, Sons MarysviJ'e, Ohio 43040
-------
—,
I
• •>
O.H. Srr.'.t
.'•:•".' *
ATTM: -L-.ry M; Clc-i-k
»<
- - .*-. - • . /
* Vi . ' -
* t . •• •• ~ -.•--..•••••-. •••*'.-. ••'._•.* n ,.-« -r j
Ma t*^/ *• *•' I •'* * t'V! /V*,''"'/"1"' " • '" • • v *^ "*-1* *- *• ' * A ** * *•'*.••- • ' - •.'••.*.* •-* t ••""*'.* t
I • ^~-i^,^' IW '^i^:^:^/^^^.:44^*':"11--;.^;^ ..r,-.'^.<--5
Gentlemen:1" . *'.?.f^^'**-*'if:;?\ ^^>4":':*:" ^••:^H---^-'r^
^ ^ --
The labsling referred to above; .Submitted 1n connection with registration
under the Federal Insecticids, Fungicide, end-Rodenticide Act, as'amended,
is acceptable, ana 2.-stamped copy is enclosed for your records. . ;
John H. Las
1 Product Manager (22)'
' Fungicide Herbicide Branch
Registration Division
Enclosure -: T™-.™.-:
WH-567:FHB:JHLee:nlo:acs:635-6767:11/29/76
-------
THE LAWN PtiOPLE fj * 1 O--.« 0 ^n-
U lil ULVU U L-'U/.'
Marysville. Ohio 43040
(513)642-6015
November 12, 1976
EPA Registration Division (WH-567)
Office of Pesticide Programs
Environmental Protection Agency
Washington, D.C. 20460
Attn: Mr. John Lee, PM-22
Subject: ProTurf California Fertilizer Plus Fungicide
EPA Reg. No. 533-56
Resubmission
Gentlecen:
Enclosed are five copies of finished labeling for subject
product including the following revisions:
1) "EPA Est. 538-OH-l" has been added to the front
panel below the ingredient statement.
2) "EPA Reg. No. 538-56-AA" has been changed to
"EPA Reg. No."' 538-56".
If you have any questions concerning this matter, please
give me a call at 513/644-0011, extension 2104.
Respectfully yours,
Federal K«isul-aCcir7 Specialist ,. ,
// C t «. . ,. i
/
ca _ ... . __. -'-- --- - — r-cfc,
enc. " re I
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**:••
"
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-------
/'
1 tOi-3
NET WEIGHT 45 IBS. (20/» Kg)
-
CO
ir » > •! .P*
, _.
r r
vXra «..-•*«•
r» nric
H rf^-j-V'ri'ijVrKn^l ii-'^'i"!! !>•"'! '/^M"
VsyC-i.a/-4« ^>>tj U JjJ;v>.'J Ltt-^ii Vji»i:.it;»'»i?i3
<^ a c r
ll it'/J J _i^ .-.A J ^i/ U Cfci VS#
FOR USE ON WINTER TURF DISEASES
LlJ
£-0
tii
C )
:»!
o
/
re:
(Ive i.?!)
for hun.
X t'.» «-, «»vr.f\ /^••»<*>"«'i.-"e ».«!•
lf«'*"^»*.!- • •^^.•••^/••w-i-j.**;*!
t -»*.'f"T |
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*•'.';:-•. •'. <%••-.•.'••••";•••!•*. "•"':••.'.•?.
DIRECTIONS FOR USE
This product shall be used only by or under the direct supervision of golf
course superintendents.
for use on winter turf diseases
Fertilizes turfgrasses. Controls fungus activity causing pink snowmold
(Fusarium nivale) and gray snowmold (Tvphula spp)
SUGGESTED SPREADER SETTINGS
/„.
to provide proper distribution calibrate spreader before application.
45 LBS (20.4 Kg) TREATS 11,000 SQ FT (% ACRE/1022 SQ M) AT NORMAL RATE
45 LBS (20.4 Kg) TREATS 5.500 SQ FT (1/8 ACRE/511 SQ M) AT DOUBLE RATE
GROUND OR WIDTH OF
SPREADER PTO SPEED COVERAGE
SPREADER SETTING "
NORMAL RATE DOUBLE RATE I
Scotts (Drop Type) 3 mph
Scotts Rotary 3 mph
Lely-WTR &
WFR Models 4.5 mph
Lely-HR 450 rpm
{PTO Model) @ 4.5 mph
Gandy 8 ft
A Series IVodel 4.5 mph
overlap wheels
8 feet
16 feet
16 feet
overlap wheels
67*
1
5111
5111
20
N
6% III
6% II!
27
FOR USEOiS! GREENS.TEES, AND APRONS
Apply to moist or dry grass-
To control snowmoki — apply DOUBLE RATE in fall, laia winter and
early spring.
ProTurf Division. 0 M Scott & Sons. Marysville. Ohio 43040
• 1 • »
> •
* ft
-------
J
NET WEIGHT 45 LBS. {20.4 Kg)"
___-., J. . . ,. ... .... ... ^ . p-
'"."''• i - • •'" ." ' '
•"s" .'..i J " .-"""T^- ""•—• --C •-..
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^™* ; , i ' x* • • ~ -*
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kvj
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f T ^^ ^irt " **• * ^?^^ ^'^T^*^ *'* ^^^\ ^ ^ *^— V .** - ^ ' J ^ • f'T Cf^T ,^^^ ^ ^
'•',..:• •.:•;,••!; i i ; : • . .- . f • i ••.» .4 i > : ^ , • !. /v i '5. . f
Vii' 'C-'j J ii U ^.i' '.; li l: i. -.c-.i U V.i7 J vi J -. J J <~a '. i"; ' 5/1 Hri **i i :i'"^2
f 'W fci V.'Jti^&' S« V^tJ •] il ".r*"> ia ^^? tl V-/ i **&
U Vj»*
FOR USE OK SUiYir/iER TURF DISEASES
:•*»;' • "
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1 • K-J
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i >.- ^*
i ^5
i fc
i f*'
i «••
i t'».
1 ?5"
J CVk.« •
1 ^*^^
tn
0
1976
:.cr>r-;.-;i.^ Ac!,
ric.i ••t»emcr»!i;«cf e^i1'-:"
r^ •.,•*!",t...-v?f«rvi.iia. wx
* P t ..
li 0 >•''«' *•«, 4 i'^J J**« 10-*fc *.•''* - 0>'r /C*/
r-hrr^«;.s,w
?«* I
tr* I
ltU»<.CJ.
-------
,-. i
2 ^i **-
/c-O-
<•*!••• • t » * V I
U-r'-vrna TQ!'fi>l~'£>" ''';
;iluMi»d Icl Like; ^.
DIRECTIONS FOR USE
for use on siimsc.er turf diseases
Fertilizes turfgrss^s. Co;urn!s /unf,us sctivir/ Criusinn brov/npatcli. leafspot,
dollarspoi, re J llirt-iid aiv.i copper spot. Alio controls moss.
SUGGESTED SPREADER SETTINGS
*
To provide proper distribution calibrate spreader before application.
45 L5S (20.4 Kg) TREATS 11,000 SQ FT {'/, ACRE/1022 SO M) AT NORMAL RATE
45 LBS (20.4 Kg) TREATS 5.500 SQ FT (1/G ACRE/511 SO IW) AT DOUSLS: RATE
GROUND OR WIDTH OF SPREADER SETTING
SPHEADEH PTO SPEED COVF.RAGE NOHMAL RATE DOUBLE RATE
Scbtts (Drop Type) 3 mph overlap \vhsals
Scons Rotary 3 mph . 8 feet
Lely-WTR &
VVFR Models 4.5 mph 16 test
Lely-HR 450 rpm 1C feet
(?TO Mode!) @ 4.5 mph
Gandy 8 ft
A Series IVode! 4.5 mph overlap wheels
511!
511!
20
N
6^ II!
6/ill I
27
I > > •
Apply to moist or dry fjrass. On o'ichccdra apply to art leavgs and
then ?prini'.!= lightly to \vjsh off partic'es.
On put-.irg c'-t"?".s -• :r.r/ I'-'; t;ieJ svc,-/ rrion'.:- it NORMAL RATE
durinr; g.-c-.v-'a ;<^.t^ ;r. r::vjntion or con:ro!. Interim protection
can bo scin-jvcd with ProTi!rf Droad S;)j;ciri>rn Fungicide. Minis svirfacs
lightly after application to ovoid pickup on sf-.ocs, golf balls or maintenance
equipment.
For a![ cthor ,•»•••.'•.» — •t'-.s b-^fcra fun^o: djrn::i-9 appears or when syr.iptom
are first notice-id, f'/i.ny ho rcpsr.tsd evory oth°r month at NORMAL RATE.
!f dise3£:! is s?v?r-; r,r •.-.;.-. :.. ..,..;: ;:• i.-vjioacx.-:; Apply ?.i Ou(:3L£ RATE.
To control mns; — apply any;:mo .-•; r.'OnMAL RATE to me.rst faliace.
Follow up at two week intervals vvirh PruTurf Bio.id S;;t'Ctrum Fungicide
as ne?c!rd.
-------
i ^..v..;,::;!
! .-
_../ *
-h r
i I 1 '
-l
n
.
n
fi
FOR USE CN
SUMMER TUrt? DISEASES
Ore ?
«. 006
1 1978
.-» . .....
WJ.TT'J! i' r-j'lr.-.r/ *.'M s•:.'• s'<-.i cr r•:•'.-.: >.v> n-?v 1.1 cjw of in.
in:.o.i. -,».•»;s:.'..- .^ *y*"n:j:,-j- f ?• ^-;.;ii ;;;.,ivjn C's.-rr::y. A".j< 'j<-.-.s. «.n.'i t'.l
wpr.;i''. .ifJii::;:Cii-il). Cl
-------
* *
• i »
.-; r-s /«•, e* :'r, r* **\ (?\ fc*;? r<* r q r**?*. >, .••." :•; • ^ £=•?:; /rj a .**••
i'fM-V^lM iT^'SSi'i'i ri L'i! -r1 I? .•t«;jyvJ^*-!! .M
>U \«#UiW ^.^xs^'Jvu.1 k'jwiiB U biiUu>.U . *
k t
• ' I > •
Prevent* or arrertt fur.gu* activity causing disease such as brownpatch. leaf-
spot, dollarspot. red thread and copfwrspot. Also controls most.
SUGGESTED SPREADER SETTINGS
to provide proper distribution calibrate spreader before application.
25 UBS (11.8 Kq) TRrATS 11,C005Q FT (/i ACRE/1022 SO M) AT NORMAL KATE
26 LBS (11.8 Kg) TREATS 5.500 SO FT (1/3 ACRE/511 SO M) AT OOUSLC RATE
CROU.VJ SrtiD COVERA55
SPREADER SlTTI-Jf!
KOSV4L BOU31.S
RAVE RATc
Scotts (Drop Type) 3 mph overlap wheels 7 9Vj
Gahdy 8 ft A Series Model 4.5 mph overlap wheels 25 35
42 In Model 2.5 mph overlap whocli 37 46
FOR USE ON TURFGRASSES OR DICHONDRA
Use before disease appaars or when si'mptorr.s are first
notlcsd. Repent S3 necessary. To arrest sevare infection
usa double rate.
Foliage may ba either moist or dry when making applica-
tion (except !"3ss control requiros spplicaticn to moist
foliage only). On 22!? [ircans, rinse surface iightiy aftsr
applicsticr: to c;voi.1 picl'.up en slices, gc!f bsiis or iTisin-
ProTurf Divif ion, 0 M S=ctt &. Sens Marysvillo, Ohio 43040
-------
0.15. Scott " inns Ccnpany
AlTri: Gary". Cfltrk
MarysvUle, CH 43G40
Gentlemen:
Subject: PROTURF FERTILIZER plus FUNSICIDE
(For lisa on Winter Turf Diseases)
EPA Reg. Ho. 53S-36 ' '
Letter of Koveitiber 12,* 1976 ' ' '
. N - . • ' . • •' . .
Tha labeling raferred to above"; submitted in connection with registration
ur.dsr tha Federal Insecticide, Fungicide, and Rodenticida Act, as asianded,
is acceptable, and a stsnipsd copy is enclosed for your records.
John H. Lee ' .
Product .Manager (22) " " "
Fungicide Herbicide Branch
Registration Division * '" '
» • * • ,
Enclosure « "
r> ........
WH-567:FH8:JHLee:nlo:acs:628-6767:11/29/76
-------
.
LAWN PEC PUS
M f
Mar/svills. Ohio 43040
(5] 3} 642-6 01 5
Novenfaer 12, 1976
EPA Resistratiou Division 07H-567)
Office of Pe3ticide Programs
Environcental Protection Agency
^Washington, D. C. .20460
Attn: Mr. John Lee, K-t-22
Subject: ProTurf Fertilizer Plus Fungicide
EPA Reg. No. 538-36
Resubtnissioa
Gcntleucn:
Enclosed are five copies of finished labeling for subject
product, including the following revision:
"EPA Reg. No. 538-36-AA" has been changed
to "EPA Reg. No. 538-36".
If you have any questions concerning'this catter, please give
oe a call at 513/644-0011, extension 2104.
Respectfully -yours,
• <<<•*•
c- » •
Federal /legulatory Specialist1
ca - » •
•. • • • *
er.c. •
-------
" f~
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' O' • • •>'.,••..-• V
i< ^•^r-\:Tiri.^ \\
\\ /;.o (/..-!;.//'{ L /j .-/>• ;•
u-: 1 197B
^ /H
n n
[I [ih; j"; ;-^X:! 17 • ^ i'' =
FOR USE ON V.'JNTER TURP DtSEASSS
PC?? PRO?E3SSO?tf.L USE ONLY
''" NET WEIGHT 45'/= IBS (21.1 Kg)
?•* 5 3
• •- * — «• c •• • •—
. :-. ,. .^VW.^-^/-
c «
< * r f t *
-------
r
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DIRECTIONS FOR USE
Thij product j!>»!l lit used only by or uncter the direct yjparvijiorvof golf
course «:|icrir.WrK!«ftK.
tor use on v.-inter turf diwase.
fmffifi". tuKrcsrv:?. Controls funr,"? sctivirt' cil'j'.ir.'j p:nk snowmold
(i~m.iri»m r.iv'iei ami jrcy sriownu'ld (Tynh'itj ;p;;)
SUGGESTED SPF'.CADER SETTINGS
to provide proper distribution calibrate spreader before application.
Stt LBS (21.1 KQ) TREATS 22.000 SO FT (V> ACRE/20-14 SQ M) AT NORMAL RATE
VA LBS (21.1 Kg) TREATS 11,00020 FT ('« ACRc/1022 SQ M) AT DOUBLE RATE
4G'/t LBS (21.1 Kg) TREATS 44,000 SQ FT (1 ACRS/^C88 SQ Ml AT HALF RATE
CRO'.l'OOif *i0T*«Or
03.TVJ K.'l/
Scons (Oru3 T»0«l
Scorts Pniary
i!» ovefijowhe«H 41.'. 6 3V»
Sfeet D G 8
6
G
«.Sin;h IStecl 2V,rr 3Vitt IVtK
Lcly-MR 450.-en 16!cot 2'.iiz 3'.tt I'/.c
(PTO Mutfell (ji.5 mrrt
Ginrty 2n ASe.-ics 4.^rjh overlap wliteis 13'.'i l7Vi lO'.'i
MgdrU2'ir.cJcl 2.5 rr.n!i oisrljp *!iccls 2* 30 19
FOR USE OfJ GREENS, TEES. ANO APRONS
Apply lu moisi or dry grass.
To tontrol snowmold-apply DOUBLE RATE in fall (heforc
first snow), late winter and early spring.
ProTurf Division,OM Scott & Sons. Marysvills.Ohio 43040
-------
\A /GJ.V
' M ! ! ! '': .'
• • I '^' I '. i
c.
r^cnn
h hJ !M; I/ .r,s; !vl.r[ I^jj
FOR USE ON SUT.'.VcS TURF OS5GASES
f^^rarr-.--=:i.**-?^.-e-*^^nv^: :.'/*t; •: •.- ' '• . '."cicj— WT :»::.'•?!- ;•*:
US"-;'! •••:. M> :... ;;•"!/»: wt.--fi:?
P'Sf-.-fP »'-.-. 0 U ?.-;- I J,,-,
5%
< • •
i • ••
« • •
i • •
-------
.'•?.''>,'/.•*
I •* -r'" I1"1 -," • ' ' ' •
<»••»«'*;•!»:;<••!•
«•/•"• •'" r>j oi i;-<>t. A!«: control: rnoa.
SUGGESTED sraEADcR SETTINGS
To provide proper distribution calibrata spreader before application.
LBS (21.1 KS) TRSATS 22.000 SQ FT ('4 ACRE/2014 SQ M) AT NORMAL RATE
46'-i LDS (21.1 Kg) TREATS 11,000 SQ FT (% ACRE/1022 SQ M) AT DOUHLE RATE
46V4 LBS (21.1 Kg) TREATS 'W.C'JO SO FT (1 ACRE/--.OS3 SQ M) AT HAUF RATE
WiTTMOl
tz:;?:-j.
s?.-i«ocs irrnvi
Ov«fl5pwh«!«lS A'.'i
3 RI;.I 3 fcut 0
G
G
3'A
e
VVrP M
Ulj-KP 4SCr;.-n 15fist 2'/iC: 3YiXT I'.'tiz
(PTO MuCtf) «i.S r-.;^
Gjnrtr S h 4 Series < 5 r-;li ov«rli>nnh-c!j 12'.'» t7'/i 10'.'.
MoCcU2 model 2.5 r:sh ove.'l«?ol;««ls 24 30 19
Apply to moist or dry grass.
Putting greens—may ba used every (wo weeks at NORMAL
RATE Curing Crowing season (or prevention or control. In-
terim protection can tJ oc;i:evod witd ProTurf Sroad Spec-
trum Fungicidfc. Syrinci surljcs ligh;iy ofter appli;ation ;o
avoid pickup on shoes, ijoif balls or maintenance equipment.
All other areas—use before fungus dama^a appears or
when symptoms arc first noticed. May be repeated every
month a; NORMAL RATE. I! disease is severe or more
feeding is desired apply ?.t DOUBLE RATE.
To cv.nt;o! moss-zpply anytime at NORMAL RATE to moist
foliage. Follow up at tv/o wo ok intervals cs r.e:ded.
ProTuH Division,O.V. Sccr. SSons. Marysville.Ohio43040
-------
Parsou C
Poet Omci-v
Craud LndgB MlcSzlssa
Attcuiica: J>. /:» S',
ocn
letter o£
srCJ CGECEHTEAES "d
ccoolsted.
Suhait two copies of tiia SLcished Ihbal vfc'iu.rsris'cias ii
l S,
G-. Alftsrd,
Enclcsare-sbaapod label
IS PDSI 9-S5-5 "
10-10-68
-------
V ' ' .i I mi*^*4
\
.'s KOK USK "*'!"
Rrrd *hc.ul.l he clemmd an.I xvcll r>n--'! Ix-lore tn-atin^. f.Ifi
SUMvKY CONCKNTUATI-; "(JO" miir-l I-: d.in:..d \vi;h •.•..-,',T I
lowinj; table shows |>i»|"-r (!i!uUnn for IKC nf SKKU JJAVKIt "<•'
Trcatcr: i
i --H—1
i n"~'
, . I I C; ,
'••'..' !.—.'
[ This V/j/I H/c SsofJ Grwfn
A ^ a nn r i •. '•". 'i .r, ? n? 3 ?-;.si /p.s r s n
---.'i _ . iiijj -A«;-.)V. • :. *{.:.• n.j li W i. -o \i-.,s J ^ a \-^> u
DANGER — '-:t/ our OF REACH OF CHILDREN
Sec dir^.cti" ••-;.' :'JicJ for additional warnings t
1
nti 'o!c sfotcmcnt j:id oihc;- required warning statements on '•
l!;c direction panel r £
ACV!'. E INOVtDIENTS: fHtNYt MLSCUKIC AMMONIUM ACETATE ................ 13.30?'. - J
II.JKT |NC-:::jlENTSi [[[ *.. '86.50% ' |
CONTAINS: METAUIC ^C'CUHY .............. . ..................... 7.0% •
N.
J
KHKI)
'VvinlvF
OATS
s)-;i-:i>
SAVI-:IC "co"
r;.niion
»)=i.- a)
OIK- (!)
\VATI:U
Cnll'ii.
^»
12
St.UIUCY
I'.tiCiXKT
2:i i-.-.
::.i cr.
| SKI-
1 CA'I
1 !•"•
1 20
3,,y
Aililili'iiui! dy<- may l-c t«Mcd if ilr.tii"--! j
U:i:i'. Kll'n'ivr iciilrnl may mi! li.l
nmoiinln MIC usi'il. !
V/An.N!f-!0 . " /--'•-
""*N ANTIIIf)TK — If •.•.vallov.-rd, rrivc nnlU •>; v. I •• •• .••' ,-,-:K |((-al..-.n '•
luhlc!!|>:innfiil rii" snil in n i:l;i:;r. nf wnrni v.!il( !. !•..•'• ;— p'jr.t i:i;lil -..
M Repeat mills or v/hitc i.-f (;KJ; lirnlcu wi'h \v..'. •-. Call a r-I.J-sii:.?
V I
if^^'WnriiiiiK — May Pn>«lm-" JJrlayd Cli<-i"i--;i! liiirnM. Do i.ct I-'
» Thin pvoilnrl .'iliC'lliil IT i-dM.-i'dfivil |iipi:-'iic.ir. i;:;:i !i;:ndlv.l \v'n!
(]unlc ventilation .ror t!ii- (.pt-ralnr. !f -s-iiVd • •'. .•••.in, ini:>i'..l:.T!t'.
V with soap rind water. ;-i.iy lur lal::l il' v.\:ii!i. •. .-,i. !'i,, (,f t col :.
I clolhiiiK- If it ;'"vp?< ai:d ul'i cluiV.i:ro in n
Destroy il I>J' prrfi:rnliiii: or
i!i.si-nnl in
;K TO 1 •UKCIIAXKK — I'ar.inns I'h.-niiral Works Inc. n:\
': warranty, expressed or implied,, roiicciiiin^ tj-.c use of tliis .pro '*
-------
I
rou USB
.r.o.l an.) w.-ll vim I bi fo:v treating;. LIQUID SKKD SAVKR
A TIC "liO" must !.:; diluted with wnlrr before use. The fol-
!>er dilution for i,n. ul .ilCKIJ SAVKR "i!0" in a Slurry Seed
r,o"
nn
fir
I.IIHUY
IK'KI'T
~>:i\:c~. H
2:1 rr.
Si-.ri)
CAT12
P is—
20
UATR I'KIl
IIUSIII'L
« fl. 01.
'/« fl. oz.
(!)
Mll.Ull if lli-MI'i ll.
.1 ilosairi:. Kifci-iivc rmitror innv not In- obtained if lowor
owed. ?;ivo !i\;^v •.:<.• \vliito of ejrtt bealen with wntcr, then n
.1 ;;la.-.s of warm -.vali-:, nnd repeat until vomit fluid is clear.
f eri: be:Uen wild water. Cull a phy.;ician inimediately.
re Delayed Ohci.'.icnl Uurns. On nr.i breathe spray mist.
• ec.rv.iU'ied pais- anus and handled v.ilh cave. Allow ndc-
o i-|.ci-nt.ii-. If s; i'lej m» uf
wheat run nui be cnnlrollcd by liny known chviiiicnl i-rcil li'-iipr.cr.t.
I'AKSONS SKI-:I) SAVF.H SI.UItUY CONCKNTIUTK •'$<>" wl.en properly t'iiiar-.l
will 0 ' aeeordinu to table on "dircrtionu fur use." It i* impoi'lant lluil .'-«\ !•>•
band, allnwint; iwo cups to empty into niticbino b-.fon* 1.1'MII; |'i;iin drop in'-.
trealer. After llow of jrrain has been shut elf (or hutch t'lir. iliron;;li), lot iniii-'ni:i •
operate u few seconds to empty rvmnininp; (train fr-,iii] In-iU'i inl-> \>i>x, lbei> tur;i
motor olF, Always use fresh, clean water, when nialdrig pi»|Mi dilution.
I.AIIKL TltKATKI) SKKUS —•• />/...->-•.>
Treated seeds should be plainly lubclol or '.ac^eil ii'1 fuilr/ws:
NKKCTKD SKED — POISONOUS TO ANIMAL AND MAN.
110 NOT USE FOH FOOD. FKKfJ Oil OIL."
USDA RETG, NO. ISeo-57
1 GALLC
-Lc:^
*•• •
v
-------
Persona Chedccl Works
Attention: Kr. A. R. Fox
Eoct Offics SOS 146
Grand Led-c, !:* saigaa 48837
Gentleman:
Subject: FAESOH5 S/1SD SAVER B.1AND LIQUID READY MIX
USDA Reg. lia. 1969-55
Your letter of Septeabar 4, 1963
The labeling referred ta above, subsdtted in connection tfith
registration under ths Federal Insecticide, Funsictde, end
RcdenticirJe Act is acceptable, end a stamped copy is enclosed
for your records.
It. is assumed thdt the word "Poison" will be printed in red.
Sincerely ycura,
j.u.,,.-' :•'• nix?-J?.
Harold G. Alford
Assistant Director
for Registration
1 Enclosure
j . Stamped Label
•,
i
i .
i
A-A
ARS:P.1:HSH:ibf 79-25-68
-------
^,,^.>«-JlN|*f^^;,ii
•••'$ •' ' T"J'i "V^'Ti ''-' ^ /--:A :A'/ 1 "ii s'-"' -'!i j
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. f 1 /^r^^"^^-^^-^^ 1 •
\ 1 ///I:: 'r.rrr-v //^vMOr.'iA t,
? :i it.-: "n I _ I <:r:r:ci \ i
*• i ? Jr;: v.::--,} p */ «*B C'-V Vo J's^/Vir I r:/:- A1- •*''--,. I f ;
'v^V'r0^.-^ r:p /- v,r OATC: x^VaTwfe^ ? "
^S.. •^i>' ® U i..ii'uj'V V-yi-l » *J) -s^ign^x- WJ j
p' rVl.\.r... .v :;:.'••..,.- -XK, - I*' Vv*' ..•:•-.•.,*.;,.•-, ^
[• WARNING .- ;lilc r.lir.-.vs i>n:pi>i n.y.,..- '
SKH.)
Q o^l^G
(j «: U t!
UJ coBS^r"
1- |§Rp||
>O 'j|;! O'lSo
[.U Wj'i.'H'o0
'*>^ LiJ LJ '** j- (^ U
f/1 f* M o »"? "^
-^* k P c *** '
"** P lM U, 0 t-'
*
A
• [
it
!
:.
WIIKAT
OATS i
UAKLIiY
TI.AX
Sco mnchiu
vnnmi.s -
!;l*t »l W.IM.I
»ll n !'l.>%lri:
\Vnrliinil:
r on tl(il.:iM^.
Sinn- hi ,n
nun* ci»iti«-i:lr
.Ali.M O-Malic
)a fl. OK. per l)ii.
2 'inii.|'i pun liinil.
II l|lllll|l-C |MT llH.
!i ll. *•'•*
piMirnl.s pnii lonii.
'.< ilniiiii.-; pi:r !ni.
f» tr. <".i|> lo (i^;,
liinnnls p.'in Imiil.
!) iliinips per bu.
Ad:iptors or
(,'oMMTsinn Kits
'; n. < z.
per li!i.
Vi H. f r..
l-i-r In.
"i ll. 17.
p<;r hi.
1 '-i ll. )/..
|irl In.
IV. r- i
•';'• ''.'
1
^!
' 1
•••; r j
per |
I'.S 1 '
PIT '
c niiiiunl for rtip xirr mid ;>uhl.in« >pr III tr> ^
V< (.!'•> 'I i- *j
\Vnlrl, II'. -1 II I'IMt until. \*ililil ll-ii.l 1 • '•• ir.
l» ;•• .1! 1
* ".ii. !
Un-.ll II .r-..:,jlilv ulltl I...M ,!...,;.
i
fi«t| nl.iif. Kr«-|i n.Ml'.li.-r .1. .. .1. >-. in.l ,:. 1 in « -. . '
; :
-------
.1 u:id \vi-!l rin-i
ws |sr
'|ifi
:';i,-o tivaliiiL,'.
•.H.oiinl.-.:
Mot to he diluted with
.1.1.
.\d:i;ilni.s T
(°»nt i-r.ti.in .its
•'H il. <•£.
m-r bu.
M II. •:::.
p-.-i V.i.
1 1 -.• :',. i-/.
I ,,,,.
>
:>i II. oz.
per bu.
'•>:, II. OZ.
;•>•!• bu.
•!', II. Oi.
per bu.
.._ ._ -
1 '.i II. i'a.
pi-r bu.
Slurry Machines
'/<_• 11. oz. per bu.
1M c,-. flip In 10.5 poundii
n. .i! 1 pi. per );nl. wuler
Sct-il Calc 15
'.i 11. «''/.. per bu.
L' I fi-. flip lu t>.5 piiuncld
I:N .- 1 Vi pi. per |;al. \valer
^i-nl Hale 1!0
'.-: ll. o-/.. per bu.
1' .' i -.'. flip tu 111 pounds
us.- 1 '.'i pt. per I'.nl. wuter
S>v.l liale IH
1 '.i II. «.z. per bu.
J ! cr. cup tu 'J pounds
u>i- J pi. per >;•»!. water
, S«-,l«»u.|0
and p.<:i lead.
\-t- ,r:ll i:r »!.!!.- .'I i .:il l>. ..!.-u willi u-.il.-i. lh.-:i a l.il,lr\|tiji.iifnl i>f fciilt In u
... i,l II.M.I .. f..,,. li...,.il ,,,,U ,,r wh,.^- ..f i-u^ I.,.,I,,, vv.Il, w.,l.-r.
>!..
i.l.
.11,
•il.-
Il In
. .1 Cliiitiu.il b:,iu. l><* in<: l.fi-alhc ^1'iay uii^l. Do not tot In i-yc>, on shin
.:,.i |,..,..!l..i^.
.l.i:.i,-r ^1. *.:-,!. wo ,,ol ^.-1 i,i i-frs. mi .skin «>r (Itill.in^. \V.t\li lltaroiiulily.
.I<.
I,,
Tlii
,,lii
. ..
ill ,1)L- I..H..K or .miilo |h;i|
nj uKI fliilln.iK.
into
...,i« (!li, ...it .il M'.iLt. Inf. :mit of »ori;huinu, brown lorwu .-mint of barley, uii'l loose kii'.'it of \vlifjt
can iu;t bu controlled by any !aio\vn chemical seed treutnieiit.
PAIl.SONS LIQUID SEED RAVER will dye need red ami compiles with tho VS..td
l.inva" iTgimlinn tlic detection of tiuntcd seed /;ruiiu.
•Tor tmiliiifr seed Kiuin use PARSONS LIQUID SKED SAVtR uccoriliiif to ti.llc
on "rlinxtions for uao." It in iinpurlunt that iniicliine run u few iiunuli.-.i bu/oio trruiinx'.
So; that niarliine ia clean i.iul in ^oud u|iLT:ainj; condiliun l>cforu treutii.rf. Do not lot
sulutiun stand in licater fur extended periods of tinU'.
CAUTION
This product should be considered poisonous nnd bundled with cure. Allow adtqur.ta
ventilation for the operator. If spilled on skin, wasii thoroughly with soup and water.
May be futal if swallowed. Do not reu.sc empty container. I'cstroy it by performing o/
l^ury or discard in a Mife place.
I..VIIi:i. Tlfl::.-VI'KI» SKKIIS
TrcateJ sccdu Khotild be plainly labeled or lucked iui follows:
"DISINFECTED SEED — POISONOUS TO ANIMAL AND MAN.
DO NOT USE FOR FOOD. FEED- OR OIL."
USDA REG. NO. 19G9-5O :
t GALLON
1
Inc.
-------
3 9
Parsons Chcnical V.'crks
Attn: A. R. Fox
P.O. Box KG
Grand Ledge, Michigan 48337 . .
Gentleman: . •
Subject : PARSONS SEED SAVER OUST DRILL BOX SEED TREATMENT
File Symbol 19S9-RR . , .
Your letter of Hay 18, 1970 .
Please refer to the enclosed PR Notice 72-5.
Since the subject product contains rrercu;-y, and .is subject to cancel
lation we cannot process your submission. ' . .
Sincerely,
T. E.
Chief,
Fungicida-Hsrbicide Branch
Enclosure
PR Mot. 72-5
EPA:PR:R5-7-:je 4-74-72
-------
o.1;. lui'Aniiu.MT >_'f / r,t(ic.uL"UJnt
ACKICULIOCAI. fit '.'.'MtCH t'EI'.VICK
l'».*. OAlCOr AI'1'I.K.ATION
Anril 7. 1970
2. NAMU cr rcONOMic coi:,ON /.I/us/ In: tamr pmluci «J"is
on lnl>cl-do not Hit acliv<: in
Seed Saver Dust
Pri11 Rnv Ti
'i/.i.'
ROOENTICIOEQ GERMICIOE-DISINrECTANTd]
4.INAM6 5 MAILIKC AOD.TESi OP FIRM TO WHOM RCCISTF
\{Include Zip Ci'dtl
ICISTRATION IS TO DE ISSUED
PARSON'S rirrMir'T V'^?.!CS, IXC.
P. 0. Bo:; MO
Grand Lecl^c ,. Michigan 48337
6. TYPE OF FORMULATION
V/E1TACLE
CRANUUAHr~!
PReE€URI7ED
EMULSIFIADLE LIOOICQ BAITt 1
5. 15 THE REGISTRANT SHCV/rl IN
ITCH 4 TH& M/iNUFACTUf-.ERT
NO tZU
(If "fi'o ". :ee instruction 5 0:1
OTHER (Specify)
7. TYPE OF CONTAIN KR
CUASSI 1
OTHER (Specify)
8. NET CONTENTS OR CONTAINER SIZES
2-ih. and 6-lh.
t. MANNER IN V/MICh UABEL IS AFFIXED TO PROOOCT
LITHOGRAPHED^ PAPER.
STENeli.ED(~~1
jOTHER (Specify)
10.. P.LACE V.'HEftE DIRECTION'S FOR USE APPEAR
... ON
IN PRINTED MATTER ACCOMPANYING PRODUCT I I
II.3A.TA sue.viTYto \viT.M THIS Ar»fLic/.Tic.M (Itleri tify end submit in triplic;:e)
'EFriCACY DATA^U TOXICOLOGY DATAQ . RESIDUE DATAl |
OTHER (Specify-};
PETITION FOR TOLERANCE I i
..ANY ADDITIONAL PERTINENT INFORMATION (Do not enter cc.-.fid.->nrisJ fomuls hcri-ue item M.befaw)
TKE FOLLOWING MUST S- cUCMITVC'J VV.T.'i A??'_iCAT I'.'iN
five JS) topio of r.f^poifd iobcling, mc'os'i.-.g all piintcd cr grapt.ic nolle; whicli
. may-oany I!IT jo!e~of this j:fcducT. Cc^:'cs mint 1>J clocrly IcjcbU ooj It'cnileol.
f>'3 'Ti ce^.'e; of Mio ii'roisrs 'w'MjIo, »ri-.v:'-c :>s :.•*::-.« -5^? sr-': ;.••:•-:-.;•
of lCE f5N THIS
PIKCR TO THIS FILE SYV.23L !IO.:
!•!. SIGNATURE cv A'J fii^..;;;/- 3 - TM :;k;- '^-. •:.•! r.^T
CTOCK or f ni OI:M n.i-io ijuiv
v/iii t.:. u::nj LI.MIII. L.'.'HAU.. 11.^
-------
P.O. cox i i 6 — c u A ;; D L E u G t. KICHICAK
April 7, 1970
N>r. Harold G. Alford • •
Assistant Director for Kepistration
t). S. Dcpt. of Agriculture-
Agricultural Research Service
Pesticides Regulation Division .
Washington D/C. 20250
Dear Mr. Alford: '
We are enclosing five (5) corrected SHED SAVEP DUST
(Drill Box Seed~Trcatr!ent) labels. Also enclosed is
five (5) copies of the formula for your information
We trust that this product will now be in line for
registration.
Yours truly, ..
PARSON'S CHEMICAL' WORKS, Inc.
/ • // ^ •' . .
'•'-A V-V<^ /->t
A'. R. Fox, Technical Dept.
ARF/pr
enc.
-------
r .
••«••- —.-.: t.-
;• ;--.:. •••«}.
• u-;--. I.'.-R c :• . ff.rtor./ol
AntiJofc:
r.iilk or »hili jr ;-vi t.-cfcn with
o( worm
. I
»;U». r K-; ..' ur.UI vjT.ir liuij n ;i.-.ir. Ki-; :_t milk
"' Ji *•• -I: of ;..; L.'iiin yith w^:.-. Coll « !'l.)ii.-ton
"i 'r ' '' DANGER
-I' KEEP OLT OF REACH C'f CHILDREN
j * Sec C;.icr foncls for AtJcfificnr.l Ccuvions
I Ts'ET WEIGHT 2 i-'C'JN'OS
'.] T-JTATS IG eu-.'HCLS \--.j
\ rT~~7 i""7•'." "'"T"™,"' """" ""rrrn f '•{
' I I'.' !'J.U •.'.' l.'-C.l 'Jji.',-:' i'J'.lj;.'i)'J'it(\ •!»• "4 • •
~.: . ^. • . "..;••* ..-^.. V..... ..t.-'iii--'•'.'::{ '• »
f-:I •••'•'•
'THE'EASY'MODERN".
. METHOD TO TREAT V ::
SEED GRAIN -' . .'•;''
V/ARK'IKG:
May Produce Dtlcycd Chcmi- .
cnl Ourns! Do not breathe dust.
Da not get in eyes, on skin or on .
clothing. Wash thoroughly after
handling. . . ;•.'..
USDA NO.
WHKAT
RYE
ll\:i.ill> IM:,;I..,;, s»r. r.i-~.< il /, i. r.i.it
DI.'I-J.'I. TO i:n> l''r :;„.
.Sliniiv .S;.iiil
nr liunl . 2 f".
(tnvcreil Sn
l::»fk l.mist- Km ill — Stripe
S/m. IH
2 Oj.
2 n/..
2 O/..
• . .Or IIKC n:ie pciiiml !•. n l,n.-h.-l< n( rrrd yrain.
I) 1 .1 i:. 0 T I O N S
fie Aurc fr«l Ki.'iin is v.-rlj r\\i>-i nr.il troroiij;hly clf.in o
trcntin;- >vi!h DUST, to ;>..| trcr.l u,.;,!( or I'o-.r Cirf.'i.-.at-.f.ii
test sci-il> or xi-c.ls II..-.; .-,.••> r«-:il d.»rk with Smut Du.-l. Kcr
• IK III r i.tr.n.-l» end yii.M.s ;>:.••.>•.'. r.iftiit l.ich Cci-min.ilii.i :c^t
ifi J:.. £)ij!<... the rnn to '•<•>: .»n u;i m.-iti r'Ui.
Apply fAK-'jONS SKKl) .SAVU: DUST dlrrclly to diy tccxpr'.-».'.ed or ini|.I;nt, ;.••
rr.nilo 3.1 to Ihc ejects i.f ;,mii t,t tl.c rcvuil.i lo \i-. ai.-tiii.i-il
if not iistrl in nrc"»liiii.-i: «ili. (iir«:rtin:;i or r»l;.l>!i»!i'-il ».'«.'c
pr.ictirc. The huycr cnur-t •• .•.mm: r.H ri..-;;ic/;.siliili:y. in.:lui|!.-i;
injury or damn).'*', rcairiu :i- fio/.i iti rniiu.ic K-, »crh. or in
coinMnnllon uiih other ITIH'I ii i|-.
CAUTION
Provide ilc lo Hear u MA*', of .v-t hj;. Ji.crcKicT o-':: the
no.'.c and mouth vliilc woiUi-t;; v i;'n I.,; ri-.-i. Do ,-.ct ^.1
dust on tkin, nr.j -specially nhiv: vci-.^piiin;. I' 3 nil >.. j t.-.i
trotted with DUST for any food p>irp<;:;o. >'ct to U sKiiUAci.
Do not rCL.sc empty container. i'Jt'&'rc.y it by jjcif.irilir.; cr
tf. Bury or dixcird in a » .fe f'uct.
'' ••:. RfCISTCRfD IH U.S. PAfiHT OfflCE SO. J70.K4 .
.. : LABEL T;:r;.V7 2:0 SEED5
Treated seeds should b;- jilainly labeled or ti;;£c;l
' rii follows:
"DISINFECTED SEED— POISONOUS TO AK:;-f AI.
.. AND MAN. HO NOT US!-: FOR S'OCD.
- : K:-;::D on OIL/'
Manufacturing C'-..:;:i?li Since If-Jo
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20-160
MAR T 1979
OFFICE Of ENFORCEMENT
SUBJECT: Enforcement of the Administrator's Emergency Orders
Suspending 2,4,5-T and Silvex Registrations
FROM: A. E. Conroy II, Director
Pesticides and Toxic Substances
Enforcement Division
TO: Enforcement Division Directors
Pesticide Branch Chiefs
On February 23, 1979, the Administrator signed Emergency Suspension
Orders pursuant to FIFPA section 6(c)(3) immediately suspendirrj the
registrations of all pesticide products containing 2,4,5-T for fores-
try uses (including site preparation, conifer release, and brush and
weed control), rights-of-way uses (including' brush and weed control),
and pasture uses _V, and of all pesticide products containing Silvex
for forestry uses (including site preparation, conifer release, and
brush and weed control), rights-of-way uses (including brush and weed
control), pasture uses, home and garden uses, commercial/ornamental
turf uses (including recreational area uses), and aquatic weed control/
ditch bank uses (use on rice not suspended),'. pending the final outcc.vie
of Agency cancellation proceedings which v/ere also initiated by Order
of the Administrator on February 28th. Copies of these Orders are
being mailed under separate cover. The purpose of this memorandum is
to set forth the Agency1s enforcement strategy concerning products
suspended by the February 28th Orders. It is the Agency's intention
to ensure that the Administrator's Orders are strictly complied with
by all affected persons, including manufacturers, foraulators, regis-
trants, wholesalers, retailers, distributors, government agencies,
and users.
jy Pasture is defined as land producing forage for animal consumption,
"harvested by grazing, which has annual or more freqi:ent cultivation,
seeding, fertilization, irrigation, pasticide application, and other
similar practices applied to it. Fencerows enclosing pastures are in-
cluded as cart of the oasture.
-------
-2-
I. SUSPENSION ORDER PROVISIONS
The February 281± Orders provide:
(1) As of February 28, 1979, all registrations of pesticide
products containing 2,4,5-T and Silvex for the uses described
above are suspended. For 2,4,5-T this means that in addition
to the uses cancelled in 1970, all pasture land, right-of-way
and forestry uses are now suspended. For Silvex this means
that all aquatic (except for use on rice), home and garden,
recreation area, as well as. pasture land, right-of-way and
forestry usss are now suspended. None of the products with
any of the suspended uses may be sold or distributed in the
United States. The Agency is officially notifying by certi-
fied mail all affected registrants of products any use of which
has been suspended by the February 28th Orders (hereafter referred
to as suspended products).
(2) As of February 28, 1979, all 2,4,5-T and F51vex
products, regardless of how and when they were obtained, may
only be used or applied for non-suspended uses, and only if-
the particular product in the user's possession is currently
labeled for one of the allowable uses.
II. . CATEGORIES OF 2,4,5-T AND SILVEX PRODUCTS
The following is a numerical breakdown of producers and registrants
of the suspended products:
Producers
2,4,5-T: 43
Silvex: 58
TOTAL 101 */
Registrants
2,4,5-T: 80
Silvex: __87
TOTAL 167
V There is an overlap in the production of suspended 2,4,5-T and •
Silvex products. As a result, there is only a total of 81 individual
producers of such products.
-------
-3-
Distributor Registrants
2,4,5-T: 376
Silvex: 382
TOTAL 758
There are seven (7) 2,4,5-T registrants and fifteen (15) Silvex registrants
not affected by the Administrator's Suspension Orders.
There are three categories of 2,4,5-T and Silvex products:
(A) Federally registered products, all uses of which have been
suspended. An example of a product in this category would be a
product registered for use only in forests. None of the products
in this category nay be sold, distributed or used in the United
States during the duration of the Administrator's Suspension Orders.
(B) Federally registered products, some usss.of v/hich have been
suspended.. There is a category of registered products some of but
not all of whose uses were suspended by the February 28th-Orders.
An example of a product in this category would be a product registered
for use on range land as well as for forest use'(the former being
a permitted use, the latter being a suspended one). Until the
completion of certain initial procedural steps resulting from the
Notices of Cancellation as well as the Suspension Orders, which will
help clarify the future status of products in this category, such
products may not be sold or distributed for use in the United States.
PTSED will be preparing further guidance on the .status of thase
products after discussions with OGC and OPP. Products in this
category may only be used or applied for non-suspended uses,
and only if the particular product in the user's possession is
currently labeled for an allowable use.
(C) Federally registered products, no uses of which have been
suspended. There is a small number of federally registered 2,4,5-T
and Silvex products none of whose uses were suspended by the
February 28th Orders, and whose sale", distribution and use may con-
tinue. An example of a product in this category would be a product
registered for use only on rice. Also included in this category
are 2,4,5-T and Silvex technicals, which are registered for manufac-
turing use only.
You will be receiving shortly a list of suspended product
registration numbers, product names, registrant names, and the
names and addresses of establishments where 2,4,5-T and Silvex
products with suspended uses have been produced. You will also
receive a copy of the site/registration listing. In order to
-------
-4-
determine whether a particular product fits into category A or
B, you will only need bo look up the product by its registration
mmber and determine whether all or only some of its listed uses
have been suspended.
In addition to the federally registered products discussed
in paragraphs A through C above, all products being sold pursuant
to State 24(c) registrations are subject to the requirements of
the Administrator's February 23th Suspension Orders. A final list
of these products is not yet available. As soon as this infor-
mation is prepared, it will ba forwarded to the;regional offices.
In the meantime, the regional offices should inform the States in
their regions that State registrations for suspended uses of 2,4,5-T
and Silvex issued pursuant to FIFRA section 24~(c) hava also been
suspended by tha Administrator's February 23th Orders, and that no
further State 24(c) registrations may be issued for suspended uses
of the affected products.
Intrastate registrations with assigned accession numbers are not
included in the Administrator's February 23th Orders. A listing of
these products and the States in which they are registered is being
mailed under separate cover. The regional offices should contact
the State agencies responsible for the original registrations to see
that appropriate steps are taken by the States to limit the possible
distribution, sale and use of these products consistent with the
Administrator's .Suspension Orders of February 28th.
III. ENFORCEMENT POLICY AND STRATEGY
A. POLICY .
The Office of Enforcement intends to ensure that the Administrator's
February 23th Orders are strictly complied with. The Agency's enforcement
policy has a two-fold objective: 1) to prevent the distribution and
sale of suspended 2,4,5-T and Silvex products; and 2) to prevent any
use of these products for other than non-suspended uses.
The general policy of the Agency has been to request a national
recall where product registrations have been suspended in order to prevent
an imminent hazard to man or the environment. However, because of the
emergency nature of the Administrator's actions and the fact that such
a recall approach would not have the effect of immediately halting sales,
distribution, and use, the Office of Enforcement is issuing Stop Sale,
Use and Removal Orders as quickly as possible to all registrants, distri-
butor registrants and producers of 2,4,5-T and Silvex products subject to
the Administrator's Orders, as well as to all identifiable large scale
users of these products. In addition, the Agency is taking special steps
to notify interest groups who represent orcducers, sellers and user/appli-
cators of the suspended products of the Administrator's Orders and the
resulting legal obligations.
-------
-5-
B. STRATEGY
The initial Stop Sale, Use, or Removal Orders directed at 2,4,5-T
and Silvex registrants, producers, distributor registrants, identifiable
large scale users and federal government agencies V have been prepared
and sent by certified mail by PTSED. A copy of the Stop Sale Order forms
and cover letter being used are being mailed under separate cover. Each
region will be sent a copy of each Stop Sale Order issued to any person
within their region. A regional contact has been named at the bottom
of each Stop Sale Order. This contact person should be able to assist
the recipients of the Stop Sale, Use, or Removal Orders with any ques-
tions that might arise. In addition, the cover letter accompanying the
Stop Sale Orders requests that certain information be provided to the
regional contact person specified on the Stop Sale Order. Note that
certain information from producers of the suspended products is manda-
tory in accordance with section 7(c)(2) of FIFRA. The information
requested is intended to assist the Agency in tracking shipments of
the suspended products through the channels of trade. Additional
information is requested of all recipients of the Stop Sale Orders to
assist EPA in monitoring compliance. The regional offices who will be
receiving information from Stop Sale recipients should maintain the :
information about stocks on hand and report monthly and cumulative totals
to PTSED by the 10th of each month.
The regional offices, working closely with States, are to conduct
books and records inspections at establishments of registrants or
producers v,ho fail to comply with the.Agency's request for information
about suspended products. Such inspections will be necessary in order
to obtain, updated information about quantities of production and loca-
tions of recent shipments.
The regional offices and States should visit the headquarters
offices or major distribution points of food, drug, hardware, lumber,
garden supply, variety stores, etc., to inform them of the Suspension
Orders and obtain assurances that they will take immediate action to
instruct their outlets to remove the suspended products from sale. In
addition, the regional offices and the States will undertake special
marketplace inspections at a representative sampling of these and other
retail--outlets in order to monitor compliance-with the Administrator's
Orders. The dealers and retailers who are visited are to be advised •
of the Administrator's February 28th Orders and asked to voluntarily
remove suspended products from their shelves(if they have not already
done so). Persons who refuse or for some other reason fail to comply
voluntarily with an inspector's request to remove the suspended pro-
ducts from his available stocks should be issued a Stop Sale, Use, or
Removal Order. Further decisions about future efforts aimed at the
retail level will depend on the degree of voluntary compliance
occurring at that level. FT3ED should be kept advised as to the
extent of voluntary compliance as well as any problems concerning
the retail sale of suspended products.
V*Twelve federal aqencies have been sent Stop Sale, Use, or Removal •
Orders. A list is being mailed undet separate cover.
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-6-
Since the time for annual spraying with some of the suspended
products is imminent, regional offices and the States should take
immediate steps to inform users and applicators of the Administrator's
February 28th Orders. Although the regional offices and cooperating
State personnel should first seek voluntary compliance, they should
not hesitate to issue Stop Sale, Use, or Removal Orders to persoqs who
are holding quantities of the suspended products for application. Such
orders may be issued to applicators who are in the process of making
an application with a suspended product. An inspection of the appli-
cator's business establishment is not required for the issuance of such
an order. A copy of the Stop Sale, Use, or Removal Order form applicable
to users (as opposed to producers or registrants) is being mailed under
separate cover for your information and/or use.
Once final action has been concluded on requests for an expedited
hearing pursuant to the provisions of section 6(c), and the status of
2,4,5-T and Silvex products pending the outcome of the future cancella-
tion proceedings has been settled, the Agency will review the need for
a possible request for a voluntary recall of the suspended products by
the .registrants and producers. Until that time the Stop Sale, Use or
Removal Orders will remain in effect, subject to suggestions from the
affected parties about possible disposition of the current stocks of
suspended products.
C. SUKMASy OF PROPOSED ENFORCEMENT RESPONSIBILITIES
1. Headquarter's Responsibility
a. Issue Stop Sale, Use, or Removal Orders via certified mail
to all registrants, distributor registrants and producers of
all suspended 2,4,5-T and Silvex products.
b. Issue Stop Sale, Use, or Removal Orders to Federal agencies
involved with the use or application of the suspended products.
c. Issue Stop Sale, Use, or Removal Orders to identifiable large
scale users of the suspended products after conferring with the
regional office.
d. Supply regional offices with copies of the following: .
1) The Administrator's Suspension and Cancellation Orders.
2) Copies of the Stop Sale, Use, or Removal Order forms and
accompanying cover letter.
3) Stop Sale, Use, or Removal Orders mailed by EPA Hdqrs.
2. Regional office Responsibility
a. Notify States of the Administrator's Suspension Orders and
Agency enforcement strategy, and develop cooperative approach
to implementation of the enforcement strategy.
-------
-7-
b. Compile information supplied by producers concerning 1978-79
distribution, as well as additional information requested from
all Stop Sale, Use, or Removal Order recipients. Report data to
PTSED on monthly basis.
c. Conduct books and records inspections at those major producer
establishments, who do not supply the requested information, to
update information about quantities of production and locations
of shipments.
d. Review information obtained from producers (.per b. and c. above)
to identify recipients of shipments of the suspended products in
order to target distributor and marketplace inspections.
e. Contact headquarters offices or major distribution points of
food, drug, hardware, lumber, garden supplies, variety stores etc.
to inform them of the Sus.pension Orders and to solicit their coopera-
tion in informing their customers of the Suspension Orders.
f. Conduct marketplace inspections in order to locate possible
improper retail sale or distribution of suspended products.
g. Undertake special efforts to inform State pesticide user associa-
tions, applicators and other users about the Suspension Orders and
thair legal requirements.
h. Issue SSUROs when appropriate.
i. Undertake appropriate enforcement action against any persons
violating the terms of the Administrator's Suspension Orders or
SSUROs.
j. Regional contact person, with assistance from EPA Headquarters,
should be prepared to answer questions about the Agency's actions
and to assist persons directly affected (e.g. producers, registrants,
sellers, users, applicators, etc.) with compliance.
3. State Responsibility
States, especially those with''Cooperative Enforcement Agreements,
are expected to cooperate fully with the enforcement efforts outlined
in' this memorandum. Specifically, they will be asked to assist
in items c, d, e, f, g, h, and i above.
17. ENFORCEMEOT ACTIONS
Enforcement actions will be taken in accordance with normal procedures
and at levels consistent with those set forth in the Case Proceedings Manual
against any person found in violation of the 2,4,5-T and Silvex Suspension
Orders or Agency SSUROs. Note: Section 26 of the amended FIFRA, which
grants to the States the primary enforcement responsibility for pesticide
use violations, does not extend to situations involving the use of a
£ ;spended product in violation .of Sections 12(a)(2)(J) or 12(a)(2)(I).
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-8-
V. DISPOSAL OF 2,4,5-T AND SILVEX PRODUCTS
Until the conclusion of Agency cancellation proceedings involving
2,4,5-T and Silvex registrations, persons requesting information about
the possible disposal of quantities of the suspended products should be
advised to place the material in storage in accordance with label direc-
tions .
VI. INDEMNITIES
PTSEJD has been advised by the Office of General Counsel that con-
sideration of requests for indemnification under section 15 of FIFRA
by parsons possessing quantities of the suspended products will not
take place until the conclusion of Agency cancellation proceedings for
the suspended products.
VII. INQUIRIES
Any questions about this memorandum and the 2,4,5-T or Silvex
Suspension Orders should be directed to the appropriate regional
coordinator.
VIII. SEM1 UNDER SEPARATE COVER
(1) Administrator's Suspension Orders, Feb. 28, 1979.
(2) Administrator's Notices of Cancellation, Feb. 28, 1979.
(3) PT3ED Stop Sale Order forms and cover letter.
(4) List of Intrastate 2,4,5-T and Silvex Products.
(5) Copies of Headquarters-Issued Stop Sale, Use, or Removal
Orders.
(6) List of federal agencies sent Stop Sale Order.
(7) List of federally registered 2,4,5-T and Silvex products
suspended by the Administrator's Feb. 28, 1979 Orders.
(8) Site/registration listing.
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
APR 0 5 1P7P
OFFICE OF ENFORCEMENT
SUBJECT: Further Guidance Concerning Enforcement of the Administrator's
Emergency Orders Suspending 2,4,5-T and Silvex Registrations
FROM: A. E. Conroy II, Director
Pesticides and Toxic Substances
Enforcement Division
TO: Enforcement Division Directors
Pesticide- Branch Chiefs
In a Tremor and urn dated March 7, 1979, I explained the Agency's
enfoL'ce.-nent strategy concerning 2,4,5-T and Silvex products suspended
y the Administrator on February /.8th. In that memo r and U.T. I indicated
1- I would provide you with additional, guidance concerning the status
icrally registered 2,4,5-T and Silvex products v.hich 'nave both sus-
p3.._^c and non-suspended uses on their labels. In the meantime, such
products cculd not be sold or distributed for use in the United States.
However, affected products in the user's or applicator's .possession could
be used or applied -for non-suspended uses, if the particular product
in the user's possession was currently labeled for an allowable use.
In a letter dated March 22, 1979, the Agency advised registrants of
2,4,5-T and Silvex products .with both suspandei and non-suspended uses
on their labsls that they would be allowed to distribute .and sell such
products for use in the United States once they had prepared adequate
interim labeling designed to inform the purchaser that certain of the
uses on the label are allowable, but that others are suspended. I have
attached a copy of the letter, \vhich is self explanatory, and do not
plan to surmrarize it in this memorandum.
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—2—
As you will see, registrants of such products have been instructed
to send copies of their interim labeling to the appropriate regional
office along with information about what steps they have taken to com-
ply with the letter. Since many of the products are distributed and
sold throughout the United States, as each regional office receives
copies of the interim labeling, they should forward copies to all
the other EPA regional offices. A list of regional contacts who are
responsible for matters relating to 2,4,5-T and Silvex products is
attached to the March 22nd letter. Although the Agency is not re-
quiring advance approval for each registrant's interim labeling, the
regional office receiving the original of the interim labeling should
briefly review each label as it is received to make certain that on
its face it appears adequate to inform purchasers of the product that
certain of its uses are no longer allowable. Any questions about
specific interim labeling should be directed to fir. A. J. Dellavecchia,
Chief of PTSED's Policy and Guidance Branch, and his staff.
As you know, immediately following' the release of the Administrator's
February 23th Orders, PTSED issued over 1,000 Scop Sale, Use, or Removal
Orders to all affected 2,4,5-T and Silvex registrants, producers and
distributor registrants. As a result of the Agency's subsequent decision
to allow certain, of the registrants to prepare interim labeling so they
can cell and distribute their products which have sore non-suspended
uses on their labels, it will be necessary to formally vacate.,or lift
the Stop Sale Orders affecting those products v'oich can be properly
relabeled. In other words, registrants who have prepared interim label-
ing can only begin to sell and distribute their products as scon as the
interim labeling is attached and after they have notified EPA of their
actions. Other 2,4,5-T and Silvex products in their custody or control
which were subject to the Stop Sale Order and/or which have not been
properly relabeled still may not be moved in commerce without advance
approval from the appropriate EPA regional office.
A question has been raised whether the Stop Sale, Use, or Removal
Orders issued by PTSED should be amended, vacated, etc. by PTSED or by
the appropriate regional office. Once the Stop Sale Order has been
issued, it is the responsibility of the regional office listed on the
Order to take whatever future action is appropriate in connection with
that Order. For example, if a distributor registrant is able to arrange
for the return of a particular product to the registrant or producer, it
will be the regional office's responsibility to amend or vacate the Stop
Sale Order to allow the pesticide to be returned.
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-3-
A question has also been raised about the possible violation of
the Administrator's Suspension Orders if a pesticide dealer attempts to
return quantities of the suspended products to the distributor, producer
or registrant. Although the Administrator's Orders state that "the sale,
distribution, or other movement in commerce (emphasis added) and the use
of all such pesticide products ... is prohibited", it is not the Agency's
intention to prevent the return by a dealer of suspended products to a
registrant, producer, or distributor. However, it is necessary for the
Agency to know v^ether quantities of the suspended, products are going to
be moved in commerce, to whom, in what quantities and for what purposes.
Therefore, if a dealer plans to return unsold quantities of suspended
products to a producer or distributor he should first contact the approp-
riate EPA regional office in writing notifying them of his plans and
wait for confirmation before actually shipping the material. If the
saiTB dealer is subject to a federal Stop Sale, Use, or Removal Order,
it will be necessary for him to have the Order vacated or lifted before
he ships the pesticide. Similarly, if the products under his control
have been detained pursuant to a State order, it will be necessary for
him to contact the appropriate State officials about his plans to return
the pasticide(s).
Finally, based on an extensive computer listing provided by the
Office of Pesticide Programs of possible users of suspended 2,4,5-T or
Silvex products, PTSED is about to begin issuing approximately 24,000
Stop Sale, Use, or Rerraval Orders. These Orders will be sent directly
to various persons who might be holding suspended products for use or
planning to use such products including timber tract owners, aerial
applicators, lawn service companies, electric power companies, pipeline
operators, railroads, irrigation operators, etc. A complete listing of
the persons receiving such Orders, broken down alphabetically, by State,
will be sent to each regional office along with a copy of the cover
letter and Stop Sale forms.as soon as the Orders have been mailed.
Attachment
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON. D.C. 20460
AUG 2 0 1979
OFFICE Of ENFORCEMENT
SU2JECI: Further Guidance on the Cancellation and Suspension of 2,4,5-T
and Silvex
10: Enforcement Division Directors
Pesticides Branch Chiefs
On July 9, 1979, the Assistant Administrator for Toxic Substances
signed two notices of intent to hold hearings pursuant to FIFRA section
6(b)(2) to determine whether or not the uses of 2,4,5-T and silvex not
subject to the Emergency Suspension Orders of February 23, 1979 should
be cancelled (copies attached). This essentially ;ieans that all uses
of 2,4,5-T and siivex will now be reviewed as part of the ongoing can-
cellation proceedings.
In preparing the two notices the Office of General Counsel concluded
that the list of non-suspended uses of both 2,4,5-T and silvex products
was broader than originally assumed. In my earlier guidance '.Terror anda
I expressed the Agency's view that only rice, rangeland, sugarcane and
certain orchard uses of these products ware not affected by the February 23,
1973 Suspension Orders. This sa-.e view was expressed in the Registration
Division/Pesticides and Toxic Substances Enforce.nent Division March 22, 1979
letter to all 2,4,5-T and silvex registrants.
It is now the Agency's view that a number of uses of both 2,4,5-T and
silvex that wsre previously considered to be suspended are not suspended
and products with these additional -uses on their labeling can be sold and
used in the United States p2ncing-the outcoirve of the cancellation proceed-
ings. According to the 6(b)(2) notice, in addition to use on rice and
rangeland, non-crop usss of 2,4,5-T at the following sites are not suspended:
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airports; fences, htxiciorov/s (not ut'v-r.vi.'-X' incl'icicd in suspended uccs, e.g.,
rights-of-way, pasture); lurr^rr yaroc; refineries; non-food crop areas;
storage areas; wastelands (not otherwise included in suspended uses, e.g.,
forestry); vacant lots; tank farms; industrial sites and areas (not other-
wise included in suspended uses, e.g., rights-of-way). ,
Similarly, according to the 6(b)(2) notice, in addition to use on rice,
rangeland, sugarcane and orchards, non-crop uses of silvex at the following
sites are not suspended: fencerows, hedgerows, fences (not otherwise included
in the suspended uses, e.g. rights-of-way, pasture, home and garden);
industrial sites or buildings (not otherwise included in suspended uses,
e.g. rights-of-way, convnercial/ornaTental turf); storage areas; waste
areas; vacant lots; and parking areas. Attached to this memorandum is
a revised version (dated July 24, 1979) of the list of suspended and
non-suspended uses for 2,4,5-T and silvex products. This list supersedes
the version provided to you in connection with my guidance of April
5th and the March 22nd letter to affected registrants.
A. E. Conroy II,/Director
Pesticide and Toxic Substances
Enforcement Division
V
Attachment
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SU3LANDED OSES
2,4,5-T I/
[2,4,5-trichlorophenoxy acetic acid,
esters, amine salts)
Firetrails and lanes
Forest lands, management areas,
plantations, and stumplands
Rights-of-way: highways, pipelines,
powerlines, utilities, roadsides,
roadways, etc.
Pasture
3ILVEX I
[2-{2,4,5-tr ichlorophenoxy) propionic
acid, esters, amine salts]
i
Farm buildings
Forestlarxls and management areas
Golf courses
Home use, lawns, grass, ornamental
turf, patios, sidewalks, drive-
ways, farmyards
Ditchbanks, drainage ditchbanks
Ponds, pond margins, standing
water
Lake, lake margins
Rights-of-way, all; roadsides,
roadways, etc.
Pasture
Ditches - water
Parks, athletic fields .
Marshlands, canals, aquatic sites
NON-SUSPENDED USES
2,4,5-T
Rice
Rangelard
Airports
Fences, hedgerows (not otherwise
included in suspended uses, e.g.
rights-of-way, pasture)
Lumberyards
Refineries
Nonfood crops
Storage areas
Noncrop areas
Wastelands (not otherwise included
in suspended uses, e.g., forestry)
Vacant lots
Industrial sites and areas (not
otherwise included in suspended
uses, e.g., rights-of-wayj
SILVEX
Rice
Rangeland
Sugarcane
Preharvest fruit drop of apples,
prunes and pears
Fence rows, hedgerows, fences (not otherwise
included in suspended uses, e.g., rights-
of-way, pasture, home and garden)
Nonfood crop areas
Nonerop areas
Storage areas
Waste areas
Vacant lots, parking areas, etc.
Industrial sites or buildings (not
otherwise included in suspended
uses, e.g., r ights-of-way,
commercial/ornamental turf)
I/ Certain uses of 2,4,5-T were suspended and cancelled in 1970. P. R. Notice
70-11, April 20, 1970, suspended the registrations for products containing
2,4,5-T and bearing directions for all uses in l?kos, oonds and ditchbanks, and
liquid formulations for use around the hoire, recreation areas, and similar sites.
P. R. Notice 70-13, May 1, 1970, cancelled the registrations of 2,-1,5-T projects
including all granular formulations for use uroun3 tha home, recreation areas
and similar sites,.and all uses on food crops intended for human consumption,
except for products whose labeling could be modified by deleting cuch claims.
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•tJ sr/.
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
• WASHINGTON. D.C. 20460
NQV 7 B79
OFFICE OF ENFORCEMENT
MEMORANDUM
SUBJECT: CBCP Suspension Order Enforcement Strategy
TO: Enforcement Division Directors
Pesticides Branch Chiefs
Background
On September 8, 1977, the Administrator announced his intention to take
two separate suspension actions with respect to pesticide products containing
dibromochloropropane (DBCP). These actions were taken pursuant to his autho-
rity under Section 6(c) of the Federal Insecticide, Fungicide and Rodenticide
Act, as amended (FIFRA). On October 27, 1977, because no registrants invoked
their right to a hearing pursuant tc Section 6(c)(2), the Administrator
issued a Suspension Order concerning DBCP products. The order was based on
the findings that DBCP is carcinogenic and also found to damage human repro-
ductive functions and may cause sterility in males. The October 27, 1977,
Suspension Order therefore proposed two separate actions: (1) the
"Unconditional11 or "Specific Food Use" Suspension of all products registered
for use on nineteen (19) specific food crops in which DBCP residues occurred,
or appeared likely to occur in the edible portion of the treated crop; and
(2) A "Conditional" Suspension of DBCP products registered for all other end
uses. The conditionally suspended uses were: cotton, soybeans, citrus, grapes,
pineapples, peaches, nectarines, plums, almonds, commercial okra, commercial
lima beans, commercial snap beans, commercial southern peas, berries (black-
berries, blueberries, loganberries, dewberries, boysenberries, raspberries),
strawberry nursery stock, apricots, cherries, figs, walnuts, bananas, turf
(commercial and residential) and ornamentals (commercial and residential). For
the conditionally registered uses it was thought that risks to applicators
could be sufficiently reduced on an interim basis by placing restrictions on
the product, such as, limiting use to certified applicators using respirators
and. protective clothing.
On July 18, 1979, the Administrator announced his intention to suspend
all remaining uses of pesticide products containing dibromochloropropane
(DBCP). This Notice of Intent to Suspend is based on additional information
showing that the conditional suspension is not adequate to reduce the risks
associated with continued use of DBCP, and in turn prevent an imminent hazard
during the time required to complete full scale cancellation proceedings which
are now pending pursuant to Section 6(b) of FIFRA. The new findings reveal
that DBCP residues may occur even in crops which are not grown in contact with
or in close proximity to treated soil; that treatment with DBCP may result in
contamination of water supplies, including drinking water sources; and that
application of DBCP may result in ambient air levels of DBCP at sites outside
the application area and may result in ambient air levels of DBCP at the site
of application several days after application.
-------
Pursuant to Sec±ion 6(c)(2) of FIFRA, each registrant of a DBCP product
was given the opportunity to request an expedited hearing on the question
of vhether an imminent hazard existed. Three registrants requested such a
hearing and following these proceedings the Administrative Law Judge presiding
on the issue, ruled that an imminent hazard did in fact exist and recommended
to the Administrator that all remaining uses of pesticide products containing
dibromochloropropane be suspended.
On October 29, 1979, the Administrator issued a Suspension Order suspend-
ing all products containing dibromochloropropane with the exception of those
products bearing directions for use on pineapples. This usage was strictly
limited to the State of Hawaii.
A copy of the Notice of Intent to Suspend, the Recommended Decision by
Administrative Law Judge, Gerald Harwood, the Suspension Order, a copy of
the recall letters sent to registrants of DBCP products, and a list of reg-
istrants and registered DBCP products are enclosed.
This memorandum represents EPA's Enforcement Strategy to be used in
relation to this Suspension Action.
Enforcement Policy . ... ._ .
The Agency intends to ensure that the Administrator's Order is strictly
complied with by all affected persons, including manufacturers, formulators,
registrants, v&olesalers, retailers and users.
On November 5, 1979, the Pesticides and Toxic Substances Enforce-
ment Division notified by certified mail all registrants and/or
producers of products containing DBCP requesting that they:
a. remove from sale down to and including the retail level
all existing stocks of products bearing suspended uses;
b. recall those products which do not bear directions for use
on pineapple;
c. relabel with interim or amended labeling those products
bearing directions for use on pineapple. :
The interim' labeling"we proposed would bear the statement "For
Sale for Use on Pineapples in Hawaii Only". No product may
be legally shipped after March 1, 1980, without approved amended
labeling. Those products in the state of Hawaii bearing directions
for use on pineapples shall be removed from sale until they have
been relabeled with interim or approved amended labeling. Under
no circumstances shall relabeled products be sold at the retail
level in any state other than Hawaii.
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-3-
Enforcement Procedures . . ...
1. After initial contact with the registrant, an inspector from the
~~ Regional Office or State should visit affected registrants to
discuss the recall action and monitor the steps taken to comply
with the recall. Proper storage of recalled products should
be stressed. See Section 14 of the Pesticides Inspection Manual
for information on procedures to be followed in monitoring the
recall.
2. If a firm refuses to recall its products, the Regional Office in
cooperation with the States shall issue Stop Sale, Use or Removal
Orders and/or seizures to effect removal of the products from the
channels of trade.
3. Vhen necessary the Regional Offices and States will take
appropriate enforcement action against those persons found
in violation of the DBCP Suspension Order.
Regional Offices shall request States to identify and recall products
bearing intrastate labels since intrastate products represent a major share
of those registrations which are currently active. The Regions should also
inform the States that only products bearing federal registrations were
sent recall letters by PTSED. Those Hawaiian intrastate products bearing
directions for use on pineapples may be relabeled if the state so wishes.
Use of Existing Stocks and Disposal .
As stated in the Administrator's Suspension Order, the use of existing
stocks of DBCP (except those products bearing directions for use on pineapples
in Hawaii) is prohibited and would be in violation of the Suspension Order and
subject to enforcement action. Persons desiring to dispose of stocks of DBCP
products should be apprised that they may arrange with the appropriate regions
to ship their products for disposal. This may include returning the product
to the supplier, or disposal in accordance with directions provided by the
Office of Solid Waste. Disposal questions may be referred to Mr. Ray Krueger
(202-472-9403).
Export ' '
DBCP products may be exported. Exportation must be in accordance with
FIFRA Section 17(a) which includes a requirement that the product must t
bear specific labeling. Registrants exporting DBCP products affected"
by the Suspension Order should also be cautioned in relation to the
stipulation signed by the Department of State concerning the utilization
of U.S. funds for U.S. AID regulation entitled "Pest Management Program,
Interim Pesticides Procedures", published in the Federal Register on
January 7, 1976. The notice states that AID will not provide assistance
for the procurement or use of a pesticide which has been finally suspended
or cancelled by EPA.
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Indemnification
The Office of Enforcement has been advised by the Office of General Counsel
that registrants of DBCP products would not be eligible to make any claim for
an indeminity payment until the registration of their pesticide is canceled,
(See section. 15(a) of FIFRA). Any questions concerning indemnities should
be directed to Mr. Mitchell Bernstein, Office of General Counsel (202-426-9448).
Inquiries
. Should you have any questions concerning any facet of this memorandum and
the DBCP Suspension Order, please contact the appropriate Regional Coordinator.
A. E. Conroy n, Director
Pesticides and Toxic Substances
Enforcement Division
Enclosures
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3 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
.£ WASHINGTON. O.C. 20460
'«<
2JUL1982
OPFICE OP
PESTICIDES AND TOXIC SUBSTANCES
MEMORANDUM
TO: Air and Waste Management Division Directors /'
Pesticide Branch Chiefs
SUBJECT: General Compliance Strategy for Products Suspended
Under §3(C)(2)(B) of FIFRA
Actdched Is the final General Compliance Strategy for
products suspended under §3(c)(2)(B) of FIFRA. The final
strategy incorporates comments received on the May 10, 1992,
draft. Also attached is a complete fist of suspension actions
initiated or accomplished under section 3(c)(2)(B) of FIFRA by
OPP. This list will be updated as needed by OPP.
A. E. Conroy A I ,/Director
Pesticides arid "Foxic Substances
Enforcement Dyi vision
Attachments
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GENERAL COMPLIANCE STRATEGY FOR PRODUCTS SUSPENDED UNDER
§3(c)(2)(B) OF FIFRA
Ov e rview
Section 3(c)(2)(B) of the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) authorizes the Administrator to request
additional data on registered products in order to allow EPA to
further evaluate the product's active ingredient. Registrants
who fail to produce the data requested face suspension of their
product. A Notice of Intent to Suspend (NOIS) is issued by the
Office of Pesticide Programs (OPP) for specific products produced
by a registrant if the registrant fai.ls to take steps to produce the
data requested. The NOIS is sent by certified mail to the affected
registrants. Effective suspension of a product is acccnplished
through the issuance of a StopSale, Use or Removal Order (SSliRO)
and tinely coordination between Headquarters, Regions and .States.
Regulated Industry
Requests for additional data made pursuant to Section 3 (c ) (2 ) (B)
are directed to all registrants who produce & product containing the
specific active ingredient.
R e q u fFelnVh t s of The Rule
Section 3 (c ) ( 2 ) ( 3 ).. of the.Federal Insecticide, Fungicide, and
Rodenticide Act (F IF3A ):
- Authorizes the Administrator" to require additional data on
^ chemical to further evaluate the chemical and to support
existing registrations.
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; -2-
- Requires registrants to take appropriate steps to secure the
additional data within 90 days or face suspension.
- Grants EPA the authority to Issue a Notice of Intent to Suspend
If a registrant fails to take steps to secure the required data.
- Allows a registrant and other parties to request a hearing
within 30 days of receipt of the NOIS 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 disposition of existing stocks is consistent with the Act.
The effective date of the suspension is affected by the
registrant's request for c ;,caring. -
Each registrant originally i: given the following options for
complying with the data request:
1) develop the re quired 'data himself or jointly with other
registrants;
2; certify that the product is exempt because it is an end-
use product formulated from a registered, non-suspended
manufacturing use or technical grade product purchased
from another producer;
3) request and receive a waiver of some or all of the data
requ i rements; cr
4) voluntarily request cancellation.
Failure to exercise any of these options within certain
specified time periods results- in the suspension of the reg i s-
trant's product.
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-3-
Infore ernent Objective's ~~~
The aim of the compliance strategy Is to stop the manufacture,
and possibly the distribution, of products subject to the suspen-
sion. This can be accomplished through the Issuance of a SSURO to
the registrant at the point of manufacture. Because suspensions
initiated pursuant to §3(c)(2)(B) are based on a failure to submit
data rather than on product deficiencies, it is not necessary to
recall suspended products from the marketplace.
1
The sale and use of existing stocks of suspended products which
are already in the marketplace is allowed to continue for a period
deemed appropriate by the Administrator. Production is commonly
permitted for 120 days after receipt of the NOIS by the registrant.
Types of Violations •
Section 12(a)(2)(J) of the Act prohibits the violation of a
suspension order issued under §6. There is, however, no specific
unlawful act under §12 for the violation of a"r§3(c) (2) (3) suspension
order. Under §13 of the Act, the Administrator may issue a SSURO
when a product is suspended. By issuing a SSURO, any person viola-
ting the §3(c)(2)(B) suspension order would therefore be in violation
of §12(a) (2) (I), which prohibits violation of a SSURO, and subject
to the penalties thereunder. It is essential that each registrant
of a suspended product be issued a SSURO in order for the §3(c)(2)(R)
suspension to have the force of law.
1 Existing stocks are those packaged, labeled and released for-
shipment at the time production is suspended.
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-4-
TTdnf ini s t r a t i v e ConsideratTIT ns
Program Management
Upon final suspension, PTSED will send the regions:
1) A copy of the HOIS issued by OPP including,
a) a list of companies and specific products affected
b) the Agency's decision on the disposition of existing
stocks;
c) dates when production must cease; and
2) Any pertinent supporting documents.
The NOIS will allow the registrant a period of time, determined
by OPP, after the effective date of the suspension notice to stop
production of the suspended product(s). Additionally, registrants
will, generally, be allowed a period of ti.^ie to dispose of existing
stocks of the suspended product(s).
Prior to the dat-2 *hen all product ion must stop, the region
will send any affected registrants a copy of the fJOIS and a SSURO,
effective the day after the production' termination date. 'The cover
letter which accompanies the NOIS and SSU'30 should include a
discussion of the options available to the registrant to remove
the suspension. 0?P shall be contacted by the Region to discuss
what options are available to the registrant of the suspended
product. States should be notified by the.region of the suspension
action upon the region's receipt of the PTSED transmittal and should
be provided with copies of all the information the region has received
from PTSED.
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- D -
The Regions should also work with the States in which the
affected registrants are headquartered to schedule inspections of
the affected registrants. Production facilities of affected regis-
trants should be visited by the State after termination of the time
period allowed by the NOIS for production. Normally, only one
inspection should be necessary for each registrant. States should
determine that production of the suspended product has been halted
and that the registrant understands the options available to lift
:
the suspension, should the registrant so desire. States should
explain that the EPA will allow existing stocks of the suspended
products to be sold for the period of time authorized by the
Administrator. States should also determine the amount of existing
stocks of suspended products in the control of the registrant and
report this information to EPA. Dealers, possessing products"
produced prior to the production termination date, will not.be
afrfected by any time li:iit for the sale of existing stocks .
Intrastate products included in a §3(c)(2)(G) action are to
be treated as federally registered products. States nay take
action against these products and are encouraged to do so. Regions
are expected to assist in any State effort to suspend or restrict
the sale and distribution of suspended intrastate products.
ATT o c a 11 on of Respo.n s i D iTTtie s
1) Headquarters Responsibility.
a) Provide Regions with strategy for §3(c)(2)(B) suspensions.
b) Provide Regions with copies of all pertinent correspondence
in this suspension action.
c) Effective dates of suspension actions.
2
PEPS No. 3, 40 CFR 162.17
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-6-
2) Regional Responsibility
a) Send copies of Notice of Intent to Suspend and the SSURO
by certified mail to all registrants of suspended products
b) Provide guidance for State enforcement efforts.
c) Encourage States to suspend intrastate registrations.
3) State Responsibi1i ty
a) Conduct follow-up inspections to ensure compliance ;
with the SSURO.
b) Suspend intrastate' registrations if possible.
Penalties
Violation of the SSURO is a violation of Section 12(a)(2)U)
and subject to the penalties found under section 14(a)(l) and'
-------
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-------
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TOXAPHENE CANCELLATION COMPLIANCE STRATEGY
Overv i ew
On May 25, 1977 £PA issued a Notice of Rebuttable Presump-
tion Against Registration and Continued Registration of Pesticide
Products Containing Toxaphene. This RPAR notice was issued pri-
marily on the basis of studies showing that toxaphene causes
tumors in laboratory animals, acute toxicity of toxaphene to
aquatic organisms, and the high likelihood that toxaphene causes
reductions in the populations of nontarget animal species. Fur-
ther examination of the data available to the Agency showed that
toxaphene is extremely persistent, moves readily through the
environment, contaminates habitats of vulnerable aquatic and avian
species at levels sufficient to reduce their populations, and that
humans are exposed to toxaphene through occupational contact
and contamination of a range of food products, particularly fish.
On October 18, 1982 the Agency announced it's decision to
cancel most uses of toxaphene. This action was taken pursuant to
Section 6 of the Federal Insecticide, Fungicide and Rodenticide
Act, as amended (FIFRA). On November 29, 1982, the Agency "pub-
lished in the Federal Register, 47 FR 53784 the notice
cancelling most uses of toxaphene, the conditions for continued
registration of toxaphene for certain uses, disposition of
existing stocks and hearing rights of affected registrants. The
cancellation is effective 30 days after notification by the
RegistrationDivision.
Requirements of the Rule
A11owable Uses
The order cancels all uses of toxaphene with the following
* ~. c a p *. i o n s :
1) Dipping of beef cattle and sheep to control scabies.
2) Use on cotton, corn or small grains to control armyworms,
cutworms or grasshoppers. Use is restricted to $18 emer-
gency exemptions on 1y.
3) Use on pineapples to control mealybug and pineapple gummosis
moth and use on bananas for weevil control in the Virgin
Islands and Puerto Rico only.
4) Manufactjring use only for formulating to products listed
above.
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- 2 -
The order further restricts use to certified applicators, speci-
fies protective clothing to be worn when mixing or applying the
pesticide, and mandates improved directions for use, disposal,
and to reduce exposure.
Used dip solutions must be disposed of in accordance with the
Resource Conservation and Recovery Act (RCRA). If the owner
generates more than 1000 kg of used dip solution per month or
more than 1000 kg of used dip solution in combination with other
hazardous waste, the material must be treated as a hazardous
waste subject to subpart C of RCRA. Any user who wishes to manage
the disposal of this material as a.- hazardous waste must obtain a
permit to serve as a hazardous wa'ste facility pursuant to RCRA.
The label may exempt from these disposal requirements any farmer/ •
rancher who uses the product solely to treat beef cattle or sheep
which he and/or his immediate family owns as individuals.
Existing Stocks
Existing stocks are defined in the order a those stocks of
cancelled toxaphene products existing within the territorial
United States on or before November 29, 1982.
The rule allows the use of existing stocks of toxaphene
in the following manner:
1 ) Existing stocks within the physical possession of
regi strants, (i.e., stocks stored in faci1ities
owned or Te~ased by the registrant or within the
the registrants direct control):
a) If the formulation is of a type that permits label
conversion to one of the following uses, the re-
labeled product may be sold and used until December 31
1986. Existing stock may be relabeled for:
1) control of sicklepod in soybeans and peanuts
only in States with this use as a current or
future §24 -xc) registration,
2) use on insects in rro-till corn,
3) use on dry or southern peas, or
4) §13 emergency use exemptions,
b) If the formulation is of a type that does not permit
label conversion, the product may be sold for one
(1) year (until December 31, 1983) utilizing amended
1 abeli ng.
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c) Registrants wishing to qualify for the existing stocks
provisions of the order must notify EPA, within 30 days
of receipt of the notice, of their decision regarding
disposition of existing stocks and provide EPA with
an itemized inventory of their stocks. Failure by a
registrant to notify EPA of their decision to attempt
to qualify for the provisions for existing stocks
will cancel the product and require the registrant
to dispose of existing stocks of that product within
90 days of publication of the order. Cancelled
existing stocks must be disposed of as required by
the Resource Conservaton and Recovery Act (RCRA).
d) Any registrant wishing-to sell" or distri bute~ any
existing stocks in their possession must either
relabel or apply supplemental labeling to the product
as required by the Notice sent by Registration Divi-
sion, OPP.
Existing stocks of registered technical products must be used
in the formulation of products with registered uses prior to manu-
facturing any new toxaphene technical chemical.
Existing stocks of any type may not be sold, distributed or
used after December 31, 19-86.
2) Existingstocks outside the physical possession of regis-
trants (i.e.,products alreadyin the channels oftrade
or in the possession of dealers and retailers).
a) Existing stocks already in the channels of trade or
in the possession of dealers retailers may be sold,
shipped or distributed for use in accordance with
the labeling accompanying the product until Decem-
ber 31, 1983. These products may be used until Decem-
ber 31, 1936 utilizing existing labeling. Any existing
stocks of this type unsold as of December 31, 1983
must be cilsoosed of according to RCRA regulations.
3) Existing stocks in tne nands of users
a)
EXT s
be u
cer
c i g *. -j e
V
x i
i n
st
the
ing 1
hands
abel i
0
ng
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un
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til
s may
Decem
Hearing Right.;
The or-.*?- .;•"•"* "3 j - - ••: - •- •• r • •:; ^ •.'••ant s the opportunity for
a hearing PJ <•:,-, --. :? :j-j . • ~'.~s~. .]'j:h a hearing will consider
only whethe^ ; i:: ---. i i: •: • • •.:..- •••;-.•. ed and pursued appropriate
action to ..••;:• - : • ;'-.- • ;-e • .•: : - : the time provided or whether
the Admi n ••:•.•-v-~. •' .:?«•.--'; .-,:•<:•• •••;:•» -d i ng the disposition of
existing s r. • •.: - : ; •.-;:.:••-: .-•••.• :: r. Act.
-------
Any action concerning the registrant's products-wi11 De held
in abeyance pending the outcome of the hearing.
Regulated Industry
Appendix A of this strategy lists those registrants affected
by this order.
Enforcement
The Agency's efforts to achieve compliance with this order "
shall be directed towards assuring that cancelled products are
disposed of properly and that proper labeling is affixed to those
products introduced to or remaining in the marketplace.
Compliance Monitoring
Compliance monitoring of this order will be achieved first
through inspections of affected producer establishments and
secondarily, dealer inspections and marketplace surveillance.
Producer establishment inspections shall be conducted to
determine if the registrant is complying with the order. Producer
establishment inspections will be conducted in the following order
of priority:
1) Inspection of registrants with cancelled products.
2) Inspection of registrants with non-convertible existing
stocks, i.e. products which cannot be relaoeled and
must be sold within one year.
3) Inspection of registrants with existing s r. T c k s which
can be relabeled to one of the allowable existing
stocks uses.
4) Inspection of registrants with products .< -i i c h will
remain registered.
It is likely that registrants may have products W;-M ;h fall
into some or all of the categories listed above. Tr.Q Agency
is most concerned that cancelled products are di>po.sed of
properly. For products which may be sold after relabeling, the
inspector should determine what types of toxaphene products are
in the registrant's possession (i.e., products with registered
uses, relabeled existing stocks or existing stocks that cannot be
relabeled) and whether they are properly labeled. The inspector
should also determine whether the manufacturing use product used
in the formulation of registered products is a new chemical or
previously manufactured. Registrants must use existing stocks of
manufacturing use product to manufacture registered products until
-------
such stocks are depleted. Registrants may not sell..or distribute
any toxaphene not labeled for a registered use or not labeled in
accordance with the existing stocks provisions of this order.
Regions will provide the States with all pertinent materials
regarding the order and work closely with the States to develop a
compliance monitoring schedule.
After initial producer establishment inspections have been
conducted, regions will coordinate marketplace inspections witn
the States to determine compliance with the existing stocks pro-
visions of the order.
Dealer inspections and marketplace surveillance will be
conducted to assure that products are properly labeled and sold.
Existing stocks of toxaphene already on dealer's shelves may be
sold without label modification until December 31, 1983, provided
the registrant has notified EPA within 30 days of their decision
to attempt to qualify for the existing stocks provisions of the
order. Dealer inspections will become a major activity after
December 31, 1983, the last date existing stocks which do-not
have allowable uses on the label may be sold.
Use inspections will become critical after the December 31,
1986 cut-off date for all uses of existing stocks. Use inspec-
tions may be conducted before then at the option of the Region
and the State or if problems regarding the use of toxaphene are
not ed.
Administrative Considerations
Allocation of Resources
1) EPA Headquarters - EPA headquarters shall:
a) Provide Regions with a copy of the cancellation
order, compliance strategy and a list of names and
addresses of affected registrants.
b) Provide the Regions with a list of those registrants
who intend to amend their regisration and remain
registered, registrants who intend to relabel their
existing stocks of toxaphene for permitted uses, and
those who took no action and therefore face cancel-
lation of their product.
c) Provide the Regions with the yearly inventory of
existing stocks of toxaphene.
-------
6 -
d) Provide additional support and guidance as the
Regi ons may requi re.
2) Regi ons - The regions shall:
a) Provide the States with copies of the materials
received from headquarters.
b) Coordinate inspectional activities related to this
order with the States.
/
c) Provide support and guidance as the States may
requi re.
3) States - The States shall:
a) Conduct producer establishment inspections of
registrants affected by this order.
b) Conduct dealer inspections and marketplace surveil-
lance to determine compliance with existing stock
provisions of this order.
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-------
5/10/82
FIFRA COMPLIANCE PROGRAM POLICY COMPENDIUM
A. E. Conroy II, Director
Pesticides and Toxic Substances
Enforcement Division
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The Compl i o.ioe Program Policies contained in this compendium
and the Policy ana Criteria Notices published by the Office of.
Pesticide Progr:,r,s have been cross referenced by subject matter
in a "Key Word Index" located at the end of this compendium.
Copies of the Policy and Criteria Notices are not provided but
a list of all current' Notices is attached.
These Compliance Program Policies will supersede all existing
P o 1 ici.es.
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FIFRA COMPLIANCE PROGRAM POLICY INDEX PAGE
TITLE NUMBER
Use Recommendations 2.1
Label ing of Outer Containers 2.2
Shipment Prior to Registration 3.1
Distributor Registrations 3.2
Fumigation of Truck Vans on Flatbed Rail Cars 3.3
Custom Blenders 3.4
Production of Pesticides for Personal Use 3.5
Contract Manufacturing 3.6
Written Examinations for Private Paillcide 4.1
Applicators
Custom Blenders 7.1
Release of Pesticide Production Data 10.1
Using Registered Or Experimental Use Permit 12.1
Pesticides In A Manner Not Included On
The Label Or Permit
Pesticides Closed Transfer, Mixing/Loading and 12.2
Application Equipment (Closed Systems)
Authority for Use Inspections 12.3
Making Restricted Use Pesticides Available 12.4
to Persons Without Pesticide Applicator
Certi f icati.on
Pesticide Processing in Foreign-Trade Zones 17.1
Waiver of Notice of Arrival Requirements 17.2
Special Local Needs Labeling 24.1
ChildResistantPackaging 25.1
Transfer of Use Enforcement Primacy to the States 26.1
Referral of State Misuse Cases to EPA 26.2
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FIFRA COMPLIANCE PROGRAM POLICY SECTION 2 INDEX PAUE
TITLE " NUMBER
Use Recommendations 2.1
Labeling of Outer Containers 2.2
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FIFRA COMPLIANCE PROGRAM POLICY No. 2.1
Use Recommendations
FIFRA Section; 2(ee)
Issue:
Should the Agency allow the advocacy of Section 2(ee) uses
by any person without regard to his financial interest in the
sale of pesticides?
Policy:
To the extent that Section 2(ee) allows a particular use, any
person, regardless of his financial interest in the sale of pesti-
cides, may legally recommend or advertise such uses provided that
recommendations made under Section 2(ee) pertaining to the amount
of diluent used in applying pesticides for forestry or agricultural
purposes is in accordance with the Advisory Opinion issued March 3,
1931 (46 FR 14965)J
Discussion;
Background
Federal jurisdiction over- the use of pesticides was established
through the'1972 amendments to the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA), Sections 3(d)(l); 4; 1 2(a) (-2) (G) . .
Acceptance of the label submitted with the registration of a pesti-
cide product by the U.S. Environmental Protection Agency (EPA) is a
central part of- the pesticide registration process. The pesticide
label dictates the approved uses for each registered pesticide. Any
use of a registered pesticide which is inconsistent with its labeling
is unlawful, (Section 12(a)(2)(G)).
In 1975, the Pesticides and Toxic Substances Enforcement Division
(PTSED) initiated a series of Pesticide Enforcement Policy Statements
(PEPS). The PEPS are designed- to inform interested members of the
public about the policies adopted by the Agency in the exercise of
its prosecutorial discretion in the enforcement of FIFRA (40 FR
19526). Such exercise of prosecutorial discretion has been- guided
in each instance by the legislative history of the 1972 FIFRA amend-
ments which states that it was the intent of Congress to ensure that
the Agency evaluate the meaning of the term "inconsistent with the
label" in a common sense manner,
Supersedes Federal Register Notice, (Vol. 44, No. 112, Friday,
June 8, 1979, p. 33151 ), which limited Section 2(ee) recom-.
mendations to user/applicators. This Policy does not prospec-
tively amend any existing pesticide labeling; all changes in
a registered pesticide label must still be -approved by the
Agency.
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(H.R. Rep. No. 92-511, 92d Cong. 1st Sess., 16 (1971)). In
accord with this Congressional direction, the PTSEO determined
that some uses or applications which were not expressly stated on
the label were, nonetheless, to be allowed. In particular, the
following uses were not subject to prosecution:
1) Use of registered pesticides at less than the label
dosage rate (40 FR 19529; 40 FR 42914); (PEPS #1).
2) Use of registered pesticides for the control of unnamed
target pests in structural pest control (40 FR 41175);
(PEPS #2).
3) Use of registered pesticides for the control of pests
not named on the label in agriculture and other non-
structural pest control (41 FR 4.1142); (PEPS #5).
4) Use of aerial application techniques where the label
instruction does not specifically prohibit such use
(42 FR 21496); (PEPS #7).
The PEPS permitted these limited deviations from the
language of the registered pesticide label only where the lab?'
does not explicitly proscribe such uses. Thus the question ut
"what" nonlabel uses were permissible was addressed by the PEPS.
The second issue of "who" could recommend these uses was also-
answered by the PEPS.
All of the deviations permitted under the PEPS were subject
to the restriction that only "knowledgeable experts" cfould
recommend them. Under the PEPS, States could designate know-
ledgeable experts subject to certain educational and experiential
standards. For example, knowledgeable experts could include
persons employed by State Cooperative Extension Services, State
Land Grant Colleges, and State Agriculture Departments.
The PEPS denied the designation of "knowledgeable expert"
to individuals whose primary source of personal income is
directly derived from the sale or distribution of pesticides.
This limitation precluded pesticide sales representatives,
marketing employees, or advertising agents from advocating PEPS
deviations. The PEPS justified this position by reliance on
Section 12(a)(l)(B) which makes it unlawful for any person with
a financial interest in pesticide marketing to make a claim which
differs substantially from registered pesticide labeling.
In short, the PEPS have had two consequences. First, they
made certain pesticide use deviations permissible even though
the uses do not appear on the registered pesticide label. Secondly,
all persons with a direct financial interest in the sale of
pesticides were forbidden under Section 12(a)(l)(B) from recom-
mending any of the pesticide uses permitted by the PEPS.
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3 - 2.1
Federal P-esticide Act of 1978
FIFRA was again amended by enactment of the Federal Pesticide
Act of 1978 (FPA). The FPA broadened the construction of Section
12(a)(2)(G) of FIFRA by adding Subsection 2(ee). Section 2(ee)
defines the term "to use any registered pesticide in a manner
inconsistent with its labeling." According to the language of
this new section, it is a violation of Section 12(a)(2)(G) to use
a registered pesticide "in a manner not permitted by the labeling"
with the exception of four specific areas. The areas specifically
excluded from enforcement are almost identical to those previously
listed in the PEPS.2 Under Section 2(ee) it is not a misuse to:
1) Apply a pesticide at any dosage, concentration, OP
frequency less than that specified on the labeling
(PEPS' #1) ;
2) Apply a pesticide against any target pest not specified
on the labeling if the application is to the crop,
animal, or site specified on the labeling (unless the
label states that the pesticide may be used only against
pests specified on the label) (PEPS #2,5);
3) Employ any method of application not prohibited by the
labeling (PEPS #7); and
4) Mix a pesticide or' pesticides with a fertilizer when
such mixture Is not prohibited by the labeling. (This
issue was not expressly dealt with by PEPS but was
covered by Policy and Criteria Notice 2000.1, Fertilizer-
Pesticide Combinations.)
Thus, Section 2(ee) defines by lay certain uses which will
notbe considered inconsistent with labeling even though these
uses are not listed. The PTSED responded to Section 2(ee) by
publishing a Federal Register Notice which rescinded PE-PS numbers
1, 2, 5, and 7 (Vol . 44, No. 112, p. 33151). As explained in
the Federal Regi ster, the PTSED restricted the advocacy of Section
2(ee~] uses to user/applicators. The PTSED has now reconsidered
its earlier position and has decided to remove this restriction.
Experience has demonstrated that the earlier policy prevented
certain qualified individuals from recommending authorized
deviations from the express terms of the label. The following
examples illustrate the problem:
0 In States with farm cooperatives there are individuals
! who both use and sell pesticides. These individuals
were prevented from recommending authorized uses.
It should be noted that while the FPA amends existing Federal
law concerning pesticide misuse, it does not purport to affect
State laws.
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4 - 2.1
0 Likewise, pest advisors who serve as IPM consultants
OP farm management consultants were prevented from
recommending Section 2(ee) uses solely because they
may also be directly or indirectly connected to the
sale of pesticides.
The new PTSED position is also supported by the statutory
language of Section 2(ee). Since Section 2(ee) uses are no
longer considered misuse, any recommendations made regarding
these uses will not be viewed as substantially different from
use directions appearing on the label. Accordi ng-ly, it is
PTSED policy that Section 12(a)(l)(B) no longer prohibits
financially interested persons from recommending or advertising
such uses. Thus, to the extent that Section 2(ee) allows a
particular use, any person may advocate that use, provided
that recommendations made under Section 2(ee)(l) pertaining
to the amount of diluent used in applying pesticides for forestry
or agricultural purposes is made in accordance with the Advisory
Opinion issued March 3, 1981 (46 FR 14965).
Civil Liability
This new policy not only implements the Congressional
intent of Section 2 (e e) to allow beneficial nonlabel pesticid-e
uses but also provid-es for strong enforcement to ensure appropriate
recommendations of such uses.
relaxes the administrative or
who recommend pesticide uses.
no longer limits the advocacy
financial interest in the use
The policy statement in no way
other civil liability of persons
The only change is that the PTSED
of permitted uses on the basis of
The Agency will, however, take
enforcement action under Section 12(a)(l)(B) against any person
with a financial interest who makes pesticide use recommendations
which exceed the limits of Section 2(ee). Additionally, any
person who recommends Section 2(ee) uses, of course, remains
liable for possible civil damages arising out of his own negligence.
See Also:
FIFRA Compliance Program Policy No. 12.1 Using Registered or
Experimental Use Pesticides in a Manner not.Included on the LaDel,
Policy and Criteria Notice 2000.1, Ferti1izer-Pesticide Combin at ions
Key 'Words:
Fertilizer-Pesticide Mixture, Knowledge Expert, Misuse, Target
Pest, 2(ee), Use Inconsistent with the Labeling, Use Recommendations,
A. E. Conroy I
Pesticides and,'
Enforcemen
(0
Date
rector
ic Substances
vision
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FIFRA COMPLIANCE PROGRAM POLICY No. 2.2
Labeling of Outer Containers
FIFRA Section: 2(q)
I s s u e:
When must a label be attached to a shipping container of a
pesticide product?
Pol Icy:
A label must be attached to a shipping container of a
pesticide if the customary practice of the manufacturer is
to retail the product to consumers without opening the outer
shipping container to sell the product in individual units.
Discussion:
Section 2(q)(2)(C) of FIFRA states that a pesticide 1s
misbranded unless a label is affixed to its container and to
the outside container or wrapper of the retail package.
The regulations at 40 CFR 162.10(a)(4) (i) state in part:
The label shall appear on or be securely attached
to the immediate container of the pesticide product.
. . . If the immediate container is enclosed within
a wrapper or outside container through which the
label cannot be clearly read, the label must also
be securely attached to such outside wrapper or con-
tainer, if it is part of the package as customarily
distributed or sold. (emphasis added)
The preamble to these regulations clearly states EPA's
intention to continue its policy which requires labeling on
retail packages for sale but not on shipping containers. If
it is customary to sell a product in its shipping container • .
rather than in individual units, the outer container must also
bear a full end use label. If a product is generally sold in
individual units and 'only occasionally by the case, the outer
container would not be required to bear labeling, since the outer
container is not intended to serve as a retail unit.
The purpose of requiring labeling on the retail package, be
it the shipping container or individual units, is to allow the
person who uses the pesticide to read the entire label and be
fully informed about the product. Failure to properly label
the retail package is considered to be misbranding and is a
violation of Section 12(a)(l)(E).
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i - 2.2
References;
Letter of June 16, 1976, from A. E. Conroy II, to
Mr. C. M. Elnhorn of USS Agri-Chemicals.
Memorandum of September 10, 1976, from A. E. Conroy II to
Pesticide Branch Chiefs and Enforcement Division Directors.
Key Words:
Labeling, Outer Containers, Shipping Containers.
A. E. Conroy II/Di/ector
Pesticides and Tox/c Substances
Enforcement
ate
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FIFKA COMPLIANCE PROGRAM POLICY SECTION 3 INDEX PAGE
TITLE ... NUMBER
Shipment Prior to Registration 3.1
Distributor Registrations 3.2
Fumigation of Truck Vans on Flatbed Rail Cars 3.3
Custom Blenders 3.4
Production of Pesticides for Personal Use 3.5
Contract Manufacturing 3.6
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rlFRA COMPLIANCE PROGRAM POLICY No. 3.1
Shipment Prior to Registration
FIFRA Section: 3
Issue:
May a pesticide product which is not sold under an
Experimental Use Permit (EUP) be shipped to distributors prior
to being registered with EPA?
Pol icy:
A pesticide product not sold under an EUP may be shipped
prior to final approval of its EPA registration under certain
circumstances. The registrant must apply to EPA for a temporary
exemption to registration requirements; demonstrate a compelling
need for the distributor to receive the product before its EPA
registration is finalized; detail a plan for control of the
product prior, to registration; and receive EPA approval of the
exemption request. ,
Discussion:
Section 3(a) of FIFRA states:
... no person in'any State may distribute,
sell, offer for sale, hold for sale, ship,.
deliver for shipment, or receive and (having
so received) deliver[y]' (six) or offer to
deliver, to any person any pesticide which
is not registered with the Administrator.
The exemptions to this requirement found in Section 3(b) do not
address delivery of an unregistered pesticideto a distributor.
However, the Agency will consider granting an exemption of this
type as a matter of policy if certain conditions are met. When
granting such exemptions, the Agency will consider: whether regis.
tration is imminent (final printed labeling waiting approval);
the type of pesticide; the need for such action; and the regis-
trant's ability to maintain control over the product to prevent
itssalepriortoregistration.
Upon receiving EPA ap-proval of the exemption request, the
registrant must contact each EPA Region and State involved and
inform them of the shipments. The registrant must provide the
Regions and States with exact shipping data including the point
of origin, the date of shipment, the name of the carrier, the
name and address of the consignee, the name and telephone number
of the responsible person at the consignee's, and the expected
date of arrival. The registrant must also provide the Regions
with a plan for control and handling of the product to prevent
its sale or use prior to registration. If the product does not
become registered as anticipated, the registrant must notify the
Regions and States immediately and no further shipment or dis-
tribution of the product is allowed until it is fully registered.
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2 - 3.1
Failure to fulfill the conditions of the exemption or sale
of the product at the distributor level prior to registration
is a violation of Section 12(a)(1)(A) of FIFRA.
See Also:
Regi stration.
References :
March 21, 1978 letter from A. E. Conroy II, Director, PTSED,
to Ingrid K. Allen, Registration Coordinator, Agricultural
Ch em icals Division, Fisons, Inc. ;
Key Words;
Exemptions, Shipment, Unregistered Pesticides.
.E. Conroy
Pesticides and/oAic Substances
Enforcement Division
MAY
J_£
Date
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FIFRA COMPLIANCE PROGRAM POLICY No. 3.2 •
Distributor Registrations
FIFRA Section: 3
Issue:
May a distributor repackage a pesticide which it intends to
sell under a supplemental registration?
Pol icy:
A distributor may repackage a pesticide it sells under a
supplemental registration only if it is under contract to the
basic registrant to do so.
Discussion:
Manufacturing or packaging a pesticide under contract and
distributing a pesticide under a supplemental registration are
two separate activities.
Section 3(b)(l) of FIFRA and the regulations at 40 CFR
162.5(o)(l) allow for the transfer of an unregistered pesticide
from one registered establishment to another registered establish-
ment operated_ by the same producer .sol ely for packaging or use as
a constituent' part of another pesticide produced at the second
establishment. The.term "operated by the same producer", is
defined at 40 CFR 162.3(dd) to mean another establishment owned
by the registrant or an establishment operated by a person under
contract to the registrant.
Under supplemental registration, a distributor of a registered
pesticide product is permitted to market that pesticide product
under the distributor's brand name if it adheres to the conditions
described at 40 CFR 162.6(b)(4)(i). The regulations require, in
part, that distributor products be manufactured and packaged by the
same person who manufactures and packages the previously registered
pesticide product (40 CFR Part 162.6 (b) (4) (i ) (B)). Labeling is
considered as part of packaging for the purposes of these regula-
tions. . These provisions preclude more than one person from producing
a product.
The contract manufacturing policy may be applied to situations
where a person, under contract to a manufacturer to produce or
repackage a product, also wishes to distribute the product under
a supplemental registration, a supplemental registrant (distributor)
may repackage a pesticide, which it intends to sell under its own
brand name, only if it is under contract to the basic registrant to
do so. Where such a contractual arrangement exists, the supplemental
registrant acts as an agent for the basic registrant and is held
to the same standards of adulteration and misoranding imposed on the
registrant at the time of registration.
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2 - 3.2
A supplemental registrant under contract to the basic registrant
may also label or repackage the product for other distributors.
However, the product must bear the contractor's (supplemental regis-
trant's) establishment number and the distributor number assigned to
the firm whose brand name appears on the label.
Any supplemental registrant's (distributor's) name appearing
on the label must be qualified by terms such as "packed for",
"distributed by", or "sold by".
The Agency feels that this policy protects both the public and .
the environment for several reasons. The product produced by the
contractor is fully registered with EPA by the basic registrant;
In, addition the product must conform to the standards held for the
basic registration and to the requirements for supplemental regis-
trations.
Liability for any violation of Section 1? in such a contractual
arrangement may rest with either or both parties to the contract
depending upon the circumstances associated with the violation.
See A1 so:
FIFRA Compliance .Program Policy No. 3.6., Contract Manufacturing
References: . . •
40 CFR Part 162. 26(b)(4)(i), (11), (iii).
Memo of August i9, 1977, from A. E. Conroy II to Ed Johnson,
OPP, titled "Contract Manufacturers".
Memo of December 13, 1976, from A. E. Conroy II, PTSEO, to
Regional Enforcement Division Directors and Pesticide Branch
Chiefs titled "Relation Between Contract Manufacturers and
Packagers and Distributors of Supplementary Registered P.roducts".
Key Words:
Contract Manufacturing, Distributor Registrations, Repackaging,
Supplemental Registrations.
A. E. Conroy 11 Director
Pesticides andfTo/xic Substances
Enforcement DivVsion
' y 0 1582
Date
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FIFRA COMPLIANCE PROGRAM POLICY No. 3.3
Fumigation of Truck Vans on Flatbed Rail Cars
FIFRA Section; 3
Issue:
Will EPA, in the absence of specific label directions, allow
the fumigation of truck vans with pesticide products that generate
phosphine gas while the vans are being transported on flatbed rail-
road cars?
Pol icy:
EPA will allow truck vans being
rail cars to be fumigated provided:
transported on flatbed
1) the pesticide label contains directions which allow
the use of the product in sealed boxcars and hopper
cars while in transit, on the commodity being carried
in the truck van, and these directions are followed;
2) the truck vans are sealed and placarded during
fumigation; and
3) the truck vans are ful 1-y aerated in accordance with label
di rections1-prior to removal from the flatbed rail car.
For the purposes of this policy, a truck van is defined
as the container portion of any highway truck, trailer or semi-
trailer having a demountable chassis.
Discussion:
The Agency finds that the use of aluminum phosphide products to
fumigate truck vans while the vans are being transported on flatbed
rail cars is allowable provided the conditions mentioned above are
met.
This policy also applies to all other registered products which
generate phosphine gas and bear directions for use in sealed boxcars
and hopper cars. The Agency feels that the construction of truck
vans is sufficiently similar to the construction of boxcars and
hopper cars that there is no greater risk of exposure to phosphine
gas during and after fumigation on rail cars provided that care is
taken to properly seal, label, and aerate the truck vans. EPA
feels that fumigation of truck vans while on rail cars provides
the least risk of exposure when compared to other alternatives.
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2 - 3.3
The Agency will not extend this interpretation to allow
the fumigation of truck vans being transported over the highway
because of concerns that the driver and other members of the public
could be exposed to phosphine gas.
Key Uords:
Aluminum Phosphide Products, Fumigation, Labeling, Phosphine
Gas, Phostoxin, Rail Cars, Truck Fumigation, Truck Vans.
A.' E. Conroy I.I/ Director
Pesticides and Tbxi/c Substances
Enforcement Divj/sion
w
'0 £82
Date
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FIFRA COMPLIANCE PROGRAM POLICY No. 3.4
Custom Blenders
FIFRA Section; 3
Issue;
Are custom blenders of pesticides subject to the requirements
of Section 3 of FIFRA?
Policy; ' '
Although custom blenders of pesticides are subject to the
registration requirements of Section 3, they need not meet these
requirements when certain prescribed conditions are met.
Pi scussion; * •• '
Section 3 of FIFRA requires any person who produces a pesticide
to register that pesMcide w*th the Administrator before selling or
distributing it. Custom blenders provide the service of mixing pes-
ticides to a customer's specifications, usually a pesticide/s)-ferti-
lizer(s) or pesticide-pesticide mixture. Custom blending is considered
production under Section 3. The Agency, however, has determined that
registration of certain custom blends is not nece'ssary to fulfill the
intent of FIFRA. • . • .
In order for a custom blender to avoid liability for failure
to meet the requirements of Section 3, the following conditions must
be met:
1) the blend is prepared to the order of the user and is
not held in inventory by the blender; and
2) the pesticide(s) used in the blend bears end-use
labeling* directions which do not prohibit use of the
product in such a blend; and
3) the blend is prepared in a registered establishment;
and
4). the blend is delivered to the user together with:
* The term "end-use labeling" means labeling containing directions
for use in pest control and otherwise meeting the requirements of
40 CFR 162.10. Labeling indicating that a product is intended only
fijar use in manufacturing or formulating pesticides shall not be;con-
sideredend-uselabeling.
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a) a copy of the end-use labeling of the
pesticide used in the blend, and
b) a statement specifying the composition
of the mixture.
The Agency feels that the public will be adequately protected without
Section 3 registration of custom blends if custom blenders meet these
criteria.
If a custom blend does not meet the criteria listed above, it
must be registered as a pesticide in accordance with the requirements
of Section 3.
^-
The limited obligations of custom blenders under Section 3
are independent of their obligations under FIFRA Sections 7 and 3.
See Also:
Custom Blenders - FIFRA Compliance Program Policy No. 7.1,
Policy and Criteria Notice 2000.1
References:
Memo to Pesticide iranch Chiefs and Enforcement Division
Directors from Edwin L. Johnson and A. E. Conroy II, dated
September 3, 1975, titled "Interim Regulations Regarding
Registration of Custom Blends and Custom Blending Establish-
ments."
Memo to Pesticide Branch Chiefs from A. E. Conroy II, dated
September 10, 1980, titled "Custom Blender's Identification
for ERSS."
PR Notice 73-1
Key Words:
Custom Blenders, Fertilizer-Pesticide Mixtures, Registration.
A.E. Conroy II,/Director
Pesticides and Ld'xic Substances
Enforcement Division
•••# I Q (982
Dace
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FIFRA COMPLIANCE PROGRAM POLICY NO. 3.5
Production of Pesticides for Personal Use
FIFRA Sections: 3, 7
Issue:
May a person lawfully produce a pesticide for his own use
without registering his product or establishment?
Pol icy:
Generally, a person may lawfully produce a pesticide for
his own use without registering his product or establishment.
Discussion;
Section 3 of FIFRA requires a pesticide producer to register
his product only if he sells or distributes the pesticide.
Furthermore, the regulations (40 CFR Part 167) which address the
registration of pesticide producing establishments under FIFRA
Section 7 state that persons who produce pesticides solely for
application by themselves are not required to register th.eir
establishments. Thus, a person who produces a pesticide solely
for personal use is not required under FIFRA to register the
pesticide or th'e producing establishment.
The Agency considers any application of an unregistered
pesticide for other than personal use to be distribution of an
unregistered pesticide, a violation under Section 12(a)(l)(A)
of FIFRA. This includes applying an unregistered pesticide to
another person's property for other than monetary consideration.
Furthermore, a person applying an unregistered pesticide for
hire, only to provide a service of controlling pests without
delivering any unapplied pesticide to any person so served, would
be considered a distributor and, is therefore, subject to the
higher penalties set forth in section 14(a)(l) and 14(b)(l) of
FIFRA. (see S. Rep. .No. 95-1138, 95tn Cong., 2nd Sess. 44-45
(1978)).
References:
Memorandum to Roy Clark, Region IV, dated April 9, 1981
titled "Interpretation of FIFRA §162.4(c) (6).
Senate Report No. 95-1188, 95th Congress, 2nd Session
44-45 (1978).
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2 - 3.5
Key Words:
Establishment Registration, Product Registration.
A/E. Conroy II, Dfreo'tor
Pesticides and Toxic/Substances
Enforcement DivisJ'on
Q 1982
Date
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FIFRA COMPLIANCE PROGRAM POLICY NO. 3.6
Con tract "'Manufacturing
FIFRA Section: 3(b)(1)
Issue:
May an unregistered pesticide be lawfully transferred
between two separately owned registered establishments?
Policy:
An unregistered pesticide may be lawfully transferred
between two separately owned registered establishments if
one establishment is operating under contract to the other.
Under such a contractual arrangement, the establishment under
contract must produce the product in question solely for the
company to,, whom it is under contract.
Discussion:
Section 3(b) of FIFRA provides an exception to the general
requirement of Section 3(a-) that all pesticides moving in commerce
be registered. Specifically, Section 3(b)(l) of FIFRA provides
that an unregistered pesticide may be transferred if:
. . . the transfer is from one registered establ i shm'ent
to another registered establishment operated by the same
producer solely for packaging at the second establishment
or for use as a constituent part of another pesticide
produced at the second establishment ....
The phrase "operated by the same producer" as used in
Section 3(b)(l) has been defined in 40 CFR 162.3(dd) to mean:
. . . (1) another registered establishment owned by
the registrant of the pesticide product or (2) another
registered establishment operated under contract with
the registrant of the pesticide either to package
the pesticide product or to use the pesticide as a
constituent part of another pesticide product, pro-
vided that the final pesticide product., is registered
by 'the transferor establishment.
Under such a contractual arrangement, the establishment
under contract must produce the product solely for the company
to whom it is under contract.
-------
2 - 3.6
Any attempt by the establishment under contract to sell or
distribute the product to another person would be considered
sale or distribution of an unregistered pesticide under Section
12(a)(l)(A) of FIFRA. The basic registrant is responsible for
any product produced by an establishment under contract.
The following are acceptable activities under the contract
manufacturing policy:
Company A, the end use registrant may contract with Company B
to manufacture an end use product or process an intermediate
formulation Into an end use product. Company A may also contract
with company B to produce a technical substance which company A
into an end-use product. Company B may contract
to perform some or all of its contract obligations
At no time, however, may Company B'or C sell or
end use product to anyone other than Company A.
also contract with Companies 0 and £ to produce the
then processes
with Company C
with Company A.
distribute the
Company A may
same technical substance or the same end use product or to process
the same intermediate into the same end use product.
The Agency feels that this contract manufacturer policy
protects both the public and the environment for several reasons.
The product is fully registered with EPA by the company letting
the contract, and the product must conform to the standards held
for the basic registration. Both companies may be held liabje
for any product found in violation of FIFRA. .
See Also : r
FIFRA Compliance Program Policy No. 3.2, Distributor
Registrations.
References:
Memo of August 19, 1977, from A. E. Conroy II, PTSED to
Ed Johnson, OPP titled "Contract Manufacturers."
Key Words:
Contract Manufacturing, Distributor Registrations,
Establishment Transfer, Unregistered Pesticides.
A. E. Conroy
Pesticides ard
Enforcement
i rector
'bxic Substances
i v i s i o n
MAY I 0
Date
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FIFRA COMPLIANCE PROGRAM POLICY SECTION 4 INDEX PAGE
Written Examinations for Private Pesticide 4.1
Applicators
-------
FIFRA COMPLIANCE PROGRAM POLICY No. 4.1
Written Examinations for Private Pesticide Applicators
FIFRA Section; 4(a)(l)
Issue:
May a State Certification Plan approved by EPA under FIFRA
require a private pesticide applicator to pass a written examina-
tion to become certified or recertified?
Pol icy:
A State Certification Plan may require a private applicator
to pass a written examination or other equivalent method of
evaluating competency as a prerequisite to becoming certified or
recertifi ed.
Pi scussion;
Under FIFRA Sections 3(d) and 12(a)(2)(F), applicato'rs must
be certified before they may legally obtain and use pesticides
classified for restricted use. FIFRA Section 4 establishes two
different routes for certification: certification by a State
pursuant tn a Plan approved by the Administrator, or certification
by the Administrator in cases where States have chosen not to
submit a Plan. Only two States, Colorado* and Nebraska, do not
have plans for certification of pesticide applicators.
FIFRA Section 4(a)(2) describes the criteria used by the
Administrator in d-eciding whether to approve a State-submitted
Certification Plan. Section 4(a)(2)(E) states that a Plan sub-
mitted by a State must contain "satisfactory assurances that State
standards for the certification of applicators of pesticides con-
form with those standards prescribed by the Administrator" under
FIFRA Section 4(a)(l). Section 4(a)(l) provides that a State
Certification Plan must specify a method by which an applicator
will establish his competency.
Under FIFRA, the Administrator may not require a private
applicator to pass an examination to establish competency for
certification or require a State Plan to contain such a provision.
* Colorado i s in the process of developing a certification plan,
which will initially cover only commercial applicators.
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- 2 -
FIFRA Section 4(a)(l) prohibits the Administrator from requiring
private applicators to pass an examination to establish competency
for certification in EPA-administered certification programs.
Section 4(a)(l) also specifies "... That the certification standard'
for a private applicator shall, under a State plan submitted for
approval, be deemed fulfilled by his completing a certification form
..." However, a State may wish to adopt a certification program
which is more stringent than that prescribed under FIFRA Section 4
and related regulations. A State may on its own initiative choose
to require a private applicator to pass an examination to establish
competency for certification.
EPA's policy of.accepting State Certification Plans which require
private applicators to pass written examinations is supported by the
lack of a statutory prohibition against such an action and the legis-
lative history. The Senate and House conference report clearly
affirmed the right of a State to require the passing of a written
examination by a private applicator. The right of a State to require
the passing of a written examination by a private applicator has
been of fir.*:**1 EPA policy since the passage of FIFRA. Pursuant to
this policy :he Administrator has approved State Plans requiring the
passing of a written examination by a private applicator as well as
State Plans using methods other than written examinations to establish
private applicator competency.
See Also:
Reference:
Letter dated August 30, 1982 from Edward C. Gray, Acting
Associate General Counsel, Pesticides Division to Mr. Frank
Graham, Florida Department of Agriculture, re: State --Imposed
Requirement for Examination of Private Applicators.
Letter dated November 16, 1982 from Robert M. Perry, Associate
Administrator for Legal and Enforcement Counsel and General Counsel
to J. T. Griffiths, the Citrus Growers Association, subject: State
- Imposed Requirements for Examination of Private Applicators.
Key Words:
Establi sh
certi fi cati on.
competency, written exami nati-on, private applicator
A. E. Conroy II, Director
Compliance Monitoring Staff
Office of Pesticides and Toxic Substances
1983
Date
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FIFKA COMPLIANCE PROGRAM POLICY SECTION 7 INDEX PAGE
TITLE NUMBER
Custom Blenders 7.1
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FIFRA COMPLIANCE PROGRAM POLICY No. 7.1
Custom Blenders
FIFRA Section; 7
Issue:
Are custom blenders of pesticides subject to the requirements
of Section 7?
Pol icy;
Although custom blenders of pesticides are subject to the
Section 7 establishment registration requirements they are not
required to meet the reporting requirements of Section 7 if they
meet certain conditions.
Discussion:
r ______
concern'ing p r o -
lations promul
that a custom
rements of
Custom blenders provide the service of mixing pesticides
to a customer's specifications. The custom blend is usually a
pesticide(s)-fertilizer(s) mixture or a mixture of pesticides
derived from an end-use formulation.
The Agency has, however, determined that subjecting custom
blending establishments to all provisions of Section 7 is not
necessary for effective regulation of the industry. • Therefore
the Agency will not require producers of those ble-nds exempt
from Section 3* to meet certain Section 7 requirements.
requires that all pesticide producers must
hments in which they produce pesticides.
n fho Anonrv annual rann rt e r/inrorn'inn nrn_
*To be exempt from Section 3, a custom blend must meet the following
requi rements:
1) the blend is prepared to the order of the user and is
not held in inventory by the blender, and
2) the pesticide(s) used in the blend bear(s) end-use labeling
directions which do not prohibit use of the product in such
a blend, and
3) the blend is prepared in a registered establishment, and
4) the blend is delivered to the user together with:
a) a copy of the end-use labeling of the pesticide
used in the blend, and
b) a statement specifying the composition of_the mixture.
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2 - 7.1
All custom blenders, whether or not their blends must meet
Section 3 requirements, must register their establishments with EPA
This is necessary to provide the Agency with the locations of pes-
ticide blending operations. The Agency will use'this information in
scheduling Section 8 inspections and in tracing contaminated or oth
pesticides in violation of the law.
i
Custom blenders whose blends need not meet Section 3
requirements are not required to report on amount produced at
the establishment or to place their establishment number on the
pesticide produced. Normally, the Agency requires the establish-
ment number to be placed on a product in order to allow EPA to
trace a shipment of pesticides which may be in violation of the
Act. Since a custom blend'is used within a day or two of purchase
and the user knows the person who manufactured the blend, placing
the establishment number on the blend has little value.
Production data is required for registered pesticides, so
the Agency knows how much of a pesticide is produced and who pro-
duces it. This information is useful not only to know the total
production of pesticides but to assist EPA in recall actions or
other actions where knowledge of production is essential. Because
EPA does not require custom blenders to meet the Section 3 require-
ments of FIFRA, the Agency would not be consistent in asking for
production information on a blend which does not require registrati?
Custom blenders remain subject to the provisions of Section a*
of FIFRA as well as to all requirements relating to proper use of
pesticides including transport, storage and disposal.
See Also:
Custom Blenders - FIFRA Compliance Program Policy No. 3.4
References:
See references in FIFRA Compliance Program Policy No. 3.4
Key 'dords:
Custom Blenders, Establishment Registration, Reporting.
Conroy II/Di/ector
Pesticides and/Tox/c Substances
Enforcement
iVjAY I 0 IQQ?
Date
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FIFRA COMPLIANCE PROGRAM POLICY SECTION 10 INDEX PA'"
TITLE NUMBER
Release of Pesticide Production Data 10.1
-------
FIFRA COMPLIANCE PROGRAM POLICY No. 10.1
Release of Pesticide Production Data
FIFRA Section; 10
N
Issue:
Under what circumstances will EPA release yearly production
data for particular pesticides?
Policy:
The EPA will not release an individual producer's production
data for a specific pesticide. The Agency will release production
data in the aggregate, without individual producer identification,
at the request or order of an EPA Administrative Law Judge in a
data compensation proceeding under FIFRA Section 3(c)(l)(0). In
such a case, the EPA will indicate the confidential nature of the
data to une Judge. When EPA responds to a Congressional request
for confidential data, the Office of Legal Counsel will decide
whether co release the data.
Discussion;
Production data which producers submit under FIFRA Section
7(c)(l) is confidential (Section 7(d)) and thus may not be released
by EPA (Section 10(b)). In many cases, aggregate yearly data which
does not identify individual producers may not be confidential.
However, there is a risk, in some cases, that the requestor may
ascertain the identities of individual producers when combining
the aggregate data with other information in his possession.
The Freedom of Information Act (FOIA)(5 U.S.C. Section 552)
does not require an Agency to create a record in respons.e to an
FOIA request. The EPA regulations state: "The Freedom of Infor-
mation Act does not require the creation of new records in response
to a request ... The Act establishes requirements for disclosure
of exi sting records" (40 CFR Section 2.105(a), emphasis added).
The UnitedStates Supreme Court has endorsed this reading of FOIA;
NLRB v. Sears Roebuck, 421 U.S. 132, 161-162. Aggregation of
pesticide production data submitted to EPA is clearly the creation
of new records.
While EPA could choose to release aggregate pesticide production
data even where not required by FOIA, it has decided not to do so
due to the risk of unintended disclosure of confidential data.
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2 - 10.1
FIFRA Section 10(b) authorizes the release of certain
confidential pesticide data to other Federal agencies; however,
production data is not included. Also, FIFRA does not .authori ze
the release of production data to States. Therefore, EPA will
not routinely release individual or aggregate production data to
other Federal Agencies or States. Release of confidential pesti-
cide data to Congress, including the General Accounting Office,
is governed by EPA-wide policy (40 CFR Part 2). When EPA responds
to a Congressional request for confidential pesticide data, the
Office of Legal Counsel must be contacted, since that Office will
decide whether to release the data.
Reference:
Protective Order, -October 2-2, -1981 , -Union -G-ar-b-ide- -v-. Thompson'
Hayward. FIFRA COMP. Docket Nos. 27 & 45, 40 CFR Part 2.
Key Words:
C-;rT identi al i ty , Establishment Regi strati on ..-Product ion Data.
A. E. Con.roy, 11, D rector
Pesticides and/Toxic Substances
Enforcement
ivsion
i-.nl
0 1982
Date
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FIFRA COMPLIANCE PROGRAM POLICY SECTION 12 INDEX PAGE
TITLE NUMBER
Using Registered Or Experimental Use Permit 12.1
Pesticides In A Manner Not Included On
The Label Or Permit
Pesticides Closed Transfer, Mixing/Loading and 12.2
Application Equipment (Closed Systems)
Authority for Use Inspections 12.3
Making Restricted Use Pesticides Available 12.4
to Persons Without Pesticide Applicator
Ce rt i f i cat i on
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FIFRA COMPLIANCE PROGRAM POLICY NO. 12.1
Using Registered Or Experimental Use Permit Pesticides
In A Manner Not Included On The Label Or Permit
FIFRA Section: 12
Issue;
May a person legally use
pesticide for testing purposes
permit?
Pol icy;
registered or experimental use
not authorized by the label or
A person may legally use a registered or experimental use
-pest i cide--for- testing -pur-p-o-ses—i-n--a--man-rve-r -n-o-t---a-trth-o-ri-ze-d—by—the
label or the permit if:
1. The purpose of the use is only to determine' the
pesticidal value of the substance or its toxicity or
other properties, and
2. No one conducting the test expects to obtain any
benefit in pest control from its use.
In addition, other specific conditions must be met for pesticide
uses as described in 40 CFR Part 172.3(a)(l) for land use, Part
172.3(a)(2) for aquatic use and Pa.rt 172.3(a)(3) for animal
treatments.
Pi scussi on:
The experimental use permit (EUP) regulations provide
at 40 CFR Part 172.2(a) that any person wishing to accumulate
data necessary to register a substance under the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA) may apply
for an EUP for:
o A pesticide not registered with the Agency, or
o A use of a registered pesticide not previously
approved in the registration.
1 "For testing purposes" as defined in this policy refers to pesticide
use for: a land use as described in 40 CFR Part 172.3(a)(l), an
aquatic use as defined in Part 172.3(a)(2) and animal treatments as
defined in Part 172.3(a)(3).
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2 - 12.1
However, those regulations also provide at 40 CFR Part
172.3(a) that a person does not need an EUP to test a substance
or mixture of substances where the only purpose of the test
is to determine Its pestiddal value, its toxlcity or other
properties, and where the persons conducting the test do not
expect to receive any pest control benefit from the tests.
The regulations at 40 CFR Part 172.3(a)(l) state that such
a purpose is presumed for land use tests if:
o The total cumulative acreage treated does not exceed
10 acres for a particular substance or mixture of
substances against a particular pest, and
o The food or feed crops Involved 1n, or affected by
such tests shall be destroyed or consumed only by
.experimental an.imals unless a tolerance or exemption
from the need for a tolerance has been established.
These crops include crops subsequently grown on
such land which may reasonably be expected to contain
residues of such substances or mixtures of substances.
The regulations at 40 CFR Part 172.3(a)(2) state ti.at such
a purpose is presumed for aquatic use tests if:
o The total area treated does not exceed 1 surface acre
of water for a particular substance or mixture of
substances against a particular pest,
o The waters used in such tests will not be used for
irrigation purposes, drinking water supplies or body
contact recreational activities, and
o No such tests may be conducted in any waters which
contain, or which would affect, eny fish, shellfish
or other plants or animals taken for recreational or
commercial purposes unless a tolerance or exem-ption
from tolerance has been established.
The regulations at 40 CFR Part 172.3(a)(3) state such a
purpose is presumed for animal treatments if:
o The tests are conducted only on experimental animals,
and
o No animals may be tested if they may be used in food
or feed unless a tolerance or an exemption from tolerance
has been established.
2 This poli cy does riot limit, but rather supplements the existing
policy regarding uses not authorized by the label but allowed under
FIFRA §2(ee).
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3 - 12.1
The regulations also state at 40 CFR Part 172.3(c) that an
EUP is not required if a registered pesticide is used in a
test to determine its pesticidal value for a use not set forth
on the label if the requirements at 40 CFR Part 173(a) are met.2
It 1s not a misuse violation of FIFRA to use a
non-registered substance in tests to determine pesticidal
value, toxlcity or other properties under the previously-cited
restrictions. Therefore, 1t is also not a violation to use
a substance with an EUP in a manner contrary to the provisions
of the permit, if the use is in tests which meet the conditions
at 40 CFR Parts 172.3(a), 172.3(a) (1),' 172.3(a)(2) and 172.3(a)(3)
a s set forth above.
See AlsoT - - ••
FIFRA Compliance Program Policy No. 2.2 - Use Recommendations
Key Words:
Experimental Use Permit (EUP), 2(ee), Use Recommendations.
'E. Conroy II, Director
Pesticides and Toxi a Sub/stances
Enforcement Division
MAY I 0 £8?
Date
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FIFRA Compliance Program Policy No. 12.2
Pesticides Closed Transfer, Mixing/Loading and
Application Equipment (Closed Systems)
FIFRA Section:
12(a)(2)(G)
I ssue:
Will the Environmental Protection Agency take an enforce-
ment action under FIFRA Section 12(a)(2)(G) against the operator
who uses a closed system to mix, load, transfer or apply pesticides
without wearing the personal protective equipment required by
the pesticide product label?
P o 1 i cy : *
The Agency will not take an enforcement action under FIFRA
Section 12(a)(2)(G) against the operator of a closed system who
does not wear the persons^ protective equipment required by the
pesticide product label, provided the conditions outlined in
this poli cy are met.
Pi scuss ion:
The FIFRA Compliance Program Policy No. 12.2 issued May 10,
1982 said the Agency would take enforcement action under Section
12(a)(2)(G) against the operator for not wearing personal protec-
tive equipment required by the label if a closed system was used
in transferring, mixing, loading or applying pesticides.
The California Department of Food and Agriculture and the
Arizona Board of Pesticide Control petitioned the Agency to
reconsider the May 10 policy. They stated that the pesticide
label directs safety requirements at the most hazardous pesticide
use situations without considering less hazardous situations.
Further, the May 1982 policy may actually hinder the development
of new equipment designed to safely handle pesticides.
The Agency's position is that wearing the personal protective
equipment required by the pesticide label provides the greatest
level of user protection. However, the Agency recognizes that
technological and engineering advancements have made significant
contributions in the field of pesticide use safety. One such
advancement is the development of closed systems.
*This policy replaces FIFRA Compliance Program Policy
No. 12.2 issued May 10, 1982.
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-2-
For purposes of this policy, a closed system is hardware
designed to empty and rinse pesticide containers, mix or dilute
the pesticide, and transfer the pesticide, its diluents, and
the container rinsing agent to the application equipment without
permitting the pesticide to escape.
Preliminary field experiences indicate that the incidents
of pesticide exposure to persons operating a closed system gen-
erally arise due to one of the following conditions:
o Pesticide leaks at seals, gaskets, hoses, or seams caused
by worn or poor quality parts, or by parts eroded when the
chemicals are allowed to stand in the container.
o Pesticide leaks at the couplings caused by high internal
pressures or incomplete coupling due to non-matching parts
or operator carelessness.
o Improper use of equipment due to disregard for proper
mixing/loading proced^cs or lack of training.
There are, however, many documented instances when a closed
system has been used without resulting in an exposure from its
use. Therefore, the Agency will amend its May 10, 1982, policy
and will not take an enforcement action if the operator can show
the following:
o Records are available for the current operating year which
show that a cleaning schedule and maintenance program (which
includes flushing the system so that pesticides are not
allowed to stand in the system for more than one work day)
has been developed and is administered.
o Records are available which indicate that the operator has
received training (when, by whom) in operating procedures as
prescribed by the closed system manufacturer and has been
informed of the potential hazards of closed system misuse
or improper maintenance before using.
o Written instructions for operating the system are posted on
or near the closed system.
o All personal protective equipment required by the label is
available for the operator at all times during mixing and
loading or transfer operations.
Notwithstanding the requirements of this policy, if all of
the personal protective equipment required by the label is not
worn while using a closed system and a pesticide exposure occurs,
the Agency may take an enforcement action under FIFRA Section
12(a)(2)(G) against the operator of the closed system.
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-3-
See Also:
FIFRA Compliance Program Policy No. 12.2 "Closed Application
System" issued May 10, 1982.
The Pesticide Misuse Review Committee (PMRC) Advisory Opinion
Nos. 14, 18, 125, 205, 293, and 315.
October 12, 1982 letter from Ms. Lori Johnston, Assistant
Director, Pest Management, Environmental Protection and Worker
Safety, Department of Food and Agriculture, State of California
to Mr. Edwin Johnson, Director, Office of Pesticide Programs,
EPA.
July 1, 1982 letter from Mr. R. W. Sweet, Administrator,
Board of Pesticide Control, State of Arizona to Mr. Phillip C.
Martinelli, Director, Division of Plant Industry, Nevada Depart-
ment of Agriculture, State of Nevada.
References:
"Closed System Update" by R.W. Brazelton, N.B. Akesson, and
K.T. Maddy, January 1980.
Key Words:
Closed System, Personal Protective Equipment.
-rr
A. E. Conroy M,/Director
Compliance M on i Wring Staff
Office of Pesticides and Toxic Substances
15 DEC 1983
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FIFRA COMPLIANCE PROGRAM POLICY No. 12.2
Closed Application Systems
FIFRA Section; 12
Issue;
Should EPA take enforcement action if protective equipment
required by the pesticide label is not worn by workers when
mixing and loading pesticides into closed application systems?
Pol icy;
EPA will take enforcement action under Section 12(a)(2)(G)
for failure to wear protective equipment required by the label.
Discussion;
The term "closed application system" means a device or
combination of devices designed to empty and rinse perticide con-
tainers, to mix and/or dilute the pesticide and to transfer the
pesticide to application equipment or a holding vessel v;1thout
permitting pesticides to escape into the surrounding environment.
Generally, any use of a registered pesticide inconsistent
with the product's label is a violation of FIFRA Secti on_ 12(a) (2) (G)
In the case of a closed mixing system with an automatic 'container
opening feature, failure to wear protective clothing required by
the product label would be a violation of this section. It is
pa'rticul arly important to wear protective clothing when using
closed systems because these systems are usually used in conjunction
with especially hazardous pesticides.
Reference:
Pesticide Misuse Review Committee Advisory Opinion # 315
Key Word Heading:
Closed Application System, Misuse
A. E. Conroy IV, 0/rector
Pesticides and/To/ic Substances
Enforcement (Or/i si on
MAY I Q IPS?
Date
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FIFRA COMPLIANCE PROGRAM POLICY No. 12.3
Authority for Use Inspections
FIFRA Section: 12(a)(2)(G), 9(b)
Issue:
May EPA conduct routine "use inspections" where pesticides
are not held for distribution or sale?
Policy;
EPA may conduct use inspections to enforce Section 12(a)(2)(G)
of FIFRA with the consent of the owner or person in charge of the
p r em i s e s.
Discussion:
FIFRA Section 9(a) provides authority for EPA to inspect
establishments .or other places where pesticides are held for
distribution or sale. Upon a showing that there'is reason to'
believe that the provisions of FIFRA have been violated, EPA
inspectors may obtain warrants to inspect such establishments
pursuant to section 9(b).
Notwithstanding the limitation of Section 9, EPA has developed
a program of pesticide use surveillance to enforce Section
!2(a)(2)(G) of FIFRA. This Section makes it unlawful to use a
pesticide in a manner inconsistent with its labeling. To enforce
this subsection and to prevent pesticide misuse, EPA may routinely
undertake "use inspections", as part of a neutral administrative
inspection scheme. However, inspectors must obtain the consent of
the owner or person in charge of the premises to be inspected.
Well established Fourth Amendment principles require that the
consent be knowing and voluntary.
Within the framework outlined above, EPA inspectors may also
obtain samples of pesticides or devices, and samples of any con-
tainers or labeling for such pesticides or devices, if necessary
for the use inspection. Any such samples must be obtained in
accordance with the receipt procedure described in Section 9(a).
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2 - 12.3
Reference:
Letter from William L. Hazeltine to Congressman Harold T.
Johnson dated August 12, 1975.
Key Word Headings;
Inspections, Misuse, Use Inspections.
-ri-
A. E. Conroy 1 1 , XH rsrctor
Pesticides and T^xij/ Substances
Enforcement Division
MAY 10 (982
_
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FIFRA Compliance Program Policy No. 12.4
Making Restricted Use Pesticides Available to Persons
Without Pesticide Applicator Certification
FIFRA Section: 12(a)(2)(F)
Issue:
In a State where the EPA Administrator conducts the pesticide
applicator certification and training program, will EPA take
enforcement action against pesticide dealers who make restricted
use pesticides (RUP's) available for use to persons who are not
certified applicators?
P o 1 i cy:
In a State where the Administrator conducts the pesticide
applicator certification and training program,* EPA will take
enforcement action against any pesticide dealer who cannot
document that the restricted use pesticide made available to
a person who is not a certified applicator will be applied by
a certified applicator.
Discussion:
Section 12(a)(2)(F) of FIFRA states:
It shall be unlawful for any person to make available any
registered pesticide classified for restricted use for
some or all purposes other than in accordance with section
3(d) and any regulations thereunder; Provided, That it
shall not be unlawful to sell, under regulations issued by
the Administrator, a restricted use pesticide to a person
who is not a certified applicator for application by a
certified applicator.
- This policy affects only pesticide dealers making restricted
use pesticides available to uncertified persons in States or
on Indian reservations where the Administrator conducts the
pesticide applicator certification and training program.
States having approved FIFRA §4 State Plans and wishing to
adopt a similar procedure of making restricted use pesticides
available to uncertified persons shall submit to the Adminis-
trator a plan containing minimum standards as outlined in 40
CFR Part 171. Such a procedure should contain the require-
ments as outlined in this policy and in "IX. Purchase By
Uncertified Persons For Use By Certified Applicators" of the
document entitled "Optional Procedures for Classification of
Pesticides Uses by Regulation; Pesticide Use Restrictions"
published in the FEDERAL REGISTER of February 9, 1978 (43 FR
page 5783).
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-2-
The term "make available for use" means to distribute, sell,
ship, deliver for shipment, or receive and (having so received)
deliver, to any person. However, this term excludes transactions
solely between persons, who are pesticide producers ,•• regi strants,
wholesalers, or retail sellers, acting only in those capacities.
EPA has not promulgated rules covering the sale of RUP's to
uncertifed persons but plans to do so in the near future. In
the meantime, EPA's policy is to ensure that RUP's are made
available only to persons, qua!ified to use them safely, without
making- it unduly burdensome for certified applicators to obtain
RUP's.
Until promulgation of the pertinent regulations, the Agency will
implement the following policy:
The Agency will not take enforcement action under FIFRA §12(a)(2)(F)
against any person who can document that he made a RUP available
to an uncertified person for use by an applicator certified for
its use.
Adequate documentation consists of a record for each transaction
either on the sales invoice or in a document accompanying the
invoice, which includes the following information:
(A) The name and residence or business address of the person,
whether certified or uncertified, to whom the RUP is made available^
(B) The name and residence or business address of the
certified applicator who will use the restricted use pesticide,
if this is different from (A)^
(C) The certified applicator's certification number, the
State (or other governmental unit) that issued his cert-i f i cati on
card, the expiration date of the certification, and the categories
in which the applicator is certified, if appropriate.
(D) The product name, EPA registration number, and the
State special local need registration number, granted under
§24(c) of the FIFRA (if any) on the label of the pesticide.
(E) The quantity of the pesticide made available for
use in trie transaction.
(F) The date of the transaction.
At the time of each transaction, EPA recommends that the dealer
obtain the information required in (A)-(C) above and assure himself
that the RUP is made available for use by a certified applicator
by examining one of the following sets of documents:
(1) The original of the certified applicator's certifi-
cation card, and a driver's license or other State,
County or Tribal identification document issued to
the uncertified person to whom the restricted use
pesticide is made available.
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-3-
(2) A photocopy or facsimile of the certified
applicator's certification card, a statement signed
by the certified applicator authorizing the
uncertified person to purchase the restricted use
pesticide on his behalf, and a driver's license
or other State, County or Tribal identification
document issued to the uncertified person to whom
the restricted use pesticide is made available.
(3) A photocopy or facsimile of the certified applicator's
certification card, a copy of a signed contract or
agreement between the uncertified person to whom the
product is being made available for use and the
identified certified applicator which provides for
the use of the restricted use pesticide by the
identified certified applicator and a driver's
license or other State, County or Tribal identi-
fication document issued to the the uncertified
person to whom the restricted use pesticide is made
available.
The Agency will take enforcement actions for first time violations
of FIFRA §12(a)(2)(F) as follows:2
1) If a dealer -sells a RUP to a person who has never been
certified an'd that person did not purchase the RUP for a
certified applicator, a penalty should be assessed fron
the "adverse effects highly probable" ca-tegory of the
FIFRA civil penalty matrix.
2) If a dealer sells a RUP to a person, for his own use,
whose certification has expired more than 12 months
prior, a penalty should be assessed from the "adverse
effects unknown" category of the FIFRA civil penalty
matrix.
Penalties should be assessed in accordance with the FIFRA
Enforcement Policy - Interim Penalty Guidelines, dated
June 11, 1981 from A.E. 'Conroy II, Director, Pesticides and
Toxic Substances Enforcement Division to Regional Enforcement
Division Directors and Pesticide Branch Chiefs and the July 31,
1974, Federal Notice entitled "Guidelines for the Assessment of
Civil Penalties under Section 14 of the Federal Insecticide,
Fungicide and Rodenticide Act as amended"
-------
3)' If a dealer sells a RUP to a person, for his own use,
and his certification has expired within the past 12 months,-
a penalty should be assessed from the "adverse effects not '
probable" category of the FIFRA civil penalty matrix.
4) If a dealer sells a 'RUP to an uncertified person without
documentation to prove the RUP is to be used' by a certified'
applicator, but the RUP is actually applied by a certified
applicator, a notice of warning should be sent for the
first violation.
5) If a dealer sells a RUP to a certified commercial applicator
who is not certified in the appropriate category, a penalty
should be assessed from the "adverse effects not probable
category of the FIFRA civil penalty matrix.
Penalties for dealers continuing to make RUP's available for use to
uncertified persons for use by certified applicators without the
necessary documentation should be assessed under-the "adverse effects
highly probable" category of the FIFRA civil penalty matrix.3
See Also;
Federal Register Notice of July 31, 1974, pages 27711-22 entitled
"Guidelines for the As^ssment of Civil Penalties under Section
14(a) of the Federal Insecticide, Fungicide and Rodenticide Act
as amended" [7 U.S.C. 136 1(a)].
FIFRA Enforcement Policy - Interim Penalty Guide!ines,'dated
June 11, 1981, from A.E. Conroy 11,.Oirector, Pesticides and
Toxic Substances Enforcement Division to Regional Enforcement
Division Directors and Pesticide Branch Chiefs.
References
Memo entitled "Enforcement Policies for Products Restricted
through Regulation" dated July 20, 1978, from A.E. Conroy II to
the Enforcement Division Directors and Pesticide Branch Chiefs.
Key Words;
Certified Applicator, Dealer, Make Available For Use, Restricted
Use Pesticide, RUP's, Uncertified Person.
A. E. Conroy In,\Director
Compliance Morn to ring Staff
Office of Pesticides and. Tj3/ic Substances
MAY 1 8 1983
Date
3 EPA will take enforcement action under FIFRA 12(a)(2)(F) and
12(a)(2)(G) against any uncertified person who uses a RUP and
is not under the supervision of a certified applicator.
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FIFRA COMPLIANCE PROGRAM POLICY SECTION 17 INDEX PAGE
-. -NUMBER
Pesticide Processing in Foreign-Trade Zones 17.1
Waiver of Notice of Arri val . Requi rements 17.2
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FIFRA COMPLIANCE PROGRAM POLICY - No. 17.1
Pesticide Processing 1n Foreign-Trade Zones
FIFRA Section: 17(c)
Issue:
Are pesticides which enter a foreign trade zone for further
processing or repackagl ag. .subject ..t.o.. th.e. r.e-qu..i rements. o.f.-E.LF-RA.?
Poli cy:
A product which legally enters a foreign-trade zone for
processing or repackaging is not subject to the requirements of
FIFrtA.
Discussion:
Foreign-trade zones or "freeports" are areas within the United
States where products may be stored, processed, manipulated, manu-
factured and reshipped without being subject to the customs laws of
the United States governing the entry of goods and the payment of
du ty .
Foreign-trade zones are established under the Foreign-Trade
Zones Act and the general regulations and rules of procedure of
the Foreign-Trade Zones Board contained in 15 CFR Part 400. The
regulations contained in 19 CFR Part 146 govern admiss-ion of
merchandise into a foreign-trade zone; manipulation, manufactur-
ing, processing, etc. in a zone; exportation of merchandise from
a zone; and transfer of merchandise from a zone into United States
Customs territory.
In order to be considered exempt from the requirements of
Customs and FIFRA, a pesticide product must be in full compliance
with the laws regarding entry into the foreign-trade zone; be
processed within the zone; and be reshipped to foreign points.
Any product which enters the United States from a foreign-trade
zone is subject to Customs laws and the requirements of FIFRA.
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2 - 17.1
The only products legally entering a foreign-trade zone which
are subject to the requirements of FIFRA are those which were
produced in the United States or which entered into the United
States and subsequently enter the foreign trade zone under the
custody of United- States Customs for processing or repackaging.
References:
19 CFR Part 146
Key Words:
Foreign Trade Zones, Freeports, Processing, Registration,
Repackagi ng.
fa ' <~"
A. £. Conroy II,
Pesticides and T
Enforcement Di
or
Substances
on
MAY I Q ISP
Date
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FIFRA COMPLIANCE PROGRAM POLICY NO. 17.2
Waiver of Notice of Arrival Requirements
FIFRA Section: 17(c). 17(e)
Issue;
Can Importers of multi-use chemicals and pesticides imported
for non-pesticidal purposes obtain a waiver from "Notice of
Arrival" requirements?
Pol Icy:
Importers of multi-use chemicals and pesticides imported for
non-pesticidal purposes can be granted a waiver from "Notice of
Arrival" requirements.
Discussion:
Pesticides and devices imported into the United States must
be in compliance with Section 17(c) of FIFRA. Section 17(c")
states that pesticides or -devices which are adulterated, mis-
branded or otherwise violate *the provisions set forth in the
Act or are injurious to health or the environment may be refused
entry into the country. The Secretary of the Treasury is'
empowered by Section 17(e) of FIFRA to prescribe regulations for
the enforcement of Section 17(c). 19 CFR Part 12.110 through
12.117 regulates the importation of pesticides and devices into
the U.S. The regulations state in part that pesticides and
pesticide products imported into the U.S. will not be released
by U.S. Customs unless accompanied by a completed Notice of
Arrival of Pesticides and Devices form (EPA Form 3540-1). To
assist in monitoring compliance with this requirement, EPA
developed a checklist of frequently encountered pesticides and
distributed it to U.S. Customs commodity import specialists.
Some of the pesticide chemicals which appear on the list
may be multi-use chemicals imported for non-pesticidal uses or
pesticides imported for chemical analysis or other testing. As
a matter of policy, the Agency will allow persons importing
products for such purposes to request a waiver from the Notice
of Arrival requirements. Such requests must be made in writing
to EPA Headquarters and must state (1) the chemical being
imported together with its EPA registration number, if regis-
tered; (2) the purpose for which the product is being imported;
(3) the amount of chemical being imported; and (4) if known, the
.port of entry (If there is more than one, all ports of entry
should be listed).
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2 - 17.2
If EPA Headquarters approves the request, a copy of the
request and the waiver granted will be sent to each affected
Region.
To expedite future shipments, the Regions should encourage
importers to file a copy of the waiver with Customs for each
subsequent entry of the product.
References;
FIFRA Compliance Program Policy No. 2.4, Multi-Use Chemicals,
19 CFR Part 12.110 through 12.117. •
Key Words:
Imports, Multi-Use Products, Notice of Arrival.
A. E. Conroy 11/, Director
Pesticides andjToxi^/ Substances
Enforcement D\ivis^on
MAY . .
Date
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FIFRA COMPLIANCE PROGRAM PULICY SECTION 24 INDEX PAGE
TITLE NUMBER
Special Local Needs Labeling 24.1
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FIFRA COMPLIANCE PROGRAM POLICY No. 24.1
Special Local Needs Labeling
FIFRA Section: 24(c)
Issue:
Wi'l 1 the Agency permit a registrant to print or affix Section
24(c) (Special Local Need) labeling on Federal labeling?
Pol icy:"' •- -- - ....
The Agency will permit Section 24(c) labeling to appear on
Federal labeling under certain conditions.
Discussion:
Sectio.n 24(c) of FIFRA states that a State may register addi-
tional uses of federally registered pesticides for di stri buti'on and
use within that State to meet special local needs provided that
no such use has been previously denied, disapproved or cancelled
by EPA. The Agency has 90 days to review such a registration. If
the Agency does not deny a use within this time period, the use is
considered to be registered under Section 3 for distribution and
use only within that State. If the use is for a food or feed
crop, a tolerance or exemption must exist for that use. 40 CFR
Part 162.150-162.156 sets forth the regulations governing tne
registration of products under Section 24(c).
Part 162.153(e) requires that labeling governing any State-
registered uses of a Federally registered product be made available
at the time of use. As a matter of convenience for both the regis-
trant and the user, Section 24(c) use directions may appear on a
Federal label provided the directions are clearly identified and
separate from Federal labeling. Either a distinct border around
the Section 24(c) uses or a sticker which does not obscure the
information on the Federal label is an acceptable means of con-
veying Section 24(c) information. The labeling must also clearly
identify the State in which the Section 24(c) use is allowed. If
a specific identical use has been registered in a number of States,
the registrant may list all the States which have registered the
use. The registrant must use the statement "For distribution and
use only within (name of State(s)" on all Section 24(c) labeling.
A product bearing Section 24(c) uses on the label may only be sold
in those States listed.
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2 - 24.1
This policy applies only to additional State registered uses
of a Federally registered product. Lt does not not apply to
State registered products.
See Also:
Section 24(c) Registration Guidelines 40 CFR Part 162.150-162.156,
i
References:
Letter of June 23, 1977 from A. E. Conroy II to Mr. Arthur F.
Gohlke, Cities Service Company.
. \+
Key Uords:
Intrastate Use, Labeling, Special Local Need, 24(c).
A. I. Ccnroy 11 ,/OTrb'Ctor
PesticHes and Toxi Substances
Enforcement D/ivi/ion
MAY i
Date
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FIFRA COMPLIANCE PROGRAM POLICY SECTION 25 INDEX PAGE
HUE NUMBER
Child Resistant Packaging ' 25.1
-------
C h i 1 d •"> e s i' t ci n t P li c k £~ i 'i r ...
FIFRA Section: 25(c)(3)
I ssu.e:
Are small packages of pesticide products whicn are labeled
"For Agricultural Use Only" or which have directions expressed
in number of pounds per: acre but which are marketed for homeowner
use automatically excluded from the Child Resistant Packaging
( CP.P ) requi rement?
Poli cy:
Labeling a- pesticide "For Agricultural Use Only" or expressing
the dosage rate in pounds per acre, label language usually reserved
for "agricultural" products, does not automatically remove the
pesticide from the Child Resistant Packaging requirements.
Discussion:
The Child Resistant Packaging Regulation, 40 CFR 152.15,
requires a pesticide to be in such c-ackag.i ng if it meets certain
criteria. One criterion is that the product is intended for use
in. on or around all structures, vehicles or areas associated >> i t n
the household or homelife.
Labeling a—product "For Agricultural Use Only" removes a
product from the CR? recui rement .only if the label statement is
consistent with other label language and ma r'< 2 t.i n : practices for
agricultural use. If, for example, the product is marketed in
Expressing the use directions in terms of number of pounds
per acre do-33 not in or by itself preclude rc-3 i de~ t ? £ i use. This
also wo'j'd net affect whether cr not a prod-jc" reuu"'" = 3 Cu?.
Therefore, where the package size is small, the product is
marketed, in home and garden stores, cr "he entire net contents,
if applied at the labeled dosage rate, would only cover 3 limited
area, such as a home garden clot, CRP wo'jlc b= requires if th3
CR? criteria are met regardless of whether the label also states
"For A-ricu 1 tural lisa Cr.ly" or the d:sag£ rate is ixpressed in
agricultural terms, such as pounds per acre.
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-2-
Additionally, a oroduct "ay be ;7n sbranded. iccorci'in.: to
t n e proposed Registration Guidelines for Labeling, if the
dosage rate exceeds the net contents of the product.
References:
40 CFR Part 162.16
Memorandum to Roy P. Clark, Region IV. from A. E. Ccnroy II,
dated July 27, 1982.
Key Words:
Agricultural Use Only
Child Resistant Packaging
Label ing
A . \ E . ' ;S-6 n r o y II, 0 i r ectc r
P e s"'t i c i d e s and Toxic Substance
Enforcement Division
Oats
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FIFHA COMPLIANCE PROGRAM POLICY SECTION 26 INDEX PAGE
TITLE " NUMBER
Transfer of Use Enforcement Primacy to the States 26.1
Referral of State Misuse Cases to EPA 26.2
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FIFRA COMPLIANCE PROGRAM POLICY No. 26.1
Transfer of Use Enforcement Primacy to the States
FIFRA Section; 26
Issue:
At what point does primary enforcement responsibility
for pesticide use violations (primacy)' transfer from EPA to
a State?
Pol 1cy:
Primacy authority 1s transferred to a State when the State
formally accepts a written offer by the Administrator to convey
such authority. Primacy is also transferred when a cooperative
enforcement agreement is signed by the Administrator and the
State, unless the terms of the agreement specify ot'hirwise.
Discussion;
Section 26 of FIFRA authorizes the Administrator to grant
primacy to a State if the State has adopted adequate laws and
adequate procedures for implementing such laws, or if'the State
has an approved certification plan that meets the adequate laws
and procedures criteria. In addition, States may obtain primacy
by entering into a cooperative agreement for the enforcement of
pesticide use restrictions under Section 23 of FIFRA.
To'transfer primacy through the first two mechanisms, the
Administrator will write to the Governor offering to grant
primacy to the State. The Administrator's letter will request
a formal response to the offer of primacy. The transfer of
primary use enforcement responsibility will not be effective
until the Governor or his representative posts a written response
accepting primacy. With respect to the third mechanism, when
a State signs a cooperative agreement which calls for the State
to monitor and enforce compliance with pesticide use restrictions,
such State assumes use enforcement primacy unless the terms of
the agreement specify otherwise. Thus the signing of an agree-
ment which specifically states that the assumption by a State of
primacy depends upon the occurrence of an event does not transfer
primacy authority until the event takes place. Cooperative
enforcement agreements which do not contain such conditions
will serve to convey primacy to a State upon signature of the
Governor and the Administrator or their duly designated
Representatives.
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Key Words:
2 - 26.1
Certification Plan, Cooperative Enforcement Agreement,
Primacy, State Authority, Use Enforcement.
A. E. Conroy II,.Di
Pesticides and Tox
Enforcement Div
HAY 10 1982
Date
bstances
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FIFRA COMPLIANCE PROGRAM POLICY No. 26.2
Referral of State Misuse Cases to EPA
FIFRA Section: 26
Issue:
Is it legally permissible for the Environmental Protection
Agency to prosecute Federal pesticide misuse violations which
are based on evidence collected by State inspectors following
State procedures?
Pol icy:
As long as States follow basic Constitutional evidentiary
procedures, evidence collected under State authority can be used
to prosecute violations of Federal pesticides laws.
Discussion:
Pursuant to Section 26 of FIFRA, most States now exercise
primary enforcement responsibility for pesticide misuse violations.
Although the Federal government retains concurrent authority
with the States to prosecute misuse violations, this power is
not .ordinarily exercised.
Accordingly, States with primacy generally conduct use
inspections under the authority of State law. In the usual
pesticide misuse case, State law provides ample enforcement
authority for the State to effectively prosecute misuse violations.
Consequently, the States need not generally refer misuse cases
to the EPA for prosecution under the parallel Federal authorities.
However, there are two instances where the States may choose
to refer misuse cases to EPA for Federal prosecution:
1) When the misuse is prohibited by Federal law, but not by State
1 aw , or,
2) When both State and Federal law prohibit the misuse, but
the. State lacks adequate resources to pursue prosecution.
When either of these types of misuse cases is referred
to EPA for action, the Agency will review the case file
to ensure that the State inspection procedures adhere to basic
Constitutional guarantees. Information collected by State
inspectors is not excluded in court merely because it is
gathered by State inspectors; instead it is subject to the
common law rules of evidence or to the Federal Rules of
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2 - 26.2
Evidence. The Issue of the admlsslbi1ity of evidence derived
from State inspections involves the analysis of two questions:
(1) was the information and evidence obtained by State inspec-
tors legally obtained, and (2) is that evidence within the scope
of admissible evidence. If both of these questions can be
affirmatively answered for any given information, then that
evidence may be properly introduced into a civil or criminal
proceeding to enforce a violation of the FIFRA.
Accordingly, the wide variety of State inspection procedures
do not affect the capacity of the Agency to accept a misuse case
for prosecution. States may follow their own inspection procedures
without regard to whether or not the misuse case will be referred
to the Agency. The eventual referral of the case to the Agency
for prosecution does not require a State inspector to change any
existing State inspection procedures.
Key Words;
Evidence, Misuse, Privacy, State Authority .
A< E. Conroy II, Di^etnTor
Pesticides and To^fc/Substances
Enforcement
• W I OISS2
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KEY WORD INDEX
FCPP = FIFRA Compliance Program Policy
PCN •= Office of Pesticide Programs Policy and Criteria Notices
Adverti si ng
Aeri al Appli cati on
Agricultural Use Only
Aircraft, Airplane
Aluminum Phosphide Products
Amended Registration
and Classification
2162.1 PCN, 2162.3 PCN
2190.1 PCN
25.1 FCPP
2190.1 PCN
3.3 FCPP
2460.2 PCN
Batch Parameters
2476.1 PCN
Certified Applicator
Certi fication Plan
Changed Use Patterns
Child Resistant Packaging
Chiorof1uorocarbons
Classification
Classification of Disinfectant-
Type Products
Classification Statement
Clean Air Act
Clean Water Act
Closed System
12.4 FCPP
26.1 FCPP
2460.2 PCN
25.1 FCPP
2300.1 PCN
2460.2 PCN
2460.1 PCN
2165.1 PCN
2155.2 PCN
2180.1 PCN
12.2 FCPP
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Commensual Rodenticide Raits
Conditional Registration
Con f i dent i ali ty
Cooperative Enforcement
Agreement
Contract Manufacturing
Custom Blenders
2164.1 PCN, 2164.2 P'CN
3068.2 PCN
10.1 FCPP
26.1 FCPP
3.2 FCPP, 3.6 FCPP
3.4 FCPP, 7.1 FCPP
Data Requirements
Dealer
Dimethyl Sul foxi de.
Di sclaimers
Di sinfectants
Disinfectant-Type Product
Distributor Registrations
Domestic Use
2075.1 PCN
12.4 FCPP
2475.2 PCN
2163.1 PCN
2460.1 PCN
2460.1 PCN
3.2 FCPP, 3.6 FCPP
2460.1 PCN
Emeti c
End Use Product
Environmental Hazard Label
Establish Competency
Establishment Registration
Establishment Transfer
Evi dence
2161.1 PCN
2010.2 PCN
2180.1 PCN
4.1 FCPP
3.5 FCPP, 7.1 FCPP, 10.1 FCPP
3.6 FCPP
26.2 FCPP
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Exempti ons
Experimental Use Permits
Eye Irritation
3.1 FCPP
12.1 FCPP, 2162".3 PCN
2161 .2 PCN
Feed and Pesticide Mixtures
Fertilizer-Pesticide Mixtures
Fi re Retardant
Food Fragrances
Foreign Trade Zones
Freeports
Fumigation
2000.2 PCN
2.1 FCPP, 3.4 FCPP, 2000.1 PCN
2475.1 PCN
2155.1 PCN
17.1 FCPP
17.1 FCPP
3.3 FCPP
Gascons Products
(Under Pressure)
2300.1 PCN
He!i copter
2190.1 PCN
Imports
Inspecti ons
Intra State Use
17.2 FCPP
12.3 FCPP
24.1 FCPP
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Knowledgeable Expert
2.1 FCPP
Label , Labeli ng
Liability Limitations
Liquid Products
2.2 FCPP, 3.3 FCPP, 24.1 FCPP,
25.1 FCPP,
2160.1 PCN
2163.1 PCN,
2170.1 PCN,
2300.1 PCN;
2163.1 PCN
2300.1 PCN
2010.1 PCN, 2076.1 PCI
2161.1 PCN, 2162.1 PCf
2164.1 PCN, 2165.1 PCf
2130.1 PCN, 2190.1 PC!
3085.2 PCN
Mail Order Advertisement
Make Available for Use
Mi suse
Multi-Purpose or Multi-Use
Substances
Multi-Use Products
Multiple Formulations
Multiple Labels
Museum Use
2162.1 PCN
12.4 FCPP
2.1 FCPP, 1 2.2 FCPP,' 12.3 FCPP,
26.2 FCPP
2.1 FCPP, 2050.1 PCN
17.2 FCPP
2000.2 PCN
2010.1 PCN
2030.2 PCN'
New Use Patterns
Non-Crop Application
Non-Cropland
Non-Flammable
Non-Pesticidal Purposes
Notice of Arrival
2460.2 PCN
2160.1 PCN
2160.2 PCN
2300.1 PCN
2.1 FCPP, 2050.1 -PC N
17.2 FCPP . •; :'
Outer Containers
2.2 FCPP
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Personal Protective Equipment
Pesticidal Use
Petitioner Eligibility
Phosphine Gas
Phostoxin
12.2 FCPP
2050.1 PCN
2100.3 PCN
3.3 FCPP
3.3 FCPP
Point Source Discharge Products 2180.1 PCN
Pressurized Products
Primacy
Private Applicator Certification 4.1 FCPP
Processing 17.1 FCPP
Product Registration 3.5 FCPP
Production Data 10.1 FCPP
2300.1 PCN
26.1 FCPP, 26.2 FCPP
Rail Cars
Reentry Statements
Reformulation
' Reformulation of End-Use
Products
Registration
-^.'Released- for Shipment
Repackaged End-Use Products
3.3 FCPP
2076.1 PCN
2010.2 PCN
2010.2 PCN
3.4 FCPP, 3.5 FCPP, 17.1 FCPP,
2010.2 PCN, 2460.2 PCN
2030.1 PCN
2010.2 PCN
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Repackagi ng
Reporti ng
Reregi strati on
Restricted Use Pesticide (RUP)
Rodenticides
3.2 FCPP , 17.1 FCPP, 2010.2 PCM
7.1 FCPP
2476.1 PCN
12.4 FCPP7 . •• ..'.--i:
.2164.1 PCN, 2164.2 PCN
Safening Agent
Seed Treatment
Shi pping Contai ners
Shipment .
Ski n Irri tati on
Sodium Chlorate
Sol vents
Special Local Need
State Authority
Substantially Similar Pesticide
Supplemental Registrations
T
Target Pest
Tolerances
Toxicity Criteria
Trademark Names
Truck Fumigation
Truck Vans
Twenty-four (c), [24(c)]
Two (ee), [2(ee)]
2255 PCN. ...
21 70.1; .PCN '
2.2 F.CP-P'r
3.1 FCPP
2161.2 PCN >
2475.1 PCN
2155.2 PCN
24.1 FCPP
26.1 FCPP, 26.2 FCPP
3060.2 PCN
3.2 FCPP
"'- >i-'
2.1 FCPP
2100.1 PCN, 2100.3 PCN, 2135.1 PO.
2161.2 PCN
2162.2 PCN
3.3 FCPP
3.3 FCPP
24.1 FCPP
2.1 FCPP, 12.1 FCPP
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Uncerti fred Person
r,'cr 1. U n r e g is t
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V)
o
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