United State*
Environmental Protection Toxic SufetaflQM
Agency Enforce wtO**ien
&EPA
Federal Insecticide, Fungicide,
and Rodenticide Act
Compliance/Enforcement
Guidance Manual
Policy Compendium
Volume 5: FIFRA Compliance
Program Policy Compendium
-------
Table of Contents
Volume 5 of the FIFRA Compliance Enforcement Guidance Manual Policy Compendium contains the
FIFRA Compliance Program Policy Compendium documents, issued by the Office of Compliance
Monitoring that are currently in effect. The Table of Contents of the remaining volumes, FIFRA
miscellaneous sources, and a list of obsolete documents are contained in the Appendices.
Any questions or comments concerning these documents should be addressed to:
Director, Policy and Grants Division
Office of Compliance Monitoring (EN-342)
Office of Pesticides and Toxic Substances
U.S. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460
Volume 5: FIFRA Compliance Progam Policy Compendium
Number Title
2.1: Use Recommendations
2.2: Labeling of Outer Containers
2.3: Under the Direct Supervision of a Certified Applicator
in EPA Administered Programs
3.1: Shipment Prior to Registration
3.2: Distributor Registration
3.3: Fumigation of Truck Vans on Flatbed Rail Cars
Date
05/10/82
05/10/82
04/05/85
05/10/82
05/10/82
05/10/82
FIFRA Compliance/Enforcement
Policy Compendium
Guidance Manual
September 1992
-------
Volume 5
Table of Contents
FIFRA Compliance Progam Policy Compendium (continued)
Number Title
3.4: Custom Blender
3.5: Production of Pesticides for Personal Use
3.7: Temporary Conversion of Cropland (Revised)
3.8: The Use of Products Labeled "For Manufacturing Use Only"
to Produce Pesticides for Personal Use
3.9: Status of Supplemental Registration
3.10: Use of California's Methyl Bromide Fact Sheet
4.1: Written Examinations for Private Applicators
7.1: Custom Blenders
10.1: Release of Pesticide Production Data
12.1: Using Registered or Experimental Use Permit Pesticides
in a Manner Not Included On the Label or Permit
12.2: Pesticides Closed Transfer, Mixing/Loading and
Application Equipment (Closed Systems) (Revised)
12.3: Authority for Use Inspections
12.4: Making RUPs Available for Use Other than in Accordance
with Section 3(d) of FIFRA (Revised)
12.5: The Use of a Diluent Not Specified on the Product Label
12.6: Enclosed Cab Use for Pesticide Application
12.7: Enforcement of the Label Improvement Program for
Pesticides Applied Through Irrigation Systems (Chemigation)
Date
05/10/82
05/10/82
02/10/88
08/29/86
07/06/87
09/01/92
07/28/83
05/10/82
05/10/82
05/10/82
12/15/83
05/10/82
07/22/86
02/27/84
08/08/90
06/20/90
FIFRA Compliance/Enforcement
Policy Compendium
ii
Guidance Manual
September 1992
-------
Volume 5
Table of Contents
FIFRA Compliance Progam Policy Compendium (continued)
Number Title Date
17.1: Pesticide Processing in Foreign-Trade Zones 05/10/82
17.2: Waiver of Notice of Arrival Requirements 05/10/82
24.1: Special Local Needs Labeling 05/10/82
25.1: Child-Resistant Packaging 09/01/82
26.1: Transfer of Use Enforcement Primacy to the States 05/10/82
26.2: Referral of State Misuse Cases to EPA 05/10/82
FIFRA Compliance/Enforcement
Policy Compendium
in
Guidance Manual
September 1992
-------
FIFRA COMPLIANCE PROGRAM POLICY COMPENDIUM
A. E. Conroy II, 01 rector
Pesticides and Toxic Substances
' Enforcement Ui vi s io'n
-------
The Compliance Program Policies contained In this compendium
and tne Policy and Criteria Notices published by the Office of
Pesticide Programs 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 Compl1ance Program Policies will supersede all existing
policies.
-------
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
Dy any person without regard to his financial interest 1n the
sale of pesticides?
•
Policy;
To the extent that Section 2(ee) allows a particular use, any
person, regardless of his financial Interest 1n 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 1n applying pesticides for forestry or agricultural
purposes 1s In accordance with the Advisory Opinion Issued March 3,
1981 (46 FR 14965).1
D1 scusslon;
Background
Federal jurisdiction over the use of pesticides was established
through the 1972 amendments to the Federal Insecticide, Fungicide,
and Rodentldde Act (FIFRA), Sections 3(d)(1); 4; 12(a)(2)(6).
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 1s 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 1n the exercise of
its prosecutorlal discretion In the enforcement of FIFRA (40 FR
19526). Such exercise of prosecutorlal 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,
"HSupersedes Federal Register Notice, (Vol. 44, No. 112, Friday,
June 8, 197$, 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 a-pproved by the
Agency.
-------
2 - 2.1
(H.R. Rep. No. 92-511, 92d Cong. 1st Sess., 16 (1971)). in
accord with this Congressional direction, the PTSED 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 12).
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 41142); (PEPS 15).
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 label
does not explicitly proscribe such uses. Thus the question of
"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" could
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 1s
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)(1)(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 1n the sale of
pesticides were forbidden under Section 12(a)(l)(B) from recom-
mending any of the pesticide uses permitted by the PEPS.
-------
3 - 2.1
Federal Pesticide 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 1n a manner
inconsistent with its labeling." According to the language of
this new section, 1t 1s a violation of Section 12(a)(2)(G) to use
a registered pesticide "1ft 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, or
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 12,5);
3) Employ any method of application not prohibited by the
labeling (PEPS 17); and
4) Mix a pesticide or pesticides with a fertilizer when
.such mixture 1s 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 law certain uses which will.
not be considered Inconsistent with labeling even though these
uses are not listed. The PTSEO responded to Section 2(ee) by
publishing a Federal Register Notice which rescinded PEPS numbers
1..2, 5, and 7 (Vol. 44, No. 112, p. 33151). As explained In
the Federal Register, tne PTSED restricted the advocacy of Section
2(ee) uses to user/applIcators. The PTSEO 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 fa no cooperatives there are Individuals
who both use and sell pesticides. These Individuals
were prevented from recommending authorized uses.
T.It should be noted that while the FPA amends existing Federal
law concerning pesticide misuse. It does not purport to affect
State laws.
-------
4 - 2.1
0 Likewise, pest advisors who serve as IPM consultants
or 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 PTSEO position 1s 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. Accordingly, 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 nay advocate that use, provided
that recommendations made under Section 2(ee)(l) pertaining
to the amount of diluent used 1n applying pesticides for forestry
or agricultural purposes Is made 1n 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(ee) to allow beneficial nonlabel pesticide
uses but also provides 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 1n no way
other civil liability of persons
The only change is that the PTSEO
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 Label.
Policy and Criteria Notice 2000.1. Fertilizer-Pesticide Combinations
Key Words; - • • •
Fertilizer-Pesticide Mixture, Knowledge Expert.
Pest, 2(ee), Use Inconsistent with the Labeling, Use
Misuse, Target
Recommendation:
A.' E. Conroy I
Pesticides and,'
Enforcemen
MAT
'i>ector
ic Substances
vision
ite
-------
FIFRA COMPLIANCE PROGRAM POLICY No. 2.2
Labeling of Outer Containers
FIFRA Section; 2(q)
Issue;
When must a label be attached to a shipping container of a
pesticide product?
•
Pol1cy;
A label must be attached to a shipping container of a
pesticide If the customary practice of the manufacturer 1s
to retail the product to consumers without opening the outer
shipping container to sell the product In individual units.
Pi scussion;
Section 2(q)(2)(C) of FIFRA states that a pesticide is
misbranded unless a label 1s affixed to Its container and to
the outside container or wrapper of the retail package.
The regulations at 40 CFR 162.10(a)(4)(1} 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, 1f It 1s 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
1t 1s 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 1n
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
1t 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 1s considered to be misbrandlng and 1s a
violation of Section 12(a)(l)(E).
-------
2.2
References;
Letter of June 16. 1976, from A. E. Conroy II, to
Mr. C. M. Elnhorn of USS Agr1-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/D1/ector
Pesticides and (fox/c Substances
Enforcement Dvx/s1on
MAT
.
D
ate
-------
FIFRA COMPLIANCE PROGRAM POLICY No. 2.3
Under the Direct Supervision of a Certified Applicator
in EPA Administered Programs
/
FIFRA Section 2(e)(4) •
Issue:
What specific operational relationship and oversight
constitute work "under the direct supervision of a certified
applicator" in EPA administered programs?
Pol icy:
This statement of compliance program policy sets forth
the standard that the Agency will employ in determining
whether the use of an RUP was performed "under the direct
supervision of a certified-applicator."
The certified applicator is responsible for assuring
that those working under his direct supervision are qualified
to handle pesticides in general and are competent in the
use (as defined in 40 CFR 162.3{oo)) of specific restricted
use pesticides (RUP).
The certified applicator must maintain oversight of
the pesticide use operation from onset to completion, being
at all times aware of hazards presented by the situation.
Furthermore, the certified applicator in supervising the
work of a noncertified applicator must: (1) determine the
level of experience and knowledge of the noncertified appli-
cator in the use of a pesticide; 2) provide verifiable,
detailed guidance on how to conduct each Individual pesticide
use performed under his direct supervision; (3) accompany
the noncertified applicator to at least one site which would
be typical of each type of pesticide use that the noncertified
applicator performs; (4) be accessible to provide further
instructions at all times during the noncertified applicator's
use of the RUP; (5) to be able to be physically on the site,
should the need arise, where the pesticide use or storage 1s
taking place within a reasonable period of time; (6) In the case
of a certified commercial applicator, maintain for at least two
years, records regarding the types, amounts, uses, dates and
places the RUP was used required by 40 CFR 171 .7(b)(1)(111)(E).
-------
-2-
Di scussi on:
FIFRA Section 2(e)(4) defines the phrase "under the direct
supervision of a certified applicator" and, 40 CFR 171.6 estab-
lishes "Standards for Supervision of Noncertified Applicators
by Certified Private and Commercial Applicators." These pro-
visions place on the supervising certified applicator authority
and responsibility for ensuring that any noncertified applicators
working under his direct -supervision will use an RUP safely and
effectively.
To effectively discharge these responsibilities, the
certified applicator must assure that each of the following
steps has been taken.
I. Experience and Knowledge of the Noncertified Applicator
The certified applicator must review the noncertified
applicator's experience and knowledge of both general and
restricted use pesticides. This review will be used by the
certified applicator to determine the extent and type of
training and oversight the noncertified applicator will require.
The certified applicator must assure that the noncertified
applicator is familiar with and understands pesticide labeling
instructions, especially those instructions relating to the
prevention of hazard to man and the environment. Furthermore,
the certified applicator must assure that the noncertified.
applicator is able to recognize poisoning symptoms 'and know
the appropriate procedures to follow in the event of a poisoning
incident.
II. Instructions to Noncertified Applicators
The certified applicator must provide the noncertified
applicator with verifiable, detailed guidance regarding the
pesticide use to be performed (the Agency suggests written
instructions as an effective method of providing verifiable,
detailed guidance to the noncertified applicator). The
Instructions (to the noncertified applicator) must address
such matters as the types and amount of pesticides to be
used, the maintenance and calibration of the equipment to be
used, and the presence and nature of any unique risk of
environmental or health exposure. If a noncertified applicator
will be using several different RUPs at different types of
sites, then the certified applicator must accompany the
noncertified applicator to at least one site for each
different type of pesticide use. The rroncertl f led applicator
must also be Informed of the pesticide labeling Instructions,
especially those Instructions relating to the prevention
of hazards to man and the environment.
-------
-3-
III. Assurance that the Noncertified Applicator is Competent
The certified applicator must assure that the noncertified
applicator is competent in the use of a/i RUP and understands
the instructions provided. At a minimum, the instructions must
be given at a level and in a language understood by the non-
certified applicator. 'In addition to the required verifiable,
detailed guidance, the certified applicator must ask questions
of the noncertified applicator to ensure his understanding of
the instructions. When the noncertified applicator has not
previously used the particular RUP, or if there is any
doubt about the noncertified applicator's understanding of the
instructions, the certified applicator must, in addition to on
site instruction, provide on-the-job training and observe the
performance of the noncertified applicator before leaving
the site.
IV. Accessibility of Certified Applicator
Section 171.6 states "... the availability of the certified
applicator must be directly related to the hazard of the situ-
ation." The Agency has interpreted this statement to require
the physical presence of the certified applicator on site when
the use of an RUP poses a potentially serious hazard to man or
the environment. Plus, the physical presence of the certified
applicator is required on site when it is specified on the
label .
Both 40 CFR 171.6 and FIFRA Section 2(e)(4) require that
in cases where the physical presence of the certified applicator
is not required, the certified applicator "...1s available 1f
and when needed...". The Agency Interprets this provision to
require, at a minimum, the availability by telephone or radio
of the certified applicator Immediately before, during and
after the noncertified applicator's use of an RUP. The certified
applicator must also have the capability to be physically on
site, within a reasonable period of time, should the need
arise. The potential or real consequences of a delay In
arriving on site will be taken into consideration, when
determining what 1s "a reasonable period of time".
V. Records
Commercial applicators are required by 40 CFR 171.7(b)(l)
(11i)(E). to maintain for two years, records regarding the types,
amounts, uses, dates and places of application of RUPs. The
requirement at 40 CFR 1 71 .7(b)(1 ) (111) (E) applies to both com-
mercial applicators applying RUPs and commercial applicators
supervising the application of RUPs.
-------
-4-
VI. Classification of Pesticide Dealers as Commercial
Applicators
Any dealer who sells RUPs to persons who are not certified
and who then supervises the uses of those products must
be certified as a commercial, not private, applicator. If the
dealer has received payment from the sale of the RUP and the
product will be used on-land owned by the purchaser or by some
third party, the dealer cannot be deemed under FIFRA Section
2(e)(2) or 40 CFR 171.2(a)(20) to be a private applicator.
VI I. Liability
The certified applicator is responsible for ensuring the
safe and effective use of any pesticide used under his direct
supervision. Accordingly, the certified applicator is subject
to enforcement liability, for violations that are committed
by the noncertified applicator who is operating "under his
direct supervision." The certified applicator cannot use as
a defense against such liability, the ignorance or negli-
gence of the applicator who is operating under his direct
supervision, as it is his responsibility to ensure that the
noncertified applicator is competent and has been provided
adequate supervision. Where an RUP is misused by a noncer-
tified applicator, EPA will initiate enforcement action
against both the noncertified applicator and the certified
applicator who supervised the use. The certified applicator
will not be held liable if he can prove that he did not have
any knowledge and did not, in any manner, Instruct or authorize
the noncertified applicator's use of an RUP. Hence, if the
noncertified applicator 1s found not to be performing under
the direct supervision of a certified applicator, he 1s in
violation of FIFRA §§12(a)(2)(F) and 12(a)(2)(G).
See Also:
40 CFR 171.6
EPA v. Singleton Spray Service, Co.
A. E. Conroy II memo of October 21, 1981, to Leo J.
Alderman entitled "Request for Interpretation of
'Under the Direct Supervision"1.
-------
-5-
Key Words:
Direct supervision, certified applicator, noncertified
applicator, pesticide dealer, commercial applicator, private
applicator.
\-
A. E. Conroy II, Dire
Office of Compl i aofi-e—ffo'n i t.oring
Office of Pesticides and Toxic ^ubstances
Date 7
-------
FIFRA. COMPLIANCE PROGRAM POLICY SECTION 3 INDEX PAGE
TITLE NUMBER
Shipment Prior to Registration 3.1
Distributor Registration 3.2
Fumigation of Truck Vans on Flatbed Rail Cars 3.3
Custom Blenders 3.4
Production of Pesticides for Personal Use 3.5
Temporary Conversion of Cropland (Revised) •• 3.7
The Use of Products Labeled "For Manufacturing Use Only" 3.8
to Produce Pesticides for Personal Use
Status of Supplemental Registration 3.9
Use of California's Methyl Bromide Fact Sheet 3-10
-------
FIFRA COMPLIANCE PRUGKAM POLICY No. 3.1
Shipment Prior to- Registration
FIFRA Section; 3
Issue;
May a pesticide product which 1s 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.
Pi scussion;
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
^ *o received) deliver[y] (sic) 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 pesticide to 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
its sale prior to registration.
Upon receiving EPA approval 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.
-------
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)(l)(A) of FIFRA.
See Also;
Reg1stration.
References:
March 21. 1978 letter from A. E. Conroy II, Director, PT3ED,
to Ingrld K. Allen, Registration Coordinator, Agricultural
Chemicals Division, Fisons, Inc.
Key Words;
Exemptions, Shipment, Unregistered Pesticides.
'E. Conroy II^XTTflector
Pesticides and/Toxic Substances
Enforcement division
MAY ,
Date
-------
FI (A COMPLIANCE PROtiRAM POLICY No. 3.2
Distributor Registrations
FIFRA Section; 3
Issue:
Hay a distributor repackage a pesticide which It intends to
sell under a supplemental registration?
Pol1cy;
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.
Pi scussion;
Manufacturing or packaging a pesticide under contract and
distributing a pesticide under a supplemental registration are
two separate activities.
Section 3
162.5(b)(l) a
from one regi
ment opera.ted
a constituent
establishment
defined at 40
by the regist
contract to t
(b)(1) of FIFRA and the regulations at 40 CFR
llow for the transfer of an unregistered pesticide
stered establishment to another registered establish.
by the same producer solely for packaging or use as
part of another pesticide produced at the second
The term "operated by the same producer" Is
CFR 162.3(dd) to mean another establishment owned
rant or an establishment operated by a person under
he registrant.
Under.supplemental registration, a distributor of a registered
pesticide product is permitted to market that pesticide product
under the distributor's brand name 1f 1t adheres to the conditions
described at 40 CFR 162.6(b)(4)(1). 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) (1) (B)). Labeling 1s
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 misbranding Imposed on the
registrant at the time of registration.
-------
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 tc
the firm whose brand name appears on the label.
on
Any supplemental
the label must be
registrant's (distributor's) name appearing
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 1s fully registered with EPA by the basic
In, addition the product must conform to the
basic registration and to the requirements for supplemental regis-
trations.
regi strant.
standards held for the
Liability for any violation of Section 12 in such a contractual
arrangement may rest with either or both parties to the contract
depending upon the circumstances associated with the violation.
See Also;
FIFRA Compliance Program Policy No. 3.6., Contract Manufacture
References;
40 CFR Part 162.26(b)(4)(1), (11), (111).
Memo of August 19, 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 Supplemental1y Registered Products".
Key Words;
Contract Manufacturing, Distributor Registrations, Repackaging,
Supplemental Registrations. '
A. E. Conroy I
Pesticides and
Enforcement Di
rector
ic Substances
ion
/ U
Date
-------
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 transported on flatbed
rail cars to be fumigated provided:
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 fully aerated in accordance with label
directions 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 1s 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 ears. 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.
-------
2 - 3.3
The Agency *i11 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 Words;
Aluminum Phosphide Products, Fumigation, Labeling, Phosphine
Gas, Phostoxin, Rail Cars, Truck Fumigation, Truck Vans.
A. £. Conroy II, Director
Pesticides and Tpxi/c Substances
Enforcement DivJ^ion
W /Q
'Date
-------
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?
Pol1cy;
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.
Discussion;
Section 3 of FIFRA requires any person Mho produces a pesticide
to register that pesticide with tne Administrator before selling or
distributing It. Custom blenders provide the service of mixing pes-
ticides to a customer's specifications, usually a pestidde(s)-fert1-
lizer(s) or pesticide-pesticide mixture. Custom blending 1s considered
production under Section 3. The Agency, however, has determined that
registration of certain custom blends 1s not necessary to fulfill the
Intent of FIFRA.
In order for a custom blender to avoid liability for failure
to meet the requirements of Section 3, tne following conditions must
be met:
1) the blend 1s prepared to the order of the user and is
not held in Inventory by the blender; and
2) the pest1c1de(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 1s prepared In a registered establishment; ; .
and ... '
4) the blend 1s 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
for use 1n manufacturing or formulating pesticides shall not be con-
sidered end-use labeling.
-------
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 8.
See Also;
Custom Blenders - FIFRA Compliance Program Policy No. 7.1,
Policy and Criteria Notice 2000.1
References;
Memo to Pesticide Branch 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 'rom A. E. Conroy II, dated
September 10, 1980, titled "Custom Blender's Identification
for ERSS."
PR Notice 73-1
A
Key Words;
Custom Blenders, Fertilizer-Pesticide Mixtures, Registration.
x'
A.E. Conroy II./Director
Pesticides and toxic Substances
Enforcement Division
-W I Q J982
Date
-------
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;
•^•^^^•iWHM* ^
Generally, a person may lawfully produce a pesticide for
his own use without registering his product or establ1snment.
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 FIFKA
Section 7 state that persons who produce pesticides solely for
application by themselves are not required to register their
establishments. Thus, a person who produces a pesticide solely
for personal use Is not required under FIFRA to register the
pesticide or the 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 FJFRA. 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. Rtp. No. 95-1188, 95th Cong., 2nd Sess. 44-45
(1978)). . , , .
References:
•
Memorandum t'o Roy Clark, Region IV, dated April 9, 1981
titled "interpretation of FIFRA §162.4(0(6).
Senate Report No. 95-1188, 95th Congress, 2nd Session
44-45 (1978).
-------
2 - 3.5
Key Words:
Establishment Registration, Product Registration.
A. E. Conroy II, Of rector
Pesticides and Tox/i'c/Substances
Enforcement Divi^on
•W I 0 1982
Z57F5
-------
FIF3A COMPLIANCE PROGRAM POLICY No. 3.7
Temporary Conversion of Cropland
FIF3A Section; 3
Issue:
*
In order to kill localized weeds or other pests on cropland,
nay a person temporarily convert the affected cropland to non-
cropland, so they may use the higher dosage rates specified for
noncrop use, or so they may use products labeled for noncrop
use only?
Policy:
Cropland cannot be temporarily converted to noncropland
for the purposes of using the greater application rates allowed
by noncrop use labeling. A pesticide may not be used on cropland
at higher than the labeled crop use dosage rates in order to
kill localized weeds, or other pests, unless the label directions
"for that pesticide provide for spot treatment directions on
cropland.
Additionally, cropland may not be temporarily converted
to noncropland for the purposes of using products which are not
registered for use on crops.
Discussion;
Labeling for noncrop uses often allow for greater application
rates of pesticides than those application rates stipulated for
use on crops. Additionally, crop rotation restrictions, which
specify a period of time during which certain crops cannot be
planted in a field after a pesticide has been applied, are not
addressed on noncrop use labeling. Therefore, the Agency
believes the temporary conversion of cropland to noncropland
would Inadvisably allow for the use of Increased dosage rates
and the use of pesticides which could result 1n Injury or
illegal residue to crops planted on that land In the future.
However, spot treatment labeling, which may allow for greater
application rates of pesticides than those application rates
listed for typical crop use, does stipulate crop rotation
restrictions.
The Agency considers fallow land, grazing land, pastureland,
no-till land (Including acreage enrolled In the Department of
Agriculture's Conservation Reserve Program) and other cultivated
lands to be cropland. The use of a pesticide on cropland at the
higher application rates specified by noncrop use labeling, or
the use of a pesticide on cropland which 1s not registered for
use on crops, 1s a violation of FIFRA §12(a)(2)(6), the use of a
registered pesticide 1n a manner Inconsistent with Its labeling.
-------
2-3.7
References:
Memorandum from John B. Ritch, Jr., of Registration Division,
to Lyn V. Frandsen, of Region X, dated March 1976, regarding a
definition of noncropland.
Criteria and Policy Notice No. 2160.2, dated April 16, 1979,
"DefinitionofNoncropland".
"Pesticides For Conservation use Acreage Fact Sheet", dated 1933
Memorandum from A. E. Conroy II to C. Alvln Yorke, dated
February 26, 1986, regarding the temporary conversion of cropland.
Memorandum from Art Losey, State of Washington Department
of Agriculture, to John Seltz of OCM, dated December 8, 1986,
regarding his position on the April 9, 1986 draft of
FIFRA Compliance Program Policy No. 3.7.
Memorandum from Art Losey, State of Washington Department
of Agriculture, to Kevin Pifer, Rod Awe, et. al., dated June
30, 1987, regarding the draft Policy For Pesticide Use on
Conservation Reserve Acreage.
Key Words;
Cropland, Crop Rotation Restrictions, Conservation Reserve
Program (CRP), Noncropland, Spot Treatment.
John J. Neylan III, Director
Policy and Grants Division
Office of Compliance Monitoring
Office of Pesticides/and Toxic Substances
FEB 10688
-------
FIFKA COMPLIANCE PKJbKAM PULKY No. j.b
Tne use of Mroaucts Ldoeled "For rtanutacturina use
To Produce Pesticides For Personal use
Section:
Issue:
*
May a person use a pruduct laoelea "Kor Manufacturing use
only", «n1cn aoes not oear detailed directions for use, to proauce
a ^estidoe for tneir own use?
^ol icy:
A person i.iay not use a Manufacturing use only product,
wnicn does not Dear detailed directions for use, tu produce a
pesticide for tneir own use, unless tnat person registers the
formulated end-use product wltn tne EPn.
J1 scusslon ;
*fne tPA* Interprets tne laoel statement "For Manufacturing
use only" to mean that products bearing tnls statement are
Intended only for formulation Into registered products. Tne
regulations further elaborate on this Interpretation 1n 40 LFR
Part iol.lu (1 )(1)I11 1 MM) which states tnat manufacturers are
only permitted to omit detailed directions for use from the
laoel provided "tne product l>1tn the omitted use dlrectlonsj
Mill not come Into tne hands of the general public except
after Incorporation Into finished products." 40 CFK Part
ioi.lu(1 ) (1)(111 MC) further states: "detailed directions for
use may oe omitted from tne laoellny of pesticides which are
Intended for use only oy formulators In preparing pesticides1
for sale to tne public ... and provided tne product as finally
manufactured Is registered."
Therefore* any pesticide formulated from a product laoeled
"For Manufacturing Use only", wltnout detailed directions fur
use on Its label, must De registered wltn tne Agency, even though
1t 1s for personal use and will not oe sold or distributed.
Tne use of a "For Manufacturing use Only" product, In wnlcn
detailed directions for use do not appear on tne label, for any
purpose other than tne production of a registered pesticide, would
oe considered a violation of KiFKA 9i*(a ) (t) (li) , tne use. of a
registered pesticide 1n a manner Inconsistent with Us laoelln*.
-------
•i -
see also:
F I K KH V.JMKL
For Personal use"
POLICY 3.S -- "Production of Pesticides
K e ferences:
Memorandum from A. t. Conroy II to H. Kir* Lucius, dated
F-eoruary a, i*eo, re^arainy cne use of ^1nc • Pnos^hlde and
For Kodenc tontrol in Florida iu^arcane Fields.
Memorandum from oonn «. Kitcn, jr., ulrector of Keyistration
jivisiun, to M. t. tonroy II, dated Keoruary 2b, 1^74,
Hesticlde Products intended "For Manufacturing use only".
4u
Hart
Mu.ras:
Manufacturing use Only, Hersondl use, Product Registration
M. £. Conrfoy II, Ulrector
office of Compliance Monitorin^
Utfice of Pestlddes^ana Toxic iuostances
291996
____
-------
FIFRA Compliance Program Policy No. 3.9
Status of Supplemental Registration
FIFRA Section; 3
Issue;
What Is the status of supplemental or distributor registra-
tions when the Agency takes action against a basic registration?
Policy;
Actions taken against the basic registration are equally
binding on supplemental registrations. Further* a registrant
may be held liable for violations committed by Its supplemental
registrants or distributors.
Discussion;
The holder of a registration of a pesticide product (the
"registrant" or "basic registrant") may allow the registered
product to be sold or distributed under the name, address, and.
brand name of another person (called a "distributor" or
"supplemental registrant"), under the conditions set forth 1n
40 CFR 162.6(b)(4). Distributor products are Identified as
such through the use of a special numerical suffix to the
basic registration number on the label. As stated 1n 40 CFR
I62.6(b)(4)(111), a supplemental registrant (distributor) Is
deemed by EPA to be an agent of the basic registrant for all
purposes under FIFRA. Further, as stated In the preamble to
the final rule promulgating 40 CFR 162.6(b)(4) (49 FR 380,
381, January 4, 1984): "Supplemental registration 1s not registra-
tion of a separate product under FIFRA sec. 3, but permits an
existing registrant to market his registered product, bearing
a different name and address, through a distributor". Because
a supplemental registrant 1s considered to be the agent of the
basic registrant, the basic registrant 1s legally accountable
for violations of FIFRA committed by Its supplemental registrant
with respect to the distributor product.
-------
-2-
When EPA notifies a basic registrant of an action (e.g., a
notice of intent to cancel, a notice of intent to suspend, or a
stop sale, use, and removal order (SSURO)) against a registered
pesticide, it does not separately notify supplemental registrants
of the action. Thus, a'basic registrant would be well advised
to promptly inform each of its supplemental registrants of
actions EPA takes with respect to the basic registration, in
order that the basic registrant may avoid being held accountable
for FIFRA violations by a supplemental registrant. For instance,
when a pesticide product's registration 1s suspended after
notice to the basic registrant, all versions of that product
are suspended, including those bearing a supplemental registrant
label. Likewise, when a SSURO is Issued to a basic registrant
with regard to a registered pesticide product, the terms of the
SSURO are equally applicable to supplemental registrants of the
product. If a supplemental registrant markets a product 1n
violation of a cancellation or suspension order or SSURO, both
the basic registrant and the supplemental registrant 'are in
violation of FIFRA and will be held liable for such violation.
See also
Distributor Registrations - FIFRA Compliance Program
Policy No. 3.2.
References
Memorandum from A.E. Conroy II to Anthony Baldi, dated*
March 19, 1987, regarding the status of supplemental registrations
when the Agency takes action against a basic registration.
Memorandum from John J. Neylan III to R1ck Tlnsworth, dated
March 25, 1987, regarding FIFRA §3(c)(2)(B) Suspension Notices.
PR Notice 82-3, 20 September 1982, "Notice to Producers,
Registrants, and Foraulators".
40 CFR §162.6(b)(4)(1).
40 CFR §l62.6(b)(4)(111).
-------
-3-
Key words
Supplemental registrations,
regi strant/di stHbutor liability
basic registrations,
I.E. Conroy
Office of Co
Office of Pesticide
Director
lance Monitoring
and Toxic Substances
-------
FIFRA COMPLIANCE PROGRAM POLICY No. 3.10
Use of California's Methyl Bromide Fact Sheet
FIFRA Section; 3
Issue;
Label directions for all Methyl Bromide products require
that customers sign an EPA Fact Sheet before structural
fumigation occurs. Through regulation the state of California
requires a California fact sheet be signed. Will EPA allow
California's Fact Sheet (revised May 1992) to be used in lieu of
EPA's Fact Sheet for customer signature before fumigation in
California?
Policy:
Upon review of both Fact Sheets, the Office of Pesticide.
Programs has determined that use of the California Fact Sheet
(Revised May 1992) would be sufficient to meet the Agency's
intent in notifying customers prior to beginning fumigation. At
the request of the Office of Pesticide Programs, the Office of
Compliance Monitoring will allow applicators in California only
to use California's Fact Sheet (Revised May 1992) for customer
signature in lieu of EPA's Fact Sheet for customer signature
before the applicator starts the fumigation process.
Discussion;
Methyl Bromide registrants voluntarily agreed to a label
revision of Methyl Bromide' products with structural (commercial
and residential) fumigation use directions on the label due to
health concerns of structural fumigants. Methyl Bromide
Registrants with structural fumigation uses on their product
labels have revised their aeration and reentry directions
according to the Interim Approved Labeling. A Federal
requirement of the new, approved label language is that
applicators give their customers a fact sheet for their review
and signature before the fumigation process begins. In addition
to this Federal requirement, the state of California has passed
regulations requiring applicators in California to give their
customers the California Fact Sheet for review and signature.
Without this policy, both fact sheets are required to be
presented to the customer and signed. The Office of Pesticide
Programs has reviewed both fact sheets and have requested the
Office of Compliance Monitoring to allow applicators in
California only to use the California Fact Sheet (Revised May
1992) in lieu of both. The EPA Fact Sheet is required to be
signed in all other states.
-------
References
Letters from:
D. Barolo, Office of Pesticide Programs, to J. Neylan,
Director, Policy and Grants Division, and P. Flaherty,
Chief, Pesticides Enforcement Policy Branch, 8/6/92;
J. Neylan, Office of Compliance Monitoring, to FIFRA
Addressee List including Regional and Headquarters.Division
Directors, Branch Chiefs, and Section Chiefs, SEP I I9S2.
Key Words;
Methyl Bromide, Structural Fumigants, Fact Sheet
Poliy andGrajijte Division
Offi/ce of ^Compliance Monitoring
Office of Prevention, Pesticides
and Toxic Substances
SEP I I9S2
_____
-------
FIFRA COMPLIANCE PROGRAM POLICY SECTION 4 INDEX PAGE
HILL NUMBER
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
recertlfled.
Discussion;
Under FIFRA Sections 3(d) and 12(a)(2)(F), applicators 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 to a Plan approved by the Administrator, or certification
by the Administrator 1n 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 1n deciding 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)(1). 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 is in the process of developing a certification plan,
which will Initially cover only commercial applicators.
-------
- 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)(1) 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 Us 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 1s 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 official EPA policy since the passage of FIFRA. Pursuant to
this policy the 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:
Establish competency, written examination, private applicator
certification.
A. E. Conroy II, Director
Compliance Monitoring Staff
Office of Pesticides and Toxic Substances
ZfcTjUL 1983
DTti
-------
F1FRA COMPLIANCE PROGRAM POLICY SECTION 7 INDEX PAGE
TITLE NUMBER
Custom Blenders 7.1
-------
FIFRA COMPLIANCE PROGRAM POLICY No. 7.1
Custom Blenders
FIFRA Section; 7
Issue:
Are custom blenders of pesticides subject to the requirements
if Section 7?
Pol1cy;
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 1f they
meet certain conditions.
D1scusslon;
Section 7 of FIFRA requires that all pesticide producers must
register those establishments 1n which they produce pesticides.
They must also submit to the Agency annual reports concerning pro-
duction and distribution of the pesticides. The regulations promul
gated pursuant to this section (40 CFR 167) provide that a custom
blender 1s a producer and Is thus subject to the requirements of
Section 7.
Custom blenders provide the service of mixing pesticides
to a customer's specifications. The custom blend Is usually a
pest1cide(s)-fertil1zer(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 1s not
necessary for effective regulation of the industry. Therefore
the Agency will not require producers of those blends exempt
from Section 3* to meet certain Section 7 requirements.
*To be exempt from Section 3. a custom blend must meet the following
requlrements: .
1) the blend Is prepared to the order of the user and 1s
not held In Inventory by the blender, and
2) the pestlclde(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 1s 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 speclfyTrTg the composition of the mixture.
-------
2 • 7.1
All custom blenders, whether or not their blends must meet
Section 3 requirements, must register their establishments witn 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 other
pesticides 1n violation of the law.
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 1s 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 1s produced and who pro-
duces it. This Information 1s 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 registration
Custom blenders remain subject to the provisions of Section 3
of FIFRA as well as to all requirements relating to proper use of
pesticides Including transport, storage and disposal.
See A1so;
Custom Blenders • FIFRA Compliance Program Policy No. 3.4
References;
See references In FIFRA Compliance Program Policy No. 3.4
Key Words;
Cus torn Blenders, Establishment Registration, Reporting.
•
. Conroy II/01/ector
Pesticides and/Tox./c Substances
Enforcement
,-;AY i n too?
Date
-------
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
Issue:
Under what circumstances will EPA release yearly production
data for particular pesticides?
•
Pol1cy;
The EPA will not release an Individual producer's production
data for a specific pesticide. The Agency will release production
data 1n the aggregate, without Individual producer Identification,
at the request or order of an EPA Administrative Law Judge 1n a
data compensation proceeding under FIFRA Section 3(c)(l)(D). In
such a case, the EPA will Indicate the confidential nature of the
data to the Judge. When EPA responds to a Congressional request
for confidential data, the Office of Legal Counsel will decide
whether to release the data.
Discussion;
Production data which producers submit under FIFRA Section
7(c)(1) 1s 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 1n his possession.
The Freedom of Information Act (FOIA)(5 U.S.C. Section 552)
does not require an Agency to create a record 1n response 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 existing records" (40 CFR Section 2.105(a), emphasis added).
The United States Supreme Court has endorsed this reading of FOIA;
NLRB v. Sears Roebuck. 421 IT.S. 132. 161-162. Agg'regatlon of
pesticide production data submitted to EPA 1s 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.
-------
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 .authorl 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
1s governed by EPA-wide policy (40 CFR Part 2).
to a Congressional request for confidential
Office of Legal Counsel must be contacted,
decide whether to release the data.
Reference:
Office,
_,. When EPA responds
pesticide data, the
since that Office will
Protective Order,-Octob-er 2-2, 1981, Union-G-arbide *•» Thompson
Hayward, FIFRA COMP. Docket Nos. 27 & 45, 40 CFR Part 2.
Key Words;
Confidentiality, Establishment Registration, Production Data.
A. E. Conroy, 11, Director
Pesticides and/Toxic Substances
Enforcement DLiv/sion
•W 1 0 1982
Date
-------
F.IFRA COMPLIANCE PROGRAM POLICY SECTION 12 INDEX PAGE
TITLE NUMBER
Using Registered or Experimental Use Permit Pesticides 12.1
in a Manner Not Included on "the Label or Permit
Pesticides Closed Transfer,--Mixing/Loading and 12.2
Application Equipment (Closed Systems) (Revised)
Authority for Use Inspections 12.3
Making RUP's Available for Use Other Than in Accordance 12.4
With Section 3(d) of FIFRA (Revised)
The Use of a Diluent Not Specified on the Product Label 12.5
-------
FIFRA COMPLIANCE PROGRAM POLICY NO. 12.1
Using Registered Or Experimental Use Permit Pesticides
I"^A Man'ner Not Included On fne Label Or Permit ' ""
FIFRA Section; 12
Issue:
May a person legally use a
pesticide for testing purposes1
permit?
Pol icy;
registered or experimental use
not authorized by the label or
A person may legally use a registered or experimental use
pesticide for testing purposes in a manner not authorized by the
label or the permit 1f:
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 Part 172.3(a)(3) for animal
treatments.
\
Discussion;
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 Rodentlcide 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 1n 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 1n Part 172.3(a)(3).
-------
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 pesticidal value, its toxicity 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 in, or affected by
such tests shall be destroyed or consumed only by
experimental animals 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)
purpose is presumed for aquatic use tests if:
state that such
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, any flsn, shellfish
or other plants or animals taken for recreational or
commercial purposes unless a tolerance or exemption
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'anlmals,
and
o No animals nay be tested If they may be used in food
or feed unless a tolerance or an exemption from tolerance
has been established.
K Thi
Pol 1c
TIFRA
Ji s pol icy does hot li.mit, but rather supplements the existing
:y regarding uses not authorized by the label but allowed under
' §2(ee).
-------
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 is not a misuse violation of FIFRA to use a
non-registered substance in tests to determine pesticidal
value, toxicity or other properties under the previously-cited
restrictions. Therefore, It 1s 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)(l), 172.3(a)(2) and 172.3(a)(3)
as set forth above.
See Also;
FIFRA Compliance Program Policy No. 2.2 - Use Recommendations
Key Words;
Experimental Use Permit (EUP), 2(ee), Use Recommendations.
i. E. Conroy II, plreptor
Pesticides and Toxic/ Substances
Enforcement Division
'MAY I 0
Date
-------
FIFRA Compliance Program Policy No. 12.2
Pesticides Closed Transfer. Mixing/Loading and
Application Equipment (Closed Systems)
FIFRA Section;
12(a)(2)(G) . '
«k
Issue:
Will the Environmental Protection Agency take ,an enforce- -
ment action under FIFRA Section 12(a)(2)(G) dgalnst 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?
Policy:*
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 personal protective equipment required by the
pesticide product label, provided the conditions outlined in
this policy are met.
Discussion;
The FIFRA Compliance Program Policy No. 12.2 Issued May 10,
^982 sai*d 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 Nay 1982 policy may actually hinder the development
of new equipment designed to safely handle pesticides.
The Agency's position 1s 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 Nay 10, 1982.
-------
-2-
For purposes of this policy, a closed system is hardware
designed to empty and rinse pesticide-centalners, 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.
of
era
•mittlng the pesticide to escape.
Preliminary field experiences Indicate that the Incidents
pesticide exposure to persons operating a closed system gen-
illy 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 procedures or lack of training.
There are, however, many documented Instances when a closed
System has been used without resulting 1n an exposure from Its
use. Therefore, the Agency will amend Us Hay 10, 1982, policy
and will not take an enforcement action 1f 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 1s administered.
o Records are available which Indicate that the operator has
received training (when, by whom) 1n 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 ntar the closed system.
o All personal protective equipment required by the label 1s
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 1s 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.
-------
-3-
S e e 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, a05, 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 \I./D1rector
Compliance MonlWrlng Staff
Office of Pesticides and Toxic Substances
15 DEC 1983
-------
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
premi ses.
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
12(a)(2)(6) 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 roust 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).
-------
2 - 12.3
Reference;
Letter from William 1. Hazeltlne to Congressman Harold T
Johnson dated August 12, 1975.
Key Word Headings;
Inspections, Misuse, Use Inspections.
A. E. Conroy 11, X)1 rerctor
Pesticides and tojilpr Substances
Enforcement Dlvrsion
MAY 10
•^•ta^BMMH
late
-------
FIFRA COMPLIANCE PROGRAM POLICY No. 12.4
Making RUP's Available For Use Other Than in Acco-dance
With Section 3(d) of FIFRA
Section; FIFRA §12(a ) (2) (FJ
FIFRA §3(d)
Issue:
In States with EPA approved State certification and t-aining
programs, when will. EPA take enforcement action against pesticide
deale-s who make restricted use pesticides (RUP) available to
persons who are not certified applicators?
Pol icy:*
If a pesticide dealer cannot document that a restricted use
pesticide made available to a person who is not a certified
applicator is to be applied by a certified applicator, or under
the direct supervision of a certified applicator, then EPA may
take enforcement action for the FIFRA §12(a)(2)(F) violation unless
the State takes appropriate enforcement action under Us law.
Discussion;
Generally, a violation involving the sale of an RUP to a
person who 1s not a certified applicator Is a violation of
State law, and the State would take enforcement action, under
current policy, States wishing to make RUP's available to
persons other than certified applicators may only do so 1f
they submit to the Administrator an amendment to their State
Plan under FIFRA §4 containing the minimum standards as outlined
at 40 CFR Part 171.11(g)(2)(11). If a State does not have an
EPA approved plan which allows the sale of an RUP to a person who
1s not a certified applicator, and enforcement action 1s not
taken by the State under Its law, EPA may take enforcement
action under FIFRA §12(a) (2)(F).
Section 12(a)(2)(F) of FIFRA states:
It shall be unlawful for any person to make available
for use, or to use, 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 1t shaU not be unlawful
to sell, under regulations Issued by the Administrator,
a restricted use pesticide to a person who 1s not a
certified applicator for application by a certified
applicator.
1 FIFRA Compliance Program Policy No. 12.4 Issued May 18, 1983
was superseded by the FIFRA §4 regulations found at 40 CFR
171.11. These regulations apply only to States with federally
operated certification and training programs. This new policy
12.4 1s applicable to all other States.
-------
EPA is planning to issue regulations cove-ing the sale of
RUP's to persons who a-e not certified applicators in States
whe-e the Administrator does not conduct the pesticide applicato-
ce-ti fication and t-aining p-og!"am.2 However, in light of the
Administrative Law Judge decision on Tierra Verde Company, -Inc.,
and until regulations affecting all States have been published,
the following policy will apply when federal action is approp-iate
in States with fede-a-lly approved State ce-ti f ication and training
p-og-ams:
1) If a dealer sells an RUP to a pe-son who is not a
certified applicator, and that dealer can adequately
document^ that the RUP was to be used by, or unde-
the di-ect supe-vision of a certified applicato", then
the Agency will take no action against the dealer for
a violation of FIFRA §12(a ) (2) (F ).
2) If a dealer sells an RUP to a person who is not a certi-
fied applicator without documentation to prove the RUP
was to be used by a certified applicator, and the dealer
can prove the RUP was actually applied by a certified
applicator, or under the direct supervision of a certified
applicator, then this would be considered a minor viola-
tion. Under FIFRA section 9(c)(3) the EPA will Issue
a notice of warning to the dealer.
3) Anytime a dealer sells an RUP to a person who 1s not a
certified applicator, and the dealer cannot prove that-
the pesticide was used by a certified applicator, or
under a certified applicator's direct supervision, the x
EPA will Issue a civil complaint. The penalty will be
assessed in accordance with section 3 of 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.4
2 The EPA has already promulgated regulations allowing the
sale of RUP's to uncertified applicators 1n States where the
Administrator conducts the pesticide applicator certification
program (see 40 CFR 171.11). Other States may presently allow
the sale of RUP's to a person who 1s not a certified applicator
1f they have a plan approved by the Administrator containing
the minimum standards listed in 40 CFR 171.11.
3 Adequate documentation consists of all the Information listed
at 40 CFR I7l.ll(g)(2)(11).
4 The EPA may take enforcement action for a violation of FIFRA
§12(a)(2)(F) against any uncertified applicator that uses an
RUP and 1s not under the supervision of a. certified applicator.
EPA enforcement action will be 1n accordance with FIFRA §§26 and
27. The penalty will be assessed 1n accordance with the FIFRA
Enforcement Policy - Interim Penalty Guidelines, dated June
11, 1981. The June 11, 1981 Interim Penalty Guidelines are
found 1n the FIFRA Compliance/Enforcement Guidance Manual.
-------
See
"FIFRA Enforcement -So' icy - Interim Penalty Guidelines",
June 11, 1981, from A. E. Conroy, Director, Pesticides and
~oxic Substances Enforcement Division to Regional Enforcement
Division Directors and Pesticide Branch Chiefs, F IFPA Compl i i
t Guidance Manual.
Reference :
FIFRA Compliance Program Policy No. 12.4, "Making Restricted
Use Pesticides Available to Persons Without Pesticide Applicator
Certification, dated May 18, 1983.
Administrative Law Judge decision on Tierra Verde Company,
Inc., December 2, 1985, Docket No. FIFRA-09-CU22-C-85-1.
40 CFR 171.11
Key Words:
Certified
Restricted Use
Applicator, Dealer,
Pesticides,
Make Available For Use,
Office Of Compn
Office of Pesticides
XL 22
01 rector
Monitoring
Toxic Substances
DatT
-------
FIFRA Compliance Monitoring Policy No. 12.5
The Use Qf_a Diluent Not Specified
On Tne Product Label
FIFRA Secti on : »
12(a)(2)(G)
Issue:
Is the use of a diluent not specified on the pesticide label
a violation of FIFRA?
Pol icy :*
Under FIFRA Section 12(a)(2)(G), it is unlawful to use any
'registered pesticide 1n a manner inconsistent with Its labeling.
If the label specifies a substance as the product's diluent, the
use of any other substance as a diluent 1s considered a use In-
consistent with the label and constitutes a misuse violation under
Section 12(a)(2)(G) .
In instances where no diluent 1s specified on the label, water
must be used as the diluent.
Discussion:
This policy applies to the use of any substance as a diluent,
which is not specified on the label (e.g. vegetable oil, kerosene,
diesel fuel, fuel oil,). This policy also applies to ultra-low,
low volume, or conventional application systems.
The Agency 1s Issuing this policy 1n response to the practice
of some applicators to use diluents not specified on the label.
Specifically, the use of vegetable oil by some applicators as a
diluent because of Its slow evaporation properties. The Agency
is concerned that this practice will have adverse health effects
if the pesticide does not evaporate at the anticipated rate (I.e., •-
residues 1n excess of tolerances). In addition, there may be adverse
safety Impacts to farmworkers who are exposed to a pesticide that
does not evaporate as rapidly as anticipated. The applicators state
that the use of vegetable oil as the diluent results In a pesticide
dosage less than that specified on the label. In the opinion of
the applicators, the use of vegetable oil as the diluent can there-
fore be justified in ultra-low volume (ULV) applications under Sec-
tion 2(ee)(l) and the March 3, !98lAdv1sory Opinion Issued under
Section 2(ee) .
* This policy does not supersede or affect existing policies on
tank mixing, or mixing with dry fertilizers or mixing with liquid
fertilizers, nor does this policy address additives, adjuvants or
surfactants.
-------
Section 2(ee)(l) states that applying a pesticide at any
dosage, concentration, or frequency less than that specified on
the labeling is not considered a use inconsistent with the label.
The March, 1981 Advisory Opinion permits the use of a product at
a dosage less than the specified label in ULV applications,
(provided such use is recommended by an appropriate State or
Federal agency, and the use pattern is submitted to and approved
sy EPA).
The provisions of Section 2(ee)(l) and the March, 1981"
Advisory Opinion apply on!/ to the use of the diluent specified
PJ1 tne 1 abel . Neither Section 2(ee) nor the March, 1981 Advisory
Opinion permits a discretionary choice of diluent. The use of a
diluent not specified on the label, regardless of resulting dosage
or application method, constitutes a misuse under Section 12(a)(2)(G)
To determine a legal choice of product diluent, applicators
must consult the pesticide labeling, pesticide exemptions, 24(c)
registrations, or other pertinent EPA policy documents.
See Also:
"Ultra-low Volume or Low Volume Pesticide Application: Issuance
of Advisory Opinion", Federal Regi ster Vol. 46. No. 41, March 3,
1981.
References:
Key Words:
Ultra-low volume application, Low volume applications, diluent,
FIFRA Section 2(ee), vegetable oil diluent.
tf.e
A. E. Conroy I K"~"P/I rector
Compliance Monliox/ng Staff
Office of Pesticides and Toxic Substances
FEB 2 f::::;
-------
Interim FIFRA Compliance Program Policy No. 12.6
Enclosed Cab Use for Pesticide Application
FIFRA Section:
12(a)(2)(G)
Will the U. S. Environmental Protection Agency take an
enforcement action under FIFRA section 12(a)(2)(G) against the
applicator who uses an appropriate enclosed cab to apply '
pesticides without wearing the personal protective equipment
required by the pesticide product labeling?
Policy;
The Agency will not take an enforcement action under FIFRA
section 12(a)(2)(G) against an applicator for using an enclosed
cab instead of personal protective equipment required by the
pesticide product labeling, provided the conditions outlined in
this interim policy are met. This policy applies to ground
methods of application only.
Discussion;
$he Agency recognizes that technological and engineering
advancements have made significant contributions in the area of
protection during pesticide application. There is documented
evidence that certain enclosed cabs can provide applicator
protection equivalent or superior to that provided by personal
protective clothing and equipment (PPE) .
However, for these enclosed cabs to be used in lieu of PPE,
certain potential problems must be addressed. It is of
particular importance that these problems be addressed for
enclosed cabs used for protection from respiratory hazards.
Problems observed during field observations include:
Insufficient data on the effectiveness of protection
provided.
Insufficient operating and maintenance instructions
that allow the user to maintain effectiveness.
Insufficient records showing the user is following
manufacturer's recommendations.
Insufficient training and documentation of training.
Insufficient instruction on user protection if exit is
necessary during use and how to avoid contamination of
equipment.
-------
Conditions!
During ground methods of pesticide application an enclosed
cab may be used instead of the personal protective equipment
required by the product labeling provided the following
conditions are met. To ensure protection equivalent or superior
to that provided by label-required personal protective equipment,
enclosed cabs and users must meet all the following minimum
requirements for purposes of this policy:
1) For labeling instructions that require dermal or eye
protection, an enclosed cab must provide a nonporous barrier
totally surrounding the occupants of the cab that prevents
contact with the spray mist, dust, or treated surfaces.
2) Long-sleeved shirt, long-legged pants, shoes and socks must
be worn in the cab. Uncontaminated personal protective
clothing and equipment, including a properly functioning and
maintained respirator, required by the product labeling to
be used during application must be available inside the
enclosed cab.
3) If exiting the enclosed cab, PPE required by the labeling
must be worn if:
- exit is made into the treated area, or
- exit is made while the day's application is
incomplete and contact is made with contaminated
application equipment, such as during an adjustment to
nozzles, or
- the use of PPE outside the cab is otherwise required
by the labeling.
PPE must be removed before reentering the cab and stored
outside the cab. PPE may be taken into the cab only if it is
enclosed in a chemical resistant container, such as a
plastic bag.
4) For labeling instructions that require the use of
respiratory protection during application, an enclosed cab
with a properly functioning positive-pressure
filtration/purification system may be used in lieu of a
respirator and other labeling required PPE.
Cabs used in lieu of respiratory protection must be approved
by the State in which the pesticide is being applied.
States must submit a written statement agreeing to approve
cabs used in lieu of respiratory equipment to the
-------
appropriate EPA Regional office within ten days of
implementing the policy. At a minimum, to qualify for State
approval, the State must determine, based on data supplied
by the manufacturer, that the positive-pressure
filtration/purification system will maintain airborne
concentrations below an applicable recognized occupational
exposure limit value plus a 10 fold safety factor. (Note:
Federal/State law may have applicable limits.) If there is
no established permissible exposure limit (PEL), the
protection provided must meet the protection factor provided
by the respiratory protection equipment required by the
labeling. If a State does not set up such an approval
program, the respiratory protection device required by the
labeling must be worn.
Note: Those States wishing to do so may use California's list
of approved cabs. States are cautioned that this policy does not
apply to fumigants unless, as part of their approval program, the
State, after review of research presented, makes the
determination that the enclosed cab provides protection
equivalent to an applicable PEL or labeling required PPE, as
outlined above.
In addition to all of the above requirements, the operator
must make available at the request of the inspector:
- Operating and maintenance instructions to be followed
in order to maintain required air levels and a cab
interior free from contamination.
- Documentation which shows that the manufacturer's
recommended operating, cleaning, and maintenance
instructions are being followed by the operator/owner
of the equipment.
- Documentation which indicates that the cab operator
. has received instruction in the proper operation as
specified by the manufacturer and has been informed of
any potential hazards associated with misuse or
improper operation and maintenance.
See Also;
FIFRA Compliance Program Policy No. 12.2 "Pesticides Closed
Transfer, Mixing/Loading and Application Equipment Systems
(Closed Systems)11 issued December 15, 1983.
FIFRA Compliance Program Policy No. 12.2 "Closed Application
Systems" issued May 10, 1982.
-------
Key Words;
Enclosed Cabs, Personal Protective Equipmen
Engineering Controls.
Respirators,
JoKrt J. NeylajJ IIl'./Director
PoWcy and Grants Tuvision
Office of Compliance Monitoring
Date
-------
UNITED STATES EMVIRONMENTAL PROTECTION AGENCY
MAY 30 1991
MEMORANDUM
SUBJECT: Extension of the FIFRA Compli
Program Policy 12.7 on Chemig
FROM: John J. Neylan III,
Policy and Grants Di
Office of Compliance
TO: Addressees
-342)
The attached policy on chemigation and chemigation equipment
..went into effect on April 11, 1989. The coyer .-.memorandum to the
policy stated that it would be in effect for one year while the
: Office of Pesticide Programs (OPP) reviewed the issue and decided
;.whether or not to impose label changes. In the Spring of 1990,
• the policy was extended by one year.
-:;.. ' Based on a memorandum from OPP which indicated that more time
A is needed, we have decided to extend the policy until further
^notice. The policy will remain in effect until OPP has completed
decision making and such decisions are implemented. ....
If you have any questions, please contact Virginia Lathrop at
tFTS 398-8292. ' .
'f-Attachment
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
•-";_--. !.-.•;. WASHINGTON. D.C. 20460
OFFICE OF
Hill MM ,.»._ PESTICIDES AND TOXIC SUBSTANCES
JUN 20 1990
MEMORANDUM '
SUBJECT:., Extension of the Interim Final FIFRA Compliance
Program Policy 12.7 on Chemigation
FROM:. - John J. Neylan III, Director -/?#&/u-> -JCMVZ&J fSJ^
Policy and Grants Division (EN-342) /
TO: Addressees
The attached guidance on chemigation and chemigation
equipment was put into effect by this Office on-April 11,' 1989.
The interim final policy stated that it would be in effect" f^>rv^ t
one year from the date of the policy. During this time the
Office of Pesticide Programs (OPP) was'to review the issue and
decide whether or not to impose label, changes to address the-v- * •-
issue. Anne Lindsay, Director of Registration Division, OPP, has
informed us that it is their intent to revise labeling and has ..
requested that we extend the policy for one year-.-•• Based on OPP1 s
recommendation, we are extending the policy until
April 11, 1991.
If you have any questions, please contact me at 382-7825.
Attachment
cc: Anne E. Lindsay
Douglas. D. Canpt .
-------
Attachment
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
APR I I 1989
or
PCSTICIDBS AND TOXIC SUBSTANCES
MEMORANDUM
SUBJECT:
FROM:
Interim Final FIFRA Complianc
TO:
John J. Neylan III, Director
Policy and Grants Division
Office of Compliance Monitori
Addressees
Attached is an Interim Final FIFRA Compliance Program Policy
12.7 (chemigation) for immediate use, as well as for your review
and comment. Please forward a copy of this policy to each State
with which EPA has a FIFRA cooperative enforcement agreement for
State review and comment.
This policy addresses the enforcement of the label provisions
which were required in PR Notice 87-1. The policy states that EPA
will not take an enforcement action under FIFRA section 12(a)(2)(G)
against a person for using chemigation equipment which is not
specified on the label if it is specified on a current list of
comparable systems issued by EPA's Office of Pesticide Programs
(OPP). A Chemigation Committee established by OPP has the respon-
sibility for preparing and updating the list of approved, comparable
equipment.
The attached list is the first, preliminary identification of
comparable systems prepared by OPP. Because this list is subject
to updates and modifications, it has not been made a part of this
policy. Rather, the policy refers to "a current list of comparable
systems," and provides information on how to obtain the list.
This is an interim final policy which will be in effect for
year from the date of this policy. During that year, OPP will .
review the issue of chemigation equipment and will decide whether
or not to impose label changes to address the issues. Depending
on the conclusions of this review, thfs interim policy may be
withdrawn, modified, or extended.
• Please submit your comments on this policy to Jan Bearden
•of my staff, mail code EN-342, E-mail EPA 7201, within 30 days of
the date of this memorandum.
one
Atta chments
-------
INTERIM FINAL FIFRA COMPLIANCE PROGRAM POLICY NO. 12.7
Enforcement of the Label Improvement Program for
Pestic'fdes Applied Tnrougn irrTgatto.n Systems (Cheimiga'ti on)
FIFRA Section: 12(a)(2)(6)
Issue:
The PR Notice 37-1, which deals with chemigation,
requires labels to bear very specific directions as to what
equipment may be used. The States and the regulated community
have indicated that other comparable systems'exist and have
requested EPA to allow such systems to be used instead of
what is specified on the label.
•Policy:
Discussion:
The PR Notice 87-1 was issued on March 11, 1987, under
EPA's Label Improvement Program (LIP). PR Notice 87-1
required: 1) registrants of pesticide products which are
applied through chemigation to revise their labels to include
additional use directions.and equipment for chemigation; and
2) labels released for shipment after April 30, 1988, to be
amended to comply with this Notice.
EPA recognizes that other, comparable technologies
exist for the application of pesticides through chemi.q.ation
besides those IJsted on the label. Such technologies have
been proposed to the Agency by grower groups, equipment
manufacturers, and State regulators. To evaluate such
technologies, OPP has organized a Chemigation Committee
consisting primarily of agricultural engineers from various
parts of the country. Based on the Committee's evaluations,
a list of comparable equipment has been prepared and will be
updated or modified, as appropriate.
-------
-2-
- Although current labels require very specific equipment
to be used for chemigation and prohibit the use of any other
type of irrigation system, EPA will, allow the use of alter-
native technologies which are approved by OPP
and contained on an approved list at the time
for this purpose
of application.
Please note
as identified on
be followed. To
systems, contact
(RSB-H7505C)
U.S. EPA, 401
that any applicable restrictions or requirements
the list and all other label directions must
obtain a copy of a current list of comparable
the Chief of the Registration Support Branch,
Registration Division,"Office of Pesticide
M Street, S.W., Washington, D.C. 20460.
References
PR Notice 87-1
Letters from:
J. Downing, Ocean
Chief, Policy and
Monitoring (OCM) ,
J. Downing, Ocean
Hew Jersey Dept. of Environmental
T. Ellwanger, Office of Pesticide
Committee, 12/8/88;
T. Ellwanger, Office of Pesticide
Spray Cranberries, Inc. to
Analysis Branch," Office of
9/12/88;
Spray Cranberries, Inc. to
Programs,
P. Flaherty,
Compliance
R. Ferrarin,..
Protection, 9/14/88;
Programs, to Chemigation
Programs, to P. Flaherty,
Chief, Policy and Analysis Branch. OCM, 2/21/89.
Key Words:
Enforcement, Chemigation, PR Notice 87-1
John J. Neylan III
Di rector
Policy and Grants Division
Office of Compliance Monitoring
APR I I
Date
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
MAR 22
orricc OP
PESTICIDES AND TOXIC SUBSTANCE
MEMORANDUM
SUBJECT: List of Alternative Chemigation Safety Equipment
FROM: Anne E. Lindsay, Director /•) C
Registration Division (H7505C)A/>L^£-'*
Office of Pesticide Programs C/XV /
TO: Phyllis Flaherty, Acting Director"
Policy and Grants Division (EN-342)
Office of Compliance Monitoring
Please find attached OPP's approved list of alternative
chemigation safety equipment. These devices are offered as
alternatives to certain required components of chemigation
systems in PR Notice 87-1, the Chemigation Label Improvement
Program. I am sure you are aware of the urgency to' get this
information into the hands of State and Federal regulators as
soon as possible for the impending growing season. If we can
be of assistance in the timely distribution, please let us
know. There are several grower groups, equipment manufac-
turers, committee members, and other interested parties with
whom we have been working, so we would appreciate several
copies of the final document. I have been advised that there
may be some further expansion of this list of alternatives
upon further consideration of the Chemigation Committee.
Please contact Dr. Tom Ellwanger (557-1700) on the
status of the mailout and if there are questions on the
technical aspects of the project.
Attachment
-------
List of Alternative Chemiqation Safety Equipment
PR Notice 87-1, the Label Improvement Program for
Chemigation, issued March 11, 1987 requires that the labeling
of agricultural pesticides intended for application through
irrigation systems must include the use of certain types of
safety devices to protect ground water from pesticide
contamination.. As a result of comments and new information
received subsequent to issuance, a list of alternative devices
to those included in PR Notice 87-1 has been considered and
approved for use. In some cases these alternative devices
may be less expensive, more reliable, or more available than
some .of those devices originally required. Be advised that
all of the devices originally included in PR Notice 87-1 are
still acceptable and that the PR Notice 87-1 is, in its
entirety, still in effect. Devices required in PR Notice-
87-1 which have no listed alternatives are still required
components of all chemigation systems. The original devices
as required in PR Notice 87-1 and their corresponding
alternatives are listed below:
Original Device
Functional normally closed, solenoid-operated valve
located on the intake side of the injection pump.
Alternative Device 1
Functional spring-loaded check valve with a minimum of
10 psi cracking pressure. The valve must prevent irrigation
water under operating pressure from entering the pesticide
injection line and must prevent leakage from, the pesticide
supply-tank on system shutdown. This valve must be constructed
of pesticidally resistant materials. [Note: this single
device can substitute for both the solenoid-operated valve
and the functional, automatic, quick closing check valve in
the pesticide injection line.]
Alternative Device 2 •
Functional normally closed hydraulically operated check
valve. The control line must be connected to the main water
line such that the valve opens only when the main water line
is adequately pressurized. This valve must prevent leakage
from the pesticide supply tank on system shutdown. The valve
must be constructed of pesticidally resistant materials.
-------
-2-
Alternative Device 3
Functional vacuum relief valve located in the pesticide
injection line between the positive displacement pesticide
injection pump and the check valve. This alternative is
appropriate for only those chemigation systems using a positive
displacement pesticide injection pump and is not for use with
venturi injection systems. This valve must be elevated at
least 12 inches above the highest fluid level in the pesticide
supply tank and must be the highest point in the injection .
line. The valve must open at 6 inches water vacuum or less
and must be spring loaded or otherwise constructed such that
it does not leak on closing. It must prevent leakage from
the pesticide supply tank on'system shutdown. The valve must
be constructed of pesticidally resistant materials.
Original Device
Functional main water line check valve and main water
line low pressure drain.
Alternative Device 1
Gooseneck pipe loop located in the main water line
immediately downstream of the irrigation water pump. The
bottom side of the pipe at the loop apex must be at least 24
inches above the highest sprinkler or other type of water
emitting device. The loop must contain either a vacuum relief
or combination air and vacuum relief valve at the apex of the
pipe loop. The pesticide injection port must be located
downstream of the apex of the pipe loop and at least 6 inches
below the bottom side of the pipe at the loop apex.
Original Device
Positive displacement pesticide injection pump.
Alternative Device 1
Venturi systems including those inserted directly into*
the main water line, those installed in a bypass system, and
those bypass systems boosted with an auxiliary water pump.-
Booster or auxiliary water pumps must be connected with the
system interlock such that they are automatically shut off
when the main line irrigation pump stops, or in cases where
there is no main line irrigation pump, when the water pressure
decreases to the point where pesticide distribution is adversely
affected. Venturies must be constructed of pesticidally
resistant materials. The line from the pesticide supply tank
to the venturi must contain a functional, automatic, quick
closing check valve to prevent the flow of liquid back toward
-------
-3-
the pesticide supply tank. This valve must be located
immediately adjacent to the venturi pesticide inlet. This
same supply line must also contain.either a functional normally
closed solenoid-operated valve connected to the system interlock
or a functional normally closed hydraulically operated valve
which opens only when the main water line is adequately pres-
surized. In bypass systems as an option to placing both
valves in the line from the pesticide supply tank, the check
valve may be installed in the bypass immediately upstream of
the venturi water inlet and either the normally closed solenoid
or hydraulically operated valve may be installed immediately
downstream of the venturi water outlet.
Original Device
Vacuum relief valve.
Alternative Device 1
Combination air and vacuum relief valve.
-------
FIFRA COMPLIANCE PROGRAM POLICY - No. 17.1
Pesticide Processing In Foreign-Trade Zones
FIFRA Section; 17(c)
Issue;
Are pesticides which enter a foreign trade zone for further
processing or repackaging subject to the requirements of FIFRA?
Pol icy;
A product which legally enters a foreign-trade zone for
processing or repackaging is not subject to the requirements of
FIFKA.
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
duty.
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 IS CFR Part 400. The
regulations contained in 19 CFR Part 146 govern admission 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 Taws 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.
-------
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,
Repackagl ng.
fa• C"
A. E. Conroy II,
Pesticides and T
Enforcement 01 v'
.VAY I Q I3P
Date
-------
FJFRA COMPLIANCE PROGRAM POLICY NO. 17.2
Waiver of Notice of Arrival Requirements
FIFRA Section; 17{c), 17(eJ
Issue;
of
Can Importers
for non-pesticidal
Arrival" requirements?
Pol Icy;
multi-use chemicals and pesticides Imported
purposes obtain a waiver from "Notice of
Importers of multi-use chemicals and pesticides imported for
non-pestiddal 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 1s
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 1n 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 ft to U.S. Customs commodity Import specialists.
Somt of the pesticide chemicals which appear on the list
may be multi-use chemicals Imported for non-pestiddal 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 1s being Imported;
(3) the amount of chemical being Imported; and (4) 1f known, the
port of entry (If there Is more than one, all ports of entry
should be listed).
-------
2 - 17.2
If EPA Headquarters approves the request, a copy of the
request and the waiver granted will be sent to each affected
Regi on.
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 IV* Director
Pesticides and/Toxic/ Substances
Enforcement
MAY 10
Date
-------
FIFRA COMPLIANCE PROGRAM POLICY SECTION 24 INDEX PAGE
TITLE NUMBER
Special Local Needs Labeling 24.1
-------
FIFRA COMPLIANCE PROGRAM POLICY No. 24.1
Special Local Needs Labeling
FIFRA Section; 24(c)
Issue;
W111 the Agency permit a registrant to print OP affix Section
24(c) (Special Local Need) labeling on Federal labeling?
Pol1cy;
The Agency will permit Section 24(c) labeling to appear on
Federal labeling under certain conditions.
Discussion:
Section 24(c) of FIFRA states that a State may register addi-
tional uses of federally registered pesticides for distribution 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 the
registration of products under Section 24(c).
Part 162.153(e) requires that labeling governing any State-
registered uses of a Federally registered product bt made available
at the time of ust. As a matter of convenience for both the regis-
trant and the user. Section 24(c) use directions nay 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 1s an acceptable means of con-
veying Section 24(c) Information. The labeling must also clearly
Identify the State 1n which the Section 24(c) use 1s 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)11 on all Section 24(c) labeling.
A product bearing Section 24(c) uses on the label may only be sold
1n those States listed.
-------
2 - 24.
This policy applies only to additional State registered uses
of a Federally registered product. It does not not apply to
State registered products.
See Also:
Section 24(c) Registration Guidelines 40 CFR Part 162.150-162.156
References;
Letter of June 23, 1977 from A. E. Conroy II to Mr. Arthur F.
Gohlke, Cities Service Company.
Key Words;
Intrastate Use, Labeling, Special Local Need, 24(c).
/7-c. Csvt^*-j
A. E. Conroy 11 ,/0Tr> c t o r
Pesticides and toxl.or' Substances
Enforcement 0/iv1/ion
MAY I
Date
-------
C^Hd Resistant
Section: 25(c)(3)
I s s u e :
Are snail packages -of pesticirte products which are labeled
"• or Agricultural Use Only" or which have directions expressed
in nunner of pounds per acre but which are marketed for homeowner
use automatically excluded from the Child Resistant Packaging
( C2P i requ i rement?
Policy:
Labeling a pesticide "For Agricultural Use Only" or expressing
the dosage rate in pounds per acre, label language usually reserve.d
for "agricultural" products, does not automatically remove the
pesticide fron the Child Resistant Packaging requirements.
Discussion:
The CM'irt Resistant Packaoing Reflation. 40 CFP 162.16.
^squires a ctesticifie to be in such oickaoing if it meets certain
criteria. One criterion is that the product is intended for use
in. on or around all structures, vehicles cr areas associated with
the Household or
Laoelinq a product "For Agricultural ,'se Only" removes a
product from the CR? requirement only if the label statement i s
consistent with other label language" and larketinq practices for
agricultural use. If. for example, the product is marketed in
nome or garden stores, or the entire net contents, ff applied at
the labeled dosage rate, would only cover a limited area such as
a home garden, or other label language inplies residential use.
the product would require CRP if the other CRP criteria apply.
Expressing the use directions in terns of number of pounds
per acre does not in or by itself preclude residential use. This
also would not affect whether or not a product requires CRP.
Therefore, where the package size is small, the product is
narketed fn hone and garden stores, or the entire net contents.
if applied at the labeled dosage rate, would only cover a limited
area, sucn as a home garden plot. CRP would be required if the
C3P criteria are met regardless of whether the label also states
"For Agricultural Use Only" or the dosage rate is expressed in
agricultural terms, such as pounds per acre.
-------
-2-
Additionally, a product "iay be misbranderl. according to
tne orososed 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. Conroy II.
dated July 27. 1982.
Kev v;ords:
Agricultural Use Only
Child Resistant "acfcaging
Labeling
-)
\q
A.l£. k6nroy II. Director
Perticides and Toxic Substances
Enforcemgnj Oivijj.on
Date
-------
FIFRA COMPLIANCE PROGRAM POLICY No. 26.1
Transfer of Use Enforcement Primacy to the States
FIFRA Section; 26
I.ssue;
At what point does primary enforcement responsibiHty
for pesticide use violations (primacy) transfer from EPA to
a State?
Pol Icy;
Primacy authority is 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 otherwise.
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 privacy. With respect to tht third mechanism, when
a State signs a cooperative agreement which calls for the State
to monitor and enforce compliance with pesticide ust restrictions,
such Statt assumes ust enforcement primacy unless the terms of
the agreement specify otherwise. Thus tht signing of an agree-
ment which specifically states that tht assumption by a State of
primacy depends upon tht occurrtnct of an tvtnt dots not transfer
primacy authority until tht tvtnt takes place. Cooperative
enforcement agreements which do not contain such conditions
will strvt to convey primacy to a Statt upon signature of the
Govtrnor and tht Administrator or their duly designated
representatives.
-------
2 - 25.1
Key Words :
Certification Plan, Cooperative Enforcement Agreement,
Primacy, State Authority, Use Enforcement.
A. £. Conroy II,. 01
Pesticides and Tox
Enforcement Olv
MAY JO
Date
bstances
-------
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 2$ 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 casts to EPA for Federal prosecution:
1) When the misuse Is prohibited by Ftdcrat law, but not by State
law, or,
2) When both State and Federal law prohibit.the misuse, but
the Statt lacks adequate resources to pursue prosecution.
When either of these types of misuse cases 1s 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 1s
gathered by State Inspectors; Instead It Is subject to the
common Taw rules of evidence or to the Federal Rules of
-------
2 - 25.2
Evidence. The Issue of the admissibi11ty 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, Primacy* State Authority.
A
-------
Index
The documents in this index are referenced by the Compendium subject/volume abbreviation and the date
of the document. However, FIFRA Compliance Program Policy Compendium documents are referenced
by the subject/volume abbreviation and the document number. The abbreviations for the subject/volumes
in this index are as follows:
TG - Technical Guidance (Volume 1);
SRG - State-Related Guidance (Volume 2);
ES - Enforcement Strategies (Volume 3);
ERP - Enforcement Response Policies (Volume 4); and
FCPP - FIFRA Compliance Program Policy Compendium (Volume 5)
Agricultural use only, FCPP 25.1
Alar. See Daminozide
Aldicarb
stop sale, ES 04-30-90
Aldrin, TG 02-00-90
Aluminum Phosphide products, FCPP 3.3
Amitraz, TG 02-00-90
Antifouling paints, ES 04-21-83
Antimicrobial pesticide, TG 05-28-86
Application review procedures, SRG 06-13-89
Arsenic Trioxide, ES 06-06-89, TG 02-00-90
Basic registrations, FCPP 3.9
Benomyl, TG 02-00-90
BHC, TG 02-00-90
Bithionol, TG 02-00-90
Books and records. See Recordkeeping and reporting
Bromoxynil, TG 02-00-90
conditional registration and cancellation of certain
products, ES 07-06-89
Bromoxynil Butyrate, TG 02-00-90
Bulk shipments, TG 07-11-77
Cadmium, TG 02-00-90
Calcium Arsenate. See Wood Preservatives
Cancellation order, TG 08-21-90
Captafol, TG 02-00-90
Captan, TG 02-00-90
FIFRA Compliance/Enforcement Guidance Manual
Policy Compendium September 1992
-------
Carbon Tetrachloride, TG 02-00-90
cancellation, ES 07-11-87
Cedar Chemical Company, ES 06-15-88
Certification plan, FCPP 26.1
Certified applicators, TG 11-29-83, TG 04-25-84, FCPP 2.3,
FCPP 12.4
Chemigation, FCPP 12.7
Child-resistant packaging, ES 06-08-81, FCPP 25.1
Chloranil, TG 02-00-90
Chlordane/heptachlor, TG 02-00-90
corn use, ES 08-27-76
suspension, ES 01-15-76, ES 01-22-76, ES 02-19-76,
ES 11-23-76
enforcement strategy, ES 3-23-76
termiticides
cancellation and suspension, ES 04-13-88
revised compliance strategy, ES 04-13-88
Chlordimeform, TG 02-00-90
cancellation strategy, ES 06-19-89
existing stocks, ES 02-09-89, ES 06-19-89
recall, ES 06-19-89
Chlorobenzilate, TG 02-00-90
Civil compliance, TG 01-16-80
Civil liability, TG 10-22-81
Civil penalties, TG 07-12-79, SRG 02-24-81
Civil penalty
assessment, TG 01-17-80
calculation, ERP 07-02-90
matrix, ERP 02-10-86
Commercial applicator, FCPP 2.3
Communications strategy
FIFRA and TSCA GLPs, ES 04-25-90
Compliance monitoring inspection, ES 06-15-88
Compound 1080, ES 07-25-86, TG 02-00-90
Confidentiality, FCPP 10.1
Conservation Reserve Program (CRP), FCPP 3.7
Contract manufacturing, FCPP 3.2
Cooperative agreement, SRG 07-31-89, FCPP 26.1
application requirements, SRG 06-13-89
funds, SRG 06-13-89
implementation, ES 11-22-83
Copper Arsenate, TG 02-00-90
Credentials, SRG 12-18-80
Creosote, ES 10-23-86, TG 02-00-90
Criminal penalties, TG 07-12-79
Crop rotation restrictions, FCPP 3.7
FIFRA Compliance/Enforcement Guidance Manual
Policy Compendium September 1992
-------
Cropland, FCPP 3.7
Custom blenders, FCPP 3.4, FCPP 7.1
Cyanazine, TG 02-00-90
Cyhexatin, TG 02-00-90
Daminozide (Alar), TG 02-00-90
agreement to halt sales, ES 06-14-89
final compliance monitoring strategy, ES 10-20-86
Data call-in requirements, ES 09-13-85
DBCP, TG 02-00-90
suspension order, ES 11-07-79
DDD (TDE), TG 02-00-90
Dealer, FCPP 12.4
Dealer/distributor, ES 02-09-89
Diallate, TG 02-00-90
Dibromochloropropane. See DBCP
Dicofol, TG 02-00-90
Dieldrin. See Aldrin
Diluent, FCPP 12.5
Dimethoate, TG 02-00-90
Dinoseb, TG 02-00-90, ES 04-17-87, ES 03-14-88, ES 06-15-
amendment to suspension, ES 04-02-87
cancellation, ES 03-28-88, ES 06-15-88, ES 03-03-89
emergency suspension, ES 10-07-86
exemption requirements, ES 04-02-87
stipulated order, ES 03-28-88
suspension order, 04-17-87
Direct supervision, FCPP 2.3
Disinfectants, TG 02-00-90
Distributor registrations, FCPP 3.2
District court injunction, ES 03-28-88
Drinking water, TG 08-30-75, ES 10-00-80
EBDC, TG 02-00-90
compliance strategy, ES 03-12-90(a), ES 03-12-90(b)
EDB, TG 02-00-90
grain uses, ES 02-03-84, ES 02-06-84(a), ES 02-06-84(b)
soil fumigation use, ES 10-06-83
suspension, ES 10-06-83, ES 02-03-84, 02-06-84(a)
Electronic mosquito repelling devices, TG 02-00-90
Emergency exemptions, ES 03-14-88
Enclosed cabs, TG 02-00-90, FCPP 12.6
Endangered species, TG 02-01-88, SRG 06-13-89, SRG 07-31-89
Endrin, TG 02-00-90
FIFRA Compliance/Enforcement Guidance Manual
Policy Compendium September 1992
-------
Enforcement, FCPP 12.7
Enforcement actions, TG 08-30-75, TG 12-19-79
Enforcement responsibility, primary. See Primacy
Engineering controls, FCPP 12.6
EPN, TG 02-00-90
Establish competency, FCPP 4.1
Establishment registration, ERP 02-10-86, FCPP 3.5, FCPP 7.1,
FCPP 10.1
Ethylene bisdithiocarbamate. See EBDC
Ethylene dibromide. See EDB
Evidence, FCPP 26.1
Executive agencies, TG 01-16-80
Exemptions, FCPP 3.1
Experimental use permit (EUP), FCPP 12.1
Exporting
unregistered pesticides, TG 07-28-80
Existing stocks, TG 08-21-90
chlordimeform, ES 02-09-89, ES 06-19-89
Exports. See Imports and exports
Federal facilities, TG 01-16-80
Fertilizer
pesticide mixture(s), FCPP 2.1, FCPP 3.4
Financial status, TG 10-17-80
Fish and Wildlife Service (FWS), ES 07-25-80
Fluoroacetamide, TG 02-00-90
Foreign trade zones, FCPP 17.1
Form 10-K. See 10-K Statements
Free ports, FCPP 17.1
Fumigants, ES 04-21-83
Fumigation, FCPP 3.3
Good Laboratory Practices (GLPs)
and data audits, ES 11-22-83, ES 01-15-85
notification plan, ES 04-25-90
question and answer document, TG 05-12-92
Good Laboratory Practice (GLP) Standards
agreement
interagency; Department of Health and Human Services,
National Toxicology Program, ES 01-15-85
memorandum of; for conduct of laboratory inspections and
data audits, ES 01-15-85
equipment, ES 11-29-83, ES 01-15-85
inspections, ES 01-15-85
F1FKA Compliance/Enforcement Guidance Manual
Policy Compendium September 1992
-------
Good Laboratory Practice (GLP) Standards (continued)
organization and personnel, ES 11-29-83, ES 01-15-85
quality assurance unit, TG 08-17-89
records and reports, ES 11-29-83, TG 08-17-89, ES 01-15-85
regulations, ES 01-15-85
standard operating procedures, TG 08-17-89
testing, ES 11-29-83, 01-15-85
testing facilities, ES 11-29-83, ES 01-15-85, TG 08-17-89
Government agency
state or local, SRG 02-24-81
Grain uses
EDB, ES 02-03-84, ES 02-06-84(a), ES 02-06-84(b)
Grant application forms, SRG 06-13-89
Ground water, SRG 07-31-89, SRG 06-13-89
Heptachlor. See Chlordane/heptachlor
HTLV-III/LAV, TG 05-28-86
Imports, FCPP 17.2
and exports, TG 11-19-76
Indemnification claims, ES 10-06-83
Inorganic arsenicals, ES 10-23-86, ES 06-06-89
Inspections, FCPP 12.3
establishment, TG 01-24-77
Good Laboratory Practice Standards, ES 01-15-85
labeling, ES 04-21-83
pesticide use, TG 01-24-77, SRG 12-18-80
Intrastate use, FCPP 24.1
Kepone, TG 02-00-90
Knowledge expert, FCPP 2.1
Label Improvement Program (LIP), ES 04-21-83
Labeling, TG 10-22-81, TG 05-28-86, TG 02-00-90, SRG 09-01-92, FCPP 2.2,
FCPP 3.3, FCPP 24.1, FCPP 25.1
changes, TG 02-21-88
requirements for exported pesticides, devices, and pesticide
active ingredients, TG 07-28-80
Lead Arsenate. See Wood Preservatives
Level of action, ERP 07-02-90
FIFRA Compliance/Enforcement . Guidance Manual
Policy Compendium September 1992
-------
Lindane, TG 02-00-90
compliance monitoring strategy, ES 04-25-85
notice of intent to cancel, ES 07-10-86
LIP Notice. See Label Improvement Program
Livestock protection (LP) collars, ES 07-25-86
Love v. Thomas, ES 03-28-88
Low volume applications, FCPP 12.5
Maintenance fees
registration, TG 08-21-90
Make available for use, FCPP 12.4
Manufacturing use only, FCPP 3.8
Mercury, TG 02-00-90
cancellation, ES 10-28-76
settlement, ES 01-06-77
biocides, registration, ES 09-12-90
phenylmercuric acetate, cancellation, ES 09-12-90
Methyl Bromide
California Fact Sheet, FCPP 3.10
Label Revision, SRG 09-01-92
Metaldehyde, TG 02-00-90
Mirex, TG 02-00-90
Misuse, FCPP 2.1, FCPP 12.3, FCPP 26.2
Monocrotophos, TG 02-00-90
Multi-use products, FCPP 17.2
OMPA, TG 02-00-90
Oxyfluorfen, TG 02-00-90
Neutral administrative inspection scheme, ES 09-03-85
NOIC, ES 06-15-88
Noncertified applicator, FCPP 2.3
Noncropland, FCPP 3.7
Notice of arrival, FCPP 17.2
Notice of intent to suspend (NOITS), ES 09-03-85
Outer containers, FCPP 2.2
Parathion, TG 02-00-90
PCBs, TG 02-00-90
PCNB, TG 02-00-90
FIFRA Compliance/Enforcement Guidance Manual
Policy Compendium September 1992
-------
Penalties
civil. See Civil penalties
criminal. See Criminal penalties
Pentachlorophenol. (See also Wood Preservatives), ES 10-23-80
PEPS (Pesticide Enforcement Policy Statements), TG 04-01-76,
TG 07-08-76, TG 06-08-79
institution of, TG 05-05-75
Permissible Exposure Limitation (PEL) Program, ES 10-23-86
Personal protective equipment, FCPP 12.2, FCPP 12.6
Personal use, FCPP 3.8
Pest control
devices, TG 11-19-76
electromagnetic, TG 02-00-90
nonhazardous, TG 12-19-79
preventive, TG 07-08-76
nonstructural, TG 06-08-79
structural, TG 06-08-79
Pesticide
cancellation, TG 02-00-90
restricted use, TG 02-00-90
suspension, TG 02-00-90
Pesticide dealer, FCPP 2.3
Pesticide Enforcement Policy Statements. See PEPS
Pesticide use
at less than label dosage rate, TG 06-08-79
by veterinarians, TG 11-01-79
control of pests not named on the label, TG 06-08-79 (See
also Pest control - nonstructural)
control of unnamed target pests, TG 06-08-79
enforcement, TG 01-24-77
uses which do not appear on label, advocacy of, TG 10-22-81,
TG 05-28-86
Phenarsazine Chloride, TG 02-00-90
Phosphine gas, FCPP 3.3
Polychlorinated Biphenyls. See PCBs
Polychlorinated Terphenyls, TG 02-00-90
PR Notice 87-1, FCPP 12,7
Primacy, SRG 05-11-81, SRG 01-05-83, SRG 10-02-85, FCPP 26.1,
FCPP 26.2
rescission of, ES 11-22-83
Private applicator, SRG 02-24-81, FCPP 2.3
certification, FCPP 4.1
Processing, FCPP 17.1
Producer, ERP 02-10-86
Product labeling, ES 04-21-83
Product registration, FCPP 3.5, FCPP 3.8
F1FKA Compliance/Enforcement Guidance Manual
Policy Compendium September 1992
-------
Production data, FCPP 10.1
Program oversight
evaluation and reporting, SRG 06-13-89
Pronamide, TG 02-00-90
Purifiers. See water purification devices
Quaternary Ammonium Compounds, TG 02-00-90
Rail cars, FCPP 3.3
Recall
chlordimeform, ES 06-19-89
dinoseb, ES 03-14-88
Recordkeeping and reporting, TG 11-19-76, TG 11-29-83,
TG 04-25-84
Referrals, SRG 10-02-85
Registered use pesticides, TG 11-01-79, SRG 02-24-81
Registrant
reporting requirements, TG 08-23-78
Registrant/distributor liability, FCPP 3.9
Registration, FCPP 3.4, FCPP 17.1
of establishments, TG 11-19-76
Repackaging, FCPP 3.2, FCPP 17.1
Reporting. See also Recordkeeping and reporting, ERP 02-10-86,
FCPP 7.1
Reporting requirements
study and experimental data, TG 07-12-79
Request procedures
large numbers of samples or investigations, TG 07-30-80
procedures complaint followup, TG 07-30-80
sample or label, TG 07-30-80
Rescission proceedings, SRG 05-11-81
Respirators, FCPP 12.6
Restricted use pesticides (RUP), TG 02-00-90, FCPP 12.4
Rhone-Poulenc, ES 07-06-89, ES 04-30-90
Safrole, TG 02-00-90
Salt water emesis, ES 04-21-83
Seed treatments, TG 02-00-90
Shipment, FCPP 3.1
Shipping containers, FCPP 2.2
Silvex. See 2,4,5-T and Silvex
Sodium Arsenate. See Wood Preservatives
Sodium Arsenite. See Wood Preservatives
FIFRA Compliance/Enforcement Guidance Manual
Policy Compendium September 1992
-------
Sodium Cyanide, TG 02-00-90
Sodium Fluoride, TG 02-00-90
Sodium Monofluoroacetate. See Compound 1080
Soil fumigation use
EDB, ES 10-06-83
Special local need, FCPP 24.1
Special packaging. See Child-resistant packaging
Spot fumigation, ES 02-06-84(a), ES 02-06-84(b)
Spot treatment, FCPP 3.7
State authority, FCPP 26.1, FCPP 26.2
Stop Sale, Use, or Removal Order, TG 12-19-79, TG 08-21-90,
ES 09-03-85,
aldicarb, ES 04-30-90
dinoseb, ES 03-14-88, ES 06-15-88
Strategic Planning and Measurement System (SPMS), SRG 10-02-85
Strobane, TG 02-00-90
Strychnine, TG 02-00-90
Supplemental registrations, FCPP 3.2, FCPP 3.9
Suspensions, ES 09-03-85
Target pest, FCPP 2.1
10-K statements, TG 10-17-80
Termiticides, ES 04-21-83
Thallium Sulfate, TG 02-00-90
TOK, TG 02-00-90
Toxaphene, TG 02-00-90
cancellation, ES 01-01-83
Toxic collar. See Livestock Protection Collars
Transfer, TG 07-11-77
Tributyltin, TG 02-00-90
Trifluralin, TG 02-00-90
Truck fumigation, FCPP 3.3
2,4-D, TG 02-00-90
2,4,5-T and Silvex, TG 02-00-90
cancellation, ES 03-07-79
suspension, ES 04-05-79, ES 08-20-79
2,4,5-TCP, TG 02-00-90
Ultra-low volume application, FCPP 12.5
Unregistred pesticides, FCPP 3.1
Use enforcement, FCPP 26.1
Use inconsistent with the labeling, FCPP 2.1
Use inspections, FCPP 12.3
Use recommendations, FCPP 2.1, FCPP 12.1
F1FKA Compliance/Enforcement Guidance Manual
Policy Compendium September 1992
-------
Vegetable oil diluent, FCPP 12.5
Velsicol Chemical Corporation, ES 04-13-88
Vinyl Chloride, TG 02-00-90
Violation history, TG 10-17-80
Water purification devices, TG 08-30-75, TG 03-15-76, ES 10-00-80
Wood Preservatives, ES 10-23-86, TG 02-00-90
Worker protection program, SRG 06-13-89, SRG 07-31-89
Worker protection statements, TG 02-00-90
Written examinations, FCPP 4.1
FIFRA Compliance/Enforcement Guidance Manual
Policy Compendium September 1992
10
------- |