United Statw
EnrironniMital Pn
EPA
Off to of
Paitlcidw and Toxte Subatanaai September 1988
540/RS-88-131
WarfiingtonDC 20400
Guidance for the
Reregistration of
Pesticide Products
Containing 4-(2,4 -DICHLORO
PHENOXY) BUTYRIC ACID
(2,4-DB)
as the Active Ingredient
-------
OMB Control No. 2070-0057
Expires 11/89
GUIDANCE FOR THE
REREGISTRATION OP PESTICIDE PRODUCTS
4-(2,4-DICHLOROPHENOXY)BUTYRIC ACID
(2,4-DB)
AND ITS SALT, AMINE AND ESTERS
AS THE ACTIVE INGREDIENT
CAS REGISTRY NO. 94-82-6
OPP SHAUGHNESSY NO. 030801 (ACID)
EPA CASE NUMBER — GS-0196
September 1988
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
-------
TABLE OP CONTENTS
I. Introduction 1
II. Chemicals Covered by this Standard .,.,,..... 4
A. Description of Chemicals
B. Use Profile
C. Background
III. Agency Assessment 7
A. Summary
B. Toxicology Assessment
C. Other Science Findings
D. Tolerance Reassessment
IV. Regulatory Position and Rationale 14
A. Regulatory Positions and Rationales
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Labeling
V. Products Subject to this Standard 21
VI. Requirements for Submission of Generic Data 23
A. What are generic data?
B. Who must submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI requirements
E. Registrant requests regarding data
requirements and agency responses
P. Testing protocols and standards
G. Procedures for requesting a change in
protocol
H. Procedures for requesting extensions of time
I. Data Format and reporting requirements
J. Existing stocks provisions upon suspension or
cancellation
VII. Requirement for Submission of Product-Specific Data . 30
VIII. Requirement for Submission of Revised Labeling ... 31
IX. Instructions for Submittal 3?
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products (sole active)
D. End use products (multple active)
-------
APPENDICES
II
DATA_APPENDICES
Guide to Tables
Table A
Table B
LABELING APPENDICES
Summary of label requirements and table
40 CFR 162.10 Labeling Requirements
Physical/Chemical Hazards Labeling Statements
Storge Instructions
Pesticide Disposal Instructions
Container Disposal Instructions
111• BIBLIOGRAPHY APPENDICES
Guide to Bibliography
Bibliography
IV. FORM S_APPENDIC E S
EPA Form 8580-1
EPA Form 8580-6
FIFRA §3(c)(2)(B) Summary Sheet
EPA Form 8580-4
EPA Form 8580-27
Certification of Attempt to Enter Into an
Agreement with Other Registrants for
Development of Data
Product Specific Data Report
Generic Data Exemption Statement
11
-------
GLOSSARY OF TERMS AND ABBREVIATIONS
ADI; Acceptable Daily Intake
a.i.: active ingredient
CAS: Chemical Abstract Services (number)
CSF: Confidential Statement of Formula
EEC: Estimated Environmental Concentration
EPA: The U.S. Environmental Protection Agency (Agency)
FIFRA: The Federal Insecticide, Fungicide, and Rodenticide
Act
LC50: Median lethal concentration - a statistically
derived concentration of a substance that can be
expected to cause death in 50% of test animals,
expressed as weight or volume of test substance per
volume of air or water or per weight of feed (e.g.,
mg/1 or ppm).
LD50: Median lethal dose - a statistically derived single
dose that can be expected to cause death in 50% of
test animals when administered by the route
indicated, expressed as weight of substance per
unit weight of test animal (e.g., rag/kg).
LEL: Lowest Effect Level
MPI: Maximum Permissible Intake
MRID: Master Record Identification (number) - EPA's
system of tracking studies used in support of
registration.
NPDES: National Pollution Discharge Elimination System
NOEL: No Observed Effect Level
OPP: The Office of Pesticide Programs of the U.S. EPA
OES: The Office of Endangered Species, U.S. Fish and
Wildlife Service
PHI: Preharvest Interval
RfD: Reference Dose
-------
I. INTRODUCTION
EPA has established the Registration Standards program
in order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be
reviewed and standards set for compliance with FIFRA. The
standards are applicable to reregistration and future
applications for registration of products containing the same
active ingredient. Each registrant of a product containing an
active ingredient subject to this Standard who wishes to
continue to sell or distribute that product must bring his
product and labeling into compliance with FIFRA, as
instructed by this Standard.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA. In its review EPA
identifies:
1. Studies that are acceptable to support the data
requirements for the currently registered uses of the
pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to
protect man and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon request,1 focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and
conclusions from available data in its files pertaining to
the pesticide active ingredient. However, during the review
of these data the Agency is also looking for potential
hazards that may be associated with the end use products that
contain the active ingredient. The Agency will apply the
provisions of this Registration Standard to end use products
if necessary to protect man and the environment.
-'-The scientific reviews and Compendium of Uses may be
obtained from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield,
VA 22161. Telephone (703) 487-4650.
-------
EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the pesticide and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their
registrations in compliance with FIFRA. These steps may
include:
1. Submittal of data in support of product
registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of the
pesticide to reduce the levels of impurities or contaminants;
4. Restriction of the use of the pesticide to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of Intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154 to
examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency may
propose additional regulatory actions, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
EPA has authority under the Data Call-in (DCI)
provisions of FIFRA sec. 3(c)(2)(B) to require that
registrants submit data to answer our questions regarding the
chemical, toxicological, and environmental characteristics
and fate of a pesticide. This Registration Standard lists the
data EPA believes are necessary to resolve our concerns about
this pesticide. These data are listed in the Tables A, B, and
C in Appendix I. Failure to comply with the DCI requirements
enumerated in this Registration Standard may result in
issuance by EPA of a Notice of Intent to Suspend the affected
product registrations.
Registrants are reminded that FIFRA sec. 6(a)(2)
requires them to submit factual information concerning
possible unreasonable adverse effects of a pesticide at any
-------
time that they become aware of such information. Registrants
must notify the Agency of any information, including interim
or preliminary results of studies, if that information
suggests possible adverse effects on man or the environment.
This requirement is independent of the specific time
requirements imposed by EPA for submittal of completed
studies called in by the Agency and continues as long as the
products are registered under FIFRA.
-------
II. CHEMICALS COVERED BY THIS STANDARD
A. DESCRIPTION OF CHEMICALS
This Standard covers 4-(2,4-dichlorophenoxy)butyric acid
(2,4-DB) and its inorganic salt, amine and esters.
The acid is not formulated as an end-use product; instead the
typical end-use product, as applied, is a formulation of a sodium
salt, dimethylamine, or ester (2-butoxyethyl or isooctyl) of the
parent compound. With these formulations, the esters or amine may
greatly influence the physical characteristics, biological activity
and environmental fate of the chemical. The Agency has little or
no data to evaluate the behavior of these compounds in the environ-
ment. Therefore, the data requirements in this Standard address
not only the acid and its inorganic salt but also the amine salt
and esters.
Identifying characteristics, codes, and structures are shown
below:
Chemical Name: 4-(2,4-dichlorophenoxy)butyric acid
Empirical Formula: CioH10G12°3
Molecular Weight: 249.1
CAS Registry Number: 94-82-6
Shaughnessy Number: 030801
Chemical Name: 2,4-DB, Sodium salt
Empirical Formula: CioH
Molecular Weight: 271.1
CAS Registry Number: 10433-59-7
Shaughnessy Number: 030804
Chemical Name: 2,4-DB, Dimethylamine salt
Empirical Formula: Ci2H17cl2N03
Molecular Weight: 294.23
CAS Registry Number: 2758-42-1
Shaughnessy Number: 030819
Chemical Name: 2,4-DB, 2-butoxyethyl ester
Empirical Formula: Ci6H22cl2°4
Molecular Weight: 349.30
CAS Registry Number: 32357-46-3
Shaughnessy Number: 030853
-------
Chemical Name: 2,4-DB, Butyl ester
Empirical Formula: C^ijHi 301903
Molecular Weight:. 305-26
CAS Registry Number: 6753-24-8
Shaughnessy Number: 030856
Chemical Name: 2,4-DB, Isooctyl ester
Empirical formula: ^i8^26^"'-2^3
Molecular Weight: 36.1.37
CAS Registry Number: 1320-15-6
Shaughnessy Number: 030863
B. U_SE PROFILE
Type of Pesticide: Herbicide; Plant Growth Regulator
Pests Controlled: Broadleaf Weeds
Registered Uses: Terrestrial, food
Predominant Uses: Weed control in agricultural crops
[alfalfa (16-67% of total usage), soybeans (27-533),
peanuts (5-13*)> and clover (less than 2$)]
Mode of Activity: Beta oxidation to 2,4-D acid which
stimulates nucleic acid and protein synthesis affecting
the activity of enzymes, respiration, and cell division.
Broadleaf plants exhibit epinasty, malformed leaves,
stems, and roots.
Formulation Types Registered: salt, aralne and ester liquids
(emulsifiable concentrate, soluble concentrate)
Methods of Application: Aerial and ground equipment
C• BACKGROUND
On December 3, 1986, the Agency issued a preliminary
notification of Special Review to registrants of 2,^1-DB and
2,4-DP (a similar notice was Issued to 2,4-D registrants on
September 22, 1986).* This notice was based on epidemiological
evidence thab indicated an association between farm herbicide ase
of phenoxy herbicides (including 2,4-D) and cancer (non-Hodgkin's
lymphoraa). 2,4-DB and 2,4-DP were considered for review at the
same time since these compounds are structurally related to
2,4-D.
*The Special Review process, described in MO CFR Part 154, is the
mechanism by which the Agency determines whether a pesticide poses
unresonable adverse effects to man or the environment. In Special
Review, the Agency weighs the risk of pesticide use against the
benefits of use. Documents are made available during the process
to permit public participation in EPA's deliberations prior to
any final determination of regulatory action.
-------
The Agency has subsequently issued a proposed decision
not to intiate a special review for 2,4-D, 2,4-DB and 2,4-DP
(53 FR 9590, March 23, 1988). In this document the Agency
proposed that special review is not appropriate at this time
for any of the compounds and that a decision regarding whether
to group 2,4-D, 2,4-DB and 2,4-DP in future review activities
will be made as additional metabolic and toxicologic data are
developed. Final action has not been taken on this proposal.
As part of the Agency's strategy on dioxins, the Agency
issued a Data Call-in in June 1987 requiring registrants to
analyze their 2,4-DB products for certin halogenated
dibenzo-p-dioxin or dibenzofuran (HDD and HDF) contaminants.
This notice was issued based on the Agency's assumption
that, because of the chemical structure, class and certain
manufacturing and processing conditions, 2,4-DB products
could be contaminated with HDDs or HDFs. Draft protocols
for analyzing the pesticide have been submitted. The
Agency is evaluating the proposed methods to determine
whether they meet the requirements specified in the Data
Call-in Notice.
-------
III. AGENCY ASSESSMENT
A. SUMMARY
The Agency has reviewed all data, submitted to support
registration of 2,4-DB products, available through November 1987-
Based on the review of these data, EPA has reached the
conclusions set forth in this Standard. A summary of those
conclusions follows. Additional discussion is contained in the
remainder of this Chapter.
1. When 2,4-DB is formulated as an ester or amine, the
physical characteristics, biological activity and fate in the
environment will be affected. EPA has little or no data to
evaluate the changed effects resulting from the conversion to
an ester or an amine. Therefore, the data requirements imposed
by this Standard include testing for the 2,4-D3 esters and anine
as well as the acid.
2. The Agency has concluded that existing data are inadequate
to assess the carcinogenic potential of 2,4-DB. Although under
conditions of the study, 2,4-DB was not oncogenic in the rat, in
a mouse oncogenic study there was a weak but possible dose-
relationship involving hepatocellular carcinomas in males.
A new mouse oncogenicity st.udy or historical control data -on
certain tumor incidence in the strain of mice utilized at the
testing facility are required before the significance of these
results can be determined.
3. Concern about possible neurotoxic effects for the family
of 2,4-D compounds (2,4-D, 2,4-DB, and 2,4-DP) has prompted the
requirement for a special neurotoxicity study on 2,4-D. A special
study is not required for 2,4-DB at this time. Pending the outcome
of the 2,4-D s.tudy, however, precautionary labeling requiring
gloves is required for all end-use products.
4. Concern about possible groundwater contamination exists
for the family of 2,4-D compounds (2,4-D, 2,4-DB, and 2,4-DP).
Additional data and a label warning are required.
As a result of this review, the Agency has identified data
necessary to further evaluate environmental and human risks
associated with the use of 2,4-DB. These data must be submitted
in order to maintain registration of products or register new
products containing 2,4-DB. These data are listed in the Data
Tables contained in Appendix I.
7
-------
B. TOXICOLOGICAL _AS_SESSMENT
This section discusses data available to the Agency for
2,4-DB acid and 2,4-DB[x] compounds where [x] refers to the
substituted dimethylamine salt, 2-butoxyethanol ester, butyl
ester, or isooctyl ester.
1. Acute _Toxicity__Studies
Acceptable acute oral, acute dermal, primary eye irritation,
and primary skin irritation studies indicate that 2,4-DB acid is
mildly toxic (Category III and IV). Acute inhalation and skin
sensitization testings are data gaps. No data are available for
the 2,4-DB[x] compounds.
2. Subchrpnic Toxicity Studies
An acceptable 90-day study in dogs fed 0, 2.5, 8, 25, or
80 mg/kg/day of 2,4-DB acid showed mortality, body weight depression,
and histopathological findings at 25 and 80 mg/kg/day. The lowest-
observed effect level (LOEL) was 25 mg/kg/day; the no-observed-
effect level (NOEL) was 8 mg/kg/day.
In a rat study, decreases in body weight were seen. The
LOEL was 1000 ppm and NOEL 316 ppm. Although this sbudy does not
meet Agency requirements, a new study is not required because an
acceptable chronic feeding study is available for 2,4-DB acid.
No data are available for 2,4-DB[x] compounds. Data are
required for the amine and esters.
3. Ch rqn i c To x i c i ty/One ogen i ci t y Studies
• An acceptable chronic feeding study in CD rats fed 0, 3, 30,
or 90 mg/kg/day of 2,4-DB acid showed decreased mean body weight
gains, changes in blood chemistry, hematology parameters, and
significantly lower heart weights than control at higher dose levels.
The LOEL for systemic effects was 30 mg/kg/day and the NOEL was 3
mg/kg/day. Under conditions study 2,4-DB acid was not oncogenic in
the rat.
In an oncogenlcity study in CD-I mice fed 0, 3.75, 37.5,
and 112.5 mg/kg/day of 2,4-DB acid there was a no conclusive
evidence of oncogenicity. However, there was a weak, but possibly
dose related increased incidence of hepatocellular carcinomas
in males.
8
-------
This mouse study was deficient because historical control
data on certain tumor incidences (bronchiolar adenomas and carcinomas,
as well as hepatocellular carcinomas) from males of Grl:CD®l(OR)(BR)
mice utilized at the testing facility were not submitted. Unless
the data are submitted, the study must be repeated.
Additionally, justification has to be made that the highest
dose tested (112.5 mg/kg/day) is a maxinum tolerated dose (MTD) (or
is close enough to a MTD) in female mice of this strain.
4. Terato logy _Stu_dle s
In a mouse study with 2,4-DB acid the maternal toxicity
and fetotoxic NOEL was 60 mg/kg/day, but this study is inadequate
because it utilized two dose levels rather than the required three
treatment levels.
In a rabbit study with 2,4-DB, acid the maternal toxicity
NOEL and fetotoxic NOEL was 12 mg/kg/day, but this study is
inadequate because it utilized two dose levels rather than the
three required and there was an excessive incidence of nonpregnant
females.
New teratology studies are required for 2,4-D8 acid.
No data are available for the 2,4-DB[x] compounds, and
teratology studies are required for each ester and amine.
5. Reproduction Studies
In an acceptable two-generation reproduction study in
CD rats fed 0, 3, 15, and 75 mg/kg/day of 2,4-DB acid, the
reproductive NOEL was 15 mg/kg/day. At 75 mg/kg/day ovarian weight
was significantly less in treated dams than in controls, mean birth
weights were lower, fewer total pups were born per litter, greater
number of pups were dead at birth, and extremely high pup mortality
occurred during the lactation period.
6. Mu^agenicity Studies
In an Ames study, 2,4-DB acid tested negative with and
without metabolic activation. A Chinese Hamster Ovary HGPRT
assay suggests that with activation 2,4-DB acid is a weak mutagen
Immediately below doses causing high levels of cytotoxicity. No
evidence of rnutagenic activity in this assay was observed without
activation, but this part of the assay has been classified as
unacceptable because an insufficient level of cytotoxicity was reached.
In Chinese Hamster Ovary cells, 2,4-DB acid at 750 and 1000 ug/ml
without activation caused a significant increase in chromosomal
aberrations with 17.25-hour exposure, but there was no increase
In the presence of activation with a 2-hour exposure. In an
unscheduled DNA synthesis with rat hepatocytes, there was no evidence
of induction.
-------
7. Metabolism Studies
No data are available on the metabolism of 2,4-DB acid or
2,4-DB[x] compounds. Data are required for the acid, amine and
ester.
8. Ne u r o to x 1 c i t y_S t u di e s
Several instances of accidental human poisoning with
2,4-D, resulting in severe neurotoxicity, have been reported.
Since 2,4-DB is structurally related to 2,4-D, this concern exists
for 2,4-DB compounds as well. No acceptable studies for 2,4-D3
are available. A neurotoxicity study has been required 2,4-D.
If the 2,4-D study shows neurotoxlc effects, studies may be
required using 2,4-DB.
C . OTHER SCIENCE FINDINGS
1. Environmental Pate
The Agency has no acceptable data pertinent to the fate of
2,4-DB acid or 2,4-DB[x] compounds.
a. Groundwater
Available data for 2,4-D suggest that chemicals in
the 2,4-D family of compounds (2,4-D, 2,4-DB, and 2,4-DP) has the
potential to contaminate groundwater. The Agency is requiring
data to further assess the mobility of these compounds.
b. Reentry
Based on data available to the Agency, 2,4-DB
products do not meet the toxiclty criteria specified in
40 CFR 158 for reentry data and the time of application •
to weeds coupled with rapid dissipation, limits the exposure of
workers reentering the area of application. Reentry data are
not being required at this time.
c . Pesticide_Inc 1 d_e_nt__Mqn 11qring__Sy;ait^em_ (PIMS)
PIM3 files covering the period 1966 to 1979 reported
incidents involving drift damage to nontarget plants from aerial
(173 reports) and ground (104 reports) application, as well as
volatilization (35 reports) for unspecified 2,4-D (family)
compounds.
10
-------
2 • E c o 1 o g 1 c a 1_E f f e c t s
Available data are insufficient to completely assess the
ecological effects of 2,4-DB acid and 2,4-DB[x] compounds to
wildlife and aquatic organisms. The following preliminary
conclusions can be made, however, based on available data,
(NOTE: all figures are 1,050 values):
a. Avian Effects
No acceptable acute oral data are available on day
2,4-DB compound. The Agency has acceptable dietary studies on
2,4-DB acid and 2,4-DB sodium salt to characterLae fch'^e
compounds as practically nontoxic (> 5000 ppra, respectively) to
waterfowl and upland game birds on a subacute basis. There are
no avian subacute oral data available for the 2,4-DB[x] compounds,
and these data are required.
b. Aquatic Organism Effects
Acceptable data on 2,4-DB acid and 2,4-DB sodium salt
indicates these compounds are moderately to slightly toxic to
freshwater fish (fathead minnow 18 ppm, bluegill sunfish 7.5
and 17 ppm, rainbow trout 2.0 and 14 ppn, depending on test
conditions). There are no acceptable data for acute toxicity to
freshwater invertebrates on any 2,4-DB compound. There are no data
available on acute toxicity to freshwater fish for the 2,4-D3[x]
compounds.
c. Nontarg et_I n s e_c_t _Ef feet s
Acceptable data on 2,4-DB dimethylamine indicates a
low toxicity to bees. Data from a honey bee acute contact study
are required for 2,4-DB isooctyl and 2-butoxyethanol esters.
d- Nqiit_ar_get___Plarit Effects
There are no data available to evaluate phytotoxicifcy
of 2,4-DB compounds to nontarget plants. Since 2,4-DB is a
broadleaf herbicide, there is a potential hazard to nontarget
plants from existing uses.
e. Endangered Species
Because of limited environmental fate and ecological
effects data, hazard assessments for endangered species cannot
be completed at this time. When additional data are received,
the Agency will determine whether consultation with the Office
of Endangered Species (OES), U.S. Pish and Wildlife Service is
appropriate.
1 1
-------
Chem i sjt rjr
The Agency has noted that 2,4-DB may be contaminated
with tetra- through heptahalognated dibenzo-p-dioxins or
dibenzofurans, or N-nitrosamines. Certain polyhalognated
dibenzo-p-dioxin or dibenzofuran congeners have found to
be mutagenic, oncogenic, teratogenic and to cause reproductive
toxicity. Nitrosamines have been found to be oncogenic.
Analytical data to identify and quantify tetra- through
heptachlorrinated dibenzo-p-dioxin or dibenzofuran contaminants
were required in a Data Call-in Notice issued in June 1987.
Analytic data to identify and quantify N-nitrosamine are being
required, as specified in the data tables.
D • TOLE RAN C E_AS S E S S M E NT
Tolerances of 0.2 ppm have been established for residues of
2,4-DB and its metabolite 2,4-D in or on alfalfa, clover, mint
hay, peanuts, soybeans, soybeans hay, and birdsfoot trefoil (40
CFR 180.331). No Mexican tolerance or Codex MRL exists for,
residues of 2,4-DB. Therefore, no compatibility question exists
with respect with Codex MRL.
EPA has evaluated the residue and toxicology data supporting
these tolerances. The following issues were considered during
this evaluation:
o Whether the current tolerances and food additive regulations
are sufficient to cover the actual residues resulting from
the use (including FIFRA section 24(c) and intrastate uses).
o Whether group tolerances can be established in accordance
with 40 CFR 180.34(f).
o Whether, in the absence of tolerances, restrictions on
use, grazing, or feeding of treated commodities are
necessary.
o Whether the tolerances are expressed accurately and in
current terminology.
The regulatory results of the Agency's review are set out in
the Regulatory Positions and Rationale section.
1 • Residue .Data
The residue data reviewed in support of these tolerances
include the following:
a. Data on the nature of the residues in both plants
and animals, including identification of major metabolites and
degradates of 2,4-DB. The nature of the residue is not adequately
understood.
12
-------
b. Analytical methodology for determining the levels
of residues of 2,4-DB in plants and animals. The nature of the
residue in plants and animals has not been adequately described.
Therefore, the adequacy of available analytical methods cannot be
determined.
c. Storage stability data. These data demonstrate that
residues of 2,4-DB and 2,4-D are relatively stable in soybeans,
peanuts, and alfalfa for up to 1 year when stored at -20 °C.
Additional data are required.
d. Data on the magnitude and levels of residues of
2,4-DB in individual raw agricultural commodities. Data are
not adequate to support the established tolerances.
2. Toxicology Data
The toxicology data for 2,4-DB are insufficient to
determine an Acceptable Daily Intake (ADI). However, a
Provisional Acceptable Daily Intake (PADI) has been
calculated based on a rat chronic feeding study with a
NOEL of 3 mg/kg/day and using an uncertainty factor of
300. The PADI with a 300-fold safety factor is calculated
to be 0.01 mg/kg/day. A comparison of the published
tolerances to the PADI was conducted using the Tolerance
Assessment System, Routine Chronic Analysis. Based on the
analysis a Theortical Maximum Residue Contribution (TMRC)
for the U.S. population was calculated to be 0.000083
mg/kg/day, which utilizes 0.83 percent of the PADI. Using
the TMRC provides a conservative estimate since it does
not consider the effect of processing on residue levels in
the raw agricultural commodity, that actual residue levels
may be lower than the established tolerance, and that less
than 100 percent of the crop is treated.
13
-------
IV. REGULATORY_POSITION_AND_RATIONALE
A • REGUL^ATORY_Pg S FT ION S _AN D_RAT I ONALE S
Based on review and evaluation of available data on 2,4-DB,
the Agency has made the following determinations. Where label
revisions are imposed, specific language is set forth in the
Labeling portion of this section.
1. The Agency will not place 2,4-DB in Special Review at
this time.
Rati_qnal_e. In December 1986, the Agency issued a
preliminary notification of special review to the registrants
of 2,4-DB and 2,4-DP, based on epidemiologic evidencce
available at that time (a similar notice had been issued to
2,4-D registrants in September 1986). After additional
evaluation of this evidence the Agency subsequently concluded
that these data were inadequate to assess oncogenic potential
for the 2,4-D family of compounds (2,4-D, 2.4-DB and 2,4-DP).
Therefore, in March 1988, EPA proposed not to initiate a
special review of any of the chemicals at this time.
The Agency's concerns regarding toxicological effects have.not
been fully resolved. Additional epidemiological studies are
expected to be completed soon and additional laboratory studies
are required by this Standard. As these data become available,
the Agency will further evaluate potential risks from these
compounds and could initiate a special review at a later time
and/or consider additional regulatory action, if appropriate.
A decision whether to group 2,4-D, 2,4-DB and 2,4-DP in future
review activities will be made as additional metabolic and
toxicologic data are developed.
2. The Agency will not restrict the use of 2>4-DB products
to certified applicators.
Rationale. Based on available data, 2,4-DB products
have not met or exceeded any criteria specified in 40 CFR 152.170
which would indicate a need to restrict the use of 2,4-DB to
certified applicators only.
3. The Agency will require data on the amines and esters
of 2,4-DB as well as the acid.
Rationale. When 2,4-DB is formulated as an amine or
ester, the biological activity and fate in the environment will
be affected. Since the Agency has little or no data to evaluate
the effects of the [x] moiety, data are needed on each [x] compound
to evaluate these characteristics for the particular amine or
ester form.
14
-------
4. The Agency will not establish tolerances for significant
new food uses of 2,4-DB.
Rat_i_qn_a^e. The current residue chemistry and toxicology
data are not sufficient to assess existing and pending tolerances.
Therefore, the Agency will not consider any significant new food
uses until data are available to resolve these issues.
5. The Agency will propose the following technical changes
in listing of 2,4-DB tolerances (i) the commodity entry "alfalfa"
will be amended to "alfalfa forage" and "alfalfa hay"; (ii) the
commodity entry "birdsfoot trefoil" will be amended to "birdsfoot
trefoil forage" and "birdsfoot trefoil hay"; and (iii) the
commodity entry "clover" will be amended to "clover forage" and
"clover hay."
Rati^qnal^e. These technical changes are required because the
addition of "forage" and "hay" clarifies the tolerance statements.
6. The Agency will revise the,tolerance statement to
include 2,4-DB sodium salt, 2,4-DB dimethylamine salt, 2,4-DB
2-butoxyethanol ester, and 2,4-DB isooctyl ester; if the
registrants propose to maintain the use of these 2,4-DB[x]
compounds, and provide data to support the tolerances for
these salt, amine and esters.
Rationale. The registered uses for 2,4-DB are for the
2,4-DB[x] compounds and they must be a part of the tolerance
statement.
7. The Agency will require that registration be proposed
for use on mint and appropriate supporting data be submitted
or the Agency will revoke the tolerance of 0.2 ppm for residues
of 2,4-DB in or on mint hay. Registrants will have three months
to notify the Agency of which option they choose.
Rationale. There is no registered use for mint. Therefore,
this tolerance is unnecessary if registration is not proposed and
supporting data not submitted.
8. The Agency is requiring a groundwater warning statement
on the labels of 2,4-DB products.
Rationale. Although available data for phenoxy herbicides
suggest that the 2~,4-D family of compounds may be mobile in many
soil types, and has'the potential to contaminate groundwater, its
potential to contaminate groundwater is limited by its rapid rate
of degradation and uptake by target plants. However, residues of
phenoxy herbicides have been detected in groundwater, mostly from
point sources, such as mixing, loading and disposal. Since the
phenoxy herbicides could be a potential groundwater contaminant,
a label statement will advise users to exercise caution when
handling phenoxy herbicide products to prevent such contamination.
15
-------
The Agency is currently finalizing its Agricultural Chemicals
in Groundwater Strategy and its policy for restricting the
use of pesticide products which may reach groundwater. When
the policies are in place, the Agency will consider what
action is appropriate for phenoxy herbicide products and
other products containing ingredients which may reach
groundwater.
9. The Agency is requiring the use of gloves *rhen lining,
loading or applying 2,4-DB products.
Rationale. The major route of exposure to workers
handling 2,4-DB~is~ dermal. Use of gloves will mitigate
potential hazards involving dermal exposure.
10. The Agency is not requiring a reentry interval for 2,4-D3
products.
Rationale. Based on data available to the Agency, 2,4-DB
products are of fow toxicity and the time of the application
coupled with dissipation limits the exposure of workers ree.ntering
the area of application. There are no reentry concerns with this
chemical at the present time.
11. The Agency is requiring analytical chemistry for 2,4-D3
products to evaluate contamination with tetra- through
heptahalognated dibenzo-p-dioxins or dibenzofurans, and N-
nitrosamines.
Rationale. Polyhalogenated dibenzo-p-dioxins or
dibenzofurans may be formed during manufacture of 2,4-DB, and
N-nitrosamines may be formed during the manufacture or storage
of products containing 2,4-DB amines. The Agency does not
have sufficient data to determine the extent or* significance )"
the contamination.
12. The Agency will immediately review certain data as they
are submitted.
Rationale. Because of concerns regarding potential
risks from 2,4-D~B"use, the Agency believes it is essential that
the following data be reviewed as they are received: all toxi-
cological studies; dioxin, furan and nitrosamlne analysis;
octanol/ water partition coefficient; vapor pressure; leaching
and adsorp'ci-on/desorptlon; spray drift; plant and animal
metabolism studies and validation methods; and freshwater fish
and invertebrate acute toxicity studies.
16
-------
13. While data gaps are being filled, currently registered
manufacturing-use products and end-use products containing 2,4-DB
may be sold, distributed, formulated, and used, subject to the terms
and conditions specified in this Standard. However, significant new
uses will not be registered. Registrants must provide or agree
to develop additional data, as specified in the data tables, in
order to
-------
B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard,
manufacturing-use products (MPs) and end-use products (EPs)
must contain 2,4-DB acid or 2,4-DB[x] compounds, bear required
labeling, and conform to the product composition, acute
toxiclty limits, and use pattern requirements listed in this
document.
0. ACCEPTABLE_RANGES_ANDLIMITS
1. Product Composition Standard
To conform to this Standard, MPs and EPs must contain
2,4-DB acid or 2,4-DB[x] compounds. Each formulation proposed for-
registration must be fully described with an appropriate certifi-
cation of limits, stating maximum and minimum amounts of active
and inert ingredients present in the product as well as impurities.
2. Acute_To_x_icity Limits
The Agency will consider registration of technical grade,
MPs, or EPs containing 2,4-DB acid or 2,4-DB[x] compounds, provided
the products are supported by appropriate acute toxicity data and
the labeling for the product bears appropriate precautionary state-
ments for the toxicity category in which the product is placed.
3. Use Patterns
To be registered under this Standard, MPs must be labeled
for formulation into other MPs or into EPs bearing federally-
registered uses. The use index (EPA Compendium of Acceptable Uses)
lists all federally-registered uses of 2.4-DB acid and 2,4-DB[x]
compounds, as well as approved maximum application rates and
frequencies.
The use patterns currently registered are terrestrial
food.
18
-------
D. LABELING
All products must bear appropriate labeling as specified in
40 CPR 156.10, PR Notices 83-2, 83-3, and 87-1, and below.
Appendix II contains further information on label requirements.
1. Timeframes for Compliance
Pesticide products containing 2,4-DB acid or 2,4-DB[x]
compounds may not be released for shipment by the registrant after
October 1, 1989 unless the product bears amended labeling that
complies with the requirements of FIFRA, as set forth in this
Registration Standard.
Pesticide products containing 2,4-DB acid or 2,4-DB[x]
compounds may not be distributed or sold by any person after
October 1, 1990 unless the product bears amended labeling that
complies with the requirements of this Standard.
In addition to the labeling requirements above, the
following must appear on the labeling of all MPs and EPs.
2• Ingredient Statement
The ingredient statement for 2,4-DB products must list
the active ingredient as:
4-(2,4-dichlorophenoxy)butyric acid .... %
or
4-(2,4-dichlorophenoxy)butyric acid,
(salt, amlne or ester) %
4-(2,4-dichlorophenoxy)butyric acid
equivalent * . .
3. Use _Pjittern ^Statements
All manufacturing-use products must state that they are
intended for formulation into end-use products for acceptable
use patterns. However, no use may be included on the label
where the registrant fails to agree to comply with the data
requirements in Table A for that use pattern.
-------
4. Precautionary Statement
a. Envirqnmental_Hazards
1) Manufacturing-use products: "Do not discharge
effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or waters unless this product is specifically
identified and adrassed in an NPDES permit. Do not discharge
effluent containing this product to sewer systems without previously
notifying the sewage treatment plant authority. For guidance,
contact your State Water Board of Regional Office of EPA."
2) End-use products: "Do not apply directly to water
or wetlands (swamps, bogs, marshes, or potholes). Do not contaminate
water when disposing of equipment washwaters."
b. GroundwateP_ A_dvisory__(end^u_se pj? odu c t s_)_
. "This product can reach groundwater as a result of
mixing and loading. To minimize groundwater contamination Pr>xa
spills during mixing, loading and cleaning of equipment, take the
following steps:
Mixing and Loading: When mixing, loading or applying
this product, wear chemical re'sistant gloves. Wash nondisposabla
gloves throughly with soap and water before removing.
The mixing and loading of spray mixtures into the spray
equipment must be carried out on an impervious pad (i.e., concrete
slab, plastic sheeting) large enough to catch any spilled material.
If spills occur, contain the spill by using an absorbent material
(e.g, sand, earth or synthetic absorbent). Dispose of the
contaminated absorbent material by placing in a plastic bag and
following disposal instructions on this label.
Triple rinse empty containers and add rinsate to the
mixing tank.
Cleaning of Equipment: When cleaning equipment, do
not pour the wahwa'teTr o~n the "gro'und; spray or drain over a
large area away from wills and other water sources."
20
-------
V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the pesticides
identified in Section II.A. are subject to certain
requirements for data submittal or changes in composition,
labeling or packaging of the product. The applicable
requirements depend on whether the product is a manufacturing
or end use product and whether the pesticide is the sole
active ingredient or one of multiple active ingredients.
Products are subject to this Registration Standard as
follows:
A. Manufacturing use products containing this pesticide as
the sole active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to
the manufacturing use product.
2. The data requirements listed in Tables A and B.2
3. The labeling requirements specified for
manufacturing use products in Section IV.
4. Administrative requirements (application forms,
Confidential Statement of Formula, data
compensation provisions) associated with
reregistration.
B. Manufacturing use products containing this pesticide as
one of multiple active ingredients are subject to:
1. The data requirements listed in Table A.
2Data requirements are listed in the three Tables in
Appendix I of this Registration Standard. The Guide to
Tables in that Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to
all products containing the pesticide subject to this
Registration Standard. Table B lists product-specific data
applicable to manufacturing-use products. The data in Tables
A and B need not be submitted by an end-use producer who is
eligible for the generic data exemption for that active
ingredient.
Table C lists product-specific data applicable to end-
use products. The Agency has decided that, in most cases, it
will not require the submittal of product-specific data for
end-use products at this time. Therefore, most Registration
Standards do not contain a Table C.
21
-------
2. The labeling requirements specified for
manufacturing use products in Section IV.
C. End use products containing this pesticide as the sole
active ingredient are subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV if they pertain to
the end use product.
2. If eligible for the generic data exemption,3 the
data requirements listed in Table C.
3. If not eligible for the generic data exemption, the
data requirements listed in Table A and the data
requirements listed in Table C.
4. The labeling requirements specified for end use
products in Section IV.
D. End use products containing this pesticide as one of
multiple active ingredients are subject to:
1. If not eligible for the generic data exemption, the
data requirements listed in Tables A and C.
2. If eligible for the generic data exemption, the
data requirements listed in Table C.
3. The labeling requirements specified for end use
products in Section IV.
3If you purchase from another producer and use as the
source of your active ingredient only EPA-registered
products, you are eligible for the generic data exemption for
generic data concerning that active ingredient (Table A) and
product-specific data for the registered manufacturing use
product you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change sources of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption and
become subject to the data requirements in Table A.
2) If no producer subject to the generic data
requirements in Table A agrees to submit the required data,
all end-use producers lose the exemption, and become subject
to the data requirements in Table A.
22
-------
VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
tie submitted by registrants to maintain in effect the
registration of products containing this active ingredient.4
A. What are generic data?
Generic data pertain to the properties or effects of a
particular active ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often
required for ecological effects studies and applies to all
products having that formulation type. These are classed as
generic data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the active ingredient in his product is
complying with the data request.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
required data. If the registrants who have committed to
generate and submit the required data fail to take
appropriate steps to meet the requirements or are no longer
in compliance with this data requirements notice, the Agency
will consider that both they and you are not in compliance
and will normally initiate proceedings to suspend the
registrations of both your product(s) and their product(s)
unless you commit to submit and submit the required data in
the specified timeframe. In such cases, the Agency
generally will not grant a time extension for submitting the
data.
Registrations granted after issuance of this Standard
will be conditioned upon submittal or citation of the data
listed in this Registration Standard.
23
-------
If you are not now eligible for a generic data
exemption, you may qualify for one if you change your source
of supply to a registered source that does not share
ownership in common with your firm. If you choose to change
sources of supply, the Confidential Statement of Formula must
identify the new source(s) and you must submit a Generic Data
Exemption Statement.
If you apply for a new registration for products
containing this active ingredient after the issuance of this
Registration Standard, you will be required to submit or cite
generic data relevant to the uses of your product if, at the
time the application is submitted, the data have been
submitted to the Agency by current registrants. If the
required data have not yet been submitted, any new
registration will be conditioned upon the new registrant's
submittal or citation of the required data not later than the
date upon which current registrants of similar products are
required to provide such data. See FIFRA sec. 3(c)(7)(A).
If you thereafter fail to comply with the condition of that
registration- to provide data, the registration may be
cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing this
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
D. How to comply with DCI requirements.
Within 90 days of your receipt of this Registration
Standard, you must submit to EPA a completed copy of the form
entitled "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA'Form
8580-1, enclosed) for each of your products. On that form
you must state which of the following six methods you will
use to comply with the DCI requirements:
1. You will submit the data yourself.
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also
provide EPA with documentary evidence that an agreement has
been formed which allows you to rely upon the data to be
submitted. Such evidence may be: (1) your letter offering to
join in an agreement and the other registrant's acceptance of
your offer, (2) a written statement by the parties that an
agreement exists, or (3) a written statement by the person
24
-------
who will be submitting the data that you may rely upon its
submittal. The Agency will also require adequate assurance
that the person whom you state will provide the data is
taking appropriate steps to secure it. The agreement to
produce the data need not specify all of the terms of the
final arrangement between the parties or a mechanism to
resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number, as part of your 90-day response. The
request must include the following information:
a. A list of the members of the consortium;
b. The name and address of the designated
representative of the consortium, with whom EPA
will correspond concerning the data;
c. Identity of the Registration Standard containing
the data requirement;
d. A list of the products affected (from all members
of the consortium); and
e. Identification of the specific data that the
consortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submittals by the consortium.
3. You have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your
registration for non-compliance with the DCI. EPA has
determined that, as a general policy, it will not suspend the
registration of a product when the registrant has in good
faith sought and continues to seek to enter into a data
development/cost sharing program, but the other registrants
developing the data have refused to'accept its offer. [If
your offer is accepted, you may qualify for Option 2 above by
entering into an agreement to supply the data.]
In order to qualify for this method, you must:
1. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for
Development of Data" (EPA Form 8580-6, enclosed).
2. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of
your offer (such as a certified mail receipt). Your offer
must, at a minimum, contain the following language or its
equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to FIFRA sec.
25
-------
3(c)(2)(B) in the [name of active ingredient] Registration
Standard upon terms to be agreed or failing agreement to be
bound by binding arbitration as provided by FIFRA section
The remainder of your offer may not in any way attempt
to limit this commitment. If the other registrant to whom
your offer is made does not accept your offer, and if the
other registrant informs us on a DCI Summary Sheet that he
will develop and submit the data required under the DCI,
then you may qualify for this option. In order for you to
avoid suspension under this method, you may not later
withdraw or limit your offer to share in the burden of
developing the data.
In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. If the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of
suspension proceedings, unless you commit to submit and
submit the required data in the specified timeframe. In such
cases, the Agency generally will not grant a time extension
for submitting the data.
4. You request a waiver of the data requirement. If
you believe that a data requirement does not (or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use
factors that lead you to believe that a requirement does not
apply. Since the Agency has carefully considered the
composition and uses of pesticide products in determining
that a data requirement applies, EPA does not anticipate
that many waivers will be granted. A request for waiver does
not extend the time-frames for developing required data, and
if your waiver request is denied, your registration may be
suspended if you fail to submit the data. The Agency will
respond in writing to your request for a waiver.
5. You request that EPA amend your registration by
deleting the uses for which the data are needed. You are not
required to submit data for uses which are no longer on your
label.
6. You request voluntary cancellation of the regis-
tration of your product (s) for which the data are needed.
E. Registrant Requests Regarding Data Requirements and
Agency Responses
All requests for modification of data requirements
(inapplicability, waiver), approval of protocols or protocol
26
-------
changes, or time extensions must be submitted in writing. The
original requirement remains in effect unless the Agency has
notified you in writing that it has agreed to a change in the
requirement. While being considered by the Agency, such
requests for changes in the requirements do not alter the
original requirements or extend the time allowed for meeting
the r equ i r ement.
F. Test Protocols and Standards
All studies required under this Notice must be conducted
in accordance with test standards outlined in the Pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing. All testing must
be conducted in accordance with applicable Good Laboratory
Practices regulations in 40 CFR Part 160.
The Pesticide Assessment Guidelines, which are
referenced in the Data Tables, are available from the
National Technical Information Service (NTIS), Attn: Order
Desk, 5285 Port Royal Road, Springfield, VA 22161 (tel:
703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if the
OECD-recommended test standards conform to those specified in
the Pesticide Data Requirements regulation (Part 158.70).
Please note, however, that certain OECD standards (such as
test duration, selection of test species, and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be
be modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158. Normally,
the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accord
with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania Avenue, N.W., Washington, D.c.
20006.
G. Procedures for requesting a change in test protocol.
If you will generate the required data and plan to use
test procedures which deviate from EPA's Pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing Programme, you must submit for EPA
approval the protocols you propose to use.
You should submit your protocols before beginning
testing, because the Agency will not ordinarily accept as
sufficient studies using unapproved protocols. A request for
protocol approval will not extend the timeframe for submittal
of the data, nor will extensions generally be given to
27
-------
conduct studies due to submittal of inappropriate protocols.
The Agency will respond in writing to your request for
protocol approval or change.
H. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time.
EPA will view failure to request an extension before the
data submittal response deadline as a waiver of any future
claim that there was insufficient time to submit the data.
While EPA considers your request, you must strive to meet the
deadline for submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you have
taken to meet the testing deadline. Time extensions normally
will not be granted due to problems with laboratory capacity
or adequacy of funding, since the Agency believes that with
proper planning these can be overcome. The Agency will
respond in writing to any requests for extension of time.
I. Data Format and Reporting Requirements
All data submitted in response to this Notice must
comply with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of
results, and the adequacy of any required supporting (or raw)
data, including, but not limited to, requirements referenced
or included in this Notice or contained in PR Notice 86-5
(issued July 29, 1986). All studies must be submitted in the
form of a final report; a preliminary report will not be
considered to fulfill the submittal requirement.
J. Existing stocks provision upon suspension or
cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under FIFRA
sec. 3(c)(2)(B), an existing stocks provision for the
registrant is not consistent with the Act. Accordingly, the
Agency does not anticipate granting permission to sell or
distribute existing stocks of suspended product except in
rare circumstances. If you believe that your product will be
suspended or cancelled and that an existing stocks provision
should be granted, you have the burden of clearly
demonstrating to EPA that granting such permission would be
consistent with the Act. The following information must be
included in any request for an existing stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of existing
28
-------
stocks and your estimate of the time required for their sale
or distribution; and
2. Demonstration that such a provision would be
consistent with the provisions of FIFRA.
29
-------
VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that
certain product-specific data are required to maintain your
registrations in effect. Product-specific data are derived
from testing using a specific formulated product, and, unlike
generic data, generally support only the registration of that
product. All such data must be submitted by the dates
specified in this Registration Standard.
If you have a manufacturing use product, these data are
listed in Table B. If you have an end use product, the data
are listed in Table C. As noted earlier, the Agency has
decided that it will not routinely require product-specific
data for end use products at this time. Therefore, Table C
may not be contained in this Registration Standard; if there
is no Table C, you are not required to submit the data at
this time.
In order to comply with the product specific data
requirements, you must follow the same procedures as for
generic data. See Section VI.D through J. You should note,
however, that product chemistry data are required for every
product, and the only acceptable responses are options
VI.D.I. (submit data) or VI.D.6. (cancellation of
registration).
Failure to comply with the product-specific data
requirements for your products will result in suspension of
the product's registration.
30
-------
VIII. REQUIREMENT FOR SUBMITTAL OF REVISED LABELING
FIFRA requires each product to be labeled with
accurate, complete and sufficient instructions and
precautions, reflecting the Agency's assessment of the data
supporting the product and its uses. General labeling
requirements are set out in 40 CFR 156.10 (see Appendix II -
LABELING and SUMMARY). In addition, labeling language
specific to products containing this pesticide is specified
in Section IV.D of this Registration Standard. Responses to
this Registration Standard must include draft labeling for
Agency review.
Labeling must be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for storage
in 8-1/2 x 11 files. Draft labeling must indicate the
intended colors of the final label, clear indication of the
front panel of the label, and the intended type sizes of the
text.
If you fail to submit revised labeling as required,
which complies with 40 CFR 156.10 and the specific
instructions in Section IV.D., EPA may seek to cancel the
registration of your product under FIFRA sec. 6.
31
-------
IX. INSTRUCTIONS FOR SUBMITTAL
All submittals in response to this Registration
Standard must be sent to the following address:
Office of Pesticide Programs
OPP Mailroom (TS-767C)
Environmental Protection Agency
401 M St., SW
Washington, B.C. 20460
Attn: 2,4-DB Registration Standard
All submittals in response to this Registration
Standard are non-fee items, including 90-day responses,
protocols and waiver requests, data, and revised labeling.
Submittals must be clearly identified as being in response to
the Registration Standard. Under no circumstances may
Registration Standard responses be combined with other types
of filings for which fees are required.
A. Manufacturing Use Products (MUPs) containing the subject
pesticide as sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit for each product subject to this Registration
Standard:
a. Generic Data Exemption Statement (EPA Form 8580-3),
if applicable, or the "FIFRA Section 3(c)(2)(B)
Summary Sheet" (EPA Form 8580-1), with appropriate
attachments.
b. Confidential Statement of Formula (EPA Form
8570-4).
c. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40
CFR 152.80-152.99.
2. Within 9 months from receipt of this document you
must submit:
a. Application for Pesticide Registration (EPA Form
8570-1).
b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental
labeling.
d. Product Specific Data Report (EPA Form 8580-4).
-"' 32
-------
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is
delayed or aborted so that the schedule cannot be met,
immediately notify the Agency of the problem, the reasons for
the problem, and your proposed course of action.
B. Manufacturing Use Products containing the subject
pesticide in combination with other active ingredients.
1. Within 90 days from receipt of this document, you
must submit:
a. Generic Data Exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA sec. 3(c)(2)(B) Summary
Sheet, with appropriate attachments (EPA Form
8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
2. Within 9 months of receipt of this document, you
must submit:
Three copies of draft labeling, including the container
label and any associated supplemental labeling.
3. Within the time frames set forth in Table A, you
must submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is
delayed or aborted so that the schedule cannot be met,
immediately notify the Agency of the problem, the reasons for
the problem, and your proposed course of action.
C. End Use Products containing the subject pesticide as
sole active ingredient.
1. Within 90 days from receipt of this document, you
must submit:
a. Generic data exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA Section 3(c)(2)(B)
Summary Sheet, with appropriate attachments (EPA
Form 8580-1).
b. Confidential Statement of Formula (EPA Form
8570-4).
2. Within 9 months from receipt of this document you
must submit:
a. Two copies of any product-specific data, if
required by Table C.
33
-------
b. Product Specific Data Report (EPA Form 8580-4) , if
Table C lists required product-specific data.
c. Three copies of draft labeling, including the
container label and any associated supplemental
labeling.
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is
delayed or aborted so that the schedule cannot be met,
immediately notify the Agency of the problem, the reasons for
the problem, and your proposed course of action.
D. End Use Products containing the subject active
ingredient as one of multiple active ingredients
1. Within 90 days from receipt of this document, you
must submit:
a. Generic data exemption Statement (EPA Form 8580-3),
if applicable, or the FIFRA Section 3(c)(2)(B)
Summary Sheet, with appropriate attachments (EPA
Form 8580-1).
b. Confidential Statement of Formula (EPA Form
8570-4).
2. Within 9 months from the receipt of this document,
you must submit:
Three copies of draft labeling, including the container
label and any associated supplemental labeling.
3. Within the times set forth in Table A, you must
submit all generic data, unless you are eligible for the
generic data exemption. If for any reason any test is
delayed or aborted so that the schedule cannot be met,
immediately notify the Agency of the problem, the reasons for
the problem, and your proposed course of action.
34
-------
I. DATA APPENDICES
35
-------
GUIDE TO TABLES
Tables A, B, and C contain listings of data requirements
for the pesticides covered by this Registration standard.
Table A contains generic data requirements that
apply to the pesticide in all products, including
data requirements for which a "typical formulation"
is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
Table C contains product-specific data requirements that
apply only to an end use product.
The data tables are generally organized according to the
following format:
1. Data Requirement: (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR P.art 158.
The reference numbers accompanying each test refer to the
test protocols set out in the Pesticide Assessment
Guidelines, which are available from the National Technical
Information Service, 5285 Prot Royal Road, Springfield, VA
22161.
2. Test Substance (Column 2). This column lists the
composition of the test substance required to be used for the
test, as follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure Active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The
following letter designations are used for the given use
patterns:
A = Terrestrial, food
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
F = Greenhouse, non-food
G = Forestry
-------
H = Domestic outdoor
I = Indoor
Any other designations will be defined in a footnote to the
table.
4. Does EPA have data? (Column 4). This column indicates
one of three answers:
YES - EPA has data in its files that completely
satisfy this data requirement. These data may be
cited by other registrants in accordance with data
compensation requirements of Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but
such data do not fully satisfy the data
requirement. In some cases, the Agency may possess
data on one of two required species or may possess
data on one test substance but not all. The term
may also indicate that the data available to EPA
are incomplete. In this case, when the data are
clarified, or additional details of the testing
submitted by the original data submitter, the data
may be determined to be acceptable. If this is the
case, a footnote to the table will usually say so.
NO - EPA either possesses no data which are
sufficient to fulfill the data requirement, or the•
data which EPA does possess are flawed
scientifically in a manner that cannot be remedied
by clarification or additional information.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the
identifying number of each study. This normally is the
Master Record Identification (MRID) number, but may be a GS
number if no MRID number has been assigned. Refer to the
Bibliography Appendices for a complete citation of the study.
6. Must additional data be syb. nutted.? (Column 6). This
column indicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column e
indicates that the Agency has only partial data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not
require its submission because of the unique characteristics
of the chemical; because data on another chemical can be used
to fulfill the data requirement; or because the data
requirement has been waived or reserved. Any such unusual
situations will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 6
requires that data be submitted, this column indicates when
37
-------
the data are to be submitted, based on the issuance date of
the Registration Standard. The timeframes are those
established either as a result of a previous Data Call-in
letter, or standardized timeframes established by PR Notice
85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
-------
Table A
Generic Cata Requirements for 2,4-EB Acid and 2,4-DB[x] Compounds!/
r
H
Test £
Data Requirement Substance F
Subpart
Product
61-2 -
61-3 -
Analysis
62-1 -
Physical
63-2 -
63-3 -
63-4 -
63-5 -
63-6 -
63-7 -
63-8 -
C Product Chemistry
Identity
Description of Beginning
Materials and Manufac-
turing Process
Discussion of Formation
of Impurities
and Certification of Product
Preliminary Analysis
and Chemical Characteristics
Color
Physical State
Odor
Melting Point
Boiling Point
Density, Bulk Density,
or Specific Gravity
TGAI
TGAI
Ingredients
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Solubility TGAI or PAI
toes EPA
lave Data T<
>atisf y Thi!
Requirement'
No
No
No
No
No
No
No
No
No
No
3
3 Bibliographic
? Citation?/
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Must Additional
Data Be Submitted?
Yea!/
Yes!/
Yes!/
Yes6/
Yes6/
Yes6./
Yes!J_/
YesM/
Yes!/
Yes!/
Tlmeframe
for
Submission
6 Months
6 Months
12 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
-------
Table A
Generic Data Requirements for 2,4-DB Acid and 2,4-DB[x] Compounds!/ (cont'd)
Does EPA
Have Data To Timeframe
Test Satisfy This Bibliographic Must Additional for
Data Requirement Substance Requirement? Citation^/ Data Be Submitted? Submission
§158.190 Product Chemistry
Physical and Chemical.Characteristics (cont'd)
63-9 - Vapor Pressure
63-10 - Dissociation Constant
63-11 - Octanol/Water Partition
Coefficient
63-12 - pH
63-13 - Stability
Other Requirements;
64-1 - Submittal of Samples
TGAI or PAI
itant TGAI or PAI
"tition PAI
TGAI
TGAI
No
No
No
No
No
N/A
N/A
N/A
N/A
N/A
Yes!/
Yes!/
YesM/
YesMO/
Yes!/
6 Months
6 Months
6 Months
6 Months
6 Months
N/A
N/A
N/A
I/Requirements apply to 2,4-DB Acid as well as to the sodium salt, dimethylamine, 2-butoxyethyl ester, butyl ester, and
isooctyl ester forms, where [x] refers to the substituted salt, amine or ester.
j?/Although product chemistry data may have been submitted in the past, the Agency has determined that these data
must be resubmitted. New requirements have been introduced and previously submitted data must be updated.
Therefore, bibliographic citations for the old data are not applicable.
4U
-------
Tkble A
Generic Data Requirements for 2,4-DB Acid and 2,4-DB[x] Compounds!/ (cont'd)
§158.190_Product Chemistry Footnotes (cont'd)
3/Complete information must be provided regarding the nature of the process (batch or continuous); the relative
amounts of beginning materials and the order in which they are added; the chanical equations for each Intended
reaction; equipment used to produce each intermediate and the final product; reaction conditions; the duration
of each step of the process; purification procedures; and quality control measures. In addition, the name and
address of the manufacturer, producer, or supplier of each beginning material used in the manufacture of each
product must be provided, along with information regarding the properties of those materials. In order to assess
the potential for contamination with halogenated dibenzo-p-dioxins and dibenzo furans, the description of the
manufacturing process must also include the range of temperature conditions, pressure, and pH at each reaction step.
Refer to the data requirements set forth in the Agency's June 1987 Data Call-in Notice for analytical chemistry
data on halogenated diben^o-p-dioxins/dibenzofurans in 2,4-DB. These data are due as specified in the Data
Call-in Notice.
_4/A detailed discussion of all Impurities that are or may be present at 0.1% based on knowledge of the beginning
materials, chemical reactions (Intended and side) in the manufacturing process, and any contamination during and
after production must be submitted. This discussion must also address the possible formation of dibenzo-p-dioxins
and dibenzo furans for all products and N-nitrosamines for amines. Refer to the data requiranents set forth in
the Agency's June 1987 Data Call-in Notice for analytical chemistry on halognated dibenzo-p-dioxins/dibenzofurans
in 2,4-DB. These data are due as specified in the Data Call-in Notice.
5i/Five or more representative samples must be analyzed for the amount of active ingredient and each Impurity for which
certified limits are required. Complete validation data (accuracy and precision) must be submitted for each
analytical method used.
^/Physicochemical characteristics (color, physical state, odor, melting point, boiling point, specific gravity,
solubility, vapor pressure, dissociation constant, partition coefficient, pH, and stability) as required in
40 CPR 158.190 and more fully described in the Pesticide Assessment Guidelines, Subdivision D, must be submitted.
7/Data required if the technical chemical is a solid at room temperature.
F/Data required if the technical product is a liquid at room temperature.
9/Data. required if the technical product is organic and nonpolar.
10/Data required if the test substance is dispersible in water.
41
-------
Table A
Generic Data Requirements for 2,4-DB Acid and 2,4-DB[x] Compounds^/
Data Requirement
§158.240 Residue Chemistry
171-4 - Nature of Residue
(metabolism)
- Plants
- Livestock
171-4 - Residue Analytical
Methods
171-4 - Storage Stability
Test Does EPA Bibliographic r
Substance Have Data? Citation D<
PAIRA Partially 00004685,
00116018
PAIRA and No
plant meta-
bolites
TGAI and Partially 00004718
metabolites 00018284
00037371
00046125
00087925
00102943
00115135
00116018
00132034
00161196
TEP and Partially 00116018
metabolites , 00132034
Time frame
lust Additional for
ata Be Submitted? Submission2/
Yes3/ 18 Months
Yes4'5/ 18 Months
Yes^'7/ 15 Months
Yes8/ 15 Months
A')
-------
Table A
Generic Data Requlranents for 2,4-DB Acid and 2,4-DB[x] Compoundal/ (cont'd)
;a Requirement
j8.240 Residue Chemistry
L-4 - Magnitude of the Residue
in Plants
- Legume Vegetables
- Soybeans
- Processed Soybean
Commodities
- Foliage of Legume
Vegetables
- Soybean forage and
Hay
- Nongrass Animal Feeds
- Alfalfa
- Clover
- Trefoil
Test Does EPA Bibliographic
Substance Have Data? Citation
TEP Partially 00018284
00037371
00106319
00115135
00116018
TEP Partially 00037371
00087925
00116018
TEP Partially 00061012
00116018
TEP Partially 00061012
00132034
TEP Partially 00061012
00116018
Must Additional
Data Be Submitted?
Yes!/
Yes!?/
Yes!!/
Yes.12j.ll/
YeslV
Yesl5/
Timeframe
for
Submission*
18 Months
24 Months
18 Months
18 Months
18 Months
18 Months
-------
Table A
Generic Data Requirements for 2,4-DB Acid and 2,4-DB[x] Compounds!/ (cont'd)
Data Requirement
§15.8.240Jtesl;due_Chemis_try
171-4 - Magnitude of the Residue
in Plants (cont'd)
- Miscellaneous Commodities
- Mint
- Peanuts
- Processed Peanut
Products
171-4 - Magnitude of Residue
in Meat/Mi Ik/Poultry/
Eggs
Test
Substance
Does EPA Bibliographic
Have Data? Citation
Must Additional
Data Be Submitted?
Time frame
for
Submission?/
TEP
TEP
TGAI or
plant meta-
bolites
Partially
Partially
Partially
00102943
00161196
00116018
00004701
00027041
00116018
Yesli/
Yesl7/
18 Months
18 Months
24 Months
ReservedI2
1/Requirements apply to 2,4-DB Acid as well as to the sodium salt, dlmethylamine, 2-butoxyethyl ester, butyl ester, and
isooctyl ester forms, where [x] refers to the substituted salt, amine or ester.
2/For Magnitude of the Residues in Crops, the timeframes for submitting data are 18 or 24 months, as appropriate
~~ commencing with the 1989 planting season.
3/Data depicting the distribution and metabolism of ring-labeled [lilC]2,4-DB in or on alfalfa, soybeans (mature seed
and forage), and an oilseed crop. IT metabolisa is not similar In these three crops, additional studies using other
crops may be required. A completely characterized test substance representative of technical 2,4-DB (including
impurities) used In commercial formulations must be applied foliarly at rates sufficiently high to permit characteri-
zation of i4c-residues. Sample intervals must Include the day of application and the identities and quantities of
residues in or on mature plant parts must be determined in order to elucidate terminal residues. Representative
samples must also be analyzed by proposed and/or existing enforcement methods to ascertain that all residues of
concern are determined.
VMetabolisrn studies using ruminants and poultry must be submitted. Animals must be dosed for at least 3 days with
ring-labeled [1^C]2,4-DB (acid) at a level high enough to permit quantification of the ^C-resldues. If necessary
hydrolysis and reextraction of samples and aqueous fractions must be applied to release any l4Q_conjUgates. Milk
and eggs must be collected within 24 hours of the final dose. The distribution and characterization of residues must
-------
Table A
Generic Data Requirements for 2,4-DB Acid and 2,4-DB[x] Compoundal/ (cont'd)
§jL58.240_Residue Cheiilstry Footnotes (cont'd)
be determined in milk, eggs, liver, kidney, muscle, and fat. Samples from these studies must also be analyzed using
all current and proposed enforcement methods to ascertain that the methods are capable of adequately recovering and
quantifying all residues of toxicologic concern. [If the required plant metabolism studies using a radiolabeled
dimethylarnlne salt of 2,4-DB reveal that dlmethylamine, per se, and/or the dimethylamine salt will occur as a
residue in or on alfalfa, birdsfoot trefoil, clover, mint", peanuts, soybeans, and soybean hay, metabolism studies
in ruminants and poultry are also required using [l^G]dimethylamine or the [l^C] dimethylamine salt.]
^/Data depicting the nature of 2,4-DB residues in swine are also required if the required metabolism studies with
ruminants and poultry reveal that the metabolism of 2,4-DB in these animals differs from that in rats.
_6/A PAM Vol. I, Section 222 multiresidue protocol for the determination oF chlorophenoxy acids and esters is
currently employed for enforcement purposes and will suffice for the testing of 2,4-DB per se under the PAM I
protocols I-IY [40 OPR 158.240(b)(15)].
7/If the required animal metabolism data reveal metabolites of concern, analytical methods for data collection
and tolerance enforcement (including multiresidue procedures) will be required.
j8_/All residue data requested in this Standard inust be accompanied by sample storage data (storage conditions and time
stored) and data depicting the stability of residues under the conditions and for the time Intervals specified.
9/Data depicting 2,4-DB residues of concern In or on soybeans harvested 60 days after a single postemergence broadcast
application with the soluble concentrate liquid (SO/L) sodium (Na) salt of 0.05 Ib ai/A and the emulsifiable concen-
trate (EC) dlmethylamine (DMA) salt at 0.06 Ib ai/A. Each formulation must be applied in 5 gallons of water using
aerial equipnent (in separate tests). Otests must be conducted in IL (1655), IN (8%), IA (14%), and MM (9/0 or OH (1%)
since these States collectively produced ca. 50% of the 1984 U.S. soybean crop and represent the major U.S. soybean
production regions.
j.O/If no detectable residues of 2,4-DB are observed at a 5X application rate, no processing study is required. If howev
the needed data indicate that measurable, weathered residues occur in soybeans, a processing study must be submitted
depicting 2,4-DB residues of concern in the processed commodities meal, hulls, soapstock, crude oil, and refined oil,
and the milling dust from soybeans.
_ll_/Data depicting 2,4-DB residues of concern in or on soybeans harvested 60 days after a single postemergence broadcast
application with the SC/L Na salt of 0.05 Ib ai/A and the EC DMA salt at 0.05 Ib a I/A. Each formulation must be
applied in 5 gallons of water using aerial equipment (in separate tests). Tests must be conducted in IL (16%),
IN (8%), IA (14%), and MM (9%) or OH (7%) since these Stabes collectively produced ca. 50% of the 1984 U.S. soybean
crop and represent the major U.S. soybean production regions.
^12/Data depicting 2,4-DB residues of concern In or on Forage and hay of established alfalfa harvested 30 days following
aerial application oF an EC formulation of the dimethyl am I ne salt at 1.5 Ib ae/A and the 2 Ib ae/gal EC formulation
of the isooctyl ester at 1.0 Ib ae/A each in a separate test. The tests must be conducted In CA (8%), CO (3%), or
NE (6%); IA (7%), IL (4%), or KS (5%); MI (6%), MN (7%), SD (4%) or WI (12%), and NY (3%), OH (3%), or PA (3%) which
collectively accounted For ca. 70% oF the 1985 U.S. production of alfalfa.
45
-------
Table A
Generic Data Requirements for 2,4-DB Acid and 2,4-DB[x] Compoundai/ (cont'd)
§158.240 Residue Chemistry Footnotes (cont'd)
13/Data depicting 2,4-DB residues of concern in or on forage and hay of seedling alfalfa harvested 60 days following
aerial application of an EC formulation of the dimethylamine salt at 1.5 lb ae/A and the 2 Ib ae/gal EC formulation
of the butoxyethanol ester at 1.0 lb ae/A each in a separate test. The tests must be conducted in CA (8$), CO (350,
or NE (6%); IA (7%), IL (4%), or KS (5%); MI (6%), MN (7%), SD (4%) or WI (12%), and NY (3%), OH (3%), or PA (3%)
which collectively accounted for ca. 70% of the 1985 U.S. production of alfalfa.
14/Data depicting 2,4-DB residues of concern in or on forage and hay of clover harvested 60 days following a single
postemergence broadcast application of an EC EMA salt formulation at 1.5 lb ae/A and the 2 lb ae/gal EC isooctyl
ester formulation at 1 lb ae/A. Each formulation must be applied in 5 gallons of water using aerial equipment
(in separate tests). Tests must be conducted in CA (99% ladino clover), IL (11% red clover) or MO (11% red clover),
and OR (29% alsike clover) because these States represent the major regions of 1982 U.S. clover acreage.
jVData required for alfalfa will be translated to birdsfoot trefoil. Refer to footnotes 13 and 14 for details of
data requirements.
16/Data reflecting 2,4-DB residues of concern in or on mint hay harvested at the minimum interval between application
and harvest (ca. 60 days) following a single postemergence application of the 1.75 lb/gal EC EMA salt and the 2 lb/
gal EC isooctyl ester formulations at 1 lb ae/A in separate tests. Tests must be conducted in OR and WA since
these States produced 74% of the 1985 U.S. mint (spearmint and peppermint) grown for oil.
17/Data 2,4-DB residues of concern in or on peanuts harvested 30 days following the last of two applications of
an EC formulation of the 2,4-DB dimethylamine salt (030819) at 0.4 lb ae/A. Test must be conducted in AL (36%)/
PL (5%)/GA (13%) and NC (28%)/VA (18%), States which collectively account for ca. 100% of 1985 commercial peanut
production, excluding product in Ml, OK, and TX.
18/Data depicting 2,4-DB residues of concern in meal, crude and refined oil, and soapstock processed from
peanuts bearing measurable weathered residues. If residues concentrate in any of these processed commodities,
then appropriate food/feed additive tolerance must be proposed.
19/Following receipt and evaluation of the required plant and animal metabolism data and residue data for soybeans
and nongrass animal feeds, specific data requirements for livestock feeding studies will be established.
-------
Table A
Generic Data Requirements for 2,4-DB Acid and 2,4-DB[x] CompoundsV
Test Use
Data Requirement Substance Patterns
§158.290 Environmental Fate
Degradation Studies - Lab
161-1 - Hydrolysis TGAI or PAIRA A
Photode gradation
161-2 - In Water TGAI or PAIRA A
161-3 - On Soil TGAI or PAIRA A
161-4 - In Air TGAI or PAIRA A
Metabolism Studies - Lab
162-1 - Aerobic Soil TGAI or PAIRA A
162-2 - Anaerobic Soil TGAI or PAIRA A
162-3 - Anaerobic Aquatic TGAI or PAIRA
163-4 - Aerobic Aquatic TGAI or PAIRA
Mobility Studies
163-1 - Leaching and Adsorption/ TGAI or PAIRA A
Desorption
163-2 - Volatility (Lab) TEP A
164-3 - Volatility (Field) TEP A
Does EPA
Have Data To Timeframe
Satisfy This Bibliographic Must Additional for
Requirement? Citation Data Be Submitted? Submission
No
No
No
No
No
No
No
No
No
No
No
Yes
Yes
Yes
Yes
Yes
Yes
No^/
No2/
Yes
Yes
Yes
9 Months
9 Months
9 Months
9 Months
27 Months
27 Months
12 Months
12 Months
15 Months
47
-------
Table A
Generic Data Requirements for 2,4-DB Acid and 2,4-DB[x] Compounds!/ (cont'd)
Test
Data Requirement _ Substance
§158.290 Environmental Fate
Dissipation Studies j^ Field
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
165-5 - Soil, Long-Term
Accumulat iqn_Studies
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Nontarget
Organisms
Does EPA
Have Data To
Use Satisfy This Bibliographic
Payi®T.ns Requirement? Citation
Time frame
Must Additional for
Data Be Submitted? Submission
TEP
TEP
TEP
TEP
A No
No
No
No
Yes
No!/
No!/
No!/
27 Months
TEP
PAIRA
TEP
TEP
TGAI or PAIRA
TEP
No
No
No
No
No
No
Jte serve d5/
Yes
fte served§/
No!/
Yes
Nol/
39 Months
12 Months
-------
liable A
Generic Data Requirements for 2,4-DB Acid and 2,4-DB[x] Compounds!/ (cont'd)
§158.290 Environmental Fate Footnotes
I/Requirements apply to 2,4-DB Acid and the dimethylamine salt, 2-butoxyethyl ester, butyl ester and
isooctyl ester forms, where [x] refers to the substituted amine or ester. The sodium salt is considered
equivalent to the acid.
2/2,4-DB [x] products have no registered aquatic or aquatic impact uses, therefore, no aquatic data are required.
3/2,4-DB [x] products have no registered forestry uses, therefore, no forestry data are required.
¥/Tank mix data requirements are not being Imposed by this Standard.
5/Soil long-term study is reserved pending results of an acceptable field dissipation study.
F/The rotational crop field study is reserved pending the results of an acceptable confined rotational crop study.
7/Data are not required to support current registered uses or are otherwise not applicable to this standard.
49
-------
Generic
Table A
Data Requirements for 2,4-DB Acid and 2,4-DB[x] Compounds!/
Data
§158
Requirement
.340 Toxicology
Test
Substance
Does EPA
Have Data To
Satisfy This
Requirement?
Bibliographic Mast Additional
Citation Data Be Submitted?
Time frame
for
Submission
Acute Testing
81-1
81-2
81-3
81-7
- Acute Oral Toxicity - Rat
- Acute Dermal Toxicity
- Acute Inhalation
Toxicity - Rat
- Acute Delayed
Neurotoxicity - Ifen
Acid TGAI
Salt TGAI
Amine TGAI
Esters TGAI
Acid TGAI
Salt TGAI
Amine TGAI
Esters TGAI
Acid TGAI
Amine TGAI
Esters TGAI
Acid TGAI
Amine TGAI
Esters TGAI
Yes
No
No
No
Yes
No
No
No
No
No
No
No
No
No
00092159 No
00128854
Yes
Yes
Yes
00128854 No
Yes
Yes
Yes
Yes
Yes
Yes
No!/
No£/
No£/
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
9 Months
Subchronic Testing
82-1
- 90-Day Feeding
- Rodent
Acid TGAI
Amine TGAI
Esters TGAI
No
No
No
No!/
Yes
Yes
15 Months
15 Months
-------
Table A
Generic Data Requirements for 2,4-DB Acid and 2,4-DB[x] Compounds!/
Data Requirement
82-1 - 90 Day Feeding (cont'd)
- Nonrodent (Dog)
82-2 - 21-Day Dermal
82-3 - 90-Day Dermal
82-4 - 90-Day Inhalation
82-5 - 90-Day Neurotoxicity
Does EPA
Have Data To
Test Satisfy This Bibliographic
Substance Requirement? Citation
Acid TGAI
Amine TGAI
Esters TGAI
Acid TGAI
Amine TGAI
Esters TGAI
Acid TGAI
Amine TGAI
Esters TGAI
Acid TGAI
Amine TGAI
Esters TGAI
Acid TGAI
Amine TGAI
Esters TGAI
Yes 00104739
No
No
No
No
No
No
No
No '
No
No-
No
No
No
No
Timeframe
Must Additional for
Data Be Submitted? Submission
No
Yes
Yes
Yes
Yes
Yes
NoV
No?/
No!/
NoV
IfaJ/
No!/
No!/
No!/
No!/
18 Months
18 Months
12 Months
12 Months
12 Months
-------
Table A
Generic Data Requirements for 2,4-DB Acid and 2,4-DB[x] Compoundai/ (cont'd)
Does EPA
Have Data To
Test Satisfy This Bibliographic Must Additional
Data Requirement Substance Requirement? Citation Data Be Submitted?
§158.3^0 Toxicology
Chronic Testing
83-1 - Chronic Toxicity (2 Species)
- Rodent Acid TGAI
Amine TGAI
Esters TGAI
- Nbnrodent (Dog) Acid TGAI
Amine TGAI
Esters TGAI
83-2 - Cncogenicity Study (2 Species)
- Rat (preferred) Acid TGAI
Amine TGAI
Esters TGAI
- Mouse (preferred) Acid TGAI
Amine TGAI
Esters TGAI
83-3 - Teratogenicity (2 Species)
- Rat Acid TGAI
Amine TGAI
Esters TGAI
- Rabbit Acid TGAI
Amine TGAI
Esters TGAI
Yes
No
No
No
No
No
Yes
No
No
No
No
No
No
No
No
No
No
No
40257501 No
Reserve d^/
Reserve d£/
Yes
Reserved°/
Reserved!/
40257501 No
Reserve d^/
Reserve d2/
Yes!/
Reserve d^/
Reserved"/
Yes
Yes
Yes
Yes
Yes
Yes
Timeframe
for
Submission
50 Months
6 Months
15 Months
15 Months
15 Months
15 Months
15 Months
15 Months
-------
Table A
Generic Data Requlranents for 2,4-DB Acid and 2,4-DB[x] Corapoundai/ (cont'd)
Data Requirement
§158. 3*10 Toxicology
83-4 - Reproduction - Rat
(2-Generation)
Mutagenicity Testing
84-2 - Gene Mutation
84-2 - Structural Chromosomal
Aberration
84-2 - Other Mechanisms of
Mutagenicity
Special Testing
85-1 - General Metabolism Acid
Amine
Ksters
85-X - Neurotoxiclty (Dermal)
Does EPA
Have Data To
Test .Safety This Bibliographic
Substance Requirement Citation
Acid TGAI Yes 40257503
Amlne TGAI No
Esters TGAI No
Acid TGAI Partially 40257504
40257505
Amine TGAI No
Esters TGAI No
Acid- TGAI Yes 40257506
Amine TGAI No
Esters TGAI No
Acid TGAI Yes 40257507
Amine TGAI No
Esters TGAI No
PAI or PAIRA No
PAI or PAIRA No
PAI or PAIRA No
Acid TGAI No
Amine TGAI No
Esters TGAI Ifo
Must Additional
Data Be Submitted
No
Reserve d^/
Reservedly
Yes8/
Yes
Yes
No
Yes
Yes
No
Yes
Yes
Yes
Yes
Yes
Reserved^/
Reserve d2/
Reserved!/
Timeframe
for
Submission
9 Months
9 Months
9 Months
12 Months
12 Months
"12 Months
12 Months
24 Months
24 Months
24 Months
-------
Table A
Generic Data Requirements for 2,4-DB Acid and 2,4-DB[x] Gompoundal/ (cont'd)
158.340 Toxicology Footnotes
I/Requirements apply to 2,4-DB Acid as well as to the sodiun salt, dlmethylamine, 2-butoxyethyl ester, butyl ester and
" isooctyl ester forms, where [x] refers to the substituted salt, amine or ester.
2/This test is required only for compounds which are organophosphate inhibitors of cholinesterase, or related to
~~ such inhibitors or metabolites of such inhibitors. 2,4-DB compounds are not organophosphates, therefore, a study is
not required.
3/This requirement is waived for 2,4-DB Acid/sodium salt based on the submission of an acceptable chronic feeding
~~ study in the rat.
VThis study is not required for the registered use patterns.
5/Since an acute neuroto*Lolty study is not required, this study is not required.
I/This study will be required for the amine and esters if basic studies show significant toxicology difference from the
~~ 2,4-DB Acid/sodium salt, or will be required if residues of the amine or esters appear on the raw agricultural
commodities.
7/Either a new study is required or the mouse oncogenicity study on file must be upgraded to acceptable by submission
~~ of historial control data on tumor incidences (bronchiolar adenomas and carcinomas, as well as hepatocelluar
carcinomas) from males of this strain of mice at the testing facility and justification that 750 ppn in the Maximum
Tolerated Dose in female mice of this strain.
8/An acceptable CHO/HGPRT study without metabolic activation is required for 2,4-DB Acid.
9/A special neurotoxicity study for 2,4-DB compounds is reserved pending the outcome of the 2,4-D neurotoxicity study.
-------
Table A
Generic Data Requirements for 2,4-DB Acid and 2,4-DB[x] Compounds!/
Does EPA
Have Data To Timeframe
Test Use Satisfy This Bibliographic Must Additional for
Data Requirement __ Substance Patterns. Requirement? Citation DataJEte Submitted? Submission
§158.390 Reentry Protection
132-1 - Foliar Dissipation
132-2 - Soil Dissipation
133-3 - Dermal Exposure
133-4 - Inhalation Exposure
§158.440 Spray Drift
201-1 - Droplet Size
201-2 - Drift Field
TEP
TEP
TEP
TEP
TEP
TEP
A
A
A
A
A
A
No
No
No
No
No
No
No!/
No!/
No!/
No!/
Ye si/
Yes!/
6 Months
6 Months
I/Requirements apply to 2,4-DB Acid as well as to the sodiun salt, dimethyl ami ne, 2-butoxyethyl ester, butyl ester and
isooctyl ester forms, where [x] refers to the substituted salt, amine or ester.
^/Reentry data requirements are not being Imposed under this Standard. Although 2,4-DB [x] products are registered
for use on crops whose production and/or harvest would require human tasks characterized by a likelihood of dermal
and inhalation exposure, time of application coupled with dissipation limits the exposure of workers reentering
area of application. In addition, 2,4-DB [x] does not meet the toxlcity requirements for §158.340.
_3_/Spray drift data are being required under this Standard because 2,4-DB [x] meets the phytotoxicity requirement
§158.440. The droplet spectrum study is to be performed to reflect the nozzle and other equipment types to be
used In the application of 2,4-DB [x] to crops. The spray drift field evaluation to be performed to reflect
the application equipment, use pattern, and typical locations of use, which includes different weather factors,
in the application of 2,4-DB [x] for these uses.
55
-------
Table A
Generic Data Requirements for 2,4-DB Acid and 2,4-DB[x] Compounds!/
Data Requirement ______ _
|158 . 490 Wildlife and Aquatic Organisms
Ebes EPA
Have Data To Timeframe
Test Use Satisfy This Bibliographic Must Additional for
Substance Patterns Requirement? Citation Data Be Submitted? Submission
71-1 - Acute Avian Oral Toxicity
71-2 - Avian Subacute Dietary
Toxicity
- Upland Game Bird and
waterfowl
71-3 - Wild Mammal Toxicity
71-4 - Avian Reproduction
71-5 - Simulated and Actual
Field Testing
- Mammals and Birds
Aquatic Organisms Testing
72-1 - Freshwater Fish Toxicity
- Warmwater and Coldwater
TGAI
TGAI
TGAI
TGAI
TEP
TGAI
72-2 - Acute Toxicity to Freshwater TGAI
Invertebrates
No
Partially
No
No
No
Partially
No
00022923
40094602
40762601
40762602
Yes!/
Yes!/
No!/
Nol/
No!/
Yes5/
Yes
9 Months
9 Months
9 Months
9 Months
-------
Table A
Generic Data Requirements for 2,4-DB Acid and 2,4-DB[x] Compounds!/ (cont'd)
Does EPA
Have Data To Time frame
Test Use Satisfy This Bibliographic Mist Additional for
Data Requirement^ Substance JPatterns Requirement? _^tation Data Be Subj^ltted?_Submlssion
§158.490 Wildlife and Aquatic Organisms
Aquatic Organisms Testing (cont1d)
72-3 - Acute Toxicity to TGAI
Estuarine and Marine
Organisms
72-4 - Pish Early Life Stage TGAI
and Aquatic Invertebrate
Life Cycle
72-5 - Pish Life Cycle
72-6 - Aquatic Organism
Accumulation
72-7 - Simulated and Actual
Field Testing
- Aquatic Organisms TEP
No
No
TGAI A
TGAI, A
PAI, or
Degradation
Product
No
No
Nol/
Reserve d§/
Re served§/
Reserved^./
No
Reserved§/
I/Requirements apply to 2,4-DB Acid as well as to the sodiun salt, dlmethylamine, 2-butoxyethyl ester, butyl ester and
~~ isooctyl ester forms, where [x] refers to the substituted salt, amine or ester.
2/Requirement applies to 2,4-DB Acid. Testing is to be conducted with bobwhite quail. Data for 2,4-DB[x] compounds
are reserved pending results of Avian Subacute Dietary Toxicity Studies.
3/The Agency has acceptable data for 2,4-DB Acid and 2,4-DB Sodiun Salt. Data must be submitted for the amine and
esters. Testing is to be conducted with bobwhite quail.
_4/Data are not required to support current registered uses or are otherwise not applicable to this standard.
F/The Agency has acceptable data for 2,4-DB Acid and 2,4-DB Sodiun Salt. Data must be submitted for the amine and
esters.
6/Reserved pending results of the acute and environmental fate studies.
-------
Table A
Generic Eata Requirements for 2,4-DB Acid and 2,4-DB[x] Compounds!/
Test Use
Data Requirement_ Substance Patterns^
Does EPA
Have Data To Tlmeframe
.Satisfy This Bibliographic Must Additional for
Requirement? _Citation_ Data Be Submitted? Submission
§158.540 Plant Protection
121-1 - Target Area Phytotoxicity
Nontarget Area Phytotoxicity
TIER_I
122-1 - Seed Germination/Seedling
Emergence
122-1 - Vegetative Vigor
122-2 - Aquatic Plant Growth
TIER II
123-1 - Seed Germination/Seedling
Emergence
123-1 - Vegetative Vigor
123-2 - Aquatic Plant Growth
TIER II
124-1 - Terrestrial Field
124-1 - Aquatic Field
TEP
TGAI
No
No
No!/
Nol/
TGAI
TGAI
TGAI A
TGAI A
TGAI A
TEP
TEP
No
No
No
No
No
No
No
Nol/
Nol/
Yes
Yes
Yesl/
Reserved^.,
Reserved^/
9 Months
9 Months
9 Months
-------
•Cable A
Generic Data'Requirements for 2,4-DB Acid and 2,4-DB[x] Compounds (Cont'd)
§15<3.540_Plant_Protectio_n Footnotes
I/Requirements apply to 2,4-DB Acid as well as to the sodiun, diraethylamine, 2-butoxyethyl ester, butyl ester and
~~ isooctyl ester forms, where [x] refers to the substituted salt, amine or ester.
£/Data not required to support current registered uses or are otherwise not applicable to this standard.
3/Eata are avaiable in the open literature on the phytotoxicity of the phenoxys to broadleaf plants; therefore, testing
should be conducted at the Tier II level to establish ECfcjo values.
VData on the algae Selenastrum capricornutum is required.
5/Reserved pending re's'uTts' "o"f "Tie"? "II."
-------
Table A
Generic Data Requirements for 2,4-DB Acid and 2,4-DB[x] Compounds]/
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data To Timeframe
Satisfy This Bibliographic Must Additional for
Requirement? Citation Data Be Submitted? Submission
§158.590 Nontarget Insect
Nontarget Insect Testing - Pollinators
141-1 - Honey Bee Acute Contact TGAI
Toxicity
141-2 - Honey Bee - Toxicity of TEP
Residues on Foliage
141-4 - Honey Bee Subacute
Feeding Study
141-5 - Field Testing for TEP
Pollinators
Nontarget Insect Testing - Aquatic Insects
142-1 - Acute Toxicity to
Aquatic Insects
142-2 - Aquatic Insect Life
Cycle Study
142-3 - Simulated or Actual Field
Testing for Aquatic
Insects
Partially
No
No
00018842
Yes2/
Reserved-'/
Reserved'*/
Reserved-V
9 Months
Reserved/
Reserved^/
-------
Table A
Generic Data Requirements for 2,4-DB Acid and 2,4-DB[x] Compounds^/ (cont'd)
Data Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data To
Satisfy This Bibliographic
Requirement? Citation
Time frame
Must Additional for
Data Be Submitted? Submission
§158.590 Non target Insect
Nontarget Insect Testing - Aquatic Insects (cont'd)
143-1 - Nontarget Insect
thru Testing - Predators
143-3 - and Parasites
Reserved/
1 /Requirements apply to 2,4-DB Acid as well as to the sodium, dimethylamine, 2-butoxyethyl ester, butyl ester and
isooctyl ester forms, where [x] refers to the substituted salt, amine or ester.
2/The Agency has acceptable data for 2,4-DB dimethylamine. Data must be submitted for 2,4-DB butoxyethyl ester and
2,4-DB isooctyl ester.
VAs data from the acute contact test indicate low toxicity for 2,4-DB dimethylamine; no further testing is required
for this form of 2,4-DB. Reserved for 2,4-DB butoxyethyl ester and 2,4-DB isooctyl ester pending evaluation of data
from acute contact test.
4/Reserved pending development of test methodology.
5/Reserved pending Agency decision as to whether the data requirement should be established.
-------
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing 2,4-DB Acid
and 2,4-DB[x] CompoundsV
Data Requirement
§158.190 Product Chemistry
Product Identity
Does EPA
Have Data To
Test Satisfy This
Substance Requirement?
Bibliographic Must Additional
Citation2/ Data Be Submitted?
Timeframe
for
Submission
61-1 - Product Identity and MP -
Disclosure of
Ingredients
61-2 - Description of Beginning MP
Materials and Manufac-
turing Process
61-3 - Discussion of Formation MP
of Impurities
Analysis and Certification of Product Ingredients
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods to
Verify Certified Limits
No
No
No
N/A
N/A
N/A
Yes3/
Yes4/
Yes5/
6 Months
6 Months
6 Months
MP
MP
MP
No
No
No
N/A
N/A
N/A
Yes6/
Yes7/
Yes8/
12 Months
1 2 Months
12 Months
-------
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing 2,4-DB Acid
and 2,4-DB[x] Compounds1/ (cont'd)
Data Requirement
§158.190 Product Chemistry
Physical and Chemical Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-7 - Density, Bulk Density,
or Specific Gravity
63-12 - pH
63-14 - Oxidizing or Reducing
Action
63-1 5 - Flammability
63-16 - Explodability
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Miscibility
63-20 - Corrosion Characteristics
Test
Substance
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
Does EPA
Have Data To
Satisfy This
Requirement?
No
No
No
No
No
No
No
No
No
No
No
No
Bibliographic
Citation2/
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Must Additional
Data Be Submitted?
YesV
Yes9/
Yes9/
YesV
Yes9,10/
Yes9,11/
Yes9'12/
Yes9'13/
YesV
Yes9'14/
Yes9'15/
YesV
Timeframe
for
Submission
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
1 5 Months
6 Months
6 Months
1 5 Months
-------
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing 2,4-DB Acid
and 2,4-DB[x] Compounds!/ (cont'd)
Does EPA
Have Data To Timeframe
Test Satisfy This Bibliographic Must Additional for
Data Requirement^ Substance Requirement?^ _ Citationf-/ DataJBe Submitted? _ Subjnlssion_
§158.190 Product Chemistry
OtherJRequirements
64-1 - Submlttal of Samples N/A N/A N/A No
I/Requirements apply to 2,4-DB Acid as well as to the sodiun salt, dlmethylamine, 2-butoxyethyl ester, butyl ester and
isooctyl ester forms, where [x] refers to the substituted salt, amine or ester.
2/Although product chemistry data may have been submitted in the past, the Agency has determined that these data must
~~ be resubmltted. New requirements have been introduced and previously submitted data must be updated. Therefore,
bibliographic citations for the old data are not applicable.
VThe chemical name, nominal concentration, Chemical Abstracts (CAS) Registry Number, and purpose of the active
ingredient and each intentionally added inert must be provided. For the active ingredients, the following must also
be provided: The product's common and trade names; the molecular, structural, or empirical formulas; the molecular
weight or range; and any experimental or internally assigned company code numbers.
VComplete information must be provided regarding the nature of the process (batch or continuous); the relative amounts
~~ of beginning materials and the order in which they are added; the chemical equations for each intended reaction,
equipment used to produce each Intermediate and the final product; reaction conditions; the duration of each step of
the process; purification procedures and quality control measures. In addition, the name and address of the manu-
facture producer, or supplier of each beginning material used in the manufacture of each product must be provided,
along with information regarding the properties of those materials. In order to assess the potential for contamina-
tion with halogenated dibenzo-p-dloxins and dlbenzofurans, the description of the manufacturing process must also
include the range of temperature conditions, pressure, and pH at each reaction step. Refer to the data requirements
set forth in the Agency's June 198? Data Call-in Notice for analytical chanistry data on halognated dibenzo-p-
dioxins/dibenzofurans in 2,4-DB. These data are due as specified in the Data Call-in Notice.
5/A detailed discussion of all impurities that are or may be present at 0.1% based on knowledge of the beginning
materials, chemical reactions (intended and side) in the manufacturing process, and any contamination during
and after production must be submitted. This discussion must also address the possible formation of
dibenzo-p-dioxins and dibenzofurans for all products and N-nitrosamines for amines. Refer to the data requirements
set forth in the Agency's June 1987 Data Call-in Notice for anaytical chemistry data on halogenated dibenzo-p-
dioxins/ dibenzofurans in 2,4-DB. These data are due as specified in the Data Call-In Notice.
-------
Table B
Product-Specific Data Requirements for Manufacturing-Use Products Containing 2,4-DB Acid
and 2,4-DB[x] Compounds!/ (cont'd)
§158.190 Product Chemistry Footnote (cont'd)
6/Five or more representative samples must be analyzed for the amount of active ingredient and each Impurity for which
~~ certified limits are required. Complete validation data (accuracy and precision) must be submitted for each
analytical method used. All nitrosamines must be identified and quantified in six samples of each amine; two samples
must be analyzed shortly after production, 3 months after production, and 6 months after production. A method
sensitive to 1 ppm of M-nitroso contaminants must be used. An upper limit must be provided (and certified) for all
nitrosamines found. Certifications should be submitted on EPA Fbrm 8570-4 (Rev. 2-85).
7/Upper and lower limits for the active ingredient and each Intentionally added inert, and upper limits for each
~~ impurity present at 0.1/5 (w/w) and each "toxicologically significant" impurity present at < 0.1% (w/w) must be
provided and certified. Also, an explanation of how each certified limit was established must provided (e.g., sample
analyses using validated analytical procedures, quantitative estimates based on amounts of ingredients used, etc.)
Limits for Impurities not associated with the active ingredient need to be provided only if they are considered to
be of toxicological significance, regardless of the concentration at which they are present. Certification must be
submitted on EPA Fbrrn 8570-4 (Rev. 2-85).
8/Analytical methods must be provided to determine the active ingredient, and each "toxlcologically significant"
~ impurity and intentionally added inert for which certified limits are required. Each method must be accompanied
by validation studies indicating its accuracy and precision. These methods must be suitable for enforcement of
certified limits.
9/Physicochanical characteristics (color, physical state, odor, melting point, boiling point, specific gravity,
solubility, vapor pressure, dissociation constant, partition coefficient, pH, and stability) as required in
40 CPR 158.190 and more fully described in the Pesticide Assessment Guidelines, Subdivision D, must be submitted.
10/Data required if test substance is dispersible in water.
TT/Data required if product contains oxidizing or reducing agents.
l2/~Da.ta required if product contains combustible liquids.
T3/Data required if product is potentially explosive.
Pf/Data required if product is a liquid.
15/Data required if product is a liquid and is to be diluted with petroleum solvents.
-------
Table B
Product Specific Data Requirements for Manufacturing-Use Products Containging 2,4-DB Acid
and 2,4-DB[x] Compounds!/
Data
§158.
Acute
81-1
81-2
81-3
81-4
81-5
81-6
Test
Requirement Substance
340 Toxicology
Testing
- Acute Oral Toxicity - Rat MP
- Acute Dermal Toxicity MP
- Acute Inhalation MP
Toxicity - Rat
- Primary Eye Irritation - MP
Rabbit
- Primary Dermal Irritation - MP
Rabbit
- Dermal Sensitization MP
Guinea Pig
Does EPA
Have Data To
Satisfy Tnis
Requirement?
Partially
Partially
No
Partially
Partially
No
Bibliographic
Citation
00092159
00128854
00128854
00092160
00128854
-
Must Additional
Data Be Submitted?
Ye si/
Yes!/
Yes
Yes2/
Yes?/
Yes
Time frame
for
Submission
9 Months
9 Months
9 Months
9 months
9 months
9 months
I/Requirements apply to 2,4-D3 Acid as well as the sodium salt, dimethyl amine, 2-butoxyethyl ester, butyl ester, and
isooctyl ester forms, where [x] refers to the substituted salt, amine or ester.
I/The Agency has acceptable data for 2,4-DB Acid only. Data must be submitted for the amine and ester manufacturing-
use products.
-------
II. LABELING APPENDICES
67
-------
SUMMARY-1
LABEL CONTENTS
40 CFR 156.10 requires that certain specific labeling
statements appear at certain locations on the label. This is
referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered in
the upper part of the panel. The name of a product will not be
accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address of
the registrant or distributor is required on the label. The name
and address should preferably be located at the bottom of the
front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is required
on all labels or on the container of the pesticide. The
preferred location is the bottom of the front panel immediately
above the company name and address, or at the end of the label
test. The net contents must be expressed in the largest suitable
unit, e.g., "1 pound 10 ounces" rather than "26 ounces." In
addition to English units, net contents may be expressed in
metric units. [40 CFR 156.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration number
assigned to the pesticide product must appear on the label,
preceded by the phrase "EPA Registration No.," or "EPA Reg. No."
The registration number must be set in type of a size and style
similar to other print on that part of the label on which it
appears and must run parallel to it. The registration number and
the required identifying phrase must not appear in such a manner
as to suggest or imply recommendation or endorsement of the
product by the Agency. [40 CFR 156.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
ment at which the product was produced, and may appear in any
suitable location on the label or immediate container. It must
also appear on the wrapper or outside container of the package if
the EPA establishment number on the immediate container cannot be
clearly read through such wrapper or container.
[40 CFR 156.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active
ingredient and the total percentage by weight of all inert
ingredients. The preferred location is immediately below the
product name. The ingredients statement must run parallel with,
68
-------
SUMMARY-2
and be clearly distinguished from, other text on the panel. It
must not be placed in the body of other text. [40 CFR 156.10(g)]
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
. above 5 to 10 10 point 6 point
above 10 to 15 ' 12 point ' 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely.
[40 CFR 156.10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING, or
CAUTION) is required on the front panel immediately below the
child hazard warning statement. [40CFR 156.10(h)(1)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal, or
inhalation toxicity, the word "Poison" shall appear on the label
in red on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word POISON. [40 CFR 156.10(h)(1)(i)
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A Statement Of
practical treatment (first aid or other) shall appear on the
label of pesticide products in toxicity Categories I, II, and
III. [40 CFR 156.10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "see Side (or
Back) Panel for Additional Precautionary Statements" is required
on the front panel for all products, unless all required
precautionary statements appear on the front panel.
[40 CFR 156.10(h)(1)(iii)]
69
-------
SUMMARY-3
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together on the
label under the heading "PRECAUTIONARY STATEMENTS." The
preferred location is at the top of the side or back panel
preceding the directions for use, and it is preferred that these
statements be surrounded by a block outline. Each of the three
hazard warning statements must be headed by the appropriate
hazard title. [40 CFR 156.10(h)(2)]
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 156.10(h)(2)(i)]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of the
hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 156.10(h)(2)(ii)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria in
the PHYS/CHEM Labeling Appendix. The requirement is based on the
results of the flashpoint determinations and flame extension
tests required to be submitted for all products. These
statements are to be located in the side/back panel precautionary
statements section, preceded by the heading "Physical/Chemical
Hazards." Note that no signal word is used in conjunction with
the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA see. 3(d)
requires that all pesticide formulations/uses be classified for
either general or restricted use. Products classified for
restricted use may be limited to use by certified applicators or
persons under their direct supervision (or may be subject to
other restrictions that may be imposed by regulation).
In the Registration standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified for
restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must reflect
this determination (see below).
70
-------
SUMMARY-4
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During the
Agency's review of your application, your proposed classification
determination will be evaluated in accordance with the provisions
of 40 CFR 162.11(c). You will be notified of the Agency's
classification decision.
Classification Labeling Requirements
If your product has been classified for restricted use, the
following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in
40 CFR 156.10(h)(1)(iv).
b. Directly below this statement on the front panel, a
summary statement of the terms of restriction must
appear (including the reasons for restriction if
specified in Section I). If use is restricted to
certified applicators, the following statement is
required: "For retail sale to and use only by
Certified Applicators or persons under their direct
supervision and only for those uses covered by the
Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified for
restricted use, and some are unclassified, several courses of
action are available:
a. You may label the product for Restricted use. If
you do so, you may include on the label uses that are
unrestricted, but you may not distinguish them on the
label as being unrestricted.
b. You may delete all restricted uses from your label
and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted
-7
-------
SUMMARY-5
simultaneously. Note that the products will be
assigned separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use this
product in a manner inconsistent with its labeling." This
statement appears at the beginning of the directions for use,
directly beneath the heading of that section.
Item 10A. REENTRY STATEMENT - If a reentry interval has
been established by the Agency, it must be included on the label.
Additional worker protection statements may be required in
accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical content. These instructions must be grouped and appear
under the heading "Storage and Disposal" in the directions for
use. This heading must be set in the same type sizes as required
for the child hazard warning. Refer to Appendix II, STOR,
PEST/DIS, and CONT/DIS to determine the storage and disposal
instructions appropriate for your products.
Item-IOC. DIRECTIONS FOR USE - Directions for use must be
stated in terms which can be easily read and understood by the
average person likely to sue or to supervise the use of the
pesticide. When followed, directions must be adequate to protect
the public from fraud and from personal injury and to prevent
unreasonable adverse effects on the environment. [40 CFR 156.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product are
termed collateral labeling. Such labeling may not bear claims or
representations that differ in substance from those accepted in
connection with registration of the product. It should be made
part of the response to this notice and submitted for review.
-------
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
3
4
6A
6B
7
7A
7B
LABEL ELEMENT
Product name
Company name
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
s tatement
Front panel
precaut ionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,"
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
Note type size requirements.
-------
ITEM
7C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and III
•
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and III
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category I:
Front panel
unless refer-
ral statement
is used.
Others :
Grouped with
side panel
precaut ionary
statements.
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must oe grouped under the headings in
8A, 8B, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-------
cn
ITEM
8C
9A
9B
10A
10B
IOC
LABEL ELEMENT
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150°F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
In the
directions
for use
In the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its labeling."
Must be set apart amf clearly distin-
guishable frcm from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
-------
Chapter I—Environmental Protection Agency
§156.10 Labeling Requirements for Pesticides and Devices.
(a) General—(1) Contents of the label. Every pesticide
product shall bear a label containing the information specified by
the Act and the regulations in this Part. The contents of a
label must show clearly and prominently the following:
(i) The name, brand, or trademark under which the product is
sold as prescribed in paragraph (b) of this section;
(ii) The name and address of the producer, registrant, or
person for whom produced as prescribed in paragraph (c) of this
section;
(iii) The net contents as prescribed in paragraph (d) of this
section;
(iv) The product registration number as prescribed in paragraph
(e) of this section;
(v) The producing establishment number as prescribed in para-
graph (f) of this section;
(vi) An ingredient statement as prescribed in paragraph (g) of
this section;
(vii) warning or precautionary statements as prescribed in
paragraph (h) of this section;
(viii) The directions for use as prescribed in paragraph (i)
of this section; and
(ix) The use classification(s) as prescribed in paragraph (j)
of this section.
(2) Prominence and legibility. (i) All words, statements,
graphic representations, designs or other information required on
the labeling by the Act or the regulations in this part must be
clearly legible to a person with normal vision, and must be placed
with such conspicuousness (as compared with other words, state-
ments, designs, or graphic matter on the labeling) and expressed
in such terms as to render it likely to be read and understood
by the ordinary individual under customary conditions of purchase
and use.
(ii) All required label text must:
(A) Be set in 6-point or larger type;
(B) Appear on a clear contrasting background; and
(C) Not be obscured or crowded.
(3) Language to be used. All required label or labeling text
shall appear in the English language. However, the Agency may
require or the applicant may propose additional text in other
languages as is considered necessary to protect the public. When
additional text in another language is necessary, all labeling
requirements will be applied equally to both the English and
other-language versions of the labeling.
(4) Placement of Label—(i) General. The label shall appear
on or be securely attached to the immediate container of the
76
-------
pesticide product. For purposes of this Section, and the mis-
branding provisions of the Act, "securely attached" shall mean
that a label can reasonably be expected to remain affixed during
the foreseeable conditions and period of use. 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 container,
if it is a part of the package as customarily distributed or
sold.
(ii) Tank cars and other bulk containers—(A) Transportation.
While a pesticide product is in transit, the appropriate
provisions of 49 CFR Parts 170-189, concerning the transportation
of hazardous materials, and specifically those provisions con-
cerning the labeling, marking and placarding of hazardous materials
and the vehicles carrying them, define the basic Federal require-
ments. In addition, when any registered pesticide product is
transported in a tank car, tank truck or other mobile or portable
bulk container, a copy of the accepted label must be attached to
the shipping papers, and left with the consignee at the time of
delivery.
(B) Storage. When pesticide products are stored in bulk
containers, whether mobile or stationary, which remain in the
custody of the user, a copy of the label of labeling, including
all appropriate directions for use, shall be securely attached to
the container in the immediate vicinity of the discharge control
valve.
(5) False or misleading statements. Pursuant to section
2(q)(l)(A) of the Act, a pesticide or a device declared subject
to the Act pursuant to § 162.15, is misbranded if its labeling is
false or misleading in any particular including both pesticidal
and non-pesticidal claims. Examples of statements or representations
in the labeling which constitute misbranding include:
(i) A false or misleading statement concerning the composition
of the product;
(ii) A false or misleading statement concerning the effectiveness
of the product as a pesticide or device;
(iii) A false or misleading statement about the value of the
product for purposes other than as a pesticide or device;
(iv) A false or misleading comparison with other pesticides or
devices;
(v) Any statement directly or indirectly implying that the
pesticide or device is recommended or endorsed by any agency of
the Federal Government;
(vi) The name of a pesticide which contains two or more
principal active ingredients if the name suggests one or more but
not all such principal active ingredients even though the names
of the other ingredients are stated elsewhere in the labeling;
(vii) A true statement used in such a way as to give a false
or misleading impression to the purchaser;
(viii) Label disclaimers which negate or detract from labeling
statements required under the Act and these regulations;
77
-------
(ix) Claims as to the safety of the pesticide or its ingredients,
including statements such as "safe," "nonpoisonous," "noninjurious,"
"harmless" or "nontoxic to humans and pets" with or without such
a qualifying phrase as "when used as directed"; and
(x) Non-numerical and/or comparative statements on the safety
of the product, including but not limited to:
(A) "Contains all natural ingredients";
(B) "Among the least toxic chemicals known"
(C) "Pollution approved"
(6) Final printed labeling. (i) Except as provided in
paragraph (a)(6)(ii) of this section, final printed labeling must
be submitted and accepted prior to registration. However, final
printed labeling need not be submitted until draft label texts
have been provisionally accepted by the Agency.
(ii) Clearly legible reproductions or photo reductions will be
accepted for unusual labels such as those silk-screened directly
onto glass or metal containers or large bag or drum labels. Such
reproductions must be of microfilm reproduction quality.
(b) Name, brand, or trademark. (1) The name, brand, or
trademark under which the pesticide product is sold shall appear
on the front panel of the label.
(2) No name, brand, or trademark may appear on the label which:
(i) Is false or misleading, or
(ii) Has not been approved by the Administrator through
registration or supplemental registration as an additional name
pursuant to § 162.6(b)(4).
(c) Name and address of producer, registrant, or person for
whom produced. An unqualified name and address given on the
label shall be considered as the name and address of the producer.
If the registrant's name appears on the label and the registrant
is not the producer, or if the name of the person for whom the
pesticide was produced appears on the label, it must be qualified
by appropriate wording such as "Packed for ***," "Distributed by
***," or "Sold by ***" to show that the name is not that of the
producer.
(d) Net weight or measure of contents. (1) The net weight or
measure of content shall be exclusive of wrappers or other
materials and shall be the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the net content statement
shall be in terms of liquid measure at 68°F (20°C) and shall be
expressed in conventional American units of fluid ounces, pints,
quarts, and gallons.
(3) If the pesticide is solid or semisolid, viscous or
pressurized, or is a mixture of liquid and solid, the net content
statement shall be in terms of weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be stated in terms of the
largest suitable units, i.e., "1 pound 10 ounces" rather than
"26 ounces."
78
-------
(5) In addition to the required units specified, net content
may be expressed in metric units.
(6) Variation above minimum content or around an average is
permissible only to the extent that it represents deviation
unavoidable in good manufacturing practice. Variation below a
stated minimum is not permitted. In no case shall the average
content of the packages in a shipment fall below the stated
average content.
(e) Product registration number. The registration number
assigned to the pesticide product at the time of registration
shall appear on the label, preceded by the phrase "EPA Registration
No.," or the phrase "EPA Reg. No." The registration number shall
be set in type of a size and style similar to other print on that
part of the label on which it appears and shall run parallel to
it. The registration number and the required identifying phrase
shall not appear in such a manner as to suggest or imply
recommendation or endorsement of the product by the Agency.
(f) Producing establishments registration number. The producing
establishment registration number preceded by the phrase "EPA
Est.", of the final establishment at which the product was produced
may appear in any suitable location on the label or immediate
container. It must appear on the wrapper or outside container of
the package if the EPA establishment registration number on the
immediate container cannot be clearly read through such wrapper
or container.
(g) Ingredient statement—(1) General. The label of each
pesticide product must bear a statement which contains the name
and percentage by weight of each active ingredient, the total
percentage by weight of all inert ingredients; and if the pesticide
contains arsenic in any form, a statement of the percentages of
total and water-soluble arsenic calculated as elemental arsenic.
The active ingredients must be designated by the term "active
ingredients" and the inert ingredients by the term "inert
ingredients," or the singular forms of these terms when appropriate.
Both terms shall be in the same type size, be aligned to the same
margin and be equally prominent. The statement "Inert Ingredients,
none" is not required for pesticides which contain 100 percent
active ingredients. Unless the ingredient statement is a complete
analysis of the pesticide, the term "analysis" shall not be used
as a heading for the ingredient statement.
(2) Position of ingredient statement. (i) The ingredient
statement is normally required on the front panel of the label.
If there is an outside container or wrapper through which the
ingredient statement cannot be clearly read, the ingredient
statement must also appear on such outside container or wrapper.
If the size or form of the package makes it impracticable to place
the ingredient statement on the front panel of the label, permission
may be granted for the ingredient statement to appear elsewhere.
(ii) The text of the ingredient statement must run parallel
with other text on the panel on which it appears, and must be
clearly distinguishable from and must not be placed in the body
of other text.
79
-------
(3) Names to be used in ingredient statement. The name used
for each ingredient shall be the accepted common name, if there
is one/ followed by the chemical name. The common name may be
used alone only if it is well known. If no common name has been
established, the chemical name alone shall be used. In no case
will the use of a trademark or proprietary name be permitted unless
such name has been accepted as a common name by the Administrator
under the authority of Section 25(c)(6).
(4) Statements of percentages. The percentages of ingredients
shall be stated in terms of weight-to-weight. The sum of per-
centages of the active and the inert ingredients shall be 100.
Percentages shall not be expressed by a range of values such as
"22-25%." If the uses of the pesticide product are expressed as
weight of active ingredient per unit area, a statement of the
weight of active ingredient per unit volume of the pesticide
formulation shall also appear in the ingredient statement.
(5) Accuracy of stated percentages. The percentages given
shall be as precise as possible reflecting good manufacturing
practice. If there may be unavoidable variation between manu-
facturing batches, the value stated for each active ingredient
shall be the lowest percentage which may be present.
(6) Deterioration. Pesticides which change in chemical
composition significantly must meet the following labeling re-
quirements :
(i) In cases where it is determined that a pesticide formulation
changes chemical composition significantly, the product must bear
the following statement in a prominent position on the label: "Not
for sale or use after [date]."
(ii) The product must meet all label claims up to the expiration
time indicated on the label.
(7) Inert ingredients. The Administrator may require the name
of any inert ingredient(s) to be listed in the ingredient statement
if he determines that such ingredient(s) may pose a hazard to man
or the environment.
(h) Warnings and precautionary statements. Required warnings
and precautionary statements concerning the general areas of
toxicological hazard including hazard to children, environmental
hazard, and physical or chemical hazard fall into two groups; those
required on the front panel of the labeling and those which may
appear elsewhere. Specific requirements concerning content,
placement, type size, and prominence are given below.
(1) Required front panel statements. With the exception of the
child hazard warning statement, the text required on the front
panel of the label is determined by the Toxicity Category of the
pesticide. The category is assigned on the basis of the highest
hazard shown by any of the indicators in the table below:
80
-------
Hazard Indicators
Oral LDcn
50
Inhalation LC
Derma 1 LD
Eye effects
Skin effects
1
Up to and
Including
50 mg/kg
Up to and
Including
.2 mg/l Iter
Up to and
Including
200 mg/kg
Corrosive;
cornea 1 opacity
not reversible
within 7 days
Corrosive
Toxicity c
1 1
From 50 thru
500 mg/kg
From .2 thru
2 mg/llter
From 200
thru 2000
Cornea/ opacity
reversible
within 7 days;
Irritation
persisting for
7 days
Severe Irritation
at 72 hours
:ategor les
1 1 1
From 500 thru
5000 mg/kg
From 2 thru
20 mg/f Iter
From 2,000 thru
20,000
No cornea! opacity;
Irritation
reversible
within 7 days
Moderate Irritation
at 72 hours
IV
Greater than
5000 mg/kg
Greater than
20 mg/f Iter
Greater than
20,000
No Irritation
Mild or slight
Irritation at
72 hours
(i) Human hazard signal word.--(A) Toxicity Category I. All
pesticide products meeting th'e criteria of Toxicity Category I
shall bear on the front panel the signal word "Danger." In
addition if the product was assigned to Toxicity Category I on
the basis of its oral, inhalation or dermal toxicity (as distinct
from skin and eye local effects) the word "Poison" shall appear
in red on a background of distinctly contrasting color and the
skull and crossbones shall appear in immediate proximity to the
word "poison."
All pesticide products meeting the
front panel'
(B) Toxicity Category II,
criteria of Toxicity Category
the signal word "Warning."
(C) Toxicity Category III.
criteria of Toxicity Category
the signal word "Caution."
(D) Toxicity Category IV.
criteria of Toxicity Category
the signal word "Caution."
II shall bear on the
All pesticide products meeting the
III shall bear on the front panel
All pesticide
IV shall bear
products meeting the
on the front panel
8
-------
(E) Use of signal words. Use of any signal word(s) associated
with a higher Toxicity Category is not permitted except when the
Agency determines that such labeling is necessary to prevent
unreasonable adverse effects on man or the environment. In no
case shall more than one human hazard signal word appear on the
front panel of a label.
(ii) Child hazard warning. Every pesticide product label shall
bear on the front panel the statement "keep out of reach of
children." Only in cases where the likelihood of contact with
children during distribution, marketing, storage or use is
demonstrated by the applicant to be extremely remote, or if the
nature of the pesticide is such that it is approved for use on
infants or small children, may the Administrator waive this
requirement.
(iii) Statement of practical treatment—(A) Toxicity
Category I. A statement of practical treatment (first aid or
other) shall appear on the front panel of the label of all
pesticides falling into Toxicity Category I on the basis of oral,
inhalation or dermal toxicity. The Agency may, however, permit
reasonable variations in the placement of the statement of
practical treatment is some reference such as "See statement of
practical treatment on back panel" appears on the front panel
near the word "Poison" and the skull and crossbones.
(B) Other toxicity categories. The statement of practical
treatment is not required on the front panel except as described
in paragraph (h)(1)(iii)(A) of this section. The applicant may,
however, include such a front panel statement at his option.
Statements of practical treatment are, however, required elsewhere
on the label in accord with paragraph (h)(2) of this section if
they do not appear on the front panel.
(iv) Placement and prominence. All the required front panel
warning statements shall be grouped together on the label, and
shall appear with sufficient prominence relative to other front
panel text and graphic material to make them unlikely to be over-
looked under customary .conditions of purchase and use. The
following table shows the minimum type size requirements for the
front panel warning statements on various sizes of labels:
Size of label front panel
in square inches
Over 30
Poir
Required
signal word,
all capitals
6
10
12
14
18
its
"Keep out
of reach of
Children"
6
6
8
10
12
-------
(2) Other required warnings and precautionary statements. The
warnincs and precautionary statements as required below shall appear
together on the label under the general heading "Precautionary
Statements" and under appropriate subheadings of "Hazard to Humans
and Domestic Animals," "Environmental- Hazard" and "Physical or
Chemical Hazard."
(i) Hazard to humans and domestic animals. (A) Where a hazard
exists to humans or domestic animals, precautionary statements
are required indicating the particular hazard, the route(s) of
exposure and the precautions to be taken to avoid accident, injury
or damage. The precautionary paragraph shall be immediately
preceded by the appropriate hazard signal word.
(B) The following table depicts typical precautionary statements.
These statements must be modified or expanded to reflect specific
hazards.
Toxic lt>
category
Precautionary statements by toxicIty category
Oral, Inhalation, or dermal toxlclty
Skin and eye local effects
IV . .
Fatal (poisonous) If swallowed [Inhaled or
abso-bed through skin). Do not breathe
vapor [dust] or spray mist). Do not get
In eyes, on skin, or on clothing [Front
panel statement of practical treatment
requ'red.l.
Hay be fatal If swallowed [Inhaled or |
absorbed through the skin]. Do not breathe]
vapors [dust or spray mist]. Do not get ln|
eyes, on skin, or on clothing. [Appropriate)
first aid statements required.]. |
I
Harmful If swallowed [Inhaled or absorbed |
through the sklnl. Avoid breathing vapors |
[dust or spray IB 1st!. Avoid contact with |
skin [eyes or clothing!. [Appropriate |
first aid statement required.]. |
I
[No precautionary statements required.]. |
Corrosive, causes eye and skin damage [or
skin Irritation). Do not get In eyes, on
skin, or on clothing. Wear goggles or face
shield and rubber gloves when handling.
Harmful, or fatal If swallowed.
[Appropriate first aid statement required.!
Causes eye [and skin] Irritation. Do not
get In eyes, on skin, or on clothing.
Harmful If swallowed. [Appropriate first
aid statement required.].
Avoid contact with skin, eyes or clothing.
In case of contact Immediately flush
eyes or skin with plenty of water. Get
medical attention If Irritation persists.
[No precautionary statements required.],
(ii) Environmental hazards. Where a hazard exists to non-
target organisms excluding humans and domestic animals, precautionary
statements are required stating the nature of the hazard and the
appropriate precautions to avoid potential accident, injury or
83
-------
damage. Examples of the hazard statements and the circumstances
under which they are required follow:
(A) If a pesticide intended for outdoor use contains an active
ingredient with a mammalian acute oral LD5Q of 100 or less, the
statement "This Pesticide is Toxic to Wildlife" is required.
(B) If a pesticide iatended for outdoor use contains an active
ingredient with a fish acute LC$Q of 1 ppm or less, the statemeni
"This Pesticide is Toxic to Fish" is required.
(C) If a pesticide intended for outdoor use contains an activs
ingredient with an avian acute oral LD$Q of 100 mg/kg or less, 01
a subacute dietary LC^Q of 500 ppm or less, the statement "This
Pesticide is Toxic to Wildlife" is required.
(D) If either accident history or field studies demonstrate
that use of the pesticide may result in fatality to birds, fish
or mammals, the statement "This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar application to agricultural
crops, forests, or shade trees, or for mosquito abatement
treatments, pesticides toxic to pollinating insects must bear
appropriate label cautions.
(F) For all outdoor uses other than aquatic applications the
label must bear the caution "Keep out of lakes, ponds or streams
Do not contaminate water by cleaning of equipment or disposal of
wastes."
(iii) Physical or chemical hazards. Warning statements on th
flammability or explosive characteristics of the pesticide are
required as follows:
Flash point
Required text
(A) PRESSURIZED CONTAINERS
Flash point at or below 20*F; If there Is a
flashback at any valve openjng.
Flash point above 20*F and not over 80"F or If
the flame extension Is more than IB in. long
at a distance of 6 1 n. from the flame.
Extremely flammable. Contents under pressure.
Keep away from fire, sparks, and heated
surfaces. Do not puncture or Incinerate
container. Exposure to temperatures above
130*F may cause bursting.
Flammable. Contents under pressure. Keep away
from heat, sparks, and open flame. Do not
puncture or Incinerate container. Exposure to
I temperatures above 130*F may cause bursting.
Contents under pressure. Do not use or store
near heat or open flame. Do not puncture or
Incinerate container. Exposure to tempera-
tures above 130*F may cause bursting.
(B) NONPRESSURIZED CONTAINERS
Extremely flammable. Keep away from fire,
sparks, and heated surfaces.
Flammable. Keep away from heat and open flame.
Do not use or store near heat or open flame.
84
-------
(i) Directions for Use—(1) General requirements—(i) Adequacy
and clarity of directions. Directions for use must be stated in
terms which can be easily read and understood by the average
person likely to use or to supervise the use of the pesticide.
When followed, directions must be adequate to protect the public
from fraud and from personal injury and to prevent unreasonable
adverse effects on the environment.
(ii) Placement of directions for use. Directions may appear
on any portion of the label provided that they are conspicuous
enough to be easily read by the user of the pesticide product.
Directions for use may appear on printed or graphic matter which
accompanies the pesticide provided that:
(A) If required by the Agency, such printed or graphic matter
is securely attached to each package of the pesticide, or placed
within the outside wrapper or bag;
(B) The label bears a reference to the directions for use in
accompanying leaflets or circulars, such as "See directions in
the enclosed circular." and
(C) The Administrator determines that it is not necessary for
such directions to appear on the label.
(iii) Exceptions to requirement for direction for use—(A)
Detailed directions for use may be omitted from labeling of
pesticides which are intended for use only by manufacturers of
products other than pesticide products in their regular manu-
facturing processes, provided that:
(^.) The label clearly shows that the product is intended for
use only in manufacturing processes and specifies the type(s) of
products involved.
(2_) Adequate information such as technical data sheets or
bulletins, is available to the trade specifying the type of
product involved and its proper use in manufacturing processes;
(_3) The product will not come into the hands of the general
public except after incorporation into finished products; and
(£) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(B) Detailed directions for use may be omitted from the labeling
of pesticide products for which sale is limited to physicians,
veterinarians, or druggists, provided that:
(JJ The label clearly states that the product is for use only
by physicians or veterinarians;
(2) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment; and
(3_) The product is also a drug and regulated under the provisions
of the Federal Food, Drug and Cosmetic Act.
(C) Detailed directions for use may be omitted from the labeling
of pesticide products which are intended for use only by formulators
in preparing pesticides for sale to the public, provided that:
(^) There is information readily available to the formulators
on the composition, toxicity, methods of use, applicable restrictions
or limitations, and effectiveness of the product for pesticide
purposes ;
85
-------
(2) The label clearly states that the product is intended for
use only in manufacturing, formulating, mixing, or repacking for
use as a pesticide and specifies the type(s) of pesticide products
involved;
O) The product as finally manufactured, formulated, mixed, or
repackaged is registered; and
(£) The Administrator determines that such directions are not
necessary to prevent unreasonable adverse effects on man or the
environment.
(2) Contents of Directions for Use. The directions for use
shall include the following, under the headings "Directions for
Use" :
(i) The statement of use classification as prescribed in
162.10(j) immediately under the heading "Directions for Use."
(ii) Immediately below the statement of use classification,
the statement "It is a violation of Federal law to use this
product in a manner inconsistent with its labeling."
(iii) The site(s) of application, as for example the crops,
animals, areas, or objects to be treated.
(iv) The target pest(s) associated with each site.
(v) The dosage rate associated with each site and pest.
(vi) The method of application, including instructions for
dilution, if required, and type(s) of application apparatus or
equipment requried.
(vii) The frequency and timing of applications necessary to
obtain effective results without causing unreasonable adverse
effects on the environment.
(viii) Specific limitations on reentry to areas where the
pesticide has been applied, meeting the requirements concerning
reentry provided by 40 CFR Part 170.
(ix) Specific directions concerning the storage and disposal
of the pesticide and its container, meeting the requirements of
40 CFR Part 165. These instructions shall be grouped and appear
under the heading "Storage and Disposal." This heading must be
set in type of the same minimum sizes as required for the child
hazard warning (See Table in § 162.10(h)(1)(iv).)
(x) Any limitations or restrictions on use required to prevent
unreasonable adverse effects, such as:
(A) Required intervals between application and harvest of food
or feed crops.
(B) Rotational crop restrictions.
(C) Warnings as required against use on certain crops, animals,
objects, or in or adjacent to certain areas.
(D) [Reserved] (
(E) For restricted use pesticides, a statement that the
pesticide may be applied under the direct supervision of a
certified applicator who is not physically present at the site of
application but nonetheless available to the person applying the
pesticide, unless the Agency has determined that the pesticide
may only be applied under the direct supervision of a certified
applicator who is physically present.
86
-------
(F) Other pertinent information which the Administrator
determines to be necessary for the protection of man and the
environment.
(j) Statement of Use Classification. By October 22, 1976, all
pesticide products must bear on their labels a statement of use
classification as described in paragraphs (j)(l) and (2) of this
section. Any pesticide product for which some uses are classified
for general use and others for restricted use shall be separately
labeled according to the labeling standards set forth in this
subsection, and shall be marketed as separate products with
different registration numbers, one bearing directions only for
general use(s) and the other bearing directions for restricted
use(s) except that, if a product has both restricted use(s) and
general use(s), both of these uses may appear on a product labeled
for restricted use. Such products shall be subject to the
provisions of § 162.10(j ) (2 ).
(1) General Use Classification. Pesticide products bearing
directions for use(s) classified general shall be labeled with
the exact words "General classification" immediately below the
heading "Directions for Use." And reference to the general
classification that suggests or implies that the general utility
of the pesticide extends beyond those purposes and uses contained
in the Directions for Use will be considered a false or misleading
statement under the statutory definitions of misbranding.
(2) Restricted use classification. Pesticide products bearing
direction for use(s) classified restricted shall bear statements
of restricted use classification on the front panel as described
below:
(i) Front panel statement of restricted use classification.
(A) At the top of the front panel of the label, set in type of
the same minimum sizes as required for human hazard signal words
(see table in S 162.10(h)(1)(iv)), and appearing with sufficient
prominence relative to other text and graphic material on the
front panel to make it unlikely to be overlooked under customary
conditions of purchase and use, the statement "Restricted Use
Pesticide" shall appear.
(B) Directly below this statement on the front panel, a summary
statement of the terms of restriction imposed as a precondition
to registration shall appear. If use is restricted to certified
applicators, the following statement is required: "For retail
sale to and use only by Certified Applicators or persons under
their direct supervision and only for those uses covered by the
Certified Applicator's certification." If, however, other
regulatory restrictions are imposed, the Administrator will define
the appropriate wording for the terms of restriction by regulation,
(k) Advertising. [Reserved]
[40 FR 28268, July 3, 1975; 40 FR 32329, Aug. 1, 1975; 40 FR
38571, Aug. 21, 1975, as amended at 43 FR 5786, Feb. 9, 1978;
amended at 53 FR 15952, May 4, 1988]
87
-------
Criteria
PHYSICAL-CHEMICAL HAZARDS
Required Label Statement
I. Pressurized Containers
A.
Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
B.
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
ALL OTHER PRESSURIZED
CONTAINERS
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire,
sparks, and heated
surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents
under pressure. Keep
away from heat, sparks,
and flame. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do
not puncture or incine-
rate container. Exposure
to temperatures above
130°F may cause bursting.
Extremely flammable.
Keep away from fire,
sparks, and heated
surfaces.
Flammable, keep away
from heat and open flame,
Do not use or store near
heat and open flame.
None required.
-------
STORAGE INSTRUCTIONS FOR PESTICIDES
HEADING; All products are required to bear specific label
instructions about storage and disposal. Storage and
disposal instructions must be grouped together in the
directions for use portion of the label under the heading
STORAGE AND DISPOSAL. Products intended solely for domestic
use need not include the heading "STORAGE AND DISPOSAL."
STORAGE INSTRUCTIONS: All product labels are required to
have appropriate storage instructions. Specific storage
instructions are not prescribed. Each registrant must
develop his own storage instructions, considering, when
applicable, the following factors:
1. Conditions of storage that might alter the composition
or usefulness of the pesticide. Examples could be
temperature extremes, excessive moisture or humidity,
heat, sunlight, friction, or contaminating substances or
media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might
include positioning of the container in storage, storage
or damage due to stacking, penetration of moisture, and
ability to withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
4. Instructions on what to do if the container is damaged
in any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage
occurs.
5. General precautions concerning locked storage, storage
in original container only, and separation of
pesticides during storage to prevent cross-
contamination of other pesticides, fertilizer, food, and
feed.
6. General storage instructions for household products
should emphasize storage in original container and
placement in locked storage areas.
89
-------
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for
domestic use, must bear explicit instructions about pesticide
disposal. The statements listed below contain the exact
wording that must appear on the label of these products:
1. The labels of all products, except domestic use, must
contain the statement:
"Do not contaminate water, food, or feed by storage
or disposal."
2. Except those products intended solely for domestic use,
the labels of all products that contain active
ingredients that are Acute Hazardous Wastes or are
assigned to Toxicity Category I on the basis of oral or
dermal toxicity, or Toxicity Category I or II on the
basis of acute inhalation toxicity must bear the
following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper
disposal of excess pesticide, spray mixture, or
rinsate is a violation of Federal Law. If these
wastes cannot be disposed of by use according to
label instructions, contact your State Pesticide or
Environmental Control Agency or the Hazardous Waste
representative at the nearest EPA Regional Office
for guidance."
3. The labels of all products, except those intended for
domestic use, containing active or inert ingredients
that are Toxic Hazardous Wastes or meet any of the
criteria in 40 CFR 261, Subpart C for a hazardous waste
must bear the following pesticide disposal statement:
"Pesticide wastes are toxic. Improper disposal of
excess pesticide, spray mixture, or rinsate is a
violation of Federal Law. If these wastes cannot
be disposed of by use according to label
instructions, contact your State Pesticide or
Environmental Control/Agency, or the Hazardous
Waste representative at the nearest EPA Regional
Office for guidance."
4. Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
90
-------
"Wastes resulting from the use of this product may
be disposed of on site or at an approved waste
disposal facility."
5. Products intended for domestic use only must bear the
following disposal statement:
"Securely wrap original container in several layers
of newspaper and discard in trash."
91
-------
CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following container
disposal statements:
Container Type
Statement
Non-aerosol products |Do not reuse container (bottle, can, jar).
(bottles, cans, iars)I Rinse thoroughly before discarding in trash
Non-aerosol products |Do not reuse bag. Discard bag in trash.
(bags)
Aerosol products
I Replace cap and discard containers in
I trash. Do not incinerate or puncture.
2. All other products must bear container disposal instructions,
based on container type, listed below:
Container Type
Statement
Metal
containers
(non- aerosol)
Plastic containers
Glass containers
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reused^/, dispose of in the same manner.
Completely empty bag into application equip-
ment. Then dispose of empty bag in a sani-
tary landfill or by incineration, or, if
allowed by State and local authorities, by
burnina. If burned, stay out of smoke.
Return empty cylinder for reuse (or
similar wording).
V Manufacturer may replace this phrase with one indicating whether
and how fiber drum may be reused.
-------
III. BIBLIOGRAPHY APPENDICES
9
-------
Guide to Use of This Bibliography
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated
elsewhere in the Standard. Primary sources for studies
in this bibliography have been the body of data
submitted to EPA and its predecessor agencies in support
of past regulatory decisions. Selections from other
sources including the published literature, in those
instances where they have been considered, will be
included.
2. UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published
materials, this corresponds closely to an article. In
the case of unpublished materials submitted to the
Agency, the Agency has sought to identify documents at a
level parallel to the published article from within the
typically larger volumes in which they were submitted.
The resulting "studies" generally have a distinct title
(or at least a single subject), can stand alone for
purposes of review, and can be described with a
conventional bibliographic citation. The Agency has
attempted also to unite basic documents and
commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this
bibliography are sorted numerically by "Master Record
Identifier," or MRID, number. This number is unique to
the citation, and should be used at any time specific
reference is required. It is not related to the six-
digit "Accession Number" which has been used to identify
volumes of submitted studies; see paragraph 4(d)(4)
below for a further explanation. In a few cases,
. entries added to the bibliography late in the review
may be preceded by a nine-character temporary
identifier. These entries are listed after all MRID
entries. This temporary identifier number is also to be
used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record
Identifier (MRID), each entry consists of a citation
containing standard elements followed, in the case of
material submitted to EPA, by a description of the
earliest known submission. Bibliographic conventions
used reflect the standards of the American National
Standards Institute (ANSI), expanded to provide for
certain special needs.
a. Author. Whenever the Agency could confidently
identify one, the Agency has chosen to show a
personal author. When no individual was
identified, the Agency has shown an identifiable
94
-------
laboratory or testing facility as author. As a
last resort, the Agency has shown the first
submitter as author.
b. Document Date. When the date appears as four
digits with no question marks, the Agency took it
directly from the document. When a four-digit date
is followed by a question mark, the bibliographer
deduced the date from evidence in the document.
When the date appears as (19??), the Agency was
unable to determine or estimate the date of the
document.
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a
document title. Any such editorial insertions are
contained between square brackets.
d. Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses
include (in addition to any self-explanatory text)
the following elements describing the earliest
known submission:
(1) Submission Date. The date of the earliest
known submission appears immediately following
the word "received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number or other
administrative number associated with the
earliest known submission.
(3) Submitter. The third element is the
submitter, following the phrase "submitted
by." When authorship is defaulted to the
submitter, this element is omitted.
(4) Volume Identification (Accession Numbers).
The final element in the trailing parentheses
identifies the EPA accession number of the
volume in which the original submission of the
study appears. The six-digit accession number
follows the symbol "CDL," standing for
"Company Data Library." This accession number
is in turn followed by an alphabetic suffix
which shows the relative position of the study
within the volume. For example, within
accession number 123456, the first study would
be 123456-A; the second, 123456-B; the 26th,
123456-Z; and the 27th, 123456-AA.
95
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-DB Standard
MRID CITATION
00004685 Linscott, D.L. (1964) Degradation of 4-(2,4-Dichlorophenoxy)-but-
yric acid [4-(2,4-DB)] in plants. Journal of Agricultural and
Food Chemistry 12(1):7-10. (Also in unpublished submission re-
ceived Sep 16, 1968 under 8F0676; submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:092090-AD)
00004701 Bache, C.A.; Hardee, D.D.; Holland, R.F.; Lisk, D.J. (1964) Absence
of Phenoxyacid herbicide residues in the milk of dairy cows at
high feeding levels. Journal of Dairy Science XLVII(3):298-299.
(Also in unpublished submission received Sep 12, 1968 under
8F0676; submitted by Dow Chemical U.S.A., Midland, Mich.; CDL:
092980-0)
00004718 Hagin, R.D.; Linscott, D.L. (1965) Determination of 4-(2,4-Dichlor-
ophenoxy)-butyric acid (2,4-DB) and 2,4-Dichlorophenoxyacetic
acid (2,4-D) in forage plants. Journal of Agricultural and Food
Chemistry 13(2):123-125. (Also in unpublished submission re-
ceived Sep 12, 1968 under 8F0676; submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:092980-AJ)
00009181 Atkins, E.L., Jr.; Anderson, L.D.; Greywood, E.A. (1969) Effect of
Pesticides on Apiculture: Project No. 1499. (Unpublished study
received Jul 29, 1976 under 352-342; prepared by Univ. of Cali-
fornia—Riverside, Dept. of Entomology, submitted by E.I. du
Pont de Nemours & Co., Wilmington, Del.; CDL:224800-C)
00018284 E.I. du Pont de Nemours & Company (1972) Data Supporting the Use
of Lorox Linuron Weed Killer plus Butyrac 175 as a Tank Mixture
as a Directed Postemergence Spray To Control Certain Weeds in
Soybeans. Summary of studies 002892-B and 002892-C. (Unpub-
lished study received Jul 16, 1973 under 352-270; CDL:002892-A)
00022923 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary
Toxicities of Environmental Pollutants to Birds: Special Scien-
tific Report—Wildlife No. 191. (U.S. Dept. of the Interior,
Fish and Wildlife Service, Patuxent Wildlife Research Center;
unpublished report)
00027041 Bache, C.A.; Hardee, D.D.; Holland, R.F.; et al. (19??) Absence of
Phenoxyacid herbicide residues in the milk of dairy cows at high
feeding levels. Journal of Dairy Science ? (? ):298-299. (Also
in unpublished submission received Jan 2, 1980 under 2217-641;
submitted by FBI-Gordon Corp., Kansas City, Kans.; CDL:241575-T)
96
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-DB Standard
MRID CITATION
00037371 Shea, D.; Stanovick, R.P.; Parochetti, J.; et al. (1973) Final Re-
port: Analysis for 2,4 DB Residues in Soybeans (Mature Bean and
Forage). (Unpublished study including letter dated Mar 16, 1973
from M.D. Parkins to Richard J. Otten, received Jun 7, 1973
under 264-164; prepared by Environmental Sciences Corp. and
others, submitted by Union Carbide Agricultural Products Co.,
Ambler, Pa.; CDL:002131-B)
00046125 Yip, G. (1964) Herbicides and plant growth regulators: Determina-
tion of herbicides in oils. Journal of the Association of
Official Analytical Chemists 47(6):1116-1119. (Also in unpub-
lished submission received on unknown date under .6F0459; sub-
mitted by U.S. Dept. of Agriculture, Agricultural Research
Service, unknown location; CDL:098165-I)
00061012 National Agricultural Chemical Association (1967?) Summary of Resi-
dues. (Compilation; unpublished study received May 15, 1967 un-
der 8F0670; CDL:091172-AN)
00087925 Mobay Chemical Corporation (1978) Sencor Residue Chemistry on
Soybeans: Supplement No. 5. (Compilation; unpublished study
received Dec 16, 1981 under 3125-277; CDL:246510-A)
00092159 Holsing, G.C. (1969) Final Report: Acute Oral Administration—Rats:
Project No. 656-105. (Unpublished study received Dec 16, 1970
under 1F1089; prepared by TRW, Inc., submitted by Rhodia, Inc.,
New Brunswick, N.J.; CDL:090849-B)
00092160 Holsing, G.C. (1969) Final Report: Acute Eye Irritation—Rabbits:
Project No. 656-108. (Unpublished study received Dec 16, 1970
under 1F1089; prepared by TRW, Inc., submitted by Rhodia, Inc.,
New Brunswick, N.J.; CDL:090849-C)
00102943 Interregional Research Project No. 4 (1978) Petition for the Use
of 2,4-DB on Spearmint and Peppermint. (Unpublished study re-
ceived May 24, 1982 under 2E2694; CDL:070875-A)
00104739 Holsing, G.C.; Kundzin, M.; Voelker, R.W., Jr. (1969) Final Report:
Three-month Dietary Administration—Albino Rats: Project
No. 656-109. (Unpublished study received Dec 16, 1970 under
1F1089; prepared by TRW, Inc., submitted by Rhodia, Inc., New
Brunswick, N.J.; CDL:090849-I)
97
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-DB Standard
MRID CITATION
00106319 Uniroyal Chemical (1979) Alanap-L: Label Amendment for Tank Mix
with Butyrac 200 or Butoxone Overtop of Soybeans. (Compilation;
unpublished study received Mar 8, 1979 under 400-49; CDL:
237772-A)
00115135 Uniroyal Chemical (1982) [Study: RESCUE Residue on Soybeans].
(Compilation; unpublished study received Sep 15, 1982 under 400-
166; CDL:248367-F)
00116018 Rhodia, Inc. (1972) [Study: 4(2,4-DB) Residues in Selected Crops].
(Compilation; unpublished study received May 31, 1972 under
1F1089; CDL:090848-A)
00128854 Myers, R.; Coleman, J.; Bellich, N.; et al. (1982) Technical
2,4-DB Acid: Acute Toxicity and Irritancy Studies: Project
Report 45-188. (Unpublished study received Apr 19, 1983 under
264-273; submitted by Union Carbide Agricultural Products Co.,
Inc., Research Triangle Park, NC; CDL:250433-A)
00132034 Interregional Research Project No. 4 (1980) The Results of Tests on
the Amount of 2,4-DB Residues Remaining in or on Oats, Including
a Description of the Analytical Method Used. (Compilation; un-
published study received Oct 13, 1983 under 4E2982; CDL:
072030-A)
00161196 Rhodia, Inc., Chipman Div. (1974) The Results of Tests on the
Amount of 4-(2,4-dichlorophenoxy Butyric Acid (2,4-DB)
Remaining in or on Peppermint Including A Description of the
Analytical Method Used. Unpublished compilation. 63 p.
40094602 Johnson, W.; Finley, M. (1980) Handbook of Acute Toxicity of
Chemicals to Fish and Aquatic Invertebrates: Resource Publi-
cation 137. US Fish and Wildlife Service, Washington, D.C.
106 p.
40257501 Mackenzie, K. (1987) Lifetime Dietary Combined Chronic Toxicity and
Oncogenicity Study in Albino Rats with 2,4-DB: Laboratory Pro-
ject No. HLA 6158-103. Unpublished study prepared by Hazleton
Laboratories America, Inc. 3095 p.
40257503 Bottomley, A.; Bowman, A.; Offer, J.; et al. (1986) 2,4-DB—Effect
on Two Generations of the Rats: Laboratory Project ID: UNC/138-
R. Unpublished study prepared by Huntingdon Research Centre
Ltd. 549 p.
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the 2,4-DB Standard
MRID CITATION
40257504 Jagannath, D. (1987) Mutagenicity Test on 2,4-DB Technical 98.03%
... in the Ames Salmonella/Microsome Reverse Mutation Assay:
HLA Study No.: 9360-0-401TR. Unpublished study prepared by
Hazleton Laboratories America, Inc. 32 p.
40257505 Young, R. (1987) Mutagenicity Test on 2,4-DB, Technical ... in the
CHO/HGPRT Forward Mutation Assay: HLA Study No.: 9360-0-435.
Unpublished study prepared by Hazleton Laboratories America,
Inc. 35 p.
40257506 Ivett, J. (1987) Mutagenicity Test on 2,4-DB Tech 98.03% in an in
vitro Cytogenic Assay Measuring Chromosomal Aberration Frequen-
cies in Chinese Hamster Ovary (CHO) Cells: HLA Study No.
9360-0-437. Unpublished study prepared by Hazleton Laboratories
America, Inc. 30 p.
40257507 Cifone, M. (1987) Mutagenicity Test on 2,4-DB Technical, 98.03% in
the Rat Primary Hepatocyte Unscheduled DNA Synthesis Assay:
HLA Study No. 9360-0-447. Unpublished study prepared by Hazle-
ton Laboratories America, Inc. 24 p.
40762601 McCann, J. (1976) Biological Report of Analysis of Amchem Technical
2,4-DB: Rainbow Trout (salmo gairdneri): Static Jar Test 928.
Unpublished study prepared by Terrestrial and Aquatic Biology
Laboratory. 1 p.
40762602 McCann, J. (1976) Biological Report of Analysis of Amchem Technical
2,4-DB: Bluegill (lepomis macrichirus): Static Jar Test 938.
Unpublished study prepared by Terrestrial and Aquatic Biology
Laboratory. 1 p.
99
-------
IV FORMS APPENDICES
100
-------
EPA Form 8580-1
OMB Approval NO. 2070-0057
Expires 11/30/89
FIFHA SECTION 3ICH2H6I SUMMARY SHEET
EPA REGISTRATION NO
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With respict to ttit nquinmtnt to submit "gtniric" data impostd by tht FIFRA sKtion 3(C)(2)(B) notici comaintd m the rtferenced
Guidance Oocumtnt. I am responding in ttii following minntr:
G 1. I will submit dm in i ttmtly minntr to »t«fy tht following requirtmmts. If tht ttfl procidurn I will u«t dt«mt from (or trt not
spicifitd in) tht Rtgmntion Guidilinn or tht Protocols contnmd in thi Rtponi of Exptn Groups to tnt Chtmicjlt Group. OECD
Cnwnetls Toting Progrimmi, I melon thi protocols thn I will ust:
D 2, I hivi mnrid into in agrwmint with om or mori othir regotrents undir FIFRA SKtion 3(C)(2)(B)(ii) to atisty thi following dita
nquinmintv Thi tim, ind iny required protocols, will b« submintd to EPA by:
NAME OF OTHER REGISTRANT
D 3. I melon i complltid "Cinification of Animpt to Entir Into an Agriimint with Othir Rtcutrants for Otvilopmint of Oiu" with
rispict to thi following dio nquinmints:
G 4. I raquBt thit you imind my regiitntion by dinting thi following UMI (this option a not ivuliolt to applicants for niw producu):
G S. I rtqum voluntary cancillition of thi registntion of this product (Thu option is not tviilibli to applicants for niw products.)
REGISTRANTS AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
101
-------
EPA Form 8580-6
OMB Approval NO. 2070-0057
Expires 11/30/89
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
(To nullify. cmifyALL *™ '«"»> FOR DEVELOPMENT OF DATA
1. 1 am duly aumorized to represent the following firm(j) who are subject to the require-
ments of » Notice under FIFRA Section 3(cl(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
NAME OF FIRM
GUIDANCE DOCUMENT OATE
ACTIVE INGREDIENT
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop iointly, or to share in the cost of developing, the following required
items or data:
3. My firm hat offend in writing to enter into such an agreement Copies of the off en are attached. That offer was irrevocable and included an offer to t
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all ttrms could not be reached otherwise. This offer was mad
to the following firm(s) on the following dated):
NAME O* PIMM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) abo>
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly infor
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This natemei
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
OATE
102
-------
OMB Approval No. 2070-0057
Expires 11/30/89
EPA Reg. No..
PRODUCT SPECIFIC DATA REPORT
Date
Guidance Document for
Registration
Guideline No.
Subpart C
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test
Identity of
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Meltincr point
Boilina point
Density, bulk-
density, or
specific aravity
Solubility
Vapor pressure
Dissociation
constant
Test not
required
for my
product
listed
above
(check
below)
Octanol/water |
partition |
coefficient |
rfl 1
I am complying with
data requirements bv
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
MRID Numbers
Assigned
1
EPA Form 8580-4
103
-------
OMB Approval No. 2070-0057
Expires 11/30/89
EPA Reg. No..
PRODUCT SPECIFIC DATA REPORT (cont'd)
Date_
Guidance Document for
Registration
Guideline No.
Subpart C
PRODUCT
CHEMISTRY
(cont'd)
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
Sec. 158.340
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
81-7
Name of Test
Stability
Qxidi zing/reducing
reaction
Flanmabilitv
Fxplnrlahi.litv
Storaae stability
Viscosity
Miscibilitv
Corrosion
characteristics
Dielectric break-
down voltacre
Acute oral
toxicitv. rat
Acute dermal
toxicity. rabbit
Acute inhalation,
toxicitv. rat
Primary eye
irritation, rahbii-
Primary dermal
irritation
Dermal sensitiza-
tion.
Acute Delayed
neurotoxicity , hen
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements bv
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
i
(For EPA Use Only)
MRID Numbers
Assigned
EPA Form 8580-4 (cont'd)
104
-------
CMB Approval No. 2070-0057
Expiration Date 11/30/89
DATA EXEMPTION STATEMENT
EPA Product Registration Number:.
Registrant's Name and Address:
As an authorized representative of the registrant of the product identified above, I
certify that:
(1) I have read and am familiar with the terms of the Notice from EPA dated
concerning a requirement for submission of "generic" data on the active
ingredient named under FIFRA Section 3(c)(2)(B).
(2) My firm requests that EPA not suspend the registration of our product, despite
our lack of intent to submit the generic data in question, on the grounds that the
product contains the active ingredient solely as the result of the incorporation into
the product of another product which contains that active ingredient, which is
registered under FIFRA Section 3, and which is purchased by us from another producer.
(3) An accurate Confidential Statement of Formula (CSF) for the above-identified
product is attached to this statement. That formula statement indicates, by company
name, registration number, and product name, the source of the subject active
ingredient in my firm's product, or
The CSF dated on file with EPA is complete, current and accurate and
contains the information requested on the current CSF Form 8570-4. The registered
source(s) of the above named active ingredient in my product(s) is/are and
their registration number (s) is/are •
My firm will apply for an amendment to the registration prior to changing the source
of the active ingredient in our product.
(4) I understand, and agree on behalf of my firm, that if at any time any portion of
this Statement is no longer true, or if my firm fails to comply with the undertakings
made in this Statement, my firm's product's registration may be suspended under FIFRA
Section 3(c)(2)(B).
(5) I further understand that if my firm is granted a generic data exemption for the
product, my firm relies on the efforts of other persons to provide the Agency with the
required generic data. If the registrant (s) who have conmitted to generate and submit
the required data fail to take appropriate steps to meet requirements or are no longer
in compliance with this Notice's data requirements, the Agency will consider that both
they and my firm are not in compliance and will normally initiate proceedings to
suspend the registrations of my firm's product (s) and their product (s), unless my firm
commits to submit and submits the required data in the specified time frame. I
understand that, in such cases, the Agency generally will not grant a time extension
for submitting the data.
Registrant's authorized representative:
(Signature
Dated:
(Typed)2
EPA Form 8570-27
105
------- |