GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
CHLOROBENZIIATE
AS THE ACTIVE INGREDIENT
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460
DECEMBER 30, 1983
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TABLE OF CONTENTS
Introduction 1
I. Regulatory Position 4
II. Requirement for Submission of Generic Data .18
III. Requirement for Submission of Product-Specific
Data 39
IV. Submission of Revised Labeling and Packaging
Information 43
A. Label Contents
1. Product Name
2. Company Name and Address
3. Net Contents
4. Product Registration Number
5. Producing Establishment
Registration Number
6A Ingredient Statement
6B Pounds Per Gallon Statement
7. Front Panel Precautionary Statements
7A Child Hazard Warning Statements
7B Signal Word
7C Skull and Crossbones and Word Poison
7D Statement of Practical Treatment
7E Referral Statement
8. Side/Back Panel Precautionary Labeling
8A Hazard to Humans and Domestic Animals
8B Environmental Hazard
8C Physical or Chemical Hazard
9 Misuse Statement
10A Storage and Disposal Block
10B Directions for Use
B. Collateral Information
V. Instructions for Submission 48
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APPENDICES
I Bibliography
II FIFRA §3(c)(2)(B) Summary Sheet - EPA Form 8580-1
III Certification of Attempt to Enter Into an Agreement
With Other Registrants for Development of Data
EPA Form 8580-6
IV Product Specific Data Report (End-Use Products)
EPA Form 8580-4
V-l 40 CFR §162.10 Labeling Requirements
V-2 Table of Labeling Requirements and Sample Labels
V-3 Physical/Chemical Hazards Labeling Statement
V-4 Storage and Disposal Statements
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INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA Section 3(g), as amended in 1978, directs EPA to
reregister all pesticides as expeditiously as possible. Each
registrant of a manufacturing use product of the active
ingredient who wishes to continue to sell or distribute that
product must apply for reregistration.
To fulfill this Congressional mandate, we have established
the Registration Standards program which will review all pesti-
cide active ingredients first registered before January 1, 1977,
These pesticides will be reviewed in use clusters which are
prioritized on the basis of a ranking scheme giving preference
to pesticides used on food and feed crops.
The Registration Standards program involves a thorough
review of the scientific data base underlying pesticide
registrations and an identification of essential but missing
studies which may not have been required when the product
was initially registered or studies that are now considered
insufficient. Our reassessment results in the development
of a regulatory position, contained in this document, on
each pesticide and its uses. The regulatory position may
require the registrant to modify product labels to provide
additional precautionary statements, restrict the use of the
pesticide to certified applicators, provide reentry intervals,
modify uses or formulation types, specify certain packaging
limitations, or other requirements to assure that proper use
of the pesticide poses no potential adverse effects to human
health or the environment.
The scientific review, which is not contained herein
but is available upon request, concentrates on the technical
grade of the active ingredient and identifies missing generic
data. However, during the review of these data we are also
looking for potential hazards that may be associated with
the end-use (formulated) products that contain the active
ingredient. If we find serious concerns, we will bring
end-use products under the provisions of the Registration
Standards program to the extent necessary to protect the
public.
EPA has the authority under FIFRA §3(c)(2)(B) to require
that registrants submit data that will answer our questions
regarding the hazard that may result from the intended use of
the pesticide under review. Further, it is the Agency's policy
under §3(c)(2)(B) that these data are not required to be
submitted by those registrants who qualify for the formulator's
exemption [FIFRA §3(c)(2)(D)]. Normally, this means that the
registrants who are responsible for filling the data gaps are
the "'manufacturing-use product producers (basic suppliers of
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the active ingredient). However, end-use producers will not
qualify for the formulator's exemption if the source of their
active ingredient: (1) is not registered with EPA, and/or (2)
is produced by the registrant's firm, or a firm which has
ownership in common with the registrant's firm. These end-use
producers can qualify for the formulator's exemption if they
change their source of supply to a registered source, provided
the source does not share ownership in common with the regist-
rant's firm. If the end-use product registrant decides to
switch sources, a new Confidential Statement of Formula, EPA
Form 8570-4, must be submitted to the appropriate Product
Manager within 90 days of receipt of this Guidance Document.
The chart on the following page shows what is generally
required of those who do and do not qualify for the formulator's
exemption in the Registration.Standards program. " "
If you decide to request the Agency to discontinue the
registration of any of your products subject to the reregistra-
tion requirements of this Guidance Document, please notify
the Product Manager named in the cover letter, within 90
days from the receipt of this document, that you wish to
voluntarily cancel the registrations). If you decide to
maintain your product registrations), you must provide the
information described in the following pages within the time-
frames outlined. EPA will issue a notice of intent to cancel
or suspend the registration of any currently registered
product if you fail to comply with the requirements set
forth in this Guidance Document.
This Guidance Document will be supplemented by EPA with
additional information about compliance with data support
requirements. In Monsanto v. Acting Administrator,, EPA was
enjoined from implementing §3(c)(l)(D) of FIFRA. EPA has
decided that as long as this injunction is in effect, it will
proceed with the requirements in this Guidance Document which
do not require compliance with the provisions of §3(c)(l)(D).
In other words, EPA will not at this time require current
registrants to apply to amend their product registrations to
make changes in the labeling, packaging, or composition.
The Agency will supplement the Document with additional
guidance when this litigation concludes. Failure to comply
with the provisions of the subsequent guidance will also
result in issuance by EPA of an intent to cancel the affected
product registrations).
Registrants are reminded that §6(a)(2) of FIFRA requires
you at any time to submit factual information raising concerns
of possible unreasonable adverse effects of a pesticide. You
should notify the Agency of interim results of studies in
progress if those results show possible adverse effects.
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PRODUCTS SUBJECT TO THE
REGISTRATION STANDARDS PROGRAM
ACTION(S) REQUIRED TO
MAINTAIN REGISTRATION
I. Products That Do Not Qualify
For The Formulator's Exemption
A. Single Active Ingredient
Products*
These products must be reregis-
tered. To obtain reregistration,
labeling, packaging and data
requirements must be satisfied
in accordance with the Regis-
tration Standards Guidance
Document.
B. Multiple Active Ingredient
Products
These products will not be
reregistered at this time.
However, generic data required
to continue the registration of
the active ingredient under
review, as described in the
Registration Standards Guidance
Document, will be required and
some labeling precautions may
also be required.
II. Products That Do Qualify For
The Formulator's Exemption
Only when additional restric-
tions or labeling are needed to
protect man or the environment
will these products be subject
to the Registration Standard
requirements. Affected products
will be dealt with in a variety
of ways, including but not
limited to the Label Improvement
Program and special intent
to cancel notices.
* End-use products of registrants who also produce a manufacturing-
use product will not be required to be reregistered provided that
registrant fulfills the requirements specified in the Guidance
Document for manufacturing-use product(s). Such end-use products
will be subject to the labeling changes required for products in "II
above. If there are no manufacturing-use products registered by any
company end-use products will be required to be reregistered.
NOTE: If all registrants in "I" above fail to meet
I-A and B above, then the registrants in "II" lose
qualify for the formulator's exemption and become
requirements in I-A and B.
the requirements
their right to
subject to the
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I. REGULATORY POSITION
A. INTRODUCTION
This guidance document describes the Agency's regulatory position on registration
of manufacturing use products (MPs) containing the miticide chlorobenzilate. The
Agency's position is based on an evaluation of all registered uses and registered
MP's with chlorobenzilate as the sole active ingredient. The document also con-
siders known chemical and toxicological properties of this chemical as well as
the established tolerances for residues in or on food and feed commodities. From
these considerations the Agency sets forth the data and labeling requirements that
must be met by registrants and applicants of chlorobenzilate products in order
for the products to be reregistered or registered under this document. In order
to be registrable under this document, technicals and manufacturing use products
must list chlorobenzilate as the sole active ingredient. The tables accompanying
this document list the data gaps which must be satisfied through submission of
additional information. Future MPs that differ appreciably from those described
in this document may require that amendments be made to this document to reflect
the differences.
B. DESCRIPTION OF CHEMICAL AND USE PROFILE
Chlorobenzilate- .CifiHi4Cl?0^; mol. wt. 325.20;
C.A.S. » 510-15-6, Shaughnessy # 028801.
Chlorobenzilate is the accepted common name for ethyl 4,4'-dichlorobenzilate.
Trade names and other names include Acaraben™, Akar1", Folbex1", Geigy 338, Benzilan,
Rospin and Kop-Mite.
Technical chlorobenzilate is a brownish viscous liquid. It has a boiling point
of 141-142°C at 0.06mm Hg and a melting point of 35-37°C (pure material). At a
temperature of 19.4°C, 86.9 grams of the technical material is soluble in 100 ml.
of xylene. The material is virtually insoluble in water and infinitely miscible
in benzene, acetone and other organic compounds. Under normal conditions,
chlorobenzilate is stable at room temperature.
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This miticide is produced in the United States by the Ciba-Geigy Corp. The
chemical is also produced overseas by Nippon Kayaku Co., Japan and Makhteshim
Beer-Sheva, Israel.
The federally registered formulated (end use) products containing chlorobenzilate
are single active ingredient formulations. There are no mixtures with other
active ingredients. Chlorobenzilate is commercially formulated as a four pound
emulsifiable concentrate and the only registered use for the chemical is on
citrus. This use is restricted to the states of Arizona, California, Florida
and Texas. Foreign uses also include smokestrips for use in honey bee hives
to control the bee-mite Acarapis woodi. In addition to the. federal registrations,
there remain three Florida intrastate products for use on citrus. There are
no active Special Local Need registrations.
C. REGULATORY POSITION
Based on a review and evaluation of all available data and other relevant
information on chlorobenzilate, the Agency has made the following determina-
tions:
1. Neither this Agency nor the state of California has established a
reentry interval for field workers entering treated fields. Con-
sidering acute toxicity alone, chlorobenzilate would not normally
require a reentry interval. However, in keeping with established
Agency policy for chemicals having an inadequate data base for
evaluation of reentry exposure, and which have chronic toxic effects,
a 24-hour reentry interval is now required. The registrant can either
accept this interval or submit data to establish a different interval.
This interval is considered provisional and the Agency reserves the
right to revise this reentry interval and to impose additional label
requirements after receipt and review of the data required in Table A
and B of this Guidance Document.
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2. Although the Agency is unable to complete a full tolerance reassessment
because of certain residue chemistry and toxicology data gaps, the
Agency concludes that no change in the present tolerance for citrus is
warranted at this time. Additional residue data may necessitate a
revision of this tolerance and the establishment of a food and/or feed
additive tolerance(s).
3. Manufacturing-use products containing chlorobenzilate as a sole active
ingredient may be registered for sale, distribution, reformulation, and
use, under the terms and conditions set forth in this Guidance Document.
4. Registrants must provide or agree to develop additional data, as specified
in the tables attached to this Guidance Document in order to maintain
existing registrations or to obtain new registrations of substantially
similar MPs.
5. On May 26, 1976, the EPA published in the Federal Register (41 FR 21517)
a Notice of Rebuttable Presumption Against Registration and Continued
Registration (RPAR) of pesticide products containing chlorobenzilate.
The Agency concluded that the chemical induced oncogenic effects in ex-
perimental mammals. The Agency's position was not successfully rebutted.
Since chlorobenzilate has been determined to pose an oncogenic risk,
this chemical "triggers" criteria for unreasonable adverse effects
listed in Section 162.11 (a) of Title 40 of the U.S. Code of Federal
Regulations. The Agency has concluded, via the RPAR process (Federal
Register (44 FR 9548) February 13, 1979, " Notice of Intent to Cancel
Registrations and Deny Applications for registration of all non-citrus
chlorobenzilate uses," that by limiting the use to citrus, classifying
chlorobenzilate products for restricted use, and by upgrading the
protective clothing requirements, the exposure level and risks would
be lowered to acceptable levels. The benefits were determined to exceed
the risks and the chemical was allowed continued use under the terms
set forth in our "Notice of Intent to Cancel or Deny" published in
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1979. These RPAR findings have been confirmed in this review. However,
other gaps in the data base preclude the completion of the Agency's
total risk assessment for this pesticide chemical. Registrants had to
comply with certain labeling changes and agree to develop and submit to
this Agency the following residue and exposure studies:
Residue Chemistry and Exposure Studies
*a. Citrus Fractionation Study
*b. Feeding Citrus By-Products to Cattle Study (Ruminant Feeding Study)
**c. Residue Monitoring of Milk from Pulp Fed Cattle and Residue - .
Monitoring of By-Products of Citrus Processing
d. Citrus Pickers Exposure Study
e. Aerial Applicator Exposure Study
***f. Ground Applicator Exposure Study
The Agency received little response from registrants concerning the
filling of the above data gaps. Consequently, on July 22, 1982 this
Agency mailed a 3(c)(2)(B) "Data Call in Notice" to all registrants
requiring that certain "generic" and the above residue and exposure
* If residues concentrate in citrus pulp additional ruminant feeding
studies may be required.
** This study has been eliminated since this information can be obtained
in the Citrus Fractionation and Feeding Citrus By-Product to Cattle
study as proposed in protocols submitted by Ciba-Geigy in February of
1980.
*** This study has been submitted by Florida Citrus Mutual and is no longer
considered a data gap.
T
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data be filled. As outlined in that document, time frames and sched-
ules for the submission of these data were to be maintained and per-
iodic reports were to be prepared and sent to the Agency. To date the
need for one study has been eliminated, one study has been submitted,
and protocols have been received and reviewed for two studies. All
registrants of chlorobenzilate products remain bound by this document
and the time frames for the completion of the data have been incorporated
into Table A of this guidance document. These data are indicated by an
asterisk in the footnotes of the tables.
6. The Agency has received a report indicating the presence of manufacturing
impurities at relatively low levels in one technical chlorobenzilate pro-
duct. (The identified impurities include certain isomers and analogs of
DDT/l However, the analytical method used in this study was not provided
and did not quantify the compounds identified. Since DDT and other re-
lated compounds are of substantial concern to the Agency, all registrants
will be required to quantify their contaminants at the lowest level of
detection using the best available technology.
D. REGULATORY RATIONALE
The Agency has determined that registration of chlorobenzilate should con-
tinue after considering the following:
1. Adequate studies are available to assess the acute oral and dermal
toxicological effects of this chemical to humans.
2. Chlorobenzilate was found to be oncogenic. j This finding was based
mainly on an oncogenicity screening study reported by Kotin, Falk,
Pallotta et aJ^. (1969) and a study reported by Hazleton Laboratories
(Horn, 1954). Additionally, a study by Hollingsworth, Woodard, and
Woodard (1966) and an NCI report (Hazleton, 1978) were cited in the
Agency's "Notice of Intent to Cancel."
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Rebuttals to the oncogenicity "trigger" successfully eliminated the
Horn (1954) and the Hollingsworth, Woodard and Woodard (1966) studies
but not the Kotin, Falk and Pallatta et^ al. nor the NCI study. The
Carcinogen Assessment Group (CAG) concluded that there was a small,
but real, oncogenic risk to users. All uses of chlorobenzilate were
cancelled except for citrus in an effort to reduce exposure. Label-
ing changes were required and the applicator protective clothing
requirements were upgraded (see Section G) to further reduce this
exposure.
The data show that the populations at risk with respect to chloroben-
zilate use include pesticide applicators and citrus pickers. These
populations are exposed to the chemical at the time of application
and/or for a period of time following application. The Agency has
selected restricted use classification and reentry intervals as a
means of reducing exposure to these populations.
The key concept behind the restricted use classification is that
certification can generally upgrade applicator skills and that with
more skill and knowledge applicators are more likely to use pesticides
carefully and efficiently. It would, therefore, be reasonable to
conclude that a general upgrading of the skills of chlorobenzilate
applicators would result in reduced exposure.
The data base for chlorobenzilate is inadequate for evaluation of
reentry exposure to citrus pickers and other field workers. Therefore,
establishment of a 24-hour reentry interval is in keeping with
established Agency policy for chemicals having an inadequate data
base for evaluating reentry exposure and which have chronic toxic
effects.
3. A three generation rat reproduction study resulted in reduced test-
icular weights, however, the reproductive parameters were not affect-
ed at the dosage levels tested. The Agency in its RPAR conclusions
required that registrants provide another multigeneration reproduction
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study. This study has been received by the Agency and the results
indicate that chlorobenzilate does not adversely affect reproductive
performance nor produce "testicular atrophy" at dosage levels up to
100 mg/kg per day. This is no longer considered a data gap.
4. The current tolerance of 5 ppm on citrus is not adequately supported
by residue data because the analytical procedure included an unaccept-
able extraction step. However, no adverse data have been submitted to
the Agency suggesting that this tolerance level will not protect the
public. Market basket surveys by the Food and Drug Administration
show that residues in citrus have not exceeded the tolerance.
5. The most recent Pesticide Incident Monitoring Systems (PIMS) records
available lists four pesticide incidents involving chlorobenzilate.
However, none of these accidents could be wholly attributable to this
chemical. No pesticide fatalities were involved and only two persons
required medical attention.
6. The available data base is insufficient to fully assess the environ-
mental fate of chlorobenzilate. However, since the data suggest
that chlorobenzilate degrades fairly rapidly and both it and its de-
gradates have low mobility, groundwater contamination is considered
unlikely. Data on the octanol/water partition coefficient, volatility,
leaching and reentry are required. Once the data gaps are filled, ad-
ditional data may be required.
7. There are insufficient ecological effects data to complete a hazard
assessment of the use of chlorobenzilate on citrus. When the Agency
receives data from the required studies in this Guidance Document, a
hazard assessment will be completed. Also, our analysis of these
requested data may necessitate additional studies such as acute tox-
icity testing to estuarine and marine organisms. The amount of DDT
and related compounds contaminating chlorobenzilate products is of
special ecological concern and will mandate further investigation.
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8. Under FIFRA, the Agency cannot cancel or withold registration simply
because data are unavailable or inadequate (see Section 3(c) (2)(B)
and 3(c)(7) of FIFRA). This Guidance Document provides a mechanism
for identifying data needs and calling in these data. The data will
then be evaluated and a determination will be made as to the continued
registrability of this chemical.
E. Criteria for Products Subject to the Guidance Document
This Guidance Document covers pesticide products that contain chlorobenzilate
as a sole active ingredient; the chart on page three describes the extent -to
which such products are subject to this Document. Applicants for registration
or reregistration of such products must comply with all terms and conditions
described herein. This includes making a commitment to fill data gaps on a
schedule specified by the Agency. Also, applicants for reregistration must
follow the instructions contained in this Guidance Document and complete and
submit the appropriate forms within the specified times. End-use products
must be in compliance with the label changes specified in this Document.
F. Acceptable Ranges and Limits
1. Product Composition Standards
To be fully covered under this Guidance Document, manufacturing use
products (MP's) must contain chlorobenzilate as the sole active
ingredient. Each MP formulation proposed for registration must be
fully described with an appropriate certification of limits. However,
because the Agency is concerned about possible DDT and related
compounds as impurities in the technical material, quantification of
these impurities must be at a level of detection below 0.1% of the
technical using the best suitable validated analytical methods
(preferably gas liquid chromatography or high performance liquid
chromotography).
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2. Acute Toxicity Limits
The Agency will consider for registration any MP whose acute toxicity
category (I, II, III or IV) is supported by adequate acute toxicity
data and labeling, including appropriate precautionary statements.
The Agency has determined that the appropriate signal word for
chlorobenzilate products is "CAUTION".
3. Use Patterns
To be registered under this Guidance Document, MP's may be labeled
for formulation only into end-use products for citrus crops under the
terrestrial nondomestic food crop uses (ground and aerial applications)
grouping.
G. Required Labeling
All manufacturing-use products and end-use products containing chlorobenzilate
must bear appropriate labeling as specified in 40 CFR 162.10. Additionally,
these products must also comply with the labeling requirements outlined in
the Agency's Notice of Intent to Cancel Registrations and Deny Applications
for Registrations of Pesticide Products Containing Chlorobenzilate published
in the Federal Register (44 FR 9548) February 13, 1979. Those requirements,
as well as labeling requirements identified in the development of this document
are set forth below.
When the data to be submitted under this Guidance Document have been reviewed,
the Agency may impose additional labeling requirements.
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1. Label Requirements for All Chlorobenzilate Products
"General Precautions"
"Take special care to avoid getting chlorobenzilate in eyes, on skin
or on clothing. Avoid breathing vapors or spray mist If chlorobenzilate
gets on clothing, remove contaminated clothing and wash affected parts
of body with soap and water. If extent of contamination is unknownr
bathe entire body thoroughly. Change to clean clothing. Wash hands with
soap and water each time before eating, drinking or smoking. At the
end of each work day, bathe entire body with soap and plenty of water.
Wear clean clothes each day and launder before reusing."
"Handling Precautions"
"Heavy-duty rubber or neoprene gloves and apron must be worn during load-
ing, unloading, and equipment clean-up."
2. Label Requirements for Manufacturing-Use Products
Statement of Environmental Hazards
"ENVIRONMENTAL HAZARDS"
"This pesticide is toxic to wildlife. Do not discharge into
lakes, streams, ponds or public water except in accordance
with a NPDES permit. For further guidance, contact the near-
est EPA Regional Office."
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3. Label Requirements for End-Use Products
a. The following "Restricted Use Statement" must be added to the
label.
| RESTRICTED USE PESTICIDE
I
| For retail sale to and use only by certified applicator or
| persons under their direct supervision and only for those
| uses covered by the certified applicator's certification.
b. The labeling must state, "This product is restricted to the
states of Arizona, California, Florida and Texas."
c. "Required Clothing and Equipment for Application"
"One-piece overalls which have long sleeves and long pants con-
structed of finely-woven fabric as specified in the USDA/EPA
Guide for Commercial Applicators. Wide brimmed hat. Heavy
duty fabric work gloves. Any article which has been worn
while applying chlorobenzilate must be cleaned before reusing.
Clothing which has been drenched or has otherwise absorbed con-
centrated pesticide must be buried or burned"
"Facepiece respirator of the type approved for pesticide spray
applications by the National Institute for Occupational Safety
and Health. Instead of clothing and equipment specified above,
the applicator can use an enclosed tractor cab which provides
a filtered air supply (as described by Taschenberg and Bourke,
1975), and which allows no more than 0.41 mg/day total exposure
to chlorobenzilate. For aerial applicators: Aerial application
may be conducted without the specified clothing and equipment."
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d. Statement of Environmental Hazards
"ENVIRONMENTAL HAZARDS"
This product is toxic to wildlife. Do not apply directly to
water or wetlands. Do not contaminate water by cleaning of
equipment or disposal of wastes.
e. Reentry Statement
"Do not enter treated citrus groves within 24 hours."
H. Tolerance Reassessment
Based on the established tolerances published in 40 CFR 180.109, the theoretical
maximum residue contribution (TMRC) from chlorobenzilate residues to the human
diet is calculated to be 0.7017 mg/day from a 1.5 kg food diet for a 60 kg per-
son. Because all uses of chlorobenzilate except citrus have been cancelled,
the Agency has recalculated the TMRC, Acceptable Daily Intake (ADI) and Maximum
Permissible Intake (MPI). These values are 0.2859 mg/day/1.5 kg (3.81% of the
ADI), 0.125 mg/ kg/day and 7.50 mg/day/60 kg, respectively. These ADI and MPI
values are all considered provisional since a data gap exists for a chronic
feeding study in a second species. Another reassessment and recalculation of
the ADI and MPI will be done when studies required to fill the toxicology data
gaps have been submitted and validated. If different values are obtained then
the ratio between the MPI and TMRC will be reviewed. It is possible, at that
time, that the established tolerances may be affected.
According to 40 CFR 180.109, tolerances are established on residues of chloro-
benzilate in or on raw agricultural commodities as follows:
15 ppm in or on almond hulls,
5 ppm in or on apples, citrus fruits, melons and pears,
0.5 ppm in or on cottonseed,
0.5 ppm in or on meat, fat, and meat byproducts of cattle and sheep,
0.2 ppm in or on alinonds and walnuts.
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The tolerances for apples, melons, pears, cottonseed, almond hulls, almonds
and walnuts were established for residues resulting from uses on these com-
modities. These uses were cancelled and the tolerances are scheduled to be
revoked in fiscal year 1984. The tolerance for meat, fat, and meat byproducts
of cattle and sheep will be retained to cover residues resulting from citrus
use.
Residue data on citrus processed commodities (molasses, pulp, and oil) will
be required showing the amount of residues present. If the residues are
found to concentrate in processed commodities, a petition for a food additive
tolerance(s) will have to be submitted or this use must deleted from the label
This requirement was not in place when the original tolerance for citrus was
approved. Also, additional ruminant feeding studies may be required.
International Tolerances
The following tolerances for residues of chlorobenzilate have been
established in:
Canada: 5 ppm apples, cantaloupes, citrus fruits, pears
Mexico: 5 ppm citrus fruits, apples, melons, pears
0.5 ppm cotton(seed)
0.2 ppm nuts
The latest Codex Alimentarius entry and tolerances for chlorobenzilate are:
Maximum
Residue limit
(Mg/Kg)
Almonds 0.2 shell-free basis
Apples 5.0
Cantaloupe 1.0
Citrus fruit 1.0
Grapes 2.0
Melons 1.0
Milk 0.05
Pears 2.0
Tomato 0.2
Walnuts 0.2 shell-free basis
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The Maximum Residue Limit for citrus is not currently in harmony with the
established tolerances for citrus fruit in the U.S.A., Mexico and Canada.
Until the residue data requested for citrus use is submitted and reviewed
to determine the appropriate tolerance level, the lowering of the current
5 ppm tolerance level is not warranted.
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II. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
A. This portion of the guidance document is a Notice
issued under the authority of FIFRA Section 3(c)(2)(B)
and describes, in table format, the data required
for maintaining the registrability of each product.
Additionally, a bibliography (Appendix I) is
included that identifies that data considered as
part of the data base supporting this standard. EPA
has determined that additional generic data described
in this Notice must be submitted to EPA for evaluation
in order to maintain in effect the registrations)
of your product(s) identified as an attachment to
the cover letter accompanying this guidance document.
As required by FIFRA Section 3(c)(2)(B), you are
required to take appropriate steps to comply with
this Notice.
EPA may suspend the registration of each of those products
unless, within the specified time, you have informed EPA
how you will satisfy the requirements of this Notice.
Any such suspension will remain in effect until you have
complied with the terms of this Notice.
B. What Generic Data I/ Must Be Submitted. You may ascertain
which generic data you must submit by consulting Table A
at the end of this chapter. That table shows all the
generic data needed to evaluate the continued registrability
of all products, and the dates by which the data must be
submitted. The required data must be submitted2/. Any
necessary studies must be conducted in accordance with
acceptable protocols, examples of which are contained
in EPA's Pesticide Assessment Guidelines^/, and, for the
most part, in the approved protocols of the Organization
for Economic Cooperation and Development (OECD). If
you wish not to develop data which are necessary to
support the registration or reregistration of certain
uses appearing in your labeling, you may delete those
uses at the time you submit your revised labeling.
_!/ Generic data pertain to the properties or effects of a
particular ingredient, and thus are relevant to an evaluation of
the risks of all products containing that ingredient (or all such
products having a certain use pattern), regardless of any such
product's unique composition or use. Product-specific data relate
only to the properties or effects of a product with a particular
composition (or a group of products with closely similar composition)
_2/ U.S. EPA, 1982. Pesticide Registration; Proposed Data
Requirements - Part 158. FEDERAL REGISTER of November 24, 1982
(47 FR 53192).
_3/ U.S. EPA, 1983. Pesticide Assessment Guidelines, National
Technical Information Service, Springfield, VA.
18
-------
Also for certain kinds of testing (generally ecological
effects), EPA requires the test substance to be a "typical
formulation," and in those cases EPA needs data of that
type for each major formulation category (e.g., emulsifiable
concentrates, wettable powders, granulars, etc.) These
are classified as generic data and when needed are
specified in Table A. EPA may possess data on certain
"typical formulations" but not others. Note; The "typical
formulation" data should not be confused with product-
specific data (Table B) which are required on each
formulation. Product-specific data are further explained
in Chapter IV of this document.
C. Options Available for Complying With Requirements
to Submit Data
Within 90 days of your receipt of this Notice you must
submit to EPA a completed copy of the form entitled "FIFRA
Section 3(c)(2)(B) Summary Sheet" [EPA Form 8580-1, Appendix
II] for each of your products. On that form you must state
which of the following methods you will use to comply with
the requirements of this Notice:
1. (a) Notify EPA that you will submit the data, and
(b) either submit the existing data you believe
will satisfy the requirement, or state that
you will generate the data by conducting
testing. If the test procedures you will
use deviate from (or are not specified in)
the Registration Guidelines or protocols
contained in the Reports of Expert Groups
to the Chemicals Group, Organization for
Economic Cooperation and Development (OECD)
Chemicals Testing Programme, you must enclose
the protocols you will use.
2. Notify EPA that you have entered into an agreement
with one or more other registrants to jointly
develop (or share in the cost of developing) the
data. If you elect this option, you must notify-EPA
which registrant(s) are parties to the agreement.
3. File with EPA a completed "Certification of Attempt to
Enter Into an Agreement With Other Registrants for
Development of Data" (EPA Form 8580-6, Appendix III)V
4. Request that EPA amend your registration by deleting the
uses for which the data are needed. (This option is not
available to applicants for new products.)
V FIFRA Section 3(c)(2)(B) authorizes joint development of
data by two or more registrants, and provides a mechanism by
which parties can obtain an arbitrator's decision if they agree
(Footnote continued at bottom of next page)
19
-------
5. Request voluntary cancellation of the registrations)
of your products for which the data are needed.
D. Procedures for Requesting Changes in Testing Methodology
and Extensions of Time
EPA recognizes that you may disagree with our conclusions
regarding the appropriate ways to develop the required
data or how quickly the data must be submitted. If the
test procedures you plan to use deviate from (or are not
specified in) the registration guidelines or protocols
contained in the reports of the Expert Groups to the
Chemical Groups, Organization for Economic Cooperation
and Development (OECD) Chemicals Testing Programme, you
must submit the protocol for Agency review prior to the
initiation of the test.
If you think that you will need more time to generate the
required data than is allowed by EPA's schedule, you may
submit a request for an extension of time. The extension
request must be submitted in writing to the Product
Manager. The extension request should state the reasons
why you conclude that an extension is appropriate. While
EPA considers your request, you must strive to meet the
deadline for submitting the required data.
(Footnote continued from previous page)
to jointly develop data but fail to agree on all the terms of
the agreement. The statute does not compel any registrant to
agree to develop data jointly.
In EPA's opinion, joint data development by all registrants
who are subject to the requirements to submit a pertinent item
of data or a cost-sharing agreement among all such registrants
is clearly in the public interest. Duplication of testing could
increase costs, tie up testing facilities, and subject an unneces-
sarily large number of animals to testing.
As noted earlier, EPA has discretion not to suspend the
registration of a product when a registrant fails to submit data
required under FIFRA Section 3(c)(2)(B). EPA has concluded that
it is appropriate to exercise its discretion not to suspend in
ways which will discourage duplicative testing. Accordingly, if
(1) a registrant has informed us of his intent to develop and
submit data required by this Notice; and (2) a second regis-
trant informs EPA that it has made a bona fide offer to the
first registrant to share in the expenses of the testing [on
terms to be agreed upon or determined by arbitration under FIFRA
Section 3(c)(2)(B)(iii)]; and (3) the first registrant has declined
to agree to enter into a cost-sharing agreement, EPA will not
suspend the second firm's registration. While the first firm is
not required to agree to jointly develop data, EPA is not required
to force the second firm to engage in economically inefficient
duplicative testing in order to maintain its registration.
20
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORDBENZIIATE
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2
§158.120 Product Chemistry
Product Identity;
61-1 - Identity of Ingredients TGAI
61-2 - Statement of Composition TGAI
61-3 - Discussion of Formation of TGAI
Ingredients
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis TGAI
62-2 - Certification of limits TGAI
62-3 - Analytical Methods for TGAI
Enforcement of Limits
Physical and Chemical Characteristics
63-2 - Color TGAI
63-3 - Physical State TGAI
63-4 - Odor TGAI
63-5 - Melting Point TGAI
63-6 - Boiling Point TGAI
63-7 - Density, Bulk Density, or TGAI
Specific Gravity
Partially
Partially
Partially
Partially
Partially
Partially
Yes
Yes
No
N/A
Yes
Yes
Yes3,4
000774383, GS007508Ub Yes3,4
00077423, 00077438a,
GS0075080b
00077443a, 00077405
00077411, GS0075080b
GS0075080b
GS0075080b
00077435, 00077442a
GS0075079b, GS0075080b
00077423, 00077411
00077423, 00077411
00077423, 00077411
00077423, 00077411
a. Data' submitted by Makhteshim Beer-Sheva Chem. Works, Ltd. These data may be compensable.
b. Data submitted by Ciba-Geigy. These data may be compensable.
Yes3,4
Yes5,6
Yes6
Yes6
Yes6
Yes
No7
Yes6
Yes6
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHDOROBENZILATE
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
Requ i reme nt? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2
§158.120 Product Chemistry
(continued)
63- 8 - Solubility
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
PAI
PAI
PAI
TGAI
TGAI
TGAI
Yes
Yes
No
No
N/A
Partially
No
00077423, 00077411
GS0075080b
00077423, 00077411
00077423, 00077411
Yes6
Yes6
Yes
Yes
No»
Yes6
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLOROBENZILATE
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
Requ i reme n t? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2
§158.120 Product Chemistry
(continued)
1. Composition: 1GAI = Technical grade of the active ingredient; PAI = Pure active ingredient; Choice = Choice of
several test substances determined on a case-by-case basis.
2. Data must be submitted no later than three months .
3. Updated information must be supplied on identity and quantity of impurities and inerts. A comparison of the con
fidential statements of ingredients show that there is a good possibility for the presence of DDT and/or related
compounds (DDE) as impurities in the technical material. Quantification must be made with a sensitivity
below 0.1% of the technical material.
4. Data submitted by Ciba-Geigy and Makhteshim. All others must submit these data.
5. Analysis of at least five production batches is required.
6. Data submitted by Ciba-Geigy. All others must submit these data.
7. Since the material is liquid, no data are required.
8. Since chlorobenzilate is insoluable in water, no pH data are required.
9. The Agency will request samples when the need arises.
10. No validation data for any of the methods were submitted. These data are required. If the DDT-like impurities
were detected by T.L.C., a description of the method should be submitted as well as adequate validation data.
(Preferrably we require data by HPLC or Mass Spec.)
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLOROBENZILATE
Data Requirements
Composition
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2
§158.125 Residue Chemistry
171-4 - Nature of Residue (Metabolism)
- Plants
- Livestock
171-4 - Residue Analytical Method
- Plant residues
- Animal residues
171-4 - Storage Stability Data
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use
Citrus Fruits
PAIRA
PAIRA and plant
metabolites
TGAI and metabolites
TGAI and metabolites
PAI
TEP
Partially
Partially
Yes
Yes
Yes
Partially
00077457
00077400
00078289, 00077407
GS0075035, 00077402
00077423, 00077411
00077457, 00077448
00077416, 00077470
00077445
Yes3
Yes 4
No5
No5
No
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR CHLOROBENZILATE
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
Requ i rement ? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2
§158.125 Residue Chemistry
171-4 - Magnitude of the Residues-
Residues Studies for Each
Food Use (con't)
Meat/milk/poultry/eggs
Processed Commodities
Citrus Molasses
Citrus pulp, dried
Citrus oil
TGAI or plant
metabolites
TGAI
TGAI
TGAI
Partially
00078288, 00077434
00077384
No7
No
No
No
Yes 8
Yes8
Yes 8
LT)
CM
Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled; TEP =
Typical end-use product; EP = End-use product.
Data must be submitted no later than 36 months
2.
3.
Metabolism data are required Which determine the extent of metabolism, degradation and/or breakdown of chloro-
benzilate in citrus.
4. A 14c radioactive metabolism study in a large ruminant is required.
5. If additional metabolism data show concern for the presence of possible metabolites, then alternate methodology
may be required.
6. Data should be submitted which reflects resulting residue levels in or on the whole fruit (oranges, lemons, grape-
fruit) from the maximum recommended label rates including aerial applications and repeat (3 or more) applications.
7. Large animal and poultry radiolabelled metabolism studies are needed. Depending on the results of these studies
and the results of the processing study, additional feeding studies and/or a tolerance for meat, milk, poultry and
and eggs may be required.
8. If residues are found to concentrate in processed commodities, a food and/or feed additive tolerance will be
required and additional ruminant feeding studies may be required.
*9. A citrus fractionation study is needed. This study must be submitted by February of 1984.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLOROBENZILATE
Data Requirement
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis
Photodegradat ion
161-2 - In water
161-3 - On soil
161-4 - In Air
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
MOBILITY STUDIES:
1 Use 2
Composition Pattern
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A
TGAI or PAIRA A
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Requirement? (Yes, Bibliographic Under t'IFRA Sectioi
No or Partially) Citation 3(c)(2)(B)?3
No
No
No'
No
Partially
N/A
N/A
N/A
Yes
Yes
Yes
Yes
00049143b, GS0075041 Yes4
No5
No6
No6
CN
163-1 - Leaching and
Adsorpt ion/Desorpt ion
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
TGAI or PAIRA A
TEP A
TEP A
No
No
No
Yes
Yes
Yes
b. Data submitted by Ciba-Geigy. These data may be compensable.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLOROBENZILATE
Data Requirement
§158.130 Environmental Fate
(continued)
DISSIPATION STUDIES-FIELD:
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-4 - Combination and
Tank Mixes
164-5 - Soil, Long-term
ACCUMULATION STUDIES:
165-1 - Rotational Crops
(Confined )
165-2 - Rotational Crops
(Field)
165-3 - Irrigated Crops
165-4 - In Fish
165-5 - In Aquatic Non-Targei
Does EPA Have Data
To Satisfy This
1 Use 2 Requirement? (Yes, Bibliographic
Composition Pattern No or Partially) Citation
TEP A Partially 00077368k
TEP - N/A
TEP - N/A
N/A
TEP A No
PAIRA A N/A
TEP A N/A
TEP A N/A
TGAI or PAIRA A No
t TEP A No
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3
Yes7
No«
No9
NolO
Yes
No11
No11
No12
Yes13
Reserved 14
Organisms
b. Data submitted by Ciba-Geigy. These data may be compensable.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLOROBENZ J.IATE
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
1 Use 2 Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement _ Composition __ Pattern _ No or Partially) _ Citation _ 3(c)(2) (B)?3 _
158.130 Environmental Fate
(Continued)
Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled;
TEP = Typical end-use product.
The use pattern is coded as follows: A= Terrestrial, Food Crop; B= Terrestrial, Non-Food; C= Aquatic, Food Crop;
D= Aquatic, Non-Food; E= Greenhouse, Food Crop; F= Greenhouse, Non-Food; G= Forestry; H= Domestic Outdoors;
1= Indoor.
Data must be submitted no later than 36 months _ .
Data are required identifying the degradation products and their rates of degradation.
This study is not required for this use pattern in the guidelines.
Data required only for aquatic uses.
Data are required on one, preferably two domestic soils where the pesticide is to be used.
There are no registered aquatic impact uses.
There are no registered forestry uses.
This guidance document deals only with single active ingredients.
Citrus is not considered a rotational crop.
Not required if citrus is treated conventionally with the pesticide. This study is required if the pesticide is
intentionally added to the irrigation water.
Fish accumulation studies are not required if the registrant can show that the active ingredient or its principal
degradation product (s) will not reach water, persist in water or accumulate in tissues of animals.
These data are required only if data from §165-4 shows potential for residues of chlorobenzilate to accumulate.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHIDROBENZILATE
Data Requirement
§158.135 Toxicology
ACUTE TESTING:
81-1 - Oral LD50 - Rat
81-2 - Dermal LE^Q
81-3 - Inhalation LCso ~ Rat
81-7 - Acute Delayed
Neurotoxicity - Hen
SUBCHRONIC TESTING:
82-1 - 90-Day Feeding -
Rodent , Non-rodent
82-2 - 21-Day Dermal
82-3 - 90-Day Dermal
82-4 - 90-Day Inhalation -
1
Composition
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
TGAI
Use 2
Patterns
A
A
A
A
A
A
A
A
Does EPA Have Data
To Satisfy This
Requirement? (Yes, Bibliographic
No or Partially) Citation
Yes 00080422A
Yes 00080422A
No
No
Yes 00077463
No
No
No
Must Additional
Data Be Submitted
Under F1FRA Section
3(c)(2)(B)?3
No
No
Yes
to4
No
No5
No5
No6
Rat
82-5 - 90-Day Neurotoxicity-
Hen/M animal
TGAI
No
No4
CTi
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLOROBENZIIATE
Data Requirement
1 Use 2
Composition Pattern
Does EPA Have Data
To Satisfy This
Requ irement? (Yes,
No or Partially)?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)3
§158.135 Toxicology
(continued)
CHRONIC TESTING;
83-1 - Chronic Toxicity - TGAI
2 species: Rodent
and Non-rodent
83-2 - Oncogenicity Study - TGAI
2 species: Rat and
Mouse preferred
83-3 - Teratogenicity - TGAI
2 species
83-4 - Reproduction, TGAI
2-generation
MUTAGENICITY TESTING
84-2 - Gene Mutation TGAI
84-2 - Chromosomal Aberration TGAI
84-2 - Other Mechanisms of TGAI
Mutagenicity
A
A
A
A
A
Partially
Yes
No
Yes
No
No
No
00077463
GS0075001
GS0075081b
Yes7
No
Yes8
No
Yes
Yes
Yes
b. Data submitted by Ciba-Geigy. These data may be compensable.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLOROBBNZILATE
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
1 Use 2 Requirement? (Yes, Bibliographic Under F1FRA Section
Data Requirement Composition Pattern No or Partially) Citation 3(c) (2) (B)?3
§158.135 Toxicology
(continued)
SPECIAL TESTING
85-1 - General Metabolism PAI or PAIRA A Yes 00075003 No
85-2 - Domestic Animal Safety Choice A N/A - No9
1. Composition: TGAI= Technical grade of the active ingredient.
2. The use pattern is coded as follows: A= Terrestrial, Food Crop; B= Terrestrial, Non-Food Crop; C= Aquatic,
Food Crop; F= Greenhouse, Non-Food; G= Forestry; H= Domestic, Outdoor; 1= Indoor.
3. Data must be submitted no later than 36 months .
4. This study is not required because the chemical is not an organophosphate and is is not structurally related to a
substance that causes delayed neurotoxicity.
5. Not required because the acute dermal toxicity is Category III.
6. Not required. This use does not result in repeated inhalation exposure.
7. Testing requires a rodent and a non-rodent species. A rodent study is still needed.
*8. These data are required to be submitted by October of 1984.
9. Not required because there are no domestic animal uses.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLORBENZIIATE
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
1 Use 2 Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition Pattern No or Partially) Citation 3(c)(2)(B)?3
§158.145
Aquatic
Wildlife and
Organisms
AVIAN AND MAMMALIAN TESTING
71-1 -
71-2 -
71-3 -
71-4 -
71-5 -
Avian Oral LD5Q TGAI A No
Avian Dietary LC5n TGAI A No
Wild Mammal Toxicity TGAI A No
Avian Reproduction TGAI A No
Simulated and Actual TEP A No
Yes
Yes
- Reserved'*
Yes
- Reserved^
Field Testing -
Mammals and Birds
AQUATIC ORGANISM TESTING
72-1 - Freshwater Fish LC50 TGAI
72-2 - Acute LC50 Freshwater TGAI
Invertebrates
72-3 - Acute LC5o Estuarine TGAI
and Marine Organisms
72-4 - Fish Early Life TGAI
Stage and Aquatic
Invertebrate Life-Cycle
70-l(d) Reptile and Amphibian TGAI
A
A
A
A
No
No
No
No
No
og
CO
Yes
Yes
Yes
Yes
Reserved^
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR CHLOROBENZILATE
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
1 Use 2 Requirement? (Yes, Bibliographic Under F.IFRA Section
Data Requirement Composition Pattern No or Partially) Citation 3(c) (2)(B)?3
§158.145 Wildlife and
Aquatic Organisms
(continued)
72-5 - Fish - Life-Cycle TGAI A No - Yes
72-6 - Aquatic Organism TGAI, PAI OR A No - Reserved4
Accumulation Degradation
Product
72-7 - Simulated or Actual TEP A No - Reserved4
Field Testing -
Aquatic Organisms
ro
1. Composition: TGAI = Technical grade of the active ingredient; PAI = pure active ingredient;
TEP = Typical end-use product;
2. The use patterns are coded as follows: A= Terrestrial, Food Crop; B= Terrestrial Non-Food Crop; C= Aquatic,
Food Crop; D= Aquatic, Non-Food; E= Greenhouse, Food Crop; F= Greenhouse, Non-Food; H= Domestic Outdoor;
1= Indoor.
3. Data must be submitted no later than 36 months .
4. Reserved pending the outcome of the five basic studies (ecological effects), environmental fate data,
toxicology data and residue chemistry data. When these respective studies have been evaluated then a
determination will be made as to whether or not additional studies are required in order to complete a
hazard assessment of the citrus use pattern.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLOROBENZILATE
Data Requirement
1 Use 2
Composition Pattern
Does EPA Have Data
To Satisfy This
Requ i rement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3
§158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS:
141-1 - Honey bee acute TGAI
contact LD50
141-2 - Honey bee - toxicity TEP
of residues on
foliage
141-3 - Wild bees important in TEP
alfalfa pollination -
toxicity of residues
on foliage
141-4 - Honey bee subacute
feeding study
141-5 - Field testing for TEP
pollinators
A
Yes
No
N/A
N/A
No
00036935
No
No4
No5
Reserved^
No4
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR CHIOROBENZILATE
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted A.
Use 2 Requirement? (Yes, Bibliographic Under FIFRA Sectioiy'
Data Requirement Compos it ion* Pattern No or Partially) Citation 3(c)(2)(B)?3 //
§158.155 Nontarget Insect /
(continued)
NONTARGET INSECT TESTING -
AQUATIC INSECTS;
142-1 - Acute toxicity to
aquatic insects A Reserved7
142-2 - Aquatic insect
life-cycle study A Reserved7
142-3 - Simulated or actual
field testing for
aquatic insects A Reserved7
143-1 - NONTARGET INSECT
TESTING - PREDATORS
thru AND PARASITES
143-3 A Reserved7
1. Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
2. The use pattern is coded as follows: A= Terrestrial, Food Crop; B= Terrestrial, Non-E'ood; C= Aquatic, Food Crop;
D= Aquatic, Non-Food; E= Greenhouse, Food Crop; F= Greenhouse, Non-Food; G= Forestry; H= Domestic Outdoor;
1= Indoor.
3. Data must be submitted no later than 36 months .
_ _
4. An acute contact LDso test shows chlorobenzilate is non-toxic to honey bees, no further testing is required.
5. Required only if pesticide is intended for foliar application to seed alfalfa.
6. Reserved pending development of test methodology.
7. Reserved pending Agency decision as to whether the data requirement should be established.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLOROBENZILATE
Data Requirement
1 2
Composition Pattern
Does EPA Have Data
To Satisfy This
Requ i rement ? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3
§158.140 Reentry Protection
132-1 - Foliar Dissipation
132-1 - Soil Dissipation
133-3 - Dermal Exposure
133-4 - Inhalation Exposure
TEP
TEP
TEP
TEP
A
A
A
A
Partially
No
Partially
No
Yes5, 6
GS0075082
GS0075002, GS0075082 Yes5, 6
///
//'
GS0075082 Yes5,6 .-''/
1.
2.
3.
4.
*5.
6.
Composition: TEP= Typical end use product.
The use pattern is as follows: A= Terrestrial, Food Crop; B= Terrestrial, Non-Food; C= Aquatic,
Food Crop; F= Greenhouse, Non-Food; G= Forestry; H= Domestic, Outdoor; 1= Indoor.
Data must be submitted no later than 36 months .
A field dissipation study is required. Those results should satisfy this requirement.
Citrus picker, and aerial applicator exposure data are required. These data may suffice for
this requirement. These data must be submitted by February of 1984.
An interim 24 hour reentry interval is required pending the submission and evaluation of
reentry data.
ro
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLDROBENZILATE
Does EPA Have Data
To Satisfy This
1 Use 2 Requirement? (Yes
Data Requirements Composition Pattern No or Partially)
Must Additional
Data Be Submitted
, Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?
§158.150 Plant Protection
121-1
- TARGET AREA
PHYTOTOXICITY EP A No
No3
NONTARGET AREA PHYTOTOXICITY
122-1
122-1
122-2
123-1
123-1
123-2
124-1
124-2
TIER I
- Seed Germination/ TGAI A No
Seedling Emergence
- Vegetative Vigor TGAI A No
- Aquatic Plant Growth TGAI A No
TIER II
- Seed Germination/ TGAI A No
Seedling Emergence
- Vegetative Vigor TGAI A No
- Aquatic Plant Growth TGAI A No
TIER III
- Terrestrial Field TEP A No
- Aquatic Field TEP A No
No3
No3
No3
,4
No3 //
No3 ,
No3
No3
No3
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR CHLOROBENZILATE
Data Requirements
Composition
Does EPA Have Data
To Satisfy This
Use 2 Requirement? (Yes,
Pattern No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under b'IFRA Section
3(c)(2)(B)?
§158.150 Plant Protection
(Continued)
1. Composition: TGAI= Technical grade of the active ingredient; TEP= Typical end-use product.
EP= End-use product.
2. The use pattern is coded as follows: A= Terrestrial, Food Crop; B= Terrestrial, Non-Food; C= Aquatic, Food Crop;
D= Aquatic, Non-Food; E= Greenhouse, Food Crop; F= Greenhouse, Non-Food; G= Forestry; H= Domestic Outdoor;
1= Indoor.
3. These requirements are generally waived unless it is believed there is a phytotoxicity problem.
oo
ro
-------
III. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Note: This chapter applies only to manufacturing-use products,
not end-use products.
A necessary first step in determining which statements must
appear on your product's label is the completion and submission
to EPA of product-specific data listed on the form entitled
"Product Specific Data Report" (EPA Form 8580-4, Appendix IV) to
fill "gaps" identified by EPA concerning your product. Under the
authority of FIFRA Section 3(c)(2)(B), EPA has determined that
you must submit these data to EPA in order to register or reregister
your product(s). All of these data must be submitted not later
than six months after you receive this guidance document.
"Product-Specific Data Requirements for Manufacturing-Use
Products" appearing in Table B permit you to determine which
product-specific data you must submit. This can be done by
examining the entries in the column of those tables entitled
"Must Data Be Submitted Under §3(c)(2)(B)."
39
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PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING CHIDROBENZILATE
Data Requirement
Compos it ion
Does EPA Have Data
To Satisfy This
Requ irement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2
§158.120 Product Chemistry
Product Identity
61-1 - Identity of Ingredients
61-2 - Statement of Composition
61-3 - Discussion of Formation
of Ingredients
Analysis and Certification
of Product Ingredients;
62-1 - Preliminary Analysis
62-2 - Certification of Limits
62-3 - Analytical Methods for
Enforcement of Limits
Physical and Chemical
Characteristics
63-2 - Color
63-3 - Physical State
63-4 - Odor
63-7 - Density, bulk density, or
specific gravity
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
Partially
Partially
Partially
Partially
Partially
Partially
Yes
Yes
No
Yes
00077423, 000774383
GS0075080b
00077438a, GS0075080b
00077443a, 00077405
00077411, GS0075080b
GS007508Qt>
GS007508Qb
00077435, 00077442^
GS0075079b, GS0075080b
00077423, 00077411
00077423, 00077411
00077423, 00077411
a. Data submitted by Makhtishem Beer-Sheva Chem.
b. Data submitted by Ciba-Geigy. These data may
Vforks, Ltd. These data may be compensable.
be compensable.
Yes3,4
Yes3,4
Yes3,4
Yes5,6
Yes6
Yes6
Yes 6
Yes
Yes6
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING CHLOROBENZILATE
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
Requ i reme nt ? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2
§158.120 Product Chemistry
(continued)
63-12 - pH
63-14 - Oxidizing or reducing
action
63-15 - Flammability
63-16 - Explodability
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Miscibility
Other Requirements
64- 1 - Submittal of Samples
MP
MP
MP
MP
MP
MP
MP
MP
N/A
No
No
No
No
No
No
No
No7
Yes
Yes
Yes
Yes
Yes
Yes
1. Composition: MP = Manufacturing-use product; Choice = Choice of several test substances determined on a case-by-
case basis.
2. Data must be submitted no later than three months .
3. Updated information must be supplied on identity and quantity of impurities and inerts. A comparison of the con-
fidential statements of ingredients show that there is a good possibility for the presence of DDT and/or related
compounds (DDE) as impurities in the technical material. Quantification must be made with a sensitivity
below 0.1% of the technical material.
4. Data submitted by Ciba-Geigy and Makhteshim. All others must submit these data
5. Analysis of at least five production batches is required
6. Data submitted by Ciba-Geigy. All others must submit these data.
7. Since chlorobenzilate is insoluable in water, no pH data are required.
8. The Agency will request samples when the need arises.
9. No validation data for any of the methods were submitted. These data are required. If the DDT-like impurities
were detected by T.L.C., a description of the method should.be submitted as well as adequate validation data.
(Preferrably we require data by HPLC or Mass Spec.)
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING CHLOROBENZILATE
Data Requirement
§158.135 Toxicology
ACUTE TESTING
81-1 - Oral LD5Q - Rat
81-2 - Dermal LD50
81-3 - Inhalation LC5o - Rat
81-4 - Primary Eye
1
Composition
MP
MP
MP
MP
Does EPA Have Data
To Satisfy This
Requ i rement ? ( Yes ,
No or Partially)
Yes
Yes
No
No
Bibliographic
Citation
00080422A
00080422A
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2
No
No
Yes
Yes
Irritation - Rabbit
81-5 - Primary Dermal
Irritation
81-6 - Dermal Sensitization
MP
MP
No
No
Yes
Yes
CM
1. Composition: MP = Manufacturing-use product.
2. Data must be submitted no later than 36 months
-------
IV. SUBMISSION OF REVISED LABELING AND PACKAGING INFORMATION
Note: This chapter applies only to manufacturing-use products,
not end-use products.
The Agency requires applicants for registration or reregistra-
tion to ensure that each label (1) contains accurate, complete,
and sufficient instructions and precautions, reflecting the
results of data concerning the product and its ingredients, and
(2) incorporates labeling format and terminology which are suffi-
ciently standardized to avoid user confusion.
As part of your application, you will be required to submit
draft labeling consistent with: applicable product-specific
data; the precautionary statements and use directions; and the
regulations concerning classification [40 CFR §162.11(c)], pack-
aging [40 CFR §162.16], and labeling [40 CFR §162.10, Appendix
V-l an V-2], as indicated by the following paragraphs of this
chapter of the guidance document.
You must submit the revised labeling set forth in this guidance
package within 90 days of receipt of this guidance package.
A. Label Contents
40 CFR §162.10 (Appendix V-l) 'requires that certain spe-
cific labeling statements must appear at certain locations
on the label. This is referred to as format labeling.
Specific label items listed below are keyed to Tables D, E,
and (Appendix V-2).
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. See Appendix
V-2. [40 CFR Sl62.10(b)]
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.
See Appendix V-2. [40 CFR §162.10(c)]
Item 3. NET CONTENTS - A net content statement is required
on all labels. The preferred location is the bottom of the
front panel immediately above the company name and address,
or at the end of the label text. The net contents must be
stated in terms of weight, expressed as avoirdupois pounds
43
-------
and ounces, and stated in terms of the largest suitable unit,
i.e., "1 pound 10 ounces" rather than "26 ounces." In
addition to the required units specified, net contents may be
expressed in metric units. See Appendix V-2. [40 CFR
§162.10(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. See Appendix V-2.
[40 CFR §162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment 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 registration number on
the immediate container cannot be clearly read through such
wrapper or container. See Appendix V-2. [40 CFR §162.10(f)]
Item 6. INGREDIENT STATEMENT - An ingredient statement
is required on the front panel and 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 ingredient
statement must run parallel with, and be clearly distinguished
from, other text on the panel. It must not be placed in the
body of other text. See Appendix V-2. [40 CFR 162.10(g)]
Item 6A. POUNDS PER GALLON STATEMENT - For liquid
agricultural formulations, the pounds per gallon of active
ingredient must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - All labels
are required to have precautionary statements grouped together
on the front panel, preferably within a block outline. The
table below shows the minimum type size requirements on
various size labels, as set forth in the Regulations.
44
-------
Size of Label
on Front Panel
in Square Inches
5 and under
above 5 to 10
above 10 to 15
above 15 to 30
over 30
Signal Word as Re-
quired Minimum Type
Size All Capitals
6 point
10 point
12 point
14 ooint
18 point
"Keep Out of Reach
of Children"
as Required
6 point
6 point
8 point
10 point
12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - All labels are
required to have the statement "Keep Out of Reach of Children"
located on the front panel above the signal word except where
contact with children during distribution or use is unlikely.
See Appendix V-2. [40 CFR §162. 10 ( h) ( 1 ) ( ii ) ]
Item 7B. SIGNAL WORD - The signal word (Caution, Warning,
or Danger) is required on the front panel immediately below
the child hazard warning statement. See Appendix V-2.
[40 CFR §162.10 (h) (1) (i)]
Item 1C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, inhala-
tion, or dermal 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. See Appendix V-2. [40 CFR
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. See Appendix V-2. [40 CFR §162. 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.
See Appendix V-2. [40 CFR §162. 10( h) (1 ) ( iii ) ]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements as 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. See Appendix V-2. [40 CFR §162.10
45
-------
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 taken to avoid
accident, injury or damage. See Appendix V-2. [40 CFR §162.10
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. See Appendix V-2. [40 CFR
Item 8C. PHYSICAL OR CHEMICAL HAZARD
1. Flammability statement. Precautionary statements
relating to flammability of a product are required
to appear on the label if it meets the criteria in
Appendix V-3. 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 flam-
mability statements.
2. Criteria for declaration of non-f lammability . The
following criteria will be used to determine if a
product is non-flammable:
a. A "non-flammable gas" is a gas (or mixture of
gases) that will not ignite when a lighted match
is placed against the open cylinder valve.
b. A "non-flammable liquid" is one having a flash-
point greater than 350°F (177°C) as determined
by the method specified in 40 CFR §163. 61-8 (c ) ( 13 )
(ii) of Subpart D.
c. A "non-flammable aerosol" is one which meets the
following criteria:
i. The flame extension is zero inches, using the
method specified in 40 CFR §163. 61-8 (c ) ( 13 ) (.ii ) ;
ii. There is no flash back; and
iii. The flashpoint of the non-volatile liquid
component is greater than 350°F (177°C),
determined by the method specified in 40 CFR
§163.61-8(c)(13) (i).
46
-------
3. Declaration of non-flaitimability. Products which meet
the criteria for non-flammability specified above may
bear the notation "non-flammable" or "nonflammable
(gas, liquid, etc.)" on the label.
It may appear as a substatement to the ingredients
statement, or on a back or side panel, but shall not
be highlighted or emphasized (as with an inordinately
large type size) in any way that may detract from
precaution.
4. Other physical/chemical hazard statements. When
chemistry data submitted in accordance with 40 CFR
§163.61-10(c) demonstrate hazards of a physical or
chemical nature other than flammability, appropriate
statements of hazard will be prescribed. Such
statements may address hazards of explosivity,
oxidizing or reducing capability, or mixing with
other substances to produce toxic fumes.
Item 9. MISUSE STATEMENT - The following statement is
required on your label: "It is a violation of Federal law to
use this product in a manner inconsistent with its labeling."
See Appendix V-2. [40 CFR §162.10(1)(2)(ii)]
Item 10A. 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. Make certain that the statement you use
pertains specifically to your product. 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 V-4 for the latest specific
storage and disposal product label statements.
Item 10B. DIRECTIONS FOR USE - 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. See
Appendix V-2. [40 CFR §162.10]
B. Collateral Information
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, and other 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,
47
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V. INSTRUCTIONS FOR SUBMISSION
All applications prepared in response to this Notice should
be addressed as follows:
Jay S. Ellenberger
Phone No. (703)-557-2386
Registration Division (TS-767)
Office of Pesticide Programs
Environmental Protection Agency
Washington, D.C. 20460
For each product for which continued registration is desired:
1. Within 90 days from receipt of this document, you must'
submit the "FIFRA Section 3(c)(2)(B) Summary Sheet" EPA
Form 8580-1 and revised labeling. Refer to Appendix
II with appropriate attachments.
2. Within 6 months from receipt of this document registrants
must submit:
a. Confidential Statement of Formula, EPA Form 8570-4.
b. Product Specific Data Report, EPA Form 8580-4 (Appendix
III).
c. Two copies of any required product-specific data.
3. Within the time set forth in Table A, all generic data
must be submitted by the affected registrant(s).
Note; If for any reason any required test is delayed or aborted
so that meeting the agreed submission time will be delayed,
notify the Product Manager listed above.
You will be informed at a later date when you must submit your
Application for Amended Pesticide Registration (EPA Form 8570-1).
48
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Appendix II-l
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under this Guidance Document
00017801 Kotin, P.; Falk, H.; Pallotta, A.J.; et al. (1968) Evaluation
of Carcinogenic, Teratogenic, & Mutagenic Activities of
Selected Pesticides and Industrial Chemicals: Vol. 1.
Bethesda, Md.: Bionetics Research Laboratories. (Report No.
NCI-DCCP-CG-1973-1-1; incomplete study; also In unpublished
submission received Mar 17, 1976 under 38329-2; submitted by
Consolidated Chemical, Co., Denver, Colo.; CDL:225259-N)
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975) Toxicity of
Pesticides and Other Agricultural Chemicals to Honey Bees: Labo-
ratory Studies. By University of California, Dept. of Entomolo-
gy. ?: UC, Cooperative Extension. (Leaflet 2287; published
study.)
00049143 Rothwell, D.F.; Wheeler, W.; Hubbell, D.H. (1970) Persistence and
Microbiological Effects of Acarol and Chlorobenzilate in Two
Florida Soils. (Unpublished study received Nov 10, 1980 under
100-614; prepared by Univ. of Florida, Depts. of Soil Science
and Food Science, submitted by Ciba-Geigy Corp., Greensboro,
N.C.; CDL:099692-1)
00075003 R. Schattner Company (1966) Tests with Ristex to Control Various
Organisms. (Compilation; unpublished study received May 28,
1964?; Jun 9, 1966 under 8383-1; CDL:050703-B)
00075918 Horn, H.J. (1954) Final Report: Chronic Feeding Studies—Rats.
(Unpublished study received Jul 5, 1955 under PP0013; prepared
by Hazleton Laboratories, submitted by Geigy Chemical Corp.,
New York, N.Y.; CDL:090089-C)
00077368 Guth, J.A.; Senn, U.; Imhof, R. (1975) Chlorobenzilate (G-23992):
Dissipation of Residues of Chlorobenzilate and Two of Its Metab-
olites in a Silty Loam Soil after Application of AKAR 50 EC:
No. RVA 323/75. (Unpublished study received Oct 28, 1976 under
100-458; prepared by Ciba-Geigy, Ltd., Switzerland, submitted by
Ciba-Geigy Corp., Greensboro, N.C.; CDL:226572-C)
00077384 Geigy Chemical Company (1966) Chlorobenzilate Residues in Sheep
and Cattle Tissues. (Unpublished study received oh unknown
date under 9F0779; CDL:097544-J)
00077400 Geigy Chemical Company (1964) Chlorobenzilate, Technical—Metabolic
Distribution and Excretion of Chloropropylate and Chlorobenzi-
late in Dogs. (Unpublished study received on unknown date under
9F0779; CDL:097544-Z)
00077402 Harris, H.J. (1955) Colorinetric determination of ethyl 4,4'-
dichlorobenzilate (Chlorobenzilate) as a spray residue. Journal
of Agricultural and Food Chemistry 3(11):939-941. (Also In un-
published submission received Dec 27, 1967 under 8F0685; CDL:
092990-D)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under this Guidance Document
00077405 Geigy Chemical Company (19??) Name, Chemical Identity and Composi-
tion of Chlorobenzilate. (Unpublished study received Feb 4,
1966 under 9H0007; CDL:221563-A)
00077407 Geigy Chemical Corporation (19??) The Determination of Chlorobenzi-
late and Chloropropylate in Plant Materials. Ardsley, N.Y.:
Geigy. (Analytical bulletin no. 9; also In unpublished submis-
sion received Feb 4, 1966 under 9H0007; CDL:221563-C)
00077411 Geigy Chemical Corporation (19??) Chlorobenzilate—Chloropropylate
Petition: Section A: Name, Chemical Identity and Composition
of Chlorobenzilate and Chloropropylate. (Unpublished study
received Sep 30, 1966 under 6F0463; CDL:092752-B)
00077413 Hollingsworth, R.L.; Wbodard, M.W.; Woodard, G. (1966) Chloro-
benzilate Safety Evaluation by Dietary Feeding to Rats for 104
Weeks. Final rept. (unpublished study received Sep 30, 1966
under 6F0463; prepared by Woodard Research Corp., submitted
by Geigy Chemical Corp., New York, N.Y.; CDL:090513-A)
00077416 Wolfenbarger, D.O. (1962) Chlorobenzilate Residues—Limes: AG-A
324. (Unpublished study received Sep 30, 1966 under 6F0463;
prepared in cooperation with Univ. of Florida, Subtropical
Experiment Station, submitted by Geigy Chemical Corp., New York,
N.Y.; CDL:090513-D)
00077423 Geigy Chemical Corporation (19??) Chlorobenzilate Formulations.
Ardsley, N.Y.: Geigy. (Chlorobenzilate technical bulletin
no. 61-1; also In unpublished submission received Jun 16, 1963
under PP0379; CDL:092665-C)
00077434 Mattson, A.M.; Insler, M. (1966) Chlorobenzilate Residues in
Sheep and Cattle Tissues. (Unpublished study received Nov 23,
1967 under 7F0615; submitted by Geigy Chemical Co., Ardsley,
N.Y.; CDL:090801-E)
00077435 Geigy Chemical Corporation (19??) Determination of Chlorobenzilate
in Commercial Formulations. Ardsley, N.Y.: Geigy. (Technical
release—analytical bulletin no. 4; also In unpublished sub-
mission received May 29, 1967 under 7F0615; CDL:092907-B)
00077438 Agan Chemical Manufacturers, Limited (19??) Benzilan: Chloroben-
zilate Acaricide, Especially for Mite Control in Citrus. (Un-
published study received Jul 10, 1972 under 11603-12; CDL:
014052-A)
00077442 Makhteshim Beer-Sheva Chemical Works Limited (1972) Manufacturing
Instructions for Technical Benzilan. (Unpublished study re-
ceived Mar 30, 1973 under 11678-13; CDL:126343-A)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under this Guidance Document
00077443 Makhteshim Beer-Sheva Chemical Works Limited (1973) Percent Compo-
sition of the Technical Chemical Including the Percent of Each
Impurity. (Unpublished study received Mar 30, 1973 under 11678-
13; CDL:126343-B)
00077445 Geigy Chemical Corporation (1956) Results of Tests on the Amount of
Residue Remaining Including Description of the Analytical Method
Used: Chlorobenzilate. (Unpublished study received on unknown
date under PP0182; CDL:092458-C)
00077448 Geigy Chemical Corporation (1955) Residue of Chlorobenzilate on
Apples, Pears, Cantaloupes, Melons and Lemons. (Compilation;
unpublished study received Apr 11, 1955 under PP0013; CDL:
090012-A)
00077457 Gunther, F.; et al. (19??) Persistence Residue Data for Chloroben-
zilate in Peel of Field-sprayed, Washed Lemons. (Unpublished
study received Feb 5, 1955 under PP0013; prepared by Univ. of
California—Riverside, Citrus Experiment Station, submitted by
Geigy Chemical Corp., New York, N.Y.; CDL:092297-E)
00077463 Tusing, T.W. (1965) Final Report: Two-year Dietary Feeding Study-
Purebred Beagles. (Unpublished study, including letter dated
Aug 6, 1965 from T.W. Tusing to Frank L. Lyman, received Oct 25,
1965 under 6F0463; prepared by Hazleton Laboratories, Inc., sub-
mitted by Geigy Chemical Corp., New York, N.Y.; CDL:090511-C)
00077470 Geigy Chemical Corporation (1957) Chlorobenzilate Residues from
Grapefruit, Tangerines and Oranges. (Compilation; unpublished
study received on unknown date under PP0182; CDL:090210-B)
00078288 Johnston, C.D. (1960) Examination of Milk for Residues following
Feeding of Chlorobenzilate to Dairy Cows. (Unpublished study,
including letter dated Nov 11, 1960 from C.D. Johnston to Joseph
Marrus, received Jun 16, 1963 under PP0379; prepared by Woodard
Research Corp., submitted by Geigy Chemical Co., Ardsley, N.Y.;
CDL:090409-E)
00078289 Blinn, R.C.; Gunther, F.A.; Kolbezen, M.J. (1954) Microdetermina-
tion of the acaricide ethyl p , p -dicholorobenzilate (Chloro-
benzilate). Journal of Agricultural and Food Chemistry 2(21):
1080-1083. (Also In unpublished submission received Feb 5, 1955
under PP0013; submitted by Geigy Chemical Corp., New York, N.Y.;
CDL:092297-D)
00080422 Gray, E.H. (1952) Acute Oral Toxicity, Acute Dermal Irritation, Re-
peated Dermal Irritation. (Unpublished study received Oct 28,
1965 under 6G0504; prepared by Hazleton Laboratories, submitted
by Geigy Chemical Corp., New York, N.Y.; CDL:090588-D)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION GUIDANCE DOCUMENT BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under this Guidance Document
GS0075001 Weisburger, J. H.; Weisburger, E. K.; et al. (1978) Dietary adminis-
tration for two years (rats); for 18 months (mice). Prepared by
the National Cancer Institute NCI-CG-TR-75.
GS0075002 Iwata, Y., M.E. Dusch, G.E. Carman, and F.A. Gunther (1979) Worker
environment research: residues from carbaryl, chlorobenzilate,
dimethoate, and trichlorfon applied to citrus trees. J. Agric.
Food Chem. 27(6): 1141-1145.
GS0075035 Beckman and Bebenue (1964) Microcoulometric Gas Chromatographic
Analysis of Grapes and Cottonseed for chlorobenzilate Residues.
J. Agric. Food Chem. 12: 183. . . .
GS0075041 Miyazaki, S., G.M. Boush, and F. Matsumara (1970) Microbial de-
gradation of chlorobenzlate (ethyl-4,41- dichlorobenzilate)
and chloropropylate (isopropyl- 4, 4'- dichlorobenzialte).
J. Agric. Food Chem. 18(1): 87-91.
GS0075079 Ciba-Geigy (1972) Nature and extent of impurities in technical
chlorobenzilate. (unpublished) Presented to the Joint
Meeting of FAO/WHO in 1972. "Chlorobenzilate Joint Meeting
on Pesticide Residues."
GS0075080 Ciba-Geigy (1983) Additional Information of DDT-like Impurities
Found in Chlorobenzilate mechnical and Supporting Methodology
(unpublished).
GS0075081 Ciba-Geigy (1983) Reports of Investigations made with respect
to the safety of the miticide chlorobenzilate (2-generation
Reproduction Study-Rat), (unpublished study received Sep 1,
1983 under 100-533; CDL:251140,251141,251142).
GS0075082 Nigg, Herbert N., and Janes H. Stamper (1983) Exposure of Spray
Applicators and Mixer-Loaders to Chlorobenzilate. Arch.
Environ. Contain. Toxicol. 12: 477-482.
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