PB84-158983
GUIDANCE FOR THE REREGISTRATION
OF MANUFACTURING-USE
AND CERTAIN END-USE
PESTICIDE PRODUCTS
CONTAINING NALED (034401)
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, DC 204060
June 1983
EPA/5 40-RS-83-004
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Table of Contents
Section Page
I. Introduction . 1
II. Regulatory Position and Rationale 3
III. Requirement for Submission of Generic Data 24
IV. Requirement for Submission of Product-Specific
E5at a ..............a ........... 24
V. Submission of Revised Labeling and Packaging
Information 59
A. Label Contents 59
1. Product Name 59
2. Company Name and Address . 59
3. Net Contents 59
4. Product Registration Number 60
5. Producing Establishment
Registration Number. ........ 60
6A Ingredient Statement 60
6B Pounds Per Gallon statement 60
7. Front Panel Precautionary Statements 60
7A Child Hazard Warning Statements. . . 61
7B Signal Word. 61
7C Skull and Crossbones and Word Poison ...... 61
7D Statement of Practical Treatment ... 61
7E Referral Statement .......61
8. Side/Back Panel Precautionary Labeling 61
8A Hazard to Humans and Domestic Animals. 62
8B Environmental Hazard ,.62
8C Physical or Chemical Hazard. 62
9 Misuse Statement ......... 63
10A Storage and Disposal Block ...........63
10B Directions for Use 63
B. Collateral Information ...............63
i • a.-
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APPENDICES
III-l Bibliography. 65
II1-2 FIFRA 53(c)(2)(B) Summary Sheet - EPA Form 8580-1 . . 75-A
III-3 Certification of Attempt to Enter Into an Agreement
With Other Registrants for Development of Data
EPA Form 8580-6 . . 75-B
IV-1 Product Specific Data Report (End-Use Products) ... 76
V-2 Table of Labeling Requirements 78
V-3 Physical/Chemical Hazards Labeling Statement 81
V-5 Storage and Disposal Instructions .... 82
Note: Appendices V-l, V-4, and V-6 are not germane to this
document and are not included.
Also attached to this document are copies of the letters sent to
registrants transmitting the document and notifying them of the
studies required.
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I. INTRODUCTION
The Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) Section 3(g), as amended in 1978, directs the Environ-
mental Protection Agency (EPA) to reregister all currently
registered products as expeditiously as possible. Each regis-
trant of a currently registered product who wishes to continue
to sell or distribute that product in commerce must apply
for reregistration.
This guidance document sets forth certain of the require-
ments for registration and reregistration of all manufac-
turing-use products (MPs) containing the subject chemical as
the sole active ingredient. These requirements include:
that certain scientific data be submitted and that certain
standards of toxicity, composition, labeling, and packaging
be met. Registrants of MPs are referred to all Sections and
Tables for specific information regarding their responsibili-
ties under this guidance document.
This guidance document also sets forth the data require-
ments for those end-use products which contain the subject
active ingredient and for which the source of that active
ingredient is (1) not registered with EPA or (2) produced by
the registrant's firm, or a firm which has ownership in
common with the registrant's firm, or (3) both (1) and (2).
Registrants of such end-use products can exempt themselves
from these requirements if they change their source of supply
to a registered source, provided the source (i.e., registered
active ingredient product) is obtained from a firm that does
not share ownership in common with the registrant1s 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.) Registrants
of affected end-use products are referred to only Sections
II, III, and VI and Table A for specific information regarding
their responsibilities under this guidance document.
It should be noted that end-use products containing the
subject active ingredient will not be reregistered at this
time. Any necessary labeling changes will be implemented
under the Agency's Label Improvement Program at a future
time.
EPA will issue a notice of intent to cancel or suspend
the registration of any currently registered product if the
registrant fails to comply with the requirements set forth
in this guidance document and with the requirements contained
in subsequent information from EPA about compliance with
certain data support requirements.
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This guidance document has been prepared to provide regis-
trants with specific information on how they may reregister
their manufacturing-use products or maintain their end-use
products' registration, (Refer to the cover letter's attach-
ment for a listing of your affected products.) If for any
reason you decide to request that the Agency discontinue the
registration of any of your products subject to the registra-
tion requirements in this 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 registration(s). If you decide to maintain your product
registration(s), you must provide the information described
in the following pages within the timeframes outlined.
Registrants are reminded that Section 6(a)(2) of FIFRA
requires you at any time to submit factual information raising
concerns of possible unreasonable adverse effects of a pesti-
cide. You should notify the Agency of interim results of
studies in progress if those results show possible adverse
effects.
This guidance document will be supplemented by EPA with
additional information about compliance with data support
requirements. In Monsanto v. Administrator, EPA was recently
enjoined by the District Court for the Eastern District of
Missouri from implementing in any way the "mandatory data
licensing" aspects of §3(c)(l)(D) of FIFRA. EPA is assessing
the implications of the injunction for the reregistration
process. Because this situation is currently unresolved,
EPA has decided to proceed with the requirements in this
guidance package which do not relate to the "data licensing"
issue and to supplement the package with additional guidance
when circumstances permit.
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II REGULATORY POSITION AND RATIONALE
A. INTRODUCTION
This Registration Standard describes the regulatory posi-
tion of the Environmental Protection Agency (the Agency)
on registered manufacturing-use products (MPs) containing
the insecticide-acaricide, naled. The Agency's position
is based on a consideration of available data for all cur-
rently registered uses and registered MPs with naled as the
sole active ingredient. This position is based on a number
of considerations. The Standard considers labeling require-
ments, tolerances, "Special Local Need" registrations author-
ized by FIFRA Section 24(c), as well as Federal registration
granted or pending under FIFRA Section 3, Finally, the
Agency sets forth the data requirements that must be met to
register products covered by this document.
This Standard only addresses registration requirements for
current or substantially similar future MPs and their inter-
mediaries. Naled MPs that differ appreciably from those
described here may require amendments to the Standard.
B. CHEMICAL DESCRIPTION AND USE PROFILE
In the United States, naled is the American National Standards
Institute (ANSI) approved common name for a halogenated
organophosphorus insecticide-acaricide manufactured by the
Chevron Chemical Company. The chemical name is 1,2-dibromo-
2r2-dichloroethyl dimethyl phosphate. Other names include
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Dibrom®, Ortho-Dibrom®, RE 4355, and phosphoric acid 1,2-
dibrom-2 ,2-dichloroethyl dimethyl ester. The Chemical
Abstracts Registry (CAS) number for naled is 300-76-5, and
the EPA chemical code number is 034401.
Manufacturing-use naled is a light, straw-colored oily liquid
with a slightly pungent odor. The pure compound is a white
low melting point solid. The boiling point for pure naled
is 120°C at 0.5 mm Hg and the vapor pressure is 2 x 10"^
mm Hg at 20°C. The empirical formula is C^-^C^PB^C^
and the molecular weight is 381, Naled has a limited solu-
bility in aliphatic solvents; is highly soluble in oxygenated
solvents such as ketones and alcohols? and a low solubility
in water.
There are currently three registered raanufacturing-use products
consisting of the technical grade of naled (90%)r and
fifteen (15) registered end-use products containing naled
as the sole active ingredient. There are also currently
eighty-five (85) products containing naled in combination
with other pesticides. In addition, there are twenty-six
(26) FIFRA Section 24(c) "Special Local Need" registraions.
Naled is a non-systemic insecticide-acaricide registered
for use on field, vegetable, and orchard crops; livestock
and poultry, and their surroundings; greenhouses; forest
and wasteland; agricultural, domestic, medical, and com-
mercial establishments; and urban and rural outdoor areas
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(mosquito control). The major use sites are: fruit, nut,
vegetable, and field crops? adult mosquito control; pets,
and livestock.
Naled is formulated into dusts (4% and 6%), impregnated
materials (10%-25%), emulsifiable concentrates (2-7,2 lb/
gal and 6%-26%), soluble concentrates/liquid (2.35-14 lb/
gal,and 11.4% and 20%), and ready-to-use liquids (1.26-
12.6 lb/gal and 1%-15%). Naled is applied on agricultural
crops by using aircraft and ground equipment including mist
blowers and foggers.
C. REGULATORY POSITION
Based on a review and evaluation of all available data and
other relevant information on naled, the Agency had made the
following determinations:
1. Manufacturing-use products containing naled as the
sole active ingredient may be registered for sale, distri-
bution, and reformulation into end-use products, for use,
subject to the terms and conditions specified in this Standard,
2. Registrants must provide or agree to develop addi-
tional data, as specified in TABLE A and TABLE B of this
Standard, in order to maintain existing registrations or
to obtain new product registrations.
3. Available data do not indicate that any of the
criteria cited in 40 CFR 162.11 (b) have been equalled or
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exceeded at this time. However, gaps in the data base pre-
clude the completion of the Agency's risk assessment for
naled.
4. Although the Agency is unable to complete a tolerance
reassessment for naled because of a number of residue chemistry
and toxicology data gaps, the Agency has concluded, based on
available data, that no changes in present tolerances are
necessary at this time. The Agency has also considered the
residues of inorganic bromide, resulting from the use of naled
on crops and in meat, milk, poultry and eggs, and does not
anticipate these residues to be of toxicological concern, and
no additional residue data on inorganic bromides are needed.
However, the Agency is concerned about organic brominated
metabolites of naled and its impurities. Accordingly,
additional data on this organic bromide in plants and
animals are being requested.
D. REGULATORY RATIONALE
The Agency has determined that it should continue to allow
the registration of products containing naled, after con-
sidering the following:
1. Acute animal toxicity data indicate that technical
naled is in Toxicity Category I on the basis of eye irritation,
and Toxicity Category II on the basis of acute oral and dermal
effects. Technical naled has been assigned Toxicity Category I
for acute inhalation effects, pending receipt and evaluation of
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a valid acute inhalation study. Human hazard precautionary-
statements associated with Toxicity Category I and Toxicity
Category II labeling [40 CFR 162.10 (h)(2)(i)] should minimize
the acute hazards associated with these routes of exposure.
2. Dichlorvos (DDVP), a metabolite of naled was origin-
ally referred to the Rebuttable Presumption Against Registration
(RPAR) process because scientific studies indicated that
dichlorvos was mutagenic and might cause cancer, nerve damage
and birth defects in laboratory animals. The RPAR Decision
Document on Dichlorvos, was issued by the Agency on September
30, 1982, In this document the Agency evaluated the available
data on dichlorvos in accordance with 40 CFR 162.11 (Criteria
for Determination of Unreasonable Adverse Effects) and con-
cluded that the existing evidence does not support the issuance
of an RPAR for dichlorvos and consequently, that an RPAR
for naled as a precursor of dichlorvos is also not warranted.
However, the Decision Document concluded that additional
data on carcinogenicity and mutagenicity are needed to complete
the risk assessment for dichlorvos. Because the data base was
incomplete, DDVP was removed from the RPAR process and returned
to the registration process. On March 23, 1983, the Agency
issued a Data Call-in Notice under FIFRA Section 3(c)(2)(b),
requesting data on potential mutagenic effects of dichlorvos
be submitted by March 23, 1985. Additionally, the Agency
will wait until the ongoing National Cancer Institute (NCI)
dichlorvos bioassay on carcinogenicity is completed (currently
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scheduled for completion in 1984) and evaluated prior to
determining if additional data on the carcinogenicity of
d ichlorvos will be required. Since d ichlorvos is a metabolite
of naled, evaluation of these studies will be necessary
for the completion of the naled risk assessment.
3. No other human toxicological hazards of concern to
the Agency have been identified in studies reviewed for this
Standard,
4. Based on residue chemistry and toxicological consid-
erations, there is no evidence to suggest that the current
tolerances are likely to expose the public to unreasonable
adverse effects.
5. The Agency has, for the period 1970-1981 (primarily
1979-1981) received reports of 55 pesticide incidents involving
naled, either as sole active ingredient or in combination
with other active ingredients. Of these 55 incidents, 40
involved definite or possible human exposure. In at least 9
of these cases there was a physician's diagnosis of pesticide
poisoning. In 26 incidents there was medical and/or emergency
room treatment with only one additional case requiring
hospitalization. No fatalities were reported.
It is not certain from the summary information provided in
the Pesticide Incident Monitoring System (PIMS) report what
products or types of products were involved in these ex-
posures, or whether some incidents may have resulted from
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deliberate misuse and/or carelessness, or whether labeling
directions were disregarded.
There were 6 reported incidents involving children 5 years
of age or younger. In each of these incidents there was
possible oral exposure. In at least one of these incidents
a physician's diagnosis of pesticide poisoning was made.
Jl i n i ^ 4 ri ys 4* ri a v» 4» a i « *.» K a 1* y*\ i i /-» +• «-» v- f>«r r\ rt /•<» 4~ t\ v/Nrl 11 n +• e»
Ay m 1 il f 1 u XS liO u CSIT uu 1 IT WF19p tQQ UlCX»S OI. t j pG OH JJI. OQ uC lS
were involved. These incidents occurred during a period when
the Agency did not require child-resistant packaging. The
requirement of child-resistant packaging for products with
acute oral LDgQ values of 1500 mg/kg or less, approved for
residential application (40 CFR 162.16} should reduce potential
risks of accidental exposure.
The absence of reported fatalities, taken in conjunction with
the apparent adequacy of medical and/or emergency room treat-
ment in the vast majority of reported cases (only one reported
case involving hospitalization) suggests an acceptably low
level of risk associated with incidental or accidental exposure
to naled products.
6. Naled degrades fairly rapidly with half-lifes of
f 8 hours in soils and f 25 hours in aqueous solutions.
Dichlorvos is also rapidly degraded in soil with half-lifes
of 2.3 - 8.0 hours. Naled exhibits low to intermediate
mobility in soils, whereas dichlorovos is intermediately
mobile to mobile. Limited data indicate that the rapid
dissipation and relatively low mobility of naled and inter-
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mediate mobility of <3ichlorvos in soil will mitigate con-
tamination of ground water.
7. Based on studies available to assess hazards to
wildlife and aquatic organisms, naled is characterized as
very highly toxic to bees and aquatic invertebrates. It is
moderately to highly toxic to fish and slightly toxic to
upland game birds and waterfowl. Insufficient data are
available to assess the toxicity of naled to estuarine and
marine organisms. Label precautionary statements required
by this Standard should reduce the hazard to fish and other
wildlife. After data gaps are filled, the potential hazards
to terrestrial and aquatic species will be better defined
and additional labeling requirements may be imposed.
8. Data are requested by the Agency to address organic
bromide residues which may result from naled uses and are of
human toxicological concern. Additional data may be requested
if these residues are found to be significant.
9. The wildlife risk assessment indicates that naled
residues on treated feed would not become hazardous to birds
unless sixteen (16) pounds active ingredient per acre or
greater were applied. Since the maximum registered application
rate is four (4} pounds active ingredient per acre the warning
"Birds feeding on treated areas may be killed" is inappro-
priate and should be deleted from all naled product labels.
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10. Under FIFRA, the Agency cannot cancel or withhold
reg istration simply because data are missing or inadequate
[see FIFRA Sections 3(c)(2)(B) and 3(c)(7)]. Rather, issuance
of this Standard provides a mechanism for identifying data
needs. These data will be reviewed and evaluated when they
are received and the Agency will determine at that time
whether they will affect the registration(s) of naled.
E. CRITERIA FOR REGISTRATION UNDER THIS'STANDARD
To be covered by this Standard, products must contain naled
as the sole active ingredient, bear required labeling, and
conform to the product composition, acute toxicity limits,
and use pattern requirements listed in Section F of this
document.
The applicant for registration or reregistration of products
subject to this Standard must comply with all terms and con-
ditions described herein. These include making a commitment
to fill data gaps on a schedule specified by the Agency.
Applicants for registration under this Standard must follow
the instructions contained in this guidance package and
complete and submit the appropriate forms within the time
specified.
F * ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be covered under this Standard, manufacturing-use products
must contain naled as the sole active ingredient. Each MP
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formulation proposed for registration must be fully described
and include an appropriate certification of limits for all
contaminates and impurities, and carry-over starting materials
and/or intermediates above the level of 0.1% in the technical
product.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade
products and MPs containing naled for any acute toxicity
category, provided that the labeling of those products bears
appropriate precautionary statements.
3. Use Patterns
To be registered under this Standard manufacturing-use
products containing naled may be labeled for formulation
only into end-use products for:
° Terrestrial, food uses on: alfalfa (forage, seed),
almonds, beans (dry, succulent), broccoli, Brussels
sprouts, cabbage, cantaloupes, cauliflower, celery,
chard (including Swiss), collards, cotton, cucumbers,
eggplants, grapefruit, grapes, honeydew melons, hops,
kale, lemons, lettuce, muskmelons, oranges, pastures
(forage grasses and legumes 5(including those for live-
stock and dairy cattle) , peaches, peas (succulent) ,
peppers, pumpkins, rangeland, safflower (seed), soybeans
(beans: dry and succulent), spinach, squash (winter,
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summer), strawberries, sugar beets, tangerines, tomatoes,
turnips, turnip greens, walnuts, and watermelons.
° Terrestrial, non-food uses on: athletic fields, camp
sites, cull piles, dwellings (including campers, hotels,
motels, tourist courts, patios, and yards}, fence rows,
municipalities, ornamental conifers (including arborvitae,
Douglas fir, hemlock, juniper, pine and spruce), ornamental
deciduous trees (including ash, birch, black walnut, box-
elder, crabapple, dogwood, elm, evergreen pear, flowering
plum, flowering/ornamental quince, locust, magnolia,
maple, oak, sycamore, walnut, and willow), ornamental
grasses (including dichondra), ornamental herbaceous
plants (including aster, Canterbury bells, carnations,
dahlias, daisies, gladiolus, iris, marigold, nursery
stock, stock, and zinnia), ornamental lawns, ornamental
plants (including nursery stock), ornamental turf,
ornamental woody shrubs (including aucaba, azalea,
hibiscus, holly, juniper, nursery stock, pittosporum,
privet and snowball), residential areas, roses (including
nursery stock), sewage plants, swimming pool areas,
theaters (open air), and tobacco.
° Aquatic, food uses on: rice.
° Aquatic, non-food uses on; marinas, swamps, swimming
pool areas, and tidal marshes.
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Greenhouse, food uses on: vegetable crops (including
cucumbers, mushrooms, and tomatoes).
Greenhouse, non-food uses on: ornamental plants (in-
cluding carnations, chrysanthemum, poinsettias, roses,
and snapdragons).
Forestry uses on: forest trees - conifers (including
arborvitae, Douglas fir, fir, hemlock, juniper, pine
and spruce), forest trees - deciduous (including ash,
birch, black walnut, boxelder, dogwood, elm, locust,
magnolia, maple, oak, sycamore, walnut, and willow),
and woodlands.
Domestic, outdoor uses on: dog houses, kennels, and
dwellings (including campers, hotels, motels, tourist
courts, patios and yards).
Indoor uses on: animal buildings (for other than dairy
cattle, poultry and pets)(including barns, feeding areas,
shelters, and stables)(including cattle, goats, hogs,
horses, and sheep), animal hospitals (for pets and other
animals), calf barns, canneries, cats, cider mills,
corrals, dairy barns (including milk rooms, equipment, and
barnyards), dogs, dog houses, domestic dwellings (including
campers, hotels, motels and tourist courts), drive-ins,
factories, feedlots, garbage containers, garbage dumps,
kennels (dog), livestock feeding areas, loading docks,
meat packing establishments, pens, poultry droppings,
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poultry houses (including equipment and yards)(including
those for chickens, pheasants,and turkeys), poultry
packing/processing plants, restaurants, warehouses, and
wineries.
G. REQUIRED LABELING
All manufacturing-use products containing naled must bear
appropriate labeling as specified in 40 CFR 162.10. Other
portions of the guidance package contain specified infor-
mation regarding label requirements.
1. Use Pattern Statements
The ingredients statement for MPs must list the active
ingredient as:
Naled, (1,2-d ibromo-2,2-d ichloroethyl
dimethyl phosphate) %.
In addition, all MPs must state that they are intended only
for formulation into end-use products for any of the use
patterns listed above. They must specify specific sites
listed in Use Patterns in Section F.3. A limiting factor
will be the data that supports these use patterns. No use
may be included on the label, or labeling, where the registrant
fails to agree to comply with the data requirements in either
TABLE A for that use pattern, or TABLE B.
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2. Precautionary Statements
Labels for all MP products containing naled must bear state-
ments reflecting the acute human toxicity of the compound.
Naled is in Toxicity Category I on the basis of eye irritation
effects and Category II on the basis of acute oral and acute
dermal toxicity or effects. The Agency has no valid acute
inhalation or dermal sensitization data for naled. The re-
quired precautionary statements associated with Toxicity
Category I and II are specified in 40 CFR §162.10.
The following environmental hazard statement must appear on
the manufacturing-use product labels:
"This product is toxic to fish, aquatic invertebrates,
and wildlife. Do not discharge into lakes, streams,
ponds or public water unless in accordance with NPDES
permit. For guidance contact your regional office of
the Environmental Protection Agency."
Labeling changes to end-use products (EPs) are not required
by this Standard, however, based on data reviewed by the Agency
the following statements will be required for EPs under the
Agency's Label Improvement Program.
°"This pesticide is toxic to fish, aquatic invertebrates,
and wildlife. Do not apply directly to water or wet-
lands. Runoff from treated areas may be hazardous to
aquatic organisms in neighboring areas. Do not contamin-
ate water by cleaning of equipment or disposal of wastes."
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°"This product is highly toxic to bees exposed to direct
treatment on blooming crops or weeds. Do not apply this
product or allow it to drift to blooming crops or weeds
while bees are actively visiting the treatment area."
The following "General Warnings and Limitations" statements
must appear on end-use product labels which bear directions
for aquatic use on food or feed crops:
°"Do not use with highly alkaline materials such as lime
or bordeaux mixture. Shrimp and crabs may also be
killed at application rates recommended. Do not apply
to tidal or marsh waters which are important shrimp
producing areas."
The term "Birds feeding on treated areas may be killed" is
inappropriate and should be deleted from all labels (reference
D. Regulatory Rationale, 9).
PR Notice 83-2, dated March 29, 1983, sets forth current
Agency policy on required label changes for reentry and
farmworker safety. A reentry interval of 24 hours for the
use of naled on crops is required. The Agency reserves the
right to revise this reentry interval after receipt and
review of the data required in TABLE A and TABLE B of this
Standard.
The Agency may impose additional label requirements after the
receipt and review of the data to be submitted under this
Standard. 17
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H. TOLERANCE REASSESSMENT
A summary of the tolerances for combined residues of naled
and 2,2-dichlorovinyl dimethyl phosphate (DDVP) in or on
raw agricultural commodities resulting from the application
of naled formulations to growing crops, livestock and poultry
(40 CFR 180.215, July 1981) is presented in Table I at the end
of this section.
Canadian and Mexican tolerances are presented for comparison?
it is not known whether these tolerances are for combined
residues of naled and DDVP or for residues of naled alone.
No international maximum residue limits (MRLs) have presently
been established by the Codex Alimentarius Commission.
United States tolerances are identical with those of Canada
and Mexico in all cases except peas and peppers, for which
the U.S. and Canadian tolerances are 0.5 ppm and Mexican
tolerances are 1 ppm (Table I). It must be noted that the
commodities are defined differently by the respective countries
in these two cases (see footnotes b and c in Table I). As
previously mentioned, it is not known whether Canadian or
Mexican tolerances are expressed in terms of combined residues
of naled and DDVP (as U.S. tolerances are) or in terms of
naled alone. Based on the above, as well as the absence of
Codex MRLs for naled residues, compatibilities of international
tolerances cannot be fully assessed at this time.
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The components of the residue from the metabolism in plants
which are of concern are naled and DDVP, and to a lesser
extent, organic bromide. Additional data on the residues of
organic bromide are being requested. Tolerances exist for
combined residues of naled and DDVP (expressed as naled) and
should continue to reflect the concern for these two components.
The components of the residue from the metabolism in animals
which are of concern are the same as those in or on plants.
However, data on the metabolism of naled in poultry are
missing and this constitutes a data gap.
The Theoretical Maximum Residue Contribution (TMRC) is 1.1021
mg/day as naled, assuming a 1.5 kg diet, based on the tolerances and
food factors for all of the commodities for which U.S. tolerances
are established. No Acceptable Daily Intake (ADI) or Maximum
Permissible Intake (MPI) figures have been established, due
to the absence of acceptable toxicological data for naled.
Reassessment of the established naled tolerances must await
receipt and evaluation of the required data as set forth in
TABLE A and TABLE B.
The tolerances for combined residues of naled and DDVP are
supported for almonds (hulls and nuts), rice grain and forage,
safflower seed , sugar beet roots and tops, and fat, meat and
meat byproducts of cattle, goats, hogs, horses and sheep, and
milk. No additional data are required for walnut meats because
the residues in the consumed portion are expected to be mininal.
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Tolerances are partially supported (for some uses) for forage
legumes (alfalfa), grapes, grass forage, lettuce, summer
squash, and tomatoes.
Additional data are required to support the tolerances for
beans (dry and succulent), broccoli, Brussels sprouts, cabbage,
cauliflower, celery, collards , cottonseed, cucumbers, eggplant,
eggs, grapefruit, hops, kale, lemons, melons, mushrooms,
oranges, pea forage, peaches, peas, peppers, poultry (fat,
tTioaf nries 2a 4- Kty—fv k*a/^ n r* c* \ tni "i TOT'ilf t ri cs er%\7Kckan -P v 5S n10 C? *"% t ss ('¦'» H
lilt- d w f lllt^ d l, vjy pi Ou ULib / f puitipj\, 111 o / buyuudil I. O J_ ay t? j o p 1 ila.C II t
strawberries, Swiss chard, tangerines, turnip tops, and
winter squash.
Data are required on residues in the processed products of:
citrus (any member fruit), cottonseed, grapes, hops, rice,
and tomatoes. Data are also needed for turnip roots. A
tolerance must be established for this commodity.
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TABLE I. SUMMARY OF PRESENT TOLERANCES FOR NALED
_ Tolerances (ppm)
Commodity United States ' Canada Mexico"*
Almonds (hulls, nuts) 0.5 — --
Beans (dry, succulent) 0,5 0.5 0.5
Broccoli 1.0 1.0 1.0
Brussels sprouts 1,0 1.0 —
Cabbage 1.0 1.0 --
Cattle (fat, meat, meat 0.05
by-products)
Cauliflower 1.0 1.0
Celery 3.0 — 3.0
Citrus fruits a/ 3.0 3.0 3.0
Collards 3.0
Cottonseed 0.5 — 0.5
Cucumbers 0.5 0.5 0.5
Eggplant 0.5 0.5 0.5
Eggs 0.05 — —
Goats (fat, meat, meat 0.05
by-products)
Grapes 0.5 — 0.5
Grasses, forage 10.0
Hogs (fat, meat, meat 0.05 -- —
by-products 5
Hops 0.5
Horses (fat, meat, meat
by-products) 0.0 5
21
-------
TABLE I (Continued)
Commodity
Tolerances (ppm)
United States
Canada
Mexico
Kale
Legumes, forage
Lettuce
Melons
Milk
Mushrooms
Peaches
Peas b/
Pecans
Peppers c/
Poultry (fat, meat, meat
by-products)
Pumpkins
Rice
Safflower seed
Sheep (fat, meat, meat
by-products)
Soybeans
Spinach
Squash (summer, winter)
Strawberries
3.0
10.0
1.0
0.5
0.05
0.5
0.5
0.5
0.5
0.05
0.5
0.5
0.5
0.05
3.0
0.5
1.0
1.0
0.5
0.5
0.5
0.5
0.5
0.5
3.0
0.5
1.0
1.0
0.5
0.5
1.0
0.5
1.0
0.5
0.5
3.0
0.5
1.0
22
-------
TABLE I (Continued)
Tolerances
Commodity United States Canada Mexico
Sugar beets (roots, tops)
0.5
—
—
Swiss chard
3.0
3.0
—
Tomatoes
0.5
0.5
0.5
Turnips, tops
3.0
3.0
—
Walnuts
0.5
0.5
.—.
All other raw agricultural
0.5
0.5
—
commodities except those
listed *3/
a/ United States tolerances are for grapefruit, lemons and
tangerines; Canadian and Mexican tolerances are for all
citrus fruits.
b/ United States tolerance is for succulent peas only?
Canadian and Mexican tolerances are for all peas.
c/ The Mexican tolerance is for chili peppers only; the
United States and Canadian tolerances are for all peppers.
d/ To account for area pest (fly and mosquito) control.
23
-------
Ill. 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 III-l) 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 registration(s)
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 VMust Be Submitted. You may ascertain
which generic data you must submit by consulting Table A
at the end of this section. 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 submitted and any
necessary studies must be conducted in accordance with
EPA-approved protocols, the Pesticide Registration
Guidelines 2,/, or data collected under 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.
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
1/ 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).
2J The Pesticide Registration Guidelines were reproposed on
November 24, 1982 in 47 Federal Register 53192,
24
-------
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 Section 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
III-2] 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. Not ify 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-3)*/
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.)
jV 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
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.
(Footnote continued at bottom of next page)
25
-------
5. Request voluntary cancellation of the registration(s)
of your products for which the data are needed, (This
option is not available to applicants for new products.)
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 EPA1s 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 extens ion is appropriate. While
EPA considers your request, you must strive to meet the
deadline for submitting the required data.
(Footnote continued from previous page)
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.
26
-------
IV. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Note; This section 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-1)
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)."
V' Product specific data pertains to data that support the
formulation which is marketed; it usually includes product
chemistry data and acute toxicology data.
27
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED 1/
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
2/ Requirement? (Yes,
No or Partially)
Bibliographic
Citation V
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)? V
§158.120 Product Chemistry
(continued)
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density, or
Specific Gravity
TGAI
TGAI
TGAI
TGAI
TGAI
Yes
Yes
Yes
Yes
Partial
00074790
G5092040
00074790
G5092040
G5092040
00074653; 00074724*
00074790; G5092040
00074653; 00074724*
00074790; G5092040
No
No
No
No
Yes 8/
*Data submitted by Chevron Chemical Company. These data may be compensable.
28
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED 1/
Data Requirement
Composition
Does EPA Have Data
TO Satisfy This
2/ Requirement? (Yes,
No or Partially)
Bibliographic
Citation V
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)? V
§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
1GAI OR PAI
TGAI OR PAI
IGAI OR PAI
PAI
TGAI
TGAI
Choice
Yes
Yes
No
No
No
Yes
00074653
00074790
GS092040
00074653
00074790
GS092040
00074653
00074724
00074790
No
No
Yes
Yes
Yes
No
No 9/
29
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
§158.120 Product Chemistry
(continued)
1/ Naled 90% technical is the only technical product. The cited data may be used to satisfy the requirements for
technical naled manufactured by the process submitted by the Chevron Chemical Co. (00074653 and 00074791)
containing 90% naled (or similar percentages accepted on a product by product basis).
2/ Composition: TGAI = Technical grade of the active ingredient; PAI = Pure active ingredient; Choice = Choice of
several test substances determined on a case-by-case basis.
3/ All data cited were submitted by the Chevron Chemical Company.
4/ Data must be submitted no later than June 1986.
5/ Adequate data has been submitted by Chevron Chemical Company. Other producers must address these data requirements.
6/ The analytical methods used were inadequately described. Identification and quantification of impurities present
at >0.1% (W/W) is required.
7/ There was a discrepancy of the limits. An update of the technical naled limits and quality control method
(including validation data); adequate sampling (five or more production batches); and limit certification are required
8/ The data are conflicting. Clarification of the specific gravity of technical naled is required.
9/ May be required on a case-by-case basis.
30
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Data Requirements
Composition
Does EPA Have Data
To Satisfy This
1/ 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
PAIRA
- Livestock
PAIRA and plant
metabolites
- Animal residues
Partial
Partial
171-4 - Residue Analytical Method
- Plant residues TGAI and metabolites Partial
TGAI and metabolites Yes
00074836
GS092090*
00074654
00074647
00074844
00059386
GS092091*
GS092092*
00074721; 00074806*
00074647; 00073820
00074725
GS092026
00073821*
Yes 3/,4/
Yes 3/
Yes 4/
No
171-4 - Storage Stability Data
PAI
No
Yes 5/
*Data submitted by Chevron Chemical Company. These data may be compensable.
31
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Data Requirements
Composition
Does EPA Have Data
To Satisfy This
1/ Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?^/
§158.125 Residue Chemistry
(continued)
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use 6/
- Root and Tuber Vegetable Group
° Sugar Beet Roots
° Turnip Roots
- Leaves of Root and Tuber
Vegetables (Human Food or
Animal Feed) Group 87
° Sugar Beet Tops
° Turnip Tops
Leafy Vegetables Group
(Except Brassica)
° Celery
° Lettuce
° Spinach
° Swiss Chard
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
Yes
No
Yes
Partial
Partial
Partial
Partial
Partial
00074836; 00073821*;
00073815*; 00073819*
00074836; 00073821*;
00073815*; 00073819*
00073820
00074836; 00073821*;
00074722
00073820; 00074807
00073820; 00074722
00074836
No
Yes 7/
No 9/
Yes 10/
Yes 11/
Yes 12/
Yes 13/
Yes 13/
*Data submitted by Chevron Chemical Company.These data may be compensable.
*3 O
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
1/ Requirement? (Yes,
No or Partially)
Bibliograph ic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?V
§158.125 Residue Chemistry
(continued)
171-4 - Magnitude of the Residue -
Residue Studies (continued)
- Brassica (Cole) Leafy
Vegetable Group
° Broccoli
° Brussels Sprouts
° Cabbage
° Cauliflower
° Collards
° Kale
- Legume Vegetables (Succulent
and Dried) Group
° Beans
° Peas
° Soybeans
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
Partial
No
Partial
Partial
Partial
Partial
Partial
Partial
Partial
00074836; 00073820
00074836
00073820
00073821*
00073821*
00074836; 00073846*;
00073820; 00074699;
00073821; 00074729
00073846*
00073821*; 00073846*
Yes 14/
Yes 15/
Yes 14/
Yes 14/
Yes 14/
Yes 14/
Yes 16/
Yes 17/
Yes 18/
*Data submitted by Chevron Chemical Company. These data may be compensable.
33
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
1/ Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)??/
§158.125 Residue Chemistry
(continued)
- Foliage of Legume
Vegetables Group
° Bean Foliage
° Pea Foliage
° Soybean Foliage
- Fruiting Vegetables
(Except Cucurbit) Group
° Eggplants
° Peppers
° Tomatoes
- Fruiting Vegetables
(Cucurbit) Group
° Cucumbers
° Melons
° Pumpkins
° Sumnmer Squash
° Winter Squash
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
Partial
Partial
Partial
NO
Partial
Partial
Partial
Partial
No
Partial
No
00074836; 00073820;
00073821*; 00073846*;
00074699; 00074729
00073846*
00073821*; 00073846*
00074836*; 00073820
00074836; 00073820;
00075668
00073820; 00075668
00073820
00073820
Yes 19/
Yes 20/
Yes 21/
Yes 22/
Yes 23/
Yes 24/
Yes 25/
Yes 26/
Yes 27/
Yes 28/
Yes
*Data submitted by Chevron Chemical Company. These data may be compensable.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
1/ Requirement? (Yes,
No or Partially)
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)? 2
§158.125 Residue Chemistry
(continued)
- Citrus Fruits (Citrus Spp.,
Fortunella Spp.) Group
° Grapefruit
TEP
No
—
Yes
° Lemons
TEP
Partial
00073820
Yes 29/
° Oranges
TEP
Partial
00073820; 00074807
Yes 30/
° Tangerines
TEP
No
-
Yes
- Stone Fruits Group
° Peaches
TEP
Partial
00074836*; 00073821*
Yes 31/
- Small Fruits and
Berries Group
° Grapes
TEP
Partial
00074836; 00073821*;
00074728; 00073817*
Yes 32/
° Strawberries
TEP
Partial
00073820
Yes 33/
- Cereal Grains Group
° Rice Grain
TEP
Partial
00074723; 00073820;
Yes 34/
*Data submitted by Chevron Chemical Company. These data may be compensable.
35
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Data Requirement
Composition
Does EPA Have Data
Tb Satisfy This
1/ Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)? 2
§158.125 Residue Chemistry
(continued)
- Forage, Fodder, and Straw
of Cereal Grains Group
° Rice Forage
- Grass, Forage, Fodder
and Hay Group
° Grass Forage (Pasture
and Range)
- Non-Grass Animal Feeds
(Forage, Fodder, Straw,
and Hay) Group
° Alfalfa
- Tree Nuts Group 38/
° Almonds
° Walnuts
TEP
TEP
TEP
TEP
TEP
Yes
Partial
Partial
Yes
Yes
00074723
00073820
00073816*
00073830
00073821*
No 35/
Yes 36/
00074836; 00073821*; Yes 37/
00073818*; 00072816
No 39/
No
*Data submitted by Chevron Chemical Company. These data may be compensable.
36
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Data Requirement
1/
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
(continued)
- Miscellaneous
° Cottonseed
° Hops
° Mushrooms
° Safflower Seed
All Other Agricultural
Commodities
Food Producing Animals
° Meat and milk
TEP
TEP
TEP
TEP
TEP
EP, TGAI or plant
metabolites
Poultry and eggs
EP, TGAI or plant
metabolites
Partial
Partial
Partial
Yes
No
Yes
Partial
00074700; 00073821*;
00074845*
00073846*
GS092093
00073846*; 00074845*
GS092094
GS092092*
GS092095*
00073821*
GS092026
GS092096
00074692*
Yes 40/
Yes 41/
Yes 42/
No 43/
No 44/
No 45/
Yes 46/,47/
* Data submitted by Chevron Chemical Company. These data may be compensable.
37
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
§158.125 Residue Chemistry
(continued)
1/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabeled; TEP =
Typical end-use product; EP = End-use product.
2/ Data must be submitted no later than June 1986.
3/ Data are needed on the identity and amount (if any) in plants and animals of organic brominated components of the
residue derived from naled itself or from its bromine-containing impurities. A protocol for this study must be
submitted and approved by the Agency, prior to initiation of the study. The protocol must include a scheme for
tracking organic-brominated residues.
_4/ Methodology and data on residues of naled and DDVP determined separately for two representative crops such as lettuce
and rice grain are needed.
5/ Seme residue storage data is required to indicate a potential for the loss of residues between sampling and analysis.
6/ The following agricultural commodities are arranged in order of crop groups in accordance with Draft Proposed
40 CFR 180.34(f) [see FR 47(93)20635(5-13-82)] . Satisfaction of the crop group requirements for a given group would
allow the establishment of a tolerance for all members of that group. To satisfy the requirements, the use patterns
must be similar for all members of the crop group and maximum residues (tolerances) generally must not vary by more
than a factor of five. Residue data for all of the representative commodities, or suitable substitutes, must be
presented in order to establish a group tolerance; these representative crops are listed under the crop group sections
which follow.
7/ No tolerances exists for turnip roots, yet residues are to be expected from the use on naled on turnips. These
residues need to be covered by either a crop group tolerance (as previously indicated) or an individual tolerance.
The lack of residue data on turnip roots constitutes a data gap for an individual tolerance, should one be requested.
8/ Data are available for both of the two representative commodities (sugar beet tops and turnip tops) needed to satisfy
the requirements for this crop group. Based on the available data, however, a group tolerance cannot be established
for the following reasons: 1) Residue data for turnip tops do not support the established tolerance, 2) Naled uses for
turnips and sugar beets are substantially different in terms of the rates and formulations applied for, and 3) The
tolerances for sugar beet tops (0.5 ppm) and turnip tops (3.0 ppm) differ by ;more than a factor of five.
9/ The available data support the tolerance for combined residues of naled and DDVP in or on sugar beet tops from the
established use, and even under exaggerated rates of application. The restriction against feeding sugar beet tops
to livestock appears unnecessary.
10/ Data are needed which reflect aerial and ground applications of the 4 or 6% Dusts (D) and 7.2 lb/gal Emulsifiable
Concentrates (ECs) according to the use pattern. This will include five or more applications per season at the
highest recommended rates.
38
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
§158.125 Residue Chemistry
(continued)
11/ Data are needed which reflect the following: 1) Five or more ground applications of the 7.2 lb/gal EC at 1.35 lb ai/A,
2) Five or more aerial applications of the 4 or 6% D at 2.0 lb ai/A, and 3) Five or more ground applications of the
4 or 6% D at 2.0 lb ai/A.
12/ The available data support the established tolerance for head lettuce after applications of the 7.2 lb/gal EC.
Additional data are required which reflect both aerial and ground applications of either the 4 or 6% D; at least three
applications at 2.0 lb ai/A must be made. All of the above data are required for leaf lettuce as well (including data
for the 7.2 lb/gal EC). These data are to include at least one study to show residues in head lettuce, with and
without wrapper leaves.
13/ Data are needed which reflect aerial and ground applications of the 4 or 6% dusts and the 7.2 lb/gal EC according to
the use pattern. This will include five or more applications per season at the highest recommended rates.
14/ Data are needed which reflect five or more seasonal applications, with aerial and ground equipment, of the 4 or 6% D
at 2.01b ai/A and of the 7.2 lb/gal EC at 1.8 lb ai/A.
15/ No residue data for Brussels sprouts are available for review; the tolerance can be supported by grouping with other
crops whose tolerances are supported, or by residue data for the individual tolerance.
16/ Data are required which reflect three or more applications of the 7.2 lb/gal EC and the 4 or 6% D formulations
during the fruiting period with aerial and ground equipment.
17/ Data are required which reflect at least three applications of the 4% D and the 7.2 lb/gal EC at the maximum rates
during the fruiting period. Both aerial and ground equipment must be used. Dried, succulent, and edible-pod types
must be included.
18/ Data are needed which reflect at least five aerial and ground applications of the 7.2 lb/gal EC at 1.35 lb ai/A;
three of these treatments must be made during the fruiting period. Data are also needed to determine the residues
in processed soybean products (crude and refined oil, hulls, meal, and soapstock) to establish the necessity of
food additive tolerances for residues in these products.
19/ Data are required which reflect three or more applications of the 7.2 lb/gal EC and the 4 or 6% D formulations with
aerial and ground equipment. The restriction against feeding bean forage to livestock appears unnecessary.
20/ Data are required which reflect at least three applications of the 4% D and 7.2 lb/gal EC at the maximum rates be
made during the fruiting period using aerial and ground equipment.
21/ Data are needed which reflect at least five aerial and ground applications of the 7.2 lb/gal EC at 1.35 lb ai/A for
forage; three of these treatments must be made during the fruiting period for residue studies on pods and vines.
22/ No residue data for eggplant are available for review; the tolerance can be supported by grouping with other fruiting
vegetables (except cucurbits) whose tolerances are supported, or by residue data for the individual tolerance.
39
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
§158.125 Residue Chemistry
(continued)
23/ Data are needed which reflect five aerial and ground applications of the 4% D and the 7.2 lb/gal EC; at least three
of these applications must be made during the fruiting period.
24/ The available data support the established tolerance for tomato fruit following ground applications of the 7.2 lb/gal
EC. Data are still needed which reflect: 1) Five aerial applications of the 7.2 lb/gal EC at 0.9 lb ai/A (at least
three applications must be made during the fruiting period), 2) Five aerial and ground applications of the 4% D at
2.0 lb ai/A (at least three applications must be made during thr fruiting period, 3) Five foliar greenhouse sprays
with the 7.2 lb/gal EC at 0.9 lb ai/100 gal (at least three applications must be made during the fruiting period),
4) Ten greenhouse fumigations with the ROT and 7.2 lb/gal EC at 16 fl oz of product/50,000 cu ft, and 0.28 lb
ai/50,000 cu ft, respectively, (at least five applications must be made during the fruiting period), and 5) Residues
in processed tomato products (ketchup, paste, and wet and dry pomace).
25/ Data are needed which reflect the following: 1) Five aerial and ground applications of the 4% D at 2.0 lb ai/A (at
least three applications must be made during the fruiting period), 2) Five aerial and ground applications of the
7.2 lb/gal EC at 1.35 lb ai/A (at least three applications must be made during the fruiting period), and 3) Ten
greenhouse fumigations using the 7.2 lb/gal EC and 10% RTU at 0.28 lb ai/50,000 cu ft and 16 oz product/50,000 cu ft,
respectively (at least five applications must be made during the fruiting period).
26/ Data are needed which reflect the following: Five aerial and ground applications of the 4% D at 2.0 lb ai/A (at least
three applications must be made during the fruiting period).
27/ Data are needed which reflect the following: 1) Five aerial and ground applications of the 4% D at 2.0 lb ai/A (at
least three applications must be made during the fruiting period), and 2) Five aerial and ground applications of the
7.2 lb/gal EC at 1.35 lb ai/A (at least three applications must be made during the fruiting period). The available
data on rice straw are applicable to other grain straws and indicate that these contribute substantially to the
bromide ion content of the animal diet.
28/ The available data support the established tolerance for summer squash treated with ground applications of the
7.2 lb/gal EC. Additional data are required which reflect the following: 1) Five aerial applications of the
7.2 lb/gal EC at 1.35 lb ai/A (three or more applications must be made during the fruiting period), and 2) Five
aerial and ground applications of the 4% D at 2.0 lb ai/A (three or more applications must be made during the
fruiting period).
29/ Data are needed which reflect 10 aerial and ground applications of the 4% D and 7.2 lb/gal EC at 4.0 and 1.8 lb
ai/A, respectively; five or more of these applications must be made during the fruiting period.
30/ Data are needed which reflect 10 aerial and ground applications of the 4% D and 7.2 lb/gal EC at 4.0 and 1.8 lb
ai/A, respectively; five or more of these applications must be made during the fruiting period. Data is also
needed on processed products, cold pressed oil, peel, dehydrated pulp and molasses (fractionation study).
40
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
§158.125 Residue Chemistry
(continued)
31/ Data are required which include the following; 1) Ten ground applications of the 7.2 lb/gal EC at 0.68 lb ai/100 gal
sprayed to the point of runoff, 2) Ten aerial and ground applications of the 4% D at 3.2 lb ai/A.
32/ The available data support the established tolerance for grapes based on residues resulting from ground application of
the 7.2 lb/gal EC. Additional dat are required which reflect 10 aerial and ground applications of the 4% D at 2.0 lb
ai/A. Also, data pertaining to naled residues in the following grape products (juice, wet and dehydrated pcmace,
raisins, and raisin waste) are needed to determine if food additive tolerances should be established for these
products.
33/ Data are required which reflect five aerial and ground applications of the 4 or 6% D at 2.0 lb ai/A and the 7.2
lb/gal EC at 0.9 lb ai/A.
34/ The available data support the established tolerance for residues of naled and DDVP in or on rice resulting from the
use of the 7.2 lb/gal EC. Data are required for rice products (hulls and milled products and by-products) to
determine if feed additive tolerances need be established for these products.
35/ The available data support the established tolerance for residues of naled and DDVP in or on rice forage resulting
from the use of the 7.2 lb/gal EC.
36/ The available data support the established tolerance on pasture and range grasses for foliar ground application of
the EC and SC/L formulations. Data are required, however, which reflect five aerial applications of the EC
and one of the SC/L formulations at 0.9 and 0.75 lb ai/A, respectively. Also, residue data are required which reflect
five aerial and ground applications of the 4% D at 0.4 lb ai/A. In addition, residue data for grass hay are needed
to determine if a separate, or increased, tolerance should be established for this dehydrated product.
37/ The available data support the established tolerance for alfalfa forage following treatment with the EC and SC/L
formulations. Additional data are required which reflect five aerial and ground applications of the 4% D. Residue
data for alfalfa hay are also needed to determine if a separate, or increased, tolerance should be established for
this dehydrated product.
38/ A group tolerance may not be established at this time because the almond and walnut uses are distinctly different,
and because additional data are required for pecans.
39/ The available data support the established tolerance for almond hulls and nuts following a dormant application. In
addition, the data indicate that three foliar applications at 3.0-6.0 lb ai/A do not result in tolerance-exceeding
residues in or on almond hulls and meats 28 days after the final treatment. The use pattern could thus be expanded
to include foliar applications of the 7.2 lb/gal EC if such a need is anticipated.
41
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
§158.125 Residue Chemistry
(continued)
40/ Data are required for cottonseed which reflect five aerial and ground applications of the 4% D and 7.2 lb/gal EC at
1.4 and 0.9 lb ai/A, respectively. If residues are, in fact, present in undelinted seed, then additonal residue
data (reflecting the above doses) for cottonseed hulls, meal, refined oil, and soapstock are required to determine
if food additive tolerances should be established for these proccessed products.
41/ Data are required on hops which reflect five aerial and ground applications of the 4% D and 7.2 lb/gal EC at 1.0 and
0.9 lb ai/A, respectively. Also, data are required concerning residues in dried spent hops.
42/ Data from the following uses are needed: 1) 20 applications of the 7.2 lb/gal EC used as a RTU at 6.75 oz ai/50,000
cu ft, and 2) 20 applications of the 10% ROT at 5 fl oz/50,000 cu ft.
43/ The available data support the established tolerance for combined residues of naled and DDVP in or on safflower seed
and indicate that food additive tolerances need not be established for safflower meal and oil. This data cannot be
translated to other oilseeds because their fractions inlude hulls and soapstock.
44/ A tolerance of 0.5 ppm is established for combined residues on naled and DDVP in or on all raw agricultural
commodities, except those otherwise listed in 40 CFR 180.125 (July 1981), from use of naled formulations for area
pest (fly and mosquito) control. The recommended rates are consistently lower (frequently 0.02-0.25 lb ai/A) for
area pest uses than for crop pest uses (usually 0.68-4.0 lb ai/A). Although it is a major use on naled formulations,
area pest usage will result in intermittent and variable exposure of a given commodity to naled residues. For these
reasons, the submission of data to support this extensive tolerance is not required. All commodities included in this
tolerance will, of course, be subject to enforcement of this tolerance.
45/ The available data support the established tolerances for combined residues of naled and DDVP from dietary sources in
the meat and milk of cattle. The data are considered supportive of the tolerances for residues in the meat and milk
of otherr animals (goats, hogs, horses and sheep) as well. The contribution of combined residues on naled and DDVP to
meat and milk from the use of naled at its reduced rates on or around livestock is not expected to be significant in
relation to the levels which result from dietary sources.
46/ Residue data are needed on eggs and poultry resulting from 10 bird-spray treatments with either the 3.6 or 7.2 lb/gal
EC at 0.45 lb ai/20 gal.
47/ Data submitted to the Agency was conducted by Industrial Bio-Test Laboratories (IBT) and has been determined to be
invalid.
42
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Data Requirement
1/ Use 2/
exposition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Must Additional
Data be Submitted
Bibliographic Under FIFRA Section
Citation 3(c) (2) (B)?3/
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis
Photodegradation
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:
TGAI or PAIRA A,B,C,D,
E,F,G,H
TGAI or PAIRA A,B,C,G
TGAI or PAIRA A,G
TGAI or PAIRA A,C,E,F
TGAI or PAIRA A,B,D,E,
F,H
TGAI or PAIRA A,G
TGAI or PAIRA C,D,G
TGAI or PAIRA C,D
163-1 - Leaching and TGAI or PAIRA A,B,C/D/
Adsorption/Desorption E,F,G,H
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
TEP
TEP
A,E,F
A,E,F 8/
No
No
No
No
Partial 4/
No 5/
No
Partial 6/
Partial 7/
No
No
00074759*
00074691*
00074885*
00074644**
00064796*
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Reserved 9/
*Data submitted by Chevron Chemical Company. These data may
c*Data submitted by National Chemsearch, Division of NCH Corp,
be compensable.
These data may be compensable.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Data Requirement
1/ Use 2/
Composition Pattern
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)?-V
§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-Target
Organisms
TEP
TEP
TEP
TEP
TEP
PAIRA
TEP
TEP
TGAI or
PAIRA
TEP
A,B,H
C,D
G
A,B,C,
D,G
D
No
Partial 10/
No
Not Applicable
Reserved 11/
No
No
No
Yes
Yes
00074645*
00074643*
00074643*
Yes
Yes
Yes
Yes
Reserved 12/
Yes
No U/
No
*Data submitted by National Chemsearch, Division of NCH Corp. These data may be compensable.
44
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
§158.130 Environmental Fate
(continued)
1/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled;
TEP = Typical end-use product.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; OAquatic, 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 June 1986.
4/ Tests with specified purity of radiolabeled or technical material required (composition test material not given).
5/ Anerobic aquatic studies replace the anerobic soil studies.
6/ Half-life was aiven, but only on one metabolite (DDVP). No information was given on DDVP metabolism, nor on
sediment. Data from the intended use area(s) is required.
7/ Aged leaching tests are required to identifiy metabolites and degradation rates. No absorption/desorption data
were submitted, therefore all data are required.
8/ Label modifications for the greenhouse use may be necessary because of high volatility and toxicity (Category II)
of the metabolite DDVP. A decision will be made after an additional aerobic soil metabolism study is submitted
and evaluated.
9/ Data requirement depends on the results of the laboratory studies.
10/ Partial information obtained from sewage water; additional data required on dissipation from other aquatic
impact areas.
11/ This study is required only if the aerobic soil metabolism study described in 162-1 demonstrates that for
field and vegetable crop use, the total amount of pesticide, excluding bound residues in soil, is greater
than 50% of the amount of pesticide initially applied at the time when a subsequent application would occur.
12/ Reserved pending results of 165-1.
13/ No data on the accumulation of naled in fish are required because 1) naled has a half life of less than 4 days
in water, 2) naled has an octanol water partition coefficient of less than 1000, and 3) no detectable residues
were found in fish samples.
45
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Data Requirement
Does EPA Have Data
To Satisfy This
1/ Use 2/ Requirement? (Yes,
Composition Patterns No or Partially)
B ibliograph ic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
§158.135 Toxicology
ACUTE TESTING:
81-1 - Oral LD50 - Rat
82-1 - 90-Day Feeding -
Rodent, Non-rodent
82-2 -
82-3 -
82-4 -
82-5 -
21-Day Dermal - Rabbit
90-Day Dermal - Rabbit
90-Day Inhalation -
Rat
90-Day Neurotoxicity-
Hen/Mairmal
TGAI
81-2 - Dermal LD50 - Rabbit TGAI
81-3 - Inhalation LC50 ~ Rat TGAI
81-7 - Delayed TGAI
Neurotoxicity - Hen
SUBCHRONIC TESTING:
TGAI
TGAI
TGAI
TGAI
TGAI
A,B,C,D,E
F,G,H,I
A,B,C,D,E,
F,G,H,I
A,B,C,D,E,
F ,H,I
A,B,C,D,E,
F,G,H,I
A,D,E,I
A,B,H,I
E ,F, I
Yes
Yes
NO
Yes
Yes
No
Reserved 4/
No
No
00049330
00074795
05016607
00065468
00074829*
00074663
00049330
00074656*
00074843
00074817
05016607
GS092097*
00074862
No
No
Yes
No
No
Yes
Yes
No 5/
*Data submitted by Chevron Chemical Company. These data may be compensable.
A C
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
§158.135 Toxicology
(continued)
1/ Carpos.ition: TGAI = Technical grade of the active ingredient; PAI = Pure active ingredient; PAIRA = Pure active
ingredient, radiolabeled; Choice = Choice of several test substances determined on a case-by-case basis.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; OAqautic, 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 June 1986.
4/ Reserved pending results of 82-2 (21-day dermal).
5/ Not required since 81-7 (acute delayed neurotoxicity) does not show neurotoxicity.
6/ This study is to be completed by April 3, 1985, in accordance with the 3(c)(2)(B) Data Call-in Notice issued
April 3, 1981.
7/ Data previously sbumitted to the Agency was conducted by Industrial Bio-Test Laboratories (IBT) and has been
determined to be invalid.
8/ This study is to be completed by September 3, 1983, in accordance with the 3(c)(2)(B) Data Call-in Notice issued
April 3, 1981 and a request for a 3-month extension.
9/ This data requirement is statisfied for bacterial testing only.
10/ Reserved pending results of subchronic and chronic testing.
47
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR NALED
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
1/ 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition Pattern No or Partially) Citation 3(c) (2) (B)?V
§158.140 Reentry Protection
132-1 -
Foliar Dissipation
TEP
A,B
No
- Yes 4/
132-1 -
Soil Dissipation
TEP
A,B
NO
No 5/
133-3 -
Dermal Exposure
TEP
A,B
No
No 5/
133-4 -
Inhalation Exposure
TEP
A,B
No
No 5/
1/ Composition: TEP = Typical end-use product.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; OAquatic, 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 June 1986.
4/ Use California reentry interval of 24 hours for all crops, or submit foliar dissipation data to establish a
decline curve.
5/ Only foliar dissipation data are required.
48
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Data Requirement
Does EPA Have Data
To Satisfy This
1/ Use 2/ Requirement? (Yes,
Composition Pattern No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
§158.145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Avian Oral LD50
71-2 - Avian Dietary LC50
71-3 - Wild Mammal Toxicity
71-4 - Avian Reproduction
71-5 - Simulated and Actual
Field Testing -
Mammals and Birds
AQUATIC ORGANISM TESTING
72-1 - Freshwater Fish LC50
TCAI
TGAI
TGAI
TGAI
TEP
TGAI
A,B,C,D,G Yes
A,B,C,D, Yes
e,f,g,h,
1 i/
A,B,C,D,G No
A,B,C,D,G No
AfBfC/D/G No
A,B,C/D,
e,f,g,h,
I 4/ Yes
GS092099
00028757
05003107
GS092101
GS092102
No
No
No 5/
No 5/
No 5/
No
-do-
TEP
C,D,G
Partial
GS092101
GS092102
GS092017
Yes 6/
49
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Data Requirement
1/ Use 2/
Composition Pattern
Does EPA Have Data
Tb Satisfy This
Requ irement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
§158.145 Wildlife and
Aquatic Organisms
(continued)
72-2 - Acute LC50 Freshwater
Invertebrates
TGAI
AfG/C/D,
E/F/G/H,
I 4/
Yes
GS092100
No
-do-
TEP
C,D,G
No
Yes 6/
72-3 - Acute LC50 Estuarine
and Marine Organisms
TGAI
C,D,G
Partially 7/
GS092104
00074684
Yes
72-4 - Fish Early Life
Stage and Aquatic
Invertebrate Life-Cycle
72-5 - Fish - Life-Cycle
72-6 - Aquatic Organism
Accumulation
72-7 - Simulated or Actual
Field Testing -
Aquatic Organisms
TGAI
TGAI
TGAI, PAI OR
Degradation
Product
TEP
C,D,G
C,D,G
C, D,G
C,D,G
Reserved 8/
Reserved 9/
Reserved 9/
Reserved 9/
50
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
§158.145 Wildlife and Aquatic Organisms
(continued)
1/ Composition: TCAI = 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; G=Forestry; H=Domestic Outdoor; 1=Indoor.
3/ Data must be submitted no later than June 1986.
4/ Only one species is required for the E,F,H and I use patterns.
5/ This data is not normally required.
6/ In addition to the technical, data must be submitted on unique formulations that are formulated for use in
aquatic sites.
7/ In addition to the technical, testing is required for establishing the acute toxicity of the technical pesticide to
estuarine/marine invertebrates when the end-use product is expected to enter the estuarine or marine environment in
significant concentrations because of its use or mobility patterns. In the case of naled, it is used for mosquito
control in estuarine marshes and swamps. Studies will include 48 hour oyster embryo-larvae or 96 hour shell
deposition, 96 hour juvenile shrimp and 96 hour estuarine finfish (spot or pinfish). The available studies do
not satisfy any of the guideline requirements and do not provide an adequate basis for assessing naled. Since naled
is very highly toxic to Daphnia, it is essential to conduct the appropriate tests on estuarine organisms.
8/ Reserved pending submission of appropriate environmental fate studies (e.g., hydrolysis) which are needed to
determine the persistence of naled in the aquatic environment.
9/ Reserved pending submission of appropriate environmental fate studies (e.g., dissipation and hydrolysis studies)
which are needed to determine if hazardous concentrations of naled will reach or accumulate in the aquatic environ-
ments when products are used as directed.
51
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Data Requirements
Composition
Does EPA Have Data
To Satisfy This
1/ Use 2/ Requirement? (Yes,
Pattern No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
§158.150 Plant Protection
121-1 - TARGET AREA EP
PHOTOTOXICITY
NONTARGET AREA PHYTOTOXICITY
TIER I
122-1 - Seed Germination/ TGAI
Seedling Emergence
122-1 - Vegetative Vigor TGAI
122-2 - Aquatic Plant Growth TGAI
TIER II
123-1 - Seed Germination/ TGAI
Seedling Emergence
123-1 - Vegetative Vigor TGAI
123-2 - Aquatic Plant Growth TGAI
TIER III
124-1 - Terrestrial Field TEP
124-2 - Aquatic Field TEP
No
No
No
No
No
No
No
No
NO
No 4/
No 4/
No 4/
No 4/
No 4/
No 4/
No 4/
No 4/
No 4/
1/ Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
EP = End-use product.
2/ The use patterns are coded as follows: A=Terrestr.ial, Food Crop; B=Terrestrial, Non-Food Crop; 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 .
4/ These requirements are generally waived unless it is believed there is a phototoxicity problem.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
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/
§158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS:
141-1 - Honey bee acute
contact LD50
141-2 - Honey bee - toxicity
of residues on
foliage
TGAI
TEP
A,B,G,H Yes
A,B,G,H Yes
00036935
00060628
00037799
05000837
No
No
141-3 - Wild bees important in TEP
alfalfa pollination -
toxicity of residues
on foliage
141-4 - Honey bee subacute TEP
feeding study
141-5 - Field testing for TEP
pollinators
A 4/
Yes
A,B,G,H Reserved 5/
A,B,G,H No
00060628
05000837
No
No 6/
53
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR NALED
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)? V
§158.155 Nontarget Insect
(continued)
NONTARGET INSECT TESTING -
AQUATIC INSECTS:
142-1 - Acute toxicity to - Reserved 7/
aquatic insects
142-2 - Aquatic insect - Reserved 7/
life-cycle study
142-3 - Simulated or actual - Reserved 7/
field testing for
aquatic insects
143-1 - NONTARGET INSECT - Reserved 7/
TESTING - PREDATORS
thru AND PARASITES
143-3
V Composition: TGAI = Technical grade of the active ingredient; TEP = Typical end-use product.
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestr.ial, Non-Food; OAquatic, Food Crop:
I>Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indoor.
3/ Data must be submitted no later than (ojQh .
4/ Data required only for pesticides intended for foliar application to seed alfalfa.
5/ Reserved pending development of test methodology.
6/ May be required under the following conditions:
i) Data from the honey bee subacute feeding study (141-4) indicate adverse effects on colonies, especially
effects other than acute mortality (reproductive, behavioral, etc.);
ii) Data from residual toxicity studies (141-2 and 141-3) indicate extended residual toxicity; or
iii Data derived from studies with organisms other than bees indicate properties of the pesticide beyond acute
toxicity such as the ability to cause reproductive or chronic effects.
7/ Reserved pending decision as to whether data requirement should be established.
54
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FDR MANUFACTURING-USE PRODUCTS CONTAINING NALED 1/
2/
Data Requirement
Composition
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation V
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)? V
§158.120 Product Chemistry
Product Identity:
61-1 - Identity of Ingredients
61-2 - Statement of Composition
MP
MP
61-3 - Discussion of Formation of MP
Ingredients
Yes
Partial
Partial
00074653
00074724
GS092040
00074653
00074791*
00065493; 00065494*
00074653; GS092040
No
Yes 5/
Yes 6/
Analysis and Certification of Product
Ingredients
62-1 - Preliminary Analysis MP
62-2 - Certification of Limits MP
62-3 - Analytical Methods for MP
Enforcement of Limits
Physical and Chemical Characteristics
63-2 - Color MP
Partial
Partial
Partial
Yes
00065493*; 00065494*; Yes 6/
00074655; 00074653
00065493*; 00065494*; Yes]/
00074653
00065494*; 00074653 Yes 7/
00074655; 00074724
00074846; G5092006
00074790 No
G5092040
*Data submitted by Chevron Chemical Company. These data may be compensable.
55
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING NALED
Data Requirement
Composition
2/
Does EPA Have Data
To Satisfy This
Requ irement? (Yes,
No or Partially)
Bibliographic
Citation V
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)? 4/
§158.120 Product Chemistry
(continued)
63-3 - Physical State
63-4 - Odor
63-7 - Density, Bulk Density, or
Specific Gravity
63-12 - pH
63-14 - Oxidizing or reducing
action
63-15 - Flammability
63-16 - Explodability
63-17 - Storage Stability
63-18 - Viscosity
63-19 - Miscibility
63-20 - Corrosion
Other Requirements:
64- 1 - Submittal of samples
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
Yes
Yes
Partial
No
Yes
Partial
Yes
Yes
Yes
Yes
Yes
00074790
G5092040
00074790
G5092040
00074653; 00074724
00074790; G5092040
00074790
00074790
00074790
00074653
00074790
GS092040
00074790
GS092040
00074790
GS092040
No
No
Yes 8/
Yes
No
Yes 9/
No
No
No
No
No
MP
No 10/
56
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING NALED
§158.120 Product Chemistry
(continued)
1/ Naled 90% technical is the only manufacturing-use product.
The cited data may be used to satisfy the requirements for manufacturing-use naled manufactured by the process
submitted by the Chevron Chemical Co. (00074653 and 00074791) containing 90% naled (or similar percentages accepted
on a product by product basis).
2/ Composition: MP = Manufacturing-use product.
3/ All data cited were submitted by the Chevron Chemical Company.
4/ Data must be submitted no later than December 1983.
5/ Adequate data has been submitted by the Chevron Chemical Company. Other producers must address these data
requirements.
6/ The analytical methods used were inadequately described. Identification and quantification of impurities
present at >0.1% (W/W) is required.
7/ There was a discrepancy of the limits. An update of the manufacturing-use naled limits and quality control method
(including validation data); adequate sampling (five or more production batches); and limit certification are required
8/ The data are conflicting. Clarification of the specific gravity of manufacturing-use naled is required.
9/ The data are unclear. Clarification of the flammab.ility of the manufacturing-use naled is required.
10/ May be requested on a case-by-case basis.
57
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING NALED
Data Requirement
Composition
1/
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/
§158.135 Toxicology
ACUTE TESTING
81-1 - Oral LD50 - Rat
81-2 - Dermal LD50 ~ Rabbit
81-3 - Inhalation LC50 ~ Rat
81-4 - Primary Eye
Irritation - Rabbit
81-5 - Primary Dermal
Irritation - Rabbit
81-6 - Dermal Sensitization -
Guinea Pig
MP
MP
MP
MP
MP
MP
Yes
Yes
No
Yes
Yes
No
00049330
00074795
05016607
00065468
00074829*
00074663
00049330
GS092002
GS092001
GS092098
No
No
Yes
No
No
Yes 3/
1/ Composition: MP = Manufacturing-use product.
2/ Data must be submitted no later than December 1983.
3/ Data submitted to the Agency was conducted by Industrial Bio-Test Laboratories (IBT) and has been determined to
be invalid.
*Data submitted by Chevron Chemical Gompany. These data may be compensable.
58
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V. SUBMISSION OF REVISED LABELING AND PACKAGING INFORMATION
Note: This section 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—1 and V-2], as indicated by the following paragraphs of this
section of the guidance document.
You will be informed later when you must submit the revised
labeling set forth in 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 F (Appendix VI-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-l. [40 CFR §162.10(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-l. [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
59
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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-l. [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-l.
[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-l. [40 CFR 5162.10(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 d istinguished
from, other text on the panel. It must not be placed in the
body of other text. See Appendix V-l. [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.
60
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Size of Label
on Front Panel
In Square Inches
Signal Word as Re-
quired Minimum Type
Size All Capitals
"Keep Out of Reach
of Children"
as Required
above 5 to 10
above 10 to 15
above 15 to 30
over 30
5 and under
6 point
10 point
12 point
14 point
18 point
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-l. [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 ¥-1.
[40 CFR §162.10 (h)(1)(i)]
Item 7C. 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-l. [40 CFR
§162.10(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. See Appendix V-l. [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-l. [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 1. [40 CFR §162.10
(h)(2)]
61
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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-l. [40 CFR §162,10
(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. See Appendix V-l. [40 CFR
§162.10(h)(2)(i i)]
Item 8C. PHYSICAL OR CHEMICAL HAZARD
1. Flammability statement. Precautionary statements
relating to flammab.ility 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-flammability. 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) .
62
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3. Declaration of non-flammability. 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-l. [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 r 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-5 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-l. [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.
63
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VI. INSTRUCTIONS FOR SUBMISSION
All applications prepared in response to this Not ice should
be addressed as follows:
William H. Miller
Phone No. (703) 557-2600
Registration Division (TS-7 67)
Office of Pesticide Programs
Environmental Protection Agency
Washington, D.C, 20460
A. For each manufacturing-use 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. Refer to Appendix III-2 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 IV-1).
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.
B. For each affected product for which continued registration
is desired, within 90 days from receipt of this document
submit the "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1, Appendix III-2) with appropriate attachments.
C. You will be informed at a later date when you must submit
your Application for Amended Pesticide Registration (EPA
Form 8570-1) and the revised labeling set forth in this
guidance package.
64
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Appendix III-l
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 explana-
tion. 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 1isted 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
65
-------
Appendix II1-1
(continued)
shown an identifiable 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 fol-
lowing 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 with in 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.
6 6
-------
Appendix III-l (continued)
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
00028757 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary
Tbxicities of Environmental Pollutants to Birds. By U.S. Fish
and Wildlife Service, Patuxent Wildlife Research Center. Wash-
ington, D.C.: U.S. Fish and Wildlife Service. (Special scienti-
fic report—wildlife no. 191; also in unpublished submission re-
ceived Apr 2, 1980 under 464-556; submitted by Dow Chemical
U.S.A., Midland, Mich.; CDL:242149-F)
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.)
00037799 Johansen, C. (1961) Bee Poisoning Investigations, 1961: Report
No. 8577. (Unpublished study received Mar 26, 1975 under 3125-
EX-119; prepared by Washington State Univ., submitted by Mobay
Chemical Corp., Kansas City, Mo.; CDL:094390-1)
00049330 Gaines, T.B. (1969) Acute toxicity of pesticides. Toxicology and
Applied Pharmacology 14:515-534. (Report no. 25529; also in
unpublished submission received Jul 15, 1976 under 3125-EX-135;
submitted by Mobay Chemical Corp., Kansas City, Mo.; CDL:
226487-E)
00059386 Casida, J.E.; McBride, L.; Niedermeier, R.P. (1961) Metabolism of
0,0-Dimethyl 2,2-dichlorovinyl phosphate (Vapona (R) or DDVP)
in Relation to Residues in Milk and Mammalian Tissues. (Unpub-
lished study received on unknown date under unknown admin, no.;
prepared by Univ. of Wisconsin, Depts. of Entomology and Dairy
Husbandry, submitted by Shell Chemical Co., Washington, D.C.;
CDL:120596-C)
00060628 Johansen, C.A.; Eves, J. (1965) Bee Poisoning Investigations, 1965:
Report No. G-1705; Report No. 17338. (Unpublished study, in-
cluding letter dated Jun 12, 1973 from C.A. Johansen to A.D. Co-
hick, received Mar 27, 1974 under 4F1485; prepared by Washington
State Univ., Dept. of Entomology, submitted by Chemagro Corp.,
Kansas City, Mo.; CDL:092011-1)
00064796 Pack, D.E. (1980) Mobility of Naled and Dichlorvos in Soil As De-
termined by Soil Thin-layer Chromatography: File No. 722.2.
(Unpublished study received Oct 20, 1980 under 239-1633; submit-
ted by Chevron Chemical Co., Richmond, Calif.; CDL:243547-A)
67
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Appendix III-l (continued)
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
00065468 Berteau, P.E.; Deen, W.A.; Dimmick, R.L. (1976) Studies of Effects
of Particle Size on the Toxicity of Insecticide Aerosals. Final
rept. By Univ, of California—Berkeley, Naval Biosciences Labo-
ratory for U.S. Dept. of the Army. N.P. (Contract no. MIPR-
5962; published study; CDL:229222-A)
00065493 Chevron Chemical Company (19??) Composition of Technical Naled.
(Unpublished study received Mar 19, 1976 under 239-2444; CDL:
229289-F)
00065494 Hayman, E.L.; Friedrich, W.E.; Carlstrom, A.A, (1971) Deteraiina-
ticn of Impurities in Technical Dibrom. (Unpublished study
received Mar 19, 1976 under 239-2444; submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:229289-H)
00072816 Dow Chemical U.S.A. (19??) Results of Tests on the Amount of Resi-
due Remaining, Including a Description of the Analytical Method:
Chlorpyrifos, (Unpublished study received Mar 13, 1973 under
3F1370; CDL.-093656-K)
00073815 Chevron Chemical Company (1971) Bromide Ion Residues Resulting from
the Use of Dibrom (R) (Naled) on Forage Crops. (Compilation;
unpublished study, including test nos. T-2175 and T-2176, re-
ceived Sep 21, 1972 under 0F0975; CDL:091678~A)
00073816 Chevron Chemical Company (1972) Total Bromide Ion Levels in
Alfalfa, Pasture and Range Grass. (Compilation; unpublished
study received on unknown date under 0F0975; CDL:091678-B)
00073817 Chevron Chemical Company (1972) Bromide Ion Concentrations of
Grapes Treated with Naled. (Compilation; unpublished study
received on unknown date under 0F0975? CDL:091678-C)
00073818 Chevron Chemical Coitpany (1971) Residue Data Sheets of Naled on
Alfalfa; Test No. T-2177. (Compilation; unpublished study,
including test no. T-2178, received Aug 20, 1973 under 0F0975;
CDL:091679-E)
00073819 Chevron Chemical Company (1971) Residue Data Sheets of Naled on
Sugar Beets: Test No. T-2179. (Compilation; unpublished study
received Aug 20, 1973 under 0F0975; CDL:091679-F)
00073820 Chevron Chemical Company (1966) Dibrom (R) Naled: The Results of
Tests on the Amount of Residue Remaining Including a Description
of the Analytical Methods Used. Includes residue methods RM-3
dated Jul 28, 1966, RM-3A dated Aug 18, 1966, RM-3C dated Aug
22, 1966 and RM-3E dated Aug 16, 1966. (Compilation; unpub-
lished study received Sep 20, 1966 under 7F0532; CDL:090647-A)
68
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Appendix ITI-1 (continued)
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
00073821 Chevron Chemical Company (1970) Dibrom (R) Naled: The Results of
Tests on the Amount of Residue Remaining Including a Description
of the Analytical Methods Used. Includes methods RM-3 dated Jul
28, 1966, RM-3A dated Aug 18, 1966 and RM-3G dated Oct 31, 1969.
(Compilation; unpublished study received Mar 27, 1970 under
0F0975; CDL:091677-A)
00073830 Chevron Chemical Company (1974) Summary of Almond Residue Trials,
(Compilation; unpublished study received Apr 7, 1975 under
5F1614; CDL: 094559-B)
00073846 Chevron Chemical Company (1970) Dibrom (R) Naled: Hie Results of
Tests on the Amount of Residue Remaining, Including a Descrip-
tion of the Analytical Methods Used. (Compilation; unpublished
study received on unknown date under 1F1078; CDL:093389-B)
00074643 Pack, D.E. (1976) Residues of Naled and DDVP in Aquatic Organisms
Living in Dibrom 14 Treated Water: File No. 721.11/Dibrcm S-249.
Includes method RM-3G-3 dated Feb 23, 1973. (Unpublished study,
including letter dated Mar 24, 1976 from J.B, Leary to Michael
L. Paulson, received Apr 8, 1976 under 1769-203; prepared by
Chevron Chemical Co., submitted by National Chemsearch, Div. of
NCH Corp., Irving, Ttex.; CDL:224602-A)
00074644 Leary, J.B. (1974) Rate of Decay of Naled in Sewage Water: File
No. 721.2. (Unpublished study received Dec 30, 1974 under 1769-
203; prepared by Chevron Chemical Co., submitted by National
Chemsearch, Div. of NCH Corp., Irving, Tex.; CDL:224603-B)
00074645 Leary, J.B.; Miesch, M.D., Jr. (1974) National Chemsearch Skychoda
Fate of Naled in a Sewage Treatment Plant: File No. 721.2.
(Unpublished study received Dec 30, 1974; May 12, 1976 under
1769-203; prepared by Chevron Chemical Co., submitted by Nation-
al Chemsearch, Div. of NCH Corp., Irving, Tex.; CDL:224603-C)
00074647 Chevron Chemical Company (1966) Analysis of Dibrom
-------
Appendix III-l (continued)
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
00074655 Chevron Chemical Company (1966) Qrtho Method of Analysis—D-IX-a:
Dibrem (R) Naled by Gas Chromatograph. Method dated May 27,
1966. (Unpublished study received Sep 12, 1966 under 7F0532;
CDL:092821-J)
00074656 Schwartz, C.S.y Cox, G.E.; Stevens, K.R. (1978) The Evaluation of
Dibrom as a Potential Neurotoxic Agent following Oral Adminis-
tration to Hens Protected by Atropine Sulfate: Laboratory
No. 5981. (Unpublished study received Dec 21# 1978 under 239-
1633; prepared by Food and Drug Research Laboratories, Inc.,
submitted by Chevron Chemical Co., Richmond, Calif.? CDL;
236682-A)
00074663 Elsea, J.R. (1958) Acute Dermal Application. Rev. (Unpublished
study received Sep 20, 1966 under 7P0532; prepared by Hazleton
Laboratories, submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:090644-E)
00074684 Chevron Chemical Coitpany (1960) Toxicology Reports: Dibrem in Oys-
ters. (Compilation; unpublished study received Sep 20, 1966
under 7F0532; CDL:090646-N)
00074691 Leary, J.B. (1971) Rate of Hydrolysis of Naled in Aqueous Solution:
File No. 721.2. (Unpublished study received Jul 30, 1971 under
1F1111; submitted by Chevron Chemical Co., Richmond, Calif.;
CDL:090881-A)
00074692 Chevron Chemical Company (1971?) Description of a Residue Test (T-
2360) To Determine Bromide Ion Residues in Poultry Tissue and
Eggs following the Application of Ortho Fly Killer D (36% Naled)
in Poultry Houses and on Laying Hens: File No. 741.11. (Unpub-
lished study received Mar 4, 1972 under 1F1111; CDL:090881-B)
00074699 Kohn, G.K. (1959) Letter sent to G.S. Hensill dated Dec 16, 1959:
Dibrom residues—pole beans. (Unpublished study received Jan
14, 1960 under 239-1281; submitted by Chevron Chemical Co.,
Richmond, Calif,; CDL:119766-A)
00074700 Chevron Chemical Company (1965) Dibrom Residues in Spinach, Grain
Sorghum and Cotton. (Compilation; unpublished study received
Jul 9, 1965 under unknown admin, no.; CDL:124538-A)
00074721 Chevron Chemical Company (1957?) Analysis of Dibrom Residues.
Undated method RM-III. (Unpublished study received Feb 19, 1958
under unknown admin, no.; CDL:119738-A)
70
-------
Appendix (continued)
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
00074722 Kohn, G.K. (1958) Letter sent to G.S. Hensill dated Feb 14, 1958:
Dibrom residues. (Unpublished study received Feb 19, 1958 under
unknown admin, no.; submitted by Chevron Chemical Co., Richmond,
Calif.,- CDL: 119738-8)
00074723 Chevron Chemical Company (1964) Residue Data Sheets: Dibrom in
Rice: Test No. T-508. (Compilation; unpublished study, includ-
ing test nos. T-551 and T-544, received Mar 12, 1965 under un-
known admin, no.? CDL:119745-F)
00074724 Ospenson, J.N. (1958) Letter sent to G.K. Kohn dated Feb 4, 1958:
Dibrom—physical and chemical properties. Includes method dated
Apr 3, 1957. (Unpublished study received Feb 10, 1958 under un-
known admin, no.? submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:119717-A}
00074725 Chevron Chemical Company (19??) Proof of Recovery of Dibrom from
Fortified Crop Extracts Utilizing Standard Procedure. (Unpub-
lished study received Jan 23, 1959 under unknown admin, no.?
CDL:119737-A)
00074728 Sessions, A.? Pack, D.E. (1959) Residue Data Sheet: Grapes: Test
No. T-76. (Unpublished study received Jan 23, 1959 under un-
known admin, no.; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:119737-D)
00074729 Wegenek, E.G.; Pack, D.E. (1959) Residue Data Sheet: Beans: Test
No. T-87. (Unpublished study received Jan 23, 1959 under un-
known admin. no.; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:119737-E)
00074759 Leary, J.B. (1970) Decomposition of Naled and DDVP in Soils: File
No. 721.2. (Unpublished study received Nov 27, 1970 under un-
known admin, no.; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:120336~A)
00074790 Chevron Chemical Company (1965?) Product Chemistry Data for Chevron
Naled Technical. (Unpublished study received Oct 17, 1977 under
239-1633; CDL:232095-A)
00074791 Chevron Chemical Company (19??) Naled (l,2~Dibromo-2,2-dichloro-
ethyl Dimethyl Phosphate): Manufacturing Process. (Unpublished
study received Oct 17, 1977 under 239-1633; CDL:232095)
71
-------
Appendix III-l (continued)
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
00074795 Chevron Chemical Company (19??) Acute Oral Toxicity—Albino Rats:
Summary of Reactions. (Unpublished study received Feb 2, 1959
under 239-1280? CDL:050010~D)
00074806 California Chemical Company (1961) Project Report—Dibrom Residue:
Analytical Procedures; File 740.10. (Unpublished study received
Feb 21, 1963 under PP0330; CDL:090359-D)
00074807 Ospenson, J.N. (1963) Letter sent to G.K. Kohn dated Feb 14, 1963:
Dibrom and metabolite residue studies on oranges and lettuce.
(Unpublished study received Feb 21, 1963 under PP0330; submitted
by California Chemical Co., Richmond, Calif.; CDL:090359-1)
00074817 Vfeir, R.J. (1958) Final Report: Subacute Feeding—Rats. (Unpub-
lished study received Feb 13, 1959 under 239-1281; prepared by
Hazleton Laboratories, submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:050424-D)
00074829 Narcisse, J.K.; Cavalli, R.D. (1971) Acute Dermal Toxicity of Naled
Technical and Dibrom 8E: SOCAL 212/VI:41 (S-293). (Unpublished
study received Jan 4, 1974 under 239-1281; submitted by Chevron
Chemical Co., Richmond, Calif.; CDL:050854-A)
00074836 California Chemical Company (1960) Summary of Typical Dibrom Resi-
due Data in This Petition. (Compilation; unpublished study re-
ceived Sep 1, 1961 under PP0330; CDL:090357-J)
00074843 Ives, M. (1962) Report to Ortho Division—California Chemical Com-
pany: Demyelination Studies in Chickens—Dibrom. (Unpublished
study received Aug 20, 1962 under PP0330; prepared by Industrial
Bio-Test Laboratories, Inc., submitted by California Chemical
Co., Richmond, Calif.; CDL:090358-G)
00074844 Casida, J.E.; McBride, L.; Niedermeier, R.P. (1961) Metabolism of
0,0-Dimethyl 2,2-Dichlorovinyl Phosphate (Vapona (R) or DDVP)
in Relation to Residues in Milk and Mammalian Tissues. (Unpub-
lished study received Aug 20, 1962 under PP0330; prepared by
Univ. of Wisconsin, Depts. of Entomology and Dairy Husbandry,
submitted by California Chemical Co., Richmond,
090358-H)
00074845 Chevron Chemical Coitpany (1973) Summary and Data on Residues of
Naled in Cotton and Safflower. (Compilation; unpublished study
received Jan 9, 1974 under 1F1078: CDL:093391-A)
72
-------
Appendix III-l (continued),
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
00074846 Chevron Chemical Company (1964) Analysis of Dibrom. Method dated
Jul 21, 1964, (Unpublished study received Jun 23, 1965 under
unknown admin, no.? CDL:102845-A)
00074862 Weir, R.J. (1958) Final Report: 90-day Oral Administration—Dogs.
(Unpublished study received Jun 12, 1958 under unknown admin,
no.; prepared by Hazleton Laboratories, submitted by Chevron
Chemical Co., Richmond, Calif.; CDL.-102887-A)
00074885 Chevron Chemical Company (1969) Analysis of Naled and DDVP Resi-
dues: File No. 740.01. Method RM-3G dated Oct 31, 1969. (Un-
published study received Nov 30, 1970 under 0F0975; submitted
by Chevron Chemical Co., Richmond, Calif.; CDL:095468-A)
00075668 Chevron Chemical Company (1961) Residue of Dibrom on the Tbmato
and Cucumber: CSC-513 No. 502-6. (Compilation; unpublished
study, including report nos. CSC-513 no. 502-5, CSC-513 no.
502-4, CSC-513 no. 502-2 and CSC-513 no. 502-3, received Jul 24,
1961 under 239-1466; CDL:119776-A)
05000837 Johansen, C.A. (1972) Toxicity of field-weathered insecticide
residues to four kinds of bees. Environmental Entomology
1(3):393-394.
05003107 Macek, K.J.; Hutchinson, C.j Cope, O.B. (1969) The effects of
temperature on the susceptibility of bluegills and rainbow
trout to selected pesticides. Bulletin of Environmental
Contamination and Toxicology 4(3):174-183.
05016607 Brzezicka-Bak, M.; Bojanowska, A (1969) Toksycznosc Podostra
insektycdow fosforoorganicznych: naledu, etoatu metylowego i
supracidu Subacute toxicity of the organophosphorus
insecticides naled, methyl ethoate and supracide Roczniki
Panstwowego Zakladu Higieny. Annals of the Polish Institute
of Hygiene. XX(4):463-469.
73
-------
Appendix III-l (continued)
OFFICE OF PESTSICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
GS092001 Bullock, C. H. and J. K. Narcisse. 1975. Bie skin irritation
potential of Dibrcm-14 Concentrate (CC 5511). Study No.
S-741, Standard Oil Company of California, SOCAL 659/XX:115,
November 19, 1974.
GS092002 Bullock, C.H., and J.K. Narcisse. 1975. The eye irritation
potential of Dibram-14 Concentrate (CC 5511). Study No.
S-742, Standard Oil Company of California, SOCAL 659/XX:114,
November 19. 1974.
GS092006
GS092017
GS092026
GS092040
GS092090
Carlstrora, A.A. 1975. Gas-liquid chromatographic determination
of naled in pesticide formulations, JAGAC 58(6)tll62-1168.
Dean, H.J, J.R. Colquhoun, H.A. Simonin. 1977. Toxicity of
Methoxychlor and Naled to Several Life Stages of Landlocked
Atlantic Salmon. N.Y. Fish and Game J. 24:144-153.
California Spray-Chemical Corporation. 1959. 14-Day milk
residue study - dairy animals. Unpublished study prepared
by Hazelton Laboratories for Chevron Spray Chemical Cor-
poration, and submitted under 1F1111.
Chevron Chemical Company. 1966. Name, Chemical Identity and
Composition of the Pesticide Chemical; Dibrom. (Unpub-
lished study received Oct 22, 1974 under 239-163,
Accession No. 233083).
Chevron Chemical Company. 1981. [Ethyl-l-14C]Naled Plant
Metabolism. Pages 6-30 in Metabolism chemistry data for
Chevron Naled Technical. (Received Oct. 14, 1981 under
unknown admin, no.)
GS092091 Casida, J.E., L. McBride, and R.P. Niedermeier. 1962. Metab-
olism of 2,2-dichlorovinyl dimethyl phosphate in relation
to residues in milk and mammalian tissues. J. Agric. Food
Chem. 10:370-377.
GS092092 Chen, Y.S., 1981. Metabolism of (Ethyl-l-14C] Naled in a
Lactating Goat. Unpublished study received March 4, 1982,
under 239-1633; submitted by Chevron Chemical Company,
Richmond, California.
GS092093 Chevron Chemical Company. 1969. Naled residues in mushrooms.
Unpublished study prepare by Green Giant Co., and submitted
under 1E1100 by Chevron Chemical Company.
74
-------
Appendix III-l (continued)
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
GS092094 Lynn, G.E. et al. 1962? Studies of the Occurrence of Bromides
in the Milk of Cows Fed Sodium Bromide and Grain Fumigated
with Methyl Bromide. Study received Jan. 8, 1962, under
Pesticide Petition No. 345; submitted by Hie Dew Chemical
Co., Midland, Michigan.
GS092095 Chevron Chemical Company. 1970. Naled pasture and milk
residue study. Unpublished study submitted under 0F0975.
GS092096 Getzendaner, M. E., 1963. A study of Bromide Residues in
Chicken Tissues and Eggs from Ingestion of Methyl Bromide
Fumigated Feed. Study received June 5, 1963, under Pesti-
cide Petition No. 345; submitted by the Dow Chemical Company.,
Midland, Michigan.
GS092097 Lough, R.L., P. Batham, C. Bier, B. Legg, P, Aran jo, J. W.
Hooper, B. Broxup, B. E. Osborne, and B. G. Proctor.
1981. DTBROM^: Four week subchronic oral toxicity
study in rats. (Conducted by BioResearch Laboratories,
Ltd., 87 Senneville Rd., Senneville, Quebec H9X 3R3, Canada,
for Chevron Chemical (Canada) Ltd., 3228 South Service
Rd., Burlington, Ontario L7N 3H8, Canada. Unpublished
report. EPA Accession No. 246496.)
GS092098 Phillips, L., Steinberg, M., Maibach, H. I., and Akers, W.A.
1972. Comparison of rabbit and human skin response to
certain irritants. Toxicol. Appl. Pharmacol. 21:369-382.
GS092099 Tucker, R.K. and P.G. Crabtree. 1970. Handbook of Toxicity of
Pestsicides to Wildlife. Bur. Sport Fisheries and Wildlife,
EWRC, Fish and Wildlife Service, USDI. Publ. 84.
GS092100 Wheeler, R.E. 1972. 48 Hour Acute Static Toxicity of Naled
(SX820) to 1st Stage Nymph Water Fleas (Daphnia magna straus),
(Unpublished ??).
GS092101 USEPA. 1977. Biological Report of Analysis. Static Jar Test
No. 1061. Animal Biology Laboratory, Jan 13, 1977.
(Unpublished),
GS092102 USEPA. 1971. Fish toxicity laboratory report. Test No. 304.
Animal Biology Laboratory, May 11-17, 1971. (Unpublished).
GS092103 Shiau, S.T., R.A. Huff, and I.C. Felkner. 1981. Pesticide
mutagenicity in Bacillus subtilis and Salmonella typhimurium
detectors. J. Agric. Fd. Chem. 29:268-271.
GS092104 Haskin, H. and R.G. Haines. 1960. Fish and Wildlife Toxicity
Report. Chevron Chemical Co. OR-513, No. 241-36-38.
August 31, 1960.
75
-------
APPENDIX III-2 OMB Approval No. 2000-04S8 (Expires 12-31-83)
FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by the FIFRA section 3(C)(2)(B) notice contained in the referenced
Guidance Document, 1 am responding in the following manner:
~ 1. I will submit data in a timely manner to satisfy the following requirements. If the test procedures 1 will use deviate from (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, GECD
Chemicals Testing Programme, I enclose the protocols that I will use:
D 2, I have entered into an agreement with one or more other registrants under F1FRA section 3(C)(2)(B)(ii) to satisfy the following data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
EH 3. I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements:
CI 4. 1 request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
~ 5, I request voluntary cancellation of the registration of this product. (This option is not available to applicants for new products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
run 8580-1 (10-82)
7 5-A
-------
APPENDIX II1-3
OMB Approval No, 2000-0468 (Expires: 12-31-83)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
(To qualify, certify ALL four items} pOR DEVELOPMENT OF DATA
1. f am duly authorized to represent the following firm(s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
guidance document date
ACTIVE INGREDIENT
NAME OF FIRM
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 jointly, or to share in the cost of developing, the following required
items or data;
3. My firm has offered in writing to enter into such an agreement. Copies of the offers are attached. That offer was irrevocable and included an offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii! if final agreement on all terms could not be reached otherwise. This offer was made
to the following firm(s) on the following date(s):
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accepted mv 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) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B). (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
DATE
Form 8580-6 (10-82)
-------
Appendix IV-1
PRODUCT SPECIFIC DATA REPORT
EPA Registration No. Guidance Document for
Date
-| ^ | Test not | |
1 [required!I am complying with 1
I I for my [data requirements byl
I (product I |Submit-I
j 1listed | |ting j
| |above j jData ((For EPA Use Only)
Registration ! I(check | I(At- 1Accession Numbers
Guideline No. j Name of Test jbelow) j Citing MRTD# 1 tached) j Assigned
§158,20 1
PRODUCT i
CHEMISTRY j
61-1
! Identity of I |
I ingredients | j
1 1
1 1
61-2
I Statement of [ 1
I composition I |
1 1
I 1
61-3
j Discussion of | j
I formation of | |
I ingredients | |
1 1
1 1
I 1
62-1
I Preliminary | 1
I analysis 1 1
I i
1 1
62-2
I Certification of [ j
j limits I I
1 1
I 1
62-3
I Analytical methods 1 I
| for enforcement | |
1 limits 1 I
i 1
1 !
I 1
63-2
I Color | |
I 1
63-3
I Physical state | 1
1 1
63-4
I Odor j I
i 1
63-5
I Melting point j |
! I
63-6
I Boiling point | |
1 I
63-7
| Density, bulk- | |
I density, or | j
I specific gravity | I
1 i
1 1
I !
63-8
| Solubility | |
I I
63-9
I Vapor pressure 1 |
1 1
63-10
I Dissociation | |
I constant | |
1 1
1 !
7 6
-------
Appendix IV-1
PRODUCT SPECIFIC DATA REPORT
EPA Registration No. Guidance Document for
Date
I Test not| I
I required11 am complying with I
|for my [data requirements by|
(product | |Submit-i
Ilisted | I ting 1
I above 1 |Data ](For EPA Use Only)
Registration | I(check | I(At- (Accession Numbers
Guideline No.I Name of Test [below) [Citing MRID#1tached)|Assigned
63-12
1 PH !
1 1 i
63-13
I Stability I
1 1 I
63—14
I Oxidizing/reducing|
| reaction |
1 1 1
1 II
63-15
| Flammability |
1 1 I
63-16
1 Explodability |
1 1 1
63-17
1 Storage stability |
I 1 1
63-18
| Viscosity |
I 1 I
63-19
I Miscibility |
I 1 1
63-20
[ Corrosion I
I characteristics I
I 1 1
1 I 1
63—21
I Dielectric break- I
I down voltage I
1 1 1
1 I 1
§158.135
1 1
1 1
1 I 1
1 1 I
TOXICOLOGY
1 1
1 1
1 1 1
1 1 I
81-1
I Acute oral LD-50, |
I rat I
1 I 1
I I I
81-2
I Acute dermal |
I LD-50 I
1 1 1
1 1 1
81-3
I Acute inhalation, I
j LC-50 rat |
1 I 1
1 I 1
81-4
I Primary eye 1
I irritation, rabbit|
I 1 I
i 1 I
81-5
| Primary dermal j
I irritation |
I 1 1
1 ! I
81-6
j Dermal sensitiza- I
I tion I
I I 1
1 I 1
77
-------
APPENDIX V—2
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED (REFER ID THE SAMPLE LABELS FOLLOWING)
APPLICABILITY |
PLACEMENT ON LABEL
ITEM
I LABEL ELEMENT
OF REQUIREMENT I
REQUIRED
PREFERRED
COMMENTS
1
I Product name
1
All products |
Front panel
Center front
panel
2
1 Company name
I and address
1
All products |
None
Bottom front
panel or end
of label text
If registrant is not the producer, must
be qualified by "Packed for . .
"Distributed by. . .," etc.
3
I Net contents
1
1
All products I
None
Bottom front
panel or end
of label text
May be in metric units in addition to
U.S. units
4
I EPA Est. No.
1
All products I
None
Front panel
Must be in similar type size and run
parallel to other type.
5
I EPA Reg. No.
1
1
1
1
All products |
None
Front panel,
immediately
before or
following
Reg. No.
May appear on the container instead of
the label.
6A
I Ingredients
| statement
1
All products I
Front panel
Immediately
following
product name
Text must run parallel with other text
on the panel.
6B
I Pounds/gallon
| statement
1
1
Liquid products |
where dosage I
given as lbs. I
ai/unit area |
Front panel
Directly below
the main
ingredients
statement
7
I Front panel
| precautionary
| statements
All products I
Front panel
All front panel precautionary statements
must be grouped together, preferably
blocked.
7A
I Keep Out of Reach
1 of Children
I (Child hazard
| warning)
All products |
Front panel
Above signal
word
Note type size requirements.
7B
I Signal word
1
1
1
All products |
Front panel
Immediately
below child
hazard
warning
Note type size requirements.
78
-------
APPENDIX V-2 (continued)
1
| APPLICABILITY |
PLACEMENT ON LABEL
1
ITEM
| LABEL ELEMENT
I OF REQUIREMENT |
REQUIRED |
PREFERRED
I COMMENTS
7C
i Skull & cross-
I bones and word
I POISON (in red)
1
1
1
I All products |
I which are Cat- |
| egory I based |
I on oral, der- |
I mal, or inhala- |
I tion toxicity |
Front panel |
1
1
1
1
1
Both in close
proximity to
signal word
1
1
1
1
1
1
7D
I Statement of
1 practical
I treatment
1
1
1
1
1
1
1
I All products I
1 in Categories |
1 I, II, and III |
1 1
1 1
1 1
1 1
1 1
1 1
1 1
Category I: I
Front panel |
unless refer-|
ral statement|
is used. |
Others: j
Grouped with |
side panel |
precautionary|
statements. |
Front panel
for all.
1
1
1
1
1
1
1
1
1
1
7E
I Referral
I statement
1
1
1
1
1
| All products I
I where pre- |
I cautionary |
I labeling |
I appears on |
1 other than |
| front panel. |
Front panel |
1
1
1
1
1
1
1
1
1
1
1
1
1
8
I Side/back, panel
I precautionary
I statements
1
1
I All products |
1 1
1 1
1 1
1 1
None |
1
1
1
1
Top or side
of back panel
preceding
directions
for use
1 Must be grouped under the headings in
I 8A, 8B, and 8C; preferably blocked.
1
1
1
8A
I Hazards to
I humans and
I domestic
I animals
| All products |
I in Categories |
I I, II, and III |
1 1
None |
1
1
1
Same as above
1 Must be preceded by appropriate signal
1 word.
1
1
8B
I Environmental
I hazards
1 All products I
1 1
None |
1
Same as above
I Environmental hazards include bee
I caution where applicable.
79
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APPENDIX V-2 (continued)
| APPLICABILITY |
PLACEMENT ON LABEL
1
ITEM
I LABEL ELEMENT
I OF REQUIREMENT |
REQUIRED |
PREFERRED
I COMMENTS
8C
1 Physical or
I chemical
I hazards
I All pressurized |
I products, others!
I with flash |
I points under |
I 150°F |
None |
1
1
1
1
Same as above
1
1
1
1
1
9A
I Restricted
I All restricted |
Top center |
Preferably
I Includes a statement of the terms of
I block
I products |
1 1
1 1
of front |
panel |
1
blocked
I restriction. The words "RESTRICTED USE
1 PESTICIDE" must be same type size as
1 signal word.
9C
I Misuse
I statement
| All products |
1 1
1 1
1 1
1 1
1 1
1 1
1 1
Immediately |
following |
statement of|
classifica- |
tion or |
ahead of |
directions |
for use I
1
1
1
1
1
1
1
1
10A
| Re-entry
I statement
1 All |
1 cholinesterase |
I inhibitors I
In the |
directions |
for use |
Immediately
after misuse
statement
1
1
1
10C
| Storage and
I disposal block
| All products |
1 1
1 1
1 1
1 1
1 1
1 1
1 1
In the |
directions I
for use I
1
1
1
1
1
Immediately
before
specific
directions
for use or
at the end of
directions
for use
1 Must be set apart and clearly distin-
I guishable from from other directions
I for use.
I
1
1
I
1
10D
I Directions
I All products I
None |
None
1 May be in metric as well as U.S. units
U.S.
I for use
1 1
1
1
80
-------
Appendix V-3
PHYSICAL—CHEMICAL HAZARDS
Criteria
I. Pressurized Containers
Required Label Statement
Flashpoint at or below
20°F? or if there is a
flashback at any valve
opening.
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.
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.
C. ALL OTHER PRESSURIZED
CONTAINERS
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 incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
II
Non-Pressurized Containers
A. Flashpoint at or below
20°F.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
B. Flashpoint above 20°F
and over 80°F.
Flammable. Keep away from
heat and open flame.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150 ° F.
Do not use or store near
heat and open flame.
None required.
81
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Appendix ¥-5
STORAGE AND DISPOSAL INSTRUCTIONS FOR PESTICIDES
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." The STORAGE AND DISPOSAL heading
must appear in the minimum type size listed below:
iSize of label
I front panel in
square inches
Required type size
for the heading
STORAGE AND DISPOSAL
(all capitals)
110 and under 6 point
|Above 10 to 15 . 8 point
[Above 15 to 30 .... 10 point
|Over 30. ..... 12 point
Storage and disposal instructions must be set apart and
clearly distinguishable from other directions for use.
Blocking storage and disposal statements with a solid line is
suggested as a means of increasing their prominence.
A. 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.
82
-------
Appendix ¥-5
(continued 5
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.
B. 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
appearing on the "Acutely Hazardous" Commercial Pesticide
Products List (RCRA "E" List) at the end of this appendix
or are assigned to Toxicity Category I on the basis of
oral or dermal toxicity, skin or eye irritation potential,
or Toxicity Category I or II on the basis of acute inhala-
tion toxicity must bear the following pesticide disposal
statement:
"Pesticide wastes are acutely hazardous. Improper dis-
posal 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."
The labels of all products, except those intended for
domestic use, containing active or inert ingredients
that appear on the "Toxic" Commercial Pesticide Products
List (RCRA "F" List) at the end of this appendix or
presently meet any of the criteria in Subpart C, 40 CFR
261 for a hazardous waste must bear the following pesticide
disposal statement:
83
-------
Appendix V-5
(continued)
"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."
Labels for all other products, except those intended for
domestic use, must bear the following pesticide disposal
statement:
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
fac ility."
3. 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."
C. Container Disposal Instructions
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. All products intended for domestic use must bear one
of the following container disposal statements:
Container Type Statement
I Non-aerosol products | Do not reuse container (bottle f can, jar). j
[(bottles, cans, jars)I Rinse thoroughly before discarding in trash.]
I Non-aerosol products | Do not reuse bag. Discard bag in trash. 1
I (bags) j |
I Aerosol products I Replace cap and discard containers in 1
j 1 trash. Do not incinerate or puncture. ]
2. The labels for all other products must bear container disposal
instructions, based on container type, listed below:
Container Type
Statement
Metal
containers
(non-aerosol)
Triple rinse (or equivalent). Then offer |
for recycling or reconditioning, or puncturej
and dispose of in a sanitary landfill, or by'
other procedures approved by state and local!
authorities. I
iPlastic containers
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,
Glass containers
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
84
-------
Appendix V-5
(continued)
Container Type
Statement
I Fiber drums
Iwith liners
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^f dispose of in the same manner.
I Paper and
I plastic bags
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
I Compressed gas
[cylinders
Return empty cylinder for reuse (or
similar wording).
^Manufacturer may replace this phrase with one indicating whether
and how fiber drum may be reused.
2. The labels for all other products must bear container
disposal instruct ions, based on container type, listed
on the first page of this Appendix.
85
-------
Appendix V-5
(continued)
Pesticides that are hazardous wastes under 40 CFR 261.33(e) and
when discarded.
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients, (no inerts);
Acrolein
Aldicarb
Aldrin
Allyl alcohol
Aluminum phosphide
4-Aminopyridine
Arsenic acid
Arsenic pentoxide
Arsenic trioxide
Calcium cyanide
Carbon disulfide
p-Chloroaniline
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2-Cyclohexyl-4,6-dinitrophenol
Dieldrin
0 ,0-Diethy1 S- I 2-ethylthio ) ethyl J phosphorodithioate
(disulfoton, Di-Syston)
0,0-Diethy1 0-pyraziny1 phosphorothioate (Zinophos)
Dimethoate
0r0-Dimethyl O-p-nitrophenyl phosphorothioate (methyl parathion)
4,6-Dinitro-o-cresol and salts
4,6-Dinitro-o-cyclohexylphenol
2,4 Dinitrophenol
Dinoseb
Endosulfan
Endothall
Endrin
Famphur
Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
Hydrogen cyanide
Methomyl
alpha-Naphthy1thiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion
86
-------
Appendix V-5
(continued)
"Acutely Hazardous" Commercial Pesticides (RCRA "E" List)
Active Ingredients continued;
Phenylmercuric acetate (PMA)
Phorate
Potassium cyanide
Propargyl alcohol
Sodium azide
Sodium cyanide
Sodium fluoroacetate
Strychnine and salts
0,0,0,0-Tetraethyl dithiopyrophosphate (sulfotepp)
Tetraethyl pyrophosphate
Thallium sulfate
Thiofanox
Toxaphene
Warfarin
Zinc phosphide
There are currently no inert ingredients for commercial pesticides
on the "Acutely Hazardous" List (RCRA "E" List).
87
-------
Appendix V-5
(continued)
"Toxic" Commercial Pesticide Products {RCRA "F" List)
Active Ingredients:
Acetone
Acrylonitrile
Amitrole
Benzene
Bis(2-ethylhexy1)pthalate
Cacodylic acid
Carbon tetrachloride
Chloral (hydrate)
Chlordane (technical)
Chlorobenzene
4-Chloro-m-cresol
Chloroform
o-Chlorophenol
4-Chloro-o-toluidine hydrochloride
Creosote
Cresylic acid
Cyclohexane
Decachlorooctahydro-1,3,4-raetheno-2H-cyclobuta[c,d]-pentalen-2-one
(kepone, chlordecone)
1,2-Dibromo-3-chloropropane (DBCP)
Dibutyl phthalate
5-3,3-(Dichloroallyl diisopropylthiocarbamate (diallate, Avadex)
o-Dichlorobenzene
p-Dichlorobenzene
Dichlorodifluoromethane (Freon 12®)
3,5-Dichloro-N-(1,l-dimethyl-2-propynyl) benzamide (pronamide,Kerb)
Dichloro diphenyl dichloroethane (DDD)
Dichloro diphenyl trichloroethane (DDT)
Dichlorethyl ether
2,4-Dichlorophenoxyacetic, esters and salts (2,4-D)
1.2-Dichloropropane
1.3-Dichloropropane (Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl 4,4'-dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (EDB)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocyclopentadiene
Hexachloroethane
Hydrofluoric acid
88
-------
Appendix V-5
(continued)
"Toxic" Commercial Pesticide Products (RCRA "F" List)
Active Ingredients;
Isobutyl alcohol
Lead acetate
Lindane
Maleic hydrazide
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2,2'-Methylenebis (3,4,6-trichlorophenol) (hexachlorophene)
Methylene chloride
Methyl ethyl ketone
4-Methyl-2-pentanone (methyl isobutyl ketone)
Naphthalene
Nitrobenzene
p-N itrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentaclorophenol
Phenol
Phosphorodithioic acid, 0,0-diethyl, methyl ester
Propylene dichloride
Pyridine
Resorcinol
Safrole
Selenium disulfide
Silvex
1.2.4.5-Tetrachlorobenzene
1,1,2,2-Tetrachloroethane
Tetrachloroethylene
2.3.4.6-Tetrachlorophenol
Thiram
Toluene
1,1,1-Trichloroethane
Trichloroethylene
Trichloromonofluoromethane (Freon 11®)
2.4.5-Trichlorophenol
2.4.6-Trichlorophenol
2,4,5-Trichlorophenoxyacetic acid (2,4,5-T)
Xylene
89
-------
Appendix V-5
(continued)
"Toxic" Commercial Pesticide Producls (RCRA "P" List)
Inert Ingredients;
Acetone
Acetonitrile
Acetophenone
Acrylic acid
Aniline
Benzene
Chlorobenzene
Chloroform
Cyclohexane
Cyclohexanone
Dichlorodifluoromethane (Freon 12®)
Diethyl phthalate
Dimethylamine
Dimethyl phthalate
1, 4-D.ioxane
Ethylene oxide
Formaldehyde
Formic acid
Isobutyl alcohol
Meleic anhydride
Methyl alcohol (methanol)
Methyl ethyl ketone
Methyl methacrylate
Naphthalene
Saccharin and salts
Thiourea
Toluene
1,1r1-Tr i chloroe thane
1,1,2-Trichloroethane
Trichlorofluoromethane (Freon 11®)
Vinyl chloride
Xylene
90
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D,C. 20460
OFFICE OF
PESTICIDES AND TOXIC SUBSTANCES
CERTIFIED MAIL
SUBJECT: Initiation of Reregistration Process for Manufacturing-
Use Products and Certain End-Use Products Containing
Naled as the Single Active Ingredient
Dear Registrant:
In accordance with the Federal Insecticide, Fungicide,
and Rodenticide Act (FIFRA), as amended, EPA's Office of
Pesticide Programs has begun the reregistration process for
pesticide products containing the subject ingredient. Signifi-
cant changes to the statute were made in 1972, 1975, and
1978; thus, current requirements may be substantially different
from those in effect at the time your product(s) were registered.
The first phase of reregistration requires that you (1) make
a commitment to the Agency regarding data development and
(2) subsequently submit revised product labeling and associated
information.
This mailing contains the Guidance Document for prepara-
tion of submissions, as well as a listing of your affected
product(s) (Attachment A), and a separate list of registrants
with products subject to this manufacturing-use standard and
which contain this active ingredient (Attachment B). The
latter list is for the purpose of cooperative data development.
The Guidance Document sets out the Agency's evaluation
of all available data pertaining to the subject chemical and
its* registered uses, and its rationale for the regulatory
actions being taken at this time. Additionally, the Guidance
Document contains instructions describing certain of the
91
-------
2
steps you must take to maintain registration for your product(s).
Products not brought into compliance with the Guidance Document
as supplemented by subsequent information from EPA about compliance
with certain data support requirements will be subject to suspension
and/or cancellation.
Specifically, the enclosed Guidance Document does the
following:
1. Introduces the purpose of this document.
2. Explains the Agency's policy regarding data submis-
sion and identifies, in table format, the data
that must be submitted to complete the Agency's
evaluation of each product. In addition, a
bibliography identifying the data which is considered
part of the data base supporting the registration
standard is included.
3. Sets out time-frames for submission of required
data.
4. Explains how to revise labeling for maufacturing use
products. (As the Guidance Document explains,
labeling is not required at this time.)
5. Provides submission instructions.
Because of the variety and complexity of the requirements,
and the short statutory time-frames available for certain
actions, it is essential that you understand the specific require-
ments and procedures in order that you may respond in a correct
and timely manner. Since a part of these requirements is under
Section 3(c)(2)(B) of FIFRA, your first response may be required
within 90 days from receipt of this letter. Please note that
if you do not respond or do not comply fully with the requirements,
your application may be rejected or your product registration
cancelled or suspended.
If, after reviewing this material, you do not understand
what you must do or how or when you must respond, please contact
the Product Manager listed below who will assist you in every
reasonable way. If you wish to discuss the data requirements
or request that certain data be waived, you must write to the
Agency and indicate those data requirements with which you take
issue and your rationale for doing so. After the Agency has
had a chance to review your submission, the Product Manager will
contact you to set up a meeting for the purpose of resolving all
issues relative to data requirements.
92
-------
3
Please note that this guidance document will eventually
be supplemented by EPA with additional information about
compliance with data support requirements. In Monsanto v.
Administrator, EPA was recently enjoined by the District
Court for the Eastern District of Missouri from implementing
in any way the "mandatory data licensing" aspects of §3(c)(l)(D)
of FIFRA. EPA is assessing the implications of the injunction
for the reregistration process. Because of this unresolved
situation, EPA has decided to proceed with the requirements in
this guidance package which do not relate to the "data licensing"
issue and to supplement the package with additional guidance
when circumstances permit.
If you have any questions concerning this Guidance Document,
you may contact the Product Manager listed below:
Mr. William H. Miller
Product Manager 16
Registration Division (TS-767)
Office of Pesticide Programs
Environmental Protection Agency
Washington, D.C. 20460
Telephone: 703/557-2600
Sincerely,
Douglas D, Campt, Director
Registration Division (TS-767)
Enclosure
93
-------
ATTACHMENT A
PRODUCTS AFFECTED BY THIS
REREGISTRATION PROCESS
Following is a list of your products affected by this rereg-
istration process. If this list is incomplete or inaccurate
in any way, please notify the Product Manager (PM) identified
xn j^0 Is tt01T
94
-------
ATTACHMENT B
REGISTRANTS WITH PESTICIDE PRODUCTS CONTAINING
THE ACTIVE INGREDIENT
The information attached will allow registrants with pesticide
products containing the above ingredient to contact one
another regarding joint data development or sharing the cost
of data development under section 3(c)(2}(B) of FIFRA, This
information includes the following: EPA Reg, No,, company
name, company address, active ingredient, percentage of active
ingredient and type of formulation, such as Manufacturing-Use
Product (MP), Technical Product (TP), Wettable Powder (WP),
and Emulsif iable Concentrate (EC).
95
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