NALED
Pesticide Registration Standard
(034401)
June 1983
Office of Pesticides and Toxic Substances
Environmental Protection Agency
401 M Street, SW
Washington, DC 20460
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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
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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-
2,2-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 10~4
mm Hg at 20°C. The empirical formula is C4H7O4PBr2Cl2
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 manufacturing-use products
consisting of the technical grade of naled (90%), 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
--—' s*
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-
cfe£
12.6 Ib/gal and 1%-15%). Naled is applied on agricultural
crops by using aircraft and ground equipment including mist
-T|
blowers and foggers.i
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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.
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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 it 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 carcinogenic-ity 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
dichlorvos will be required. Since dichlorvos 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 1970-1S81 (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.
Again, it is not certain what products or type of products
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 LDso values of 1500 rag/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
£ 3 hours in soils and 5 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
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dissipation and relatively low mobility of naled and inter-
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mediate mobility of dichlorvos 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
registration 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
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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.
3i Use Patterns
• *
To be registered under this Standard manufacturing-use
products containing naled may be labeled for formulation
only into end-use products for:
0 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)(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.
0 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.
0 Aquatic, food uses on: rice.
* Aquatic, non-food uses on: marinas, swamps, swimming
pool areas, and tid^l marshes.
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0 Greenhouse, food uses on: vegetable crops (including
cucumbers, mushrooms, and tomatoes).
0 Greenhouse, non-food uses on: ornamental plants (in-
cluding carnations, chrysanthemum, poinsettias, roses,
and snapdragons).
0 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.
* *
0 Domestic, outdoor uses on: dog houses, kennels, and
dwellings (including campers, hotels, motels, tourist
courts, patios and yards).
0 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, feedlotSy 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-dibromo-2,2-dichloroethy1
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 P.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. Oo 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.
o n
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.1
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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.
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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 ODVP 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,
meat, meat by-products), pumpkins, soybean forage, spinach,
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
Commodity
\
Almonds ( hulls , nuts )
Beans (dry, succulent)
Broccoli
Brussels sprouts
Cabbage
Cattle (fat, meat, meat
by-products )
Cauliflower
Celery
Citrus fruits a/
Collards
Cottonseed
Cucumbers
Eggplant
Eggs
Goats (fat, meat, meat
by-products )
Grapes
Grasses, forage
Hogs (fat, meat, meat
by-products )
Hops
Horses (fat, meat, meat *
by-products)
Tolerances (ppm)
United States Canada
0.5
0.5 0.5
1.0 1.0
1.0 1.0
1.0 1.0
0.05
1.0 1.0
3.0
"3.0 " 3.0
3.0
0.5
0.5 0.5
0.5 0.5
0.05
0.05
0.5
10.0
0.05
0.5
0.05
Mexico
—
0.5
1.0
—
__
. —
—
3.0
3.0
—
0.5
0.5
0.5
—
— —
0.5
—
-—
—
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TABLE I (Continued)
Commodity
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
Tolerances (ppm)
United States Canada
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
Mexico
—
—
1.0
0.5
—
—
0.5
1.0
0.5
1.0
-—
—
0.5
—
—
0.5
3.0
0.5
1.0
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TABLE I (Continued)
Tolerances
Commodity United States Canada Mexico
Sugar beets (roots, tops)
Swiss chard
Tomatoes
Turnips, tops
Walnuts
All other raw agricultural
commodities except those
listed
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III. 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 I/Must 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
I/ Generic data pertain to the properties or effects of a
particular ingredient, and thus are relevant to an evaluation of
the risks of all products containing that ingredient (or all such
products having a certain use pattern), regardless of any such
product's unique composition or use. Product-specific data relate
only to the properties or effects of a product with a particular
composition (or a group of products with closely similar composition)
2/ The Pesticide Registration Guidelines were reproposed on
November 24, 1982 in 47 Federal Register 53192.
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type for each major formulation category (e.g., emulsiftable
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. Notify EPA that you have entered into an agreement
with one or more other registrants to jointly
develop (or share in the cost of developing) the
data. If you elect this option, you must notify EPA
which registrant(s) are parties to the agreement.
3. File with EPA a completed "Certification of Attempt to
Enter Into an Agreement With Other Registrants for
Development of Data" (EPA Form 8580-6, Appendix III-3)V
4. Request that EPA amend your registration by deleting the
uses for which the data are needed. (This option is not
available to applicants for new products.)
V FIFRA Section 3(c*)(2)(B) authorizes joint development of
data by two or more registrants, and provides a mechanism by
which parties can obtain an arbitrator's decision if they agree
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)
22
-------
5. Request voluntary cancellation of the registrations)
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 EPA's schedule, you may
submit a request for an extension of time. The extension
request must be submitted in writing to the Product
Manager. The extension request should state the reasons
why you conclude that an extension is appropriate. While
EB& 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.
23
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR HALED I/
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
63-3 -
63-4 -
Product Chemistry
(continued)
Physical State TGAI Yes
Odor TGAI Yes
00074790
G5092040
00074790
G5092040
No
No
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density, or
Specific Gravity
TGAI
TGAI
TGAI
Yes
Yes
Partial
G5092040 No
00074653| 00074724* No
00074790; G5092040
00074653? 00074724* Yes 8/
00074790; G5092040
*Data submitted by Chevron Chemical Company. These data may be compensable.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED I/
Does EPA Have Data
To Satisfy This
2/ Requirement? (Yes, Bibliographic
Data Requirement Composition No or Partially) Citation V
Must Additional
Data Be Submitted
Under FIFRA Secti<
3(c)(2)(B)? V
§158.120 Product Chemistry
63- 8
63- 9
63-10
63-11
63-12
63-13
Other
(continued)
- Solubility TGAI OR PAI Yes
- Vapor Pressure TGAI OR PAI Yes
*
- Dissociation constant TGAI OR PAI No
- Octanol/water partition PAI No
coefficient
- pH TGAI No
- Stability TGAI Yes
Requirements;
00074653
00074790
GS092040
00074653
00074790
GS092040
-
-
-
00074653
00074724
00074790
No
No
Yes
Yes
Yes
No
64- 1 - Submittal of samples
Choice
No 9/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
§158.120 Product Chemistry
(continued)
I/ 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 Juna lqfifi •
V Adequate data has been submitted by Chevron Chemical Company. Other producers must address these data requirements.
|/ 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.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Data Requirements
Composition
I/
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No. or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
§158.125 Residue Chemistry
171-4 - Nature of Residue (Metabolism)
- Plants
PAIRA
- Livestock
PAIRA and plant
metabolites
- Animal residues
171-4 - Storage Stability Data
PAI
Partial
Partial
171-4 - Residue Analytical Method
- Plant residues TGAI and metabolites Partial
TGAI and metabolites Yes
No
00074836
GS092090*
00074654
00074647
00074844
00059386
GS092091*
GS092092*
00074721; 00074806*
00074647; 00073820
00074725
GS092026
00073821*
Yes 3/,4/
Yes 3/
Yes 4/
No
Yes 5/
*Data submitted by Chevron Chemical Company. These data may be compensable.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Data Requirements
Composition"
Does EPA Have Data
To Satisfy This
Requireroent? (Yes,
No, or Partially)
Bibliographic
Citation •
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
S158.125 Residue Chemistry
(continued)
171-4 - Magnitude of the Residue-
Residue Studies for Each
Food Use 6/
- Root and Tuber Vegetable Group
*
0 Sugar Beet Roots
0 Turnip Roots
- Leaves of Root and Tuber
Vegetables (Human Food or
Animal Feed) Group 8/
0 Sugar Beet Tops
0 Turnip Tops
Leafy Vegetables Group
(Except Brassica)
0 Celery
0 Lettuce
0 Spinach
0 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 ll/
Yes \2/
Yes 13/
Yes 13/
*Data submitted by Chevron Chemical Company. These data may be compensable.
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TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
I/ Requirenrent? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition No or Partially) Citation 3(c)(2)(B)?2/
§158.125 Residue Chemistry
(continued)
171-4 - Magnitude of the Residue -
Residue Studies (continued)
- Brass ica (Cole) Leafy
Vegetable Group
0 Broccoli TEP Partial
0 Brussels Sprouts TEP No
0 Cabbage TEP Partial
0 Cauliflower TEP Partial
0 Collards TEP Partial
0 Kale TEP Partial
- Legume Vegetables (Succulent
and Dried) Group
0 Beans TEP Partial
0 Peas TEP Partial
0 Soybeans TEP Partial
00074836; 00073820
-
00074836
00073820
00073821*
00073821*
00074836; 00073846*;
00073820; 00074699;
00073821; 00074729
00073846*
00073821*; 00073846*
Yes 14/
Yes 15/
Yes U/
Yes 14/
Yes JL4/
Yes 14/
Yes 16/
Yes IT/
Yes IB/
*Data submitted by Chevron Chemical Company.These data may be conpensable
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TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Data Requirement
§158.125 Residue Chemistry
(continued)
- Foliage of Legume
Vegetables Group
0 Bean Foliage
*
0 Pea Foliage
0 Soybean Foliage
~ Fruiting Vegetables
(Except Cucurbit) Group
0 Eggplants
0 Peppers
0 Tomatoes
- Fruiting Vegetables
(Cucurbit) Group
0 Cucumbers
0 Melons
0 Pumpkins
0 Summmer Squash
0 Winter Squash
y
Composition
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Partial
Partial
Partial
-
No
Partial
Partial
Partial
Partial
No
Partial
No
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?V
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
I/
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)? 2
§158.125 Residue Chemistry
(continued)
- Citrus Fruits (Citrus Spp.,
Fortunella Spp.) Group
0 Grapefruit
0 Lemons
0 Oranges
0 Tangerines
- Stone Fruits Group
0 Peaches
- Small Fruits and
Berries Group
0 Grapes
0 Strawberries
- Cereal Grains Group
0 Rice Grain
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
No
Partial
Partial
No
Partial
Partial
Partial
Partial
00073820
00073820; 00074807
Yes
Yes 29/
Yes 30/
Yes
00074836*? 00073821* Yes 31/
00074836; 00073821*; Yes 32/
00074728; 00073817*
00073820 Yes 33/
00074723; 00073820; Yes 34/
*Data submitted by Chevron Chemical Company.These data may be ccmpensable.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Data Requirement
Composition
I/
Does EPA Have Data
To Satisfy This
Requ i rement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B>? 2
§158.125 Residue Chemistry
(continued)
- Forage, Fodder, and Straw
of Cereal Grains Group
0 Rice Forage
- Grass., Forage, Fodder
and Hay Group
0 Grass Forage (Pasture
and Range)
- Non-Grass Animal Feeds
TEP
Yes
TEP
Partial
00074723
00073820
00073816*
No 35/
Yes 36/
(Forage. Fodder, Straw,
and Hay) Group
0 Alfalfa TEP Partial
•.
- Tree Nuts Group 38/
0 Alnonds TEP Yes
0 Walnuts TEP Yes
00074836; 00073821*;
00073818*; 00072816
00073830
00073821*
Yes 37/
No 39/
No
*Data submitted by Chevron Chemical Company. These data may be conpensable.
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TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Data Requirement
!/
Composition
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)? 2
§158.125 Residue Chemistry
(continued)
- Miscellaneous
0 Cottonseed
0 Hops
0 Mushrooms
0 Safflower Seed
j
- All Other Agricultural
Commodities
- Food Producing Animals
TEP
TEP
TEP
TEP
TEP
Partial
Partial
Partial
Yes
No
00074700} 00073821*}
00074845*
00073846*
GS092093
00073846*} 00074845*
Yes 40/
Yes 41/
Yes 42/
No 43/
No 44/
0 Meat and milk EP, TGAI or plant Yes •
metabolites
0 Poultry and eggs EP/ TGAI or plant Partial
metabolites
GS092094
GS092092*
GS092095*
00073821*
GS092026
GS092096
00074692*
No 45/
Yes 46/,47/
*Data submitted by Chevron Chemical Company. These data may be compensable.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
§158.125 Residue Chemistry
(continued)
I/ Composition: TGAI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled; TEP
Typical end-use product? EP = End-use product.
2/ Data must be submitted no later than _ tnn^ IQRA
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/ Some 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)1 . Satisfaction of the crop group requirements for a given group would
allow the establishlment 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 Ib/gal Emulsifiable
Concentrates (ECs) according to the use pattern. This will include five or more applications per season at the
highest recommended rates.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
§158.125 Residue Chemistry
(continued)
ll/ Data are needed which reflect the following: 1) Five or more ground applications of the 7.2 Ib/gal EC at 1.35 Ib ai/A,
2) Five or more aerial applications of the 4 or 6% D at 2.0 Ib ai/A, and 3) Five or more ground applications of the
4 or 6% D at 2.0 Ib ai/A.
12/ The available data support the established tolerance for head lettuce after applications of the 7.2 Ib/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 Ib ai/A must be made. All of the above data are required for leaf lettuce as well (including data
for the 7.2 Ib/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 Ib/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 Ib/gal EC at 1.8 Ib 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 Ib/gal EC and the 4 or 6% D formulations
during the fruiting period with aerial and ground equipment. .
IT/ Data are required which reflect at least three applications of the 4% D and the 7.2 Ib/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 Ib/gal EC at 1.35 Ib 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 Ib/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 Ib/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 Ib/gal EC at 1.35 Ib 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.
-------
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 Ib/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 Ib/gal
EC. Data are still needed which reflect: 1) Five aerial applications of the 7.2 Ib/gal EC at 0.9 Ib 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 Ib ai/A (at least three applications must be made during thr fruiting period, 3) Five foliar greenhouse sprays
with the 7.2 Ib/gal EC at 0.9 Ib ai/100 gal (at least three applications must be made during the fruiting period),
4) Ten greenhouse fumigations with the RTU and 7.2 Ib/gal EC at 16 fl oz of product/50,000 cu ft, and 0.28 Ib
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 Ib ai/A (at
least three applications must be made during the fruiting period), 2) Five aerial and ground applications of the
7.2 Ib/gal EC at 1.35 Ib ai/A (at least three applications must be made during the fruiting period), and 3) Ten
greenhouse fumigations using the 7.2 Ib/gal EC and 10% RTU at 0.28 Ib 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 Ib 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 Ib ai/A (at
least three applications must be made during the fruiting period), and 2) Five aerial and ground applications of the
7.2 Ib/gal EC at 1.35 Ib 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 Ib/gal EC. Additional data are required which reflect the following: 1) Five aerial applications of the
7.2 Ib/gal EC at 1.35 Ib 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 Ib 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 Ib/gal EC at 4.0 and 1.8 Ib
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 Ib/gal EC at 4.0 and 1.8 Ib
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).
-------
TABLE A
GENERIC DATA REQUIREMENTS TOR NALED
§158.125 Residue Chemistry
"(continued)
31/ Data are required which include the following; 1) Ten ground applications of the 7.2 Ib/gal EC at 0.68 Ib ai/100 gal
sprayed to the point of runoff, 2) Ten aerial and ground applications of the 4% D at 3.2 Ib ai/A.
32/ The available data support the established tolerance for grapes based on residues resulting from ground application of
the 7.2 Ib/gal EC. Additional dat are required which reflect 10 aerial and ground applications of the 4% D at 2.0 Ib
ai/A. Also, data pertaining to naled residues in the following grape products (juice, wet and dehydrated pomace,
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 Ib ai/A and the 7.2
Ib/gal EC at 0.9 Ib 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 Ib/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 Ib/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 Ib ai/A, respectively. Also, residue data are required which reflect
five aerial and ground applications of the 4% D at 0.4 Ib 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 Ib 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 Ib/gal EC if such a need is anticipated.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
S158.125 Residue Chemistry
(continued)
40/ Data are required for cottonseed which reflect five aerial and ground applications of the 4% D and 7.2 Ib/gal EC at
1.4 and 0.9 Ib 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 Ib/gal EC at 1.0 and
0.9 Ib 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 Ib/gal EC used as a KIU at 6.75 oz ai/50,000
cu ft, and 2) 20 applications of the 10% RTU 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 ppra 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 Ib ai/A) for
area pest uses than for crop pest uses (usually 0.68-4.0 Ib 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 Ib/gal
EC at 0.45 Ib ai/20 gal.
47/ Data submitted to the Agency was conducted by Industrial Bio-Test Laboratories (IBT) and has been determined to be
invalid.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Data Requirement
I/ Use 2/
Coropoaition 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
i
TGAI or PAIRA C,D,G
i
TGAI or PAIRA CfD
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 be compensable.
**Data submitted by National Chemsearch, Division ,of NCH Corp. These data may be compensable.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
JL/ Use 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition Pattern No or Partially) Citation 3(c)(2)(B)?V
§158.130 Environmental Fate
(continued)
DISSIPATION STUDIES-FIELD:
164-1
164-2
164-3
164-4
164-5
- Soil
- Aquatic (Sediment)
- Forestry
- Combination and
Tank Mixes
- Soil, Long-term
TEP
TEP
TEP j
i
TEP
TEP
A,B,H
C,D
G
A
No - Yes
Partial 10/ 00074645* Yes
No - Yes
Not Applicable
*
Reserved ll/
ACCUMULATION STUDIES: :
165-1
165-2
165-3
165-4
165-5
- Rotational Crops
(Confined)
- Rotational Crops
(Field)
- Irrigated Crops
- In Fish
- In Aquatic Non-Target
Organisms
PAIRA
i
TEP
TEP
TGAI or
PAIRA
TEP
A
A
C
A,B,C,
D,G
D
No - Yes
No - Reserved 12/
No - Yes
Yes 00074643* No 13/
Yes 00074643* No
*Data submitted by National Chemsearch, Division of NCH Corp. These data may be conpensable.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
§158.130 Environmental Fate
(continued)
\J 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=Terres trial, Non-Food; C=Aquatic, Food Crop;
D=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 _ _ .Tlinp i
_ _ _
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 given, 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 i dent if iy 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.
ll/ 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.
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR NALED
Does EPA Have Data
To Satisfy This
I/ Use 2/ Requirement? (Yes, Bibliographic
Data Requirement Composition Patterns No or Partially) Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
§158.135 Toxicology
ACUTE TESTING:
81-1
81-2
81-3
81-7
- Oral LD5Q - Rat TGAI A,B,C,D,E Yes
F,G,H,I
- Dermal ID$Q - Rabbit TGAI A,B,C,D,E, Yes
F,G,H,I
- Inhalation LCso - Rat TGAI A,B,C,D,E, No •
F,H,I
- Delayed TGAI A,B,C,D,E, Yes
Neurotoxicity - Hen F,G,H,I
00049330
00074795
05016607
00065468
00074829*
00074663
00049330
-
00074656*
00074843
No
No
Yes
No
SUBCHRONIC TESTING:
82-1
82-2
82-3
82-4
82-5
- 90-Day Feeding - TGAI A,D,E,I Yes
Rodent, Non-rodent
- 21-Day Dermal - Rabbit TGAI A,B,H,I No
- 90-Day Dermal - Rabbit TGAI Reserved 4/
- 90-Day Inhalation - TGAI E,F,I No
Rat
- 90-Day Neurotoxicity- TGAI No
Hen/Mammal
00074817
05016607
GS092097*
00074862
-
-
-
—
No
Yes
-
Yes
No 5/
*Data submitted by Chevron Chemical Company. These data may be compensable.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Data Requirement
Does EPA Have Data
To Satisfy This
I/ Use 2/ Requirement? (Yes,
Composition Pattern No or Partially)?
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
§158.135 Toxicology
(continued)
CHRONIC TESTING;
83-1 - Chronic Toxicity -
2 species: Rodent
and Non-rodent
«
83-2 - Oncogenicity -
2 species: Rat and
Mouse preferred
83-3 - Teratogenicity -
2 species
83-4 - Reproduction - Rat
2-generation
MUTAGENICITY TESTING
84-2 - Gene Mutation
84-2 - Chromosomal Aberration
84-2 - Other Mechanisms of
Mutagenicity
SPECIAL TESTING
85-1 - General Metabolism
TGAI
A,B,C,E,H,I No
TGAI A,B,C,E,H,I
TGAI A,B,C,E,H,I
TGAI A,B,C,E,H,I
TGAI A,B,C,E,H,I
TGAI A,B,C,B,H,I
TGAI A,B,C,E,H,I
PAI or A,B,C,E,H,I
PAIRA
No
No
No
85-2 - Domestic Animal Safety Choice B,HfI
Partial 7/,9/
No
No
Reserved 7/,10/
Reserved 10/
GS092103
Yes 6/,7/
Yes 6/,7/
Yes 7/,8/
Yes 6/,7/
Yes
Yes
Yes
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
§158.135 Toxicology
(continued)
I/ Composition: TGAI = Technical grade of the active ingredient; PAI = Pure active ingredient; PAIRA = Pure active
ingredient, radiolabelled; 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; I=Indoor.
3/ Data roust 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. .
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Does EPA Have Data
To Satisfy This
I/ 2/ Requirement? (Yes,
Bibliographic
Must Additional
Data Be Submitted
Under FIFRA Section
Data Requirement Composition Pattern No or Partially) Citation 3(c)(2)(B)?3/
§158.140
132-1 -
132-1 -
133-3 -
133-4 -
Reentry Protection
Foliar Dissipation TEP A,B No
Soil Dissipation TEP A,B No
Dermal Exposure TEP A,B No
Inhalation Exposure TEP A,B No
Yes 4/
No 5/
No 5/
No 5/
I/ Composition: TEP = Typical end-use product. >j
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; O=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Indcor.
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.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Does EPA Have Data
To Satisfy This
I/ Use 2/ Requirement? (Yes, Bibliographic
Data Requirement Composition Pattern No or Partially) Citation
$158.145
Aquatic
Wildlife and
Organisms
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
AVIAN AND MAMMALIAN TESTING
71-1 -
71-2 -
71-3 -
71-4 -
71-5 -
Avian Oral LDso
Avian Dietary LC5Q
*
Wild Mammal Toxicity
Avian Reproduction
Simulated and Actual
Field Testing -
Mammals and Birds
TGAI A,B,C,D,G Yes
TGAI A,B,C,D, Yes
E,F,G,H,
I 4/
TGAI A,B,C,D,G No
TGAI A,B,CfD,G No
TEP A,B,C,D,G No
GS092099
00028757
-
-
-
No
No
No 5/
No 5/
No 5/
AQUATIC ORGANISM TESTING
72-1 -
Freshwater Fish 1X50
-do-
TGAI . A,B,C,D,
E,F,G,H,
I 4/ Yes
TEP C,D,G Partial
05003107
GS092101
GS092102
GS092101
GS092102
GS092017
No
Yes 6/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Data Requirement
I/ Use 2/
Composition Pattern
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
§158.145 Wildlife and
Aquatic Organisms
(continued)
72-2 - Acute LC5Q Freshwater TGAI
Invertebrates
-do- TEP
A,G,C,D,
E,F,G,H,
I 4/
C,D,G
Yes
No
GS092100
No
Yes 6/
72-3 - Acute LC$Q 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
CfD,G
C,D,G
Reserved 8/
Reserved 9/
Reserved 9/
C,D,G Reserved 9/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
§158.145 Wildlife and Aquatic Organisms
(continued)
\J Composition: TGAI = Technical grade of the active ingredient; PAI = pure active ingredient;
TEP = Typical end-use product;
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food Crop; OAquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Dcmestic Outdoor; I=Indoor.
3/ Data must be submitted no later than June 1986 •
4/ Only one species is required for the B,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.
-------
TABLE A
. GENERIC DATA REQUIREMENTS FOR NALED
Data Requirements
Composition"
Does EPA Have Data
To Satisfy This
Use 2/ Requirement? (Yes,
Pattern No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
S158.15Q Plant Protection
121-1 - TARGET AREA EP
PHYTOTOXICITY
NONTARGET AREA PHYTOIDXICITY
TIER I
j.
122-1 - Seed Germination/ TGAI
Seedling Emergence
No
No
No 4/
122-1
122-2
123-1
123-1
123-2
124-1
124-2
- Vegetative Vigor
- Aquatic Plant Growth
TIER II
- Seed Germination/
Seedling Emergence
- Vegetative Vigor
- Aquatic Plant Growth
TIER III
- Terrestrial Field
- Aquatic Field
TGAI
TGAI
TGAI
TGAI
TGAI
TEP
TEP
NO
No
No
No
No
No
No
No 4/
No 4/
No 4/
No 4/
No 4/
No 4/
No 4/
I/ 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:
D=Aquatic, Non-Food; E=Greenhouse, Food
3/ Data must be submitted no later than _ .
4/ These requirements are generally waived unless it is believed there is a phototoxicity problem.
A=Terrestrial, Food Crop; B=Terrestrial, Non-Food Crop; C=Aquatic, Food Crop;
Crop; F=Greenhouse, Non-Food; G=Forestry; H=Doraestic Outdoor; I=Indoor.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Data Requirement
I/ 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)?3/
§158.155 Nontarqet Insect
NONTARGET INSECT TESTING -
POLLINATORS;
141-1 - Honey bee acute
contact 11)50
141-2 - Honey bee - toxicity
of residues on
foliage
TGAI A,B,G,H Yes
TEP A,B,G,H Yes
00036935
00060628
00037799
05000837
No
No
141-3 - Wild bees iiqportant in TEP
alfalfa pollination -
toxicity of residues
on foliage
141-4 - Honey bee subacute TEP
feeding study
141-5 - Field testing for TEP
pollinators
A4/
Yes .
A,B,G,H Reserved 5/
A,B,G,H No
00060628
05000837
No
No 6/
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR NALED
Does EPA Have Data
To Satisfy This
Regu i rement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?
§158.155 Nontarget Insect
(continued)
NONTARGET INSECT TESTING -
AQUATIC INSECTS;
142-1 - Acute toxicity to
aquatic insects
4.
142-2 - Aquatic insect
life-cycle study
142-3 - Simulated or actual
field testing for
aquatic insects
143-1 - NONTARGET INSECT
TESTING - PREDATC
thru AND PARASITES
143-3
Reserved T/
Reserved 7/
Reserved 7/
•
Reserved 7/
I/ 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=Terrestrial, Non-Food; OAquatic, Food Crop:
D=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 ; .
4/ Data required only for pesticides intended for foliar application to seed alfalfa.
Ij/ 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.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING NALED I/
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
2/ Requirement? (Yes, Bibliographic Under FIFRA Sectii
Data Requirement Composition No or Partially) Citation V 3(c)(2)(B)? V
§158.120
Product Chemistry
Product Identity:
61-1 -
61-2 -
61-3 -
Identity of Ingredients MP \ Yes
StatemenJ: of Composition MP Partial
Discussion of Formation of MP Partial
00074653
00074724
GS092040
00074653
00074791*
00065493; 00065494*
f\f\nr* 4s~r*>-*\ .jr-hnS*kS% *-k/"l A f\
NO
Yes 5/
Yes 6/
Ingredients
00074653; GS092040
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 7/
00074653
00065494*; 00074653 Yes 7/
00074655; 00074724
00074846; G5092006
00074790 No
G5092040
"Data submitted by Chevron Chemical Company. These data may be compensable.
-------
PRODUCT SPECIFIC DATA REQUIREMENTS
TABLE B
FOR MANUFACTURING-USE PRODUCTS CONTAINING NALED
2/
Data Requirement Composition
§158.120 Product Chemistry
63-3 -
63-4 -
63-7 -
63-12
63-14
63-15
63-16
63-17
63-18
63-19
63-20
Other
(continued)
Physical State MP
• Odor MP
»
• Density, Bulk Density, or MP
Specific Gravity
- pH MP
- Oxidizing or reducing MP
action
- Flamnability MP
- Explodability MP
- Storage Stability MP
- Viscosity MP
- Miscibility MP
- Corrosion MP
Requirements:
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Requirement? (Yes, Bibliographic Under FIFRA Sectii
No or Partially) Citation 3/ 3(c)(2)(B)? V
Yes 00074790 No
G5092040
Yes 00074790 No
G5092040
Partial 00074653; 00074724 Yes 8/
00074790; G5092040
No - Yes
Yes' 00074790 No
Partial 00074790 Yes 9/
Yes- 00074790 No
Yes 00074653 No
Yes 00074790 No
GS092040
Yes 00074790 No
GS092040
Yes 00074790 No
GS092040
64- 1 - Submittal of samples
MP
No 10/
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING NALED
§158.120 Product Chemistry
(continued)
I/ 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 npr lqai .
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 flammability of the manufacturing-use naled is required.
10/ May be requested on a case-by-case basis.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING NALED
Data Requirement
Composition
I/
Does EPA Have Data
To Satisfy This
Requi rement? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?2/
S158.135 Toxicology
ACUTE TESTING
81-1 - Oral LDso - Rat
81-2 - Dermal LDso ~ Rabbit
81-3 - Inhalation LC5n - 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/
I/ Composition: MP = Manufacturing-use product.
2/ Data must be submitted no later than Dec 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 Company. These data may be conpensable.
-------
... .,.-.:.. .-.••:..•: . ..,-...,. •..•....;•. ••'.-. •/. ,• ' -• -•••• '.APPENDIX III -• 1- '• '•
Guide to Use of This Bibliography
I. ••- CONTENT OF-^ 3I3LIOGRAP3Y.- This bibliography contains" '"' '
citations of all stadias considered relevant by £?A 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 2PA 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 C? 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
MSID, number. This number is unique to the citation, and
should be used at any time- specific reference is required.
It is not related to the six-digit 'Accession Number' which
has been used to identify volumes of submitted studies; see
paragraph 4(d)(4) below for a further explanation. In a few
cases, entries added to the bibliography late in the review
may be preceded by a nine-character temporary identifier.
These entries are listed after all MRID entries. This
temporary identifier number is also to be used whenever
specific reference is needed.
4. • FORM 0? ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of materials
submitted to SPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standardq institute
(ANSI), expanded to provide for certain special needs.
a. •Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has shown
an identifiable laboratory or testing facility as
author. As a last resort, the Agency has shown the
first known submitter as author.
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b. Document Date. When the.date appears as four digits .
•• •-.••'•w-tta no question marks, the"Agency took it directly
from the "document. When a four-digit data is followed
by a question sarfc, the bibliographer deduced the date
from evidence in the document. When, the date appears. .
•••:-V • as•{IS??')/..the Agency was unable to' determine or. :'. :
estimate the date of the docuaent.
c. Title. In some cases it has been necessary for Agency
bibliographers to create or enhance a document title.
Any such editorial insertions are contained between
'square brackets.
d. Trailing Parentheses. For studies submitted to the'
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the
following elements describing, the earliest Jcnovn
submission:
(1) Submission Date. Immediately following the word
'received* appears the date of the earliest known
submission.
(2)' Administrative Number. The next element,
immediately following the word 'under', is the
registration number/ experimental 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.
i
(4) Volume Identification (Accession Numbers).
The final element in the trailing parentheses
identifies the SPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession- number follows
'the symbol 'COL1, standing for "Company Data
Library". This accession number is in turn
. followed by an alphabetic suffix which shows the •
relative position of the study within, the volume.
For example, within accession number 123456,. the
first study would be 123456-A; the second, 123456-
8; the 26th 123456-2; and the 27th, 123456-AA.
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base
Registration Under the Standard
Supporting
00028757 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary
Toxicities 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-I)
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,O-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-I)
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)
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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.; Dirrmick, 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 Array. N.P. (Contract no. MIPR-
5962; published study; CDL:229222-A)
00065493 Chevron Chemical Company (19??) Conposition 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) Determina-
tion of Impurities in Technical Dibrcm. (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 Dibrcm (R)- (Naled) on Forage Crops. (Compilation;
unpublished study, including test nos. T-2175 and T-2176, re-
ceived Sep 21, 1972 under OF0975; 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 OF0975; CDL:091678-B)
00073817 Chevron Chemical Company (1972) Bromide Ion Concentrations of
Grapes Treated with Naled. (Compilation; unpublished study
received on unknown date under OF0975; CDL:091678-C)
00073818 Chevron Chemical Company (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 OF0975;
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 OF0975; CDL:091679-F)
00073820 Chevron Chemical Company (1966) Dibrcm (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)
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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
OF0975; 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: The 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/Dibrom 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, Tex.; 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 Dibron (R) Naled Resi-
dues by Acetylcholinesterase Inhibition: File 740.10. Method
RM-3 dated Jul 28, 1966. (Unpublished study received Sep 12,
1966 under 7F0532; CDL:092821-A)
00074653 Chevron Chemical Company (1966) Name, Chemical Identity and Compo-
sition of the Pesticide Chemical: Dibrom. (Unpublished study
received Sep 12, 1966 under 7F0532; CDL:092821-H)
00074654 Chevron Chemical Company (1966) Naled: The Degradation and Metabol-
ic Fate in Biological Media. Rev. (Unpublished study received
Sep 12, 1968 under 7F0532; CDL:092821-1)
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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) Ortho Method of Analysis—D-DC-a:
Dibrcm (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.; Cox, G.E.; Stevens, K.R. (1978) The Evaluation of
Dibrcm 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 7F0532; prepared by Hazleton
Laboratories, submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:090644-E)
00074684 Chevron Chemical Company (1960) Toxicology Reports: Dibron 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:
Dibrcm 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) Dibrcm 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 Dibrcm Residues.
Undated method RM-III. (Unpublished study received Feb 19, 1958
under unknown admin, no.; CDL: 119738-A)
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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:
Dibrcm residues. (Unpublished study received Feb 19, 1958 under
unknown admin, no.; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:119738-B)
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.; CDLsll9745-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)
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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:
Sunraary 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-I)
00074817 Weir, 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 Dibrcm 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) Sunmary 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, Calif.; CDL:
090358-H)
00074845 Chevron Chemical Company (1973) Summary and Data on Residues of
Naled in Cotton and Safflower. (Compilation; unpublished study
received Jan 9, 1974 under 1F1078: CDL:093391-A)
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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 OF0975; submitted
by Chevron Chemical Co., Richmond, Calif.; CDL:095468-A)
00075668 Chevron Chemical Company (1961) Residue of Dibrom on the Tomato
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
K3)s393-394.
05003107 Macek, K.J.; Hutchinson, C.; 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 Pcdostra
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.
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OFFICE OF PEST5ICIDE 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. The skin irritation
potential of Dibron-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 Dibrcm-14 Concentrate (CC 5511). Study No.
S-742, Standard Oil Company of California, SOCAL 659/XX:114,
November 19, 1974.
GS092006 Carlstrcm, A.A. 1975. Gas-liquid chronatographic determination
of naled in pesticide formulations. JAQAC 58(6):1162-1168.
GS092017 Dean, H.J, J.R. Colquhoun, H.A. Sincnin. 1977. Toxicity of
Methoxychlor and Naled to Several Life Stages of Landlocked
Atlantic Salmon. N.Y. Fish and Game J. 24:144-153.
GS092026 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.
GS092040 Chevron Chemical Company. 1966. Name, Chemical Identity and
Composition of the Pesticide Chemical: Dibron. (Unpub-
lished study received Oct 22, 1974 under 239-163,
Accession No. 233083).
GS092090 Chevron Chemical Company. 1981. [Ethyl-l-l4C]|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-^ichlorovinyl 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-l^C] 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.
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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 aJL. 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 The Dow Chemical
Co., Midland, Michigan.
GS092095 Chevron Chemical Company. 1970. Naled pasture and milk
residue study. Unpublished study submitted under OF0975.
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. Aranjo, J. W.
Hooper, B. Broxup, B. E. Osborne, and B. G. Proctor.
1981. DIBROMR: 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,
DWRC, 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. Chenu 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.
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