GUIDANCE FOR THE
REREGISTRATION OF MANUFACTURING-USE
AND CERTAIN END-USE PESTICIDE PRODUCTS
CONTAINING
June 1983
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
Washington, DC 20460
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Table of Contents
Section Page
I. Introduction , I
II. Regulatory Position 3
III. Requirement for Submission of Generic Data ....... 21
IV. Requirement for Submission of Product-Specific . ••'
Data 24
7. Submission of Revised Labeling and packaging
Information '
A. Label Contents .
1. Product Name 25
• 2. Company Name and Address 25
3. Net Contents . . 25
4. Product Registration Number 25
5. Producing Establishment
Registration Number. . . 25
6A Ingredient Statement 2'6
63 Pounds Per Gallon Statement 25
7. Front Panel precautionary S'cataments 25
7A Child Hazard Warning Statements • 27
7B Signal Word 27
7C Skull and Crossbones and Word poison 27
7D Statement of Practical Treatment 27
7E Referral Statement 27
3. Side/Back Panel Precautionary Labeling 27
8A Hazard to Sumans and Domestic Animals 28
83 Environmental Hazard 23
8C Physical or Chemical Hazard 23
9 Misuse Statement 29
10A Storage and Disposal 31ock 29
10B Directions for Qse 29
3. Collateral Information . . 29
VI. instructions for Submission
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APPENDICES
III-l Bibliography
III-2 FIFRA §3(c)(2)(B) Summary Sheet - SPA Form 8580-1
III-3 Certification of Attempt to Enter Into an Agreement
With Other Registrants for Development of Data
EPA Porm 8580-6
IV-1 Product Specific Data Report (End-ase Products)
EPA Form 8580-4
V-l 40 CFR §162.10 Labeling Requirements
V-2 Table of Labeling Requirements and Sample Labels
V-3 Physical/Chemical Hazards Labeling. Statement
V-5 Storage and Disposal Statements
Note: Appendices V-4 and V-6 are not germane to this
document and are not included.
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I. INTRODUCTION
FIFRA Section 3(g) / as amended in 1978, directs EPA to
reregister all currently registered products as expeditiously as
possible. Each registrant of a currently registered product who
wishes .to continue to sell or distribute that product in commerce
must apply for reregistration.
,-^
. ' Tliis guidance document sets forth certain of the requirements
for registration and reregistration of all manufacturing-use
products (MPs) containing the subject chemical as the sole active
ingredient^ these requirements include: that certain scientific
data be submitted and that certain standards of toxicity, compo-
sition, labeling, and packaging be met. Registrants of MPs are
referred to all Sections and Tables for specific information
regarding their responsibilities under this guidance document.
This guidance document also sets forth the data requirements
for those end-use products which contain the subject active
ingredient 'and for which the source of that active ingredient is
(1) not registered with EPA or (2) produced by the registrant's
firm, or a firm which has ownership in common with the regis-
trant's firm, or (3) both (1) and (2). Registrants of such
end-use products, can exempt themselves from these requirements
if they change their source of supply to a registered source,
provided the source (i.e., registered active ingredient product)
is obtained from a firm that does not share ownership in common
with the registrant's firm. (If the end-use product registrant
decides to switch sources, a new confidential statement of fcmula,
EPA Form 8570-4, must be submitted to the appropriate .Product
Manager within 90^days of receipt of this guidance document.)
Registrants of affected end-use products are referred to only
Sections II, III, and VI and Table A for specific information
regarding their responsibilities under this guidance document.
It should be noted that end-use products containing the
subject active ingredient will not be reregistered at this time.
Any necessary labeling changes will be implemented under the
Agency's Label Improvement Program at a future time.
EPA will issue a notice of intent to cancel or suspend the
registration of any currently registered product if~the registrant
fails to comply with the requirements set forth in this guidance
document and with the requirements contained in subsequent informa-
tion from EPA about compliance with certain data support requirements.
This guidance document has been prepared to provide registrants
with specific information on how they may reregister their
manufacturing-use products or maintain their end-use products'
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registration. (Refer to the cover letter's attachment for a
listing of your affected products.) if for any reason you decide
to request that the Agency discontinue the registration of any of
your products subject to the registration requirements in this
document, please notify the Product Manager named in the cover
letter, within 90 days from the receipt of this document, that
you wish to voluntarily cancel the registration(s). If you decide
to maintain your product registration(s), you must provide the
information described in the following pages within the time-
frames outlined.
Registrants are reminded that Section 6(a)(2) of FIPRA requires
you at any time to submit factual information raising concerns of
possible unreasonable adverse effects of a pesticide, you should
notify the Agency of interim results of studies in progress if
those results show possible 'adverse effects..
This guidance document will be supplemented by EPA with
additional information about compliance with data support require-
ments.. In Monsanto v. Administrator, EPA was recently enjoined.
by the District Court for the Eastern District of Missouri from
implementing in any way the "mandatory data licensing" aspects
of §3(c)(l)(D) Of PIPRA. EPA is assessing the implications of
the injunction for the reregistration process. Because this
situation is currently unresolved, EPA has decided to proceed
with the requirements in this guidance package which do not
relate to the "data licensing" issue and to supplement the package
with additional guidance when circumstances permit.
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II REGULATORY POSITION AND RATIONALE
A. INTRODUCTION
£This Registration Standard describes the regulatory posi-
tion of the Environmental Protection Agency (the Agency)
on registered manufacturing-use products (MPs) containing
the insecticide-acaricide, naled. The Agency's position
is based on a consideration of available data for all cur-
rently registered uses and registered MPs with naled as the
sole active ingredieot-j This position is based on a number
•»
of considerations. The Standard considers labeling require-
ments, tolerances, "Special Local Need" registrations author-
ized by FIFRA Section 24(c), as well as Federal registration
granted or pending under FIFRA Section 3. Finally, the
Agency sets forth the data requirements that must be met to
register products covered by this document.
(This Standard only addresses registration requirements for
current or substantially similar future MPs and their inter-
mediaries. Naled MPs that differ appreciably from those
described here may require amendments to the Standard.!
B. CHEMICAL DESCRIPTION AND USE PROFILE
In the United States, naled is the American National Standards
Institute (ANSI) approved common name for a halogenated
organophosphorus insecticide-acaricide manufactured by the
Chevron Chemical Company. The chemical name is 1,2-dibromo-
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 estar. 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 C4H7
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(mosquito control). The major use sites are: fruit, nut,
vegetable, and field crops; adult mosquito control; pets,
and livestock.
Maled is formulated into dusts (4% and 6%), impregnated
materials (10%-25%), emulsifiable concentrates (2-7.2 lb/
gal and 6%-26%), soluble concentrates/liquid (2.35-14 lb/
gal,and 11.4% and 20%), and ready-to-use liquids (1.26-
12.6 Ib/gal and 1%-15%). Naled is applied on agricultural
crops by using aircraft and ground equipment including mist
blowers and foggers.
C. REGULATORY POSITION
Based on a review and evaluation of all available data and
other relevant information on naled, the Agency had made the
following determinations:
1. Manufacturing-use products containing naled as the
sole active ingredient may be registered for sale, distri-
bution, and reformulation into end-use products, for use,
subject to the terms and conditions specified in this Standard.
2. Registrants must provide or agree to develop addi-
tional data, as specified in TABLE A and TABLE B of this
Standard, in order to maintain existing registrations or
to obtain new product registrations.
•*
3. Available data do not indicate that any of the
criteria cited in 40 CFR 162.11 (b) have been equalled or
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exceeded at this time. However, gaps in the data base pre-
clude the .completion of the Agency's risk assessment for
naled.
4. Although the Agency is unable to complete a tolerance
reassessment for naled because of a number of residue chemistry
and toxicology data gaps, the Agency has concluded, based on
available data, that no changes in present tolerances are
necessary at this time. The Agency has also considered the
residues of inorganic bromide, resulting from the use of naled
on crops and in meat, milk, poultry and eggs, and does not
anticipate these residues to be of toxicological concern, and
no additional residue data on inorganic bromides are needed.
However, the Agency is concerned about organic brominated
metabolites of naled and its impurities. Accordingly,
additional data on this organic bromide in plants and
animals are being requested.
D. REGULATORY RATIONALE
The Agency has determined that it should continue to allow
the registration of products containing naled, after con-
sidering the following:
1. Acute animal toxicity data indicate that technical
naled is in Toxicity Category I on the basis of eye irritation,
and Toxicity Category if 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)J should minimize
the acute hazards associated with these routes of exposure.
2. Dichlorvos (DDVP), a metabolite of naled was origin-
ally referred to the Rebuttable Presumption Against Registration
(RPAR) process because scientific studies indicated that
dichlorvos was mutagenic and might cause cancer, nerve damage
and birth defects in laboratory animals. The RPAR Decision
Document on Dichlorvos, was issued by the Agency on September
30, 1982. In-this document the Agency evaluated the available
data on dichlorvos in accordance with 40 CFR 162.11 (Criteria
for Determination of Unreasonable Adverse Effects) and con-
cluded that the 'existing evidence does not support the issuance
of an RPAR for dichlorvos and consequently, that an RPAR
for naled as a precursor of dichlorvos is also not warranted.
However, the Decision Document concluded that additional
data on carcinogenicity and rautagenicity 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 1970-1981 (primarily
1979-1981) received reports cf 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 mg/kg or less, approved for
residential application (40 CFR 162.16) should reduce potential
risks of accidental exposure.
The absence of reported fatalities, taken in conjunction with
the apparent adequacy of medical and/or emergency room treat-
ment in the vast majority of reported cases (only one reported
case involving hospitalization) suggests an acceptably low
level of risk associated with incidental or accidental exposure
to naled products.
6. Naled degrades fairly rapidly with half-lifes of
£ 8 hours in soils and £ 25 hours in aqueous solutions.
Dichlorvos is also rapidly degraded in soil with half-lifes
of 2.3 - 8.0 hours. Naled exhibits low to intermediate
•*
mobility in soils, whereas dichlorovos is intermediately
mobile to mobile. Limited data indicate that the rapid
dissipation and relatively low mobility of naled and inter-
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mediate mobility of 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.
10
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10. Onder 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 ? of this
document.
The applicant for registration or reregistration of products
subject to this Standard must comply with all terms and con-
ditions described herein. These include making a commitment
to fill data gaps on a schedule specified by the Agency.
Applicants for registration under this Standard must follow
the instructions contained in this guidance package and
complete and submit the appropriate forms within the time
specified.
F. ACCEPTABLE RANGES AND LIMITS
•*
1. Product Composition Standard
To be covered under this Standard, manufacturing-use products
must contain naled as the sole active ingredient. Each MP
11
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formulation proposed for registration must be fully described
and include an appropriate certification of limits for all
contaminates and impurities, and carry-over starting materials
and/or intermediates above the level of 0.1% in the technical
product.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade
products and MPs containing naled for any acute toxicity
category, provided that the labeling of those products bears
appropriate precautionary statements.
3. Use Patterns
To be registered under this Standard manufacturing-use
products containing naled may be labeled for formulation
only into end-use products for:
• Terrestrial, food uses on: alfalfa (forage, seed),
almonds, beans (dry, succulent), broccoli, Brussels
sprouts, cabbage, cantaloupes, cauliflower, celery,
chard (including Swiss), collards, cotton, cucumbers,
eggplants, grapefruit, grapes, honeydew melons, hops,
kale, lemons, lettuce, muskmelons, oranges, pastures
(forage grasses and legumes)(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.
0 Aquatic, non-food uses on: marinas, swamps, swimming
pool areas, and tid^l marshes.
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9 Greenhouse, food uses on: vegetable crops (including
cucumbers, mushrooms, and tomatoes).
* Greenhouse, non-food uses on: ornamental plants (in-
cluding carnations, chrysanthemum, poinsettias, roses,
and snapdragons).
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.
' 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, feedlots^, garbage containers, garbage dumps,
kennels (dog), livestock feeding areas, loading docks,
meat packing establishments, pens, poultry droppings,
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poultry houses (including equipment and yards)(including
those for chickens, pheasants,and turkeys), poultry
packing/processing plants, restaurants, warehouses, and
wineries.
G. REQUIRED LABELING
All manufacturing-use products containing naled must bear
appropriate labeling as specified in 40 CFR 162.10. Other
portions of the guidance package contain specified infor-
mation regarding label requirements.
1. Use Pattern Statements
The ingredients statement for MPs. must list the active
ingredient as:
Naled, (l,2-dibromo-2,2-dichloroethyl
dimethyl phosphate) %.
In addition, all MPs must state that they are intended only
for formulation into end-use products for any of the use
patterns listed above. They must specify specific sites
listed in Use Patterns in Section F.3. A limiting factor
will be the data that supports these use patterns. No use
may be included on the label, or labeling, where the registrant
fails to agree to comply with the data requirements in either
TABLE A fpr that use pattern, or TABLE B.
•*
IS
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2. Precautionary Statements
Labels for all MP products containing naled must bear state-
ments reflecting the acute human toxicity of the compound.
Naled is in Toxicity Category I on the basis of eye irritation
effects and Category II on the basis of acute oral and acute
dermal toxicity or effects. The Agency has no valid acute
inhalation or dermal sensitization data for naled. The re-
quired precautionary statements associated with Toxicity
Category I and II are specified in 40 CFR §162.10.
•»
The following environmental hazard statement must appear on
the manufacturing-use product labels:
"This product is toxic to fish, aquatic invertebrates,
and wildlife. Do not discharge into lakes, streams,
ponds or public water unless in accordance with NPDES
permit. For guidance contact your regional office of
the Environmental Protection Agency."
Labeling changes to end-use products (EPs) are not required
by this Standard, however, based on data reviewed by the Agency
the following statements will be required for EPs under the
Agency's Label Improvement Program.
""This pesticide is toxic to fish, aquatic invertebrates,
and .wildlife. Do not apply directly to water or wet-
•*
lands. Runoff from treated areas may be hazardous to
aquatic organisms in neighboring areas. Do not contamin-
ate water by cleaning of equipment or disposal of wastes."
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""This product is highly toxic to bees exposed to direct
treatment on blooming crops or weeds. Do not apply this
product or allow it to drift to blooming crops or weeds
while bees are actively visiting the treatment area."
The following "General Warnings and Limitations" statements
must appear on end-use product labels which bear directions
for aquatic use on food or feed crops:
'"Do not use with highly alkaline materials such as lime
or bordeaux mixture. Shrimp and crabs may also be
killed at application rates recommended. Do not apply
to tidal or marsh waters which are important shrimp
producing areas."
The term "Birds feeding on treated areas may be killed" is
inappropriate and should be deleted from all labels (reference
D. Regulatory Rationale, 9).
PR Notice 83-2, dated March 29, 1983, sets forth current
Agency policy on required label changes for reentry and
farmworker safety. A reentry interval of 24 hours for the
use of naled on crops is required. The Agency reserves the
right to revise this reentry interval after receipt and
review of the data required in TABLE A and TABLE B of this
Standard.
*
The Agency may impose additional label requirements after the
receipt and review of the data to be submitted under this
Standard.
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H. TOLERANCE REASSESSMENT
A summary of the tolerances for combined residues of naled
and 2,2-dichlorovinyl dimethyl phosphate (DDVP) in or on
raw agricultural commodities resulting from the application
of naled formulations to growing crops, livestock and poultry
(40 CFR 180.215, July 1981) is presented in Table I at the end
of this section.
Canadian and Mexican tolerances are presented for comparison;
it is not known whether these tolerances are for combined
residues of naled and DDVP or for residues of naled alone.
No international maximum residue limits (MRLs) have presently
been established by the Codex Alimentarius Commission.
United States tolerances are identical with those of Canada
and Mexico in all cases except peas and peppers, for which
the U.S. and Canadian tolerances are 0.5 ppm and Mexican
tolerances are 1 ppra (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 Q.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 (ppra)
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 (pom)
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
-------
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 d/
0.5
3.0 3.0
0.5 0.5 0.5
3.0 3.0
0.5 0.5
0.5 0.5
a/ United States tolerances are for grapefruit, lemons and
tangerines; Canadian and Mexican tolerances are for all
citrus fruits.
b/ United States tolerance is for succulent peas only;
Canadian and Mexican tolerances are for all peas.
c/ The Mexican tolerance is for chili peppers only; the
United States and Canadian tolerances are for all peppers,
d/ To account for area pest (fly and mosquito) control.
-------
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 registrations)
of your product(s) identified as an attachment to
the cover letter accompanying this guidance document.
As required by FIFRA Section 3(c)(2)(B), you are
required to take appropriate steps to comply with
this Notice.
EPA may suspend the registration of each of those products
unless, within the specified time, you have informed EPA
how you will satisfy the requirements of this Notice.
Any such suspension will remain in effect until you have
complied witli the terms of this Notice,
B. What Generic Data I/Must Be Submitted. You may ascertain
wnich 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 oT 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.
21
-------
type for each major formulation category (e.g./ emulsifiable
concentrates, wettable powders, granulars, etc.) These
are classified as generic data and when needed are
specified in Table A. EPA may. possess data on certain
"typical formulations" but not others. Note; The "typical
formulation" data should not be confused with product-
specific data (Table B) which are required on each
formulation. Product-specific data are further explained
in Section 17 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 SPA
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" (SPA 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
E3A 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)(3)(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 NALED 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 Product Chemistry
(continued)
63-3 - Physical State
63-4 - Odor
4
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density, or
Specific Gravity
TGAI
TGAI
TGAI
TGAI
TGAI
Yes
Yes
Yes
Yes
Partial
00074790 No
G5092040
00074790 No
G5092040
G5092040 No
00074653; 00074724* No
00074790; G5092040
00074653; 00074724* Yes 8/
00074790; G5092040
*Data submitted by Chevron Chemical Company. These data inay 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)? 4/
SI 58. 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
S15B.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.
Ji/ All data cited were submitted by the Chevron Chemical Company,
4/ Data must be submitted no later than ]una IWifi •
5/ Adequate data has been submitted by Chevron Chemical Company. Other producers must address these data requirements.
~b/ The analytical methods used were inadequately described. Identification and quantification of impurities present
at >0.1% (W/U) 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.
-------
TABUS A
GENERIC DATA REQUIREMENTS DOR NALED
Data Requirements
Composition
Does EPA Have Data
To Satisfy This
Requirement? (Yes,
No, or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIPRA Section
3(c)(2)(B)?V
§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
00074836
GS092090*
00074654
00074647
00074844
00059386
GS092091*
GS092092*
00074721; 00074806*
00074647; 00073820
00074725
GS092026
00073821*
Yes 3/,4/
Yes 3/
Yes 4/
No
No
Yes 5/
*Data submitted by Chevron Chemical Company. These data may be canpensable.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Data Requirements
Does EPA Have Data
To Satisfy This
I/ Requirement? (Yes,
Composition 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 BrassicaT
0 Celery
TEP
TEP
TEP
TEP
TEP
Yes
No
Yes
Partial
Partial
00074836 j 00073821*1
00073815*; 00073819*
00074836; 00073821*;
00073815*; 00073819*
00073820
00074836; 00073821*;
00074722
No
Yes 7/
No 9/
Yes 10/
Yes U/
0 Lettuce
0 Spinach
0 Swiss Chard
TEP
TEP
TEP
Partial
Partial
Partial
00073820; 00074807
00073820; 00074722
00074836
Yes 12/
Yes 13/
Yes 13/
-------
TABLE A
GENERIC DATA REQUIREMENTS R3R NALED
I/
Data Requirement Composition
§158.125 Residue Chemistry
(continued)
171-4 - Magnitude of the Residue -
Residue Studies (continued)
- Brass ica (Cole) Leafy
Vegetable Group
0 Broccoli
0 Brussels Sprouts
0 Cabbage
0 Cauliflower
0 Col lards
0 Kale
- Legume Vegetables (Succulent
and Dried) Group
0 Beans
0 Peas
0 Soybeans
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Requirement? (Yes, Bibliographic Under FIFRA Section
No or Partially) Citation 3(c)(2)(B)?2/
Partial
No
Partial
Partial
Partial
Partial
Partial
Partial
Partial
00074836; 00073820
-
00074836
00073820
00073821*
00073821*
00074836; 00073846*;
00073820; 00074699;
00073821; 00074729
00073846*
00073821*; 00073846*
Yes H/
Yes 15/
Yes 14/
Yes H/
Yes 14/
Yes W
Yes 16/
Yes IT/
Yes IB/
*Data submitted by Chevron Chemical Company. These data may be cornpensable.
-------
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 Summer Squash
0 Winter Squash
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
I/ Requirement? (Yes, Bibliographic Under FIFRA Section
Composition No or Partially) Citation 3(c)(2)(B)?2/
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
Partial
Partial
Partial
No
Partial
Partial
Partial
Partial
No
Partial
No
00074836; 00073820}
00073821*| 00073846* j
00074699; 00074729
00073846*
00073821*| 00073846*
00074836*; 00073820
00074836; 00073820;
00075668
00073820; 00075668
00073820
-
00073820
-
Yes 19/
Yes 20/
Yes 2l/
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 POR HALED
Data Requirement
Composition
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
TEP
TEP
TEP
TEP
TEP
TEP
TEP
No
Partial
Partial
No
Partial
Partial
Partial
0 Strawberries
- Cereal Grains Group
0 Rice Grain TEP Partial
*Data submitted by Chevron Chemical Company. These data may be canpensable.
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/
-------
TABLE A
GENERIC DATA REQUIREMENTS tOR NALED
Data Requirement
Does EPA Have Data
To Satisfy This
J_/ Requirement? (Yea,
Composition No or Partially)
Bibliographic
Citation
Must Additional
Data Ba Submitted
Under PIPRA Section
3(c)(2)(B)? 2
§158.125 Residue Chemistry
(continued)
- Forage, Fodder, and Straw
of Cereal Grains Group
0 Rice Forage
- Grass., Forage, Podder
and Hay Group
0 Grass Porage (Pasture
and Range)
- Non-Grass Animal Peeds
TEP
TEP
Yes
Partial
00074723
00073820
00073816*
No 35/
Yes 36/
(Forage, Fodder, Straw,
and Hay) Group
0 Alfalfa TEP
- Tree Nuts Group 38/
0 Almonds TEP
0 Walnuts TEP
Partial 00074836; 00073821*;
00073818*; 00072816
Yes 00073830
Yes 00073821*
Yes 37/
No 39/
No
*Data submitted by Chevron Chemical Company. These data may be conpensable.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
I/
Data Requirement Composition
§158.125 Residue Chemistry
(continued)
- Miscellaneous
0 Cottonseed TEP
0 Hops TEP
0 Mushrooms TEP
0 Saff lower Seed TEP
- All Other Agricultural TEP
Commodities
- Food Producing Animals
0 Meat and milk EP, TGAI or plant
metabolites
0 Poultry and eggs EP, TGAI or plant
metabolites
Does EPA Have Data
To Satisfy This
Requ i rement? ( Yes ,
No or Partially)
Partial
Partial
Partial
Yes
No
Yes •
Partial
Must Additional
Data Be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)? 2
00074700; 00073821*|
00074845*
00073846*
GS092093
00073846*1 00074845*
GS092094
GS092092*
GS092095*
00073821*
GS092026
GS092096
00074692*
Yes 40/
Yes 41/
Yes 42/
No 43/
No 44/
No 45/
Yes 46/,47/
•Data submitted by Chevron Chemical Company. These data may be oompensable.
-------
TABLE A
GENERIC DATA REQUIREMENTS TOR 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 im»(i__i_£ifl£ i_
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-broroinated 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) Isee FR 47(93)20635(5-13-82)]. Satisfaction of the crop group requirements for a given group would
allow the establishlment of a tolerance for all members ot 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 coromodities (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 POR 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. .
17/ 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.
IB/ 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
foragej 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 winch 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
branide ion content of the animal diet.
28/ The available data support the established tolerance for simmer 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 lb/gai 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 EOR 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 availably 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/ Hie available data support the established tolerance for residues of naled and DDVP in or on rice forage resulting
from the use of die 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
SI58.125 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 RTU 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 ppm is established for combined residues on naled and DDVP in or on all raw agricultural
commodities, except those otherwise listed in 40 Cf'R 180.125 (July 1981), from use of naled formulations for area
pest (fly and mosquito) control. The recomnanded 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/
Ccmposition Pattern
Does EPA Have Data
To Satisfy This
Requ i rement? (Yes,
No or Partially)
Must Additional
Data be Submitted
Bibliographic Under FIFRA Section
Citation 3(c)(2)(B)?V
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB;
161-1 - Hydrolysis
Photodegradat ion
161-2 - In water
161-3 - On soil
161-4 - In Air
METABOLISM STUDIES-LAB;
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aquatic
162-4 - Aerobic Aquatic
MOBILITY STUDIES;
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,
P. II
TGAI or PAIRA A,G
TGAI or PAIRA C,D,G
TGAI or PAIRA C,D
163-1 - Leaching and TGAI or PAIRA A,B,C,D,
Adsorption/Desorption E,F,G,H
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
TEP
TEP
A,E,F
A,E,F 8/
No
No
No
No
Partial 4/
No J5/
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
**Data submitted by National Chemsearch, Division .of NCH Corp.
be condensable.
These data may be compensable.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
I/ 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 A,B,H
TEP C,D
TEP G
TEP
TEP 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 A
TEP A
TEP C
TGAI or A,B,C,
PAIRA D,G
TEP D
Mo - 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 compensable.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR HALED
§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=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 jnnn, \f,\\h •
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.
T/ Aged leaching, tests are required to identifiy metabolites and degradation rates. No absorption/desorption data
were submitted, therefore all data are required.
8/ Label modifications for the greenhouse use may be necessary because of high volatility and toxicity (Category II)
of the metabolite DDVP. A decision will be made after an additional aerobic soil metabolism study is submitted
and evaluated.
9/ Data requirement depends on the results of the laboratory studies.
10/ Partial information obtained from sewage water; additional data required on dissipation from other aquatic
impact areas.
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.
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.
-------
TABUS A
GENERIC DATA REQUIREMENTS FOR NALED
Does EPA Have Data
To Satisfy This
I/ Use 2/ Requirement? (Yes, Bibliographic
Data Requirement Composition Patterns No or Partially) Citation
S158.135
Toxicology
Must Additional
Data Be Submitted
Under FIFRA Section
3
-------
TABLE A
GENERIC DATA REQUIREMENTS TOR 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 No
TGAI A,B,C,E,H,I No
TGAI A,B,C,E,ll,I No
TGAI A,B,C,E,H,I
TGAI A,B,C,E,li,I
TGAI A,B,C,E,H,I
PAI or A,B,C,E,H,I
PAIRA
85-2 - Domestic Animal Safety Choice B,I1,I
Partial 7/,9/
No
No
Reserved 7/,10/
Reserved 1Q/
GS092103
Yes 6/,7/
Yes 6/,7/
Yes 7/,8/
Yes 6/,T/
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} PAJRA = 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 Crops 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 must be submitted no later than June 19G6 .
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 sbuinitted 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.
1Q/ Reserved pending results of subchronic and chronic testing. .
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
I/ 2/ Requirement? (Yes, Bibliographic Under FIFRA Section
Data Requirement Composition Pattern No or Partially) Citation 3(c)(2)(B)?V
§158.140 Reentry Protection
132-1 - Foliar Dissipation TEP A,B No
132-1 - Soil Dissipation TEP A,B No
133-3 - Dermal Exposure TEP A,B No
133-4 - Inhalation Exposure TEP A,B No
Yes 4/
No 5/
No 5/
No 5/
I/ Composition: TEP = Typical end-use product.
2/ The use patterns are coded as follows; A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; OAquatic, Food Crop;
D=Aquaticf Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H-Dojnestic Outdoorj I=Indoor.
3/ Data must be submitted no later than June 1986 .
4/ Use California reentry interval of 24 hours for all crops, or submit foliar dissipation data to establish a
decline curve.
5/ Only foliar dissipation data are required.
-------
TABLE A
GENERIC DATA REQUIREMENTS TOR 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 LD5Q
Avian Dietary (£50
«
Wild Mammal Toxicity
Avian Reproduction
Simulated and Actual
Field Testing -
Mainnals and Birds
TGAI A,B,C,D,G Yes
TGAI A,B,C,D, Yes
E,F,G,H,
I I/
TGAI A,B,C,D,G No
TGAI A,B,C,D,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 LC5Q
-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 HOR NALED
I/
Data Requirement Composition
§158.145 Wildlife and
Aquatic Organisms
(continued)
72-2 - Acute LCso Freshwater TGAI
Invertebrates
-do- TEP
72-3 - Acute LCso Estuarine TGAI
and Marine Organisms
72-4 - Fish Early Life TGAI
Stage and Aquatic
Invertebrate Life-Cycle
72-5 - Fish - Life-Cycle TGAI
72-6 - Aquatic Organism TGAI, PAI OR
Use 2/
Pattern
A,G,C,D,
E,F,G,H,
I I/
C,D,G
C,D,G
C,D,G
C,D,G
C,D,G
Does EPA Have Data
To Satisfy This
Requirement? (Yes, Bibliographic
No or Partially) Citation
Yes GS092100
No
Partially 7/ GS092104
00074684
Reserved 8/
Reserved 9/
Reserved 9/
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)?3/
No
Yes 6/
Yes
Accumulation
72-7 - Simulated or Actual
Field Testing -
Aquatic Organisms
Degradation
Product
TEP
C,D,G Reserved 9/
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR NALED
§158.145 Wildlife and Aquatic Organisms
(continued)
I/ Compositions TGAI = Technical grade of the active ingredient; PAI = pure active ingredient;
TEP = Typical end-use product;
2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial/ Non-Food Crop; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; 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 E,F,II and I use patterns.
]y 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
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)?V
§158.150 Plant Protection
121-1 - TARGET AREA
PHYTOTOXICITY
EP
No
No _4/
NONTARGET AREA PUYTOTQXICITY
TIER I
*
122-1 - Seed Germination/
Seedling Emergence
TGAI
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: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food Crop; C=Aquatic, Food Crop;
D=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Domestic Outdoor; I=Iridoor.
3/ Data must be submitted no later than .
j4/ These requirements are generally waived unless it is believed there is a phototoxicity problem.
-------
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)?3/
§158.155 Nontarget Insect
NONTARGET INSECT TESTING -
POLLINATORS;
141-1 - Honey bee acute
contact LD5Q
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 important in TEP
alfalfa pollination -
toxicity of residues
on foliage
141-4 - Honey bee subacute TEP
feeding study
141-5 - Field testing for TEP
pollinators
A 4/
A,B,G,II Reserved 5/
A,B,G,H No
00060628
05000837
No
No 6/
-------
TABLE A
GENERIC DATA REQUIREMENTS TOR NALED
Data Requirement
I/ Use 2/
Composition Pattern
Does EPA Have Data
To Satisfy This
Requ i rement? (yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under FIFRA Section
3(c)(2)(B)? 3/
§158.155 Nontarget Insect
(continued)
NONTARGET INSECT TESTING -
AQUATIC INSECTS;
142-1 - Acute toxicity to
aquatic insects
*
142-2 - Aquatic insect
life-cycle study
142-3 - Simulated or actual
field testing for
aquatic insects
143-1 - NONTARGET INSECT
TESTING - PREDATC
thru AND PARASITES
143-3
Reserved 7/
Reserved 7/
Reserved 7/
Reserved 7/
\J 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.
4/
5
Reserved pending development of test methodology.
6/ May be required under the following conditions:
i) Data from the honey bee subacute feeding study (141-4) indicate adverse effects on colonies, especially
effects other than acute mortality (reproductive, behavioral, etc.);
ii) Data from residual toxicity studies (141-2 and 141-3) indicate extended residual toxicity; or
iii Data derived from studies with organisms other than bees indicate properties of the pesticide beyond acute
toxicity such as the ability to cause reproductive or chronic effects.
T/ Reserved pending decision as to whether data requirement should be established.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING NALED I/
Data Requirement
Composition
2/
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)? 4/
§158.120 Product Chemistry
Product Identity;
61-1 - Identity of Ingredients
61-2 - StatemenJ: of Composition
MP
MP
61-3 - Discussion of Formation of MP
Ingredients
Yes
Partial
Partial
00074653 No
00074724
GS092040
00074653 Yes 5/
00074791*
00065493| 00065494* Yes 6/
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
Yet
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.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING NALED
I/
Data Requirement Composition
Does EPA Have Data Must Additional
To Satisfy This Data Be Submitted
Requirement? (Yes, Bibliographic Under FIFRA Secti<
No or Partially) Citation V 3(c)(2)(B)7 V
§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
Odor
»
Density, Bulk Density, or
Specific Gravity
- pH
- Oxidizing or reducing
action
- Flammability
- Explodability
- Storage Stability
- Viscosity
- Miscibility
- Corrosion
Requirements:
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
MP
Yes
Yes
Partial
No
Yes'
Partial
Yes-
Yes
Yes
Yes
Yes
00074790
G5092040
00074790
G5092040
00074653| 00074724
00074790; G5092040
-
00074790
00074790
00074790
00074653
00074790
GS092040
00074790
GS092040
00074790
GS092040
No
No
Yes 8/
Yes
No
Yes 9/
No
No
No
No
No
64- 1 - Submittal of samples
MP
No 10/
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING NALED
SI58.120 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/ DataJmust be submitted no later than iv-r i nfll •
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 flaiuuability of the manufacturing-use naled is required.
10/ May be requested on a case-by-case basis.
-------
TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACIURING-USE PRODUCTS CONTAINING NALED
Data Requirement
Composition
I/
Does EPA Have Data
To Satisfy This
Requ i rernent? (Yes,
No or Partially)
Bibliographic
Citation
Must Additional
Data Be Submitted
Under PIFRA Section
3(c)(2)(B)?2/
S158.135 Toxicology
ACUTE TESTING
81-1 - Oral LD5o - Rat
81-2 - Dermal LDso - Rabbit
81-3 - Inhalation LC5o - Rat
81-4 - Primary Eye
Irritation - Rabbit
81-5 - Primary Dermal
Irritation - Rabbit
81-6 - Dermal Sensitization -
Guinea Pig
HP
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/ Compositions 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-Teat Laboratories (IBT) and has been determined to
be invalid.
*Data submitted by Chevron Chemical Company. These data may be canpensable.
-------
IV. REQUIREMENT ?OR SUBMISSION OF PRODUCT-SPECIFIC DATA
Note: This section applies only to manufacturing-use products,
not end-use products.
A necessary first step in determining which statements must
appear on your product's label is the completion and submission
to SPA of product-specific data*" listed on the fora entitled
'Product Specific Data Report" (SPA Form 8580-4, Appendix IV-1)
to fill "gaps" identified by EPA concerning your product. Under
the authority of PIFSA Section 3(c)(2)(3), EPA has determined
that you oust submit, these data to SPA in order to register or
reregister your product(s). All of these data oust be submitted
not later than six months after you. receive this guidance document,
"Product-Specific Data Requirements for Manufacturing-Use
Products" appearing in Table 3 permit you to determine which
product-specific data you must submit. This can be done by
examining the entries in the column of those tables entitled
"Must Data .Be- Submitted Under §3(c) ( 2) ( 3) ."
jy Product specific data pertains to data that support the
formuTation which is marketed; it usually includes product
chemistry data and acute toxicology data.
24
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V. SUBMISSION OF REVISED LABELING AND PACKAGING INFORMATION
Note: This section applies only to manufacturing-use products,
not end-use products.
The Agency requires applicants for registration or reregistra-
tion to ensure that each label (1) contains accurate/ complete,
and sufficient instructions and precautions, reflecting the
results of data concerning the product and its ingredients, and
(2) incorporates labeling format and terminology which are suffi-
ciently standardized to avoid user confusion.
As part of your application, you 'will be required to submit
draft labeling consistent with: applicable product-specific
data; the precautionary statements and use directions; and the
regulations concerning classification [40 CFR §162.11(c)], pack-
aging [40 CFR §152.15], and labeling [40 CFR §152.10, Appendix
V-l and V-2], as indicated by the following paragraphs of this
section of the guidance document.
?ou will be informed later when you must submit the revised
labeling set fortii in this guidance package.
. A. Label Contents
40 CFR §152.10 (Appendix V-l) requirss that certain spe-
cific labeling statements must appear at certain locations
en the label. This is referred to as fsrr.ac labeling.
Specific label icsins liscad below are keyedco Taoies D, 2,
and ? (Appendix VT-2).
Item 1. PRODUCT MAWS - The name, brand, or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading. See Aopendix
7-1. [40 CFR §162.lO(b)l
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required' on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
See Appendix*7-1. [40 CFR SlS2.10(c)]
Item 3. NET CONTENTS - A net content statement is required
on all labels. The preferred location is the bottom of the
front panel immediately above the company name and address,
or at the end of the label text. The"net contents must be
stated in terms of weight, expressed as avoirdupois pounds
25
-------
and ounces, and stated in terns of the largest suitable unit,
i.e., "1 pound 10 ounces" rather than "26 ounces." In
addition to the required units specified, net contents may be
expressed in metric units. See Appendix 7-1. [40 CFR
3162. I
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "SPA Registration" No. ," or "EPA
Reg. NO." Tfte registration number must be set in type of a
size and style similar to other orinc on that part of the
label on which it appears and must run parallel to it.. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product bv the Agency. See Aopendix 7-1.
[40 C?R J162.10(a)l
Item 5. SPA ESTABLISHMENT NUMBER - The SPA establishment
number, preceded by the phrase "SPA Sst." is the final estab-
lishment at .which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment registration number on
the immediate container cannot .be clearly raad through such
wrapper or container. See Appendix 7-1. [40 CFR §162.10(f)]
Item 6. INGREDIENT STATEMENT - An ingredient statement
is required on the front panel and must contain the name and
percentage by weight of each active ingredient and the total
percentage by weight of all inert ingredients. The preferred
location is Immediately below the product name.. The ingredient
statement must run parallel with, and be clearly distinguished
from, other text on the panel. It must not be placed in the
body of other text. See Appendix 7-1. [40 CFR 162.10(g)]
Item 6A. POUNDS PER GALLON STATEMENT - For liquid
agricultural formulations, the pounds per gallon of active
ingredient must be indicated on- the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - All labels
are required to have precautionary statements grouped together
on the front panel, preferably within a block outline. The
table' below. shows the minimum type size requirements on
various size labels, as set forth in the Regulations.
26
-------
Size of Label Signal Word as Re- "Keep Out of Reach
on ?ront Panel • quired Minimum Type of Children"
in Square Inches Size_All Capitals' as Required
5 and under 6 point S point
above S to 10 10 point 6 point
above 10 to 15 12 point 3 point
above 15 to 30 14 point 10 point
over 30 13 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - All labels are
required to have the statement "Keep Out of Reach of Children"
located on the front panel above the signal word except where
contact, with children during distribution or use is unlikely.
See Appendix V-l. [40 CFR §162.10(h)(1)(ii)]
Item 7B. SIGNAL WORD — The signal word (Caution, Warning/
or Danger) is required on the front panel immediately below
the child hazard warning statement. See Apoendix V-i.
[40 CFR §162.10 (h)(l)(i)J
I tarn 7C. SKULL & CROSSBONES AND WORD "POISON"' - On products
assigned a toxicity Category. I on the basis of oral, inhala-
tion, or dermal toxicity, the word "Poison" snail appear en
the label in rad on a background of distinctly contrasting
color and the skull and crossbones shall appear in immediate
crcxiaiitv to the word poison. See Apoendix V-l. [40 CF3
SIS 2.10(h)(l)(i)j
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid.or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. See Appendix V-l. [40 CFR §162.10(h)(1)(iii)].
Item- 72. REFERRAL STATEMENT - The statement "See Side
(or Sack) Panel for Additional precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements apoear on the front panel.
See Appendix V-l. [40 CFR SlS2.10(h](1)(iii)]
Item 3. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements as listed below must aopear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The .preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title.. See Appendix V-l. [40 CFR §162.10
27
-------
I tarn 3 A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the .
route(s) of exposure and the precautions taken to avoid
accident, injury or damage. See Apoendix 7-1. [40 C?R §152.10
Item 38. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating tile natura of
the- hazard and the appropriate precautions to avoid potential
accident, injury, or damage. See Appendix v-1. [40
Item 3C.. PHYSICAL OR CHEMICAL HAZARD;
1. ?lammability statement. Precautionary statements
relating to" clammabilfty of a product ara required.
to appear on the label if it meets the criteria in
Appendix V-3. The requirement is based on the results
• of the flashpoint determinations and flame extension
teats required to be submitted far ail products..
These statements are to be located in the side/bacJc
panel precautionary statements section, pracaded by
the heading "Physical/Chemical Hazards. " Mota that
no signal word is used in conjunction with the flam-
mability statements.
2. Criteria for declaration of ncn-flammability. The
following criteria will oe used to detaraine if a
product is non— flammable:
a. A "non-flammable gas" is a gas for mixture of
gases) that will not ignite when a lighted match
is placed against the open cylinder valve.
b. A "non-flammable liquid" is one having a flash-
point greater than 350°? (177"C) as determined
by the method specified in 40 CFR §163.61-3(0(13)
( ii) of Subpart D.
c. A "non-flammable aerosol" is one which meets the
following criteria:
i. The flame extension is zero inches, using the
method specified in 40 CFH §163 .61-3 ( c) ( 13) ( ii) ;
ii. There is no flash back; and
*
iii. The flashpoint of the non-volatile liquid
component" is greater than 350°? (177°C),
determined by the method soecified in 40 C?R
. §163.61-3(0 (13) (i) .
28
-------
3. Declaration of non-flammability. Products which meet
tiie critaria for non-flammaoility specified above may
bear the notation "non-flammable" or "nonflammable
(gas/ liquid, etc.)" on the label.
It may appear as a substatement to the ingredients
statement/ or on a back or side panel, but shall not
be highlighted or emphasized (as with an inordinately
large type size) in any way that may detract from
precaution.
4. Other physical/chemical hazard statements. When
chemistry data submitted in accordance with 40 CFS
5lS3.Sl-10(c) demonstrate hazards of a physical or
chemical nature other than flammability/ appropriate
statements of hazard will be prescribed. Such
statements may address hazards of explosivity,
oxidizing or reducing- capability, or mixing with
other substances to produce toxic fumes.
'Item 9. MISUSE STATEMENT - The following statement is
required on your label: "It is a violation of Federal law to
use this product in a manner inconsistent with its labeling."
See Appendix v-1. [40 C?3 3152.10(1)(2)(ii)1
Item 10A. STORAGE AtfD DISPOSAL 3LOCK - All labels are
required to bear storage and disposal statements. These
statements are developed for specific containers, sizes, and
chemical ccncant. Make certain that the statement you use
pertains specifically to your product. These instructions
must be grouped and appear under the heading "Storage and
Disposal1* in the directions for use. This heading must be
set in the same type sizes as required for the child hazard
warning. Refar to Appendix 7-5 for the latest specific
storage and disposal product label statements.
Item 1QB. DIRECTIONS ?OR OSS - Directions for use must
be stated in terms which can be easily read and understood by
the average person likely to use or to supervise the use of
the pesticide. When followed, directions must be adequate to
protect the public'from fraud and from personal injury and to
prevent unreasonable adverse effects on the environment. See
Appendix 7-1. (40 CFS §162.10]
3. Collateral Information '
Bulletins, leaflets, circulars, brochures, data sheets,
flyers-,- and other graphic printed matter which is referred to
on the label or which*is to accompany the product are termed
collateral labeling. Such labeling may not bear claims or
representations that differ in substance from those accepted
in connection with registration of the product. It should be
made part of the response to this notice and submitted for review.
29
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VI. INSTRUCTIONS FOR SUBMISSION
All applications prepared in response to this Notice should
be addressed as follows:
(Product Manager]
Phone No. (703)
Registration Division (TS-767)
Office of Pesticide Programs
Environmental Protection Agency
Washington, O.C. 20460
A. For each manufacturing-use product for which continued
registration is desired:
1. Within 90 days from 'receipt of this document/ you must
submit the "FIFRA Section 3(c)(2)(B). Summary Sheet"
SPA Fora 3530-1. Refer to Appendix I II- 2 with
appropriate attachments.
2. Within 6 months from receipt of this document registrants
must submit:
a. Confidential Statement of Formula, SPA Form 3570-4.
b. Product Specific Data Report, EPA Fern 8.580-4
(Appendix" IV- 1) .
c. Two copies of any required product-specific data.
3. Within the time set forth in Table A, all generic data
must be submitted by • the affected registrant s ) .
Note; If for any reason any required test is delayed or
aborted so that meeting the agreed submission time
will be delayed, notify the Product Manager listed
above.
3. For each affected product for which continued registration
is desired, within 90 days from receipt of this document
submit the "FIFRA Section 3(c)(2)(3) Summary Sheet" (SPA
Fora 3580-1, Appendix III-2) with appropriate attachments.
C. you will be informed at a later date when you must submit
your Application for Amended Pesticide Registration (SPA
Form 8570-1) and the revised labeling set forth in this
guidance package.
30
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III. -
Guide to Use of This Siiliography
1. • CONTENT OP" 3I3L10GSAPSY." This bibliography contains" '"• '
citations of all studies considered relevant by S?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 £?A acd
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? SMT7.Y. The unit of- entry in this bibliography is
called a "study". In the case of published materials, this '
corresponds closely ta'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 wera submitted. The resulting "studies"
generally have a distinct title (or at least a single
subject), can stand alone far purposes of rsview, 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. IDSITTI? I CATION or SMTSliS. • The entries in" this- bibliography
are sorted numerically by "Master P.ecors Identifier*, cr
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; se-e
paragraph 4(d)(4) below for a further explanation. In a few
cases, entries added to the bibliography lats in the review
may be. preceded by a nine-character temporary identifier.
These entries, are listed after all MSIB~eneri.es. This
temporary identifier number is also to be used whenever
specific reference is needed.
4. FORM 0? 2JT3Y. 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 Standardc institute
(ANSI), expanded to provide for certain special needs.
a.
could confidently identify
show a personal*author.
fied, the Agency has 'shown
testing facility as
-------
b. Cccuaent Data. When the. date ace-ears as four digits
• " -with no question marfcs, the ''Agency too* • it directly •
from the document. When a four-digit: dace is followed
&y a question sarfc/ tte biiliccrasftar csduesd the data
iron evidence in the- document. When, the cat a as? ears. .
'••-•';.-- 'as^ (i ???'), the Agency was unable to-' de carmine dr. .' '• .' • "
estimate ue dace cf'cne dccuaer.c.
c. Title. In scae cases it Jias be-an necessary for Agency
biolicgraphers co creace or enhance a dccunenc title.
Arty suci: editorial insertions are contained between
'square brackets.
d. Trailing Parentheses. For studies submitted to
Agency in the past, tne trailing parentheses include
(in addition to any self -explanatory text) the
following elements, describing the earliest &:cvn
submission :
(1) Submission Date. Immediately following the word
'received' appears the date-' of the earliest known
submission.
(2)' Administrative Muiaaer. The nesc eleaenc,
immediately following the word 'under', is the.
registration number, experimental peraic number,
petition number, or other administracive nustser '
associated wich the earliest known suiraissiea .
(3) Subiait'ter. The third element is the susaitcer,
following the phrase 'submitted by'., '-then
authorship is defaulted to the subaitcar, this
element is emitted.
i
(4) Volume Identification (Accession Mu.TJbers ) .
The final element in the trailing parentheses
identifies the £?A accession number of the volume
in which the original submission of the study
appears. The six-digit accession- number follows
the symbol 'CDL1, 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, wichin accession number 12345 6 * the
first study would be 123455-A; the second, 1234 SS
B; the 2Sth 1234S6-2; and the 27th, 123456-AA.
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
00028757 Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary
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-S)
00059386 Casida, J.E.; McBride, L.; Niedermeier, R.P. (1961) Metabolism of
0,0-Dimethyl 2,2-dichlorovinyl phosphate (Vapona (R) or DDVP)
in Relation to Residues in Milk and Mammalian Tissues. (Unpub-
lished study received on unknown date under unknown admin, no.;
prepared by Univ. of Wisconsin, Depts. of Entomology and Dairy
Husbandry, submitted by Shell Chemical Co., Washington, D.C.;
CDL:120596-C)
00060628 Johansen, C.A.; Eves, J. (1965) Bee Poisoning Investigations, 1965:
Report No. G-1705; Report No. 17338. (Unpublished study, in-
cluding letter dated Jun 12, 1973 from C.A. Johansen to A.D. Co-
hick, received Mar 27, 1974 under 4F1485; prepared by Washington
State Univ., Dept. of Entomology, submitted by Chemagro Corp.,
Kansas City, Mo.; CDL:092011-I)
00064796 Pack, D.E. (1980) Mobility of Naled and Dichlorvos in Soil As De-
termined by Soil Thin-layer Chrcmatography: File No. 722.2.
(Unpublished study received Oct 20, 1980 under 239-1633; submit-
ted by Chevron Chemical Co., Richmond, Calif.; CDL:243547-A)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
00065468 Berteau, P.E.; Deen, W.A.; Dimmick, R.L. (1976) Studies of Effects
of Particle Size on the Toxicity of Insecticide Aerosals. Final
rept. By Univ. of California—Berkeley, Naval Biosciences Labo-
ratory for U.S. Dept. of the Any. N.P. (Contract no. MIPRr
5962; published study; CDL:229222-A)
00065493 Chevron Chemical Conpany (19??) Conposition of Technical Naled.
(Unpublished study received Mar 19, 1976 under 239-2444; CDLi
229289-F)
00065494 Hayman, E.L.; Friedrich, W.E.; Carlstrora, A.A. (1971) Determina-
tion of Impurities in Technical Dibron. (Unpublished study
received Mar 19, 1976 under 239-2444; submitted by Chevron
Chemical Co., Richmond, Calif.; CDL;229289-fl)
00072816 Dow Chemical U.S.A. (19??) Results of Tests on the Amount of Resi-
due Remaining, Including a Description of the Analytical Method:
Chlorpyrlfos. (Unpublished study received Mar 13, 1973 under
3F1370; CDL:093656-K)
00073815 Chevron Chemical Company (1971) Bromide Ion Residues Resulting from
the Use of Dibrom (R)- (Naled) on Forage Crops. (Compilation;
unpublished study, including test nos. T-2175 and T-2176, re-
ceived Sep 21, 1972 under 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-en- -
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)
-------
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) Dibron (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/Dibrcm. S-249.
Includes method RM-3G-3 dated Feb 23, 1973. (Unpublished study,
including letter dated Mar 24, 1976 from J.B. Leary to Michael
L. Paulson, received Apr 8, 1976 under 1769-203; prepared by
Chevron Chemical Co., .sutmitted 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)
N
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)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
00074655
00074656
00074663
00074684
00074691
00074692
00074699
00074700
00074721
Chevron Chemical Gcmpany (1966) Ortho Method of Analysis—D-IX-a:
Dibrcm (R) Naled by Gas Chromatograph. Method dated May 27,
1966. (Unpublished study received Sep 12, 1966 under 7F0532;
CDL;092821nJ)
Schwartz, C.S.; Cox, G.2.; Stevens, K.R. (1978) The Evaluation of
Dibrom as a Potential Neurotoxic Agent following Oral Adminis-
tration to Hens Protected by Atropine Sulfate: Laboratory
No. 5981. (Unpublished study received Dec 21, 1978 under 239-
1633; prepared by Food and Drug Research Laboratories, Inc.,
submitted by Chevron Chemical Co., Richmond, Calif.; CDL:
236682-A)
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-S)
Chevron Chemical Company (1960) Toxicology Reports: Dibrcm in Oys-
ters. (Compilation; unpublished study received Sep 20, 1966
under 7F0532; CDL:090646-N)
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)
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:090381-B)
Kohn, G.K. (1959r Letter sent to G.S. Hensill dated Dec 16, 1959:
Dibrom residues—pole beans. (Unpublished study received Jan
14, 1960 under 239-1281; submitted by Chevron Chemical Co.,
Richmond, Calif.; CDL:119766-A)
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)
Chevron Chemical Conpany (1957?) Analysis of Dibrcm Residues.
Undated method RM-III. (Unpublished study received Feb 19,
under unknown admin, no.; CDL:119738-A)
1958
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered Co be Part of the Data Base Supporting
Registration Under the Standard
00074722 Kchn, 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: Dibrcm in
Rice: Test No. T-508. (Compilation; unpublished study, includ-
ing test nos. T-551 and T-544, received Mar 12, 1965 under un-
known admin, no.; CDL:119745-F)
00074724 Ospenson, J.N. (1958) Letter sent to G.K. Kchn dated Feb 4, 1958:
Dibron—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 Dibrcm 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-S)
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-Dibrcmo-2,2-dichloro-
ethyl Dimethyl Phosphate): Manufacturing Process. (Unpublished
study received Oct 17, 1977 under 239-1633; CDL:232095)
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
00074795 Chevron Chemical Company (19??) Acute Oral Toxicity—Albino Rats:
Summary of Reactions. (Unpublished study received Feb 2, 1959
under 239-1280; CDL:050010-D)
00074806 California Chemical Company (1961) Project Report—Dibrcm Residue:
Analytical Procedures: File 740.10. (Unpublished study received
Feb 21, 1963 under PP0330; CDL:090359-D)
i
00074807 Ospenson, J.N. (1963) Letter sent to G.K. Kchn dated Feb 14, 1963:
Dibrcm and metabolite residue studies on oranges and lettuce.
(Unpublished study received Feb 21, 1963 under PP0330; submitted
by California Chemical Co., Richmond, Calif.; CDL:090359-1)
00074817 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.; CDLi050424-D)
00074829 Narcisse, J.K.; Cavalli, R.D. (1971) Acute Dental 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) Summary of Typical Dibrcm 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—Dibron. (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,O-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) Sumnary and Data on Residues of
Naled in Cotton and Safflower. (Compilation; unpublished study
received Jan 9, 1974 under 1F1078: CDL:093391-A)
-------
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 Dibrcm. 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 Hazletcn Laboratories, submitted by Chevron
Chemical Co., Richmondr 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:09546S-A)
00075668 Chevron Chemical Company (1961) Residue of Dibrom on the Tomato
and Cucumber: CSC-513 No. 502-6. (Compilation; unpublished
study, including report ncs. 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 Jchansen, C.A. (1972) Toxicity of field-weathered insecticide
residues to four kinds of bees. Environmental Entomology
l(3):393-394.
05003107 Macek, K.J.; Hutchinson, C.; Ccpe, O.B. (1969) The effects of
temperature on the susceptibility of bluegills and rainbow
trout to selected pesticides. Bulletin of Environmental
Contamination and Toxicology 4(3):174-183.
05016607 Brzezicka-Bak, M.; Bojanowska, A (1969) Toksycznosc Podostra
insektycdcw fosforoorganicznych: naledu, etoatu metylowego i
supracidu Subacute toxicity of the organophosphorus
insecticides naled, methyl ethoate and supracide Rcczniki
Panstwcwego Zakladu Higieny. Annals of the Polish Institute
of Hygiene. XX(4):463-469.
-------
OFFICE OF PESTSICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
GS092001 Bullock, C. H. and J. K. Narcisse. 1975. The skin irritation
potential of Dibrom-14 Concentrate (CC 5511). Study No.
S-741, Standard Oil Company of California, SCCAL 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 Carlstron, A.A. 1975. Gas-liquid chronatographic determination
of naled in pesticide formulations. JAOAC 58(6):1162-1168.
GS092017 Dean, H.J, J.R. Colquhoun, H.A. Siraonin. 1977. Toxicity of
Methoxychlor and Naled to Several Life Stages of Landlocked
Atlantic Salmon. N.Z. 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 1P1111.
GS092040 Chevron Chemical Company. 1966. Name, Chemical Identity and
Composition of the Pesticide Chemical: Dtbron. (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.)
V-
GS092091 Casida, J.E., L. McSride, and R.P. Niedermeier. 1962. Metab-
olism of 2,2-dichlorovinyl dimethyl phosphate in relation
to residues in milk and mammalian tissues. J. Agric. Food
Chem. 10:370-377.
GS092092 Chen, Y.S., 1981. Metabolism of (Ethyl-l-l^C] Naled in a
Lactating Goat. Unpublished study received March 4, 1982,
under 239-1633; submitted by Chevron Chemical Conpany,
Richmond, California.
GS092093 Chevron Chemical Company. 1969. Naled residues in mushrooms.
Unpublished study prepare by Green Giant Co., and submitted
under lEllOO by Chevron Chemical Company.
-------
OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registration Under the Standard
GS092094 Lynn, G.E. et al. 1962? Studies of the Occurrence of Bronides
in the Milk of Cows Fed Sodium Bromide and Grain Fumigated
with Methyl Bromide. Study received Jan. 3, 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. DIBRCM-R: 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
3d., Burlington, Ontario_L7N 3E3, Canada. Unpublished
report. EPA Accession No. 246496.)
G3092098 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 ??).
GS0921Q1 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.e. Felkner. 1981. Pesticide
:; mutagenicity in Bacillus subtilis and Salmonella tvphimurium
detectors. J. Agric. Fd. Chem. 29:268-271.
•»
GS092104 Haskin, H. and R.G. Haines. 1960.. Fish and Wildlife Toxicity
Report. Chevron Chemical Co. OR-513, No. 241-36-38.
August 31, 1960.
-------
OMu Aaurwat No.
RFRA SECTION 3(C)(2J(B) SUMMAflY SHEST
JCTNAME
IANTS HAMS
DATS GUIDANCE DOCUMENT ISSUED
rantcrtn a» nqunmtnfO admit "gammf' dittunpoad by tin rlFHA action 3(CJ(2(B) nonet contained in tin refwotod
1 sni rcQUfitiura, in tft^ foilowiii^ nuonw*
1 1. . I Will aitalft daotin I tiffl*V nwmr to atfafy till followmg rwjui«msm». If tn« to« oroeiaum J will ua davim from (or are nor
saeoflM ini tfl* flwjnsretion GuidMnus or~3ii Pnnocou conoiiwi in tin) fliuui U of SxcwT GrQtios to til* Chvniaii Grouo,
Chwiidlt Ttainq Preqramnn, 1 endoa on pnjtosni*Bat I vwil use
urv uilw i ByutTBiiu undflf FiFRA scxion w(CJ'2]{o)(ii}
'Mil be siiimittra TS £?A byr
tiis foUotwnq dst3
. OF OTHEH HEGJSTHANT
1 I andost a csmoluod "C«tif!cacon of Atnmprta EntwInto an AgrwmsntvmA Qtftw flagotramsfor Gavalooment of Data'' with
L ! raquer tiiat you amamt my nqturatiun by difrang tin failowino; ua* (tfiw omioir is not avaiiaoi* to aopiieams for n«w qniducai:
. 11 niUBl voluntary camUtnon of tin taqiauitiun of tilts produce (ThijootJon is not jvailabw to aopiicannfor mwproductjj
VNTS AUTHOBIZHO HS?RESSNTATlve
I SIGNATURE
OATS
3880-1
-------
HI-3
OMB Aoomvat No. 20004*68 fSxains: 11-31-33!
CSaTIFICATlON OF ATTEMPT TO SNTEH
INTO AN AGREEMENT WITH OTHER REGISTRANTS
(To vaiify, ortrfy ALL four nmroi fs<3« DEVELOPMENT OF DATA
1. I am duty authorized to represent tf» following ffrmd) who are- subject to the require-
ments of a Notice- under Pi PR A Section 3(d(2)(B) contained in a Guidanc* Document
to submit data concerning tti* active ingredient:
MAMCOPnRM
auiOAwca aacuMBNT OATH
ACT1VS INGHBOI8NT
e?A COMPANY NUMBER
(This firm or orouo of firms is lefurrad to below as "my firm".)
2. My firm is willing to davotao and. aibmrr *• data as required by ttnt Notics, if nocassary. Howaver, my firm would prafartD errtar
into an jqiaamant wrtrt or» or morw OT*MT rogucrams to. dovotop. joirrrJy, or TO $har» in tn» cast at davrtoping, Sia following required
items or data:.
X. My firm hat orhnd iirwmJngtirtfflBrima ajcrran nymmm. Caaia of tfttoffan am attadiad. That offer \va» irrevocable and indutad an onV to ba
aatmd by an aroitranort dseiaoa under FiFHA Sacacn 3(d(2MB)(ifi) if final agnwrnsnt on ail tarmt cauid not 3» rwenM attianra. This affar was mada
to ttit-fodowmg ftrmisj «i tJi« Wlowing dataisir
NAME OF FIRM
. . _
OATEOFOPF3H
^
(owavar, nona ortnoaa nrm
-------
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-------
*****"*"
f 143-10
cacy. anil safely of Ilia formulated
end HUB product. may not consider any
data aa supporting the application.
except (lie following data:
(I) Tlia data (lie applicant ho* sub-
mitted to EPA under paragraph (b) pf
( lib section;
(1) Olhcr du|a pertaining |o (lie
safety ol the product's active Ingredi-
ents, rather than to (he safc|y of MlP
end-use product; and
(9) Existing tolerance*, food additive
regulations. exemptions, anil oilier
clearances Issued under tlio federal
Food. Drug. and Cosmetic Ac|. ,
(o) If the applicant know* that any
Item of data lie submitted under Ihuj
scc(loii was generated by (or at Ilie ex-
pense of) another person who origlnuj-
|y submitted the data (p BPA (or (Mi
predecessor. UflOA) on or after Janu-
ary I. l0'/0. Ifi aupport an application
for registration. experiment*! use
penult, or amendment *i|dlny ft new
(ise to an existing registration, or for
rcrcglulralJon (unless the applicant
an<| the original data submitter |iaye
readied written agreement on the
amount and the fcnna of payment of
any compensation, that may be pay-
able under f'lfllA sectjou
SicUlHDHII) with regard to approval
pf the application), the applicant «hall
inbuilt to PPA a statement |hal he
liaa furnished to each aiich Identified
original data submitter;
(DA notification of the applicant'*
Intent to apply for registration. Includ-
ing the proposed product name;
(il) An offer to pay the person com-
pensation. wllh regard to the approval
of the application, to the extent re-
quired by PIFttA sections
'
tit An Idenllflcatltin of the |lem(«)
of data to which the offer applies;
(4) An offer to commence negotia-
tions |o ascertain the amount ami
lermi of compensation to be paid; ami
(6) Tlio applicant'? name, address.
and lelephono number.
(f) If the applicant'* product con-
tains any active Ingredient oilier than
(hone that are present solely because
of the Incorporation Into the product.
di|r|ng formulation, pf one or inoro
oilier registered pesllcldo product*;
purchased from another producer,
Ihen fhe applicant shal| also comply
IIIU 40 — f fo|a<|lan t>f finvhoiirn«ii|
with | iaj 8 I a« to aiich active Ingredi-
ent. and tlio application shall contain
a.n acknowledgment lha.t for pnrpaaeu
of flpltA section {l(0)(f )(r» the ap|>||
cation relics on (and any reuniting reg-
istration should be regarded a» |f jj
were boned on the Ailiiiliilulmiui 'a con
slderallon of) the following data:
(|) All data submitted or apecl(tca|ly
cited by the applicant In nuppoft of
(lie feglutrallon; ami
(3) Bach plher Item of «!»!» Ill M'f
'Agency'* f;|les which:
f || Concenis the properties or ef (ecl^
Of any «uch act|yo pigrejlenl; an<| .
(II) la one of the type* of duta, (hat
fiPJ( would require to be suLmltled for .
•clentlfto review by IJPA If the appli-
cant nought the InlM"! r*-'glalr«lion
Miidcr VKllA flection j(p)i6) of •
product with composition and Intend-
ed Uses Identical to those proposed for
the applicant's product, under the
data requirements In effect on ilie
dola t'PA approves the appl|canj'a
prenenf application. ' '
(0ccji. I. I.
«» pf
(a) Ucncrul-U) Contend oj /7i«
label |iv«ry pesticide pri>4i|ct« alialj
jiear a lubel containing Ilie hiforma-
lion specified by the Ac) and the regil-
|at|oiu In this Part. The contonU of a
label in nut show cleafly ai|i| |)roni|
pcnlly Ilia following:
(I) Tlio name, brand, or |i»iltiu»i>
under wjiloh the product Is. sold a a pre-
ncrlbed In paragraph (b) of thlo sec-
tion; • '
(It) The name and ailJicua of the
producer, registrant, or person for
Whom produced as prescrlpetj |i| puia-
graph (d of thU section;
(III) The net contents M prescrlliei|
In paragraph (d) of this section;
(!v) T|ie prodncf regl«|ratlui|
pumber an pieuiii|bct| In paragraph (o)
pf I lila section;
(v) The producing eutablMiinent
pinuber as preacrlbed |n PUfaurajili (f)
of Ihl4«ecilon;
(vl> An Ingredient statement as pie
«i:r|uei| ||| purpgraph jfg) of l/lla *tc
tlon;
APPENDIX V-l
(ylll Warning or precautionary ulate-
pients as preserved |l| paragraph such terms as |o rep,dpr |(
likely lo be read and understood, by
tlie pri|lnary Individual under i
ary con Jit Ions of purchase and,
(II) All required label text DIM
(A) lie act (n 0 point or larger type;
(U) Appear on a clear contrasting
background; and
(O) Not be obscured or crowded.-
f}) t-anauaoe (o tie tiicit. A|| required
label or labeling fexf s|ial| appear In
the tlngllsli language. Ifuweycr. the
Agency niay require or (lie applicant
may propose additional text In other
languages as 14 considered necessary (Q
project ||ie public. When additional
(cxt In another language Is necessary.
all labeling requirement*! will be ap-
plied equally (a both the tfugltoli and.
oilier (angnigo versions of (he
M» Placement '
Tlie label sliall appear on or be secure-
ly attached, to tho Immediate contain-
er of the pesticide product. For pur-
pones of this flection, ani| tlie inl«-
I'fniKl .ig provisions of (he Act. "se-
curely attached" shall mean Unit *
lain:) can reasonably be expected to
remain affixed during the furcucimble
ci'iiiliiloim and period of nue. If the tin-
Ilicdlule container (a eucloued wllhln 4
flipper or oulalde conlalper through
Milch the label cannot be clearly r«"M.
Ilie |ubu| iiuiol also bo securely at-
laclied to unch uiilslde wrapper or co'n-
lahier; If It |u a part pf (he package 04
ciulomarlly dlalflbiiled praulcl.'
(||l V'fifi^ «••«»< unit other bulk eon-
(otncH-iA) Truntportullou. While *
|'"||cl<|p product U |n transit. |/ie ap
proprlale provision* of 40 CFIl 1'ufts
(10 180, concerning the traiispoi tallun
of ha2ard.ous materials, and specifical-
ly those provision* concerning tlie la-
beling, inarklng and placarding of haz-
ardous piaierlala amf the veltlclea car-
rying them, define the basic F'oilerul
requirements. In addition, when any
registered pesticide product it trans-
ported, In a lank car. fank truck or
Other niubllo or |ior|ablo bulk noiilalit-
t>r. a copy of the accepted label must
bo attached to l|ie ahl|>plng papci«,
and left with HID consignee at l|ie time
pf 4c|lvc| y.
(M> yfaiat/e. When pcstMdo prod-
ucta are stored In bulk containers.
whether mobile or stationary, which
remain In the custody of the user, a
copy of (he label of labeling. Including
all appropriate djrecllona for use. shall
be securely attached to the container
lit (he Immediate vicinity of the ilia
charge control valve.
(6) >'«fj<> of intileaJInf ttatfintiiti.
i'ursuant to flection 2(ri)f|)(A) of tlie
Act. a pesticide or a declared
subject lo the Act pursuant lu | IflJ Ifi.
|s iii|sbiunde4 If |ts labeling Is lalue ur
ftifedeadlng In any particular Includhig
both pesilcliuil and lion peallcldul
dahlia. Vxampleti of statements or re|»-
fcaentatfona In the labeling ivhlcji co|i
•iltnfe mlsbraiidl|iu Include:
(|) A fuloe or misleading alateiiient
concerning the composition of the;
product;
(II) A false or misleading statement
ponucrnlng the effectiveness of ihii
product as a pesticide or device;
(III) 4 false or misleading »falcmcnt
abuii! the value of tlia product for
purposes other than as a peullclde or
device;
-------
JU1IO
(vll) A true aialement uacd In auch 4
way au to give a false or mla.luai)li>f Im-
prcKiloii la tho purchaser;
(vlll) I-a be I disclaimer* which ncga|o
or detract from labeling alatemenU re-
quired under the Act anuj tlieae regula-
tions;
(Ix) Claliua M to the safely of the
peullclde or IU Ingredlenla. Including
•lalemcnt* aucli aa "aafe." "nonpoUun-
ou*." "naiilnjur|ou*." "harmlea*" or
"iionloxle to huiiiana and pela" with
or without auch a qualifying p)iraac 04
"when uacd ad directed"; ai>4
(x) Man-numerical and/or coiujiara-
tlve atalumentu on the *afe|v of |ho
product. Including but not limited to:
(A) "C'onlalim all Datura) Ingredi-
ent*";
In addition to. the required null* ''
apecUled. net content | frottuctna tilailMnieiitt unit
frafion nujiiter. The pnuluclng eclab-
IMiment reglatrutlqn number |.reced
H by lha phraae "JfipA Kit.", uf (lie
||il»l ealablUhment at which Die prod
|ict wa« produced may appear In any
(tillable location on the label or Imma-
«tl»|« conlulner. It ninut appear on Ihe
^rapper or ouUlde container of the
wckage If the EPA eslaldhdimcn! reg
|.lr*l on number on tlio fini|iedlata
widalner cannot ba clearly read
(hrongli auch wrapper pr container
ig) fnorirdleiif tlaleiuant-t |) oJj,er.
at T|.e label of each pe.llclde pfoduJi
nmal be«r » .lalemenl whlc|, contain*
IN name ai(d percentage by weight of
t.cl, »cllve Ingredient " • • • ' '
i; ai|d It M'e pu*t|clde cuntftln* ar
,r..[t |n any forin. * alalemenl of Hie
jicrccntage* of (otal and w*|er aoluble
trtcnlc calculated a« e|eine|)ta| «r-
iciilc The a.ctlve (ngretllcnU nmaf be
dcilgnated by the term "active Ingredl:
nil*" afid the Inert IngredlonU by tha
iciin ''Inert Ingredient*.*' or tlie l|ngu"
jir form* of (heao |erm« wlieii ap|>ro-'
piltlo. Doth lerm* ahall be ||i Ilia
itine type «lze. be aligned |u the aume
(utrglii *ud be equally prominent. The
mUmcnt "Inert IngrcdlenU. none*' U
lull required lor pesticide* w))lch con-
' l*|ii |f)lt percent active lngred|ent«.
Unl**4 tho Ingredient atateincnt la a
(umpleie anulyal* of Ihe peatleldc. |he
lc(|ii "anulyald" ahall not be uued a« A
licidlng for the Ingredient «Ulemcn|.
(i) FOttllou n/t»mredUnt ttulcnient.
IU 'I'M Ingredient alalement |a nor-
n»lly required on the front pane) of
the |«be|. If there la an outride con-
Ulncr or wrapper through which the
(nvteUlcnl alal*in~>« •
-- . -.-.~..BI> willlill ing
rt»d"~il,r Ii"'ain1e»»l cannot be cleaily
^KyffJSKZei
pSl'ff"^'-"
''""I Pane %r I e llblr"11 °." V"
'»»y be granl.,1 f >' if1' «?crM>l«a|oi|
^^^..^"Ir.iJ^-Ju.red.e,,,
"S ', ,lteVunr !«- '."^'""l •»••-
^f^^ss
tiys^^stift
^MSiUrir* v» <"*««««'
f'^llll -I ah be ""n1 ^ ettcl('"
"»l IUUM llfl "l ' «U:<:c"l«"l
^K-JLSsx^y^
—......... nunie may be uacd alone only
If It U well known. If no common name
|ia<* been ealubllahed. the chemical
name alone fihull be uaed. In no tuue
w||| |he ii*e of * trademark or propri-
etary name be per mil ted iiulcaa auch
rianie |iaa beef) Accepted aa a common
nanie by the Adinlnlairalor under the
authority of Section 3&cr>:en(uve* The
pcrcenlagea of Ingredlenla ahall be
alated ID term* of welght-lq-welght.
1'he auin of percentages! of the acllvo
•nd |lie Inert Ingredliinla thall be 100.
percentage* a|ial) not be exprcascd by
flange of valtieu auch aa "i3 36%.'' II
lie psea of |he pealleldo product are
f xnreaaed aa weight of active (ngreill-
ei|i per unit area, a alulement of the
weight of Ncl|ve Ingredient per unit
volume of |he peallclde formulullon
•hall abo appear In the Ingredient
•latitinent.
(IS) 4vcutacit O/ ituUtt vervculnvct.
The percentage* given ahull bo aa pre-
clue an poaa|ble reflecllng good manu-
facturing practice. If there may be un-
avoidable variation between muuufue-
lurlng buleliea, |I|O value alated for
«ac|i active Ingredient alial| be the
|owe*| percentage which may be prea-
«nt.
(HI VcfaitoruHon reallcldea which
change In chemical composition' alg-
jiliicaiUly niuul meet the following la-
bellng reqiiheinenl*:
(I) In caaea where It I* dulermlncd
that » peatlclde formulalloii change*
chemlcu) ponipoulllon algulfleantly.
the product mual bear the following
•lutemenf |n a prominent |ioalllon on
|ho label: "Mot for aule or u^e after
fdalol."
(II) The product muat meet nil label
plalma lip |o the expiration time Indi-
cated oh the label.
(7) Inert fnitieitleitl*. The Admlnl*-
traior inay require the iiume of any
Inert Ingredlcnl(a) to be Haled In the
Ingredleiit alatement If he determine*
that «ucl( Ingredlenl(a) may pose a
Itaiturd to man or the environment.
(h) Iftfmlua* and iiieciJiidoiiaiv
ttatementt. |teoulred warnlnga and
precautionary alulentcnfa concerning j
tho general urea* of tjixlcologlcul '
|iazar'd Including hazard to Children.
0nvlionmenlal (ucnurd. anil physical or
c|ieni|cii| liAKurd full |n|o two ^niiiiu;
-------
40—
yf |nvlioiiui*ii|
ihoue required on the front pane) of
(he labeling mitl (hone which may
appear elaewhere. fi»eclf|u require-
ments concerning content, placement.
lyita «lze. and prondnence are given
below.
(I) Uequlicil front panel ttalemeult.
With the exception, of (he child
hazard warning statement. the text re-
quired oil ()>e Ironl paue| ol Ilio label
(a determined by the Toxlclly Catego-
ry o| Ilia petdlclde. Tlie cu|ci(ury i) »u-
digued on the haalu of ilia hliiheul
hazard nhown by any of (lie |nJI<:n|oia
la tliu table below:
I
U«l I O_ .......... ......... I V ktuvl bitfefria M f MM 4« fun MM (ny'»J f IOM ^ gnu UMI Kg/ Oiulw fun 4o>*| (ly
»8'l» ..... k« ** '
Uj>W»nillna«Iiig I fiw» 4 t»u t ««/•••.... fi«*« IUM M my/ft*. (fcMUi |IM t» «
u taou — h
CtMlttll 4ttl«Uttf
MVMttfe »*il I
u liluMua ^ JJ
"
i
I
<|l Human hutaiit tli/nal utortf— (A)
'fax(cit]> Caleoorv I. All peallclda prod-
ucU meeting lite criteria, 01 T^tlcUy
pategory 1 filial) bear on (|>o |roi4
panel (lie ulgnal word "Danger." |u ad-
dition If Hie product Wtt« aaiilgned to
Toxlclly Category | on tlie baaU of IU
oral. Inlialailoit or dermal tonlclty Ui
dlullnct from akin and eyo loca) ef-
fecUl (lie word "Poluon" altull anpear
In red oi) a background of dlalluctly
coiiiiaullng color and (lie «kn|l an4
croualioncu nhall appear In liiiincillulo
proximity to Ilio word "po|aoii."
(U) r«*Jclil/ ('ulegoiv II. Al| pet.ll-
clde produciu meeting (lie criteria of
Toxliilty Category II ihal) bear on i|io
front |>unc| (lie ulgne| wor4 "V/">»-
Ing."
(Ck roxlniii/ Catenary Iff. All peatl-
clde producU meeting tlie criteria of
Toklclty Category 111 ulial) Lear on
the front panel (ho itlgna| word ''Can-
tlon."
(O> ToxMlv CateooTV IV- Al* I"1"11
clde prodiicta meeting Ilio criteria of
Toxlclly Category IV iliall bear on tlie
front panel the algnal word "Caution."
ybik \lie oj tli/uu| wutilt. Hue of any
nal wpnl(a) associated with a higher
•(•oxIuKy Category U nut permitted
except when the Agency delta
ihal quc|( labeling U necciuary to
Ven|. unreanonable aJveioo cflecln "i|
|iian or (he envlronmeiit. In DO ctu.o
Khali more t|ian one humaii |iazar>|
«Ui^l word appear on the front paiie|
of a label.
(II) Child fto«unf u>amlu0. feivcry pen-
llclde product label aliall bear on Hie
fl'ont paiie) the utatumcnl "keep out ol
reaeh of children." Only In enact
Where the likelihood of contact u/llli
children Uuiliig dUtrlbutlun. nmikut
log. ulorugu or Use U demonulraUd liy
Ihe appllcunt to bu extremely remule.
or If Ihe nature of Ihe pcatloi4u U "'cli
llml It |u approve^ for uue on lufaii^
or umall children, may the Adiulublra-
(or waive Ihln rcijulreiiient.
(III! Statement (J practical tuut
ment (At Toitulty Caltaarv /• A
•laleiiient of practical treatment (lli«(
aid or oilier) ahull appear oa Ihe I""''
panel of (be label of all peatleliktt I»U
Ing Into Toxlclly Category I uu (>>«
baaU of oral. Inhalation or iltrmul lot-
Mty. The Agency may. bawcvcr.
permit rcaaonal>|e yarlalKiuii In H'(
placement of |he tdatement of |>ucll
Cu| treatment la aomo reference -""-''
an "See ulatement of practical ti'J'
oil back panel" appcaii) u" I'"
APPENDIX V-l
(ooiitlnuad)
|—p»vlianiu«ii|o|
||0|if puiiel near the word "1'ulaou"
ami (hi: bkull and cros^boneu.
Ui> Other (M\cllv cateoorlet. Tlio
alalmiient of practical treatment la not
rvqii|red an tlie front panel except aa
described In paragraph UiHlMIUMA) of
|hln section. Tlia applicant may. how-
ever, |nc|ude a,uc|i a front panel nUte-
inent at llU option. StuleinenU of
p|ac||ea) (reklment are. however, re-
quired eluewlierp on t|io |abe| In
•ccuril wllh paragraph (|0<» ol (hi*
amflpf) |f they da not appear 0!) |l">
front panel.
(Ivl J'lucemeiil «n4 pro>|ifn«iice. All
(he rc fi'ont panel warning «lalo-
IDeiijj) ahall bu groupeif together oil
the lube), and aliall appear wllh aiiffl-
c|c|it prominence relative to other
ffoiil panel text and graphic |naterla|
la niuke then) unlikely (o bu OV*»d
»•«•
14M
f~«
II
14
I*
a
it
ta
U u>unitntn ami pie-
ttateineiit*. '|'ho wariilngii
precu|illonary alatemento «a ie-
<)ii|re|| below thal| •ppear together on
(ho label under the general heading
''Precautionary filalemciuV ana
under appropriate aiibheadlngii of
"Hazard tu Humana and Pomc^lli: Ant-
mala." ''IJnvlronniental Ifuxard" am|
<'rhyulca| or Chemical fla^ard."
1(1) llatuHl to hunmnt uitti itutnc»lla
anlmalt. (0iial
word. '
(14) 'file following table deplc|a typi-
cal precautionary tlalemeiiU. Thetia
alaleiiicntti iniiat be modi/lei) or ex-
panded, ip (effect
« l«l>J a •<•
it tU >ui«uanl i»»
Do lUil (H l» •»•«.
(V
AniM UkHu4 »•• M tk-Ui^ In «»• 04
-------
I;
ii
pf p»v|rai!P.!«ii)
llona (a ayo|4 potential accldenf.
Injury or damage., livamplc* of l)ie
hazard ulutemenU and fhp c|fcu,in-
atancea natter which Iliey fro reuujiei)
follow:
i A) If ft peatlclde Intended lor out-
door uuu conlalna «u active Ingredient
with c mammalian acu|e pra| I-IX. of
106 or leas, the alatement "ThU Vcall-
clJo la Toxla la Wildlife" la require*).
(Hi 11 ii pesticide Intended for Ou|-
daor use coidalna an active Ingredient.
with a. I bit acule 1X5.. of 1 ppnt or |e*a. '
the statement "Thla 1'ealMde M T«*lo
|o Msh" la required.
(fj) II » pesticide Intended for out-
door uuu contalna an active Injjredlcnt
with an avlau acute pral IIX. of 160
nig/VB or lea*, or a •ubaculo dietary
I.C.. at 600 ppm or Una. the nUtemcnl
"TMa Wallcldo Id To*|a to yfl|d)|fc" ^
required. *
||llf ^0—
tin If either accident Idfllory or
alndlea demonstrate that uue of till)
pcutlc|du (nay (eau|l hi fuUllly to
bird*. (lu|| of inaiiiiitalu. (ho statement
<'Thla pesticide (a extremely lai(|ii 1 4
wlldllfd (flsli," In r«iulf«ali>-
jiient treatments. peallcldeu |ox|a |u
pollinating |naec|a, |t)iiu| bear apprnprl-
(la labeic|iiil|ona.
put of |uke«.
nondd or ulrettina. |>o pot contaminate
V/ater tiy cleaning iut:nt or din-.
|ioual of wauUa."
(Ill) l'/)t/ilcul or chemical huaantt.
Wuriklng ttalcnienU oi) the fUntmubll-
Ity or ekpluulvo chai'acterlti|lca 4! (tie
o art) ic(jtilre4 «4 fullou/a:
I «MI« |f • t««lji»it
' *'
•»' f l MM IWM *a* f
AJwv. M- f M «U Ov« (ttt'r
«y tu«ll
(I) IHrccUoiif /or Uie-(|) ilciurol
rcaulrauieiid—(It Adequacy «u<| c|uf-
f/l> a/ 4'rcc<|on*. PlrectlaiM for lue
iniut lie alutcd In tcrma wh)c|i coi) lie
eaully read anil undcmluud |ty the
f verage IICIHUD likely to MHO or to au-
pervliie tlio liao of t|ie |>cullc|da. Wl'un
followed, direction* imiut be adcqiiulo
to protect the pnlillo from frautl and
from iicruonal ln|ury and I" prevent
unreasonable adyerde e|fecl« oil t|>e
envlronntent.
(II) t'lucenteut tj dlicctluni far uie.
may appear on any portion
of |ho |nbel provided that Iliuy tit
coiuiplcnoiui enough to bo vaully r"1!
by l|io uuer of the peatlclilu |>rutliic(.
nireciluna for uae' luay wi'pc«r iin
printed or graphic matter tulilul) »'•
compunlea the pcul|clde provided |l>*l:
(A) |f retinlrcd by the Agency, nucl>
pilnled or graphic matter in utcaitlt
tllachcd to each package o( ilip I'"!'
cldo. or placed within Ihu piibMt
wrapper or bug;
(II) The (abut beara a rctuieucc to
the dlrcclloiut for turn In acuoiii|)*nylni
leadeta or circular*, nucli ft ''&* ".
rtcllona |n Ihu encloued, cliciilwr:" »'>J
V-i
(bontinued)
(C) 'I he Administrator
that It (4 no| necessary fqi
(|pns fo appear mi (|ie |u|;e
(|||) KsctvUuni fa Koujftiiitfiil /u|
rfjiecfloii /pr »«<>~IA) Uelalled d|rcp-
(loiis for Mfle may be ow« l.||a| (he
(irpdnct la Intended for uae pnly In
manufacturing proccusea and specifics,
||te lypeU) pf product n Involved.
(J) Adequate Information anc|) aa
technical data aheela pr bulletins, la
tvallable to ll>0 liado «|>ecl/y|ng the
lype pf product Involved and II*
' proper use In ijka|iufactii||ng pfoccaa-
t»;
(j) The product w|l| not come hilo
lite fiaiida pf the general public excapl
tfter Incorporation |nia ilnlshed, |>rp(|-
McU; am| .
(ft The Administrator delerinlneo
Iliat aiich d'rec||p|ia are nut neccuaary
a prevent unreasonable adverse ef
(ceU oil man or Ihe environment-
l(e(|
|a pnyalclana. velerlnarlana, pr d.r|ig-
|Uli. provided that:
(I) The label clearly alatoa (hat the
piuJuct Is. fpr use only )iy p|iyalc|an«
(if velerlnarlana;
(II The Administrator dctermlfiea
Ijikt such dlrect|on« are not ueceaiary
la prevent unreasonable adverue ef-
la;u on inaii or the environment; and
(1) The product Is also * drug and
Uiiiilaled tinder the provlaluna of t|ie
hiicml Food. Drug and (Ji>amcl|c Act.
f pealicldu prod-
i|c|a (nvplvcd.;
({) The prPi|i|ct oa finally inaiiufac-
Inlfcd. fproinlitlud. i»|«ci|. or repack-
aged Is reg|4|ered; and
«> The Adn'|uls!ralpr dctermlnea
thaf anc|i «||reclloiia are not necessary
to prevent unreasonable ndverae ef-
fccln on (nail or l|ie environment.
()) Cunlentt aj Ditectlont fur Vic.
T|IC dlreclloiu for lisa «liall Includu
fhe following, under Hie liuudliiga "p|-
Ifectlona: for Ilac";'
(I) The alateintiitt of iuo classifica-
tion |uj prescribed In Idxl0(|) Immedl-
ately niuler (|ie heading "Dlrectloiui
for flue."
(||) |ii|inedlaicly below the atale-
nient of use clusjlllcallon. the slate-
meiit "It la n violation uf 1-Vdeial law
|o uae fhld product In a manner Incon-
alstcnt will) lla labeling."
(Ill) The t(U The dosage r«*° associated w|t|i
f|)ch alle and pest.
(vlt.T'he method of application. In-
cluding Instructions fur tlllutlon, II ro-
QUlred, and lypc(a) pf app|l<:a(|oi| ap-
parutiui or equipment reiiulrcd.
(vll) The frei|liency and timing of ap-
plications necctuiary la ublalu effective
resulla without pausing uarcaaonuble
adverse effecla on Ihe environment.
(v|ll) dpeclflc llmllutloita on reentry
to areas where the pesticide liaa been
applied, (neetlng the reiiulicmcnU
cPncemlng reentry provided by 40
C'FB Part 170.
(|x) Specific dlrcullona cuncernlnii
the atorAge and disposal of f lie pcstf-
cldu and Us cunlalner, meellikg the re-
dulremenU of 40 6'1'ft f'art I Aft. Tlieoe
Inulrnctlans shall bo grouiied and
appear under the jieadlng "Storage
and Plsposa)." 'flt'a |>eudhig must lie-
-------
trnquired for the. cnjJd hazard waxn-
ittifl«u,j
(X) ^T 1*nH*?*<'*ti
ffl» required to orerwe un
"**
CAj Required: intamU* between- a»
attention nut hamssr o£ food: or reed;
(O Wtmtngy aa required.
cercalx? crocs, animait. oojecta. or
» vtfitfffTTt fjr
CD) CTteserredl
ba* aecasaarr 'or iii
cboss suraoses isd. i
talnrt to tteOlncsiflBS /ar Oi» irta a*
or mM
(23 jjotrxttri Usr
f^sKtfsu& producty
for useiA) classified
bear ir*t*mfnn. of rescicsed: u» das-
cied.
**•-
sdfied aeiowr
(U /TWii ^oae^ j
pradocs f
** and jeierai. uattaJ. bad
oi tbese uses mar aooew on a. produce.
Lateied ror restricted, usa. Sucir
che acpruuriate vordin?' for the*
by regulation.
OU AdTerfisisc SZeserredl
?a. aass. Juiy i lars: « ?s: KSSSI
1J7S: 40 ?H 28371. iug. 2JL 13TS. as:
»t 43 7S S73«. Jrtu3. 1373J
prodocsfc b^irtHg- dtrecflon* for*
zenessi shall bo* !a»
bated; «ttft ths I*TMB. words- "GesenJ.
bfiiov tiic*
bMriing "Clreefions far Uas."
eni nttUty of she- sesfiede sxiead*
• '••*• ' ^
-------
ABSENCES V"—
f TttJT
38£ lit* CTD^h 0*
UU -*"y
T'GQTlir&d CO*
33XS3-
tor tae csild hazard wara-
an
LU Required interval* between- ap—
gHiritlon and terra? oi rood or reed
(3i Horarlrmal crop reatrtcaaa*,
(O Warning* a» required, agatosctis*
oxt nmrartr c-upa, anfmaK ooiecsx, or
laor adjacent ta -csnaia area*.
CD) OtegerredJ
(2) ?or teauieted. osr pesticides; ».
loollcacar wfio is
CO
pestlcldet
pesticide may snir •••« aopUed under
5il73lcall7
C?T Ctiicr- perrtocsr iEiar— artrrrr
'ta b» neessnr? for t^e proweEos oi
i|'m»r-n»»«-ig-
of &&• Classiflmtirnt-
570. ill ;eancda ?rofl-
.anat Sear en --iss- 'ar^.t a. nose-
(j;-»n-ny standards' s*c 'ort-tx Is f^*
rue ^octoes vita: dUferenc
aniy for ffenerzl oae<3J "v^* t^n- ocaer
beulnr direoaam for leauJead" used)
exceoc. caac. if a-grortuct bas botfr rs-
scicted use<3> »n^ jenerai. use'
sansidered a raise or nsfcrt ending
^strasett gtr
producsr bearing
for asKsj ciasaXIed, rcsdccact
bear
/TTWU paa«i jto^encnt a/ rsstrtci-
as* eidwi/Jcaiioiv CAJ AC tae top of
tae Crane ganet of :ae laftrt. «t in
for human hazard signal vords
caaie In ] iSZI^Chxl^ir)), and appear*
to otaer texs and capnie saterlai on
cae> f«im- r^p^j- co ^^»if» it unlikely to-.
be overlooked, imdur ""**"""Tr oandi-
fions of pnrenas* and use;, me- itace-
~»fte "Sescrtjsed; Use Pesticide" sna^I
appear.
(3) OlnfrrJy beiow thi» staxaaeaacc, ore
gmtgnritttnn :o
r. II use is rssozczsd. i
cfie foUowuur itateaest is-
reqinred: "Tor retail- sale- to and user
only by CarOSed Appllcatorr or per-
sons' "g^gr tiair riir»i-* jucerTtsicn azd
only for taoa*: uses oayersil brt2*Csr-
oeaer rssalatorr restrteions
are- fnpoanrt. me- Adminlstrazor wtll
^*^"" '^e appropriate irortlii«- f orrtae-
gj»jr»« of: .eauiuiluii by regulation.
' (iJ Advenising: OZeserredl
t*» ?s asas. JUJT i ism: 44 ?a: 22229;
AUK. I. 1973; 44 ?H 3S3TL. Any. 31. 1373. »:
tat 43 SS
-------
APPENDIX V-2
LABELING! REQUIREMENTS OP TUB PIFRA, AS AMENDED (REFER TO 'HIE SAMPLE fABBL£ FOLLOWING)
I
ITEM
1
2
3
4
5
6A
6D
7
7A
IABBL ELEMENT
Product name
Company name
and address
Net contents
*
EPA Est. No.
EPA Reg. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning)
APPLICABILITY
OF REQUIREMENT
AH products
All products
All products
All products
AH products
All products
/Liquid products
where dosage
given as Ibs,
ai/unit area
All products
All products
PLACEMENT ON [ABEL
REQUIRED
front panel
None
None
None
Npne
front panel
Front panel
Front panel
Front panel
PREFERRED
Center front;
panel
Bottom front
panel or end
of label text
Bottom front
panel or end
of label text
Front: panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
COMMENTS
If registrant is hot the producer, must
be qualified by "Packed, for , . .,"
"Distributed by. . .," etc. ;
May be in metric units in addition to
U..J3, unJfs
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
•
All front panel precautionary statements
must be grouped together, preferably
blocked.
Note type size requirements.
-------
APPEHDIX V-2 (continued)
ITEM
7B
7C
7D
7E
LABEL ELEMENT
Signal won?
Skull & cross-
bones aqd w>n)
* POISON (in red)
"
Statement of
practical
treatment
Referral
statement
APPLICABILITY
1 OP REQUIREMENT
All products
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxicity
All products
in Categories
I, II, and HI
'
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
PLACEMENT
REQUIRED
Front panel
front panel
Category I|
Front panel
unless refer-
ral statement
is used,
Others t
Grouped with
side panel
precautionary
statements.
Front pane J
CN LABEL
PREFERRED
Inroad lately
below child
hazard
warning
Both in close
proximity to
signal word
.
Front panel
• for all,
'
COMMENTS
Note type size requirements.
1
"
'•
•
-------
APPENDIX V-2 (continued)
ITEM
8
8A
8B
ec
9A'
9C
10A
LABEL ELEMENT
Side/back panel
1 precautionary
statements
Hazards to
Jiumana and
domestic
animals
Environmental
hazards
Physical or
chemical
hazards
Restricted
block
Misuse
statement
Re-entry
statement
APPLICABILITY
OF REQUIREMENT
Ajl products
All products
in Categories
I, II, and Iff
All products
All pressurized
products, others
With flash
points under
150°P
All restricted
products
All products
All
cholinesterase
inhibitors
PLACEMENT CN LABEL
REQUIRED
H°ne
hjone
None
i (
None
•'
Top center
of front
panel
Immediately
following
statement of
classifica-
tion or
ahead of
directions
for use
In tlie
directions
for use
PREFERRED
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
Same as above
Preferably
blocked
• .. -
Infned lately
after misuse
statement
COMMENTS
Must be grouped under the headings in
8A, SB, an<) 0C| preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-
Includes 3 statement of the terms of
restriction. 11*e words "RESTRICTED USB
PESriCIQG1* must be same type size as
signal word.
•
;,
-------
. ^.r^J >; .,^~-fi± i^-
APPENDIX V-2 (continued)
ITEM
IOC
10D
U.S.
LABEL ELEMENT
Storage and
disposal block
*
Directions
for use
APPLICABILITY
SOP REQUIREMENT
All products
All products '
*
PIACEMEWT ON LABEL
REQUIRED
In the
directions
for use
.None
PREFERRED
Immediately
before
specific
directions
for use or
.at the end of
directions
for use
flane
COMMENTS
Must \& grouped together, and preferably
blocked. Heading must be same type size
as child hazard warning,
1
May be in. metric as waU as U.S. units
-------
AEEEHDEC V—2
SAMFE2
PRODUCT
NAME
General Osa
PRODUCT
NAME
&» DANGER -aplSCN
Heatrletad Tae ?«3tic±ds
-------
Criteria
Appendix V-3
PHYSICAL-CHEMICAL HAZARDS
Recuired Label Statement
I* Pressurized Containers
A* Flashpoint.at or below
20"Fr or if there is a
— flashback: at any valve
opening-
B. Flashpoint: above 20"F
and not over 80°F? or
, If the flame extension
is more than 13 inches-
long at a distance of
6 inches from the
valve opening.
C. ALL OTHER PRESSPRI25P
CONTAINERS
IT.. Non—Pressurized Containers
A* Flashpoint at or below
20'F.
B. Flashpoint above 20 °F
and over 30 °F.
C. Flashpoint over- 80*?
and not over 1SO°F»
0*. Flashpoint above
ISO'F.
Extremely flammable.
Contents under pressure.
Keep away from firer sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from-
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130 *F"
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not.
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Extremely flammable. Keep
away from fire, sparks, and
heated surfaces.
Flammable. Keep away from
heat and open flame.
Do not use or store near
heat and open flame..
Hone required*
-------
Appendix V-5
STORAGE AND DISPOSAL INSTRUCTIONS FOR PESTICIDES
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AND DISPOSAL. Products
intended solely for household use need not include the heading
•STORAGE AND DISPOSAL." The STORAGE AND DISPOSAL heading
must appear in the- minimum type size listed below:
Size of label
front panel in
square inches
Required type size
for the heading
STORAGE AND DISPOSAL
(all caoitals)
10 and under .6 point
Above 10 to 15 .8 point
Above 15 to 30 10 point
Over 30 .12 point
Storage and disposal instructions must be set apart and
clearly distinguishable from other directions for use.
Blocking storage and disposal statements with a solid line is
suggested as a means of increasing their prominence.
A. Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed,
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of. storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
i friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of* container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
-------
Appendix V-5
(continued)
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled/ and precautions to minimize exposure if damage occurs.
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage1 to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage- instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
B. Pesticide Disposal Instructions;
The label of all products, except those intended solely for
household use, must bear explicit instructions about pesticide
disposal. 'The statements listed below contain the exact wording
that must appear on the label of these products:
1. The labels of all products, except household use, must
contain the statement, "Do not-contaminate water, food,
or feed by storage or disposal."
2. Except those products intended solely for household use,
the labels of all products that contain active ingredients
appearing on the "Acutely Hazardous" Commercial Pesticide
Products List (RCRA "E" List) at the end of this appendix
or are assigned to Toxicity Category I on the basis of
oral or dermal toxicity, skin or eye irritation potential,
or Toxicity Category I or II on the basis of acute inhala-
tion toxicity must bear the following pesticide disposal
statement:
"Pesticide wastes are acutely hazardous. Improper dis-
posal of excess pesticide, spray mixture, or rinsate is
a violation of Federal Law. if these wastes cannot be
disposed of by use according to label instructions,
contact your State Pesticide or environmental Control
AGency, or the Hazardous waste representative at the
nearest EPA Regional Office for guidance."
The labels of all products, except those intended for
household use, containing active or inert ingredients
that appear on the "Toxic" Commercial Pesticide Products
List (-RCRA "F" List) at the end of this appendix or
presently meet any off the criteria in Subpart C, 40 CFR
261 for a hazardous waste must bear the following pesticide
disposal statement:
-------
Appendix 7-5
(continued)
v
"Pesticide wastes are toxic. Improper disposal of excess
pesticide, spray mixture, or rinsate is a violation of
Federal Law. If these wastes cannot be disposed of by
use according to label instructions, contact your State
Pesticide or Environmental Control Agency, or the Hazardous
Waste representative at the nearest EPA Regional Office
for guidance."
Labels for all other products, except those intended for
household use, must bear the: following, pesticide disposal
statement:
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility."
•
3. Products intended for household use only must bear the
following disposal, statement: "Securely wrap original
container in several layers of newspaper and discard in
trash.."*
C. Container Disposal Instructions
The label of each product must bear container disposal
instructions- appropriate to the type of container.
1. All products intended for household use must bear one
of the following, container disposal statements:
lontainer Type Statement
Non-aerosol products
(bottles, cans, jars)
Non-aerosol products
(bags)
Aerosol products
Do not reuse container (bottle, can, jar).
Rinse thoroughly before discarding in trash.
Do not reuse bag.. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or ouncture.
2. The labels for all other products must bear container disposal
instructions, based on container type, listed below:
Container Type
Statement
Metal
containers
( non-aerosol )
Plastic containers
Glass containers
Triple rinse (or equivalent) . Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or by
other procedures approved by state and local
authorities.
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
Incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
Triple rinse (or equivalent) . Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
-------
Appendix V-5
(continued)
Container Type
Statement
Fiber drums
with liners
Paper and
plastic bags
Compressed gas
cylinders
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot be
reusedl, dispose of in the same manner.
Completely empty bag into application
equipment. Then dispose of empty bag in
a sanitary landfill or by incineration,
or, if allowed by State and local
authorities, by burning. If burned, stay
out of smoke.
Return empty cylinder- for reuse (or
similar wording) .
^Manufacturer may replace this, phrase with one indicating whether
and how fiber drum may be reused.
2. The labels for all other products must bear container
disposal instructions, based on container type, listed
on the firsc page of this Appendix.
-------
Appendix V-5
""("continued)
Pesticides that are hazardous wastes under 40 CFR 261.33(e) and (£)
when discarded.
•Acutely Hazardous* Commercial Pesticides (RCRA "S* List)
Active Ingredients, (no inerts);
| Acrolein
Aldicarb
i Aldrin
j Allyl alcohol
"•] Aluminum phosphide
j 4-Aminopyridine
1 Arsenic acid
j Arsenic pentoxide
! Arsenic trioxide
i Calcium cyanide
Carbon d'isiilfide
p-Chloroaniline
Cyanides (soluble cyanide salts, not specified elsewere)
Cyanogen chloride
2-Cyclohexyl-4/6-dinitrophenol
I Dieldrin
0,0-Diethyl S-[2-ethylthio)ethyl] phosphorodithioats
'•• (disulfoton, Di-Syston)
0,0-Diethyl 0-pyrazinyl phosphorothioate (Zinophos)
| Oimethoate.
0,0-Dimethyl 0-p-nitrophenyl phosphorothioate (methyl parathion)
4/6-Dinitro-o-cresol and salts
i : 4,6-Dinitro-o-cyclohexylphenol
] 2,4 Dinitrophenol
i Dinoseb
j. Endosulfan
: Endothall
! Endrin
1 Famphur
| Fluoroacetamide
Heptachlor
Hexanethyl tetraphosphate
Hydrocyanic acid
i . Hydrogen cyanide
Methomyl
alpha-Naphthylthiourea (ANTU)
Nicotine and salts
Octamethylpyrophosphoramide (OMPA, schradan)
Parathion_-
-------
Appendix V-5
(continued)
"Toxic* Commercial Pesticide Products (RCSA "F" List)
Active Ingredients;
Acetone
Acrylonitrile
Amitrola
Benzene
Bis(2-ethylhexyl)pthalate
Cacodylic acid
Carbon tetrachloride
Chloral (hydrate)
Chlordane (technical)
Chlorobenzene
4-Chloro-m-cresol
Chloroform
o-Chlorophenol
4-Chloro-o-toluidine hydrochloride1
Creosote
Cresylic acid
Cyclohexane
Decachlorooctahydro-1,3,4-raetheno-2H-cyclobuta[c,d]-pentalen-2-one
(kepone, chlordecone)
1,2-Dibrorao-3-chloropropane (DBCP).
Dibutyl phthalate
S-3,3-(Dichloroallyl 'diisopropylthiocarbamate (diallate, Avadex)
o-Dichlorobenzene
p-Dichlorobenzene
Dichlorodifluororaethane (Preon I2a)
3,5-Dichloro-N-(l,l-dimethyl-2-propynyl) benzamide (pronamide,Kerb)
Dichloro diphenyl dichloroethane (ODD)
Dichloro diphenyl trichloroethane (DDT)
Dichlorethyl ether
2,4-Dichlorophenoxyacetic, esters and salts (2,4-D)
1,2-Dichloropropane
1,3-Dichloropropane (Telone)
Dimethyl phthalate
Ethyl acetate
Ethyl 4,4'-dichlorobenzilate (chlorobenzilate)
Ethylene dibromide (SDB)
Ethylene dichloride
Ethylene oxide
Formaldehyde
Furfural
Hexachlorobenzene
Hexachlorocyclopentadiene
Hexachloroethane
Hydrofluoric acid
-------
Appendix V-5
(continued)
"Toxic* Commercial Pesticide Products (RCSA "F* List)
Active Ingredients:
isobutyl alcohol
Lead acetate
Lindane
Maleic hydrazide
Mercury
Methyl alcohol
Methyl bromide
Methyl chloride
2,2'-Methylenebis (3,4,6-trichlorophenol) (hexachlorophene)
Methylene chloride ' :
Methyl ethyl ketone
4-Methyl-2-pentanone (methyl isobutyl ketone)
Naphthalene
Nitrobenzene
p-Nitrophenol
Pentachloroethane
Pentachloronitrobenzene (PCNB)
Pentaclorophenol
Phenol
Phosphorodithioic acid, 0/0-diethyl, methyl ester
Propylene dichloride
Pyridine
Resorcinol
Safrole
Selenium disulfide
Silvex
1/2,4,5-Tetrachlorobenzene
1,1,2,2-Tetrachloroethane
Tetrachloroethylene
2,3,4,6-Tetrachlorophenol
Thiram
Toluene
1,1,1-Trichloroethane
Trichloroethylene
Trichloromonofluoromethane (Preon 11*)
2,4,5-Trichlorophenol
2,4,6-Trichlorophenol
2,4,5-Trichlorophenoxyacetic acid (2,4,5-T)
Xylene
-------
Appendix V-5
(continued)
"Toxic"' Commercial pesticide Producls (RCSA "F" List)
Inert ingredients:
Acetone
Acetonitrile
Acetophenone
Acrylic acid
Aniline
Benzene
Chlorobenzene
Chloroform
Cyclohexane
Cyclohexanone
Dichlorodifluororaethane (Freon 12*)
Diethyl phthalate
Dimethylamine
Dimethyl phthalate
1,4-Dioxane
Sthylene oxide
Formaldehyde
Formic acid
isobutyl alcohol
Meleic anhydride
Methyl alcohol (methanol)
Methyl ethyl ketone
Methyl methacrylate
Naphthalene
Saccharin and salts
Thiourea
Toluene
1/1,1-Trichloroethane
1,1,2-Trichloroethane
Trichlorofluoromethane (Freon 11*)
Vinyl chloride
Xylene
------- |