v>EPA
United Stctes
Environmental Protection
Agency
Office of
Pesticide* end Toxic Subttanc
Washington DC 20460
F.che. AOI
ft per
May 31, 1988
540/I\S-88-080
Pesticides
Guidance for the
Reregistration of
Pesticide Products
Containing FORM^LDEHYD
AND PATRAFORMAT ,
as the Active Ingredient
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GUIDANCE FOR THE
REREGISTRATION OF PESTICIDE PRODUCTS
CONTAINING
FORMALDEHYDE AND PARAFORMALDEHYDE
AS THE ACTIVE INGREDIENT
CASE NUMBER 556
EPA/OPP PESTICIDE CHEMICAL CODES 043001 and 043002
CAS REGISTRY NUMBERS 50-00-0 AND 30525-89-4
MAY 17, 1988
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
WASHINGTON, D.C. 20460,
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TABLE OF CONTENTS
I. introduction . . 1
II. Chemical(s) Covered by this Standard . 4
A. Description of Chemical
B. Use Profile
III. Agency Assessment . 7
A. S umma ry
B. Preliminary Risk Assessment
C. Other Science Findings
D. Tolerance Reassessment
IV. Regulatory Position and Rationale .21
A. Regulatory Positions
B. Criteria for Registration
C. Acceptable Ranges and Limits
D. Required Labeling
V. Products Subject to this Standard . . .34
VI. Requirement for Submission of Generic Data .36
A. What are generic data?
B. Who must submit generic data?
C. What generic data must be submitted?
D. How to comply with DCI requirements
E. Procedures for requesting a change in protocol
F. Procedures for requesting extensions of time
G. Existing stocks provisions upon suspension or
cancellation
VII. Requirement for Submission of Product-Specific Data . .43
VIII. Requirement for Submission of Revised Labeling 44
IX. Instructions for Submission 45
A. Manufacturing use products (sole active)
B. Manufacturing use products (multiple active)
C. End use products
D. intrastate products
E. Addresses
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APPENDICES
I. DATA APPENDICES
Guide to Tables 48
Table A 50
Table B 73
II. LABELING APPENDICES
Summary of label requirements and table 77
40 CFR 162.10 Labeling Requirements 85
Physical/Chemical Hazards Labeling Statements 94
Storage Instructions 95
Pesticide Disposal Instructions 96
Container Disposal instructions 97
III. BIBLIOGRAPHY APPENDICES
Guide to Bibliography 98
Bibliography 100
IV- FORMS APPENDICES
EPA Form 8580-1 FIFRA §3(c)(2)(B) Summary Sheet 107
EPA Form 8580-6 Certification of Attempt to Enter
Into an Agreement with Other Regis-
trants for Development of Data 108
EPA Form 8580-4 Product Specific Data Report (End-Use
Products) 109
EPA Form 8570-27 Generic Data Exemption Statement .... Ill
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. Also known as the Reference
Dose or RfD.
a.i. active ingredient
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
EEC Estimated Environmental Concentration. The estimated
pesticide concentration system in an environment,
such as a terrestrial ecosystem.
EP End Use Product
EPA U.S. Environmental Protection Agency
FIFRA Federal insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
LC50 Median lethal concentration - a statistically derived
concentration of a substance that can be expected to
cause death in 50% of test animals. It is usually
expressed as the weight of substance per weight or
volume of water or feed, e.g., mg/1 or ppm.
LD50 Median lethal dose - a statistically derived single dose
than can be expected to cause death in 50% of the test
animals, when administered by the route indicated
(oral, dermal, inhalation). it is expressed as a
weight of substance per unit weight of animal, e.g.,
mg/kg.
LEL Lowest Effect Level
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of
recording and tracking studies submitted to the Agency.
MP Manufacturing use Product
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
111
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OES Office of Endangered Species, U.S. Fish and Wildlife
Service
OTS Office of Toxic Substances
PADI provisional Acceptable Daily intake
ppm parts per million
RfD Reference Dose
TMRC Theoretical Maximal Residue Contribution
IV
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I. INTRODUCTION
The Registration Standards Program
EPA has established the Registration Standards program
in order to provide an orderly mechanism by which pesticide
products containing the same active ingredient can be reviewed
and standards set for compliance with FIFRA. The standards
are applicable to reregistration and future applications for
registration of products containing the same active ingredient.
Each registrant of a product containing an active ingredient
subject to this Standard who wishes to continue to sell or
distribute that product must bring his product and labeling
into compliance with FIFRA, as instructed by this Standard.
The Registration Standards program involves a thorough
review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to
reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for
additional data on health and environmental effects; and to
determine whether the pesticide meets the "no unreasonable
adverse effects" criteria of FIFRA.
1. Studies that are acceptable to satisfy the data
requirements for the currently registered uses of the
pesticide.
2. Additional studies necessary to support continued
registration. The additional studies may not have been
required when the product was initially registered or may be
needed to replace studies that are now considered inadequate.
3. Labeling revisions needed to ensure that the product
is not misbranded and that the labeling is adequate to protect
man and the environment.
The detailed scientific review, which is not contained
in this document, but is available upon request1, focuses on
the pesticide active ingredient. The scientific review
primarily discusses the Agency's evaluation of and conclusions
from available data in its files pertaining to the pesticide
active ingredient. However, during the review of these data
the Agency is also looking for potential hazards that may be
associated with the end use products that contain the active
ingredient. The Agency will apply the provisions of this
scientific reviews may be purchased from the National
Technical Information Service, ATTN: Order Desk, 5285 Port
Royal Road, Springfield, Virginia 22161. Orders may be placed
by telephone to National Technical Information Service at
(703) 487-4650.
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EPA's reassessment results in the development of a
regulatory position, contained in this Registration Standard,
on the ingredient and each of its registered uses. See
Section IV - Regulatory Position and Rationale. Based on its
regulatory position, the Agency may prescribe a variety of
steps to be taken by registrants to maintain their registrations
in compliance with FIFRA. These steps may include:
1. Submission of data in support of product registration;
2. Modification of product labels;
3. Modifications to the manufacturing process of a
product to reduce the levels of impurities or contaminants;
4. Restriction of the use of a product to certified
applicators or other specially trained individuals;
5. Modification of uses or formulation types; or
6. Specification of packaging limitations.
Failure to comply with these requirements may result in
the issuance of a Notice of intent to Cancel or a Notice of
Intent to Suspend (in the case of failure to submit data).
In addition, in cases in which hazards to man or the
environment are identified, the Agency may initiate a special
review of the pesticide in accordance with 40 CFR Part 154
to examine in depth the risks and benefits of use of the
pesticide. If the Agency determines that the risks of the
pesticide's use outweigh the benefits of use, the Agency may
propose additional regulatory actions, such as cancellation
of uses of the pesticide which have been determined to cause
unreasonable adverse effects on the environment.
EPA has authority under the Data Call-in (DCI) provisions
of FIFRA sec. 3(c)(2)(B) to require that registrants submit
data to answer our questions regarding the chemical, toxico-
logical, and environmental characteristics and fate of a
pesticide. This Registration Standard lists the data EPA
believes are necessary to resolve our concerns about these
pesticides. These data are listed in the Tables A, B, and in
Appendix I. Failure to comply with the DCI requirements
enumerated in this Registration Standard may result in issuance
by EPA of a Notice of intent to Suspend the affected product
reg istrations.
Registrants are reminded that FIFRA sec. 6(a)(2) requires
them to submit factual information concerning possible unreason-
able adverse effects of a pesticide at any time that they
become aware of such information. Registrants must notify the
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Agency of any information, including interim or preliminary
results of studies, if that information suggest possible
adverse effects on man or the environment. This requirement
is independent of the specific time requirements imposed by
EPA for submission of completed studies called in by the
Agency and continues as long as a product is registered under
FIFRA.
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II. CHEMICAL(S) COVERED BY THIS STANDARD
A. Description of chemical(s)
The following chemical(s) are covered by this Registration
Standard:
Chemical Name:
Formaldehyde
Paraformaldehyde
Common Name
Formic aldehyde,
Methanal, Oxomethane,
Oxyme thylene,
Methylene oxide,
Formalin
CAS Registry Number 50-00-0
Polyoxymethylene,
Mixed polyoxy-
methylene glycols
30525-89-4
EPA/OPP Pesticide
Chemical Code
Empirical Formula
043001
043002
HO(CH20)XH
Description of Physical Characteristics of Chemical
Color
Colorless
Colorless
Physical State
Odor
Melting Point
Boiling Point
Gas
Pungent
NA(gas at
room temp.)
-19.5°C(-3°F)
Crystalline,
Pe1leted/Table ted
Wettable Powder/Dust
Pungent
64°C
NA(tech. is
solid at room
temp.)
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Description of Physical Characteristics (Cont'd)
Formaldehyde
Paraformaldehyde
Solubility
Vapor Pressure
Very soluble in water
- up to 55%, soluble
in ether, alcohol
Unavailable
Dissolves slowly
in cold water, more
rapidly in hot
water, hydrolyzing
and depolymerizing
as it dissolves
Unavailable
Molecular Weight
30.03
Variable; avg. = 600
OctanoI/Water Par-
tition Coefficient
0.1348
Corrosion Charac-
teristics
B. Use Profile
Corrosive to metal
Type of Pesticide
Pests Controlled
Disinfectant,
Fungicide,
Microbiocide,
Preservative of
pesticidal formu-
lations
Bacteria, Fungi,
Viruses, Algae
Disinfectant,
Fungicide,
Microbiocide,
Preservative of
pesticidal for-
mulations
Bacteria, Fungi,
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Use Profile (Cont'd)
Formaldehyde
Paraformaldehyde
Registered Sites
Predominant Use(s)
Food and non-food
crops, farm/animal
premises, oil
recovery systems,
industrial preserva-
tives, medical prem-
ises & equipment,
industrial, insti-
tutional premises,
contents & equip-
ment, household,
preservative of
pesticidal formulation
Surface disinfectant,
industrial biocide
hatcheries, preserva-
tive of pesticidal
formulations
Sugar maple
tree tapholes,
oil recovery
systems, lockers,
locker rooms,
hatchery equip-
ment, hatcheries,
industrial preser-
vatives and
additives, preser-
vative of pestici-
dal formulation
Preservation of
oil well drilling
muds, mildew and
odor control on
commercial premises
Formulation Types
Registered
Method(s) of
Application
Gas, pelleted/tableted,
soluble concentrate/
liquid, flowable con-
centrate; 37%, 44% & 45%
formulation intermediates
(manufacturing use
products)
Spray or Dip, Wipe,
Soak, Manual Pour,
Fumigation, Automatic
Metering Devices
Pelleted, tableted
wettable powder/
dust, crystalline
Manual insert,
jet Mixer,
Generator,
Fumigation
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III. AGENCY ASSESSMENT
A. INTRODUCTION
This registration standard covers formaldehyde and para-
formaldehyde, a solid polymer of formaldehyde. Paraformaldehyde
is covered by this standard because it hydrolyzes to form
formaldehyde in an aqueous solution or depolymerizes to form
formaldehyde gas when exposed to air.
This standard covers products containing formaldehyde or
paraformaldehyde currently classified as either active or
inert ingredients. As inert ingredients, formaldehyde and
paraformaldehyde are intentionally added to preserve the
pesticidal activity of formulations by preventing deterioration
caused by bacteria and fungi. As preservatives in formulations,
formaldehyde or paraformaldehyde perform a pesticidal function.
Therefore, the Agency has determined that formaldehyde and
paraformaldehyde should be categorized as active ingredients
in all products in which they are used, including those in
which they currently are only intentionally added as an inert
ingredient. Thus, all products containing formaldehyde and
paraformaldehyde as a preservative of the formulation will be
considered to contain these chemicals as active ingredients.
B. REGULATORY HISTORY
Less than 1% of the total amount of formaldehyde produced
annually is used for pesticidal purposes. The first pesticidal
uses were registered in 1948 for formaldehyde and in 1953 for
paraformaldehyde. Formaldehyde is also one of the 55 toxic
inerts the Agency has identified for priority consideration.
Formaldehyde was assigned to this priority group on the basis
of positive carcinogenicity and mutagenicity evidence.
In 1979, interim results from a Chemical industry institute
of Toxicology (CUT) study indicated that formaldehyde produced
nasal tumors in rats. In November 1980, the Federal Panel on
Formaldehyde, formed by several Federal agencies under the
sponsorship of the National Toxicology Program, published a
report concluding that "formaldehyde should be presumed to
pose a risk of cancer to humans".
initially, the Agency focused its investigation of formal-
dehyde on the uses covered under the Toxics Substances Control
Act (TSCA). in February 1982, the Agency decided that although
formaldehyde had been found to be carcinogenic in the CUT
study (completed in 1981), the available information concerning
its cancer risk to humans did not meet the statutory criteria
("...presents or will present a significant risk of serious
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or widespread harm to human beings from cancer...") for
priority designation under section 4(f) of TSCA. In October
1983, the Agency funded the National Center for Toxicological
Research to sponsor a Consensus Workshop on Formaldehyde to
further assist in its evaluation of formaldehyde. In November
1983, the Agency rescinded its February 1982 decision and asked
for public comment to determine whether formaldehyde should
be given priority consideration under section 4(f) of TSCA.
In May 1984, the Agency announced that two formaldehyde
exposure categories, the manufacture of apparel from fabrics
treated with formaldehyde and residential exposure from
formaldehyde based resins, triggered section 4(f) of TSCA.
The Agency referred its investigation of risk to garment
workers from fabrics treated with formaldehyde to the
Occupational Safety and Health Administration (OSHA) in February,
1986 because of OSHA's jurisdiction in that area and its pro-
posed revision of the workplace exposure levels for formaldehyde
(50 FR 50412). On December 4, 1987, OSHA issued its revised
occupational safety and health standard for occupational
exposure to formaldehyde (29 CFR 1910.1048). This standard
announced the reduction of the permissible exposure limit
from 3 parts formaldehyde per million parts of air to 1 part
formaldehyde per million parts of air measured as an 8-hour
time-weighted average.
The Agency's Office of Toxic Substances (OTS) performed
a risk assessment for residential exposure triggering section
4(f) concerns. This document entitled "Assessment of Health
Risks to Garment Workers and Certain Home Residents from
Exposure to Formaldehyde" was released on April 16, 1987. This
assessment of human health risks associated with formaldehyde
states the Agency's position that formaldehyde should be
classified as a group [Bl] probable human carcinogen in accordance
with the Cancer Risk Assessment Guidelines. The hazard identi-
fication and cancer potency estimations in this risk assessment
are used in this registration standard.
C. SUMMARY
The Agency reviewed data submitted to support the registra-
tion of formaldehyde and paraformaldehyde, as well as published
reports. Based on the available data, the Agency has reached
the following conclusions.
1. Formaldehyde has been found to be carcinogenic in animal
studies and there is limited evidence of carcinogenicity in
humans. The Agency has classified formaldehyde as a Group
[Bl] Probable Human Carcinogen.
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2. Based on available exposure data, the Agency has estimated
the worst-case risks to agricultural workers from use of
formaldehyde as a preservative in a pesticide formulation to
be less than 1.2 x 10"6 [Bl] (see Section III.D). Estimates
of the dietary risk and risk to workers from non-agricultural
uses have not been calculated because necessary data are not
yet available.
3. An acceptable daily intake (ADI) has not been established
for formaldehyde. When requested toxicological data are
received, an ADI will be established. Based on requested
residue data, a tolerance reassessment will be performed.
4. At this time, the Agency is unable to assess risks to en-
dangered species because necessary data are not available to
estimate the environmental concentrations resulting from
certain uses (see Section III.E.8). The Agency is requiring
that monitoring data be submitted in order to assess the risk
to endangered species.
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D. PRELIMINARY RISK ASSESSMENT
Use of formaldehyde and paraformaldehyde ITC"' --esult in
worker exposure, both agricultural and non-agricultural, and
dietary exposure. Non-agricultural uses account for the
largest percentage of formaldehyde and paraformaldehyde used
for pesticidal applications. The use of formaldehyde and
paraformaldehyde for the preservation of drilling muds and
production fluids in secondary oil recovery systems may
result in non-agricultural worker exposure. Formaldehyde's
use for the preservation of metalworking fluids and biological
tissues, and its use in sanitization and disinfection of
non-food surfaces, instruments and equipment may also result
in non-agricultural worker exposure. Formaldehyde's use as
a preservative in products registered for use in indoor/outdoor
bait applications and toilet bowls/urinals may result in
non-agricultural worker exposure. Paraformaldehyde's use for
mold, mildew and odor control in enclosed spaces may also
result in non-agricultural worker exposure.
Agricultural worker exposure may result from use of formal-
dehyde for control of pathogenic fungi and/or bacteria on some
food crops, ornamentals, soil and planting containers, and for
control of fungi on garlic seed. Agricultural worker exposure
may also result from formaldehyde's use as a preservative
in products registered for use on tree fruit and nut crops,
vegetable crops, small fruits, field crops, cereal grain crops,
ornamentals, rangeland, golf courses, greenhouse crops, mushroom
house soil and seed treatment. Paraformaldehyde's use as a
preservative in products registered for use on tree fruit and
nut crops, vegetable crops, small fruits, seed treatment,
ornamentals and general outdoor application may also result
in agricultural worker exposure. Formaldehyde's and paraformal-
dehyde' s use for sanitization of hatching eggs may also result
in agricultural worker exposure. Paraformaldehyde1s use on
sugar maple trees may also result in agricultural worker
exposure.
Dietary exposure may result from use of formaldehyde and
paraformaldehyde as a preservative in products registered for
use on a variety of crops. Dietary exposure may also result
from formaldehyde's use on some food crops to control pathogenic
fungi and/or bacteria. Paraformaldehyde's use on sugar maple
trees may result in dietary exposure. The original exemptions
from tolerances were established on the assumption that signi-
ficant residues of formaldehyde would not be present. The
Agency is now requiring plant metabolism residue data to
determine dietary exposure.
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1. Risks to Agricultural Workers
The Agency has reliable data with which to estimate
applicator exposure for most agricultural uses. The Agency
quantified exposure for uses of formaldehyde as a
preservative in a pesticide formulation applied to orange
trees. This use pattern was chosen because it is known to
involve one of the highest levels of exposure for
agricultural application of pesticides. Specifically, the
Agency estimated the exposure of a worker mixing and loading
the pesticide and then making one application by boom sprayer
and four applications using airblast equipment. Exposure
was estimated based on a concentration of 0.3% formaldehyde
in the formulation as a preservative (0.3% concentration
was chosen because a review of the product labels indicated
this was the highest concentration expected). Exposure
estimates were calculated for a mixer/loader wearing
protective gloves, long pants and a short-sleeve shirt.
The maximum exposure levels estimated for the worker were
0.87 ug/kg/yr (inhalation) plus 397 ug/kg/yr (dermal) of
formaldehyde.
2. inhalation Risks
The OTS risk assessment for formaldehyde used the CUT
study for the dose-response modeling and calculated a unit
risk of 1.3 x 10~"5 for a daily exposure of 1 ug/m3 over a 70
year period. These calculations have been adjusted to account
for the worst-case worker exposure over a 40 year worklife as
follows:
Assuming a respiratory rate of 1.74m3/hr, a 1 ug/m3 ambient
exposure results in a daily exposure of
1 ug/m3 x 1.74 m3/hr x 24hrs = 41.76 ug/day.
Assuming a bodyweight of 60kg (human female), exposure
equals
41.76 ug/day/60 kg = 0.696 ug/kg/day
The QI can be derived as follows:
Risk = Daily exposure (mg/kg) x Q^
Q!* = 1.3 x-lCT5 = 1.87 x 10~2 (mg/kg/day)'1
0.696 mg/kg/day x 10~3
The maximum exposure inhalation level of 0.87 ug/kg/yr
for pesticide workers can be converted td a daily exposure of
2.4 x 10~6 mg/kg/day.
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Risk = 2.4 x 10"6 rag/kg/day x 1.87 x 1CT2 (mg/kg/day)-l
= 4.6 x 10~8
Since the 0^ was derived from a 70 year (lifetime) expo-
sure, this risk must be prorated for a 40 year worklife as
follows:
4.6 x 10~8 x 4jO = 2.6 x 10~8
70
Thus, the risk from inhalation exposure was estimated to be
in the range of 10~7 to 10~8.
3 . Dermal Risks
To estimate the risk to an agricultural mixer/loader/
applicator from dermal exposure, a 397 ug/kg/yr exposure
over a 40 year worklife was used. This estimate assumed 100%
dermal absorption. However, it appears that less than 10% of
radi olabeled formaldehyde penetrates the skin after 48 hours.
Of the absorbed radiolabeled formaldehyde, very little formal-
dehyde is expected to remain because it appears to rapidly
convert to formate and carbon dioxide or to combine with
tissue constituents. Therefore, exposure was adjusted for
10% dermal absorption.
Maximum expected dermal exposure = 397 ug/kg/yr.
= 1.09 ug/kg/day
Assuming 10% penetration = .109 ug/kg/day
= 1.09 x 10~4 mg/kg/day
Risk = 1.09 x 10~4 mg/kg/day x 1.87 x 10~2 (mg/kg/day)"1
= 2.0 x 10~6
Again, since the Qi was based on a 70 year exposure, this
risk must be prorated for a 40 year worklife as follows:
2.0 x 10~6 x _40 = 1.1 x 10~6
70
Thus, the risk from dermal exposure was estimated to be no
greater than 10~6, when a 10% dermal absorption was assumed.
3 . Risks to Non-agricultural Workers
The Agency does not have data to quantify applicator
exposure for the non-agricultural uses. The Agency has
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developed a strategy to obtain exposure data on the uses of
antimicrobial pesticides, many of which have non-agricultural
uses. When these data are received, as well as indoor
inhalation exposure reentry data required by this standard,
they will be used to assess the risk from non-agricultural
uses of formaldehyde and paraformaldehyde.
4. Dietary Risks
Data are not available to assess dietary risk from use
of formaldehyde and paraformaldehyde. An assessment of the
dietary risk will be made when requested residue data and
toxicology data are submitted.
E. SCIENCE FINDINGS
Most of the toxicological information on formaldehyde is
from published sources. These sources are analyzed in the
Agency's risk assessment on formaldehyde entitled "Assessment
of Health Risks to Garment Workers and Certain Home Residents
from Exposure to Formaldehyde" (April, 1987). Also, the Agency
evaluated data submitted in support of pesticide registrations.
The toxicity of paraformaldehyde is believed to be identical
to that of formaldehyde since it is known to hydrolyze or
depolymerize into formaldehyde rapidly,
1. Acute Toxicity. Numerous published acute toxicity studies
exist. However, the Agency does not have access to the raw
data supporting these published studies. Therefore, none is
adequate for FIFRA regulatory purposes. However, based on
published and/or unpublished acute toxicity studies, the fol-
lowing toxicological characteristics of formaldehyde and
paraformaldehyde are expected:
Formaldehyde
Acute oral toxicity:
Toxicity Category 3; LDso = 800 mg/kg (rat)
Acute dermal toxicity:
Toxicity Category 3; LDso > 2 g/kg
Acute inhalation toxicity:
Toxicity Category 3;
Lowest lethal concentration = 250 ppm (4hr exposure)
Primary eye irritation: Toxicity Category 1
Primary skin irritation: Toxicity Category 2
Major route of exposure; inhalation, dermal
Paraformaldehyde
Acute oral toxicity:
Toxicity Category 3; LDso > 1.6 g/kg (rat)
Acute dermal toxicity:
Toxicity Category 3; LDso > 2 g/kg
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Acute inhalation toxicity:
Toxicity Category 1; LC 50 about 14 ppm
Primary eye irritation:
Toxicity Category 1
Primary skin irritation
Toxicity Category 2
Major route of exposure: inhalation, dermal
Exposure to formaldehyde may cause irritation of the eyes
and upper respiratory system. Formaldehyde is a well-known
dermal sensitizer and after sensitivity is induced, further
exposure can elicit allergic response. Most persons experience
discomfort when exposed within the range of 0.1 to 3 ppm.
Acute oral (rat), acute dermal (rabbit), acute inhalation
(rat), primary eye irritation (rabbit) and dermal sensitization
toxicity studies are required.
2. Subchronic Toxicity. Subchronic exposures of 2 ppm or
greater have been reported to affect the mucociliary clearance
system, which may increase a person's susceptibility to
infections and other respiratory diseases. As with the acute
toxicity studies, the data are not adequate for FIFRA regulatory
purposes. A 90-day feeding study (rodent and non-rodent),
21-day dermal study (rabbit) and a 90-day inhalation study
(rat) are required. A 90-day dermal study (rabbit) is reserved
pending the results of the 21-day dermal study.
3. Chronic Feeding and Oncogenicity.
Classification. Based on the available data, formaldehyde is
classified by the Agency as a BI carcinogen because there is
sufficient evidence of carcinogenicity from animal studies,
and limited evidence of carcinogenicity in humans.
Epidemiology. Epidemiological studies indicate formaldehyde may
be a human carcinogen, though the evidence is classified as
limited because exposures to multiple chemicals may confound
the findings of excess cancers.
Twenty-eight epidemiological studies are reviewed in the
OTS risk assessment. Nine studies among different occupational
groups show significant associations between site-specific
respiratory cancer and exposure to products containing formal-
dehyde, in addition, a group of professionals exposed to
formaldehyde (anatomists, pathologists, embalmers and under-
takers) have a significantly increased mortality from leukemias
and brain neoplasms.
The National Cancer Institute (NCI) cohort study (1986)
observed significant excesses in lung and nasopharyngeal
cancers among U.S. workers occupationally exposed to formaldehyde
at 10 industrial sites. NCI (1986), however, argued that the
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lung cancer excesses provided little evidence of an association
with formaldehyde exposure since the lung cancer risk did not
increase consistently with either increasing intensity or
cumulative formaldehyde exposure. RPA concluded, after reviewing
the data, that the significant excesses in total lung cancer
mortality, in analyses either with or without a latency
period equal to or greater than 20 years, and together with
nasopharyngeal cancer mortality among formaldehyde-exposed
workers are meaningful despite the lack of significant trends
with exposure.
An OSHA-NIOSH study of 11,030 garment workers exposed to
formaldehyde for at least three months found a statistically
significant excess in mortality from cancers of the buccal
cavity and connective tissue. The study also found an excess
in mortality for cancers of the trachea, bronchus and lung,
pharnyx, bladder, leukemia and aleukemia, and other lymphopoi-
etic neoplasms, but none was statistically significant.
Animal Studies. Formaldehyde has been found to be carcinogenic
by inhalation in two strains of rats, and there is evidence of
potential carcinogenicity in mice. A February 1986 drinking
water study by Takahashi, Hasegana et. al. with formaldehyde
showed evidence of compound related carcinogenicity in the
stomach of the rat.
The CUT study was the first long-term study reporting
the carcinogenicity of formaldehyde in animals by the inhala-
tion route. This study showed a statistically significant
increase in nasal tumors in male and female Fischer 344
strain rats, with a dose-response relationship. Mice
(C57BL/6 x C3HFi) were also tested, and nasal tumors were
also observed. The incidence of tumors in the mice was not
statistically significant. However, the natural background
rate for these tumors is very low, suggesting that the tumors
were related to formaldehyde exposure.
A statistically significant number of squamous cell
carcinomas were also observed in a study conducted by another
group which exposed male Fischer 344 strain rats (same strain
as used in the CUT study) to formaldehyde by inhalation.
In another study with Sprague-Dawley male rats that were
exposed by inhalation to a mixture of formaldehyde and hydro-
chloric acid, 25 out of 99 rats developed squamous cell
carcinomas of the nose. In a second study in the same strain
of rats, statistically significant numbers of squamous cell
carcinomas of the nose were seen in rats exposed by inhalation
to formaldehyde, and a mixture of formaldehyde and hydrochloric
acid.
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Two other chronic inhalation studies have been performed
with formaldehyde in C3H mice and male Syrian golden hamsters.
Although neither study demonstrated a carcinogenic effect, both
studies had major shortcomings. in the mouse study too few
animals survived past the first year. For both studies,
incomplete histopathology of nasal tumors was performed.
In a 2-stage drinking water study in male Wistar rats,
formaldehyde was shown to be a possible tumor promoter in the
rat's stomach. The rats were first given a potent carcinogen
(N-methyl-N-nitro-N-nitrosoguanidine (MNNG)) to initiate the
formation of tumors in the stomach, and were then given a
maintenance diet of drinking water that contained 0.5% formaldehyde
Formaldehyde was found to significantly increase the incidence
of adenocarcinomas in the rat stomach. Adenomatous hyperplasias
and squamous cell papillomas were also found in the rat stomach.
The Agency is requiring oral oncogenicity and chronic
toxicity testing because data are required to support tolerances
or exemptions from tolerances.
Structure-Activity Relationship. Formaldehyde and paraformaldehyde
are structurally similar to acetaldehyde, malondialdehyde and
glycidaldehyde which have shown oncogenic activity in laboratory
animals. Inhalation of acetaldehyde (which is closest in
structure to formaldehyde) has produced tumors of the nose and
larynx in hamsters and tumors of the nose in rats. Glycidaldehyde
has produced skin tumors in mice in skin painting tests.
4. Mutagenicity. Formaldehyde has been shown to cause
genetic changes in Drosophila larvae, fungi, viruses, yeast,
mammalian cells and human cells. in vitro tests have detected
induction of single strand breaks in DNA, a small increase
in sister chromatid exchanges in mouse bone marrow, DNA-protein
crosslinks, chromosome aberrations, and marginal results in
a dominant lethal test. Based on the data reviewed by the
Consensus Workshop on Formaldehyde, they concluded that
formaldehyde acts as a weak mutagen (i.e., less than a ten-fold
increase over background). However, none of these data are
sufficient for FIFRA regulatory purposes. Gene mutation,
structural chromosomal aberration and other genotoxic effects
testing are required.
5. Developmental Toxicity. Inhalation studies in animals and
epidemiological studies in workers have not demonstrated
teratogenic effects. In a study by Marks et al. (1980) on mice,
it was found that even at a dose which killed more than 50
percent of the dams, no adverse reproductive outcomes were
observed except for an.increase in the incidence of resorptions
that was not statistically significant. None of the studies is
adequate for FIFRA regulatory purposes. Teratogenicity
studies by the oral route in the rat and rabbit are required.
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6. Reproduction. In one study, prolonged diestrus, but no
impairment of reproductive function was reported. This study
is not adequate for FIFRA regulatory purposes. A 2-generation
rat reproduction study is required.
7. General Metabolism. Formaldehyde is produced in mammalian
systems by metabolism and thus is a normal constituent of body
tissues. Such endogenous formaldehyde is produced from the
degradation of serine and other amino acids. In dogs, cats,
rabbits, guinea pigs and rats, the half-life of formaldehyde
is estimated to be one minute. Formaldehyde that enters the
body appears to convert rapidly to formate and carbon dioxide
or to combine with tissue constituents. No general metabolism
tests are required.
8. Ecological Effects. Formaldehyde (37% active ingredient)
is slightly toxic to birds on an acute oral basis and practi-
cally nontoxic to birds on a subacute dietary basis. Formalde-
hyde is slightly toxic to warmwater fish, practically nontoxic
to coldwater fish and slightly toxic to freshwater invertebrates.
Formaldehyde is slightly to practically nontoxic to estuarine
fish and moderately toxic to estuarine invertebrates.
Formulated formaldehyde products (containing 18% - 33%
formaldehyde) that have been tested are practically nontoxic
to highly toxic to estuarine and marine invertebrates and
practically nontoxic to freshwater fish.
Environmental concentrations were estimated for the use
patterns that had the potential to result in exposure to
wildlife and aquatic organisms. Estimates were made for
formaldehyde's use on grain seeds, forage fodder grasses,
turf, and in secondary oil recovery systems. Estimates were
made for paraformaldehyde1s use on sugar maple tree tap
holes and in oil well drilling muds. Estimates were made for
the use of formaldehyde and paraformaldehyde as microbiocides
in cooling towers, air scrubbers and industrial products.
Use of formulations containing less than one percent formaldehyde
and paraformaldehyde are not expected to pose a risk to fish
and wildlife species from the formaldehyde constituent.
Seed Treatment and Forage Grasses. The use of formaldehyde
is not expected to pose a hazard to terrestrial species.
Sugar Maple Trees. The Agency is unable to complete a hazard
assessment to terrestrial species on the use of paraformaldehyde
for tap holes in sugar maple trees until acute toxicity data
to birds on the end-use product are submitted.
Oil Recovery Systems and Drilling Muds. ' A potential hazard
may exist to estuarine species from the use of formaldehyde
in secondary oil recovery systems and use of paraformaldehyde
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in oil well drilling muds. Testing of additives containing
formaldehdye used as oil field microbiocides indicates the
additives are slightly toxic to highly toxic to estuarine
invertebrates. Exposure to marine and estuarine species
could occur from accidental spills and waste disposal. Data
on the toxicity of all end-use oil field microbiocides to
marine and estuarine species are required. Also, monitoring
of formaldehyde levels in waters receiving residues from the
use of the pesticide in secondary oil recovery systems
(formaldehyde) and oil well drilling muds (paraformaldehyde)
are required.
Turf. Assuming formaldehyde were applied directly to water
(one acre pond with a water depth of six inches) at the appli-
cation rate used on turf, the endangered species regulatory
trigger for aquatic organisms (1/20 of the LCsg) would be
exceeded for marine and freshwater fish and invertebrates.
The exposure is overestimated because application to turf
should not result in residues in water at as high a level as
direct application to water. The Agency cannot accurately
assess the hazard to aquatic species until residues in water
adjacent to treated turf are determined. Chemical and en-
vironmental fate data are required. These data will be
used to run a simulation model to estimate the runoff of the
pesticide from the edge of the field and the fate of the
pesticide in water. A residue monitoring study to determine
the amount of formaldehyde entering aquatic systems under
conditions of actual use on turf is reserved pending the
modeling results. Usage estimates available to the Agency
indicate little use of formaldehyde on turf, which reduces
the risk to endangered species.
Cooling Tower and Industrial Biocide Uses. Microbiocides
containing formaldehyde and paraformaldehyde are used in
cooling towers, air scrubbers and industrial products such
as metalworking fluids. Continuous discharge of industrial
effluent potentially containing formaldehyde in shallow or
enclosed bodies of water could result in environmental
concentrations which may affect endangered species. The
Agency is requiring monitoring studies to determine the
levels of formaldehyde and paraformaldehdye in effluents
from such facilities to evaluate risk to endangered species
from these facilities.
Acute and subacute studies with paraformaldehyde in birds
are required. Acute studies in freshwater fish, aquatic
invertebrates, marine and estuarine organisms with formulated
formaldehyde and paraformaldehyde products are required.
Chronic fish and aquatic invertebrate testing will be
required if residue monitoring studies indicate residues at a
level of concern. in addition, the previously mentioned
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monitoring studies are required.
9. Environmental Fate. No data are available to assess the
environmental fate of formaldehyde and paraformaldehyde.
Degradation, metabolism, mobility, field dissipation and
accumulation studies are required.
F. TOLERANCE REASSESSMENT
No tolerances have been established for residues of
formaldehyde in or on food/feed items. 40 CFR 180.1032
exempts formaldehyde from the requirement of a tolerance for
raw agricultural commodities that are used as animal feeds.
According to 40 CFR 180.1024, paraformaldehyde is exempted
from the requirement of a tolerance for residues in or on
sugar beets when applied to the soil not later than planting.
A food additive tolerance of 2 ppm has been established
(21 CFR 193.330) for residues of formaldehyde in maple syrup
resulting from use of paraformaldehyde to control microbial or
fungal growth in maple tree tap holes.
Formulations containing one percent or less of formaldehyde
or two percent or less of paraformaldehyde are exempt from the
requirement of a tolerance when used as a preservative in
pesticidal formulations applied to growing crops (40 CFR 180.
1001(d)).
There are no Canadian or Mexican tolerances or Codex
maximum residue limits (MRLs) for residues of formaldehyde in
or on agricultural commodities or in animal products. There
is no Canadian or Mexican tolerance, nor is there a Codex MRL
for residues of paraformaldehyde or formaldehyde in or on sugar
maple syrup.
The Agency has evaluated the residue and toxicology data
supporting the tolerances, exemptions from tolerances, and
reviewed all uses of formaldehyde and paraformaldehyde. Based
on the available data, the Agency concludes:
0 No tolerances or exemptions from tolerances are established
for residues of formaldehyde resulting from registered
preplant, postplant and seed treatment uses. Plant
metabolism data are required; if residues of concern are
found, residue data will be required.
0 Animal metabolism data are required because the available
data suggest that formaldehyde may occur in treated feeds.
If submitted studies show that naturally-occurring levels
of formaldehyde in feed items or in tissues, milk, and
eggs are similar to those resulting from formaldehyde
treatment of feed items, then animal metabolism studies
may be waived.
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0 Residue data are required to support the food additive
tolerance of 2 ppm for formaldehyde residues in maple syrup.
0 Current exemptions from the requirement of a tolerance for
the preservative uses are not supported by data. If
residues of concern are found in the plant metabolism
study, residue data will be required.
An acceptable daily intake (ADI) has not been established
for formaldehyde. When requested toxicological data are received,
an ADI will be established. Based on requested residue data, a
tolerance reassessment will be performed.
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IV. REGULATORY POSITION AND RATIONALE
A. REGULATORY POSITIONS
Based on review and evaluation of all available data on
formaldehyde and paraformaldehyde, the Agency has made the
following determinations. Refer to Section iv.D for specific
language for label revisions.
1. The Agency has determined that formaldehyde and parafor-
maldehyde are pesticidally active when used as a preservative
in pesticide formulations. Therefore, the Agency has
classified them as active ingredients in such formulations.
The labels of all pesticide products that contain formaldehyde
or paraformaldehyde as a preservative must list the name and
percent of the preservative constituent. Formaldehyde is
contained in approximately 309 products as an inert ingredient
and paraformaldehyde is contained in approximately 96 products
as an inert ingredient. The following statement must also
appear on the labels, "Formaldehyde (or paraformaldehyde) is
present solely to preserve the pesticide formulation and does
not otherwise contribute to the product's pesticidal activity".
Rationale; Many pesticide registrants add formaldehyde and
paraformaldehyde to their formulations to preserve the
pesticidal activity of the formulation by preventing
deterioration by bacteria and fungi. Previously, formaldehyde
and paraformaldehyde have been classified as inert ingredients
when they were added as preservatives. However, according to
FIFRA Section 2 (a) the term "active ingredient" means, among
other things, "an ingredient which will prevent, destroy,
repel or mitigate any pest". Therefore, the Agency concludes,
based on the statutory definition of an active ingredient,
that the preservatives, formaldehyde and paraformaldehyde,
are active ingredients.
A registrant who believes that the formaldehyde/parafor-
maldehyde) in his formulation is not present at a level that
would exert a preservative effect against bacteria/fungi
(i.e., will not function as a biological preservative) may
submit data demonstrating that this is so, and request that
the formaIdehyde/paraformaldehyde be designated an inert
ingredient. If he chooses this course, the registrant must
indicate his intention to do so within 90 days, and he must
submit the supporting data within 9 months after receipt of
this standard.
If the Agency agrees that the formaldehyde/paraformal-
dehyde is not present at levels sufficient to exert a
pesticidal effect, the registrant will not be required to list
the formaldehyde/paraformaldehyde as an active ingredient. in
that case, the Agency's policy statement on inert ingredients
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(in which formaldehyde and paraformaldehyde are categorized
as List 1 inerts of toxicological concern) would govern the
labeling requirements for that product.
2. The Agency has determined that formaldehyde and
paraformaldehyde will not be placed in the Special Review
process at this time. Available data are insufficient to
determine whether Special Review criteria in §154.7 are met.
The Agency is requiring data under Section 3(c)(2)(B) of
FIFRA to estimate the dietary risk and the non-dietary risk.
After these estimates are made, the Agency will consider
whether to place formaldehyde and paraformaldehyde in Special
Review.
Rationale. Although formaldehyde has been classified by the
Agency as a Bl oncogen, the Agency is able to estimate the
risk to workers for only one agricultural situation (see
section III.D). The risk to a worker in this situation was
estimated to be less than 10~6 [Bl] .
The potential risks from other uses cannot be quantified
at this time. The Agency lacks exposure data from other
agricultural and non-agricultural uses of formaldehyde and
paraformaldehyde. Data to assess the dietary and non-agricul-
tural worker risks must be evaluated before a determination as
to whether formaldehyde and paraformaldehyde should be placed
in Special Review.
3. The Agency is not classifying formaldehyde and paraformal-
dehyde products for restricted use at this time. The Agency
is requiring that product labels bear protective clothing and
equipment statements that are adequate to mitigate the hazards
of workers. After review of exposure data required by the
Standard, the Agency will reconsider whether formaldehyde and
paraformaldehyde products should be classified for restricted
use. The specific types of protective clothing and equipment
are specified in Section IV.D (5&6).
Rationale; The Agency believes that protective clothing and
equipment, as well as other protective work practices designed
to reduce exposures will mitigate the hazards such that
restricted use is not warranted.
4. The Agency will require that appropriate protective
clothing statements as specified in the labeling section be
added to formaldehyde and paraformaldehyde product labels.
Protective clothing is not required for air sanitizers,
toilet or urinal sanitizers, all pellet/tablet formulations,
crystalline, granular or impregnated paper formulations.
Products containing less than 1% formaldehyde or para-
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formaldehyde in a formulation are also exempt. However, such
products that contain other active ingredients must retain any
protective clothing requirements already on the label for those
active ingredients.
Rationale; Because of the wide variety of uses, protective
clothing requirements were tailored to suit the use category.
Refer to the Labeling Section iv.D (5&6) for protective
equipment specifics. Exemptions from protective clothing
requirements for certain use categories have been made
because exposure is expected to be low. These requirements
will reduce worker exposure, if the protective clothing and
equipment is used and maintained properly.
5. The Agency is requiring that additional protective measures
be placed on the labels of formaldehyde products intended for
indoor fumigation uses, such as egg handling facilities and
hospitals. If the concentration of formaldehyde exceeds 1 ppm
(the OSHA 8-hour time-weighted average), a respirator is re-
quired for application or reentry. in addition, registrants
must upgrade labeling to include precautionary statements,
use directions, protective clothing, statements requiring
use of NIOSH/MSHA respiratory protection devices approved
for formaldehyde and paraformaldehyde when the concentration
of the fumigant exceeds 1 ppm, use of specified direct-reading
detector devices (identified by the registrant), statements
requiring placarding of fumigated areas, aeration and reentry
statements, and storage and handling, disposal and spill and
leak procedures statements. These labeling statements are
given in Section IV.D (5&6).
Rationale; Formaldehyde has been found to be carcinogenic in
animal studies, there is limited evidence of carcinogenicity
in humans, and it has been identified as an eye irritant and
dermal sensitizer. The OSHA has set an 8-hour time-weighted
average exposure limit of 1 part formaldehyde per million
parts of air (29 CFR 1910.1048).
At this time, the Agency is not able to estimate the
risk to workers from indoor fumigation uses of formaldehyde
because exposure information are lacking. When these data
are received, the Agency will reevaluate the 1 ppm level.
6. The Agency has determined that it will not impose a cancer
hazard warning labeling statement requirement at this time.
Rationale; Although formaldehyde has been identified as a Bl
oncogen, the Agency lacks exposure data from most agricultural
and non-agricultural uses of formaldehyde and paraformaldehyde.
Only surrogate exposure data were used as a basis for deter-
mining the risk to workers for one agricultural situation (see
section III.D). Currently, oncogen warning statements are risk
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driven. Since we do not have available actual exposure data
to determine the risks associated with the pesticidal uses of
these chemicals, we will reserve the right to consider this
requirement after review of these data.
7. The Agency will consider new uses of formaldehyde and
paraformaldehyde on a case-by-case basis. Applications for
new use patterns must contain exposure data in order for the
Agency to perform a risk assessment.
Rationale; New uses of formaldehyde and paraformaldehyde will
be examined by the Agency on a case-by-case basis to determine
exposure and risk because numerous data gaps have been identi-
died for residue chemistry, environmental fate and toxicology
and because formaldehyde has been identified as a Bl oncogen.
8. The Agency has identified certain data that will receive
immediate review when submitted.
Rationale; Certain of the data being required by the Agency
are essential to resolve risk concerns, or may trigger the
need for further studies which should be initiated as soon
as possible. The following studies have been identified to
receive priority review as soon as they are received by the
Agency:
§158.125 Residue Chemistry
Plant Metabolism
Storage Stability
§158.130 Environmental Fate
Metabolism
Photodegradation
Dissipation
Accumulation studies (Fish, rotational crops)
§158.135 Toxicology
Oral oncogenicity
Chronic toxicity
§158.140 Reentry Protection
Inhalation exposure
§158.145 Ecological Effects
Residue Monitoring (Turf, oil wells and indus-
trial effluents)
9. The Agency will not impose a special label advisory
statement for endangered species at this time. Four use
patterns may possibly pose a risk to endangered species.
These are use of formaldehyde on turf, products containing
formaldehyde and paraformaldehyde that are discharged as
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industrial effluents into shallow or enclosed bodies of
water, use of formaldehyde in secondary oil recovery systems,
and use of paraformaldehyde in oil well drilling muds (see
Section III.E.8). Data being required will be used to estimate
environmental concentrations. If levels are found to exceed
the regulatory trigger for endangered species, a consultation
with the Office of Endangered Species will be initiated.
Rationale; Most uses of formaldehyde and paraformaldehyde
are not expected to pose a threat to endangered species. It
is not possible at this time to estimate the environmental
concentrations resulting from the four uses that may pose a
risk to aquatic endangered and non-endangered species.
10. While data gaps are being filled, currently registered
manufacturing-use products (MPs) and end-use products (EPs)
containing formaldehyde and paraformaldehyde may be sold,
distributed, formulated and used, subject to the terms and
conditions specified in this Standard. Registrants must
provide or agree to develop additional data, as specified
in the Data Appendices, in order to maintain existing
registrations.
Rationale; Under FIFRA, the Agency does not normally cancel
or withhold registration for previously registered use
patterns simply because data are missing or are inadequate
(see FIFRA sec. 3(c)(2)(B) and 3(C)(7). Issuance of this
Standard provides a mechanism for identifying data which
then will be required to be submitted to maintain the
registration of pesticide products containing formaldehyde
and paraformaldehyde. These data will be reviewed and
evaluated, after which the Agency will determine if additional
regulatory changes are necessary.
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B. CRITERIA FOR REGISTRATION
To be registered or reregistered under this Standard,
products must contain formaldehyde or paraformaldehyde, bear
required labeling, and conform to the product composition,
acute toxicity limits, and use pattern requirements listed in
this section.
C. ACCEPTABLE RANGES AND LIMITS
1. Product Composition Standard
To be registered or reregistered under this Standard,
manufacturing-use products (MPs) must contain formaldehyde or
paraformaldehyde as an active ingredient .JV Each MP formu-
lation proposed for registration must be fully described with
an appropriate certification of limits, stating maximum and
minimum amounts of the active ingredient which are present
in products, as well as impurities found at greater than
0.1%.
2. Acute Toxicity Limits
The Agency will consider registration of technical grade
and manufacturing-use products containing formaldehyde or
paraformaldehyde provided that the product labeling bears
appropriate precautionary statements for the acute toxicity
category in which each product is placed.
3. Use Patterns
To be registered under this Standard, manufacturing-use
products may be labeled for formulation into end-use products
only for the commodities listed below. The EPA Index to
Pesticide Chemicals lists all registered uses, as well as
approved maximum application rates and frequencies.**/
*/ Pesticide products in which formaldehyde or paraformaldehyde
~~ has previously been listed as an intentionally added inert
ingredient are also covered by this standard. Such formal-
dehyde and paraformaldehyde ingredients have been redesig-
nated as active ingredient by this standard.
**/ The EPA Use Index to Pesticide Chemicals may be purchased
from the National Technical Information Service, ATTN: Order
Desk, 5285 Port Royal Road, Springfield, Virginia 22161.
Orders may be placed by telephone to National Technical
information Service at (703) 487-4650.
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FORMALDEHYDE;
-Terrestrial food uses on:
Barley (grain crop) , grain, millet (grain crop) ,
oats (grain crop), potato, rye (grain crop),
sorghum (grain crop), wheat (grain crop)
- Terrestrial Non-Food Crop uses on:
Ornamental plants, turf
- Aquatic-non food uses on:
Drains, secondary oil recovery systems, sewage
systems, swimming pool related surfaces, shower
rooms and locker rooms
- indoors: Processed or Manufactured products &
Food or Feed Containers or Dispensers,
Barley (grain crop)(for feed), corn (grain crop)
(for feed), forage-fodder grasses (including hay
and silage), legumes and other nongrass crops
for forage-fodder, oats (grain crop)(for feed),
sorghum (grain crop)(for feed), wheat (grain crop)
(for feed), hatchery equipment, hatching egg
treatment, kennels and pet animal quarters,
laboratory animal quarters, stables, farm
premises and equipment, livestock premises and
equipment, livestock transportation vehicles,
poultry house premises and equipment, poultry
transporation vehicles, household premises and
contents, sickroom premises and contents,
commercial, industrial, and institutional
premises and equipment (non-medical), commercial
transporation vehicles, barber and beauty shop
equipment and instruments, eating establish-
ment equipment & utensils, eating establishment
premises, dental instruments, hospital critical
equipment, hospital premises and equipment,
hospital rubber and plastic items, surgical
instruments, veterinary hospital premises and
contents, latex and resin emulsions, oil recovery
drilling muds and packer fluids, paints, plastic
and polymers, specialty products, (i.e. inks,
dyes, ceramic glazes, waxes, polishes, cleansers,
photographic solutions) bathroom premises,
chemical and portable toilets, diaper pails,
toilet bowls and urinals, carpets, laundry
(hospital, commercial, and institutional), garbage
containers, air sanitizers, biological specimens,
cuspidors, environmental inanimate hard surfaces,
vomitus.
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FORMALDEHYDE (Cont inued) ;
-Preservative of pesticidal formulations.
PARAFORMALDEHYDE t
-Terrestrial food crop uses on:
Sugar maple (maple tree tapholes)
-Aquatic non-food:
Secondary oil recovery systems, lockers and
locker rooms
-Indoor: (pets & Domestic Animals & their
Man-made Premises)
Hatchery equipment, hatching egg treatment,
kennels and pet animal quarters, livestock
premises and equipment, poultry house premises
and equipment, household premises and contents,
athletic and recreational equipment surfaces,
commercial, industrial, institutional and
public premises and equipment (non-medical),
commercial transportation vehicles, barber
and beauty shop equipment and instruments,
eating establishment premises, metalworking
cutting fluids, oil recovery drilling muds
and packer fluids, bathroom premises, diaper
pails, toilet bowls and urinals, laundry
(mattresses, pillows and draperies), garbage
containers, cadavers and casket.
-Preservative of pesticidal formulations
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D. REQUIRED LABELING
in order to remain in compliance with FIFRA, manufactur-
ing-use products and end-use products must bear appropriate
labeling as specified in 40 CFR 162.10. Appendix II contains
information on label requirements.
No pesticide product containing formaldehyde or
paraformaldehyde may be released for shipment by the registrant
after May 31, 1989 unless the product bears an amended label
which complies with the requirements of this Standard.
No pesticide product containing formaldehyde or
paraformaldehyde may be distributed, sold, offered for sale,
held for sale, shipped, delivered for shipment, or received and
(having so received) delivered or offered to be delivered by
any person after May 31, 1990 unless the product bears an
amended label which complies with the requirements of this
Standard.
The following specific information must appear on the
labeling in order for products to remain in compliance with
FIFRA:
1. ingredients Statement
The ingredient statement for MPs must list the active
ingredient as:
Formaldehyde or Paraformaldehyde
2. Products that contain formaldehyde or paraformaldehyde
as a preservative must include the statement: "Formaldehyde
(or paraformaldehyde) is present solely to preserve the
pesticide formulation and does not otherwise contribute to
the product's .pesticidal activity".
3. Use Pattern Statements
All manufacturing-use products containing formaldehyde or
paraformaldehyde must state that they are intended for formu-
lation into end-use products for acceptable use patterns.
Labeling must specify sites which are listed in Use Patterns,
Section C.3. However, no use may be included on the label
where the registrant fails to agree to comply with the data
requirements in TABLE A for that use pattern.
4. FUMIGATION REQUIREMENTS
All products containing formaldehyde (10% and above) or para-
formaldehyde (25% and above) which are used for fumigation
in commercial, industrial and institutional sites such as egg
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handling facilities and hospitals should bear the following
additional labeling;
a) Detailed use directions including the statements
(1) "Persons working with the fumigant should be trained
in fumigation operations" and (2) "Two persons should be
present during the introduction of the fumigant,
initiation of aeration and testing for reentry."
b) If the concentration of formaldehyde or paraformaldehyde
in the working area, as measured by a direct reading
device, does not exceed 1 ppm, no respiratory device is
required. [The registrant must identify one or more
detector devices suitable for use with the product and
provide or reference instructions on its use.] If
this concentration is exceeded at any time, all persons
in the fumigated area must wear a respirator approved
by NIOSH/ MSHA for formaldehyde or paraformaldehyde
exposure.
c) "The applicator must placard or post all entrances to the
fumigated areas with signs bearing in English and Spanish:
- The signal word DANGER/PELIGO and the skull and
crossbones symbol
- The statement "Area under fumigation" DO NOT ENTER/NO
ENTRE"
- The date of fumigation
- Name of fumigant used
- Name, address, and telephone number of the applicator
Only the applicator may remove the placards, and only
when the concentration is below 1 ppm."
d) "After fumigation, treated areas must be aerated until the
level of formaldehyde or paraformaldehyde is below 1 ppm.
Do not allow entry into the treated area by any person
before this time unless provided with a respirator
approved by NIOSH/MSHA for formaldehyde or paraformaldehyde
exposure."
e) "Wear chemical resistant rubber gloves when handling solid
material. When fumigating an area, full-body clothing
is required. Such clothing must be cleaned after each
wearing or disposable clothing must be used."
f) "storage and Handling statements: Store in a cool, dry
well ventilated area under a lock and key. Post as a
pesticide storage area. Do not contaminate water,
food or feed by storage or disposal. Persons moving
or handling containers should wear protective clothing.
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Open container only in a well ventilated area wearing
protective clothing, gloves goggles or face shield and
respiratory protection if air levels exceed 1 ppm."
g) Disposal Statements - Label statements must conform to
the requirements of PR Notice 83-3, March 29, 1983.
h) "Spill and Leak Procedures - Evacuate immediate area of
spill or leak. Use a respirator approved by NIOSH for
formaldehyde or paraformaldehyde exposure for entry into
affected area to correct problem. Move leaking or
damaged containers outdoors or to an isolated location,
observing strict safety precautions. Work upwind if
possible. Wash fumigant into soil or cover with
soil or other absorbent material. Do not permit
entry into spill area or cleanup area by unprotected
persons until concentration of fumigant is determined
to be less than 1 ppm."
AND
Formaldehyde only;
"pesticide wastes are toxic. Improper disposal of
excess pesticide 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."
OR
Paraformaldehyde only;
"Wastes resulting from the use of this product may be
disposed of on site or at an approved waste disposal
facility."
5. MINIMUM PROTECTIVE EQUIPMENT REQUIREMENTS
Formaldehyde and paraformaldehyde products must bear state-
ments requiring the following personal protective equipment,
unless equivalent or more stringent requirements are already
on the labeling.
a) All liquid formulations, including household products
and all dusts and wettable powders containing 1% or
greater of formaldehyde or paraformaldehyde; Chemical-
resistant rubber gloves.
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b) All products for agricultural uses, including hatchery
products, oil recovery system products and kennel and
pet quarters: Chemical-resistant rubber gloves.
c) All fumigant products: A NIOSH/MSHA respirator approved
for formaldehyde exposure if concentration is above 1 ppm.
d) All products applied using a spray (except aerosol pro-
ducts) where mist is likely to occur: A protective suit
covering the entire body except the feet, hands and head,
OR long pants, long sleeve shirt and chemical resistant
apron.
e) Manufacturing use products or products for repackaging:
A NIOSH/MSHA respirator approved for formaldehyde exposure,
chemical resistant boots or shoe covers, chemical resistant
gloves, and goggles (if a full face respirator is not used)
Personal protective statements are not required for air
sanitizers, toilet and urinal sanitizers (those that act
by the flushing process) pellet and tablet formulations,
crystalline, granular and impregnated paper products.
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6. ENVIRONMENTAL HAZARDS STATEMENTS
All Formaldehyde Manufacturing Use and Formaldehyde/Para-
formaldehyde Microbiocide, MetalWorking, Oilfield, Pulp
& paper Mill Products
Labels for these manufacturing or end-use products must
bear the following environmental hazards statement:
"Do not discharge effluent containing this product into
lakes, streams, ponds, estuaries, oceans, or public
water unless this product is specifically identified
and addressed in an NPDES permit. Do not discharge
effluent containing this product into sewer systems
without previously notifying the sewage treatment plant
authority. For guidance contact your State Water Board
or Regional Office of the EPA."
7. Additional Statements for End-Use Products
a) In addition to the above statement, products with
outdoor uses that have an LC$Q to fish or aquatic
invertebrates of <0.1 ppm must include the state-
ment, "This product is toxic to aquatic organisms."
b) Products recommended for use on turf and other
nonseed treatment uses must include the following
statement on the labeling:
"Do not apply directly to water or wetlands (swamps,
bogs, marshes, and potholes). Do not contaminate
water by disposal of equipment washwaters."
c) Products recommended for seed treatment uses should
include the following statement on the labeling:
"Cover, scavenge, or incorporate spills of treated
seeds. Do not contaminate water by disposal of
equipment washwaters."
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V. PRODUCTS SUBJECT TO THIS STANDARD
All products containing one or more of the ingredients
identified in Section II.A. are subject to certain requirements
for data submission or changes in composition, labeling or
packaging of the product. The applicable requirements depend
on whether the product is a manufacturing or end use product
and whether the pesticide is the sole active ingredient or
one of multiple active ingredients.
Products are subject to this Registration standard as
follows:
A. Manufacturing use products containing formaldehyde or
paraformaldehyde as the sole active ingredient are
subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section IV, if they pertain to the
manufacturing use product.
2. The data requirements listed in Tables A and B2.
3. The labeling requirements specified for manufacturing
use products in Section IV.
4. Administrative requirements (application forms, Confi-
dential Statement of Formula, data compensation provisions)
associated with reregistration.
2 Data requirements are listed in the two Tables in Appendix
I of this Registration Standard. The Guide to Tables in that
Appendix explains how to read the Tables.
Table A lists generic data requirements applicable to all
products containing the pesticide subject to this Registration
Standard. Table B lists product-specific data applicable to
manufacturing use and end-use products. The data in Table A
need not be submitted by a producer who is eligible for the
formulator's exemption for that active ingredient.
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B. Manufacturing use products containing formaldehyde or
paraformaldehyde as one of multiple active ingredients are
subject to:
1. The data requirements listed in Table A.
2. The labeling requirements specified for manufacturing
use products in Section iv.
C. End use products containing formaldehyde or paraformaldehyde
alone or in combination with other active ingredients are
subject to:
1. The restrictions (if any) upon use, composition, or
packaging listed in Section iv if they pertain to the end
use product.
2. The labeling requirements specified for end use
products in Section IV.
3. If not eligible for the formulator's exemption, the
data requirements listed in Table A.
4. If eligible for the formulator's exemption^, the data
requirements in Table A are not required.
3 If you purchase from another producer and use as the
source of your active ingredient only EPA-registered products,
you are eligible for the formulator's exemption for generic
data concerning that active ingredient (Table A) and product
-specific data for the registered manufacturing use and
end-use product you purchase (Table B).
Two circumstances nullify this exemption:
1) If you change source of active ingredient to an
unregistered product, formulate your own active ingredient,
or acquire your active ingredient from a firm with ownership
in common with yours, you individually lose the exemption
and become subject to the data requirements in Table A.
2) If no producer subject to the generic data require-
ments in Table A agrees to submit the required data, all end
use producers lose the exemption, and become subject to those
data requirements.
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VI. REQUIREMENT FOR SUBMISSION OF GENERIC DATA
This portion of the Registration Standard is a notice
issued under the authority of FIFRA sec. 3(c)(2)(B). It
refers to the data listed in Table A, which are required to
be submitted by registrants to maintain in effect the regis-
tration of products containing formaldehyde or paraformaldehyde^
A. What are generic data?
Generic data pertain to the properties or effects of a
particular ingredient. Such data are relevant to an
evaluation of all products containing that active ingredient
regardless of whether the product contains other ingredients.
(unless the product bears labeling that would make the data
requirement inapplicable).
Generic data may also be data on a "typical formulation"
of a product. "Typical formulation" testing is often required
for ecological effects studies and applies to all products
having that formulation type. These are classed as generic
data, and are contained in Table A.
B. Who must submit generic data?
All current registrants are responsible for submitting
generic data in response to a data request under FIFRA sec.
3(c)(2)(B) (DCI Notice). EPA has decided, however, not to
require a registrant who qualifies for the formulator's
exemption (FIFRA sec. 3(c)(2)(D) and § 152.85) to submit
generic data in response to a DCI notice if the registrant
who supplies the ingredient in his product is complying with
the data request.
If you are granted a generic data exemption, you rely on
the efforts of other persons to provide the Agency with the
required data. If the registrants who have committed to
generate and submit the required data fail to take appropriate
steps to meet the requirements or are no longer in compliance
with this data requirements notice, the Agency will consider
that both they and you are not in compliance and will normally
initiate proceedings to suspend the registrations of both your
product(s) and their product(s) unless you commit to submit
and submit the required data in the specified timeframe. in
such cases, the Agency generally will not grant a time extension
for submitting the data.
4 Registrations granted after issuance of this standard
will be conditioned upon submission or citation of the data
listed in this Registration standard.
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If you are not now eligible for a formulator1 s exemption,
you may qualify for one if you change your source of supply
to a registered source that does not share ownership in
common with your firm. if you choose to change sources of
supply/ the Confidential Statement of Formula must identify
the new source(s) and you must submit a Formulator's Exemption
Statement form.
If you apply for a new registration for products containing
these ingredients after the issuance of this Registration
Standard, you will be required to submit or cite generic data
relevant to the uses of your product if, at the time the
application is submitted, the data have been submitted to the
Agency by current registrants. if the required data have not
yet been submitted, any new registration will be conditioned
upon the new registrant's submission or citation of the
required data not later than the date upon which current
registrants of similar products are required to provide such
data. See FIFRA sec. 3(c)(7)(A). If you thereafter fail to
comply with the condition of that registration to provide
data, the registration may be cancelled (FIFRA sec. 6(e)).
C. What generic data must be submitted?
You may determine which generic data you must submit by
consulting Table A. That table lists the generic data needed
to evaluate current uses of all products containing the
active ingredient, the uses for which such data are required,
and the dates by which the data must be submitted to the
Agency.
D. How to comply with PCI requirements.
Within 90 days of your receipt of this Registration
Standard, you or your agent must submit to EPA a completed
copy of the form entitled "FIFRA Section 3(c)(2)(B) Summary
Sheet" (EPA Form 8580-1, enclosed) for each of your products.
On that form you must state which of the following six methods
you will use to comply with the DCI requirements:
1. You will submit the data
2. You have entered into an agreement with one or more
registrants to jointly develop (or share in the cost of
developing) the data, but will not be submitting the data
yourself. If you use this method, you must state who will
submit the data on which you will rely. You must also provide
EPA with documentary evidence that an agreement has been
formed which allows you to rely upon the data to be submitted.
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Such evidence may be: (1) your letter offering to join in
an agreement and the other registrant's acceptance of your
offer, (2) a written statement by the parties that an agreement
exists, or (3) a written statement by the person who will be
submitting the data that you may rely upon its submission.
The Agency will also require adequate assurance that the
person whom you state will provide the data is taking appropriate
steps to secure it. The agreement to produce the data need
not specify all of the terms of the final arrangement between
the parties or a mechanism to resolve the terms.
If you and other registrants together are generating or
submitting requested data as a task force or consortium, a
representative of the group should request a Joint Data
Submitter Number from the Registration Support and Emergency
Response Branch, Registration Division. The request must
include the following information:
a. A list of the members of the consortiu;
b. The name and address of the designated representative
of the consortium, with whom EPA will correspond
concerning the data;
c. Identity of the Registration Standard containing the
data requirement;
d. A list of the products affected (from all members of
the consortium); and
e. Identification of the specific data that the con-
sortium will be generating or submitting.
The Agency will assign a number to the consortium, which
should be used on all data submissions by the consortium.
3. You have attempted to enter into an agreement to
jointly develop data, but no other registrant has accepted
your offer. You request that EPA not suspend your registration
for non-compliance with the PCI. EPA has determined that,
as a general policy, it will not suspend the registration of
a product when the registrant has in good faith sought and
continues to seek to enter into a data development/cost
sharing program, but the other registrants developing the
data have refused to accept its offer. [If your offer is
accepted, you may qualify for Option 2 above by entering into
an agreement to supply the data.]
in order to qualify for this method, you must:
a. File with EPA a completed "Certification of Attempt
to Enter into an Agreement with other Registrants for Develop-
ment of Data" (EPA Form 8580-6, enclosed).
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b. Provide us with a copy of your offer to the other
registrant and proof of the other registrant's receipt of your
offer (such as a certified mail receipt). Your offer must,
at a minimum, contain the following language or its equivalent:
[Your company name] offers to share in the burden of
producing the data required pursuant to PIFRA section
3(c)(2)(B) in formaldehyde/paraformaldehyde. Registration
Standard upon terms to be agreed or failing agreement
to be bound by binding arbitration as provided by FIFRA
section 3{ c) ( 2) (B) ( iii) .
The remainder of your offer may not in any way attempt to
limit this commitment. If the other registrant to whom your
offer is made does not accept your offer, and if the other
registrant informs us on a DCI Summary Sheet that he will
develop and submit the data required under the DCI, then you
may qualify for this option, in order for you to avoid
suspension under this method, you may not later withdraw or
limit your offer to share in the burden of developing the
data.
in addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice in a timely manner. if the other registrant fails to
develop the data or for some other reason would be subject to
suspension, your registration as well as that of the other
registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit and submit the required
data in the specified timeframe. in such cases, the Agency
generally will not grant a time extension for submitting the
data.
4. You request a waiver of the data requirement. If
you believe that a data requirement does not (or should not)
apply to your product or its uses, you must provide EPA with
a statement of the reasons why you believe this is so. Your
statement must address the specific composition or use factors
that lead you to believe that a requirement does not apply -
Since the Agency has carefully considered the composition and
uses of pesticide products in determining that a data require-
ment applies, EPA does not anticipate that many waivers will
be granted. A request for waiver does not extend the time-
frames for developing required data, and if your waiver
request is denied, your registration may be suspended if you
fail to submit the data.
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5. You request that EPA amend your registration by
deleting the uses for which the data are needed. You are not
required to submit data for uses which are no longer on your
label or chemicals which are no longer in your product.
6. You request voluntary cancellation of the registration
of your product(s) for which the data are needed.
E. Testing Protocols, Standards for Conducting Acceptable
Tests, Guidance on Evaluating and Reporting Data.
All studies required under this Notice must be conducted
in accordance with test standards outlined in the pesticide
Assessment Guidelines, unless other protocol or standards are
approved for use by the Agency in writing.
As noted herein, these EPA Guidelines, which are referenced
in the Data Tables, are available from the National Technical
information Service (NTIS), Attn: Order Desk, 5285 Port Royal
Road, Springfield, VA 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if the
OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (Part 158.70).
Please note, however, that certain OECD standards (such as
test duration, selection of test species, and degradate
identification which are environmental fate requirements) are
less restrictive than those in the EPA Assessment Guidelines
listed above. When using the OECD protocols, they should be
modified as appropriate so that the data generated by the
study will satisfy the requirements of Part 158. Normally,
the Agency will not extend deadlines for complying with data
requirements when the studies were not conducted in accord
with acceptable standards. The OECD protocols are available
from OECD, 1750 Pennsylvania, N.W., Washington, D.C. 20006.
F. Procedures for requesting a change in testing protocol.
If you will generate the required data and plan to use
test procedures which deviate from EPA's pesticide Assessment
Guidelines or the Reports of Expert Groups to the Chemicals
Group, Organization for Economic Cooperation and Development
(OECD) Chemicals Testing programme, you must submit for EPA
approval the protocols you propose to use.
You should submit >our protocols before beginning testing,
because the Agency will not ordinarily accept as sufficient
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studies using unapproved protocols. A request for protocol
approval will not extend the timeframe for submission of the
data, nor will extensions generally be given to conduct
studies due to submittal of inappropriate protocols.
G. Procedures for requesting extensions of time.
If you think that you will need more time to generate
the data than is allowed by EPA's schedule, you may submit a
request for an extension of time. Any request for a time
extension which is made as an initial response to a section
3(c)(2)(B) request notice must be submitted in writing to
the Product Manager listed at the end of this section and
must be made by the 90-day deadline for response. Once dates
have been committed to and EPA has accepted these commitments,
any subsequent requests for a time extension must be submitted
in writing to the Office of Compliance Monitoring at the
address given in IX.E.
EPA will view failure to request an extension before
the data submission deadline as a waiver of any future claim
that there was insufficient time to submit the data. While
EPA considers your request, you must strive to meet the
deadline for submitting the data.
The extension request should state the reasons why you
believe that an extension is necessary and the steps you
have taken to meet the testing deadline. Time extensions
normally will not be granted due to problems with laboratory
capacity or adequacy of funding, since the Agency believes
that with proper planning these can be overcome.
A request for an extension does not extend the timeframe
for submission of the data. If EPA denies your request for
a time extension and you do not submit the data as requested,
EPA may begin proceedings to suspend the registrations of
your products.
H. PR Notice 86-5 and Any Other Requirements Referenced or
Included Within this Notice.
All data submitted in response to this Notice must comply
with EPA requirements regarding the reporting of data,
including the manner of reporting, the completeness of results,
and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or
included in this Notice or contained in PR Notice 86-5 (issued
July 29, 1986).
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I. Existing stocks provision upon suspension or cancellation.
The Agency has determined that if a registration is
suspended for failure to respond to a DCI request under
FIFRA sec. 3(c)(2)(B), an existing stocks provision is not
consistent with the Act. Accordingly, the Agency does not
anticipate granting permission to sell or distribute existing
stocks of suspended product except in rare circumstances.
If you believe that your product will be suspended or cancelled
and that an existing stocks provision should be granted, you
have the burden of clearly demonstrating to EPA that granting
such permission would be consistent with the Act. The following
information must be included in any request for an existing
stocks provision:
1. Explanation of why an existing stocks provision is
necessary, including a statement of the quantity of
existing stocks and your estimate of the time required for
their sale or distribution; and
2. Demonstration that such a provision would be consis-
tent with the provisions of FIFRA.
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VII. REQUIREMENT FOR SUBMISSION OF PRODUCT-SPECIFIC DATA
Under its DCI authority, EPA has determined that certain
product-specific data are required to maintain your registration
in effect. Product-specific data are derived from testing
using a specific formulated product, and, unlike generic
data, generally support only the registration of that product.
All such data must be submitted by the dates specified in
this Registration standard.
If you have a manufacturing use product, these data are
listed in Table B. As noted earlier, the Agency has decided
that it will not routinely require product-specific data for
end use products at this time.
in order to comply with the product specific data require-
ments, you must follow the same procedures as for generic data.
See Section IV.D, E, F, and G. You should note, however, that
product chemistry data are required for every product, and the
only acceptable responses are options IV.D.I. (submit data)
or IV.D.6.(cancellation of registration).
Failure to comply with the product-specific data require-
ments for your products will result in suspension of the
product's registration.
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VIII. REQUIREMENT FOR SUBMISSION OF REVISED LABELING
FIFRA requires each product to be labeled with accurate,
complete and sufficient instructions and precautions, reflecting
the Agency's assessment of the data supporting the product
and its uses. General labeling requirements are set out in
40 CFR 162.10 (see Appendix II - LABELING and SUMMARY). in
addition, labeling requirements specific to products containing
this pesticide are specified in Section iv.D of this Registra-
tion Standard. Applications submitted in response to this
notice must include draft labeling for Agency review. All
labeling changes must appear on all products released for
shipment by registrants by May 31, 1989 and on all products
distributed or sold by any person by May 31, 1990.
If you fail to submit revised labeling as required,
which complies with 40 CFR 162.10 and the specific instructions
in Section IV.D., EPA may seek to cancel or suspend the
registration of your product under FIFRA sec. 6.
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IX. INSTRUCTIONS FOR SUBMISSION
A. Manufacturing Use Products (MUPs) containing formaldehyde or
paraformaldehyde as an active ingredient.
1. Within 90 days from receipt of this document, you
must submit to the Product Manager in the Registration Division
for each product subject to this Registration Standard:
a. The "FIFRA Section 3(c)(2)(B) Summary Sheet" (EPA
Form 8580-1), with appropriate attachments.5
b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
d. Evidence of compliance with data compensation
requirements of FIFRA sec. 3(c)(l)(D). Refer to 40 CFR
152.80-152.99.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Application for Pesticide Registration (EPA Form
8570-1) .
b. Two copies of any required product-specific data
(See Table B).
c. Three copies of draft labeling, including the
container label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft label must indicate
the intended colors of the final label, clear indication
of the front panel of the label, and the intended type
sizes of the text.
d. Product Specific Data Report (EPA Form 8580-4).
5 If on the Summary Sheet, you commit to develop the data,
present arguments that a data requirement is not applicable
or should be waived, or submit protocols or modified protocols
for Agency review, you must submit a copy of the Summary
Sheet (and any supporting information) to the Office of
Compliance Monitoring, which will be monitoring the data
generated in response to this notice. This submission is in
addition to responding to the Product Manager, and should be
submitted to the Office of Compliance Monitoring at the
address given at the end of this section. (Actual studies
are not to be submitted to the Office of Compliance Monitoring.)
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3. Within the times set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. if for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and
the Office of Compliance Monitoring of the problem, the
reasons for the problem, and your proposed course of action.
B. Manufacturing Use Products containing formaldehyde or
paraformaldehyde in combination with other active
ingredients.
1. Within 90 days from receipt of this document, you must
submit to the Product Manager in the Registration Division:
a. FIFRA sec. 3(c)(2)(B) Summary Sheet, with appropriate
attachments5 (EPA Form 8580-1).
b. Confidential Statement of Formula (EPA Form 8570-4)
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within 9 months of receipt of this document, you must
submit to the Product Manager:
Three copies of draft labeling, including the container
label and any associated supplemental labeling. Labeling
should be either typewritten text on 8-1/2 x 11 inch
paper or a mockup of the labeling suitable for storage in
8-1/2 x 11 files. The draft label must indicate the
intended colors of the final label, clear indication of
the front panel of the label, and the intended type sizes
of the text.
3. Within the time frames set forth in Table A, you must
submit to the Registration Division all generic data, unless
you are eligible for the formulator's exemption. If for any
reason any test is delayed or aborted so that the schedule
cannot be met, immediately notify the Product Manager and the
Office of Compliance Monitoring of the problem, the reasons
for the problem, and your proposed course of action.
C. End Use Products containing formaldehyde or paraformaldehyde
alone or in combination with other active ingredients.
1. Within 90 days from receipt of this document, you must
submit to the Product Manager in the Registration Division:
a. FIFRA Section 3(c)(2)(B) Summary Sheet, with
appropriate attachments5 (EPA Form 8580-1).
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b. Confidential Statement of Formula (EPA Form 8570-4).
c. Formulator's Exemption Statement (EPA Form 8570-27),
if applicable.
2. Within 9 months from receipt of this document you
must submit to the Product Manager:
a. Three copies of draft labeling, including the con-
tainer label and any associated supplemental labeling.
Labeling should be either typewritten text on 8-1/2 x 11
inch paper or a mockup of the labeling suitable for
storage in 8-1/2 x 11 files. The draft labeling must
indicate the intended colors of the final label, clear
indication of the front panel of the label, and the
intended type sizes of the text. End use product labeling
must comply specifically with the instructions in Section
IV (Regulatory Position and Rationale).
D. intrastate Products containing formaldehyde or paraformal-
dehyde either as sole active ingredient or in combination
with other active ingredients.
Applications for full Federal registration of intrastate
products are required to be submitted no later than July 31, 1988
E. Addresses
The required information must be submitted to the following
address:
John Lee, Product Manager 31
Registration Division (TS-767C)
Office of Pesticide Programs
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
The address for submissions to the Office of Compliance
Monitoring is:
Laboratory Data integrity Program
Office of Compliance Monitoring (EN-342)
Environmental Protection Agency
401 M St., SW
Washington, D.C. 20460
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TGUIDE-1
GUIDE TO TABLES
Tables A and B contain listings of data requirements
for the pesticides covered by this Registration standard.
Table A contains generic data requirements that apply to
the pesticide in all products, including data requirements
for which a "typical formulation" is the test substance.
Table B contains product-specific data requirements that
apply only to a manufacturing use product.
The data tables are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the
test protocols set out in the pesticide Assessment Guidelines,
which are available from the National Technical information
Service, 5285 Port Royal Road, Springfield, VA 22161.
2. Test Substance (Column 2). This column lists the composition
of the test substance required to be used for the test, as
follows:
TGAI = Technical grade of the active ingredient
PAI = Pure active ingredient
PAIRA = Pure active ingredient, radio labeled
TEP = Typical end use formulation
MP = Manufacturing use product
EP = End use product
Any other test substances, such as metabolites, will be
specifically named in Column 2 or in footnotes to the table.
3. Use pattern (Column 3). This column indicates the use
patterns to which the data requirement applies. Use patterns
are the same as those given in 40 CFR Part 158. The following
letter designations are used for the given use patterns:
A = Terrestrial, food
B = Terrestrial, non-food
C = Aquatic, food
D = Aquatic, non-food
E = Greenhouse, food
F = Greenhouse, non-food
G = Forestry
H = Domestic outdoor
I = indoor
Any other designations will be defined in a footnote to the table,
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TGUIDfi-2
4. Does EPA have data? (Column 4). This column indicates one
of three answers:
YES - EPA has data in its eiles that satisfy this data
requirement. Those data may be cited by other registrants
in accordance with data compensation requirements of
Part 152, Subpart E.
PARTIALLY - EPA has some data in its files, but such data
do not fully satisfy the data requirement. In some cases,
the Agency may possess data on one of two required species,
or may possess data on one test substance but not all.
The term may also indicate that the data available to
EPA are incomplete. In this case, when the data are
clarified, or additional details of the testing submitted
by the original data submitter, the data may be determined
to be acceptable. If this is the case, a footnote to
the table will usually say so.
NO - EPA either possesses no data which are sufficient
to fulfill the data requirement, or the data which EPA
does possess are flawed scientifically in a manner that
cannot be remedied by clarification or additional infor-
mation.
5. Bibliographic citation (Column 5). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no
MRID number has been assigned. Refer to the Bibliography
Appendices for a complete citation of the study.
6. Must additional data be submitted? (Column 6). This
column indicates whether the data must be submitted to the
Agency. If column 3 indicates that the Agency already has
data, this column will usually indicate NO. If column 3
indicates that the Agency has only partial data or no data,
this column will usually indicate YES. In some cases, even
though the Agency does not have the data, EPA will not require
its submission because of the unique characteristics of the
chemical; because data on another chemical can be used to
fulfill the data requirement; or because the data requirement
has been waived or reserved. Any such unusual situations
will be explained in a footnote to the table.
7. Timeframe for submission (Column 7). If column 5 requires
that data be submitted,this column indicates when the data
are to be submitted, based on the issuance date of the Regis-
tration Standard. The timeframes are those established either
as a result of a previous Data Call-in letter, or standardized
timeframes established by PR Notice 85-5 (August 22, 1985).
8. Footnotes (at the end of each table). Self-explanatory.
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TABLE A
GENERIC DATA REQUIREMENTS FOR FORMALDEHYDE AND PARAPORMALDEHYDE
Data Requirement Test
Substance*
§158.120 Product Chemistry
Product Identity
61-2 - Description of Beginning TGAI
Materials and Manufacturing
Process
61-3 - Discussion of Formation of TGAI
Impurities
Analysis and Certification of
Product ingredients
62-1 - Preliminary Analysis TGAI
of product Samples
62-2 - Certification of Ingredient TGAI
Limits
62-3 - Analytical Methods to Verify TGAI
Certified Limits
Physical and Chemical
Characteristics
Use Does EPA Bibliographic
Patterns Have Data?2 Citation2
All N/A N/A
All N/A N/A
All N/A N/A
All N/A N/A
All N/A N/A
Must Additional Time Frame
Data be for
Submitted? submission3
Yes 6 Months
Yes 6 Months
Yes 12 Months
Yes 12 Months
Yes 12 Months
63-2 - Color
TGAI
All
N/A
N/A
Yes
6 Months
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TABLE A
GENERIC DATA REQUIREMENTS FOR FORMALDEHYDE AND PARAFORMALDEHYDE
Data Requirement
§158.120 Product Chemistry (Continued)
Physical and Chemical Characteristics
(Continued)
63-3 - Physical State
63-4 - Odor
63-5 - Melting Point
63-6 - Boiling Point
63-7 - Density, Bulk Density,
or Specific Gravity
63-8 - Solubility
63-9 - Vapor Pressure
63-10 - Dissociation constant
63-11 - Octanol/water partition
coefficient
63-12 - pH
63-13 - Storage Stability
Test
Substance^
TGAI
TGAI
TGAI
TGAI
TGAI
TCAI or
PAI
PAI
PAI
PAI
TGAI
TGAI
Use
Patterns
All
All
All
All
All
All
All
All
All
All
All
Does EPA
Have Data?2
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Bibliographic
Citation2
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Must Additional
Data be
Submitted?
Yes
Yes
Yes4
No5
Yes<*
Yes
Yes
Yes
Yes
Yes
Yes
Time Frame
for
Submission^
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
6 Months
15 Months
-51-
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TABLE A
GENERIC DATA REQUIREMENTS FDR FORMALDEHYDE AND PARAFDRMALDEHYDE
Data Requirement Test Use Does EPA Bibliographic Must Additional Time Frame
Substance^ Patterns Have Data?2 Citation2 Data be for
Submitted? Submission3
§158.120 Product Chemistry (Continued)
Other Requirements;
64- 1 - Submittal of samples TGAI, PAI All N/A N/A No
I/ The test substance for the TGAI is 100% formaldehyde and paraformaldehyde.
2/ Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined that
these data must be resubmitted for each pesticide. New requirements have been introduced and previously submitted
data must be updated. Therefore bibliographic citations for the old data are not applicable.
3/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
4/ Not required for formaldehyde because the technical is a gas at room temperature.
5/ Not required for formaldehyde because the technical is a gas at room temperature. Not required for paraformaldehyde
because the technical is a solid at room temperature.
-52-
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TABLE A
GENERIC DATA REQUIREMENTS FOR FORMALDEHYDE AND PARAPORMALDEHYDE
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be Submitted?
Time Frame
For Submission1
§158.125 Residue Chemistry
171-2 - Chemical identity
Nature of Residue
(Metabolism)
- Plants
- Livestock
171-4 - Residue Analytical
Method
- Plant residues
- Animal residues
- Storage Stability
TGAI
171-3 - Directions for use —
171-4
See Prod.
Chem. table
Yes
PAIRA
PAIRA & Plant
Metabolites
TGAI &
Metabolites
TGAI &
Metabolites
TGAI &
Metabolites
No
partial
Partial
Partial
No
(Use index)
00082145,00123774
00124679,0082153
00124679
Yes2
Yes3
Yes*
18 Months
18 Months
Yes-
15 Months
15 Months
15 Months
-53-
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TABLE A
GENERIC DATA REQUIREMENTS FDR FORMALDEHYDE AND PARAFORMALDEHYDE
Data Requirement
Test
Substance
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be Submitted?
Time Frame
for Submission1
§158.125 Residue Chemistry (Cont'd)
171-4 - Magnitude of the
Residue Studies
for Each Food use
- Preplant & Postplant
Fumigation
0 Root & tuber vegetables
groups
0 Leaves of root and tuber
vegetables group
0 Bulb vegetables group
0 Leafy vegetables group
0 Brassica (cole) leafy
vegetables group
0 Legume vegetables
(succulent or dried)
group
0 Foliage of legume
vegetables
0 Fruiting vegetables
(except cucurbits)
group
0 Cucurbit vegetables
group
0 Citrus fruits group
0 Pome fruits group
0 Stone fruits group
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
TEP
NO
No
No
No
No
No
NO
NO
No
No
NO
NO
Reserved6
Re served6
Reserved6
Reserved6
Reserved6
Reserved6
Reserved6
Reserved6
Reserved6
Reserved6
Reserved6
Reserved6
15 Months
15 Months
15 Months
15 Months
15 Months
15 Months
15 Months
15 Months
15 Months
15 Months
15 Months
15 Months
-54-
-------
TABLE A
GENERIC DATA REQUIREMENTS FDR FORMALDEHYDE AND PARAFORMALDEHYDE
Data Requirement Test
Substance
§158.125 Residue Chemistry
- Preplant & Postplant
Fumigation (Cont'd)
0 Small fruits and TEP
berries group
c Tree Nuts group TEP
0 Cereal grains group TEP
0 Forage, fodder & straw TEP
of cereal grains group
0 Grass forage, fodder & TEP
hay group
0 Non-grass animal feeds TEP
(forage, fodder, straw
& hay) group
0 Miscellaneous crops: TEP
asparagus, cotton
(non-food), okra, olives
peanuts, & tobacco (non- food)
- Seed Treatment TEP
- Postharvest Grain TEP
Does EPA
Have Data?
NO
NO
NO
NO
NO
NO
NO
NO
Partial
Bibliographic Must Additional
Citation Data be Submitted?
Reserved6
Reserved**
Reserved6
Reserved6
Reserved6
Reserved6
Reserved6 '20
10,ll'
00123774,00124679 Reservedl2
Time Frame
For Submissionl
15 Months
15 Months
15 Months
15 Months
15 Months
15 Months
15 Months
15 Months
Treatment
Postharvest Forage,
Fodder, & Hay
Treatment
TEP
Partial
00124679
Reserved13' I4
15 Months
-55-
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TABLE A
GENERIC DATA REQUIREMENTS FOR FORMALDEHYDE AND PARAFORMALDEHYDE
Test Does EPA Bibliographic Must Additional Time Frame
Data Requirement Substance Have Data? Citation Data be Submitted? For Submission1
§158.125 Residue Chemistry
- Sugar Maple Tree TEP No Reserved16 15 Months
Taphole Treatment
- Mushrooms TEP No Reserved6 * 21 15 Months
171-4 - Magnitude of the
Residue in Animals
etc.
- Meat/Milk/Poultry/ TGAI or Plant Partial 00124679 Reserved17 15 Months
Eggs Metabolites
-Food Handling EP No Yes18'19 12 Months
Establishments
I/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
2/ Data depicting the distribution and metabolism of [14CJ formaldehyde (i) in mature potatoes grown from treated
seed pieces; (ii) in wheat grain and forage harvested at maturity following seed treatments; and (iii) in
peanut forage and hay sampled at several time intervals beginning immediately after postharvest application;
all applications must be made at rates sufficiently high to permit complete characterization of ^^residues.
3/ Metabolism studies utilizing ruminants and poultry. Animals must be dosed for three days with [14p]
formaldehyde at levels sufficient to make residue identification and quantification possible. Milk and
eggs must be collected twice daily during the dosing period. Animals must be terminated within 24 hours of
the final dose. The distribution and characterization of residues must be determined in milk, eggs, liver,
kidney, muscle, and fat.
-56-
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TABLE A
GENERIC DATA REQUIREMENTS FOR FORMALDEHYDE AND PARAPORMALDEHYDE
§158.125 Residue Chemistry
4/ Residue methods are required which are suitable to provide data demonstrating the identity and magnitude of
all residues of concern resulting from the registered uses and also provide a means of enforcement of any
tolerances deemed necessary. All methods selected for enforcement purposes must be subjected to EPA method
tryouts.
5/ All of the requested residue data in this standard must be accompanied by information on the duration and
conditions of sample storage prior to residue analysis and data which describe the stability of residue under
the storage conditions used. Storage stability data will be required for formaldehyde and any metabolites
which are determined from the requested metabolism data to constitute residues of concern.
Reserved data requirements; The timeframe for data which are reserved begins when the study is required.
6/ If residues of concern are found in or on agriculture crops in the studies requested for Nature of the
Residues in/on plants, the following residue data will be required.
Data depicting residues of concern in or on representative commodities in this crop group as indicated in
40 CFR 180.34 after a single preplant fumigation with the 37% SC/L formulation at 435.6 gal/A 2-3 days before
planting of seed and a single postplant, plant bed fumigation (required for crops grown or started in cold
franes, frames, flats, greenhouses or hot beds only) with the same formulation at 17 gal/A after the seeds are
planted and covered. Tests must be conducted in major U. S. production regions for each crop.
7/ Specify all use rates in terms of Ib ai/100 gal water as well as pints product per 100 gal water.
8/ Depiction of residues of concern in or on corn, rice, sorghum, and wheat at maturity after seed treatments at
the maximum permissible rate. Upon fulfillment of these data requirements an appropriate Cereal Grains crop
group tolerance will be established, unless, the registered uses (see above) differ significantly for crops in
the Cereal Grains, in which case residue data will also be required for each crop with significantly different
uses. Data for each crop must be geographically representative of total U. S. production.
9/ Depiction of residues of concern in or on potatoes at maturity after seed piece treatments at the maximum
permissible rate and duration of treatment. Tests must be conducted in CA, CO, ID, ME, ND, WA, and WI; states
which adequately represent total U. S. potato production (Agricultural Statistics, 1984, p. 1656, preliminary
1983 data).
-57-
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TABLE A
GENERIC DATA REQUIREMENTS FOR FORMALDEHYDE AND PARAPORMALDEHYDE
§158.125 Residue Chemistry
10/ Depiction of residues of concern in or on onions at maturity after seed treatment at the maximum permissible
rate, and duration of treatment. Tests must be conducted in OR, the only state currently having a registered
use.
ll/ Depiction of residues of concern in or on garlic at maturity after seed treatment of 24 pints/100 gal water
of the 37% SC/L formulation. Tests must be conducted in CA.
12/ If the results of the studies required for Nature of the Residues in Animals and Magnitude of the Residue in
Animals show that residues of concern will occur in animals due to registered stored ccmnodities applications,
tolerances must be established. The following residue data will be required for each of the crops with a
registered stored commodity use prior to the establishment of a tolerance.
Representative commodities of the Cereal Grains Group, corn, rice, sorghum, and wheat, (barley or oats should
be substituted for rice since there is no registered use for rice) must be treated within six hours after
harvest with 1.6, 2.0, 2.6, and 3.0 Ib ai/2000 Ib grain using the 10% RTU formaldehyde formulation. The above
rates should be applied respectively to corn with <20%, 21-30%, 31-35%, and 36-40% moisture content utilizing
a pressure sprayer system. Residues of concern must be determined in grain samples taken at regular intervals
beginning immediately after harvest.
13/ For the Foliage of the Legume Vegetables Group, data depicting residues of concern in or on forage of any
variety of beans (Phaseolus spp.), peas, and soybeans are required. Forage not in storage must be treated with
the following rates: 1 Ib ai/ton (500 ppm) wet hay at 20 to 24% moisture, 1000 ppm wet hay at 25 to 29% moisture,
and 150 ppm wet hay at 30 to 35% moisture. Additionally tests must be conducted in which 2 Ibs ai/ton (1000
ppm) fresh forage are applied by metering with forage in soils or pits. A sufficient number of tests must be
conducted to adequately characterize the maximum residue level in or on Foliage of Legume vegetables resulting
from the registered uses.
14/ For the Cereal Grains Group, data depicting residues of concern in or on forage of corn, wheat, and any other
cereal grain crop, such as sorghum, are required. The data must be collected as outlined above in the data
requirements for the Foliage of Legume Vegetables Group.
-58-
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TABLE A
GENERIC DATA REQUIREMENTS FOR FORMALDEHYDE AND PARAPORMALDEHYDE
§158.125 Residue Chemistry
15/ For the Non-grass Animals Feeds (forage, fodder, straw, and hay) Group, data depicting residues of concern in
or on alfalfa and clover are required. The data must be collected as outlined above in the data requirements
for the Foliage of Legume Vegetables Group.
16/ If the requested plant metabolism studies demonstrate that residues of concern will result from the use of
paraformaldehyde, the following residue data will be required. Depiction of residues of concern in sugar
maple syrup processed from maple tree sap after application of paraformaldehyde at 0.0088 oz. ai/taphole.
Mature trees should be tapped in February or March and samples obtained (>l quart/sample) throughout the sap
run period.
17/ if the required animal metabolism data (refer to Nature of the Residues in Animals for details)
demonstrate that detectable residues of concern of formaldehyde occur in animals, then additional data will
be required; specific data requirements regarding the magnitude of the residues in animals will be detailed
at that time.
18/ The 0.2% RTU formaldehyde formulation must be applied undiluted with scrubbing to the surface of pots and
pans rinsed two minutes after application. The 37% SC/L formuation must be diluted to a solution containing
1380 ppn formaldehyde and used liberally to wash the inside of refrigerators. The 34% SC/L MAI formulation
must be applied at a concentration of 523 ppm by spraying all surfaces until completely wetted (alternatively,
the registrant may propose a maximum use rate per unit floor area or surface area of treated surfaces, and
apply the maximum Ib ai in the required tests, in two different types of eating establishment premises, such
as restaurant and school dining areas). The registrant must determine, from the above applications, residues
of concern frcm direct deposition of spray droplets on food, volatilization and subsequent absorption by foods,
and all other possible modes of exposure of foods and residue transfer routes as outlined in the EPA Pesticide
Assessment Guidelines, Subdivision O, Residue Chemistry, 171-4(0(5). Representative food samples must be
examined for residues of concern from these possible modes of exposure; the food must include an oily food
(eg., butter), baked cereal product, beverages, raw and processed meats, and fresh fruits and vegetables
(lettuce) Tests must also include conditions of possible misuse of formaldehyde and exaggerated exposure,
eg., applying an exaggerated rate or direct exposure of foods to the formaldehyde solution applied (Refer to
EPA'pesticide Guidelines for details of the type of data required.
-59-
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TABLE A
GENERIC DATA REQUIREMENTS FOR FORMALDEHYDE AND PARAPORMALDEHYDE
§158.125 Residue Chemistry
19/ The 95% Cr formulation of paraformaldehyde must be applied at 0.31 Ib of formulation per 756 ft3 as a fvmigant
in two different types of eating establishment premises such as restaurant and school dining areas. Possible
residues transfer routes and residues of concern on representative foods must be examined as outlined above in
the formaldehyde data requirements.
20/ Data depicting formaldehyde residues of concern in or on these miscellaneous crops following foliar application
(and at postharvest for asparagus) of the formaldehyde FIC formulation at representative geographic locations
according to the labeling directions at the maximum registered rate. Samples of all raw agricultural ccmmodi-
tie from each crop group must be collected at the shortest interval after application in which they could be
used for food or feed purposes.
2V Data depicting formaldehyde residues of concern in or on mushrooms collected following the last of multiple
soil applications of the formulation registered for this use at 0.0294 Ib. ai/100 Ib. soil. A maximum permis-
sible number of applications must be proposed.
-60-
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TABLE A
GENERIC DATA REQUIREMENTS FDR FORMALDEHYDE AND PARAFORMALDEHYDE
Data Requirement
§158.130 Environmental Fate
DEGRADATION STUDIES-LAB:
161-1 - Hydrolysis
Photodegradation
161-2 - in water
161-3 - On soil
161-4 - in Air
METABOLISM STUDIES-LAB:
162-1 - Aerobic Soil
162-2 - Anaerobic Soil
162-3 - Anaerobic Aouatic
Test
Substance
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
TGAI or PAIRA
Use Does EPA Bibliographic
Patterns Have Data? Citation
A,B,D No
F,G,H
A,BfD No
F,G
A,B,G NO
E,F,I No
A,B,E NO
F,G,H
A NO
DfG NO
Must Additional
Data be
Submitted?
Yes
Yes
Yes
No2
Yes
Yes3
Yes4
Time Frame
for
Submission^
9 Months
9 Months
9 Months
27 Months
27 Months
27 Months
162-4 - Aerobic Aquatic
TGAI or PAIRA D,G
No
Progress reports:
12 & 24 Months
27 Months
Progress reports:
12 & 24 Months
-61-
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TABLE A
GENERIC DATA REQUIREMENTS FOR FORMALDEHYDE AND PARAPORMALDEHYDE
Data Requirement
§158.130 Environmental Fate -
MOBILITY STUDIES:
163-1 - Leaching and
Adsorp t ion/De sorp t ion
163-2 - Volatility (Lab)
163-3 - Volatility (Field)
DISSIPATION STUDIES-FIELD:
164-1 - Soil
164-2 - Aquatic (Sediment)
164-3 - Forestry
164-5 - Soil, Long-term
ACCUMULATION STUDIES:
Test
Substance
Continued
TGAI or PAIRA
TEP
TEP
TEP
TEP
TEP
TEP
Use Does EPA Bibliographic
Patterns Have Data? Citation
A,B,D,E No
F,G,H
A,E,F,I NO
A,E,F,I NO
A,B,H No
D,G No
G No
A No
Must Additional
Data be
Submitted?
Yes
Yes
Reserved5
Yes
Yes4
Yes
Reserved^
Time Frame
for
Submission*
12 Months
12 Months
15 Months
27 Months
27 Months
27 Months
50 Months
165-1 - Rotational Crops
(Confined)
165-2 - Rotational Crops
(Field)
165-4 - in Fish
PAIRA
TEP
TGAI or PAIRA A,B
D,G
NO
NO
NO
Yes
Reserved^
Yes
39 Months
progress reports:
12, 24 & 36 months
50 Months
12 Months
-62-
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GENERIC DATA
TABLE A
FOR FORMALDEHYDE AND PARAFORMALDEHYDE
Data Requirement
Test Use Does EPA Bibliographic
Substance Patterns Have Data? Citation
Must Additional Time Frame
Data be Submitted? for
Submission1
§158.130 Environmental Fate - Continued
ACCUMUIATION STUDIES;
(Continued)
165-5 - In Aquatic Non-Target
Organisms
TEP
D,G
No
12 Months
I/ Data must be submitted within the time frame indicated, based on the date of the Guidance Document.
2/ Data not required based on label statements concerning ventilation of indoor areas during fumigation and prior
to worker reentry.
3/ Not required if an acceptable anaerobic aquatic metabolism study is submitted.
4/ Not required if registrant can demonstrate that no direct discharge of water containing formaldehyde or para-
formaldehyde occurs.
5/ Data deferred pending receipt of laboratory volatility data. Timeframe will begin when study is required.
6/ Requirement for data is deferred pending the receipt of data on aerobic soil metabolism and terrestrial
field dissipation. Timeframe will begin when the study is required.
7/ This study is reserved pending the results of the confined study.
8/ Not required if laboratory fish accumulation study shows no bioaccumulation.
-63-
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TABLE A
GENERIC DATA REQUIREMENTS FOR FORMALDEHYDE AND PARAPORMALDEHYDE
Data Requirement
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
Must Additional Time Frame
Data be for
Submitted? Submission^
§158.140 Reentry Protection
132-1 - Foliar Dissipation
132-1 - Soil Dissipation
133-3 - Dermal Exposure
133-4 - Inhalation Exposure
TEP
TEP
TEP
TEP
A,B,F
G
A,BrF
G
A,B,F
G
NO
NO
NO
NO
No
NO
NO
Yes2
27 Months
Protocol: 3 Months
Progress reports:
12 & 24 Months
I/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
2/ Data are required for greenhouse and indoor uses, such as egg hatcheries and hospitals. A protocol should be
submitted, prior to developing data.
-------
TABLE A
GENERIC DATA REQUIREMENTS FOR FORMALDEHYDE AND PARAFORMALDEHYDE
Date Requirement
Test
Substance
Use
Patterns
Does EPA
Have Data?
Bibliographic
Citation
Must Additional
Data be
Submitted
Time Frame
for
Submission1
§158.135 Toxicology
ACUTE TESTING;
81-1 - Acute Oral Toxicity - Rat TGAI
A,BfD,I Partial
81-2 - Acute Dermal Toxicity TGAI
- Rabbit
81-3 - Acute inhalation Toxicity TGAI
- Rat
A,B,D,I Partial
A,B,D,I Partial
119785, 65508 Yes
137297, 127060
127059, 75459
127500, 66997
65508, 137247 Yes
127060, 127059
65511, 122750
79674, 119785
69393, 127500 Yes
137297, 127059
56308, 82134
132494, 82130
56309, 117674
82132, 119785
9 Months
9 Months
9 Months
SUBCHRONIC TESTING:
82-1 - 90-Day Feeding:
- Rodent,
- Non-rodent (Dog,
Chicken)
TGAI
TGAI
A,B,D,I No
A,B,D,I NO
127069
Yes
Yes
15 Months
18 Months
-65-
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TABLE A
GENERIC DATA REQUIREMENTS FOR FORMALDEHYDE AND PARAPORMALDEHYDE
Data Requirement Test Use Does EPA Bibliographic Must Additional Time Frame
Substance Patterns Have Data? Citation Data be for
Submitted? Submission1
§158.135 Toxicology - Continued
82-2 -
82-3 -
82-4 -
21-Day Dermal - Rabbit TGAI
90-Day Dermal - Rabbit TGAI
90-Day inhalation: TGAI
- Rat
A,B,D,I Partial 51255 Yes 12 Months
A,B,D,I No Reserved2 15 Months
A,B,D,I Partial 82134 Yes 15 Months
CHRONIC TESTING:
83-1 -
83-2 -
Chronic Toxicity -
2 species:
- Rodent, and TGAI
- Non-rodent (Dog) TGAI
Oncogen icity -
- inhalation
2 species:
- Rat (preferred) TGAI
- Mouse (preferred) TGAI
A,B,D,I Partial GS556-001 Yes 50 Months
progress reports:
12, 24 & 36 Months
A,B,D,I No Yes 50 Months
Progress reports:
12, 24 & 36 Months
A,B,D,I Yes GS556-001 No
A,B,D,I Yes GS556-001 No
-66-
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TABLE A
GENERIC DATA REQUIREMENTS FOR FORMALDEHYDE AND PARAFORMALDEHYDE
Data Requirement
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
Must Additional Time Frame
Data be for
Submitted? Submission*
§158.135 Toxicology - Continued
CHRONIC TESTING
83-2 - Oncogenicity (Continued)
- Oral (gavage)
2 species:
- Rat (preferred)
TGAI
83-3 -
83-4 -
Teratcgenicity -
2 species:
- Rat
- Rabbit
Reproduction - Rat
2-generation
TGAI
TGAI
A,B,D,I No
- Mouse (preferred) TGAI A,B,D,I No
A,B,D,I NO
A,B,D,I NO
Yes
Yes
Yes
Yes
50 Months
Progress reports:
12, 24 & 36 Months
50 Months
Progress reports:
12, 24 & 36 Months
15 Months
39 Months
Progress reports:
12, 24 & 36 Months
MUTAGENICITY TESTING
84-2 - Gene Mutation (Ames Test) TGAI
A,B,D,I Partial
132492
GS556-001
Yes
9 Months
-67-
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TABLE A
GENERIC DATA REQUIREMENTS FDR FORMALDEHYDE AND PARAPORMALDEHYDE
Data Requirement Test use Does EPA Bibliographic Must Additional Time Frame
Substance Pattern Have Data? Citation Data be for
Submitted? Submission3-
§158.135 Toxicology - Continued
MUTAGENICITY TESTING
(Continued)
84-2 - Structural Chrcmosanal TGAI
Aberration
84-4 - Other Genotoxic effects TGAI
A,B,D,I Partial
GS556-001
Yes
A,B,D,I Partial
GS556-001
Yes
12 Months
12 Months
SPECIAL TESTING
85-1 - General Metabolism
85-2 - Dermal Penetration
86-1 - Special Requirement
Domestic Animal Safety
PAI or PAIRA A,B,D,I Yes
PAI or PAIRA A,B,D,I NO
Choice
A,B,D,I
NO
124672, 82147 No
Yes
Reserved3
12 Months
Variable
I/ Data must be submitted within the time frame indicated, based of the date of the Guidance Document.
2/ Data requirement is contingent upon the results of the subchronic 21 day dermal test. Timeframe begins when the
study is required.
3/ Data from tests on domestic animals may be required to support the registration of an end-use product if cats, dogs,
cattle, pigs, sheep, or other domestic animals will be exposed through direct application for pest control and con-
sumption of treated feed. The applicant should contact the Agency to determine what toxicological data are required.
Timeframe begins when the study is required.
-68-
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TABLE A
GENERIC DATA REQUIREMENTS FOR FORMALDEHYDE AND PARAFORMALDEHYDE
Data Requirement
Test Use Does EPA Bibliographic
Substance Pattern Have Data? Citation
Must Additional Time Frame
Data be for
Submitted? Submission^
S158.145 Wildlife and
Aquatic Organisms
AVIAN AND MAMMALIAN TESTING
71-1 - Avian Single-Dose
Oral
71-2 - Avian Dietary LCsO
- Upland Game Bird
and
- Waterfowl
- Upland Game Bird
and
Waterfowl
AQUATIC ORGANISM TESTING
72-1 - Freshwater Fish LCso
Formaldehyde
TGAI
A,B,D,G Yes
H,I5
Paraformaldehyde
TGAI A,B,D
Formaldehyde
TGAI
TGAI
G,H
Paraformaldehyde
TGAI A,B,D
TGAI
Formaldehyde
TGAI
TEP
No
No
A,B,D,H NO
A,B,D,G,H
(E,I)5'6 Yes
D Partial
00148774
A,B,D,G
H,(E,I)5
A,B,D
Yes
Yes
00148773
00148775
00132485
00101857
No
Yes2
NO
NO
Yes2
Yes2
No
Yes3
9 Months
9 Months
9 Months
9 Months
-69-
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TABLE A
GENERIC DATA REQUIREMENTS FDR FORMALDEHYDE AND PARAFORMALDEHYDE
Data Requirement Test Use
Substance Pattern
S158.145 Wildlife and
Aquatic Organisms - Continued
AQUATIC ORGANISM TESTING Continued
72-1 - Freshwater Fish LCjQ Paraformaldehyde
(continued)
TGAI
TEP
72-2 - Aquatic invertebrate Formaldehyde
Acute EGjQ TGAI
TEP
Paraformaldehyde
TGAI
TEP
72-3 - Estuarine and Marine Formaldehyde
Organism TGAI
Acute LCso
TEP
A,B,D,H
D
A,B,D,G
(E,IP
D
A,B,DfH
(I)5
D
(A,B)5D
D
Does EPA Bibliographic
Have Data? Citation
No
Partial 00101857
Yes 00148772
No
No
No
Yes 00148770
Partial 00128086
00126394
00126396
Must Additional Time Frame
Data be for
Submitted? Submission1
No7
Yes3
No
Yes3
L~
Yes3
No
Yes3
9 Months
9 Months
9 Months
12 Months
-70-
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TABLE A
GENERIC DATA REQUIREMENTS FOR FORMALDEHYDE AND PARAPORMALDEHYDE
Data Requirement Test Use Does EPA Bibliographic Must Additional Time Frame
Substance Pattern Have Data? Citation Data be for
Submitted? Submission1
§158.145 Wildlife and Aquatic Organisms - Continued
AQUATIC ORGANISM TESTING - Continued
72-4 - Fish Early Life Stage, Formaldehyde D No Reserved9 15 Months
and Aquatic Inverte- TGAI
brate Life Cycle Studies
70-1 - Special Test Formaldehyde &
Residue Monitoring Paraformaldehyde
- Turf application TEP B No Reserved^ 12 Months
- Oil wells and TEP D No Yes8 12 Months
industrial effluents
I/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document.
2/ Studies must be submitted using technical paraformaldehyde, the solid polymer of formaldehyde.
3/ Data fron testing with the applicant's end-use product is required to support the registration of each end-use
product for which: an ingredient in the end-use formulation other than the active ingredient is expected to enhance
the toxicity of the active ingredient or to cause toxicity to aquatic organisms. This test must therefore be con-
ducted using all formulations registered for use in oil drilling and recovery operations.
4/ Because of the high application rates of formaldehyde on turf, and the practice of irrigation immediately following
application, a residue monitoring study will be reserved pending the receipt of environmental fate data and the
results of SWRRB-EXAMS simulation.
5/ Required to support registrations of the manufacturing end-use product.
-71-
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TABLE A
GENERIC DATA REQUIREMENTS FOR FORMALDEHYDE AND PARAPORMALDEHYDE
§158.145 Wildlife and
Aquatic Organisms - Continued
6/ Required for only one species of fish (cold water or warm water) only.
7/ Testing of technical paraformaldehyde on aquatic species is not required because in solution it will become formalde-
hyde.
8/ Monitoring of formaldehyde levels in waters receiving residues from the use of the pesticide (formaldehyde or para-
formaldehyde) in secondary oil recovery systems and other industrial effluents such as cooling towers, air scrub-
bers, metalworking fluids and oil well drilling muds, is required. Based on use information (i.e., geographic sites
and amount used, etc.) registrants will be required to develop acceptable protocols (within 3 months) to sample a
representative number of the above sites. Studies are required to assess the release of formaldehyde into the
environment due to concern for chronic effects to aquatic organisms. Any protocol developed for monitoring this
chemical must consider the following requirements: (i) use of standard analytical methods, i.e., HPLC or MSGC to
measure formaldehyde, (ii) sites selected for sampling must be where formaldehyde is currently being used and must
be representative of small and large facilities and/or volume, (iii) sites selected must also be representative of
(l)a range in volume of the receiving water bodies or rivers and (2) freshwater and estuarine ecosystems;
(iv) samples taken for analysis must be taken before treatment, after treatment, and from receiving waters,
(v) sampling should be done at regular intervals for a long enough period of time to account for such things as
seasonal variations.
9/ Fish early life stage and aquatic invertebrate life cycle studies are reserved pending the completion of aquatic
residue monitoring studies.
-72-
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FORMALDEHYDE
Data Requirement
Test Use
Substance1 Patterns
Does EPA Bibliographic
Have Data?2 Citation2
Must Additional Time Frame
Data be for
Submitted? Submission^
§158.120 Product Chemistry
Product Identity;
61-1 - Product Identity and MP
Disclosure of
ingredients
61-2 - Description of Beginning MP
Materials and
Manufacturing Process
61-3 - Discussion of Formation MP
of impurities
Analysis and Certification of Product
ingredients
62-1 - Preliminary Analysis MP
62-2 - Certification of Limits MP
62-3 - Analytical Methods to Verify MP
Certified Limit
All
All
All
All
All
All
N/A
N/A
N/A
1SI/A
N/A
N/A
Nl/A
N/A
Yes
Yes4'5
Yes6
Yes
Yes7
Yes8
6 Months
6 Months
6 Months
12 Months
12 Months
12 Months
-73-
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FORMALDEHYDE
Data Requirement Test Use Does EPA Bibliographic Must Additional Time Frame
Substance, Patterns Have Data?^ Citation^ Data be for
Submitted? Submission3
§158.120 Product Chemistry (Continued)
Other Requirements;
64- 1 - Submittal of sanples MP All N/A N/A No
I/ Test Substance: The 37%, 44% and 45% Formulation intermediate products serve as the manufacturing-use products.
(There are not any registered paraformaldehyde manufacturing use products.)
2/ Not applicable. Although product chemistry data may have been submitted in the past, the Agency has determined that
these data must be resubmitted for each manufacturing use product. New requirements have been introduced and
previously submitted data must be updated. Therefore bibliographic citations for the old data are not applicable.
3/ Data must be submitted within the time frame indicated, based on the date of the Guidance Document.
4/ Details of the manufacturing process, including the relative amounts of beginning materials, a description of the
equipment used to produce the product, reaction conditions, the duration of each step of the process, purification
procedures and quality control measures.
5/ The name and address of the manufacturer, producer, or supplier of each beginning material used to manufacture
the formulation intermediate and the technical product from which it is produced. A copy of all available speci-
fications, data sheets, and other documents in which the manufacturer, producer, or supplier of each beginning
material used to produce the formulation intermediate and the formaldehyde technical from which it is produced.
6/ A discussion of each impurity believed to be present at >0.1%, based on knowledge of the beginning materials, all
possible chemical reactions and any contamination.
7/ Upper and lower limits must be provided, validated and certified for formaldehyde and each intentionally added
inert ingredient. Upper and lower limits must be provided and validated for each impurity associated with formal-
dehyde present at >0.1% (w/w) of the technical material.
8/ Quantitative methods to determine formaldehyde and all impurities for which a certified limit is required in the
formulation intermediates. Each method must be accompanied by validation studies of the precision and accuracy
of the method.
-74-
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FORMALDEHYDE AND PARAFORMALDF.HYDE
Data Requirement
Test Use Does EPA Bibliographic
Substance Patterns Have Data? Citation
Must Additional
Data be
Submitted?
Time Frame
for
Submission1
§158.135 Toxicology
ACUTE TESTING
81-1 - Acute Oral Toxicity - Rat
MP
A,B,D,I Partial
119785,65508
137297,127060
127059,75459
127500,66997
Yes
9 Months
81-2 - Acute Dermal Toxicity
- Rabbit
MP
A,B,D,I
Partial
65508,137247
127060,127059
65511,122750
79674,119785
Yes
9 Months
81-3 - Acute inhalation Toxicity
- Rat
81-4 - Primary Eye
Irritation - Rabbit
MP
MP
A,R,D,I
A,B,D,I
Partial
Partial
69393,127500
137297,127059
56308,82134
132494,82130
56309,117674
119785,82132
132490,65516
66997,127059
127071,127060
119785,127500
60059,132488
43591,65508
137297
Yes
Yes
9 Months
9 Months
-75-
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TABLE B
PRODUCT SPECIFIC DATA REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS CONTAINING FORMALDEHYDE AND PARAFORMALDEHYDE
Data Requirement
Test
Substance
Use
Patterns
Does EPA Bibliographic Must Additional Time Frame
Have Data? Citation Data be for
Submitted Submission1
§158.135 Toxicology (Cont'd)
81-5 - Primary Dermal
Irritation - Rabbit
MP
81-6 - Dermal Sensitization MP
- Guinea Pig
A,B,D,I
A,B,D,I
Partial 124552,43592 Yes
65517,66997
65514,137297
127503,127060
127059,134117
75459
Partial 132494,96223 Yes
54714
9 Months
9 Months
I/ Data must be submitted within the time frame indicated, based on the date of the Guidance Document.
-76-
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SUMMARY-1
LABEL CONTENTS
40 CFR 162.10 requires that certain specific labeling
statements appear at certain locations on the label. This
is referred to as format labeling. Specific label items listed
below are keyed to the table at the end of this Appendix.
Item 1. PRODUCT NAME - The name, brand or trademark is
required to be located on the front panel, preferably centered
in the upper part of the panel. The name of a product will
not be accepted if it is false or misleading.
Item 2. COMPANY NAME AND ADDRESS - The name and address
of the registrant or distributor is required on the label.
The name and address should preferably be located at the
bottom of the front panel or at the end of the label text.
Item 3. NET CONTENTS - A net contents statement is
required on all labels or on the container of the pesticide.
The preferred location is the bottom of the front panel
immediately above the company name and address, or at the end
of the label text. The net contents must be expressed in the
largest suitable unit, e.g., "1 pound 10 ounces" rather than
"26 ounces." In addition to English units, net contents may
be expressed in metric units. [40 CFR 162.10(d)]
Item 4. EPA REGISTRATION NUMBER - The registration
number assigned to the pesticide product must appear on the
label, preceded by the phrase "EPA Registration No.," or "EPA
Reg. No." The registration number must be set in type of a
size and style similar to other print on that part of the
label on which it appears and must run parallel to it. The
registration number and the required identifying phrase must
not appear in such a manner as to suggest or imply recommendation
or endorsement of the product by the Agency.
[40 CFR 162.10(e)]
Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment
number, preceded by the phrase "EPA Est." is the final estab-
lishment at which the product was produced, and may appear
in any suitable location on the label or immediate container.
It must also appear on the wrapper or outside container of
the package if the EPA establishment number on the immediate
container cannot be clearly read through such wrapper or container.
[40 CFR 162.10(f)]
Item 6A. INGREDIENTS STATEMENT - An ingredients statement
is required on the front panel. The ingredients statement must
contain the name and percentage by weight of each active ingredient
and the total percentage by weight of all inert ingredients.
The preferred location is immediately below the product name.
The ingredients statement must run parallel with, and be clearly
distinguished from, other text on the panel. It must not be
placed in the body of other text. [40 CFR 162.10(g)]
-77-
-------
SUMMARY-2
Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricul-
tural formulations, the pounds per gallon of active ingredient
must be indicated on the label.
Item 7. FRONT LABEL PRECAUTIONARY STATEMENTS - Front panel
precautionary statements must be grouped together, preferably
within a block outline. The table below shows the minimum type
size requirements for various size labels.
Size of Label Signal Word "Keep Out of Reach
on Front Panel Minimum Type Size of Children"
in Square Inches All Capitals Minimum Type Size
5 and under 6 point 6 point
above 5 to 10 10 point 6 point
above 10 to 15 12 point 8 point
above 15 to 30 14 point 10 point
over 30 18 point 12 point
Item 7A. CHILD HAZARD WARNING STATEMENT - The statement
"Keep Out of Reach of Children" must be located on the front
panel above the signal word except where contact with children
during distribution or use is unlikely. [40 CFR 162 .10(h)(1)(ii)]
Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING,
or CAUTION) is required on the front panel immediately below
the child hazard warning statement. [40 CFR 162.10 (h)(l)(i)]
Item 7C. SKULL & CROSSBONES AND WORD "POISON" - On products
assigned a toxicity Category I on the basis of oral, dermal,
or inhalation toxicity, the word "poison" shall appear on the
label in red on a background of distinctly contrasting color and
the skull and crossbones shall appear in immediate proximity to
the word POISON. [40 CFR 162.10(h)(1)(i)]
Item 7D. STATEMENT OF PRACTICAL TREATMENT - A statement
of practical treatment (first aid or other) shall appear on
the label of pesticide products in toxicity Categories I,
II, and III. [40 CFR 162.10(h)(1)(iii)]
Item 7E. REFERRAL STATEMENT - The statement "See Side
(or,Back) Panel for Additional Precautionary Statements" is
required on the front panel for all products, unless all
required precautionary statements appear on the front panel.
[40 CFR 162.10(h)(l)(iii)]
Item 8. SIDE/BACK PANEL PRECAUTIONARY LABELING - The
precautionary statements listed below must appear together
on the label under the heading "PRECAUTIONARY STATEMENTS."
The preferred location is at the top of the side or back
panel preceding the directions for use, and it is preferred
that these statements be surrounded by a block outline. Each
of the three hazard warning statements must be headed by the
appropriate hazard title. [40 CFR 162.10(h)(2)].
-78-
-------
SUMMARY-3
Item 8A. HAZARD TO HUMANS AND DOMESTIC ANIMALS - Where a
hazard exists to humans or domestic animals, precautionary
statements are required indicating the particular hazard, the
route(s) of exposure and the precautions to be taken to avoid
accident, injury or damage. [40 CFR 162.10(h) (2 ) (i ) ]
Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to
non-target organisms excluding humans and domestic animals,
precautionary statements are required stating the nature of
the hazard and the appropriate precautions to avoid potential
accident, injury, or damage. [40 CFR 162.10(h)(2)(ii ) ]
Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY
Precautionary statements relating to flammability of a product
are required to appear on the label if it meets the criteria
in the PHYS/CHEM Labeling Appendix. The requirement is
based on the results of the flashpoint determinations and
flame extension tests required to be submitted for all products.
These statements are to be located in the side/back panel
precautionary statements section, preceded by the heading
"Physical/Chemical Hazards." Note that no signal word is
used in conjunction with the flammability statements.
Item 9A. RESTRICTED USE CLASSIFICATION - FIFRA sec. 3(d)
requires that all pesticide formulations/uses be classified
for either general or restricted use. Products classified
for restricted use may be limited to use by certified applicators
or persons under their direct supervision (or may be subject
to other restrictions that may be imposed by regulation).
In the Registration Standard, the Agency has (1) indicated
certain formulations/uses are to be restricted (Section IV
indicates why the product has been classified for restricted
use); or (2) reserved any classification decision until
appropriate data are submitted.
The Regulatory Position and Rationale states whether
products containing this active ingredient are classified
for restricted use. If they are restricted the draft label(s)
submitted to the Agency as part of your application must
reflect this determination (see below).
If you do not believe that your product should be classified
for restricted use, you must submit any information and
rationale with your application for reregistration. During
the Agency's review of your application, your proposed classi-
fication determination will be evaluated in accordance with
the provisions of 40 CFR 162.11(c). You will be notified of
the Agency's classification decision.
-79-
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SUMMARY-4
Classification Labeling Requirements
If your product has been classified for restricted use,
the following label requirements apply:
1. All uses restricted.
a. The statement "Restricted Use Pesticide" must
appear at the top of the front panel of the label. The
statement must be set in type of the same minimum size
as required for human hazard signal word (see table in 40
CFR 162.10(h)(1)(iv)
b. Directly below this statement on the front panel,
a summary statement of the terms of restriction must
appear (including the reasons for restriction if specified
in Section I). If use is restricted to certified applicators,
the following statement is required: "For retail sale
to and use only by Certified Applicators or persons
under their direct supervision and only for those uses
covered by the Certified Applicator's Certification."
2. Some but not all uses restricted. If the Regulatory
Position and Rationale states that some uses are classified
for restricted use, and some are unclassified, several courses
of action are available:
a. You may label the product for Restricted use.
If you do so, you may include on the label uses that
are unrestricted, but you may not distinguish them
on the label as being unrestricted.
b. You may delete all restricted uses from your
label and submit draft labeling bearing only unrestricted
uses.
c. You may "split" your registration, i.e., register
two separate products with identical formulations, one
bearing only unrestricted uses, and the other bearing
restricted uses. To do so, submit two applications for
reregistration, each containing all forms and necessary
labels. Both applications should be submitted simul-
taneously. Note that the products will be assigned
separate registration numbers.
Item 9B. MISUSE STATEMENT - All products must bear the
misuse statement, "It is a violation of Federal law to use
this product in a manner inconsistent with its labeling."
This statement appears at the beginning of the directions
for use, directly beneath the heading of that section.
-80-
-------
SUMMARY-5
Item 10A. REENTRY STATEMENT - If a reentry interval
has been established by the Agency, it must be included on
the label. Additional worker protection statements may be
required in accordance with PR Notice 83-2, March 29, 1983.
Item 10B. STORAGE AND DISPOSAL BLOCK - All labels are
required to bear storage and disposal statements. These
statements are developed Cor specific containers, sizes, and
chemical content. These instructions must be grouped and
appear under the heading "Storage and Disposal" in the directions
for use. This heading must be set in the same type sizes as
required for the child hazard warning. Refer to Appendix II,
STOR, PEST/DIS, and CONT/DIS to determine the storage and
disposal instructions appropriate for your products.
Item IOC. DIRECTIONS FOR USE - Directions for use nust
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.
[40 CFR 162.10]
COLLATERAL LABELING
Bulletins, leaflets, circulars, brochures, data sheets,
flyers, or other written or graphic printed matter which is
referred to on the label or which is to accompany the product
are termed collateral labeling. Such labeling may not bear
claims or representations that differ in substance from those
accepted in connection with registration of the product. It
should be made part of the response to this notice and submitted
for review.
-81-
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SUMMARY-6
LABELING REQUIREMENTS OF THE FIFRA, AS AMENDED
ITEM
1
2
3
4
5
6A
6B
7
7A
7B
LABEL ELEMENT
Product nane
Company nane
and address
Net contents
EPA Reg. No.
EPA Est. No.
Ingredients
statement
Pounds/gallon
statement
Front panel
precautionary
statements
Keep Out of Reach
of Children
(Child hazard
warning )
Signal word
APPLICABILITY
OF REQUIREMENT
All products
All products
All products
All products
All products
All products
Liquid products
where dosage
given as Ibs.
ai/unit area
All products
All products
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
None
None
None
None
Front panel
Front panel
Front panel
Front panel
Front panel
PREFERRED
Center front
panel
Bottom front
panel or end
of label text
Botton front
panel or end
of label text
Front panel
Front panel,
immediately
before or
following
Reg. No.
Immediately
following
product name
Directly below
the main
ingredients
statement
Above signal
word
Immediately
below child
hazard
warning
COMMENTS
If registrant is not the producer, must
be qualified by "Packed for . . .,'
"Distributed by. . .," etc.
May be in metric units in addition to
U.S. units
Must be in similar type size and run
parallel to other type.
May appear on the container instead of
the label.
Text must run parallel with other text
on the panel.
All front panel precautionary statements
must be grouped together, preferably
blocked .
Note type size requirements.
Note type size requirements.
-82-
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SUMMARY-7
ITEM
1C
7D
7E
8
8A
8B
LABEL ELEMENT
Skull & cross-
bones and word
POISON (in red)
Statement of
Practical
Treatment or
First Aid
Referral
statement
Side/back panel
precautionary
statements
Hazards to
humans and
domestic
animals
Environmental
hazards
APPLICABILITY
OF REQUIREMENT
All products
which are Cat-
egory I based
on oral, der-
mal, or inhala-
tion toxic ity
All products
in Categories
I, II, and ill
All products
where pre-
cautionary
labeling
appears on
other than
front panel.
All products
All products
in Categories
I, II, and ill
All products
PLACEMENT ON LABEL
REQUIRED
Front panel
Category^ I:
Front panel
unless refer-
ral statement
is used.
Others :
Grouped with
side panel
precautionary
statements .
Front panel
None
None
None
PREFERRED
Both in close
proximity to
signal word
Front panel
for all.
Top or side
of back panel
preceding
directions
for use
Same as above
Same as above
COMMENTS
Must be grouped under the headings in
8A, 88, and 8C; preferably blocked.
Must be preceded by appropriate signal
word.
Environmental hazards include bee
caution where applicable.
-83-
-------
SUMMARY-8
ITEM
8C
9A
9B
10A
10B
IOC
LABEL ELEMENT
Physical or
chanical
hazards
Restricted
block
Misuse
statement
Reentry
statement
Storage and
disposal block
Directions
for use
APPLICABILITY
OF REQUIREMENT
All pressurized
products, others
with flash
points under
150 °F
All restricted
products
All products
PR Notice 83-2
or as determined
by the Agency
All products
All products
PLACEMENT ON LABEL
REQUIRED
None
Top center
of front
panel
Immediately
following
heading of
directions
for use
in the
directions
for use
in the
directions
for use
None
PREFERRED
Same as above
Preferably
blocked
Immediately
after misuse
statement
Immediately
before
specific
directions
for use or
at the end of
directions
for use
None
COMMENTS
Refer to Appendix II guide
PHYS/CHEM
Includes a statement of the terms of
restriction. The words "RESTRICTED USE
PESTICIDE" must be same type size as
signal word.
Required statement is:
"It is a violation of Federal law
to use this product in a manner
inconsistent with its label ing."
Must be set apart and clearly distin-
guishable from from other directions
for use.
Refer to Appendix II guides STOR,
CONT/DIS, and PEST/DIS for further
information and required statements.
May be in metric as well as U.S. units
-84-
-------
§ 162.10 Title 40—Protection of Environment
0 162.10 Labeling requirement*.
(a) General—<1) Contents of the
label Every pesticide products shall
bear a label containing the Informa-
tion specified by the Act and the regu-
lations in this Pan. The contents of a
label must show clearly and promi-
nently the following:
(i) The name, brand, or trademark
under which the product is sold as pre-
scribed In paragraph (b) of this sec-
tion:
(ii) The name and address of the
producer, registrant, or person for
-85-
-------
Chapter I—Environmental Protection Agency
§162.10
whom produced as prescribed In para-
graph (c) of this section:
(111) The net contents as prescribed
in paragraph (d) of this section;
(iv) The product registration
number as prescribed in paragraph (e)
of this section:
(v) The producing establishment
number as prescribed in paragraph (f)
of this section:
(vt) An ingredient statement as pre-
scribed in paragraph (g) of this sec-
tion:
(vti) Warning or precautionary state-
ments as prescribed in paragraph (h)
of this section:
(vlii) The directions for use as pre-
scribed in paragraph (1) of this section;
and
(Ix) The use classification^) as pre-
scribed in paragraph (]) of this section.
(2) Prominence and legibility. (1) All
words, statements, graphic representa-
tions, designs or other Information re-
quired on the labeling by the Act or
the regulations in this part must be
clearly legible to a person with normal
vision, and must be placed with such
conspicuousness (as compared with
other words, statements, designs, or
graphic matter on the labeling) and
expressed in such terms as to render it
likely to be read and understood by
the ordinary individual under custom-
ary conditions of purchase and use.
(11) All required label text must:
(A) Be set In 8-point or larger type:
(B) Appear on a clear contrasting
background; and
(C) Not be obscured or crowded.
(3) La.nffua.0e to be used. All required
label or labeling text shall appear in
the English language. However, the
Agency may require or the applicant
may propose additional text in other
languages as Is considered necessary to
protect the public. When additional
text In another language Is necessary.
all labeling requirements will be ap-
plied equally to both the English and
other-language versions of the label-
ing.
(4) Placemen* of Label—(i) General
The label shall appear on or be secure-
ly attached to the immediate contain-
er of the pesticide product. For pur-
poses of this Section, and the mis-
branding provisions of the Act. "se-
curely attached" shall mean that a
label can reasonably be expected to
remain affixed during the foreseeable
conditions and period of use. If the im-
mediate container is enclosed within a
wrapper or outside container through
which the label cannot be clearly read.
the label must also be securely at-
tached to such outside wrapper or con-
tainer. If It is a part of the package as
customarily distributed or sold.
(11) TanJt can and other bulk con-
tainers—(A) Transportation. While a
pesticide product Is In transit, the ap-
propriate provisions of 49 CFR Parts
170-189. concerning the transportation
of hazardous materials, and specifical-
ly those provisions concerning the la-
beling, tpa,rking and placarding of has-
ardous materials and the vehicles car-
rying them, define the basic Federal
requirement*. In addition, when any
registered pesticide product la trans-
ported In a tank car. tank truck or
other mobile or portable bulk contain-
er, a copy of the accepted label must
be attached to the shipping papers.
and left with the consignee at the time
of delivery.
(B) Storage. When pesticide prod-
uct* are stored In bulk containers.
whether mobile or stationary, which
remain in the custody of the user, a
copy of the label of labeling. Including
all appropriate directions for use. shall
be securely attached to the container
In the immediate vicinity of the dis-
charge control valve.
(S) FaLte or misleading ttntcmentt.
Pursuant to section 2(qXlXA) of the
Act. a pesticide or a device declared
subject to the Act pursuant to
1182.15. is mlsbranded If Its labeling is
false or misleading In any particular
Including both pesticldal and non-pes-
ticidal claims. Examples of statements
or representations In the labeling
which constitute mlsbrandlng Include:
(1) A false or misleading statement
concerning the composition of the
product;
(11) A false or misleading statement
concerning the effectiveness of the
product as a pesticide or device;
(111) A false or misleading statement
about the value of the product for
purposes other than as a pesticide or
device:
(Iv) A false or misleading comparison
with other pesticides or drvices;
-86-
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§ 162.10
Title 40—Protection of Environment
(v) Any statement directly or indi-
rectly implying that the pesticide or
device is recommended or endorsed by
any agency of the Federal Govern-
ment:
(vi) The name of a pesticide which
contains two or more principal active
ingredients If the name suggests one
or more but not all such principal
active ingredients even though the
names of the other ingredients are
stated elsewhere in the labeling;
(vii) A true statement used in such a
way as to give a false or misleading im-
pression to the purchaser:
(viii) Label disclaimers which negate
or detract from labeling statements re-
quired under the Act and these regula-
tions;
(ix) Claims as to the safety of the
pesticide or its Ingredients, including
statements such-as "safe," "nonpoison-
ous." "noninjurious," "harmless" or
"nontoxic to humans and pets" with
or without such a qualifying phrase as
"when used as directed"; and
(x) Non-numerical and/or compara-
tive statements on the safety of the
product, including but not limited to:
(A) "Contains all natural ingredi-
ents":
(B) "Among the least toxic chemi-
cals known"
(C) "Pollution approved"
(6) Final printed labeling, (i) Except
as provided in paragraph (aX6Xil) of
this section, final printed labeling
must be submitted and accepted prior
to registration. However, final printed
labeling need not be submitted until
draft label texts have been provision-
ally accepted by the Agency.
(11) Clearly legible reproductions or
photo reductions will be accepted for
unusual labels such as those silk-
screened directly onto glass or metal
containers or large bag or drum labels.
Such reproductions must be of micro-
film reproduction quality.
(b) Name, brand, or trademark. (1)
The name, brand, or trademark under
which the pesticide product is sold
shall appear on the front panel of the
label.
(2) No name, brand, or trademark
may appear on the label which:
(1) Is false or misleading, or
(11) Has not been approved by the
Administrator through registration or
supplemental registration as an addi-
tional name pursuant to S 162.6(b)(4).
(c) Name and address of producer.
registrant, or person for whom pro-
duced. An unqualified name and ad-
drers given on the label shall be con-
sidt red as the name and address of the
pr< cucer. If the registrant's name ap-
pears on the label and the registrant is
not the producer, or if the name of the
person for whom the pesticide was
produced appears on the label, it must
be qualified by appropriate wording
such as "Packed for • • V "Distribut-
ed by • • V or "Sold by • • — to show
that the name is not that of the pro-
ducer.
(d) Net weight or measure of con-
tents. (1) The net weight or measure
of content shall be exclusive of wrap-
pers or other materials and shall be
the average content unless explicitly
stated as a minimum quantity.
(2) If the pesticide is a liquid, the
net content statement shall be In
terms of liquid measure at 68* F (20*C)
and shall be expressed in conventional
American units of fluid ounces, pints.
quarts, and gallons.
(3) If the pesticide is solid or semi-
solid, viscous or pressurized, or is a
mixture of liquid and solid, the net
content statement shall be in terms of
weight expressed as avoirdupois
pounds and ounces.
(4) In all cases, net content shall be
stated in terms of the largest suitable
units, l.e., "1 pound 10 ounces" rather
than "26 ounces."
(5) In addition to the required units
specified, net content may be ex-
pressed in metric units.
(6) Variation above minimum con-
tent or around an average is permissi-
ble only to the extent that It repre-
sents deviation unavoidable in good
manufacturing practice. Variation
below a stated minimum is not permit-
ted. In no case shall the average con-
tent of the packages in a shipment fall
below the stated average content.
(e) Product registration number.
The registration number assigned to
the pesticide product at the time of
registration shall appear on the label.
preceded by the phrase "EPA Regis-
tration No.." or the phrase "EPA Reg.
No." The registration number shall be
set in type of a size and style similar to
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Chapter I—Environmental Protection Agency
§ 16Z10
other print on that pan of the label
on which it appears and shall run par-
allel to it. The registration number
and the required identifying phrase
shall not appear in such a manner as
to suggest or imply recommendation
or endorsement of the product by the
Agency.
(f) Producing establishments regis-
tration number. The producing estab-
lishment registration number preced-
ed by the phrase "EPA Est.". of the
final establishment at which the prod-
uct was produced may appear in any
suitable location on the label or imme-
diate container. It must appear on the
wrapper or outside container of the
package if the EPA establishment reg-
istration number on the -Immediate
container cannot be clearly read
through such wrapper or container.
(g) Ingredient statement—(1) Gener-
al. The label of each pesticide product
must bear a statement which contains
the name and percentage by weight of
each active ingredient, the total per-
centage by weight of all inert ingredi-
ents; and if the pesticide contains ar-
senic in any form, a statement of the
percentages of total and water-soluble
arsenic calculated as elemental ar-
senic. The active ingredients must be
designated by the term "active ingredi-
ents" and the inert ingredients by the
term "inert ingredients." or the singu-
lar forms of these terms when appro*
priate. Both terms shall be in the
same type size, be aligned to the same
margin and be equally prominent. The
statement "Inert Ingredients, none" is
not required for pesticides which con-
tain 100 percent active Ingredients.
Unless the ingredient statement is a
complete analysis of the pesticide, the
term "analysis" shall not be used as a
heading for the ingredient statement.
(2) Position of ingredient statement
(i) The ingredient statement is nor-
mally required on the front panel of
the label. If there is an outside con-
tainer or wrapper through which the
ingredient statement cannot be clearly
read, the ingredient statement must
also appear on such outside container
or wrapper. If the size or form of the
package makes it impracticable to
place the ingredient statement on the
front panel of the label, permission
may be granted for the ingredient
statement to appear elsewhere.
(ii) The text of the ingredient state-
ment must run parallel with other
text on the panel on which it appears.
and must be clearly distinguishable
from and must not be placed in the
body of other text.
(3) Names to be used in ingredient
statement. The name used for each in-
gredient shall be the accepted
common name, if there is one. fol-
lowed by the chemical name. The
common name may be used alone only
if it is well known. If no common name
has been established, the chemical
name alone shall be used. In no case
will the use of a trademark or proprie-
tary name be permitted unless such
name has been accepted as a common
name by the Administrator under the
authority of Section 25(cX6).
(4) Statements of percentages. The
percentages of ingredients shall be
stated in terms of weight-to-weight.
The sum of percentages of the active
and the inert ingredients shall be 100.
Percentages shall not be expressed by
a range of values such as "22-25%." If
the uses of the pesticide product are
expressed as weight of active ingredi-
ent per unit area, a statement of the
weight of active ingredient per unit
volume of the pesticide formulation
shall also appear in the ingredient
statement.
(5) Accuracy of stated percentage*.
The percentages given shall be as pre-
cise as possible reflecting good manu-
facturing practice. If there may be un-
avoidable variation between manufac-
turing batches, the value stated for
each active Ingredient shall be the
lowest percentage which may be
present.
(6) Deterioration. Pesticides which
change in chemical composition sig-
nificantly must meet the following la-
beling requirements:
(i) In cases where It Is determined
that a pesticide formulation changes
chemical composition significantly,
the product must bear the following
statement in a prominent position on
the label: "Not for sale or use after
tdatel."
(ii) The product must meet all label
claims up to the expiration time indi-
cated on the label.
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§ 162.10
Title 40—Protection of Environment
(7) Inert ingredients. The Adminis-
trator may require the name of any
inert ingredient(s) to be listed in the
ingredient statement if he determines
that such ingredienUs) may pose a
hazard to man or the environment.
(h) Warnings and precautionary
statements. Required warnings and
precautionary statements concerning
the general areas of lexicological
hazard including hazard to children.
environmental hazard, and physical or
chemical hazard fall into two groups:
those required on the front panel of
the labeling and those which may
appear elsewhere. Specific require-
ments concerning content, placement.
type size, and prominence are given
below.
(1) Required front panel statements.
With the exception of the child
hazard warning statement, the text re-
quired on the front panel of the label
is determined by the Toxicity Catego-
ry of the pesticide. The category is as-
signed on the basis of the highest
hazard shown by any of the indicators
In the table below:
Oimi LD»
Iflftfllflftofl LVj»»
Owmtf U>» _
Stun «ff«cti
1
Up U «nd rafadng SO
mg/kg.
Up to and rabOng 2
rng/kwr
Up ID «na nduOnq 200
mg/kg
•flfm 7 Q(y&
Tonefly c
II
From SO ffw SOO rrq/kg
Front 2 ttwu 2 rng/Mv
From 200 tin 2000
dayi. rmjtxyi
p«n»i»ig lex 7 dayt
hour*
•Ugon*t
III
kg
From 2 thru 20 mg/hMr
From 2.000 ttvu 20.000
wtfwi 7 rtByi
hour*
(V
*«
GrMUf than 20 mg/kMr
Gra*Mf ttwi 20.000
Mild ex tfagfit mutton at
72 hour*
(i) Human hazard signal word—(A)
Toxicitv Category I. All pesticide prod-
ucts meeting the criteria of Toxicity
Category I shall bear on the front
panel the signal word "Danger." In ad-
dition If the product was assigned to
Toxicity Category I on the basis of its
oral, inhalation or dermal toxicity (as
distinct from skin and eye local ef-
fects) the word "Poison" shall appear
In red on a background of distinctly
contrasting color and the skull and
croasbones shall appear in immediate
proximity to the word "poison."
(B) Toxicitv Category H. All pesti-
cide products meeting the criteria of
Toxicity Category n shall bear on the
front panel the signal word "Warn-
ing."
(C) Toxicitv Category III. All pesti-
cide products meeting the criteria of
Toxicity Category III shall bear on
the front panel the signal word "Cau-
tion."
(D) Toxicity Category IV. All pesti-
cide products meeting the criteria of
Toxicity Category IV shall bear on the
front panel the signal word "Caution."
(E) Use of signal words. Use of any
signal word(s) associated with a higher
Toxicity Category is not permitted
except when the Agency determines
that such labeling is necessary to pre-
vent unreasonable adverse effects on
man or the environment. In no case
shall more than one human hazard
signal word appear on the front panel
of a label.
(ii) Child hazard warning. Every pes-
ticide product label shall bear on the
front panel the statement "keep out of
reach of children." Only in cases
where the likelihood of contact with
children during distribution, market-
Ing, storage or use is demonstrated by
the applicant to be extremely remote.
or if the nature of the pesticide is such
that it is approved for use on infants
or small children, may the Administra-
tor waive this requirement.
(ill) Statement of practical treat-
ment-
-------
Chapter I—Environmental Protection Agency
§ 162.10
basis of oral, inhalation or dermal tox-
icity. The Agency may, however.
permit reasonable variations in the
placement of the statement of practi-
cal treatment is some reference such
as "See statement of practical treat-
ment on back panel" appears on the
front panel near the word "Poison"
and the skull and crossbones.
(B) Other toxicity categories. The
statement of practical treatment is not
required on the front panel except as
described in paragraph (hXIXiiiXA) of
this section. The applicant may. how-
ever, include such a front panel state-
ment at his option. Statements of
practical treatment are, however, re-
quired elsewhere on the label In
accord with paragraph (h)(2) of this
section if they do not appear on the
front panel.
(iv) Placement and prominence. All
the require front panel warning state-
ments shall be grouped together on
the label, and shall appear with suffi-
cient prominence relative to other
front panel text and graphic material
to make them unlikely to be over-
looked under customary conditions of
purchase and use. The following table
shows the minimum type size require-
ments for the front panel warning
statements on various sizes of labels:
Pond
Sue ol label front panel i
ncnes
'Keep out
* !°',-£2L01
capitals
5 and under
Above 5 to 10 ...
Above 10 to IS
Above IS to 30
Over 30
10
14
18
8
8
8
10
12
(2) Other required warnings and pre-
cautionary statements. The warnings
and precautionary statements as re-
quired below shall appear together on
the label under the general heading
"Precautionary Statements" and
under appropriate subheadings of
"Hazard to Humans and Domestic Ani-
mals." "Environmental Hazard" and
"Physical or Chemical Hazard."
(1) Hazard to humans and domestic
animals. (A) Where a hazard exists to
humans or domestic animals, precau-
tionary statements are required indi-
cating the particular hazard, the
route(s) of exposure and the precau-
tions to be taken to avoid accident,
injury or damage. The precautionary
paragraph shall be immediately pre-
ceded by the appropriate hazard signal
word.
(B) The following table depicts typi-
cal precautionary statements. These
statements must be modified or ex-
panded to reflect specific hazards.
Toncrry
category
Precaunonvy statements by toocrty category
Onl. rrelaton. or dermal loncrry
I
Skm and eye local effects
FIUI (pononouai 1 (wallowed (tfinaled or absorbed
j nvougn stun) Do not breathe vaoor (dual or tony
j mat). Oo noi gel n eye*, on stun, or on aothng
[Front panel sunement of practical treatment re-
I qu»edl
May be latal rl swallowed (.aihaled or absorbed
I through the stun) Do no) breathe vapon (dust or
spray mstl. Do no< gat In eyee. on sum. or on
dotnmg. [Appropriate hrft ax) statements requred)
Harmful rl swallowed (inhaled or absorbed through me
I Hun) AVON) breaifrng vapor* [dual or spray mvtj
j Avoid contact with nun (eyet or dotttng] (Appro-
priate tint aid ttaiemeni requred )
(No precautionary statements lequved )
I Corrosive, cam** eye and slun damage (or tkir
| rrnanon). Oo not get n eye* on slun. or on
I dothmg Wear jogtfsa or race meid and ruboat
, >ove« when nandhng Karmtui o> UUI rl •wallowed
' (Appropriate Til ax) statement requred 1
Caueea eye (and skm] mutton Oo not gel m eyes.
on slun. or on ctoOtng. Harmful it swaltowed tAp-
oroonate frst aid suUatnent
AvoxJ contact with stun, eyes or ctotnrng In casa of
contact
-------
§ 162.10
Title 40—Protection of Environment
stances under which they are required
follow:
(A) If a pesticide intended for out-
door use contains an active ingredient
with a mammalian acute oral LDM of
100 or less, the statement "This Pesti-
cide is Toxic to Wildlife" is required.
(B) If a pesticide intended for out-
door use contains an active ingredient
with a fish acute LCM of 1 ppm or less.
the statement "This Pesticide is Toxic
to Fish" is required.
(C) If a pesticide Intended for out-
door use contains an active ingredient
with an avian acute oral LDM of 100
mg/kg or less, or a subacute dietary
LCM of 500 ppm or less, the statement
"This Pesticide is Toxic to Wildlife" is
required.
(D) If either accident history or field
studies demonstrate that use of the
pesticide may result in fatality to
birds, fish or mammals, the statement
"This pesticide is extremely toxic to
wildlife (fish)" is required.
(E) For uses involving foliar applica-
tion to agricultural crops, forests, or
shade trees, or for mosquito abate-
ment treatments, pesticides toxic to
pollinating insects must bear appropri-
ate label cautions.
(F) For all outdoor uses other than
aquatic applications the label must
bear the caution "Keep out of lakes.
ponds or streams. Do not contaminate
water by cleaning of equipment or dis-
posal of wastes."
(ill) Physical or chemical hazards.
Warning statements on the flammabil-
ity or explosive characteristics of the
pesticide are required as follows:
Ftasn pont
(A)PMESa
Flash pom at or baton 20* f. t there • a flashback si
Flain pont above 20* F and not over 80' F or rt the
oft In from the flame
Reoured text
UIUZEO CONTAINERS
Extremely flammable Contents unoer pressure Keep eway from
comaner Expoaure to temperature! above 130' f may cause
bursting.
Flammable Contents under pressure Keep away from heal
Exposure to temperatures above t30° f may rsiise burctmg
flame. Do not puncture or ronerata container Exposure to
temperatures above 130* F may cause bursting
(B) NONMttMUfllZCD CONTAmcftS
At or below 20* F..
Above 20- F end not over SO' F.
Above tar f and not over ISO" F.
Keep eway from nra. spartu. and healed
Exfevmaly flammable
surfaces
Flammable. Keep away from heat end open flame
Do not use or store neer heat or open flame
(i) Direction* for Ute-4l) General
requirement*—(I) Adequacy and clar-
ity of directions. Directions for use
must be stated In terms which can be
easily read and understood by the av-
erage person likely to use or to super-
vise the use of the pesticide. When fol-
lowed, directions must be adequate to
protect the public from fraud and
from personal injury and to prevent
unreasonable adverse effects on the
environment.
(ii) Placement of directions for use.
Directions may appear on any portion
of the label provided that they are
conspicuous enough to be easily read
by the user of the pesticide product.
Directions for use may appear on
printed or graphic matter which ac-
companies the pesticide provided that:
(A) If required by the Agency, such
printed or graphic matter is securely
attached to each package of the pesti-
cide, or placed within the outside
wrapper or bag;
(B) The label bears a reference to
the directions for use in accompanying
leaflets or circulars, such as "See di-
rections in the enclosed circular:" and
(C) The Administrator determines
that It is not necessary for such direc-
tions to appear on the label.
(lii) Exceptions to requirement for
direction for use—iA) Detailed direc-
tions for use may be omitted from la-
beling of pesticides which are intended
-91-
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Chapter I—Environmental Protection Agency
§ 162.10
for use only by manufacturers of prod-
ucts other than pesticide products in
their regular manufacturing processes.
provided that:
U) The label clearly shows that the
product Ls intended for use only In
manufacturing processes and specifies
the type prevent unreasonable adverse ef-
fects on man or the environment.
(B) Detailed directions for use may
be omitted from the labeling of pesti-
cide products for which sale is limited
to physicians, veterinarians, or drug-
gists, provided that:
il) The label clearly states that the
product Is for use only by physicians
or veterinarians:
(2t The Administrator determines
that such directions are not necessary
to prevent unreasonable adverse ef-
fects on man or the environment; and
(3) The product is also a drug and
regulated under the provisions of the
Federal Food. Drug and Cosmetic Act.
-------
§162.11
Title 40—Protection of Environment
(E) For restricted use pesticides, a
statement that the pesticide may be
applied under the direct supervision of
a certified applicator who is not phys-
ically present at the site of application
but nonetheless available to the
person applying the pesticide, unless
the Agency has determined that the
pesticide may only be applied under
the direct supervision of a certified ap-
plicator who is physically present.
(F) Other pertinent information
which the Administrator determines
to be necessary for the protection of
man and the environment.
(j) Statement of Use Classification.
By October 22. 1976, all pesticide prod-
ucts must bear on their labels a state-
ment of use classification as described
in paragraphs classified general shall be la-
beled with the exact words "General
Classification" Immediately below the
heading "Directions for Use." And ref-
erence to the general classification
that suggests or implies that the gen-
eral utility of the pesticide extends
beyond those purposes and uses con-
tained in the Directions for Use will be
considered a false or misleading state-
ment under the statutory definitions
of mlsbrandlng.
(2) Restricted Use Classification.
Pesticide products bearing direction
for use(s) classified restricted shall
bear statements of restricted use clas-
sification on the front panel as de-
scribed below:
(1) Front panel statement of restrict-
ed use classification. (A) At the top of
the front panel of the label, set In type
of the same minimum sizes as required
for human hazard signal words (see
table in { 162.10(h)(lXiv», and appear-
ing with sufficient prominence relative
to other text and graphic material on
the front panel to make it unlikely to
be overlooked under customary condi-
tions of purchase and use. the state-
ment "Restricted Use Pesticide" shall
appear.
(B) Directly below this statement on
the front panel, a summary statement
of the terms of restriction imposed as
a precondition to registration shall
appear. If use is restricted to certified
applicators, the following statement is
required: "For retail sale to and use
only by Certified Applicators or per-
sons under their direct supervision and
only for those uses covered by the Cer-
tified Applicator's certification." If.
however, other regulatory restrictions
are Imposed, the Administrator will
define the appropriate wording for the
terms of restriction by regulation.
(k) Advertising. [Reserved]
[40 PR 28268. July 3. 1975: 40 FR 32329.
Aug. 1. 1975: 40 FR 36571. Aug. 21. 1975. u
•mended at 43 FR 5786. Feb. 9. 1978]
-93-
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Criteria
PHYS/CHEM-1
PHYSICAL/CHEMICAL HAZARDS
Required Label Statement
I. Pressurized Containers
A. Flashpoint at or below
20°F; or if there is a
flashback at any valve
opening.
Flashpoint above 20°F
and not over 80°F; or
if the flame extension
is more than 18 inches
long at a distance of
6 inches from the
valve opening.
All Other Pressurized
Containers
II. Non-Pressurized Containers
A. Flashpoint at or below
20°F.
B. Flashpoint above 20°F
and not over 80°F.
C. Flashpoint over 80°F
and not over 150°F.
D. Flashpoint above
150°F.
Extremely flammable.
Contents under pressure.
Keep away from fire, sparks,
and heated surfaces. Do not
puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Flammable. Contents under
pressure. Keep away from
heat, sparks, and flame. Do
not puncture or incinerate
container. Exposure to
temperatures above 130°F
may cause bursting.
Contents under pressure.
Do not use or store near
heat or open flame. Do not
puncture or 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.
None required.
-94-
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STORAGE INSTRUCTIONS FOR PESTICIDES
Heading;
All products are required to bear specific label instructions
about storage and disposal. Storage and disposal instructions
must be grouped together in the directions for use portion of
the label under the heading STORAGE AMD DISPOSAL. Products
intended solely for domestic use need not include the heading
"STORAGE AND DISPOSAL."
Storage Instructions;
All product labels are required to have appropriate storage
instructions. Specific storage instructions are not prescribed.
Each registrant must develop his own storage instructions,
considering, when applicable, the following factors:
1. Conditions of storage that might alter the composition or
usefulness of the pesticide. Examples could be temperature
extremes, excessive moisture or humidity, heat, sunlight,
friction, or contaminating substances or media.
2. Physical requirements of storage which might adversely
affect the container of the product and its ability to
continue to function properly. Requirements might include
positioning of the container in storage, storage or damage
due to stacking, penetration of moisture, and ability to
withstand shock or friction.
3. Specifications for handling the pesticide container,
including movement of container within the storage area,
proper opening and closing procedures (particularly for
opened containers), and measures to minimize exposure
while opening or closing container.
4. Instructions on what to do if the container is damaged in
any way, or if the pesticide is leaking or has been
spilled, and precautions to minimize exposure if damage occurs
5. General precautions concerning locked storage, storage in
original container only, and separation of pesticides
during storage to prevent cross-contamination of other
pesticides, fertilizer, food, and feed.
6. General storage instructions for household products should
emphasize storage in original container and placement in
locked storage areas.
-95-
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PEST/DIS-1
PESTICIDE DISPOSAL INSTRUCTIONS
The label of all products, except those intended solely for domestic
use, must bear explicit instructions about pesticide disposal. The
statements listed below contain the exact wording that must appear on
the label of these products:
1. The labels of all products, except domestic use, must contain the
statement, "Do not contaminate water, food, or feed by storage or disposal."
2. Except those products intended solely for domestic use, the labels
of all products that contain active ingredients that are Acute Hazardous
Wastes or are assigned to Toxicity Category I on the basis of oral or
dermal toxicity, or Toxicity Category I or II on the basis of acute
inhalation toxicity must bear the following pesticide disposal statement:
"Pesticide wastes are acutely hazardous. Improper disposal of
excess pesticide, spray mixture, or rinsate is a violation of Federal
Law. if these wastes cannot be disposed of by use according to
label instructions, contact your State Pesticide or Environmental
Control Agency, or the Hazardous Waste representative at the nearest
EPA Regional Office for guidance."
3. The labels of all products, except those intended for domestic use,
containing active or inert ingredients that are Toxic Hazardous Wastes
or meet any of the criteria in 40 CFK 261, Subpart C for a hazardous
waste must bear the following pesticide disposal statement:
"Pesticide wastes are toxic. Improper disposal of excess pesticide,
spray mixture, or rinsate is a violation of Federal Law. If these
wastes cannot be disposed of by use according to label instructions,
contact your State Pesticide or Environmental Control Agency, or the
Hazardous Waste representative at the nearest EPA Regional Office
for guidance."
4. Labels for all other products, except those intended for domestic
use, must bear the following pesticide disposal statement:
"Wastes resulting from the use of this product may be disposed of on
site or at an approved waste disposal facility."
5. Products intended for domestic use only must bear the following
disposal statement: "Securely wrap original container in several layers
of newspaper and discard in trash."
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CONTAINER DISPOSAL INSTRUCTIONS
The label of each product must bear container disposal
instructions appropriate to the type of container.
1. Domestic use products must bear one of the following
container disposal statements:
Container Type
Statement
Non-aerosol products
(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 bay. Discard bag in trash.
Replace cap and discard containers in
trash. Do not incinerate or puncture.
2. All other products must
based on container type, listed
,'/
Container Type
bear container disposal
below:
Statement
i nstructions,
Metal
containers
(non-aerosol)
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.
Plastic containers
Triple rinse (or equivalent). Then offer
for recycling or reconditioning, or puncture
and dispose of in a sanitary landfill, or
incineration, or, if allowed by state and
local authorities, by burning. If burned,
stay out of smoke.
stay out ot smoKe.
Triple rinse (or equivalent). Then dispose
of in a sanitary landfill or by other
approved state and local procedures.
P/-Mn»^1 *i *- £* 1 t» am r\ *- \ 7 1 i r» *i v- Ktr e H a U- i rwi a r» rl
Glass containers
Fiber drums
with liners
Completely empty liner by shaking and
tapping sides and bottom to loosen clinging
particles. Empty residue into application
equipment. Then dispose of liner in a
sanitary landfill or by incineration if
allowed by state and local authorities.
If drum is contaminated and cannot he
reused^, 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.
Paper and
plastic bags
Compressed gas
cylinders
Return empty cylinder
similar wording)
for reuse (or
Manufacturer may replace this phrase with one indicating
whether and how fiber drum may be reused.
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GUIDE TO USE OF THIS BIBLIOGRAPHY
CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Standard. Primary sources for studies in this
bibliography have been the body of data submitted to EPA
and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they have
been considered, will be included.
UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study." In the case of published materials,
this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency
has sought to identify documents at a level parallel to
the published article from within the typically larger
volumes in which they were submitted. The resulting
"studies" generally have a distinct title (or at least a
single subject), can stand alone for purposes of review,
and can be described with a conventional bibliographic
citation. The Agency has attempted also to unite basic
documents and commentaries upon them, treating them as a
single study.
IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by "Master Record Identifier," or
MRID, number. This number is unique to the citation, and
should be used at any time specific reference is required.
It is not related to the six-digit "Accession Number"
which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for a further explana-
tion. In a few cases, entries added to the bibliography
late in the review may be preceded by a nine-character
temporary identifier. These entries are listed after
all MRID entries. This temporary identifier number is
also to be used whenever specific reference is needed.
FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
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Author. Whenever the Agency could confidently identify
one, the Agency has chosen to show a personal author.
When no individual was identified, the Agency has
shown an identifiable laboratory or testing facility
as author. As a last resort, the Agency has shown
the first submitter as author.
Document Date. When the date appears as four digits
with no question marks, the Agency took it directly
from the document. When a four-digit date is followed
by a question mark, the bibliographer deduced the
date from evidence in the document. When the date
appears as (19??), the Agency was unable to determine
or estimate the date of the document.
Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a document
title. Any such editorial insertions are contained
between square brackets.
Trailing Parentheses. For studies submitted to the
Agency in the past, the trailing parentheses include
(in addition to any self-explanatory text) the fol-
lowing elements describing the earliest known submission:
(1) Submission Date. The date of the earliest known
submission appears immediately following the word
"received."
(2) Administrative Number. The next element,
immediately following the word "under," is the
registration number, experimental use permit
number, petition number, or other administrative
number associated with the earliest known submission,
(3) Submitter. The third element is the submitter,
following the phrase "submitted by." When
authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library-" This accession number is in turn
followed by an alphabetic suffix which shows the
relative position of the study within the volume.
For example, within accession number 123456, the
first study would be 123456-A; the second, 123456-
B; the 26th, 123456-Z; and the 27th, 123456-AA.
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Foonaldehyde/paraformaldehyde Standard
MRID CITATION
00043591 Abbott, D.D. (1970) Eye Irritation—Rabbit: Report L&H 72158-2.
(Unpublished study including letter dated May 19, 1970 from D.D.
Abbott to Charles Kaitz, received Jun 1, 1970 under 6035-33;
prepared by La Wall and Harrisson Research Laboratories, Inc.,
submitted by Vineland Laboratories, inc., Vineland, N.J.; CDL:
107119-A)
00043592 Abbott, D.D. (1970) Primary Skin irritation—Rabbit: Report L&H
72158-2. (Unpublished study including letter dated May 19, 1970
from D.D. Abbott to Charles Kaitz, received Jun 1, 1970 under
6035-33; prepared by La Wall and Harrisson Research Laborato-
ries, submitted by Vineland Laboratories, inc., Vineland, N.J.;
CDL:107119-B)
00051255 Cotchan, T.; Siegmund, E. (1961) Letter sent to S. Krop dated May
12, 1961: Glutaraldehyde, local toxicity. (Unpublished study
received May 12, 1961 under unknown admin, no.; prepared by
Ethicon, Inc., submitted by Surgikos, Inc., Arlington, Tex.;
CDL:104808-A)
00054714 Marzulli, F.N.; Maibach, H.I. (1973) Antimicrobials: Experimental
contact sensitization in man. journal of the Society of Cos-
metic Chemists 24:399-421. (Also in unpublished submission re-
ceived Nov 16, 1976 under 1258-840; submitted by Olin Corp.,
Stamford, Conn.; CDL:226870-X)
00056308 Skog, E. (1950) A toxicological investigation of lower aliphatic
Aldehydes: I. Toxicity of Formaldehyde, Acctaldehyde, Propional-
dehyde and Butyraldehyde; as well as of Acrolein and Crotonal-
dehyde. Acta Pharmacologica et Toxicologica 6:299-318. (Also
in unpublished submission received Oct 6, 1976 under 52-231;
submitted by West Chemical Products, Inc., Lynbrook, N.Y.; CDL:
226499-A)
00056309 Carpenter, C.P.; Smyth, H.F., Jr.; Pozzani, u.C. (1949) The assay
of acute vapor toxicity, and the grading and interpretation of
results on 96 chemical compounds. Journal of industrial Hygiene
& Toxicology 31(6):343-346. (Also in unpublished submission re-
ceived oct 6, 1976 under 52-231; submitted by West Products,
inc., Lynbrook, N.Y.; CDL:226499-B)
00060059 Baroid (19??) Primary Eye Irritation Data Summary. (Unpublished
study received Mar 28, 1973 under 17664-15; CDL:226787-B)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Formaldehyde/Paraformaldehyde Standard
MRID CITATION
00065508 Cannon Laboratories, Incorporated (1975) Summary of Preservative
DF-35 # 3T1522: Laboratory Nos. 5E-6921, 5E-6923, 5E-6924, 5E-
6922. (Unpublished study received Jan 11, 1977 under 10000-4;
submitted by Hallemite Lehn & Fink, Montvale, N.J.; CDL:
229296-A)
00065511 Becker, J.; Parke, G.S.E. (1975) Acute Dermal LD50 Study on Rab-
bits. (Unpublished study received Jan 11, 1977 under 10000-4;
prepared by Cannon Laboratories, inc., submitted by Hallemite
Lehn & Fink, Montvale, N.J.; CDL:229296-D)
00065514 St. Pierre, F.; Parke, G.S.E. (1976) Report on primary Dermal Ir-
ritation Study in Rabbits: Laboratory No. 6E-4231. (Unpublished
study received Jan 11, 1977 under 10000-4; prepared by Cannon
Laboratories, inc., submitted by Hallemite Lehn & Fink, Mont-
vale, N.J.; CDL:229296-G)
00065516 Becker, J.; Parke, G.S.E. (1976) Report on Rabbit Eye Irritation:
Laboratory No. 6E-3481. (Unpublished study received Mar 31,
1977 under 10000-5; prepared by Cannon Laboratories, inc., sub-
mitted by Hallemite Lehn & Fink, Montvale, N.J.; CDL:229284-B)
00065517 Becker, J.; Parke, G.S.E. (1976) Report on Primary Dermal Irrita-
tion Study in Rabbits: Laboratory No. 6E-3480. (Unpublished
study received Mar 31, 1977 under 10000-5; prepared by Cannon
Laboratories, inc., submitted by Hallemite Lehn & Fink, Mont-
vale, N.J.; CDL:229284-E)
00066997 McGee, G.J.; Freeman, L. (1971) LD50—Rats; Primary Skin irrita-
tion—Rabbits; Primary Eye irritation—Rabbits: Experimental
Reference No. A-451. (Unpublished study received Mar 13, 1972
under 10865-1; prepared by KG Laboratories, Inc., submitted by
DDR Pharmaceutical Corp., Copiaque, N.Y.; CDL:100197-A)
00069393 McGee, G.J.; Goldhamer, R.E. (1972) Acute inhalation: Experimental
Reference No. A-451. (Unpublished study received Mar 15, 1972
under 10865-1; prepared by Bicmetric Testing, inc., submitted by
DDR Pharmaceutical Corp., Copiaque, N.Y.; CDL:100196-A)
00075459 Biesemeier, J.A. (1976) Report: WARF institute No. 6041564. (Un-
published study received Jul 12, 1976 under 1677-77; submitted
by Economics Laboratory, Inc., St. Paul, Minn.; CDL:233683-A)
00079674 Moldovan, M. (1971) Rabbit Eye Irritation Study: I.B.L. No. 8870.
(Unpublished study received Feb 9, 1977 under 15382-14; prepared
by Food and Drug Research Laboratories, inc., submitted by Kalo
Laboratories, Inc., Kansas City, MO.; CDL:235651-D)
-101-
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations under the FormaIdehyde/Paraformaldehyde Standard
MRID CITATION
00082130 Horton, A.W.; Tye, R.; Stemmer, K.L. (1963) Experimental carcino-
genesis of the lung: Inhalation of gaseous formaldehyde or an
aerosol of coal tar by C3H mice. Journal of the National Cancer
institute 30(1):31-40. (Published study; CDL:095382-R)
00082132 Salem, H.; Cullumbine, H. (1960) Inhalation toxicities of some
aldehydes. Toxicology and Applied pharmacology 2:183-187. (Al-
so in unpublished submission received Oct 15, 1973 under 4G1438;
submitted by Chevron Chemical Co., Richmond, Calif.; CDL:
095382-T)
00082134 Coon, R.A.; Jones, R.A.; Jenkins, L.J., Jr.; et al. (1970) Animal
inhalation studies on ammonia, ethylene glycol, formaldehyde,
dimethyl amine, and ethanol. Toxicology and Applied Pharmacology
16:646-655. (Also in unpublished submission received Oct 15,
1973 under 4G1438; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:095380-W)
00082145 Mills, S.C.; Sharry, L.F.; Cook, L.J.; et al. (1972) Metabolism of
14C formaldehyde when fed to ruminants as an aldehyde-
casein-oil complex. Australian Journal of Biological Science
25:807-816. (Also in unpublished submission received Oct 15,
1973 under 4G1438; submitted by Chevron Chemical Co., Richmond,
Calif.; CDL:095383-L)
00082147 Chevron Chemical Company (19??) Metabolism of Cl4-Formaldehyde
in Mice. (Unpublished study, including published data, received
Oct 15, 1973 under 4G1438; CDL:095383-N)
00082153 Chevron Chemical Company (1972) Determination of Residues of Ortho
13,745 and Two of Its Metabolites in Corn: File No. 740.01.
Method RM-15-2 dated Sep 15, 1972. (Unpublished study received
Oct 15, 1973 under 4G1438; CDL:095383-U)
00096223 Marzulli, F.N.; Maibach, H.I. (1974) The use of graded concentra-
tions in studying skin sensitizers: Experimental contact sen-
sitization in man. Food and Cosmetics Toxicology 12(2):219-227.
(Also in unpublished submission received Mar 3, 1975 under 100-
491; submitted by Ciba-Geigy Corp., Greensboro, N.C.; CDL:
140055-0)
00101857 Bentley, R. (1975) Acute Toxicity of Ten Baroid Compounds to Blue-
gill ... and Rainbow Trout (Salmo gairdneri). (Unpublished
study received May 20, 1975 under 17664-8; prepared by Biono-
mics/ EG & G, submitted by Baroid, Div. of N.L. industries,
inc., Houston, TX; CDL:222885-A)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Formaldehyde/Paraformaldehyde Standard
MRID CITATION
00117674 Davis, T.; Battista, S.; Kensler, C. (1965) Effect of Cigarette
Smoke, Acrolein and Formaldehyde on Pulmonary Function. Taken
from: Source unknown 24(2). (Abstract 2147; also in unpub-
lished submission received Jun 17, 1976 under 201-118; submit-
ted by Shell Chemical Co., Washington, DC; CDL:224738-A)
00119785 Arthur D. Little, Inc. (1966) Acute Toxicity of Mold-X in Rats,
Rabbits and Guinea pigs: C-68441. (Unpublished study received
Sep 5, 1967 under 9870-1; submitted by Span Assoc., Inc., Oil
City, PA; CDL:100671-A)
00122750 Fink, R.; Beavers, J.; Brcwn, R.; et al. (1981) Eight-day Dietary
LC50—Bobwhite Ouail: 10318001: MEHSL Study No. 2001-80. Final
rept. (Unpublished study received Dec 20, 1982 under 359-708;
prepared by Wildlife international Ltd. and Washington College,
submitted by Rhone-Poulenc, inc., Monmouth Junction, NJ; CDL:
071322-D)
00123774 Chevron Chemical Co. (1973) The Results of Tests on the Amount of
Residue MBP Remaining, including a Description of Analytical
Methods Used. (Compilation; unpublished study received 1973 un-
der 4G1438; CDL:093832-AL)
00124552 Phillips, L.; Steinberg, M.; Maibach, H.; et al. (1972) A compar-
ison of rabbit and human skin response to certain irritants.
Toxicology and Applied Pharmacology 21:369-382. (Also in unpub-
lished submission received 1972 under 4G1438; submitted by Chev-
ron Chemical Co., Richmond, CA; CDL:093832-P)
00124671 Koivusalo, M. (1956) Studies on the metabolism of methanol and
formaldehyde in the animal organism. Acta physiological Scandi-
navica 39(131) :9-103. (Also in unpublished submission received
Apr 15, 1974 under 4F1488; submitted by Celanese Chemical Co.,
Dallas, TX; CDL-.094622-B)
00124672 Malorny, G.; Rietbrock, N.; Schneider, M. (1965) The Oxidation of
Formaldehyde to Formic Acid in Blood: Investigation of the
Metabolism of Formaldehyde. A translation of: Die oxydation
des formaldehyds zu ameisensaure im blut, ein beitrag zum
stoffwechsel des formaldehyds. Naunyn-Schmiedebergs Arch. Exp.
Path. U. Pharmak. 250:419-436. (Unpublished study received
Apr 15, 1974 under 4F1488; submitted by Celanese Chemical Co.,
Dallas, TX; CDL:094622-C)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Formaldehyde/Paraformaldehyde Standard
MRID CITATION
00124679 Celanese Chemical Co. (1973) Analtyical Methods: Formaldehyde.
(Compilation; unpublished study received Apr 15, 1974 under
4F1488; CDL:094622-J)
00126394 Heitmuller, T. (1975) Acute Toxicity of Surflo-B17 to Larvae of
the Eastern Oyster ..., pink Shrimp ..., and Fiddler Crabs
(Uca pugilator). (Unpublished study received Jul 15, 1975
under 17664-5; prepared by Bionomics—EG & G, Inc., submitted
by Baroid Div., N.L. industries, inc., Houston, TX; CDL:
222880-A)
00126396 Heitmuller, T. (1975) Acute Toxicity of Surflow-B19 to Larvae of
the Eastern Oyster ..., pink Shrimp ..., and Fiddler Crabs
(Uca pugilator). (Unpublished study received Jul 15, 1975
under 17664-15; prepared by Bionomics—EG & G, Inc., submitted
by Baroid Div., N.L. Industries, inc., Houston, TX; CDL:
222884-A)
00127059 Gainer, A. (1972) Results of Analyses: Rats—Rabbits: Lab No. A-
4894. (Unpublished study received Jan 18, 1973 under 17664-5;
prepared by Analytical and Testing Laboratories, submitted by
Baroid, Div. of N.L. industries, Inc., Houston, TX; CDL:
004622-B)
00127060 Baroid (1972) Surflo B19: Toxicity Study—Rats and other Sub-
jects. (Compilation; unpublished study received Jan 18, 1973
under 17664-15; CDL:004629-A)
00127069 Thomas R.; Murdock M. (1970) Subacute Studies—Chickens: Oral.
(Unpublished study received jun 30, 1970 under 9600-1; submitted
by Deist Chemical & Research Co., Anaheim, CA; CDL:005886-A)
00127071 Thonas, R.; Murdock, M. (1970) Eye Toxicity—Rabbits: 2 Weeks.
(Unpublished study received jun 30, 1970 under 9600-1; submitted
by Deist Chemical & Research Co., Anaheim, CA; CDL:005886-C)
00127500 Gainer, A. (1972) Results of Analyses: Surflo B-19L Rats, Rab-
bits: Lab No. A-4894. (unpublished study received Jan 18, 1973
under 17664-15; prepared by Analytical and Testing Laboratories,
submitted by Baroid Div., N.L. Industries, Inc., Houston, TX;
CDL:237199-A)
00127503 Levenstein, I. (1979) LD50 Test: Rabbits: Green Liquid #2812: As-
say No. 93445. (Unpublished study received Jan 23, 1979 under
2596-71; prepared by Leberco Laboratories, submitted by Hartz
Mountain Corp., Harrison, NJ; CDL:237325-A)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be part of the Data Base Supporting
Registrations Under the Formaldehyde/paraformaldehyde Standard
MRID CITATION
00128086 Heitmuller, T. (1975) Acute Toxicity of Surflo-B16 to Larvae of
the Eastern Oyster ..., pink Shrimp ..., and Fiddler Crabs
(Uca pugilator). (Unpublished study received Jul 15, 1975
under 17664-9; prepared by Bionomics—EG & G, Inc., submitted
by Baroid Div., N.L. industries, inc., Houston, TX; CDL:
222882-A)
00132485 Bills, T.; Marking, L.; Chandler, J. (1977) Formalin: Its toxicity
to nontarget aquatic organisms, persistence, and counteraction.
Pages 1-7, in U.S. Fish Wildl. Serv. invest. Fish Control, 73.
S.I.: s.n.. (Also in unpublished submission received Oct 26,
1983 under 44797-15; submitted by NL Treating Chemicals/NL In-
dustries, Inc., Houston, TX; CDL:251681-A)
00132488 Henson, E. (1959) The toxicology of some aliphatic aldehydes.
Journal of Occupational Medicine l(Aug):457-462. (Also in un-
published submission received oct 26, 1983 under 44797-15; sub-
mitted by NL Treating Chemicals/NL Industries, Inc., Houston,
TX; CDL:251682-B)
00132490 Carpenter, C.; Smyth, H. (19??) Chemical burns of the rabbit cor-
nea. Source unknown 29:1363-1372. (Also in unpublished sub-
mission received Oct 26, 1983 under 44797-15; submitted by NL
Treating Chemicals/NL Industries, Inc., Houston, TX; CDL:
251682-E)
00132492 Auerbach, C.; Moutschen-Dahmen, M.; Moutschen, J. (1977) Genetic
and cytogenetical effects of formaldehyde and related compounds.
Mutation Research 39:317-347. (Also in unpublished submission
received Oct 26, 1983 under 44797-15; submitted by NL Treating
Chanicals/NL Industries, inc., Houston, TX; CDL:251682-G)
00132494 Griesemer, R.; Ulsamer, A.; Arcos, J.; et al. (1982) Report of the
Federal Panel on Formaldehyde. Environmental Health Perspec-
tives 43(Feb):139-168. (Also in unpublished submission received
Oct 26, 1983 under 44797-15; submitted by NL Treating Chemicals/
NL industries, inc., Houston, TX; CDL:251682-I)
00134117 Bryant, H. (1967) 971 Germicide Sterilized Vinyl Plastic (PVC); 971
Germicide Sterilized Rubber Material; Cidex Germicide Sterilized
Plastic (PVC); Cidex Germicide Sterilized Rubber Material:
Project HRC 929. (Unpublished study received Feb 27, 1968 under
unknown admin, no.; submitted by ?; CDL:117595-C)
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OFFICE OF PESTICIDE PROGRAMS
REGISTRATION STANDARD BIBLIOGRAPHY
Citations Considered to be Part of the Data Base Supporting
Registrations Under the Formaldehyde/Paraformaldehyde Standard
MRID CITATION
00137247 Juhr, V.; Klomburg, S.; Haas, A. (1978) Trankwassersterilisation
mit peressigsaure. Z. Versuchstierk. 20:65-72. (Also in un-
published submission received Jan 27, 1984 under 887-46; sub-
mitted by Bonewitz Chemical Services, Inc., Burlington, IA,
CDL:252312-G)
00137297 Exxon Corp. (1973?) Formaldehyde: Toxicity in Animals. (Unpub-
lished study received Jan 30, 1984 under IL 84/1; submitted by
State of Illinois, Springfield, IL; CDL:252394-A)
00148770 N.L. Treating Chemical Co. (1985) Acute Toxicological Evaluations
of Estuarine Organisms...unpublished compilation prepared by
EnviroSystems, Inc. in cooperation with Anatec Laboratories.
34 p.
00148772 Miller, p. (1985) Acute Toxicity of Formalin on Daphnia magna.
Unpublished study prepared by N L. Treating Chemicals. 29 p.
00148773 Fletcher, D. (1983) 8-Day Dietary LC50 Study with Surflo-B315 in
Bobwhite Quail: BLAL No. 83 QC 39. Unpublished study prepared
by Bio-Life Associates. 17 p.
00148774 Fletcher, D. (1984) Acute Toxicity Study with Surflo-B315 in Bob-
white Quail: BLAL No. 83 QD 38. Unpublished study prepared by
N.L. Treating Chemicals. 20 p.
00148775 Fletcher, D. (1983) 8-Day Dietary LC50 Study with Surflo-B315 in
Mallard Ducklings: BLAL No. 83 DC 40. Unpublished study pre-
pared by Bio-Life Associates, Ltd. 17 p.
GS0556-001 Committee on Toxicology (1980) Formaldehyde: An Assessment of
Its Health Effects. Unpublished study prepared by Board on
Toxicology and Environmental Health Hazards, National Research
Council, National Academy of Sciences, under contract N000014-
79-C-0049 to the Office of Naval Research. 45 p.
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Form Approved. OMB No. 2070-0057. Approval expires 11-30-89.
FIFHA SECTION: 3(C)(2)(li) SUMMARY SHEET
EPA REGISTRATION NO.
PRODUCT NAME
APPLICANT'S NAME
DATE GUIDANCE DOCUMENT ISSUED
With respect to the requirement to submit "generic" data imposed by the FIFRA section 3(C)(2)(B) notice contained in the referenced
Guidance Document, I am responding in the following manner:
G 1. I will submit data in a timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or are not
specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, OECD
Chemicals Testing Programme, I enclose the protocols that I will use:
O 2. I have entered into an agreement with one or more other registrants under FIFRA section 3(C)(2)(B)(ii) to satisfy the fallowing data
requirements. The tests, and any required protocols, will be submitted to EPA by:
NAME OF OTHER REGISTRANT
G 3. I enclose a completed "Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data" with
respect to the following data requirements:
G 4. I request that you amend my registration by deleting the following uses (this option is not available to applicants for new products):
G 5. I request voluntary cancellation of the registration of this product. (This option is not available to applicants for new products.)
REGISTRANT'S AUTHORIZED REPRESENTATIVE
SIGNATURE
DATE
EPA Form 8580-1 (10-82)
-107-
-------
Fomi Aoorovcd. OMB No. 2070-0057. Exolrw 11-30-89
(To qualify, certify ALL four items)
CERTIFICATION OF ATTEMPT TO ENTER
INTO AN AGREEMENT WITH OTHER REGISTRANTS
FOR DEVELOPMENT OF DATA
1. I am duly authorized to represent the following firm{s) who are subject to the require-
ments of a Notice under FIFRA Section 3(c)(2)(B) contained in a Guidance Document
to submit data concerning the active ingredient:
GUIDANCE DOCUMENT DATE
ACTIVE INGREDIENT
NAME OF FIRM
EPA COMPANY NUMBER
(This firm or group of firms is referred to below as "my firm".)
2. My firm is willing to develop and submit the data as required by that Notice, if necessary. However, my firm would prefer to enter
into an agreement with one or more other registrants to develop jointly, or to share in the cost of developing, the following required
items or data:
3. My firm has offered in writing to enter into such an agreement. Copies of the offers are attached. That offer was irrevocable and included an offer to be
bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(iii) if final agreement on all terms could not be reached otherwise. This offer was made
to the following firm(s) on the following date(s):
NAME OF FIRM
DATE OF OFFER
However, none of those firm(s) accepted my offer.
4. My firm requests that EPA not suspend the registration(s) of my firm's product(s), if any of the firms named in paragraph (3) above
have agreed to submit the data listed in paragraph (2) above in accordance with the Notice. I understand EPA will promptly inform
me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2)(B), (This statement
does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request.
TYPED NAME
SIGNATURE
DATE
EPA Form 8580-6 (10-82)
-108-
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OMB Approval No. 2070-0057 (Expires 11/30/89)
PRODUCT SPECIFIC DATA REPORT
EPA Reg. No.
Date
Registration Standard for
Registration
Guideline No.
§158.120
PRODUCT
CHEMISTRY
61-1
61-2
61-3
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
Name of Test
Identity of
ingredients
Statement of
composition
Discussion of
formation of
ingredients
Preliminary
analysis
Certification of
limits
Analytical methods
for enforcement
limits
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk-
density, or
specific gravity
Solubility
Vapor pressure
Dissociation
constant
Oc tanol/wa ter
partition
coefficient
pH
Test not
required
for my
product
listed
above
(check
below)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
For EPA Use Only)
MRID Numbers
Assigned
EPA Form 8580-4
-109-
-------
Registration
Guideline No.
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
§158.135
TCKICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
Name of Test
Stability
Oxid i z i ng/r educ i ng
reaction
Flammability
Explodability
Storage stability^
Viscosity
Miscibility
Corrosion
character ist ics
Dielectric break-
down voltage
Acute oral
toxicity, rat
Acute dermal
toxicity, rabbit
Acute inhalation,
toxicity, rat
Primary eye
irritation, rabbit
Primary dermal
irritation
Dermal sensitiza-
tion
Test not
required
for my
product
listed
above
( check
below)
I am complying with
data requirements by
Citing MRID
Number or
EPA Accession
Number
Submit-
ting
Data
(At-
tached)
(For EPA Use Only)
MRID Numbers
Assigned
-110-
-------
OMB Approval No. 2070-0057
Expiration Date 11/30/89
GENERIC DATA EXEMPTION STATEMENT
EPA Product Registration Number:
Registrant's Name and Address:
As an authorized representative of the registrant of the product identified
above, I certify that:
(1) I have read and am familiar with the terms of the Notice from EPA dated
concerning a requirement for submission of generic data on the
active ingredient named under FIFRA Section 3(c) (2) (B).
(2) My firm requests that EPA not suspend the registration of our product,
despite our lack of intent to submit the generic data in question, on the grounds
that the product contains the active ingredient solely as the result of the
incorporation into the product of another product which contains that active
ingredient, which is registered under FIFRA Section 3, and which is purchased by
us from another producer.
(3) An accurate Confidental Statement of Formula(CSF) for the above-identified
product is attached to this statement. That formula statement indicates, by
company name, registration number, and product name, the source of the subject
active ingredient in my firm's product, or
The CSF dated on file with EPA is complete, current and accurate and
contains the information requested on the current CSF Form No. 8570-4. The
registered source(s) of the above named active ingredient in my product(s) is/are
and their registration number(s) is/are .
(4) My firm will apply for an amendment to the registration prior to changing
the source of the active ingredient in our product to one that is not registered
and purchased.
(5) I understand, and agree on behalf of my firm, that if at any time any
portion of this Statement is no longer true, or if my firm fails to comply with
the undertakings made in this Statement, my firm's product's registration may be
suspended under FIFRA Section 3(c)(2)(B).
(6) I further understand that if my firm is granted a generic data exemption
for the product, my firm relies on the efforts of other persons to provide the
Agency with the required generic data. If the registrant(s) who have committed
to generate and submit the required data fail to take appropriate steps to meet
requirements or are no longer in compliance with this Notice's data requirements,
the Agency will consider that both they and my firm are not in compliance and
will normally initiate proceedings to suspend the registrations of my firm's
product(s) and their product(s), unless my firm commits to submit and submits
the required data in the specified time frame. I understand that, in such cases,
the Agency generally will not grant a time extension for submitting the data.
Registrant's authorized representative:
(Signature)
Dated:
(Typed)
EPA Form 8570-27
-111-
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