540/RS-92-186
United StctM Office of September 1991
Environmental Protection Pesticide Programs
Agency
Reregistration
Eligibility Document
(RED)
Sodium Diacetate
-------
REREGISTRATION ELIGIBILITY DOCUMENT
SODIUM DIACETATB
LIST D
CASE 4001
ACETIC ACID
SEPTEMBER 1991
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
WASHINGTON, D.C.
-------
SODIUM DIACETATE REREGISTRATION ELIGIBILITY TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Branch
Steve Jarboe Biological Analysis Branch
Richard Michell Biological Analysis Branch
Gail Tomimatsu Biological Analysis Branch
Phyllis Johnson Biological Analysis Branch
Environmental Fate and Effects Division
Martha Sager Science Analysis and Coordination Staff
Betsy Grim Science Analysis and Coordination Staff
Roy Bingham Environmental Fate and Groundwater Branch
John Noles Ecological Effects Branch
Health Effects Division
Esther Saito Science Analysis and Coordination Branch
Pat McLaughlin Toxicology Branch II
Laura Morris Occupational and Residential Exposure Branch
Christine Olinger Chemistry Branch II - Reregistration Support
Program Management and Support Division
Maureen Sherrill Information Services Branch
Registration Division
Sidney Jackson Herbicide-Fungicide Branch
Pat Critchlow Registration Support Branch
Special Review and Reregistration Division
Barbara Briscoe Accelerated Reregistration Branch
Kathy Davis Accelerated Reregistration Branch
Jean Frane
Eran Gasko
Policy and Special Projects Staff
Office of General Counsel
Beverly Updike Office of Compliance Monitoring
-------
TABLE OF CONTENTS
PAGE
GLOSSARY OF TERMS AMD ABBREVIATIONS
EXECUTIVE SUMMARY
I. INTRODUCTION 1
II. ACTIVE INGREDIENT8 COVERED BY THE REREGISTRATION ELIGIBILITY
DECISION DOCUMENT 2
A. IDENTIFICATION OF ACTIVE INGREDIENT 2
B. USE PROFILE 2
C. REGULATORY HISTORY 3
III. AGENCY ASSESSMENT OF ACTIVE INGREDIENT 4
A. DESCRIPTION OF ACTIVE INGREDIENT
AND ASSESSMENT OF PRODUCT CHEMISTRY 4
B. HUMAN HEALTH ASSESSMENT 5
1. TOXICOLOGY DATA 5
2. DIETARY EXPOSURE 8
3. OCCUPATIONAL EXPOSURE 9
4. HUMAN RISK ASSESSMENT 10
C. ENVIRONMENTAL ASSESSMENT 10
1. ENVIRONMENTAL FATE ASSESSMENT 10
2. ECOLOGICAL EFFECTS ASSESSMENT 11
3. ENVIRONMENTAL RISK ASSESSMENT 11
IV. REREGISTRATION DECISION FOR SODIUM DIACETATE 11
A. DETERMINATION OF ELIGIBILITY 11
B. ADDITIONAL GENERIC DATA REQUIREMENTS 12
C. LABELING REQUIREMENTS 12
V. PRODUCT REREGISTRATION 12
A. DETERMINATION OF ELIGIBILITY 12
-------
' B. PRODUCT-SPECIFIC DATA REQUIREMENTS 12
C. LABELING REQUIREMENTS 13
APPENDICES
A. APPENDIX A - USE PATTERNS SUBJECT TO REREOISTRATION
FOR 80DIUM DIACETATE 15
B. APPENDIX B - GENERIC DATA REQUIREMENTS FOR REREGI8TRATI0N
OF SODIUM DIACETATE AND DATA CITATIONS SUPPORTING
REREOISTRATION
1. GUIDE TO APPENDIX B 18
2. PRODUCT CHEMI8TRT 19
3. RESIDUE CHEMISTRY 20
4. TOXICOLOGY 21
5. ECOLOGICAL EFFECT8 21
6. ENVIRONMENTAL FATE 21
C. APPENDIX C - BIBLIOGRAPHY
1. GUIDE TO APPENDIX C 23
2. BIBLIOGRAPHIC CITATIONS 25
ill
-------
GLOSSARY OF TERMS AND ABBREVIATIONS
CAS Chemical Abstracts Service
CFR Code of Federal Regulations
CSF Confidential Statement of Formula
EPA U.S. Environmental Protection Agency
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
GRAS Generally Recognized As Safe
MRID Master Record Identification (number). EPA's system of
recording and tracking studies submitted to the EPA.
ppm parts per million
RED Reregistration Eligibility Document
-------
EXECUTIVE SUMMARY
The Environmental Protection Agency first registered a
pesticide product containing sodium diacetate in 1968. Currently,
sodium diacetate is registered in two end-use products as a
fungicide and bactericide to prevent spoilage in post harvest
feed crops. Both of the two registered products contain sodium
diacetate as a single active ingredient.
The data base to support the reregistration of sodium
diacetate is sufficient to allow the Agency to conduct
reasonable risk assessments for these registered uses of sodium
diacetate. These data support the Agency conclusion that the uses
of sodium diacetate will not result in an unreasonable public
health risk or unreasonable adverse effects to the environment.
The Agency has conducted a tolerance risk assessment for sodium
diacetate and our conclusions are discussed in Section III.B.2.
Therefore, the Agency has determined that all products containing
sodium diacetate as an active ingredient are eligible for
reregistration.
Before reregistering each product, the Agency is requiring
product specific data to be submitted within eight months of the
issuance of this document. After reviewing these data and
labels, the Agency will determine the reregistration eligibility
of a product based on whether or not that product meets the
requirements in section 3(c)(5) of the Act, that is, whether the
product composition and labeling are acceptable and the product's
uses will not cause unreasonable adverse effects to the
environment. If these conditions are met, EPA will reregister the
products.
Active ingredients subject to reregistration in this case
included the chemical acetic acid. Since there are currently no
products registered with acetic acid as an active ingredient,
this document only addresses sodium diacetate.
i
-------
I. INTRODUCTION
In 1968, the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) was amended to accelerate the reregistration of
products with active ingredients registered prior to November 1,
1984. The amended Act provides a schedule for the reregistration
process to be completed in nine years. There are five phases to
the reregistration process. The first four phases of the process
focus on identification of data requirements to support the
reregistration of an active ingredient and the generation and
submission of data to fulfill the requirements. The fifth phase
is a review by the U.S. Environmental Protection Agency (referred
to as "the EPA") of all data submitted to support reregistration.
Section 4(g)(2)(A) of FIFRA states that in Phase 5 "the
Administrator shall determine whether pesticides containing such
active ingredient are eligible for reregistration" before calling
in data on products, section (4(g)(2)(B) and either reregistering
products or taking "other appropriate regulatory action",
sections 4(g)(2)(C) and (D). Thus, reregistration involves a
thorough review of the scientific data base underlying a
pesticide's registration. The purpose of the 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" criterion of FIFRA 3(c)(5).
This document presents the EPA's decision regarding the
reregistration eligibility of sodium diacetate. The document
consists of five sections. Section I is this introduction.
Section II describes sodium diacetate, its uses and regulatory
history. Section III discusses the human health and
environmental assessment based on the data available to the EPA.
Section IV discusses the reregistration eligibility decision for
sodium diacetate and Section V discusses product reregistration
requirements. Additional details concerning the Agency's review
of available data are available on request.
The FIFRA list of active ingredients to be reregistered
included acetic acid in this case. As there are no products
currently registered with acetic acid as an active ingredient,
the reregistration eligibility of acetic acid is not an issue.
Acetic acid will be removed from the list of chemicals undergoing
reregistration, and a complete data base to support a
registration with acetic acid will be required by the Agency
prior to the issuance of the registration or amendment.
EPA's reviews of specific reports and information on the
set of registered uses considered for EPA's analyses may
be obtained from: EPA, Freedom of Information, 401 M
St., S.W., Washington, D.C. 20460.
-------
II. ACTIVE INGREDIENT COVERED BY THIS REREGISTRATION ELIGIBILITY
DECISION DOCUMENT
A. IDENTIFICATION OF ACTIVE INGREDIENT
' Chemical Name: Sodium diacetate
CAS Number: 126-96-5
Office of Pesticide Programs Chemical Code Number:
044008
Trade Name: Dykon
Empirical Formula: CH3COONaCH3COOH
B. USE PROFILE FOR SODIUM DIACETATE
Type of Pesticide: Fungicide, bactericide
Pests Controlled: Molds, including most post-harvest
fungi and bacteria associated with soil, grasses, and
terrestrial feed crops.
Registered Use Patterns and Sites: Terrestrial Feed
Crops: Alfalfa (postharvest), clover (postharvest),
field corn (postharvest), grasses (postharvest),
oats (postharvest), sorghum (postharvest), and
timothy (postharvest).
Formulation Types Registered: A 50% dust and a 100%
soluble concentrate / solid formulation are
registered.
Methods of Application:
The products are applied to the hay during the
baling process, using a Gandy 902 JR applicator
with the dust formulation or a pump spray with the
soluble concentrate / solid formulation. The
application rate is determined by the moisture
content of the forage. Forage at 15 to 20 percent
moisture is treated with 1.5 to 2 lbs. of the
active ingredient per ton of forage. Forage with
20 to 25 percent moisture is treated with 2.5 lbs.
of the active ingredient per ton of forage, the
maximum permitted rate.
The products are applied to silage as an "aid" in
fermentation, to preserve corn, hay, sorghum,
oats, and grass stored in conventional upright,
oxygen limiting, pit and bunker silos. The
2
-------
products are applied at the time of chopping or at
the blower when silage is being loaded into the
silo using a Gandy 902 JR applicator with the dust
formulation or a liquid applicator with the
soluble concentrate / solid. Corn, hay, grass,
oats, and sorghum silage at 50 to 70 percent
moisture content is treated with the products at
0.5 to 1 lb. active ingredient per ton of silage;
for high moisture ensiled corn at 25 to 35 percent
moisture, the recommended application rate is 1 to
2 lbs. of the dust or 2 to 3 lbs. of the soluble
concentrate / solid formulation per ton of ensiled
com.
Limitations: Do not use these products on hay with
more than 25 percent moisture content, on silage
with less than 50 or more than 70 percent moisture
content, or on high-moisture ensiled corn with
less than 25 or more than 35 percent moisture
content. With treated hay, bales should be stacked
to maximize ventilation. Hay is to be fed to
livestock and poultry only. Untreated hay must not
be stored on treated hay while curing out. Water
must not be contaminated by cleaning of equipment
or disposal of wastes.
C. REGULATORY HISTORY
In 1968 the Agency first registered a pesticide
product with sodium diacetate as an active ingredient
in a dust formulation, as a food preservative to
control molds and rope-forming bacteria in breads and
cake. Later registrations were issued for products used
on livestock feed crops to preserve the quality of the
feed.
An exemption from tolerance was issued by the
Agency on May 15, 1981 (40 CFR 180.1058), based on the
status of the chemical as Generally Recognized as Safe
(GRAS) (21 CFR 184.1754), for the uses of sodium
diacetate as a post-harvest application fungicide to
the following feeds: alfalfa hay, barley grain, Bermuda
grass hay, blue grass hay, brome grass hay, clover hay,
corn grain, cowpea hay, fescue hay, lespedeza hay,
lupines, oat grain, orchard grass hay, peanut hay,
peavine hay, rye grass hay, sorghum grain, soybean hay,
sudan grass hay, timothy hay, vetch hay, and wheat
grain. This exemption is still appropriate.
3
-------
III. AGENCY ASSESSMENT OF ACTIVE INGREDIENT
The EPA has conducted a thorough review of the scientific
data base for sodium diacetate. Based on the evaluation of these
data, the EPA has no reason to request additional data, except as
confirmatory information.
A. DESCRIPTION OF ACTIVE INGREDIENT AND ASSESSMENT OF
PRODUCT CHEMISTRY
Sodium diacetate is a white crystalline solid at
room, temperature with a slightly pungent odor. It
decomposes above 150°C and is hygroscopic. It is
described as a "bound" compound of sodium acetate and
acetic acid. It is soluble in water, liberating acetic
acid. It is slightly soluble in alcohol and is
insoluble in ether (5).
Certain chemistry data to support sodium diacetate
for reregistration are not currently available to the
Agency. The studies are being called in under the
product-specific data call-in for the product labeled
as 100 % sodium diacetate. The studies required are as
follows:
Guideline number name
61-1 Chemical Identity
61-2(a) Beginning materials and
Manufacturing Process
61-2(b) Discussion of Impurities
62-1 Preliminary Analysis
62-2 Certification of Limits
62-3 Analytical Method
63-7 Density
63-9 Vapor Pressure
63-10 Dissociation Constant
63-11 Octanol/Water Partition Coefficient
63-12 pH
63-13 Stability
The Agency believes that the large body of
information in the public literature describing sodium
diacetate is adequate. The potential impurities which
may be introduced in manufacture of the chemical are
also of little concern. The additional data required
from the registrant are confirmatory in nature.
4
-------
B. HUMAN HEALTH ASSESSMENT
1. Toxicology
The Agency is relying on information from published
scientific sources. For the data base EPA is using data on
acetic acid and acetates in addition to data on sodium
diacetate. EPA concludes that this collection of data from
different sources and on different but related chemical
compounds is appropriate and sufficient for EPA to conduct
an adequate toxicological assessment of the pesticidal use
of sodium diacetate. EPA concludes no additional toxicity
data on sodium diacetate are necessary.
Sodium diacetate is a hydrated molecular complex of
acetic acid and sodium acetate which dissociates to acetate,
sodium, and hydrogen ions, and information on the toxicity
of acetates and acetic acid is relevant in determining the
safety of sodium diacetate. In addition, the ions produced
by the dissociation of the sodium diacetate molecule are
normal components of plants and animals, and of human foods.
Acetates are normal metabolic intermediates in living
organisms and are formed during the metabolism of food
substances. Acetates and acetic acid have long been used
safely and without major adverse effects in both human and
animal foods at moderate levels of consumption (3). There is
a substantial volume of information on acetates and acetic
acid in the literature which covers major biological
considerations, and the safety of sodium diacetate can be
based upon the information about the safety of acetates in
general. Thus, there is no reason to expect adverse effects
from the reasonable pesticide use of sodium diacetate. The
discussions which follow will include information based on
acetic acid as well as sodium diacetate.
The Food and Drug Administration, in 21 CFR 184.1754,
lists sodium diacetate as a substance generally recognized
as safe (GRAS) for use in food as an antimicrobial agent,
flavoring agent, and pH control agent. That Agency for use
as a sequestrant for animal feed (21 CFR 582.6754).
The Food and Drug Administration, in 21 CFR 184.1005,
lists acetic acid as a substance generally recognized as
safe (GRAS) for use in food. The listing includes uses for
curing and pickling, flavoring, pH control, solvent,
vehicle, and boiler water additive, with use levels of up to
9.0 percent acetic acid in condiments and relishes.
5
-------
a. Acute Toxicity
Acetic acid has toxic effects on the central nervous
system and kidneys. Inhaled acetic acid vapor is irritating
to the upper respiratory tract (1).
Based on acute toxicity studies with sodium diacetate,
the Agency classifies sodium diacetate as Tox category IV
for oral and dermal toxicity. The oral LD50 in rats is 5,600
mg/kg. The dermal LD*0 in rats is greater than 2,000 mg/kg.
In an acute rat inhalation study of 8 hours duration, the
only finding was some evidence of slight petechial
hemorrhage in the lungs; an LCc0 was not determined. Sodium
diacetate is an eye irritant with category II toxicity. An
eye irritation study in rabbits found chemosis and redness
which, in some animals, persisted through the seventh day.
Another eye irritation study in rabbits found severe corneal
necrosis with a 15 percent solution but only trace injuries
with a 5 percent solution. A primary dermal irritation study
in rabbits found no irritation with a 50 percent solution, a
Tox. category IV classification.
TOXICITY ROUTE
~ALX7E
CATEGORY
ACUTE ORAL
5600 M6/KG
IV
ACUTE DERMAL
> 2000 MG/KG
IV
ACUTE INHALATION
NOT DETERMINED
****
EYE IRRITATION
CORNEAL INVOLVEMENT
CLEARING IN 8 - 21
DAYS
II
DERMAL IRRITATION
NO IRRITATION
IV
SKIN SENSITIZER
NOT DETERMINED
****
b. Subchronic Toxicity
Workers exposed to acetic acid through the inhalation
route may tolerate concentrations up to 30 ppm without
severe injury if acclimatized. Subchronic studies conducted
in various animal species and with differing dosing regimes
of acetic acid are reported in the science literature. In
one subchronic inhalation study, male rats exposed for 95
days to 0.01, 0.2, or 5.0 mg/m acetic acid vapor in air
developed progressive muscle imbalance, increases of blood
cholinesterase activity and serum globulins, and decreases
of serum albumins in the two higher doses. The highest dose
group also had raised white blood cell counts and decreases
in ascorbic acid levels (6).
6
-------
An 8 week feeding study with rats fed 2 percent sodium
diacetate in the diet found no effects and concluded that
the NOEL was greater than 1,000 mg/kg body weight.
In a subchronic study four groups of three to six rats
were given 0.01, 0.1, 0.25, or 0.5 percent acetic acid in
drinking water (up to 390 mg/kg body weight) for periods of
nine to 15 weeks. Fluid intake was the sane in all groups.
Rats at the 0.5 percent level experienced immediate,
progressive reduction in body weight gain, loss of appetite,
and up to a 27 percent reduction in food consumption.
Mortality was unaffected. None of these effects were seen at
the lower doses (2, 3).
In another experiment, groups of three to four rats
survived for 14 days when given 1800 mg/kg body weight per
day of free acid intragastrically or 4200 - 4800 mg/kg body
weight of sodium acetate, but survived only three to five
days on daily intra-gastric doses of 2400 mg/kg body weight
of free acid. Animals lost weight and showed blistered paws
and reddened noses before death at fourteen days. No
autopsies were done (4).
Four groups of two young pigs each were fed daily diets
containing 0, 240, 720, 960, or 1200 mg/kg body weight per
day for successive 30-day periods to a total of 150 days.
There were no significant differences in growth rate, weight
gain, early morning urinary ammonia, and terminal blood pH
between controls and test groups. No autopsies were done
(2) .
c. Other Toxicoloaical Effects
Teratologic testing of apple cider vinegar containing 5
percent acetic acid was done in pregnant rabbits, mice, and
rats at up to 1,600 mg/kg body weight daily. These tests did
not show any maternal or fetal effects. In another study,
there were no teratogenic effects seen in developing chicken
embryos in which up to 200 mg of sodium acetate / kg of egg
was injected into the egg's air cell or yolk. However, there
was an LDS0 of 91.5 mg/kg when injected into the yolk of
unincubated eggs (3).
Different mutagenicity testing with sodium acetate or
acetic acid has generally not shown positive results.
Female rabbits given doses of 0.1 to 0.2 g/kg body
weight of acetic acid twice a day orally for five months or
0.1 to 0.7 g/kg body weight of acetic acid in drinking water
for 13 months did not express tumors. Male rats given oral
doses of 350 mg/kg body weight of sodium acetate three times
weekly for 63 days, then 140 mg/kg body weight three times
7
-------
weekly for 72 days showed no signs of tumors after 135 days
(3).
d. Metabolism
Acetic acid is absorbed readily from the
gastrointestinal tract and from the lungs (FASEB, Clayton).
It is also incorporated naturally and readily into
intermediary metabolism by most tissues of the body and is
thus utilized rapidly (1).
Acetate is completely utilized in oxidative metabolism
or in anabolic syntheses. Isotope experiments have shown
acetate to be utilized in the formation of glycogen,
carbohydrate intermediates, phospholipids, and fatty acids,
as well as in cholesterol and steroid synthesis (1, 3, 4).
In addition, it participates in the acetylation of amines
and may be converted to alanine by transamination and thence
incorporated into proteins of plasma, liver, kidney, gut
mucosa, muscle, and brain (4). It has been estimated that
the rat forms acetate at the rate of one percent of its body
weight per day (3).
2. Dietary Exposure and Tolerance Assessment
Since acetic acid is completely utilized in metabolism
in the formation of glycogen, carbohydrate intermediates,
phospholipids, and fatty acids, as well as in cholesterol
and steroid synthesis, the residues in meat, milk, or
poultry are considered to be negligible. Acetic acid and
sodium diacetate are exempt from the requirement of a
tolerance when used post-harvest on alfalfa, barley grain,
Bermuda grass, bluegrass, brome grass, clover, corn grain,
cowpea hay, fescue, lespedeza, lupines, oat grain, orchard
grass, peanut hay, peavine hay, rye grass, sorghum grain,
soybean hay, sudan grass, timothy, vetch, and wheat grain
(40 CFR 180.1029 and 180.1058). Acetic acid is also exempt
from the requirement of a tolerance when applied (as an
inert ingredient) to growing crops or to raw agricultural
commodities after harvest as described in 40 CFR
180.1001(c). Both acetic acid and sodium diacetate are
considered by the Food and Drug Administration to be
Generally Recognized as Safe (GRAS) (21 CFR 184.1005 and
184.1754) for use in food.
Since no pesticide products currently contain acetic
acid as an active ingredient, EPA intends to revoke the
exemption from tolerances established at 40 CFR 180.1029.
EPA also intends to revoke exemptions from tolerances
for crops not registered for 6odium diacetate. This will
include the exemptions from tolerances established at 40 CFR
8
-------
180.1058 for the following postharvest applications: barley
grain, cowpea hay, fescue hay, lespedeza hay, lupines,
peanut hay, peavine hay, soybean hay, vetch hay, and wheat
grain. These uses are not listed on product labelling for
sodium diacetate.
3. Occupational Bxposw
Mixer and loader workers nay experience significant
exposure during the nixing and loading of the soluble powder
for liquid application. Likewise, for the dust formulation,
the potential for significant worker exposure exists via the
dermal and inhalation routes during mixing and loading. If
conducted in a closed system, the potential for exposure
during mixing / loading would be minimized. Exposure to
applicators should be minimal, based on the application with
mechanical applicators.
When used in accordance with the product label
directions and precautions, EPA believes such exposure
would vary depending on whether the products are applied to
conventional square bales or to round stacks of hay.
Activities involving square bales may require more human
contact since they are more portable and more likely to be
moved by hand than the larger round bales.
While EPA lacks worker exposure data specific to sodium
diacetate and its registered uses, it believes that these
uses could provide varying degrees of dermal, inhalation,
and eye exposure during mixing, loading, and application of
the pesticide products and the handling of treated bales of
hay.
Exposure can result from application of both the dust
and liquid spray products. Current product labels do not
direct workers to wear protective clothing or equipment such
as gloves, long sleeves and pants, or goggles. However, EPA
does not believe there is a need to acquire exposure data on
sodium diacetate in order to conduct a detailed exposure
assessment because of the low acute toxicity, except for eye
irritation, and the absence of significant sub-chronic and
chronic toxicity.
As described above, sodium diacetate is applied to
various livestock feedstuffs for preservative value. EPA has
exempted sodium diacetate from the requirement of tolerances
on these items on the basis of their being Generally
Recognized as Safe (GRAS). EPA believes any exposure to
sodium diacetate, its degradates sodium acetate and acetate,
metabolic by-products through the consumption of meat, milk,
poultry, and eggs from livestock fed treated feed is
inconsequential.
9
-------
4. Human Risk Assessment
As discussed above in the occupational and dietary
exposure assessments, EPA concludes the exposure to humans
from proper application of sodium diacetate to livestock
feed items raises a concern for eye hazards to workers and
is otherwise inconsequential for the general public
consuming meat, milk, poultry, and eggs. In order to
mitig? ;e the potential for exposure to the eyes during
handling and application of the products, EPA is requiring
through this document the use of protective equipment. The
specific requirements are provided in Section V.C., Product
Reregistration Labeling Requirements.
EPA has also briefly discussed above sodium diacetate's
chemistry relative to sodium acetate and acetate as well as
chemical and metabolic properties of these individual
compounds. Given these compounds' low toxicities, natural
occurrence, and inherent functions in the metabolic pathways
of humans and domestic animals EPA is not concerned about
the negligible human dietary exposure or risk from the use
of sodium diacetate. The Agency is therefore not requiring
any human health studies for sodium diacetate.
ENVIRONMENTAL ASSESSMENT
EPA is relying on general knowledge about sodium
diacetate's use pattern, its chemistry and toxicity on which
to base its environmental assessments. No generic data on
this active ingredient is required. EPA believes it has
sufficient information on sodium diacetate to assess the
possible effects of this pesticide active ingredient on the
environment.
1. Envirc>"i"Attfc»l Fate Assessment
Applications of sodium diacetate to post-harvest
livestock feed crops are primarily within farm
facilities so there is limited environmental exposure.
Exposure to aquatic environments from runoff will
only result in short-term pH changes that will be
counteracted by the natural buffering capacity of the
water.
There is sufficient knowledge about sodium
diacetate to make an assessment that the compound's
impact on the environment will be negligible.
2. Ecological Effects Assessment
Sodium diacetate is applied to post-harvest
10
-------
terrestrial feed crops primarily inside farm
facilities, presenting little potential for exposure to
non-target organisms. In addition, because sodium
diacetate and its degradates have low toxicity and are
normally present and function in metabolic pathways of
animals, the risk to wildlife is minimal.
yt Environmental Risk Assessment
The Agency does not foresee the potential for
significant risks associated with the specified use of
sodium diacetate. No hazard or exposure issues have
been identified that need to be addressed further.
Therefore, no environmental fate or ecological effects
data are required to support the reregistration of
sodium diacetate.
XV. REREGISTRATION DECISION FOR 80DIUM DIACETATE
A. DETERMINATION OF ELIGIBILITY
Section 4(g)(2)(A) of FIFRA requires EPA to determine,
after submission of relevant data concerning an active
ingredient, whether products containing the active
ingredient are eligible for reregistration. As no products
are currently registered with acetic acid as an active
ingredient and the chemical is not supported for
reregistration, the Agency will require submission of a
complete study data base for registration applications which
include acetic acid as an active ingredient prior to the
issuance of the registration or amendment. For products
containing sodium diacetate as an active ingredient, the EPA
has waived the requirement of the submission of the generic
(i.e., active ingredient specific) data except for product
chemistry to support reregistration. Rather, it has
consulted and relied upon published literature as a source
for technical information. The Agency has completed its
review of these generic data, and has determined that the
data are sufficient to support reregistration of products
containing sodium diacetate. Appendix B identifies the
generic data requirements that the EPA reviewed as part of
its determination of reregistration eligibility of sodium
diacetate and lists the submitted studies that the Agency
found acceptable.
The data identified in Appendix B as well as
information from the open literature are sufficient to allow
the EPA to conduct a reasonable risk assessment for the
registered uses of sodium diacetate. The data available to
the EPA supports the conclusion that the registered uses of
sodium diacetate will not result in unreasonable adverse
effects to humans or the environment. The EPA has
11
-------
determined that all products containing sodium diacetate as
the active ingredient are eligible for reregistration. The
reregistration of particular products is addressed in
section V of this document ("Product Reregistration").
The EPA made its reregistration eligibility
determination based upon the target data base required for
reregistration, the data identified in Appendix B, the
current guidelines for conducting acceptable studies to
generate such data, and the published literature. Although
the EPA has found that products containing sodium diacetate
are eligible for reregistration, it should be understood
that the tePA may take appropriate regulatory action, and/or
require the submission of additional data to support
reregistration of products containing sodium diacetate if
new information comes to the EPA's attention or if the data
requirements for registration (or the guidelines for
generating such data) change.
B. ADDITIONAL GENERIC DATA REQUIREMENTS
The generic data base supporting the reregistration of
products containing sodium diacetate has been reviewed and
determined to be complete for reregistration.
C. LABELING REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS
CONTAINING SODIUM DIACETATE
There are no manufacturing-use products registered with
sodium diacetate as an active ingredient.
V. PRODUCT REREGISTRATION
A. DETERMINATION OF ELIGIBILITY
Based on the reviews of the generic data for the active
ingredient, sodium diacetate, the products containing this
active ingredient are eligible for reregistration. Section
4(g)(2)(B) of FIFRA calls for the EPA to obtain any needed
product-specific data regarding the pesticide after a
determination of eligibility has been made. The EPA will
review these data when they have been submitted and/or cited
and determine whether to reregister individual products.
B. PRODUCT SPECIFIC DATA REQUIREMENTS
The product-specific data requirements are stated in
attachment C.
C. LABELING REQUIREMENTS FOR END-USE PRODUCTS CONTAINING
SODIUM DIACETATE
12
-------
The labels and labeling of all products must
comply with EPA's current regulations and requirements.
Follow the instructions in the Product Reregistration
Handbook with respect to labels and labeling.
To address the classification of sodium diacetate as
Toxicity Category II for eye irritation, the following
statement must be included:
" Causes eye irritation. Do not get in eyes. Wear
goggles or a face shield during use."
13
-------
APPENDIX A
USE PATTERNS SUBJECT
TO REREGISTRATION FOR
SODIUM DIACETATE
14
-------
APPENDIX A: USE PATTERNS SUBJECT TO REREGISTRATION FOR CASE #4001: ACETIC ACID, AND SALTS
SITE
AppIcaUon Typ«. Application Timing Are*"»tk>" Equipment
Fotm
Maximum
Application
Rate
(•I)
Max. #
Apps.
Max. #
Apps. e
Max. Rat*
Mln. Interval
Between Apps.
a Max. Rata
(Days)
Restricted
Entry
Interval
(days)
Geographic
Limitations
Use limitations
Allowed
Disallowed
active Ingredient« SODIUM DIACETATE
FOOQfFS) USES
ALFALFA (FORAGE/FOOOER/STRAW/HAY-NON
GRASS)
Stored commodity non-fumigation; Postharveat;
Equipment not on label
Spray; Poatharveat; Equipment not on labal
not spec/S
2.5 lb al/ton
not
apec
not spec
not spec
not spec
none
none
hay moisture must be < 25%; treated
hay may only be fed to livestock or
poultry
SC/L
2.5 to ai/ton
not
spec
not spec
not spec
not spec
none
none
hay moisture must be < 25%; treated
hay may only be fed to livestock or
poultry
CLOVER (FORAGE/FOOOER/STRAW/HAY-NON
GRASS)
Stored commodity non-lumlsation; Postharveat;
Equipment not on labal
Spray; Postharveat; Equipmant not on label
not spec/S
2.5 to ai/ton
not
spec
not spec
not spec
not spec
none
none
hay moisture must be < 25%; treated
hay may only be led to livestock or
poultry
SC/L
2.5 to ai/ton
not
spec
not spec
not spec
not spec
none
none
hay moisture must be < 25%; treated
hay may only be fed to Kveatock or
poultry
CORN (FORAGE/FOOOER/HAY-GRASS)
Stored commodity non-fumigation; Postharveat;
Equipment not on label
Spray; Postharveat; Equipmant not on label
not spec/S
2 to ai/ton
not
spec
not spec
not spec
not spec
none
none
aVage moisture must be < 70%; high
moisture ensiled com must be < 35%
SC/L
3 to ai/ton
not
spec
not spec
not spec
not spec
none
none
silage moisture must be < 70%; high
moisture ensHed com must be < 35*
GRASSES (FORAGE/FOOOER/HAY-GRASS)
Stored commodity non-fumigation; Postharveat;
Equipment not on label
Spray, Postharveat; Equipment not on label
not spec/S
2.5 to ai/ton
not
spec
not spec
not spec
not spec
none
none
hay moisture must be < 25%; treated
hay may only be fed to livestock or
poultry; silage moisture must be < 70%
SC/L
2.5 to ai/ton
not
spec
not spec
not spec
not spec
none
none
hay moisture must be < 25%; treated
hay may only be fed to livestock or
poultry; silage moisture must be < 70%
A-16
-------
m
9mm
»Mli Hm Ni
M
Mm. #
Mm. #
Mm. feto
Mm. MmmI trtwM*
Afp*. # Mm. Am*
"-"TV
Mot*
•M
AMmmd
——
OATS (FORAGE/FODDER/HAY-GRASS)
Stored oommodity non-fumigation; PoitharvMt;
Equipment not on label
Spray; Poatharveat; Equipment not on label
not epec/S
1 lb ai/ton
not
epec
not
apeo
not apao
not *pac
none
nona
hay moiatura must be < 25%;
treated hay may only be fad to
livestock or poultry; ailaga moiatura
must be < 70%
SCA.
1 lb ai/ton
not
apeo
not
epec
not apao
not spec
none
nona
hay moiatura muat be < 25%;
treated hay may only be fad to
livestock or poultry; ailaga moiatura
must be < 70%
SORGHUM (FORAGE/FODDER/HAY-GRASS)
Stored oommodity non-fumigation; Poatharveat;
Equipment not on label
Spray; Poatharveat; Equipment not on label
not spec/S
1 lb ai/ton
not
apeo
not
epec
not apao
not apao
none
nona
hay moiatura muat be < 25%;
treated hay may only be fad to
livestock or poultry; ailaga moiatura
muat ba < 70%
SC/L
1 lb ai/ton
not
apeo
not
apeo
not apao
not apac
none
nona
hay moiatura must ba < 25%;
treated hay may only ba fad to
livaatock or poultry; ailaga moiatura
muat ba < 70%
TIMOTHY (FORAGE/FODOER/HAY-GRASS)
Stored oommodity non-fumigation; Poatharveat;
Equipment not on label
Spray; Poatharveat; Equipment not on label
not epec/S
2.5 lb ai/ton
not
apeo
not
apeo
not apao
not apoc
nona
nona
hay moiatura muat ba < 25%;
treated hay may only ba fad to
livestock or poultry; ailaga moiatura
muat ba < 70%
SCA.
2.5 lb ai/ton
not
epeo
not
apeo
not apao
not apac
nona
nona
hay moiatura muat ba < 25%;
treated hay may only be fad to
livestock or poultry; ailaga moiatura
must ba < 70%
Abbreviations used
Header: mix. - maximum; min. - minimum; epps. - application; not apac. - not apacifiad; NA - not applicable
Form: not apac/S - form not apaoifiad/aolid; SCA. - soluble concentrata/aolid
Rata: ai - active ingredient
A-16
-------
APPENDIX B
GENERIC DATA REQUIREMENTS FOR REREGISTRATION
OF SODIUM DIACETATE AND DATA CITATIONS
SUPPORTING REREGISTRATION
17
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which
support the reregistration for the pesticide covered by this
Reregistration Eligibility Document.
Appendix B contains generic data requirements that apply to
the pesticide in all products, including data requirements for
which a "typical formulation" is the test substance.
The data table 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. Use Pattern (Column 2). This column indicates the use
patterns to which the data requirement applies. The following
letter designations are used for the given use patterns:
A
Terrestrial food
B
Terrestrial feed
C
Terrestrial non-food
D
Aquatic food
E
Aquatic non-food outdoor
F
Aquatic non-food industrial
G
Aquatic non-food residential
H
Greenhouse food
I
Greenhouse non-food crop
J
Forestry
K
Residential
L
Indoor food
M
Indoor non-food
N
Indoor medical
0
Indoor residential
Any other designations will be defined in a footnote to the
table.
3. Bibliographic citation (Column 3). If the EPA 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.
18
-------
APPENDIX B
DATA SUPPORTING GUIDELINE REQUIREMENTS FOR REREGISTRATION OF SODIUM DIACETATE
GUIDELINE
CITATION
TITLE OF
STUDY
USE
PATTERNS
BIBLIOGRAPHIC
CITATION
PRODUCT CHEMISTRY
61-1
61-2(a)
61-2(b)
62-1
62-2
62-3
63-7
63-9
63-10
63-11
63-12
63-13
Chemical Identity B
Beginning Materials B
and Manufacturing Process
Discussion of Impurities B
Preliminary Analysis B
Certification of Limits B
Analytical Method B
Density B
Vapor Pressure B
Dissociation Constant B
Octanol/Water Partition B
Coefficient
pH B
Stability B
data required
data required
data
data
data
data
data
data
data
data
required
required
required
required
required
required
required
required
data required
data required
19
-------
DATA SUPPORTING GUIDELINE REQUIREMENTS FOR REREGISTRATION OF 80DIUM DIACETATE
GUIDELINE
CITATION
TITLE OF
8TUDY
USE
PATTERNS
BIBLIOGRAPHIC
CITATION
171-4(a)
171-4(b)
171-4(c)
171-4(d)
171-4(e)
171-4(i)
171-4(j)
171-4(1)
Nature of Residue
Plants
Nature of Residue
Animals
B
B
Residue Analytical Method B
Plants
Residue Analytical Method B
Animals
Storage Stability
B
Magnitude of Residue B
Food Handling Establishments
Magnitude of Residue B
Meat, Milk, Poultry, Eggs
Processed Food
B
waived
waived
waived
waived
waived
waived
waived
waived
20
-------
DATA SUPPORTING GUIDELINE REQUIREMENTS FOR REREGISTRATION OF SODIUM DIACETATB
GUIDELINE TITLE OF USE BIBLIOGRAPHIC
CITATION 8TUDY PATTERNS CITATION
TOXICOLOGY
EPA waived 40 CFR 158 requirements for reasons discussed in section III.
ECOLOGICAL EFFECTS
EPA waived 40 CFR 158 requirements as discussed in section III.
ENVIRONMENTAL FATE
EPA waived 40 CFR 158 requirements for reasons discussed in section III.
The citations listed in the bibliography (Appendix C) were used to support these decisions.
21
-------
APPENDIX C
BIBLIOGRAPHIC CITATIONS
FOR
SODIUM DIACETATE
22
-------
GUIDE TO APPENDIX C
1. CONTENT OF BIBLIOGRAPHY. This bibliography contains
citations of all studies considered relevant by EPA in
arriving at the positions and conclusions stated elsewhere
in the Reregistration Eligibility Document. 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 othe" sources,
including the published literature, in those inscances where
they have been considered, will be included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is
called a "study". In the case of published materials, this
corresponds closely to an article. In the case of
unpublished materials submitted to the EPA the EPA 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
EPA has attempted also to unite basic documents and
commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography
are sorted numerically by Master Record Identifier, or MRID
number. This number is unique to the citation, and should
be used at any time specific reference is required. It is
not related to the six-digit "Accession Number" which has
been used to identify volumes of submitted studies; see
paragraph 4(d)(4) below for further explanation. In a few
cases, entries added to the bibliography late in the review
may be preceded by a nine-character temporary identifier.
These entries are listed after all MRID entries. This
temporary identifier number is also to be used whenever
specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier
(MRID), each entry consists of a citation containing
standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known
submission. Bibliographic conventions used reflect the
standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a. Author. Whenever the EPA could confidently identify
one, the EPA has chosen to show a personal author.
When no individual was identified, the EPA has shown an
identifiable laboratory or testing facility as author.
As a last resort, the EPA has shown the first submitter
as author.
23
-------
b. Document date. When the date appears as four digits
with no question marks, the EPA 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 EPA was unable to determine or estimate the
date of the document.
c. Title. In some cases, t has been necessary for EPA
bibliographers to create or enhance a document title.
Any such editorial insertions are contained between
square brackets.
d. Trailing parentheses. For studies submitted to the EPA
in the past, the trailing parentheses include (in
addition to any self-explanatory text) the following
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.
24
-------
OFFICE OF PESTICIDE PROGRAMS
REREGISTRATION ELIGIBILITY DOCUMENT
BIBLIOGRAPHY
The following are the sources of the references cited in this document:
(1) Clayton, G.D., and Clayton, F.E., eds., 1982. Patty's Industrial
Hvaiene and Toxicology. 3rd revised edition, Vol 2c. Wiley
Interscience, NY.
(2) FAO/WHO Techn. Rep. Ser. No. 539, 1974.
(3) FASEB, 1977. "Evaluation of the Health Aspects of Acetic Acid, Sodium
Acetate, and Sodium Diacetate as Food Ingredients". NTIS PB-274 670.
(4) J.R. Geigy S.A. (1970) Documenta, Geigy, 7th ed. Basle? as cited in
FAO/WHO World Health Org. Techn. Rep. Ser. No. 539, 1974.
(5) The Merck Index. Tenth edition, (1983), p. 1234.
(6) Tracor-Jitco, Inc. (1974) Scientific Literature Reviews on Generally
Recognized as Safe (GRAS) Food Ingredients, Acetic Acid and Acetates.
Prepared for FDA. NTIS PB-234 898.
25
-------
APPENDIX D
PRODUCT DATA CALL-IN
26
-------
DRAFT COPY Page 1 Of 3
United States Environnental Protection Agency
For
m Approved
Washington,
D.
C.
20460
OMN No. 2070-0107
REQUIREMENTS STATUS
AND REGISTRANT'S RESPONSE
Approval Expiree 12-31-W
INSTRUCTIONS: PI en* type or print In Ink. PImm read carefully the attached Instruction* and eupply the Inforaation nqrntid
or
thla fona.
Use additional aheet(a)
If necesaary
1. Company naw and Addreea
2.
Case § and
Name
3. Date and
Type of DCI
SAMPLE COMPANY
4001 Acetic acid, and
salts
PRODUCT
SPECIFIC
NO STREET ADDRESS
ID# NNNNNN-RD-NNNN
NO CITY, XX
00000
EPA Reg. No. NNNNNN-NNNNN
4. Guideline
5. Study Title
5
<
Progress
6. Use
7. Teat
8. Time
9. Registrant
Requirement
1
Reporte
Pattern
Substance
Frame
Roapona#
Ntafcer
J
1
2
3
PRODUCT CMEHISTRY - REOJLMt CNBIICM.
.... v.v. .. v v.
s-
s '• ;:'
8 BOS.
61-2(b)
Discussion of Impurities (1,3)
ALL
MP/EP
8 nos.
62-1
Preliminary Mtlyiti (1,4)
ALL
MP/EP
8 DOS.
62-2
Certification of limits (1,5)
ALL
MP/EP
8 nos.
62—3 -
Analytical Method i- (D
ALL
MiyEPSiiiiiii
8 nos. :>-
• :*S
63-2
Color
ALL
MP/EP
8 nos.
63-3
Physical itate
ALL
MP/EP ""
8;nos
63-4
Odor
ALL
MP/EP
8 nos.
63-5
Melting Point <6)
ALL
MP/EP
: 8: nos.";."-'
63-6
Boiling Point (7)
ALL
MP/EP
8 nos.
63-7
Density
ALL
MP/EP ^
8 nos.v
63-8
Solubility
ALL
MP/EP
8 nos.
63-9 -V
Vapor Pressure
ALL
MP/EP
:;8:-«ioaIlf
*
63-10
Dissociation Constant
ALL
MP/EP
8 nos.
10. Certification
11.
Dete
1 certify that the statements mads on thla fona and all attachment! are true, accurate, and complete.
1 acknowledge thet any knowingly falae or misleading statement nay be punishable by fine, iapritorment
or both under applicable law.
Signature and Title of Coapany'a Authorized Representative
12. Name of Conpany Contact
13.
Pti
«ne Nusber
-------
I
DRAFT COPY
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: PI en* type or print In Ink. Pleoee read carefully tin attached Instructions and supply the Intonation requested on this fonaT
llu additional sheet(s) If naccaaary
Page 2 of 3
Fona Appc cved
am No. 2070-0107
Approval Cxplraa 12-31-92
1. Company nana and
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case i and Mane
4001 Acetic acid, and salts
EPA Reg. No. NNNNNN-NNNNN
S. 0at« and Typa of DCI
PRODUCT SPECIFIC
ID# NNNNNN-RD-NNNN
7. Teat
Substance
8. Tlae
FraaM
9. Registrant
RuponN
MP/EP
8 WOS.
MP/EP
8 BIOS.
MP/EP
8 BIOS*
¦ ¦ ¦ *y ¦ :¦*
MP/EP
8 BIOS.
MP/EP
8 'b»os« "?:;:
> «¦ - \ '
MP/EP
8 BIOS.
mp/ep .r 'w "
; 8-ads:iirI
W < * A , A
MP/EP
8 BIOS.
MP/EP "V"""""?
v8:iBK>ep|t:
MP/EP
8 BIOS.
Jy|P
8 BIOS*
V A V
MP/EP
8 BIOS.
• : • Xyx-.s* ; •••
•v'
V . ^ .
MP/EP
8 BIOS.
MP/BP^^P^x
8 Bioowf i'
* / syv «
MP/KP
8 moa*
s , SW
MP/EP
8 BK>8.
V..-
MP/EP
8 BOS.
*. Guideline
Requl roMnt
Ikater
5. Study Tltla
Progress
Report*
6. Use
Pattarn
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
64-1
81-1
81-2
81-3
81-4
81-5
0ct/ltat«r partltlen CMf.(8)
pN (9)
Stability
Oxldlzing/Reducing ActlonpO)
FlMMablllty (11)
Explodablllty (12)
Storage stability'
Vlacoalty (13)
Nlaclblllty (H)
Corroalon characteristics
Dielectric breakdown wlt(U) •
Submittal of saaples (16)
ACUTE TOKICITT - REBUUW CHEMICAL
Acuta oral to*, rat (1,5,6)
Acuta denial tax. (1,2,6)
rabbit/rat
Acuta frftal. ton rit (3)
Prlnary eye (2)
Irrltatlon-rabbit
Primary denaal lrrltatlon(1,2)
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
Initial to Indicate certification as to Inforawtlon on this
(full text of certification is on page one).
Date
i
-------
DRAFT COPY Page 3 Of 3
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
»
form Approved
am No. 2070-0107
Approval Eiplrw 12-31-92
INSTRUCTIONS: Please type or print in Ink. Please read carefully the attached instruction* and a«^ply the Information
Uii additional aheet(a) If necessary
riquNtad «
i till* for*.
1. Coapany nana and Mdreaa
SAMPLE COMPANY
HO STREET ADDRESS
NO CITY, XX 00000
2.
Cate f and Naaa
4001 Acetic acid, and salts
EPA Reg. No. NNNNNN-NNNNN
--
3. Data and Tjpa of OCI
PRODUCT SPECIFIC
ID# NNNNNN-RD-NNNN
4. Guideline
Requirement
Nuriwr
5. Study Tltla
R
Progress
Reporta
6. Uaa
Pattern
7. Teat
SUwtanc*
S. Tlaa
Fraaw
9. Registrant
RMpOfM
1
2
3
81-6
tenitfl MntitlMtton (4)
1
ALti
wyEP
0 MOB.'
Initial to indicate certification a* to Infonaatlon on thia pas*
(full text of certification ia on page one).
Data
-------
DRAFT COPY
Page 1 of l
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES FOR GUIDELINE REQUIREMENTS
The following notM are referenced in coluan two (J. Study Title) of the Requirement* Statue and registrant's Reponee font
Case # and Name: 4001 Acetic acid, and salts
PRODUCT CNBUSTir - REGULAR OEM CM.
1 Requirements pertaining to product identity, composition, anslysis, and certification of ingredients are detailed further In the foltoning sectlena: *158.155 for
product identity end composition (61*1); *158.160, 158.162, and 158.165 for description of atarting isateriela and Manufacturing process (61-2); *158.167 for
diacuaalon of formation of impurities (61-3); *158.170 for preliminary analysis (62-1); *158.175 for certification of llalta (62-2); and *158.180 for enfoitsamnt
enalytical Methods (62-3).
2 A schematic diagraai and/or brief description of the production process will suffice If the pesticide Is not el reedy under full acale production and an experimental
uae penait Is being sought.
3 If the pesticide is not el ready under full scale production and an experimental uae penait la sought, a diacuaalon of unintentional Ingredient* shell be submitted to
the extent this information is available.
6 Required to support the registration of each menufecturlng-uee product (Including regietered TGAls) ae well aa and-use products produced by an Integrated systsm.
Oata on other end-use products Mill be required on a case-by-case basts. For pesticides In the developaent atete, ¦ rudimentary product analytical method and data
Mill eufflce to support en experiawntel use penait.
5 Certified llaiits are not required for Inert ingredients in products proposed for experiment el use.
6 Required If technicel chemical la solid at rooai temperature.
7 Required if technical chemical la liquid at room temperature.
8 Required If technicel chemicel is organic and nen-potar.
9 Required If test tiAistencet ere dlsperslble with Meter.
10 Required If product contains en oxldiiing or reducing agent.
11 Required if product contains coafcuetible liquids.
12 Required If product la potentially explosive.
13 Required if product is a liquid.
14 Required if product la an esulsiflafele liquid and la to be diluted Mith petroleua solvents.
15 Required if end-use product is liquid and ia to be used eround electrical equipment.
16 Basic manufactures are required to provide the Agency ulth e eaaple of each TGAI used to formulate a product when the new TGAI la first used aa • formulating
Ingredient in products regietered inder FIFRA. A eample of the active ingredient (PAI) au it able for uae aa an analytical standard la also required at this time.
Sample* of end-use producta produced by an integrated system must be submitted on e case-by-cese beaie. Material aafety data aheet* ahoutd aaosgawif sample* aa
apecified by OSHA in 29 CFR 1910.1200.
ACUTE TONICITY - REGUUW CHEMICAL
1 Hot required 1f teat material I* a gas or highly volatile.
2 Hot required If test meterlal ia corrosive to skin or has pH less than 2 or greater than 11.5; such a product Mill be classified as Toxicity Category I on the bad*
of potential eye and dermal irritation effecta.
3 Required if the product conelsts of, or under conditions of use Mill result In, en Inhelable meterlal (e. g., gas, volatile ¦Ustanctl, or aeroMl/particulate).
4 Required unless repeated dermal exposure doee not occur under conditlone of use.
5 Special testing (acute, aubchronic, and/or chronic) is required for organophospotea, and may be required for other cholIneateraae Irfiibltor* and other pesticide*
Mhich hove demonstrated a potential to adveraely affect the viaual aystem. Regiatrants should consult. Mith the agency for development of protocols end methodslogy
prior to initiation of studies.
6 Testing of the IP dilution is required if It can be reasonably anticipated thet the results of such testing may meet the crlterie for restriction to use by certified
applicatora apecified in 40 CFR 152.170(b) or the criteria for Initiation of speciel review specified in 40 CFR 154.7 (a)(1).
-------
DRAFT COPY
Page 2 of 1
United States Environaental Protection Agency
Washington, D. C. 20460
FOOTNOTES FOR GUIDELINE REQUIREMENTS
Hit following note* ar« r«ftr«nced In colwn tuo (5. Study Tltlt) of th# »«ylnwnti Status and ro«Utrant'« RapenM for*
Case f and Nane: 4001 Acetic acid, and salts
------- |