United States
Environmental Protection
Agency
Office of Prevention, Pesticides
And Toxic Substances
(7508W)
EPA738-R-93-OI7
September 1993
&EPA Registration
Eligibility Decision (RED)
Boric Acid and its
Sodium Salts
Recycled/Recyclable
Printed with Soy/Canola Ink on paper that
contains at least 50% recycled fiber
-------
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
FEB | 6- 1994
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERHFTRD MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case Boric Acid And
Its Sodium Salts which includes the active ingredients boric acid, sodium tetraborate
decahydrate (borax decahydrate), sodium tetraborate pentahydrate (borax pentahydrate),
sodium tetraborate (anhydrous borax), disodium octaborate tetrahydrate, disodium ©elaborate
(anhydrous), and sodium inelaborate. The enclosed Reregistration Eligibility Decision (RED)
contains the Agency's evaluation of the data base of these chemicals, its conclusions of the
potential human health and environmental risks of the current product uses, and its decisions
and conditions under which these uses and products will be eligible for reregistration. The
RED includes the data and labeling requirements for products for reregistration. It also
include requirements for additional generic data on the active ingredients to confirm the risk
assessments.
To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED". This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses. The first set of required responses are due 90 days from
the date of this letter. The second set of required responses are due 8 months from the
date of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.
If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative
Franklin Gee at (703) 308-8008. Address any questions on required generic data to the
Special Review and Reregistration Division representative Mario F. Fiol at 703-308-8049.
Sincerely yours,
Enclosures
r U^~ ,*
Daniel M. Barolo, Direc$rx
Special Review and
Reregistration Division
-------
-------
SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
I- DATA CALL-IN (PCI) OR "90-DAY RESPONSE"—If generic data are
required for reregistration, a DCI letter will be enclosed
describing such data. If product specific data are required,
another DCI letter will be enclosed listing such requirements.
If both (generic and product specific) data are required, a
combined Generic and Product Specific letter will be enclosed
describing such data. Complete the two response forms provided
with each DCI letter (or four forms for the combined), by
following the instructions contained. You must submit the
response forms for each product and for each DCI within 90 days
of the date of this letter (RED issuance date) ; otherwise, your
product may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER REQUESTS—No time extension
requests will be granted for the 90-day response. Time extension
requests may be submitted only with respect to actual data
submissions. Requests for data waivers must be submitted as part
of the 90-day response. Requests for time extensions should be
submitted in the 90-day response, but certainly no later than the
8-month response date. All data waiver and time extension
requests must be accompanied by a full justification. All
waivers and time extensions must be granted by EPA in order to go
into effect.
3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"—You
must submit the following items for each product within eight
months of the date of this letter (RED issuance date) .
a- Application for Rereqistration (EPA Form 8570-1) . Use
only an original application form. Mark it "Application for
Reregistration." Send your Application for Reregistration (along
with the other forms listed in b-e below) to the address listed
in item 5.
b- Five copies of draft labeling which complies with the
RED and current regulations and requirements. Only make labeling
changes which are required by the RED and current regulations (40
CFR 156.10) and policies. Submit any other amendments (such as
formulation changes, or labeling changes not related to
reregistration) separately. You may delete uses which the RED
says are ineligible for reregistration. For further labeling
guidance, refer the labeling section of the EPA publication
"General Information on Applying for Registration in the U.S.,
Second Edition, August 1992" (available from the National
Technical Information Service, publication #PB92-221811;
telephone number 703-487-4650).
c- Generic or Product Specific Data. Submit all data in a
format which complies with PR Notice 86-5, and/or submit
citations of data already submitted and give the EPA identifier
(MRID) numbers. Before citing these studies, you must make sure
-------
that they meet the Agency's acceptance criteria (attached to the
DCI) .
d. Two copies of the Confidential Statement of Formula
(CSF) for each basic and each alternate formulation. The
labeling and CSF which you submit for each product must comply
with P.R. Notice 91-2 by declaring the active ingredient as the
nominal concentration. You have two options for submitting a
CSF: (1) accept the standard certified limits (see 40 CFR
§158.175) or (2) provide certified limits that are supported by
the analysis of five batches. If you choose the second option,
you must submit or cite the data for the five batches along with
a certification statement as described in 40 CFR §158.175(e). A
copy of the CSF is enclosed; follow the instructions on its back.
e. Certification With Respect to Citation of Data.
Complete and sign this form (EPA form 8570-29) for each product.
Cite-all is not a valid option for reregistration.
4 . COMMENTS IN RESPONSE TO FKDERAIi REGISTER NOTICK—Comment s
pertaining to the content of the RED may be submitted to the'
address shown in the Federal Register Notice which announces the
availability of this RED.
5. WHERE TO SEND PRODUCT SPECIFIC DCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB-0024)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PKB-0024)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. KPA'S REVIEWS—EPA will screen all submissions for
completeness; those which are not complete will be returned with
a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also
try to respond to all 8-month submissions with a final
reregistration determination within 14 months after the RED has
been issued.
-------
United States
Environmental Protection
Agency
Prevention, Pesticides
And Toxic Substances
(75O8W)
EPA-738-F-93-006
September 1993
R.E.D. FACTS
Boric Acid
Pesticide All pesticides sold or used in the United States must be registered by
Reregistration EPA, based on scientific studies showing that they can be used without
posing unreasonable risks to people or the environment. Because of
advances in scientific knowledge, the law requires that pesticides which
were first registered years ago be reregistered to ensure that they meet
today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing undue hazards to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this
and explains why in a Reregistration Eligibility Decision (RED) document.
This fact sheet summarizes the information in the RED document for boric
acid and its sodium salts, which includes the seven active ingredients boric
acid, sodium tetraborate decahydrate (borax decahydrate), sodium
tetraborate pentahydrate (borax pentahydrate), sodium tetraborate
(anhydrous borax), disodium octaborate tetrahydrate, disodium octaborate
(anhydrous), and sodium metaborate.
Use Profile
Pesticide products containing boric acid and its sodium salts are
registered in the U.S. for use as insecticides, fungicides and herbicides.
As insecticides, some act as stomach poisons in ants, cockroaches,
silverfish and termites, while others abrade the exoskeletons of insects. As
herbicides, some cause desiccation or interrupt photosynthesis in plants,
while others suppress algae in swimming pools and sewage systems. As
fungicides, several are wood preservatives which control decay-producing
fungi in lumber and timber products.
Boric, acid and its sodium salts are used on several agricultural and
many non-agricultural sites including residential, commercial, medical,
veterinary, industrial, forestry and food/feed handling areas. They are
marketed in many formulations including liquids, soluble and emulsifiable
concentrates, granulars, powders, dusts, pellets, tablets, solids, paste,
baits, and crystalline rods.
-------
Regulatory
History
The quantities of boric acid and its sodium salts applied as pesticides
are modest compared to amounts used for other, non-pesticidal purposes.
Further, boric acid, borax and boron-containing salts are ubiquitous hi the
environment. Boron occurs naturally in water, fruits, vegetables and
forage crops, and is an essential nutrient for plants as well as an essential
element for many organisms.
Boric acid was first registered as a pesticide in the U.S. in 1948.
Currently, 189 pesticide products are registered which contain boric acid or
one of its sodium salts as an active ingredient.
In February 1986, EPA issued two related documents dated
November 1985, the "Boric Acid and Boron Containing Salts Registration
Standard" (NTIS #PB87-101903), and a General Registration Standard
entitled, "Guidance for the Registration and Reregistration of End-Use
Pesticide Products Containing the Insecticidal Uses of Boric Acid." About
43 boric acid products, used indoors for cockroach and silverfish control,
were reregistered under the General Registration Standard. Producers of
those products need only submit current labels and Confidential Statements
of Formula for the products to remain reregistered.
EPA has determined that, because they are of low toxicity and occur
naturally, boric acid and its sodium salts should be exempted from the
requirement of a tolerance (maximum residue limit) for all raw agricultural
commodities. The Agency has established such exemptions and removed
the previously established tolerances for residues of boric acid and certain
derivatives in cotton seed and citrus fruits (please see 58 FR 44282); two
other derivatives will be similarly exempted soon. Because boric acid is
registered for crack and crevice use hi food and feed handling
establishments, the potential exists, though unlikely, for residues to occur
hi food. EPA therefore is establishing food and feed additive tolerances
for boric acid and its sodium salts.
In developing this RED, the active ingredient sodium metaborate was
added from another reregistration case. Also, this RED originally was to
have included boric oxide as an active ingredient. However, since no
registered products currently contain that active ingredient, it is not
included.
Human Health
Assessment
Human Toxicity
The toxicity of boric acid and its six sodium salts are expected to be
similar. Information on the effects of these boron-related compounds hi
humans, supplemented by data from laboratory animal studies, were used
by EPA to evaluate then: toxicity.
Boric acid generally is of moderate acute toxicity., and has been
placed hi Toxicity Category IQ for most acute effects including oral and
-------
dermal toxicity, and eye and skin irritation. Sodium tetraborate (anhydrous
borax) products have been placed in Toxicity Category I indicating a high
degree of acute toxicity for eye irritation effects.
A subchronic borax feeding study using dogs resulted in blood and
metabolism disorders as well as effects to the testes, endocrine system,
brain weight, and size ratios among various organs and glands.
In chronic oncogenicity studies using mice, rats and beagle dogs,
boric acid and borax were found not to be carcinogenic; however,
testicular effects and decreases in body weight resulted at high dose levels.
EPA has classified boric acid as a "Group E" carcinogen, indicating that it
shows "evidence of noncarcinogenicity" for humans.
In reproductive and developmental toxicity studies using rats, mice
and rabbits, maternal liver and kidney effects and decreased weight gain as
well as decreased fetal body weights were observed. In two studies, at the
highest dose levels, no litters were produced. Prenatal mortality occurred
at the highest dose levels in the rabbit study. Boric acid does not cause
mutagenicity.
Dietary Exposure
Tolerances were established for residues of boron resulting from the
use of boric acid and its sodium salts on cottonseed (30 ppm) and citrus
fruits, postharvest (8 ppm) (please see 40 CFR 180.271.) EPA's review of
new toxicology studies raised no concerns. Further, boron occurs naturally
in fruits and vegetables at much higher levels (200 to 300 ppm in red
cabbage). Therefore, the Agency is exempting these compounds from the
requirement of a tolerance and revoking the existing tolerances. EPA is
establishing food/feed additive regulations to cover the use of boric acid
salts for crack and crevice treatments at food and feed handling
establishments (please see 58 FR 44282, and a soon-to-be-issued Federal
Register notice).
Occupational and Residential Exposure
Boric acid and its sodium salts are applied both indoors and outdoors,
in residential, commercial, medical, veterinary and industrial areas, in food
handling establishments, hi swimming pools and sewage systems, hi lakes,
ponds and reservoirs, and in treating wood. Depending on the use site,
boric acid may be applied using aircraft, a spreader, airblower, power
duster, squeeze applicator, aerosol can or knife/spatula. The potential for
dermal and inhalation exposure exists among applicators and people
reentering treated areas.
As a prudent measure to reduce any potential risks to handlers, EPA
is requiring that all products containing boric acid and its sodium salts
(except products for residential use) bear personal protective equipment
(PPE) requirements. These must consist of at least the use of a long-
sleeved shirt, long pants, shoes, socks and chemical-resistant gloves. If
-------
end-use product labeling already bears PPE requirements that are more
protective than these items, the more protective requirements must be
retained.
The Worker Protection Standard (WPS) for Agricultural Pesticides
(40 CFR 156 and 170) established an interim restricted-entry interval (REI)
of 12 hours for boric acid and its sodium salts. EPA is retaining this REI
for uses within the scope of the WPS, as a prudent risk mitigation measure
to protect workers. During the REI, workers may enter treated areas only
under the few narrow exceptions allowed in the WPS.
Human Risk Assessment
Dietary risk is not a concern with boric acid and its sodium salts
since no direct food uses are registered and tolerances have been revoked.
Applicators and others in treatment areas may be exposed to boric acid and
its sodium salts during or after application. However, there is no
reasonable expectation that these pesticide uses may constitute a hazard or
risk to people involved in, or near to, handling or application activities.
Proper care and adhering to label directions and precautions should reduce
exposure and any associated risk.
Environmental
Assessment
Environmental Fate
No new environmental fate data are required for reregistration of
boric acid and its sodium salts because only relatively small amounts of
boric acid are used as pesticides, and significant amounts of boron are
present naturally in soil and water. Surface soil contains relatively high
levels of boron. Boron salts occur naturally in low concentrations in most
unpolluted waterways (both surface water and seawater). In some areas,
boron occurs in surface waters in concentrations that have been shown to
be toxic to commercially important plants.
Ecological Effects
Available studies indicate that technical boric acid is practically
nontoxic to birds, fish and aquatic invertebrates, and relatively nontoxic to
beneficial insects. The boric acid rights-of-way herbicide use pattern poses
a potential risk to aquatic invertebrates, including some that are
endangered. However, risk probably is mitigated by the practice of
limiting treatment to small strips of land, thereby limiting the amount of
contaminated runoff into adjacent aquatic environments.
Boric acid's noncrop herbicidal use also may harm endangered or
threatened plants. EPA is requiring three phytotoxicity studies (seed
germination, seedling emergence and vegetative vigor) to assess these
risks. EPA is deferring endangered species labeling requirements until the
Agency publishes the Endangered Species Protection Program plan and
guidance for registrants. Labeling will refer users to county bulletins for
area-specific use limitations.
-------
Ecological Effects Risk Assessment
EPA's concerns regarding risks to birds, fish and wildlife species are
minimal. Boric acid's limited outdoor use patterns, low toxicity, and
natural presence in terrestrial and aquatic environments are mitigating
factors for any potential risk to nontarget organisms.
Additional Data EPA is requiring three phytotoxicity studies to further assess the risks
Required or" boric acid and its sodium salts to non-target plants and endangered plant
species. However, these studies are not part of the target data base and do
not affect the reregistration eligibility of boric acid and related active
ingredients. The Agency also is requiring product-specific data including
product chemistry, acute toxicity and efficacy studies, revised Confidential
Statements of Formula, and revised product labeling for reregistration.
EPA already has reregistered all 43 boric acid products covered by
the General Registration Standard. For these products, only current
labeling and Confidential Statement of Formulas must be submitted to
ensure that they still meet the criteria set forth in that document.
Product Labeling
Changes Required
The labeling of all end-use products containing boric acid and its
sodium sails must comply with EPA's current pesticide labeling
requirements. In addition:
• Compliance with Worker Protection Standard (WPS) - Any product
whose labeling permits use in the production of an agricultural plant on any
farm, forest, nursery or greenhouse must comply with the labeling require-
ments of:
• PR Notice 93-7, "Labeling Revisions Required by the Worker
Protection Standard (WPS)," and
• PR Notice 93-11, "Supplemental Guidance for PR Notice 93-7."
Unless specifically directed in the RED, all statements required by these
two PR Notices must appear on product labeling exactly as instructed in
the Notices. Labels must be revised by April 21, 1994, for products
distributed or sold by the primary registrant or supplementally registered
distributors, and by October 23, 1995, for products distributed or sold by
anyone.
• Personal Protective Equipment (PPE) Requirements
Products NOT Primarily Intended for Home Use
The PPE requirement for handlers of all end-use products except
those intended primarily for home use is:
"Applicators and other handlers must wear:
—Long-sleeved shirt and long pants
—Chemical-resistant or waterproof gloves*
—Shoes plus socks
-------
* The glove statement is that established through the instructions in
Supplement Three of PR Notice 93-7."
Registrants must compare the PPE requirements in this section with
those on their product labeling, and retain the more protective PPE.
Products Primarily Intended for Home Use
No new PPE requirements need to be added. However, any PPE
requirements on current product labeling must be retained.
• Entry Restrictions
Products NOT Primarily Intended for Home Use
o Uses Within the Scope of the WPS: A 12-hour restricted entry
interval (REI) is required for all uses within the scope of the WPS,
except on products intended primarily for home use. The PPE for
early entry should be that required for applicators of boric acid and
its sodium salts, except that the requirement for an apron or
respirator is waived. Registrants should insert this REI and PPE into
the standardized statements required by PR Notice 93-7.
• Sole Active Ingredient Products: Must be revised to adopt
the entry restrictions set forth in this section, and any
conflicting entry restrictions on current labeling must be
removed.
• Multiple Active Ingredient Products: Registrants must
compare the entry restrictions set forth in this section to the
entry restrictions on their current labeling and retain those
which are more protective. A specific time period hi hours or
days is considered more protective than "until sprays have
dried" or "dusts have settled."
° Uses Not Within the Scope of the WPS: No new entry restrictions
must be added. However, any entry restrictions on current product
labeling must be retained.
Products Primarily Intended for Home Use
No new entry restrictions need to be added. However, any entry
restrictions on current product labeling must be retained.
• Products Under the General Boric Acid Registration Standard
Labels must comply with the format labels issued with the Standard.
Five copies of current labeling must be submitted.
• Products Not Under the General Registration Standard
Labels must bear the following Environmental Hazards statements, if
appropriate:
° Terrestrial Food and Feed Use and Non-Crop Products
"Do not apply directly to water, or to areas where surface
water is present or to intertidal areas below the mean high-
-------
water mark. Do not contaminate water when disposing of
equipment washwaters or rinsate."
° Indoor Use Products with Effluent
"Do not discharge effluent containing this product into lakes,
streams, ponds, estuaries, oceans or other waters unless in
accordance with the requirements of a National Pollutant Dis-
charge Elimination System (NPDES) permit and the permitting
authority has been notified hi writing prior to discharge. Do
not discharge effluent containing this product to sewer systems
without previously notifying the sewage treatment plant
authority. For guidance, contact your State Water Board or
Regional Office of the EPA."
Labels with uses on carpets and floors to combat fleas, cockroaches,
ants and siiverfish must bear the following under Directions for Use:
° Use Restrictions
"Children and pets should not be hi treatment area until after
application is completed. Do not treat pets with this product.
Avoid contamination of feed and foodstuff. Avoid
contamination of ornamental plants."
° Carpets
"Apply to dry surfaces only. Apply directly on carpets where
pets frequently traffic or sleep. Work powder deeply into
fibers and mat with a broom or rug rake. Any powder visible
after application must be brushed into carpet fibers or
removed."
° Upholstery
"Remove loose cushions. Apply along creases and into corners
and furniture wells. Do not apply product to exposed fabric.
Any product visible after application must be removed."
Regulatory
Conclusion
The use of currently registered pesticide products containing boric
acid and its sodium salts in accordance with approved labeling will not
pose unreasonable risks or adverse effects to humans or the environment.
Therefore, all uses of these products are eligible for reregistration. These
products will be reregistered once the required product-specific data,
Confidential Statements of Formula and revised labeling are received and
accepted by EPA.
Boric acid products that already have been reregistered under the
General Registration Standard will remain reregistered as long as current
labeling and Confidential Statements of Formula are submitted, and demon-
strate that these products still meet the criteria set forth in the Standard.
-------
Boric acid products which also contain other active ingredients will
be reregistered only after the other active ingredients are determined to be
eligible for reregistration.
For More
Information
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for boric acid and its sodium salts during a 60-
day time period, as announced in a Notice of Availability published hi the
Federal Register. To obtain a copy of the RED document or to submit
written comments, please contact the Pesticide Docket, Public Response
and Program Resources Branch, Field Operations Division (7506C), Office
of Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
Following the comment period, the boric acid RED document will be
available from the National Technical Information Service (NTIS), 5285
Port Royal Road, Springfield, YA 22161, telephone 703-487-4650.
For more information about EPA's pesticide reregistration program,
the boric acid and its sodium salts RED, or reregistration of individual
products containing these active ingredients, please contact the Special
Review and Reregistration Division (7508W), OPP, US EPA, Washington,
DC 20460, telephone 703-308-8000.
For information about the health effects of pesticides, or for
assistance in recognizing and managing pesticide poisoning symptoms,
please contact the National Pesticides Telecommunications Network
(NPTN). Call toll-free 1-800-858-7378, between 8:00 am and 6:00 pm
Central Time, Monday through Friday.
-------
REREGISTRATION ELIGIBILITY DOCUMENT
BORIC ACID AND ITS SODIUM SALTS
BORIC ACID
SODIUM TETRABORATE DECAHYDRATE (BORAX DECAHYDRATE)
SODIUM TETRABORATE PENTAHYDRATE (BORAX PENTAHYDRATE)
SODIUM TETRABORATE (ANHYDROUS BORAX)
DISODIUM OCTABORATE TETRAHYDRATE
DISODIUM OCTABORATE (ANHYDROUS)
SODIUM METABORATE
LIST A
CASE 0024
ENVIRONMENTAL-PROTECTION-AGENCY
OEFICE-OF-FESTICIDE-PROGRAMS
SFECIAL-REVIEW-AND-REREGISTRATION-DIVISION
-------
-------
TABLE OF CONTENTS
BORIC ACID REREGKTRAHON ELIGIBILITY TEAM iii
GLOSSARY OF TERMS AND ABBREVIATIONS v
EXECUTIVE SUMMARY vii
I. INTRODUCTION 1
H. CASE OVERVIEW 2
A. CHEMICAL OVERVIEW 2
B. USE PROFILE 5
C. ESTIMATED USAGE OF PESTICIDE 17
D. DATA REQUIREMENTS 17
E. REGULATORY HISTORY 18
HI. SCIENCE ASSESSMENT 19
A. Physical Chemistry Assessment 19
B. Human Health Assessment 22
1. Toxicology Assessment 22
a. Acute Toxicity 22
b. Subchronic Toxicity 24
c. Chronic Toxicity/Oncogenicity 24
d. Reproductive and Developmental Toxicity 25
e. Mutagenicity 26
f. Metabolism 26
g. Reference Dose/Carcinogenicity 26
2. Exposure Assessment 27
a. Dietary 27
b. Occupational and Residential 28
3. Risk Characterization 29
C. Environmental Assessment 29
1. Environmental Fate 29
2. Ecological Effects 30
a. Terrestrial Data 30
b. Aquatic Data 31
c. Beneficial Insects' Data 3*
d. Effects on Plants Data
e. Endangered Species Concern
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
1. Eligibility Decision
2. Eligible and Ineligible Uses
-------
B. Regulatory Position 34
1. Tolerance Reassessment 34
V. ACTIONS REQUIRED BY REGISTRANTS 36
A. Manufacturing-Use Products 36
1. Generic Data Requirements 36
2. Labeling 37
B. End-Use Products 38
1. Product-Specific Data Requirements 38
a. Products Under the General Registration Standard for
Boric Acid 38
b. Products Under the Boric Acid and Boron Containing
Salts Registration Standard 38
c. Products not included in either Boric Acid Standards . . 39
2. Labeling 39
a. Compliance with the Worker Protection Standard .... 39
b. Compliance with the Existing Stocks Provision 41
c. Products Under the General Boric Acid Standard 42
d. Products Not Under General Boric Acid Standard .... 42
VI. APPENDICES
Appendix A- Use Patterns Subject to Reregistration
Appendix B- Table of the Generic Data Requirements and Studies Used to Make the
Reregistration Decision
Appendix C- Citations Considered to be Part of the Data Base Supporting the
Reregistration of Boric Acid and its Sodium Salts
Appendix D- List of Available Related Documents
Appendix E- Combined Generic and Product Specific Data Call-in Notice
Attachment 1 -
Attachment 2 -
Attachment 3 -
Attachment 4 -
Attachment 5 -
Attachment 6 -
Attachment 7 -
Data Call-In Chemical Status Sheet
Generic Data Call-in and Product Specific Data Call-in
Response Forms with Instructions
Generic Data Call-in and Product Specific Data Call-in
Requirements Status and Registrants' Response Forms
with Instructions
EPA Grouping of End-Use products for Meeting Acute
Toxicology Data Requirements for Reregistration
EPA Acceptance Criteria
List of Registrants Receiving this Notice
Cost Share and Data Compensation Forms and
Confidential Statement of Formula Form with Instructions
-------
BORIC ACID REREGISTRAHON ELIGIBILITY TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Dave Thomas
William Gross
Mel Crystal
Yvette Hopkins
Phyllis Johnson
Margaret Cogdell
Gabe Patrick
Steve Jarboe
Biological Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Economic Analysis Branch
LUIS, Biological Analysis Branch
LUIS, Biological Analysis Branch
LUIS, Biological Analysis Branch
LUIS, Biological Analysis Branch
Environmental Fate and Effects Division
Mary Frankenberry
John Noles
Brinson Connerly-Perks
Health Effects Division
Jane Smith
Randolph Perfetti
Melba Morrow
Judy Smith
Registration Division
Shyam Mathur
Ian Blackwell
Daniel Peacock
Rame Cromwell
Karen P. Hicks
Science Analysis and Coordination Staff
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Chemical Coordination Branch
Chemistry Branch U
Toxicology Branch n
Occupational and Residential Exposure Branch
Registration Support Branch
Registration Support Branch
Insecticide-Rodenticide Branch
Insecticide-Rodenticide Branch
Fungicide-Herbicide Branch
Policy and Special Projects Staff
Jean Frane Special Review and Reregistration Section
Office of General Counsel
Bob Perlis
Laurel Celeste
iii
-------
Special Review and Reregistration Division
Linda Propst Reregistration Branch
Mario Fiol Reregistration Branch
-------
a.i.
CAS
GLOSSARY OF TERMS AND ABBREVIATIONS
Active Ingredient
Chemical Abstracts Service
COMMODITY CHEMICAL Is a chemical that may have many uses such as a
feedstock used in the production process for other
chemicals and/or final non-pesticidal uses. Some of
these chemicals may have pesticidal uses.
CSF Confidential Statement of Formula
EEC Estimated Environmental Concentration. The estimated pesticide concentration
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
HDT Highest Dose Tested
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/lorppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected
to cause death in 50% of the test animals when administered by the route
indicated (oral, dermal). It is expressed as a weight of substance per unit
weight of animal, e.g., mg/kg.
LD10 Lethal Dose-low. Lowest Dose at which lethality occurs
T.F.T, Lowest Effect Level
LOEL Lowest Observed Effect Level
MATC Maximum Allowable Toxicant Concentration
-------
GLOSSARY OF TERMS AND ABBREVIATIONS (cont.)
MTCRONUTREENT A nutrient that plants require in only small or trace amounts.
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and
tracking studies submitted.
N/A Not Applicable
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
ppm Parts Per Million
RAC Raw Agricultural Commodity
RED Reregistration Eligibility Decision Document
RfD Reference Dose
RS Registration Standard
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TC Toxic Concentration. The dose at which a substance
produces a toxic effect.
TMRC Theoretical Maximum Residue Contribution
VI
-------
EXECUTIVE SUMMARY
This Reregistration Eligibility Decision document (RED) addresses the eligibility for
reregistration of pesticide products containing boric acid and its sodium salts; specifically it
includes products containing boric acid, sodium tetraborate decahydrate (borax decahydrate),
sodium tetraborate pentahydrate (borax pentahydrate), sodium tetraborate (anhydrous borax),
disodium octaborate tetrahydrate, disodium octaborate (anhydrous), and sodium metaborate.
Hereafter, in this document, this group of chemical compounds will be referred to as "boric
acid and its sodium salts."
Boric acid and its sodium salts are acaricides, algaecides, fungicides, herbicides, and
insecticides used on a variety of agricultural, non-agricultural, residential, commercial,
medical, industrial, and foody'feed handling sites. Boric acid and its sodium salts are
formulated in a number of ways. Uses for boric acid include those for direct application to
food and feed.
The first boric acid pesticide product was registered in 1948. Currently, there are
189 products containing boric acid or related compounds that are subject to this RED. In
February 1986, the Agency issued two registration standards, the Boric Acid and Boron
Containing Salts Registration Standard (NTIS PB87-101903) and a General Registration
Standard, entitled Guidance for the Registration and Reregistration of End-Use Pesticide
Products Containing the Insecticidal Uses of Boric Acid. Both documents were dated
November 1985, but not issued until February 1986. The Agency issued minor revisions to
both documents in April 1986.
This RED includes in the reregistration case sodium metaborate which was initially
grouped in a different registration standard but it is included here because this chemical is a
sodium salt of boric acid. Originally, this RED was to have included boric oxide as an
active ingredient. However, since there currently are no registered products with this active,
boric oxide will not be included in this document.
The Agency has classified boric acid and its sodium salts as a Group E carcinogen
(evidence of non-carcinogenicity for humans). A reference dose for the boron equivalents of
boric acid and borax was calculated to be 0.09 mg/kg/day based on a no observable effect
level (NOEL) of 8.80 mg/kg/day in a combined sub-chronic (38 weeks) and chronic (two
years) study in dogs. An uncertainty factor of 100 accounts for inter-species extrapolation
and intra-species variability.
Boron occurs naturally in water, fruits, vegetables, and forage crops, and is an
essential nutrient for plants. Based on the review of the toxicological data base and because
boric acid occurs naturally, with little if any residues of boron expected above endogenous
levels, the Agency determined that boric acid and its sodium salts should be exempted from
the requirement of a tolerance on all raw agricultural commodities. Therefore, on August
20, 1993 the Agency established exemptions from the requirement of a tolerance for residues
vii
-------
of boric acid and certain derivatives on all raw agricultural commodities and removed
previously established tolerances in cotton seed and citrus fruits (58 FR 44282). The Agency
will issue a federal register notice proposing to amend the exemption from tolerances to
include the two derivatives, sodium tetraborate pentahydrate (borax pentahydrate) and
disodium octaborate (anhydrous), omitted in the original notice. Also, because products
containing boric acid salts are registered for crack and crevice use in food and feed handling
establishments, the potential exists, even though unlikely, for residues to occur in food.
Therefore, the Agency is establishing food and feed additive regulations for boric acid and its
sodium salts in food and feed handling establishments.
There is minimal concern for risk to fish and wildlife based on the limited outdoor
use patterns, low toxicity, and boron's natural occurrence in terrestrial and aquatic
environments. However, in order to further assess the potential risks to non-target plants
and to endangered plant species, the Agency is requiring three phytotoxicity studies. These
requirements are not part of the target data base and do not affect the reregistration eligibility
of boric acid and its sodium salts.
The Agency has determined that the uses of boric acid and its sodium salts will not
cause unreasonable risk to humans or the environment and all of the uses are eligible for
reregistration.
Unlike products covered by the Boric Acid and Boron Containing Salts Registration
Standard, the Agency has already reregistered all boric acid products used only for domestic
and nondomestic indoor use for cockroach and silverfish control which were covered by the
General Boric Acid Standard. For these products, the only requirement imposed by this
RED is the submission of a current label and CSF to insure that each product is still in
compliance with its special certification form submitted earlier.
Before reregistering the products containing boric acid and its sodium salts, the
Agency is requiring the submittal or citation of product specific data: product chemistry,
acute toxicity, and efficacy (if needed), a revised Confidential Statement of Formula (CSF),
and revised labeling within eight months of the issuance of this document. After these data
and revised labels have been reviewed and determined to be acceptable, the Agency will
reregister a product based on whether or not it meets the requirements in Section 3(c)(5) of
FEFRA. Those products containing more than one active ingredient will be eligible for
reregistration only when the other active ingredients are determined to be eligible for
reregistration.
vixi
-------
I.
INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FEFRA) was
amended to accelerate the reregisfration 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
Agency") of all data submitted to support reregistration.
FERRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for registration" before
calling in data on products and either reregistering products or taking "other appropriate
regulatory action." Thus, reregistration 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" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility
of the registered uses of boric acid and its sodium salts. The document consists of six
sections. Section I is the introduction. Section n describes boric acid and its sodium salts,
their uses, data requirements and regulatory history. Section HI discusses the human health
and environmental assessment based on the data available to the Agency. Section IV presents
the reregistration decision for boric acid and its sodium salts. Section V discusses the
reregistration requirements. Finally, Section VI is the Appendices which support this RED.
Additional details concerning the Agency's review of applicable data are available on
request.1
1 EPA's reviews of data on the set of registered uses considered for EPA's
analysis may be obtained from the OPP Public Docket, Field Operations Division (H7506C),
Office of Pesticide Programs, EPA, Washington, DC 20460.
-------
H. CASE OVERVIEW
A. CHEMICAL OVERVIEW2
The following active ingredient(s) are covered by this Reregistration Eligibility
Decision:
(1) boric acid
Chemical Name: boric acid
CAS Registry Number: 10043-35-3
OPP Chemical Code: 011001
Empirical Formula: H3BO3
Basic Manufacturer: U. S. Borax
(2) sodium tetraborate decahydrate (borax decahydrate)
Chemical Name: sodium tetraborate decahydrate (Borax 10 Mol)
CAS Registry Number: 1303-96-4
OPP Chemical Code: 011102
Empirical Formula: Na^O?. 10H2O
Basic manufacturer: U.S. Borax
(3) sodium tetraborate pentahydrate (borax pentahydrate)
Chemical Name: Sodium tetraborate pentahydrate (Borax 5 Mol)
CAS Registry Number: 11130-12-4 or 12179-04-3
OPP Chemical Code: 011110
Empirical Formula: Na2B4O7. 5H2O
Basic Manufacturer: U.S. Borax
The November 1985 Registration Standard reviewed the data requirements for
registered products containing boric acid and boron containing salts (borax and
disodium octaborate tetrahydrate). Since there are no longer active products
containing boric oxide, this document will not assess the data requirements for
boric oxide.
-------
(4) sodium tetraborate (anhydrous borax)
Chemical Name: sodium tetraborate (Anhydrous Borax)
CAS Registry Number: 1330-43-4
OPP Chemical Code: 011112
Empirical Formula: Na2B4O7
Basic Manufacturer: U.S. Borax
(5) disodium octaborate tetrahvdrate
Chemical Name: disodium octaborate tetrahydrate
Trade Name: Polybor* 3
CAS Registry No.: 12008-41-2
OPP Chemical Code: 011103
Molecular Formula: Na^gO^. 4H2O
Basic Manufacturer: US Borax
(6) disodium octaborate (anhydrous)
Chemical Name: Timber Rods
CAS Registry Number: 12008-41-2
OPP Chemical Code: 011107
Empirical Formula: Na2B8O13
Basic Manufacturer: Chemical Specialties
(7) sodium metaborate
Chemical Names: sodium metaborate
CAS Registry No.: 15293-77-3
OPP Chemical Code: 011104
Empirical Formula: NaBO2
Basic Manufacturer: US Borax and J. R. Simplot Co.
-------
The table below lists the active ingredients and additional names by which the
chemicals are known.
ACTIVE INGREDIENT AND ADDITIONAL NAMES
FOR
BORIC ACID AND ITS SALTS
•4
Active Ingredient
•>, •• ' ' j
boric acid
sodium tetraborate decahydrate
sodium tetraborate pentahydrate
sodium tetraborate anhydrous
disodium octaborate (anhydrous)
disodium octaborate tetrahydrate
sodium inelaborate
boric oxide
Additional Name(s)
boracid acid
orthoboric acid
disodium tetraborate decahydrate
sodium borate decahydrate
borax decahydrate
sodium biborate 10H2O
sodium pyroborate lOHjO
disodium tetraborate pentahydrate
borax pentahydrate
sodium borate pentahydrate
sodium biborate 5H2O
sodium pyroborate 5H2O
disodium tetraborate (anhydrous)
borax (anhydrous)
sodium borate (anhydrous)
sodium biborate (anhydrous)
sodium pyroborate (anhydrous)
none
none
none
boric anhydride
boron oxide
boron trioxide
boron sesquioxide
-------
B. USE PROFILE
The following is a general use profile for the registered uses for boric acid and its
sodium salts. A detailed table of eligible uses as well as the methods, application rates,
limitations, and use restrictions is included in Appendix A.
A) Chemical; boric acid (011001)
Type of Pesticide: Acaricide, Algaecide, Fungicide, Herbicide, Insecticide
Mechanism of Action:
(Plants): At herbicide quantities, boric acid causes plant desiccation.
(Fungi): Inhibits the growth of fungi by preventing the production of
conidia or asexual spores.
(Insects): Acts as a stomach poison against ants, cockroaches, silverfish,
and termites.
Use Groups And Sites
AQUATIC NON-FOOD INDUSTRIAL
Sewage systems.
TERRESTRIAL FOOD+FEED
Agricultural crops/soils (unspecified), orchards (unspecified).
TERRESTRIAL NON-FOOD CROP
Agricultural uncultivated areas, commercial/institutional/industrial
premises/equipment (outdoor), golf course turf, nonagricultural rights-of-
way/fencerows/hedgerows, nonagricultural uncultivated areas/soils, ornamental
lawns and turf recreational areas, refuse/solid waste sites (outdoor), wood
protection treatment to forest products (seasoned).
INDOOR FOOD
Barns, barnyards/auction barns, commercial transportation facilities (feed/food
empty), eating establishments, food handling areas (food contact), eating
establishments food serving areas (food contact), food processing plant
nonfood handling areas, food processing plant premises (nonfood contact),
food/grocery/marketing/storage distribution facility premise.
household/domestic indoor food handling areas, meat processing plant
premises (nonfood contact), poultry (egg/meat), poultry processing plant
premises (nonfood contact).
INDOOR NON-FOOD
Eating establishments, animal kennels/sleeping quarters (commercial),
commercial storage/warehouses premise (indoor), commercial transportation
-------
facilities (nonfood/nonfood) commercial/institutional/industrial'
premises/equipment (indoor), eating establishments nonfood areas (nonfood
contact), specialized animals.
INDOOR MEDICAL
Hospitals/medical institutions premises (human/veterinary).
INDOOR RESIDENTIAL
Household/domestic dwellings, household/domestic dwelling contents,
household/domestic dwelling indoor premises, pet living/sleeping quarters,
refuse/solid waste containers (garbage cans), wood protection to
buildings/products (indoor).
OUTDOOR RESIDENTIAL
Household/domestic dwellings outdoor premises, ornamental lawns and turf,
pet living/sleeping quarters.
Pests: Ants, cockroaches, silverfish, termites and decay producing fungi.
Formulation Types Registered
Single Active Ingredient Products
Wettable Powder
99.0%
Dust
99.0%, 64.0%, and 65.0%
Liquid Concentrate
26.3%
Ready-to-Use Paste
50.0%
Pelleted/Tableted
40.0%
Bait Tube
53.3%
Method and Rates of Applications
Several methods of application are used to apply boric acid including fixed-
wing aircraft, aerosol can, knife or spatula, shaker can, spoon, mop, portable
line sprayer, pump spray bottle, boat, pressure sprayer, spreader, hand
application, bulbous dusters, power duster, wood pressure treating equipment
and ready-to-use paste tube applicators.
-------
Limitations
Avoid depositing product onto exposed food and feed processing, preparation
and serving surfaces, or introducing material into air. Do not apply when
food processing facility is in operation. Any product visible after application
must be brushed into cracks and crevices, or removed. Place product in areas
that are inaccessible to children and pets.
B) Chemical; sodium tetraborate decahydrate (011102)
Type of Pesticide: Fungicide, Insecticide, Herbicide,
Mechanism of Action: Acts as an abrasive on the exoskeleton of insects, and as a
stomach poison. It is also used as a herbicide to control weeds; used as a
preservative on wood products against decay fungi, and as an algae suppressant in
swimming pools and sewage systems.
Use Groups And Sites
FORESTRY
Forest tree management/forest pest management (conifer stump treatment)
TERRESTRIAL NONFOOD CROP
Ornamental lawns and turf, industrial areas (outdoor), paved areas (private
roads/sidewalks), wood pressure treatment to forest products, wood protection
treatment to forest products (unseasoned and seasoned).
AQUATIC NONFOOD INDUSTRIAL
Sewage systems.
AQUATIC NONFOOD OUTDOOR
Wood protection treatment to aquatic structures/items.
INDOOR FOOD
Household domestic dwelling indoor food handling areas (crack and crevice),
food processing plant premises feed/food empty, food processing plant
nonfood handling areas, eating establishments food handling areas (food
contact), eating establishments food serving areas (food contact),
food/grocery/marketing/storage/ distribution facility premises, commercial
transportation facilities feed/food empty.
INDOOR NONFOOD
Specialized animal housing, animal kennels/sleeping quarters (commercial),
specialized animals, commercial transportation faculties nonfeed/nonfood,
-------
eating establishments non-food areas (nonfood contact), commercial/
institutional/industrial premises/equipment (indoor).
INDOOR MEDICAL
Hospitals/medical institutions premises (human/veterinary)
INDOOR RESIDENTIAL
Household/domestic dwelling indoor premises/contents, wood protection
treatment to buildings/products indoor.
OUTDOOR RESIDENTIAL
Ornamental lawns and turf, household/domestic dwelling outdoor premises,
wood protection treatment to buildings/products outdoor
Pests: decay and soft rot fungi, sapstain, molds; wood boring beetles (including
powderpost beetles, furniture beetles, old house borers and longhorn beetles),
subterranean termites, dampwood termites, drywood termites, cockroaches,
sweet-eating ants, grease eating ants, pavement ants, little black ants, black
carpenter ants, odorous ants, silverfish, palmettobugs; algae, klamath weed,
weeds (unspecified).
Formulation Types:
Single Active Ingredient Products
Water Soluble Powder
100%
Granular
99.5%
Liquid
5.4% and a 4%
Multiple Active Ingredient Products
Paste
40% + 1 other active ingredient (AT)
Solid Bait
5% + 1 other active ingredient (AI)
Liquid
2% + 2 other active ingredients (AI's)
Method and Rates of Application
The wood preservatives paste is applied by hand using trowel/brush, caulking
gun, or bandage. Liquid wood preservative is applied using pressure treating
plants, spray box flow coaters, dip tanks, sprayers or brushes.
8
-------
C)
The liquid ant bait is dispensed by hand to a cardboard tray and the solid bait
is marketed in a RTU child resistant bait station.
The granular herbicide is broadcast by hand using a suitable distribution
device (preferably a mechanical spreader) at a rate of 10 to 15 lb/100 sq ft, for
klamath weed the rate may be reduced to 3 to 4 lb/100 sq ft.
The granules may also be dissolved in water and applied by power sprayer at
the same rate.
The granular fungicide is applied to stumps within two days of cutting using a
granular shaker, one pound will treat 50 sq ft of stump surface.
The dust/powder is applied using pressurized duster/blower, bulbous duster or
other suitable dusting equipment. For exterior use the dust is applied at 8
lb/3,000 sq ft.
The rates of borax applied to some sites are unclear and not identified.
Therefore, they cannot be accurately reported in this profile.
Use Limitations
Wood Preservative Paste - do not drill holes in utility poles closer than two
feet.
Ant Baits - avoid contamination of feed and foodstuffs.
Dust/Powder - not to be used in food areas of food handling establishments
other than as crack and crevice treatment and after treatment any surface
powder must be brushed into cracks and crevices or removed. Only to be
applied to areas inaccessible to children.
Herbicide Spray or Granules - non-selective and therefore can only be used
in areas where vegetation is not wanted, if weed growth is heavy cut
vegetation before treatment.
Chemical: sodium tetraborate pentahydrate (011110)
Type of chemical: Algaecide, Herbicide, Insecticide
Mechanism of Action: Acts as an abrasive on the exoskeleton of insects and as a
stomach poison. It is also used as a herbicide to control weeds & in swimming pools
to suppress algal growth. In field crops, it is used to correct or prevent boron
deficiencies.
-------
Use groups and sites:
TERRESTRIAL NONFOOD CROP
Nonagricultural uncultivated areas/soils, industrial areas (outdoor), paved areas
(private roads/sidewalks).
AQUATIC NONFOOD RESIDENTIAL
Swimming pool water systems.
INDOOR FOOD
Household/domestic dwellings indoor food handling areas, commercial
transportation facilities (feed/food-empty), food processing plant premises
(non-food contact), food processing plant nonfood handling areas, eating
establishments food handling/serving areas (food contact),
food/grocery/marketing/storage/distribution facility premise.
INDOOR NONFOOD
Commercial transportation facilities (non feed/ nonfood), eating establishments
nonfood areas (nonfood contact) commercial/institutional/industrial premises/
equipment (indoor).
INDOOR MEDICAL
Hospitals/medical institutions premises (human/ veterinary).
INDOOR RESIDENTIAL
Household/domestic dwellings indoor premises.
Pests: algae, klamath weed, poison ivy, leafy spurge, Canada thistle, wild morning
glory, wild oats, ryegrass, johnsongrass, poison oak; cockroaches, ants,
silverfish
Formulation types:
Single Active Ingredient Products
Granular
96%
Dust
74%
Soluble concentrate/solid
99.5%
Multiple Active Ingredient Products
38% + 2 other active ingredients
10
-------
D)
Methods and rates of application:
Granular - In fall, winter, or when needed, broadcast, apply spot or
prepaying treatment by spreader, granule applicator, or hand at 0.2-13 Ib
AI/100 sq ft.
Dust - When needed, apply indoor general surface, voids, crack & crevice, or
spot treatment by squeeze applicator, duster, or bulbous duster using ready-to-
apply dust.
Soluble concentrate/solid - Initially & for subsequent, maintenance, or
winterizing treatment, apply at 1 Ib AI/1,000 gal pool water.
Use limitations:
Do not contaminate lawns, trees, shrubs, crops, & other desirable plants. Do
not contaminate water, feed, or foodstuffs. Do not use in edible product areas
of food handling establishments.
Chemical: sodium tetraborate (011112)
Type of chemical: Acaricide, Herbicide, Insecticide
Mechanism of Action:
Use Groups and Sites:
Acts as an abrasive on the exoskeleton of insects and as a
stomach poison. Used as a herbicide to control weeds.
TERRESTRIAL NONFOOD CROP
Nonagricultural rights-of-way/fencerows/ hedgerows, industrial areas
(outdoor), agricultural uncultivated areas/soils, recreational areas, pavec! areas
(private roads/sidewalks), commercial/institutional/ industrial
premises/equipment (outdoor).
INDOOR RESIDENTIAL
Ornamental herbaceous plants, ornamental woody shrubs & vines, ornamental
&/or shade trees, ornamental nonflowering plants.
Pests: Powder post beetles, furniture beetles, old house borers, longhorn beetles,
ants, mealy bugs, spider mites, aphids, scale insects; broadleaf weeds, grasses
Formulation Types:
Single Active Ingredient Products
Emulsifiable concentrate
0.28%
11
-------
E)
Granular
100%
Bait/liquid ready to use
5%
Multiple Active Ingredient Products
Soluble concentrate/liquid
11.41% + 1 other active ingredient (AI)
Methods and Rates of Application:
Emulsifiable concentrate - Apply foliar spray with sprayer at 3 tsp of 0.28%
product/pt water.
Granular - In fall, winter, or when needed, broadcast or apply spot treatment
by spreader or hand using 2.7 to 11 Ib AI/100 sq ft. When needed, apply
prepaying treatment at 5 Ib AI/100 sq ft.
Liquid ready-to-use - When needed, apply few drops of 5 % product along ant
trails and small amount in cracks & crevices.
Soluble concentrate/liquid - Apply with power or knapsack sprayer. The
rates of sodium tetraborate cannot be calculated in terms of AI from the label
and, therefore are not reported in this profile.
Use limitations
Do not deposit product over exposed surfaces. Do no contaminate water,
food, or food processing surfaces or surfaces likely to be contacted by food.
Do not contaminate lawns, trees, shrubs, crops, and other desirable plants.
Chemical: disodium octaborate tetrahydrate (011103)
Type of Pesticide: Fungicide, insecticide
Mechanism of action:
Use groups and sites:
Acts as an abrasive on the exoskeleton of Insects and as
a stomach poison, used as a fungicide on wood products
to control decay fungi
TERRESTRIAL FOOD + FEED CROP
Compost/compost piles, manure
12
-------
TERRESTRIAL NONFOOD CROP
Animal kennels/sleeping quarters (commercial), refuse/solid waste sites
(outdoor), wood pressure treatment to forest products.
AQUATIC NONFOOD INDUSTRIAL
Sewage systems.
AQUATIC NONFOOD OUTDOOR
Wood protection to aquatic structures/items.
OUTDOOR RESIDENTIAL
Wood protection treatment to buildings/products outdoor
INDOOR FOOD
Food/grocery/marketing/storage/distribution facility premise, poultry
(egg/meat).
INDOOR NONFOOD
Commercial storages/warehouses premises (indoor), eating establishments food
handling & serving areas (nonfood contact), commercial/institutional/industrial
premises/equipment.
INDOOR MEDICAL
Hospitals/medical institutions premises (human/ veterinary).
INDOOR RESIDENTIAL
Household/domestic dwellings and contents, wood protection treatment to
buildings/products indoor, pet living/sleeping quarters
Pests: brown rot, fungal decay, white rot, wood rot/decay fungi; ants, cockroaches,
fleas, house fly, soldier fly, latrine fly, silverfish, termites, wood boring
insects
Formulation types:
Single Active Ingredient Products
Soluble concentrate/liquid
40% (includes 1 product for manufacturing use)
Soluble concentrate/solid
99.4%
Formulation not identified/solid
98%
13
-------
F)
Methods and rates of application:
Soluble concentrate/solid
Use when needed. Apply compost or manure treatment by dust gun or
hand at 20 Ib active ingredient (AI)/1,000 ft2. Spray at 44 Ib AI/1,000
ft2. Sprinkle at 20 to 49 Ib AI/1,000 ft2. Apply wood protection
treatment by pressure or by dip-diffusion in tank at 140 to 380 Ib
AI/100 gal solution. Apply nonsoil contact nonfumigation with sprayer
or brush at 6.5 to 29 Ib AI/1,000 ft2 or by tank or injection at 1 to 3.75
Ib AI/gal solution. Mop at 0.25 Ib Al/gal solution. Apply indoor
premise treatment by carpet shampooer at 2 to 3.3 Ib AI/1,000 ft2.
Soluble concentrate/liquid
Use when needed. Apply nonsoil contact nonfumigation by sprayer,
brush, or injection using maximum rate (23 % solution) for protection
from subterranean and Formosan termites.
Use limitations:
Do not use in edible product areas of food processing plants or on counter tops
and other surface areas where food is prepared. Do not use in serving areas
while food is exposed. Do not contaminate feed, water, or food. Do not use
to treat lumber that will contact soil or be exposed to leaching by weather.
Chemical: disndiiim octaborate (anhydrous) (011107)
Type of chemical: Fungicide
Mechanism of action:
Used to prevent and control decay fungi in lumber and
timber products.
Use groups and sites:
TERRESTRIAL NONFOOD CROP
Wood protection treatment to forest products (seasoned and unseasoned).
OUTDOOR RESIDENTIAL
Wood protection treatment to buildings/products outdoor.
INDOOR RESIDENTIAL
Wood protection treatment to buildings/products indoor.
Pests: decay fungi.
14
-------
G)
Formulation types:
Crystalline rod
100%
Methods and rates of application:
Rods are inserted into holes drilled to appropriate size and sealed with wooden
dowels, wood filler or caulk. For remedial treatment the rate is 4.14 oz (6.0 oz boric
acid equivalent) per cubic foot of wood, and for preventative treatment the rate is
1.38 oz (2.0 oz boric acid equivalent) per cubic foot of wood.
Use limitations:
None.
Chemical; sodium metaborate (011104)
Type of Chemical: Herbicide
Mechanism of Action:
Use groups and sites:
Sodium metaborate is taken up by plant roots. Once it
enters the leaves, it interrupts the photosynthetic
pathway; thereby, causing the plant to die.
TERRESTRIAL NON-FOOD CROP
Agricultural uncultivated areas, airports/landing fields, industrial areas
(outdoor), nonagricultural outdoor buildings/structures, nonagricultural rights
of way/fencerows/hedgerows, nonagricultural uncultivated areas/soils,
nonagricultural uncultivated soil sterilization, and recreational areas.
AQUATIC NON-FOOD INDUSTRIAL
Drainage systems (ditch banks).
OUTDOOR RESIDENTIAL
Paths/patios, paved areas (private roads/sidewalks), nonagricultural rights-of-
way/fencerows/hedgerows.
Pests: Sand burr, poison ivy, poison oak, bermudagrss, bindweed, bluegrass, Canada
thistle, crabgrass, dallisgrass, downy brome, smooth brome, dock, wild carrot, sweet
clover, sheep sorrel, dandelion, plantain, bouncingbet, goldenrod, asters, daisies,
dogbane, field bindweed, horsenettte, johnsongrass, kochia, leafy spurge, nutsedge,
paragrass, Russian knapweed, Russian thistle, sunflower, whitetop, and willow.
15
-------
Formulation types
Multiple Active Ingredient Products
Granular
94.0% + 1 active ingredient (AT).
68.0% + 1 active ingredient (AI).
66.5% + 2 active ingredients (AI's)
55.6% + 2 active ingredients (AI's)
54.0% + 1 active ingredient (AI).
50.0% + 2 active ingredients (AI's).
Pelleted/tableted
50.0% + 3 active ingredients (AI's).
Formulation not identified/solid
50.0% + 1 active ingredient (AI)
Soluble concentrate/liquid
19.0% + 1 active ingredient (AI).
10.0% + 1 active ingredient (AT).
10.0% + 2 active ingredients (AI's).
9.08% + 1 active ingredient (AI).
9.0% + 1 active ingredient (AI).
8.75% + 2 active ingredients (AI's).
6.0% + 1 active ingredient (AI).
4.57% + 1 active ingredient (AI).
Ready-to-use liquid
10.0% + 1 active ingredient (AI).
Method and rates of application
Granular soil treatment—When needed, broadcast by power spreader, at 35-
376 Ibs Al/acre.
PeIIeted7tableted~When needed, broadcast by spreader or shaker can at 200
Ibs Al/acre.
Formulation not identified/solid-Use as broadcast treatment when needed at
436 Ibs Al/acre.
Soluble concentrate/liquid—When needed, apply by hand sprayer, sprinkler
can, or power sprayer. Maximum rates vary with the formulation and weeds
to be controlled, rates range from 148.8 to 543.6 Ibs AI/A.
Liquid ready-to-use~When needed, apply by edging treatment to lawn, apply
with squeeze applicator at 0.0512 Ib AI/100 linear feet.
16
-------
Use limitations
Sodium metaborate is not selective and may be toxic to all types of vegetation. It
may render the entire area totally or partially unproductive for one or more years.
Take care to confine application to the particular area intended to be treated and
prevent its contact with lawns, trees, shrubs, crops and other desirable plants which
are not intended to be destroyed or injured. This includes precautions in treating
areas which may be underlaid by roots of adjacent valuable plants. Do not drain or
flush equipment near these areas.
C. ESTIMATED USAGE OF PESTICIDE
This section presents information on the pesticide uses of boric acid and its sodium
salts. The estimates provided are derived from a variety of published and proprietary
sources available to the Agency. The data, reported on an aggregate and site (crop) basis,
reflect annual fluctuations in use patterns as well as the variability in using data from various
information sources.
Data from the US Bureau of Mines (1989-1991) report "agricultural uses" of boron
minerals averaged 133 metric tons (293,265 Ibs.) per year. The pesticide uses are believed
to be smaller in volume than the agricultural uses. However, data from the late 1970's early
1980's suggest a much greater usage of boric acid.
Additionally, no technical product is registered for sodium metaborate. Historically,
there has been moderate usage of sodium metaborate on rights-of-way, railroads and
industrial sites. It is reported that wood preservative uses are second in volume to insecticide
uses.
D. DATA REQUIREMENTS
Data requested in the Boric Acid and Boron Containing Salts Registration Standard
covered product chemistry, ecological and environmental effects, toxicology and residue
chemistry studies for manufacture and end-use products containing boric acid and two sodium
salts, sodium tetraborate decahydrate (borax decahydrate), and disodium octaborate
tetrahydrate. Appendix B of this document identifies the generic data that the Agency
reviewed as part of its determination of reregistration eligibility of boric acid and its sodium
salts and lists the acceptable studies.
17
-------
E. REGULATORY HISTORY
Borate is the accepted common name for the metal salts of boric acid which comprise
the following family of chemicals: sodium tetraborate decahydrate, sodium tetraborate
pentahydrate, sodium tetraborate (anhydrous borax), disodium octaborate (anhydrous),
disodium octaborate tetrahydrate, and sodium metaborate.
The first boric acid product was registered as a pesticide in 1948. In February 1986,
the Agency issued two registration standards, dated November 1985, for products containing
boric acid and related compounds. The EPA issued minor revisions to both documents in
April 1986.
The Boric Acid and Boron Containing Salts Registration Standard covered technical
and end-use products containing boric acid and and two sodium salts, sodium tetraborate
decahydrate (borax decahydrate), and disodium octaborate tetrahydrate. This standard
required submission of certain forms; revised labeling; and additional product and residue
chemistry, environmental and ecological effects, toxicology and efficacy data.
The Agency also published the General Registration Standard, Guidance for the
Registration and Reregistration of End-Use Pesticide Products Containing the Insecticidal
Uses of Boric Acid. This document covered only boric acid products of 99 to 100% purity
which were used primarily for cockroach control. Because of the low toxicity and reduced
risk of such products and the extensive data base available for boric acid in the public
literature, the Agency only required submission of an application form and a special
Certification Form verifying the product's adherence to certain specifications concerning
composition, form, supplier, and labeling.
Prior to development of the Boric Acid and Boron Containing Salts Registration
Standard, the Agency had combined under one active ingredient three distinct sodium salts of
boric acid; sodium tetraborate decahydrate, sodium tetraborate pentahydrate, and sodium
tetraborate. In the same manner, the Agency had also combined under once active ingredient
disodium octaborate decahydrate and disodium octaborate. During the development of this
RED, the product chemistry characteristics of each chemical indicated that each chemical is
unique in its characteristics and that each chemical should also be uniquely identified.
Furthermore, another sodium salt of boric acid, sodium metaborate, which is
supported by data from actives included in the Boric Acid Registration Standard of 1985, was
not included in the 1985 Registration Standard, but was later assigned to the barium
metaborate case. Because sodium metaborate is a sodium salt of boric acid, the data
supporting boric acid and other sodium salts also supports sodium metaborate. Therefore,
the Boric Acid Reregistration Eligibility Team decided to include sodium metaborate in the
boric acid and its sodium salts reregistration case.
18
-------
Additionally, the Boric Acid Registration Standard did not include the related
compound boric oxide as one of the active ingredients in the boric acid case. This oversight
was noted in the March 1990 "Reregistration Plan for Chemicals in List A." At that time
the Agency intended to correct this oversight by including boric oxide during the
reregistration of boric acid and its sodium salts. However, because there are no active
registrations for products containing boric oxide, this RED will not include boric oxide.
Currently, there are 189 products containing boric acid or related compounds that
should be subject to this RED: 121 products subject to the Boric Acid and Boron Containing
Salts Registration Standard; 43 products subject to the General Boric Acid Standard; and 25
sodium metaborate products not subject to either standard.
SCIENCE ASSESSMENT
The Agency has conducted a thorough review of the scientific data base for boric acid
and its sodium salts for the purpose of determining the reregistration eligibility of these
pesticides.
A. Physical Chemistry Assessment
The physical and chemical properties of boric acid and its sodium salts are as follows:
(1) boric acid
TGAI: boric acid
Molecular weight: 61.88
Color: white
Physical State: solid crystalline powder
Odor: none
Melting Point: 170.9°C ± 0.2°C(340°F) [melts without
decomposition]
Specific Gravity: 1.5128 at 20°C
Solubility: 4.72% at 20°C
Vapor Pressure: less than 10"* torr at 20°C
Octanol/Water Partition Coefficient: 0.175
pH: 5.1 (1% solution at 20°C)
Stability: stable
(2) sodium tetraborate decahydrate (borax decahydrate)
TGAI: sodium tetraborate decahydrate
Molecular weight;: 381.87
Color: white
19
-------
Physical State: crystalline powder
Odor: none
Melting Point: 62°C (144°F) [begins to dissolve in water of hydration]
Density: 1.73
Solubility: 4.70 g/lOOml at 20°C (68°F)
Vapor Pressure: < 10"6 Torr
pH: 9.24 (1% solution) at 20°C
Stability: stable
(3) sodium tetraborate pentahydrate (borax pentahydrate)
TGAI: sodium tetraborate pentahydrate
Molecular Weight: 291.35
Color: white
Physical state: a mild white alkaline salt
Odor: none
Melting Point: < 200°C (with decomposition)
Density: 1.818
Solubility: In water 1.52% (0°C), 3.59% (20°C), 4.43% (25°C), 50.13%
(100°C). In organic solvents at 25°C: 16.9% (MeOH), 31.1%
(Ethylene glycol).
Vapor Pressure: < 10"6 Torr
pH: 9.26 (0.1% solution); 9.24 (1.0% solution) and 9.32 (4.71% saturated
solution) at 20°C
Stability: stable under ordinary conditions
(4)
TGAI: sodium tetraborate (anhydrous borax)
Molecular Weight: 201.27
Color: white
Physical State: solid crystalline or amorphous
Odor: none
Melting Point: 742°C (1367°F)
Density: 2.367
Solubility: It is soluble in water but at much slower rate than regular borax.
The solubility of finely divided crystalline disodium tetraborate
in methanol and ethylene glycol, expressed as wt
% Na2O.2B2O3 are 16.7% and 30% respectively.
Vapor Pressure: < 10"6 Torr
pH: data gap
Stability: stable under ordinary conditions
20
-------
(5) disodium octaborate tetrahydrate
Color: White. Munsell Color: 5.0 Y 9.24/1.25
Physical State: Powder
Odor: None
Specific gravity (bulk density): 25-35 Ibs/cubic foot
Solubility: 9.5% at20°C
pH: 8.5 (1% solution at 23°C)
Storage stability: Stable
Corrosion Characteristics: Non-corrosive to steel and most metals. May be
slightly corrosive to Al.
(6) disodium octaborate (anhydrous)
TGAI: disodium octaborate (anhydrous)
Molecular Weights 340.31
Color: clear to opaque
Physical State: solid rods
Odor: odorless
m.p.: data gap
Density: 1.8 g/ml at 20°C
Storage Stability: data gap
(7) sodium metaborate
TGAI: sodium metaborate
Molecular weight: 65.82
Color: white
Physical State: solid white pieces or powder
Odor: none
Melting Point: Fuses to clear glass at 966°C (1770°F). Some
vaporization occurs at 1230°C (2246°F).
Bulk Density (Tetrahydrate): loose Pack (51-55 Ibs/ft3) and Tight Pack
(55-61 Ibs/ft3.
Solubility: soluble in water, solution being strongly
alkaline
Vapor Pressure: less than 10"6 Torr
Octanol/Water Partition Coeff: Data gap
pH: 11.82 (6% aqueous solution of tetrahydrate)
Stability: the crystals will pick up carbon dioxide if exposed to air,
forming sodium carbonate and Borax
21
-------
There are several product chemistry requirements not fully satisfied for boric acid and
its sodium salts. Although data gaps exist, these requirements are not critical to the
reregistration eligibility decision. The Agency is requiring additional product chemistry data
at this time to satisfy these data gaps. The requirements and data gaps are presented in
Appendix B.
B. Human Health Assessment
1. Toxicology Assessment
Boric Acid and its sodium salts include sodium tetraborate decahydrate, sodium
tetraborate pentahydrate, sodium tetraborate (anhydrous borax), disodium octaborate
(anhydrous), disodium octaborate tetrahydrate, and sodium metaborate. The toxicity of all
these boron related chemicals is expected to be similar. At the time of the Registration
Standard, oncogenicity, teratogenicity, as well as a battery of mutagenicity studies were
required. The information available on the effects of boric acid and its sodium salts in
humans, supplemented with the data available on their toxicity in laboratory animals, is
sufficient to evaluate the toxicity of boric acid and its sodium salts. The laboratory animal
data consist of the following:
a. Acute Toxicity
ACUTE TOXICITY VALUES - BORIC ACID
TEST
RESULT
CATEGORY
OralLD50
Dermal LD50
Inhalation LCSO
3.45 g/kg
> 2 g/kg
m
m
Not Required
22
-------
The following table is derived from Manufacturing Use-Products considered
lexicologically similar to the boric acid technical.
ACUTE TOXICITY VALUES - BORIC ACID
TEST
RESULT
CATEGORY
Eye irritation
Skin irritation
Dermal
Sensitization
no cornea! opacity,
conjunctivitis cleared
by day 4
erythema present in
1/6 animals at 72 hours
m
m
Not Required
ACUTE TOXICITY VALUES
SODIUM BORATE (ANHYDROUS BORAX)
TEST
OralLDjo
Dermal LD50
Inhalation LC50
RESULT
4.6 g/kg(M)
> 2 g/kg
not conducted w/technical
CATEGORY
m
in
Not
Applicable/
Required
23
-------
The following table is derived from Manufacturing Use Products considered
lexicologically similar to the sodium tetraborate technical.
ACUTE TOXICITY VALUES
SODIUM TETRABORATE (ANHYDROUS BORAX)
TEST
Eye irritation
Skin irritation
Dermal
Sensitization
RESULT
irritation and comeal opacity
evident at day 14
no skin irritation
—
CATEGORY
I
IV
Not
Applicable
b. Subchronic Toxicity
In a subchronic (3 month) feeding study in dogs, borax was tested at doses of 0, 3, 35
or 268 mg/kg/day for males and 0, 2, 22 or 192 mg/kg/day for females. The systemic
NOEL was 35 mg/kg/day for males and 22 mg/kg/day for females, and the LOEL was 268
mg/kg/day and 192 mg/kg/day based on clinical pathology; decreased hematocrit and
hemoglobin; hemosiderin in the spleen; liver and kidneys; testicular pathology; and,
widening of the adrenal cortex in the area of the zona reticularis. Lipid accumulation was
also present in the zona reticularis, and in high dose females, there was an increase in brain
weight. In males, there were decreases in the testes/brain, testes/body, thyroid/body and
thyroid/brain ratios. Although this study was classified as supplementary, the information is
considered adequate for use in risk assessment.
c. Chronic Toxicity/Oncogenicity
A two-year chronic feeding/oncogenicity study using boric acid was conducted with
B6C3F1 mice. The compound was administered in the diet at levels of 0, 2500 or 5000 ppm
(approximately 0, 450, or 1150 mg/kg/day). No clinical signs of toxicity were observed
during the course of the study. Testicular pathology was present at the highest dose tested
and consisted of testicular atrophy and interstitial cell hyperplasia. Other pathological
findings included a dose related increase (at both levels) in the incidence of splenic lymphoid
depletion in male mice that was believed to be associated with stress and a dose related
increase in the incidence of pulmonary hemorrhage that was of unknown biological
significance. The compound was not found to be carcinogenic at the levels tested. A NOEL
for systemic toxicity was not determined; the LOEL for systemic toxicity was 2500 ppm
(approximately 450 mg/kg/day) based on the pathological findings.
24
-------
A two-year chronic oncogenicity/feeding study with borax was conducted in Sprague
Dawley rats. Animals received doses of 0, 65, 154 or 515 mg/kg/day during the course of
the study. The chronic NOEL was determined to be 154 mg/kg/day and the LOEL was 515
mg/kg/day based on reported decreases in body weight, possible anemia and testicular
tubular atrophy. The test material was not found to be carcinogenic.
In another study, beagle dogs received borax at doses of 0, 13, 26 or 77 mg/kg/day in
the feed for a duration of two-years. The NOEL was 77 mg/kg/day (HDT). An additional
study was conducted for 38 weeks! in which beagles received the test material in the feed at
doses of 0 or 359 mg/kg/day. At 359 mg/kg/day, weight decreases were reported for both
sexes, and in males, testicular atrophy, decreased testicular weight and decreased testes/body
weight ratios were reported. Both of these studies were classified as supplementary;
however, the Agency has determined that the information was sufficient for conducting a risk
assessment.
d. Reproductive and Developmental Toxicity
Pregnant Sprague Dawley rats were administered boric acid in the diet at dose levels
of 0.1%, 0.2%, 0.4%, or 0.8% (approximately 0, 78, 163, 330, or 539 mg/kg/day). The
test material was administered from day 0 through day 20 of gestation for the three lower
dose levels. At 0.8%, the compound was administered on gestation days 6 through 20. The
rationale for providing the test substance for a period that was greater than the period of
organogenesis was to allow the dams to reach a steady state with regard to boric acid
concentrations. At the highest dose level, exposure to the test material was initiated at a
later period in order to minimize preimplantation loss and early embryo lethality. The
maternal NOEL was determined to be 0.1 % (78 mg/kg/day) and the maternal LOEL was
determined to be 0.2% (163 mg/kg/day) based on increased liver and kidney weights. The
developmental NOEL was 0.1 % (78 mg/kg/day) and the developmental LOEL was 0.2%
(163 mg/kg/day) based on decreased fetal body weight and the increase in the incidence of
fetuses/litter with variations (short rib XEDT).
Dose levels of 0, 0.1%, 0.,2% or 0.4% (0, 248, 452, or 1003 mg/kg/day) boric acid
were administered to pregnant CD-I mice in the diet from gestation days 0-17. A maternal
NOEL was not established; the LOEL for maternal toxicity was 0.1% (248 mg/kg/day) based
on the increased incidence of dilated renal tubules. The developmental NOEL was 0.1 %
(248 mg/kg/day) and the developmental LOEL was 0.2% (452 mg/kg/day) based on
decreased average fetal body weights.
Doses of 0, 62.5, 125 or 250 mg/kg/day were administered by gavage to pregnant
New Zealand white rabbits on gestation days 6 through 19, inclusive. The maternal NOEL
was 125 mg/kg/day and the maternal LOEL was 250 mg/kg/day based on the presence of
vaginal bleeding, decreased weight gain during the treatment period, and decreased gravid
uterine weights that were secondary to prenatal mortality. The developmental NOEL was
125 mg/kg/day and the developmental LOEL was 250 mg/kg/day based on prenatal mortality
25
-------
as characterized by the increase in the total number of resorptions. At this dose level, there
was also an increase in the incidence of fetuses with enlarged aortas, intraventricular septal
defects and great vessels arising from the right ventricle. Pre implantation losses were also
higher at 250 mg/kg but this is probably the result of a dosing error since the compound was
supposedly administered after implantation.
In a two generation reproduction study conducted in mice, boric acid was
administered throughout the study in the diet at levels of 0, 1000, 4500, or 9000 ppm (0,
150, 675 or 1350 mg/kg). The NOEL for parental and reproductive toxicity was 1000 ppm
(150 mg/kg). The parental LOEL was 4500 ppm based on decreases in organ weights in
both sexes. The reproductive LOEL was also 4500 ppm based on decreased fertility and
decreased pup weight. At this dose, the average number of days between litters increased
after the second litter and the number of dams producing litters decreased significantly. At
the highest dose tested, no litters were produced and the males in this group had a decrease
in sperm concentration and motility when compared to controls.
In a reproduction study conducted in Sprague Dawley rats, borax was administered in
the feed at doses of 0, 65, 154 or 515 mg/kg/day for three generations. The systemic and
reproductive NOELs were 154 mg/kg/day and the systemic and reproductive LOELs were
515 mg/kg/day. At this dose level, there was a reported decrease in weight gain during the
pre-mating period in both sexes and food efficiency was lower in females. The testes in
males were atrophied and there was a reported decrease in the number of corpora lutea in
females at the highest dose tested. Additionally, no litters were produced when high dose
males were mated to high dose females. When high dose females were mated to control
males, there was a reported decrease in the number of litters and pup survival was adversely
affected. This study was classified as supplementary, but can be used for risk assessment.
e. Mutagenicity
Boric acid has not shown evidence of genetic toxicity. The compound was negative
for gene mutations in both bacteria and mammalian cells (in vitro). When administered to
male and female Swiss mice, the results did not show a significant increase in the frequency
of micronucleated polychromatic erythrocytes in bone marrow cells, i.e., chromosomal
aberration (in vivo).
f.
Metabolism
No metabolism studies are required.
g. Reference Dose/Carcinogenicity
The OPP/HED RfD Peer Review Committee reviewed all the toxicological data
(previously summarized in this document) and concluded that a Reference Dose (RfD) for the
boron equivalents of boric acid and borax was calculated to be 0.09 mg/kg/day based on 1) a
26
-------
no observable effect level (NOEL,) of 8.80 mg/kg/day (as boron equivalents) for testicular
atrophy observed at 29 mg/kg/day (active ingredient) in combined sub-chronic (38 weeks)
and chronic (two years) studies in dogs, and 2) an uncertainty factor of 100 to account for
inter-species extrapolation and intra-species variability.
The OPP Carcinogenicity Peer Review Committee has classified boric acid as a
"Group E" carcinogen, evidence of non-carcinogenicity for humans.
2. Exposure Assessment
a. Dietary
Tolerances for residues of boron resulting from the use of boric acid and its sodium
salts had been established under (40 CFR 180.271) on cottonseed (30 ppm) and citrus fruits
(8 ppm, postharvest).
Boric acid and its salts are acaricides, algeacides, fungicides, herbicides, and
insecticides which are registered for various non-food, agricultural, medical, and food
handling establishment applications. Additionally, boron occurs naturally in water, fruits and
vegetables, and forage crops, and is an essential nutrient for plants. In pears and
strawberries the levels may reach 160 ppm, and in red cabbage occasionally as high as 200
to 300 ppm. The increment of added boron residues resulting from pesticide use of boric
acid and the boron-containing salts is insignificant compared to levels of naturally occurring
boron in citrus and cottonseed. For example, lemons average 1 ppm incremental boron due
to treatment, compared with 2.5 ppm boron which is endogenous.
The Boric Acid and Boron Containing Salts Registration Standard indicated that the
Agency would consider revoking the existing tolerances and replacing them with an
exemption as well as establishing food additive regulations to cover the food/feed handling
uses at the time the required toxicology studies were submitted and reviewed.
Therefore, based on the review of the toxicological data base and because boric acid
occurs naturally with little if any residues of boron expected above endogenous levels, the
Agency has determined that boric acid and its sodium salts should be exempted from the
requirement of a tolerance on all raw agricultural commodities. Therefore, on August 20,
1993, the Agency established exemptions from the requirement of a tolerance for residues of
boric acid and certain derivatives on all raw and agricultural commodities and removed the
previously established tolerances (in cotton seed and citrus fruits). The Agency will issue a
federal register notice proposing to amend the exemption from tolerances to include the two
derivatives, sodium tetraborate pentahydrate (borax pentahydrate) and disodium octaborate
(anhydrous), omitted in the original notice. Also, because products of boric acid salts are
registered for crack and crevice use in food and feed handling establishments, and the
27
-------
potential exists, even though unlikely, for residues to occur in food, the Agency is
establishing food and feed additive regulations for boric acid and its sodium salts in food and
feed handling establishments.
With these actions, there are no residue chemistry data requirements remaining for
boric acid and its sodium salts. The tolerances for residues of boron under 40 CFR 180.271
have been revoked and food and feed additive regulations will be proposed under 40 CFR
185 and 186, respectively.
b. Occupational and Residential
The products registered for use which contain boric acid as the active ingredient are
applied in aquatic, outdoor and indoor sites (i.e., commercial, industrial, domestic dwellings,
food handling establishments, sewage systems, wood protection treatment to buildings, etc).
Depending on the use site, boric acid may be applied using a spreader, fixed-wing aircraft,
knife/spatula, airblower, power duster, squeeze applicator, or aerosol can. Based on the use
patterns, the potential for dermal and inhalation exposure exists, (i.e., exposure to persons
applying the products, exposure to humans reentering the treated areas, etc.).
With regards to toxicity, boric acid and its sodium salts are human poisons by
ingestion. For boric acid, death in infants has resulted from ingestion of less than 5 grams
and adults have died after ingestion of 5 to 20 grams. Technical grade boric acid is
classified as an acute oral toxicity category HI chemical, and an acute dermal toxicity
category HI chemical. Contact involving concentrated solutions or nearly pure solid
formulations of boric acid may also produce primary eye irritation; additionally, dermal
irritation may also occur if accidental contact occurs (i.e. considered toxicity category IV for
primary skin irritation).
The potential for dermal and inhalation exposure exists. However, if the products are
used in accordance with the label instructions and considering the lack of lexicological
concern, data are not required for the reregistration of boric acid (and its related
compounds).
The Agency considers the use of a long-sleeved shirt, long pants, shoes, socks, and
chemical-resistant gloves a prudent risk-mitigation measure to protect handlers from exposure
to boric acid (and its related compounds). Therefore, the Agency requires that all products
that contain boric acid (and its related compounds) bear personal protective equipment
requirements for handlers that are at least as protective as these items. If the end-use
product labeling already bears personal protective equipment requirements that are more
protective than these items, the more protective requirement must be retained.
The Agency has determined that, at this time, the personal protective equipment
discussed in this section need not apply to residential uses of boric acid (and its related
compounds). The predicted frequency, duration, and degree of exposure in residential uses
28
-------
should not warrant the risk mitigation measures being required for occupational exposed
users.
The Worker Protection Standard (WPS) for Agricultural Pesticides — 40 CFR Parts
156 and 170 — established an interim restricted-entry interval (REI) of 12 hours for boric
acid (and its related compounds) because the known acute toxicity categories for acute
dermal toxicity, skin irritation potential, eye irritation potential are Toxicity Category HI or
IV. The Agency considers the 12-hour REI for this chemical a prudent risk-mitigation
measure to protect workers. Therefore, the Agency retains the 12-hour REI for uses within
the scope of the WPS and will allow workers to enter areas treated with boric acid (and its
related compounds) during the REI only in the few narrow exceptions allowed in the WPS.
The Agency has determined, at this time, the entry restrictions discussed in this
section need NOT apply to uses of boric acid (and its related compounds) not within the
scope of the Worker Protection Standard for Agricultural Chemicals, including out-of-scope
commercial uses and homeowner uses. The predicted frequency, duration, and degree of
exposure as a result of such uses should not warrant the risk mitigation measures being
required for persons engaged in the production of agricultural plants for commercial or
research purposes.
3.
Risk Characterization
The human risks associated with boric acid and its salts are known. Ingestion of
boric acid (>5 grams) by (adult) humans is fatal. There are no direct food application uses
for boric acid and its salts; therefore, there are no dietary concerns based on their current
label uses. There is no reasonable expectation that pesticidal or biocidal uses may constitute
a hazard or risk to people involved in handling or application activities. Proper care and
appropriate adherence to label precautions and directions should reduce exposure. No
additional hazard or exposure data are required for reregistration eligibility.
C. Environmental Assessment
The Agency has determined that no new environmental fate data are required because
of the relatively small amount of boric acid employed for most uses as a pesticide, and the
already significant amounts of boron present in soil and water.
1.
Environmental Fate
Boric acid exists in three crystalline forms, with melting points varying from 170 to
200° C.; its solubility in water is 13,000 parts per million. Dilute aqueous solutions contain
predominantly undissociated H3BO3 molecules, the pK^ being 9.14. The apparent acid
strength of boric acid is increased by strong electrolytes. In the presence of excess CaCl2 the
strength of boric acid becomes equivalent to that of carboxylic acids.
29
-------
Boric acid, borax, and boron-containing salts are ubiquitous in the natural
environment. Available boron occurs in nature in the form of a number of closely related
compounds which differ chiefly in the water of hydration associated with the molecule and
are not easily differentiated. Because of this, the following discussion refers to the group as
"boric acid," "boron," or "the boron salts." The specie which occurs in solution is the BO3'3
cation. More complex mineral forms containing boron may gradually release it in the form
of borate as a result of weathering. The range of boron as a micronutrient in soil is 5-150
ppm, and representative surface soil contains 50 ppm. Boron salts occur naturally in low
concentrations in most unpolluted waterways. A study reviewed by the Agency indicated
that the adsorption and desorption coefficients were less than 1. This study provided
information to confirm that the compound is mobile. The average concentration for boron in
surface waters has been reported to range from 0.001 mg/liter to 0.1 mg/liter. Seawater
boron concentrations average 4.5 mg/liter. In some geographical areas such as the American
Southwest, boron occurs in surface waters in concentrations that have been shown to be toxic
to plants of commercial importance. Most of the naturally occurring boron is inorganic, but
because it is an essential element for many organisms there is an organically-bound
component.
2. Ecological Effects
The following data and risk assessment summaries are based upon boric acid's limited
outdoor use patterns. The Agency's concerns for risks to fish and wildlife species are
minimal. The limited outdoor use patterns, low toxicity and boron's natural occurrence in
terrestrial and aquatic environments are mitigating factors for any potential risk to nontarget
organisms.
a. Terrestrial Data
Five studies reviewed by the Agency provide sufficient information to characterize
technical boric acid as "practically nontoxic" to avian species on an acute oral and dietary
basis. The LD50 value for bobwhite quail is greater than 2510 mg/kg. The dietary LC50
value for mallard duck and bobwhite quail are greater than 5620 ppm and 10,000 ppm,
respectively.
The Agency does not anticipate that avian species will be adversely impacted by the
outdoor use patterns of boric acid. Although the nonagricultural areas and rights-of-way
require high application rates, certain mitigating factors reduce the risk potential; i.e., the
infrequent use confined to limited treatment areas and the low avian acute oral and dietary
toxicity minimize any unreasonable exposure risk. There have been no records or
documentation of field mortalities associated with the use of boric acid submitted to the
Agency.
Three other sites which may require high treatment rates are airports/landing fields,
agricultural drainage ditches, and industrial drainage ditches. These three sites do not
30
-------
involve large scale acreage similar to agricultural sites. The airport/landing fields use is for
weed control, as needed. The agricultural and industrial drainage systems' uses are intended
to keep ditchbanks and culverts clear of vegetation, to keep drainages clear of debris, and to
promote rapid drainage. The Agency does not anticipate that these use patterns will
adversely impact non-target organisms.
b. Aquatic Data
Four studies reviewed by the Agency provide sufficient information to characterize
technical boric acid as "practically nontoxic" to fish and aquatic invertebrates. Acute LC50
values for rainbow trout and bluegill sunfish are > 1100 ppm and > 1021 ppm, respectively.
The acute toxicity value (EC50) for the aquatic invertebrate Daphnia magna ranged from 133
to 226 ppm. One of the studies reviewed indicated that chronic toxicity value (MATC -
Maximum Allowable Toxicant Concentration) for Daphnia magna is between 6 and 13 ppm.
Therefore, based upon the available acute toxicity data for fish and invertebrates, it was
determined that aquatic invertebrates are more sensitive than fish.
However, public literature studies indicate that risk to fish and invertebrates from the
outdoor use patterns of boric acid is expected to be minimal because of the low toxicity and
infrequent uses. Although the rights-of-ways use pattern requires high application rates, the
Agency does not anticipate that aquatic invertebrates will be at risk because of the following
mitigating factors; i.e., boron naturally occurs in surface waters inhabited by both fish and
invertebrates, there are no official reports in the Agency's files of field effects of boric acid
on aquatic ecosystems, and the rights-of-way use pattern is usually limited to treatment of
small strips of land (e.g., railroad lines, power lines) thereby limiting the amount of
contaminated runoff into adjacent aquatic environments.
Additionally, industrial point sources that discharge effluent into surface waters are
subject to NPDES (National Pollutant Discharge Elimination System) permitting process via
the EPA's Office of Water. Label statements for these use patterns require users or
dischargers to contact the EPA or appropriate state agencies before discharging effluent into
surface waters.
c.
Beneficial Insects' Data
A study reviewed by the Agency provides sufficient information to characterize
technical boric acid as "relatively nontoxic" to beneficial insects. The honey bee acute
contact LD50 was greater than 362.58 ppm.
The Agency does not anticipate that beneficial insects will be at risk as a result of the
use of boric acid. Further, most of the boric acid use patterns for insect control are limited
to indoor use. Outdoor uses are considered to be infrequent.
31
-------
d. Effects on Plants Data
Seed germination/seedling emergence and vegetative vigor are terrestrial phytotoxicity
studies required for herbicides applied to terrestrial food, terrestrial nonfood, aquatic nonfood
(excluding residential) and forestry sites if any of the following conditions exist:
• The vapor pressure of the TGAI is equal to or greater than 1.0 x 10-5mm Hg
at 25°C and the TEP is not thoroughly incorporated immediately after
application.
• The TEP (excluding granular formulations) is applied by forced air, air blast,
or through sprinkler irrigation.
• Endangered or threatened plant species are associated with the site of
application (i.e., "rights-of-way").
• There are field incidents of plant phytotoxicity to commercially important
plants. The potential phytotoxicity hazard to commercially important plants
(e.g. citrus) has also been noted in the public literature.
Because boric acid and its sodium salts meet all the above conditions, the Agency is
requiring these terrestrial phytotoxicity studies.
In addition, aquatic plant testing is required for any herbicide applied to terrestrial
nonfood (rights-of-way and ditchbanks), aquatic food, aquatic nonfood (excluding residential)
and forestry sites. Boric acid and its sodium salts are used in some of these sites .
Therefore, to meet this requirement the following species are to be tested: Selenastrum
capricornutum. Lemna gibba. Skeletonema costatum. Anabaena flos-aquae. and freshwater
diatom.
However, these data requirements are not considered to be part of the target data.
base, and therefore, they do not affect the reregistration eligibility of boric acid and its
sodium salts.
e. Endangered Species Concern
The literature on boric acid indicates that the noncrop herbicidal use has the potential
to harm endangered and threatened plant species. The Agency is requiring data on the
phytotoxicity of the active ingredient on non-target plants to help determine whether the
noncrop herbicidal use of boric acid and its sodium salts may affect listed endangered or
threatened plants. Should the data indicate that their use may affect listed endangered or
threatened species of plants, the Agency will consult with the U.S. Fish and Wildlife
Service.
32
-------
At the present time, the Agency is working with the U.S. Fish and Wildlife Service
and other federal and state agencies to develop a program to avoid jeopardizing the continued
existence of listed species by the use of pesticides. When the Endangered Species Protection
Program is implemented and subsequent guidance is given, endangered species labeling
amendments may be required on affected end-use products. Labeling statements for end-use
products will likely refer users to county specific bulletins specifying detailed limitations on
nse to protect endangered species.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FJFRA. calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether products containing the active
ingredients are eligible for reregistration. The Agency in the Boric Acid and Boron
containing Salts Registration Standard previously identified and required the submission of
the generic (i.e., active ingredient; specific) data required to support reregistration of products
containing boric acid and its sodium salts as active ingredients. The Agency has completed
its review of these generic data, and has determined that the data are sufficient to support
reregistration of all products containing boric acid and its sodium salts (products containing
boric acid, sodium tetraborate decahydrate, sodium tetraborate pentahydrate, sodium
tetraborate (anhydrous borax), disodium octaborate decahydrate, disodium octaborate
(anhydrous), and sodium metaborate). Appendix B identifies the generic data requirements
that the Agency reviewed as part of its determination of reregistration for boric acid and its
sodium salts, and lists the submitted studies that the Agency found acceptable.
The data identified in Appendix B were sufficient for the Agency to assess the
registered uses of boric acid and its sodium salts and to determine that boric acid and its
sodium salts products can be used without resulting in unreasonable adverse effects to man
and the environment. The Agency therefore finds that all products containing boric acid and
its sodium salts as the active ingredients are eligible for reregistration. The reregistration of
particular products is addressed in Section V of this document.
The Agency made its reregistration eligibility determination based upon the target data
base required for reregistration, the current guidelines for conducting acceptable studies to
generate such data and the data identified in Appendix B. Although the Agency has found
mat all uses of boric acid and its sodium salts are eligible for reregistration, it should be
understood that the Agency may take appropriate regulatory action, and/or require the
submission of additional data to support the registration of products containing boric acid and
fts sodium salts, if new information comes to the Agency's attention or if the data
requirements for registration (or the guidelines for generating such data) change.
33
-------
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredients of boric acid and
its sodium salts, the Agency has sufficient information on the health effects of boric acid and
its sodium salts and their potential for causing adverse effects in fish and wildlife and the
environment. Therefore, the Agency concludes that products containing boric acid and its
sodium salts for all uses are eligible for reregistration.
The Agency has determined that boric acid and its sodium salts, labeled and used as
specified in this RED document, will not pose unreasonable risks or adverse effects to
humans or the environment.
However, before reregistering these products, the Agency is requiring the submittal or
citation of product specific data (chemistry, acute toxicity, and efficacy (if needed), a revised
Confidential Statement of Formula (CSF), and revised labeling within eight months of the
issuance of this document. Refer to Section VI of this document. After these data and
labeling have been found acceptable, the Agency will reregister a product if it meets the
requirements in Section 3(c)(5) of EEFRA. Those products containing more than one active
ingredient will be eligible for reregistration only when the other active ingredients are
eligible for reregistration.
Unlike products covered by the Boric Acid and Boron Containing Salts Registration
Standard, the Agency has already reregistered all products covered by the General
Registration Standard for Boric Acid. For these products, the only additional requirement in
this RED will be the submission of a current label and CSF to insure that each product is
still in compliance with its special certification form submitted earlier.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of boric acid and its sodium salts are eligible
for reregistration.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for boric acid
and its sodium salts. Where labeling revisions are imposed, specific language is set forth in
Section V of this document.
1. Tolerance Reassessment
Boron occurs naturally in water, fruits, vegetables, and forage crops, and is an
essential nutrient for plants. In pears and strawberries the levels may reach 160 ppm, and in
red cabbage occasionally as high as 200 to 300 ppm. The increment of added boron residues
resulting from pesticide use of boric acid and the boron-containing salts is insignificant
34
-------
compared to levels of naturally occurring boron in citrus and cottonseed. For example,
lemons average 1 ppm incremental boron due to treatment, compared with the 2.5 ppm
boron which is endogenous.
Existing tolerances of boron resulting from the use of boric acid and certain
derivatives were established under 40 CFR 180.271, for cottonseed (30 ppm) and citrus fruits
(8 ppm, post-harvest). Codex maximum residue limits (MRL's) have not been recommended
for boron, and tolerances have not been established in Canada or Mexico for residues of
boron in any food or feed commodity. The Boric Acid and Boron Containing Salts
Registration Standard indicated that the Agency would consider revoking the existing
tolerances and replacing them with an exemption as well as establish food additive
regulations to cover the food/feed handling uses at such time as the required toxicology
studies were submitted and reviewed.
No toxicological concerns have been raised by the review of the toxicology data.
Based on this and the fact that the increment of added boron residues resulting from pesticide
use of boric acid and boron containing salts is insignificant compared to levels of naturally
occurring boron, the Agency has determined that boric acid and its sodium salts should be
exempted from the requirements of a tolerance on all raw agricultural commodities under
Section 408. This exemption in 40 CFR 180 will also cover the fire ant control use of boric
acid in agricultural areas. In addition, because boric acid salts are registered for crack and
crevice use in food and feed handling establishments, the Agency will propose food and feed
additive regulations for boric acid and its salts at food/feed handling sites under Section 409
of FFDCA. With these actions, there are no residue chemistry data requirements remaining
for boric acid and its sodium salts.
On August 20, 1993, the Agency established an exemption from the requirement of a
tolerance for residues of boric acid and its salts on all raw agricultural commodities and
removed the following established tolerances in cotton seed and citris fruits under 40 CFR
180.271.
The exemption has been established under 40 CFR 180.1121, and reads as follows:
"An exemption from the requirement of a tolerance for residues of boric acid, sodium
tetraborate decahydrate (borax decahydrate), sodium tetraborate (anhydrous borax),
disodium octaborate tetrahydrate, sodium inelaborate, and boric oxide is established in
raw agricultural commodities when used as insecticides, herbicides or fungicides pre-
or postharvest in accordance with good agricultural practices."
The Agency will issue a federal register notice to amend the exemption from
tolerances to include the two derivatives, sodium tetraborate pentahydrate (borax
pentahydrate) and disodium octaborate (anhydrous), omitted from the original notice.
35
-------
The Agency will propose establishing the following food and feed additive regulations
under 40 CFR 185 and 186 respectively:
o CFR 40 185:
"A food additive regulation is established permitting the use of boric acid, sodium
tetraborate decahydrate (borax decahydrate), sodium tetraborate pentahydrate (borax
pentahydrate), sodium tetraborate (anhydrous borax), disodium octaborate tetrahydrate,
disodium octaborate (anhydrous), sodium metaborate, and boric oxide in food handling
establishments in accordance with the following prescribed condition:
Application shall be limited solely to careful treatment in food handling establishments
where food and food products are held, processed, prepared or served such that
contamination of food or food contact surfaces shall be avoided."
o CFR 40 186:
"A feed additive regulation is established permitting the use of boric acid, sodium
tetraborate decahydrate (borax decahydrate), sodium tetraborate pentahydrate (borax
pentahydrate), sodium tetraborate (anhydrous borax), disodium octaborate tetrahydrate,
disodium octaborate (anhydrous), sodium metaborate, and boric oxide in animal feed
handling establishments in accordance with the following prescribed condition:
Application shall be limited solely to careful treatment in animal feed handling
establishments where feed and feed products are held, processed, prepared or sold
such that contamination of feed or feed contact surfaces shall be avoided."
V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for the
reregistration of both manufacturing-use and end-use products of boric acid and its sodium
salts.
A. Manufacturing-Use Products
1. Generic Data Requirements
The generic data base supporting the reregistration of boric acid and its sodium salts,
for all eligible uses has been reviewed and determined to be substantially complete.
However, some additional product chemistry information must be submitted and there exists
a data gap for phytotoxicity studies. All of the product chemistry data for boric acid and its
sodium salts were originally required in the Boric Acid and Boron Containing Salts
36
-------
Registration Standard and are therefore not included in a generic Data Call-in issued with
this RED document. Nevertheless, the herbicidal uses justify the requirement of
phytotoxicity studies in order to further assess the potential risks to non-target plants and to
endangered plant species. Additionally, public literature studies cite the possible
phytotoxicity hazard of boron to commercially important plants. The following phytotoxicity
studies are required:
123-1 (a) Seed, germination/seedling emergence
123-l(b) Vegetative vigor
123-2 Aquatic plant growth with Lemna gibba, Skeletonema costatum
Anabaena flosaquae, and a freshwater diatom (Navicula).
2. Labeling
All manufacturing-use products or end-use products that may be contained in an
effluent discharged to the waters of the United States or municipal sewer systems must bear
the following revised effluent discharge labeling statement:
"Do not discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans or other waters unless in accordance with the requirements of a
National Pollutant Discharge Elimination System (NPDES) permit and the permitting
authority has been notified in writing prior to discharge. Do not discharge effluent
containing this product to sewer systems without previously notifying the local sewage
treatment plant authority. For guidance contact your State Water Board or Regional
Office of the EPA.
All affected products distributed or sold by registrants and distributors (supplemental
registrants) must bear the above labeling by October 1, 1995. All products distributed or
sold by persons other than registrants or supplemental registrants after October 1, 1997 must
bear the correct labeling. Refer to PR Notice 91-8: Revised Policy to Provide Applicants
Other Than Basic Manufacturers An Opportunity To Submit Generic Data and Receive Data
Compensation For It, PR Notice 93-10: Effluent Discharge Labeling Statements and, 40 CFR
152.46(a)(l) for further information. Additionally, all products must be in compliance with
current labelling regulations as spectified in
40 CFR 156.10.
37
-------
B. End-Use Products
1. Product-Specific Data Requirements
Section 4(g)(2)B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility has been
made. The product specific data requirements are listed in Attachment 3 of Appendix (E), in
the Combined Generic and Product Specific Data Call-in Notice.
a.
Products Under the General Registration Standard for Boric
Acid
o
o
For products that meet the criteria of the Guidance for the General Registration
Standard and were registered and/or reregistered under the Agency's General Reregistration
Standard:
o The registrant relied on available data to support registration or reregistration,
products are 100% boric acid or 99% boric acid with one of the following inert
ingredients: 1 % tricalcium phosphate, 1 % magnesium stearate, 1 % calcium silicate,
1% diatomaceous earth;
o Certified limit for the active ingredient for all formulations containing one of the inert
ingredients specified above is 99.0 to 99.5%; with a certified limit for the inert being
0.5 to 1.0%;
Products are in Toxicity Categories in and IV;
Products are used only for domestic and nondomestic indoor use for cockroach, ant,
and silverfish control;
o Registrants and applicants purchase their technical from a registered source, and have
adopted one of the standard labels);
the Agency is requiring submission of a current label and a CSF within 8 months of
receipt of this document.
b. Products Under the Boric Acid and Boron Containing Salts
Registration Standard
For products under the Boric Acid and Boron Containing Salts Registration Standard,
the Agency is requiring submission of documentation of their previous successful
completion of the product specific data requirements within 90 days of the receipt of this
document. If the Agency verifies this documentation, it will only require submission of
a revised label and revised CSF within 8 months of receipt of this document. After the
Agency reviews this material, the Agency will determine whether to reregister each product
based on whether or not it meets the requirements in section 3(c)(5) of the Federal
Insecticide, Fungicide and Rodenticide Act. Those products which contain other active
38
-------
ingredients will be eligible for reregistration only when the other active ingredients are
determined to be eligible for reregistration.
Registrants must review previous data submissions to ensure that they meet current
EPA acceptance criteria (Appendix E, Attachment 5) and if not, commit to conduct new
studies. If a registrant believes that previously submitted data meet current testing standards,
then study MRID numbers should be cited according to the instructions in the Requirement
Status and Registrants Response Form provided for each product. For batching options to
satisfy data requirements refer to Appendix E, Attachment 4.
c.
Products not included in either Boric Acid Standards
For products not included in either of the two previously issued standards (i.e.,
sodium metaborate), the registrants must either submit product specific data or cite
previously submitted data to support their registrations and submit revised labeling,
CSFs, application for reregistration, and a certification with respect to citation of data
within 8 months of receipt of this document before the products will be considered for
reregistration. After the Agency reviews these data and the revised labels, the Agency will
determine whether to reregister each product based on whether or not it meets the
requirements in section 3(c)(5) of the Federal Insecticide, Fungicide and Rodenticide Act.
Those products which contain other active ingredients will be eligible for reregistration only
when the other active ingredients are determined to be eligible for reregistration. Refer to
Appendix E, Attachment 4 on batching for options to satisfy data requirements.
2. Labeling
The labels and labeling of all products must comply with EPA's current regulations
and requirements as specified. Please follow the instructions in the Summary of Instructions
for Responding to the Reregistration Eligibility Decision Document with respect to labels and
labeling.
The Agency has determined that the current label precautions are still applicable and
are required for product reregistration.
a. Compliance with the Worker Protection Standard
Any product whose labeling reasonably permits use in the production of an
agricultural plant on any agricultural establishment (farm, forest, nursery, or greenhouse)
must comply with the labeling requirements of PR Notice 93-7, "Labeling Revisions
Required by the Worker Protection Standard (WPS), and PR Notice 93-11, "Supplemental
Guidance for PR Notice 93-7," which reflect the requirements of EPA's labeling regulations
for worker protection statements (40 CFR part 156, subpart K). These labeling revisions are
necessary to implement the Worker Protection Standard for Agricultural Pesticides (40 CFR
Part 170) and must be completed in accordance with, and within the deadlines specified in,
39
-------
PR Notices 93-7 and 93-11. Unless otherwise specifically directed in this RED or by other
EPA guidance, all statements required by PR Notices 93-7 and 93-11 are to be on the
product labeling exactly as instructed in those notices.
o After April 21, 1994, except as otherwise provided in PR Notices 93-7
and 93-11, all products within the scope of those notices must bear WPS PR-
Notice-complying labeling when they are distributed or sold by the primary
registrant or any supplementary registered distributor.
o After October 23, 1995, except as otherwise provided in PR Notices
93-7 and 93-11, all products within the scope of those notices must bear WPS
PR-Notice-complying labeling when they are distributed or sold by any person.
Personal Protective Equipment Requirements
» Uses On Products NOT Primarily Intended for Home Use: The personal
protective equipment (PPE) requirement for pesticide handlers on all end-use
products, except those intended primarily for home use (see tests in PR Notice
93-7 and 93-11), is:
"Applicators and other handlers must wear:
—Long-sleeved shirt and long pants
—Chemical-resistant or waterproof gloves (see instructions
* below)
—Shoes plus socks
(*) The glove statement is the statement established through the
instructions in Supplement Three of PR Notice 93-7.
End-use products that contain boric acid (and its related compounds)
must compare the personal protective equipment requirements set forth in this
section to the personal protective equipment requirements, if any, on their
current labeling and retain the more protective required PPE. For guidance in
choosing which requirement is more protective, see Supplement Three of PR
Notice 93-7. If the existing labeling requires a respirator, use the guidance in
Supplement Three of PR Notice 93-7 to determine the appropriate respirator
statement.
" Uses of Products Primarily Intended for Home Use: For products
primarily intended for home use (see tests in PR Notice 93-7 and 93-11), do
not add any additional personal protective equipment requirements (PPE) for
such products, however, any PPE requirements on the current product labeling
must be retained.
40
-------
Entry Restrictions
• Products NOT Primarily Intended for Home Use
Uses Within the Scope of the WPS: A 12-hour restricted entry interval
(REE) is required for all uses within the scope of the WPS (see PR Notice 93-
7) on all end-use products, except those intended primarily for home use (see
tests in PR Notice 93-7 and 93-11). This REI should be inserted into the
standardized REI statement required by PR Notice 93-7. The personal
protective equipment for early entry should be the PPE required for applicators
of boric acid (and its related compounds) except that the requirement for an
apron or respirator is waived. This PPE should be inserted into the
standardized early entry PPE statement required by PR Notice 93-7."
Sole-active-ingredient end-use products that contain boric acid (and its
related compounds) must be revised to adopt the entry restrictions set
forth in this section. Any conflicting entry restrictions on their current
labeling must be removed.
Multiple-active-ingredient end-use products that contain boric acid
(and its related compounds) must compare the entry restrictions set
forth in this section to the entry restrictions on their current labeling
and retain the more protective entry restrictions. A specific time-period
in hours or days is considered more protective than "sprays have dried"
or "dusts have settled."
Uses Not Within the Scope of the WPS: Do not add any additional entry
restrictions for uses not within the scope of the WPS, however, any entry
restrictions on the current product labeling for those uses must be retained.
Products Primarily Intended for Home Use: For products primarily
intended for home use (see tests in PR Notice 93-7 and 93-11), do not add any
additional entry restrictions for such products, however, any entry restrictions
on the current product labeling must be retained.
b. Compliance with the Existing Stocks Provision
Registrants may generally distribute and sell products bearing old labels/labeling for
26 months from the date of the issuance of this Reregistration Eligibility Decision Document
(RED). Persons other than registrants may generally distribute or seE such products for 50
months from the date of the issuance of this RED. However, existing stocks time frames
will be established case-by-case, depending on the number of products involved, the number
of label changes, and other factors. Refer to "Existing Stocks of Pesticide Products;
Statement of Policy", Federal Register. Volume 56, No. 123, June 26, 1991.
41
-------
c. Products Under the General Boric Acid Standard
Labels must comply with the format labels issued with the General Boric Acid
Standard. Submit five copies of current labeling.
d. Products Not Under General Boric Acid Standard
Labels must comply with 40 CFR 156.10 and the requirements listed below, if they
are appropriate.
o Environmental Hazard Section -
1) Terrestrial Food & Feed and Non-Crop
Do not apply directly to water, or to areas where surface water is present or to
intertidal areas below the mean high-water mark. Do not contaminate water
when disposing of equipment washwaters or rinsate.
2) Indoor Uses with Effluents
Do not discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans or other waters unless in accordance with the requirements of
a National Pollutant Discharge FJimination System (NPDES) permit and the
permitting authority has been notified in writing prior to discharge. Do not
discharge effluent containing this product to sewer systems without previously
notifying the local sewage treatment plant authority. For guidance contact
your State Water Board or Regional Office of the EPA.
o Under "Directions for Use" -
Labels for uses associated with boric acid on carpets and floors to combat
fleas, cockroches, ants, and silverfish:
Use Restrictions -
Children and pets should not be in treatment area until after application
is completed. Do not treat pets with this product. Avoid
contamination of feed and foodstuff. Avoid contamination of
ornamental plants.
42
-------
Carpets -
Apply to dry surfaces only. Apply directly on carpets where pets
frequently traffic or sleep. Work powder deeply into fibers and mat
with a broom or rug rake. Any powder visible after application must
be brushed into carpet fibers or removed.
Upholstery -
Remove loose cushions. Apply along creases and into corners and
furniture wells. Do not apply product to exposed fabric.. Any product
visible after application must be removed.
43
-------
-------
VI,
APPENDICES
-------
-------
A
Q
H
O
H
CM
o
CQ
V
•fc,
y\
^j*
CN
O
V
H
CQ
APPENDIX A - I
(A
1
4J
(0
_J
cv
=>
13
•g >. § to
•^ l_» C— 23
h c £ o
w1" c 5
.|g<*~ «
"^ _.
•o g
o
cation, When needed, Spi
.D/DOMESTIC DWELLING OUT
mr~ c
Is
g-2
(Q
ca
1
Q>
C
CO
•*
CO
4) CO
11 i
** 3 z
r °
h-
Q_
LU _J
O O Z LU
z o a: o LU a
O Q£ C3 Z O — •
3E C3 •-• •-• CO
UI CO UJ
Q; LU co LU a:
O CO 3 •• O£
O ^ O, 0£
2! ^% O O O
Q£ O C3 Ca 1—
o o z ra
-00 UJ — • 0
a. o t— co
!CUJ=EZ OCtfQi*—
CO LU UJ ^ C3 CD *v
7t ZD S S H- 1—
Jrf a. a. z LU LU co
| 33 SS^i
§f-\ O O : Z
ct: LU LU o »~
O •>« ^s. O
-.OCOCO OCOCOO
T^ O LU UJ l^ UJ LU O
g^ 21 CO CO I CO CO O
Jj ^ LU LU ZUJLUZ
c uj o_ o. a. o- z
<- CO CO
5; •—— i -J *UJ
0 ^
Q.
«CO
e-g
|i
r_ =
on, When needed, Portabl
.D/DOMESTIC DUELLINGS IN
£0
Ss
w «
£§
5
CO
o
(M
73
jj **"
ij
(D
3
cr
CO
CO
I
LU
f
8 Is!
O Q O
u_ O Q£ «—
O O O
a; LU o LU
u- ^ sc o
— o
1 8 .. § S §
O O (X O O
Z u- 3 z C£
_i o —* CD ••
O CD UJ 3
O •• CO O
Q. o ui a. ^ cd
SZ CO => C3
— Z3 0
a: a? ^* LU
C3 O D£. CO
• •CO O 3 — 1
LU O. LU UJ O «C
CO Z3 CO CO O ^ —
Q- S — i ? Z
C3 LU ^^ O£ LU
•>- a: o <£ o
i— LU a. o t- z —
a. co o z — co
£ ID >• LU LU O£ UJ
LU i— 1 E LU Ct
•— =£ a. »—
8^-v -J O *— LU Q£
1- — Z = > 0
o o o — a — o
O 1— u- LU ^.
-------
<3
"m
o
w
Itl «
T5 C £ O
g^c £
Qd
-j O
> * ra ^ *5
illij &
-"^^
§
^B J3 ^j •*•
ei *^ o; ^*
^^
"*
U.
Application Type, Application Timing, Application Equipment
USE SITE/USE GROUP
BORIC ACID (CHEMICAL 011001)
o
o>
i3
4> **~
Z C
l
CO
m
U.
1
g
z
g
"3!
IBait station, When needed, Unspecified
ANIMAL KENNELS/SLEEPING QUARTERS (COMMERCIAL) USE GROUP:
PET LIVING/SLEEPING QUARTERS USE GROUP: INDOOR RESIDENT!
SEWAGE SYSTEMS USE GROUP: AQUATIC NON-FOOD INDUSTRIAL
SPECIALIZED ANIMALS USE GROUP: INDOOR NON-FOOD
T3
•8
OJ
in
T,
o *^
= £
&
«
CO
u_
I
§ 0^ g
LU o a: —
o o o
C£ O U- O LLI
O O O i a £
o a u. o~cz
u- z z o
•— « O£ o
ce o a a; •• a
§a o o o a. 5=
o •• Q o o 3 "—
£3 O CX. Z u. o O
z LU 3 — • i z o:
•-• O Z *-* CD ••
8C3 •• Z LU =>
a. •• co o
g z co 5 Q =3 S
0- """ = 0 0 a: ~ UJ
C3 Z C3 0£ CO
•• CO UJ ••* Q 3 -J
LU O. LU CO LUO «t—l
CO ID CO O COO ^^<
Bait station, When needed, Unspecified
COMMERCIAL TRANSPORTATION FACILITIES-FEED & FOOD EMPTY 1
EATING ESTABLISHMENTS USE GROUP: INDOOR FOOD
FOOD PROCESSING PLANT PREMISES (NON-FOOD CONTACT) USE GRC
FOOD/GROCERY/MARKETING/STORAGE/DISTRIBUTION FACILITY PREM1
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR FOOD HANDLING AREAS
ANIMAL KENNELS/SLEEPING QUARTERS (COMMERCIAL) USE GROUP:
COMMERCIAL TRANSPORTATION FACILITIES-NON-FEED/NON-FOOD 1
COMMERCIAL/INSTITUTIONAL/INDUSTRIAL PREMISES/EQUIPMENT (U
HOSPITALS/MEDICAL INSTITUTIONS PREMISES (HUMAN/ VETERINARY)
HOUSEHOLD/DOMESTIC DWELLINGS USE GROUP: INDOOR RESIDENT
PET LIVING/SLEEPING QUARTERS USE GROUP: INDOOR RESIDENTI
SEWAGE SYSTEMS USE GROUP: AQUATIC NON-FOOD INDUSTRIAL
SPECIALIZED ANIMALS USE GROUP: INDOOR NON-FOOD
•o
1
3.
~g
*•?•
O ^
CD
cr
CD
< *
<-t h-
t— 3Z
Z UJ
UJ O
as
UJ
UJ O£
O£
§8
0 Q
O t~*
IBait station, When needed, Package applicator
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR PREMISES USE GROUP:
HOUSEHOLD /DOMESTIC DWELLING OUTDOOR PREMISES USE GROUP:
o
M
4-» *««.
••- en
ro c
J2 0 •
•^ 4-*
x± 4-» «*-
O C0
CD -M
• CO
CD
-
< •—
h^ 2
5C UJ
UJ C
2 S
O — 4
|g-
8Z
LU
< O Q
a. cn >
a
CO
o
GJ
CO
"-
_ J
Q.
8
o
c
~
..
O-
B
C LU
» Contact treatment or Surface treatment, When needed, Aerosol
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR FOOD HANDLING AREAS 1
-------
o
•IJ
CO
:£
c
» CD
^S
§o-
=> Z
g-
cj i— uj a.
«S O CO
1— < 13 >-
CJ O <^ Ij
"5 CD C3 CD Z
55 uj uj uj ^
g CO CO CO
>- z
a: uj
zS
— CO
a: uj
c g (
2
303:
.o
«t
•>
O>
C
tQJOiCOl—
Qi UJ
»< «: '
isr
(y •-• 3.
go>
c z a:
e- -
."
-------
4»
•n
cli^i s
S^llx I
US
1
T3
LLO.£)LL.aOO
= •— = 3 Z I Z 0= Z
- ~*g~g~cs«»
z .. {g „ g
"* :D o § o 3 °
Q£ U Q£ Q; Q OS *•> O£ Ul
UJ o CO «_• Q *-^ t
g uj co ui o uj uj ui o ui <: —i
£5 t/> 3 to o co co cooco *S <
L. ^ Sg Q! ^ 5 ^ P 2- £
— iwcj»—coo.«co:o»— *- z •— o
^; ^ co>-<
•*t iE t~ ^ ^- Q£ LL. Ul ^ fg m (/j
4j UJ =C •>— ^~"^tyj_ZtUJC^UJ
HI O ^ *^
O *"^ —J '
ono a.
Z UJ Z CO 3 Q.
I O£ ^^ Ul O
to. co or
CO CO « C3
ui _j <: E
»-« —=:•-• o co
—J UJ CJ Ul O Z> Ul U Z —I
PcoiCtE 0£h^COCOM = <^CU§
r;^cocoo«rco*^3:i—coocoui«-i
; co K-. _. uj uj z
o o
LL. UJ
1 £
s;
0£ UI
U CO
u,3^
Pg2
sss
t- Ul Q£
Z H-
O Ul CC
°^s
uj a:
ac a.
a: o
g|g
lie
•-• o o — i
CL a. o z
BID 2 ui
o a
Oi Qi _J «-i
C3 C3 < CO
»-» UJ
uj ui on oc
CO CO t—
=D O CO 0=
UJ Q
Q; o
Qi Q
co co uj 3:
UI U1 »— —«
CO C/3
a.
g^
O I
o :
!l
o cu :
z en 3 i
^ UJ O I
eo c& i
: ex :
i en
iB§8
5 o
I _l «- «t UJ I
'Bi
5 uzeneneneses
°.;:<-' — '-zz
0)^*02—I—J—li-«i-i
.SS:h"S
S m-! e
* s
eo CD en
<: < en
UI
< CO GO CO O
of i— •-« en en t-< *-•
u-ocjujF— *-*^-
en o: o o z
ui ui *
gg
. eg :
o Q- i
Of 0£ C£ O >-
^SS5
aJa:c9ac3a.cL.e3zc£_ic£c£Soc3^
mUJZZC2£ X^UII—
-------
CO
c
o
CD
*J
-J
CD
CO
2*. «
O > CO
"tL •K fc 5
*• iS *• =
CO C ..
o — ^
o:
5 cu to O
^ > CU • Q£ •£,
" z
c
o
l-l s
^s-
B
0
u.
i
S
n Type, Application Timing, Application Equif
i/USE GROUP
(CHEMICAL 011001)
0 S S
.3 in 0
I= S
5
4-» M-
'I
O)
4-»
""* IT
tn co
^§
*—
°
i—
2 _i
CO <
UJ —.
35
oe. ui
Q Q
needed, Brush
.D/DOMESTIC DUELLINGS CONTENTS USE GROUP IND
NG/SLEEPING QUARTERS USE GROUP: INDOOR RES
§o>
3
3 CO
jJ'O UJ
CO z °-
3
0
!s~
0 °t-
-
"85
co m
3o
o-
UJ
~1
z 'o
CO
73
0)
4J 1^
Z C
CO
3
O
0
|
§
o
u.
O
8
Q
|
remise treatment, Uhen needed, Shaker can
CENNELS/SLEEPING QUARTERS (COMMERCIAL) USE
a.-*-
•gg
CO =
.22
o<:
UI
1°1
^ 0 1
S. CO
-g
*• I*-
si
CD
3
cr
o o
3 O
u-
i
z
o o — J
Sz z
r/t" UJ UJ • • UJ O til ^^
" co co a. co Q co
0 Z CL O —• >- "
UJ — > >v* ^^ *** f\
r-DfCOOOO ^»<^
mCL«£Q£ O t— J— Z O
eral surface treatment, When needed, Shaker <
)CERY/MARKET I NG/STORAGE/D I STR! BUT I ON FACI L I TY
.D/DOMESTIC DUELLINGS INDOOR FOOD HANDLING AR
CENNELS/SLEEPING QUARTERS (COMMERCIAL) USE
1AL STORAGES/WAREHOUSES PREMISES (INDOOR) US
1AL TRANSPORTATION FACILITIES--NON-FEED/NON-F
1AL/IMSTITUTIONAL/INDUSTRIAL PREMISES/EQUIPME
ESTABLISHMENTS NON-FOOD AREAS (NON-FOOD CONTA
.S/MEDICAL INSTITUTIONS PREMISES (HUMAN/VETER
.D/DOMESTIC DWELLINGS INDOOR PREMISES USE G
[ZED ANIMALS USE GROUP: INDOOR NON-FOOD
jjjcxo ucjo «r o — i
^u. =
c
•*
0
o
o •
i*
O"
O* CO
cs
o
J
»-«
1—
?i
rr* co
ieral surface treatment, When needed, Unspeci'
.D/DOMESTIC DUELLINGS USE GROUP: INDOOR RE
*I
°>S
i. i"
§1
•g"
J
4-> H-
Z *O
S.
CO
I
CO
o
CU
CO
o
£_
gof
Q.
1—
UJ
o
CO
LU
O£
O
O
O
Q.
B
C3
UI
CO
f£
Q
treatment, When needed, Aerosol can
DTECTION TREATMENT TO BUILDINGS/PRODUCTS INDC
cr o«
0°-
*-s
o 2
-------
a
"m
_i
I
2^-
0- "* ^
^li*l «
5£ -2 S. . ^
** s:
Ei
115 I
lu"
1
J.
Application Type, Application Timing, Application Equipwen
USE SITE/USE GROUP
BORIC ACID (CHEHICAL 011001)
-a -a
|«.£
0 °Z.
g"^ *f~
c. o
« ° S.
«S to
t_
eo P?
II
\i
U.
t
§Q —I
§O
2
O Q *i" Q *l" S?
ZU- 0 § ~ § g _I
O O t-*- O n. o a: h-
a_Oli-=COO.O LU
S5zg2g5.. S
go o. co
z o: tu => uj
•• O •• CO • • O C£
UIO.Q;OO.r)a.a;
coraoorp 52 ^ °^
rV «— \ »^ fv* ^^ QX III Q
U Z C3 Oi U CO 0
t/> •- O 3 _1 Z
UJUl ••UJOUI >- z •• i^
Hop, When needed. Hop
FOOD/GROCERY/HARKETING/STORAGE/DISTRIBUTION FACILITY PRE
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR FOOD HANDLING AREAS
ANIMAL KENNELS/SLEEPING QUARTERS (COHMERCIAL) USE GROU
COMMERCIAL STORAGES/WAREHOUSES PREMISES (INDOOR) USE GR
COMMERCIAL TRANSPORTATION FACILITIES--NON-FEED/NON-FOOD
COMMERCIAL/INSTITUTIONAL/INDUSTRIAL PREMISES/EQUIPMENT (
EATING ESTABLISHMENTS NON-FOOD AREAS (NON-FOOD CONTACT)
HOSPITALS/MEDICAL INSTITUTIONS PREMISES (HUMAN/VETERINAR
HOUSEHOLD/DOMESTIC DWELLINGS USE GROUP: INDOOR RESIDE
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR PREMISES USE GROUP
PET LIVING/SLEEPING QUARTERS USE GROUP: INDOOR RESIDEN
SPECIALIZED ANIMALS USE GROUP: INDOOR NON-FOOD
•a
a
li
i
CO
-a
4_, H-
Z C
1
3
1—
§
O
u
5
c
|
u
u
M
o
E
O£
C
CO -^
Nonsoil contact nonfumigation, When needed, Dip tank or Spr
WOOD PROTECTION TREATMENT TO FOREST PRODUCTS (SEASONED)
1
s
(0
•I
o
CD
o
— ' tf
CM w
O
CO
_,
5
CO
UJ
O£
Ul
1
UJ
CO
I
o
^
<-»
Perimeter treatment, When needed, Unspecified
COMMERCIAL/INSTITUTIONAL/INDUSTRIAL PREMISES/EQUIPMENT (I
NON-FOOD
•o
Q>
c
CO
5"o
g-f
og
1
« Sewer treatment, When needed, Duster
SEWAGE SYSTEMS USE GROUP: AQUATIC NON-FOOD INDUSTRIAL
I
Ul
CO
•p
V
(D
§
Sewer treatment, When needed, Shaker can or Spoon
SEWAGE SYSTEMS USE GROUP: AQUATIC NON-FOOD INDUSTRIAL
T3
tu
cu
c
s
•a
u
z c
CT
<=>
»Spot treatment, When needed. Spoon
BARNS/BARNYARDS/AUCTION BARNS USE GROUP: INDOOR FOOD
fl]
"S ,_.r
a> 4_i H-
G> O •*-
C 2 O
co a
<£ CO
^
10
O) •!->
O
•o a.
O CO
o
0
o
§
o
1
M
a!
S
UJ <
CiO *-i
3 H-
Ispot treatment, When needed, Spoon or Unspecified
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR FOOD HANDLING AREAS
HOUSEHOLD/DOMESTIC DWELLINGS USE GROUP: INDOOR RESIDEh
1
0)
0)
c
CO
<
•o
o>
31 c
§
ET
o
u.
c
c
O
C
Spot treatment, When needed. Unspecified
MEAT PROCESSING PLANT PREMISES (NON-FOOD CONTACT) USE GR
-a
a>
01
^
CO
,
co °>
"~ o
1
<
1-
z
UJ
o
to
UJ
4
Spot treatment, When needed, Brush
HOUSEHOLD/DOMESTIC DWELLINGS CONTENTS USE GROUP: INDOOR
PET LIVING/SLEEPING QUARTERS USE GROUP: INDOOR RESIDENTI
1
(U
CO
-a JS
__» <
*O c
a.
3
Ispot treatment, When needed, Duster
SEWAGE SYSTEMS USE GROUP: AQUATFC NON-FOOD INDUSTRIAL
-------
CO
c
o
4-1
i—
1— Z
Z UJ
ui a
o •—
•-i CO
CO Ul
UJ C£
OS O
Q K-
28
*» ••
II
C9 CS
UJ UJ
CO CO
Z> 3
0 CO CO
X UJ UJ
Q (O CO
.2 = z
, UJ UJ
<° CZ.OL
111
fiJi
pot treatment, When needed,
HOUSEHOLD/DOMESTIC DWELLI
HOUSEHOLD/DOMESTIC DWELLI
CO
TJ
CU
•g
CU
c
CO
8.
CO
^
cu
CO
in
o
Q
§
u.
0 -J
2: <
o o
o o o
O u- UJ
o i E
o
o •• °* «*^
u. o a
i C£ Z
o "" ol
Z UJ 3
CO •• O
oi =3 a. ai
8 3"
O ^^ ^C in
z as u co
O UJ - Z
Z3 v^ ^as uj
a? i- Pz 2
O Z CJ *- CO
\a •<. os. \u
Ul Z 1— UJ 0£
co a- z i—
Z) —• O UJ OS
J CO O Z 2 i
< UJ LL- Z3 Z
•-< CO 1 = O
CJ —• Z v^ .. z
t_ o: z o Q.
U UJ UJ Z CO =3 OS
.X E os v^ uj o o
TX E a. co as o
2j S CO i- CS 0
•o cj — i «c E- z
W ^^ ^ III III 111 tM
«? as o o O co o
"• <: z u- — CD as
^3 1-1 1 t— Z CS
pot treatment, When needed,
ANIMAL KENNELS/SLEEPING Q
COMMERC I AL/ I NST I TUT IONAL/
EATING ESTABLISHMENTS NON
HOSPITALS/MEDICAL INSTITU
HOUSEHOLD/DOMESTIC DWELLI
SPECIALIZED ANIMALS USE
CO
•u
•§
•X o
10 0
o
_,
1—
z
UJ
Q
CO
UJ
OS
g
8
g
UJ
CO
Z3
, Unspecified
NGS CONTENTS
pot treatment, When needed,
HOUSEHOLD/DOMESTIC DWELLI
CO
cu
cu
CO
o
o
o .
— 4-»
-Q \
*""* u
in «
o
_,
<
^_
z
UJ
0
CO
UJ
o
o
o
-t
, Unspecified
ERS USE GROUP
pot treatment, When needed,
PET LIVING/SLEEPING QUART
CO
in
S
•o
4-» ***
o£
= c
•o
cu
4-» **"
o "J3
Z i—
CD
IT
t.
^2.0 3
CO
"g
•+-
S.
Q
£_
o
u
^N
tD
QJ
Ql
3
D"
0<
If
ll
§.§
CO 2
o —
u §
pot treatment, When needed,
SEWAGE SYSTEMS USE GROUP
CO
l£
CO 4->
E"~ IT
CO
ff\ f-\
• C3
CO O
CO
CO
^
1
0
z
1
LL.
1
, Unspecified
: AQUATIC NON
pot treatment, When needed,
SEWAGE SYSTEMS USE GROUP
CO
.1
z u
- Z
§CS ^^ ^ in
UJ i— z *-* as
O CO Z •— CO O
Z ~^ in OS tn Q
— E ui as o
a. t— z.
Q O O *^ 8 CO
0 <£ UJ Z O 1—
O UJ 3 "" 0
fcj co z O
o E a. a.
Q O UJ
in
ro
73
cu
4-» **"
o '£
2 c
CO
*
CO
m
Q
g
u-
§
O.
o
CO
)
Q <
"5? ^ z
•2z g'
S- ,-. Q
"o ^^ co
CO I— ^
Q.Z 0s
III
i_ —> ca
°§5
ui *-•
.2 ^
"3 LU I'
+•* CO
fll
i|s
oid treatment, When needed,
OMMERCIAL/INSTITUTIONAL/INI
HOUSEHOLD/DOMESTIC DWELLI
=> u
-------
"8
"§
8.
-------
A
Q
H
O
\J
H
PH
o
V
A"
03
O
V
rt
CQ
r^
*•
o
o
•H
-P
j_j
in
Q)
5-1
Q)
-P
o
(1)
"Q*
CO
. AiPPENDIX A - Use patterns
CO
O
CD
f
C/l
T3
CO — * *«*
•5 >- 5 «
•- 'c *" O
»>" c 5
02
~" c ra £
d E | ^ « &
J^ CD 4 to
§ .
\ 1 Si -5
CO — •* ^T
*t
0
u.
(=
pplication Type, Application Timing, Application Equi
USE SITE/USE GROUP
ODIUH TETRABORATE DECAHYDRATE (CHEMICAL 011102)
< to
0
to
2
<->F
o r.
== c
CD
CT
CO
U.
„!
O£ ^
O Z
Z UJ
_i o
CO
• . UJ
Q. ce
O fg
o
Ul Z
CO "-
co a.
< D
Ul O
a- a-
ait station, Uhen needed. Unspecified
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR FOOD HANDLING A
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR PREMISES USE G
m
o
c
•*
u
4-» **"
o "^3
2 c
CO
D
cr
CO
s
UJ
CO
UJ
en.
o
o
*-•
CL
s
o;
ait station, When needed. Unspecified
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR PREMISES USE G
CO
o
+-» c •
_Q 4J
CD O
*~ CO *
CO
CO
.J
£-
3; LU
«— ' O
Z CO
UJ 111
O Ctf
CO Ct
Ul Q
c£ o
o o
o
5
0
*• Lt-
Q. _1
o o
EiT Z
ait station, When needed, Unspecified
HOUSEHOLD/DOMESTIC DUELLING OUTDOOR PREMISES USE G
ORNAMENTAL LAWNS AND TURF USE GROUP: TERRESTRIAL
m
•o
01
o •—
-i
CO
_Q M-
~* cr
PO CO
o o
•^ o
1— O
CO
0
CO
o
u.
z
o
z
a:
§co
ti i
u_ ct:
^ Ul
O 1—
roadcast, When needed, By hand or Spreader
INDUSTRIAL AREAS (OUTDOOR) USE GROUP TERRESTRIAL N
PAVED AREAS (PRIVATE ROADS/SIDEUALKS) USE GROUP:
CO
01
•M S-
o —
= 8
Q.
CO
1
*•?
o r
== c
CD
U
C3
ZiZ
>
OS
UJ O
to o
o
§u_
CK:
it. o
o
tn o
I— -C
UJ
£
O Q.
-J u. O
CD C£
C/} O LU
UJ Q
o S =
S CO
h- ". UJ
<: o. co
Si 3 =
^N Qi Ul
t— CJ o;
CJ Q-
< Ul
,1— C/3 >-
rack & crevice treatment, When needed, Bulbous dustei
EATING ESTABLISHMENTS FOOD HANDLING AREAS (FOOD CON
AREAS (FOOD CONTACT) USE GROUP: INDOOR FOOD
FOOD PROCESSING PLANT PREMISES (NONFOOD CONTACT) .U
FOOD/GROCERY/MARKET I NG/STOR AGE/D I STR I BUT I ON FAC I L I T
CJ
i
J
•M M-
o •—
Z8
o.
01
*~ t.
2 ®
** CD
•M
t- .j
CO ^
-S
_l
to
t
p
z
Ul
Ul
C£
CU
O
o
o
3=
Q.
a:
u
Ul
C/9
3
O
UJ
z
ip, Uhen needed, Dip tank
WOOD PROTECTION TREATMENT TO FOREST PRODUCTS (SEASO
o
•g
•a
o
o
c
CO
•*
J
4-» **~
O **j
z c
~'oi:o*~'o« 5o!
C3 u. Z UJ =>
" •• C/J O
ZICOO^QQ^ CXC3
osoBog^
eg zozo:c?a:co— i
LU Ul UJ O *-•
co co en ui a ui i—
so! o!z3~r3?ui
-n Ul 13 Z) ^ G£ a
g o: o co o ^<~
£>- C3UJOOZI— «-«Ul
ndoor general surface treatment, When needed, Unspeci
COMMERCIAL TRANSPORTATION FACILITIES- -FEED/FOOD EMP
FOOD/GROCERY/MARKET I NG/STOR AGE/D I STR I BUT I ON FAC I L I T
FOOD PROCESSING PLANT NON-FOOD HANDLING AREAS USE
HOUSEHOLD/DOMESTIC DUELLINGS INDOOR FOOD HANDLING A
ANIMAL KENNELS/SLEEPING QUARTERS (COMMERCIAL) USE
COMMERCIAL TRANSPORTATION FACILITIES--NONFEED/NON-Fi
COMMERCIAL/INSTITUTIONAL/INDUSTRIAL PREMISES/EQUIPM
EATING ESTABLISHMENTS NON-FOOD AREAS (NONFOOD CONTA
HOSPITALS/MEDICAL INSTITUTIONS PREMISES (HUMAN/VETE
HOUSEHOLD/DOMESTIC DUELLINGS USE GROUP: INDOOR
SPECIALIZED ANIMALS USE GROUP: INDOOR NON-FOOD
*""*
13
0)
4-* f-
0 —
Z U
0)
Q-
CO
1
4J **~
® 4J
z C
CO
§-
CJ
8
o
u.
f
O _l
z <
o
O O Ul
80 u- o s: .
o i z
O O z —i ce:
LU U- O O
z ..
805 o o o; cVI z
0 C3 0 => ~-
o a u. o o
o — • a.
Z Ul D
.... wo
a. a. a: " D ot:
S3 0 0. C3
O O 3
ce a: a o ^^ ui
Ul Ul O —
co co ui a i—
Z) Z) •• CO Z « Z
o. r> — >- ui
CO O •< —
«£ D£ O 1— Z CO
>- UJ O O Z •— UJ
H" ^ O UJ Q£ /v
njection treatment, Uhen needed, Power duster
COMMERCIAL TRANSPORTATION FACILITIES--FEED/FOOD EMP
HOUSEHOLD/DOMESTIC DUELLINGS INDOOR FOOD HANDLING A
ANIMAL KENNELS/SLEEPING QUARTERS (COMMERCIAL) USE
COMMERCIAL TRANSPORTATION FACILITIES--NONFEED/NON-F
COMMERCIAL/INSTITUTIONAL/INDUSTRIAL PREMISES/EQUIPM
HOSPITALS/MEDICAL INSTITUTIONS PREMISES (HUMAN/VETE
HOUSEHOLD/DOMESTIC DUELLINGS USE GROUP: INDOOR
SPECIALIZED ANIMALS USE GROUP: INDOOR NON-FOOD
~
-------
a
If I 1
j£ C ^,
Q) ^^
oc
TSgraf ^
*• p* &) • Q;C 5_
fcO
V? O
1
S
is * ^
^•S s 2
(3 «-* °-
*
I
Application Type, Application Timing, Application Equipment
USE SITE/USE GROUP
SODIUM TETRABORATE DECAHYDRATE (CHEMICAL 011102)
.1
4-* *+•»
O **-
V)
1
jQ
"™*
rq
>o
o
o
U.
1
O — J
zs
§Q "- 0 3E
H » 535
LU U. O O
o Q 8 o: olz
O Q !*• O O
=C K ^ g g
5S UJ ID
** »t (7) Q
a So a!3 S
grv* f^ Q ^^ tt»
C9 z o: of co _i
«~i C3 O 3 o o co
H-« o: o uj
2 t- o a a
£_ a z o i—
o «c —•
•jj •• •• Q. o
*~ o o
. UJ UJ
O UJ UJ CO U
oil contact nonfumigation, When needed, Brush or Caulk gun
WOOD PROTECTION TREATMENT TO AQUATIC STRUCTURES/ I TENS U!
WOOD PROTECTION TREATMENT TO BUILDINGS/PRODUCTS INDOOR Ui
WOOD PROTECTION TREATMENT TO BUILDINGS/PRODUCTS OUTDOOR I
WOOD PROTECTION TREATMENT TO FOREST PRODUCTS (SEASONED) I
CO
TD
111
"^
O *~
Z CJ
CO
1
•M 4-
O *•""
3 c
&
o:
g
UU
C
C
§
Q.
U,
pot treatment, When needed, Unspecified
EATING ESTABLISHMENTS FOOD SERVING AREAS (FOOD CONTACT) I
CO
"8
*^"
o «^
0)
o
0
o •
.a *~'
-• u-
CO
0
CM
g
O
o
o .
^ 4-*
JD **7
•~* o
OJ
g
_
C!
a:
UJ
c
u
a:
prinkle, When needed. Shaker can
HOUSEHOLD/DOMESTIC DWELLINGS CONTENTS USE GROUP: INDOOR
"S
•^
O '«—
z u
s.
CO
o
o
o •
jO" **^
_. tr
CO
o
OJ
X^ *""*
>•
O£.
CO
UJ
o
IU.
tump treatment. When needed, Shaker can or Sprayer
FOREST TREE MANAGEMENT/FOREST PEST MANAGEMENT USE GROUP:
SITE NOT SPECIFIED
CO
-------
CO
§
CD
CD
CO
"8 -
*• x a
"~ £> *-
*• i5 **
a> •" c
0) •—
o:
— era £
^ > Q) • Q£
£ CO «C CO
C
o
£ CD jf\
X "|
z "o.
Q.
E
o
u.
G>
'5
IT
Ul
C
O
CO
u
a
*c
CD
C
'i
c
o
CD
o
5i
£°
c|
.?£
4-» ^Jj
US OT
|=
y-\
CO
1
1
0
£
03
^^
i
o
1
I
UJ.
U
UJ
i
e
x
5
HI
o
H
1
g
S
H-
S001UM
2
I?
8.
CO
2
**'£
°£
z c
§
°"
o;
8
O
u_
Is!
o
o o
O Ul
O Z
"• ~i
C£. O •• O
0 0 Q. Z
O O ZJ •-
Q U- O
5: i of
_ z ej ••
o a.
• • ^ CO O
a. ctf ^ a:
30 0
*%
~ 0 =3 <
UJ O •-•
CO O ^ 1—
a. •— >- uj
S^-' Ctf Q
«I —
< os i— z en
ui a z •— ui
Ctf Ul rv> OC
<: ui E ui
co a. i— a;
2 ^ > O C
—• a ^o o
_1 Ul Z Z u.
? < uj § a
3: —• (O 3= " Z
O — i ^ Q.
§LU UJ CO O C
~E ce. ui o: 5
U- g CL CO <3 C
a: o -i E uj —
Q v^ ^ Ul CO
S" O CO 5 O. ••
2 Z O£ 1— Q.
3 "" H^ ra z c
o ^2 ?^ ^ ^ 52 K
Z Z) "- f^ Z
~tT j ° ^j ^ j {J
-g _i a < — -i ±
c o CL 2 z o
r- <-> Ul Z) " CJ -
S — -i i- -J — g
2
Q. C
£•"-
4-- ^
i ^
4"* li
co £
CD "—
c
§5
"E
£ a:
o °-
•gi
o
a. ca
8 >:
T3 —' CO
•— CO C_
3 E D.
O" CO CO
CD >- CO
JJ O) t-
10 o a.
t 'CO
Jc g »
S1.S
C t- 4J
O 0) -M
CJ 4-» 0)
CD CD
_. C CD
JD •— CO
CO CO
CD
- ; 0)
• -•a
T3
t- CO 2
.W L.
S C-
c -2 c
O 4-> 3
O CD
U CO
CD *r" CD
—' —• O
J3 D. CO
3 D.H-
—• CO C.
CO T3 CO
II -2 >.
H- CO
cn— t-
•^. v a.
U C CO
CO CO
3 o a.
2 7.x
4^—*
CO *O O CD
§ca s- 3
u o
— a: 0) t-
4J I C_ O
co T3 ca jz
.2-3§-~
—- O^ CO »
•oS2r
^as
11 " ..&
CCO£ «
•i • .2 «•
• .^3 CD
3 '5 CD CD
S ^ « _
1!
CO
3
CO
II CO 4-> O •
CO O «*- O
. CO •— 4J
XII C CD
CO II 3
m co CD —•
CD—'
CO CD
"8
•
CD
•a
8.
c
CO
CU
4-«
CD
CO
*t-
o
1'
0)
J=
-------
-------
A
Q
H
o
U
H
O
V
«fc
A
(Nl
0
O
V
w
to
Q\
£
o
c
0
•H
-p
(0
-p
u
•H
0^
Q}
w
?•
4J
-P
0)
CO
C
0)
4J
-P
'C -g ffl §
a:
_. cu
'ia c ra ** *-*
• > S . S ">
c «- 3 CO >•
. . CQ < CD
Z
C
O
1 i 2 C
x .S « S
•^- ^
*
e
O
u.
c
>
-•
N-
CO
*«•*
o
CO
_J
1—
Ul
o
CO
UJ
o.
1
t. §
Ij
"D *•*
-§ "J
1 =
^ Ql
treatment,
LEEPING QUAI
IE
c
•a
•*•
o ••-
Z 0
s.
GO
^.J
— • Q-
>0 <»
"~ o
CO
*^.
o
CO
c
o>
CO
3
L.
o
•g
CD
*d- 8
*~
CO
s
CO
cC
H-
UJ
0
CO
Ul
1
2
0.
u
Ul
CO
Uhen needed; Sprayer
LINGS INDOOR PREMISES
treatment,
^ESTIC DUEL
ndoor premise
HOUSEHOLD/DO!
*""
u
o •—
z o
s.
CO
•^i
— ' £•
>o m
*~ o
CO
£
CO
t- CL
l|
23 LU Q
X LU O
0 U. U.
*~ + C£
^ O LU
ImS
^ CO LU
» ^"
r; LU o:
a: H-
§ls
c E Q-
CD
=
,_
^
^fe
£i
M •*
O
•*
CO
c^
CO
.0
Q
U.
1
Z
O —I
s z s
o a: >-
u. O O
o ui
C£. Q E
8 2
§ Q "" O — 1
o z o LU
U Z CO O CC
O OS
• • LU rtf (3 C£
O. CO O Q O
BID 0 ^ 0 LU 0
Q Oi O CO O
C3 LU •-• S 1 !-•
CO O Z
LU •-• Z O ^*
CO E •• •— Z >- ••
r> LU Q. v^ a: Q.
0:0 of < 3 — i
CL O 1— O Z O _ Q£ Z 0 I- CU —
i— >-<3Luoa:uce
o. i— z: z LU i—
Z*-iLUa.*-i|— LUCO
LU _1 CO •— LU CO ID
o o a ^- z
ojc^uiaz — Q
a o —• co z co o t
LU^Q:ZO>'Z i o
U-ULUUIOCOUIZZ
i ca E of Q ui a: o
CJC3I— Z3Q:z""<=5
U- O£ < Z i— i C3 Q£
O Z> 1-1 IU 1— Z "C3
Si— a — co zj •- o.
CO — 1 3 >— — 1 ID Ul
— •-. C3 < i-i_lOCO
1— C3 Z ^ t— LUOf^
-iOCOC03U
t- — a. — t- z Q
o or K- ui »— z •-* uico
5-O Ul LU =) Ul O (0 —1
,Z«£v,inxvx.COLU
co§^om ^*
Z E >- ••
g^sss
o a. z o
ui o •— D:
CO O >- Ctl CD
3 ^ »— U]
—• •— 1— Ul
— 1 Ul CO
f""^ + CJ ^.=
O u- • Ul O
o>
-------
Q CO _J
*-• UJ
to o;
ui
a: cc t-
o co
o uj
a a:
t— 01
a 3 UI
Z O I-
-------
•M
11
CU
CO
T3 __
•—he. t
i; c 2 o
a:
o
.! s^s ^
c i- 2 (i! °^ >*
z •£ o a. x S
00 < (D
— z
c
o
E "^ -^
§ CO 2 •-
I|S
E
o
U.
C
Si
cation Timing, Application Equipn
RAHYDRATE (CHEHICAL 011103)
Application Type, Appli
USE SITE/USE GROUP
DISODIUH OCTABORATE TET
5
o ••—
Q-
co
JD •
H-
8^" cr
CO
CO
^
CO
_J
^ 1—
h- UJ
Z O
UJ •-•
O CO
*-• LU
CO C£
0,8
0 0
O 1—
•Q 3
3E O
• • Q-
||
•a; o
Ul
UJ CO
CO O
^
O£
ritf o
gation, When needed, Unspecified
rMENT TO BUILDINGS/PRODUCTS INDOO
FMENT TO BUILDINGS/PRODUCTS OUTDO
Nonsoil contact nonfumi
WOOD PROTECTION TREAl
WOOD PROTECTION TREAl
1
4-* *^-
o ••*-
Z 0
CU
Q_
CO
CD
0>
S.
CO
o
to
8
?
o
I—
CO
Ul
UJ
1—
n_
|
UJ
CO
s*^
Ci
gation, When needed, Unspecified
fMENT TO FOREST PRODUCTS (SEASONE1
1 Nonsoil contact nonfumi
WOOD PROTECTION TREAl
2
"o •*"
zs
Q
CO
CO
O
O
Jj N—
*Q CO
C>
CO
o
CO
u.
1
o
— J
C/3
UJ
(nt, When needed, Sprayer
[TES (OUTDOOR) USE GROUP: TERR
1 Outdoor general treatme
REFUSE/SOLID WASTE S]
o
§
o •
5S
CO
o
CO
§
o
u_
1
2
o
5
1—
CO
Ul
C£
?Yl
mt, When needed, By hand or Dust
ING QUARTERS (INDOOR) USE GROUP:
Outdoor premise treatme
ANIMAL KENNELS/SLEEP!
CM
^ J
-^ •
5°
CO
o
CO
o
o
u.
o
_J
1—
CO
UJ
0£
Ul
1 —
mt, When needed, Sprayer
ING QUARTERS (INDOOR) USE GROUP:
Outdoor premise treatme
ANIMAL KENNELS/SLEEP!
•D
CU
o •—
z u
CO
o
o
o
.U *4-
M3 CO
e>
CO
^
CO
o
u.
z
o
_J
1—
CO
UJ
Ul
1—
"CL
!i
JZ ~
"I
11
» Outdoor treatment, When
REFUSE/SOLID WASTE S!
1
o •*-
a
CO
0
o
o
f- CO
00
^
CO
I—
z
UJ
o
CO
UJ
o
o
o
ihampoo machine
JELL INGS CONTENTS USE GROUP: IN
» Shampoo, When needed, S
HOUSEHOLD/DOMESTIC Dl
5
o •*•
Z 0
CD
Q
CO
-^ C
CO •
•o
o. o
CD O
• O
_,
^
CO
o
o
o
3
o
£^
u.
1
z
. o
u
J—
ra
a
o.
CD
UJ
CO
"
:ion, When needed, Injection
rMENT TO AQUATIC STRUCTURES/ ITEMS
Soil contact nonfumigat
WOOD PROTECTION TREA'
J
o •—
Z 0
s.
CO
«-, C
CO •
o
CNJ O
_,
u
CO
_J
z o
.. a.
II
a. u
C3
UJ
UJ CO
co r>
o
a.
oe. o
:ion, When needed, Injection
rMENT TO BUILDINGS/PRODUCTS INDOO
rMENT TO BUILDINGS/PRODUCTS OUTDO
Soil contact nonfumigat
WOOD PROTECTION TREA'
WOOD PROTECTION TREA'
-o
V
O "-
z u
s.
CO
^» c
CD •
O> 3
• o
_,
o
CO
I
u.
Q
C£
CO
Ul
o w
2|
CO
0
CO
h-
z
Ul
0
_J CO
z
UJ •—
a;
o a.
o 3
o o
sede, Shampoo machine or Sprayer
SELLINGS CONTENTS USE GROUP: IN
SELLINGS INDOOR PREMISES USE GR
Spot treatment, When ne
HOUSEHOLD/DOMESTIC Dl
HOUSEHOLD/DOMESTIC Dl
.1
O *•"
z u
S
0)
(0
o>
*
CO
0
CO
1—
UJ
o
UJ
O£
g
o
0
Q_
1
a
Is
.s
ll
»Spot treatment, When ne
PET LIVING/SLEEPING i
73
CU
O "~
z o
s,
CO
"S
;*~
CO
cr
CO
CJ
CO
u-
=;
O
z
C£.
1—
W
UJ
UJ
TJ •—
0
Sn O
S.QS
to"
= CO
•s3
IB
il
% UJ
I!
Wood protection treatme
WOOD PROTECTION TREA
-------
3
4>> CO
O C_
== Q.
g>:
j= a
"- CO
o x
11
111
c
o
£
1.5 £
"g
u >
cu
0-8:
W Q
CO CO
gfe
DJ
T3 H '
U
2L
g
CO
01
13
X
§
CU
O o UJ O o
|iU I
a.—- u o
ifS-n °£-
II II ~* 4J" £
. z *r o *
fillI 1
B't> L- 4J to "S
S O t? t» q> g-
^< 3 "~ •£ •£ ^
8|>°S °
O **— —*
-------
A
Q
H
u
U
H
05
O
OQ
V
A"
CN
O
O
V
w
CO
o
c
o
•H
-P
(C
-p
w
•H
>Y\
0)
Q)
J-l
0
-P
.p
f\
0)
•n
3
to
CO
C
0)
-P
-P
a
0)
in
•
«<
X
H
Q
S
w
ft
ft
^c
4-*
CO
_J
0)
3
2>.« «
'£ $ V 2
AJ c ij o
« •" c S
o •-
06
"CO C *3 "^ s*
."= ^ 3 CO " |-
= | a! & x S
z
c
o
| -g cu .C
•— o to ra
o
u-
1
g
S
Ul
c
o
'•M C
CO O
o *-
"a. o
< -i
S
5 |
•S 0
1 *^
C CO
co p
o 7
^3 x
(/) m
™^ p
°S ^
"S.3 8
a. •«
1 Q
.2
0 —
z u
S.
CO
J
>o ^
CM r
• o
a:
u
_l O U.
_1 —• U. Z
«C t— I O
•_i a- z z
1— Ul O
ssz^
Q CO -I S
•- ui < ta
U> 0£ •— t—
It 1 /V (/J
£^ O£ ^— Ul
o co o:
o^ o ui of
o a o£ ui
o i- a: i-
r>
•• CL CL O
|||g
a: u co ui
U CO
ui ui o
Ul CO CO
S133^
o: x-% uj
a: o o 35
o o ui o
o o z co
Q t- O <
Z Z> CO Ul
•0 "- O < CO
p u> z
§{2£2 SB
-= 0 CJ
.,.3 O CO CO
"881313
>S g z> g
•S en «> o; o:
g C3 C3 O. CL
<" S S i_ i-
o a co co
c — 1 — 1 Ul Ul
3 CD m u. u.
.0 o o o
c t— t- >- 1—
.2 H- K- 1- 1-
gz zz z
s 111 in m in
^ 0£ Q£ OS Q£
^ 1— 1— l_ 1—
§n 3C SC 3C
O O O
5 u o o o
rj uj uj uj LU
§!!!!
° a. CL CL a.
^8888
§§§§§
o
z
"o. ii
Q.
(D -D
c c
1 £
73
0)
CO
'> '
ffi
i:
•g
CO
0)
CO
o .=
S S
H- ^
O 4.,
S <°
S g
n .2
a.
a.
CO
13
*^ ^
CO
§
a
CO
H-
o
C-
(I)
-------
-------
A
Q
H
O
O
CQ
V
A
/\
^*
tN
O
V
w
CQ
S
0
M-l
O
•H
-P
S
-P
U
•H
tn
0)
0)
J-i
o
JJ
o
0)
•n
-§
C
Q)
-P
-P
(0
a
CO
i
X
I—I
APPEND:
CO
c
o
CO
o
CO
1-1 »
"*"**'* 3
He?; o
»UJ c 5
a; ""
_, cu
c E S .S «>.
'^* CU ^j o , CO
J5 CO < CO *•*
c
o
2 +* ^
(0 Z
•«— H-
pplication Type, Appl
USE SITE/USE GROUP
ODIUH TETRABORATE PEN
< C/»
5
o *^*
z u
s.
u
4^
^3 .
CT
CO CO
"§
*~°
u
c.
o
CJ
§
u.
^
g H^
O CO
U— "•
i ac
O UJ
Z 1—
<: ••
£8
co a:
UJ C3
0£ UJ
UJ CO
° a! ~
"^ 13 CO
g-UjS
"5 UJ
° § £
•. l^r ^J
roadcast, When needed
INDUSTRIAL AREAS (01
NONAGRICULTURAL UNCl
CO
•g
TJ
o
c
CO
a. co
r* O£ UJ
1— O Ctf
CJ O.
< UI
1— CO >-
U — 1
5 duster
G AREAS (FOOD
NFQOD CONTACT
TR I BUT I ON FAC
ded, Bulbous
:OOD HANDLIN
>REM!SES (NO
'STORAGE/DIS
*•* fn
^ CO 1— Z
rack & crevice. When
EATING ESTABLISHMENl
FOOD PROCESSING PLA!
FOOD/GROCERY/MARKET]
u
•o
•a
a>
c
CO
P"
n r> a. ui z> ^ ctfa.
g; =g<" H.^2-3
"i^S^SggSlg
So. t- < O E < UJ
gJZUJ« U.0.1— 1— UJ
S-Q O — Z O CJ ^
t;; o «i -i — ui z
...u- -OI— «-«CQUJO
r^^-OO—i«-'»-'UJ-J— J
"cKCLC3°ceeec35°
^ 0 u, u, ac o o uj = =
I
o •—
£
CO
0
o .
O ^J
]^H"
' O"
C3
_
§
U.
Z
I—
CO
UJ
C£
C£
UI
1—
^8
c. =
O
l|
needed, By
tOADS/SIDEWA
C "-
jz Hjf
repaving treatment, U
PAVING AREAS (PRIVA1
Q-
I
o —
z o
g
CO
o
0
o .
t~ 4J
J3 **"
•O
CO
C3
_
O
u.
|
_J
t—
CO
UJ
Q£
C£
UJ
H-
CL
|
u
UJ
5s
i|
needed, Uns
tOADS/SIDEWA
S
«- UJ
repaving treatment, U
PAVING AREAS (PRIVA1
a.
i
2 O
S
CO
T3
4-» **"
O ^
CD
O
Q
8
U-
O
O
a
a!
|
U
UJ
z
JJ
t—
§
CJ
g
o
u_
CO
•I
o C!
ll
"8*1
g-_
_ 2
pot treatment, When n
EATING ESTABLISHMENl
CO
1
o
c
CO
v.£
— .
O"
-O 01
OX 0
CM 0
«- O
ca
•8
'o
0>
a.
I
a>
V
pot treatment, When n
SITE NOT SPECIFIED
CO
"g
"g
CD
C
"*
o
J_. **-
4J ,
O £
'I
o
1
U-
Z <
O
O£ •-«
go o
O UJ
Q O Q E
§u_ z O — i
o o <:
U_ Qi Z .. Q _
O Q. Z 1—
o z o M S
Q «- Q C3 •• •-*
Z Z D- CO
•• co o ex
0. ID Q£
3Q: Z3 ^» UJ O
C3 O Q: CO Q
C3 UJ CD O •— »
en a
uj :D iij z *-»
CO CO •-•>-•-
ID o ^ or a.
co - QJ Q z — or
i— o: o LU o£ O
§ — z o -^
— 1 --* Ul Z
O O "^. «£
tu z uj co z: co
^•N. <: uj uj o uj
O 3= U- CO 3= CO
UJ 3E •—• vx •— •
UJ O O Z Z
U- O Z UJ CO UJ
i o « a: UJ Q:
1 U_ • Q_ CO 0_
CO CO >-4
t_ >— O 1— «-» Q£ O
Jj ^ 0 ^- Q£ Q- Q
jTi _J ^ —J 1— Z
*r « ^_ ^- co co —
2? c_> o Z3 z
o£S2§2|
•gg|§51|
g"" 1— UJ
_ « 5
oid treatment, When n
COMMERCIAL TRANSPORI
HOUSEHOLD/DOMESTIC I
COMMERCIAL TRANSPORI
COMMERCIAL/INSTITUT]
HOSPITALS/MEDICAL II
HOUSEHOLD/DOMESTIC I
-
CO ^
ater treatment, Initi
SWIMMING POOL WATER
3
-------
•g -
.l§ras ~
= l§^°=
-Ists s
r* •-
o> (o .;!:
.
OB)
3
O E
i o c
! 4-> 3
3-
S.
E
o 3
&
o >.
Ul
WO) Q.«-
_« m
. L. 4-. O >. ,°
c
-n
p
. APPENDIX A - Use patterns
CO
c
o
CD
0)
CO
T3
^ S— ? £_
«- C » 0
• J 1— mj VJ
UJ T^ **"
to c ..
Q) •— ^
o;
__, o
•^ C C3 -M ^
• > 5j a 5 co
c i: at to 2^
•^ «J JJJ Q. .
roadcast, Fall or When needed or Winter, By hand or
AGRICULTURAL UNCULTIVATED AREAS USE GROUP: TERR
INDUSTRIAL AREAS (OUTDOOR) USE GROUP: TERRESTRIA
NONAGR I CULTURAL RIGHTS-OF-UAY/FENCEROWS/HEDGEROWS
m
TD
o>
-M H-
o •—
Q.
J
o"-
CD
3
a
_,
m
ait application. When needed, Unspecified
SITE NOT SPECIFIED
m
CD
4-* H-
O •—
"I
CO
ii
t^ CO
CM O
«- O
_,
cn
§
U.
1
O
as
<
ex
^-
M
UJ
or
o:
UJ
»—
repaying treatment, When needed, Low pressure
PAVED AREAS (PRIVATE ROADS/SIDEWALKS) USE GROUP:
Q-
J
•M S-
O •—
CO
£?*"
in co
o o
in o
|
U.
O
_j
<
I—
en
Ul
Of
UJ
i—
repaying treatment, Uhen needed, Unspecified
PAVED AREAS (PRIVATE ROADS/SIDEWALKS) USE GROUP:
ex
"8
4-> M-
O •—
Z U
CO
£
h- ID
O O)
O
o
o
CJ
Ul
_ J
_J ~
_,22
i— uj en
^ Q UJ
UJ •— Of
a en
en o: o
III Q
a: a: a
pray, Foliar Sprayer
ORNAMENTAL HERBACEOUS PLANTS USE GROUP: INDOOR
ORNAMENTAL NONFLOUERING PLANTS USE GROUP: INDOO
ORNAMENTAL WOODY SHRUBS AND VINES USE GROUP: IN
en
T!
d>
«-» H-
O •—
Z U
8.
CO
CD
^
CM
to
—1
cn
|
CJ
§
II
o
_i
n Q£
O t—
U UJ
O UJ
O t—
u-
1
|-Z8B
£ _l U. Of
10 Of 0 Ul
$ Ul -1 0
pray treatment. When needed, Knapsack sprayer or Pov
AGRICULTURAL UNCULTIVATED AREAS USE GROUP: TERR
INDUSTRIAL AREAS (OUTDOOR) USE GROUP: TERRESTRIA
NONAGR I CULTURAL RIGHTS-OF-WAY/FENCEROUS/HEDGEROWS
RECREATIONAL AREAS USE GROUP: TERRESTRIAL NON-F
en
T3
O
O
CD
C
CO
•* •
.Q **-
CM CO
0 0
«- O
%
O£.
U
|
i
1
-i
o ?Z
of cn
CJ UJ
8 Of
UJ
O I—
u_
1
o o ex
z 8 S
< i C9
•-> z
Of O HI
t— z en
en r>
Ul -I
pot treatment, When needed, Unspecified
AGRICULTURAL UNCULTIVATED AREAS USE GROUP: TERR
INDUSTRIAL AREAS (OUTDOOR) USE GROUP: TERRESTRIA
NONAGR I CULTURAL RIGHTS-OF-UAY/FENCEROWS/HEDGEROWS
en
.
CD O CD
U- Of
-------
Use Limitations
O ?** S^ ^
s ~ ^
o:
— • c 2
.! ? £ • ee S
•£ « 2 8. . «
£ 01 «c o °
"• z
|
IIs 9
£ CX
*
§
o
u.
1
JJ
pplication Type, Application Timing, AppUca'
USE SITE/USE GROUP
OOIUH HETABORATE (CHEMICAL 011104}
< to
•o
61
4-* *^
O •"••
Z U
s.
CO
^ *J
-^ tr
VQ W
eS °
°
•f _J
«:
o P
oc. z
CJ itt
o
§co
UJ
U. Of
1
O o
U 1 1—
§« 0
Q£
Z 1— +
CO
«J UJ ~J
< 0£ <
Of III 1—
' t— 1— Z
CO UJ
UJ O
Of •• »-l
ce CL co
UJ g UJ
U Of
O- uj o
o => £
UJ + U.
CO CO 1
13 3 Q Z
O Q O
ce O z
Ul u.
CO C3 1 _1
roadcast, When needed, Shaker can
NONAGR I CULTURAL OUTDOOR BUILDINGS/STRUCTURE
NONAGR I CULTURAL RIGHTS-OF-WAY/FENCEROWS/HED
OUTDOOR RESIDENTIAL
PATHS/PATIOS USE GROUP: TERRESTRIAL NON
RECREATIONAL AREAS USE GROUP: TERRESTRIA
m
"S
• t 1£
o ••-
§.
CO
^j
—' cr
OJ «
«\i °
°
C3
|
U
u_
i
O O. O
ZOO
-J CJ u.
«s t
Of Q O
ft— O Z O
CO U. O
UJ 1 — 1 O
Of Z < U.
o: O —• i
ui z o: z
1— 1— O
—1 CO Z
«C UJ
O 0. Of Of «t
U Q O CO H- Of
o o: ui i—
§— i u- cs o: co
«S 1 Of •• UJ
••*• Z UJ UJ O_ Of
u. o: o co i— =} o:
• >- z r> o uj
5= co o; i—
O ID _ I •• C3
z a < a.
f_ Z •-• O UJ ••
2 5 S uj of of
o i^ O ^v* UJ UJ VS
Arco u. a ca co co
roadcast or Spray, When needed, Spreader or i
AIRPORTS/LANDING FIELDS USE GROUP: TERRE
DRAINAGE SYSTEMS USE GROUP: AQUATIC NON-
INDUSTRIAL AREAS (OUTDOOR) USE GROUP: TE
NONAGR I CULTURAL RIGHTS-OF-WAY/FENCEROWS/HED
NONAGR I CULTURAL UNCULTIVATED AREAS/SOILS U
NONAGR I CULTURAL OUTDOOR BUILDINGS/STRUCTURE
PAVED AREAS (PRIVATE ROADS/SIDEWALKS) USE
m
T3
j_i IT"
o-t
z u
Q.
CO
«"» «t.
~" cr
in co
O 0
*- o
Q
8
u_
2
2
5
*-
CO
UJ
O£
UJ
1—
Q.
roadcast, When needed, Shaker can
REFUSE/SOLID WASTE SITES (OUTDOOR) USE GROU
00
•o
*•* tr"
o .^
(U
Q.
CO
<
i
™" '
iP
r-*-
0
DC
D_
o
O
Ll_
•z.
O CL
2 O
—1 CJ
co u_ 5
uj i O
•as 2 u.
C£. O I
UJ 2 2
h- O
— 1 2
Q. ^ <
§3 t— •_
O co a;
o; UJ i—
u- CD a: co
i O£ UJ
gut iijt rv
co »— Q:
2O UJ
h-
_J ••
O O.
h- 3 o; z)
co o o o
II 1 f* fyf
D£ UJ tit U
Di C3 CO
roadcast, When needed Spreader
INDUSTRIAL AREAS (OUTDOOR) USE GROUP: TE
NONAGR I CULTURAL RIGHTS-OF-WAY/FENCEROWS/HED
NONAGR I CULTURAL UNCULTIVATED AREAS/SOILS U
PAVED AREAS (PRIVATE ROADS/SIDEWALKS) USE
CQ
IS
*-» !T
O £
z o
S
CO
^+j
5 ^
CM «
Is- ^
°
U
1
U.
1
2
1
- H-
B>
+ a!
fesi
Sou
TH. U_
dging treatment, When needed. Squeeze applies
PATHS/PATIOS USE GROUP: TERRESTRIAL NON-
PAVED AREAS (PRIVATE ROADS/SIDEWALKS) USE
RESIDENTIAL
UJ
•o
•-"
o •—
£
^W
c
in ta
ON c:
«- o
*
U.
2
O
2
^f
O£
h-
CO
UJ
o:
UJ
H-
a!
|
C9
repaying treatment, When needed, Shaker can
PAVED AREAS (PRIVATE ROADS/SIDEWALKS) USE
Q,
•o
0)
•"-
o —
z o
a
Ul
^.J
~* a
CVJ »
^ O
2
0
u.
c
2
^
C£
C/3
Ul
UJ
H-
I-
« a
repaying treatment, When needed, Spreader or
PAVED AREAS (PRIVATE ROADS/SIDEWALKS) USE
a.
•a
o>
•f
o *•-
2 O
QJ
a.
to
J
£*^
•>* w
ro <-i
' CJ
. J o
** 0
h-
Q£
U.
i
^
,y.
|
UJ
O£
Qi
UJ
h-
«
Qi
repaying treatment, When needed, Sprayer
PAVED AREAS (PRIVATE ROADS/SIDEWALKS) USE
Q.
-------
CO
•M
'i
0
CO
=3
•o __
"£J >• > to
«£ c £
o >- **
Of
" o • of P
.5 o 3 °> ro
^ CO
a
LU"
CO
f*
CL
O)
£ S
e &
Type, Application Ti
ISE GROUP
ORATE (CHEMICAL 0111
— * m
°z S
^ i
'Z M =
CL Q
< 55
"S
"o •£
CL
CO
.O H-
~* £
LA CO
tx o
^— ^5
^~
u
g
o
u- o
^ 4-
O
2 =1 13 Of
c Z H- CD
n5 ^
0 2 S ~~ co
ilsl§ i
.;; 2 LU LU o
o •• O •-*«-• H-
"%=i5»^ 8
fc<5 3 co - H- co co _ i *-•
aw^222^
^ LU O O£ Oi »— > CO U-
._, o: O «t <: LU ua
o Q 2 cx o. o: a:
a.
CO
z -^
O o! 3 ^
h- O Of CO
S~cf z o CD LU
O Of
—1 Z LU Of
cs
0 0.
Z LU ID
— CO CO O
ID 3 Of
0 Of "
O LU LU
u- CO U CO
( LU O 2
gOf LU
^ 3=
Z H- •>« CO
0=3 —
^^ of O O
J— h- Of CO
§"BS?
O CO SE <£
< CS LU UJ
Z u. Of
needed, Sprayer
SYSTEMS USE GROUP:
.TURAL OUTDOOR BUILD
.TURAL RIGHTS-OF-WAY
.TURAL UNCULTIVATED
^ .
4J H-
O •-
Z O
8.
(0
<
5
o
(M
^^
0
a.
O
of
o
Q
§
u_
o a.
2 O
-J U
—• o
CO U-
LU i
LU 2
_J
a. a:
o z> i—
80 co
C£ LU
LL. CD Qi
2 LU LU
O CO H-
2 O
< 0-
te co o
CO O CD
LU C£
a: LU LU
o; o co
LU O O
1- LU
3=
• • CO —t
t£ LU *X
auco
LU LU LU
j_ W LL. QC
fi\ ^ ^x ^
needed, Power spray*
. AREAS (OUTDOOR)
.TURAL RIGHTS-OF-WAY
.TURAL UNCULTIVATED
^5 h-* ** Qj
•* CO CD CD
O Q ^ 2
0200
t_ -• z z
Q.
CO
"8
4-» H-
O —
a
CO
§ .
2 *j
^ *
CO
^h.
_,
u
8
O
LL.
1
O
s
H-
LU
LU
t—
a.
|
LU
CO
ID
needed, Sprayer
. AREAS (OUTDOOR)
ray, When
INDUSTRIAL
CL
CO
"g
ss
2 O
CL
CO
CO
o
o .
^•£
•^ •
"^ D*
""J" *"
•
o
o
^^
0.
o
of
CJ
£3
o
o
u.
go.
z O
.r..« tJ
£"z O O <
£ ~ZZQ.
CL
CO
IS
o S
= 8
CL
CO
d^s~
cr
oi *"
O o
«- o
*"
(3
-J
H-
Z
LU
O
CO
o
0
1
+
8
o
u_
1
0
z
<
Of
1—
CO
LU
Of
Of
LU
1—
.=
73
•8
§8
ray, When
PATHS/PAT!
CL
CO
-------
•g
2
*f-
I
-------
APPENDIX B
Table of the Generic Data Requirements
and Studies Used to Make the
Reregistration Decision
-------
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for
the pesticide Boric Acid and Its Sodium Salts covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to Boric Acid and Its Sodium Salts
in all products, including data requirements for which a "typical formulation" is the test
substance.
The data table is organized in 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 in the Pesticide Assessment Guidelines,
which are available from the National Technical Information Service, 5285 Port
Royal Road, Springfield, VA 22161 (703) 487 - 4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the
data requirements apply. 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
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). 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, or a scientific study available in the public
literature. Refer to the Bibliography appendix for the citation of the study or
publication.
-------
-------
- ^ &
11!
u
i
•••I
•2
3
P
^
^^ ^H ^J T^j ^J i^
-------
g
•
•<»
o
oo
§
o o
00 00
§
1
bfi
i
PM
1
I
-------
§3s
H i
I
I
I
I
O O
a a
3 3
§
B
1
1 f
6
a
O O O O O O
OO QO GO QO QO OO
^ *H i"H TH ^^ ^H
fO f^ fO f*^ f*} fO
ON O\ Ov 9\ ON O\
oo oo
51
H
i
O O
QO QO
O
oo
II
i -|
i I
o\ iH
-------
S
191
I
a
1
3
-------
V
u
00
o
00 00
^* 'fyH^HiH^'^^^SI^'^'^'
e> oooooooonooo
OO OO 00 OO OO OO OO 00 OO ^< OO OO OO
3
H
0
-------
4)
I
!
Ill
I
J
CM
s s
SO CO
99?
i
-------
£
4)
o
oo
rr
o
rr
o
oo
OO 00
^ 1H T-l
O O O
OO OO OO
o ®
00 00
o
oo
o\ _^ _.
8 3 5? 3
^. ^ PH ^ ^ ^.
o o n o o o
QO QO "^ OO QO OO
n H
i i
I
I
-------
i
Jl
a a
§ S
-------
w
S
-------
iS.
'•SO.2
£g
PQ
H
t
3
II
I
ii
a
rci
53 f|
a
l|
l§
9|
a
1 £
3 |
§ g
•3 S
-------
••B
£
'E1
i,
CO
o o
oo oo
OOOOOOOO
QO QO GO QO OO OO CO QO
ON
o s 2i & •<
Z Tf Tf -^ Q
0!
i
*S
H
s
*i
3
fe
g
y
§
I
•c
s
1
CO
11
-------
i
i «
PQ |
B
II
1
WO
fsi
S W3 .IS
-------
"S
§•
&
Cfl K
^^^^ Qj
i j PN d
^r V 55
M ^S
F^^ CM »^2
£
1
i
I
!
na ?1
&% «
« 8 -§
r
8«
i
cc
•g
I
ECTS
a
3
op
o
oo"
iH
o
TT
o
I
I
8
1
V©
•« »
fl ^
.^< sS
^N ©
g H
J S
-------
§
I
$
1
•8
a
"a
t3
A
^
"Ss
•v »\
C3 kjrf
O »-?
Gro
TS
1
a
i
iii
3 j
i
'!•!
-1^
sss
iii
i5 = B
Hi
* 2 &
g^ «
6 «g J
I S'S
IS-*
l^l
«g^.2
1^1
1-a 2
(2 §£
!
-------
lei
tf Q°5
a^5
sa^
ui |
1S
-------
a
00
8
A,B,C,D,E,F,G,
1
c
00
S
i
i
-------
•S
II §
iN'l
•iSi
tt g
H 1
B ta^ M
ge 2
3
I
•o
a
I
i
"d
§
cc
i
I
i
I
•i
§
I
1
!
^
&
I
I
'f
oe
-------
g 05
11
o3 £
PS
H
13
fc
5!
o>
•25
a§
IS
§
s
£.
^a
%
g
*0|
S^;§
^^«
o« -2
I
PQ
3
j
o
E i
1
^ «2
il
r
*<
* fc"
!1
.S
-------
£
u
•J"
I
I
•s
a
•a
in
"D
I a
1
i
I
5
i
i
i!
•S ^3
i
i i
-------
-------
APPENDIX C
Citations Considered to be Part
of the Data Base
Supporting Reregistration
-------
-------
GUIDE TO APPENDIX C
CONTENTS 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 other sources
including published literature, in those instances where
they have been considered, are 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 materiails 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 also attempted 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 uses whenever a 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 identifying
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
standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a. Author. Whenever the author could confidently be
identified, the Agency has chosen to show a personal
author. When no individual was identified, the Agency
has shown a identifiable laboratory or testing facility
as the author. When no author or laboratory could be
identified, the Agency has shown the first submitter as
the author.
-------
b.
d.
Document Date. The date of the study is taken directly
from the document. When the date is followed by a
question mark, the bibliographer has deduced the date
from the evidence contained 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 the
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
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.
When authorship is de-faulted 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", which stands 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.
-------
BIBLIOGRAPHIC CITATIONS
FOR
BORIC ACID AND ITS SODIUM SALTS
REREGISTRATION ELIGIBILITY DECISION DOCUMENT
42931800
42931801
42931802
42931803
42931804
GS0024-017
GS0024-018
GS0024-019
GS0024-020
U.S. Borax (1993) Resubmission of Old Product Chemistry Data for
Borates in Support of Registration. Transmittal of 4 studies.
Handler, R. (1978) Monograph on Borax, Boric Acid and Borates.
Washington, D.C.: Food and Drug Administration. (FDA Report
Number FDA/BF/-79/6) Original Reference Number 005009134.
Faith, W.L., ed.; Keyes, D.B., Ed; Clark, R.L. (1957). Industrial
Chemicals: P. 156-160: Third Edition: New York, London, Sydney:
John Wiley & Sons. Original Reference Number 005014487.
May, F.H., Inventor; American Potash & Chemical Corporation (1960)
Process for Producing Pure Boric Acid and Potassium Sulfate. U.S.
patent 2,948,592. August 9. 5 pages.
U.S. Borax Research Corporation. (19??) Boron Compounds (Oxides,
Acid, Borates): P. 67-110 in Kirk-Othmer Encyclopedia of Chemical
Technology, Volume 4, 3rd edition (1978) John Wiley & Sons, Inc.
Fink, R (1982) Acute Oral LD50 for Bobwhite Quail; Project No. 135-
106; Prepared by Wildlife Intenational Ltd. jfor U.S. Borax, Anahaim,
CA.
Beavers, J.B. January 21, 1984. Eight-day dietary LC50 - Bobwhite
Quail - Polybor. Final REport. TX-82-3. Prepared by Wildlife
International Ltd, St. Michaels, MD. Submitted to Borax; Anahaim,
CA.
Beavers, J.B. May 21, 1984. A Dietary LC50 study on the Bobwhite
with Boric Acid. Final Report. Project No. 176-102a. Prepared by
Wildlife International, St. Michaels, MD. Submitted to Kerr McGee
Chemical Corporation. Oklahoma City, OK. EPA Accession Number
254367. (HCOBORO2)
Beavers, J.B. January 21, 1984. Eight-day dietary LC50 - Mallard
Duck - Polybor. Final Report. TX-82-4. Prepared by Wildlife
International, St. Michaels, MD. Submitted to U.S. Borax; Anaheim,
CA. No EPA Accession Number provided.
-------
GS0024-021
GS0024-022
GS0024-023
GS0024-027
GS0024-028
GS0024-029
GS0024-030
Beavers, J.B. May 21, 1984. A dietary LC50 study the Mallard with
Boric Acid. Final Report. Prokect No. 176-103. Prepared by
Wildlife International, St. Michaels, MD. Submitted to Kerr McGee
Chemical Corporation. Oklahoma City, Ok. EPA Accession Number
254367.
U.S. EPA (1982) Fish Toxicity Laboratory Report Static Test No.
2571. (Unpublished report concerning the toxicity of Boric Acid,
93.9% on rainbow trout; prepared by the Chemical and Biological
Investigations Branch, ARC, Beltsville, MD.
U.S. EPA (1982) Aquatic Invertebrates laboratory Report. Static Test
No. 2750. (Unpublished report on Daphnia magna: prepared by the
Chemical and Biological Investigations Branch, ARC, Beltsville, MD.
U.S. Borax Corporation. Toxicology 20 Mule Team Boric Acid. Vol
I. (Compilation: unpublished study received March 5, 1981 under
1623-117; CDL:244539).
U.S. Borax Corporation. Toxicology 20 Mule Team Boric Acid. Vol.
n (Compilation: unpublished study received March 5, 1981 under
1624-117; CDL: 244540).
U.S. Borax Corporation. Toxicology 20 Mule Team Boric Acid. Vol.
m. (Compilation: unpublished study received March 5, 1981 under
1624-117; CDL: 244541).
U.S. Borax Corporation. Toxicology 20 Mule Team Boric Acid. Vol.
IV. (Compilation: unpublised study received March 5, 1981 under
1624-117; CDL: 244542).
-------
APPENDIX D
List of Available Related Documents
-------
-------
The following is a list of available documents related to Boric Acid and its Sodium
Salts. It's purpose is to provide a path to more detailed information if it is needed. These
accompanying documents are part of the Administrative Record for Boric Acid and its
Sodium Salts and are included in the EPA's Office of Pesticide Programs Public Docket.
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Information System (LUIS) Report
3. Boric Acid and its Sodium Salts RED Fact Sheet
4. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
5. Guidance for the Reregistration of Pesticide Products Containing Boric Acid
and Boron Containing Salts as the Active Ingredient. Issued November 1985.
(NTTS publication Number PB87-101903).
6. Guidance for the Registration and Reregistration of End-Use Pesticide Products
Containing the Insecticidal Uses of Boric Acid — General Registration
Standard. Issued November 1985.
-------
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION. PESTICIDES
AND TOXIC SUBSTANCES
PR NOTICE 91-2
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDES
ATTENTION: Persons Responsible for Federal Registration of
Pesticide Products.
SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement
I. PURPOSE:
The purpose of this notice is to clarify the Office of
Pesticide Program's policy with respect to the statement of
percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(s)
specified in the ingredient statement on the label must be stated
as the nominal concentration of such ingredient (s), as that term
is defined in 40 CFR 158.153 (i). Accordingly, the Agency has
established the nominal concentration as the only acceptable
label claim for the amount of active ingredient in the product.
II. BACKGROUND
For some time the Agency has accepted two different methods
of identifying on the label what percentage is claimed for the
ingredient (s) contained in a pesticide. Some applicants claimed a
percentage which represented a level between the upper and the
lower certified limits. This was referred to as the nominal
concentration. Other applicants claimed the lower limit as the
percentage of the ingredient (s) that would be expected to be
present in their product at the end of the product's shelf-life.
Unfortunately, this led to a great deal of confusion among the
regulated industry, the regulators, and the consumers as to
exactly how much of a given ingredient was in a given product.
The Agency has established the nominal concentration as the only
acceptable label claim for the amount of active ingredient in the
product.
Current regulations require that the percentage listed in
the active ingredient statement be as precise as possible
-------
reflecting good manufacturing practices 40 CFR 156.10(g) (5) . The
certified limits required for each active ingredient are intended
to encompass any such "good manufacturing practice" variations 40
CFR 158.175(C)(3).
The upper and lower certified limits, which must be proposed in
connection with a product's registration, represent the amounts
of an ingredient that may legally be present 40 CFR 158.175. The
lower certified limit is used as the enforceable lower limit for
the product composition according to FIFRA section 12(a)(1)(C),
while the nominal concentration appearing on the label would be
the routinely achieved concentration used for calculation of
dosages and dilutions.
The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual
product composition because the nominal concentration would be
the amount of active ingredient typically found in the product.
It is important for registrants to note that certified
limits for active ingredients are not considered to be trade
•secret information under FIFRA section 10(b). In this respect the
certified limits will be routinely provided by EPA to States for
enforcement purposes, since the nominal concentration appearing
on the label may not represent the enforceable composition for
purposes of section 12(a)(1)(C).
III. REQUIREMENTS
As described below under Unit V. " COMPLIANCE SCHEDULE," all
currently registered products as well as all applications for new
registration must comply with this Notice by specifying the
nominal concentration expressed as a percentage by weight as the
label claim in the ingredient (s) statement and equivalence
statements if applicable (e.g., elemental arsenic, metallic zinc,
salt of an acid). In addition, the requirement for performing
sample analyses of five or more representative samples must be
fulfilled. Copies of the raw analytical data must be submitted
with the nominal ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR
158.170. All products are required to provide certified limits
for each active, inert ingredient, impurities of toxicological
significance (i.e., upper limit (s) only) and on a case by case
basis as specified by EPA. These limits are to be set based on
xepr@eeutb.cive sampling and chemical analysis (i.e., quality
control) of the product.
The format of the ingredient statement must conform to 40
CFR 156-Labeling Requirements For Pesticides and Devices.
After July 1, 1997, all pesticide ingredient Statements must
be changed to nominal concentration.
-------
IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lower then the minimum
level to achieve efficacy. This is extremely important for
products which are intended to control pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 153.640.
In those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make
the registration process more uniform and more manageable for
both the agency and the regulated community. It is the Agency's
intention to implement the requirements of this notice as,
smoothly as possible so as not to disrupt or delay the Agency's
high priority programs, i.e., reregistration, new chemical, or
fast track (FIFRA section 3(c)(3)(B). Therefore,
applicants/registrants are expected to comply with the
requirements of this Notice as follows:
(1) Beginning July 1, 1991, all new product registrations
submitted to the Agency are to comply with the
requirements of this Notice.
(2) Registrants having products subject to reregistration
under FIFRA section 4 (a) are to comply with the
requirements of this Notice when specific products are
called in by the Agency under Phase V of the
Reregistration Program.
All other products/applications that are not subject to
(1) and (2) above will have until July 1, 1997, to
comply with this Notice. Such applications should note
"Conversion to Nominal Concentrations on the
application form. These types Or amendments will not be
handled as "Fast Track" applications but will be
handled as routine requests.
VI. FOR FURTHER INFORMATION
Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.
(3)
Axui* fi.
Registration Division (Ji-7505
-------
-------
APPENDIX E
Generic and Product Specific Data Call-in Notice
-------
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
GENERIC AND PRODUCT SPECIFIC
DATA CALL-IN NOTICE
FEB | 6 1994
CERTIFIED MAIL
OFFICE OF
PESTICIDES AND TOXIC
SUBSTANCES
Dear Sir or Madam:
This Notice requires you.and other registrants of pesticide
products containing the active ingredient identified in
Attachment A of this Notice, the Data Call-In Chemical Status
Sheet, to submit certain data as noted herein to the U.S.
Environmental Protection Agency (EPA, the Agency). These data are
necessary to maintain the continued registration of your
product(s) containing this active ingredient. Within 90 days.
after you receive this Notice you must respond as set forth in
Section III below. Your response must state:
1. How you will comply with the requirements set forth in
this Notice and its Attachments 1 through 7; or
2. Why you believe you are exempt from the requirements
listed in this Notice and in Attachment 3 (for both
generic and product specific data), the Requirements
Status and Registrant's Response Form, (see section
III-B); or
3. Why you believe EPA should not require your submission
of data in the manner specified by this Notice (see
section III-D).
If you do not respond to this Notice, or.if you do not
satisfy EPA that you will comply with its requirements or should
be exempt or excused from doing so, then the registration of your
product(s) subject to this Notice will be subject to suspension.
We have provided a list of all of your products subject to this
Notice in Attachment 2. All products are listed on both the
generic and product specific Data Call-In Response Forms. Also
included is a list of all registrants who were sent this Notice
(Attachment 6).
The authority for this Notice is section 3(c) (2) (B) of the
Federal Insecticide, Fungicide and Rodenticide Act as amended
(FIFRA) , 7- U.S.C. section 136a(c) (2) (B) . Collection of this
information is authorized under the Paperwork Reduction Act by
OMB Approval No. 2070-0107 and 2070-0057 (expiration date
3-31-96).
Printed on Recycled Paper
-------
This Notice is divided into six sections and seven
Attachments. The Notice itself contains information and
instructions applicable to all Data Call-in Notices. The
Attachments contain specific chemical information and
instructions. The six sections of the Notice are:
Section
Section
Section
Section
I
II
III
IV
Section V
Section VI
Why You are Receiving this Notice
Data Required by this Notice
Compliance with Requirements of this Notice
Consequences of Failure to Comply with this
Notice
Registrants' Obligation to Report Possible
Unreasonable Adverse Effects
Inquiries and Responses to this Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Generic Data Call-in and Product Specific Data
Call-in Response Forms with Instructions
3 - Generic Data Call-in and Product Specific Data
Call-in Requirements Status and Registrant's
Response Forms with Instructions
4 - EPA Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirements for Reregistration
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms
SECTION I.
WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active
ingredient (s) and reevaluated the data needed to support
continued registration of the subject active ingredient(s). This
reevaluation identified additional data necessary to assess the
health and safety of the continued use of products containing
this active ingredient (s) . You have been sent this Notice because
you have product(s) containing the subject active ingredients.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The data required by this Notice are specified in the
Requirements Status and Registrant's Response Forms: Attachment
(for both generic and product specific data requirements).
Depending on the results of the studies required in this Notice,
additional studies/testing may be required.
-------
II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the
data requirements specified in the Requirements Status and
Registrant's Response E'orms (Attachment 3) within the timeframes
provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in
accordance with test standards outlined in the Pesticide
Assessment Guidelines for those studies for which guidelines have
been established.
These EPA Guidelines are available from the National
Technical Information Service (NTIS), Attn: Order Desk, 5285 Port
Royal Road, Springfield, Va 22161 (Telephone number:
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 (40 CFR § 158.70) . When
using the OECD protocols, they should be modified as appropriate
so that the data generated by the study will satisfy the
requirements of 40 CFR § 158. Normally, the Agency will not
extend deadlines for complying with data requirements when the
studies were not conducted in accordance with acceptable
standards. The OECD protocols are available from OECD, 2001 L
Street,. N.W., Washington, D.C. 20036 (Telephone number 202-785-
6323; Fax telephone number 202-785-0350).
All new studies and proposed protocols submitted in response
to this Data Call-in Notice must be in accordance with Good
Laboratory Practices [40 CFR Part 160].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B)
NOTICES ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-in does not in
any way supersede or change the requirements of any previous Data
Call-In(s), or any other agreements entered into with the Agency
pertaining to such prior Notice. Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of
Intent to Suspend their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
You must use the correct forms and instructions when
completing your response to this Notice. The type of Data
Call-in you must comply with (Generic or Product Specific) is
-------
specified in item number 3 on the four Data Call-in forms
(Attachments 2 and 3).
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice
for generic and product specific data must be submitted to the
Agency within 90 days after your receipt of this Notice. Failure
to adequately respond to this Notice within 90 days of your
receipt will be a basis for issuing a Notice of Intent to Suspend
(NOIS) affecting your products. This and other bases for issuance
of NOIS due to failure to comply with this Notice are presented
in Section IV-A and IV-B.
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
1. Generic Data Requirements
The options for responding to this Notice for generic data
requirements are: (a) voluntary cancellation, (b) delete use(s),
(c) claim generic data exemption, (d) agree to satisfy the
generic data requirements imposed by this Notice or (e) request a
data waiver(s).
A discussion of how to respond if you choose the Voluntary
Cancellation option, the Delete Use(s) option or the Generic Data
Exemption option is presented below. A discussion of the various
options available for satisfying the generic data requirements of
this Notice is contained in Section III-C. A discussion of
options relating to requests for data waivers is contained in
Section III-D.
Two forms apply to generic data requirements, one or both of
which must be used in responding to the Agency, depending upon
your response. These two forms are the Data-Call-in Response
Form, and the Requirements Status and Registrant's Response Form,
(contained in Attachments 2 and 3, respectively).
The Data Call-in Response Forms must be submitted as part of
every response to this Notice. The Requirements Status and
Registrant's Response Forms also must be submitted if you do not
qualify for a Generic Data Exemption or are not requesting
voluntary cancellation of your registration(s). Please note that
the company'' s authorized representative is required to sign the
first page of both Data Call-In Response Forms and the
Requirements Status and Registrant's Response Forms (if this form
is required) and initial any subsequent pages. The forms contain
separate detailed instructions on the response options. Do not
alter the printed material. If you have questions or need
assistance in preparing your response, call or write the contact
person(s) identified in Attachment 1.
-------
a.
Voluntary Cancellation -
You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active
ingredient that is the subject of this Notice. If you wish to
voluntarily cancel your product, you must submit completed
Generic and Product Specific Data Call-in Response Forms
(Attachment 2), indicating your election of this option.
Voluntary cancellation is item number 5 on both Data Call-in
Response Form(s). If you choose this option, these are the only
forms that you are required to complete.
If you chose to voluntarily cancel your product, further
sale and distribution of your product after the effective date of
cancellation must be in accordance with the Existing Stocks
provisions of this Notice, which are contained in Section IV-C.
b.
Use Deletion -
You may avoid the requirements of this Notice by eliminating
the uses of your product to which the requirements apply. If you
wish to amend your registration to delete uses, you must submit
the Requirements Status and Registrant's Response Form
(Attachment 3), a completed application for amendment, a copy of
your proposed amended labeling, and all other information
required for processing the application. Use deletion is option
number 7 under item 9 in the instructions for the Requirements
Status and Registrant's Response Forms. You must also complete a
Data Call-in Response Form by signing the certification, item
number 8. Application forms for amending registrations may be
obtained from the Registration Support Branch, Registration
Division, Office of Pesticide Programs, EPA, by calling (703)
308-8358.
If you choose to delete the use(s) subject to this Notice or
uses subject to specific data requirements, further sale,
distribution, or use of your product after one year from the due
date of your 90 day response, is allowed only if the product
bears an amended label.
c. Generic Data Exemption -
Under section 3(c)(2)(D) of FIFRA, an applicant for
registration of a product is exempt from the requirement to
submit or cite generic data concerning an active ingredient if
the active ingredient in the product is derived exclusively from
purchased, registered pesticide products containing the active
ingredient. EPA has concluded, as an exercise of its discretion,
that it normally will not suspend the registration of a product
which would qualify and continue to qualify for the generic data
-------
exemption in section 3 (c) (2) (D) of FIFRA. To qualify, all of the
following requirements must be met:
(i) . The active ingredient in your registered product must
be present solely because of incorporation of another
registered product which contains the subject active
ingredient and is purchased from a source not connected with
you;
(ii) . Every registrant who is the ultimate source of the
active ingredient in your product subject to this DCI must
be in compliance with the requirements of this Notice and
must remain in compliance; and
(iii) . You must have provided to EPA an accurate and
current "Confidential Statement of Formula" for each of your
products to which this Notice applies.
To apply for the Generic Data Exemption you must submit a
completed Data Call-In Response Form, Attachment 2 and all
supporting documentation. The Generic Data Exemption is item
number 6a on the Data Call-in Response Form. If you claim a
generic data exemption you are not required to complete the
Requirements Status and Registrant's Response Form. Generic Data
Exemption cannot be selected as an option for responding to
product specific data requirements.
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 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 Data Call-
in 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 and their product (s) ,
unless you commit to submit and do submit the required data
within the specified time. In such cases the Agency generally
will not grant a time extension for submitting the data.
d.
Satisfying the Generic Data Requirements of this Notice
There are various options available to satisfy the generic
data requirements of this Notice. These options are discussed in
Section III-C.l. of this Notice and comprise options 1 through 6
of item 9 in the instructions for the Requirements Status and
Registrant's Response Form and item 6b on the Data Call-in
Response Form. If you choose item 6b (agree to satisfy the
generic data requirements) , you must submit the Data Call-In
Response Form and the Requirements Status and Registrant' s
Response Form as well as any other information/data pertaining to
the option chosen to address the data requirement. Your response
must be on the forms marked "GENERIC" in item number 3.
6
-------
e.
Request for Generic Data Waivers.
Waivers for generic data are discussed in Section III-D.l.
of this Notice and are covered by options 8 and 9 of item 9 in
the instructions for the Requirements Status and Registrant7s
Response Form. If you choose one of these options, you must
submit both forms as well as any other in format ion/data
pertaining to the option chosen to address the data requirement.
2. Product Specific Data Requirements
The options for responding to this Notice for product
specific data are: (a) voluntary cancellation, (b) agree to
satisfy the product specific data requirements imposed by this
Notice or (c) request a data waiver(s).
A discussion of how to respond if you choose the Voluntary
Cancellation option is presented below. A discussion of the
various options available for satisfying the product specific
data requirements of this Notice is contained in Section III-C.2.
A discussion of options relating to requests for data waivers is
contained in Section III-D.2.
Two forms apply to the product specific data requirements
one or both of which must be used in responding to the Agency,
depending upon your response. These forms are the Data-Call-in
Response Form, and the Requirements Status and Registrant's
Response Form, for product specific data (contained in
Attachments 2 and 3, respectively). The Data Call-in Response
Form must be submitted as part of every response to this Notice.
In addition, one copy of the Requirements Status and Registrant's
Response Form also must be submitted for each product listed on
the Data Call-In Response Form unless the voluntary cancellation
option is selected. Please note that the company's authorized
representative is required to sign the first page of the Data
Call-in Response Form and Requirements Status and Registrant's
Response Form (if this form is required) and initial any
subsequent pages. The forms contain separate detailed
instructions on the response options. Do not alter the printed
material. If you have questions or need assistance in preparing
your response, call or write the contact person(s) identified in
Attachment 1.
a.
Voluntary Cancellation
You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active
ingredient that is the subject of this Notice. If you wish to
voluntarily cancel your product, you must submit a completed Data
Call-In Response Form, indicating your election of this option.
Voluntary cancellation is item number 5 on both the Generic and
-------
Product Specific Data Call-in Response Forms. If you choose this
option, you must complete both Data Call-in response forms.
These are the only forms that you are required to complete.
If you choose to voluntarily cancel your product, further
sale and distribution of your product after the effective date of
cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
b. Satisfying the Product Specific Data Requirements of
this Notice.
There are various options available to satisfy the product
specific data requirements of this Notice. These options are
discussed in Section III-C.2. of this Notice and comprise options
1 through 6 of item 9 in the instructions for the product
specific Requirements Status and Registrant's Response Form and
item numbers 7a and 7b (agree to satisfy the product specific
data requirements for an MUP or EUP as applicable) on the product
specific Data Call-in Response Form. Note that the options
available for addressing product specific data requirements
differ slightly from those options for fulfilling generic data
requirements. Deletion of a use(s) and the low volume/minor use
option are not valid options for fulfilling product specific data
requirements. It is important to ensure that you are using the
correct forms and instructions when completing your response to
the Reregistration Eligibility Decision document.
c. Request for Product Specific Data Waivers.
Waivers for product specific data are discussed in Section
III-D.2. of this Notice and are covered by option 7 of item 9 in
the instructions for the Requirements Status and Registrant's
Response Form. If you choose this option, you must submit the
Data Call-in Response Form and the Requirements Status and
Registrant's Response Form as well as any other information/data
pertaining to the option chosen to address the data requirement.
Your response must be on the forms marked "PRODUCT SPECIFIC" in
item number 3.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
1. Generic Data
If you acknowledge on the Generic Data Call-In Response Form
that you agree to satisfy the generic data requirements (i.e. you
select item number 6b) , then you must select one of the six
options on the Generic Requirements Status and Registrant's
Response Form related to data production for each data
requirement. Your option selection should be entered under item
number 9, "Registrant Response." The six options related to data
production are the first six options discussed under item 9 in
8
-------
the instructions for completing the Requirements Status and
Registrant's Response Form. These six options are listed
immediately below with information in parentheses to guide you to
additional instructions provided in this Section. The options
are:
(1) I will generate and submit data within the specified
timeframe (Developing Data)
(2) I have entered into an agreement with one or more
registrants to develop data jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been
submitted previously to the Agency by anyone
(Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study
classified by EPA as partially acceptable and
upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified
as acceptable or an existing study that has been
submitted but not reviewed by the Agency (Citing an
Existing Study)
Option 1. Developing Data
If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency
requirements as referenced herein and in the attachments. All
data generated and submitted must comply with the Good Laboratory
Practice (GLP) rule (40 CFR Part 160) , be conducted according to
the Pesticide Assessment Guidelines (PAG) and be in conformance
with the requirements of PR Notice 86-5. In addition, certain
studies require Agency approval of test protocols in advance of
study initiation. Those studies for which a protocol must be
submitted have been identified in the Requirements Status and
Registrant's Response Form and/or footnotes to the form. If you
wish to use a protocol which differs from the options discussed
in Section II-C of this Notice, you must submit a detailed
description of the proposed protocol and your reason for wishing
to use it. The Agency may choose to reject a protocol not
specified in Section II-C. If the Agency rejects your protocol
you will be notified in writing, however, you should be aware
that rejection of a proposed protocol will not be a basis for
extending the deadline for submission of data.
A progress report must be submitted for each study within 90
days from the date you are required to commit to generate or
undertake some other meams to address that study requirement,
such as making an offer to cost share or agreeing to share in the
cost of developing that study. This 90-day progress report must
include the date the study was or will be initiated and, for
-------
studies to be started within 12 months of commitment, the name
and address of the laboratory (ies) or individuals who are or will
be conducting the study.
In addition, if the time frame for submission of a final
report is more than 1 year, interim reports must be submitted at
12 month intervals from the date you are required to commit to
generate or otherwise address the requirement for the study. In
addition to the other information specified in the preceding
paragraph, at a minimum, a brief description of current activity
on and the status of the study must be included as well as a full
description of any problems encountered since the last progress
report.
The time frames in the Requirements Status and Registrant's
Response Form are the time frames that the Agency is allowing for
the submission of completed study reports or protocols. The noted
deadlines run from the date of the receipt of this Notice by the
registrant. If the data are not submitted by the deadline, each
registrant is subject to receipt of a Notice of Intent to Suspend
the affected registration(s).
If you cannot submit the data/reports to the Agency in the
time required by this Notice and intend to seek additional time
to meet the requirements (s) , you must submit a request to the
Agency which includes: (1) a detailed description of the expected
difficulty and (2) a proposed schedule including alternative
dates for meeting such requirements on a step-by-step basis. You
must explain any technical or laboratory difficulties and provide
documentation from the laboratory performing the testing. While
EPA is considering your request, the original deadline remains.
The Agency will respond to your request in writing. If EPA does
not grant your request, the original deadline remains. Normally,
extensions can be requested only in cases of extraordinary
testing problems beyond the expectation or control of the
registrant. Extensions will not be given in submitting the 90-day
responses. Extensions will not be considered if the request for
extension is not made in a timely fashion; in no event shall an
extension request be considered if it is submitted at or after
the lapse of the subject deadline.
Option 2. Agreement to Share in Cost to Develop Data
If you choose to enter into an agreement to share in the
cost of producing the required data but will not be submitting
the data yourself, you must provide the name of the registrant
who will be submitting the data. You must also provide EPA with
documentary evidence that an agreement has been formed. Such
evidence may be your letter offering to join in an agreement and
the other registrant's acceptance of your offer, or a written
statement by the parties that an agreement exists. The agreement
to produce the data need not specify all of the terms of the
10
-------
final arrangement between the parties or the mechanism to resolve
the terms. Section 3 (c) (2) (B) provides that if the parties cannot
resolve the terms of the agreement ttiey may resolve their
differences through binding arbitration.
Option 3. Offer to Share in the Cost of Data Development
If you have made an offer to pay in an attempt to enter into
an agreement or amend an existing agreement to meet the
requirements of this Notice .and have been unsuccessful, you may
request EPA (by selecting this option) to exercise its discretion
not to suspend your registration (s) , although you do not comply
with the data submission requirements of this Notice. EPA has
determined that as a general policy, absent other relevant
considerations, it will not suspend the registration of a product
of a registrant who has in good faith sought and continues to
seek to enter into a joint data development/cost sharing program,
but the other registrant (s) developing the data has refused to
accept the offer. To qualify for this option, you must submit
documentation to the Agency proving that you have made an offer
to another registrant (who has an obligation to submit data) to
share in the burden of developing that data. You must also submit
to the Agency a completed EPA Form 8570-32, Certification of
Offer to Cost Share in the Development of Data, Attachment 7. In
addition, you must demonstrate that the other registrant to whom
the offer was made has not accepted your offer to enter into a
cost-sharing agreement by including a copy of your offer and
proof of the other registrant's receipt of that offer (such as a
certified mail receipt). Your offer must, in addition to anything
else, offer to share in the burden of producing the data upon
terms to be agreed to or, failing agreement, to be bound by
binding arbitration as provided by FIFRA section 3 (c) (2) (B) (iii)
and must not qualify this offer. The other registrant must also
inform EPA of its election of an option to develop and submit the
data required by this Notice by submitting a Data Call-in
Response Form and a Requirements Status and Registrant's Response
Form committing to develop and submit the data required by this
Notice.
In order for you to avoid suspension under this option, you
may not withdraw 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. If the other registrant fails to develop the data or for
some other reason is subject to suspension, your registration as
well as that of the other registrant normally will be subject to
initiation of suspension proceedings, unless you commit to
submit, and do submit, the required data in the specified time
frame. In such cases, the Agency generally will not grant a time
extension for submitting the data.
11
-------
Option 4 . Submitting an Existing Study
If you choose to submit an existing study in response to
this Notice, you must determine that the study satisfies the
requirements imposed by this Notice. You may only submit a study
that has not been previously submitted to the Agency or
previously cited by anyone. Existing studies are studies which
predate issuance of this Notice. Do not use this option if you
are submitting data to upgrade a study. (See Option 5) .
You should be aware that if the Agency determines that the
study is not acceptable, the Agency will require you to comply
with this Notice, normally without an extension of the required
date of submission. The Agency may determine at any time that a
study is not valid and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an
existing study, all of the following three criteria must be
clearly met;
a. You must certify at the time that the existing study is
submitted that the raw data and specimens from the
study are available for audit .and review and you must
identify where they are available. This must be done in
accordance with the requirements of the Good Laboratory
Practice (GLP) regulation, 40 CFR Part 160. As stated
in 40 CFR 160.3 "^[rjaw data' means any laboratory
worksheets, records, memoranda, notes, or exact copies
thereof, that are the result of original observations
and activities of a study and are necessary for the
reconstruction and evaluation of the report of that
study. In the event that exact transcripts of raw data
have been prepared (e.g., tapes which have been
transcribed verbatim, dated, and verified accurate by
signature) , the exact copy or exact transcript may be
substituted for the original source as raw data. 'Raw
data1" may include photographs, microfilm or microfiche
copies, computer printouts, magnetic media, including
dictated observations, and recorded data from automated
instruments." The term "specimens", according to 40 CFR
160.3, means "any material derived from a test system
for examination or analysis."
b. Health and safety studies completed after May 1984 also
must also contain all GLP-required quality assurance
and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants also must
certify at the time of submitting the existing study
that such GLP information is available for post May
1984 studies by including an appropriate statement on
or attached to the study signed by an authorized
official or representative of the registrant.
12
-------
c. You must certify that each study fulfills the
acceptance criteria for the Guideline relevant to the
study provided in the FIFRA Accelerated Reregistration
Phase 3 Technical Guidance and that the study has been
conducted according to the Pesticide Assessment
Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according
to the PAG may be submitted to the Agency for
consideration if the registrant believes that the study
clearly meets the purpose of the PAG. The registrant is
referred to 40 CFR 158.70 which states the Agency's
policy regarding acceptable protocols. If you wish to
submit the studyr you must, in addition to certifying
that the purposes of the PAG are met by the study,
clearly articulate the rationale why you believe the
study meets the purpose of the PAG, including copies of
any supporting information or data. It has been the
Agency's experience that studies completed prior to
January 1970 rarely satisfied the purpose of the PAG
and that necessary raw data usually are not available
for such studies.
If you submit an existing study, you must certify that the
study meets all requirements of the criteria outlined above.
If EPA has previously reviewed a protocol for a study you
are submitting, you must identify any action taken by the Agency
on the protocol and must indicate, as part of your certification,
the manner in which all Agency comments, concerns, or issues were
addressed in the final protocol and study.
If you know of a study pertaining to any requirement in this
Notice which does not meet the criteria outlined above but does
contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such
study is in the Agency's files, you need only cite it along with
the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
Option 5. Upgrading a Study
If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The
Agency will review the data submitted and determine if the
requirement is satisfied. If the Agency decides the requirement
is not satisfied, you may still be required to submit new data
normally without any time extension. Deficient, but upgradeable
studies will normally be classified as supplemental. However, it
is important to note that not all studies classified as
supplemental are upgradeable. If you have questions regarding the
classification of a study or whether a study may be upgraded,
call or write the contact person listed in Attachment 1. If you
13
-------
submit data to upgrade an existing study you must satisfy or
supply information to correct all deficiencies in the study
identified by EPA. You must provide a clearly articulated
rationale of how the deficiencies have been remedied or corrected
and why the study should be rated as acceptable to EPA. Your
submission must also specify the MRID number (s) of the study
which you are attempting to upgrade and must be in conformance
with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a
study classified as unacceptable and determined by the Agency as
not capable of being upgraded.
This option also should be used to cite data that has been
previously submitted to upgrade a study, but has not yet been
reviewed by the Agency. You must provide the MRID number of the
data submission as well as the MRID number of the study being
upgraded.
The criteria for submitting an existing study, as specified
in Option 4 above, apply to all data submissions intended to
upgrade studies. Additionally, your submission of data intended
to upgrade studies must be accompanied by a certification that
you comply with each of those criteria, as well as a
certification regarding protocol compliance with Agency
requirements.
Option 6. Citincr Existing Studies
If you choose to cite a study that has been previously
submitted to EPA, that study must have been previously classified
by EPA as acceptable, or it must be a study which has not yet
been reviewed by the Agency. Acceptable toxicology studies
generally will have been classified as "core-guideline" or "core-
minimum." For ecological effects studies, the classification
generally would be a rating of "core." For all other disciplines
the classification would be "acceptable." With respect to any
studies for which you wish to select this option, you must
provide the MRID number of the study you are citing and, if the
study has been reviewed by the Agency, you must provide the
Agency's classification of the study.
If you are citing a study of which you are not the original
data submitter, you must submit a completed copy of EPA Form
8570-31, Certification with Respect to Data Compensation
Requirements.
2. Product Specific Data
If you acknowledge on the product specific Data Call-In
Response Form that you agree to satisfy the product specific data
requirements (i.e. you select option 7a or 7b), then you must
14
-------
select one of the six options on the Requirements Status and
Registrant's Response Form related to data production for each
data requirement. Your option selection should be entered under
item number 9, "Registrant Response." The six options related to
data production are the first six options discussed under item 9
in the instructions for completing the Requirements Status and
Registrant's Response Form. These six options are listed
immediately below with information in parentheses to guide
registrants to additional instructions provided in this Section.
The options are:
(1) I will generate and submit data within the specified
time-frame (Developing Data)
(2) I have entered into an agreement with one or more
registrants to develop data jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been
submitted previously to the Agency by anyone
(Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study
classified by EPA as partially acceptable and
upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified
as acceptable or an existing study that has been
submitted but not reviewed by the Agency (Citing an
Existing Study)
Option 1. Developing Data -- The requirements for developing
product specific data are the same as those described for generic
data (see Section III.C.I, Option 1) except that normally no
protocols or progress reports are required.
Option 2. Agree to Share in Cost to Develop Data — If you enter
into an agreement to cost share, the same requirements apply to
product specific data as to generic data (see Section III.C.I,
Option 2). However, registrants may only choose this option for
acute toxicity data and certain efficacy data and only if EPA has
indicated in the attached data tables that your product and at
least one other product are similar for purposes of depending on
the same data. If this is the case, data may be generated for
just one of the products in the group. The registration number of
the product for which data will be submitted must be noted in the
agreement to cost share by the registrant selecting this option.
Option 3. Offer to Share in the Cost of Data Development —The
same requirements for generic data (Section III.C.I., Option 3)
apply to this option. This option only applies to acute toxicity
and certain efficacy data as described in option 2 above.
15
-------
Option 4. Submitting an Existing Study — The same requirements
described for generic data (see Section III.C.I.,. Option 4) apply
to this option for product specific data.
Option 5. Upgrading a Study — The same requirements described
for generic data (see Section III.C.l., Option 5) apply to this
option for product specific data.
Option 6. Citing Existing Studies -- The same requirements
described for generic data (see Section III.C.l., Option 6) apply
to this option for product specific data.
Registrants who select one of the above 6 options must meet
all of the requirements described in the instructions for
completing the Data Call-in Response Form and the Requirements
Status and Registrant's Response Form, and in the generic data
requirements section (III.C.l.), as appropriate.
III-D REQUESTS FOR DATA WAIVERS
1. Generic Data
There are two types of data waiver responses to this Notice.
The first is a request for a low volume/minor use waiver and the
second is a waiver request based on your belief that the data
requirement(s) are not appropriate for your product.
a.
Low Volume/Minor Use Waiver
Option 8 under item 9 on the Requirement s Status and
Registrant's Response Form. Section 3(c) (2) (A) of FIFRA
requires EPA to consider the appropriateness of requiring
data for low volume, minor use pesticides. In implementing
this provision, EPA considers low volume pesticides to be
only those active ingredients whose total production volume
for all pesticide registrants is small. In determining
whether to grant a low volume, minor use waiver, the Agency
will consider the extent, pattern and volume of use, the
economic incentive to conduct the testing, the importance of
the pesticide, and the exposure and risk from use of the
pesticide. If an active ingredient is used for both high
volume and low volume uses, a low volume exemption will not
be approved. If all uses of an active ingredient are low
volume and the combined volumes for all uses are also low,
then an exemption may be granted, depending on review of
other information outlined below. An exemption will not be
granted if any registrant of the active ingredient elects to
conduct the testing. Any registrant receiving a low volume
minor use waiver must remain within the sales figures in
their forecast supporting the waiver request in order to
remain qualified for such waiver. If granted a waiver, a
16
-------
registrant will be required, as a condition of the waiver,
to submit annual sales reports. The Agency will respond to
requests for waiveirs in writing.
To apply for a low volume, minor use waiver, you must
submit the following information, as applicable to your
product (s), as part of your 90-day response to this Notice:
(i). Total company sales (pounds and dollars) of all
registered product, (s) containing the active ingredient. If
applicable to the active ingredient, include foreign sales
for those products that are not registered in this country
but are applied to sugar (cane or beet), coffee, bananas,
cocoa, and other such crops. Present the above information
by year for each of the past five years.
(ii) Provide an estimate of the sales (pounds and
dollars) of the active ingredient for each major use site.
Present the above information by year for each of the past
five years.
(iii) Total direct production cost of product(s)
containing the active ingredient by year for the past five
years. Include information on raw material cost, direct
labor cost, advertising, sales and marketing, and any other
significant costs listed separately.
(iv) Total indirect production cost (e.g. plant
overhead, amortized plant and equipment) charged to
product(s) containing the active ingredient by year for the
past five years. Exclude all non-recurring costs that were
directly related to the active ingredient, such as costs of
initial registration and any data development.
(v) A list of each data requirement for which you seek
a waiver. Indicate the type of waiver sought and the
estimated cost to you (listed separately for each data
requirement and associated test) of conducting the testing
needed to fulfill each of these data requirements.
(vi) A list of each data requirement for which you are
not seeking any waiver and the estimated cost to you (listed
separately for each data requirement and associated test) of
conducting the testing needed to fulfill each of these data
requirements.
(vii) For each of the next ten years, a year-by-year
forecast of company sales (pounds and dollars) of the active
ingredient, direct production costs of product(s) containing
the active ingredient (following the parameters in item 2
above), indirect production costs of product(s) containing
17
-------
the active ingredient (following the parameters in item 3
above) , and costs of data development pertaining to the
active ingredient.
(viii) A description of the importance and unique
benefits of the active ingredient to users. Discuss the use
patterns and the effectiveness of the active ingredient
relative to registered alternative chemicals and
non-chemical control strategies. Focus on benefits unique to
the active ingredient, providing information that is as
quantitative as possible. If you do not have quantitative
data upon which to base your estimates, then present the
reasoning used to derive your estimates. To assist the
Agency in determining the degree of importance of the active
ingredient in terms of its benefits, you should provide
information on any of the following factorsr as applicable
to your product (s) : (a) documentation of the usefulness of
the active ingredient in Integrated Pest Management, (b)
description of the beneficial impacts on the environment of
use of the active ingredient, as opposed to its registered
alternatives, (c) information on the breakdown of the active
ingredient after use and on its persistence in the
environment, and (d) description of its usefulness against a
pest (s) of public health significance.
Failure to submit sufficient information for the Agency to
make a determination regarding a request for a low volume/minor
use waiver will result in denial of the request for a waiver.
b. Request for Waiver of Data
Option 9, under Item 9, on the Requirements Status and
Registrant's Response Form. This option may be used if you
believe that a particular data requirement should not apply
because the requirement is inappropriate. You must submit a
rationale explaining why you believe the data requirements
should not apply. You also must submit the current label(s)
of your product(s) and, if a current copy of your
Confidential Statement of Formula is not already on file you
must submit a current copy.
You will be informed of the Agency's decision in
writing. If the Agency determines that the data requirements
of this Notice are not appropriate to your product (s) , you
will not be required to supply the data pursuant to section
3 (c) (2) (B) . If EPA determines that the data are required for
your product (s) , you must choose a method of meeting the
requirements of this Notice within the time frame provided
by this Notice. Within 30 days of your receipt of the
Agency's written decision, you must submit a revised
Requirements Status and Registrant's Response Form
• indicating the option chosen.
18
-------
2. Product Specific Data
If you request a waiver for product specific data because
you believe it is inappropriate, you must attach a complete
justification for the request including technical reasons, data
and references to relevant EPA regulations, guidelines or
policies. (Note: any supplemental data must be submitted in the
format required by PR Notice 86-5) . This will be the only
opportunity to state the reasons or provide information in
support of your request. If the Agency approves your waiver
request, you will not be required to supply the data pursuant to
section 3 (c) (2) (B) of FIFRA. If the Agency denies your waiver
request, you must choose an option for meeting the data
requirements of this Notice within 30 days of the receipt of the
Agency's decision. You must indicate and submit the option
chosen on the product specific Requirements Status and
Registrant's Response Form. Product specific data requirements
for product chemistry, acute toxicity and efficacy (where
appropriate) are required for all products and the Agency would
grant a waiver only under extraordinary circumstances. You should
also be aware that submitting a waiver request will not
automatically extend the due date for the study in question.
Waiver requests submitted without adequate supporting rationale
will be denied and the original due date will remain in force.
SECTION IV.
CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products
subject to this Notice due to failure by a registrant to comply
with the requirements of this Data Call-in Notice, pursuant to
FIFRA section 3 (c) (2) (B) . Events which may be the basis for
issuance of a Notice of Intent to Suspend include, but are not
limited to, the following:
1.
2.
3.
4.
5.
Failure to respond as required by this Notice within 90
days of your receipt of this Notice.
Failure to submit on the required schedule an
acceptable proposed or final protocol when such is
required to be submitted to the Agency for review.
Failure to submit on the required schedule an adequate
progress report on a study as required by this Notice.
Failure to submit on the required schedule acceptable
data as required by this Notice.
Failure to take a required action or submit adequate
information pertaining to any option chosen to address
19
-------
the data requirements (e.g., any required action or
information pertaining to submission or citation of
existing studies or offers, arrangements, or
arbitration on the sharing of costs or the formation of
Task Forces, failure to comply with the terms of an
agreement or arbitration concerning joint data
development or failure to comply with any terms of a
data waiver).
Failure to submit supportable certifications as to the
conditions of submitted studies, as required by Section
III-C of this Notice.
Withdrawal of an offer to share in the cost of
developing required data.
Failure of the registrant to whom you have tendered an
offer to share in the cost of developing data and
provided proof of the registrant's receipt of such
offer or failure of a registrant on whom you rely for a
generic data exemption either to:
i. Inform EPA of intent to develop and submit the data
required by this Notice on a Data Call-in Response Form
and a
Form.
Requirements Status and Registrant's Response
ii. Fulfill the commitment to develop and submit the
data as required by this Notice; or
iii. Otherwise take appropriate steps to meet the
requirements stated in this Notice,
unless you commit to submit and do submit the required
data in the specified time frame.
Failure to take any required or appropriate steps, not
mentioned above, at any time following the issuance of
this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted
within the required time) is unacceptable and constitutes a basis
for issuance of a Notice of Intent to Suspend. The grounds for
suspension include, but are not limited to, failure to meet any
of the following:
1) EPA requirements specified in the Data Call-in Notice
or other documents incorporated by reference (including, as
applicable, EPA Pesticide Assessment Guidelines, Data
20
-------
Reporting Guidelines, and GeneTox Health Effects Test
Guidelines) regarding the design, conduct, and reporting of
required studies. Such requirements include, but are not
limited to, those relating to test material, test
procedures, selection of species, number of animals, sex and
distribution of animals, dose and effect levels to be tested
or attained, duration of test, and, as applicable, Good
Laboratory Practices.
2) EPA requirements regarding the submission of protocols,
including the incorporation of any changes required by the
Agency following review.
3) 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
86-5. All studies must be submitted in the form of a final
report; a preliminary report will not be considered to
fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale,
distribution and use of existing stocks of a pesticide product
which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by
registrants of existing stocks for a suspended registration when
a section 3(c) (2) (B) data request is outstanding generally would
not be consistent with the Acfs purposes. Accordingly, the
Agency anticipates granting registrants permission to sell,
distribute, or use existing stocks of suspended product(s) only
in exceptional circumstances. If you believe such disposition of
existing stocks of your product(s) which may be suspended for
failure to comply with this Notice should be permitted, you have
the burden of clearly demonstrating to EPA that granting such
permission would be consistent with the Act. You also must
explain 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, distribution, and
use. Unless you meet this burden, the Agency will not consider
any request pertaining to the continued sale, distribution, or
use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s)
as a response to this Notice and your product is in full
compliance with all Agency requirements, you will have, under
most circumstances, one year from the date your 90 day response
to this Notice is due, to sell, distribute, or use existing
21
-------
stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end
users to sell, distribute or use such existing stocks until the
stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient
for which the Agency has particular risk concerns will be
determined on a case-by-case basis.
Requests for voluntary cancellation received after the 90
day response period required by this Notice will not result in
the agency granting any additional time to sell/ distribute, or
use existing stocks beyond a year from the date the 90 day
response was due, unless you demonstrate to the Agency that you
are in full compliance with all Agency requirements, including
the requirements of this Notice. For example, if you decide to
voluntarily cancel your registration six months before a 3-year
study is scheduled to be submitted, all progress reports and
other information necessary to establish that you have been
conducting the study in an acceptable and good faith manner must
have been submitted to the Agency, before EPA will consider
granting an existing stocks provision.
SECTION V.
REGISTRANTS' OBLIGATION TO REPORT POSSIBiLE
UNKEASONAKLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states
that if at any time after a pesticide is registered a registrant
has additional factual information regarding unreasonable adverse
effects on the environment by the pesticide, the registrant shall
submit the information to the Agency. Registrants must notify the
Agency of any factual information they have, from whatever
source, including but not limited to interim or preliminary
results of studies, regarding unreasonable adverse effects on man
or the environment. This requirement continues as long as the
products are registered by the Agency.
SECTION VI.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and .
procedures established by this Notice, call the contact person(s)
listed in Attachment 1, the Data Call-in Chemical Status Sheet.
All responses to this Notice must include completed Data
Call-in Response Forms (Attachment 2)and-completed Requirements
Status and Registrant's Response Forms (Attachment 3) , for both
(generic and product specific data) and any other documents
required by this Notice, and should be submitted to the contact
person(s) identified in Attachment 1. If the voluntary
cancellation or generic data exemption option is chosen, only the
22
-------
Generic and Product Specific Data Call-in Response Forms need be
submitted.
The Office of Compliance Monitoring (OCM) of the Office of
Prevention, Pesticides and Toxic Substances (OPPTS), EPA, will be
monitoring the data being generated in response to this Notice.
Sincerely yours,
Daniel M. Barolo, Director
Special Review and
Reregistration Division
Attachments
The Attachments to this Notice are:
-i _
2 -
3 -
4 -
5 -
6 -
7 -
Data Call-in Chemical Status Sheet
Generic Data Call-in and Product Specific Data
Call-in Response Forms with Instructions
Generic Data Call-in and Product Specific Data
Call-in Requirements Status and Registrant's
Response Forms with Instructions
EPA Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirements for Reregistration
EPA Acceptance Criteria
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms
23
-------
-------
Attachment 1
Generic and Product Specific Data Call-in Notice
Data Call-in Chemical Status Sheet
-------
-------
Generic and Product Specific Data Call-In
Chemical Status Sheet
for
Boric Acid and its Sodium Salts
INTRODUCTION
You have been sent this combined Generic and Product
Specific Data Call-In Notice because you have product(s)
containing boric acid and its sodium salts; specifically this
Notice covers products containing boric acid, sodium tetraborate
decahydrate (borax decahydrate) , sodium tetraborate pentahydrate
(borax pentahydrate), sodium tetraborate (anhydrous borax),
disodium octaborate tetrahydrate, disodium octaborate
(anhydrous), and sodium metaborate.
This combined Generic and Product Specific Data Call-in
Chemical Status Sheet contains an overview of data required by
this combined notice, and points of contact for inquiries
pertaining to the reregistration of boric acid and its sodium
salts. This attachment is to be used in conjunction with:
• The Combined Generic and Product Specific Data Call-In
Notice (Appendix E),
• The Generic Data Call-In and Product Specific Data
Call-In Response Forms with Instructions (Attachment 2)
• The Generic Data Call-In and Product Specific Data
Call-In Requirements Status and Registrant's Response
Forms with Instructions (Attachments 3),
• EPA's Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirements for Reregistration
(Attachment 4) ,
• The EPA Acceptance Criteria (Attachment 5),
• List of registrants receiving this combined DCI
(Attachment 6), and
• The Cost Share and Data Compensation Forms
(Attachment 7)
Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the data
base for Boric Acid and its Sodium Salts are contained in the
Requirements Status and Registrant's Response Forms. (Attachment
3) . The Agency has concluded that additional data on Boric Acid
and its Sodium Salts are needed for specific products. These
data are required to be submitted to the Agency within the time
frame listed. These data are needed to fully complete the
reregistration of all eligible Boric Acid and its Sodium Salts
products.
-------
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of
Boric Acid and its Sodium Salts, please contact Mario F. Fiol at
(703) 308-8049.
If you have any questions regarding the product specific
data requirements and procedures established by this Notice,
please contact Sue Rathman at (703) 308-8049.
All responses to this Notice for the product specific data
requirements should be submitted to:
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB-0024)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express;
Document Processing Desk (RED-SRRD-PRB-0024)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
-------
Attachment 2
Generic and Product Specific Data Call-in Notice
Data Call-in Response Forms
With Instructions
-------
-------
Instructions For Completing
The
"Data Call-in Response Forms"
For The Generic And Product Specific Data Call-in
INTRODUCTION
These instructions apply to the Generic and Product Specific
"Data Call-in Response Forms" and are to be used by registrants
to respond to generic and product specific Data Call-ins as part
of EPA's Reregistration Program under the Federal Insecticide,
Fungicide, and Rodenticide Act. Ttie type of data call-in
(generic or product specific) is indicated in item number 3
("Date and Type of DCI") on each. form. BOTH "Data Call-in
Response" forms must be completed.
Although the form is the same for both generic and product
specific data, instructions for completing these forms are
different. Please read these instructions carefully before
filling out the forms.
EPA has developed these forms individually for each
registrant, and has preprinted these forms with a number of
items. DO NOT use these forms for any other active ingredient.
Items 1 through 4 have been preprinted on the form. Items 5
through 7 must be completed by the registrant as appropriate.
Items 8 through 11 must be completed by the registrant before
submitting a response to the Agency.
The public reporting burden for this collection of
information is estimated to average 15 minutes per response,
including time for reviewing instructions, searching existing
data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send
comments regarding the burden estimate or any other aspect of
this collection of information, including suggestions for
reducing this burden, to Chief, Information Policy Branch, Mail
Code 2136, U.S. Environmental Protection Agency, 401 M St., S.W.,
Washington, D.C. 20460; and to the Office of Management and.
Budget, Paperwork Reduction Project 2070-0107, Washington, D.C.
20503.
-------
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-in
Item 1. ON BOTH FORMS: This item identifies your company name,
number and address.
Item 2. ON BOTH FORMS: This item identifies the case number,
case name, EPA chemical number and chemical name.
Item 3. ON BOTH FORMS: This item identifies the type of Data
Call-in. The date of issuance is date stamped.
Item 4. ON BOTH FORMS: This item identifies the EPA product
registrations relevant to the data call-in. Please
note that you are also responsible for informing the
Agency of your response regarding any product that you
believe may be covered by this Data Call-in but that is
not listed by the Agency in Item 4. You must bring any
such apparent omission to the Agency's attention within
the period required for submission of this response
form.
Item 5. ON BOTH FORMS: Check this item for each product
registration you wish to cancel voluntarily. If a
registration number is listed for a product for which
you previously requested voluntary cancellation,
indicate in Item 5 the date of that request. Since this
Data Call-in requires both generic and product specific
data, you must complete item 5 on both Data Call-in
response forms. You do not need to complete any item
on the Requirements Status and Registrant's Response
Forms.
Item 6a. ON THE GENERIC DATA FORM: Check this Item if the Data
Call-in is for generic data as indicated in Item 3 and
you are eligible for a Generic Data Exemption for the
chemical listed in Item 2 and used in the subject
product. By electing this exemption, you agree to the
terms and conditions of a Generic Data Exemption as
explained in the Data Call-in Notice.
If you are eligible for or claim a Generic Data
Exemption, enter the EPA registration Number of each
registered source of that active ingredient that you
use in your product.
Typically, if you purchase an EPA-registered product
from one or more other producers (who, with respect to
the incorporated product, are in compliance with this
and any other outstanding Data Call-in Notice), and
-------
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-in
incorporate that product into all your products, you
may complete this item .for all products listed on this
form. If, however, you produce the active ingredient
yourself, or use any unregistered product (regardless
of the fact that some of your sources are registered),
you may not claim a Generic Data Exemption and you may
not select this item.
Item 6b. ON THE GENERIC DATA FORM: Check this Item if the Data
Call-in is for generic data as indicated in Item 3 and
if you are agreeing to satisfy the generic data
requirements of this Data Call-in. Attach the
Requirements Status and Registrant's Response Form that
indicates how you will satisfy those requirements.
NOTE: Item 6a and 6b are not applicable for Product
Specific Data.
Item 7a. ON THE PRODUCT SPECIFIC DATA FORM: For each
manufacturing use product (MUP) for which you wish to
maintain registration, you must agree to satisfy the
data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to
maintain registration, you must agree to satisfy the
data requirements by responding "yes."
FOR BOTH MUP and EUP products
You should also respond "yes" to this item (7a for
MUP's and 7b for EUP's) if your product is identical to
another product and you qualify for a data exemption.
You must provide the EPA registration numbers of your
source(s); do not complete the Requirements Status and
Registrant's Response form. Examples of such products
include repackaged products and Special Local Needs
{Section 24c) products which are identical to federally
registered products.
If you are requesting a data waiver, answer "yes" here;
in addition, on the "Requirements Status and
Registrant's Response" form under Item 9, you must
respond with option 7 (Waiver Request) for each study
for which you are requesting a waiver.
NOTE: Item 7a and 7b are not applicable for Generic
Data.
-------
INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-in
Item 8.
Item 9.
Item 10.
Item 11.
ON BOTH FORMS: This certification statement must be
signed by an authorized representative of your company
and the person signing must include his/her title.
Additional pages used in your response must be
initialled and dated in the space provided for the
certification.
ON BOTH FORMS: Enter the date of signature.
ON BOTH FORMS: Enter the name of the person EPA should
contact with questions regarding your response.
ON BOTH FORMS:
contact.
Enter the phone number of your company
Note: You may provide additional information that does not
fit on this form in a signed letter that accompanies
your response. For example, you may wish to report
that your product has already been transferred to
another company or that you have already voluntarily
cancelled this product. For these casesr please supply
all relevant details so that EPA can ensure that its
records are correct.
-------
Generic
Data Call-in Response Form
-------
-------
Hi
O
V
01
i
t-i
i
o
p- p*
o in a
t-l 0 9
o o w
t} 1 1 -rt
9 O O di
? S p- «
5 0 0 fl
! 7i
z o
B
£ 1 1
^t
O
G
d)
S*
_,
O
4J
Pi
S ° 0
£ ^ o»
CO
_. • M
1i} u S
4-J Q ^p
<1) w *!*
ed States Environn
Washington
DATA CALL-
-P
.,-1
B
1
*H
1
41
f*
O
•s.
4J
to
!
B
1
§
&
B
•H
9
ix
1
O
•d
a
c
A
latruotii
41
1.
I
,
Ink. Please raad carefully th
a
41 0
B a
~H 0
9
8
9 *H
•y "a*
9 41
a 9
5 _»
2 *
m B
§ 5
H 41
B jj
01 9
5 S
M
H
O
9
J?
CJ
c *™~^
o W
9 w
S 1
.
K
4-!
'id
CO
g
•H
O
K
4-i
•ri
*^l
-H §
9 ^^
§ "2
55 •r-I
T3 M •*
S «1
s Si
j? o g
0 0
N
o
o
C/D O
n t/1 O
S wo
S >j Pi
"^ ^^ f^
•e i ^ x
C K? r , *^
* 0 W «
1 w >-•
a w PS H
0 t-3 E-i M
>, P-i CO O
| CO & &
*
a
fl!
0
vl
•3
1
41
O
!
Oi
r»
1 6. Generic Data
"^ ii~
e so
a cu jz jj
Boa
CU G3 4 9
5 41 i e
x: a H i
6 41 -H C
Q 9 d a
« IH'D 9 41
•H n K a
•H a = -H
4> 41 O b>
on *a 9
3 a a 9 a!
T) 41 H
SO C 41 T>' C
41 5 -H B •
Ql § 41 O 9
>,.| 8 « §
S&ia5 a
^ * y 1 5 s
r- H u 14 w o!
T) TJ
e 9 n
a p« A 41
S B §
B 41 a a
S e 41 is »
S * 9 1 i
a "i^S sii
"a dM
4J JJ O 0*
f° S B o a!
o^S^ =
14 4J 9 -H B •
& § 41 Si
e o o 41 9
r- n (4 >« 01 OS
0 1)
-H e -o
M 4) S
3 -3 41 T) .
B B H r
a a S n a
•H a C o B
41 O 41 O
« B
a 41 41 a
9 H fl g -
H " j|-S
fl 41 tj'-H
W 0 0 t 1
41 •
n « te
6a. I am claiming a Generii
Data Ebcemption because 1
obtain the aotiva ingrediei
from the source EPA regis-
tration numbar listed baloi
i i
a d
O -H 3
4J a 51 H
M 9 p
1 H * § »
H §12?
• 4 M f4 Q
U> O &-P JJ
ll
<|
«i
*z^
^
JL
§
0
a
Ok
• B
9 9
41 I
9 3
H 0
|-.3
•d -H
i!
O 9
s a
H -H
s«
hia form and all attachment* i
or misleading •tatement may b>
izad Representative
:. i
Is 1
!!. i
4J -H S «J
4J H
•J l^t .D t-l
4J e < o
« fl O
**f o
9 41 .H H
J3 fl £b 41
§41 JC 04 -H
41 1? E<
•H 41
-H *H ^ M
41 -H o j: 3
«0 H H O 0>
8
*H
-------
-------
Product Specific
Data Call-in Response Form
-------
-------
H
o
H
0)
1C
Pu
X
CM
O
U
EH
Q
§
i
r^>
o
oin co
«-O 01
OO I-
o> oo '5.
o oo ia
«- CM CM
OL • *m
• * 1
t- CO Q.
0 3E £
»- o <:
O
C
0)
tr>
C
O
i
•rt
•P 0
O VO
V
> -H
c x: •
t_
C CO
•- CO
- Ol
H-
4-> CO
CU "S
•a at
u .c
a.
.. CO
I!
Hi
K CD
n 01
E CO
O
H
CM
« H
CJ U
° w
0 w
8.
-ft
_ o
1? D
CD Q
£ O
* CU
ra
rH
(d
3
•H
O
CO
CO
-P
•H
>2
•o
-H
o
-H
5 O
= m
CD
CO O
S o
CNJ
O
O
CO 0
CO 0
s*g°
£ 55 Q
S^S*
§ eu •< x
I 0 EH
" o w ^
£ W X
i W « En
c iJ EH H
£Cui CO U
|3 O O
O t/1 1^4 S
•
a
4-*
CD
U
H-
(j
d
^_,
u
t.
Q-
*""
CD
CD
O
U
t-
cu
c
01
^
ETI
O CO
CD a. jr 4-»
DOC
a_ tu co w
-C CO c_ Z<
c i; — c
CO CU 3 CO
Xj= crt-
CO H- 4-» Ol 4-*
— co a: co
« « § = '5
U CD T3 CD
3 CO. CO CU Q£
-TJ 4^ »
o o c 4J -n =
CU E 4J CO 01
Ol 0) C CO
X 0) t- Ol CO C
• CD O~ t- CO CO
_Q CU O 4-> CV
N- •— £- H- (/) O£
~n cu co
C 0. J= V
CO 3 O C
£L 4-» S CO
=3 0) 4-> 01 -
z x: CD i- 4-i
CD ID 3 CD
XJT D" t-
eo H- v at 4->
••-CO Of CO
4J 4-» O "" O)
O CO "DO)
3 ca to cu ee
o o c *^ "n =
Q. fc 4J CO &
StU £Z OT
= «- £ ™ 3 §
D> 3 E 4-> Q.
• CD O* C- CD CO
CO - 4->
^^ x: 3 co
co 4-> cr—
• 4-> CU D)
_D co c a: ai
000=0:
0 C I
— cu • o
•j ___ rj _to —
Z """ CU 5) J3
0) Ol t- 0)
O CO Ol £- T3
CD CD •"- < 4J
o a. co
J> U (0 3
Ex: c
SCU 4^ CU
x x: c
UI C 4J O
• 4-J 4^ O CO
CO CO -Q £- C.
sO Q 0 -4- 4J
1 1
10 C
O — 3
*-» CO O> — >
-c !c 2 S
CO 4->
•*- fl-» C •
3 — • O O X
_ o -a 4J ^
c o co t-
• CO fi- C. ID
in O :Q- 4-i 4J
u
3 C
T3 O
t- 4J
o (D
C.
a. co
ui •—
D>
• 0)
«4- Q£
S
.
<
^
S
a
H
s
^H
to
o*
4-»
• C
4-* E
QJ C
— ' 0
g- w
o u
g r.
4-* M-
CO
- CD
01 X:
t- -^
4-> C
3
CD 0>
C ra
cu E
E
.C 4J
O £T
(D QJ •
4-» O CJ
ffl 4-» >
(0 •—
— ' CO ID
*D C S
C •— W
(D "D GJ
E^S g.
o "w ^
S— »c—
CO OJ
*•- t_ N
x: o —
-*-• t_
c w ^
(D D
_QJ H- <:
CD X CO
cog . ¥
+-*••- 3 ro
S i 2 g-
EC o
V .^ OJ CJ
4-» — ^
CO > ^2 H-
*-" C CD O
CO CD U
.— o> c
0 4,-g -D CO
M- X— ' 3 O
— >*- 3 t_
J •- 0 Xj 3
5 t- It O CO
o eu o xi c
O CO U)
OD — — O CO
L-
-^
z
cu
^
x:
^
*~
4-f
U
ID
5
u
X
1
u
D
^
fo
2
•
«-
-------
-------
Attachment 3
Generic and Product Specific Data Call-in Notice
Requirements Status and Registrant's Response Forms
With Instructions
-------
-------
Instructions For Completing
The
"Requirements Status and Registrant's Response Forms"
For The Generic and Product Specific Data Call-in
INTRODUCTION
These instructions apply to the Generic and Product Specific
"Requirements Status and Registrant's Response Forms" and are to
be used by registrants to respond to generic and product specific
Data Call-in's as part of EPA's reregistration program under the
Federal Insecticide, Fungicide, and Rodenticide Act. The type of
Data Call-in (generic or product specific) is indicated in item
number 3 ("Date and Type of DCI") on each form. Both
"Requirements Status and Registrant's Response" forms must be
completed.
Although the form is the same for both product specific and
generic data, instructions for completing the forms differ
slightly. Specifically, options for satisfying product specific
data requirements do not include (1) deletion of uses or (2)
request for a low volume/minor use wai-ver. Please read these
instructions carefully before filling out the forms.
EPA has developed these forms individually for each
registrant, and has preprinted these forms to include certain
information unique to this chemical. DO NOT use these forms for
any other active ingredient.
Items 1 through 8 have been preprinted on the form. Item 9
must be completed by the registrant as appropriate. Items 10
through 13 must be completed by the registrant before submitting
a response to the Agency.
The public reporting burden for this collection of
information is estimated to average 30 minutes per response,
including time for reviewing instructions, searching existing
data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send
comments regarding the burden estimate or any other aspect of
this collection of information, including suggestions for
reducing this burden, to Chief, Information Policy Branch, Mail
Code 2136, U.S. Environmental Protection Agency, 401 M St., S.W.,
Washington, D.C. 20460; and to the Office of Management and
Budget, Paperwork Reduction Project 2070-0107, Washington, D.C.
20503.
-------
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-in
Item 1. ON BOTH FORMS: This item identifies your company name,
number and address.
Item 2. ON THE GENERIC DATA FORM: This item identifies the
case number, case name, EPA chemical number and
chemical name.
ON THE PRODUCT SPECIFIC DATA FORM: This item
identifies the case number, case name, and the EPA
Registration Number of the product for which the Agency
is requesting product specific data.
Item 3. ON THE GENERIC DATA FORM: This item identifies the
type of Data Call-in. The date of issuance is date
stamped.
ON THE PRODUCT SPECIFIC DATA FORM: This item
identifies the type of Data Call-in. The date of
issuance is also date stamped. Note the unique
identifier number (ID#) assigned by the Agency. This
ID number must be used in the transmittal document for
any data submissions in response to this Data Call-in
Notice.
Item 4. ON BOTH FORMS: This item identifies the guideline
reference number of studies required. These
guidelines, in addition to the requirements specified
in the Data Call-in Notice, govern the conduct of the
required studies. Note that series 61 and 62 in
product chemistry are now listed under 40 CFR 158.155
through 158.180, Subpart c.
Item 5. ON BOTH FORMS: This item identifies the study title
associated with the guideline reference number and
whether protocols and 1, 2, or 3-year progress reports
are required to be submitted in connection with the
study. As noted in Section III of the Data Call-in
Notice, 90-day progress reports are required for all
studies.
If an asterisk appears in Item 5, EPA has attached
information relevant to this guideline reference number
to the Requirements Status and Registrant's Response
Form.
-------
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-in
Item 6. ON BOTH FORMS: This item identifies the code
associated with the use pattern of the pesticide. In
the case of efficacy data (product specific
requirement), the required study only pertains to
products which have the use sites and/or pests
indicated. A brief description of each code follows:
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
O Indoor residential
Item 7. ON BOTH FORMS: This item identifies the code assigned
to the substance that must be used for testing. A brief
description of each code follows:
EUP
MP
MP/TGAI
PAI
PAI/M
PAI/PAIRA
PAIRA
PAIRA/M
PAIRA/PM
TEP
TEP %
TEP/MET
TEP/PAI/M
End-Use Product
Manufacturing-Use Product
Manufacturing-Use Product and Technical
Grade Active Ingredient
Pure Active Ingredient
Pure Active Ingredient and Metabolites
Pure Active Indredient or Pute Active
Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled
and Metabolites
Pure Active Ingredient Radiolabelled
and Plant Metabolites
Typical End-Use Product
Typical End-Use Productr Percent
Active Ingredient Specified
Typical End-Use Product and Metabolites
Typical End-Use Product or Pure Active
Ingredient and Metabolites
-------
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-in
TGAI
TGAI/PAI
TGAI/PAIRA
TGAI/TEP
MET
IMP
DEGR
*
Technical Grade Active Ingredient
Technical Grade Active Ingredient or
Pure Active Ingredient
Technical Grade Active Ingredient or
Pure Active Ingredient
Radiolabelled
Technical Grade Active Ingredient or
Typical End-Use Product
Metabolites
Impurities
Degradates
See: guideline comment
Item 8. This item completed by the Agency identifies the time
frame allowed for submission of the study or protocol
identified in item 5.
ON THE GENERIC DATA FORM: The time frame runs from the
date of your receipt of the Data Call-In-notice.
ON THE PRODUCT SPECIFIC DATA FORM: The due date for
submission of product specific studies begins from the
date stamped on the letter transmitting the
Reregistration Eligibility Decision document, and not
from the date of receipt. However, your response to
the Data Call-in itself is due 90 days from the date of
receipt.
Item 9. ON BOTH FORMS: Enter the appropriate Response Code or
Codes to show how you intend to comply with each data
requirement. Brief descriptions of each code follow.
The Data Call-in Notice contains a fuller description
of each of these options.
Option 1. ON BOTH FORMS: (Developing Data) I will conduct a
new study and submit it within the time frames
specified in item 8 above. By indicating that I
have chosen this option, I certify that I will
comply with all the requirements pertaining to the
conditions for submittal of this study as outlined
in the Data Call-in Notice and that I will provide
the protocols and progress reports required in
item 5 above.
Option 2. ON BOTH FORMS: (Agreement to Cost Share) I have
entered into an agreement with one or more
registrants to develop data jointly. By indicating
-------
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-in
that I have chosen this option, I certify that I
will comply with all the requirements pertaining
to sharing in the cost of developing data as
outlined in the Data Call-in Notice.
However, for Product Specific Data, I
understand that this option is available for acute
toxicity or certain efficacy data ONLY if the
Agency indicates in an attachment to this notice
that my product is similar enough to another
product to qualify for this option. I certify that
another party in the agreement is committing to
submit or provide the required data; if the
required study is not submitted on time, my
product may be subject to suspension.
Option 3. ON BOTH FORMS: (Offer to Cost Share) I. have made
an offer to enter into an agreement with one or
more registrants to develop data jointly. I am
also submitting a completed "Certification of
offer to Cost Share in the Development of Data"
form. I am submitting evidence that I have made
an offer to another registrant (who has an
obligation to submit data) to share in the cost of
that data. I am including a copy of my offer and
proof of the other registrant's receipt of that
offer. I am identifying the party which is
committing to submit or provide the required data;
if the required study is not submitted on time, my
product may be subject to suspension. I understand
that other terms under Option 3 in the Data
Call-in Notice apply as well.
However, for Product Specific Data, I
understand that this option is available only for
acute toxicity or certain efficacy data and only
. if the Agency indicates in an attachment to this
Data Call-in Notice that my product is similar
enough to another product to qualify for this
option.
Option 4. ON BOTH FORMS: (Submitting Existing Data) I will
submit an existing study by the specified due date
that has never before been submitted to EPA. By
indicating that I have chosen this option, I
certify that this study meets all the requirements
pertaining to the conditions for submittal of
-------
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-in
existing data outlined in the Data Call-in Notice
and I have attached the needed supporting
information along with this response.
Option 5. ON BOTH FORMS: (Upgrading a Study) I will submit
by the specified due date, or will cite data to
upgrade a study that EPA has classified as
partially acceptable and potentially upgradeable.
By indicating that I have chosen this option, I
certify that I have met all the requirements
pertaining to the conditions for submitting or
citing existing data to upgrade a study described
in the Data Call-in Notice. I am indicating on
attached correspondence the Master Record
Identification Number (MRID) that EPA has assigned
to the data that I am citing as well as the MRID
of the study I am attempting to upgrade.
Option 6. ON BOTH FORMS: (Citing a Study) I am citing an
existing study that has been previously classified
by EPA as acceptable, core, core minimum, or a
study that has not yet been reviewed by the
Agency. If reviewed, I am providing the Agency's
classification of the study.
However, for Product Specific Data, I am
citing another registrant's study. I understand
that this option is available ONLY for acute
toxicity or certain efficacy data and ONLY if the
cited study was conducted on my product, an
identical product or a product which the Agency
has "grouped" with one or more other products for
purposes of depending on the same data. I may also
choose this option if I am citing my own data. In
either case, I will provide the MRID or Accession
number (s). If I cite another registrant's data,
I will submit a completed "Certification With
Respect To Data Compensation Requirements" form.
FOR THE GENERIC DATA FORM ONLY; The following three options
(Numbers 7, 8, and 9) are responses that apply only to the
"Requirements Status and Registrant's Response Form" for
generic data.
-------
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific ^Data Call-In
Option 7. (Deleting Uses) I am attaching an application for
amendment to my registration deleting the uses for
which the data are required.
Option 8. (Low Volume/Minor Use Waiver Request) I have read
the statements concerning low volume-minor use
data waivers in the Data Call-in Notice and I
request a low-volume minor use waiver of the data
requirement. I am attaching a detailed
justification to support this waiver request
including, among other things, all information
required to support the request. I understand
that, unless modified by the Agency in writing,
the data, requirement as stated in the Notice
governs.
Option 9. (Request for Waiver of Data) I have read the •
statements concerning data waivers other than low-
volume minor-use data waivers in the Data Call-in
Notice and I request a waiver of the data
requirement. I am attaching a rationale explaining
why I believe the data requirements do not apply.
I am also submitting a copy of my current labels.
(You must also submit a copy of your Confidential
Statement of Formula if not already on file with
EPA). I_understand that, unless modified by the
Agency in writing, the data requirement as stated
in the Notice governs.
FOR PRODUCT SPECIFIC DATA: The following option (number 7)
is a response thai: applies to the "Requirements Status and
Registrant's Response Form" for product specific data.
Option 7. (Waiver Request) I request a waiver for this
study because it is inappropriate for my product.
I am attaching a complete justification for this
request, including technical reasons, data and
references to relevant EPA regulations, guidelines
or policies. [Note: any supplemental data must be
submitted in the format required by P.R. Notice
86-5]. I understand that this is my only
opportunity to state the reasons or provide
information in support of my request. If the
Agency approves my waiver request, I will not be
required to supply the data pursuant to Section
3(c) (2) (B) of FIFRA. If the Agency denies my
waiver request, I must choose a method of meeting
-------
INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-in
the data requirements of this Notice by the due
date stated by this Notice. In this case, I must,
within 30 days-of my receipt of the Agency's
written decision, submit a revised "Requirements
Status" form specifying the option chosen. I also
understand that the deadline for submission of
data as specified by the original Data Call-in
notice will not change.
Item 10. ON BOTH FORMS;
Item 11.
Item 12,
This item must be signed by an
authorized representative of your
company. The person signing must include
his/her title, and must initial and date
all other pages of this form.
ON BOTH FORMS: Enter the date of signature.
ON BOTH FORMS: Enter the name of the person EPA should
contact with questions regarding your
response.
Item 13. ON BOTH FORMS;
Enter the phone number of your company
contact.
NOTE; You may provide additional information that does not
fit on this form in a signed letter that accompanies
this your response. For example, you may wish to report
that your product has already been transferred to
another company or that you have already voluntarily
cancelled this product. For these cases, please supply
all relevant details so that the Agency can ensure that
its records are correct.
-------
Generic
Requirements Status and Registrant's Response Form
-------
-------
f,
O
(
tr
Cl
/
H
m
i
(0
o
r* r-
o in Q
rH O
§p.
ft*
|3J
KS., tta
r* Ifl
O TO
CD O
rrt AI
rti TO
G fib
0
•H TO
-P •>
S ° b
A ^ TO
H * S
nj . H
-P Q S
g j~ B
o £ *
ij ^ 8
j>.S §
G & g
» 1 w
CD *" TO
CO g
CD H
-P t>
H &
D B
1
OJ
-rl
4>
g
1
Q
ID
H
. B
O
-rl
V
S
0
5
ID
rH*
1
Q
1
0
a
§
attached instruct:
JS
^
H
S
g
•0
-1
ID
a
H
P*
•«
3 Q
li O
4 fi
*W
D -H
*i •*•
JJ Dl
—
jj f£]
«J rn
a v-'
en
rH
O
O
Ti rH
-H rH
O 0
m
O S
.T! ^
!B rn o
•a *. -d
|o g I
tN
01
n
2
^
a
i
B
ft
a
.
iH
*
B
4J
n a)
•rl a
Cn B
01
«£
ID
| |
• M
CO b
O
•P B
S 5
EH Q
r- CQ
a
VO O4
n
n
£8 *.
If
HI
CUCSOBOOOrt
JJ
•rl
£4
3
4J
CQ
»
ID
31
I45 s
i* §
•^ iS S
• • *
co ra co
o O o
£ € Ei
CM CM CM
rH H rH
H 14 H
EH 6H EH
O O O
«
i
1 ft 1
H O D*
•O tn
S ? C
> JJ 7"
C -H
0 i) 0
Ol TO rl
•8 0 o
S S1 &
M >. flj
K * *
"iflS"
rH rH CM
m to ro
CM rsi CM
rH rH r-I
0
.
*>
• B
0 ID
« i
rt 0
§••3
5 «
a
1
a true, acourate, i
punishable by fine
u
n
i a
O B
a ID
£ 1 ID
HO «
b> 'B
TIB ID
§3 S
1 -3 1
» « i
•H H N
s ° T!
ID 0
S " -15
0 HI 4J
« i« i§
Ifl »>1 01
t7* !>f
n d • c
il " ^
4J H
M >1 JJ >W
Al C 0 0
ra d o
•rl (P
a -p H H
: J3 a Q, jj
j 4j V a ^
1 10 O rt T3
> X ft> O B
1 -rl 0 X B
• 88°° §i
> r) *rl
H H H O CO
8
s
0
1
cn
,
CO
4J
O
J
^
3
o
:
(0
i,
o
I
1
1
rH
-------
rH
«H
O
rH
<1>
fr
TO
04
fy
§
J"£
flj w
I i
V> g
^ S H
oS §
rj CM |fl
8
^ O EQ
jj * S
"i* Q M
^ |I
I S o
If B
111
„ td
S & |
CO fi
"ffl O
»1
i ^»
s
.
•o
•d "o
•r) (0
rfj O
^^ _ t
o I'M
e -H 1 o
1 O B
"S •* rH
Q HO
HH ^* O O
«
3 C -P -P
nJ 0 | H
•H O O
O (D O O
xi -P o o
M JJ -p
(D 03
rj CO M M
0) 0) 0)
-------
rH
IH
o
v^
r- r- M
o o o a
a. H
| B S
£ 1 51
>i U
O O]
G5S
5S
a) o
(^ A.
rtj 0}
H
C S
0
-H O]
+J
Oi ^ OJ
HO S
/i\ />
I fi I
tes Enviror
Washingto
TS STATUS 1
(0 53
TO S
(D H
-P &
g
if § "2,
S -5
ID 4J O
cn O H
^ '-"5f "P
^ ID to
ra ;> o;
* * *
72
iH rH CM
I 1 1
CO CO CO
CM CM CM
i-H r-{ rH
ID
.p
a
.
1-1
•P
0 0
•s i
H 0
B *H
8|
1-S
.§
a
M >i
§-°
o o
:i
9 n
M -H
41 S
s_«
ad all attachment:
ing statement may
sentative
8-3 S
a u
00 0.
l| 'J
•3 X N
X O -H
* « 8
§ ° £
Q 9
ID ,
me- e
HI |
•P H
a >i^> >-l H
B J3 O Qi 4J
0 .p J3 S H
•H 4J «J El
•P 4J
o a o M TJ
0 J3 Bl 3 C
•rt jj t) TJ a
S t>lr3 § ID
4J >H ^ h
8 3|S 5
I--°< !
rH H 1-1 0 W
h
•i
1
o •
c
o
£
m
1-1
a
jj
c
0
B
IQ
O
"H
0
ID
a
-t
-------
H
«W
O
t-H
-------
rH
1-t
C
c
rt
04
0
o
fa
4
PC!
Q
a\
H
1
o
t- r-
o to tn
rH O IP
O 0 It
•0 1 1 -H
IP o o a,
> t- r- N
0 0 O W
0. N ^ H
S B S,
§, 0 #
*Su ^-**
K*1 m
U GO
A
41
jf
a.
(L
3
1
Q
n
1
»j
0
3
U
1
•s
1 '
u
0
s
1
5f
!
a
o
•d
u
n
-. rt
* xW *
— SiS
fJ:/iQ:
rH>M CM
i x-xtx i
COvZO CO
CMJiCSJ. CM
lHxf-rH
0
1
u
H
•u
- B
•g |
H 0
Qi n
§ f
*• £!
tjj IM
4J c a o
m io u
*H -IP
0 -P H H
B J3 0 Q, V
0 43 J3 Q, -H
j +> 0 H
o to fl) y "^
f-§ §
B
J -H 0 .B 3
J H 5 O a
« o jj 2
O «] Ol
0 MM
•H H H 0 M
tj
S
!
J
CO
1
5
o
1 '
5
p
2
B
CJ
rH
-------
H
ns
•H H
o a.
•H
O CD
Jj j^J
O CD
4J C71
IH CD
a m
-------
rH
0
£
n
CM
PU
o
0
EH
fcl
OH
Q
vo
rt
(*)
1
to
0
c- t-
o to n
iH O (!)
O 0 U
•S 1 1 -rl
ID O O Q,
> r- r- (T
0 o o ei
n eg N
D. H
Q, • M
a >
CM &
0 S Of
6. O «!
^1 u
o m
0) O
o~> Pi
t< CO
G j«
o
•H CO
4-> *
j. *~? 5^
4J »ai 3
£ ^ CO
r-, ' S
H Q O
t} °' ^
s ri" 8
5 C ^
es Enviror
Washingto
S STATUS K
•P 6*
n5 5«
jj m
co 2
3 B
D §
PI
R
3
>n O>
0 ~~
lo <0
&t HH
T3 P^
(8 |ij j f [
(P !_J_
«o
m
CM
rH
rH n
TS rH §
•H rH |
O 0 &
rt! |
t 8 4J
(P j^ g
1 * 1
^t* *
J o s5 3
.
^4
0}
D)
1
Tl
g
(0
a
1
rH
^
S
1 „
•rf n
£ P4
n
o\ o^
1.
• I
00 b
0)
0
•P B
n o
0 JJ
Ei n
••§
r- 01
a) S
n o
JJ
u> cu
m
n
111 «
II
H
CuCiOBOOOKl
4
JJ
£
3
JJ
01
.
to
B4J
•H d
S "3? c
n it)
*s*
(D '4J1 O
tn ;.itf -H
JJ 4-J
to tr> a
S *? 5^
W ^ rt;
* 4c -K
7E
rH r-t CM
1 t 1
ro fo ro
CM iCM CM
rH rH t-H
9
JJ
Q
H
H
4J
,
§ »
(D .C
3 0
H -H
JJ C
a a
,Q
1 all attachments
ig statement may
mtative
•W K IP
CD "o^ C
S» D.
W H ID
on K
•BO -rl
JJ M
if, f
E '&> ^
n B B
c s a a,
1J >i J2 ^
JJ B ffl 0
n a u
-rl ID
IP JJ H H
B J2 to Cti JJ
rl JJ 0 B
1 1ll I
Jj q B
M M 0 X 3
• 8 § ^ §1
O M -H
i-l H H 0 W
Q)
•9
1
1
CO
H
jj
O
10
JJ
1
10
&4
•H
0
ID
t
TH
-------
H
d-d
1 *" —
-------
c
J—
(
fl
Hi
>H
cu
o
o
£"*
fa
r- P- M
0 O O H
M eg oj
8- 3
fit * <8
< 0 !>
a o
R *H
O § "*
Cu O rij
*sj r_^
r^i ED
0 0]
0) O
rji Pi
«! 01
c i
0
•H CO
0 o E»
CM m
, H
iH rj O
(0 . H
G Q *
§ fl" §
0 ®
JJ
|j tn J2
PC P
fcl §
H w i*
flj 09
CO i£
0) *" 03
fd 55
co i
j3
(1) H
H S
0
1
*
o
•8
O
4>
n
0
1
S
C
0
4>
&
0
c
•H
o
£
H
&
ff
n
1
a
01
c
nstructio
attached i:
JS
•p
9
44
S
S
o
(P
^
fl)
a
r?
cu
print in ink.
icaaaary
Vf
8 c
(D 'H
&
>f — -
-P TO
0) 4J
m is
3
O s -t;
-H 1 2
<]J ^ . O
§ O £ (3
» p « 3
TJ Hh 0
g o g 3
N
Q]
n
o
1
|D
rtj
•S
§
1
§
e
c
|
H
C
a
n ID
•H 01
CM
en
EQ
8,8 «
g 8-
H
o.oiof.000^
1
01
to
0)
H §
| 1
^11
,.
ra w ra
o O o
6 fi S
CM ca CM
rH r*t i-l
U it? 0
&* ^f B
u ^ u
.
i
3 X
«jt 'S
i &&
I'M
\ « H
1 4 *
(D ^P O
Ql flj r\
•a « i!
o bi d
W »> fli
* * *
us
^"^ ^^
rS t-l CM
1 t 1
CO CO CO
CM JM CM
ID
4)
«
a
H
JJ
(D a
o 1
H 0
o y
•0 -9
oT -H
0
"1
ll
M -H
4> C
a a
0 0
A
01
1 4.
•£? -P
"a 1
M TO (fl
tfl -P
*d -H n
aj *U o
el §•
,3 IH
4J C OJ 0
M ID
1 lii i
1 rH 3 ID
U H 5 O 0
ffl O o r"
• 0 O &
0 H -H
iH H H O 01
H
ffl
K
ID
0
X
04
n
j
3
5
o
?
3
2j
3
O
}
a
|
H
-------
rH
4H
O
d)
Cr
rt
fc
o1
C5
2.
y
"« cfl
g B
*° i
o o §
•3 S S
£« g
fii 53
r*< jjj
3« |
"HQ H
i - ei
i s s
Ifi
M*
1 1
nj Q
co v
*o S
Q) w
4J *
•rl *
g
t^
4J (d
-H iH
O ft
•H
O 0)
O 0)
P*t G
ft-d
4H §
HUC
C fTJ
0)
(1) 0)
M tfl
•H M
3 itf
(D 1
M C
O
CD a
J-i * *
4J ni n)
«H 03 rH rH
-H M 1 1
4J CO CO CO
CO -H CM CM
3 M rH H
*n
HUM
CO WJ O O
-------
rH
4-1
o
fl
fl
Hi
»
eu
o
o
£_,
r
m
i —
4J TO
ID 4J
rH *
H
1 1
5 -H
-I -p
I 3
H °
1 1
S CD
m CJ3
0
So ^
B M ca
« g LU
£ w
Q ^
m
g
rH 3
T)'~l |
O 0 i
l3J ,§
"^ SB S
rn o
T) * 0
9^, | |
T CM I ^
g 0 1 §
30 g g
*;
a
01
ID
•c
•n
B
a
ID
a
1
B
O
g
U
tH
4,
g
ll
n d)
•H 01
tn c
03 QJ
n
• §
CT erf
1.
CO t,
,s
« §
ID 4J
B 0
t~ CO
, g
g$
4J
• a
U> Qt
P>
n
H
II
O.BSOBOOOH
4J
•§*
3
4J
CO
IO
0>
B -P
rH O
•8 I
•H S M
jfl
W TO CO
0 O O
g fi S
CM CM CM
H H H
EH ?•< tl
0<^ 0
S1
S *
3 j£
111
fl) At O
^ JJ
(D .to |3
05 ^ «i*
to K*- fq;
-iX * *
Si
tH T-» CM
1 i i
CO fO CO
CM ra CM
rH rrt rH
ID
4J
rH
rH
0 §
•8 1
rH O
0 1
a
(f
•P t 01
S *ri ^
n C . c1
*J -H S i3 *i
•p B a o
moo
« -U H H
B j; o a, 4J
o -P x a. -ri
rl JJ O H
•P -P
a « ID » -s
D J3 Ol ffl B
M JJ -0 -8 a
m OB
iH !>iH 3 ffl
•P « * H
H -rl O fl 3
f4J C 4> .P
iH M H 0 01
n
0
1
B
1
^
o
(0
p
c
o
u
0
Q.
44
0
3
i
•H
-------
H
O
H
0)
tT
fCt
CM
o1
^
if»
J-n
«J CO
g 1
Jj S
O 3
d) S P*
•P ^f p
O o oi
•
•H Q H
i - W
11
•H e
2 -H pj
«» g
CO 1:2
..> )!>• v2
jj Ef
co S
73 S
CD u
*"^
CQ
P
O
-8
!
CD
2
o
3
0
o
•d g
-H 3
O -H
rt, T)
O 1 CQ
-H | -H
e H -a Q
Jog
* PQ «
•g » r-
a HO
* <3« g t-J
a o 1 «-«
o o g o
1
g
8
F3
1
GUIDBLI
CD
4J
3
O
-P
M
CD
•d
O
G
•rl •
CQ
CQ CD
CD -rl
•H O
TJ CD
JJ CQ
CQ
-P
4J nJ
•H H
O pi»
x "d
0 CD
_|_t J^
O CD
•P O*
51 S
OiTJ
IH CD
%
CD CD
fc CJi
•H H
&4J
CD 1
0) G
f£j • »
4J 0 — ~
.p nl nJ
^i ^^^ ^>^
m CQ iH rH
4J CQ CO CO
CQ -H CM CM
3 M t-J «-i
•n
1 < 1 ~^ *-^
nJ Q
^•^ ^i^-
i-J r-t CM
III
CO CO CO
CM CM CM
H tH iH
-------
t^-
0
a
cu
H
14
D
H
q
U
t!
3
u>
o
J
CO
1
o
r- c-
o to n
rt 0 ID
O 0 H
•d i i -H
goo ft,
r- r- M
o o o a
M CM CX)
a. rt
<3< O P
K 0
g M
fa 0 I
^t I'll
U 09
a ss
(1) O
(7> 0|
rij 01
U
C tf
0
-H TO
-P ••
1) ^D Z
o S |
_ CN ttn.
_, . H
•H Q O
1°* §
C 0 3
:ates Envirc
Washingt
INTS STATUS
•P M
co S
•o S
0) H
-P t>
f»f ^^|
C itfi
0
rH
1>
m Pj 01
g S 0
8 o o o
*D ^^ 00 £21
«: oo
« SH rH O
. Company name an<
CIBA-GEIG
P.O. BOX
GREENSBOR
rt
•P
g
4J
•rt n
tn fi
(D 0
• S
o> oi
ID
J ffl
•r( (U
•I
CO &
s
y
n a
ip jj
H Q
• •§
r- tn
C
ID u
0] Q)
& -P
u> cu
<«)
a
M H
rt
B-PiOKOOOrf
^5
4J
-H
1
01
U)
. Guideline
aquirement
imber
*"*
w ra ca
0 O 0
S S S
CM 0} CM
rH H rH
H V4 W
3 3 u
H ft EH
.,,,,.
O *J O
§
1 «
•H M S
•3 & *
O rt 41
•^ 0 rt
G S
C
2 *
a >1
and all attaohmen
ading statement ma
resentative
8 ID 0,
M rt O
* "a -g
38 -H
® O
cm Je
O rt 4)
a 3
1^
"-S s 1
c s 5 a
ID 0 rt E
f A: ID o
41 rt
4) C! Id 0
n a u
. Certification
certify that the ,
acknowledge that ,
both undar appli
gnature and Title
O MM
rt H H 0 01
u
8
K
a
o
M
cu
CO
.p
o
10
4>
C
5
Q,
"8
1
CSJ
tH
-------
H
"H
O
H
0)
tn
Iv
rt i
w
O
e
CD
Cn
rtj eo
pj B
o g
t> o 1
CD W) M
•p -^ 3
O ,^^. EJT,-
C3 ^TB
ft« g
,_j ,r
•Sol
| - w
HI
I'll
! 1
CO Ig
Ti ^
J» ^
Jj
•f-4
3
1^
»-J
«
CD n)
4J M
(0 0
g «
•8 «
-p s
CD
§
tf *j
D 1 Ti
•H I O
I (0 I
ffl
3 M CO
t CO t TM
8 VO 1 ,H
g 0 § 0
3
w
g
8
g
GUIDEL1
CD
4J
tf;j
0
-P
CD
•o
O
•H •
CO
CO CD
CD -H
•H O
•O CD
jjj pf
-P CO
CO
•P
.p m
•H H
o di
•H
O CD
-P M
O CD
"•v. r?
fi-S
m a)
o
JJ C
c m
CD
CD CD
a) i
M a
o
(D C
rC * *
4J O -~ — .
** £, O 0
fc -P -P
CD CO
& CO i-l M
CD
-------
Product Specific
Requirements Status and Registrant's Response Form
-------
-------
tr>
\j__j
o
H
0)
(C
04
0«
o
CJ
EH
En
rtj
&
Q
S
i
to
ro
I^N.
oin co
«-O CD
OO C.
d) oo Q.
> b- r*- x
O OO UJ
C- CMCM
Q. — •
Q. • CD
< O >
Z O
"- O 1 W
O W
c *
04
<; co
O"
•H W
-P O »•
0) «* 55
-p o 2
S EH
O4 • CO
ULJ
^n
rH O
(C « W
•P Q PH
C
Q) - Q
g C S5
Cn idi
w ^^
0 -P
H &> CO
._j c !**i
>-H P
C £3
1
CO
c
o
o
E
CO
c
TJ
0)
.C
CD
CD
.S
4-*
-2-
"S
CD
O
•D
CO
CU
CU
CO
CD
O>
a.
c
5 >.
c_
•U CO
C CO
•- VI
j- CD
Q. O
01
g.~
>:~
*J CO
ai 4J
CO CU
CO 0)
s: «
• • CO
g §
2S
ii
3£ CO
» a
" =
^
^
O 53
H 55 *£
H Q Oi
u cj as ~~
0 W I O =*fc
ro 01 Q
0 O4 H
to
(0
-p
rH
CO
g
3
-H
n3
O 53
CO 53
CO 53
•P 55
-H 1
& 55
53
•O 53
'o I
3 s
Or-i
V
a,"H !3
^ CQ &i
•g (1)
«= "*
o C>J rt3
co O PJ
S o w
CM
O
O
co o
CO O
63 O
CO kj J3
CO t^l I-H
2 55 Q
s < Q X
3 04 < x
IOEH
0 ° H >
| W « EH
c K) EH H
^ O< CO O
§< O O
rf\ t^ )^»
CJ UJ « i<5
«~
C
CO
L.
CO Q>
D) Cl
CU O
CO
• CJJ
O B£
il
• f_
CO u.
Q)
O
•W C
CO CD
O 4->
tv o>
c
CU C.
CO CU
4J
• CD
M
CO
O 4-*
C. C. ^j
CL 0£
i.a£Oi— ocjo— j
01
1—
f
CO
in
||
"D §
" f §
"
f
cotB ~ IQ wifliflMcflwininiQ
OO O OOOOOOOOO
gg 'g ggggggggg
COCO CO COCOCOCOOOCOCOCOCO
v'f f
OiO) Oi QjOjO.a.a.Qja.cbci,
W^^ p -i t -4 r 4 f -j t-J }••» t^J f^ t^3 t^
W WWW J34 W W W HH W
gg g ggggggggg
OO O OOOOOOOOO
55g 55 53S355S53555553S
gg g ggggggggg
^X ^X SX KX KX *^ KX KX KX SX NX KX
1 hib 1-3 i-oh)h)h3iDbi-3h)h)
' ' "'
OO O OOOOOOOOO
QQ Q QPQQPQQQQ
UO U CJUCJUOUCJOU
PQ Pfj 0^ pf^ pQ pQ j*Q pn f*Q pQ p^ pn
' - -: -
'
.
,
^
'
o o o o
O - » . w o O
-^ * «.»-*ooooo«>
*~ ^"* «— «— *—«— inmirit/iiri*—
c
o «
••- ttl c
_ w "S ' °
1 8"C ° '5
•p g. 8) C CO CO
g e »* c o w
u — • S •" -^ .5
c-°ac§il>.'~'-a 3
3 •— t_ «•- C4JCO £
Q! 4-ffO M- COCCJ 4-*
O C4-IOJS OCO OE CD c_
BCOICO CO^>..|- *J o
T3 C C <— C- 4-> — M
_ *" *J 0 CO "- >— COO — C
E 4-»CLDCUCOC..r-M-.^- CO >. 'r-
f 3 'Z O O 3 S. -S )tl >. (_ •" .tl .Dl
U "DOC_£_OE— '+J— 'Oolc-co "U
•Q c-S •™""2oc"o^'-§S3:'x
O a. Q a o-u<:c_!a-oaO-o
a.
^
,
'
jtO ^2
-' s-' ^^ , CM <*
rHCM CM rHCOCy^C^Cr)"^r^THTH
II 1 1 1 1 1 1 1 1 1 1
H H H CMCMojconnnntr)
% VO 'E
I_
CD (1)
-Q
CO
-C 4-»
0 C
CO CU
•i-1 E
CD 4-» >
t ^ "^j
— » CO CD
CD W
ro c
•o c: cy
c — w
CO "D *
ta c • c
4-» -F- 3 CD
C 3 CO O.
EC ' o
Cl .^ CU CJ
4-* ^
CD X ^2 M-
4-" C CO O
CO CO O
O 4-> — — '
C .C CO CL -M
o 4J ^ a. —
^- 4J CO >—
co co cu c- -a
O J= D) CU C
•- ** "D "a co
•4- 0) C
•M H- ~3 C.
t. ~- O JS 3
CJ I- -V O CO
CU 0 JO C
• O CO O>
O C- •.-
L.
ja
§
a>
c
JC
.
rO
^
CO
*i
o
CO
o
u
M-
o
CD
5
CM
-------
o
M
Q)
C^
CM
CM
o
O
EH
fa
•3
P-<
Q
•o
<>
i
*•*
f)
i
oin e/i
Oo t-
TJ t t trm
S OO O.
L. CSJCM
$ £ 1
S - R-
° S
*Sj Ffl
S1 to
c a
Q) O
tr. CM
M
C K
O
•H CO
4J O »•
O vo EH
Q) ^j* a
•P o 2
ON K
5-i EH
fl3 • pd
j i /^ p<
c
Q) •• Q
e c a
r1 n S*
M w n4«
O -P
M tr. co
•H C D
>-H Ej
Cf4 ^*<
.C <<
W 10 EH
m co
ra &
0) CO
•P EH
js i
» i
13 K
Q) H
•P D
•H CU
c w
B
^
o
GO
^
o
I
63
t.
c
o
4J
L.
o
4-
C
!
£
&
10
E
CD
CO
S
4-»
U
3
i_
+J
CO
C
^J
.c
u
to
a
63
JC
4-1
£.
i
CJ
CO
u
1
«
-M
0) O
0 0
a> jz
— ' «
a.
• • GJ
CO C
z o
1— .t—
O T|J
Q£ CO
l_
co o
^C CO
S
O S
"S CM a..
l"lffl
"S B a""
01 Q
a K Q
0 CM H
10
l/l
-P
^^
ns
CO
g
3
•H
•O
O *25
co a
a
Wt^
K
•p a
•H 1
13 a
i3 a
-H a
u a
•
o o
•H a
ro O •
03 t?
•g Q)
co pcj
% ^*
0 ™
C
CO
u
•M
CO 01
•^- CO
O) C
cu o
<£ Q-
CO
• CD
oa
1
CD
• C_
CO U.
0)
u
4-> C
CO CD
O *>
h- CA
N^ C/3
C
0) L.
CA CU
• CO
>0 0.
M
CO
cy +•*
o 8.
a. a:
XEKOI— OUO— I
cu
IH
|
in
in
^4,
" c
(U E
22 u
3 .— ^
•Jt C£ ^
, ,
•, --fff
,
f r ^f
'" >. ^
""
^
* • *? •
CO W TO W "
o o o o
CO CO CO CO
- *
^
x^ •* ^^ v
s-,A % %
•. *•
fM CM CM CM ,
&i M iii m
ftpT^"aT
s S § S '
O O O O
^T: JgJ S* tjS
S 5 5 5 •*
§ « S M *
t^j 1-3 f5 1-3
<•. -^ <.
IV. r-r. CfJ* QlJ
JiJ H fa1 pt]
0 Q 'Q Q '
O U O O
CQ CQ fQ 03 .
<; r f
1 V* ,.<• .-
^ ,rv
O O
in in
{M C3 fi O ^
•»^ in .F? >n
v^ ^ ^ x^
^
,L s
. . M *e
', V*»^ §
" » 5
'JI m ' i_
, <" , 1"
>* 4J ^
^ 4J U 3
•— co a
_ •• t- , CU
X •- to at
4i | -g
5 " % a °
^ D) ?ft CO O
5282 ,
Q. O XO c- CU
X *-• r— O 4J
uj co i> o »^ 3
-. <
^
''"'';
^ -V "
""••
%
vo r~» co o
rH H T-l (N ''
} 1 1 1
f) n f) n
V0 VD V0 \O
4^ ", 5,,-J;' ,V '/'%
"* * s. f>$f V"> ^ t^^
'' •. ^' .?' f " 'V ^ '&"$.
"^ ^ ^; r~ /,, ^
,v~ ' * '£[ 'I \ * '
VJ.JV. ^ >,7 <^. ^
,, ^ ' ",' r *
.%- : .XA .-T
mm 01 w tn M
o o o o a o
' eo co aj1 co co co , "
I??5 K ,
^" * - , S/ 1 '
™f %?J Vr, ^
^ ^ •• •!» -m* ^
3 s 3 S
" ,? '' '#"' ,•'"
CM CM CM CM CM CM
PL) PL] jvt pr") [V] PT")
-aTfe CM'CM'&'CM"''''"
s S s s s s
o o o o p o ,
%Zi f^k ^4 «S j^t S
' s S s s s s
«@ 3 «S M
h^ }^ f5 hj h} hj
" C -.-, x, XiJ 1** }Si
% ^ i ] ^-C^ !^
fa fa fa; fa fa fa
W W pL^ ptQ piil P4
Q Q Q Q Q Q
U O O O O U
' P3 03 PQ CQ P3 PP
i< f< •^'^ s^t' ^"v
^ -^-V *S&.. .. ^ w .fyf.
;/!: ^f «% h*&' f"-' >'*
<« *¥, ^ ^ j^ ^
J ^>» _$? 4=g ; ' ^
V ^s '^f- ^* ^ *"^w ^
rt-, *• ^*A* ^"K ?J "" 51 ^*-
/X *» ^^ ^" ^ 'X > -^ '
**^ ^<^ " ^ *A
^X-vC ^/ \ $ ', g ,
fe •v" y "* *
** /"^. •* ff" ^
ff t^1 ^
•• "•- S ^* ' o
-• ^ ^ * o^ o » o ^ w
^ T-^ "Vt c\j «— • st ai
c. , ^ ( <
fc. 4.* *J *j ^ ^
H jR s ij
« ^ i ? i i
£0 * t> C **
L. *• 4-* **— O fll QJ
* i ^ CO X •- -4^ C -M
^ >* ^ t-O-M**-O 0)
U .,- £; •—'•*+ CO QJ
•t— ^ Q t_ N -M
X ^) .A t. — f -P- L.
O CO 4-* *^- 47 4*^ O
§i ^-*'" CW t- CO C
>* «J >^ » ^^
o o *"* o *«I 'c * , !•'
^-.-.O ?-v,<^ -s^J-* ^^ -Vfffi
jv. f ffffm ""X ff
*f ^ f ** ^ .. '** f^ ^
\ f, "%
rH f>5 CO ^1* IA VO
"11 ,t" i j i
f—j t^ f^H ^^ ^J r^
co co co co cb co
^1 jl»
*"
,
x •*
?""•• :: '
/ •»!!•..
• •
en w
.J>V)I
"co ' co
''$$*' ^ f
*J^ ,
If I'J
fi* % i!
J» .* ^ A
f Jt t "
•i >
J V ^ •'
•"x* ,•• ^
/CM CM
=• w w
o o
^ ^ f f
" ' S S
' ''M M
t-j 1-3
i %
ff M ij v
O O
CQ CQ
•O C ** 3 £
C 5 t- (0 CO
CO £ O > Q.
j-j r> fii p
CO C* —I CJ
? ^
LU
\- JJt
^ «? ;• V
>x- v ">
^t !: t
^s%co ^"ro
VJW$ ^ V .1W ^^
OJ " CN
'1 1
in " in
en en
O
CO
'*3 ^
•— 3
- ~
-------
co
H
eu
o
u
EH
fe
<3
tf
Q
yj
T
*—
to
ro
N-f**
oin co
*-o o>
oo c.
s eel
O OO UJ
c. i W
U CO
C 55
0) O
0** P^
<: co
C CM
Q
•H CO
-P 0 «.
Q) -3- JZ
-P O S
^1 |3
CM • CO
Ui_i
n
rH O
•P Q M
C
CD - Q
g C 55
Co 2
v^* r**|
0 -P
J-i cj> W
-H C &
C ,Cj
^.
3
V
5
o
3
I)
*-
11
U
Ol
L
1
C_
4-1 (0
C CO
— CO
- 01
a. u
. x^
J 03
0) 4?
M (U
2J
•0 53
•H 53
«c
O O
o>"H ^
m C\ .
™ u .
PQ &>
•g a)
» O P-i
30 H
CM
o
o
CO O
CO 0
W 0
S»K
Si 55 Q
S < Q X
< ft < X
-s S
10 U W -
i H »
° W tf EH
c i-5 EH H
£•& CO O
§•§ o o
cj "•» S 2-1
-
c
CO
W O
Ol C
O£ f^
CO
C> £^
01
•Is
CO
• c_
CO u.
CO
u
to co
0) 4-«
N- CO
o E
2 4J
• CO
•o a.
03
O> 4->
n> o ^
° g-
Q. a:
3-afOI— OCJO-J
h—
f
CO
in
o
|I
"U v
••-£_£_
o "5 ^
srfl
- - ;-' " -.- , i
* * * •% • •
W (/} CO Dl (00)
0000 00
g g g S g g
CD CO CO CO CO CO
/'
<• ' ' "'>
•> ff
~ , "
., f <
'•
fe--
^ 4^4 fit fof JJ,^ p,j Q.
£c3 £3 £3 jxi (jq pq
o o o o o o
*g .^* g ^4
^< M }< >< fc< W
^
*" -.*• ' '
^ ?""
.-^
•• f
'• f
f
,
• •
co to
0 0
g g
CO CO
*•
'
',
tf
"^•v
pj CU
W W
0 0
s" s
•:
.,
,
,
-"
•-
*"" ' ?
w
•• , ' s.
f f f
^V - <*^V ^** X^
tf\ in tn m in in
<\t CM K* *O "*" -^
*n in tn in in in
•C51 HO O' nO- O O
if* in^ u> in in in
"•. *
%^ v
f
^ « "*»w o '-M j. o "^ £
j__ iff "TJ *O "*O O CO "D *J
•*2 o^' t>J3c5 o ^ita
: U •**- "H- C H+- X|^ C. «|_ t^ ^
W cyj xy c $ o c a. cy c
11 t5l! t5J 2 tS >|
1^|3g2| S|||§J^|
».J35r5S ^t-fljfljsat-tocot.
**H:C?>S'WO>a-*-£o>Q.a.
*r« ffl .Q * "— >
O I-
t- CO CO
J3 > g.
CO O
—1 CJ
CO CO
H t-H
1 1
in in
£
CO
-------
N
ft 1
H-l
O
r-1
Si
rrf
p<
X
Ai
O
O
fe
^
r\
C
Q)
c
0
ates Environmental Protecti
Washington, D. c. 20460
4J
CO
0)
•p
-H
0
w
1
E
W
P5
S
f*&
&.
03Y DEFINATIONS FOR GUIDELI]
m
CO
g
Q
o
o
fe
Ul
H
rft
W3
g
9
•H
CO
'•1
o
•H
M
•o
CQ
O
O
CO
*
13
§
»H*
Q)
U
S CO
i^. CU
c. o
O *•* 3
.-11
3 Q. »
.C >* +•»
*" i n
0 g UJ
i ...
°* ^ *"J
*o to efl
O CD
rovided formulators purchase their active inc
is a 100 percent repackage of another regist
, users are not subject to any data requires
11 active ingredient; PAIRA = "pure" active ir
Q.4J U CU
sl i^-
3 L. CO ~
L. eg eu *-•
Q. t-
T3 TJ t. O
O CU 3 CO
L. CO Q_
O. eo cu
jc cu s:
01 O JC *••
S a*'^
• 5-t- o
O) O
£JS o-§
L. 4-» CO CO
3 O t-
4^ o j: o)
g4"*'-
' 2§J
s "c «fc 'E
'5 «- "c3
H 4J cu eu
C_ H- 4-»
a. cu H-
Z S.^ I,
• • (0 t_i
eu 10 o CD
i -D C 1-
I
•n
H __
O CO
*O 4-1
0 C
O O
H- -Q
CO)
O t—
4J CO O
CO CU O
B- o ?
Ill
UI -3 O
a.
o
u
§•1
L. H-
O C — '
O CD
T3 C O
5 •-
0 CU T3
H- CO CU
o o z
CO 0 O
§•21
< a •-*
111
crop C - Terrestrial nonfood crop D
ential H - Greenhouse food crop I
M - Indoor nonfood N
^2
CU CO
•«- cu
i,
!~g
»*- o
-•£•0
.2 g §
L. M-
4_» o
CO •»- L.
Q> 4-» O
C. CD O
t- 3 T3
£5£
iti
m a -i
CO
°tl
0.8
2-g L.
o c o
•-i O
13 -D
8"§ 3
• • S- 0 0
&•-•£-
M CO 0 _ O C
w CO «- CU
U CU 4J TO
O C. CO •>-
c?fe i-8
s1-*"
U 1 I I
g •* "• *
3 •
»-I
E
Q
UI
^y
s
n
«
Ul
CK
i
H-
VJ
o
UJ
^
1
C/3
umn two (5. Study Title) of the REQUIREMENTS
"o
u
c
•o
eu
L.
CU
«*-
01
c_
O
c
c
'5
o
"o
M-
tU
_c
h-
• •
01
CO
4J
!
o
Regular Chemical
i
S
€
1
a.
o — •
4J CO •
4J — > O TJ
t. C CO TJ "- CU
o i ™ S c £
H- p C 4-* -C 4-»
in c. u E -r: eo E
in o t. — S 4-» J5
v- **- O C- _S 3
• H- 0) 3 CU CO
CO N- C CL CO -C
in >o cu X 4-< cu
«— «— CD o> _a
•*•£-. .Q H-
m H- CD — ' to
eo * o T3 co • £
C 00 C -C T3
0 ^ 10 CO Q) £
'.M *Z co c eo >» eu
o c\j in o 4-» — * ••-
S 1 !P — C CO Tl
eo T— 4: 4J cu C cu
>o u ••— co t—
in >^ 3 TJ o)
C TJ TJ CO CU C
S" eo co t- O)
cu a. c 4J ju
O t- CM — •* — ' E 4*1
•t- a. i ca co o
(M U C 4-> <
CU O1MD CO O C
" eo — • E "5
C 3 4-> 3 0 CU 0)
"~ tj 'E **" c D) co
£- CO — <- •— C «-
CU H— —' CU C •—• O5
5 c s- "c cu — •
c- ra o 3 H- > co
tj O "D C O E
O CO 4-* CU •"• O
• CO C~ W H— CU
M- co o — • ca o 4->
CO ' ••— CO 3
i! co M- o eu cu
a, .— •— 4-> eo T3 .c
TJ e- 4-« o •— co 4->
CU t. C TJ t-
CU 4-> CU O»t-
E_ CO U CO CO O
0 E r_ - . m ~
i, analysis, and certification of ingredients
162, and 158.165 for description of starting
or preliminary analysis (62-1); *158.175 foi
luction process will suffice if the pesticide
:ion and an experimental use permit is sought
I by an integrated system or not, the technici
int of composition of the practical equivalen
isis.
in products proposed for experimental use.
§• M— ^> •!•* u w tu
.,-go 2| §|*|
C/) *> • CL) t— O 4-* CD *>~
O O CD J= Q. E-COOT3
Q_>O in 4-< Q. « eu
O*""*" H- — ' t- JQD)
OCO 0 CD W » i C
in •» o _c T3 co cu
>K-)C|O 0 O4JCD*J^>
.ti «I- '4^ ^ • "S -2 ° cu *eo
4^ >^sO Q. 30) O (O C O
C ^™* vx •*— H- — * * CO .^- — J
o>«- £. ^ o_ ••- c CL
•Oito o t"-
^§^ 5 %-"all-2«2
t-'i^S 'tl eO"-ccocu34j5
^-S - * . £ c ro ° *- ff S •?
§>O^^o£cO'2oC^l O
c^^3)4Jtt1c.S!-oQ-'0
COOCMCOOEOT3— 'CCOCO
.p- -t- ^ eo en C c- — cu ••- •— •—
C "n 4J ^^ O 4^ C- 3 CU
— £ a Etneo^-coo) i-4-'4-<
COCOECOCOC*>-Ct-CCOCOUO
tl>.ooro'cucu"~eo""3Eco-aT3
CU 4J *l t~ {0 f> "U 0) "• CU 4-1 O O
o >p~ 4^ •••• *>~ ••*• O) ^ L. *^ ^ L-
CO C *O § "° -2 •" 5 2! 4J •—
4-S5 O 4-> O CO — ' M- M-
C"DC — '•p-4-»C04J4J«CQ. .^-^
§»r- O CO 4-* ••- CU C I- UJ "O
4j'«!'" p S -2 O.'o C"OO
5 T3 CJ — JO 4-* CO*UC04-*33
^p O eo co Q} eu cu 0 4^ ^ c^ o"
OS D-*U CO< 3«-»4-»H- O>OCJO£o:
«- CM ro -* in CM ro
0
CO
0
E
co
c
4-1
O SO 2
CO
<-» O — •
>o «~ cu
CM C CO
O •— — •
*? T3 4->
«- CU C
O 3 CU
CM eo c.
O CO I-
CM •- 3
E r-,
1^ "O C
»i- L. eo
CO
CO Tl r\
CU CO C/>
C L- CO
CO —'
t> "3 s
30) c_
T3 CU O
O O£ U-
C- =
Q.^J ^
• C- 4->
O CO C
• "O CU
4-> C> 4J
SO 00 CO
§C_ 4^
CO O CO
;r the General Boric Acid Standard issued in
:a of the Boric Acid and Boron Containing Sal
lix G, Attachment C and respond with Option 8
Standard and need only submit a Confidential
•o ra c — i
C O 03 CO
"O — .E
•— CO O 4->
o> e.
cu 4-» x:
*~ 3 W %•
<- TJ 3 Z
O O E
C • 3 CO
4J CO O -^
.2 >.&.§•
D) J2 O
CU O) O
e- T3 C
£ £'>.•-
(_ M-
*J (U CL-^ — '
3^ §•§«
•D eo tr cu
CU CO JC. O
^ - -s '5 §
CU CO CO •-"
B''^ ^» 2 *"
4J O) -M
o
cu
JC
•Jr
o
c
o
.2
§•
o
;»
L.
o
o
CO
•+-
eo
CO
CO
CO
•2 c
1*4?
^
?:i
xS
H- eo
'i "S
> _
c
CO O
o o
E CU
u cu
O CO
Standard and need only submit the attached d
jsts, if needed, for additional documents or
thin 8 mos. of RED issuance.
C- 3 .-
1 Iff
D) "5)
< CU
CO
••- CO CU
(0
OJ (0 CO
ii.sSs
0 1 S-o
>. 0 E CU
O t. CO
c c •*- ••—
oi -^ 3 >
O) D" CU
jance and await t
>: I am currently
specific data r«
je submitting a r
CO 4-1
ill!
CO
CO
(0
jQ
O
c
o
X
L>
O
D)
(!)
CO
U
4V
'o
X
o
1—
CO
CD
^
H-
CO
CO
U
cu
•°
-J
'2
u
•i
o
t-
Q.
CO
u
3
CO
c
CO
-G
•M
CU
CO
2
D)
C_
0
CM
C
10
CO
eo
cu
Q.
0) CO
— -f CO
CO C.
D) O
'«
CO t—
01 e_
CO O
CO CO
CO CD
OJ CU 01
I 11
U CO CO
cu
-------
CVJ
4-1
O
CVJ
0)
(D
CM
CQ
J~^
z M
M _p
•E ^H
B RJ
& g CQ
CM
•—i d
£ |l
<] S Tl
p*1 W
J g w
"u H W
is i*
ss I -
£" § 3
States Environmental
Washington, D. C.
D KEY DEFINATIONS FOR
Name: 0024 Boric Acj
'O 5 f*
ni Wj K
% « *
c w **•
» 0 G)
g 10
^•f r* f \
^j ^j
04 P
fa
O
^
fa
p^
Q
^
•
4J
§
U
^^
(0
0)
1
o
o
fa
^
CD
— E
3 At
." >
4-> .
fc «-
a. =
"o . S
co" "1
to . eo
O) CO
O) • O 4>*
O) C) CO
• fli o -T
4> CO £
^ 3 <»-
o co x:
•i x: cu u
CD -^ .P-
= o • "o .
-2 c.s S
CO H- • C-
Ti ^^ CO D.
CD EC— 4J
x; i_ o o 3
"~ 2 CQ "D en
c ~* 3 ° c
co cu o Q-'Q-
• a! E H- -0 ^
.H 3 fc °. 2 $
CO W O t~ o (U •
•*" CQ DJ W O <0
— ' 4-» -'iCTCOCO
^^ • « O C -^ — '(DC
Xg — '.cJl^OTCU — •§
W^ -r- O tf) (OCJO D)
OC OO~*O= t-'5M~3
D -i-OL. W * 0) O -M CO
W -M O C 0» W -M CO
Ct_ CON-flJ— •CJ'Ot-O)
OZf W O Q* JT -M—^CC'»-C
•^ O • • E >-M O 4-» CD D)O
CO O V COOOU4-JOQ.-MD)<
•»-»t-«)jz j: aj in o) .
&- f- Zf 3 -M C CD *^ *^- C £. £_ O
CO'^CD D) C (R — ' flj (0 O — ^— * •!-» -M CO *J
CO O X i (A tt-O-MOOGCC O C/J
'22^_^E C E^-M3«M^OO-M4-» »W
£- W TO _C D) -CCnO)OUOO)D)D)O)D)V t~ t_ •—..-•*-•.-.,- a) xd*
got. ^ L. inQ.Q.+JMcoo.Q.Q.a.Q.'D
•M CK 4J 33 QJ 4->
COH-CW u •gooo"D"Doooooc<0
*;__c Be -» — . ••-'•o'
C u u -M NN 4^ o ^1 ^3 rf rf ^3 *n ^3 ^3 "D cfl C
-------
-------
Attachment 4
EPA Grouping of End-Use products for
Meeting Acute Toxicology Data Requirements for Reregistration
-------
-------
EPA'S BATCHING OF PRODUCTS CONTAINING BORIC ACID, ANHYDROUS SODIUM
TETRABORATE, SODIUM TETRABORATE DECAHYDRATE. SODIUM TETRABORATE
PENTAHYDRATE. ANHYDROUS DISODIUM OCTABORATE. DISODIUM OCTABORATE
TETRAHYDRATE AND SODIUM METASORATE AS THE ACTIVE INGREDIENTS FOR
MEETING ACUTE TOXICITY DATA REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of
animals needed to fulfill the acute toxicity data requirements for
reregistration of products containing the active ingredients boric
acid, anhydrous sodium tetraborate, sodium tetraborate
pentahydrate, sodium tetraborate decahydrate, anhydrous disodium
octaborate, disodium octaborate tetrahydrate and sodium metaborate,
the Agency has batched products which can be considered similar in
terms of _ acute toxicity. Factors considered in the sorting
process include each product's active and inert ingredients
(identity, percent composition and biological activity), type of
formulation (e.g., emulsifiable concentrate, aerosol, wettable
powder, granular, etc.), and labeling (e.g., signal word, use
classification, precautionary labeling, etc.). Note that the
Agency is not describing batched products as "substantially
similar" since some products within a batch may not be considered
chemically similar or have identical use patterns.
Batching has been accomplished using the readily available
information described above, and frequently acute toxicity data on
individual products has been found to be incomplete. Notwith-
standing the batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an individual product
should the need arise.
Registrants of products within a batch may choose to
cooperatively generate, submit or cite a single battery of six
acute toxicological studies to represent all the products within
that batch. It is the registrants' option to participate in the
process with all other registrants, only some of the other
registrants, or only their own products within a batch, or to
generate all the required acute toxicological studies for each of
their own products. If a registrant chooses to generate the data
for a batch, he/she must use one of the products within the batch
as the test material. If a registrant chooses to rely upon
previously submitted acute toxicity data, he/she may do so provided
that the data base is complete and valid by today's standards (see
acceptance criteria attached) , the formulation tested is considered
by EPA to be similar for acute toxicity, and the formulation has
not been significantly altered since submission and acceptance of
the acute toxicity data. Regardless of whether new data is
generated or existing data is referenced, registrants must clearly
identify the test material by EPA Registration Number.
In deciding how to meet the product specific data
requirements, registrants must follow the directions given in the
-------
Data Call-in Notice and its attachments appended to the RED. The
DCI Notice contains two response forms which are to be completed
and submitted to the Agency within 90 days of receipt. The first
form, "Data Call-in Response," asks whether the registrant will
meet the data requirements for each product. The second form,
"Requirements Status and Registrant's Response," lists the product
specific data required for each product, including the standard six
acute toxicity tests. A registrant who wishes to participate in a
batch must decide whether he/she will provide the data or depend on
someone else to do so. If a registrant supplies the data to
support a batch of products, he/she must select one of the
following options: Developing Data (Option 1), Submitting an
Existing Study (Option 4), Upgrading an Existing Study. (Option 5)
or Citing an Existing Study (Option 6) . If a registrant depends on
another's data, he/she must choose among: Cost Sharing (Option 2),
Offers to Cost Share (Option 3) or Citing an Existing Study (Option
6) . If a registrant does not want to participate in a batch, the
choices are Options 1, 4, 5 or 6. However, a registrant should
know that choosing not to participate in 3. batch does not preclude
other registrants in the batch from citing his/her studies and
offering to cost share (Option 3) those studies.
Table 1 displays the batches for the active ingredients boric acid,
anhydrous sodium tetraborate, sodium tetraborate pentahydrate,
sodium tetraborate decahydrate, anhydrous disodium octaborate,
disodium octaborate tetrahydrate and sodium metaborate.
Table 1.
Batch
1
EPA Reg. No.
239-2529
1624-117
5481-79
9444-129
9444-130
9608-2
10370-81
10370-249
43357-1
45735-1
47006-3
51311-1
64222-1
64745-3
Active Ingredient(s)
99.0% - Boric Acid
100.0% - Boric Acid
95.0% - Boric Acid
100.0% - Boric Acid
99.0% - Boric Acid
99.0% - Boric Acid
99.0% - Boric Acid
99.0% - Boric Acid
99.0% - Boric Acid
98.0% - Boric Acid
99.8% - Boric Acid
100.0% - Boric Acid
99.0% - Boric Acid
99.8% - Boric Acid
Formulation Type
Dust
Granular
Dust
Dust
Dust
Dust
Wet table Powder / Dust
Wettable Powder / Dust
Dust
Dust
Dust
Dust
Wettable Powder / Dust
Granular
-------
Batch
2
3
4
5
EPA Reg. No.
3-1
3941-17
51311-2
54314-1
60038-2
60164-1
63992-1
64396-1
65445-1
65700-1 .
10370-63
44757-3
59111-1
62962-1
66287-1
56-66
499-312
499-327
3324-7
10370-238
47362-3
50039-2
54452-2
55501-1
56667-3
57727-1
58645-1
61282-2
65445-2
475-237
4972-23
9444-131
9444-135
10370-266
Active Ingredient(s)
40.0% - Boric Acid
40.0% - Boric Acid
55.0% - Boric Acid
53.3% - Boric Acid
50.0% - Boric Acid
51.48% - Boric Acid
70.0% - Boric Acid
64.0% - Boric Acid
52.0% - Boric Acid
33.3% - Boric Acid
64.0% - Boric Acid
64.0% - Boric Acid
64.0% - Boric Acid
65.0% - Boric Acid
65.0% - Boric Acid
51.0% - Boric Acid
50.0% - Boric Acid
50.0% - Boric Acid
40.0% - Boric Acid
51.0% - Boric Acid
51.24% - Boric Acid
51.24% - Boric Acid
33.3% - Boric Acid
47.0% - Boric Acid
51.24% - Boric Acid
50.0% - Boric Acid
45.0% - Boric Acid
51.0% - Boric Acid
52.0% - Boric Acid •
2.0% - Boric Acid
6.0% - Boric Acid
5.0% - Boric Acid
5.0% - Boric Acid
5.0% - Boric Acid
Formulation Type
Tablet
Tablet
Bait
Bait
Tablet
Dust
Bait
Dust
Bait
Bait
Dust
Uettable Powder / Dust
Wettable Powder / Dust
Dust
Dust
Liquid / Bait
Liquid / Bait
Liquid / Bait
Liquid / Bait
Liquid / Bait
Liquid / Bait
Liquid / Bait
Liquid / Bait
Liquid / Bait
Liquid / Bait
Liquid / Bait
Liquid / Bait
Liquid / Bait
Liquid / Bait
Bait
Bait
Bait
Bait
Bait
-------
Batch
5 (cont'd)
6
7
8
9
EPA1 Reg. No.
56667-4
64405-2
1624-11
1624-39
1625-125
9444-132
19713-286
44313-19
54089-1
63442-1
64820-1
65382-2
65705-1
66480-2
64405-1
64405-3
64405-4
802-352
7001-292
7001-337
802-563
7001-341
Active Ingredient(s)
5.0% - Boric Acid
5.0% - Boric Acid
98.0% - Disodiun
Octaborate Tetrahydrate
98.0% - Disodium
Octaborate Tetrahydrate
98.0% - Disodium
Octaborate Tetrahydrate
98.0% - Disodium
Octaborate Tetrahydrate
98.0% - Disodium
Octaborate Tetrahydrate
98.0% - Disodium
Octaborate Tetrahydrate
99.4% - Disodium
Octaborate Tetrahydrate
98.0% - Disodium
Octaborate Tetrahydrate
98.0% - Disodium
Octaborate Tetrahydrate
98.0% - Disodium
Octaborate Tetrahydrate
98.0% - Disodium
Octaborate Tetrahydrate
98.0% - Disodium
Octaborate Tetrahydrate
40.0% - Disodium
Octaborate Tetrahydrate
40.0% - Disodium
Octaborate Tetrahydrate
40.0% - Disodium
Octaborate Tetrahydrate
66.5% - Sodium
Hetaborate Tetrahydrate
66.5% - Sodium
Hetaborate Tetrahydrate
66.5% - Sodium
Hetaborate Tetrahydrate
68.0% - Sodium
Hetaborate Tetrahydrate
68.0% - Sodium
Hetaborate Tetrahydrate
Formulation Type
Bait
Bait
Soluble Concentrate / Solid
Soluble Concentrate / Solid
Solid
Soluble Concentrate / Solid
Soluble Concentrate / Solid
Solid
Soluble Concentrate
Soluble Concentrate
Soluble Concentrate / Solid
Wettable Powder
Soluble Concentrate
Soluble Concentrate
Soluble Concentrate
Solution
Ready-To-Use Solution
Granular
Wettable Powder / Dust
Wettable Powder / Dust
Granular
Wettable Powder / Dust
-------
Batch
9 (cont'd)
10
11
12
13
14
15
16
EPA Reg. No.
10827-58
1421-151
1769-82
5905-165
5906-166
9754-7
11440-3
7001-339
7413-3
7001-345
9754-1
1624-1
51708-11
64745-1
1624-94
9444-134
64745-2
Active Ingredient(s)
68.0% - Sodium
Metaborate Tetrahydrate
6% - Sodium Metaborate
18% - Sodium Chlorate
9% Sodium Metaborate
18% Sodium Chlorate
53.84% - Sodium
Metaborate Tetrahydrate
41.04% - Sodium Chlorate
4.22% - Bromacil
55.47% - Sodium
Metaborate Tetrahydrate
41 ..07% - Sodium Chlorate
4. .22% - Bromacil
19.1% - Sodium
Metaborate Octaborate
18.1 - Sodium Chlorate
19.1% - Sodium
Metaborate Octaborate
18.1 - Sodium Chlorate
66.5% - Sodium
Metaborate Tetrahydrate
30.0% - Sodium Chlorate
1.5% - Bromacil
66.5% - Sodium
Metaborate Tetrahydrate
30.0% - Sodium Chlorate
1.5% - Bromacil
8.75% - Sodium
Metaborate Anhydrous
10.3% - Sodium Chlorate
0.41% - Bromacil
10% - Sodium Metaborate
Anhydrous
7.0% - Sodium Chlorate
0.3% - Bromacil
100% - Sodium
Tetraborate Pentahydrate
100% - Sodium
Tetraborate Pentahydrate
100% - Sodium
Tetraborate Pentahydrate
100% - Sodium
Tetraborate Decahydrate
100% - Sodium
Tetraborate Decahydrate
100% - Sodium
Tetraborate Decahydrate
Formulation Type
Uettable Powder / Dust
Soluble Concentrate
Soluble Concentrate
Tablet
Tablet
Soluble Concentrate
Soluble Concentrate
Wettable Powder / Dust
Dust
Soluble Concentrate
Soluble Concentrate
Granular
Granular
Granular
Crystalline
Dust
Soluble Concentrate / Solid
-------
Batch
16 (cont'd)
17
18
EPA Reg. No.
65161-1
66674-1
149-8
3095-47
8383-1
8383-3
8383-7
Active Ingredient(s)
100% - Sodium
Tetraborate Decahydrate
100% - Sodium
Tetraborate Decahydrate
5.4% - Sodium
Tetraborate Decahydrate
5% - Sodium Tetraborate
Decahydrate
0.47% - Sodium
Tetraborate
1.41% - Phenol
0.24% - Sodium Phenate
0.47% - Sodium
Tetraborate
1.41% - Phenol
0.24% - Sodium Phenate
0.47% - Sodium
Tetraborate
1.41% - Phenol
0.24% - Sodium Phenate
Formulation Type
Dust
Wettable Powder / Dust
Bait / Liquid
Bait / Liquid
Ready-To-Use Solution
Ready-To-Use Solution
Towelette
Table 2 lists those products the Agency was unable to batch. These
products were either considered not to be similar to other products
for purposes of acute toxicity or the Agency lacked sufficient
information for decision making. Registrants of these products
are responsible for meeting the acute toxicity data requirements
for each product.
Table 2.
Uribatched Boric Acid, Anhydrous Sodium Tetraborate, Sodium Tetraborate
Pentahydrate, Sodium Tetraborate Decahydrate, Anhydrous Di sodium Octaborate,
Di sodium Octaborate Tetrahydrate and Sodium Hetaborate.
EPA Reg. Ho.
100-479
499-220
690-48
1022-536
1083-1
Active
Ingredients
Simazine
Boric Acid
Sodium Chlorate
Sodium Tetraborate
Copper Naphthenate ..
.. 50.0%
. . 40.0%
.. 5.0%
.. 0.75%
.. 20.0%
.. 49.0%
.. 48.0%
.. 40.0%
.. 18.16%
.. 0.28%
Formulation Type
Pellet / Tablet
Pressurized Dust
Granular
Ready-To-Use Solution
Emulsifiable Concentrate
-------
Unbatched Products (continued)
EPA Reg. No.
1624-3
2869-15
3095-24
4236-8
5887-46
7001-340
7701-34
8020-1
9444-133
10356-16
18910-6
19713-204
19713-206
33436-1
33560-43
44757-4
46196-1
48211-73
49168-1
59977-1
Active Ingredient(s)
Sodium Tetraborate ..
Sodium Metaborate
Tetrahydrate
Sodium Chlorate
Ortho Boric Acid ....
Sodium Tetraborate
Sodium Metaborate
(anhydrous)
Sodium Metaborate ...
Sodium Chloride
Sodium Hetaborate
Tetrahydrate
Sodium Borate
Sodium Chlorate ..
Boric Acid
Boric Acid „.
Di sodium Octaborate,
(Anhydrous)
Boric Acid
Sodium Metaborate ....
Sodium Chlorate .....
Bromacil
Sodium Tetraborate
Pentahydrate
Sodium Chlorate
Bromacil
Boric Acid
Calcium Sulfate,
Dihydrate
Aluminum Sulfate,
Octadecahydrate
Sodium Metaborate ....
Sodium Chlorate
Bromacil
Diuron
Boric Acid
Boric Acid
Sodium Metaborate
Tetrahydrate
Sodium Chlorate
Boric Acid
...100.0%
4 57%
.. 3.11%
. . 4.0%
.. 5.0%
.. 10.0%
. . 7.0%
.. 10.1%
.. 18.5%
. 94 0%
.. 4.0%
.. 11.41%
.. 22.14%
.. 90.0%
.. 20.0%
..100.0%
.. 63.2%
. 50.0%
. 40.0%
. 8.0% .
. 38.8%
. 58.0%
. 2.5%
0 9%
. 74.0%
. 15.9%
. 50.0%
. 40.0%
2 0%
. 2.0%
. 14.72%
. 63.5%
. 66.5%
. 30.0%
. 1.5%
. 74.0%
. 18.0%
Formulation Type
Granular
Soluble Concentrate
Bait
Ready-To-Use Solution
Soluble Concentrate
Soluble Concentrate
Soluble Concentrate
Dust
Pressurized Liquid
Solid Rods
Ready-To-Use Solution
Granular
Pellet / Tablet
Soluble Concentrate /
Solid
Pellet / Tablet
Impregnated Material
Oust
Granular
Dust
Granular
-------
Unbatched Products
EPA Reg. Ho.
62190-9
AL92000300
AL92000400
(continued)
Active Ingredients
Sodium Tetraborate
Decahydrate
Sodium Borate
Didecyl Dimethyl Ammonit
Chloride
26.3%
4.0%
2.0%
2.0%
in
2.0%
Formulation Type
Soluble Concentrate /
Solid
Ready-To-Use Solution
Ready-To-Use Solution
-------
Attachment 5
EPA Acceptance Criteria
-------
-------
SUBDIVISION D
Guideline
Series 61
Series 62
Series 63
Study Title
Product Identity and Composition
Analysis and Certification of Product Ingredients
Physical and Chemical Characteristics
-------
-------
61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1- Name of technical material tested (include product name and trade name, if appropriate).
2- Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each
intentionally-added inert ingredient.
3. Name and upper certified limit for each impurity or each group of impurities present at >_ 0.1% by
weight and for certain toxicologically significant impurities (e.g., dioxins, nitrosamines) present at
9.
Purpose of each active ingredient and each intentionally-added inert.
Chemical name from Chemical Abstracts index of Nomenclature and Chemical Abstracts Service (CAS)
Registry Number for each active ingredient and, if available, for each intentionally-added inert.
Molecular, structural, and empirical formulas, molecular weight or weight range, and any company
assigned experimental or internal code numbers for each active ingredient.
Description of each beginning material in the manufacturing process.
EPA Registration Number if registered; for other beginning materials,
the following:
Name and address of manufacturer or supplier.
Brand name, trade name or commercial designation.
Technical specifications or data sheets by which manufacturer or supplier describes composition,
. properties or toxicity.
_Description of manufacturing process.
Statement of whether batch or continuous process.
Relative amounts of beginning materials and order in which they are added.
Description of equipment.
Description of physical conditions (temperature, pressure, humidity) controlled in each step and
the parameters that are maintained.
Statement of whether process involves intended chemical reactions.
Flow chart with chemical equations for each intended chemical reaction.
Duration of each step of process.
Description of purification procedures.
Description of measures taken to assure quality of final product.
Discussion of formation of impurities based on established chemical theory addressing (1) each impurity
which may be present at >_ 0.1% or was found at >_ 0.1% by product analyses and (2) certain
toxicologically significant impurities (see #3).
-------
62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered. Use a table to present
the information in items 6, 7, and 8.
Does your study meet the following acceptance criteria?
1. Five or more representative samples (batches in case of batch process) analyzed for each active ingredient
and all impurities present at > 0.1%.
2. Degree of accountability or closure > ca 98%.
3. Analyses conducted for certain trace toxic impurities at lower than 0.1% (examples, nitrosamines in the
case of products containing dinitroanilines or containing secondary or tertiary amines/alkanolamines plus
nitrites; polyhalogenated dibenzodioxins and dibenzofurans). [Note that in the case of nitrosamines both
fresh and stored samples must be analyzed.].
4. Complete and detailed description of each step in analytical method used to analyze above samples.
5. Statement of precision and accuracy of analytical method used to analyze above samples.
6. Identities and quantities (including mean and standard deviation) provided for each analyzed ingredient.
7. Upper and lower certified limits proposed for each active ingredient and intentionally added inert along
with explanation of how the limits were determined.
8. Upper certified limit proposed for each impurity present at >_ 0.1% and for certain lexicologically
significant impurities at <0.1% along with explanation of how limit determined.
9. Analytical mediods to verify certified limits of each active ingredient and impurities (latter not required
if exempt from requirement of tolerance or if generally recognized as safe by FDA) are fully described.
10. Analytical methods (as discussed hi #9) to verify certified limits validated as to their precision and
accuracy.
-------
63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered.
Does your study meet the following acceptance criteria?
63-2 Color
Verbal description of coloration (or lack of it)
Any intentional coloration also reported in terms of Munsell color system '
63-3 Physical State
Verbal description of physical state provided using terms such as "solid, granular, volatile liquid"
Based on visual inspection at about 20-25° C
63-4 Odor
Verbal description of odor (or lack of it) using terms such as "garlic-like, characteristic of aromatic
compounds"
Observed at room temperature
63-5 Melting Point
Reported in °C
Any observed decomposition reported
63-6 Boiling Point
Reported in °C
Pressure under which B.P. measured reported
Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25° C
Density of technical grade active ingredient reported in g/ml or the specific gravity of liquids reported
with reference to water at 20° C. [Note: Bulk density of registered products may be reported in lbs/ft3
or Ibs/gallon.]
63-8 Solubility
Determined in distilled water and representative polar and non-polar solvents, including those used in
formulations and analytical methods for the pesticide
Measured at about 20-25° C
Reported in g/100 ml (other units like ppm acceptable if sparingly soluble)
63-9 Vapor Pressure
Measured at 25° C (or calculated by extrapolation from measurements made at higher temperature if
pressure too low to measure at 25° C)
Experimental procedure described
Reported in mm Hg (torr) or other conventional units
63-10 Dissociation Constant
Experimental method described
Temperature of measurement specified (preferably about
20-25°C)
-------
63-11 Octanol/water Partition Coefficient
Measured at about 20-25° C
Experimentally determined and description of procedure provided (preferred method-45 Fed. Register
77350)
Data supporting reported value provided
63-12 pH
Measured at about 20-25° C
Measured following dilution or dispersion in distilled water
63-13 Stability
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined
-------
r
SUBDIVISION F
Guideline
81-1
81-2
81-3
81-4
81-5
81-6
Study Title
Acute Oral Toxicity in the Rat
Acute Dermal Toxicity in the Rat, Rabbit or Guinea
Pig
Acute Inhalation Toxicity in the Rat
Primary Eye Irritation in the Rabbit
Primary Dermal Irritation Study
Dermal Sensitization in the Guinea Pig
-------
-------
81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1- Identify material tested (technical, end-use product, etc).
2. At least 5 young adult rats/sex/group.
3. Dosing, single oral may be administered over 24 hrs.
4.* Vehicle control if other than water.
5- Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mg/kg).
6. Individual observations at least once a day.
7- Observation period to last at least 14 days, or until all test animals appear normal whichever is longer.
8. Individual daily observations.
9. Individual body weights.
10. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
-------
81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 animals/sex/group.
3.* Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
4. Dosing, single dermal.
5. Dosing duration at least 24 hours.
6.* Vehicle control, only if toxicity of vehicle is unknown.
7. Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
8. Application site clipped or shaved at least 24 hours before dosing.
9. Application site at least 10% of body surface area.
10. Application site covered with a porous nonirritating cover to retain test material and to prevent
ingestion.
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
-------
81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1.
2."
11.
12."
13."
_ Identify material tested (technical, end-use product, etc).
Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use
or contains particles of inhalable size for man (aerodynamic diameter 15 jim or less).
_ At least 5 young adult rats/sex/group.
Dosing, at least 4 hours by inhalation.
_ Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
Chamber temperature, 22° C (+2°), relative humidity 40-60%.
Monitor rate of air flow.
Monitor actual concentrations of test material in breathing zone.
Monitor aerodynamic particle size for aerosols.
Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of
respirable substance).
Individual observations at least once a day.
Observation period to last at least 14 days.
Individual body weights.
14. Gross necropsy on all animals.
-------
81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1.
2."
3.
5.
6."
7."
8."
9.*
Identify material tested (technical, end-use product, etc).
Study not required if material is corrosive, causes severe
dermal irritation or has a pH of <2 or Ml.5.
6 adult rabbits.
Dosing, instillation into the conjunctiva! sac of one eye
per animal.
Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or paniculate substance.
Solid or granular test material ground to a fine dust.
Eyes not washed for at least 24 hours.
Eyes examined and graded for irritation before dosing and
at 1, 24, 48 and 72 hr, then daily until eyes are normal
or 21 days (whichever is shorter).
Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
-------
81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1.
2."
3."
4.~
5.
Identify material tested (technical, end-use product, etc).
Study not required if material is corrosive or has a pH of <2 or _>_11.5.
6 adult animals.
Dosing, single dermal.
Dosing duration 4 hours.
Application site shaved or clipped at least 24 hours prior to dosing.
Application site approximately 6 cm2.
Application site covered with a gauze patch held in place with nonirritating tape.
Material removed, washed with water, without trauma to application site.
Application site examined and graded for irritation at 1, 24, 48 and 72 hr, then daily until normal or 14
days (whichever is shorter).
10.
11.* _ Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
-------
81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a
pHof.<2or >.11.5.
3. One of the following methods is utilized:
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehlertest •
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig.
4. Complete description of test.
5.* Reference for test.
6. Test followed essentially as described in reference document.
7. Positive control included (may provide historical data conducted within the last 6 months).
Criteria marked with an * are supplemental and may not be required for every study.
-------
Attachment 6
List of Registrants Receiving this Notice
-------
-------
•o
•H
•O
-H
O
m
o
o i n
H I O
^ ^ ffl
i 3 -o
l*i
. CM
o O
So
co r>
to o>
o co en n co en 04
Iliilllllllllllllllllllllllllll
oooooooooooooooooo
o o
o o
-------
^l" 5
. CM | tH
logo
I
s S i s 1
HOSKrHM
O
Dl
§
I
O
H
Eci
SO
EHO
CUO
aU
B
• rft
3: pa
.S
2 B
O
^
-^
rja
OO
OH
tQtS
HW
o o
PH
Q&4
o
Stao
o>iif)
ooooooooooooooooooooooooooooooo
-------
(•)
o
«
63
g
g
O]
N rtj
1-1 m
10
iH
x 10
O r-
CQ rt
9 § | § §
Is" '
X O CO
O n o
oo t^
_ -. .. co vo tn
O PI o co o w
TO I in c*i to
CO CO
o PJ o !«; x
o 10 CM o o
« 01 <0 CO, CO
g
m
g §
a 3
m 3
§ §
Ei
i
I
?H t^« ^Jt
t~ O
ooooooooooooooooooSoooooooo
-------
W
|Oe
* HO
^ »* S r-t
••» ^4 O T^
. OJ "d H
5 0 1 iH
5 o c o
1
e
jj
«
01
w
ut
o
Q
a
u
i
I
£
1
4>
|
1
O
O
y
a
r^t
1
1
1 i 1 1 I 1 1 1 1 1 1 1
m
Q a § S
Q«j|d§§goeSSH
l^iiiiEiilla
1 1 i 1 1 1 1 I 1 1 1 I
g
sa „„; I
Is 1^1 S^ «>
t28
-------
O
•H
-P
O
G
H
l~i
(0
O
m
Q
0)
3
^
I
CO
i
M
CO
•H
(1)
Pi
H
•a!
o
4J
CO
•H
1
r-
r-j
,—{
0)
•o
_cj
m
-P
a
0)
^.^
r-
O
id
S
0)
•o
•H
O
. S
•H
•a
o
W
a
a 0
g M
0 * °
g -d ffl
E: «
c *0
•» S rH
flj a «^
g 60
a.
•H
N
o
4J
a
4J
ra
as
"
Dl
CQ
ID
1
1
H
a
1
4*
i
S
I
Compan
14
CQ CQ
Q H U
h^ U
O Hi H
» 0 S S
*O O S ft O
N co S O
Cft 0* O O
*_ x S S §
O O H CO
CQ CQ lO H CO
8
01 0 1
O H 2 S
" S H 5
g g a g §
H 2 O 2 H
1 1 i 1 1
O H <
01 H B ° K
sl ill
^3* CO GO CO IO
M r< <0 O •<*
w r- IH r- t-
rH Cft Ol i-l ^f
O 0 O O O
-------
o
•H
4J
O
53
a
H
1
H
H
flS
0
1
0
i
a
z
1
0
n
i
2
!
N O O VD
rt CO 10 O
N n o <-<
m i-i r~ co . . .. .
rt en o m
g
w
1 g
?5 *s! 2
O H H
M 55 o K
O S S H
Z > O g
g
5
P
<
1 i|
^ \o i *
g 04 Ed g
01
rt x B» o
n ** 10 tH
co CM en o
o «> o r-
rt *-l en r*
o o o o
o o o o
-------
•d
-H
s
00
CM
CM
rH
-------
0)
o
•H
•P
O
55
G
H
1
H
rtl
O
"nl
Q
m
a
^
-I
fl
CO
TO
*t*
(3
M
0)
•H
I
tf
H
a
o
4J
01
•H
Hi
CM
1
tH
CO
O
O
CM
H
*""
ro"
rH
O
CM
(0
S
CO
s.
0)
•o
•H
X
O
-H
O
CO
C
. o
I o
§ -8 «
I i
§ HO
» 5 H
« 1 «-«
S I H
5 go
cq
a
4>
o
01
uf
I1
u
a
e
2
^
§
i
•^
|
«
3
I
I
1
>t
a
g
°
iH
CO
u
u
g
1
o
§
s
g
1
I
g
o
1
1
Cu
01
g
o
in
CO
o
o
-------
E
X g
01
to
o
o
§
I
OXen«r-i
•or-r-o
DaCQC— O4r^
r-XXo
CNJ
O
ffl
«S
s
53
<0
ti
M
o
•9
4J
I
1
01
§
3
u
sfe
S J
s
a
j
oo
i"
* CM
al f
04
- m a ^
o VD I rH
3 O g O
ooooooooooooooo
-------
-------
Attachment 7
Cost Share and Data Compensation Forms
and
Confidential Statement of Formula Form with Instructions
-------
-------
&EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB N». 2070-0108
2070-0057
Approval Expire* 3-31-96
Public reporting burden for this coflectlon of information Is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project {2070-0106), Washington, DC 20503.
Please-fid In blanks below.
Company Xante
Company Nnmbar
Product Xome
KPA lt*g. No.
i Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodentlcide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2}(B)(iO) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following flrm(s) on the following
date(s):
NMOT of Firm(«)
D»t* of Offer
Certification:
I certify that I am duty authorized to represent the company named above, and that the statements that I have made on
this form and afl attachments therein are true, accurate, and complete. 1 acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable taw.
Signature of Company'* Authorized R»pr«*»ntaHv«
Dal*
Mam* and Tttte (Pimm Typo or Print)
EPA Form857032 (S/91) BepiacesEPA Fonn*380.waIcKii obaulcfe
-------
-------
SEPA
United States Environmental Protection Agency
Washington, DC 20480
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
OKI N*.
---••—^^™^^™^^«^^^^^^^««»BBB«^B«^^™^iiiifcMiMrfBSifc««^Bi^^^s»Bais^™i^B»B«MBJ^^^M
Public reporting burden for this coOection of information is estimated to avenge 15 minute* per
^S^S^^^S' twitting existing data sources, eatherfng and maintaining the d,
t -.L00^ , Wormaiioa Send comments regarding the burden estimate or any other
^nformation. ineSudJng suggestions for reducing this burden, to Chief. Information PoDcy
t. Paperwo* Reduction Project {2070-OlO(5J.'washington. DC 20503.' **
Please nil In blanks below.
Cocapany Numbvr
BTA tog. »0.
I Certify tnau
1. For each study cited in support of registrattonwweflistrtfion under me Federal Jnse^
RodenScBe Aa (FIFflA) that is an cxdusive use study, I am th« origjr^c^ta submitter, or (have obtained the
nmaawn«3V*
2. That lor each study died in support of registration or reregistratfen under FIFRA that Is NOT an exrtisive use
study. I am ttie original data submitter, or I have obtained the wrinen permission oi the onginai data subrriner. or I
have mUTied n wrting thecornpanyfMs} that submtteddata i have dted and haveofferedie: (a) Pay
compensation tor those data In accordance «»8h sections 3(C)(1J(0) and 3(e){2j(D) of FJFRA: and ft) Commence
negotiation to determine wt.ct, data nr. «Ajed to the compensation reqSement of FIFRA and Ihe aSJo?
compensation due. V any. The companies I haw notified are: (check one)
3.
(J Thecorrpanle* who have submftted the studies Ssted on me back of mis form or attached
sheets, or indicated on the attached Requirements Status and Registrants' Response Form/
^^
reflistratJon or reregistralion under RFRA.
Unu-
JB^L OFFER TO PAY: I hereby oftor and agree to pay compensation to ether persons, with regard ts the
registration or reregistration at my products, to the «stent required &y FIFRA sections 3(cKl)(0) and 3{e)(2)(0).
Datp
ami nita (PIMM Tyf« «r
EM FW
-------
-------
Ul
tu
i
i
I
§
i
a
\
i!
nn
Ir
l Pr
ri
J
e
EnvfroflitMM
Pwifcki* Pro
ithinowaD
l State
8«5'S
IS 'fi
LJJ
£f
§i
of
i
§
I
N
ii"
If!
uc.
«lj
S;
1
Com
> I/M
EPA USE
s
o
I
O
_o
I
S
I
I
9
e
i
i
f
>
i
L
U
-------
Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must
be used. Two legible, signed copies of the form are required.
The following list provides some basic instructions:
a. All the blocks on the form must be filled in and answered
completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of
the responsible party must be provided.
d. All applicable information which is on the product specific
data submission must also be reported on the CSF.
e. All weights reported under item 7 must be in pounds per
gallon for liquids and pounds per cubic feet for solids.
f. Flashpoint must be in degrees Fahrenheit and flame extension
in inches.
g. For all active ingredients, the EPA Registration Numbers for
the currently registered source products must be reported
under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives
and inerts and all common names for the trade names must be
reported.
i. For the active ingredients, the percent purity of the source
products must be reported under column 10 and must be
exactly the same as on the source product's label.
j. All the weights in columns 13.a. and 13.b. must be in
pounds, kilograms, or grams. In no case will volumes be
accepted. Do not mix English and metric system units (i.e.,
pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active
ingredients must represent pure active form.
m. The upper and lower certified limits for ail active and
inert ingredients must follow the 40' CFR 158.175
instructions. An explanation must be provided if the
proposed limits are different than standard certified
limits.
n. When new CSFs are submitted and approved, all previously
submitted CSFs become obsolete for that specific
formulation.
------- |