United States Office of Prevention, Pesticides EPA738-R-95-024
Environmental Protection And Toxic Substances September 1995
Agency (7508W)
&EPA Reregistration
Eligibility Decision (RED)
Asulam
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
V
^ "N~ WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregi strati on eligibility review and decisions on the pesticide chemical case asulam which
includes the active ingredients methyl sulfanilylcarbamate and the sodium salt of methyl
sulfanilylcarbamate. The enclosed Reregi strati on 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 reregi strati on. The RED
includes the data and labeling requirements for products for reregi strati on. It may also
include requirements for additional data (generic) 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 Reregi strati on Division representative,
Jeffrey Billingslea at (703) 308-8004. Address any questions on required generic data to the
Special Review and Reregi strati on Division representative, Karen Jones at (703) 308-8047.
Sincerely yours,
Lois A. Rossi, Director
Special Review
and Reregi strati on Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1 DATA CALL-IN (PCD OR "90-DAY RESPONSE"-If generic data are required for
reregi strati on, 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 provided. 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 REOUESTS-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 Reregistration (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 reregi strati on) separately. You may
delete uses which the RED says are ineligible for reregi strati on. For further labeling
guidance, refer to 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
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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 Data Compensation Requirements. Complete
and sign EPA form 8570-31 for each product.
4 COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
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 PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'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 reregi strati on determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
ASULAM
LIST A
CASE 0265
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
ASULAM REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Estimated Usage of Pesticide 4
D. Data Requirements 4
E. Regulatory History 4
III. SCIENCE ASSESSMENT 5
A. Physical Chemistry Assessment 5
B. Human Health Assessment 7
1. Hazard Assessment 7
a. Acute Toxicity 7
b. Subchronic Toxicity 8
c. Chronic Toxicity and Carcinogenicity 8
d. Developmental Toxicity 9
e. Reproductive Toxicity 9
f. Mutagenicity 10
g. Metabolism 10
h. Neurotoxicity 10
i. Reference Dose 10
j. Other Toxicological Considerations 11
k. Other Adverse Effects 11
2. Exposure Assessment 12
a. Dietary 12
b. Occupational and Residential 21
3. Risk Assessment 22
a. Dietary 22
b. Occupational and Residential 23
C. Environmental Assessment 23
1. Ecological Toxicity Data 23
a. Toxicity to Terrestrial Animals 24
b. Toxicity to Aquatic Animals 27
c. Toxicity to Plants 30
2. Environmental Fate 33
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a. Environmental Fate Assessment 34
b. Environmental Fate and Transport 37
c. Water Resources 45
3. Exposure and Risk Characterization 46
a. Ecological Exposure and Risk Characterization 46
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 54
A. Determination of Eligibility 54
1. Eligibility Decision 55
2. Eligible and Ineligible Uses 55
B. Regulatory Position 56
1. Tolerance Reassessment 56
2. Risk Mitigation 58
3. Endangered Species Statement 60
4. Labeling Rationale 60
a. Worker Protection 60
b. Environmental Hazard 64
c. Spray Drift Advisory 64
V. ACTIONS REQUIRED BY REGISTRANTS 64
A. Manufacturing-Use Products 64
1. Additional Generic Data Requirements 64
2. Labeling Requirements for Manufacturing-Use Products 65
B. End-Use Products 66
1. Additional Product-Specific Data Requirements 66
2. Labeling Requirements for End-Use Products 66
a. Worker Protection 66
b. Environmental Hazard Statements 68
c. Application Restrictions 69
d. Application Rates 69
e. Spray Drift 70
C. Existing Stocks 74
VI. APPENDICES 75
APPENDIX A. Table of Use Patterns Subject to Reregistration 77
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 83
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Asulam 97
APPENDIX D. List of Available Related Documents 117
APPENDIX E 121
PR Notice 86-5 123
PR Notice 91-2 141
APPENDIX F. Combined Generic and Product Specific Data Call-In 147
Attachment 1. Chemical Status Sheets 167
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Attachment 2. Combined Generic and Product Specific Data Call-In
Response Forms (Form A inserts) Plus Instructions 171
Attachment 3. Generic and Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and Instructions
177
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 185
Attachment 5. EPA Acceptance Criteria 189
Attachment 6. List of All Registrants Sent This Data Call-in (insert) Notice
203
Attachment 7. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 205
APPENDIX G. FACT SHEET 215
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ASULAM REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
James Saulmon
Harry Gaede
Gabe Patrick
Environmental Fate and Effects Division
Sharlene Matten
Harry Craven
Larry Liu
Health Effects Division
Jane Smith
Linda Taylor
Steve Funk
Jeffrey Evans
Elizabeth Doyle
Registration Division
Eugene Wilson
Ian Blackwell
Biological Analysis Branch
Economic Analysis Branch
Label Use Information System Staff
Science Analysis and Coordination Staff
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Risk Characterization and Analysis Branch
Toxicology Branch II
Chemistry Branch II - Reregi strati on Support
Occupational and Residential Exposure Branch
Dietary Risk and Evaluation Section
Fungicide-Herbicide Branch
Registration Support Branch
Special Review and Reregi strati on Division
Karen Jones
Linda Propst
Carol Stangel
Office of Compliance
Rick Colbert
Office of General Counsel
Jon Fleuchaus
Reregi strati on Branch
Reregi strati on Branch
Policy, Planning and Operations Branch
Agriculture and Ecosystems Division
Pesticides and Toxic Substances Division
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE Acid Equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e.
drinking water) lifetime exposure at which adverse, non carcinogenic health effects are not
anticipated to occur.
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
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FOB Functional Observation Battery
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA) The HA values are used as informal guidance to municipalities and
other organizations when emergency spills or contamination situations occur.
HOT 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, air or feed, e.g., mg/1, mg/kg or ppm.
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, inhalation). It
is expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
Hg/g Micrograms Per Gram
mg/L Milligrams Per Liter
MOE Margin of Exposure
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
NOEC No effect concentration
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GLOSSARY OF TERMS AND ABBREVIATIONS
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*! The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
SLN Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
FAO/WHO Food and Agriculture Organization/World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
Reregistration Decision
This Reregistration Eligibility Decision document (RED) addresses the reregi strati on
eligibility of the pesticide asulam (methyl sulfanilylcarbamate) and sodium salt of asulam
(sodium salt of methyl sulfanilylcarbamate). The risk assessments and data requirements in
this document that refer to asulam also include the sodium salt of asulam.
Based on the reviews of the generic data for the active ingredients asulam and its
sodium salt, the Agency has reviewed information on the health effects of asulam and its
sodium salt and on its potential for causing adverse effects in fish and wildlife and the
environment. Based on this information, the Agency concludes that products containing
asulam for the registered uses on Christmas tree plantations, ornamentals, turf, and non-
cropland will not cause unreasonable risk to humans or the environment, and are eligible for
reregi strati on. However, at this time, the Agency is unable to make a reregi strati on eligibility
decision for the use of asulam on sugarcane.
Residue data submitted for reregi strati on showed that sugarcane concentrates in the
processed feed commodity, blackstrap molasses. Under the Delaney clause of the Federal
Food, Drug, and Cosmetic Act (FFDCA), the Agency may be barred from establishing a feed
additive regulation (tolerance) for blackstrap molasses because asulam may be found to be an
animal carcinogen within the meaning of the Delaney clause. The Agency has committed to
revoking the underlying raw agricultural commodity tolerance where food/feed additive
tolerances have been established or need to be established but cannot because of Delaney. As
part of a settlement agreement in a recent lawsuit, the Agency agreed to complete these
revocations by the year 2000. During the 5 years before final revocation, the Agency believes
it is important to amend the existing raw agricultural commodity tolerance on sugarcane to
reflect new residue data. The Agency will also establish new meat, milk, and meat by-
product tolerances. Current residue data suggest the existing tolerance should be raised to 15
ppm from 0.1 ppm. However, the registrant is submitting further additional data reflecting
longer PHI's and more accurate timing of applications which will likely result in a tolerance
level lower than the 15 ppm. After reviewing these data, the Agency will establish a new
sugarcane tolerance and require the registrant to petition for new meat, milk, and meat by-
product tolerances. These actions will prevent possible overtolerance situations and should
reduce any public confusion regarding dietary risks associated with a crop or commodity
seizure.
In addition, the Agency will also review blackstrap molasses as part of its new policy
regarding implementation of Delaney that was recently published in the Federal Register as a
response to the National Food Processors Association petition (June 14, 1995; 60 FR 31300).
The Agency will determine if blackstrap molasses is "ready-to-eat" as an animal feed. If
dilution with other feed items is necessary before animal consumption, and subsequent
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dilution lowers the level of asulam in the diluted feed mixture to the level of the raw
agricultural commodity tolerance, then a processed feed tolerance will not be necessary.
Then the new sugarcane tolerance and new meat, milk and meat by-product tolerances will
not be revoked.
Asulam exceeds the levels of concern (LOCs) for endangered and non-endangered
terrestrial and semi-aquatic plants for all uses. For non-cropland uses, asulam exceeds LOCs
for endangered and non-endangered aquatic plants. In addition, asulam exceeds the level of
concern for ground water and the Agency also has some moderate concerns regarding surface
water. The Agency is requiring additional environmental fate and ecological effects data to
confirm the environmental and ecological risk assessment for all uses of asulam.
Several risk mitigation measures are being required for asulam. These measures
include the following:
- prohibiting the aerial uses of asulam for non-cropland and Christmas trees use sites
- clarifying the non-cropland use to limit 1 gallon/A rate, 1 application/season
- clarifying the Christmas tree uses to limit 1 application/season
- clarifying the turf use to limit use to state sod farms only and 1 application/season
These risk mitigation measures would reduce the amount of asulam entering the
environment. Based on asulam's potential to contaminate surface water and to leach to
ground water, the Agency is requiring a ground water label advisory and a surface water
advisory for all asulam product registrations. Also, long term monitoring is necessary in and
near areas where asulam is used. In addition, the registrant is required to clarify the
environmental fate assessment methodology and the uncertainty associated with the extraction
technique and recovery of asulam from the laboratory versus the field studies.
Background Information
Asulam (methyl sulfanilylcarbamate) is a selective postemergent systemic carbamate
herbicide registered for the control of a variety of annual grasses and broadleaf weeds on
sugarcane, Christmas tree plantations, ornamentals, turf (St. Augustinegrass and
Bermudagrass) and non-cropland uses (boundary fences, fencerows, hedgerows, lumberyards,
storage areas and industrial plant sites, and warehouse lots). Sugarcane is the major use site
for asulam. The registered modes of application are aerial or ground spray, broadcast, band,
and spot treatment. The only end-use formulation of asulam is the sodium salt of asulam
(sodium salt of methyl sulfanilylcarbamate) which is formulated as soluble concentrate/liquid
(36.2% a.i.) There are currently 3 end-use products and 1 technical product registered for
asulam.
Asulam was initially registered as a pesticide in 1975. Technical asulam is currently
being produced in England by Rhone-Poulenc Inc. A Registration Standard for Asulam was
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issued in December 1987 (NTIS# PB88-168588). The Registration Standard summarized
available data supporting the registrations of products containing asulam. The Registration
Standard also required the submission of product chemistry, residue chemistry, toxicology,
ecological effects and environmental fate studies.
In 1989, Rhone-Poulenc voluntarily deleted the ditchbank use of asulam; therefore,
data for the ditchbank use required in the 1987 Registration Standard to support an aquatic
nonfood industrial use pattern are no longer required. In 1991, a Data Call-In (DCI) was
issued for asulam requiring the submission of neurotoxicity, plant protection, animal feeding,
dermal mixer/loader exposure and inhalation mixer/loader exposure studies. This RED
reflects a reassessment of all data that were submitted in response to the Registration Standard
and the subsequent DCI.
Supporting Rationales for Reregistration Decision
• Health Effects
Asulam is classified as Category IV for acute oral toxicity, acute inhalation toxicity
and primary dermal irritation; Category III for acute dermal toxicity and primary eye
irritation. Asulam is also a nonsensitizer. The Agency classified asulam as a Group C,
possible human carcinogen, based on thyroid and adrenal tumors in the rat study. The
Agency has decided not to quantify the carcinogenic risk by low dose linear extrapolation.
The Reference Dose (RfD) is 0.36 mg/kg/day based on a chronic dietary feeding study
in rats. The No Observed Effect Level (NOEL) in this study was 36 mg/kg/day, based on
thyroid follicular hyperplasia at 180 and 953 mg/kg/day. An uncertainty factor of 100 was
used to account for inter-species extrapolation and intra-species variability. The chronic
dietary exposure to the general population is expected to be 3.85% of the RfD. Of the
standard subgroups analyzed by the Dietary Risk Evaluation System (ORES), the exposures
for the two highest exposed subgroups, children (1-6 years old) and non-nursing infants (<1
year old), are 3.48 x 10"2 and 2.64 x 10"2 mg/kg body weight/day, respectively. These
exposure values represent 9.7% and 7.3% of the RfD, respectively. Therefore, the Agency
does not have concern for chronic dietary exposure to asulam since the RfD is not exceeded
for either the general population or any subgroup.
The Agency does not have concerns for developmental or reproductive toxicity
associated with oral exposure to asulam. There is no acute dietary toxicological endpoint of
concern (the NOEL in the developmental toxicity study in rats is 1000 mg/kg/day). There is
no toxicological endpoint of concern for short term or intermediate term occupational or
residential exposure (the NOEL in the 21-day dermal toxicity is 1000 mg/kg/day). Therefore,
neither an acute dietary risk assessment nor a short term or intermediate worker exposure or
risk assessment was performed.
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The Health Effects Division (HED) Metabolism Committee determined that although
the metabolites hydroquinone/quinone are of toxicological concern, these compounds are
naturally occurring plant constituents and the levels of hydroquinone/quinone present in the
treated sugarcane, cane sugar, and molasses may not represent a significantly different risk
than naturally occurring levels of hydroquinone/quinone. The residues for regulation and risk
assessment are the parent compound, asulam, and all metabolites containing the sulfanilamide
moiety.
The qualitative nature of asulam residue in plants, ruminants, and poultry is adequately
understood. The Agency is requiring a new plant metabolism study on sugarcane to confirm
the levels of hydroquinone and quinone contributed to the existing background levels
resulting from the use of asulam.
Previously submitted crop field trial data indicate that residues in excess of tolerances
(15 ppm) occur in/on sugarcane following treatment at the maximum registered rates. The
registrant has committed to supporting a lower tolerance for sugarcane based upon lower
application rates and longer PHI's which would change the tolerance to a level lower than 15
ppm but greater than 0.1 ppm. Residue data submitted for reregi strati on showed that
sugarcane concentrates in the processed feed commodity, blackstrap molasses. A feed
additive regulation for residues of asulam in blackstrap molasses is needed. However, under
the Delaney clause of the Federal Food, Drug, and Cosmetic Act (FFDCA), the Agency may
be barred from establishing a feed additive regulation (tolerance) for blackstrap molasses
because asulam may be found to be an animal carcinogen within the meaning of the Delaney
clause. The Agency has committed to revoking the underlying raw agricultural commodity
tolerance where food/feed additive tolerances have been established or need to be established
but cannot because of Delaney. The Agency also is establishing new meat, milk, and meat
by-product tolerances.
A confined rotational crop study utilizing radiolabeled asulam is required (GLN 165-
1). The study is essential to determine the nature of the residue in secondary crops and to
determine total residue levels at various plantback intervals. The presence/absence of
quinone and hydroquinone in the radiolabeled residue must be established.
• Occupational and Residential Exposure
There is the potential for handler (mixer/loader/applicator, etc.) exposure and post-
application exposure for the usual use-patterns associated with asulam; however, there are no
toxicological endpoints of concern for the short to intermediate term occupational exposure.
There are no residential uses for asulam; therefore, no exposure or risk is expected from
asulam to homeowners.
The Agency is requiring a restricted entry interval (REI) of 12 hours for uses within
the scope of the WPS. This 12 hour REI is the minimum acceptable REI for asulam. There
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are no special toxicological concerns about asulam that warrant the establishment of active-
ingredient-based minimum personal protective equipment (PPE) requirements.
• Environmental Fate
The environmental fate assessment is considered preliminary because of contradictory
data. Although there is a lack of acceptable terrestrial field dissipation data, the Agency has
concerns about the integrity of data for key laboratory studies. Based on supplemental data, it
appears that asulam is highly mobile and has a strong potential to leach into ground water or
move offsite into surface water. Also, based on available data (including those from
unreliable studies), asulam has the following characteristics: 1) highly to very highly soluble,
2) stable in water without light, 3) unstable in water and on soil under light; however, small
amounts of asulam were detected in surface water, 4) relatively unstable in soil under aerobic
conditions, 5) very stable in soil and sediment under anaerobic conditions, 6) very mobile in
soil, 7) not volatile, and 8) does not accumulate in fish.
The Agency is requiring additional storage stability data (aerobic soil metabolism and
anaerobic soil/aquatic metabolism) to validate the results of the laboratory studies and to
assess the need for the field dissipation study. In addition, a groundwater label advisory and a
surfacewater label advisory are required. Due to concerns about the off-target damage by the
aerial application of asulam, spray drift data (droplet size spectrum and drift field evaluation)
and a label advisory are also required.
• Ecological Effects
Technical asulam is practically nontoxic to freshwater fish and slightly toxic to
freshwater invertebrates. Also, asulam is practically nontoxic to estuarine/marine species,
honeybees, and small mammals. Chronic effects to avian species and aquatic invertebrate
cannot be fully assessed due to lack of adequate data. However, based on the overall low risk
asulam poses to aquatic and avian species, the Agency does not expect that asulam will pose a
high chronic risk to aquatic invertebrates or avian species. The Agency is requiring a
confirmatory aquatic invertebrate life cycle study. The Agency is not requiring avian
reproduction studies due to the extremely short photolytic half-life (approximately 2 hours)
and in acute studies, the practically non-toxic nature of asulam to birds and mammals.
Levels of concern from all uses of asulam have been exceeded for endangered and
non-endangered terrestrial and semi-aquatic plants. For non-cropland uses, asulam exceeds
levels of concern for endangered and non-endangered aquatic plants. Risk to nontarget plants
cannot be assessed due to the lack of adequate data. High risk to nontarget plants is likely,
based on the herbicidal properties of asulam. The Agency is requiring additional
phytotoxicity data to complete the nontarget plants risk assessment for asulam.
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In summary, based on the information currently available to the Agency, all uses of
asulam are eligible for reregistration, with the exception of sugarcane. Furthermore, the
Agency is requiring that additional confirmatory data be submitted to fulfill the generic data
requirements for reregistration of asulam.
Acute Aquatic Invertebrate Toxicity - Daphnia magna
Aerobic Soil Metabolism
Anaerobic Soil and Aquatic Metabolism
Droplet Size Spectrum
Drift Field Evaluation
Directions for Use - Label amendment (lower application rate and/or longer PHI)
Plant Metabolism Study
Magnitude of Residue - Sugarcane
Confined Rotational Crop
After reviewing additional field trial data for sugarcane, the Agency will establish a
new sugarcane tolerance and require the registrant to petition for the new meat, milk, and
meat by-product tolerances.
Certain data are not part of the reregistration target database for asulam, but
are also required:
Seedling emergence - soybeans and radish
Vegetative vigor - cucumber and onion
Before reregistering the products containing asulam, the Agency is requiring that
product specific data, revised Confidential Statements of Formula (CSF) and revised labeling
be submitted within eight months of the issuance of this document for all products containing
asulam. The product specific data include product chemistry for each registration and acute
toxicity testing. After reviewing all these data and any revised labels and finding them
acceptable in accordance with section 3(c)(5) of FIFRA, the Agency will reregister a product.
However, those products which bear uses of this or any other active ingredients which have
not been determined to be eligible for reregistration will be reregistered only when such uses
and active ingredients are determined to be eligible for reregistration.
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregi strati on of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregi strati on process to be
completed in nine years. There are five phases to the reregi strati on process. The first four
phases of the process focus on identification of data requirements to support the reregi strati on
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 reregi strati on.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregi strati on" before
calling in data on products and either reregistering products or taking "other appropriate
regulatory action." Thus, reregi strati on 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 reregi strati on eligibility of
the registered uses of asulam. The document consists of six sections. Section I is the
introduction. Section II describes asulam, its uses, data requirements and regulatory history.
Section III discusses the human health and environmental assessment based on the data
available to the Agency. Section IV presents the reregi strati on decision for asulam. Section
V discusses the reregi strati on requirements for asulam. Finally, Section VI is the Appendices
which support this Reregi strati on Eligibility Decision. Additional details concerning the
Agency's review of applicable data are available on request.
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II.
CASE OVERVIEW
A.
Chemical Overview
The following active ingredients are covered by this Reregi strati on Eligibility
Decision:
Common Name:
Chemical Name:
Chemical Family:
CAS Registry Number:
OPP Chemical Code:
Empirical Formula:
Trade and Other Names: Asulox®
Basic Manufacturer: Rhone Poulenc
Asulam
Methyl sulfanilylcarbamate
Carbarn ate
3337-71-1
106901
C8H10N204S
Common Name:
Chemical Name:
Chemical Family:
CAS Registry Number:
OPP Chemical Code:
Empirical Formula:
Basic Manufacturer:
Sodium salt of asulam
Sodium salt of methyl sulfanilylcarbamate
Carbarn ate
2302-17-2
106902
C8H9N2NaO4S
Trade and Other Names: Asulox®
Rhone Poulenc
B.
Use Profile
The following is information on the currently registered uses with an overview
of use sites and application methods. Technical asulam is a formulating use only
product. A detailed table of these uses of asulam and its sodium salt is in Appendix A.
For asulam and its sodium salt:
Type of Pesticide:
Herbicide
Use Sites: Terrestrial Food + Feed Crop
Sugarcane
Terrestrial NonFood Crop
Christmas tree plantations; industrial areas (outdoor);
nonagricultural uncultivated areas/soils; rights-of-
-------
way/fencerows/ hedgrerows; ornamental and/or shade trees;
ornamental lawns and turf; ornamental woody shrubs and vines
Target Pests: fern: western brackenfern; broadleaves: marestail,
horseweed; grasses: alexandergrass, barnyardgrass,
broadleaf panicum, bullgrass, crabgrass, foxtail,
goosegrass, itchgrass, johnsongrass, paragrass, sandbur
Formulation Types Registered:
Single active ingredient (asulam)
86.4% a.i. technical (manufacturing-use product)
Single active ingredient (sodium salt of asulam)
36.2% soluble concentrate/liquid
Method and Rates of Application:
Sodium salt of asulam (Soluble concentrate/liquid)
Apply to sugarcane as broadcast, band, or spot treatment with ground
equipment or broadcast by air at 3.34 Ib active ingredient (AI)/A. Apply to
Christmas trees as a delayed dormant spray with air or ground equipment at
3.34 Ib (AI)/A. Apply to ornamental and/or shade trees or ornamental woody
shrubs and vines as a postemergence ground broadcast at 3.34 Ib (AI)/A.
Apply to ornamental lawns and turf as a postemergence spray with ground
equipment at 2.088 Ib (AI)/A. Or, apply to industrial areas (outdoor),
nonagricultural rights-of-way/fencerows, or nonagricultural uncultivated areas
when needed as spray with ground equipment at 3.34 Ib (AI)/A or as spot
treatment at 6.68 Ib (AI)/A.
Use Practice Limitations:
Asulam
Do not discharge into lakes, streams, ponds, or public waters unless in
accordance with an NPDES permit.
Sodium salt of asulam (Soluble concentrate/liquid)
Do not apply through any type of irrigation system. Do not feed treated foliage
to livestock or graze treated areas. Do not treat within 90 days of harvest.
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C. Estimated Usage of Pesticide
This section summarizes the best estimates available for the pesticide uses of
asulam. These estimates 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.
The table below summarizes the pesticide's use.
Estimates of Typical Annual Usage of Asulam As of 5/95
State
Florida
Florida
Louisiana
Texas
Crop
Sod
Sugarcane
Sugarcane
Sugarcane
Total
Acres Treated
14,986
265,800
52,500
3,930
337,216
Percent
Crop
Treated
30
60
14
10
...
Lbs A.I.
Applied
29,971
576,786
113,925
5,895
726,577
Rate
(Ibs ai
per year
per acre)
2.00
2.17
2.17
1.50
...
Source: EPA information and National Ctr. Data
D. Data Requirements
Data required in the 1987 Registration Standard for Asulam include studies on
product chemistry, residue chemistry, toxicology, ecological effects and environmental
fate. These data were required to support the uses listed in the Registration Standard.
Appendix B includes all data requirements identified by the Agency for currently
registered uses needed to support reregi strati on.
E. Regulatory History
Asulam was first registered under the Federal Insecticide, Fungicide and
Rodenticide Act on October 24,1975. The technical product contained 96.0% asulam,
methyl sulfanilyl carbamate. The product label was revised to reflect only 86.4%
asulam on July 14,1982 which resulted from extracting almost 10% of the water in the
technical product. This technical product is presently registered and used for
formulation of two end-use products: Asulox Herbicide (EPA Registration No.
264-447) and Asulam Liquid Herbicide (EPA Registration No. 64764-3), both
products bear ingredient claims that are identical, and reflect 36.2% sodium salt of
asulam.
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The Agency issued a Registration Standard under the title of "EPA Guidance
for the Reregi strati on of Pesticide Products Containing Asulam as the Active
Ingredient" dated December, 1987. In that document the Agency listed the required
data for continuing the registration of registered pesticide products that contained or
were derived from asulam. The time lines for submitting the required data to continue
the registration of these products were stated in that document. Both product specific
and product generic data were identified if required and the date lines for submitting
the data were listed.
In the Asulam Registration Standard (RS) labeling amendments for bringing all
asulam products into compliance with existing labeling policy of the Agency at the
time of issuance of the RS were required.
On February 17,1988, the Agency's Health Effects Division Carcinogenicity
Peer Review Committee (HED-CPRC) classified asulam as a Group C, possible
human carcinogen based on adequate studies in two animal species. A second mouse
study was submitted in 1993. In October 1994, the Committee again reviewed the
data, including this mouse study and concluded that the new study would not impact
on the classification of asulam as a "Group C", possible human carcinogen.
The end uses of asulam products are for postemergence grass control in
sugarcane, Christmas tree plantations, ornamentals, turf (St. Augustinegrass and
Bermudagrass) and noncropland uses (boundary fences, fencerows, hedgerows,
lumberyards, storage areas and industrial plant sites, and warehouse lots).
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Description of Chemical
Asulam (methyl sulfanilylcarbamate) is a herbicide used for weed control on
sugarcane, Christmas tree plantations, ornamentals, turf, and noncropland uses.
Asulam is formulated into and applied as the asulam sodium salt.
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OH I °
^ X ^CH, ^^^s^ ">r" ^CH3
o o o o
Asulam Asulam, sodium salt
Empirical Formula: C8H10N2O4S (asulam)
C8H9N2NaO4S (asulam sodium salt)
Molecular Weight: 230.2 (asulam)
252.2 (asulam sodium salt)
CAS Registry No.: 3337-71-1 (asulam)
2302-17-2 (asulam sodium salt)
PC Code: 106901 (asulam)
106902 (asulam sodium salt)
Identification of Active Ingredient
Asulam is a colorless, crystalline solid with a melting point of 143-
145 °C. Asulam sodium salt is a buff-colored powder with a melting point of
212-215°C. Asulam is soluble at approximately 0.5% in water, and moderately
soluble in chlorinated hydrocarbons, petroleum oils, and hydroxylic solvents.
Asulam sodium salt is soluble at >100 g/100 mL in water at pHs 5, 6.5, and 9.
Physical Chemistry Assessment
The Asulam Guidance Document dated December 1987 required that all
new generic and product-specific data be submitted for product chemistry
guidelines. Rhone-Poulenc submitted product chemistry data for the asulam
sodium salt. These data were reviewed in the Asulam Registration Update,
dated January 15, 1991, which required additional data concerning the
following guidelines (GLNs): 61-1, 61-3, 62-2, 62-3, 63-5, 63-8, 63-10, 63-13,
63-17, and 63-20. We note although asulam sodium salt data were originally
reviewed in the Update for the 86.4% asulam T, subsequent Agency reviews
applied these data to data requirements for the asulam sodium salt, and re-
evaluated the outstanding data requirements for asulam and asulam sodium salt.
The following product chemistry guidelines have not been fully satisfied
for the Rhone-Poulenc Ag Company asulam 86.4% technical (EPA Reg. No.
264-451): GLN 61-1 product identity and disclosure of ingredients, GLN 61-2
starting materials and manufacturing process, GLN 61-3 discussion of
formation of impurities, GLN 62-1 preliminary analysis, GLN 62-2
certification of ingredient limits, GLN 62-3 analytical methods to verify the
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B.
certified limits, GLN 63-5 melting point, GLN 63-13 stability, GLN 63-17
storage stability, and GLN 63-20 corrosion characteristics. Guidelines 62-2,
63-17 and 63-20 have not been fully satisfied for the Rhone-Poulenc Ag
Company asulam sodium salt technical (EPA File Symbol No. 264-LNL).
The registrant must submit the data summarized above for the 86.4%
asulam T (EPA Reg. No. 264-451) and the asulam sodium salt T (EPA Reg.
No. 264-LNL), and either certifies that the suppliers of the starting materials
and the manufacturing process for the asulam and asulam sodium salt technical
products have not changed since the last comprehensive product chemistry
review or submit a complete updated product chemistry data package.
Human Health Assessment
1.
Hazard Assessment
The toxicological data base required to support the reregi strati on of
asulam is adequate.
a. Acute Toxicity
Acute toxicity values and categories for asulam are summarized
in the following table.
Table I: Acute Toxicity of Asulam
TEST
Oral LD,0 - Rat
Dermal LD,0 - Rabbit
Inhalation LC,0 - Rat
Eye Irritation - Rabbit
Dermal Irritation - Rabbit
Dermal sensitization -
Guinea Pig
RESULTS
> 5000 mg/kg
> 4000 mg/kg
> 5 mg/L
Mild Irritation
Not an Irritant
No Sensitization
CATEGORY
IV
III
IV
III
IV
--
* Note: Data pertaining to acute eye irritation, dermal irritation, and dermal sensitization are not required to support the reregistration of
the TGAI. These data are presented only for informational purposes.
Asulam technical displayed very low toxicity in acute toxicity
tests. The LD50 for 87.6% - 88% asulam in acute oral rat studies
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exceeded 5000 mg/kg (category IV toxicity; GLN 81-1; MRID
42110001, 40960501). The LD50 for 88% asulam in an acute rabbit
dermal study exceeded 4000 mg/kg (highest dose tested) (category III
toxicity; GLN 81-2; MRID 40960501). The LC50 for a rat inhalation
study with 88% asulam was greater than 5 mg/liter (category IV
toxicity; GLN 81-3; MRID 40960502).
Application of technical asulam to rabbit eyes produced mild
chemosis, irritation, and redness which cleared by day seven post-
treatment (category III toxicity; GLN 81-4; MRID 00098534). Asulam
was not an irritant in a primary skin irritation study in rabbits (category
IV toxicity; GLN 81-5; MRID 00098535). It did not cause dermal
sensitization in guinea pigs (GLN 81-6; MRID 00098535).
b. Subchronic Toxicity
No adverse systemic effects occurred in a 21-day dermal study
conducted at the limit dose of 1,000 mg/kg/day (only dose tested) using
New Zealand white rabbits. Although transient and slight skin irritation
was observed in a small number of treated females, the 1,000 mg/kg/day
dose was considered a NOEL. (GLN 82-2; MRID 41076901)
c. Chronic Toxicity and Carcinogenicity
A two-year combined chronic feeding/carcinogenicity study was
conducted using CD rats administered asulam at dose levels of 0, 1,000,
5,000 or 25,000 ppm (equivalent to 0, 36, 180 and 953 mg/kg/day in
males and 0, 47, 243 and 1,280 mg/kg/day in females, respectively).
The systemic NOEL was 36 mg/kg/day. Hyperplastic changes were
observed in the adrenal medulla and in thyroid follicular cells of males
at the LOEL of 180 mg/kg/day and the high dose. There was a
statistically significant increase in thyroid gland c-cell carcinomas and
in adenomas and carcinomas combined in both the low- and mid-dose
males. There was a statistically-significant increase in benign adrenal
medullary pheochromocytomas at the high dose in males. (GLNs 83-
l(a) and 83-2; MRID 00098543)
In a six-month feeding study of asulam in beagle dogs, doses of
0, 60, 300 or 1,500 mg/kg/day were administered. The systemic NOEL
was 60 mg/kg/day, the lowest dose tested. Higher doses of asulam at
300 mg/kg/day (LOEL) and 1,500 mg/kg/day (highest dose tested) were
associated with reductions in food consumption, body weight gain,
emesis, diarrhea, and reductions in red blood cells, hemoglobin and
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packed cell volume. There were also elevated thyroid and kidney
weights and reduced testicular weights. (GLN 83-l(b); MRID
00098536)
In a two-year carcinogenicity study with Charles River CD-I
mice, asulam was administered in the diet at 0, 500, 5,000 or 50,000
ppm. The systemic toxicity NOEL was 5,000 ppm or 750 mg/kg/day.
The systemic LOEL was 50,000 ppm or 7,500 mg/kg/day, based on
increased spleen weight in males and decreased brain weight and
survival in females. There was no increase in the incidence of any
tumors. (GLN83-2(b); MRID 42338201)
d. Developmental Toxicity
Doses of 0, 500, 1,000 or 1,500 mg/kg were given by gavage on
gestation days 5-17 in a developmental toxicity study with CD rats. The
NOELs for maternal and developmental toxicity in rats were 1,000
mg/kg/day. The highest dose tested showed decreased body weight
gain and a slight increase in resorptions. (GLN 83-3(a); MRID
00098538)
A study in New Zealand white rabbits evaluated asulam at 0,
150, 300 or 750 mg/kg/day by gavage on gestation days 5-20. The
maternal and developmental NOELs were 750 mg/kg/day. At 750
mg/kg/day, a borderline maternal toxic effect of decreased body weight
gain was seen, which may have been compound-related. An additional
group of animals was included in this study at 1,500 mg/kg/day which
either died or were sacrificed in extremis, leading to a maternal LOEL
of 1,500 mg/kg/day. No teratogenic effects were produced by asulam in
either rats or rabbits. (GLN 83-3(b); MRID 00098539)
e. Reproductive Toxicity
Asulam was evaluated in a two-generation reproduction study at
0, 1,000, 5,000, or 25,000 ppm in the diet of CD rats. The study found
a NOEL of 1,000 ppm (50 mg/kg/day) for reproductive effects (lowest
level tested) with a reduction in the number of live births per litter being
noted at 5,000 ppm (250 mg/kg/day) and 25,000 ppm (1,250
mg/kg/day). The parental NOEL was 250 mg/kg/day, with body weight
and organ weight decreases at 1250 mg/kg/day. The developmental
toxicity NOEL exceeded 1250 mg/kg/day. (GLN 83-4; MRID
00098540)
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f. Mutagenicity
Asulam was not mutagenic in the studies that have been
performed. The Ames Assay which is used to detect gene mutation
with S, typhimurium was negative (MRID 40415302). Mutagenicity
assays which detect structural chromosome aberrations included the
dominant lethal test in mice (MRID 00082250) and an in vitro
cytogenetics assay in human lymphocytes were negative for asulam
(MRID 40415301). In addition, the C3H/10T1/2 cell transformation
assay when performed with asulam was also negative (MRID
00098542). (GLN 84 series)
g. Metabolism
Metabolism studies were conducted in male and female Sprague-
Dawley rats. The tests used a single oral or i.v. dose, or repeated i.v.
doses for 14 days. The pharmacokinetics of asulam were similar after
all dose regimens in both sexes. Peak blood levels were attained at 0.5
hours. No unusual localization of asulam occurred in tissues and all
tissue levels were low at 72 hours. Asulam was rapidly eliminated,
mostly within 24 hours. 76.5% to 101.5% of the administered dose was
eliminated in the urine, and 1.4% to 25.3% of the dose in feces. The
major excretory product was unchanged parent compound (70% to
80%), with acetylasulam (3% to 8%) and acetylsulphanilamide (<3%)
being the two major metabolites. (GLN 85-1; MRID 41345601)
h. Neurotoxicity
An acute delayed neurotoxicity study in hens is not required.
Although asulam is chemically classified as a carbamate compound, it
differs structurally from cholinesterase inhibiting carbamates, and both
acute and other toxicity studies with asulam have produced no signs of
cholinergic or neurotoxic effects (EPA, 1987; Taylor, 1992).
i. Reference Dose
The HED RfD Peer Review Committee met on June 17, 1993
and established the RfD at 0.36 mg/kg/day based on results of a chronic
dietary feeding study in rats (MRID 00098543). The NOEL in this
study was 36 mg/kg/day, based on thyroid follicular hyperplasia at 180
and 953 mg/kg/day. An uncertainty factor of 100 was used.
There has been no WHO RfD determination to date.
10
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j. Other Toxicological Considerations
On November 12, 1987 the HED Carcinogen!city Peer Review
Committee (HED-CPRC) classified asulam as Group C, a possible
human carcinogen, based on thyroid and adrenal tumors in the rat study
(MRID 00098543). They also recommended the mouse study be
repeated and agreed to reconsider the cancer classification upon receipt
and evaluation of the new mouse study. On September 22,1994 the
HED RfD Peer Review Committee met to review the new mouse study
(MRID 42338201). The Committee concluded that the findings of the
new mouse study have no impact on the current classification of the
chemical as a "Group C", possible human carcinogen. They determined
that a low dose linear extrapolation risk model was not appropriate for
asulam.
The HED Metabolism Committee determined on December 13,
1994 that although the metabolites hydroquinone/quinone are of
toxicological concern, these compounds are naturally occurring plant
constituents and the levels of hydroquinone/quinone present in the
treated sugarcane, cane sugar, and molasses do not represent a
significantly different risk than naturally occurring levels of
hydroquinone/quinone. A new plant metabolism study, conducted on
sugarcane, is required to confirm the presence and quantity of
radiolabeled hydroquinone/quinone.
There are no concerns for developmental or reproductive toxicity
associated with oral exposure to asulam. There is no acute dietary
toxicological endpoint of concern (the NOEL in the developmental
toxicity study in rats is 1000 mg/kg/day). There is no toxicological
endpoint of concern for short term or intermediate term occupational or
residential exposure (the NOEL in the 21-day dermal toxicity is 1000
mg/kg/day).
k. Other Adverse Effects
There have been no reported incidents for asulam in the
Pesticide Incident Monitoring System (PIMS), by California during
1982-89, from the American Association of Poison Control Centers, in
the National Pesticide Telecommunication Network reports from
1984-1991 inclusive, or in the EPA Incident Data System (June, 1992 to
July, 1994).
11
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2. Exposure Assessment
a. Dietary
The current tolerance for residues of asulam per se in/on
sugarcane is 0.1 ppm [Source: 40 CFR §180.360]. The Agency is
requiring that the tolerance expression be revised to include all
metabolites containing the sulfanilamide moiety. Initially, the tolerance
expression recommendation included the metabolites hydroquinone/
quinone. Subsequently, the HED Metabolism Committee determined
on 12/13/94 that although hydroquinone/quinone are of toxicological
concern, these compounds are naturally occurring plant constituents and
the levels of hydroquinone/quinone present in the treated sugarcane,
cane sugar, and molasses do not represent a significantly different risk
than naturally occurring levels of hydroquinone/quinone. No food/feed
additive regulations have been established. The chemical structures of
the metabolites for regulation are presented in Figure A. An adequate
enforcement method is available for the determination of combined
residues of asulam and all metabolites containing the sulfanilamide
moiety in/on sugarcane.
Figure A. The chemical structures of the metabolites of concern of asulam.
Structure
Metabolite: Chemical name
Structure
Metabolite: Chemical name
H9N
H
o o
asulam: methyl-4-sulfanilyIcarbamate
sulfanilamide: 4-aminobenzenesulfonamide
H
H3C\ ,,N,
ILC.
H
O k />k II ,N,
o
CH,
O O
N4-acetylasulam: methyl 4-acetamido
benzenesulfony Icarbamate
o
o
.NIL
N4-acetylsulfanilamide: N-acety 1-4-
aminobenzenesulfonamide
12
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Directions for Use
There is one asulam end-use product (EP) is currently registered
by Rhone-Poulenc AG Company for use on food/feed crops. The 3.34
Ib ai/gal SC/L formulation (ASULOX® Herbicide, EPA Reg. No. 264-
447, accepted 8/5/93) is registered for one or two postemergence
broadcast or band applications or as a postemergence spot treatment to
sugarcane at a maximum rate of 3.34 Ib ai/A/application. Ground and
aerial applications are permitted in water spray volumes of 15-100 gal/A
and 3-5 gal/A, respectively. Aerial applications in Hawaii are permitted
in a water spray volume of 5-10 gal/A. The grazing or feeding of forage
and fodder to livestock is prohibited. A 90-day PHI has been
established. A one-year plantback interval for all crops other than
sugarcane has been established.
Previously submitted field trial data indicate that residues in
excess of tolerance will occur in/on sugarcane following treatment at the
maximum registered rates. The registrant has committed to amending
labels to reflect lower maximum application rates and/or longer PHI's
and to submit supporting field trial data in order to support a lower
tolerance level for sugarcane.
Plant Metabolism
The qualitative nature of the residue in plants is adequately
understood based on acceptable sugarcane metabolism studies. The
data indicate that asulam is metabolized via a complex pathway
involving hydrolysis of the carbamate ester, hydroxylation, and
subsequent incorporation into naturally occurring plant constituents.
The major metabolites in sugarcane are unchanged parent (asulam) and
its sulfanilamide-containing metabolites (sulfanilamide, sulfanilic acid,
N4-acetyl asulam, N4-acetylsulfanilamide), and quinone and
hydroquinone. Additionally, methyl 4-methoxybenzenesulfonyl
carbamate, 4-amino-2-hydroxybenzenesulfonic acid, and
benzenesulfonic acid were found in a nature of the residue in alfalfa
study. A new metabolism study, conducted on sugarcane, is required to
confirm the presence and quantity of radiolabeled
hydroquinone/quinone. This study is considered confirmatory.
The Metabolism Committee of the Health Effects Division has
determined that, in addition to asulam and its sulfanilamide-containing
metabolites, the asulam plant metabolite quinone/hydroquinone is of
13
-------
toxicological concern, but based on known concentrations of quinone
and hydroquinone in other food items, probably occurs at levels
comparable to background concentrations. The existing nature of the
residue in the sugarcane study indicates that 20% of the total
radiolabeled residue could be quinone/hydroquinone, but the
identification is equivocal. The new study is needed to determine if
quinone and hydroquinone are asulam metabolites; and the extent of
quinone/hydroquinone formation. The terminal residues of concern are
free and conjugated asulam, sulfanilamide, N4-acetylasulam, and
N4-acetylsulfanilamide determined as a common moiety. The chemical
structures of these metabolites for regulation are presented in Figure A.
Animal Metabolism
The qualitative nature of the residue in animals is adequately
understood based on acceptable poultry and ruminant metabolism
studies. Asulam is largely eliminated in the excreta; the major residues
identified in milk, eggs, and animal tissues are the parent and N4-
acetylsulfanilamide.
In the poultry metabolism study, laying hens were dosed with
ring-labeled [14C]asulam at 22.5 ppm in the diet for 7 consecutive days.
The maximum total radioactive residues were 0.027 ppm in egg yolks,
0.062 ppm in egg whites, 0.011 ppm in fat, 0.074 ppm in muscle, 0.444
ppm in kidneys, and 0.086 ppm in liver. The parent compound asulam,
and its metabolite N4-acetylsulfanilamide constituted the majority of the
residues in poultry, comprising 63 and 44% of the TRR, respectively, in
egg yolks, 21 and 52% of the TRR, respectively, in egg whites, 35 and
51% of the TRR, respectively, in muscle, and 83 and 14% of the TRR,
respectively, in kidney. The parent was not identified in liver samples;
N4-acetyl sulfanilamide represented 81% of the TRR in liver samples.
(MRID41561102)
In the ruminant metabolism study, two goats were dosed with
ring-labeled [14C]asulam at 20 ppm in the diet for 7 consecutive days.
The total radioactive residues were nondetectable (<0.005 ppm) in fat
and muscle, 0.162 ppm in kidneys, 0.090 ppm in liver, and up to 0.021
ppm in milk. The parent compound, asulam, constituted the majority of
the residues in milk (81% of TRR) and kidneys (100% of TRR) and its
metabolite N4-acetylsulfanilamide constitutes the majority of residues in
liver (58% of TRR). The parent was not identified in liver samples. In
14
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a previous study, sulfanilamide was found in ruminant liver and muscle,
and N4-acetylasulam was found in liver, kidney, milk, muscle, and fat.
(MRID 41561101)
The terminal residues of concern for regulation are free and
conjugated asulam, sulfanilamide, N4-acetylasulam, and
N4-acetylsulfanilamide determined as a common moiety.
Residue Analytical Methods - Plants and Animals
Adequate methods for purposes of enforcement of asulam
tolerances in/on sugarcane are available. The spectrophotometric
method for determining free and bound asulam and other compounds
containing the primary aromatic amine (sulfanilamide) moiety in/on
sugarcane is described in the Pesticide Analytical Manual (PAM), Vol.
II, as Method I. The limit of detection is 0.02 ppm in sugarcane. A
TLC procedure is used for confirmation. HPLC/UV methods, Method
Nos. 154 and 156, for determination of the combined residues of asulam
and its metabolites containing the sulfanilamide moiety in animal and
in/on plant commodities, respectively, have also undergone EPA
validation and are adequate for enforcement purposes. By these
methods, residues are converted to and determined as
N4-acetylsulfanilamide. Limits of detection for these HPLC methods
have not been specified. (MRID 42292401)
Adequate spectrophotometric methods (Method Nos. Ill and
143) were used to collect residue data for sugarcane and its processed
fractions that were discussed in the 1987 Residue Chemistry Science
Chapter. Residue data submitted since the Science Chapter were
collected using a modification of HPLC/UV Method No. 154, which is
considered adequate for data collection and tolerance enforcement
purposes.
In addition, the registrant has satisfied the requirements for data
on the recovery of asulam and its sulfanilamide-containing metabolites
using FDA Multiresidue Protocols A, D, and E (fatty and nonfatty).
These data have been forwarded to FDA for review. The FDA's
PESTDATA dated 11/6/90 (Pam Vol. I, Appendix) indicates that
recovery of asulam using Multiresidue Protocols A, D, or E is unlikely.
The updated PESTDATA dated 08/93 does not have an entry for asulam
or its metabolites.
15
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Storage Stability
A stability study (up to 18 months of storage) has been
conducted using samples of sugarcane, sugarcane forage, bagasse,
molasses, and sugar. These data indicate that residues of asulam per se
are not stable in/on sugarcane and sugarcane forage. A 60% loss each
of asulam and of sulfanilamide occurs in sugarcane during 15 months of
storage, with most of the loss occurring in the first six months of
storage. Residues of the metabolites (except sulfanilamide) are
generally stable in/on sugarcane and sugarcane forage, and residues of
both asulam and its metabolites are stable in the processed commodities.
All existing field trial results for sugarcane must be corrected by a factor
of 2.5X to account for the instability of asulam. (MRID 43234701)
Residues of asulamper se are stable under frozen conditions (-
26 to -10°C) in/on alfalfa commodities for up to 13 months, in milk for
1 week, and in animal tissues for up to 1 month. Residues containing
the sulfanilamide moiety are stable in milk and ruminant tissues for up
to 21 months. (MRID 42806201)
Magnitude of the Residue in Plants
Field residue data reflecting the current maximum registered use
patterns have been reviewed. These data indicate that residues of
asulam and its sulfanilamide-containing metabolites in/on sugarcane
will exceed the established tolerance with residues as high as 15 ppm (6
ppm corrected for 60% storage loss). The current RAC tolerance is 0.1
ppm. However, the registrant is submitting further additional data
reflecting longer PHI's and more accurate timing of applications which
will likely result in a tolerance level lower than 15 ppm. After
reviewing these data, the Agency will establish a new sugarcane
tolerance. (MRID 42088801)
Magnitude of the Residue in Processed Food/Feed
Acceptable sugarcane processing studies have been submitted
and reviewed. The sugarcane processing data indicate that asulam and
its metabolites concentrated in first strike molasses (16x). A factor of
3X is considered adequate for concentration from first strike to
blackstrap molasses. Therefore, the concentration factor for blackstrap
molasses is 48X. A feed additive tolerance for residues of asulam in
blackstrap molasses is needed. (MRID 42201501)
16
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Magnitude of the Residue in Meat. Milk. Poultry, and Eggs
Feeding studies with ruminants and poultry were discussed in the
1987 Residue Chemistry Science Chapter of the Registration Standard;
however, the adequacy of these studies was not assessed because field
trial and processing data for sugarcane remained outstanding. Although
some field trial data for sugarcane and storage stability data to support
the processing data remain outstanding, sufficient data are available to
assess the adequacy of these feeding studies.
Based on the reevaluated tolerance of 15 ppm for sugarcane, and
the 48x concentration factor for molasses, the maximum theoretical
dietary burden for ruminants is estimated to be about 100 ppm (based
on a diet consisting of 10% molasses) and the maximum theoretical
dietary burden for poultry is estimated to be nil. Molasses is not
considered a poultry feed item.
In a ruminant feeding study lactating dairy cows were dosed with
asulamper se at 50, 200, or 800 ppm in the diet (50x, 200x, or 800x the
maximum theoretical dietary burden, respectively, based on established
tolerances) for 28 days. Milk samples were collected in the morning
and evening on days 4, 7, 13, and 28 of the study. Half the test animals
were sacrificed within 24 hours of the final dose and the remaining
animals were sacrificed after a 14- or 21-day withdrawal period. All
milk and tissue samples were frozen after collection. Residues of
asulam and its metabolites containing the sulfanilamide moiety were
determined using an adequate HPLC method (Method No. 154) in fat,
kidney, liver, muscle, and milk on days 4, 7, 13, and 28. At the 50 ppm
dose level, residues ranged from 0.04 - 0.11 ppm in milk and from
<0.05 - 0.34 ppm in the tissues; at the 200 ppm dose level residues
ranged from 0.10 - 0.32 ppm in milk and from <0.05 - 1.03 ppm in
tissues; and at the 800 ppm dose level residues ranged from 0.48 - 1.16
ppm in milk and from <0.05 - 3.56 ppm in tissues. The residue level
plateaued in milk on day 13. Kidney tissue had the highest residue
levels (>4X) as compared to the other tissues. (MRID 00098553)
In a second ruminant feeding study, lactating dairy cows were
dosed with asulamper se at 0.5, 5, 50, 200, or 800 ppm in the diet
(0.5x, 5x, 50x, 200x, or 800x, respectively, the maximum theoretical
dietary burden based on existing tolerances) for 28 days. Milk samples
were collected in the morning and evening at regular intervals during
the study. Animals were sacrificed within 24 hours of the final dose and
tissue samples were collected. All milk and tissue samples were stored
17
-------
frozen (-15°C) until analyzed. Residues of asulam were determined
using an adequate spectrophotometric method. Residues were
nondetectable (<0.025 ppm) in milk from cows dosed at 0.5x-50x (0.5-
50 ppm). Residues were nondetectable (<0.05 ppm) in all tissues of
cows dosed at 0.5x (0.5 ppm) and in the fat of cows from all feeding
levels. In cows fed at 5x (5 ppm), residues were nondetectable (<0.05
ppm) in all tissues except kidney (0.06-0.12 ppm). In cows fed at 50x
(50 ppm), residues were nondetectable in all tissues except kidney
(0.11-0.13 ppm) and heart (0.06 ppm). In cows fed at 200x (200 ppm),
residues were nondetectable in all tissues except kidney (0.32-0.34
ppm) and heart (0.07 ppm). In cows fed at 800x (800 ppm), residues
were 1.19-1.39 ppm in kidney, 0.10-0.11 ppm in liver, 0.08-0.10 ppm in
muscle, 0.13-0.17 ppm in heart, and 0.07 ppm in brain. (MRIDs
00052047, 00084805, and 00113833)
In a poultry feeding study, laying hens were dosed with asulam
per se at 50, 150, and 200 ppm in the diet for 28 days. Eggs were
collected daily and pooled. The test animals were sacrificed after 2, 3,
or 4 weeks of feeding. Residues of asulam and its metabolites
containing the sulfanilamide moiety were determined using an adequate
HPLC method (Method No. 154) in eggs, kidney, gizzard, blood, heart,
liver, muscle (leg and breast), and skin. At the 50 ppm dose level
residues ranged from 0.1 - 1.0 ppm; at the 150 ppm dose level residues
ranged from 0.3 to 2.5 ppm; and at the 500 ppm dose level residues
ranged from 1.0 - 10.7 ppm. The lowest residue levels were generally
in the skin, muscle, and eggs. The highest residue levels were found in
the kidney tissue. It should be noted that there are no significant
dietary sources of asulam for poultry. (MRID 00098554)
Interpolating the 50 ppm and 200 ppm feeding studies to a 100
ppm diet, the Agency concluded that finite residues of asulam and its
sulfanilamide-containing metabolites may occur. Probable
concentrations are 0.18 ppm in milk, 0.57 ppm in kidney, 0.12 ppm in
liver, and 0.07 ppm in muscle. No residue (< 0.05 ppm) is expected in
fat. Therefore, tolerances will be required for ruminant meat, meat
byproducts, and milk. No tolerances are needed for poultry
commodities because there are currently no poultry feed items with
asulam residues.
Confined/Field Rotational Crops
An acceptable limited rotational crops study has been conducted.
No residues of asulam, acetylasulam, sulfanilamide, and/or
18
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acetylsulfanilamide were found in/on lettuce, carrots, and wheat grain,
wheat forage, and wheat straw rotated with sugar cane treated at the
maximum label rate with asulam. The data support a minimum
plantback interval of 6 months. (MRID 42980801)
A confined rotational crop study utilizing radiolabeled asulam is
required as confirmatory data. It is conceivable that the residue of
concern could contain metabolites of toxicological concern not covered
by the tolerance expression for primary crops.The study is essential to
determine the nature of the residue in secondary crops and to determine
total residue levels at various plantback intervals. The presence/absence
of quinone and hydroquinone in the radiolabeled residue must be
established.
Anticipated Residues for Dietary Exposure Assessment
Anticipated residues in sugarcane and its processed commodities
and in ruminant commodities for use in acute and chronic risk
assessment are given in Table Ha and Table lib. The calculations are
based on the most recent field trials for plant commodities and on
animal feeding studies for the ruminant commodities.
Note that the anticipated residues for plant commodities are
derived from the most recent mainland field trials. Residues were
substantially lower on HI cane than on mainland cane. Presumably this
is related to the longer growing season in HI, where canopy formation is
complete before the 90 day PHI used for the trials.
19
-------
Table Ma: Anticipated Residues of Asulam and Its
Plant Commodities
Commodity
Sugarcane
Refined Sugar
Molasses (Blackstrap)
Reassessed
Tolerance
(ppm)
153
Sulfanilamide-Containing Metabolites in
Asulam Plus
Sulfanilamide-
Containing
Metabolites Field
Trial Results (ppm)
Max1
156
154
Avg2
5.86
7205
Anticipated Residue
Asulam Plus Sulfanilamide-
Containing Metabolites
(ppm)
Acute
15
15
720
1 The maximum residue encountered in 14 mainland field trials.
2 The average of the average residues encountered at each of 14 mainland field trials
0.31 ppm - 5.34 + 0.50 ppm (MRID 42088801).
3 Based on mainland field trial data, HI data excluded.
4 No concentration (1-1 .3X) from RAC to refined sugar.
5 48X concentration from RAC to blackstrap molasses (16X to first strike molasses).
6 Adjusted for a 60% loss during storage.
Chronic
5.86
5.86
280
, range 0.67 +.
Table Mb: Anticipated Residues of Asulam and Its Sulfanilamide-Containing
Metabolites in Animal Commodities
Commodity
Milk
Cattle, meat
Cattle, mbyp
Goats, meat
Goats, mbyp
Hogs, meat
Hogs, mbyp
Horses, meat
Horses, mbyp
Sheep, meat
Sheep, mbyp
Reassessed
Tolerance (ppm)
0.2
0.1
0.6
0.1
0.6
0.1
0.6
0.1
0.6
0.1
0.6
Anticipated Residue Asulam Plus
Sulfanilamide-Containing Metabolites
(ppm)
Acute
0.2
0.1
0.6
0.1
0.6
0.1
0.6
0.1
0.6
0.1
0.6
Chronic1
0.2
0.1
0.6
0.1
0.6
0.1
0.6
0.1
0.6
0.1
0.6
1DRES adjusted chronic anticipated residues by 70% to reflect % crop treated.
20
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b. Occupational and Residential
Handler (Mixer. Loader. Applicator) Exposure
An occupational and/or residential exposure assessment is
required for an active ingredient if (1) certain toxicological criteria are
triggered and (2) there is potential exposure to handlers (mixers,
loaders, applicators, etc.) during use or to persons entering treated sites
after application is complete.
The Agency has determined that there is an exposure potential
for mixers, loaders, applicators, or other handlers during the usual use-
patterns associated with asulam. The mixing, loading, and application
methods include open pouring, broadcast (aerial and ground)
application and application with hand-held equipment.
Asulam (TGAI) is in acute toxicity category IV for acute oral
toxicity, inhalation toxicity, and primary dermal irritation; and in
category III for acute dermal and eye irritation. Asulam is not a skin
sensitizer. These toxicity categories for asulam do not trigger the acute
battery of testing. For asulam, the Agency has determined that the
toxicology criteria are not triggered. No endpoints of concern regarding
dermal toxicity, inhalation toxicity or other adverse effects have been
identified. Therefore, an occupational exposure assessment is not
required. There are no residential uses for asulam.
Post-Application Exposures
The Agency has determined that the potential exposure to
persons entering treated sites after application triggers the post-
application criteria. However, as indicated above, no endpoints of
concern regarding dermal toxicity, inhalation toxicity or other adverse
effects have been identified. Therefore, a post-application occupational
exposure assessment is not required.
Occupational-use products and homeowner-use products
There are no products containing asulam that provide directions
intended for homeowner use. Current labelling provides the statement
"for agricultural or commercial use only, not for use by homeowners."
21
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3. Risk Assessment
a. Dietary
Asulam was classified as a Group C, possible human carcinogen,
by the HED Carcinogenicity Peer Review Committee with the
recommendation not to quantify the carcinogenic risk by low dose linear
extrapolation. Two plant metabolites, hydroquinone and quinone, have
also been identified as carcinogens. Based upon the determination by
the Metabolism Committee on 12/13/94 that hydroquinone/quinone are
naturally occurring plant constituents, and the levels of
hydroquinone/quinone present in the treated sugarcane, cane sugar, and
molasses may not represent a significantly different risk than naturally
occurring levels of hydroquinone/quinone, the dietary risk assessment
does not include the metabolite quinone/hydroquinone. A new plant
metabolism study is required to confirm that radiolabeled
quinone/hydroquinone levels are in the range of naturally occurring
background levels.
Chronic Dietary Risk
The chronic dietary exposure analysis used a Reference Dose
(RfD) of 0.36 mg/kg/day. The RfD was based on the NOEL of 36
mg/kg/day from a 2-year chronic toxicity study in rats in which thyroid
follicular cell hyperplasia was observed at the mid and high doses (180
and 953 mg/kg/day, respectively) in males. An uncertainty factor of
100 was applied to account for interspecies extrapolation and
intraspecies variability.
Food uses evaluated in this analysis are the published uses of
asulam as listed in 40 CFR §180.360 plus ruminant commodities milk,
meat, and meat byproducts. The existing tolerance for sugarcane is 0.1
ppm. Based upon results of field trials this tolerance may be exceeded.
The reassessed tolerance for sugarcane is 15 ppm. There are currently
no food/feed additive tolerances for asulam, but studies indicate that a
tolerance of 720 ppm is needed for blackstrap molasses.
Anticipated residues (AR) have been determined for asulam (see
Table Ha and Table lib) and its metabolites containing the sulfanilamide
moiety. The AR of 5.8 ppm on sugarcane was based upon the average
of the residue levels detected in field trials. The 10/94 usage estimate of
70% sugarcane crop treated annually with asulam was used in this
assessment.
22
-------
The chronic dietary risk analysis for asulam and its metabolites
containing the sulfanilamide moiety was conducted for sugarcane as
cane sugar and sugar-molasses and for ruminant commodities. The
analysis assumed the higher reassessed tolerance level of 15 ppm and
100% crop treated for all commodities for the overall U.S. population
and 22 population subgroups. The exposure estimates were then
compared to the RfD for asulam to calculate estimates of chronic dietary
risk.
The ARC from the use of asulam on sugarcane for the overall
U.S. population of the 48 states is 1.39 x 10"2 mg/kg body weight/day
which represents 3.85% of the RfD. The ARCs for the two highest
exposed subgroups, children (1-6 years old) and non-nursing infants (<1
year old), are 3.48 x 10"2 and 2.64 x 10"2 mg/kg body weight/day,
respectively. These exposure values represent 9.7% and 7.3% of the
RfD, respectively.
Therefore, the Agency does not have a concern for chronic
dietary exposure to asulam since the RfD is not exceeded for either the
general population or any subgroup.
b. Occupational and Residential
There is the potential for handler (mixers/loaders/applicators,
etc.) exposure and post-application exposure for the usual use-patterns
associated with asulam; however, there are no toxicological endpoints
of concern for the short to intermediate term occupational exposure.
Therefore, minimal risk from the occupational use of asulam is
expected.
There are no residential uses for this chemical; therefore, no
exposure or risk is expected from asulam.
C. Environmental Assessment
1. Ecological Toxicity Data
The following ecological effects guideline requirements have not been
fulfilled for asulam: a freshwater aquatic invertebrate life-cycle study (72-4b),
a seedling emergence study - with soybean and radish (123-la), and a
vegetative vigor study - with cucumber and onion (123-lb). The
ecotoxicological data base, however, is adequate to characterize the acute
23
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toxicity of asulam to nontarget terrestrial and aquatic organisms when used on
terrestrial food, feed and nonfood sites.
a. Toxicity to Terrestrial Animals
In order to establish the toxicity of asulam to birds, the following
tests are required using the technical grade material: two subacute
dietary studies (LC50) on one species of waterfowl (preferably the
mallard duck) and one species of upland game bird (preferably
bobwhite quail or ring-necked pheasant), and one avian single-dose oral
(LD50) study on one species (preferably mallard duck or bobwhite
quail).
Wild mammal testing is required on a case-by-case basis,
depending on results of the lower tier studies such as acute and
subacute testing, intended use pattern, and pertinent
environmental fate characteristics.
A honey bee acute contact LD50 study is required if the
proposed use will result in honey bee exposure.
(1) Birds, Acute and Subacute
Avian Acute
No acceptable avian acute oral toxicity studies on
technical asulam have been submitted for review. However, the
collection of data on the 40 percent formulated product will
satisfy the requirement.
The acceptable acute oral toxicity tests for the 40 percent
formulated product are listed in the following table:
24
-------
Avian Acute Oral Toxicity Findings - Formulated Product
Species
Mallard
Partridge
Pheasant
Pigeon
% A.I.
40
40
40
40
LD50
>4000 ppm
(product)
>4000 ppm
(product)
>4000 ppm
(product)
>4000 ppm
(product)
Author
Ingham et al.
Ingham et al.
Ingham et al.
Ingham et al.
Date
1971
1971
1971
1971
MRID
56417
56417
56417
56417
Category
Supplemental2
Supplemental112
Supplemental1-2
Supplemental1-2
Conclusions
Practically
nontoxic
Practically
nontoxic
Practically
nontoxic
Practically
nontoxic
1. Not a recommended test species.
2. Test material is not technical.
The existing data demonstrate that a 40 percent
formulation of asulam is practically nontoxic to waterfowl and
upland game birds. Although none of the above studies were
classified as core, the collection of studies taken as a whole can
be used to satisfy the guideline requirement for an avian acute
oral study. (MRID 00056417)
Avian Subacute Dietary
No acceptable avian dietary toxicity studies on technical
asulam have been submitted for review. However, the collection
of studies taken as a whole on a 60 percent formulation of
asulam will satisfy the requirement.
The acceptable avian dietary toxicity tests for a 60
percent formulation are listed in the following table:
Avian Subacute Dietary Toxicity Findings
Formulated Product
Species
Mallard
Pheasant
% A.I.
60
60
LC50 (ppm)
>75,000 (product)
>75,000 (product)
Author
Heywood et
al.
Heywood et
al.
Date
1970
1970
MRID
56418
56419
Category
Supplemental2
Supplemental1-2
Conclusions
Practically nontoxic
Practically nontoxic
1. Not a recommended test species.
2. Test material is not technical.
The existing data demonstrate that a 60 percent
formulation of asulam is practically nontoxic to waterfowl and
upland game birds. Although none of the above studies were
25
-------
classified as core, the collection of studies taken as a whole can
be used to satisfy the guideline requirement for an avian dietary
study. (MRIDs 00056418 and 00056419)
(2) Birds, Chronic
Avian reproduction studies are required when birds may
be exposed repeatedly or continuously through persistence,
bioaccumulation, or multiple applications; or if mammalian
reproduction tests indicate reproductive hazard. Present product
labeling of asulam allows several applications of the end-use
product per growing season (specifically on sugarcane and
possibly for the non-cropland and Christmas tree use sites). The
Agency is not requesting avian reproduction studies at this time
primarily due to the extremely short photolytic half-life
(approximately 2 hours) and in acute studies, the practically non-
toxic nature of asulam to birds and mammals.
(3) Mammals
The available mammalian data indicate that both asulam
and the sodium salt of asulam are practically nontoxic to small
mammals on an acute basis with LD50s of greater than 5000 ppm
for the rat. (MRID 00111761) On a chronic basis, testing with
technical asulam in a two-generation reproduction study with
rats produced a reproductive NOEL of 1000 ppm/day and a
LOEL of 5000 ppm/day based on a decrease in live birth index.
(MRIDs 00070776 and 00098540)
(4) Insects
The minimum data required to establish the acute toxicity
to honey bees is an acute contact LD50 study with the technical
material.
The acceptable honeybee study is listed in the following
table:
26
-------
Nontarget Insect Toxicity Findings - Formulated Product
Species
Apis
mellifera
% A.I.
formulation
not reported
LD50
1.28%
mortality at
36.26 ug/bee
Author
Atkins et al.
Date
1975
MRID
00036935
Category
Core
Conclusion
Practically
nontoxic
There is sufficient information to characterize asulam as
practically nontoxic to bees. This study fulfills the data
requirement for acute toxicity testing with honey bees. (MRID
00036935)
b. Toxicity to Aquatic Animals
(1) Freshwater Fish
In order to establish the toxicity of asulam to freshwater
fish, the minimum data required on the technical grade of the
active ingredient are two freshwater fish toxicity studies. One
study should use a coldwater species (preferably the rainbow
trout) and the other should use a warmwater species (preferably
the bluegill sunfish).
Acute Studies - Technical
The acceptable acute fish toxicity studies are listed in the
following table:
Freshwater Fish Acute Toxicity Findings - TGAI
Species
Rainbow
trout
Bluegill
sunfish
% A.I.
88
96.6
•L^so
>175 ppm
>180ppm
Author
Manning
Vilkas
Date
1988
1979
MRID
40872001
98505
Category
Core
Core
Conclusions
Practically nontoxic
Practically nontoxic
There is sufficient information to characterize technical
asulam as practically nontoxic to both warmwater and coldwater
fish. The guideline requirements, 72-1 (a) and (b), have been
satisfied. (MRIDs 40872001 and 00098505)
27
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Acute Studies - Formulated Product
Although formulated product testing on fish was not
required for asulam, several studies were submitted and
reviewed.
The acceptable fish toxicity data on the formulated
products are listed in the following table:
Freshwater Fish Acute Toxicity Findings - Formulated Product
Species
Rainbow
trout
Bluefish
Goldfish
Channel
catfish
% A.I.
60
60
60
60
LC50
> 5000 ppm
(product)
> 5000 ppm
(product)
> 5000 ppm
(product)
> 5000 ppm
(product)
Author
Fraser et al.
Fraser et al.
Fraser et al.
Fraser et al.
Date
1970
1970
1970
1970
MRID
56421
56421
56421
56421
Category
Supplemental1
Supplemental1
Supplemental1'2
Supplemental1'2
Conclusions
Practically nontoxic
Practically nontoxic
Practically nontoxic
Practically nontoxic
1. Formulated product was used instead of technical grade material.
2. Not a recommended test species.
These fish studies show that a 60 percent formulated
product of asulam is practically nontoxic to both the warmwater
and coldwater fish. However, these studies were not required
and do not fulfill any guideline requirements. (MRID 00056421)
(2) Freshwater Invertebrates
The minimum testing required to assess the hazard of a
pesticide to freshwater aquatic invertebrates is a freshwater
aquatic invertebrate toxicity test, preferably using first instar
Daphnia magna or early instar amphipods, stoneflies, mayflies,
or midges.
The acceptable toxicity data are listed in the following
table:
28
-------
Freshwater Invertebrates Acute Toxicity Findings - TGAI
Species
Daphnia
magna
Daphnia
magna
% A.I.
97
88
EC50
27ppm
67ppm
Author
Roberts et al.
Manning
Date
1977
1988
MRID
98507
40977602
Category
Core
Core
Conclusions
Slightly toxic
Slightly toxic
There is sufficient information to characterize technical
asulam as slightly toxic to aquatic invertebrates. The guideline
requirement for an aquatic invertebrate EC50 study has been
satisfied. (MRIDs 00098507 and 40977602)
(3) Estuarine and Marine Animals
Acute toxicity testing with estuarine and marine
organisms is required when an end-use product is intended for
direct application to the marine/estuarine environment or is
expected to reach this environment in significant concentrations.
The use of asulam on sugarcane and turf may result in exposure
to the estuarine environment through drift and runoff. The
requirements under this category include a 96-hour LC50 for an
estuarine fish, a 96-hour LC50 for shrimp, and either a 48-hour
embryo-larvae study or a 96-hour shell deposition study with
oysters.
The acceptable acute estuarine and marine studies are
listed in the following table:
Estuarine/Marine Acute Toxicity Findings
Species
Eastern
oyster
Grass
shrimp
Fiddler crab
% A.I.
88 (asulam
sodium salt)
97
97
LC50
>185 ppm
>100ppm
>100ppm
Author
Manning
Vilkas
Schneider et
al.
Date
1989
1979
1979
MRID
41000701
98508
98509
Category
Core
Core
Supplemental1
Conclusions
Practically nontoxic
Practically nontoxic
Practically nontoxic
1. The fiddler crab is not a recommended species.
There is sufficient information to characterize technical
asulam as practically nontoxic to estuarine/marine species. The
guideline requirement for testing with a marine or estuarine fish
29
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species is waived due to the demonstrated low toxicity of asulam
to freshwater fish as well as marine and freshwater invertebrates.
The guideline requirements for estuarine/marine testing are
satisfied. (MRID 41000701, 00098508 and 00098509)
c. Toxicity to Plants
(1) Terrestrial
Terrestrial plant testing (seed germination, vegetative
vigor and seedling emergence) is required for asulam because it
is registered for use on terrestrial food (sugarcane) and terrestrial
nonfood sites (turf, rights-of-way, Christmas tree plantations)
and it may be aerially applied (sugarcane and Christmas tree
plantations). Also, Tier II terrestrial plant testing is
automatically required for herbicides, such as asulam, which are
aerially applied.
The acceptable Tier II terrestrial phytotoxicity data on the
technical material (sodium salt of asulam) are listed below:
Tier II Terrestrial Phytotoxicity Findings - TGAI
Species
Seed
germination (10
species)
Seedling
emergence (10
species)
Vegetative vigor
(10 species)
% A.I
89.5 %
asulam sodium
salt
EC25
lowest ECjj =
0.095 Ibs a.i./A
for oat radicle
length
(see below)1
lowest ECjj =
0.08 Ibs a.i./A
for lettuce shoot
length
(see below)2
lowest ECjj =
0.0002 Ibs a.i./A
for cucumber
root weight
(see below)3
Author
Chris tensen
Date
1992
MRID No.
42613801
Category
Partial"
Partial5
Partial6
4. The results from oat and radish were supplemental as the EQ5 was determined to be lower than the lowest level tested. These species need to be
retested at lower test concentrations.
5. The results from soybean and radish were supplemental as the EQ5 was determined to be lower than the NOEL. These species must be retested to
obtain an adequate dose-response.
6. The results from cucumber and onion are supplemental as the EQ5 was determined to be lower than the lowest concentration tested. These species
need to be retested at lower concentration levels.
30
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lFTier II seed germination test results: lowest observed EC values
rl = radical length; pg = percent germination
Plant Species
Cabbage
Corn
Cucumber
Lettuce
Oat
Onion
Ryegrass
Radish
Soybean
Tomato
EC25 Ibs a.i./A
0.20 (rl)
5.40 (rl)
>6.5 (pg,rl)
1.10(rl)
0.095 (rl)
3.80 (rl)
0.16(rl)
0.21 (rl)
>6.5 (rl,pg)
>6.5 (rl,pg)
2Tier II seedling emergence test results:
lowest observed EC^ values = shoot length for all test species
Plant Species
Cabbage
Corn
Cucumber
Lettuce
Oat
Onion
Ryegrass
Radish
Soybean
Tomato
EC,, Ibs a.i./A
0.10
0.86
3.60
0.08
0.15
0.26
0.14
0.11
0.26
0.86
31
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3Tier II vegetative vigor test results: lowest observed EC values
si = shoot length; sw = shoot weight; rw = root weight
Plant Species
Cabbage
Corn
Cucumber
Lettuce
Oat
Onion
Ryegrass
Radish
Soybean
Tomato
EC25 Ibs a.i./A
0.02 (sw)
>5.3 (sl,sw,rw)
0.0002* (rw)
0.07 (sw)
1.4(sw)
0.07 (si)
4.2 (sw)
0.16(rw)
1.3 (sw)
0.54(rw)
* EC value was extrapolated beyond treatment range.
Guideline requirements for terrestrial plant testing with asulam
have been partially fulfilled. Additional data are required for seedling
emergence - soybeans and radish and vegetative vigor - cucumber and
onion tests. (MRID 42613801)
(2) Aquatic
Aquatic plant testing is required for asulam because it is
registered for use on terrestrial food/nonfood sites and may be
aerially applied. The following species should be tested:
Selenastrum capricornutum, Lemna gibba., Skeletonema
costatum, Anabaena flos-aquae, and a freshwater diatom. Also,
Tier II aquatic plant testing is automatically required for
herbicides, such as asulam, which are aerially applied.
The acceptable Tier II aquatic phytotoxicity data on the
technical material (sodium salt of asulam) are listed below:
32
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Tier II Aquatic Phytotoxicity Findings - TGAI
Species
Anabaena
flos-aquae
Skeletonema
costatum
Navicula
pelliculosa
Lemna gibba
Selenastrum
capricornutu
m
% AI
89.5
asulam
sodium
89.5
asulam
sodium
89.5
asulam
sodium
89.5
asulam
sodium
89.5
asulam
sodium
EC50
5-Day EC50 =
0.70 ppm
5-Day EC50 =
0.44 ppm
5-Day EC50 =
2.3 ppm
1 4-Day EC50
= 0.14 ppm
5-Day EC50 =
0.1 8 ppm
Author
Hoberg
Hoberg
Hoberg
Hoberg
Hoberg
Date
1992
1992
1992
1992
1992
MRID No.
42613802
42560302
42631301
42611701
42560301
Category
Core
Core
Core
Core
Core
Guideline requirements for aquatic plant testing with asulam
have been fulfilled. (MRIDs 42613802, 42560302, 42631301,
42611701, and 42560301)
2. Environmental Fate
At this time, the following environmental fate guidelines are not
fulfilled for asulam: an aerobic soil metabolism study (162-1), an
anaerobic soil and aquatic metabolism study (162-2) (to include a
laboratory study investigating asulam and its degradate (sulfanilamide)
in soil under freezing conditions), and a spray drift (droplet size
spectrum) and drift field evaluation (201-1 and 202-1). Although the
studies to support the soil/aquatic metabolism data requirements can be
upgraded and other data requirements have been fulfilled, the lack of
acceptable field dissipation data and the concerns about the integrity of
data from the laboratory studies limit the Agency's ability to assess with
confidence the environmental fate of asulam. The following assessment
of the environmental fate of asulam is, in part, based on unreliable data.
As a result, the fate, ground and surface water assessments of asulam
may change after review of the additional data being required.
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a. Environmental Fate Assessment
Based on available data, the major routes of dissipation are
leaching into ground water and biotic degradation under aerobic
conditions. Asulam also dissipates by irreversible binding to soil
organic matter, and the binding appears to increase with time.
However, there is a time lag of up to 120 days during which asulam
residues can move through the soil profile under aerobic conditions.
Because of its solubility in water, rain occurring immediately
following application may increase the amount of chemical getting into
ground water. Sediment-bound residues or solubilized asulam may run
off to surface water. Therefore, surface runoff could be another major
route of dissipation.
Based on the laboratory studies, photolysis in water and on soil
appear to be major routes of degradation for asulam. However, the role
of photolysis may be less significant in the natural field conditions than
in the laboratory. This was demonstrated by the detection of low levels
of asulam residues (0.1 ppb) in a surface water study.
Based on acceptable data, the Agency concludes that asulam is
very soluble in water, with a water solubility of 4,000 ppm. One end-
use product contains the sodium salt of asulam which is very highly
soluble.
Asulam is stable to hydrolysis at pH's of 5, 7, and 9 in the
absence of light. Although this chemical photodegrades very rapidly in
aqueous solution at pH 9, with a half-life of 2 hours, no degradation
products were present at levels greater than 10 percent of the applied.
On sandy loam soil, asulam was found to be readily photodegradable
with a half-life of 1.5 hours.
Sulfanilamide, the major degradation product formed on soil,
was present at 27.4 percent of the applied two hours after exposure to
light. Based on the low vapor pressure of asulam, volatilization from
soils will not be an important dissipation route. The low octanol/water
partition coefficient suggests that asulam will have a low tendency to
accumulate in fish.
Based on supplemental data, asulam is much less persistent
under aerobic than anaerobic soil and aquatic conditions. If asulam
moves into anaerobic conditions, then biotic metabolism is greatly
34
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reduced and leaching potential is enhanced. Asulam degraded with
half-lives of 8 days in sand, 28 days in sandy loam, and 23 days in loam
soils under aerobic conditions whereas it degraded very slowly in sandy
loam soil under anaerobic conditions, where the half-life was greater
than 1 year. Asulam degraded with a half-life of 105 days in an aerobic
aquatic metabolism study.
Sulfanilamide was the major degradate detected in the
aerobic/anaerobic soil, and anaerobic/aerobic aquatic metabolism
studies. Acetyl asulam (14.3% of the applied at 7 days) was only found
in the soil incubated under anaerobic soil/aquatic environment.
Asulam is expected to be very mobile due to its low soil
adsorption coefficients (Kads=0.6-1.0; or Koc=18-l 15). Results from the
column leaching studies for unaged and aged asulam residues showed
that the parent compound has a high potential for leaching. Although
no mobility studies were conducted for the major degradate
(sulfanilamide), based on the aged leaching study for asulam,
sulfanilamide showed low mobility.
In the unaged leaching study, asulam residues in the leachates of
all four soils totaled 88.7-to-98.4 percent of the applied; the residues
remaining in the soil columns averaged 0.5-to-4.1 percent of the
applied, and were evenly distributed throughout the length of the
columns. Asulam was the only compound isolated from the leachates.
In the aged leaching study, asulam was the only compound
identified in the leachates, which contained 77 percent of the applied to
the sand soil column, 60-to-61 percent of the applied to the sandy loam,
47-to-52 percent of the applied to the sandy clay loam, and 52-to-55
percent of the applied to the clay loam. Asulam residues remaining in
the soil ranged from 14-to-17 percent in the sand to 44-to-46 percent in
the sandy clay loam columns. Small amounts of asulam and
sulfanilamide were detected in the leached soil columns.
The dissipation of asulam in the field cannot be confirmed at this
time because the registrant has not submitted any acceptable field
dissipation data. Asulam has the physical/chemical characteristics in
common with those pesticides that are known to leach to ground water
or run off to surface water.
The field dissipation/small-scale prospective ground-water
monitoring study provided little conclusive information due to the
35
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problems of residue analysis in the soil; however, it is adequate to allow
the Agency to conclude that asulam will likely reach ground water
especially under the shallow ground-water conditions associated with
sugarcane usage. Results from an asulam drinking water survey of
surface water indicates the presence of low levels of asulam (0.1 ppb) at
the intakes to community water systems. This demonstrates the ability
of the compound to move offsite into surface water.
Although the studies to support the soil/aquatic metabolism data
requirements can be upgraded and other data requirements have been
fulfilled, the lack of acceptable field dissipation data and the concerns
about the integrity of data from the laboratory studies limit the Agency's
ability to assess with confidence the environmental fate of asulam. The
above assessment of the environmental fate of asulam was, in part,
based on unreliable data. As a result, the fate, ground and surface water
assessments of asulam may change after review of the additional data
being required.
Based on the available data (including those from unreliable
studies), asulam has the following characteristics: 1) highly to very
highly soluble, 2) stable in water without light, 3) unstable in water and
on soil under light; however, small amounts of asulam were detected in
surface water, 4) relatively unstable in soil under aerobic conditions, 5)
very stable in soil and sediment under anaerobic conditions, 6) very
mobile in soil, 7) not volatile, and 8) does not accumulate in fish. With
these properties, it appears that asulam is highly mobile and has a strong
potential to leach into ground water or move offsite into surface water.
The Agency has concluded from the small-scale prospective
ground-water studies that asulam will likely reach ground water
especially under the shallow ground-water conditions associated with
sugarcane usage.
Level of Concern (LOG) criteria for asulam were exceeded for
both mobility and persistence. A weight-of-evidence evaluation for the
occurrence of low levels of asulam in the surface and ground-water
samples, and its low human and aquatic toxicity indicated that the risk
posed will likely not be significant.
36
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b. Environmental Fate and Transport
(1) Degradation
Hydrolysis
Asulam does not hydrolyze in basic and neutral sterilized
water, but does hydrolyze very slowly in acidic environments.
Uniformly ring-labeled [14C]asulam was stable in pH 7 and 9
sterile aqueous buffered solutions that were incubated in the dark
at 25 ° (+/- 1 °) Celsius for 31 days. Asulam degraded slightly in
pH 5 solution; by 31 days posttreatment, one unidentified
compound increased in formation, comprising 4.4 to 4.9 percent
of the applied radioactivity. The requirement for hydrolysis data
(161-1) has been satisfied. (MRID 40997901)
Photodegradation in water
Asulam is unstable to photolysis in water. Uniformly
ring-labeled [14C]asulam photodegraded with a half-life of 2
hours in sterile aqueous pH 9 buffer solution that was irradiated
with artificial light (xenon arc lamp) continuously for 22 days.
No degradation products were present in greater than 10 percent
of the applied during the course of the study. The half-life of
asulam under dark conditions was not calculated by the
registrant because degradation was not significant. The
requirement for photolysis in water data (161-2) has been
satisfied. (MRID 41326001)
Photodegradation on soil
Uniformly ring-labeled [14C]asulam photodegraded
rapidly (half-life =1.5 hours) on sandy loam soil samples that
were continuously irradiated with an artificial light source
(xenon lamp) at 25-28°C for up to 9 hours. The half-life of
asulam in the dark control samples was 83 hours. Sulfanilamide,
the major degradation product detected in the study, was present
at 27.6 percent of the applied two hours after exposure to light.
The requirement for photodegradation on soil data (161-3) has
been satisfied. (MRID 41326002)
37
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Aerobic soil metabolism
The submitted aerobic soil metabolism study was
reviewed and found to be unacceptable for the following
reasons:
* The results of the study could not be evaluated by the
Agency at this time because information on the storage
conditions (such as temperature) and length of storage of
the soil samples prior to extraction were not provided.
Based on the storage stability experiment for a field
dissipation/small-scale prospective ground water
monitoring study, the recovery of soil-spiked asulam and
sulfanilamide decreased with time under storage at
freezing conditions. Recoveries from soils analyzed
immediately after spiking were good and reproducible.
However, the recoveries of asulam and sulfanilamide
from the soil samples from freezing storage were very
poor. Only 9 and 45 percent of the spiked asulam and
sulfanilamide, respectively, were recovered 14 days after
freezing storage. After 75 days of storage at freezing
temperature, the recoveries were less than 2 percent and
31 percent for the applied asulam and sulfanilamide,
respectively. It appears that the decline of recovery for
soil-spiked asulam and sulfanilamide does not have a
linear relationship with the length of time during freezing
storage.
* Results from this storage stability study suggested that the
length of storage of the soil samples at freezing
temperature would significantly affect the ratio between
the extractable and unextractable residues, and
subsequently affect the percentage of residues to be
characterized and identified.
* Theoretically, the soil-spiked asulam should be recovered
readily in the storage stability study based on the
following reasons: (1) chemicals are usually
metabolically stable at freezing temperature due to the
lack of active microorganisms; (2) asulam is
unsusceptible to hydrolysis; (3) asulam has a low
tendency to bind with soil (Kd=0.6-1.0; or Koc=18-115).
Although asulam was reportedly photolytically unstable
38
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in water and on the surface of soil, these routes are
unlikely to have a significant role in the low recovery of
asulam in freezing storage because the soil samples are
usually kept in the dark in the refrigerator/freezer.
However, this study is upgradable. The registrant must:
1) submit adequate soil storage data for this study, and 2)
evaluate and validate the findings in this study, based on results
from the required storage stability study.
Results from this study are summarized below:
The degradation of asulam in soil appears to be
microbiologically mediated under aerobic conditions (with half-
lives ranging from 8-to-28 days). Asulam degraded with half-
lives of 8 days in sand, 28 days in sandy loam, and 23 days in
loam soils that were incubated in the dark at 20 °C and 75
percent of field moisture capacity. Three major compounds
other than asulam were isolated from the soils. These included
sulfanilamide and two compounds which were only
characterized as the ionic or conjugated form of asulam. The
registrant did not explain what was meant by ionic or conjugated
form of asulam. However, since harsh measures (acid-base
extraction) were taken to extract these degradates, data on the
structural identity of these degradates would be of little value.
Therefore, no additional data on the identity of these degradates
is required.
In the sandy soil, asulam was 56.5-to-63.5 percent of the
applied immediately posttreatment, and decreased to 2.8 percent
at 37 days. Between 0 and 37 days posttreatment, the alternative
ionic form of asulam decreased from an average of 22.7-to-0.5
percent of the applied, and the conjugated form of asulam ranged
from 0.8-to-6.2 percent. Sulfanilamide was 1.4-to-3.6 percent of
the applied between 0 and 18 days posttreatment. Conjugated
acetyl asulam, conjugated acetyl sulfanilamide, and
methylbenzenesulfonyl carbamate were identified in the soil in
trace amounts. (MRID 41326002)
39
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Anaerobic soil and aquatic metabolism
The submitted anaerobic aquatic soil metabolism study
was reviewed and found to be unacceptable for the same reasons
as described above in the aerobic soil metabolism section.
However, this study is upgradable using the same procedure as
noted above in the aerobic soil metabolism section.
Results from this study are summarized below:
Asulam appears to be relatively stable in sandy loam soil
under anaerobic conditions (estimated half-life greater than 1
year). Asulam was relatively stable in sandy loam soil that had
been incubated in the dark at 20 °C under anaerobic conditions
(estimated half-life greater than 1 year). Five compounds other
than asulam were detected in this study. These included
sulfanilamide, acetyl asulam, and three compounds which were
only characterized as the ionic or conjugated form of asulam.
The registrant did not explain what was meant by ionic or
conjugated form of asulam. However, since harsh measures
(acid-base extraction) were taken to extract these degradates,
data on the structural identity of these degradates would be of
little value. Therefore, no additional data on the identity of these
degradates is required.
The conjugated form of asulam was a maximum of 23.8
percent of the applied at 1 day posttreatment, then decreased to
an average of 9.4 percent by 366 days. The first alternative ionic
form of asulam (designated as Metabolite 2) was a maximum of
10.7 percent of the applied at 30 days, and the other alternative
ionic form (designated as Metabolite 3) was a maximum of 2.9
percent at 260 days. Acetyl asulam was a maximum of 14.3
percent of the applied at 7 days. Sulfanilamide was a maximum
of 3.6 percent of the applied at 366 days. (MRID 41767802)
Aerobic aquatic metabolism
The submitted aerobic aquatic soil metabolism study was
reviewed and found to be unacceptable for the same reasons as
described above in the aerobic soil metabolism section.
In the 1987 Registration Standard for asulam, aerobic
aquatic metabolism (162-4) studies were required because, at
40
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that time, it was used on ditch banks. Since the registrant has
deleted the ditch bank use on the label (EPA Registration
Number 264-447), this data requirement is no longer applicable.
However, the above study was still reviewed by the Agency
because it would provide additional information about the fate of
asulam in the aquatic environment.
If the registrant decides to add the aquatic use of asulam
on the label in the future, he/she can submit additional storage
information to upgrade this study.
Results from this study are summarized below:
Asulam appears to be relatively stable in the loam
soil/water system under anaerobic conditions (with a half-life of
105 days). Asulam degraded with a half-life of approximately
105 days in an aerobic sandy loam soil/water system that was
incubated in the dark at 20 °C. Four compounds other than
asulam were detected in this study. These included
sulfanilamide, and three compounds which were only
characterized as the ionic or conjugated form of asulam. The
study report did not explain what was meant by ionic or
conjugated form of asulam. However, since harsh measures
were taken (acid-base extraction) to extract these degradates,
data on the structural identity of these degradates would be of
little value. Therefore, no additional data on the identity of these
degradates are required.
The conjugated form of asulam increased from 2.8
percent of the applied immediately posttreatment, to 4.9 percent
at 30 days, and to a maximum of 6.1 percent at 273 days. Two
alternative ionic forms of asulam were present at a maximum of
7.8 and 19.8 percent, respectively, at 30 days. Sulfanilamide
was not found until day 15; it reached a maximum of 2.2 percent
at 273 days posttreatment. (MRID 41767801)
(2) Mobility
Leaching and adsorption/desorption
Information on the mobility of asulam in an aquatic
sediment required by the Agency prior to November 8, 1989, is
no longer needed because the registrant has deleted the ditch
41
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bank use of asulam on the label (EPA Registration Number 264-
447). However, these studies were reviewed by the Agency
because of their value in providing additional understanding of
the fate of asulam in the environment.
Results from these studies are summarized below:
Asulam is highly mobile in soil and has a strong potential
to leach into ground water or move offsite into surface water.
Data from the batch equilibrium study (Godward, 1988) indicate
that asulam is very mobile in autoclaved sand, clay loam, sandy
clay loam, and sandy loam soils, with Freundlich Kads values of
0.4-1.0 (Koc=18-115). Freundlich Kdes values ranged from 0.5-
1.6(KOC=20-127).
The mobility of asulam and its aged residues was further
confirmed in the column leaching study (Reeves, et al., 1988).
Following leaching, asulam was the only compound identified in
the leachates, which contained 77 percent of the radioactivity
applied to the sandy soil column, 60-to-61 percent of the applied
to the sandy loam, 47-to-52 percent of the applied to the sandy
clay loam, and 52-to-55 percent of the applied to the clay loam.
Residues remaining in the soil ranged from 14-to-17 percent in
the sand to 44-to-46 percent in the sandy clay loam columns; the
majority of the residues remaining in the soil were located in the
upper 6 cm of the soil columns and were unextractable with
acetone.
The batch equilibrium study and the column leaching
study are found to be acceptable to support the Leaching-
Adsorption/Desorption data requirements. However, the Agency
has concerns about the use of autoclave for sterilization of soils.
The Agency believes that physical or chemical sterilization may
indirectly alter the soil chemistry, thus complicating the
interpretation of the results obtained in the batch equilibrium
study.
Because the soil samples for the above studies were
combusted to determine the total residues (including extractable
as well as unextractable residues), the length of freezing storage
of these samples is unlikely to affect the findings. The
concentration of asulam and sulfanilamide in the aqueous
42
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samples did not appear to decline during the storage in the
refrigerator.
Results from the column leaching study along with the
batch equilibrium study have clearly demonstrated the potential
for asulam to leach in the environment. The leaching and
adsorption/desorption data requirement has been satisfied by the
submitted column leaching and batch equilibrium studies. No
additional information on the mobility of asulam and its
degradation products in soil is needed at this time. (MRIDs
41215101 and 40965001)
(3) Accumulation
Accumulation in Irrigated Crops
Regarding accumulation in irrigated crops (165-3), no
data are required. There are no registered aquatic uses for
asulam.
Bioaccumulation in Fish
Because the octanol/water partition coefficient for asulam
is very low (Kow=1.01), a bioaccumulation in fish study (165-4)
is waived.
Accumulation in Aquatic NonTarget Organisms
At this time, there are no registered aquatic uses for
asulam; therefore an accumulation in aquatic nontarget organism
study (165-5) is not required.
(4) Field Dissipation
Terrestrial
Three progress reports for the field dissipation/small-
scale prospective ground-water monitoring studies (164-1 and
166-1, respectively) were reviewed. These progress reports are
found to be unacceptable to support the Field Dissipation (164-1)
data requirement. Reasons are presented below:
43
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* The soil residue data were invalid because the analytical
methods (including the primary Analytical Method #7
and many other modified methods) could not effectively
extract and recover asulam and sulfanilamide in the soil
samples which were stored in the freezer for more than
10 months.
* Claims made in the submitted information were that the
residues of asulam and sulfanilamide in soil were either
very strongly bound or rapidly degraded (a claim
contradictory to the results of other laboratory studies),
resulting in poor method recoveries. However, no
information has been provided to explain why the
recoveries of asulam and sulfanilamide were so low, even
for the spiked soil which was kept at freezing temperature
for a relatively short period of time.
Since the field dissipation/small-scale prospective
ground-water monitoring studies are unlikely to provide any
additional information to support the Field Dissipation Data
Requirement (164-1), the final report does not need to be
submitted.
Aquatic
At this time, the aquatic field dissipation data requirement
(164-2) is not applicable because there are no registered aquatic
uses for asulam.
Forestry
At this time, the forestry field dissipation data
requirement (164-3) is not applicable because there are no
registered forestry uses for asulam.
Combination and Tank Mixes
At this time, combination and tank mixes data
requirement (164-4) is not applicable because there are no
registered combination and tank mix uses for asulam.
44
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Long-Term
At this time, long-term field dissipation data (164-5) are
not required because the Agency believes that the required
storage stability study (to investigate the fate of asulam residues
in soil under freezing storage) along with the field
dissipation/small-scale prospective ground-water monitoring
study will provide sufficient information for the understanding of
the fate of asulam in the field.
(5) Spray Drift
The registrant is required to submit data to support the
Spray Drift data requirements because aerial application of
asulam (EPA Registration Number 264-447) can cause damage
to nontarget plants due to spray drift. Rhone-Poulenc Ag
Company is a member of the Spray Drift Task Force (SDTF),
and therefore, may elect to satisfy these data requirements
through the SDTF. If the registrant wishes to satisfy these data
requirements in this manner, the procedures outlined in PR
Notice 90-3 should be followed.
c. Water Resources
(1) Ground Water
Although the small-scale prospective ground-water
monitoring (166-1) data requirement has not been satisfied, no
additional prospective ground-water studies will be required at
this time. Additional prospective ground-water study
requirements will be placed in reserve. Should long-term
monitoring demonstrate that unacceptable contamination of
ground water by asulam occurs in some use areas, further
restrictions on use could be necessary.
Three small-scale prospective ground-water studies were
required to determine the circumstances under which asulam
might leach into ground water. These reports detail the results of
three small-scale prospective ground-water studies and one
drinking water study for asulam (MRIDs 41561103, 42224701,
42534501, 41803901, 42704901).
45
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The ground-water studies were conducted at three sites in
the United States: a turf site in Florida, a sugarcane site in
Florida, and a sugarcane site in Louisiana. Due to the serious
problems of residue analysis in the soils, and dry wells at the
Louisiana site, little conclusive information concerning the
potential leaching of asulam into ground water was derived from
the studies. However, they are adequate to allow the Agency to
conclude that asulam will likely reach ground water especially
under the shallow ground-water conditions associated with
sugarcane usage.
(2) Surface Water
Results from the drinking water survey (pertaining to
drinking water derived from surface water sources) indicate the
presence of asulam (0.1 ppb) at the intakes to the community
water systems. Earlier data indicated that asulam residues would
degrade in aerobic aquatic conditions and not be carried far from
the site of application in surface water. This study demonstrates
asulam may move offsite into surface water.
3. Exposure and Risk Characterization
a. Ecological Exposure and Risk Characterization
Explanation of the Risk Quotient (RQ) and the Level of
Concern (LOC): The Levels of Concern are criteria used to indicate
potential risk to nontarget organisms. The criteria indicate that a
chemical, when used as directed, has the potential to cause undesirable
effects on nontarget organisms. There are two general categories of
LOC (acute and chronic) for each of the four nontarget faunal groups
and one category (acute) for each of two nontarget floral groups. In
order to determine if an LOC has been exceeded, a risk quotient must be
derived and compared to the LOC's. A risk quotient is calculated by
dividing an appropriate exposure estimate, e.g. the estimated
environmental concentration, (EEC) by an appropriate toxicity test
effect level, e.g. the LC50. The acute effect levels typically are:
-EC25 (terrestrial plants),
-EC50 (aquatic plants and invertebrates),
-LC50 (fish and birds), and
-LD50 (birds and mammals)
46
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The chronic test results are the:
-NOEL (sometimes referred to as the NOEC) for avian and mammal
reproduction studies, and either the NOEL for chronic aquatic studies,
or the Maximum Allowable Toxicant Concentration (MATC), the
geometric mean of the NOEL and the LOEL (sometimes referred to as
the LOEC) for chronic aquatic studies.
When the risk quotient exceeds the LOG for a particular
category, risk to that particular category is presumed to exist. Risk
presumptions are presented along with the corresponding LOC's.
Levels of Concern (LOC) and associated Risk Presumption
Mammals, Birds
IF THE LOC PRESUMPTION
0.5 High acute risk
0.2 Risk that may be mitigated through
restricted use
0.1 Endangered species may be affected
acutely
Chronic risk, endangered species may be affected
chronically,
Fish, Aquatic invertebrates
acute RQ>
acute RQ>
acute RQ>
chronic RQ> 1
IF THE
acute RQ>
acute RQ>
acute RQ>
chronic RQ> 1
Plants
IF THE
RQ>
RQ>
LOC PRESUMPTION
0.5 High acute risk
0.1 Risk that may be mitigated through
restricted use
0.05 Endangered species may be affected
acutely
Chronic risk, endangered species may be affected
chronically
LOC PRESUMPTION
1 High risk
1 Endangered plants may be affected
Currently, no separate criteria for restricted use or chronic effects
for plants exist.
47
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(1) Exposure and Risk to Nontarget Terrestrial Animals
(a) Terrestrial Animals Acute Risk
Avian and mammalian organisms may be exposed
to asulam through the consumption of food items (i.e.
grasses, insects, seeds and fruit) containing asulam
residues. Calculations of expected environmental
residues are based on the work by Hoerger and Kenaga
(1972).
A maximum application of 6.7 Ibs asulam on non-
cropland (i.e. rights-of way) is expected to produce
maximum residues on avian and mammalian food items
of 47 ppm (fruit) to 1608 ppm (short grass) and typical
residues of 10 ppm to 837 ppm.
As neither data on acute oral nor subacute dietary
testing are available for technical asulam, the avian
dietary LC50 for the 60 percent formulation (75,000 ppm)
was adjusted to 100 percent a.i. (45,000 ppm). As the
maximum expected residue of 1608 ppm falls short of the
high level of concern (0.5 LC50 = 22,500), adverse acute
effects to nontarget avian species are not expected from
the proposed reregi strati on of asulam.
The mammalian LC50 value can be estimated
using the following formula:
LC50 = LD50 x body weight (g)/ daily food consumption (g)
LC50 = 5,000 mg/kg x 0.10 kg/10 g = 50,000 ppm (young rat)
Therefore, an LD50 of 5,000 for the rat would
convert to an LC50 of 50,000 ppm. As the maximum
expected residue of 1608 ppm falls short of the high level
of concern (0.5 LC50 = 25,000), adverse acute effects to
nontarget mammalian species are not expected from the
proposed reregi strati on of asulam.
(b) Terrestrial Animals Chronic Risk
Chronic effects to avian species cannot be
assessed at this time due to lack of avian reproduction
48
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data. However, the Agency believes there is little
potential for adverse effects to avian reproduction as the
available environmental fate information indicates that
photolysis in water and soil is very rapid — approximately
2 hours. Although asulam may be applied more than
once to sugarcane and Christmas tree plantations, a
scenario reflecting the decline of residues on long grass
treated at 3.3 Ibs ai/A showed maximum residues of 367
ppm immediately after application dissipating to less than
1 ppm within one day. Even allowing for a repeat
application after 14 days, the average residues would
only be 23 ppm. Furthermore, any residue not exposed to
sunlight but subjected to rainfall will rapidly move from
the area through either leaching or surface runoff due to
asulam's high mobility. In addition, asulam has a very
low potential for bioaccumulating in birds based on the
Kow of 1.0. Lastly, the major degradate — sulfanilamide —
need not be tested as it comprised only 27.6% of the
applied parent in the soil photodegradation study.
Therefore, avian reproduction studies on the bobwhite
quail and mallard duck (71-4 a,b) are not required at this
time.
Based on the overlap between the LOEL range of
1000 ppm to 5000 ppm for mammalian reproduction and
the maximum expected residues on mammalian food
items (1608 ppm on short grass), use of asulam on
noncropland (maximum 6.7 Ibs a.i./A) may exceed levels
of concern (EEC/LOEL range) for mammalian
reproduction (risk quotient range of 0.32 to 1.6). The
LOG for mammalian reproduction is not surpassed when
compared to the typical (i.e. average) residues on short
grass (837 ppm). In addition, rights-of-way are more
likely to have long grass than short grass (typical for turf
sites). Even when compared to the maximum expected
residues on long grass (737 ppm), the LOG for
mammalian reproduction is not exceeded. Therefore, the
Agency concludes that the use of asulam on noncropland
at the maximum use rate, or any other use site, is not
likely to adversely affect mammalian reproduction.
49
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(c) Insects
Asulam may be applied during the flowering time
of a variety of nontarget plants. Thus, there is the
potential of exposure to honey bees from asulam use.
However, minimal risk to these organisms is expected as
asulam is practically nontoxic to honey bees (LD50 >
36.26 ug/bee).
(2) Exposure and Risk to Nontarget Aquatic Animals
(a) Acute Risk
Aquatic fauna may be exposed to asulam residues
via runoff and/or drift to water bodies or through an
inadvertent direct application to water. A direct
application of asulam to water would result in an
estimated environmental concentration (EEC) of 408 ppb
in six feet of water [61 ppb x 6.7 Ibs ai/A = 408 ppb].
As the aquatic EEC does not surpass the high level
of concern (0.5 LC50) for the most sensitive fish species
(0.5 LC50 = >87 ppm for the rainbow trout) or the most
sensitive aquatic invertebrate species (0.5 LC50 = 13 ppm
for Daphnia magna), acute risk to aquatic fauna are not
expected from the proposed reregi strati on of asulam.
(b) Chronic Risk
Chronic effects to fish and aquatic invertebrates
cannot be assessed at this time due to lack of data.
However, the Agency is concerned with adverse effects
to these organisms as the available environmental fate
information indicates that asulam is possibly persistent
and has a high potential to move to ground and surface
water. In addition, the unrefined aquatic EEC for a direct
application to 6 feet of water (408 ppb) exceeds 0.01 EC50
(270 ppb) for Daphnia magna. Asulam may also be
applied more than once to sugarcane and possibly to
Christmas tree plantations and non-cropland areas (label
does not specify). Therefore, a life-cycle aquatic
invertebrate study with Daphnia magna (72-4b) is
required at this time. The early life-stage fish study (72-
50
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4a) is in reserve status pending results of the daphnia life-
cycle study.
(3) Exposure and Risk to Nontarget Plants
Exposure of nontarget terrestrial and aquatic plants to
asulam is based on expected runoff from ground applications
and from runoff and drift from aerial applications (sugarcane and
Christmas tree plantations).
(a) Terrestrial and Semi-aquatic
Terrestrial plant EEC's are calculated by
estimating the runoff from one acre treated at the
maximum application rate to an adjacent one acre site.
Semi-aquatic plant EEC's are calculated by estimating the
runoff from a 10 acre site treated at the maximum
application rate to an adjacent one acre wetland area. For
example, at a maximum ground application rate of 6.7 Ibs
a.i./A (non-cropland) and anticipated 5 percent runoff of
applied pesticide, runoff into areas adjacent to treated
sites is expected to be 0.33 Ibs. a.i./A (see table below).
Runoff into a wetland area (i.e., moist, saturated or
flooded soils) away from treated sites is expected to be
approximately 3.3 Ibs a.i./A.
51
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Estimated Environmental Concentrations and Risk Quotients
USE SITE
Noncrop (rights-of-
way,
industrial,fences)
Sugarcane,
Christmas tree
plantations,
ornamentals
Turf
Rights-of-way (Sec.
24C PA)
MAX.
APPL.
RATE
(LBS
A.I./A)
6.68
3.34
2.10
1.67
LEVEL OF
CONCERN1
EC25 = 0.08 EC25
= 0.0002 EC50 =
0.14
EC25 = 0.08
EC50 = 0.14
EC25 = 0.08
EC50 = 0.14
EC25 = 0.08
EC50 = 0.14
EC25 = 0.0002
TERR.
PLANTS
ADJACENT
TO USE SITE
EEC2
(Ibs
ai/A)
0.33
0.17
0.273
0.174
0.10
0.08
0.133
0.084
Risk
Quot.
4.1
2.1
3.83
8504
1.2
1.1
1.83
4004
SEMI-
AQUATIC
PLANTS IN
WET AREAS
AWAY
EEC2
(Ibs
ai/A)
3 3
1.7
1.2s
0.174
1.0
0.8
0.583
0.084
Risk
Quot.
41
21
173
8504
12
11
83
4004
AQUATIC
PLANTS
EEC2
(ppm)
0.2
0.10
0.073
0.064
0.05
0.033
Risk
Quot.
1.5
0.73
0.513
0.46
0.35
0.213
1. Levels of Concern: atterrestrial plants - lowest
EC25 value (lettuce shoot length) = 0.08 Ibs a.i./A for seedling germination and emergence tests; this value is compared to runoff alone and runoff plus
drift calculations; lowest EQ5 value (cucumber root weight) = 0.0002 Ibs a.i./A for vegetative vigor; this value is compared to drift calculations; b)
aquatic plants - lowest ECJO value from aquatic plant studies (^emna gibba ECJO = 0.14 ppm).
2. EEC values are based on runoff from ground applications, except where noted for aerial applications to sugarcane and Christmas tree plantations.
3. EEC value and corresponding risk quotient for aerial application (runoff and drift).
4. EEC value and corresponding risk quotient for aerial application (drift only).
A high level of concern exists for both endangered
and non-endangered terrestrial and semi-aquatic plants if
the EEC exceeds the EC25 value for the most sensitive
plant species tested or, in other words, the risk quotient is
greater than 1.0. In the above table, the shaded areas
indicate that the high level of concern for endangered and
non-endangered terrestrial and semi-aquatic plants has
been exceeded for all use patterns.
The Agency has a fairly high degree of certainty
concerning these LOG exceedences for terrestrial and
semi-aquatic plants. Asulam is an herbicide which is
designed to kill plants. Therefore, it is almost a given
that LOC's will be exceeded. By how many times the
LOC's are exceeded is another question. There is an even
higher certainty that the use of asulam will adversely
52
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affect nontarget semi-aquatic plants as the risk quotients
are higher. Drift from aerial applications will certainly
pose a hazard to nontarget terrestrial and semi-aquatic
plants as the risk quotients are 400 - 850. The EC25 value
(cucumber root weight) used for the drift calculations was
extrapolated from the data because the laboratory failed
to test at sufficiently low concentrations to determine an
EC25. When this test is repeated it is expected that the
EC25 value may be even lower, thus, increasing the
magnitude by which the LOC's are surpassed.
(b) Aquatic
Aquatic EECs are calculated using the estimated
runoff from 10 acres treated at the highest registered rate
flowing into a 1 acre water body, six feet deep. For
example, at a maximum application rate of 6.7 Ibs a.i./A
(non-cropland) to a 10 acre watershed with anticipated 5
percent runoff of applied pesticide, the concentration of
asulam in six feet of water is expected to be 0.2 ppm.
A high level of concern exists for both endangered
and non-endangered aquatic plants if the EEC exceeds
the EC50 value for the most sensitive plant species tested
or, in other words, the risk quotient is greater than 1.0. In
the above table, the shaded areas beneath the aquatic
plants heading indicate that the high level of concern for
endangered and non-endangered aquatic plants has been
exceeded for the non-cropland use pattern only. Because
the risk quotient is fairly low (1.5), a refined aquatic risk
assessment will most likely reduce the EEC below the
level of concern.
(4) Endangered Species
Based on the conclusions in the preceding sections of this
risk assessment, all registered uses of asulam might pose a
significant risk to endangered terrestrial and semi-aquatic plant
species inhabiting areas adjacent to treated sites and those in wet,
low-lying areas farther away from treated sites. Use of asulam
on non-cropland areas (i.e., rights-of-way, fence rows) might
pose a risk to nearby endangered aquatic plant species as well.
53
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All endangered plant species inhabiting certain target
areas (i.e., rights-of-way) are likely to be jeopardized as they will
receive a direct application of asulam.
The Endangered Species Protection Program is expected
to be implemented in the future. Limitations on the use of
asulam will be required to protect endangered and threatened
species, but these limitations have not yet been defined (and may
be formulation specific). OPP anticipates that consultation with
the Fish and Wildlife Service will be conducted in accordance
with the species-based priority approach described in the
Program. After completion of consultation, registrants will be
informed if any required label modifications are necessary. Such
modifications would most likely consist of the generic label
statement referring pesticide users to use limitations contained in
county bulletins.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after
submission of relevant data concerning an active ingredient, whether products
containing the active ingredient are eligible for reregi strati on. The Agency has
previously identified and required the submission of the generic (i.e., active ingredient
specific) data required to support reregi strati on of products containing asulam and its
sodium salt as active ingredients. The Agency has completed its review of these
generic data, and has determined that based on the information currently available,
there are data to support reregi strati on of all products containing asulam and its
sodium salt; however, a reregi strati on eligibility decision on products registered for
use on sugarcane cannot be made at this time for reasons discussed in Section IV.A.I.
Appendix B identifies the generic data requirements that the Agency reviewed as part
of its determination of reregi strati on eligibility of asulam and its sodium salt, and lists
the submitted studies that the Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess
the registered uses of asulam and its sodium salt. The Agency has determined that
except for the use on sugarcane, asulam and its sodium salt can be used without
resulting in unreasonable adverse effects to humans and the environment. To ensure
that the potential risks of asulam are not unreasonable, the Agency is requiring the
registrant to implement certain risk mitigation measures. Provided these risk
mitigation measures are implemented, the Agency finds that all products containing
asulam and its sodium salt as the sole active ingredient are eligible for reregi strati on
54
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for all uses with the exception of sugarcane. The reregi strati on of particular products
is addressed in Section V of this document.
The Agency made its reregi strati on eligibility determination based upon the
target data base required for reregistration, the current guidelines for conducting
acceptable studies to generate such data, published scientific literature, etc. and the
data identified in Appendix B. The Agency has found that all uses of asulam and its
sodium salt, except for sugarcane, 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 asulam
and its sodium salt, if new information comes to the Agency's attention or if the data
requirements for registration (or the guidelines for generating such data) change.
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredients
asulam and its sodium salt, the Agency has sufficient information on the health
effects of asulam and its sodium salt and on its potential for causing adverse
effects in fish and wildlife and the environment. Although levels of concern are
exceeded for endangered and non-endangered plant species and surfacewater
and groundwater quality, the Agency concludes that products containing
asulam and its sodium salt for all uses, with the exception of sugarcane, once
amended to reflect the risk mitigation measures imposed in this RED, are
eligible for reregistration.
The Agency is unable to make a reregistration eligibility decision on the
use of asulam and its sodium salt on sugarcane because data show that asulam
concentrates in the processed animal feed commodity, blackstrap molasses.
Under current policies, the establishment of the necessary feed additive
regulation (tolerance) to cover residues in this commodity may be barred by the
Delaney clause of Section 409 of the Federal Food, Drug and Cosmetic Act
(FFDCA) because asulam may induce cancer in animals within the meaning of
the Delaney clause.
2. Eligible and Ineligible Uses
The Agency has determined that the use of asulam and its sodium salt
on the following use sites are eligible for reregistration: Christmas tree
plantations, ornamentals, turf (St. Augustinegrass and Bermudagrass), and non-
cropland (boundary fences, fencerows, hedgerows, lumberyards, storage areas,
industrial plant sites, and warehouse lots). The decision for the use of asulam
and its sodium salt on sugarcane cannot be made at this time because a feed
additive regulation for blackstrap molasses may be required.
55
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B. Regulatory Position
The following is a summary of the regulatory positions and rationales for
asulam and its sodium salt. Where labeling revisions are imposed, specific language is
set forth in Section V of this document.
1. Tolerance Reassessment
Tolerances Listed Under 40 CFR §180.360
The tolerances listed in 40 CFR §180.360 are for residues of asulam per
se on sugarcane. The tolerance expression must be revised to include all
metabolites containing the sulfanilamide moiety. A summary of the asulam
tolerance reassessment is presented in Table III.
The qualitative nature of the residue in animals is adequately understood
based on acceptable poultry and ruminant metabolism studies. The residue of
concern in milk, eggs, and animal tissues is asulam and its metabolites
containing the sulfanilamide moiety. The only ruminant feed item containing
asulam is molasses; there are no poultry feed items. Magnitude of the residue
studies in ruminants conducted at a slightly exaggerated rate (2X) show that
quantifiable residues of asulam and its sulfanilamide-containing metabolites in
ruminant commodities from a IX dietary exposure do occur in meat, meat
byproducts, and milk, but not in fat. Therefore, ruminant commodity
tolerances are needed, as presented in Table III.
Processed Food (40 CFR §185^ and Feed (40 CFR §186^ Tolerances
No food/feed additive tolerances have been established for asulam. An
adequate processing study has been conducted with sugarcane for asulam and
its metabolites containing the sulfanilamide moiety. A tolerance proposal is
needed for residues of asulam and its metabolites containing the sulfanilamide
moiety in the sugarcane processed commodity blackstrap molasses at 48X the
reevaluated tolerance. An appropriate tolerance would be 720 ppm, based on
the revised tolerance of 15 ppm for sugarcane.
However, as noted previously, the Agency may be barred from
establishing a food or feed additive tolerance for blackstrap molasses because
of the Delaney clause of FFDCA. This clause prohibits the establishment of a
regulation for any food/feed additive that is found to induce cancer in man or
animals. The Ninth Circuit Court of Appeals has ruled that EPA must interpret
this provision strictly. Therefore, since asulam may be found to be an animal
carcinogen within the meaning of the Delaney clause, EPA may not be able to
establish a processed feed tolerance for blackstrap molasses. Further, under
56
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current Agency policy if a food/feed additive tolerance cannot be established
due to the Delaney clause, EPA will neither establish nor continue in effect a
tolerance for the associated raw agricultural commodity. As part of the
settlement agreement in a recent court case challenging the Agency's
implementation of the Delaney clause (California vs. Browner), the Agency
committed to a schedule for determining whether revocation was warranted for
raw agricultural commodity tolerances where a food/feed additive tolerance
was needed or established and the pesticide at issue possibly was a carcinogen
within the meaning of the Delaney clause. These decisions are to be made in
three groups beginning in October 1995, with final revocation, if necessary, for
all three groups scheduled for no later than 2000.
Because final revocation, if necessary, is likely to be several years
away, the Agency believes it would be important to revise the existing raw
agricultural commodity tolerance for sugarcane from the current 0.1 ppm to 15
ppm consistent with new cropfield trial data and to establish new meat, milk
and meat by-product tolerances. Current residue data suggest the existing
tolerance should be raised to 15 ppm from 0.1 ppm. However, the registrant is
submitting further additional data reflecting longer PHI's and more accurate
timing of application which will likely result in a tolerance level lower than the
15 ppm. After reviewing these data, the Agency will establish a new sugarcane
tolerance and require the registrant to petition for new meat, milk, and meat by-
product tolerances.
These tolerances once established may ultimately be revoked as part of
the commitment to review the underlying raw agricultural tolerance for
sugarcane. The Agency recently announced certain modifications in its
policies concerning which pesticide uses require a food/feed additive regulation
(response to the NFPA Petition June 14, 1995; 60 FR 31300). These changes
may effect the need for a feed additive regulation for asulam on blackstrap
molasses. One of the policy decisions concerned "ready-to-eat" animal feeds
and under what circumstances these feeds will need a food/feed additive
regulation. Under this policy, it is possible that residues of asulam in
blackstrap molasses may be adequately covered by the tolerance in the raw
agricultural commodity (sugarcane) so that establishing a feed additive
tolerance will be unnecessary. If it can be shown that blackstrap molasses is
unpalatable when fed "as is," EPA will not categorize it as "ready-to-eat."
Further, if EPA determines that once blackstrap molasses is mixed with other
feed items before feeding and this mixing dilutes the asulam residues such that
57
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they are below the raw agricultural commodity tolerance level, it will not be
necessary to establish a feed additive regulation.
By amending and establishing tolerances for what may be an interim
period, the Agency believes it is providing appropriate and responsive
regulatory measures to avoid production of adulterated food which could be
subject to possible crop and food commodity seizures. The Agency also
believes this action will help keep any public misunderstanding or
misconception regarding dietary risk from asulam to a minimum.
Table III.
Tolerance Reassessment Summary
Commodity
Current
Tolerance (ppm)
Tolerance
Reassessment (ppm)
Tolerance listed under 40 CFR
Sugarcane
Milk
Cattle, meat
Cattle, mbyp
Goats, meat
Goats, mbyp
Hogs, meat
Hogs, mbyp
Horses, meat
Horses, mbyp
Sheep, meat
Sheep, mbyp
0.1
None
None
None
None
None
None
None
None
None
None
None
15
0.2
0.1
0.6
0.2
0.6
0.1
0.6
0.1
0.6
0.1
0.6
Comment
§180.360
Existing studies show that the current
tolerance is exceeded and that residues
are as great as 15 ppm (150X).
Based on evaluation of 50 ppm and 200
ppm feeding studies and a ruminant diet
containing a maximum of 100 ppm
asulam.
CODEX HARMONIZATION
There are no Codex MRLs established or proposed for residues of
asulam. Therefore, there are no questions with respect to compatibility of U.S.
tolerances with Codex MRLs.
2. Risk Mitigation
The Agency has determined that the current uses of asulam exceed
levels of concern for endangered and nonendangered terrestrial and semi-
aquatic plants for all uses. For noncropland uses, asulam exceeds LOCs for
58
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endangered and nonendangered aquatic plants. Several risk mitigation
measures proposed by the technical registrant, Rhone Poulenc, and accepted by
the Agency are being required. These risk mitigation measures include
reducing application rates, reducing number of applications per season,
prohibiting aerial uses for noncropland and Christmas tree use sites, and adding
groundwater and surface water label advisories. These risk mitigation
measures are required for all asulam registrants.
The technical registrant, Rhone-Poulenc, has withdrawn the
Pennsylvania SLN issued under FIFRA section 24(c) - aerial application on
rights-of-way. Likewise, Rhone Poulenc is prohibiting the aerial uses of
asulam for noncropland and Christmas trees use sites by voluntarily cancelling
aerial application. Rhone-Poulenc is clarifying the noncropland use to be
limited to 1 gallon/A rate, 1 application/season; clarifying the Christmas tree
uses to be limited to 1 application/season; and clarifying the turf use to limit
use to sod farms use only and 1 application/season. In addition, Rhone-
Poulenc also agreed to clarify the environmental fate assessment methodology
and the uncertainty associated with the extraction technique and recovery of
asulam from the laboratory versus the field studies. The clarification of the
recovery methodology will reduce the uncertainty associated with the
environmental fate assessment.
Ground water and Surface water concerns: Due to ground water and
surface water quality concerns, the following mitigation steps are required:
• Asulam has the potential to leach to ground water.
Therefore all product labels must carry a ground water
advisory. The label language for this advisory can be
found in Section V of this document.
• Rhone-Poulenc is required to initiate long-term monitoring to
determine if unacceptable contamination of ground water occurs
in some use areas. Therefore, long-term monitoring in
cooperation with the States and USGS is necessary.
• Asulam has the potential to move offsite to surface water.
Therefore all product labels must carry a surface water advisory.
The label language for this advisory can be found in Section V
of this document.
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3. Endangered Species Statement
The Agency has concerns about the exposure of threatened and
endangered plant species to asulam. Based on the conclusions discussed in the
preceding sections of this risk assessment, endangered species LOCs are
exceeded for terrestrial and semi-aquatic plants for all uses. Also, asulam
exceeds the level of concern for endangered aquatic plants for noncropland
uses.
Currently, the Agency is developing a program ("The Endangered
Species Protection Program") to identify all pesticides whose use may cause
adverse impacts on endangered and threatened species and to implement
mitigation measures that will eliminate the adverse impacts. The program
would require use restrictions to protect endangered and threatened species in
the county. Consultations with the Fish and Wildlife Service may be necessary
to assess risks to newly listed species or from proposed new uses. In the future,
the Agency plans to publish in the Federal Register a description of the
program and have available enforceable county-specific bulletins. Because the
Agency is taking this approach for protecting endangered and threatened
species, it is not imposing label modifications at this time through the RED.
Rather, any requirements for product use modifications will occur in the future
under the Endangered Species Protection Program.
4. Labeling Rationale
a. Worker Protection
Any product whose labeling reasonably permits use in the production of
an agricultural plant on any 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, PR
Notices 93-7 and 93-11. Unless otherwise specifically directed in this RED, all
statements required by PR Notices 93-7 and 93-11 are to be on the product
label exactly as instructed in those notices.
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
60
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Notice complying labeling when they are distributed or sold by the primary
registrant or any supplementally registered distributor.
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.
Uses within the scope of the Worker Protection Standard
The 1992 Worker Protection Standard for Agricultural Pesticides (WPS)
established certain worker-protection requirements (personal protective
equipment, restricted entry intervals, etc.) to be specified on the label of all
products that contain uses within the scope of the WPS. Uses within the scope
of the WPS include all commercial (non-homeowner) and research uses on
farms, forests, nurseries, and greenhouses to produce agricultural plants
(including food, feed, and fiber plants, trees, flowers, shrubs, ornamentals, and
seedlings). Uses within the scope include not only uses on plants, but also uses
on the soil or planting medium the plants are (or will be) grown in.
Some of the registered uses of asulam are within the scope of the
Worker Protection Standard (WPS) and some uses are outside the scope of the
WPS. Those that are outside the scope of the WPS include use:
• on plants grown for other than commercial or research purposes, which
may include plants in home lawns, home gardens and home
greenhouses,
• on plants that are in ornamental gardens, parks, golf courses, and public
or private lawns and grounds and that are intended only for decorative
or environmental benefit. (However, pesticides used on sod farms are
covered by the WPS).
• in a manner not directly related to the production of agricultural plants,
including, for example, control of vegetation along rights-of-way and in
other noncrop areas.
Personal Protective Equipment (PPE) for Handlers
(Mixer/Loader/Applicators)
For each end-use product, PPE requirements for pesticide handlers will
be set during reregi strati on in one of two ways:
1. If the Agency has no special concerns about the acute or other
adverse effects of an active ingredient, the PPE for pesticide handlers
will be based on the acute toxicity of the end-use product. For
61
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occupational-use products, PPE will be established using the process
described in PR Notice 93-7 or more recent EPA guidelines.
2. If the Agency has special concerns about an active ingredient due to
very high acute toxicity or to certain other adverse effects, such as
allergic effects or delayed effects (cancer, developmental toxicity,
reproductive effects, etc):
• In the RED for that active ingredient, the Agency may
establish minimum or "baseline" handler PPE
requirements that pertain to all or most occupational end-
use products containing that active ingredient.
• These minimum PPE requirements must be compared
with the PPE that would be designated on the basis of the
acute toxicity of each end-use product.
• The more stringent choice for each type of PPE (i.e.,
bodywear, hand protection, footwear, eyewear, etc.) must
be placed on the label of the end-use product.
There are no special toxicological concerns about asulam that warrant
the establishment of active-ingredient-based minimum PPE requirements.
Entry Restrictions
Entry Restrictions for Occupational-Use Products (WPS Uses)
Some of the registered uses of asulam are within the scope of the
Worker Protection Standard (WPS).
Restricted Entry Interval — Under the Worker Protection Standard
(WPS), interim restricted entry intervals (REI) for all uses within the scope of
the WPS are established based on the acute toxicity of the active ingredient.
The toxicity categories of the active ingredient for acute dermal toxicity, eye
irritation potential, and skin irritation potential are used to determine the interim
WPS REI. If one or more of the three acute toxicity effects are in toxicity
category I, the interim WPS REI is established at 48 hours. If none of the acute
toxicity effects are in category I, but one or more of the three is classified as
category II, the interim WPS REI is established at 24 hours. If none of the
three acute toxicity effects are in category I or II, the interim WPS REI is
established at 12 hours. The WPS specifically retains two types of REI's
established by the Agency prior to the promulgation of the WPS: (1) product-
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specific REI's established on the basis of adequate data and (2) interim REI's
that are longer than those that would be established under the WPS.
For occupational end-use products containing asulam as an active
ingredient, the Agency is maintaining the current a 12 hour REI pertaining to
each use of the product that is within the scope of the Worker Protection
Standard. The 12 hour REI is the minimum acceptable REI for asulam.
The WPS places very specific restrictions on entry during restricted-
entry intervals when that entry involves contact with treated surfaces. These
existing WPS protections are sufficient to mitigate post-application exposures
of workers who contact surfaces treated with asulam. The WPS REI in effect
until now was 12 hours.
Early Entry PPE — The WPS establishes very specific restrictions on
entry by workers to areas that remain under a restricted-entry interval if the
entry involves contact with treated surfaces. Among those restrictions, are a
prohibition of routine entry to perform hand labor tasks and requirement that
PPE be worn. Personal protective equipment requirements for persons who
enter areas that remain under a restricted-entry interval and contact treated
surfaces are based on the toxicity concerns about the active ingredient. The
requirements are set in one of two ways.
1. If the Agency has no special concerns about the acute or
other adverse effects of an active ingredient, it establishes
the early-entry PPE requirements based on the acute
dermal toxicity, skin irritation potential, and eye irritation
potential of the active ingredient or the minimum early-
entry requirements specified under the Worker Protection
Standard. The more protective PPE is to be used. These
minimum WPS requirements are: coveralls, chemical
resistant gloves, and shoes plus socks.
2. If the Agency has special concerns about an active
ingredient due to very high acute toxicity or to certain
other adverse effects, such as allergic effects, cancer,
developmental toxicity, or reproductive effects, it may
establish early entry PPE requirements that are more
stringent than would be established otherwise.
The personal protective equipment for early entry is the minimum
required under the WPS: coveralls, chemical resistant gloves, and shoes plus
socks.
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Entry Restrictions for Occupational-Use Products (NonWPS Uses)
Some registered uses of asulam are outside the scope of the Worker
Protection Standard (WPS). For nonWPS uses the Agency is requiring the
following.
"Do not enter or allow others to enter the treated area
until sprays have dried."
Homeowner-Use Products
There are no products containing asulam that provide directions
intended for homeowner use. Current labelling provides the statement "for
agricultural or commercial use only, not for use by homeowners." This
statement is to be maintained.
b. Environmental Hazard
The Agency is requiring labeling to address risk to wetland areas.
(Refer to Section V).
c. Spray Drift Advisory
The Agency has been working with the Spray Drift Task Force, EPA
Regional Offices and State Lead Agencies for pesticide regulation to develop
the best spray drift management practices. The Agency is now requiring
interim measures that must be placed on product labels/labeling as specified in
Section V. Once the Spray Drift Task Force completes their studies, submits
data, and the Agency evaluation is completed, there may be further refinements
in spray drift management practices.
V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for the
reregi strati on of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregi strati on of asulam and its
sodium salt for the above eligible uses has been reviewed and determined to be
substantially complete.
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In summary, based on the information currently available to the
Agency, all uses of asulam are eligible for reregistration, with the exception of
sugarcane. Furthermore, the Agency is requiring that additional confirmatory
data be submitted to fulfill the generic data requirements for reregistration of
asulam.
Chronic Aquatic Invertebrate Toxicity - Daphnia Magna
Aerobic Soil Metabolism
Anaerobic Soil and Aquatic Metabolism
Droplet Size Spectrum
Drift Field Evaluation
Directions for Use - Label amendment (lower application rate and/or
longer PHI)
Plant Metabolism Study
Magnitude of Residue - Sugarcane
Confined Rotational Crop
After reviewing additional field trial data for sugarcane, the Agency
will establish a new sugarcane tolerance and require the registrant to petition
for new meat, milk and meat by-product tolerances.
Certain data are not part of the reregistration target database for
asulam, but are also required:
Seedling emergence - soybeans and radish
Vegetative vigor - cucumber and onion
2. Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing use product (MP)
labeling must be revised to comply with all current EPA regulations, PR
Notices and applicable policies. The MP labeling must bear the following
statement under Directions for Use:
"Only for formulation into a herbicide for the following uses(s): _
(fill blank only with those uses that are being supported by MP
registrant)."
An MP registrant may, at his/her discretion, add one of the
following statements to an MP label under "Directions for Use" to
permit the reformulation of the product for a specific use or all
additional uses supported by a formulator or user group:
65
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(a) "This product may be used to formulate products for specific
use(s) not listed on the MP label if the formulator, user group, or
grower has complied with U.S. EPA submission requirements
regarding the support of such uses(s)."
(b) "This product may be used to formulate products for any
additional use(s) not listed on the MP label if the formulator,
user group, or grower has complied with U.S. EPA submission
requirements regarding the support of such uses(s) and the
Agency has registered the end-use products being produced."
B. End-Use Products
1. Additional 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 Appendix
G, the Product Specific Data Call-in Notice.
Registrants must review previous data submissions to ensure that they
meet current EPA acceptance criteria (Appendix F; Attachment E) 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.
2. Labeling Requirements for End-Use Products
a. Worker Protection
(1) Personal Protective Equipment/Entry Restrictions;
Labeling
Personal Protective Equipment (PPE) for Handlers
(Mixer/Loader/Applicators)
The PPE for mixer/loader/applicators is to be based on the acute
toxicity of the end-use product.
66
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Entry Restrictions for Occupational-Use Products (WPS Uses)
Based on the assessment of human health risks, the Agency does
not believe an increase in the REI above what is required in the Worker
Protection Standard (WPS) is warranted. The current 12 hour REI,
pertaining to each use of the product that is within the scope of the
WPS, is to be maintained. This 12 hour REI is the minimum acceptable
REI for asulam.
Early Entry PPE: The PPE for early entry are the minimum that
would be required under the WPS. These are: coveralls, chemical-
resistant gloves, shoes, and socks.
Entry Restrictions for Occupational-Use Products (NonWPS
Uses)
Some registered uses of asulam are outside the scope of the
Worker Protection Standard (WPS). For nonWPS uses the Agency is
requiring the following.
"Do not enter or allow others to enter the treated area
until sprays have dried."
(2) Other Labeling Requirements
The Agency is requiring the following labeling statements to be
located on all end-use products containing asulam that are intended
primarily for occupational use:
(a) Products Intended Primarily for Occupational Use
Engineering Controls Used
"When handlers use closed systems,
enclosed cabs, or aircraft in a manner that meets
the requirements listed in the Worker Protection
Standard for Agricultural Pesticides (WPS) [40
CFR 170.240(d)(4-6)], the handler PPE
requirements may be reduced or modified as
specified in the WPS. However, full PPE must be
available in the event that the handler exits the
aircraft, enclosed cab, etc. prior to the REI."
67
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User Safety Requirements
"Follow manufacturer's instructions for
cleaning/maintaining PPE. If no such instructions
for washables, use detergent and hot water. Keep
and wash PPE separately from other laundry."
User Safety Statements
"Users must wash hands before eating,
drinking, chewing gum, using tobacco, or using
the toilet."
"Users must leave the treated area, and
remove clothing immediately if pesticide gets
inside."
"Users must remove PPE immediately after
handling this product. As soon as possible, wash
thoroughly and change into clean clothing. Wash
the outside of gloves before removing."
Application Restrictions
"Do not apply this product in a way that
will contact workers or other persons, either
directly or through drift. Only handlers with
appropriate PPE may be in the area during
application."
(b) Homeowner-Use Products
There are no products containing asulam that provide directions
intended for homeowner use. Current labelling provides the statement
"for agricultural or commercial use only, not for use by homeowners."
This statement is to be maintained.
b. Environmental Hazard Statements
The labels of all asulam end-use products must be revised to bear
the following under the Environmental Hazard Section:
68
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Wetland Statement
"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 wash water or
rinsate."
Ground Water Advisory
"This chemical is known to leach through soil into
ground water under certain conditions as a result of
agricultural use. Use of this chemical in areas where soils
are permeable, particularly where the water table is
shallow, may result in ground-water contamination."
Surface Water Advisory
"Surface water contamination may occur in areas with
poorly draining soils and little or no buffers or in areas
where drainage systems flow directly to surface water."
c. Application Restrictions
The labels of all asulam end-use products must be revised to bear
the following application restrictions under the Directions for Use
Section:
For noncropland and Christmas tree uses:
"Aerial application is prohibited"
For turf uses:
"For sod farm use only"
d. Application Rates
The labels of all asulam end-use products must be revised to bear
the following application rates under the Crop Uses Section for the
respective crops:
For asulam use on noncropland sites:
A maximum application rate of 1 gallon/A with use limited to
single application per year.
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For asulam use on Christmas trees:
A maximum application of 1 gallon/A with use limited to single
application per year.
For asulam use on turf (sod farm use only):
A maximum application of 1 gallon/A with use limited to single
application per year.
e. Spray Drift
The following language must be placed on each asulam product
label that can be applied aerially:
"AVOIDING SPRAY DRIFT AT THE APPLICATION SITE IS
THE RESPONSIBILITY OF THE APPLICATOR."
"The interaction of many equipment and weather-related
factors determine the potential for spray drift. The
applicator is responsible for considering all these factors
when making decisions."
"The following drift management requirements must be
followed to avoid off-target movement from aerial
applications to agricultural field crops. These
requirements do not apply to forestry applications, public
health uses or to applications using dry formulations."
1. "The distance of the outer most nozzles on the boom
must not exceed 3/4 the length of the wingspan or rotor."
2. "Nozzles must always point backward parallel with
the air stream and never be pointed downwards more than
45 degrees."
"Where states have more stringent regulations, they
should be observed."
The applicator should be familiar with and take into account the
information covered in the Aerial Drift Reduction Advisory below.
70
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AERIAL DRIFT REDUCTION ADVISORY
The following aerial drift reduction advisory information must
be contained in the product labeling:
[This section is advisory in nature and does not supercede the
mandatory label requirements].
INFORMATION ON DROPLET SIZE
The most effective way to reduce drift potential is to
apply large droplets. The best drift management strategy is to
apply the largest droplets that provide sufficient coverage and
control. Applying larger droplets reduces drift potential, but will
not prevent drift if applications are made improperly, or under
unfavorable environmental conditions (See Wind, Temperature
and Humidity, and Temperature Inversions).
CONTROLLING DROPLET SIZE
o Volume - Use high flow rate nozzles to apply the
highest practical spray volume. Nozzles with
higher rated flows produce larger droplets.
o Pressure - Do not exceed the nozzle
manufacturer's recommended pressures. For
many nozzle types lower pressure produces larger
droplets. When higher flow rates are needed, use
higher flow rate nozzles instead of increasing
pressure.
o Number of nozzles - Use the minimum number of
nozzles that provide uniform coverage.
o Nozzle Orientation - Orienting nozzles so that the
spray is released parallel to the airstream produces
larger droplets than other orientations and is the
recommended practice. Significant deflection
from horizontal will reduce droplet size and
increase drift potential.
o Nozzle Type - Use a nozzle type that is designed
for the intended application. With most nozzle
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types, narrower spray angles produce larger
droplets. Consider using low-drift nozzles. Solid
stream nozzles oriented straight back produce the
largest droplets and the lowest drift.
BOOM LENGTH
For some use patterns, reducing the effective
boom length to less than 3/4 of the wingspan or rotor
length may further reduce drift without reducing swath
width.
APPLICATION HEIGHT
Applications should not be made at a height
greater than 10 feet above the top of the target plants
unless a greater height is required for aircraft safety.
Making applications at the lowest height that is safe
reduces exposure of droplets to evaporation and wind.
SWATH ADJUSTMENT
When applications are made with a crosswind, the
swath will be displaced downwind. Therefore, on the up
and downwind edges of the field, the applicator should
compensate for this displacement by adjusting the path of
the aircraft upwind. Swath adjustment distance should
increase, with increasing drift potential (higher wind,
smaller drops, etc.).
WIND
Drift potential is lowest between winds speeds of
2-10 mph. However, many factors, including droplet
size and equipment type determine drift potential at any
given speed. Application should be avoided below 2
mph due to variable wind direction and high inversion
potential. NOTE: Local terrain can influence wind
patterns. Every applicator should be familiar with local
wind patterns and how they affect spray drift.
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TEMPERATURE AND HUMIDITY
When making applications in low relative
humidity, set up equipment to produce larger droplets to
compensate for evaporation. Droplet evaporation is most
severe when conditions are both hot and dry.
TEMPERATURE INVERSIONS
Applications should not occur during a
temperature inversion because drift potential is high.
Temperature inversions restrict vertical air mixing, which
causes small suspended droplets to remain in a
concentrated cloud. This cloud can move in
unpredictable directions due to the light variable winds
common during inversions. Temperature inversions are
characterized by increasing temperatures with altitude
and are common on nights with limited cloud cover and
light to no wind. They begin to form as the sun sets and
often continue into the morning. Their presence can be
indicated by ground fog; however, if fog is not present,
inversions can also be identified by the movement of
smoke from a ground source or an aircraft smoke
generator. Smoke that layers and moves laterally in a
concentrated cloud ( under low wind conditions) indicates
an inversion, while smoke that moves upward and rapidly
dissipates indicates good vertical air mixing.
SENSITIVE AREAS
The pesticide should only be applied when the
potential for drift to adjacent sensitive areas (e.g.,
residential areas, bodies of water, known habitat for
threatened or endangered species, non-target crops) is
minimal (e.g, when wind is blowing away from the
sensitive areas).
The labels and labeling of all products must comply with EPA's current
regulations and requirements as specified in 40 CFR §156.10 and other
applicable notices.
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C. Existing Stocks
Registrants may generally distribute and sell products bearing old
labels/labeling for 26 months from the date of the issuance of this Reregi strati on
Eligibility Decision (RED). Persons other than the registrant may generally distribute
or sell 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.
The Agency has determined that registrants may distribute and sell asulam and
its sodium salt products bearing old labels/labeling for 26 months from the date of
issuance of this RED. Persons other than the registrant may distribute or sell such
products for 50 months from the date of the issuance of this RED. Registrants and
persons other than registrants remain obligated to meet pre-existing Agency imposed
label changes and existing stocks requirements applicable to products they sell or
distribute.
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VI. APPENDICES
75
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76
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APPENDIX A. Table of Use Patterns Subject to Reregistration
77
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78
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Report Run Date: 03/01/95 ) Time 13:10 APPENDIX A ) CASE 0265, [Asulam] Chemical 106902 [Sodium asulam] LUIS 2.0
ALL OF THESE USES WILL BE ELIGIBLE FOR REREGISTRATION PROVIDED CHANGES ARE MADE IN ACCORDANCE WITH THIS RED DOCUMENT.
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
THESE ARE CURRENT USES.
NON-FOOD/NON-FEED
CHRISTMAS TREE PLANTATIONS
Spray., Delayed dormant., Aircraft.
Spray., Delayed dormant., Ground.
INDUSTRIAL AREAS (OUTDOOR)
Spot treatment., When needed., Ground. SC/L NA
Spray., When needed., Ground. SC/L NA
NONAGRICULTURAL RIGHTS-OF-WAY/FENCEROWS/HEDGEROWS
Spot treatment., When needed., Ground. SC/L NA
Spray., When needed., Ground.
NONAGRICULTURAL UNCULTIVATED AREAS/SOILS
Spot treatment., When needed., Ground.
Spray., When needed., Ground.
ORNAMENTAL AND/OR SHADE TREES
Broadcast., Postemergence., Ground.
ORNAMENTAL LAWNS AND TURF
Spray., Postemergence., Ground.
ORNAMENTAL WOODY SHRUBS AND VINES
Broadcast., Postemergence., Ground. SC/L NA
SC/L NA
SC/L NA
Use
3.34 Ib A
3.34 Ib A
Use
3.34 Ib A
6. 68 Ib A
Use
3.34 Ib A
6. 68 Ib A
Use
3.34 Ib A
6. 68 Ib A
Use
3.34 Ib A
Use
2.088 Ib A
Use
3.34 Ib A
Group :
* NS
* NS
Group :
* NS
* NS
Group :
* NS
* NS
Group :
* NS
* NS
Group :
* 1
Group :
* 1
Group :
* 1
TERRESTRIAL
NS
NS
TERRESTRIAL
NS
NS
TERRESTRIAL
NS
NS
TERRESTRIAL
NS
NS
TERRESTRIAL
NS
TERRESTRIAL
NS
TERRESTRIAL
NS
NON-FOOD CROP
NS NS NS
NS NS NS
NON-FOOD CROP
NS NS NS
NS NS NS
NON-FOOD CROP
NS NS NS
NS NS NS
NON-FOOD CROP
NS NS NS
NS NS NS
NON-FOOD CROP
NS NS NS
NON-FOOD CROP
NS NS NS
NON-FOOD CROP
NS NS NS
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SITE Application Type, Application
Timing, Application Equipment )
Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
USE FOR WHICH A REREGISTRATION ELIGIBILITY DECISION HAS NOT BEEN MADE DUE TO DELANEY CLAUSE
FOOD/FEED USES
SUGARCANE
Band treatment., Cane., Ground.
Broadcast., Cane grown for stubble., Ground. SC/L NA
Broadcast., Cane., Aircraft. SC/L NA
Broadcast., Cane., Ground.
Spot treatment., Cane., Ground.
Use Group: TERRESTRIAL FOOD+FEED CROP
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LEGEND
444444
HEADER ABBREVIATIONS
Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Microbial claims only.
noted otherwise)
Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.
noted otherwise)
Soil Tex. Max. Dose : Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
Max. # Apps @ Max. Rate : Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3
years" is expressed as "4/3 yr"
Max. Dose [(AI unless : Maximum dose applied to a site over a single crop cycle or year. System calculated.
noted otherwise)/A]
Min. Interv (days) : Minimum Interval between Applications (days)
Restr. Entry Interv (days) : Restricted Entry Interval (days)
PRO Report Date : LUIS contains all products that were active or suspended (and that were available from OPP Document Center) as of this date. Some products
registered after this date may have data included in this report, but LUIS does not guarantee that all products registered after this date have
data that has been captured.
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C : Coarse
M : Medium
F : Fine
0 : Others
FORMULATION CODES
SC/L : SOLUBLE CONCENTRATE/LIQUID
ABBREVIATIONS
AN : As Needed
NA : Not Applicable
NS : Not Specified (on label)
UC : Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station (s), block, briquet,
briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part,
parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, —
APPLICATION RATE
No Calculation can be made
PPM calculated by weight
PPM Calculated by volume
USE LIMITATIONS CODES
C4 6 : Do not apply through any type of irrigation system.
C92 : For terrestrial uses, do not apply directly to water or to areas where surface water is present or to intertidal areas below the mean high water mark.
CAL : Do not contaminate water, food or feed.
G74 : Do not feed treated foliage to livestock or graze treated areas.
GI9 : Do not graze or feed fodder and forage to livestock.
HOI : day(s) preharvest interval.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
GEOGRAPHIC CODES
HI : Hawaii
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APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
83
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84
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregi strati on for
active ingredients within the case Asulam covered by this Reregi strati on Eligibility Decision
Document. It contains generic data requirements that apply to Asulam 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. Refer to the Bibliography appendix for a complete citation of the study.
85
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86
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APPENDIX B
Data Supporting Guideline Requirements for
ASULAM AND ITS SODIUM
the Reregistration of
SALT
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1 Chemical Identity
61-2A Start. Mat. & Mnfg. Process
61-2B Formation of Impurities
62-1 Preliminary Analysis
62-2 Certification of limits
62-3 Analytical Method
63-2 Color
63-3 Physical State
63-4 Odor
63-5 Melting Point
63-6 Boiling Point
63-7 Density
63-8 Solubility
63-9 Vapor Pressure
63-10 Dissociation Constant
63-11 Octanol/Water Partition
63-12 pH
63-13 Stability
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
DATA GAP
DATA GAP
DATA GAP
DATA GAP
42485801, 42485802 - DATA GAP
DATA GAP
40751501
40751501
DATA GAP
DATA GAP
WAIVED
40751501
40751501
40751501
42342004
40751501
40751501
DATA GAP
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Data Supporting Guideline Requirements for the Reregistration of
ASULAM AND ITS SODIUM SALT
REQUIREMENT
USE PATTERN CITATION(S)
ECOLOGICAL EFFECTS
71-1A
71-1B
71-2A
71-2B
71-3
71-4A
71-4B
71-5A
71-5B
72-1A
72-1B
72-1C
72-1D
72-2A
72-2B
72-3A
72-3B
Acute Avian Oral - Quail/Duck
Acute Avian Oral - Quail/Duck
TEP
Avian Dietary - Quail
Avian Dietary - Duck
Wild Mammal Toxicity
Avian Reproduction - Quail
Avian Reproduction - Duck
Simulated Field Study
Actual Field Study
Fish Toxicity Bluegill
Fish Toxicity Bluegill - TEP
Fish Toxicity Rainbow Trout
Fish Toxicity Rainbow Trout- TEP
Invertebrate Toxicity
Invertebrate Toxicity - TEP
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity -
Mollusk
A,B,C 00056417
N/A
A,B,C 00056419
A,B,C 00056418
N/A
N/A
N/A
N/A
N/A
A,B,C 00056421, 00098505
N/A
A,B,C 00056421, 40872001
N/A
A,B,C 00098507, 40977602
N/A
WAIVED
A,B,C 41000701
-------
Data Supporting Guideline Requirements for the Reregistration of
ASULAM AND ITS SODIUM SALT
REQUIREMENT
72-3C
72-3D
72-3E
72-3F
72-4A
72-4B
72-5
72-6
72-7A
72-7B
122-1A
122-1B
122-2
123-1A
123-1B
Estuarine/Marine Toxicity -
Shrimp
Estuarine/Marine Toxicity Fish-
TEP
Estuarine/Marine Toxicity
Mollusk - TEP
Estuarine/Marine Toxicity Shrimp
-TEP
Early Life Stage Fish
Life Cycle Invertebrate
Life Cycle Fish
Aquatic Organism Accumulation
Simulated Field - Aquatic
Organisms
Actual Field - Aquatic Organisms
Seed Germination/Seedling
Emergence
Vegetative Vigor
Aquatic Plant Growth
Seed Germination/Seedling
Emergence
Vegetative Vigor
USE PATTERN CITATION(S)
A,B,C 00098508, 00098509
N/A
N/A
N/A
A,B,C RESERVED pending results of life cycle
invertebraate
A,B,C DATA GAP
N/A
N/A
N/A
N/A
RESERVED
RESERVED
RESERVED
A,B,C 426 1 3 80 1 - DATA GAP
A,B,C 426 1 3 80 1 - DATA GAP
89
-------
Data Supporting Guideline Requirements for
ASULAM AND ITS SODIUM
the Reregistration of
SALT
REQUIREMENT
123-2
124-1
124-2
141-1
141-2
141-5
TOXICOI
81-1
81-2
81-3
81-4
81-5
81-6
81-7
82-1A
82-1B
82-2
Aquatic Plant Growth
Terrestrial Field
Aquatic Field
Honey Bee Acute Contact
Honey Bee Residue on Foliage
Field Test for Pollinators
.OGY
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation -
Rabbit
Dermal Sensitization - Guinea Pig
Acute Delayed Neurotoxicity - Hen
90-Day Feeding - Rodent
90-Day Feeding - Non-rodent
21-Day Dermal - Rabbit/Rat
USE PATTERN
A,B,C
A,B,C
N/A
N/A
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
N/A
A,B,C
A,B,C
A,B,C
CITATION(S)
42560301, 42560302, 42611701, 42613802,
42631301
RESERVED pending results of
Tier II testing
RESERVED pending results of
Tier II testing
00036935
40960501,42110001
40960501
40960502
00098534
00098535
00098535
00098543
RESERVED
41076901
90
-------
Data Supporting Guideline Requirements for
ASULAM AND ITS SODIUM
the Reregistration of
SALT
REQUIREMENT
82-3
82-4
82-5A
82-5B
83-1A
83-1B
83-2A
83-2B
83-3A
83-3B
83-4
84-2A
84-2B
84-4
85-1
85-2
86-1
90-Day Dermal - Rodent
90-Day Inhalation - Rat
90-Day Neurotoxicity - Hen
90-Day Neurotoxicity - Mammal
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity -
Non-Rodent
Oncogenicity - Rat
Oncogenicity - Mouse
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Gene Mutation (Ames Test)
Structural Chromosomal
Aberration
Other Genotoxic Effects
General Metabolism
Dermal Penetration
Domestic Animal Safety
USE PATTERN
N/A
N/A
N/A
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
A,B,C
N/A
N/A
CITATION(S)
WAIVED
00098543
00098536
00098543
42338201
00098538
00098539
00098540
40415302,41457501?,
00082250,40415301
00098542, 40415301, 41457501
41345601
OCCUPATIONAL/RESIDENTIAL EXPOSURE
132-1A Foliar Residue Dissipation N/A
91
-------
Data Supporting Guideline Requirements for
ASULAM AND ITS SODIUM
the Reregistration of
SALT
REQUIREMENT
132-1B Soil Residue Dissipation
133-3 Dermal Passive Dosimetry
Exposure
133-4 Inhalation Passive Dosimetry
Exposure
231 Estimation of Dermal Exposure at
Outdoor Sites
232 Estimation of Inhalation Exposure
at Outdoor Sites
233 Estimation of Dermal Exposure at
Indoor Sites
234 Estimation of Inhalation Exposure
at Indoor Sites
ENVIRONMENTAL FATE
160-5 Chemical Identity
161-1 Hydrolysis
161-2 Photodegradation - Water
161-3 Photodegradation - Soil
161-4 Photodegradation - Air
162-1 Aerobic Soil Metabolism
162-2 Anaerobic Soil Metabolism
162-3 Anaerobic Aquatic Metabolism
USE PATTERN CITATION(S)
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
A,B,C 40997901
A,B,C 41326001
A,B,C 41326002
N/A
A,B,C 4 1 76780 1 - DATA GAP
A,B,C 41 767802 - DATA GAP
A,B,C 41 767802 - DATA GAP
92
-------
Data Supporting Guideline Requirements for the Reregistration of
ASULAM AND ITS SODIUM SALT
REQUIREMENT
162-4
163-1
163-2
163-3
164-1
164-2
164-3
164-5
165-1
165-2
165-3
165-4
165-5
166-1
166-2
166-3
201-1
202-1
Aerobic Aquatic Metabolism
Leaching/Adsorption/Desorption
Volatility - Lab
Volatility - Field
Terrestrial Field Dissipation
Aquatic Field Dissipation
Forest Field Dissipation
Long Term Soil Dissipation
Confined Rotational Crop
Field Rotational Crop
Accumulation - Irrigated Crop
Bioaccumulation in Fish
Bioaccumulation - Aquatic
NonTarget
Ground Water - Small Prospective
Ground Water - Small
Retrospective
Ground Water - Irrigated
Retrospective
Droplet Size Spectrum
Drift Field Evaluation
USE PATTERN CITATION(S)
N/A 4 1 767803 - WAIVED
A,B,C 00098525,41215101,40965001
N/A
N/A
A,B,C RESERVED
N/A
N/A
N/A
A,B,C 41857701 - DATA GAP
A,B,C 42980801
WAIVED
N/A
N/A
A,B,C 41561103, 42224701, 42534501, 41803901,
42704901
N/A
N/A
A,B,C DATA GAP
A,B,C DATA GAP
93
-------
Data Supporting Guideline Requirements for
ASULAM AND ITS SODIUM
the Reregistration of
SALT
REQUIREMENT
USE PATTERN
CITATION(S)
RESIDUE CHEMISTRY
171-3 Directions for Use
171-4A Nature of Residue - Plants
171-4B
171-4C
171-4D
171-4E
171-4F
171-4G
171-4H
171-41
171-4J
Nature of Residue - Livestock
Residue Analytical Method -
Plants
Residue Analytical Method -
Animal
Storage Stability
Magnitude of Residues - Potable
H2O
Magnitude of Residues in Fish
Magnitude of Residues - Irrigated
Crop
Magnitude of Residues - Food
Handling
Magnitude of Residues -
Meat/Milk/Poultry/Egg
A,B,C
A,B
B
A,B
B
A,B
N/A
N/A
N/A
N/A
A,B
DATA GAP
00024737,00044583,
00056425,00113828
00052044, 00056424,
DATA GAP
00044580, 00056422, 00098551,41561101,
41561102
00004821, 00004822,
00056432, 00056435,
00056439, 00056440,
00098545, 00098547,
00098553,00113827,
42292401
00044584, 00052047,
00056436, 00056438,
00084790, 00084804,
00098548, 00098552,
00113831,41239701,
00052047,00098549,00098551,42806201,
43234701
43234701
00052047,00084805,00098553,00098554,
00113833
94
-------
Data Supporting Guideline Requirements for the Reregistration of
ASULAM AND ITS SODIUM SALT
REQUIREMENT USE PATTERN CITATION(S)
171-4K Crop Field Trials - Sugarcane A,B 00004821,00004823,00004824,00056441,
00056442, 00113830, 00113831, 00113836,
00113837, 00136346, 42088801, 42201501,
42292401, 42806201 - DATA GAP
171-4L Processed Food - Sugarcane A,B 00056441, 00113831, 00113836, 00136346,
42201501, 42292401, 42806201
95
-------
96
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APPENDIX C. Citations Considered to be Part of the Data
Base Supporting the Reregistration of Asulam
97
-------
98
-------
GUIDE TO APPENDIX C
1. 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 Reregi strati on 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 the published literature, in those instances where they have been considered,
are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the 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.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be used 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 identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the 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 an 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. 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
99
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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.
c. 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.
d. Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the
following elements describing the earliest 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
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume
in which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," 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.
100
-------
BIBLIOGRAPHY
MRID CITATION
EPA. (1987) U.S. EPA Guidance for the Reregi strati on of Pesticide Products
Containing Asulam as the Active Ingredient. Office of Pesticide Programs,
Washington, D.C.
Gustafon, D.I. (1992) A Small-scale Prospective Ground-Water Monitoring Study
with Asulam-Sodium, The Active Ingredient of Asulox Brand Herbicide, Applied to
Sugarcane and Turf. Unpublished progress report submitted by Rhone-Poulenc Ag.
Company, Research Triangle Park, NC. February 1992.
Hoerger, F.D. and E.E. Kenaga. (1972) Pesticide Residues on Plants Correlation of
Representative Data as a Basis for Estimation of Their Magnitude in the Environment.
Environmental Quality, Academic Press, New York. I: 9-28.
Norris, F.A. (1991) Draft, A Small-Scale Prospective Ground-water Study with
Asulam. Unpublished paper submitted by Rhone-Poulenc Ag. Company, Research
Triangle Park, NC. July 1992.
Rhone Poulenc Ag. Company. (1992) A Drinking Water Monitoring Study to Assess
Human Exposure to Residues of Asulam-Sodium, The Active Ingredient of Asulox
Brand Herbicide in High Use Areas of Florida and Louisiana. Unpublished project
update submitted by Rhone Poulenc Ag. Company. Research Triangle Park, NC.
June 1992. (No MRID Assigned).
Rhone Poulenc Ag Company. (1993) Asulam Position Paper, Rhone Poulenc Ag.
Company, April 16, 1993. Unpublished paper submitted by Rhone Poulenc Ag.
Company, Research Triangle Park, NC.
Taylor, L.L. (1992) Asulam: Response to DCI - Request for Waivers of Three
Neurotoxicity Studies; Submission of an Acute Oral Study and an 8-Week Range-
Finding Study to Support Their Claim. U.S. EPA Memorandum of January 29, 1992,
Washington, D.C. Document No. 009071.
00004821 Rhone-Poulenc, Incorporated (1977) Asulam. Summary of studies 238025-B
through 238025-D. (Unpublished study received Apr 13, 1979 under 359-662;
prepared in cooperation with Rhodia, Inc.; CDL:238025-A)
00004822 Guyton, C.L. (1977) Procedures for the Measurement of Asulam, MCPA,
Sulfanilamide and Acetylasulam in/on Flax: Forages, Straw, Seed and
101
-------
BIBLIOGRAPHY
MRID
CITATION
Mill-Processed Flax Seed Fractions. Method no. 143 dated Jul 1977.
(Unpublished study received Apr 13, 1979 under 359662; prepared by Rhodia,
Inc., submitted by Rhone-Poulenc, Inc., Monmouth Junction, N.J.;
CDL:238025-B)
00004823 Carlyle, S. (1977) Sugarcane: Final Report No.: 330977-030. (Unpublished
study including final report nos. 330977-031 and 330977-032, received Apr 13,
1979 under 359-662; prepared by Rhodia, Inc. in cooperation with United
States Sugar Corp., submitted by Rhone-Poulenc, Inc., Monmouth Junction,
N.J.; CDL: 238025-C)
00004824 Kirby, M. (1977) Sugarcane: Final Report No.: 281777-013. (Unpublished
study including final report nos. 281777-014 and 281777015, received Apr 13,
1979 under 359-662; prepared by Rhodia, Inc., submitted by Rhone-Poulenc,
Inc., Monmouth Junction, N.J.; CDL:238025-D)
00024737 Hilton, H.W.; Nomura, N.S.; Kameda, S.S.; et al. (1976) Some patterns of
herbicide and growth regulator intake, persistence, and distribution in
sugarcane. Archives of Environmental Contamination and Toxicology
4(4):385-394. (Also~In~unpublished submission received Jul 19, 1978 under
201-403; submitted by Shell Chemical Co., Washington, D.C.;
CDL:234470-AP)
00036935 Atkins, E.L.; Greywood, E.A.; Macdonald, R.L. (1975) Toxicity of Pesticides
and Other Agricultural Chemicals to Honeybees: Laboratory Studies. By
University of California, Dept. of Entomology?: UC, Cooperative Extension.
(Leaflet 2287; published study)
00044580 Craine, E.M.; Ray, W.H. (1972) Residues in the Milk and Tissues of Dairy
Cows Fed Asulam: Research Report No. EMC 72:27'. Includes methods
entitled: Milk residue analysis and Tissue residue analysis. (Unpublished study
received Dec 17, 1975 under 6F1716; prepared by Hess & Clark, submitted by
Rhodia, Inc., New Brunswick, N.J.; CDL:095193-E)
102
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BIBLIOGRAPHY
MRID
CITATION
00044583 Maycey, P.A. (1975) Herbicides: Asulam: Metabolism Studies with
Asulam-Ring 14C on Alfalfa: Report No. RES/2402. (Unpublished study
received Dec 17, 1975 under 6F1716; prepared by May & Baker, Ltd.,
England, submitted by Rhodia, Inc., New Brunswick, N.J.; CDL:095193-G)
00044584 Guardigli, A. (1975) Procedures for the Measurement of Total Asulam,
Sulfanilamide and Acetylasulam in/on Forages, Fibers and Mill-Processed Flax
Seed Fractions by Colorimetry and Thin-Layer Chromatography. Method no.
133 dated Aug 1975. (Unpublished study received Dec 17, 1975 under
6F1716; submitted by Rhodia, Inc., New Brunswick, N.J.; CDL:095193-H)
00052044 Maycey, P.A. (1975) Herbicides: Asulam: Studies with Asulam-Ring 14C on
Ryegrass: RES/2282. (Unpublished study received Dec 17, 1975 under
6F1717; prepared by May & Baker, Ltd., England, submitted by Rhodia, Inc.,
New Brunswick, N.J.; CDL:095192-B)
00052047 Craine, E.M.; Ray, W.H.; Stevens, K.R. (1972) Residues in the Milk and
Tissues of Dairy Cows Fed Asulam: Research Report No. EMC 72:27'.
(Unpublished study including report no. KRS 72:21, received Dec 17, 1975
under 6F1717; prepared by Hess & Clark, submitted by Rhodia, Inc., New
Brunswick, N.J.; CDL:095192-F)
00056417 Ingham, B. (1971) Herbicides: Asulox 40: Acute Oral Toxicity in Mallard,
Partridges, Pheasants and Pigeons: Report No. RG/1108. (Unpublished study
received Jun 11, 1972 under 2G1200; prepared by May and Baker, Ltd.,
England, submitted by Rhodia, Inc., New Brunswick, N.J.; CDL:091017-T)
00056418 Heywood, B.A.; Ingham, B. (1970) Asulox: Subacute (5 Day) Toxicity in
Mallard Ducklings: Report No. RG/857. (Unpublished study received Jun 11,
1972 under 2G1200; prepared by May and Baker, Ltd., England, submitted by
Rhodia, Inc., New Brunswick, N.J.; CDL:091017-U)
00056419 Heywood, B.A.; Ingham, B. (1970) Asulox: Subacute (5 Day) Toxicity Study
in Pheasant Chicks: Report No. RG/867. (Unpublished study received Jun 11,
1972 under 2G1200; prepared by May and Baker, Ltd., England, submitted by
Rhodia, Inc., New Brunswick, N.J.; CDL:091017-V)
103
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BIBLIOGRAPHY
MRID
CITATION
00056421 Fraser, W.D.; Jenkins, G. (1970) The Acute Toxicity of Asulam to Rainbow
Trout, Goldfish, Channel Catfish and Bluegill: Report No. 3639/70/451.
(Unpublished study received Jun 11, 1972 under 2G1200; prepared by
Huntingdon Research Centre, England, submitted by Rhodia, Inc., New
Brunswick, N.J.; CDL:091017-X)
00056422 Lim, L. (1968) Herbicides: Studies with 35S-M&B 9057 (Asulam) in a
Lactating Cow: PRG/73. (Unpublished study received Jun 11, 1972 under
2G1200; prepared by May & Baker, Ltd., England, submitted by Rhodia, Inc.,
New Brunswick, N.J.; CDL:091017-Y)
00056424 Mulcock, P.A. (1971) Asulam: Decline Studies on Sugar-Cane with
Asulam-Ring 14C: RG/1002. (Unpublished study received Jun 11, 1972 under
2G1200; prepared by May & Baker, Ltd., England, submitted by Rhodia, Inc.,
New Brunswick, N.J.; CDL:091017-AA)
00056425 Mulcock, P.A. (1971) Asulam: Metabolic Pathways and Products in Sugar
Cane: RG/1109. (Unpublished study received Jun 11, 1972 under 2G1200;
prepared by May & Baker, Ltd., England, submitted by Rhodia, Inc., New
Brunswick, N.J.; CDL:091017-AB)
00056432 Brockelsby, C.H.; Crouch, R.V.; Marshall, R.F. (1971) Asulam: Analytical
Method for Residues in Raw Sugar Products (Syrup and Molasses): RG/1159.
Method dated Sep 1971. (Unpublished study received Jun 14, 1972 under
2G1200; prepared by May & Baker, Ltd., England, submitted by Rhodia, Inc.,
New Brunswick, N.J.; CDL:091018-C)
00056435 Brockelsby, C.H. (1969) Asulam: Analytical Method for Residues in Plant
Material: Report No. PRG.479. Method dated Jun 1969. (Unpublished study
received Jun 14, 1972 under 2G1200; prepared by May & Baker, Ltd.,
England, submitted by Rhodia, Inc., New Brunswick, N.J.; CDL:091018-F)
00056436 Brockelsby, C.H. (1971) Asulam (M&B 9057): An Improved Analytical
Method for Asulam in Plant Material with Particular Reference to Sugar Cane:
RG/969. Method dated Feb 1971. (Unpublished study received Jun 14, 1972
under 2G1200; prepared by May & Baker, Ltd., England, submitted by Rhodia,
Inc., New Brunswick, N.J.; CDL:091018-G)
104
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BIBLIOGRAPHY
MRID
CITATION
00056438 Brockelsby, C.H. (1971) Asulam: An Analytical Method for Residues in Sugar
Cane: RG/1096. Method dated Jun 1971. (Unpublished study received Jun 14,
1972 under 2G1200; prepared by May & Baker, Ltd., England, submitted by
Rhodia, Inc., New Brunswick, N.J.; CDL:091018-I)
00056439 Brockelsby, C.H.; Crouch, R.V.; Marshall, R.F. (1971) Asulam: Analytical
Method for Residues in Raw Sugar Products (Dilute Juice, Clarified Juice,
Filtered Sludge): RG/1097. Method dated Jul 1971. (Unpublished study
received Jun 14, 1972 under 2G1200; prepared by May & Baker, Ltd.,
England, submitted by Rhodia, Inc., New Brunswick, N.J.; CDL:091018-J)
00056440 Brockelsby, C.H.; Crouch, R.V.; Marshall, R.F. (1971) Asulam: Analytical
Method for Residues in Raw Sugar: RG/1098. Method dated Jul 1971.
(Unpublished study received Jun 14, 1972 under 2G1200; prepared by May &
Baker, Ltd., England, submitted by Rhodia, Inc., New Brunswick, N.J.;
CDL:091018-K)
00056441 Rhodia, Incorporated (1971) Summary of Residue Data. (Reports by various
sources; unpublished study received Jun 14, 1972 under 2G1200;
CDL:091018-L)
00056442 Brockelsby, C.H. (1971) Asulam (M&B 9057): Decline Studies on Sugar Cane:
RG.975. Procedure dated Feb 1971. (Unpublished study received Jun 14,
1972 under 2G1200; prepared by May & Baker, Ltd., England, submitted by
Rhodia, Inc., New Brunswick, N.J.; CDL:091018-M)
00082250 Hastings, S.E.; Huffman, K.W. (1975) Dominant Lethal Study of Asulam in
Mice: Report No. SEH 75:94. (Unpublished study received Dec 17, 1975
under 6F1717; submitted by Rhodia, Inc., New Brunswick, N.J.;
CDL:098085-E)
00084790 Rhodia, Incorporated (1972) Summary: Safety of Asulam—Sugarcane.
Summary of studies 094626-C through 094626-S. (Unpublished study
received Nov 8, 1972 under 3F1331; CDL:094626-A)
00084804 Crouch, R.V.; Pullin, E.M. (1968) Asulam: Analytical Method for Residues in
Milk Report No. PRG.223. Method dated Jul 1968. (Unpublished study
105
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BIBLIOGRAPHY
MRID
CITATION
received Nov 8, 1972 under 3F1331; prepared by May & Baker, Ltd., England,
submitted by Rhodia, Inc., New Brunswick, N.J.; CDL:094626-Q)
00084805 Stevens, K.R.; Johnson, C.A.; Huffman, K.W. (1972) The Biological Effects of
Feeding Asulam to Dairy Cows: Report No. KRS 72:21. (Unpublished study
received Nov 8, 1972 under 3F1331; prepared by Hess & Clark, submitted by
Rhodia, Inc., New Brunswick, N.J.; CDL:094626-R)
00098505 Vilkas, A.G.; Kuc, WJ. (1979) The Acute Toxicity of Asulam Technical to the
Bluegill Sunfish Lepomis macrochirus Rafinesque: UCES Project No.
11506-48-06. (Unpublished study received Apr 16, 1982 under 359-662;
prepared by Union Carbide Corp., submitted by Rhone-Poulenc Chemical Co.,
Monmouth Junction, N.J.; CDL:070772-A)
00098507 Roberts, S.; Parke, G.S.E.; Charles, S. (1977) Static 48-hour Toxicity Study of
Asulam Technical in Daphnids: Laboratory No. 7E-7665. (Unpublished study
received Apr 16, 1982 under 359-662; prepared by Cannon Laboratories, Inc.,
submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:
070772-C)
00098508 Vilkas, A.G.; Schneider, C.E. (1979) The Acute Toxicity of Asulam Technical
to the Grass Shrimp, Palaemonetespugio: UCES Project No. 11506-48-05.
(Unpublished study received Apr 16, 1982 under 359-662; prepared by Union
Carbide Corp., submitted by Rhone-Poulenc Chemical Co., Monmouth
Junction, N.J.; CDL: 070772-D)
00098509 Schneider, C. (1979) The Acute Toxicity of Asulam Technical to the Fiddler
Crab Ucapugilator: UCES Project No. 11506-48-04. (Unpublished study
received Apr 16, 1982 under 359-662; prepared by Union Carbide Corp.,
submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.;
CDL:070772-E)
00098525 Cooper, I.C.; Unsworth, J.B. (1981) Asulam: Leaching Study with Four Soils:
AG.Tech. 19. (Unpublished study received Apr 16, 1982 under 359-662;
prepared by May & Baker, Ltd., England, submitted by Rhone-Poulenc
Chemical Co., Monmouth Junction, N.J.; CDL:070773-N)
106
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BIBLIOGRAPHY
MRID
CITATION
00098534 Ward, RJ. (1981) Asulam (Technical Grade): Primary Eye Irritation Study in
the Rabbit: Report Ref. R.Tox.57. (Unpublished study received Apr 16, 1982
under 359-662; prepared by May & Baker, Ltd., England, submitted by
Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:070776-D)
00098535 Dale, E.A.; Grimmett, I.E. (1977) Asulam: Tests for Primary Skin Irritation in
Rabbits and Skin Sensitization in Guinea Pigs: RES/2853. (Unpublished study
received Apr 16, 1982 under 359662; prepared by May & Baker, Ltd.,
England, submitted by Rhone-Poulenc Chemical Co., Monmouth Junction,
N.J.; CDL: 070776-E)
00098536 Dale, E.A.; Ingham, B.; Woolf, N.; et al. (1979) Asulam: Six Month Oral
Toxicity Study in Beagles: Report Ref. RES 3699. (Unpublished study
received Apr 16, 1982 under 359-662; prepared by May & Baker, Ltd.,
England, submitted by Rhone-Poulenc Chemical Co., Monmouth Junction,
N.J.; CDL:070776-F)
00098538 Copping, G.P. (1981) Asulam: Teratogenicity Study by the Oral Route in the
Rat: Report Ref. R.Tox.ll. (Unpublished study received Apr 16, 1982 under
359-662; prepared by May & Baker, Ltd., England, submitted by
Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:070776-H)
00098539 Copping, G.P. (1981) Asulam: Teratogenicity Study by the Oral Route in the
Rabbit: Report Ref. R.Tox. 37. (Unpublished study received Apr 16, 1982
under 359-662; prepared by May & Baker, Ltd., England, submitted by
Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:070776-I)
00098540 Brentnall, D.W.; Woolf, N. (1981) Asulam: Two Generation Reproduction
Study in the Rat: Report Ref. R.Tox. 34. (Unpublished study received Apr 16,
1982 under 359-662; prepared by May & Baker, Ltd., England, submitted by
Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:070776-J)
00098542 Thilagar, A.; Knight, R.; Reichard, G.; et al. (1979) An Evaluation of
Carcinogenic Potential of Asulam Employing the C3H/10T1/2 Cell
Transformation Assay: Study No. 596-249-8. (Unpublished study received
Apr 16, 1982 under 359-662; prepared by EG & G Mason Research Institute,
submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.;
CDL:070776-L)
107
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BIBLIOGRAPHY
MRID
CITATION
00098543 Hunter, B.; Barnard, A.V.; Street, A.E.; et al. (1981) Asulam: Toxicity and
Tumorigenicity in Prolonged Dietary Administration to Rats: HRC Report No.
M & B 95/80554. Final rept. (Unpublished study received Apr 16, 1982 under
359-662; prepared by Huntingdon Research Centre, England, submitted by
Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:070777-A)
00098545 Rhone-Poulenc Chemical Company (1981?) Plant Metabolism Studies with
Asulam. (Unpublished study received Apr 16, 1982 under 359-662;
CDL:070778-B)
00098547 Somma, N. (1981) Asulam 14C-Analytical Plant Method Validation: FDD No.
81/018. (Unpublished study received Apr 16, 1982 under 359-662; submitted
by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:070779-B)
00098548 Wargo, J.P.; Somma, N.; Piznik, M.; et al. (1981) A Common Moiety Method
for the Measurement of Asulam and Its Principal Metabolites in Plant
Substrates by High Performance Liquid Chromatography: FDD No. 81/015.
(Unpublished study received Apr 16, 1982 under 359-662; submitted by
Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.; CDL:070779-C)
00098549 Guyton, C.L.; Piznik, M.; Chow, W.; et al. (1981) Total Asulam Residues in/on
Foliage and Hay Samples of Alfalfa: FDD No. 81/019. (Unpublished study
received Apr 16, 1982 under 359-662; submitted by Rhone-Poulenc Chemical
Co., Monmouth Junction, N.J.; CDL:070779-D)
00098550 Guyton, C.L.; Piznik, M. (1982) A Comparison of Asulam Plant Residue in/on
Samples Analyzed by Analytical Method No. 133 and Method No. 156: FDD
No. 82/026. (Unpublished study received Apr 16, 1982 under 359-662;
submitted by Rhone-Poulenc Chemical Co., Monmouth Junction, N.J.;
CDL:070779-E)
00098551 Mulkey, N.S.; Herrera, R.E. (1981) Determination of 14C-Residues following
Oral Administration of 14C-Asulam to a Lactating Goat: ADC Project #517.
(Unpublished study received Apr 16, 1982 under 359-662; prepared by
Analytical Development Corp., submitted by Rhone-Poulenc Chemical Co.,
Monmouth Junction, N.J.; CDL:070780-A)
108
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BIBLIOGRAPHY
MRID
CITATION
00098552 Mulkey, N.S.; Brown, D. (1981) Validation by Radiometric and Conventional
Means of Method No. 154, a Common Moiety Method for the Measurement of
Asulam and Its Principal Metabolites in Animal Biological Substrates by High
Performance Liquid Chromatography: ADC Project No. 517-B. Rev.
(Unpublished study received Apr 16, 1982 under 359-662; prepared by
Analytical Development Corp., submitted by Rhone-Poulenc Chemical Co.,
Monmouth Junction, N.J.; CDL:070780-B)
00098553 Rhone-Poulenc Chemical Company (1981) Residue Studies of Asulam Found
in Milk and Tissue of Dairy Animals. Rev. (Compilation; unpublished study
received Apr 16, 1982 under 359-662; CDL: 070780-C)
00098554 Guyton, C.L.; Somma, N.; Piznik, M. (1981) Asulam: Chicken Feeding/
Residue Studies: FDD No. 81/016. (Unpublished study received Apr 16, 1982
under 359-662; submitted by Rhone-Poulenc Chemical Co., Monmouth
Junction, N.J.; CDL:070780-D)
00113827 Rhodia, Inc. (1973) The Results of Tests on the Amount of Residue Remaining,
Including a Description of the Analytical Method Used, of the Pesticide
Chemical: Asulam. (Compilation; unpublished study received on unknown
date under 3F1331; CDL: 093562-B)
00113828 Maycey, P. (1975) Asulam Residue Studies with Asulam-ring 14C on Sugar
Cane: RG/2158. (Unpublished study received Feb 5, 1975 under 3F1331;
prepared by May & Baker, Ltd., Eng., submitted by Rhodia, Inc., New
Brunswick, NJ; CDL:093563-A)
00113830 Brockelsby, C. (1975) Asulam Residue Studies on Sugar Cane: RG/ 2164.
(Unpublished study received Feb 5, 1975 under 3F1331; prepared by May &
Baker, Ltd., Eng., submitted by Rhodia, Inc., New Brunswick, NJ;
CDL:093563-C)
00113831 Rhodia, Inc. (1973) Study: Asulam Residue on Sugarcane. (Compilation;
unpublished study received on unknown date under 3F1331; CDL:094623-A)
00113833 Stevens, K. (1971) Letter sent to C. Johnson dated Dec 27, 1971:
Asulam—Working protocol. (Unpublished study received on unknown date
109
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BIBLIOGRAPHY
MRID
CITATION
under 2G1200; submitted by Rhodia, Inc., New Brunswick, NJ;
CDL:097980-A)
00113836 Rhodia, Inc. (1972) Residues of Asulam in Sugarcane. (Compilation;
unpublished study received on unknown date under 2G1200; CDL:097985-A)
00113837 Rhone-Poulenc, Inc. (1971) Study: Asulam Residue on Sugarcane.
(Compilation; unpublished study received Jul 19, 1971 under unknown admin.
no.; CDL:120793-A)
00136346 Brockelsby, C.; Crouch, R.; Marshall, R. (1971) Asulam: Residue Studies on
Sugar Cane. (Unpublished study received 1971 under 2G1200; prepared by
May & Baker Ltd., Eng., submitted by Florasynth, Inc., New York, NY;
CDL:097986-A)
40415301 Galloway, S.; Myhr, B. (1984) Asulam: Mutagenicity Evaluation of Asulam
Technical (Dried) in an in vitro Cytogenetic Assay Measuring Chromosome
Aberration Frequencies in Human Lymphocytes: LBI Proj. No. 20990.
Unpublished study prepared by Litton Bionetics, Inc. 24 p.
40415302 Hoorn, A. (1983) Asulum: Mutagenicity Evaluation of Asulam Technical in the
Ames Salmonella/Microsome Plate Test Preincubation Method: Genetics
Assay No. E-9177. Unpublished study prepared by Litton Bionetics, Inc. 22 p.
40751501 Buddie, G. (1988) Product Chemistry Data Requirements: Methyl
(4aminophenyl)sulphonyl carbamate, Sodium Salt. Unpublished study
prepared by May & Baker Ltd. 138 p.
40872001 Manning, C. (1988) Acute Toxicity of Asulam Technical to Rainbow Trout
(Salmo gaidneri) Under Static Conditions: Project ID: ese No.
89325-0400-2130. Unpublished study prepared by Hunter/ ESE, Inc. 76 p.
40960501 Myers, R.; Christopher, S. (1988) Asulam Sodium Salt: Acute Peroral (Rat)
and Percutaneous (Rabbit) Toxicity Studies: Laboratory Project ID 51-620.
Unpublished study prepared by Union Carbide Bushy Run Research Center.
16 p.
110
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BIBLIOGRAPHY
MRID
CITATION
40960502 Nachreiner, D.; Klonne, D. (1988) Asulam (Sodium Salt): Acute Dust Aerosol
Inhalation Toxicity Test in Rats: Laboratory Project ID 51-583. Unpublished
study prepared by Union Carbide Bushy Run Research Center. 28 p.
40965001 Reeves, G.; England, D.; Savage, E. (1988) Herbicides: Asulam-Carbon 14:
Leaching Study with Four Soils: Laboratory Project ID: D. Ag. 1118.
Unpublished study prepared by Rhone-Poulenc Agriculture. 83 p.
40977602 Manning, C. (1988) Asulam Technical: Acute Toxicity to the Water Flea
(Daphnia magna) Under Flow-Through Conditions: Proj. ID ESE No.
89325-0200-2130. Unpublished study prepared by Hunter/ESE, Inc. 73 p.
40997901 Gohdes, M. (1989) Hydrolysis of Carbon 14-Asulam in Buffered Aqeous
Solutions: Proj. ID. HLA 6224-122. Unpublished study prepared by Hazleton
Laboratories America, Inc. 62 p.
41000701 Manning, C. (1989) Asulam Technical: Acute Effect to New Shell Growth of
the Eastern Oyster (Crassostrea virgin!ca) Under Flowthrough Conditions: Proj.
ID 89325-0300-2130. Unpublished study prepared by Hunter/ESE. 94 p.
41076901 Blair, M. (1989) 21-Day Repeat Dose Dermal Toxicity Study in Rabbits:
Asulam Sodium Salt: Proj. ID 347-035. Unpublished study prepared by
International Research and Development Corp. 187 p.
41215101 Godward, P.; England, D.; Savage, E. (1988) Herbicides: Asulam carbon 14
(Na Salt) Adsorption/Desorption on Five Soils: Project ID: D.Ag.l 119.
Unpublished study prepared by Rhone-Poulenc Agriculture. 82 p.
41239701 Ver Hey, M. (1989) Determination of the Characteristics of Asulam, Asulam
Sodium...: Project ID RHONE-POULENC 1087. Unpublished study prepared
by Rhone-Poulenc 1087. 363 p.
41326001 Fathulla, R. (1989) Artificial Sunlight Photodegradation of Carbon 14-Asulam
in a Buffered Aqueous Solution: Lab Project Number: HLA/6224/123.
Unpublished study prepared by Hazleton Laboratories America, Inc. 108 p.
41326002 Obrist, J. (1989) Artificial Sunlight Photodegradation of Carbon 14-Asulam on
Soil: Lab Project Number: HLA/6224/124. Unpublished study prepared by
Hazleton Laboratories America, Inc. 96 p.
Ill
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BIBLIOGRAPHY
MRID
CITATION
41345601 Lowdon, P.; Fisher, P.; Savage, E. (1989) Asulam Biokinetics and Metabolism
in the Male and Female Rat: Lab Project Number: D.Ag. 1370. Unpublished
study prepared by Rhone-Poulenc Agriculture. 121 p.
41457501 Blacker, A. (1990) Response to EPA's Review of Two Genetic Toxicity Studies
on Asulam. Unpublished study prepared by Rhone-Poulenc Ag Co. 13 p.
41561101 Dawson, J. (1990) A Metabolism Study with Carbon-14 Asulam in Dairy Goats
(Capra Hircus): Lab Project Number: 1511: EC 89-021. Unpublished study
prepared by Agrisearch, Inc. 147 p.
41561102 Dawson, J. (1990) A Metabolism Study with Carbon 14 Asulam in Laying
Hens (Gallus gallus): Lab Project Number: 1512: EC 89023. Unpublished
study prepared by Agrisearch, Inc. 169 p.
41561103 Norris, F. (1990) A Small-Scale Prospective Groundwater Monitoring Study
with Asulam-Sodium, the Active Ingredient of Asulox Brand Herbicide,
Applied to Sugar Cane and to Turf: Lab Project Number 40809: EC-89-068:
EC-89-069. Unpublished study prepared by Rhone-Poulenc Ag. in coop, with
A&L Eastern Ag. Labs., Inc. 213 p.
41767801 Godward, P.; Fisher, P.; Lowden, P; et al. (1990) Asulam carbon 14: (Na Salt):
Aerobic Soil Metabolism supplement to MRID 41743301: Lab Project Number
P88/086: P90/385. Unpublished study prepared by Rhone-Poulenc
Agriculture. 139 p.
41767802 Godward, P.; Fisher, P.; Lowden, P.; et al. (1991) Asulam carbon 14: (Na-Salt):
Anaerobic Aquatic Soil Metabolism 0supplement to MRID 41743302: Lab
Project Number: P88/087: 162-3. Unpublished study prepared by
Rhone-Poulenc Agriculture. 112 p.
41767803 Gowdard, P.; Fisher, P.; Lowden, P.; et al. (1991) Asulam carbon 14 (Na Salt):
Aerobic Aquatic Soil Metabolism supplement to MRID 41743303: Lab Project
Number: P89/217. Unpublished study prepared by Rhone-Poulenc
Agriculture. 122 p.
41803901 Norris, F. (1991) A Small Scale Prospective Groundwater Monitoring Study
with Asulam-Sodium, the Active Ingredient of Asulox Brand Herbicide,
112
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BIBLIOGRAPHY
MRID
CITATION
Applied to Sugar Cane and to Turf: Lab Project Number: 40949: EC-89-068:
EC-89-069. Unpublished study prepared by Rhone-Poulenc Ag Co., A & L
Eastern Agricultural Laboratories, Inc., Analytical Development Corp., and
CYAL. 180 p.
41857701 Billings, T. (1991) A Confined Rotational Crop Study with carbon 14-Asulam
Using Radishes (Raphanus sativa, Spinacia oleracea), and Wheat (Triticum
aestivum): Lab Project Number: EC90-104. Unpublished study prepared by
Rhone Poulenc Ag Co. 70 p.
42088801 Williams, R. (1991) Analysis of Sugarcane and Processed Sugarcane Products
for Asulam Residues: Interim Report: Lab Project Number USA88UO5.
Unpublished study prepared by Rhone-Poulenc Ag. in coop, with
Rhone-Poulenc Ag Ltd. 149 p.
42110001 Cummins, H. (1987)FR 1398/1: Acute Oral Toxicity Study in the Rat: Lab
Project Number: 87/MBL071/011. Unpublished study prepared by Life
Science Research Ltd. 20 p.
42201501 Williams, R. (1991) Analysis of Sugarcane and Processed Sugarcane Products
for Asulam Residues: Final Report: Lab Project Number: USA88UO5.
Unpublished study prepared by Rhone-Poulenc Ag Co., and Rhone-Poulenc
Agric., Ltd. 166 p.
42224701 Norris, F. (1992) A Small Scale Prospective Groundwater Monitoring Study
With Asulam-Sodium, the Active Ingredient of Asulox Brand Herbicide,
Applied to Sugar Cane and to Turf: Progress Report: Lab Project Number:
EC-89-068: EC-89-069: R081-102. Unpublished study prepared by
Rhone-Poulenc Ag Co., A & L Eastern Ag Labs, Inc., and Analytical
Development Corp. 228 p.
42292401 Williams, R. (1992) A Common Moiety Method for the Analysis of Asulam
Residues on Sugarcane and Sugarcane Processed Fractions Using High
Performance Liquid Chromatography: Final Report: Lab Project Number:
EC-91-154. Unpublished study prepared by Rhone-Poulenc Ag Co. 41 p.
42806201 Williams, R. (1993) Stability of Asulam and Its Principal Metabolites on
Sugarcane and Sugarcane Processed Fractions During Frozen Storage:
113
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BIBLIOGRAPHY
MRID
CITATION
Preliminary Report: Lab Project Number: EC-91-151. Unpublished study
prepared by Rhone-Poulenc Ag Co. 18 p.
42292401 Williams, R. (1992) A Common Moiety Method for the Analysis of Asulam
Residues on Sugarcane and Sugarcane Processed Fractions Using High
Performance Liquid Chromatography: Final Report: Lab Project Number:
EC-91-154. Unpublished study prepared by Rhone-Poulenc Ag Co. 41 p.
42338201 Blair, M. (1992) Two Year Dietary Oncogenicity Study in Mice: Asulam
Sodium Salt: Lab Project Number: 347-036. Unpublished study prepared by
International Research and Development Corp. 2959 p.
42342004 Cicotti, M.; Weidenauer, M.; Mollard, L. (1992) Determination of the
Dissociation Constant of Asulam-Sodium Salt: Final Report: Lab Project
Number: BE-P-1-91-PK-01-BG. Unpublished study prepared by Battelle
Europe, Geneva Research Centres. 29 p.
42485801 Buddie, G. (1992) Methyl(4-aminophenyl)sulphonylcarbamate, monosodium
salt (Asulam sodium): Product Chemistry: Lab Project Number: P-87-110.
Unpublished study prepared by Rhone-Poulenc Agriculture Ltd. 30 p.
42485802 Gomez, F. (1992) Asulam-sodium Technical Grade: Analysis and Certification
of Ingredients Identification of Two Impurities: Lab Project Number: 92-17:
AG/CRLD/AN9216163. Unpublished study prepared by Rhone-Poulenc
Secteur Agro. 67 p.
42534501 Norris, F. (1992) A Small Scale Prospective Groundwater Monitoring Study
with Asulam-Sodium, the Active Ingredient of Asulox Brand Herbicide
Applied to Sugar Cane and to Turf: Progress Report: Lab Project Number:
EC-89-068: EC/89/069: 920105. Unpublished study prepared by
Rhone-Poulenc. 17 p.
42560302 Hoberg, J. (1992) Asulam Sodium-Toxicity to the Marine Diatom,
Skeletonema costatum: Final Report: Lab Project Number: 92-8-4395:
10566.0292.6221.450. Unpublished study prepared by Springborn Labs, Inc.
59 p.
114
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BIBLIOGRAPHY
MRID
CITATION
42611701 Hoberg, J. (1992) Asulam Sodium—Toxicity to the Duckweed Lemna gibba:
Final Report: Lab Project Number: 92-9-4397: 10566.0292.6222.410.
Unpublished study prepared by Springborn Labs, Inc. 64 p.
42613801 Christensen, K. (1992) Asulam Sodium—Determination of Effects on Seed
Germination, Seedling Emergence and Vegetative Vigor of Ten Plant Species:
Final Report: Lab Project Number: 92-9-4431: 10566.0292.6217.610.
Unpublished study prepared by Springborn Labs., Inc. 214 p.
42613802 Hoberg, J. (1992) Asulam Sodium—Toxicity to the Freshwater Alga, Anabaena
flos-aquae: Final Report: Lab Project Number: 92-10-4457:
10566.0292.6218.420. Unpublished study prepared by Springborn Lab., Inc.
60 p.
42631301 Hoberg, J. (1992) Asulam Sodium-Toxicity to the Freshwater Diatom,
Navicula pelliculosa: Final Report: Lab Project Number: 92-12-4519:
10566.0292.6219.440. Unpublished study prepared by Springborn Labs, Inc.
60 p.
42704901 Gustafson, D. (1993) Drinking Water Monitoring for Residues of Asulam in
High-use Areas of the United States: Lab Project Number: 41293: EC-91-153.
Unpublished study prepared by Alta Analytical Laboratory, Inc. 164 p.
42980801 See, R. (1993) Asulox Rotational Crop-Field: Lab Project Number: 1143:
USA90U03: 41351. Unpublished study prepared by Colorado Analytical
Research & Development Corp. 783 p.
43234701 Williams, R. (1994) Stability of Asulam and Its Prinicipal Metabolites on
Sugarcane and Sugarcane Processed Fractions During Frozen Storage: Final
Report: Lab Project Number: EC/91/151. Unpublished study prepared by
Rhone-Poulenc Ag Co. 65 p.
115
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APPENDIX D. List of Available Related Documents
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118
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The following is a list of available documents related to Asulam. 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 Asulam 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. Asulam RED Fact Sheet
4. PR Notice 86-5 (included in this appendix)
5. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
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APPENDIX E. PR Notices 86-5 and 91-2
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122
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PR Notice 86-5
123
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124
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
PRO WASHINGTON, B.C. 20460
July 29, 1986
OFFICE OF
PR NOTICE 86-5 PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Attention: Perspns responsible for Federal registration of
pesticides.
Subject: Standard format for data submitted under the
Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) and certain provisions of the Federal
Food, Drug, and Cosmetic Act (FFDCA).
I. Purpose
To require data to be submitted to the Environmental
Protection Agency (EPA) in a standard format. This Notice also
provides additional guidance about, and illustrations of, the
required formats.
II. Applicability
This PR Notice applies to all data that are submitted to EPA
to satisfy data requirements for granting or maintaining
pesticide registrations, experimental use permits, tolerances,
and related approvals under certain provisions of FIFRA and
FFDCA. These data are defined in FIFRA §10(d)(1). This Notice
does not apply to commercial, financial, or production
information, which are, and must continue to be, submitted
differently under separate cover.
III. Effective Date
This notice is effective on November 1, 1986. Data formatted
according to this notice may be submitted prior to the effective
date. As of the effective date, submitted data packages that do
not conform to these requirements may be returned to the
submitter for necessary revision.
IV. Background
On September 26, 1984, EPA published proposed regulations in
the Federal Register (49 FR 37956) which include Requirements for
Data Submission (40 CFR §158.32), and Procedures for Claims of
Confidentiality of Data (40 CFR §158.33). These regulations
specify the format for data submitted to EPA under Section 3 of
FIFRA and Sections 408 and 409 of FFDCA, and procedures which
must be followed to make and substantiate claims of confiden-
tiality. No entitlements to data confidentiality are changed,
either by the proposed regulation or by this notice.
OPP is making these requirements mandatory through this
Notice to gain resource-saving benefits from their use before the
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entire proposed regulation becomes final. Adequate lead time is
being provided for submitters to comply with the new
requirements.
V. Relationship of this Notice to Other OPP Policy and Guidance
While this Notice contains requirements for organizing and
formatting submittals of supporting data, it does not address the
substance of test reports themselves. "Data reporting" guidance
is now under development in OPP, and will specify how the study
objectives, protocol, observations, findings, and conclusions are
organized and presented within the study report. The data
reporting guidance will be cpmpatible with submittal format
requirements described in this Notice.
OPP has also promulgated a policy (PR Notice 86-4 dated
April 15, 1986) that provides for early screening of certain
applications for registration under FIFRA §3. The objective of
the screen is to avoid the additional cpsts and prolonged delays
associated with handling significantly incomplete application
packages. As of the effective date of this Notice, the screen
will include in its criteria for acceptance of application
packages the data formatting requirements described herein.
OPP has also established a public docket which imposes
deadlines for inserting into the docket documents submitted in
connection with Special Reviews and Registration Standards (see
40 CFR §154.15 and §155.32). To meet these deadlines, OPP is
requiring an additional copy of any data submitted to the docket.
Please refer to Page 10 for more information about this
requirement.
For several years, OPP has required that each application
for registration or other action include a list of all applicable
data requirements and an indication of how each is satisfied—the
statement of the method of support for the application.
Typically, many requirements are satisfied by reference to data
previously submitted—either by the applicant or by another
party. That requirement is not altered by this notice, which
applies only to data submitted with an application.
VI. Format Requirements
A more detailed discussion of these format requirements
follpws the index on the next page, and samples of some of the
requirements are attached. Except for the language of the two
alternative forms of the Statement of Data Confidentiality Claims
(shown in Attachment 3) which cannot be altered, these samples
are illustrative. As long as the required information is
included and clearly identifiable, the form of the samples may be
altered to reflect the submitter's preference.
- INDEX-
Text Example
Page Page
A. Organization of the Submittal Package 3 17
B. Transmittal Document 4 11
C. Individual Studies 4
C. 1 Special Considerations for Identifying Studies . . 5
D. Organization of each Study Volume 6 17
D. 1 Study Title Page 7 12
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D. 2 Statement of Data Confidentiality Claims
(based on FIFRA §10 (d) (1)) 8 13
D. 3 Confidential Attachment 8 15
D. 4 Supplemental Statement of Data Confidentiality
Claims (other than those based on FIFRA §10(d) (1)) 8 14
D. 5 Good Laboratory Practice Compliance Statement . . 9 16
E. Reference to Previously Submitted Data 9
F. Physical Format Requirements & Number of Copies .... 9
G. Special Requirements for Submitting Data to the Docket 10
A. Organization of Submittal Package
A "submittal package" consists of all studies submitted at
the same time for review in support of a single regulatory
action, along with a transmittal document and other related
administrative material (e.g. the method of support statement,
EPA Forms 8570-1, 8570-4, 8570-20, etc.) as appropriate.
Data submitters must organize each submittal package as
described in this Notice. The transmittal and any other admin-
istrative material must be grouped together in the first physical
volume. Each study included in the submittal package must then
be bound separately.
Submitters sometimes provide additional materials that are
intended to clarify, emphasize, or otherwise comment to help
Product Managers and reviewers better understand the submittal.
If such materials relate to one study, they should be
included as an appendix to that study.
- If such materials relate to more than one study (as for
example a summary of all studies in a discipline) or to the
submittal in general, they must be included in the submittal
package as a separate study (with title page and statement
of confidentiality claims).
B. Transmittal Document
The first item in each submittal package must be a trans-
mittal document. This document identifies the submitter or all
joint submitters; the regulatory action in support of which the
package is being submitted--!.e., a registration application,
petition, experimental use permit (EUP), §3 (c) (2) (B) data
call-in, §6 (a) (2) submittal, or a special review; the transmittal
date; and a list of all individual studies included in the
package in the order of their appearance, showing (usually by
Guideline reference number) the data requirement(s) addressed by
each one. The EPA-assigned number for the regulatory action
(e.g. the registration, EUP, or tolerance petition number) should
be included in the transmittal document as well, if it is known
to the submitter. See Attachment 1 for an example of an
acceptable transmittal document.
The list of included studies in the transmittal of a data
submittal package supporting a registration application should be
subdivided by discipline, reflecting the order in which data
requirements appear in 40 CFR 158.
The list of included studies in the transmittal of a data
submittal package supporting a petition for tolerance or an
127
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application for an EUP should be subdivided into sections A, B,
C, .... of the petition or application, as defined in 40 CFR 180.7
and 158.125, (petitions) or Pesticide Assessment Guidelines,
Subdivision I (EUPs) as appropriate.
When a submittal package supports a tolerance petiti9n and
an application for a registration or an EUP, list the petition
studies first, then the balance of the studies. Within these two
groups of studies follow the instructions above.
C. Individual Studies
A study is the report of a single scientific investigation,
including all supporting analyses required for logical complete-
ness. A study should be identifiable and distinguishable by a
conventional bibliographic citation including author, date, and
title. Studies generally correspond in scope to a single Guide-
line requirement for supporting data, with some exceptions dis-
cussed in section C.I. Each study included in a submittal
package must be bound as a separate entity. (See comments on
binding studies on page 9.)
Each study must be consecutively paginated, beginning from
the title page as page 1. The total number of pages in the com-
plete study must be shown on the study title page. In addition
(to ensure that inadvertently separated pages can be reassociated
with the proper study during handling or review) use either of
the following:
- Include the total number of pages in the complete study on
each page (i.e., 1 of 250, 2 of 250, ...250 of 250).
- Include a company name or mark and study number on each
page of the study, e g , Company Name-1986-23. Never reuse
a study number for marking the pages of subsequent studies.
When a single study is extremely long, binding it in mul-
tiple volumes is permissible so long as the entire study is pag-
inated in a single series, and each volume is plainly identified
by the study title and its position in the multi-volume sequence.
C.1 Special Considerations for Identifying Studies
Some studies raise special problems in study identification,
because they address Guidelines of broader than normal scope or
for other reasons.
a. Safety Studies . Several Guidelines require testing for
safety in more than one species. In these cases each species
tested should be reported as a separate study, and bound
separately.
Extensive supplemental reports of pathology reviews, feed
analyses, historical cpntrol data, and the like are often assoc-
iated with safety studies. Whenever possible these should be
submitted with primary reports of the study, and bound with the
primary study as appendices. When such supplemental reports are
submitted independently of the primary report, take care to fully
identify the primary report to which they pertain.
Batteries of acute toxicity tests, performed on the same end
use product and covered by a single title page, may be bound
together and reported as a single study.
b. Product Chemistry Studies . All product chemistry data
within a submittal package submitted in support of an end-use
product produced from registered manufacturing-use products
should be bound as a single study under a single title page.
Product chemistry data submitted in support of a technical
product, other manufacturing-use product, an experimental use
permit, an import tolerance petition, or an end-use product
128
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produced from unregistered source ingredients, should be bound as
a single study for each Guideline series (61, 62, and 63) for
cpnventional pesticides, or for the equivalent subject range for
biorational pesticides. The first of the three studies in a
complete product chemistry submittal for a biochemical pesticide
would cover Guidelines 151-10, 151-11, and 151-12; the second
would cover Guidelines 151-13, 151-15, and 151-16; the third
would cover Guideline 151-17. The first study for a microbial
pesticide would cover Guidelines 151-20, 151-21, and 151-22; the
second would cover Guidelines 151-23 and 151-25; the third would
cover Guideline 151-26.
Note particularly that product chemistry studies are likely
to contain Confidential Business Information as defined in FIFRA
§10(d)(1)(A), (B), or (C), and if so must be handled as described
in section D.3. of this notice.
c. Residue Chemistry Studies . Guidelines 171-4, 153-3,
and 153-4 are extremely broad in scope; studies addressing
residue chemistry requirements must thus be defined at a level
below that of the Guideline code. The general principle,
however, of limiting a study to the report of a single inves-
tigation still applies fully. Data should be treated as a single
study and bound separately for each analytical method, each
report of the nature of the residue in a single crop or animal
species, and for each report of the magnitude of residues
resulting from treatment of a single crop or from processing a
single crop. When more than one commodity is derived from a
single crop (such as beet tops and beet roots) residue data on
all such commodities should be reported as a single study. When
multiple field trials are associated with a single crop, all such
trials should be reported as a single study.
D.
Organization of Each Study Volume
Each complete study must include all applicable elements in
the list below, in the order indicated. (Also see Page 17.)
Several of these elements are further explained in the following
paragraphs. Entries in the column headed "example" cite the
page number of this notice where the element is illustrated.
Element
Study Title Page
Statement of Data
Confidentiality
Claims
Certification of Good
Laboratory Practice
Flagging statements
Body of Study
Study Appendices
Cover Sheet to Confi-
dential Attachment
When Required Example
Always Page 12
One of the two alternative Page 13
forms of this statement
is always required
If study reports laboratpry Page 16
work subject to GLP require-
ments
For certain toxicology studies (When
flagging requirements are finalized.)
Always - with an English language
translation if required.
At submitter's option
If CBI is claimed under FIFRA
§10(d)(1)(A), (B), or (C)
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
If CBI is claimed under FIFRA
§10(d)(1)(A), (B), or (C) Page 15
Only if confidentiality is
claimed on a basis other than
FIFRA §10(d)(1)(A), (B), or (C)
Page 14
129
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D.I. Title Page
A title page is always required for each submitted study,
published or unpublished. The title page must always be freely
releasable to requestors; DO NOT INCLUDE CBI ON THE TITLE PAGE.
An example of an acceptable title page is on page 12 of this
notice. The following information must appear on the title page:
a. Study title . The study title should be as descriptive as
possible It must clearly identify the substance(s) tested and
correspond to the name of the data requirement as it appears in
the Guidelines.
b. Data requirement addressed . Include on the title page the
Guideline number(s) of the specific requirement(s) addressed by
the study.
c. Author(s) . Cite only individuals with primary intellectual
responsibility for the cpntent of the study. Identify them
plainly as authors, to distinguish them from the performing
laboratory, study sponsor, or other names that may also appear on
the title page.
d. Study Date . The title page must include a single date for
the study. If parts of the study were performed at different
times, use only the date of the latest element in the study.
e. Performing Laboratory IdentificatJ9n . If the study reports
work done by one or more laboratories, include on the title page
the name and address of the performing laboratory or
laboratories, and the laboratory's internal project number(s) for
the work. Clearly distinguish the laboratory's project
identifier from any other reference numbers provided by the study
sponsor or submitter.
f. Supplemental Submissions . If the study is a commentary on
or supplement to another previously submitted study, or if it
responds to EPA questions raised with respect to an earlier
study, include on the title page elements a. through d. for the
previously submitted study, along with the EPA Master Record
Identifier (MRID) or Accession number of the earlier study if you
know these numbers. (Supplements submitted in the same submittal
package as the primary study should be appended to and bound with
the primary study. Do not include supplements to more than one
study under a single title page).
g. Facts of Publication . If the study is a reprint of a pub-
lished dpcument, identity on the title page all relevant facts of
publication, such as the journal title, volume, issue, inclusive
page numbers, and publication date.
D.2. Statements of Data Confidentiality Claims Under FIFRA
§10(d) (1) .
Each submitted study must be accompanied by one of the tv\ro
alternative forms of the statement of Data Confidentiality Claims
specified in the proposed regulation in §158.33 (b) and (c) (See
Attachment 3). These statements apply only to claims of data
confidentiality based on FIFRA §10(d)(1)(A), (B), or (C). Use
the appropriate alternative form of the statement either to
assert a claim of §10(d) (1) data confidentiality (§158.33 (b)) or
to waive such a claim (§158.33 (c)) . In either case, the
statement must be signed and dated, and must include the typed
name and title of the official who signs it. Do not make CBI
claims with respect to analytical methods associated with pet-
itions for tolerances or emergency exemptions (see NOTE Pg 13).
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D.3. Confidential Attachment
If the claim is made that a study includes confidential
business information as defined by the criteria of FIFRA
§10(D)(1)(A), (B), or (C) (as described in D.2. above) all such
information must be excised from the body of the study and
confined to a separate study-specific Confidential Attachment.
Each passage of CBI so isolated must be identified by a reference
number cited within the body of the study at the point from which
the passage was excised (See Attachment 5).
The Confidential Attachment to a study must be identified by
a cover sheet fully identifying the parent study, and must be
clearly marked "Confidential Attachment." An appropriately
annotated photocopy of the parent study title page may be used as
this cover sheet. Paginate the Confidential Attachment
separately from the body of the study, beginning with page 1 of X
on the title page. Each passage confined to the Confidential
Attachment must be associated with a specific cross reference to
the page(s) in the main body of the study on which it is cited,
and with a reference to the applicable passage(s) of FIFRA
§10(d)(1) on which the confidentiality claim is based.
D.4. Supplemental Statement of Data Confidentiality Claims (See
Attachment 4)
If you wish to make a claim of confidentiality for any
portion of a submitted study other than described by FIFRA §10(d)
(1)(A), (B), or (C), the following provisions apply:
- The specific information to which the claim applies must
be clearly marked in the body of the study as subject to a
claim of confidentiality.
- A Supplemental Statement of Data Confidentiality Claims
must be submitted, identifying each passage claimed confi-
dential and describing in detail the basis for the claim.
A list of the points to address in such a statement is
included in Attachment 4 on Pg 14.
- The Supplemental Statement of Data Confidentiality Claims
must be signed and dated and must include the typed name and
title of the official who signed it.
D.5. Good Laboratory Practice Compliance Statement
This statement is required if the study contains laboratory
work subject to GLP requirements specified in 40 CFR 160. Sam-
ples of these statements are shown in Attachment 6.
E. Reference to Previously Submitted Data
DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it. A copy
of the title page plus the MRID number (if known) is sufficient
to allow us to retrieve the study immediately for review. This
prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study. References to pre-
viously submitted studies should not be included in the transmit-
tal document, but should be incorporated into the statement of
the method of support for the application.
F. Physical Format Requirements
All elements in the data submittal package must be on
uniform 8 1/2 by 11 inch white paper, printed on one side only in
black ink, with high contrast and good resplution. Bindings for
individual studies must be secure, but easily removable to permit
disassembly for microfilming. Check with EPA for special
instructions before submitting data in any medium other than
paper, such as film or magnetic media.
131
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Please be particularly attentive to the following points:
• Do not include frayed or torn pages.
• Do not include carbon copies, or copies in other than
black ink.
• Make sure that photocopies are clear, complete, and
fully readable.
• Do not include oversize computer printouts or fold-out
pages.
• Do not bind any documents with glue or binding tapes.
• Make sure that all pages of each study, including any
attachments or appendices, are present and in correct
sequence.
Number of Copies Required - All submittal packages except
those associated with a Registration Standard or Special Review
(See Part G below) must be provided In three complete, identical
copies. (The proppsed regulatipns specified two copies; three
are now being required to expedite and reduce the cost of
processing data into the OPP Pesticide Document Management System
and getting it into review.)
G. Special Requirements for Submitting Data to the Docket
Data submittal packages associated with a Registration Stan-
dard pr Special Review must be provided in four copies, from one
of which all material claimed as CBI has been excised. This
fourth copy will become part of the public docket for the RS or
SR case. If no claims of confidentiality are made for the study,
the fourth copy should be identical to the other three. When
portions of a study submitted in support of an RS or SR are
claimed as CBI, the first three copies will include the CBI
material as provided in section D of this notice. The following
special preparation is required for the fourth copy.
• Remove the "Supplemental Statement of Data
Confidentiality Claims".
• Remove the "Confidential Attachment".
• Excise from the body of the study any information you
claim as confidential, even if it does not fall within
the scope of FIFRA §10(d) (1) (A), (B), or (C). Do not
close up or paraphrase text remaining after this
excision.
• Mark the fourth copy plainly on both its cover and its
title page with the phrase "Public Docket Material -
contains no information claimed as confidential".
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V. For Further Information
For further information contact John Carley, Chief,
Information Services Branch, Program Management and Support
Division, (703) 305-5240.
/S/
James W. Akerman
Acting Director,
Registration Division
Attachment 1. Sample Transmittal Document
Attachment 2. Sample Title Page for a Newly Submitted Study
Attachment 3. Statements of Data Confidentiality Claims
Attachment 4. Supplemental Statement of Data Confidentiality
Claims
Attachment 5. Samples of Confidential Attachments
Attachment 6. Sample Gpod Laboratory Practice Statements
Attachment 7. Format Diagrams for Submittal Packages and Studies
133
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ATTACHMENT 1
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
1. Name and address of submitter (or all joint submitters**)
+Smith Chemical Corporation Jones Chemical Company
1234 West Smith Street -and- 5678 Wilson Blvd
Cincinnati, OH 98765 Covington, KY 56789
+Smith Chemical Corp will act as sole agent for all submitters.
2. Regulatory action in support of which this package is
submitted
Use the EPA identification number (e.g. 359-EUP-67) if you know
it. Otherwise describe the type of request (e.g. experimental
use permit, data call-in - of xx-xx-xx date).
3. Transmittal date
4. List of submitted studies
Vol 1. Administrative materials - forms, previous corres-
pondence with Project Managers, and so forth.
Vol 2. Title of first study in the submittal (Guideline
No. )
Vol n Title of nth study in the submittal (Guideline
No.)
* Applicants commonly provide this information in a tran-
smittal letter. This remains an acceptable practice so
long as all four elements are included.
* Indicate which of the joint submitters is empowered to
act on behalf of all joint submitters in any matter
concerning data compensation or subsequent use or
release of the data.
Company Official:
Name Signature
Company Name
Company Contact:
Name Phone
134
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ATTACHMENT 2
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
Study Title
(Chemical name) - Magnitude of Residue on Corn
Data Requirement
Guideline 171-4
Author
John C. Davis
Study Completed On
January 5, 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Project ID
ABC 47-79
Page 1 of X
(X is the total number of pages in the study)
135
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ATTACHMENT 3
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under FIFRA §10(d)(1)(A),(B), or (C)
STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
No claim of confidentiality is made for any information contained in this
study on the basis of its falling within the scope of FIFRA
6§10(d)(1)(A), (B), or (C).
Company
Company Agent: Typed Name Date :
Title Signature
2. Claim of confidentiality under FIFRA §10(d)(1)(A), (B), or (C).
Information claimed confidential on the basis of its falling within the
scope of FIFRA §10(d)(1)(A), (B), or (C) has been removed to a
confidential appendix, and is cited by cross-reference number in the body
of the study.
Company:
Company Agent: Typed Name Date :
Title Signature
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
NOTE: Applicants for permanent or temporary tolerances should
note that it is OPP policy that no permanent tolerance, temporary
tolerance, or request for an emergency exemption incorporating an
analytical method, can be approved unless the applicant waives
all claims of confidentiality for the analytical method. These
analytical methods are published in the FDA Pesticide Analytical
Methods Manual, and therefore cannot be claimed as confidential.
OPP implements this policy by returning submitted analytical
methods, for which confidentiality claims have been made, to the
submitter, to obtain the confidentiality waiver before they can
be processed.
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ATTACHMENT 4
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described
by FIFRA §10(d)(1)(A), (B), or (C), but for which you claim
confidential treatment on another basis, the following informa-
tion must be included within a Supplemental Statement of Data
Confidentiality Claims:
• Identify specifically by page and line number(s) each
portion of the study for which you claim
confidentiality.
• Cite the reasons why the cited passage qualifies for
confidential treatment.
• Indicate the length of time—until a specific date or
event, or permanently--for which the information should
be treated as confidential.
• Identify the measures taken to guard against undesired
disclosure of this information.
• Describe the extent to which the information has been
disclosed, and what precautions have been taken in con-
nection with those disclosures.
• Enclose copies of any pertinent determinations of
confidentiality made by EPA, other Federal agencies, of
courts concerning this information.
• If you assert that disclosure of this information would
be likely to result in substantial harmful effects to
you, describe those harmful effects and explain why
they should be viewed as substantial.
• If you assert that the informatipn in voluntarily sub-
mitted, indicate whether you believe disclosure of this
information might tend to lessen the availability to
EPA of similar information in the future, and if so,
how.
137
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ATTACHMENT 5
EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
Example 1. (Confidential word or phrase that has been deleted
from the study)
CROSS REFERENCE NUMBER 1 This cross reference number is used in the study in place of the
following paragraph(s) at the indicated volume and page
references.
DELETED WORDS OR PHRASE, Ethvlene Glvcol
PAGE LINES REASON FOR THE DELETION FIFRA
REFERENCE
6 14 Identity of Inert Ingredient §10(d)(C)
28 25
100 19
Example 2. (Confidential paragraph(s) that have been deleted from the study)
CROSS REFERENCE NUMBER 5 This cross reference number is used in the study in place of the
following paragraph(s) at the indicated volume and page
references.
DELETED PARAGRAPH(S):
( )
( Reproduce the deleted paragraph(s) here )
PAGE LINES REASON FOR THE DELETION FIFRA REFERENCE
20. 2-17 Description of the quality control process §10(d)(l)(C)
Example 3. (Confidential pages that have been deleted from the study)
CROSS REFERENCE NUMBER 7 This cross reference number is used in the study in place of the
following paragraph(s) at the indicated volume and page
references.
DELETED PAGES(S): are attached immediately behind this page
PAGES REASON FOR THE DELETION FIFRA REFERENCE
35-41. Description of product manufacturing process § 10(d)(l)(A)
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ATTACHMENT 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
This study meets the requirements for 40 CFR Part 160
Submitter
Sponsor
Example 2.
This study does not meet the requirements of 40 CFR Part 160, and
differs in the following ways:
Submitter_
Sponsor
Study Director_
Example 3.
The submitter of this study was neither the sponsor of this study nor
conducted it, and does not know whether it has been conducted in
accordance with 40 CFR Part 160.
Submitter
139
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ATTACHMENT 7.
FORMAT OF THE SUBMITTAL PACKAGE
Transmittal Document
Related Administrative Materials
(e.g. Method of Support Statement, etc.)
Other materials about the submittal
(e.g., summaries of groups of studies
to aid in their review).
Studies submitted as unique
to the format below.
FORMAT OF SUBMITTED STUDIES
LEGEND
• Study title page.
Statement of Confidentiality Claims.
. GLP and flagging* statements - as appropriate.
Body of the study, with English
language translation if required.
Appendices to the study.
Title Page of the Confidential
Attachment.
Confidential Attachment.
Supplemental Statement
of Confidentiality Claims
* When flagging requirements
are finalised.
Documents which must be submitted as
appropriate to meet established requirements.
Documents submitted at submitter's option.
'
140
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PR Notice 91-2
141
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142
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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 pplicy 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(1) . 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
143
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product compositipn because the nominal concentration would be
the amount of active ingredient typically found in the product.
It is imp9rtant 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. Cppies 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
representative 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.
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(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.
(3) 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.
/s/
Anne E. Lindsay, Director
Registration Division (H-7505C)
145
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146
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APPENDIX F. Combined Generic and Product Specific
Data Call-In
147
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148
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\ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
GENERIC AND PRODUCT SPECIFIC
DATA CALL-IN NOTICE
CERTIFIED MAIL
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).
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 I - Why You are Receiving this Notice
Section II - Data Required by this Notice
Section III - Compliance with Requirements of this Notice
Section IV - Consequences of Failure to Comply with this Notice
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Section V - Registrants' Obligation to Report Possible Unreasonable Adverse
Effects
Section VI - 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 Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregi strati on
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 3 (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 Forms (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
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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).
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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;
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(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 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.
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
Registrant's Response Form. If you choose one of these options, you must submit both forms
as well as any other information/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.
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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 Reregi strati on 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.
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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 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 means 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 lab oratory (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
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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 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 they
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
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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.
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 'Raw 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
data' 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.
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c. You must certify that each study fulfills the acceptance criteria for the
Guideline relevant to the study provided in the FIFRA Accelerated
Reregi strati on 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 study, 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 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.
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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. Citing 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 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
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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.L, Option 3) apply to this option. This option only applies to acute
toxicity and certain efficacy data as described in option 2 above.
Option 4. Submitting an Existing Study — The same requirements described for generic data
(see Section III.C.L, 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 Requirements 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 registrant will be required, as a condition of the waiver, to
submit annual sales reports. The Agency will respond to requests for waivers 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:
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(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 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 factors, 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.
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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 produces), 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.
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.
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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. Failure to respond as required by this Notice within 90 days of your receipt of
this Notice.
2. 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.
3. Failure to submit on the required schedule an adequate progress report on a
study as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this
Notice.
5. Failure to take a required action or submit adequate information pertaining to
any option chosen to address 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).
6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. 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 Requirements Status and Registrant's
Response Form.
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.
9. Failure to take any required or appropriate steps, not mentioned above, at any
time following the issuance of this Notice.
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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 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 Act's 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 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.
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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 POSSIBLE
UNREASONABLE 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
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 Generic and Product Specific Data Call-In Response Forms need be submitted.
The Office of Compliance (OC) of the Office of Enforcement and Compliance
Assurance (OECA), EPA, will be monitoring the data being generated in response to this
Notice.
Sincerely yours,
Lois A. Rossi, Director
Special Review and
Reregi strati on Division
Attachments
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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 Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregi strati on
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Confidential Statement of Formula. Cost Share and Data Compensation Forms
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Attachment 1. Chemical Status Sheets
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ASULAM DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s)
containing Asulam.
This Generic Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregi strati on of
Asulam. This attachment is to be used in conjunction with (1) the Generic Data Call-In
Notice, (2) the Generic Data Call-In Response Form (Attachment 2), (3) the Requirements
Status and Registrant's Form (Attachment 2), (4) a list of registrants receiving this DCI
(Attachment 4), (5) the EPA Acceptance Criteria (Attachment 5), and (6) the Cost Share and
Data Compensation Forms in replying to this Asulam Generic Data Call-In (Attachment F).
Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for Asulam
are contained in the Requirements Status and Registrant's Response. Attachment C. The
Agency has concluded that additional product chemistry, ecological effects, environmental
fate, spray drift, and residue chemistry data on asulam are needed. These data are needed to
fully complete the reregi strati on of all eligible asulam products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Karen Jones at (703) 308-8047.
All responses to this Notice for the generic data requirements should be submitted to:
Karen Jones, Chemical Review Manager
Reregi strati on Branch
Special Review and Registration Division (H7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Asulam
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ASULAM DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have
product(s) containing Asulam.
This Product Specific Data Call-In Chemical Status Sheet, contains an overview of
data required by this notice, and point of contact for inquiries pertaining to the reregi strati on
of Asulam. This attachment is to be used in conjunction with (1) the Product Specific Data
Call-In Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2), (3) the
Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA
Acceptance Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6)
and (7) the Cost Share and Data Compensation Forms in replying to this Asulam Product
Specific Data Call-In (Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for Asulam are
contained in the Requirements Status and Registrant's Response. Attachment 3. The Agency
has concluded that additional data on Asulam 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 reregi strati on of all eligible Asulam products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of Asulam, please contact
Karen Jones at (703) 308-8047.
If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Franklin Gee at (703) 308-8008.
(703)308-8004.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Jeffrey Billingslea
Chemical Review Manager, Team 81
Product Reregi strati on Branch
Special Review and Reregi strati on Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Asulam
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Attachment 2. Combined Generic and Product Specific
Data Call-In Response Forms (Form A inserts) Plus
Instructions
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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 Reregi strati on Program under the Federal Insecticide, Fungicide, and
Rodenticide Act. If you are an end-use product registrant only and have been sent this DCI
letter as part of a RED document you have been sent just the product specific "Data Call-In
Response Forms." Only registrants responsible for generic data have been sent the generic
data response form The type of Data Call-In (generic or product specific) is indicated in
item number 3 ("Date and Type of DCI") on each form.
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.
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INSTRUCTIONS FOR CpMPLETING 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.
ItemS. 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 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.
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INSTRUCTIONS FOR CpMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In
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.
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INSTRUCTIONS FOR CpMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In
Item 8. 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.
Item 9. ON BOTH FORMS: Enter the date of signature.
Item 10. ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response.
Item 11. 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 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 EPA can ensure that its records are correct.
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Attachment 3. Generic and Product Specific Requirement
Status and Registrant's Response Forms (Form B inserts)
and Instructions
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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 reregi strati on program under the Federal
Insecticide, Fungicide, and Rodenticide Act. If you are an end-use product registrant only
and have been sent this DCI letter as part of a RED document you have been sent just the
product specific "Requirements Status and Registrant's Response Forms." Only registrants
responsible for generic data have been sent the generic data response forms. The type of
Data Call-In (generic or product specific) is indicated in item number 3 ("Date and
Type of DCI") on each form.
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 waiver. 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.
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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.
ItemS. 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.
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
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Item 7.
Item 8.
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
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
TGAI
TGAI/PAI
TGAI/PAIRA
TGAI/TEP
MET
IMP
DEGR
*
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 Product, Percent Active Ingredient
Specified
Typical End-Use Product and Metabolites
Typical End-Use Product or Pure Active Ingredient and
Metabolites
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 9.
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 Reregi strati on 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.
ON BOTH FORMS: Enter the appropriate Response Code or Codes to show
how you intend to comply with each data requirement. Brief descriptions of
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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 Shared I have entered into an
agreement with one or more registrants to develop data jointly. By
indicating that I have chosen this option, I certify that I will comply with
all the requirements pertaining to snaring 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: fOffer to Cost Shared 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 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
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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: rCiting 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.
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 lowvolume 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 that 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
183
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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 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: 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.
Item 11. ON BOTH FORMS: Enter the date of signature.
Item 12. 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
184
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Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
185
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186
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EPA'S BATCHING OF PRODUCTS CONTAINING ASULAM AS THE ACTIVE
INGREDIENT 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 reregi strati on of products containing the active ingredient
Asulam (methyl sulfanilylcarbamate and methyl sulfanilylcarbamate, sodium salt), 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.
Using available information, batching has been accomplished by the process described in
the preceding paragraph. Notwithstanding 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 lexicological 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. If more than one confidential statment of formula (CSF) exists for a
product, the registrant must indicate the formulation actually tested by identifying the
corresponding CSF.
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 a 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 batch for the active ingredient Asulam.
187
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Table 1
EPA Reg. No.
264-447
57242-5
64764-3
Active Ingredient
Sodium Salt of Asulam ... 36.2%
Sodium Salt of Asulam ... 36.2%
Sodium salt of Asulam ... 36.2%
Formulation
Type
liquid
liquid
liquid
Table 2 lists the product the Agency was unable to batch. This product was considered not to
be similar to other products for purposes of acute toxicity. The registrant of this product is
responsible for meeting the acute toxicity data requirements for this product.
Table 2
EPA Reg. No.
264-451
Active Ingredient
Asulam ... 96%
Formulation Type
solid
188
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Attachment 5. EPA Acceptance Criteria
189
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190
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SUBDIVISION D
Guideline Study Title
Series 61 Product Identity and Composition
Series 62 Analysis and Certification of Product Ingredients
Series 63 Physical and Chemical Characteristics
191
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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 lexicologically significant impurities (e.g., dioxins, nitrosamines) present at <0.1%.
4. Purpose of each active ingredient and each intentionally-added inert.
5. 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.
6. Molecular, structural, and empirical formulas, molecular weight or weight range, and any company
assigned experimental or internal code numbers for each active ingredient.
7. 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.
8. 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.
9. 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
lexicologically significant impurities (see #3).
192
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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 ammes/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 alon g
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 methods 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 in #9) to verify certified limits validated as to their precision and
accuracy.
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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 i f
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
194
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SUBDIVISION F
Guideline Study Title
81-1 Acute Oral Toxicity in the Rat
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
81-3 Acute Inhalation Toxicity in the Rat
81-4 Primary Eye Irritation in the Rabbit
81-5 Primary Dermal Irritation Study
81-6 Dermal Sensitization in the Guinea Pig
195
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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/grqup.
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.
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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.
6.1 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. Individuarobseryations 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.
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81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. 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 (im or less).
3. At least 5 young adult rats/sex/group.
4. Dosing, at least 4 hours by inhalation.
5. Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
6. Chamber temperature, 22° C (+2°), relative humidity 40-60%.
7. Monitor rate of air flow.
8. Monitor actual concentrations of test material in breathing zone.
9. Monitor aerodynamic particle size for aerosols.
10. Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of
respirable substance).
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.
198
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81-4 Primary Eye Irritation in the Rabbit
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, causes severe
dermal irritation or has a pH of <2 or >11.5.
3. 6 adult rabbits.
4. Dosing, instillation into the conjunctival sac of one eye
per animal.
5. Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or particulate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24 hours.
8. 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).
9.^ Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
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81-5 Primary Dermal Irritation Study
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 pH of <2 or >11.5.
3. 6 adult animals.
4. Dosing, single dermal.
5. Dosing duration 4 hours.
6. Application site shaved or clipped at least 24 hours prior to dosing.
7. Application site approximately 6 cm2.
8. Application site covered with a gauze patch held in place with nonirritating tape.
9. Material removed, washed with water, without trauma to application site.
10. Application site examined and graded for irritation at 1, 24, 48 and 72 hr, then daily until normal or 14 days
(whichever is shorter).
11.^ Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
nental £
200
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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
Buehler test
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig.
4. Complete description of test.
53 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.
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202
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Attachment 6. List of All Registrants Sent This Data Call-In (insert)
Notice
203
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204
-------
Attachment 7. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions
205
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206
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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. Following are 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.
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r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
Approval Expires 3-31-96
Public reporting burden (or 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, 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 fill In blanks below.
Company Name
Product Name
Company Number
EPA Reg. 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 Rodenticide 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)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Name of Flrm(s)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Date
Name and Title (Please Type or Print)
EPA Form 8570 32 (5/91) Replaces EPA Form 8580, which is obsolete
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
a.
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APPENDIX G. FACT SHEET
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United States
Environmental Protection
Anpnrw
Preyention^Pesticides
And Toxic Substances
;PA-738-F-95-Q21
September T995
R.E.D. FACTS
Pesticide
Reregistration
Asulam
All pesticides sold or distributed in the United States must be
registered by 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 reregi strati on, 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 unreasonable risks to human health or the environment.
When a pesticide is eligible for reregi strati on, EPA announces this
and explains why in a Reregistration Eligibility Decision (RED) document.
This fact sheet summarizes the information in the RED document for
reregi strati on case 0265, methyl sulfanilylcarbamate and sodium salt of
methyl sulfanilylcarbamate, commonly known as asulam.
Use Profile
Asulam is a selective postemergent systemic carbamate herbicide
used to control a variety of annual grasses and broadleaf weeds on
sugarcane, Christmas tree plantations, ornamentals, turf (St. Augustinegrass
and Bermudagrass) and non-cropland uses (boundary fences, fencerows,
hedgerows, lumberyards, storage areas and industrial plant sites, and
warehouse lots). Its major use site is sugarcane. The only end-use
formulation of asulam is soluble/concentrate liquid (sodium salt of asulam).
Asulam is applied by aerial or ground spray, broadcast, band, and spot
treatment.
Use practice limitations prohibit applying asulam through any type of
irrigation system; discharging into bodies of water; using treated plants for
feed or forage; and treating crops/sites within 90 days of harvest.
Regulatory Asulam was first registered as a pesticide in the U.S. in 1975. EPA
History issued a Registration Standard for Asulam in December 1987 (PB88-
168588). A 1991 Data Call-In (DCI) required additional neurotoxicity,
plant protection, animal feeding, dermal mixer/loader exposure and
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inhalation exposure data. Currently, 1 technical asulam product and 3
sodium salt of asulam products are registered.
Human Health
Assessment
Toxicity
Asulam technical is of relatively low acute toxicity. It is practically
non-toxic by the oral and inhalation routes; technical asulam is in Toxicity
Category IV (the lowest of four categories) for these effects. It is slightly
toxic by the dermal route (Toxicity Category III). It causes slight eye
irritation in rabbits (Toxicity Category III) and is not a skin sensitizer.
In a subchronic dermal study using rabbits, no treatment-related
effects were observed.
Asulam is carcinogenic in rats based on thyroid and adrenal tumors in
males. It has been classified as a Group C carcinogen — that is, a possible
human carcinogen for which there is limited animal evidence.
In a chronic toxicity study using beagle dogs, reductions in food
consumption, body weight gain, vomiting, diarrhea, and reduction in red
blood cells, increase in thyroid and kidney weights and reduced testicular
weights were noted in the high dose groups. A carcinogenic study using
mice cause increased spleen weights in males and decreased brain weights
and decreased survival in females.
In a developmental toxicity study using rats, the highest dose level
caused maternal toxic effects of decreased body weight gain and slight
increase in resorptions. In a study using rabbits, asulam caused maternal
effects of decreased body weight.
A 2-generation reproduction study showed a reduction in the number
of live births per litter, and decreases in body weight and organ weights.
Asulam is not mutagenic.
Dietary Exposure
People may be exposed to residues of asulam through the diet.
Tolerances or maximum residue limits have been established for asulam in
sugarcane (please see 40 CFR 180.360).
Residue data show that sugarcane concentrates in the processed feed
commodity, blackstrap molasses. Under the Delaney clause of the Federal
Food, Drug, and Cosmetic Act (FFDCA), EPA may be barred from
establishing a feed additive regulation (tolerance) for blackstrap molasses
because asulam may be found to be an animal carcinogen within the
meaning of the Delaney clause. The Delaney clause prohibits the
establishment of a regulation for any food/feed additive that is found to
induce cancer in man or animals. Further, under current policy, EPA would
not issue these food and feed additive tolerances, and would not continue in
effect a tolerance for the associated raw agricultural commodity, sugarcane.
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The Agency has committed to revoking the underlying raw agricultural
commodity tolerance where food/feed additive tolerances have been
established or need to be established but cannot because of Delaney. As
part of a settlement agreement in a recent lawsuit, the Agency agreed to
complete these revocations by the year 2000. During the 5 years before
final revocation, the Agency believes it is important to amend the existing
raw agricultural commodity tolerance on sugarcane to reflect new residue
data.
The Agency will also establish new meat, milk, and meat by-product
tolerances. Current residue data suggest the existing sugarcane tolerance
should be raised to 15 ppm from 0.1 ppm. However, the registrant is
submitting additional data reflecting longer pre-harvest intervals (PHIs) and
more accurate timing of applications which will likely result in a tolerance
level lower than the 15 ppm. After reviewing these data, the Agency will
establish a new sugarcane tolerance and require the registrant to petition for
new meat, milk, and meat by-product tolerances. By amending and
establishing tolerances for what may be an interim period, the Agency
believes that these actions will prevent possible overtolerance situations and
should reduce any public confusion regarding dietary risks associated with
a crop or commodity seizure.
In addition, the Agency will also review blackstrap molasses as part
of its new policy regarding implementation of Delaney that was recently
published in the Federal Register as a response to the National Food
Processors Association petition (June 14, 1995; 60 FR 31300). The Agency
will determine if blackstrap molasses is "ready-to-eat" as an animal feed. If
dilution with other feed items is necessary before animal consumption, and
subsequent dilution lowers the level of asulam in the diluted feed mixture to
the level of the raw agricultural commodity tolerance, then a processed feed
tolerance will not be necessary. Then the new sugarcane tolerance and new
meat, milk and meat by-product tolerances will not be revoked.
EPA has assessed the dietary risk posed by asulam. The chronic
dietary risk analysis assumed the higher reassessed tolerance level of 15
ppm and 100% crop treated. The Anticipated Residue Concentration
(ARC) for the overall U.S. population represents 3.85% of the Reference
Dose (RfD), or amount believed not to cause adverse effects if consumed
daily over a 70-year lifetime. The exposures for the two highest exposed
subgroups, children (1-6 years old) and non-nursing infants (<1 year old),
are 3.48 x 10"2 and 2.64 x 10"2 mg/kg body weight/day, respectively. These
exposure values represent 9.7% and 7.3% of the RfD, respectively. This
low fraction of the allowable RfD is acceptable dietary risk.
Occupational and Residential Exposure
Based on current use patterns, handlers (mixers, loaders, and
applicators) may be exposed to asulam during and after applications in
agricultural and other settings. However, there are no toxicological
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Environmental
Assessment
endpoints of concern for short to intermediate term occupational exposure.
There are no residential uses for asulam; therefore, no exposure or risk is
expected from asulam to homeowners.
The Agency is requiring that the current restricted entry interval (REI)
of 12 hours for uses within the scope of the Worker Protection Standards
(WPS) be maintained. This 12 hour REI is the minimum acceptable REI
for assulam. There are no special toxicological concerns about asulam that
warrant the establishment of active-ingredient-based minimum personal
protective equipment (PPE) requirements. The Agency is also requiring the
following early-entry PPE, which is the minimum required under the WPS:
coveralls, chemical-resistant gloves, and shoes plus socks.
Human Risk Assessment
Asulam generally is of low acute toxicity, but it is classified as a non-
quantifiableGroup C carcinogen (that is, a possible human carcinogen for
which there is limited animal evidence), and shows some evidence of
developmental and reproductive toxicity. The only food crop use is
sugarcane. However, dietary exposure to asulam residues in foods is
extremely low, as is the cancer risk posed to the general population.
Application and post-application risks to workers and others are
minimal because asulam has no toxicological endpoints of concern for the
short to intermediate term occupational exposure. Post-application reentry
workers will be required to observe a 12-hour restricted entry interval
(REI). The following early-entry PPE is the minimum required under the
WPS: coveralls, chemical-resistant gloves, and shoes plus socks.
Environmental Fate
The environmental fate assessment is considered preliminary because
of contradictory data. Although there is a lack of acceptable terrestrial field
dissipation data and the Agency has concerns about the integrity of data for
key laboratory studies, based on the supplemental data, it appears that
asulam is highly mobile and has a strong potential to leach into ground
water or move offsite into surface water. Also, based on available data
(including those from unreliable studies), asulam has the following
characteristics: 1) highly to very highly soluble, 2) stable in water without
light, 3) unstable in water and on soil under light; however, small amounts
of asulam were detected in surface water, 4) relatively unstable in soil under
aerobic conditions, 5) very stable in soil and sediment under anaerobic
conditions, 6) very mobile in soil, 7) not volatile, and 8) does not
accumulate in fish.
The Agency is requiring additional storage stability data (aerobic soil
metabolism and anaerobic soil/aquatic metabolism) to validate the results of
the laboratory studies and to assess the need for the field dissipation study.
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In addition, a groundwater label advisory and a surface water label advisory
are required. Due to concerns about off-target damage by the aerial
application of asulam, spray drift data (droplet size spectrum and drift field
evaluation) and a label advisory are also required.
Ecological Effects
Technical asulam is practically nontoxic to freshwater fish and
slightly toxic to freshwater invertebrates. Also, asulam is practically
nontoxic to estuarine/marine species, honeybees, and small mammals.
Chronic effects to avian species and aquatic invertebrate cannot be fully
assessed due to lack of adequate data. However, based on the overall low
risk asulam poses to aquatic and avian species, the Agency does not expect
that asulam will pose a high chronic risk to aquatic invertebrates or avian
species. The Agency is requiring a confirmatory aquatic invertebrate life
cycle study. The Agency is not requiring avian reproduction studies due to
the extremely short photolytic half-life (approximately 2 hours) and, in
acute studies, the practically non-toxic nature of asulam to birds and
mammals.
Levels of concern from all uses of asulam have been exceeded for
endangered and non-endangered terrestrial and semi-aquatic plants. For
non-cropland uses, asulam exceeds levels of concern for endangered and
non-endangered aquatic plants. A comprehensive risk assessment for
nontarget plants cannot be determined due to the lack of adequate data.
High isk to nontarget plants is likely, based on the herbicidal properties of
asulam. The Agency is requiring additional phytotoxicity data to complete
the nontarget plants risk assessment for asulam.
Ecological Effects Risk Assessment
Asulam poses minimal risk to honeybees. Chronic risk to birds
cannot be assessed at this time due to the lack of avian reproduction data.
However, the Agency believes there is little potential for adverse effects to
avian reproduction as the available environmental fate information indicates
that photolysis in water and soil is very rapid — approximately 2 hours.
Regarding mammals, the use of asulam on noncropland at the
maximum use rate, or any other use site, is not likely to adversely affect
mammalian reproduction.
Regarding aquatic risks, acute effects are low for aquatic
invertebrates. However, chronic effects to fish and aquatic invertebrates
cannot be fully assessed without further data.
Endangered and non-endangered species levels of concern are
exceeded for terrestrial and semi-aquatic plants for all uses of asulam. For
the noncropland use of asulam, endangered and non-endangered species are
exceeded for aquatic plants. A comprehensive risk assessment cannot be
determined for nontarget plants without further data. When the Endangered
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Risk Mitigation
Species Program goes into effect, limitation on the use of asulam will be
required to protect endangered and threatened species.
Since the current uses of asulam and its sodium salt exceed ecological
effects levels of concern, EPA is requiring the following risk mitigation
measures.
o Prohibiting the aerial uses of asulam for non-cropland and Christmas trees
use sites;
° Clarifying the non-cropland use to state 1 gallon/acre rate, 1 application
per season;
o Clarifying the Christmas tree uses to state 1 application per season;
° Clarifying the turf use to state sod farms use only and 1 application per
season;
o Ground water label advisory;
o Surface water label advisory; and
° Long term ground water monitoring in and near asulam use areas.
The registrant also is required to clarify the environmental fate
assessment methodology and the uncertainty associated with the extraction
technique and recovery of asulam from the laboratory versus the field
studies.
Additional Data EPA is requiring the following additional generic studies for asulam
an<^ its sodium salt to confirm its regulatory assessments and conclusions:
Acute Aquatic Invertebrate Toxicity - Daphnia magna;
Aerobic Soil Metabolism;
Anaerobic Soil and Aquatic Metabolism;
Droplet Size Spectrum;
Drift Field Evaluation;
Directions for Use - Label amendment (lower application rate and/or
longer PHI);
Plant Metabolism Study;
Magnitude of Residue - Sugarcane; and
Confined Rotational Crop
After reviewing additional field trial data for sugarcane, the Agency
will establish a new sugarcane tolerance and require the registrant to
petition for new meat, milk and meat by-product tolerances.
Certain data are not part of the reregistration target database for
asulam, but are also required:
Seedling emergence - soybeans and radish
Vegetative vigor - cucumber and onion
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The Agency also is requiring product-specific data including product
chemistry and acute toxicity studies, revised Confidential Statements of
Formula (CSFs), and revised labeling for reregi strati on.
Product Labeling All asulam end-use products must comply with EPA's current
ChanCIGS pesticide product labeling requirements, and with the following:
Req U i red Worker Protection
Personal Protective Equipment/Entry Restrictions; Labeling
Personal Protective Equipment (PPE) for Handlers
(Mixer/Loader/Applicators)
The PPE for mixer/loader/applicators is to be based on the acute
toxicity of the end-use product.
Entry Restrictions for Occupational-Use Products (WPS Uses)
Based on the assessment of human health risks, the Agency
does not believe an increase in the REI above what is required in the
Worker Protection Standard (WPS) is warranted. The current 12 hour
REI, pertaining to each use of the product that is within the scope of
the WPS, is to be maintained. This 12 hour REI is the minimum
acceptable REI for asulam.
Early Entry PPE: The PPE for early entry are the minimum that
would be required under the WPS. These are: coveralls, chemical-
resistant gloves, shoes, and socks.
Entry Restrictions for Occupational-Use Products (NonWPS Uses)
Some registered uses of asulam are outside the scope of the
Worker Protection Standard (WPS). For nonWPS uses the Agency is
requiring the following.
"Do not enter or allow others to enter the treated
area until sprays have dried."
Other Labeling Requirements
The Agency is requiring the following labeling statements to be
located on all end-use products containing asulam that are intended
primarily for occupational use:
Products Intended Primarily for Occupational Use
Engineering Controls Used
"When handlers use closed systems, enclosed cabs, or
aircraft in a manner that meets the requirements listed in the
Worker Protection Standard for Agricultural Pesticides (WPS)
[40 CFR 170.240(d)(4-6)], the handler PPE requirements may
be reduced or modified as specified in the WPS. However, full
PPE must be available in the event that the handler exits the
aircraft, enclosed cab, etc. prior to the REI."
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User Safety Requirements
"Follow manufacturer's instructions for cleaning/
maintaining PPE. If no such instructions for washables, use
detergent and hot water. Keep and wash PPE separately from
other laundry."
User Safety Statements
"Users must wash hands before eating, drinking, chewing
gum, using tobacco, or using the toilet."
"Users must leave the treated area, and remove clothing
immediately if pesticide gets inside."
"Users must remove PPE immediately after handling this
product. As soon as possible, wash thoroughly and change into
clean clothing. Wash the outside of gloves before removing."
Application Restrictions
"Do not apply this product in a way that will contact
workers or other persons, either directly or through drift. Only
handlers with appropriate PPE may be in the area during
application."
Homeowner-Use Products
There are no products containing asulam that provide directions
intended for homeowner use. Current labelling provides the statement,
"For agricultural or commercial use only, not for use by homeowners. "
This statement must be maintained.
Environmental Hazard
The labels of all asulam end-use products must be revised to bear the
following under the Environmental Hazard Section:
Wetland Statement
"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
wash water or rinsate."
Ground Water Advisory
"This chemical is known to leach through soil into ground
water under certain conditions as a result of agricultural use.
Use of this chemical in areas where soils are permeable,
particularly where the water table is shallow, may result in
ground-water contamination."
Surface Water Advisory
"Surface water contamination may occur in areas with
poorly draining soils and little or no buffers or in areas where
drainage systems flow directly to surface water."
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Application Restrictions
The labels of all asulam end-use products must be revised to bear the
following application restrictions under the Directions for Use Section:
For noncropland and Christmas tree uses
"Aerial application is prohibited"
For turf uses
"For sod farm use only"
Application Rates
The labels of all asulam end-use products must be revised to bear the
following application rates under the Crop Uses Section for the respective
crops:
For asulam use on noncropland sites
A maximum application rate of 1 gallon/A with use limited to single
application per year.
For asulam use on Christmas trees
A maximum application of 1 gallon/A with use limited to single
application per year.
For asulam use on turf (sod farm use only)
A maximum application of 1 gallon/A with use limited to single
application per year.
Spray Drift
The following language must be placed on each asulam product label
that can be applied aerially:
"AVOIDING SPRAY DRIFT AT THE APPLICATION SITE IS THE
RESPONSIBILITY OF THE APPLICATOR."
"The interaction of many equipment and weather-related factors
determine the potential for spray drift. The applicator is
responsible for considering all these factors when making
decisions."
"The following drift management requirements must be
followed to avoid off-target movement from aerial applications
to agricultural field crops. These requirements do not apply to
forestry applications, public health uses or to applications using
dry formulations."
1. "The distance of the outer most nozzles on the boom must
not exceed 3/4 the length of the wingspan or rotor."
2. "Nozzles must always point backward parallel with the air
stream and never be pointed downwards more than 45 degrees."
"Where states have more stringent regulations, they should be
observed."
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The applicator should be familiar with and take into account the
information covered in the Aerial Drift Reduction Advisory below.
AERIAL DRIFT REDUCTION ADVISORY
The following aerial drift reduction advisory information must be contained
in the product labeling:
[This section is advisory in nature and does not supersede the mandatory
label requirements].
Information on Droplet Size
The most effective way to reduce drift potential is to apply large droplets.
The best drift management strategy is to apply the largest droplets that
provide sufficient coverage and control. Applying larger droplets reduces
drift potential, but will not prevent drift if applications are made improperly,
or under unfavorable environmental conditions (See Wind, Temperature
and Humidity, and Temperature Inversions).
Controlling Droplet Size
o Volume - Use high flow rate nozzles to apply the highest practical
spray volume. Nozzles with higher rated flows produce larger
droplets.
o Pressure - Do not exceed the nozzle manufacturer's recommended
pressures. For many nozzle types lower pressure produces larger
droplets. When higher flow rates are needed, use higher flow rate
nozzles instead of increasing pressure.
o Number of nozzles - Use the minimum number of nozzles that
provide uniform coverage.
o Nozzle Orientation - Orienting nozzles so that the spray is released
parallel to the airstream produces larger droplets than other
orientations and is the recommended practice. Significant deflection
from horizontal will reduce droplet size and increase drift potential.
o Nozzle Type - Use a nozzle type that is designed for the intended
application. With most nozzle types, narrower spray angles produce
larger droplets. Consider using low- drift nozzles. Solid stream
nozzles oriented straight back produce the largest droplets and the
lowest drift.
Boom Length
For some use patterns, reducing the effective boom length to less than 3/4
of the wingspan or rotor length may further reduce drift without reducing
swath width.
Application Height
Applications should not be made at a height greater than 10 feet above the
top of the target plants unless a greater height is required for aircraft safety.
Making applications at the lowest height that is safe reduces exposure of
droplets to evaporation and wind.
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Swath Adjustment
When applications are made with a crosswind, the swath will be displaced
downwind. Therefore, on the up and downwind edges of the field, the
applicator should compensate for this displacement by adjusting the path of
the aircraft upwind. Swath adjustment distance should increase, with
increasing drift potential (higher wind, smaller drops, etc.).
Wind
Drift potential is lowest between winds speeds of 2 -10 mph. However,
many factors, including droplet size and equipment type determine drift
potential at any given speed. Application should be avoided below 2 mph
due to variable wind direction and high inversion potential. NOTE: Local
terrain can influence wind patterns. Every applicator should be familiar
with local wind patterns and how they affect spray drift.
Temperature and Humidity
When making applications in low relative humidity, set up equipment to
produce larger droplets to compensate for evaporation. Droplet evaporation
is most severe when conditions are both hot and dry.
Temperature Inversions
Applications should not occur during a temperature inversion because drift
potential is high. Temperature inversions restrict vertical air mixing, which
causes small suspended droplets to remain in a concentrated cloud. This
cloud can move in unpredictable directions due to the light variable winds
common during inversions. Temperature inversions are characterized by
increasing temperatures with altitude and are common on nights with
limited cloud cover and light to no wind. They begin to form as the sun
sets and often continue into the morning. Their presence can be indicated
by ground fog; however, if fog is not present, inversions can also be
identified by the movement of smoke from a ground source or an aircraft
smoke generator. Smoke that layers and moves laterally in a concentrated
cloud ( under low wind conditions) indicates an inversion, while smoke that
moves upward and rapidly dissipates indicates good vertical air mixing.
Sensitive Areas
The pesticide should only be applied when the potential for drift to adjacent
sensitive areas (e.g., residential areas, bodies of water, known habitat for
threatened or endangered species, non-target crops) is minimal (e.g, when
wind is blowing away from the sensitive areas).
Although levels of concern are exceeded for endangered and non-
ConclllSJOn endangered plant species and surfacewater and groundwater quality, the
Agency concludes that the current registered products containing asulam
and its sodium salt for all uses, with the exception of sugarcane, once
amended to reflect the risk mitigation measures imposed in this RED, are
eligible for reregi strati on. Therefore, products containing asulam and its
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sodium salt for uses on Christmas tree plantations, ornamentals, turf (St.
Augustinegrass and Bermudagrass), and non-cropland (boundary fences,
fencerows, hedgerows, lumberyards, storage areas, industrial plant sites,
and warehouse lots) are eligible for reregi strati on.
EPA is unable to make a reregi strati on eligibility decision regarding
the use of asulam and its sodium salt on sugarcane because data show that
asulam concentrates in the processed animal feed commodity, blackstrap
molasses. Under current policies, the establishment of the necessary feed
additive regulation (tolerance) to cover residues in this commodity may be
barred by the Delaney clause of Section 409 of the Federal Food, Drug, and
Cosmetic Act (FFDCA) because asulam may induce cancer in animals
within the meaning of the Delaney clause.
Asulam and its sodium salt products with eligible uses will be
reregistered once the required product-specific data, revised Confidential
Statements of Formula, and revised labeling are received and accepted by
EPA.
For More
Information
EPA is requesting public comments on the Reregi strati on Eligibility
Decision (RED) document for asulam during a 60-day time period, as
announced in a Notice of Availability published in 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.
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregi strati on Information System
at 703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA.GOV, or using ftp on FTP.EPA.GOV, or using
WWW (World Wide Web) on WWW.EPA.GOV.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fax 513-489-8695.
Following the comment period, the asulam RED document also will
be available from the National Technical Information Service (NTIS), 5285
Port Royal Road, Springfield, VA 22161, telephone 703-487-4650.
For more information about EPA's pesticide reregi strati on program,
the asulam RED, or reregi strati on of individual products containing asulam
and its sodium salt, please contact the Special Review and Reregi strati on
Division (7508W), OPP, US EPA, Washington, DC 20460, telephone 703-
308-8000.
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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 8:00 pm Eastern Standard
Time, Monday through Friday.
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