United States
Environmental Protection
Agency _^_
Prevention, Pesticides
And Toxic Substances
(7508W)
EPA-738-F-97-004
Aprif1997
R.E.D. FACT
Pesticide
Reregistration
Use Profile
1,3,5-Triethylhexahydro-
s-triazine
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 before November 1, 1984, be reregistered to ensure
that they meet today's more stringent standards.
Under the Food Quality Protection Act of 1996, EPA must consider
the increased susceptibility of infants and children to pesticide residues in
.food, as well as aggregate exposure of the public to pesticide residues from
all sources, and the cumulative effects of pesticides and other compounds
with a common mechanism of toxicity in establishing and reassessing
tolerances.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency develops
any mitigation measures or regulatory controls needed to effectively reduce
each pesticide's risks. EPA then reregisters .pesticides that met the safety
standard of FQPA and can be used without posing unreasonable risks to
human health or the environment.
When a pesticide is eligible for reregistration, EPA explains the basis
for its decision in a Reregistration Eligibility Decision (RED) document.
This fact sheet summarizes the information in the RED document for
reregistration case 3147, 1,3,5-triethylhexahydro-s-triazine.
1,3,5-Triethylhexahydro-s-triazhie, or triethylhexahydrotriazine is an
antimicrobial used as an industrial preservative treatment to control slime-
forming bacteria and fungi in adhesives, fuels, oil storage tanks, metal-
working cutting fluids, paints, slurries, rubber products, and industrial
processing chemicals. Formulations include liquid soluble concentrates.
Triethylhexahydrotriazine is added to industrial products using open-pouring
or metering pump methods.
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Regulatory
History
Human Health
Assessment
Triethylhexahydrotriazine was first registered for use as a
microbiocide and bacteriostat in the U.S. in 1967. In 1987 the Agency
issued the Antimicrobial Data Call-in Notice to obtain additional data for
this and other antimicrobial chemicals. Another Data Call-In Notice was
issued in September 1992 requiring additional toxicity and ecological effects
data in support of reregistration. Currently, two triethylhexahydrotriazine
products are eligible for reregistration.
Toxicity
In studies using laboratory animals, triethylhexahydrotriazine has been
shown to be somewhat acutely toxic via the oral and inhalation routes and
has been placed in Toxicity^Category n (the second highest of four
categories) for these effects. Because of its corrosivity, acute dermal.
toxicity and primary eye and skin irritation'studies were waived, and
triethylhexahydrotriazine has been placed in Toxicity Category I (the highest
of four categories) for these effects.
In a dermal sensitization study with guinea pigs, triethyl-
hexahydrotriazine was not a skin sensitizer. As for mutagenicity, although
in vitro mutagenicity data indicate that it is mutagenic, negative in vivo
data suggest that triethylhexahydrotriazine lacks mutagenic potential.
For short-term (1-7 days) and intermediate-term (1 week-several
months) occupational and residential risk assessments, the Agency has-
chosen the 75 mg/kg/day NOEL (for both maternal and developmental-
toxicity) from a rat developmental toxicity study. In a sub-chronic dermal
study in rats, no systemic effects were observed at any dose level.
Consistent with current data requirements for non-food use chemicals, no
chronic toxicity data have been required for triethylhexahydrotriazine.
Even though chronic occupational exposure is possible with the use of
triethylhexahydrotriazine, chronic testing for cancer and other long term
effects is not required since EPA does not believe that chronic exposure
would result hi a risk of concern.
Dietary Exposure
Current uses of triethylhexahydrotriazine do not include any food or
feed uses. Therefore dietary exposure is not anticipated and no dietary risk
assessments have been conducted.
Occupational and Residential Exposure
Based on current use patterns, EPA has determined that there is a
potential for exposure of mixers, loaders, applicators, and other handlers to
triethylhexahydrotriazine and its break-down product, formaldehyde, during
and after normal use of the pesticide in both occupational and residential
settings. EPA conducted assessments for dermal exposure only. The
Agency believes that inhalation exposure may also be a significant
component of overall exposure to triethylhexahydrotriazine because of its
high vapor pressure, particularly when triethylhexahydrotriazine-containing
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paint is used. At this time, however, EPA has no data with which to
conduct an inhalation exposure and risk assessment. Thus; the Agency is
requiring handler and post-appUcation inhalation exposure data.
Human Risk Assessment
As mentioned previously, triethylhexahydrotriazine is so corrosive that
the dermal acute toxicity and primary skin and eye irritation studies were
waived. The Agency expects that concentrated triethyl-hexahydrotriazine
products may pose significant handler risk due to this corrosivity. The
Agency is addressing these risks through the establishment of PPE
requirements that are to be included on the labeling of all end-use products
that are classified as toxicity category I or n for skin or eye irritation
potential.
EPA is generally not concerned with occupational and residential risk
if MOEs (margins of exposure) are greater than 100. For triethyl-
hexahydrotriazine, all of the primary application (occupational) dermal
MOEs are greater than 100; they range from approximately 2,100 for
exposure in wet-end additives/industrial processing chemicals using a pump
metering system, to approximately 21,000 for open-pour operations during
paint, adhesive, and rubber manufacturing and in uses for fuels/oil storage
tank bottom water. For secondary exposure, such as applying paint
containing triethylhexahydrotriazine, dermal MOEs range from greater than
300 for occupational workers'to greater than 1600 for residential
applicators.
EPA has also considered the potential hazard of exposure to
formaldehyde, a degradate of triethylhexahydrotriazine. The Occupational
Safety and Health Administration (OSHA) has a comprehensive workplace
standard for formaldehyde to protect workers in occupational settings.
Residential and other non-occupational exposure to formaldehyde is
expected to be very low. However, the Agency will require confirmatory
exposure data that includes monitoring for formaldehyde during and after
application.
Other Considerations
Because triethylhexahydrotriazine currently has no food uses and no
tolerances have been established, the specific determinations outlined in the
Food Quality Protection Act of 1996 are not required for this chemical.
Nevertheless, EPA believes that consideration of available data relating to
the special sensitivity of infants and children, as well as the potential for
aggregate exposures,and cumulative effects is prudent for
triethylhexahydrotriazine because children and other individuals could be
exposed to this compound in non-occupational settings.
Nothing in the available toxicity data base indicates special
susceptibility of infants and children to triethylhexahydrotriazine and,
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Environmental
Assessment
therefore, the Agency has concluded that an additional uncertainty factor for
estimating risk to young organisms is not warranted.
All products containing triethylhexahydrotriazine have primarily
indoor, non-food uses. Based on the available exposure information and
current use patterns, EPA does not anticipate exposure to residues of •
triethylhexahydrotriazine in food or drinking water., Thus, the only non-
occupational exposure to triethylhexahydrotriazine would be from uses in
and around the home. Among these, applying paint would yield the greatest
potential exposure. Because the dermal MOE for this reasonable worst case
exposure is high (> 1600), EPA believes that aggregate exposures from
other sources of triethylhexahydrotriazine in the home are not likely to be of
concern.
The Agency, has not yet made a determination regarding the common
mode/mechanism of toxicity of triethylhexahydrotriazine arid whether it is
appropriate to consider exposure from triethyl-hexahydrotriazine with other
compounds in order to address potential cumulative effects. However,
based on the high dermal MOE for homeowner applicators, the lack of food
uses, the unlikelihood of residues in drinking water, and the low
concentration hi paint, the Agency believes that the contribution of
triethylhexahydrotriazine exposure to the risks of other chemicals with a
common mode/mechanism of toxicity is likely to be minimal.
Environmental Fate
EPA requires only a hydrolysis study to characterize the
environmental fate of triethylhexahydrotriazine, due to its current use
patterns. EPA does not have a hydrolysis study for this active ingredient,
but, based on the behavior of structurally related chemicals; the expected
reaction products are formaldehyde and ethylamine. However, the effect of
different pHs on the rate of hydrolytic degradation is not known. Since the
data requirement is not fulfilled, EPA is requiring confirmatory hydrolysis
data on the rate of hydrolysis of triethylhexahydrotriazine at pH 5, 7, and 9,
and the reaction products must be identified.
Ecological Effects
Triemylhexahydrotriazine is slightly to moderately toxic to birds on an
acute basis and practically non-toxic on a subacute basis. It demonstrates
slight toxicity to both cold and,warm freshwater fish, and is slightly toxic to
freshwater invertebrates on an acute basis.
Ecological Effects Risk Assessment
The Agency requires only a limited number of ecotoxicology and
environmental fate studies for microbiocides with primarily indoor use
patterns. While the hazard to aquatic organisms from
triemylhexahydrotriazine has been characterized, a quantitative risk
assessment has not been conducted. The risks to aquatic environments are
regulated under the National Pollutant Discharge Elimination System
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Risk Mitigation
(NPDES) permitting program of the Agency's Office of Water. EPA does
not anticipate any exposure of concern to fish or wildlife, providing that all1
triethylhexahydrotriazine products are handled and applied as specified in
the product labeling, and discharges to the environment comply with all
federal disposal laws and the NPDES program.
To lessen the potential risks posed by triethylhexahydrotriazine and
products treated with triethylhexahydrotriazme, EPA is requiring the
following risk mitigation measures.
• EPA requires that handlers using occupational-use products wear long-
sleeve shirts, long pants, shoes, and socks as minimum work attire.
Further handler safety requirements for products containing
triethylhexahydrotriazine will be determined based on the acute toxicity
characteristics of the end-use product.
• EPA is requiring the use of meter pumps or other automatic
dispensing equipment for triethylhexahydrotriazine use in wet-end additives
and industrial processing chemicals.
• For use in paint, rubber products, industrial adhesives, or fuel/oil
storage tank bottoms, EPA is requiring that the vats to which the
triethylhexahydrotriazine is added must be closed and equipped with
mechanical vents to the outdoors.
• EPA is requiring NPDES permits for discharge of triethylhexa-
hydrotriazine effluent. '
To confirm its regulatory conclusions on triethylhexahydrotriazine,
EPA is requiring additional generic data to assess hydrolysis. Additionally,
the Agency will require exposure data from paint applications by brush,
roller, and sprayer, as well as post application monitoring data to determine
exposure to residents or occupants of areas that have been painted. These
post application data will include monitoring for degradates. Because much
of the exposure data needed for triethylhexahydrotriazine is generic in
nature and will also be required for other antimicrobial chemicals with
similar characteristics and uses, EPA is developing a generic exposure DCI
for antimicrobials. Triethylhexahydrotriazine registrants will receive the
generic antimicrobial exposure DCI at the same time as registrants of other
antimicrobial chemicals with similar uses.
Product Labeling All triethylhexahydrotriazine end-use products must comply with
Changes EPA's current pesticide product labeling requirements and with the
Required following
* Minimum (Baseline) PPE/Engineering Control Requirements
Any necessary PPE for each triethylhexahydrotriazine occupational
end-use product will be established on the, basis of the end-use
product's acute toxicity category as specified in Section V of the RED
Additional Data
Required
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document. All end-use products will be required to specify the
minimum work attire for all handlers.
The mhiimum handler work attire labeling requirement for
occupational uses of triethylhexahydrotriazine end-use products is:
"Mixers, loaders, applicators and other handlers must wear:
— Long-sleeve shirt and long pants,
— Shoes plus socks."
If the end-use product is classified as toxicity category I or II for eye
irritation potential or if data for this route of concern are waived due
to corrosivity, add:
— Protective eyewear.
If the end-use product is classified as toxicity category I or n for acute
dermal toxicity or skin irritation potential or data for either of these
routes of concern are waived due to corrosivity, add:
~ Chemical-resistant apron, and
— Chemical-resistant gloves*.
"For the glove statement, use the statement established for triethylhexahydrotriazine
through the instructions in Supplement Three of PR Notice 93-7. In addition, for
concentrated triethylhexahydrotriazine products, the corrosiveness and penetration of
triethylhexahydrotriazine must be considered. Appropriate chemical-resistant materials
must be listed on the product labeling.
If the end-use product is classified as toxicity category I or n for acute
inhalation toxicity, a respirator requirement must be added. The type
of respirator must be specified hi the statement and is based on the
acute toxicity category and the vapor pressure. EPA will assist
registrants in determining the appropriate type of respirator during the
end-use product phase of reregistration.
In addition to the minimum PPE specified above, the following
specific PPE and engineering-control requirements must be added to
labels containing the following uses.
When labeling contains uses for wet-end additives/industrial
processing chemicals, add the following:
"For use in wet-end additives/industrial processing chemicals,
meter pumps or other automatic dispensing equipment is
required. Open pouring is prohibited."
When labeling contains uses for paint, rubber products, or industrial
adhesives, or fuels/oil storage tank bottom water, add the following:
"For use hi paint, rubber products, industrial adhesives, or
fuels/oil storage tank bottom water, the vats to which
triethylhexahydrotriazine is being added must be closed and
equipped with mechanical vents to the outdoors."
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Regulatory
Conclusion
Placement in Labeling
The personal protective equipment requirements must be placed on the
end-use product labeling in the format and language specified above
and must be placed hi the "Hazards to Humans" section of the
pesticide labeling.
Other Labeling Requirements - Products Intended for
Occupational Use
The Agency is requiring the following labeling statements to be
located on all end-use products containing triethylhexahydrotriazine
that are intended primarily for occupational use. Additional handler
safety requirements will be determined based on the acute toxicity
characteristics of each end-use product.
Application Restrictions
"Do not use this product hi a way that will contact workers or
.other persons."
"Do not apply this product as a spray."
User Safety Requirements
If gloves or protective eyewear are required PPE on the end-use
product, add: •
"Follow manufacturer's instructions for cleanmg/mamtaining
PPE. If no such instructions are provided for washables, use
detergent and hot water. Keep and wash PPE separately from
other laundry. "
User Safety Recommendations
"Users should wash hands before eating, drinking, chewing
gum, using tobacco, or using the toilet."
"Users should remove clothing immediately if pesticide gets
inside. Then wash thoroughly and put on clean clothing. "
.Registrants must add the following statements only if gloves are
required PPE on the end-use product:
"Users should remove PPE immediately after handling this
product. Wash the outside of gloves before removing. As soon
as possible, wash thoroughly. "
The use of eligible triethylhexahydrotriazine products in accordance
labeling specified in this RED will not pose unreasonable adverse
effects to humans or the environment. These products will be reregistered
once the required confirmatory generic data, product specific data, revised
Confidential Statements of Formula (CSFs), and revised labeling are
received and accepted by EPA.
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For More
Information
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for triethylhexahydrotriazine 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 Reregistration Information System at
703-308-7224. They also are available on the Internet by using ftp on
FTREPA.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 triethylhexahydrotriazine 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 reregistration program,
the 1,3,5-triethylhexahydro-s-triazine RED, or reregistration of individual
products containing triethylhexahydrotriazine, please contact the Special
Review and Reregistration Division (7508W), OPP, US EPA, Washington,
DC 20460, telephone 703-308-8000.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
free 1-800-858-7378, between 9:30 am and 7:30 pm Eastern Standard
Time, Monday through Friday.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
JUH 16 m
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case 3147 which
contains the active ingredient 1,3,5-Triethylhexahydro-s-triazine. The enclosed Reregistration
Eligibility Decision (RED) contains the Agency's evaluation of the data base of this chemical,
its conclusions of the potential human health and environmental risks of the current product
uses, and its decisions and conditions under which these uses and products will be eligible for
reregistration. The RED includes the data and labeling requirements for products for
reregistration. It 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 is due 90 days from the
receipt of this letter. The second set of required responses is due 8 months from the
receipt of this letter. Complete and timely responses will avoid the Agency taking the
.enforcement action of suspension against your products.
If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative Jane
Mitchell (703)308-8061. ..'•'--
imcerely yours,
Enclosures
3is A. Rossi, Directoi
Special Review and
Reregistration Division
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1. DATA CALL-IN (PCI) OR "90-DAY RESPONSE"-If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data
are required, a DCI letter will be enclosed listing, such requirements. If both generic and
product specific data are required, a combined Generic and Product Specific DCI letter will
be enclosed describing such data. However, if you are an end-use product registrant only and
have been granted a generic data exemption (GDE) by EPA, you are being sent only the
product specific response forms (2 forms) with the RED. Registrants responsible for generic
data are being sent response forms for both generic and product specific data requirements (4
forms). You must submit the appropriate response forms (following the instructions
provided) within 90 days of the receipt of this RED/DCI letter; otherwise, your product
may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER REQUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for time extensions for product specific data
should be submitted in the 90-day response. Requests for data waivers must be submitted as
part of the 90-day response. 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 reregistration) separately. You may, but are hot
required to, delete uses which the RED says are ineligible for reregistration. 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).
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d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described hi 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-SRRP-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 reregistration determination within 14 months after the RED
has been issued.
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REREGISTRAHON ELIGIBILITY DECISION
1,3,5-Triethylhexahydro-s-triazine
LISTC
CASE 3147
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
1,3,5-TRIETHYLHEXAHYDRO-S-TRIAZINE REREGISTRATION ELIGIBILITY -
DECISION TEAM . . . . . i
ABSTRACT . . . , v
I. INTRODUCTION . . ... . . ...... 1
H. CASE OVERVIEW .... . . 2
A. Chemical Overview 2
B. Use Profile . . . ' . 2
C. Data Requirements 3
D. Regulatory History ... 3
HI. SCIENCE ASSESSMENT ......... 4
A. Physical Chemistry Assessment . . 4
B. Human Health Assessment' 4
1. Toxicology Assessment 4
a. Acute Toxicity 4
b. Subchronic Toxicity ..... l 6
c. Developmental Toxicity .7
d. Mutagenicity 7
2. Toxicological Endpoints for Risk Assessment 9
, a. Reference Dose (RfD) . . 9
b. Carcrnogemcity Classification . 9
c. Toxicology Endpoints of Concern 9
3. Occupational and Residential Exposure Assessment 10
a. - Occupational Handier Exposure Scenarios 12
b. Homeowner Handler Exposure Scenarios 13
c. Post-Application Exposure Scenarios and Assumptions . . 13
d. Exposure Estimations 15
.4. Occupational and Residential Risk Characterization . '. 17
a. Primary Application and Post-Application Scenarios
(Occupational Only) 17
b. Secondary Handler and Post-Application Scenarios ..... 18
5, Additional Occupational/Residential Exposure Studies 20
6. Other Considerations . 20
a. Potential Risks to Infants and Children ! 21
b. Aggregate exposure 21
c. Cumulative Effects . ............ 22
C. Environmental Assessment 23
1. Ecological Toxicity Data .'.. .... 23
a. Toxicity to Terrestrial Animals 23
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b. Toxicity to Aquatic Animals .24
(1) Freshwater Fish 24
(2) Freshwater Invertebrates, Acute 24
2. Environmental Fate .24
3. Exposure and Risk Characterization 25
a. Exposure and Risk to Nontarget Organisms 25
b. Endangered Species 25
IV. RISK MANAGEMENT AND REREGISTRATION DECISION . . . 25
A. Determination of Eligibility 25
B. Determination of Eligibility Decision 26
1. Eligibility Decision . 26
2. Eligible and Ineligible Uses 26
C. Regulatory Position and Labeling Rationale 27
1. Potential Risks to Infants and Children/Aggregate
Exposure/Cumulative Effects ••. 27
2. Handler Safely Requirements ....... . . 28
a. Personal Protective Equipment Requirements for
Occupational Handlers 28
b. Engineering Control Requirements for Occupational
Handlers i 29
c. Application and Post Application Exposure Data 29
d. Additional Labeling Requirements . 30
V. ACTIONS REQUIRED OF REGISTRANTS . . 30
A. Manufacturing-Use Products '. 30
1. Additional Generic Data Requirements . 30
2. Labeling Requirements for Manufacturing-Use Products 31
B.' End-Use Products 31
1. Additional Product-Specific Data Requirements 31
2. Labeling Requirements for End-Use Products 32
a. Occupational Labeling PPE Requirements for Pesticide
Handlers . . . 32
(1) PPE Requirements for Occupational Handlers ... 32
(2) PPE Requirements for Homeowner Handlers .... 33
b. Other Labeling Requirements - Products Intended for
Occupational Use 33
C. Existing Stocks . . '. .... 34
VI. APPENDICES 37
APPENDIX A. Table of Use Patterns Subject to Reregistration ....... 38
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 41
APPENDIX C. Citations Considered to be Part of the Data Base Supporting
the Reregistration of 1,3,5-Triethylhexahydro-s-triazine . . 47
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APPENDIX D.
Attachment
Attachment
Attachment 3.
Attachment
Attachment
Attachment
APPENDIX E.
Product Specific Data Call-In 53
1. Chemical Status Sheets 65
2. Product Specific Data Call-In Response Forms (Form
A inserts) Plus Instructions 66
Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions
. . . 67
EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 75
List of All Registrants Sent This Data Call-In (insert)
Notice .77
Cost Share, Data Compensation Forms, Confidential '
Statement of Formula Form and Instructions .... 79
List of Available Related Documents 87
4.
5.
6.
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1,3,5-TRIETEryOIEXAHYDRO-S-TRIAZINE REREGISTRATION ELIGIBILITY
DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Assessment '
Cynthia Szymanski
Rafael Prieto
Michele Cottrill
Frank Hernandez
Margaret Cogdell
Biological Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Economic Analysis Branch
Biological Analysis Branch
Environmental Fate and Effects Risk Assessment.
Karen Angulo
Mary Powell
Silvia C. Termes
RickPetrie
Health Effects Risk Assessment
--.j
/
Winston Dang
Raymond Locke
Kathleen Martin
Paul Lewis
Registration Support
Valdis Goncarovs
Shy am B. Mathur j
Risk Management
Bruce Sidwell
Marie Boucher
Science Analysis and Coordination Staff
Science Analysis and Coordination Staff
Environmental Fate and Groundwater Branch
Ecological Effects Branch
Occupational and Residential Exposure Branch
Toxicology Branch I
Risk Characterization and Analysis Branch
Risk Characterization and Analysis Branch
Antimicrobial Program Branch
Registration Support Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
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11
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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
FAO/WHO Food and Agriculture Organization/World Health Organization
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.
LDjg 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.
LD,0 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.
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
ill
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GLOSSARY OF TERMS AND ABBREVIATIONS
NOEC No effect concentration
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
* PHI Preharvest Interval
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
RUP Restricted Use Pesticide
SLN Special Local Need (Registrations Under Section 24 (c) of FEFRA)
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.
ug/L • Micrograms per liter
WP Wettable Powder
WPS Worker Protection Standard
IV
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ABSTRACT
The U. S. Environmental Protection Agency has completed its reregistration eligibility
decision for the pesticide 1,3,5-triemylhexahydro-s-triazine (Case 3147). This decision includes
a comprehensive reassessment of the required target data and the use patterns of the two currently
registered products. Additionally, the Agency has examined information concerning the exposure
and susceptibility of infants and children to 1,3,5-triethylhexahydro-s-triazine and available
information concerning aggregate exposure to 1,3,5-triethylhexahydro-s-triazine as well as the
potential for cumulative effects from 1,3,5-triethylhexahydro-s-triazine and other substances that
have a-common mode/mechanism of toxicity.
1,3,5-Triethylhexahydrotriazine, • or triethylhexahydrotriazine, is used as a
microbiocide/microstat in various rubber products, industrial adhesives, fuels/oil storage tank
bottom water, metalworking cutting fluids, wet-end additives/industrial processing chemicals, and
latex paints. The Agency has concluded that all uses, as prescribed in this document, will not
cause unreasonable risks to humans or the environment and therefore, all products are eligible for
reregistration.
Triethylhexahydrotriazine is moderately acutely toxic arid corrosive via the oral and
inhalation routes. Although in vitro data indicate this pesticide to be mutagenic, in vivo data
suggest that triethylhexahydrotriazine lacks in vivo mutagenic potential. EPA is concerned about
the corrosivity of triethylhexahydrotriazine and> since studies were waived due to corrosivity,
assumes that it is classified as category I for skin irritation and eye irritation potential. The
corrosivity to skin of triethylhexahydrotriazine makes dermal penetration likely, since the skin
would likely be damaged by contact with the chemical. Triethylhexahydrotriazine is classified
as toxicity category n for acute inhalation toxicity.
For short-term (1-7 days) and intermediate-term (1 week-several months) occupational and
residential risk assessments, the Agency has chosen the 75 mg/kg/day NOEL, based on both
maternal and developmental effects, from the .rat developmental toxicity study. In a sub-chronic
dermal study in rats, no systemic effects were observed at any dose level. Consistent with current
data requirements for non-food use chemicals, no chronic toxicity data have been required for
triethylhexahydrotriazine.
Because inhalation exposure data are absent and triethylhexahydrotriazine has a relatively
high vapor pressure, EPA will require data for handler and post-application inhalation exposure.
The post-application data requirement includes monitoring levels of triethylhexahydrotriazine and
its degradates in newly painted rooms where infants and children could be exposed.
Nothing hi the available toxicity data base indicates special susceptibility of infants and
children to triethylhexahydrotriazine and, therefore, the Agency has concluded that an additional
uncertainty factor for estimating risk to young organisms is not warranted at this time.
-------
All products containing triethylhexahydrotriazine have primarily indoor, non-food uses.
Based on the available exposure information and current use patterns, EPA does not anticipate
exposure to residues of triethylhexahydrotriazine in food or drinking water. Thus, the only non-
occupational exposure to triethylhexahydrotriazine would be from uses in the home. Among
these, applying paint would yield the greatest potential exposure. Because the dermal MOE for
this worst case exposure is high (> 1600), EPA believes that aggregate exposures from other
sources of triethylhexahydrotriazine hi the home are not likely to be of concern.
The Agency has not yet made a determination regarding the common mode/mechanism
of toxicity of triethymexahydrotriazine and whether it is appropriate to consider exposure from
triethylhexahydrotriazine with other compounds in order to address potential cumulative effects.
However, based on the high dermal MOE for.homeowner applicators, the lack of food uses, the
unlikelihood of residues in drinking water, and the low concentration in paint, the Agency
believes that the contribution, of triethylhexahydrotriazine exposure to the risks of other chemicals
with a common mode/mechanism of toxicity is likely to be minimal.
Before reregistering products containing triethylhexahydrotriazine, the Agency is requiring
that product specific data, revised Confidential Statements of Formula and revised labeling be
submitted within eight months of the issuance of this document. These data include product
chemistry for each registration and acute toxicity testing. After reviewing 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.
VI
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I.
INTRODUCTION
, In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984. The amended Act provides a schedule for the reregistration process to be completed in
nine years. There are five phases.to the reregistration process. The first four phases of the process
focus on identification of data requirements to support the reregistration of an active ingredient
and the generation and submission of data to fulfill the requirements. The fifth phase is a review
by the U.S. Environmental Protection Agency (referred to as "the Agency") of all data submitted
to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregistration'' before calling
in data on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review of the scientific data base underlying a
pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into law.
FQPA amends both the Federal Food, Drug, and Cosmetic Act (FFDCA) and FIFRA. The
FQPA amendments went into effect immediately. Among other things, FQPA amended the
FFDCA by setting a new standard for the establishment of tolerances. ' Because
triethylhexahydrotriazine has no food uses, and therefore no tolerances have been^established, the
specific determinations outlined in FQPA are not required for the reregistration of this chemical.
Nevertheless, EPA believes that consideration of available data relating to the special sensitivity
of infants and children, as well as the potential for aggregate exposures and cumulative effects is
prudent for triethylhexahydrotriazine because children and other individuals could be exposed to
this compound in non-occupational settings.
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of triethylhexahydrotriazine. The document consists of six sections. Section
I is the introduction. Section II describes triethylhexahydrotriazine, its uses, data requirements
and regulatory history. Section ffl discusses the human health and environmental assessment based
on the data available to the Agency. Section IV presents the reregistration decision for
triethylhexahydrotriazine. Section V discusses the reregistration requirements for
triethylhexahydrotriazine. Finally, Section VI is the Appendices which support this Reregistration
Eligibility Decision. Additional details concerning the Agency's review of applicable data are
available on request. ' ' '.
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H. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Decision:
Common Name:
Chemical Name:
Chemical Family:
Triethylhexahydrotriazine v
1 ,3i5-Triemylhexahydro-s-triazine
Triazine
B.
CAS Registry Number: 7779-27-3
OPP Chemical Code: 082901
Molecular Formula: C9H21N3
Molecular Weight: 171.29
Trade and Other Names: Vancide TH
Basic Manufacturer: R. T. Vanderbilt Company, Inc.
Use Profile
The following is information on the currently registered uses with an overview of
use sites and application methods. A detailed table of the uses of triethylhexahydrotriazine
is in Appendix A.
For triethylhexahydrotriazine:
Type of Pesticide: Microbiocide/Microbiostat (sh'me-forming bacteria)
Microbiocide/Microbiostat (slime-forming fungi)
Use Sites: Indoor Non-food
-Adhesives, Industrial
-Fuels/Oil Storage Tank Bottom Water Additive
-Metalworking Cutting Fluids
-Faults, Latex (in-can) - and aqueous slurries
-Rubber Products
-Wet-end Additives/Industrial Processing Chemicals
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Target Pests: Slime-forming bacteria and fungi
Types/Formulations Registered:
End-use product
-Soluble concentrate/liquid
Methods of Application:
Types of Treatment - Additive treatment, Industrial preservative treatment
Equipment - Not specified (registrant must specify on label) .
Timing - During manufacture, When needed, Not specified (registrant must specify on
label)
Surface Type - Not applicable
Rates of Application
Adhesives, Industrial: 95 to 475 ppm a.i. by weight;
Fuels/oil storage tank bottom water additive: 363 to 1813 ppm a.i. by weight.
Metalworking cutting fluids: 28500 ppm a.i. by weight.
Paints, latex (in-can): 475 to 1425 ppm a.i. by weight.
Rubber products: 190 to 475 ppm a.i. by weight.
Wet-end additives/industrial processing chemicals: 95 to 1425 ppm a.i. by weight.
C. Data Requirements
• , The Agency required registrants to supply additional data to support reregistration
in the Antimicrobial Data Call-In Notice of March 1987 and a Data Call-In Notice issued
in November of 1992 that included studies on product chemistry, ecological effects, and
toxicity. Appendix B includes all data requirements identified by the Agency for currently
registered uses to support reregistration.
D. Regulatory History
' In 1967, triethylhexahydrotriazine was first registered in the United States as an
active ingredient for use as a microbiocide and bacteriostat. There are currently two
active products registered for incorporation as a,preservative into adhesives, fuels, metal
working fluids, paints, slurries and latex rubber. In 1987 the Agency issued the
Antimicrobial Data Call-In Notice for toxicity data for this chemical and other
antimicrobial chemicals. Another Data Call-In Notice was issued in September 1992 for
triethylhexahydrotriazine requiring additional data in support of reregistration.
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HI. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Color:
Physical State:
Odor:
Boiling Point:
Specific Gravity:
Solubility:
Vapor Pressure:
Dissociation Constant:
100.000 gm/lOOml
1.040 gm/lOOml
0.129 gm/lOOml
pH:
Stability:
Flammability:
Storage Stability:
Viscosity:
Corrosion
Characteristics:
Colorless to slightly yellow
Liquid
Formaldehyde-like odor
205-210°C
0.89 gm/cc
Water:
Hexane:
Mineral Spirits:
15.7 mm Hg at 25°C
N/A • .. '
0.11(byGC)
11.0-11.1 (5% solution in water)
Stable under basic conditions, but decomposition was
observed in acid medium.
150°F (Tag closed cup)
Stable for more than one year when stored at room
temperature in its original container.
2.80 and 2.82 Centistokes mm2/s
Triethylhexahydrotriazine was tested
in solution of 4.8% for:
Brass (corrosion rate = 0.084 g/m2/hr),
Copper (corrosion rate = 0.011 g/m2/hr),
Low Carbon steel (corrosion rate = 0), and for
Stainless steel (corrosion rate = 0).
B. Human Health Assessment
1. Toxicology Assessment
At present, the toxicology data base for triethylhexahydrotria±ine meets the
Agency's requirements for antimicrobials. The data are adequate and will support
a reregistration eligibility determination for currently registered non-food uses.
a. Acute Toxicity
Due to the corrosivity of triethylhexahydrotriazine (pH = 11.0-
11.1), studies of acute dermal toxicity and primary eye and skin irritation
are waived. Triethylhexahydrotriazine has been tested in an acute oral
toxicity test (MRID 41773701). In young adult male and female
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CrhC'DBR rats, triethylhexahydrotriazine exhibited an acute oral LD50
value of 291- (193-440) mg/kg for male rats, 135 (79-231) mg/kg for
female rats, and 209 (156-280) mg/kg combined. The purity of the test
substance was 96.39% a.L. ,
Triethylhexahydrotriazine has been tested in an acute inhalation
toxicity test (MRID 42406101). In CrhCDBR Sprague-Dawley rats,
triethylhexahydrotriazine demonstrated an acute inhalation LC50 of 251
(249-253) mg/M3 for male rats, 260 (233-290) mg/M3 for female rats, and
254 (212-305) mg/M3 combined. The LCSO values were calculated using
actual chamber concentrations. The purity of the test substance was
96.06% a.L.
Triethylhexahydrotriazine has been tested for its potential to elicit
dermal sensitization reactions in guinea pigs (MRID 42293004).
Triethylhexahydrotriazine was not a skin sensitizer in this study. The
dermal sensitization potential of triethylhexahydrotriazine was evaluated in
10 female Hartley albino guinea pigs using nine occluded dermal induction
exposures (clipped back skin; 20 mg dose), one occluded challenge
exposure (clipped right flank skin; 4 mg dose), and one occluded
rechallenge exposure (clipped left flank skin; 4 mg dose). An irritation
control group of five additional females received only the challenge dose,
and dermal reactions of the induced animals at challenge and rechallenge
were compared to those of this control group. An additional 10 females
were induced with nine dermal exposures (clipped back skin; 0.4 mg dose)
to l-chloro-2,4-dinitrobenzene (DNCB), a known skin sensitizer, and then
challenged with this same substance (clipped right flank skin; 0.4 mg dose).
All animals in all treatment groups survived and gained weight over the test
period. After challenge with triethylhexahydrotriazine, one of the 10
animals exhibited well-defined erythema at 24 hours post-challenge. The
same animal exhibited very slight erythema at 48 hours post-challenge.
After rechallenge, four of the 10 animals exhibited, very slight erythema at
24 hours post-treatment, and this slight erythema persisted in one of these
animals at 48 hours post-treatment. No edema was observed in any animal
at any time period. No dermal reactions were observed hi the irritation
control group, and 9/10 animals in the positive control group (DNCB-
treated) exhibited skin sensitization reactions. The purity of the test
substance was 96.39% a.i..
The acute toxicity values, along with their corresponding toxicity
categories, are summarized in Table 1.
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Table 1. Acute Toxicity Values for Triethylhexahydrotriazine Technical
Guideline
81-1
81-3
81-6
Test
Oral LDjo - Rat
Inhalation LC^ - Rat
Dermal Sensitization
Guinea Pig
MRTO
41773701
42406101
42293004
Result
LDjo = 291 mg/kg (M)
LDM = 135 mg/kg (F)
LD50 = 209 mg/kg (M+F)
LC50 = 251 mg/M3 (M)
LCj,, = 260 mg/M3 (F)
LCso = 254 mg/M3 (M+F)
"(LC50 based on actual chamber
concentration) .
Triethylhexahydrotriazine was not
a sensitizer in this study.
Toxicity
Category
II
II
—
The above studies satisfy the acute toxicity data requirements for
triethylhexahydrotriazine. Among these'requirements, tests for acute
dermal toxicity, primary eye irritation in the rabbit, and primary dermal
irritation were, waived due to the chemical's corrosivity •. The test for acute
delayed neurotoxicity in the hen was also waived due to lack of
acetylcholinesterase inhibition and no structural similarity to compounds
known to cause delayed neurotoxicity.
b. Subchronic Toxicity
In a repeated dose, dermal toxicity study (MRID 41858301), male
and female Crl:CDBR Sprague-Dawley rats, 13/sex/group, were exposed
(intact skin) to triethylhexahydrotriazine for 13 weeks (6 hours/day, 5
days/week). The purity of the test substance was 96.6% a.i.. The dose
levels used were 0, 10, 30, or 100 mg/kg of body weight/day and were
based on the results of a preliminary acute dermal toxicity probe study.
Parameters examined for all rats in the study included clinical signs
of toxicity, mortality, body weights, food consumption, hematology,
clinical chemistry, urinalysis, necropsy, organ weights (liver, lung,
kidneys, testes/ovaries, brain, pituitary, and heart), organ/body weight arid
organ/brain weight ratios and histopathological examination of selected
organs/tissues. Severe dermal irritation occurred in both sexes at all doses
tested. However, no systemic effects were observed at any dose level.
Based on these findings, the dermal NOEL is <10 mg
triethylhexahydrotriazine/kg body wt./day (the lowest dose tested or LDT)
and the dermal LEL is 10 mg/kg/day (LDT), based on the gross
observation of dermal irritation which was confirmed histologically.
Dermal irritation was characterized by hyperplasia, hyperkeratosis,
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inflammation, sebaceous gland hyperplasia, and eschar formation. The
systemic NOEL is ^100 mg triethylhexahydrotriazine/kg body wt./day and
the systemic LEL is > 100 mg/kg/day (the highest dose tested or HDT),
based on the lack of systemic effects at any dose level tested.
c. Developmental Toxicity
A developmental toxicity study (MRID 41865701) was conducted
in which pregnant CrkCDBR Sprague-Dawley rats (25/group) were
administered triethylhexahydrotriazine (96.6% a.i.) by gavage during
gestation days 6-15, inclusive. The dose levels used were 0, 10, 75, or 150
mg/kg body wt./day and were selected on the basis of a previous range-
finding study.
Prior to delivery, animals were sacrificed; The uterus of each
animal was examined to determine the numbers of implantation sites,
fesorption, and live and dead fetuses. The fetuses were examined for
external, visceral, and skeletal alterations.
Maternal toxicity was observed only in the high-dose (150
mg/kg/day) group and consisted of, a significant (39%) decrease in body
weight gain during the dosing period (p<; 0.01). Therefore, the LEL for
maternal toxicity was 150 mg triethylhexahydrotriazine/kg of body wt./day
and the NOEL for maternal toxicity was 75 mg
triethylhexahydrotriazine/kg body wt./day, based on decreased body weight
gain. The LEL for developmental toxicity was 150 mg
triethylhexahydrotriazme/kg body wt./day (HDT) and the NOEL for
developmental toxicity was ,75. mg/kg/day, based on the observed
significant incidences of bilateral convoluted ureters and dilated renal
pelvises in the high-dose (150 mg/kg/day) group.
These effects were statistically significant (p ^0.05 for dilated renal
pelvises; p ^0.01 for bilateral convoluted ureters) for the high-dose (150
mg/kg/day) group, but were within historical control values for, the mid-
(75 mg/kg/day) and low-dose (10 mg/kg/day) groups. Collectively,
MRIDs 42308601, 42366200, and 42366201, and the original study (MRID
41865701), have been upgraded to acceptable.
d. Mutagenicity
Triethylhexahydrotriazine (98.0% a.i.) was evaluated in a
Salmonella typhimurium/Ames plate incorporation assay in tester strains
TA1535, TA1537, TA1538, TA98, and TA100, with and without
metabolic activation (S9), at concentrations up to those inducing
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cytotoxicity (MRID 41343401). This study showed that, in repeat trials,
triethylhexahydrotriazine demonstrated a dose-related positive for gene
reversions in two (TA98 and TA100) of the five strains tested, but only in
the presence of metabolic activation (S9) and at elevated concentrations
(100-333 fig/plate).
Triethylhexahydrotriazine (98.0% a.i.) was positive for inducing
dose-related unscheduled DNA synthesis in primary rat hepatocyte cultures
treated at triethylhexahydrotriazine concentrations of 0.03 and 0.06
jiL/mL, as determined by radioactive tracer procedures (nuclear silver
grain counts). Dose levels used were: 0, 0.001, 0.003, 0.01, 0.03, or 0.06
jiL/mL (MRID 41343402).
Triethylhexahydrotriazine (98.0% a.i.) significantly increased the
numbers of thioguanine-resistant mutants in cultures of Chinese hamster
ovary (CHO) cells at a concentration of 0.02 /iL/mL without exogenous
(S9) metabolic activation (MRID 41544801). Although less certain,
triethylhexahydrotriazine may also increase the numbers of mutants at
concentrations of 0.02, 0.025, 0.03, and 0.035 /zL/mL with metabolic
activation (S9) and at a concentration of 0.03 /iL/mL without metabolic
activation (S9). The CHO-KiBH4 (Oak Ridge National Laboratory) cell
line was used. The concentrations of triethylhexahydrotriazine tested in the
non-activated (-S9) studies were: 0, 0.03, 0.02, 0.015, 0.01, 0.007, 0.005,
and O.Q03 fjL/rnL. With metabolic activation (+S9), the concentrations of
triethylhexahydrotriazine tested were: 0.035, 0.03, 0.025, 0.02, 0.015,
0.01, 0.007, 0.0035, 0.002, and 0.001 /tL/mL. The initial test was
complemented by two confirmatory assays.
Triethylhexahydrotriazine (98.0% a.i.) did not induce micronuclei
in ICR mice in a mouse micronucleus study (MRID 41321501). Groups
of mice' (15/sex/dose) were administered single doses of
triethylhexahydrbtriazine in sterile distilled water orally by gavage at dose
levels of 0, 25,125, or 225 mg/kg body weight. Negative control animals
(0 mg/kg) received distilled water only. Five females and five males were
administered an intraperitoneal dose of 0.25 mg/kg body weight of the
positive control substance, triethylenemelamine. Five per sex of the
negative control and test groups were sacrificed at 24, 48, and 72 hours
post-dosing. Positive controls were sacrificed at 24 hours post-dosing.
Both femurs were dissected out, and smears were made from each femur.
Smears were stained with May-Gruenwald-Giemsa stain and examined by
light microscopy to determine the number of micronucleated polychromatic
erythrocytes. Mortality was increased%in the high-dose group (225 mg/kg),
in which 4/15 died and were therefore replaced with other mice. The
positive control substance caused a significant increase in the number of
8
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micronucleated polychromatic erythrocytes, while negative control animals
and all treatment groups exhibited no such increase. Although originally
classified as Unacceptable, subsequent submission of purity data on the test
substance (MRID 41738201) upgrades this study to a classification of
Acceptable.
In summary, triethylhexahydrotriazine was shown to be mutagenic
in three of the four mutagenicity tests conducted. While the three in vitro
studies suggest a mutagenic potential for gene mutation and unscheduled
DNA synthesis, the negative in vivo micronucleus study indicates that
triethylhexahydrotriazine lacks the mutagenic potential for increased
incidence of micronucleated polychromatic erythrocytes. Based on the
available toxicity data, it is concluded that triethylhexahydrotriazine has
intrinsic mutagenicity activity which is only expressed in vitro. No further
testing is required at this time.
2. lexicological Endpoints for Risk Assessment
a. Reference Dose (RfD)
Even though chronic occupational exposure is anticipated with the
use of triethylhexahydrotriazine, chronic testing is not required since the
NOEL from the 13-week rat dermal toxicity study is greater than 1000
times higher than human dermal exposure (i.e. assuming 100 percent
dermal exposure). In addition, since the NOEL from the 13-week rat
dermal toxicity study was greater than the highest dose tested, the Agency
does not believe that chronic exposure would indicate a risk of concern.
Finally, there are no registered food uses for triethylhexahydrotriazine.
Therefore, the Agency has decided not to establish an RfD for
triethylhexahydrotriazine. This class of chemicals (i.e., disinfectants,
micfobiocides, microbiostats, sanitizers, etc.) has not been reviewed by the
FAO/WHO Joint Meeting on Pesticide Residues.
b. Carcinogenicity Classification
, The cancer classification for this chemical has not been established.
Since triethylhexahydrotriazine is a non-food use pesticide, carcinogenicity
studies have not been required.
c. Toxicology Endpoints of Concern
Based on the review of the toxicology database and information on
the general use pattern for triethylhexahydrotriazine, the Agency
established toxicity endpoints to be used in the occupational and residential
, 9
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risk characterization. They are listed in Table 2. The NOEL from the 13^-
week dermal rat study was not used for short-term or intermediate-term
occupational or residential risk assessment since no systemic effects were
observed at any dose level tested. In the absence of data on dermal
absorption, 100% absorption is assumed.
Table 2. Summary of Toxicological Endpoints for Triethylhexahydrotriazine
Type of Exposure
(Duration and Route)
Endpoint (And Toxicological Effect)
Acute Dietary: oral
Endpoint is not required for this active ingredient as
triethylhexahydrotriazine is a non-food use chemicaJL
Short-Term Occupational or Residential
Exposure (one to seven days): dermal
Intermediate-Term Occupational or
Residential Exposure (one week to
several months): dermal
75 mg/kg/day (maternal oral NOEL for decreased maternal
body weight gain during entire gestation period, also
developmental NOEL for increased fetal incidences of dilated
renal pelvises and bilateral convoluted ureters)
MRIDs: 41865701; 42366200; and 42308601
3. Occupational and Residential Exposure Assessment
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.
EPA has determined that an exposure assessment is appropriate for
triethylhexahydrotriazine. There is a toxicological concern (i.e., maternal and
developmental effects via the oral route) and there is potential for workers and
residents to be exposed to triethylhexahydrotriazhie during application and post-
application.
EPA has also determined that in and near sites where
triethylhexahydrotriazine or triethylhexahydrotriazine-containing products are
being used, individuals may be exposed to formaldehyde as this pesticide is a
possible formaldehyde generator. The registrants report in their Material Safety
Data Sheet (MSDS) that: "Simulated routine customer handling suggests that
formaldehyde off-gas is unlikely to exceed any of [the Occupational'Safety and
Health Administration (OSHA) permissible exposure level (PEL) and short-term
exposure limit (STEL)] standards. Typical handling of triethylhexahydrotriazine
yielded formaldehyde off-gas levels of < 0.005 to 0.01 ppm for an 8-hour
exposure (extrapolated). Because off-gas is affected by temperature, pH and plant-
specific controls, plant-specific monitoring is recommended to establish compliance
with the standard." In May 1992 OSHA published a comprehensive workplace
standard for the protection of workers in the industrial setting due to
10
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formaldehyde-release in the workplace. The standard set a PEL of 0.75 ppm as
an 8-hour time-weighted average (TWA), a 15-rninute STEL of 2 ppm, and
prescribes that certain actions should be taken if monitoring shows levels of 0.50
ppm as an 8-hour TWA. Further, it requires monitoring before workers enter the
premises following use of formaldehyde or when potential ambient formaldehyde
is generated from other chemicals. The standard also establishes requirements for
posting of warning signs, use of personal protective equipment, medical
surveillance, hazard communication and training.
Use Patterns
Triethylhexahydrotriazine is a microbiocide/microbiostat used against
slime-forming bacteria and fungi. Triethylhexahydrotriazine is formulated as a
soluble concentrate/liquid (ranging from 93 to 95 percent active ingredient).
Triethylhexahydirotriazuie is employed in a variety of industrial uses including:
Industrial adhesives (95 to 475 ppm a.i. by weight);
Latex paints (in-can) (475 to 1,425 ppm a.i. by weight);
Rubber products (190 to 475 ppm a.i. by weight);
Fuels/oil storage tank bottom water additive (363 to 1,813 ppm a.i. by
volume); '
Metalwprkmg cutting fluids (28,500 ppm a.i. by weight);
Wet-end additives/industrial processing chemicals (95 to 1,425 ppm a.i. by
weight).
All triethylhexahydrotriazine products are intended for occupational use
when handled directly. Homeowners may be exposed to triethylhexahydrotriazine
while using products, such as paints, adhesives, or rubber products, to which
triethylhexahydrotriazme has been added. EPA has determined that there is a
potential for exposures to mixers, loaders, applicators,, or other handlers of
triethylhexahydrotriazine, products containing triethylhexahydrotriazine, and its
break-down product formaldehyde. .There are potential exposures from
applications in commercial, industrial, and residential settings. EPA has identified
two levels of handler exposures:
• Primary Handlers — persons handling end-use pesticide products containing
triethylhexahydrotriazine as an active ingredient.
• Secondary Handlers — persons handling products, such as paints,
adhesives, and metalworking/cutting fluids to which
triethylhexahydrotriazine has been added.
All handler use patterns were only assessed for dermal exposure. They
were not assessed for inhalation exposure. Although EPA believes that inhalation
exposure may be significant (the vapor pressure of triethylhexahydrotriazine is
11
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15.7 mmHg @ 25°C and it is classified as category II for inhalation toxicity), no
data are available to quantitatively assess inhalation exposure.
EPA is also aware of possible handler exposures to formaldehyde in
industrial, manufacturing, and residential settings, since formaldehyde is a possible
degradate of triethylhexahydrotriazine under certain conditions. However, no data
are available at this time upon which to assess the possible exposure and risk.
a. Occupational Handler Exposure Scenarios
Primary Occupational Handlers: Based on the use patterns, EPA
has identified two major triethylhexahydrotriazine exposure scenarios for
primary occupational handlers: (1) open-pouring the soluble concentrate
liquid formulation and (2) metering-pump applications (automatic
dispensing equipment) with the soluble concentrate liquid formulation.
Provided in Table 4 are exposure estimates for two.Open-Pour Liquid
scenarios (Manufacturing of Paint and Metal-Cutting Fluid) and one
Pump-Metering System scenario. EPA assumes that mixers and loaders are
exposed more than 7 days per year (reasonable worse-case estimate).
EPA has no data for several of the uses listed for
triethylhexahydrotriazine. However, EPA has data that may be used as a
surrogate for these uses. In this exposure and risk assessment, the
following surrogates have been used:
. • Data from pulp and paper mill uses is used as a surrogate for the
wet-end additives/industrial processing chemicals use, since both
use patterns use automatic dispensing equipment rather than open-
pour techniques; and
• Data from paint manufacturing uses are used as a surrogate for the
rubber, industrial adhesives, and fuels/oil storage tank bottom water
uses, since these use patterns use open-pour techniques rather than
automatic dispensing equipment.
Secondary Occupational Handlers: Based on the use patterns,
EPA has identified several major - triethylhexahydrotriazine exposure
scenarios for secondary occupational handlers of triethylhexahydrotriazine
containing products including: (1) paint, (2) adhesives, (3) rubber
products, and (4) metalworking/cutting fluids. EPA considers dermal
exposures while handling triethylhexahydrotriazine-contauiing paint to
represent a reasonable worse-case dermal exposure scenario for secondary
occupational handlers, other than metalworking/cutting fluid uses.
Provided in Table 4 (as Paint Application) is the exposure estimate for this
scenario.
12
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With respect to secondary occupational exposure to handlers of
metalworking/cutting fluids, this exposure assessment addresses only the
potential exposures to primary occupational handlers who are adding
triethylhexahydrotriazine into metalworkhig fluids. Although EPA
, continues to discuss with OSHA and National Institute for Occupational
Safety Health (NIOSH) the roles and responsibilities of regulating the uses
of metalworking fluids and other products in the industrial setting, OSHA
is responsible for regulating machinists' safety and exposure. Therefore,
machinists' exposures to triemylhexahydrotriazine or formaldehyde will not
be addressed in detail in this document. EPA defers to OSHA for
enforcing the formaldehyde air-level standard in industrial and
manufacturing settings.
b. Homeowner Handler Exposure Scenarios
Primary Homeowner Handlers: There are no use patterns
identified for primary homeowner handlers, since at this time all
triethylhexahydrotriazine end-use pesticide products are intended for
occupational use.
Secondary Homeowner Handlers: Based on the use patterns,
EPA has identified three major triethylhexahydrotriazine exposure
scenarios for secondary homeowner handlers of triethylhexahydrotriazine
containing products, including: (1) paint, (2) adhesives, and (3) rubber
products. (See Table 4.) EPA considers exposures while handling
iriethylhexahydrotriazine-contahiing paint to represent a reasonable worse-
case dermal exposure scenario for secondary homeowner handlers.
Provided in Table 4 (as Paint Application) is the exposure estimate for this
scenario.
c. Post-Application Exposure Scenarios and Assumptions
EPA believes there are potential exposures following applications
of triethylhexahydrotriazine in commercial, industrial, and residential
settings. EPA has identified two levels of post-application exposures as
described below.
The following post-application use patterns were only assessed for.
dermal exposure. They were not assessed for inhalation exposure.
Although EPA believes mat inhalation exposure may be of concern (the
vapor pressure of triethylhexahydrotriazine is 15.7 mmHg @ 25°C and it
is classified as category n for inhalation acute toxicity), no data are
available to quantitatively assess inhalation exposure. EPA also
13
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acknowledges possible post-application exposures to formaldehyde in
industrial, manufacturing, and residential settings.
Occupational and Homeowner Post-Application Exposure Scenarios
Primary Occupational Post-Application Exposures: Based on the
use patterns, EPA has identified two primary post-application
exposure scenarios in commercial and industrial settings: (1)
potential exposures following applications of
triethylhexahydrotriazine to open vats of liquids, such as adhesives,
rubbers, fuels/oil storage tank bottom water, and paints, and (2)
exposures to persons maintaining equipment, such as water systems,
and other industrial equipment, which contain products treated with
triethylhexahydrotriazuie.
Secondary Occupational Post-Application Exposures: Based on
the use patterns, EPA has identified several major
triethylhexahydrotriazine exposure scenarios for secondary
occupational post-application exposures, including: (1) exposures
to persons occupying areas recently painted with
triethylhexahydrotriazine-containing paint, (2) exposures to persons
occupying areas where triethylhexahydrotriazine-containing
adhesives have recently been applied, and (3) exposures while
handling recently treated rubber.
Primary Homeowner Post-Application Exposures: EPA has
identified no major triethylhexahydrotriazine exposure,scenarios for
primary homeowner post-application exposures, since at this time
all triethylhexahydrotriazine end-use pesticide products are intended
for occupational use.
Secondary Homeowner Post-Application Exposures: Based on
the use patterns, EPA has identified two .major
triethylhexahydrotriazine exposure scenarios for secondary
homeowner post-application exposures: (1) exposures while
occupying areas recently painted with triethylhexahydrotriazine-
containing paint, and (2) exposures while occupying areas where
triethylhexahydrotriazine-containing adhesives have recently been
used.
EPA believes that these primary and secondary post-
application dermal exposures in industrial settings and secondary
exposures in residential settings would be lower than dermal
exposures to primary occupational handlers. Provided in Table 3
14
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is a simple matrix illustrating this narrative description of these
primary and secondary exposures.
TableS.
Type of Exposure
Handler
Exposure
Post-Application
Exposure
Primary
Secondary
Primary
Secondary
•• , ~1 Occupational
Settings —Examples
Adding triethylhexahydrotriazine
to a vat of paint.
Professional painter using a
triethylhexahydrotriazine-
containing paint.
Standing near a vat where
triethylhexahydrotriazine was '
added.
Being in a painted room.
Residential * ' ,
. Settings — Examples
N/A. Triethylhexahydrotriazine is an industrial
chemical; homeowners would not handle it directly.
A homeowner using a triethylhexahydrotriazine-
containing paint. , ' •
N/A. Triethylhexahydrotriazine is an industrial
chemical; homeowners would not receive post-
application exposures when
triethylhexahydrotriazine is handled directly
Being in a painted room.
d. Exposure Estimations
The Agency relied on surrogate exposure data from a study
submitted by the Chemical Manufacturers Association, the assumption of
,100% dermal absorption, the use of chemical resistant gloves (except for
paint application), as well as other assumptions which are noted in Table
4 on the next two pages. Short and intermediate-term exposure estimates
were calculated for these representative use scenarios using the following
formula to estimate actual daily exposure:
unit exposure (ug/lb a.i.) x application rate (Ib a.i./used)
body wt (kg)
The following exposure and risk characterization addresses both
primary and secondary exposure for occupational and residential handlers
and post-application scenarios. All of the following exposure scenarios
(both handler and .post-application) were assessed for dermal exposure
only. Although EPA believes that inhalation exposure may be of concern
no data are available to assess inhalation exposure quantitatively.
15
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4. Occupational and Residential Risk Characterization
Based on the above exposure estimates and underlying assumptions of the short and
intermediate-term toxicological endpoint of 75 mg/kg/day, the Agency estimated the risks
with a margin of exposure (MOE). These estimates are calculated by:
MOE = NOEL/Actual Daily Exposure
a.
Primary Application and Post-Application Scenarios (Occupational
Only)
Primary application and post-application exposure scenarios are those
involving industrial uses of triethylhexahydrotriazine.
Risk Assessment
Based on available toxicity data and exposure scenarios for
triethylhexahydrotriazme, the Agency has determined that quantitative risk
characterizations for mixer/loader/applicator and handler dermal exposures are
appropriate for short- to intermediate-term exposures. Because of the selected
toxicity endpoint for this duration of exposure to triethylhexahydrotriazme, the
Agency is characterizing the risks by MOEs. Provided in Table 5 are the MOEs for
the triethylhexahydrotriazme application scenarios.
Table 5. Worker Risk Estimates for Triethylhexahydrotriazine Handler Scenarios
., i- t ' >* V x
^ * ,- *, £ f
)S?^^^^fe.J-!V
'C&bru&^&iLY
* ~ A
/. Primary JExposore v-*' „ ,,
Open-pour Liquid
Open-pour Liquid
Pump-Metering System
<,
Paint
Application
Paint Manufacturing (also surrogate for industrial adhesives,
rubbers, and fuels/oil storage tank bottom water)
Metal-Cutting Fluid
Pulp and Papermill (surrogate for wet-end additives/industrial
processing chemicals)
0.0035
0.0062
0.035
21,429
12,088
2,143
*.'',>>• ' " .Secondary Exposure ^ ' ' °
Occupational
Residential
Painting
0.225
0.046
333
' 1643
NOTE: 'MOE = NOEL/ACTUAL DAILY EXPOSURE, where NOEL = 75 mg/kg/day,
EPA generally is not concerned with occupational and residential risk if
MOEs are greater than 100. For triethylhexahydrotriazme, all the primary
application exposure dermal MOEs are greater than 100; they range from
approximately 2,100 for exposure in wet-end additives/industrial processing
chemicals using a pump metering system to approximately 21,000 for open-pour
operations during paint, adhesive, and rubber manufacturing and in uses for fuels/oil
storage tank bottom water.
As mentioned previously, triethylhexahydrotriazme is so corrosive that the
dermal acute.toxicity and primary skin and eye irritation studies were waived.
17
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Although no traditional risk assessment is currently available to evaluate risks posed
by corrosivity, the Agency has determined that triethylhexahydrotriazine products
may pose significant handler risk due to its corrosivity. The Agency is addressing
these risks through the establishment of PPE requirements that are to be included on
all end-use product labeling that are classified as toxicity category I or II for skin or
eye irritation potential.
In addition, the Agency did not conduct a quantitative risk>characterization
for chronic exposure (several months to one-year) due to the lack of a chronic
toxicological endpoint. However, based on the NOEL being greater than the highest
dose tested for subchronic toxicity (13-week dermal study), and the high MOE for
primary handlers, the Agency does not believe that a chronic exposure MOE would
indicate a risk of concern. As previously discussed, the Agency does not have data
to assess directly any post-application exposure to triethylhexahydrotriazine.
However, EPA believes that dermal exposures incurred during handling tasks are
likely to be higher than dermal exposures incurred during post-application. Because
all the dermal MOEs for handlers are greater than 100, EPA believes that the post-
application dermal MOEs would also be greater than 100.
Risk Concerns
EPA is concerned about potential inhalation exposures to
triethylhexahydrotriazine for primary handler and primary post-application
situations, since it is classified as category n for acute inhalation toxicity and the
vapor pressure is high (i.e., 15.7 mmHg at 25°C). At this time, EPA has no data
upon which to conduct an exposure or risk assessment for inhalation concerns. Due
to the Agency's concerns about potential inhalation exposure and the lack of
inhalation exposure data, the Agency is requiring primary handler and primary post-
application inhalation exposure data. Even though the Agency has concerns about
these exposure scenarios, the Agency believes that primary handler and primary
post-application inhalation exposures are not likely to be a risk of concern based on
recommendations noted in the pesticide's MSDS. The MSDS states "Effective
exhaust [must be maintained] to draw fumes and vapors away from workers to
prevent routine inhalation. If local exhaust ventilation is applied, a capture velocity
of 100 to 150 feet per minute should be maintained. Local exhaust is recommended
during product mixing." Thus, the Agency is requiring primary handler and post-
application dermal and inhalation exposure data to confirm that the risks associated
with these exposure scenarios would not indicate a risk of concern.
In addition to inhalation concerns about triethylhexahydrotriazine itself in
primary occupational settings, EPA is concerned about potential inhalation
exposures to formaldehyde (a potential triethylhexahydrotriazine degradate) in these
situations. However, since OSHA has established Permissible Exposure Level
(PEL) and Short-Term Exposure Limit (STEL) standards for formaldehyde in
industrial and manufacturing settings, EPA defers to OSHA in enforcing
formaldehyde air levels hi these settings.
b. Secondary Handler and Post-Application Scenarios
18
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Exposures to products containing triethylhexahydrotriazine as an additive
(such as paints, rubber, or adhesives) may occur in industrial, manufacturing, and
residential settings.
Risk Assessment
Secondary occupational/residential exposures are expected to be short-term
and intermediate-term. Chronic exposure is expected only for occupational
workers. Based on available toxicity data and exposure scenarios for
triethylhexahydrotriazine, the Agency has determined that a quantitative risk
characterization for painters (occupational and residential) is appropriate. Because
of the selected toxicity endpoint for short- to intermediate-term exposure to
triethylhexahydrotriazine, the Agency is characterizing the risks by MOE. Provided
in Table 5 are the MOEs for the triethylhexahydrotriazine dermal secondary handler
scenarios. The Agency did not conduct a quantitative risk characterization for
chronic exposure (several months to one-year) due to the lack of a chronic
lexicological endpoint. However, based on the NOEL being greater than the highest
dose tested (13-week dermal study), and the high MOE for painters, the Agency
does not believe that a chronic exposure MOE would indicate a risk of concern.
The Agency does not have data to assess directly post-application
(occupational or residential) dermal exposure to triethylhexahydrotriazine.
However, EPA believes that dermal exposures incurred during application are likely
to be higher than exposures incurred during post-application. Because the, painter
exposure dermal MOEs are greater than 100, EPA believes that the post-application
dermal MOEs would also be greater than 100. Thus, a quantitative assessment of
the dermal post-application exposure risks is not necessary.
Risk Concerns
EPA is also concerned about potential inhalation exposures to
triethylhexahydrotriazine for secondary handler and secondary post-application
situations, particularly when triethylhexahydrotriazine-containing paint is used, since
triethylhexahydrotriazine is classified as category n for acute inhalation toxicity and
the vapor pressure is high (i.e., 15.7 mmHg at 25°C). At this time, EPA has no
data upon which to conduct an exposure or risk assessment for inhalation concerns.
Thus, the Agency is requiring secondary handler and secondary post-application
inhalation, as well as dermal, exposure data. Even though the Agency has concerns
about potential inhalation exposures to triethylhexahydrotriazine for these exposure
scenarios, the Agency believes that secondary handler and secondary post-
application inhalation exposure are not likely to be of concern since
triethylhexahydrotriazine concentrations in paint or adhesives would be relatively
low (Usually less than 1% a.i.). The Agency is requiring these exposure data to
confirm that risks associated with these exposure scenarios are acceptable.
In addition to inhalation concerns for triethylhexahydrotriazine in secondary •
occupational and residential settings, EPA also is concerned about potential
inhalation exposures to formaldehyde (a potential triethylhexahydrotriazine
19
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degradate) in these situations. In industrial and manufacturing settings, such as
metalworking shops, EPA defers to OSHA enforcement of OSHA's formaldehyde
air-level standards. Since potential inhalation exposures may also occur in
residential settings where OSHA does not traditionally have jurisdiction, EPA is
unable to defer these concerns to OSHA enforcement. Therefore the Agency is
requiring secondary applicator and post application inhalation exposure data to
confirm that risks associated with these formaldehyde exposure scenarios are
acceptable. These inhalation exposure studies will monitor for
triethylhexahydrotriazine as well as its degradates (formaldehyde).
5. Additional Occupational/Residential Exposure Studies
Handler Studies
EPA is requiring the following confirmatory data for handler exposures:
• For painting with a brush;
• • For painting with a roller;
• For painting with a sprayer.
•
For each of these handler exposure scenarios, studies should be conducted using
guideline numbers: 231, 232, 233, and 234 for the estimation of both inhalation and dermal
exposures in indoor and outdoor sites. The ah- monitoring study must include monitoring
for potential degradates (formaldehyde) as well as monitoring for triethylhexahydrotriazine
itself.
Post-Application Studies
EPA is requiring confirmatory data for post-application exposures in painted areas where
paint is applied by brush, roller, and sprayer. For these exposure scenarios, studies should
be conducted using guideline numbers: 133-3 for dermal passive dosimetry exposure and
133-4 for inhalation passive dosimetry exposure. The air monitoring studies for paint uses
must include monitoring for the potential degradate (formaldehyde) as well as monitoring
for triethylhexahydrotriazine itself.
6.
Other Considerations
The Food Quality Protection Act of 1996 amends both FFDCA and FIFRA by
setting a new safety standard for the establishment of tolerances. In determining whether
or not a tolerance meets the new safety standard, FQPA directs EPA to consider
information concerning: the susceptibility of infants. and children to residues of the
pesticide in food; the potential for aggregate exposures from dietary as well as non-
occupational sources, such as pesticides used in and around the home; and the potential for
cumulative effects from a pesticide and other substances that have a common mechanism
oftoxicity.
Because triethylhexahydbrotriazine has no food uses, and therefore no tolerances have
been established, the specific determinations outlined in FQPA are not required for this
20
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chemical. Nevertheless, EPA believes that consideration of available data relating to the
special sensitivity of infants and children, as well as the potential for aggregate exposures
and cumulative effects is prudent for triethylhexahydrotriazine because children and other
individuals could be exposed to this compound in non-occupational settings.
a. Potential Risks to Infants and Children
In determining whether or not an additional uncertainty (safety) factor is
appropriate for assessing risks to infants and children, EPA takes into account the
completeness and reliability of the toxicity data base, the nature of the effects
observed in pre-and post-natal studies, and other information such as
epidemiological data.
Based on current data requirements, only one developmental study is usually
. required, and reproduction studies are not routinely required for non-food use
chemicals. A reproduction study has not been required for
triethylhexahydrotriazine.
The effects observed hi the triethylhexahydrotriazine developmental study
can be summarized as follows:
Results from a rat developmental toxicity study (triethylhexahydrotriazine
was administered by gavage during gestation days 6-15, inclusive) indicated both
developmental and maternal toxicity. Developmental toxicity was observed at 150
mg/kg/day (highest dose tested) and consisted of increased fetal incidences of dilated
renal pelvises and bilateral convoluted ureters. Therefore, the LEL was 150
mg/kg/day and the NOEL was 75 mg/kg/day. In terms of maternal toxicity,
decreased body weight gains were observed during the entire dosing period at 150
mg/kg/day (highest dose tested). Thus the maternal LEL was 150 mg/kg/day and
the NOEL was 75 mg/kg/day.
In the triethylhexahydrotriazme study, developmental effects occurred at the
same dose level as maternal effects. The Agency would generally be concerned
when developmental effects are seen at doses lower than those which cause maternal
effects. . . ,
Nothing in the available data suggests special sensitivity of young organisms
to triethylhexahydrotriazine. Therefore, the Agency concludes that an additional
uncertainty factor need not be applied to the short and intermediate term NOELs
selected for the triethylhexahydrotriazine risk assessments at this time.
b. Aggregate exposure
In examining aggregate exposures, EPA takes into account available
information concerning exposures from pesticide residue in food and other
exposures for which there is reliable information. These other sources of exposure
can include drinking water, and non-occupational exposures, e.g., to pesticides used
in and around the home.
21
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There are no food uses of triethylhexahydrotriazine, therefore exposure to
triethylhexahydrotriazine residues in the diet are not expected. Because the uses of
triethylhexahydrotriazine are primarily indoors, EPA does not anticipate any
significant residues in drinMrig water. Thus, the only likely non-occupational
exposure to triethylhexahydrotriazine would be from uses in the home. These
include applying paints and adhesives containing triethylhexahydrotriazine, handling
rubber products which contain it as a"preservative, and occupying the same room or
area where triethylhexahydrotriazine-containuig products are being applied or have
been used.
Based on available surrogate exposure information, applying
triethylhexahydrotriazinQ-containing paints would result hi the reasonable worst case
exposure scenario, i.e., the highest exposure, for homeowners. The dermal MOE
for this scenario is > 1600. No data are available to estimate inhalation exposure,
which could be significant given the volatility of triethylhexahydrotriazine.
Therefore, the Agency is requiring inhalation exposure data for both applicators and
post-application exposure, including measurements of air concentrations in newly
painted rooms where infants and children could be exposed. Pending receipt and
review of this inhalation exposure data, EPA believes that it is reasonable to assume
that aggregate exposures to triethylhexahydrotriazine hi the home are not likely to
be of concern based on the high MOE for dermal exposure.
c.
Cumulative Effects
The Agency has not yet made a determination regarding the. common
mode/mechanism of toxicity of triethylhexahydrotriazine and whether it is
appropriate to consider exposure to triethylhexahydrotriazine with other compounds
in order to address potential cumulative effects. There are significant structural
differences between triethylhexahydrotriazine and other more commonly known
triazine pesticides such as atrazine, simazine, and propazine. Unlike these other
triazines, triethylhexahydrotriazhie has no aromatic ring, no double bonds, and is
not chlorinated. Because of these structural dissimilarities, the Agency would not
expect a common mechanism of toxicity between triethylhexahydrotriazine and the
other triazine pesticides.
Furthermore, based on the high dermal MOE for homeowner applicators, the
lack of food uses, the unlikelihood of residues in drinking water, and the low
concentration in paint, the Agency believes that the contribution of
triethylhexahydrotriazine exposure to the risks of any other compounds with a
common mode/mechanism of toxicity is likely to be minimal considering the
currently registered triethylhexahydrotriazine uses.
22
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C. Environmental Assessment
1. Ecological Toxicity Data
a. Toxicity to Terrestrial Animals
Birds, Acute and Subacute; An acute oral toxicity study using the technical grade
of the active ingredient is required to establish the toxicity of a pesticide to birds.
The preferred test species is either mallard duck or bobwhite quail. Results of this
test are~tabulated below.
Table 6 : Avian Acute Oral Toxicity
Species
Northern Bobwhite Quail
(Colinus virginianus)
Northern Bobwhite Quail
(Colinus virginianus)
Mallard duck
(Anas platyrhyncus)
<%,AJL
96
96
96
LD^j a.i.
.Mg/KgYDay,:
311
394
595
-' lixicity '
• Category
Moderately toxic
Moderately toxic
Slightly toxic
MRD>No,
42223201
00164390
00164390
Study
Classification
Acceptable
Supplemental
Supplemental
These results indicate that triethylhexahydrotriazine is slightly to
moderately toxic to avian species on an acute oral basis. The guideline
requirement (71-1) for a biocide is fulfilled (MRID 42223201).
" ' , ' /
Two subacute dietary studies using the technical grade of the active
ingredient are required to establish the toxicity of a pesticide to birds;
however, the Agency has determined that one avian subacute dietary toxicity
study is sufficient for a biocide such as triethylhexahydrotriazine that has
only indoor use patterns. The tested species is the bobwhite quail (an upland
gamebird). Results of this test are tabulated below.
Table 7; Avian Subacute Dietary Toxicity
Species
,Northern Bobwhite Quail
(Colinus virginianus)
"%AX
96
LC^ppm) :
*" ^ 4 * •
> 5000
, / Toxieifcp , ^>
Category t, »
Practically non-toxic
MRIDJSfo.
42317001
Study
Classification
Acceptable
These results indicate that triethylhexahydrotriazine is practically
non-toxic to avian species on a subacute dietary basis. The guideline
requirement (71-2) is fulfilled (MRID 42317001).
23
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b. Toxicity to Aquatic Animals
(1) Freshwater Fish
*
One freshwater fish toxicity study is, typically required for
microbiocides; however, tests with two species are available. The tests are
conducted with the technical grade of the active ingredient in order to
establish the toxicity of a pesticide to fish. The preferred test species are
rainbow trout (a cold-water fish) and bluegill sunfish (a warm water fish).
Results of these tests are tabulated below.
Table 8 ; Freshwater Fish Acute Toxicity
Species
Ralnbow.trout
(Oncorhynchus mykiss)
Rainbow trout
(Oncorliynchus mykiss) ,
Bluegill sunfish
(Lepomis macrochirus)
%AJ.
96
96
95.
LCs,
(ppm)
35
23
31
Toxicity Category
Slightly Toxic
Slightly Toxic
Slightly Toxic
MRTONo. ^
42209701
ACC128718
ACC128718
Staay <<
Classification
Acceptable
Acceptable
Acceptable
The results indicate that triethylhexahydrotriazine is slightly toxic to
freshwater fish on an acute basis. The guideline requirement (72-1)
is fulfilled (MRIDs 42209701, ACC128718).
(2) Freshwater Invertebrates, Acute
' A freshwater aquatic invertebrate toxicity test using the technical
grade of the active ingredient is required to assess its toxicity to
invertebrates. The preferred test species is Daphnia magna. Results of this
test are tabulated below.
Table 9 ; Freshwater Invertebrate Toxicity
Species
Waterflea (Daphnia magna)
%A.I.
96
LC«/
ECjoCppm)
26
Toxicity Category
Slightly Toxic
MRIDNo.
42557301
.Study
'Classification.
Acceptable
The results indicate that triethylhexahydrotriazine is slightly toxic to
aquatic invertebrates on an acute basis. The guideline requirement (72-2) is
fulfilled (MRID 42557301).
2. Environmental Fate
Environmental Fate Assessment
The current policy for microbiocides requires a hydrolysis study. The
Agency does not have a hydrolysis study for this active ingredient, but, based on the
24
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behavior of structurally related chemicals, the expected reaction products may be
formaldehyde and ethylamine. However, the effect of different pHs on the rate of
hydrolytic degradation is not known. The data requirement is not fulfilled. Data
are needed on the rate of hydrolysis of triethylhexahydrotriazine at pH 5, 7 and 9,
and the reaction products must be identified.
3. Exposure and Risk Characterization
a. Exposure and Risk to Nontarget Organisms
The Agency requires only a limited number of ecotoxicology and
environmental fate studies for microbiocides with indoor use patterns. The available
data classify triethylhexahydrotriazine as moderately toxic to birds on an acute oral
, basis, practically non-toxic to birds on a subacute dietary basis, and slightly toxic
to freshwater fish and aquatic invertebrates on an acute basis. While the hazard to
aquatic organisms" from triethylhexahydrotriazine has been characterized, a
quantitative risk assessment has not been conducted. The risks to aquatic
environments are regulated under the NPDES permitting program of the Agency's
Office of Water. Labels for all triethylhexahydrotriazine products must require that
discharges to aquatic environments comply with an NPDES permit.
The fuel additive use of triethylhexahydrotriazhie may be associated with
periodic releases into the environment from -the purging of storage tanks. This
terrestrial use is expected to result in minimal to no exposure.
b. Endangered Species -
The Agency does not anticipate any exposure of concern to fish and wildlife,
providing that triethylhexahydrotriazine products are discharged into the
environment in accordance with all disposal laws or a NPDES permit.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
. A. Determination of Eligibility
\
Section 4(g)(2)(A) of FEFRA calls for the Agency to determine, after submission of relevant
data concerning an active ingredient, whether products containing the active ingredient are eligible
for reregistration. The Agency has previously identified and required the submission of the generic
(i.e. active ingredient specific) data required to support reregistration of products containing
triethylhexahydrotriazine. The Agency has completed its review of these generic data, and has
determined that the data are sufficient to support reregistration of all products containing
triethylhexahydrotriazine under the conditions specified in this RED. Appendix B identifies the
generic data requirements that the Agency reviewed as part of its determination of reregistration
eligibility of triethylhexahydrotriazine, and lists the submitted studies that the Agency found
acceptable. . , .
25
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The data identified in Appendix B were sufficient to allow the Agency to assess the
registered uses of triethylhexahydrotfiazine and to determine that triethylhexahydrotriazine can be
used under the conditions specified hi this RED without resulting in unreasonable adverse effects
to humans and the environment. The Agency therefore finds that all products containing
triethylhexahydrotriazine as the active ingredient are eligible for reregistration. The reregistration
of particular products is addressed in Section V of this document.
The Agency made its reregistration eligibility determination based upon the target data base
required for reregistration, the current guidelines for conducting acceptable studies to generate such
data, published scientific literature, etc. and the data identified in Appendix B. Although the
Agency has found that all uses of triethylhexahydrotriazine 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
triethylhexahydrotriazine, if new information comes to the Agency's attention or if the data
requirements for registration (or the guidelines for generating such data) change.
Under section 5 of the Occupational Safety and Health Act, 29 U.S.C. 651 et sec, every
employer has a general duty to furnish a place of employment which is free from recognized
hazards that are causing, or are likely to cause, serious physical harm. Every employer is also
required to comply with occupational safety and health standards promulgated by OSHA.
Operations such as blending and formulating using 1,3,5-Triethylhexahydrotriazine in general
industry (i.e., Standard Industrial Codes 20 - 39) may be subject to other OSHA requirements.
There is no OSHA PEL for triethylhexahydrotriazine.
Because triethylhexahydrotriazine currently has no food uses and no tolerances have been
established, the specific determinations outlined hi the Food Quality Protection Act of 1996 are not
required for the reregistration of this chemical. Nevertheless, .EPA has considered available data
relating to the sensitivity of infants and children, the potential for aggregate exposures and
cumulative effects hi its risk management decision for triethylhexahydrotriazhie because children
and other individuals could be exposed to this compound in non-occupational settings.
B. Determination of Eligibility Decision ,
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient
triethylhexahydrotriazhie, the Agency has sufficient information on the health effects of
.triethylhexahydrotriazhie and on its potential for causing adverse effects in fish and wildlife
and the environment. The Agency has determined that triethylhexahydrotriazine products,
labeled and used as specified in this Reregistration Eligibility Decision, will not pose
unreasonable risks or adverse effects to humans or the environment. Therefore, the Agency
concludes that products containing triethylhexahydrotriazine for all uses are eligible for
reregistration.
2. Eligible and Ineligible Uses
The Agency has determined that all current uses of triethylhexahydrotriazine are
eligible for reregistration.
26
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C. Regulatory Position and Labeling Rationale
The following is a summary of the regulatory positions and rationales for
triethylhexahydrotriazine. Where labeling revisions are imposed, specific language is set forth in
Section V of this document.
Labeling Rationale/Risk Mitigation Measures
"V.
1. Potential Risks to Infants and Children/Aggregate Exposure/Cumulative Effects
In determining whether infants and children are particularly susceptible to the toxic
effects of triethylhexahydrotriazine, EPA considered the completeness and reliability of the
toxicity data base, the nature of the effects observed in toxicity studies, and other
information.
Based on current data requirements, only one developmental study is usually
required for non-food use chemicals. In the developmental study for
triethylhexahydrotriazine, effects on the fetuses were seen at the same dose as effects on the
mothers. Nothing in the available toxicity data base suggests special susceptibility of young
organisms to triethylhexahydrotriazine. Therefore, the Agency has concluded that an
additional uncertainty factor need not be applied to the short-term and intermediate-term
NOELs selected for the triethylhexahydrotriazine risk assessments at this tune.
In examining aggregate exposure, EPA takes into account available information
concerning exposures from the pesticide residue in food and other exposures for which there
is reliable information. These other sources of exposure can include drinking water,, and
other non-occupational exposures to pesticides used in and around the home.
• , • - • No dietary exposure is expected since there are no food-uses of
triethylhexahydrotriazine. Because there are no outdoor uses, residues in drinking water
are unlikely. Thus, residential uses are the only potential sources of exposure that could
be aggregated. EPA assumes that applying paint containing triethylhexahydrotriazine would
, be the reasonable worst case exposure scenario for homeowners. Because the dermal MOE
for this scenario is high (> 1600), EPA believes that aggregate exposures to other sources
of triethylhexahydrotriazine in the home are not likely to be of concern. To confirm this
assumption, EPA is requiring dermal and inhalation exposure data for applicators and for
post application-exposures including monitoring air concentrations in newly painted rooms
where infants and children could.be exposed.
The Agency has ,not yet made a determination regarding the common
mode/mechanism of toxicity of triethylhexahydrotriazine and whether-it is appropriate to
consider exposure from triethylhexahydrotriazine with other compounds in order to address
potential cumulative effects.
However, based on the high dermal MOE for homeowner applicators, the lack of
food uses, the unlikelihood of residues in drinking water, -and the low concentration in
paint, the Agency believes that the contribution of triethylhexahydrotriazine exposures to
27
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the risks of other compounds with a common mode/mechanism of toxicity is likely to be
minimal considering the currently registered triethylhexahydrotriazine uses.
2. Handler Safety Requirements
During reregistration, the Agency considers handler safety requirements for
occupational and residential uses. '
a. Personal Protective Equipment Requirements for Occupational Handlers
The Agency establishes handler safety requirements when risk assessments
or general concerns suggest such requirements are appropriate. If EPA determines
that no specific handler requirements are warranted based on the potential acute or
other adverse effects of the active ingredient, the handler safety requirements will
be based on the acute toxicity characteristics of the end-use product.
The Agency is developing standardized requirements for occupational
handlers of industrial biocides, based on the acute toxicity characteristics of each
end-use product., In addition, OSHA has established requirements for hazard
communication and use of personal protective equipment for protection of workers
potentially exposed to chemical or other types of hazards in the workplace. OSHA's
hazard communication standard (29 CFR 1910.1200) establishes requirements for
labeling, preparation and dissemination of Material Safety Data Sheets (MSDSs),
training, etc., for workers potentially exposed to hazardous chemicals. OSHA
requirements for the selection and use of personal protective equipment (29 CFR
1910, Subpart I) include an assessment of the workplace to determine if hazards
potentially requiring the use of head, eye, face or foot protection are present or are
likely to be present. If hazards are identified, employers must select and have
employees use appropriate personal protective equipment (PPE) which has been
properly fitted and selected based on the potential hazard present. Employers are
required to provide training on the proper use of personal protective equipment,
when it is required, what equipment is necessary, how to properly don, doff, adjust,
and wear the PPE, the limitations of the equipment, proper care and maintenance,
useful life, and disposal of the PPE.
For triethylhexahydrotriazhie, the MSDS recommends the use of rubber
gloves, goggles, a NIOSH cartridge respirator if respiratory irritation or excessive
off-gassing occurs (respiratory protection is typically not required), arid effective
exhaust or local exhaust ventilation. If these measures are appropriately selected,
maintained, and used, worker exposures during operations where
, triethylhexahydrotriazhie is used hi paint, adhesives, rubber products, and
metalworMng/cutting fluids are expected to be reduced.
In general for occupational-use products, the Agency requires that handlers
(mixers, loaders, applicators, etc.) of all industrial biocides wear long-sleeve shirts,
long pants, shoes, and socks as rninimum work attire. For industrial biocide end-use
products that are classified as toxicity category I or n for acute dermal or skin
irritation potential, handlers are required to wear chemical-resistant gloves and a
28
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chemical-resistant apron in addition to the minimum work attire. For industrial
biocide end-use products classified as toxicity category I or n for eye irritation
potential, handlers are required to wear protective eyewear. For industrial biocide
end-use products classified as toxicity category I or n for acute inhalation toxicity,
• handlers are required to wear a respirator. The type of respirator must be based on
the acute toxicity category and the vapor pressure and must be specified on the end-
use product labeling. Table 10 summarizes the personal protective equipment
requirements for industrial biocides based on acute toxicity and corresponding
toxicity categories. EPA will assist registrants in determining the appropriate type
of respirator during the end-use product stage of reregistration.
Table 10. Personal Protective Equipment Requirements for Industrial Biocides Based on Acute
Toxicity and Corresponding Toxicity Categories
Route of Concern
Acute Dermal
Toxicity of Skin
Irritation Potential
Eye Irritant
Acute Inhalation
Toxicity
Toxicity - -
Caf egory I
Long sleeve shirt,
long pants, shoes, socks,
& chemical- resistant
gloves & apron
Protective Eyewear
Respirator
Toxicity -
'CategoryJI ' ^. '",*
Long sleeve shirt, long
pants, shoes, socks, &
chemical- resistant gloves,
& apron
Protective Eyewear
Respirator
,Toxicity „
Category HI „
Long sleeve shirt,
long pants, shoes,&
socks
No minimum
No minimum
Toxicity
Category IV ,
Long sleeve shirt,
long pants,
shoes,& socks'
No minimum
No minimum
At this time for all handler tasks, safely requirements for products containing
triethylhexahydrotriazine must be determined based on the acute toxicity
characteristics of the end-use product. It should be noted that in the case of
triethylhexahydrotriazine, there are currently no products registered solely as
manufacturing use products (MPs).
b. Engineering Control Requirements for Occupational Handlers
EPA is prohibiting open pouring and requiring the use of meter pumps or
other automatic dispensing equipment for triethylhexahydrotriazine use hi wet-end
additives and industrial processing chemicals. For use in paint, rubber products,
industrial adhesives, or fuel/oil storage tank bottoms, EPA is requiring that the vats
to which the triethylhexahydrotriazine is added must be closed and equipped with
mechanical vents to the outdoors <
c. Application and Post Application Exposure Data
EPA is requiring worker exposure data for triethylhexahydrotriazine
containing paint applied by brush, roller, and spray. Additionally, the Agency is
requiring post application monitoring data to determine exposure to residents or
occupants of areas that have been painted with triethylhexahydrotriazine-containing
paints. These post application data will include monitoring for the potential
degradate (formaldehyde) as well as for triethylhexahydrotriazine itself.
29
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These data are being required because the Agency currently has no
appropriate data available to estimate • inhalation exposure to
triethylhexahydrotriazine and because this compound is volatile. These data are
considered confirmatory because the MOEs for triethylhexahydrotriazine for dermal
exposure alone are high, greater than 300 for occupational painters and greater than
1600 for homeowners. ' . ,
However, if the results of these required studies indicate higher than
anticipated exposures to workers or homeowners applying paint or to persons
occupying newly painted areas, EPA may require additional inhalation toxicity data
and/or further restrictions on use.
d. Additional Labeling Requirements
The Agency is also requiring specific label language addressing application
restrictions, effluent discharge requirements, and user safety requirements and
recommendations. Label language is found in Part V.
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistration of both
manufacturing-use and end-use products.
A. Manufacturing-Use Products
As noted previously, there are currently no triethylhexahydrotriazine products registered
solely as manufacturing use products (MPs). Whenever possible, EPA strongly encourages
registrants to separate manufacturing use registrations from end use registrations in order to make
clear for the registrants and the Agency which specific data needs and labeling requirements apply
to each category of product. However, when one product is used for both manufacturing and end
use purposes, as is the case with triethylhexahydrotriazine, that product is subject to both sets of
labeling and data requirements.
1. Additional Generic Data Requirements •
The generic data base supporting the reregistration of triethylhexahydrotriazine for
the above eligible uses has been reviewed and determined to be substantially complete. The
Agency is requiring confirmatory data for hydrolysis and for post-application dermal and
inhalation exposures hi painted areas where paint is applied by brush, roller, and sprayer.
For these exposure scenarios, studies should be conducted using guideline numbers:
161-1 Hydrolysis
133-3 Dermal Passive Dosimetry Exposure
133-4 Inhalation Passive Dosimetry Exposure
231 Estimation of Dermal Exposure (Outdoor)
232 Estimation of Inhalation Exposure (Outdoor)
233 Estimation of Dermal Exposure (Indoor)
234 Estimation of Inhalation Exposure (Indoor)
30
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The air monitoring studies for paint uses must include monitoring for the potential
degradate (formaldehyde) as well as monitoring for txiethylhexahydrotriazine itself.
The Agency is issuing a DCI concurrent with this RED to triethylhexahydrotriazine
registrants for the hydrolysis data. However, because much of the exposure data needed
for triethylhexahydrotriazine is generic hi nature and will also be required for other
antimicrobial chemicals with similar characteristics and uses, EPA is developing a generic
exposure DCI. Triethylhexahydrotriazine registrants will receive the generic exposure DCI
at the same time as registrants of other antimicrobial chemicals with similar uses.
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 [list type of pesticide, i.e.
microbicide/rnicrobiostat/bacteriostat] for use as an additive for [list uses that are
being supported by MP registrant, i.e., industrial adhesives, metalworfcing cutting
fluid, latex paints and aqueous slurries, synthetic rubber latex, and marine fuels]."
A MP registrant may, at his/her discretion, add one of the following statements to a 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:
(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
support of such use(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 comph'ed with U.S. EPA submission requirements
regarding support of such use(s)."
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 D, the Product Specific Data Call- .
- In Notice.
Registrants must review previous data submissions to ensure that they meet current
EPA acceptance criteria and if not, commit to conduct new studies. If a registrant believes
that previously submitted data meet current testing standards, .then study MRID numbers
31
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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. Occupational Labeling PPE Requirements for Pesticide Handlers
Sole-active ingredient end-use products that contain triethylhexahydrotriazine
must be revised to adopt the handler personal protective equipment requirements set
forth in this section. Any conflicting PPE requirements on current labeling must be
removed.
(1) PPE Requirements for Occupational Handlers
Any necessary PPE for each triethylhexahydrotriazine occupational
end-use product will be established on the basis of the end-use product's
acute toxicity category as specified in Section V of this document. All end-
use products will be required to specify the minimum work attire for all
handlers.
The minimum handler labeling requirements for occupational uses of
triethylhexahydrotriazine end-use products is:
"Mixers, loaders, applicators and other handlers must wear:
— Long-sleeve shut and long pants,
— Shoes plus socks."
If the end-use product is classified as toxicity category I or n for eye
irritation potential or if data for this route of concern are waived due to
corrosiviry, add:
— Protective eyewear*
If the end-use product is classified as toxicity category I or n for
acute dermal toxicity or skin irritation potential or data for either of these
routes of concern are waived due to corrosivity, add:
— Chemical-resistant apron, and
— Chemical-resistant gloves*. ,
"For the glove statement, use the statement established for triethylhexahydrotriazine through
the instructions in Supplement Three of PR Notice 93-7. In addition, for concentrated
triethylhexahydrotriazine products, the corrosiveness and penetration of
triethylhexahydrotriazine must be considered. Appropriate chemical-resistant materials must
be listed on the product labeling.
If the end-use product is classified as toxicity category I or n for
acute inhalation toxicity, a respirator requirement must be added. The type
32
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of respirator must be specified in the statement .and is based on the acute
toxicity category and the vapor pressure. EPA will assist registrants in
determining the appropriate type of respirator during the end-use product
phase of reregistration.
In addition to the minimum PPE specified above, the following
specific PPE and engineering-control requirements must be added to labels
containing the following uses.
When labeling contains uses for wet-end additives/industrial processing
chemicals, add the following:
"For use in wet-end additives/industrial processing chemicals, meter
pumps or other automatic dispensing equipment is required: Open
pouring is prohibited."
When labeling contains uses for paint, rubber products, or industrial
adhesives, or fuels/oil storage tank bottom water, add the following:
*For use in paint, rubber products, industrial adhesives, or fuels/oil
storage tank bottom water, the vats to which
triethylhexahydrotriazine is being added must be closed and equipped
with mechanical vents to the outdoors."
Placement in Labeling
, The personal protective equipment requirements must be placed on
the end-use product labeling in the format and language specified above and
must be placed in the "Hazards to Humans" section of the pesticide labeling.
(2) PPE Requirements for Homeowner Handlers
EPA'S regulatory authority does not encompass requiring label
statements for paints or other homeowner products that have had
triethylhexahydrotriazine added as part of the manufacturing process.
However, based on EPA's assessment of potential homeowner risks, no
additional PPE is needed.
b. Other Labeling Requirements - Products Intended for Occupational Use
The Agency is requiring the following labeling statements to be located on
all end-use products containing triethylhexahydrotriazine that are intended for
occupational use. Additional handler safety requirements will be determined based
on the acute toxicity characteristics of each end-use product.
Application Restrictions
33
-------
"Do not use this product in a way that will contact workers or other
persons."
"Do not apply this product as a spray."
Timing of Applications
Labels must specify when and how often in the manufacturing process the
product is added or applied.
Effluent Discharge Restriction
"This product is toxic to fish. Do not discharge effluent containing this
product into lakes, streams, ponds, estuaries, oceans or other water unless
in accord with the requirements of a National Pollution Discharge
Elimination System (NPDES) permit and permitting authority has been
notified hi writing prior to discharge. Do not discharge this product to
sewer systems without previously notifying the local sewage treatment plant
authority. For guidance contact your State Water Board or Regional Office
. of the EPA."
User Safety Requirements
If gloves or protective eyewear are required PPE on the end-use product^
add:
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no
such instructions are available for washables, use detergent and hot water.
Keep and wash PPE separately from other laundry."
User Safety Recommendations
- "Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet."
- "Users should remove clothing immediately if pesticide gets inside. Then
wash thoroughly and put on clean clothing."
Registrant: add the following statements only if gloves are required PPE on
the end-use product:
- "Users should remove PPE immediately after handling this product. Wash
the outside of gloves before removing. As soon as possible wash
thoroughly."
C. Existing Stocks
34
-------
Registrants may generally distribute and sell products bearing old labels/labeling for 26
months from the date of the issuance of this Reregistration Eligibility Decision (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 Polity"; Federal Register, Volume
56, No. 123, June 26, 1991. _
.The Agency has determined that registrants may distribute and sell triethylhexahydrotriazine
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.
35
-------
36
-------
VI. APPENDICES
37
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for
active ingredients within the case 1,3,5-Triethylhexahydro-s-triazine covered by this
Reregistration Eligibility Decision Document. It contains generic data requirements that apply
to 1,3,5-Triethylhexahydro-s-triazine hi 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 hi
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 frbm 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
• iM 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.
41
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46
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' GUIDE TO APPENDIX C
CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Reregistration Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered,
are included.
UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
case of published materials, "this corresponds closely to an article. In the'case of
unpublished 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 tide (or at least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a
single study.
IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be 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
bases, 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.
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
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. f
47
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Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the
following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit
number, petition number, or other administrative number associated
with the earliest known submission. • f '
(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
hi 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. .
48
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BIBLIOGRAPHY
MRID
CITATION
00164390
41321501
41343401
41343402
41620501
41677801
41677802
41677803
41738201
41738202
41738203
Shellenberger, T. (1971) Letter sent to R. Sawyer dated Sept 17, 1971: Acute
lexicological evaluations of Vancide TH with wildlife: GSRI Proj. No.
NC-475. Prepared by Gulf South Research Institute, lip.
Putman, D.; Melhorn, J. (1989) Structural Chromosome Aberration: Mouse
Micronucleus: Vancide TH: Lab Project Number: T8796/ 122010.
Unpublished study prepared by Microbiological Associates, Inc. 28 p.
San, R.; Kruel, C. (1989) Mutagenicity Sahnonella/Mammalian Microsome
Plate Incorporated Assay Ames Test with Confirmation: Lab Project Number:
T8796/501014. Unpublished study prepared by Microbiological Associates,
Inc. 71 p.
Curren, R. (1989) Other Genotoxic Effects: Unscheduled DNA Synthesis in Rat
Primary Hepatocytes: Lab Project Number: T8796/380010. Unpublished study
prepared by Microbiological Associates, Inc. 30 p.
Trimmer, G. (1990) Dermal Sensitization Test in the Guinea Pig (Buehler
Method): Lab Project Number: 240822. Unpublished study prepared by Exxon
Biomedical Sciences, Inc. 44 p.
Flynn, F. (1990) Product Identity and' Composition of Hexahydro-1,3,
5-triethyl-s-triazine. Unpublished study prepared by R. T. Vanderbilt Co., Inc
25 p. ,
Flynn, F. (1990) Analysis and Certification of Product Ingredients of
Hexahydro-1,3,5-triethyl-s-triazine. Unpublished study prepared by R. T.
Vanderbilt Co., Inc. 10 p.
Flynn, F.; Agahigian, H. (1990) Physical and Chemical Characteristics of
Hexahydro-1,3,5-triethyl-s-triazine. Unpublished study prepared by R. T.
Vanderbilt Co., Inc. in assoc. with Baron Consulting Co. 5 p.
Flynn, F. (1989) Identification, Assay arid Stability of Test Substance
Hexahydro-1,3,5-triethyl-s-triazine (VANCIDE TH): Supplement. •
Unpublished study, prepared by R.T. Vanderbilt Co., Inc. 7 p.
Flyim, F. (1989) Identification, Assay and Stability of Test Substance
Hexahydro-1,3,5-triethyl-s-triazine (VANCIDE TH): Supplement.
Unpublished study prepared by R. T. Vanderbilt Co., Inc. 7 p.
Flynn, F. (1989) Identification, Assay and Stability of Test Substance
Hexahydro-1,3,5-triethyl-s-triazine (VANCIDE TH): Supplement.
Unpublished study prepared by R. T. Vanderbilt Co., Inc. 7 p.
49
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BIBLIOGRAPHY
MRH>
CITATION
41773701 Trimmer, G. (1991) Acute Oral Toxicity Test with LD50 Estimation in the Rat
with Vancide TEE: Lab Project Number: 140802. Unpublished study prepared
by Exxon Biomedical Sciences, Inc.. 44 p.
41858301 Trimmer, G. (1991) Vancide TH: 90 Day Subchronic Dermal Toxicity Study in
Rats: Lab Project Number: 240810-MRD-89-408.. Unpublished study prepared
by Exxon Biomedical Sciences, Inc. 429 p. '
41865701 Beyer, B. (1991) "Development Toxicity Study in Rats with Vancide TH": Lab
Project Number: MRD-89-408: 240834. Unpublished study prepared by Exxon
Biomedical Sciences, Inc. 274 p.
42209701 Marchado, M. (1992) Vancide TH: Acute Toxicity to Rainbow Trout
(Oncorhynchus mykiss) Under Flow-Through Conditions. Unpublished study
prepared by Springborn Labs., Inc. 56 p.
42223201 Pederson, C.; Helsten, B. (1992) Hexahydro-l,3,5-triethyl-striazine
(VANCIDE TH): 21 Day Acute Oral LD50 Study in Bobwhite Quail: Lab
Project Number: 121-003-03. Unpublished study prepared by Bio-Life
Associates, Ltd. 66 p.
42308601 Beyer, B. (1992) Supplemental Information to MRID 41865701 Developmental
Toxicity Study hi Rats with Vancide TH: Unpublished study prepared by Exxon
Biomedical Sciences, Inc. 6 p.
42317001 Pederson, C. (1992) Hexahydro-l,3,5-Triethyl-s-triazine (Vancide TH) 8-Day
Acute Dietary LC50 Study in Bobwhite Quail: Lab Project Number:
121-002-01. Unpublished study prepared by Bio-Life Associates, Ltd: 60 p.
42366200 R.T. Vanderbilt Co., Inc. (1992) Submission of Data in Response to
Antimicrobial Data Call-in for VANCIDE TH: Toxicology Study. Transmittal
of 1 study.
42366201 Beyer, B. (1992) Supplemental Information to MRID 41865701 and MRID
42308601-Developmental Toxicity Study in Rats with VANCIDE TH: Lab
Project Number: 20309. Unpublished study prepared by Exxon Biomedical
Sciences, Inc. 7 p.
42406101 Whitman, F. (1992) Vancide TH: Acute Inhalation Toxicity Study in Rats: Lab
Project Number: MRD-89-408: 140816. Unpublished study prepared by Exxpn
Biomedical Sciences, Inc. 112 p.
50
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BIBLIOGRAPHY
MRID
CITATION
42557301 Putt, A. (1992) Vancide TH-Acute Toxieity to Daphnids (Daphnia magna)
under Flow-through Conditions: Lab Project Number: 92-10-4468.
Unpublished study prepared by Springborn Labs, Inc. 58 p.
44139701 R.T. Vanderbilt Co,, Inc. (1996) pH of a 5% Aqueous Solution of hexahydro-
1,3,5-triethyl-s-triazine: Unpublished study prepared by R.T. Vanderbilt Co.,
Inc. 9 p.
51
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52
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C: 20460 ,
OFRCEOF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
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 1 of this Notice, the Data Call-in Chemical Status
Sheet, to submit certain product specific 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 m below. Your response must
state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 6; or
,2. Why you believe you are exempt from the requirements listed in this Notice and
in Attachment 3, Requirements Status and Registrant's Response Form, (see
section m-B); or ', !
3.
Why you believe EPA should not require your submission of product specific
data in the manner specified by this Notice (see section m-D).
53
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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 produces) 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, Data Call-In Response Form, as
well as a list of all registrants who were sent this Notice (Attachment 5).
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 03-31-99). .
This Notice is divided into six sections and six 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 n - Data Required By This Notice
Section ffl - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
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 - Product-Specific Data Call-In Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the
data needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional
generic data requirements are being imposed. You have been sent this Notice because you
have product(s) containing the subject active ingredient.
SECTION H. DATA REQUIRED BY THIS NOTICE
n-A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment 3,
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional testing may be required,
54
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H-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided.
n-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 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD
protocols, they should be modified as appropriate so that the data generated by the study will
satisfy the requirements of 40 CER § 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 160.3(a)(6)]. .
D-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 m. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
HI-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for 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 tb
failure to comply with this Notice are presented in Section IV-A and IV-B.
55
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m-B. OPTIONS FOR RESPONDING TO THE AGENCY
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 chose 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 ffl-C. A discussion of options relating to
requests for data waivers is contained in Section m-D.
There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used in your response to the Agency. These forms are the Data-Call-in
Response Form, and the Requirements Status and Registrant's Response Form, Attachment 2 and
Attachment 3. 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
must be submitted for each product listed on the Data Call-in Response Form unless the voluntary
cancellation option is selected or unless the product is identical to another (refer to the instructions
for completing the Data Call-In Response Form in Attachment 2). 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.
1. 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 the Data Call-in Response Form. If you choose this option, this is the only form 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.
2. 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 ffl-C of this Notice and comprise options 1 through 6 on the
Requirements Status and Registrant's Response Form and item numbers 7a and 7b on the Data
Call-in Response Form. Deletion of a use(s) and the low volume/minor use option are not valid
options for fulfilling product specific data requirements. .
3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section ffl-D of this Notice and are covered by option 7 on 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.
56
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m-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-in Response Form that you agree to satisfy the
product specific data requirements (i.e. you select item number 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)
(2)
(3)
(4)
(5)
(6)
I will generate and submit data within the specified tune frame (Developing Data)
I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
I have made offers to cost-share (Offers to Cost Share)
I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
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.
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. 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 tune 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.
57
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Option 2, Agreement to Share in Cost to Develop Data '-- Registrants may only choose
this option for acute toxicity data and certain efficacy data and only if EPA has indicated in the
attached data tables that your product and at least one other product are similar for purposes of
depending on the same data. If this is the case, data may be generated for just one of the products
in the group. The registration number of the product for which data will be submitted must be
noted in the agreement to cost share by the registrant selecting this option. 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 — This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. 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 registfation(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 your 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 hi the burden of producing the data upon
terms to be agreed or failing agreement to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii) and must not qualify this offer. The other registrant must also inform EPA
of its election of an option to develop and submit the data required by this Notice by submitting a
Data Call-In Response Form and a Requirements Status and Registrant's Response Form
committing to develop and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your offer
to share in the burdens 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 will normally 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 hi
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
58
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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(j) " '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 recprded data from automated instruments.''
The term "specimens", according to 40 CFR 160.3(k), means "any material
derived from a test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also 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.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according to the PAG may be
submitted to the Agency for consideration if the registrant believes that the study
clearly meets the purpose of the PAG. The registrant is referred to 40 CFR 158.70
which states me 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
aye 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 are
usually not available for such studies.
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If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.
-i
If you know of a study pertaining to any requirenfent 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
upgradeabie, 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 timfe 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 should also be used to cite data that has been previously submitted to upgrade
a study, but has not yet been reviewed by the Agency. You must provide the MRID number of
the data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to all
data submissions intended to upgrade studies. Additionally your submission of data intended to
upgrade studies must be accompanied by a certification that you comply with each of those
criteria as well as a certification regarding protocol compliance with Agency requirements.
Option 6, 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 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.
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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, as appropriate. . ' ~
m-D REQUESTS FOR DATA WAIVERS
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 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 hi question. Waiver
requests submitted without adequate supporting rationale will be denied and the original due date
will remain in force.
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.
3.
4.
5.
Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice.
Failure to submit on the required schedule acceptable, data as required by this
Notice.
Failure to take a required action or submit adequate mformation pertaining to any
option chosen to address the data requirements (e.g., any required action or
mformation 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).
61
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6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section ffl-C of this Notice.
7. Withdrawal of an offer to share hi 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:
a. 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;
b. fulfill the commitment to develop and submit the data as required by this
Notice; or
c. 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.
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 GeheTox 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
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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 would generally 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
must also 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 produces) 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 case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by
this Notice Will not result in the Agency granting any additional time tp 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 registratipn 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
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If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-in Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-in Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for product
specific data) and any other documents required by this Notice, and should be submitted to the
contact person(s) identified hi Attachment 1. If the voluntary cancellation or generic data
exemption option is chosen, only the Data Call-in Respo'nse Form need be submitted.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours
Attachments
1 -
2 -
3 -
4 -
5 -
6 -
is A. Rossi, Directo^
Ipecial Review and
Reregistration Division
Data Call-in Chemical Status Sheet ,
Product-Specific Data Call-in Response Form
Requirements Status and Registrant's Response Form
EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms and the Confidential Statement of
Formula Form
64
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1,3,5-TRffiTHYLHEXAHYDRO-S-TRIAZINE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION .
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing 1,3,5-triethylhexahydro-s-triazine. ,
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 reregistration of 1,3,5-
triethylhexahydro-S'triazine. 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, (6) a list of registrants receiving this DCI (Attachment 5) and (7) the Cost Share and Data
Compensation Forms in replying to this 1,3,5-triethylhexahydro-s-triazine Product Specific Data
Call-in (Attachment 6). instructions and guidance accompany each form. .
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for 1,3,5-triethylhexahydro-
s-triazine are contained in the Requirements Status and Registrant's Response, Attachment 3. The
Agency has concluded that additional data on 1,3,5-triethylhexahydro-s-triazine are'needed for
specific products. These data are required to be submitted to the Agency within the time frame listed.
These data are needed to fully complete the reregistration of all eligible 1,3,5-triethylhexahydro-s-
triazine products.
- , " • *
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding this product specific data requirements and procedures
established by this Notice, please contact Jane Mitchell at (703) 308-8061.
to:
All responses to this Notice for the Product Specific data requirements should be submitted
Jane Mitchell
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
"Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: 1,3,5-Triethylhexahydro-s-triazine
65
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR .
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes." If you choose this
option, you will not have to provide the data required by the Data Call-in Notice and
you will not have to complete any other forms. Further sale and distribution of your
product after the effective date of cancellation must be hi accordance with the Existing
Stocks provision of the Data Call-in Notice (Section IV-C).
Item 6. Not applicable since this form calls in product specific data only. However, if your
product is identical to another product and you qualify for a data exemption, you
must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide the
EPA registration numbers of your source(s); you would 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.
Item 7a. 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." 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. See Item
6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory. ' •
NOTE: You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
66
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA
Item 1-3
Item 4. -
Item 5.
Item 6.
Item 7.
Item 8.
Item 9.
Completed by EPA. Note the unique identifier number assigned by EPA in Item
3. This number must be used in the transmittal document for any data
submissions in response to this Data Call-In Notice.
The guideline reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the
requirements specified in the 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, SubpartC. ,
The study title associated with the guideline reference number is identified.
The use pattern(s) of the pesticide associated with the product specific
requirements is (are) identified. For most product specific data requirements, all
use patterns are covered by'the data requirements. In the case of efficacy data, the
'required studies only pertain to products which have the use sites and/or pests '
indicated.
The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases. -
The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Registration Eligibility Document unless EPA
determines that a longer time period is necessary.
Enter only one of the following response codes for each data requirement to
show how you intend to comply with the data requirements listed hi this table.
Fuller descriptions of each option are contained in the Data Call-In Notice:
I will generate and submit data by the specified due date (Developing Data). 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. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
I have entered into an agreement with one or more registrants to develop data „
jointly (Cost Sharing). I am submitting a copy of this agreement. I understand
that this option is available only for acute toxicity or certain efficacy data and only
if EPA indicates in an attachment to this Notice that my product is similar enough
67
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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. By the
specified due date, I will also submit: (1) a completed "Certification With
Respect To Data Compensation Requirements'' form (EPA Form 8570-29) and
(2) two completed and signed copies of the Confidential Statement of Formula
(EPA Form 8570-4).
3. I have made offers to share in the cost to develop data (Offers to Cost Share). I
understand that this option is available only for acute toxicity or certain efficacy
data and only if EPA indicates in an attachment to this Data Call-In Notice that my
product is similar enough to another product to qualify for this option. 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 also submitting a
completed "Certification of Offer to Cost Share in the Development Data"
form. 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 (Section m-C.l.) apply as well. By the specified due
date, I will also submit: (1) a completed "Certification With Respect To Data
Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies of the Confidential Statement of Formula (EPA
Form 8570-4).
4. By the specified due date, 1 will submit an existing study that has not been
submitted previously to the Agency by anyone (Submitting an Existing Study). I
certify that this study will meet all the requirements for submittal of existing data
outlined in Option 4 in the Data Call-In Notice (Section m-C.l,) and will meet the
attached acceptance criteria (for acute toxicity and product chemistry data). I will
attach the needed supporting information along with this response. I also certify
that I have determined that this study will fill the data requirement for which I
have indicated this choice. By the specified due date, I will also submit a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) to show what data compensation option I have chosen.
By the specified due date, I will also submit: (1) a completed "Certification With
Respect To Data Compensation Requirements" form (EPA Form 8570-29) and
(2) two completed and signed copies of the Confidential Statement of Formula
(EPA Form 8570-4).
5. By the specified due date, I will submit or cite data to upgrade a study classified by
the Agency as partially acceptable and upgradable (Upgrading a Study). I will
submit evidence of the Agency's review indicating that the study may be upgraded
and what information is required to do so. I will provide the MRID or Accession
number of the study at the due date. I understand that the conditions for this
68
-------
6.
7.
option outlined Option 5 in the Data Call-In Notice (Section ITI-C.l.) apply. By
the specified due date, I will also submit: (1) a completed "Certification With
Respect To Data Compensation Requirements" form (EPA Form 8570-29) and
(2) two completed and signed copies of the Confidential Statement of Formula
(EPA Form8570-4).
By the specified due date, I will cite an existing study that the Agency has
classified as acceptable or an existing study that has been submitted but not
reviewed by the Agency (Citing an Existing Study). If 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,
ah identical product or a product which EPA 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 MRDD or
Accession number(s) for the cited data on a "Product Specific Data Report" form
or in a similar format. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
I request a waiver for this study because it is inappropriate for my product
(Waiver Request). I am attaching a complete justification for this request,
including technical reasons, data and references to relevant EPA regulations,
guidelines or policies. [Note: any supplemental data must be submitted in the
format required by P.R. Notice 86-5]. I understand that this is my only
opportunity to state the reasons or provide information in support of my request.
If the Agency approves my waiver request, I will not be required to supply the
data pursuant to Section 3(c)(2)(B) of FIFRA. If the Agency denies my waiver
request, I must choose a method of meeting 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
and Registrant's Response" Form indicating 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. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
Items 10-13. Self-explanatory.
NOTE:
You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant
details so that EPA can ensure that its records are correct.
69
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Attachment 4.
There is no tox batching for this RED because there are only two end use products
containing triethylhexahydrotriazine.
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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.
b.
c.
d.
e.
f.
g-
h.
i.
j.
k.
1.
m.
n.
All the blocks on the form must be filled in and answered completely.
If any block is not applicable, mark it N/A.
The CSF must be signed, dated and the telephone number of the responsible party
must be provided.
All applicable information which is on the product specific data submission must
also be reported on the CSF.
All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids..
Flashpoint must be in degrees Fahrenheit and flame extension in inches.
For all active ingredients, the EPA Registration Numbers for the currently
registered source products must be reported under column 12.
The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
common names for the trade names must be reported.
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.
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).
All the items under column 13.b. must total 100 percent.
All items under columns 14.a. and 14.b. for the active ingredients must represent
pure active form. '
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.
When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific formulation. ,
79
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82
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United States Environmental Protection Agency
Washington, D.C. 20460
Certification of Offer to Cost
Share in the Development of Data
Form Approved
OMB No. 2070-0106,
2070-0057
Approval Expires
3-31-99
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, PM-233, 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
• • I . •
Product Name ' .
4
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 firms on the following date(s)'
Name of Firm(s)
Certification: .
Date of Offer
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)
1) Replaces EPA form 8580 which is obselete
83
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84
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Form Approved
,OMB No. 2070-0107,
2070-0057
Approval Expires
3-31-99
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 reviewinq 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-233, U.S. Environmental Protection '
%£%%££ «,SL:.S'W" Waf h'ngton, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project
(2070-0106), Washington, DC 20503. •
. .1
Please fill in blanks below.
Company Name
Company Number
Product Name
EPA Reg. No.
I Certify that:
ci StUdy °?ed in SUPP°rt °f reqistration or reregistratiion wider-fee Federal Insecticide, Fungicide and Rodenticide Act
(FIFRAHhat is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
data submitter to cite that study.
2. That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study I am the
original data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writinq the
^T/Wri^S^Sl ' ha^f£d and have Offered t0: (a) Pay comPensation for those data in accordance with sections
3(o)(1 )(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
requirement of FIFRA and the amount of compensation due, if any. The companies I have notified are. (check one)
[ 1 The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached
Requirements Status and Registrants' Response Form,"
( '
3. That I have previously complied with section 3(c)(1 )(F) of FIFRA for the studies I have cited in support of registration or
reregistration under FIFRA. , ,
Signature
Date
Name and Title (Please Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the registration
reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
or
Signature
Date
Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
85
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86
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The following is a list of available documents for 1 i3,5-Triethylhexahydro-s-triazine that
my further assist you in responding to this Reregistration Eligibility Decision document.
These documents may be obtained by the following methods:
Electronic
File format: Portable Document Format (.PDF) Requires Adobe® Acrobat or compatible
reader. Electronic copies can be downloaded from the Pesticide Special
Review and Reregistration Information System at 703-308-7224. They also are
available using ftp on FTP.EPA.GOV, or using WWW (World Wide Web) on
WWW.EPA.GOV., or contact Nancy Tompkins at (703J-308-8013.
1.
PR Notice 86-5.
2. PR Notice 91-2 (pertains to the Label Ingredient Statement).
3. A full copy of this RED document.
4. A copy of the fact: sheet for 1,3,5-Triethylhexahydro-s-triazine.
The following documents are part of the Administrative Record for 1,3,5-
Triethylhexahydro-s-triazine and may included in the EPA's Office of Pesticide Programs
Public Docket. Copies of these documents are not available electronically, but may be
obtained by contacting the person listed on the Chemical Status Sheet.
1.
2.
Health and Environmental Effects Science Chapters.
Detailed Label Usage Information System (LUIS) Report.
The following Agency reference documents are not available electronically, but may be
obtained by contacting the person listed on the Chemical Status Sheet of this RED document.
1. The Label Review Manual.
2. EPA Acceptance Criteria
87
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