United Slates Prevention, Pesticides EPA738-R-8e-01t
Environm&nial Protacliort And Toxic Substances June 1S56
Agency (750SW) ,
4vEPA Re registration
Eligibility Decision (RED)
*Dibromodicyanobutane*
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United Slates Prevention, Pesticides
E nwon mantel Protection And Toxic S u bata nets
Agtncv {7506W) .
EPA-73S-F-96-CH1
June 1S56
»EBftJ R.E.D. FACTS
Pesticide
Registration
DIBROMODICYANO-
BUTANE
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} I9B4, be
reregistered to ensure that they meet today's more stringent standards.
In evaluating pesticides for reregi strati on, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environ mental 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 can be used
without posing unreasonable risks to human health or the environment,
a pesticide is eligible for reregistmion, EPA explains the basis
for its decision in a Reregi strati on Eligibility Decision (RED) document,
This fact sheet summarizes the information in the RED document for
i
reregi strati on case 2780, dibramodieyanobutEne.
U S 6 P TOf 1 1 8 D ibr am o di cy anot> utane ( 1 , 2-dib rom Q-2, 4 -di cy anob utan e) i s a
microbioeide^mierobiosiat used to control slime-forming bacteria ind fungi
in commercial /industrial water cooling systems (recirculatingX oil recovery
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Regulatory
History
Human Health
Assessment
drilling muds/packer fluids, pulp/paper mill water systems, secondary oil,
recovery rejection water, industrial adhesives and coalings,
resin/latex/polymer emulsions,, metal working cutting fluids, paints,
specialty industrial products (including fiber processing fly ids, waxes,
polishes and inks), and wet-end additives/industrial processing chemicals,
Formulations include soluble concentrates both liquid and solid, pellets and
tablets, Dibromodieyanobutane is applied by metering pump and chemical
pu mp, Th e use pr acii ce 1 i mi tati on s i nclud e NPDES permit restrict! on,
There are no residential products registered,
Bibrornodicyanobutane was first registered as a pesticide in the IX S,
in 1980, Data Call-ins were issued by the Agency in Much, 1987
(Antimicrobial Data Call-in) and during the Phase IV Reresistration process
in June of 1991. Currently eight products formulated with
dibrofnodiey&nobutane are registered by the Agency Indirect food additive
tolerances have been established for dibromodieyatiobutane as a
preservative in food grade adhesives (see 21 CFR § 175.105) and as a
slimicide in the manufacture in food grade paper and paperboard at a
maximum level of 0.005% of dry weight fiber (see 21 CFR § 176 3QG).
These tolerances are under the jurisdiction of the U,S, Food and Drug
Administration and are not directly regulated by EPA,
Toxic jty
In studies using laboratory animals, dibromodicyanobutane generally
has been shown tq be slightly lo practically non-toxic For acute toxicity and
has been placed in Toxicity Category HI, However, it is a severe eye
irritant and a human skin sensitizer. In sub chronic studies using
dibromodieyanobytane conducted in several mammalian species, no
unusual compound related effects were observed except for thyroid
follicular cell hyperplasia observed in the high dose group in dogs. This
finding was further studied in a. special study conducted at the lowest dose
tested in die dog study (4.8 mg/kg/day) While the thyroid effect was
considered significant by the oral route, dietary exposure to
d i brom odi cyan obutan e i s exp ected to be negl i gib I e, S e veral de vel oprn ental
toxicity studies showed no-compound-related external, visceral or skeletal
abnormalities. Dibromcdicyanobirtane was positive in one mutagenicity
assay, however, this positive finding was not confirmed in multiple other
mutagenicity studies,
Dietary Exposure
The use of dibromodicyanobutane as an indirect food additive to
adhesives or food grade paper and paperboard is expected to be negligible'.
There are no registered uses of dibromodicyanobulane directly on food,
therefore,, a dietary exposure and risk assessment are not applicable.
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Occupational and Residential Exposure
No toxicologies! endpoints of concern were determined for short-term
and intermediate term occupational/residential risk, except skin
serialization and eye irritation, A subchronic dermal toxieity study
indicated lhat dibromodieyanobulane is not absorbed via the dermal route
because no syslemic toxietty wai observed following repeated derrnaJ
application,
Human Risk Assessment
1
No sub chronic endpoints of concern were triggered for
dioroniodicyanobutane Its use pattern would not typically result in chronic
exposyre, and there are no registered direct fond uses, therefore, a dietary
exposure and risk assessment are not applicable.
No lexicological endpoints of concern., except for skin seiasitization
and eye Irritation from acute exposures, were identified for occupational
exposures- Therefore, an applicator exposure analysis and quantitative risk
assessment are not warranted. To protect occupational handlers
(mixers/I oaderg/applicators) from potential exposure, appropriate personal
protective equipment (PPE) will be required based on the acute toxieity
category of the end-use product.
Additionally, secondary occupational and residential handler
exposure from treated paint, ink and wax products Are not expected to
po se a signi ficant risk b ecau se of th e low eoncentrati on/di 1 u li on factor
associated with these products.
Environmental
Assessment Environmental Fate
Dibromodieyanobutaiie is expected to be very mobile and non-
persistent in aquatic and soil environments. Dissipation is expected to be
' \ ' controlled by rapid alkaline-catalyzed hydrolysis and microbialJy-mediated
degradation. However, there is little information on the identity and
en vi r on m etital b eh avi or of d egradales,
Ecological Effects
Dibromodicyanotutane is slightly toxic to avion species on an acute
oral and sub acute dietary basis. It is also moderately toxic to fish and
aquatic invertebrates on an acute basis. Because the fish studies conducted
in 1975 provided only supplemental information and were not upgradeable
to the current standards., a new freshwater acuie toxicity fish study in
bluegill sunfish has been required.
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Additional Data
Required
Product Labeling
Changes
Required
Ecological Effects Risk Assessment
Only a limited set of ecolexicology and environmental fate studies for
microbiocides such as dibromodieyanobutane are required, The
iaformallcMi available on ecological effects of dibramodicyanobutane
indicates slight toxicily to birds on an acute oral and sub acute dietary basis
and moderate toxicity to aquatic invertebrates and estuerin a/marine animals.
The chemical is expected to degrade rapidly in aquatic environments.
While the hazard to aquatic organisms has been characterized to a limited
extent, a quantitative risk assessment has not been conducted. The Agency
currently requires (hat labels for dibromodicyanobutane products specify
that discharges to aquatic environments must comply with NPDES
permitting requirements.
The generic data base supporting the reregistratian of
dibromodicyanobutane for; the above eligible uses has been reviewed and
determined to be substantially complete. No new additional studies on
dibromodicyanobutatie are being required at this time. However, additional
information about the identity of the hydrolysis degradates has been required
because hydrolysis appears to be the major-route of degradation,
The Agency is also requiring product-specific data including product
chemistry and acute toxicily studies, revised Confidential Statements of Formula,
and revised labeling for reregl strati on for product reregistration.
All dibromodicyanobutane end-use products must comply with EPA1»
current pesticide product labeling requirements. The Agency believes it is
prudent to require additional use precautions to afford product users increased
protection from unnecessary exposure to dibromodicyanobutane. For similar
reasons the Agency is retaining current worker and environmental restrictions and
precautions for risk reduction as specified below and in Section V of the
dibromodicyanobutane RED.
To remain in compliance with FH?RA_, manufacturing use product (MP)
labeling must be revised to comply with ail current EPA regulations, PR Notices
and applicable policies, The MP labeling must bear the following statement
under Directions for Use:
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" Only for formuiati on i nto a ml crobioci de/mi croM ostai/ bacteriostat
for use as an additive for industrial adhesives, emulsions, resinftitex
and polymer systems, metalworking cutting fluids, secondary oil
recovery injection water, doll ing muds, wet-end additives/industrial
processing chemicals^ specially industrial products (includes fiber
processing fluids, waxes, polishes, and inks), and latex and oil paints
(varnish applied film),
A MP registrant may, at his/her discretion add one of the following statements to
a MP label under "Directions for Use" ts? permit the reformulation of the product
for a specific use or all additional uses supported by a forrnulalor or .user group:
(a) "This product may be used to fcumulate products for specific
use(s) not listed on the MP label if the formulate:, user group,
or grower has complied with U.S. EPA submission requirements
regarding supp on of such u se(s)."
j
(b) "This product may be used to formulate products for any
additional use(s) not listed on the MP label if the formulator,
user group, or grower has complied with U.S. EPA submission
requ i rem cuts regarding support of such use(s)."
' Effluent Discharge Labeling Statements
"Do not use in facilities discharging directly or indirectly to the
esluaritie or marine environment.11
To reduce environmental risk from di bromod icy snob utane discharge and
disposal, product labels must include the statements pertaining to effluent
discharge under the NPDES permitting system (refer to PR Notice 93-10) and
disposal under any applicable federal laws after the above statement,
Personal Protective Equipment for Occupational Uses
The minimum handler labeling requirements for occupational uses of
dibromodkyanoburane end-use products is:
"Mixers, loaders, applicators and other handlers must wear;
' ' — Long-sleeve shirt and long pants, •
, — Shoes plus socks."
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If the end-use product is classified as taxi city category I or II for eye
irritation potential, add:
— "Protective eyewear."
If the end-use product is classified as toxicity category I or II for skin
irritation potential, add:
— "Ch em i pal-reaistant apron, and
— Chemical -resistant gloves'."
If the end-yse product is classified as toxicity category I or n for acute
mhilation toxicity, a respirator requirement must be added. The type of
respirator must be specified in the statement and is based on the acute toadcity
category and the vapor pressy re-
Tor the glove ffliilcment, use Ihe statement established far dibromodicyanobulanfi •
. ' through, the instructions in Supplement Three of Pft Notice 93-7. However, the'
. con-ossiveiiess and penetration of dibromodicyanobuiaiie must bs considered and
appropriate nhcmieal-resistant materials must be listed.
Placement in Labeling ' :
The personal protective equipment requirements must be placed on the end-
yse product labeling in the location specified in PR Notice 93-7, and the format
and language of the PPE requirements must be the same as is specified in PR
Notice 93-7,
The agency is requiring the following labeling statements to be located on
all end-use products containing dibromodicyanobuiane that are intended
primarily for occupational use.
Application Restrictions
"Do not use this product in a way that will contact workers or other
persons,"-
User Sftfctv Requirement?
Registrant; add the Following statements only if gloves or protective
eyewear are required PPE on the end-use product:
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"Follgw manufacturer's instructions for cleaning/maintaining PPE, If
no such instructions for washables, use detergent and hot water. Keep
and wash PPE separately from other laundry."
jfcer 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 iniide.
Then wash thoroughly and put on clean clothing,"
Registrant: add the following statements only if glo.ves ire required
PPE on the end-use prodnct;
- "Users should rern ove PPE immediately after handling this
product. Wash the outside of gloves before removing. As soon
as possible wash thoroughly,"
1 ' S kin S ens i tiger S ta tern ent
"This product may cause skin sen sitizati on, reactions in some people,"
Clarification of Oil Prilling Mud Use
To clarify the intent of the oil recovery drilling muds/packer fluids use (as
an aquatic or terrestrial non-food use pattern), the following statement must be
added to the labels for terrestrial non-food oil/gas drilling muds and picker fluids:
"For use In terrestrial wells only"
And the following statement must be added to the precantionary labeling:
"Do not apply in marine and/or estdarine oil fields "
The following statement must be added to ihe labels for aquatic nonrfood
industrial oil/gas drilling muds and packer fluids:
"For use in offshore.wells only."
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For use in both terrestrial and offshore oil/gas drilling muds and packer
fluids, the following statement must be added:
"TMs product may be used for terrestrial end off-shore oil/gas drilling
muds an d p acker ilui ds."
Additional Directions for Use
Registrants must specify on labeling the complete directions for use for
each use pattern: site of application, type of application, timing of application,
equipment used for application, and the rate of application (dosage),"
Reg ulatory The use of currently registered products containing
Conclusion dibromodlcy anobutane in accordance with approved 1 abeling will not pose
unreasonable risks or adverse effects to humans or the environment.
Therefore, all uses of these products are eligible for reregistrmtion,
Dlbromodicyariobutane products will be reregistered once the
required product-specific data, revised Confidential Statements of Formula,
and revised labeling are received and accepted by EPA.
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for dibromodieyanobutane 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 (7S06C), Office of
Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5SQ5,
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregistmion Information System
at 703-3 QS-7224, They also are available on the Internet on EPA's gopher
server, GOPHER.EPA.GOy, or using ftp on FTP.EPA.GOV, or using
WWW (World Wide Web) on WWW.EPA. GOV.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513^189-8190, fax 513-489-8695.
Following the comment period, the dibromodicyanobutane RED
document also will be available from the National Technical Information
Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone
703-487^1650.
For more information about EPA's pesticide reregistrati on program,
the dibromodicy anobutane RED, or reregi strati on of individual products
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containing dibromodicyatiobutene, please contact the Special Review and
ReregistraUon Division (7508W), 0PP3 US EPA, Washington, DC 2M6Q,
telephone 703-308-8000.
For information about the health effects of pesiicides., 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 ajid 7:30 pm Eastern Standard
Time, Monday through Friday.
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.
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
PREVENTION,
AND "TOXIC SUB6TANCE*
CERTIFIED MAE. ' . .
• ' JUL 24 1996
Dear Registrant:
I am pleased 10 announce that the Environmental Protection Agency has completed its
reregistraticm eligibility review and decisions on the pesticide chemical case l,2-dibromo-2,4-
dicyanobutane which includes the active ingredient dibromodkyanobulane. The enclosed
Reregistratioti Eligibility Decision (RED) contains the Agency's evaluation of the data base
of this chemical, ils 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 reregistratian. The RED includes the data and labeling requirements for
products for reregistration. It may also include requirements for additional dak (generic) on
[he active ingredient 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 end timely responses. The first sef of required responses is due 90 days from
the Etceipt of this letter. The second set of required responses Is due 8 iminthg from the
dale of this letter. Complete and timely responses will avoid the Agency taking ihe
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 Reregistralion Division representative
Emesl Jones at (703) 308-8069. Address any questions on required generic daia lo the
Special Review and Reregistration Division Tepresentative Yvonne Brown at 703-308-8073.
Sincerely yours.
: Lois Rossi, Division Director
- Special Review
and Reregistralion Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED1
1- DATA CALL-IN fDCI) OR "90-DAY RESPONSE"-If feneric data are required for '
reregislration, a DCI letter will &e enclosed describing such daia_ If product specific data are
required, a DC! 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 daia_ However, if you are an end-use product registrant only and have been
granted a generic data exemptiqn (GDB) by EPA, you are being sent only the product specific
response forms (2 forms) with the RED. Regis trants responsible tor generic data are being sent
response forms for boih generic and product specific data requirements (4 forms). You must
submit the appropriate response Forms (following the instructions provided) within 90
days of thja receipt of this RED/DC! letter; otherwise, your product may lie suspended.
2- TIME EXTENSIONS AND DATA WAIVER REOPESTS-No time extension requests .
will be granted for die 90-day response. Time extension requests may be submiiied only with
respect to actual daia submissions. Requests for lime 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 lime 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-MONT1T RESPONSE "-¥011 must
submit the following items for each product within eight months of the date of this letter
I RED issuance date).
' '&• Application for Rercgistration (EPA Form 8570-IX Use only an original
application form. Mark it "Application forRenegislraiion/ Send your Application for
Reregistradon (along with die other forms listed In b-e below) to the address listed in item 5.
bV FiTfe copies of draft labding which complies with the RBD ind 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 lelaied to reregistrailon) separately! You may, but are not
required to, delete uses which the .RED says are ineligible for reregistrarion. 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 formal which complies with
PR Notice 86-5, and/or submit citations of data already submitted and give the EPA identifier
(MRJD) numbers. Before citing these studies, you must make sure that they meat the
Agency's acceptance criteria (attached to the DCI),
d. Two copies of the Confidential Statement of Formula (GSF) for each basic and
each aJ.tenure foTrruiIatiofu The labeling and CSF which you submit for each product mast
comply with P,R, Notice 91-2 by declaring the active mgieffient as the nominal concentration.
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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 tlie analysis of five batches. If
you choose the second option, you must submit or cine the data for the five batches along with a
certification statement as described in 40 CFR §158.175(c). A copy of the CSF is enclosed;
follow the instructions on its back.
e- Certification With Respect to Data Compensation Requirements, Complete and
sig n EPA form 857 0-31 for each pro duct,
4- COMMENTS IN RESPONSE TOTEDERAL REGISTER NOnCE-Comments
penaining to Ihe 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 JffiSPONSESjf9D-PAYl AND*
APPLICATIONS FOR REKEGISTRATION ffl-MQNTH RESPONSES)
Pv U.S. Mail: • •
Document Processing Desk (HED-SHKD-PUB)
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 Pestidde Programs (75Q4C) ' .
Room 26SA, Ciysrai Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
& E.PA.!S REVIEWS—EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections, EIJA win try to respond to data waiver
and lime extension requests within 60 days, EPA will also try to respond to all 8-month
submissions with a final naregisoradon determination within 14 months afwr the RED has been
issued.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregi strati on eligibility review and decisions on the pesticide chemical case l,2-dibromo-2,4-
dicyanobutane which includes the active ingredient dibromodicyanobutane. The enclosed
Reregi strati on 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 reregi strati on. The RED includes the data and labeling requirements for products
for reregi strati on. It may also include requirements for additional data (generic) on the active
ingredient 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 date of
this letter. Complete and timely responses will avoid the Agency taking the enforcement action
of suspension against your products.
If you have questions on the product specific data requirements or wish to meet with the
Agency, please contact the Special Review and Reregi strati on Division representative Ernest
Jones at (703) 308-8069. Address any questions on required generic data to the Special Review
and Reregi strati on Division representative Yvonne Brown at 703-308-8073.
Sincerely yours,
Lois Rossi, Division Director
Special Review
and Reregi strati on Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1 DATA CALL-IN (PCD OR "90-DAY RESPONSE"-If generic data are required for
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 REOUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for 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 not
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).
d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal concentration.
-------
You have two options for submitting a CSF: (1) accept the standard certified limits (see 40 CFR
§158.175) or (2) provide certified limits that are supported by the analysis of five batches. If
you choose the second option, you must submit or cite the data for the five batches along with a
certification statement as described in 40 CFR §158.175(e). A copy of the CSF is enclosed;
follow the instructions on its back.
e. Certification With Respect to 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)
Bv U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data waiver
and time extension requests within 60 days. EPA will also try to respond to all 8-month
submissions with a final reregi strati on determination within 14 months after the RED has been
issued.
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REREGISTRATION ELIGIBILITY DECISION
DIBROMODICYANOBUTANE
LISTB
CASE 2780
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
DIBROMODICYANOBUTANE
REREGISTRATION ELIGIBILITY DECISION TEAM i
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Data Requirements 4
D. Estimated Usage of Pesticide 4
E. Regulatory History 4
III. SCIENCE ASSESSMENT 5
A. Physical Chemistry Assessment 5
B. Human Health Assessment 5
1. Toxicology Assessment 5
a. Acute Toxicity 5
b. Subchronic Toxicity 6
c. Developmental Toxicity 9
d. Mutagenicity 10
e. Metabolism 10
f. Chronic Toxicity/Carcinogenicity 11
2. Dose Response Assessment 11
a. Reference Dose (RfD) for Chronic Oral Exposure 11
3. Exposure and Risk Assessment 11
a. Dietary Exposure and Risk Assessment 11
b. Occupational and Residential Exposure and Risk Assessment
11
C. Environmental Assessment 12
1. Ecological Toxicity Data 12
a. Toxicity to Birds 12
b. Toxicity to Aquatic Animals 12
2. Environmental Fate 15
a. Environmental Fate Assessment 15
b. Environmental Fate and Transport 15
3. Exposure and Risk Characterization 17
a. Ecological Exposure and Risk Characterization 17
b. Endangered Species 17
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IV. RISK MANAGEMENT AND REREGISTRATION DECISION 18
A. Determination of Eligibility 18
B. Determination of Eligibility Decision 18
1. Eligibility Decision 18
2. Eligible and Ineligible Uses 19
C. Labeling Rationale/Risk Mitigation Measures 19
1. Handler Safety Requirements 19
2. Engineering Control Requirements for Occupational Handlers 20
3. Homeowner-Use Products 20
4. Post-Application Safety Requirements 21
5. Additional Labeling Requirements 21
V. ACTIONS REQUIRED OF REGISTRANTS 21
A. Manufacturing-Use Products 21
1. Additional Generic Data Requirements 21
2. Labeling Requirements for Manufacturing-Use Products 21
B. End-Use Products 22
1. Additional Product-Specific Data Requirements 22
Labeling Requirements for End-Use Products. 23
2 23
C. Existing Stocks 25
VI. APPENDICES 29
APPENDIX A. Table of Use Patterns Subject to Reregistration 31
APPENDIX B. Table of the Generic Data Requirements andStudies Used to
Make the Reregistration Decision 39
APPENDIX C. Citations Considered to be Part of the Data Base Supportig
the Reregistration of DIBROMODICYANOBUTANE 45
APPENDIX D. Product Specific Data Call-In 51
Attachment 1. Chemical Status Sheets 63
Attachment 2. Product Specific Data Call-In Response Forms (Fom
A inserts) Plus Instructions 67
Attachment 3. Product Specific Requirement Status and Registrant
Response Forms (Form B inserts) and Instructions 69
Attachment 4. EPA Batching of End-Use Products for Meeting Da*
Requirements for Reregistration 76
Attachment 5. List of All Registrants Sent This Data Call-In (inserjt
Notice 79
Attachment 6. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 80
APPENDIX F. List of Available Related Documents 86
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DIBROMODICYANOBUTANE
REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
Michele Cottrill
Frank Hernandez
Biological Analysis Branch
Economic Analysis Branch
Environmental Fate and Effects Assessment
Laura Dye
David Farrar
Jim Hetrick
Health Effects Assessment
Tom Campbell
Paul Chin
John Redden
Registration Support Risk Assessment
Sami Malak
Shyam Mathur
Rob Travaglini
Risk Management
Yvonne Brown
Kathleen Depukat
Ecological Effects Branch
Science Analysis and Coordination Staff
Environmental Fate and Groundwater Branch
Occupational and Residential Exposure Branch
Toxicology Branch I
Risk Characterization and Analysis Branch
Registration Support Branch
Registration Support Branch
Antimicrobial Program Branch
Accelerated Reregi strati on Branch
Accelerated Reregi strati on Branch
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE Acid Equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e. drinking water)
lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment, such as
a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FOB Functional Observation Battery
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
HOT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be expected to
cause death in 50% of test animals. It is usually expressed as the weight of substance per weight or volume
of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50% of the
test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as a weight
of substance per unit weight of animal, e.g., mg/kg.
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs.
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate contaminants
in drinking water under the Safe Drinking Water Act.
Hg/g Micrograms Per Gram
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A Not Applicable
NOEC No effect concentration
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
111
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GLOSSARY OF TERMS AND ABBREVIATIONS
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
SLN Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
FAO/WHO Food and Agriculture Organization/World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
EPA has completed its reregi strati on eligibility decision regarding the pesticide
dibromodicyanobutane, Case 2780. This decision includes a comprehensive reassessment of the required
target data base supporting the use patterns of currently registered products. Dibromodicyanobutane is
an microbiocide/microbiostat used in commercial/industrial water cooling systems, pulp/paper mill water
systems, oil recovery drilling muds and packer fluids, secondary injection water, industrial adhesives and
coatings, resin/latex/polymer emulsions, metal working cutting fluids, paints (in-can and applied film),
specialty industrial products and wet-end additives/industrial processing chemicals to control slime-
forming bacteria and fungi. The Agency has concluded that all products registered for all current uses,
with the limitations imposed herein, are eligible for reregi strati on.
Dibromodicyanobutane is a severe primary eye and dermal irritant classified in toxicity category
I. Dibromodicyanobutane is classified in toxicity category III or IV for all other measures of acute
toxicity. Subacute studies were conducted in several mammalian species. No unusual compound related
effects were observed except for thyroid follicular cell hyperplasia observed in the high dose group in
dogs. This finding was further studied in a special thyroid study conducted at the lowest dose tested in
the dog study (4.8 mg/kg/day). Several developmental toxicity studies showed no compound-related
external, visceral or skeletal abnormalities. Dibromodicyanobutane was positive in one mutagenicity
assay, however, this positive finding was not confirmed in multiple other mutagenicity studies.
Indirect food additive tolerances have been established by the Food and Drug Administration for
dibromodicyanobutane for use as a preservative in food grade adhesives and as a slimicide in the
manufacture of food grade paper and paperboard at a maximum level of 0.005% of dry weight fiber.
Any dietary exposure from these uses is expected to be negligible. Therefore, a dietary exposure and
risk assessment is not applicable.
The use of dibromodicyanobutane as a microbiocide requires only a limited set of ecotoxicity and
environmental fate data. These data indicate moderate toxicity to aquatic invertebrates and
estuarine/marine animals, but rapid degradation in aquatic environments is expected. Discharge of
industrial effluent containing dibromodicyanobutane residues to aquatic environments must comply with
the NPDES permitting requirements of the Office of Water.
A new freshwater fish acute toxicity study on dibromodicyanobutane is required at this time to
confirm EPA's risk assessment and conclusions and additional information is required to upgrade the
hydrolysis study. Product-specific chemistry, confidential statements of formula, and acute toxicology
studies in addition to amended product labels are required for product reregi strati on.
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended to
accelerate the reregi strati on of products with active ingredients registered prior to November 1, 1984.
The amended Act provides a schedule for the reregi strati on process to be completed in nine years. There
are five phases to the reregi strati on process. The first four phases of the process focus on identification
of data requirements to support the reregi strati on of an active ingredient and the generation and
submission of data to fulfill the requirements. The fifth phase is a review by the U.S. Environmental
Protection Agency (referred to as "the Agency") of all data submitted to support reregi strati on.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine whether
pesticides containing such active ingredient are eligible for reregi strati on" before calling in data on
products and either reregistering products or taking "other appropriate regulatory action." Thus,
reregistration involves a thorough review of the scientific data base underlying a pesticide's registration.
The purpose of the Agency's review is to reassess the potential hazards arising from the currently
registered uses of the pesticide; to determine the need for additional data on health and environmental
effects; and to determine whether the pesticide meets the "no unreasonable adverse effects" criterion of
FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of dibromodicyanobutane. The document consists of six sections. Section I is the
introduction. Section II describes dibromodicyanobutane, its uses, data requirements and regulatory
history. Section III discusses the human health and environmental assessment based on the data
available to the Agency. Section IV presents the reregistration decision for dibromodicyanobutane.
Section V discusses the reregistration requirements for dibromodicyanobutane. 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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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregi strati on Eligibility Decision:
• Common Name: l,2-dibromo-2,4-dicyanobutane (dibromodicyanobutane)
• Chemical Name: l-bromo-(bromoethyl)-l,3-propanedicarbonitrile
• CAS Registry Number: 35691-65-7
• OPP Chemical Code: 111001
• Manufacturer: Calgon Corp
• Empirical Formula: C6H6Br2N2
• Trade and Other Names: Tektamer 38
• Molecular Weight: 26580
• Structural Formula:
CH2Br
I
NC) )C ) )CH2 ) )CH2 ) )CN
I
Br
B. Use Profile
The following is information on the currently registered uses with an overview of use sites
and application methods. A detailed table of these uses of dibromodicyanobutane is in
Appendix A.
For dibromodicyanobutane:
Type of Pesticide: Microbiocide/microbiostat (slime-forming bacteria and fungi).
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Use Sites: AQUATIC NON-FOOD INDUSTRIAL:
Commercial/Industrial Water Cooling Systems (recirculating)
Oil Recovery Drilling Muds/Packer Fluids*
Pulp/Paper Mill Water Systems
Secondary Oil Recovery Injection Water*
TERRESTRIAL NON-FOOD:
Oil Recovery Drilling Muds/Packer Fluids*
INDOOR NON-FOOD:
Adhesives, Industrial
Coatings, Industrial
Emulsions, Resin/Latex/Polymer
Metalworking Cutting Fluids
Paints, Latex (In-Can)
Paints, Latex/Oil/Varnish (Applied Film)
Specialty Industrial Products (includes fiber processing fluids, waxes,
polishes, and inks)
Wet-End Additives/Industrial Processing Chemicals
Registrants must specify on labels, as per Section V of this document, whether the product
is used on off-shore and/or terrestrial sites.
Target Pests: Slime-forming bacteria and fungi.
Formulation Types Registered:
TYPE: End use, Manufacturing use
FORM: Soluble concentrate/liquid, soluble concentrate/solid,
pelleted/tableted.
Method and Rates of Application:
EQUIPMENT: Metering pump, Chemical pump, Not specified
(registrant must specify on labeling).
TYPES OF
TREATMENT: Water treatment, Water treatment (recirculating
system), Industrial preservative treatment,
Preservative treatment, Make-up fluids treatment.
METHOD AND
RATE: Aquatic Non-Food Industrial -
5 to 1898 ppm active ingredient.
Terrestrial Non-Food -
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243 to 585 ppm active ingredient.
Indoor Non-Food -
50 to 3060 ppm active ingredient.
Up to 39200 ppm active ingredient for
metalworking cutting fluid concentrates.
TIMING: Continuous feed (initial), Continuous feed
(subsequent), Initial, Subsequent/maintenance,
Intermittent (slug)(subsequent), Shock/slug, During
manufacture, Not specified (registrant must specify
on labeling).
Use Practice Limitations: NPDES permit restriction.
C. Data Requirements
In addition to data requirements imposed to obtain the original registration of this active
ingredient, the Agency issued an Antimicrobial Data Call-In notice in March, 1987, for toxicity
and exposure data for this active ingredient and other antimicrobials. Data were also required in
the reregi strati on Phase IV Data Call-In issued on June 14, 1991. Appendix B includes all data
requirements identified by the Agency for currently registered uses needed to support
reregi strati on.
D. Estimated Usage of Pesticide
Of all the dibromodicyanobutane sites listed in the use profile, only one in-house source
from the late 1980s showed relatively low levels of annual usage. According to that proprietary
database, the biocide has a significant share of the adhesive market, while the use in paints or
paper is relatively minor.
E. Regulatory History
Pesticide products containing the active ingredient dibromodicyanobutane, (1,2-dibromo-
2,4-dicyanobutane), which is sold under its trade name of Tektamer 38, was first registered in the
United States in 1980. The primary use for this chemical is as a preservative in various aqueous
industrial applications and as a microbiocide in pulp and paper mill systems and industrial
cooling tower systems. The various acceptable industrial applications for this chemical as a
preservative include adhesives, oil recovery waters and muds, coatings, metalworking cutting
fluids, paints, plastic products, and emulsions. There are currently eight Tektamer 38 products
registered by the Agency to one registrant.
An indirect food additive tolerance has been established for dibromodicyanobutane
in food grade adhesives (see 21 CFR § 175.105). Current labeling allows the adhesive
for use only as a preservative. A tolerance also exists for the use of
dibromodicyanobutane as a slimicide in the manufacture of food grade paper and
paperboard at a maximum level of 0.005% of dry weight fiber (see 21 CFR § 176.300).
This area is under the jurisdiction of the U.S. Food and Drug Administration and is not
directly regulated by EPA.
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III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
TGAI: 1,2-dibromo-2,4-dicyanobutane
Color: Yellowish white
B.
Physical State:
Odor:
Melting Point:
Density:
Solubility:
Granular solid
Slightly sweet
52.2-53.2°C
0.970 g/ml at 20°C
Water: 0.212 g/100 ml
Organic solvents: No data provided
Vapor Pressure: 6.70 x 10'3 Pascal at 25°C
Octanol/Water
Partition
Coefficient:
Stability:
Storage
stability:
10.52orlog(10.52)= 1.022
The chemical was found to be stable when subjected to Al, Sn, Ni,
Fe, thermal and photosensitivity tests.
One year storage at room temperature did not produce any
significant change regarding purity, color, specific gravity, and
refractive index.
Human Health Assessment
1. Toxicology Assessment
a. Acute Toxicity
Acute toxicity values and categories for dibromodicyanobutane are
summarized in Table 1.
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TABLE 1 - ACUTE TOXICITY VALUES - Dibromodicvanobutane Technical
GUIDELINE
STUDY
TEST RESULT
TOXICITY
CATEGORY
81-1
Acute Oral - Rat MRID 41885501
(Technical 99.9%)
LD50 = 0.77 g/kg (M); 0.515 g/kg (F)
III
81-2
Acute Dermal - Rabbit
MRIDs 00027554 (Technical 98%)"
LD50 > 5 g/kg
IV
81-3
Acute Inhalation - Rat
MRID 00025846 (Technical 98%)*
Acute Inhalation - Rat
MRID 42526401
(Technical 99.9%)
LC50>5.09mg/L
LC50> 13.09mg/L
IV
IV
81-4
Primary Eye Irritation - Rabbit
MRID 00025848 (Technical 98%)'
Severe irritant
81-5*
Primary Dermal Irritation - Rabbit
MRIDs 00025847, 41885502 (Technical
98%)*
Severe irritant
81-6*
Dermal Sensitization - guinea pig MRID
00105188 (Technical 98%)*
Dermal Sensitization - Human
MRID 43183801 (Technical 98%)*
Not a skin sensitizer.
N/A
A skin sensitizer.
N/A
"XP-38 liquid formulation consisting of technical 98%
"This study is a requirement for manufacturing-use and end-use products (40 CFR 158).
The acute oral LD50 of dibromodicyanobutane in rats is 0.77 g/kg in males
and 0.515 g/kg in females placing it in Toxicity Category III for acute oral toxicity
(MRID 41885501). The acute dermal LD50 in rabbits is > 5 g/kg placing
dibromodicyanobutane in Toxicity Category IV for acute dermal toxicity (MRID
00027554). Two acute inhalation studies are available for dibromodicyanobutane.
The LC50 for both studies placed dibromodicyanobutane in Toxicity Category IV
for acute inhalation toxicity (MRIDs 00025846 and 42526401).
Dibromodicyanobutane is a Toxicity Category I primary eye and dermal irritant
in rabbits (MRIDs 00025847 and 41885502). Dibromodicyanobutane is a skin
sensitizer in humans, but not in Guinea pigs (MRIDs 00105788 and 43183801).
All cited studies satisfy the acute toxicity data requirements for
dibromodicyanobutane.
b. Subchronic Toxicity
In a subchronic oral toxicity study, dibromodicyanobutane (purity
unspecified) was administered to Sprague-Dawley rats exposed in utero
(10/sex/group) in the diet at dose levels of 0, 83.5, 500 and 3000 ppm (6.3, 37, and
275 mg/kg/day for males and 7.5, 43, and 360 mg/kg/day for females) seven days
before mating and throughout the 14-day mating, gestation, and lactation periods.
-------
Forty (20/sex) of the weanling offspring (Fl rats) receiving each dosage level were
randomly selected for use at the corresponding dosage level in the 90-day phase
of the study. After 13 weeks the Fx rats were necropsied and tissues preserved.
There were no compound related effects in mortality, clinical signs,
hematology, clinical chemistry, organ weights, ophthalmoscopic findings,
urinalysis, and gross pathology. Treatment related changes in the incidence of
histopathological findings were observed in the spleen only. There was a dose-
related increase in severity of splenic extramedullary hematopoiesis. The
severities were elevated (over control values) in the mid-dose group in males and
in the high-dose group in both sexes.
The NOEL is 6.3 mg/kg/day for males and 7.5 mg/kg/day for females. The
LOEL is 37 mg/kg/day for males and 43 mg/kg/day for females based on
increased severity in splenic extramedullary hematopoiesis in Fx males and
increased pituitary weight and pituitary to body weight ratio in Fx females. Effects
were seen at the high-dose group in both sexes of the Fx animals included
significant decrease in body weight, decrease in brain weight, increase in pituitary
weight, increase in pituitary to body weight ratio and pituitary to brain weight
ratio, increase in spleen to body weight ratio, and splenic hematopoiesis. In
addition, males showed a significant increase in liver to body weight ratio and
significant decrease in testes with epididymides weight and testes with
epididymides to brain weight ratio and females showed an increase in thyroid
weight and increase in thyroid to body weight ratio.
The pup weight gains on days 1-21 in both sexes of the low and mid-dose
groups were 20-25% and 10% higher than controls, respectively. However, the
weight gain in both sexes of the high-dose group were 32-36% lower than
controls. This study does not satisfy the current requirements for a 2-generation
reproduction study, but does satisfy the guideline requirement for a subchronic
oral study (GDLN 82-1) in rats (MRID 00055028).
In another subchronic oral toxicity study, dibromodicyanobutane was
administered in the diet to groups of 4-6 beagle dogs/sex at concentrations of 0,
10, 100, or4000ppm [males: 0, 0.288, 3.1, or 102 mg/kg/day; females: 0, 0.331,
3.11, or 119 mg/kg/day] for 3 months. A 3-month recovery phase followed using
2 dogs/sex at 0, 100 or 4000 ppm of the test material.
Treatment-related effects of dibromodicyanobutane were seen in the high-
dose group in both males and females. One male was euthanized in extremis on
Day 40. There were decreases in food consumption and body weights. Changes
were observed in hematology, clinical chemistry, urological parameters, gross and
microscopic pathology. In addition, hypertrophy/hyperplasia was observed in the
thyroid gland, axonal degeneration was seen in the brain and spinal cord, anemia
triggered bone marrow responses, and seminiferous tubule degeneration was seen
in the testis of male dogs. After the 3-month recovery period, a less severe form
of axonal degeneration was seen.
The LOEL for females was 3.11 mg/kg/day (100 ppm) based on clinical
7
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signs of diarrhea and emesis and the LOEL for males was 102 mg/kg/day (4000
ppm, the highest dose tested). The NOEL is 0.331 mg/kg/day (10 ppm) for
females and 3.1 mg/kg/day (100 ppm) for males. This study satisfies the
guidelines for a subchronic oral toxicity study (GDLN 82-1) in dogs (MRIDs
00055027 and 92199020).
In a third subchronic toxicity feeding study, beagle dogs (4/sex/group)
were dosed with dibromodicyanobutane in the diet at doses of 0, 167, 1000 and
4000 ppm (males: 0, 4.8, 28.9, and 101.5 mg/kg/day; females: 0, 5.3, 37.7, and
109.8 mg/kg/day] for three months. A NOEL was not attained in the study. In
this study the LOEL was considered to be 167 ppm (4.8 mg/kg/day, the lowest
dose tested) based on a dose-related increase in absolute and relative thyroid
weights in males. The LOEL for females was 167 ppm (5.3 mg/kg/day) based on
relative ovary weights. Thyroid follicular cell hyperplasia was observed at the
high dose in both sexes. (MRIDs 00055027 and 92199020).
A special study was conducted to determine the effect of the exposure to
dibromodicyanobutane on the thyroid hormones triiodothyronine (T3) and
thyroxine (T4) in dogs. In this "3-month" subchronic toxicity feeding study,
beagle dogs (4/sex/group) were dosed with dibromodicyanobutane in the diet at
doses of 0 and 167 ppm (0 and 4.8 mg/kg/day). The dose used in this study (167
ppm) is the low-dose of the 3-month dietary study in dogs described in the
preceding paragraph. The NOEL was less than 4.8 mg/kg/day (the only dose
tested). Both sexes of animals showed increased levels of thyroid stimulating
hormone-stimulated T3 and T4 and enlarged thyroids. However, thyroid weights
and organ/body weight ratios were significantly increased in females. While this
study showed significant thyroid effects via the oral route, dibromodicyanobutane
is a non-food use chemical and exposure is not expected by the oral route. This
study provided supplemental information and was supportive of the previous two
subchronic studies in dogs (MRID 43540501).
In a 21-day dermal toxicity study, Wistar rats (5/sex/dose) received
repeated dermal applications of" Tektamer 38" moistened in distilled water at 0
(vehicle control), 1000, 2000 or 4000 mg/kg, 6 hours/day, 5 days/week for 21
consecutive days. Treatment-related dermal reactions were moderate to severe
eschar, moderate to severe erythema and edema, necrosis and pale areas and
discoloration of the treated site. Dermal reactions were so severe at all dose levels
a NOEL for this effect was not determined. Histopathology confirmed the in-life
dermal reactions and were characterized as severe necrosis of the epidermis,
dermis and cutaneous muscularis. In 4/5 males and 5/5 females necrosis was
accompanied by severe leukocytic inflammation beneath the layer of necrotic
cutaneous muscularis. In spite of the severe dermal reactions, no systemic toxicity
was seen. Treatment had no adverse effect on survival, clinical signs, body
weight, body weight gain, or food consumption. There was some evidence that
the high dose may have contributed to the slight but consistent decreases seen in
hematocrit, hemoglobin, RBC and platelet values and the slight increases in the
absolute and relative liver and kidney weights. The hematological and organ
weight changes are not considered to be lexicologically significant due to lack of
in-life toxicity as well as supportive histopathological lesions in the liver, kidneys,
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or the hematopoietic system. The systemic toxicity NOEL is equal to or greater
than 4000 mg/kg/day (the highest dose tested). The dermal toxicity NOEL was
not established. The dermal toxicity LOEL is equal to or less than 1000
mg/kg/day (lowest dose tested). This study satisfies the data requirement (GDLN
82-2) for a 21-day dermal toxicity study in rats (Cerven, 1990).
c. Developmental Toxicity
A developmental toxicity study was conducted with Sprague-Dawley rats.
Dibromodicyanobutane (98% a.i.) was administered by oral gavage to rats (28-30
rats/group) daily on gestation days (GD) 6 through 15 at 0, 25, 100, or 175
mg/kg/day. Surviving dams were sacrificed on GD 20, necropsied and
reproductive status recorded. The maternal NOEL and LOEL are 25 mg/kg/day
and 100 mg/kg/day, respectively, based on significant decrease in body weight
change corrected for gravid uterine weight. The corrected body weight change
was 65% and 53% of the controls at 100 and 175 mg/kg/day, respectively. There
were no mortalities among dams. Among dams at high dose, dyspnea (11 vs 0 in
controls), hypoactivity (3 vs 0 in controls), and staining of the mouth (4 vs 0 in
controls) were reported. There was essentially no change in mean fetal weight
with respect to dose.
There were no compound-related external, visceral or skeletal variations
or malformations in dibromodicyanobutane treated fetuses in comparison to
controls on either a litter or fetal basis. The developmental toxicity NOEL is 175
mg/kg/day (the highest dose tested). Although total number of dams with
resorptions was 6, 12, 10, and 14 at 0, 25, 100, and 175 mg/kg/day, respectively,
there was no statistically significant decrease in litter size accompanying the
increased resorptions. Also, statistical analysis of the number of litters with one
or more resorptions in each group indicates a marginally significant pairwise
difference at the highest dose tested (175 mg/kg/day; 6/25 vs. 14/28, p=0.047).
In addition, there was no statistically significant dose-related trend. These reasons
plus the presence of significant maternal toxicity (i.e., maternal weight gain
decrements) at the two highest doses suggests that the resorption results are not
clearly associated with potential developmental toxicity of the test material
(MRTDs 0126562 and 92199012). This study satisfies the guideline requirement
for a developmental toxicity (GDLN 83-3) in rats.
In another developmental toxicity study, dibromodicyanobutane (100%
a.i.) was administered by oral gavage to presumed pregnant New Zealand White
(Hra: (NZW)SPF) rabbits (20/dose) at doses of 0, 10, 30, or 60 mg/kg/day on GDs
6 through 18. One doe from the 30 mg/kg/day dose group was found dead on GD
25. From the 60 mg/kg/day dose group, one doe was sacrificed moribund due to
intubation error. Two does from the control group aborted on Gds 24 and 28.
None of these findings were considered to be treatment-related. None of the
clinical and necropsy findings were treatment-related in the above mentioned does
or in those sacrificed at termination.
Decreases in maternal body weight gain occurred during Gds 6-9 at 60
mg/kg/day. Decreases in food consumption were seen during Gds 6-9 and Gds
-------
9-12 at 60 mg/kg/day. For both of these parameters, there were no statistically
significant decreases when the entire dosing interval (Gds 6-19) for each was
compared to those of the controls. Therefore, these effects were not considered
to be treatment-related. After cesarean section, no treatment-related findings were
seen during external and internal morphological examination. There were no
treatment-related skeletal, visceral or external abnormalities. Based on the results
of this study, the maternal and developmental toxicity NOEL is 60 mg/kg/day, the
highest dose tested. This study satisfies data requirements [GDLN 83-3(b)] for a
developmental toxicity study in rabbits (MRID 43540502).
d. Mutagenicity
Following is a summary of the mutagenic potential of dibromo-
dicyanobutane. These studies were negative for mutagenic effects except in an in
vitro Chinese Hamster Ovary (CHO) assay. While the in vitro CHO assay study
was positive, neither the in vivo cytogenetics assay in rats nor the UDS study
confirmed this finding. The data requirements for mutagenicity testing are
fulfilled.
Dibromodicyanobutane was not mutagenic in S. typhimurium strains
TA100, TA1535, TA1537, TA1538, and TA98 and E. coli (WPuvrA) up to
viability limits of 100 //g/ml (activated) and 20 //g/ml (non-activated) (MRID
259455). At doses of 12.5, 75.0, and 450 mg/kg/day dibromodicyanobutane did
not produce dominant lethal mutations in male mice (MRID 00055029).
Dibromodicyanobutane did not produce increases in chromosome aberrations (was
not mutagenic) in the in vivo cytogenetics assay in the rat at doses up to 50
mg/kg/day (MRID 00125850). In CHL fibroblasts at the HGPRT locus at up to
cytotoxicity limits of 50 //g/ml (activated) and up to 1 //g/ml (nonactivated),
dibromo-dicyanobutane was not mutagenic (MRID 00144412).
Dibromodicyanobutane did not induce unscheduled DNA synthesis (UDS)
up to 100 //g/ml (activated) and 10 //g/ml (non-activated) for IMR-90 human
embryonic fibroblasts (MRID 00137288). Lastly, in an in vitro Chinese Hamster
Ovary cells assay at moderately cytotoxic doses of 11.0 //g/ml (non-activated) and
at 190 /-ig/ml (activated), dibromodicyanobutane produced significant frequencies
of chromosome aberrations were produced (MRID 00128134).
e. Metabolism
The metabolism of 14C-dibromodicyanobutane was studied in male CD rats
following a single oral administration of 50 mg/kg 14C-dibromo-dicyanobutane
(labeled in the butane core of the molecule). Total recovery of radioactivity
during the 7 day collection period in the urine, feces, and respired 14C-CO2 was 84-
91%, 6-10%, and 0.5% of the administered dose, respectively. Tissue assay
showed that 7 days after administration organs contained relatively greater
concentrations of compound including the lung (2.7 ppm), liver (2.5 ppm),
kidneys (2.3 ppm), and spleen (2.3 ppm). Maximum blood concentration (71
//g/ml) of dibromodicyanobutane equivalent is attained at 5 hours post-
administration. On the basis of percent dose per whole organ, each of these
10
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retentions is calculated to be less than 0.1%, except for liver at 0.3%. Although
numerous deficiencies were noted, this study provides supplemental information.
Since the compound is rapidly absorbed and excreted, most of the radioactivity in
the urine was found during the first 24 hours post-administration (MRID
00055031).
f. Chronic Toxicity/Carcinogenicity
Chronic data are not required for non-food use chemicals unless the
subchronic studies indicate NOELs which trigger endpoints of concern or if
exposure to the chemical is chronic in nature. No subchronic endpoints of concern
were triggered for dibromodicyanobutane and its use pattern would not be chronic
in nature, therefore, no chronic data are required.
2. Dose Response Assessment
a. Reference Dose (RfD) for Chronic Oral Exposure
At a meeting of the Office of Pesticide Program's RfD/Peer Review
Committee, the Committee recommended not to establish a Reference Dose (RfD)
because there are no food uses for this chemical.
3. Exposure and Risk Assessment
a. Dietary Exposure and Risk Assessment
As discussed in the Regulatory History in Section HE. above, indirect food
additive tolerances have been established for dibromodicyanobutane for use as a
preservative in food grade adhesives and as a slimicide in the manufacture of food
grade paper and paperboard at a maximum level of 0.005% of dry weight fiber.
These uses are under the jurisdiction of the U.S. Food and Drug Administration
and not directly regulated by the EPA. Any potential dietary exposure to
dibromodicyanobutane from these uses is expected to be negligible. Therefore,
a dietary exposure and risk assessment is not applicable.
b. Occupational and Residential Exposure and Risk Assessment
An occupational and/or residential exposure assessment is appropriate for
an active ingredient if (1) certain toxicological criteria are triggered and (2) there
is potential exposure to handlers (mixers/loaders/ applicators) during use or to
persons entering treated sites after application is complete.
Neither a short-term (1 to 7 days) nor an intermediate term (7-90 days)
occupational/residential risk assessment is required, since results of the 21-day
dermal toxicity study indicate that dibromodicyanobutane is not absorbed via the
dermal route because no systemic toxicity was observed following repeated
dermal application at doses of 0, 1000, 2000 or 4000 mg/kg/day. For systemic
toxicity, the NOEL was greater than 4000 mg/kg/day (the highest dose tested).
Since toxicology endpoints of concern, except for skin sensitization and eye
11
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irritation from acute exposures, were not identified for occupational and residential
exposures, an occupational and residential mixer/loader/applicator exposure
analysis and quantitative risk assessment is not warranted at this time.
Additionally, secondary occupational and residential handler exposure
from treated paint, ink and wax products will not pose a significant risk because
of the low concentration/dilution factor associated with these products.
C. Environmental Assessment
1. Ecological Toxicity Data
The ecotoxicological data base is adequate for a limited characterization of toxicity
to nontarget terrestrial and aquatic organisms when the chemical is used as an indoor,
aquatic industrial, or terrestrial nonfood microbiocide or microbiostat. While the acute
toxicity studies in fish are not acceptable to fulfill the required guidelines, they do provide
supplemental information. An additional freshwater fish acute toxicity study has been
required to complete the target data base. This study is due to the Agency in March of
1997.
a. Toxicity to Birds
(1)
Birds, Acute and Subacute
One single-dose oral (LD50) study on one species (preferably
mallard or bobwhite quail) and one subacute dietary (LC50) study on one
species of waterfowl (preferably the mallard duck) or one species of
upland game bird (preferably the bobwhite quail or ring-necked pheasant)
are required to establish the toxicity of a microbiocide to birds. The results
of these studies indicate that dibromodicyanobutane is slightly toxic to
avian species on an acute oral and subacute dietary basis. The guideline
requirements (71-1 and 71-2) are fulfilled (MRIDs 77315, 77316).
Table 2: Avian Toxicity Findings
Species
Avian Acute Oral
Toxicity Study - Mallard Duck
Avian Subacute
Dietary Toxicity - Bobwhite Quail
% A.I.
98
98
Finding
LD50 =
1064mg/kg
LC50 =
4042 ppm
MRID No.
Author/Year
77315
R. Fink
1975
77316
R. Fink
1975
Toxicity
Category
Slightly
Toxic
Slightly
Toxic
Fulfills Guideline
Requirement?
Yes
Yes
b. Toxicity to Aquatic Animals
(1) Freshwater Fish Acute and Chronic
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One freshwater fish toxicity study using the technical grade of the
active ingredient is required to establish the toxicity of a microbiocide to
freshwater fish. The study should use a cold water species (preferably the
rainbow trout) or a warm water species (preferably the bluegill sunfish).
The results indicate that dibromodicyanobutane is moderately toxic to fish
on an acute basis. These studies, conducted in 1975, were not adequate to
fulfill the guideline requirements, but they provide supplemental
information (MRTD 63850). A new freshwater fish acute toxicity study is
required to complete the data base. This study was required in a letter to
the registrants dated March 7, 1996 and the data is due to the Agency in
March 1997.
Additionally, data from a fish early life-stage test are not required,
however, a study has been submitted and reviewed. The no observed
effect level (NOEL) is 0.75 ppm and the lowest observed effect level
(LOEL) is 1.0 ppm. The maximum allowable toxicant concentration
(MATC) level for reproduction impairment and developmental effects is
0.87 ppm. The guideline requirement (72-4) is fulfilled (MRID
41986701).
Table 3: Acute and Chronic Aquatic Toxicity Findings
Species
Freshwater Fish
Acute Toxicity -
Rainbow Trout
Freshwater Fish
Acute Toxicity -
Bluegill Sunfish
Fish Early Life-
Stage Toxicity -
Rainbow Trout
% A.I.
98
98
99.85
Findings
LC50 =
1.75 ppm
LC50 =
4.09 ppm
NOEL =
0.75 ppm
LOEL =
1.0 ppm
MATC =
0.87 ppm
MRID No.
Author/Year
63850
Bentley
1975
63850
Bentley
1975
MRID 41986701
Toxicity Category/
Endpoints Affected
Moderately Toxic
Moderately Toxic
Percent Survival
Fulfills
Guideline
Requirement?
No
No
Yes
(2)
Freshwater Invertebrates Acute and Chronic
A freshwater aquatic invertebrate toxicity test using the technical
grade of the active ingredient is normally required to assess the toxicity of
a microbiocide to freshwater invertebrates. Two studies were submitted,
reviewed and were found individually to be deficient, but when evaluated
together, these studies provided good dose response curves, correlated well
when adjusted to the active ingredient, and were sufficient to fulfill the
guideline requirement (GDLN 72-2) (MRIDs 63851 and 70890).
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Data from an aquatic invertebrate life-cycle test using Daphnia
magna are not required; however, a study was submitted and reviewed.
The NOEL is 1.4 ppm. The MATC level for reproduction impairment and
development effects is between 1.4 and 2.6 ppm. The guideline
requirement (72-4) is fulfilled (MRID 41885304).
Table 4: Aquatic Invertebrate Acute and Chronic Toxicity Findings
Species
Daphnid Acute
Toxicity -
Daphnia magna
Daphnid Acute
Toxicity -
Daphnia magna
Invertebrate Early Life-
Stage Chronic Toxicity
Daphnid
Daphnia magna
% A.I.
98
10
99.85
Findings*
EC50 =
2.16 ppm
EC50 =
3.10 ppm
NOEL =
1.4 ppm
MATC
>1.4&<2.6
MRID No.
Author/Year
63851
LeBlanc
1977
70890
LeBlanc
1978
41885304
Ward & Boeri
1991
Endpoints Affected
Moderate toxicity
Moderate toxicity
Percent survival
Fulfills
Guideline
Requirement?
Yes
Yes
Yes
Acute toxicity values are adjusted to active ingredient
(3) Estuarine and Marine Animals
Acute toxicity testing with estuarine and marine organisms (fish,
shrimp, and oyster embryo/larva or oyster shell deposition) using the
technical grade of the active ingredient is no longer required for
microbiocides; however, data were submitted and reviewed. Preferred test
organisms for estuarine/marine acute toxicity testing are the sheepshead
minnow, mysid shrimp, and Eastern oyster. The results indicate moderate
toxicity to estuarine/marine animals on an acute basis. The guideline
requirement (72-3) is fulfilled (MRIDs 41885301, 41885302 and
41885303).
Table 5: Estuarine/Marine Acute Toxicity Findings
Species
Eastern oyster
(embryo-larvae)
Mysid shrimp
Sheepshead minnow
% A.I.
99.85
99.85
99.85
LC50/EC50 (ppm)
2.6
2.8
8.3
MRID No.
Author/Year
ACC#
41885302
Ward & Boeri
1991
ACC#
41885303
Ward & Boeri
1991
ACC#
41885301
Ward & Boeri
1991
Toxicity Category
Moderately toxic
Moderately toxic
Moderately toxic
Fulfills
Guideline
Requirement?
Yes
Yes
Yes
2.
Environmental Fate
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a. Environmental Fate Assessment
A tentative qualitative environmental fate assessment can be made based
on available environmental fate and transport data. Studies have been submitted
and found to be supplemental, for hydrolysis (GDLN 161-1), aerobic aquatic
metabolism (GDLN 162-4), and leaching and absorption/desorption (GDLN 163-
1).
Dissipation is expected to be controlled by alkaline-catalyzed hydrolysis
and microbially-mediated degradation. The chemical was found to be rapidly
degraded in flooded sandy loam soil (half life under 0.864 days). The hydrolytic
half-life was 190 days at pH 5, 24.11 days at pH 7, and 12.67 days at pH 9. The
degradates cis and trans isomers of l-bromo-2,4-dicyano-l-butene and 2-
methylene-glutaronitrile were identified in the hydrolysis and aerobic aquatic
metabolism studies. These degradates appear to be precursors to more stable
unidentified degradates.
The chemical was found to be very mobile (Kd < 1) in soil and aquatic
environments. No mobility data are available for the degradates. No field studies
are required to support the current uses.
The chemical is expected to be very mobile and non-persistent in aquatic
and soil environments. However, there is little information on the identity and
environmental behavior of degradates. There are no metabolism data on
dibromodicyanobutane's rate and route of degradation in neutral and acidic
environments. However, rapid degradation was observed in an aerobic aquatic
metabolism study, and in soil slurries in a batch equilibrium study.
b. Environmental Fate and Transport
Hydrolysis (GDLN 161-1) is the only guideline data requirement for
reregi strati on of this chemical (or pesticides in general with aquatic non-food
industrial uses and regulated discharge under NPDES permits and indoor uses.
The submitted study was not completely acceptable because degradation products
making up over 10% of the applied chemical have not been identified. Since this
sole data requirement is supported by supplemental data, the study must be
upgraded. The identity of hydrolysis degradates is needed because hydrolysis
appears to be a major route of degradation. The information is required to be
submitted to the Agency by July 31, 1996.
The registrant has submitted studies of aerobic aquatic metabolism and
adsorption-desorption. These studies are not required for uses subject to the
reregistration decision, but provide supplemental information on metabolism and
mobility in aquatic systems.
(1) Degradation
15
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Hydrolysis (GDLN 161-1) A single study has been submitted. It
is not completely acceptable because of inadequate identification of
degradates. The registrant has been required to provide the Agency with
upgraded information on the identity of degradates at concentrations
greater than 10% of the applied dose.
In the study submitted, radiolabeled "Tektamer 38", at
concentrations of 10 and 40 |ig/ml, was incubated in buffer solutions at
25 °C. Half-life measurements were 190 to 198 days at pH 5, 24 to 72.8
days at pH 7, and 12.6 to 14.0 days at pH 9. In similar incubations at
45°C, "Tektamer 38" had hydrolysis half-lives ranging from 96.2 to 123
days at pH 5, 10.7 to 13 days at pH 7, and 0.6 to 0.8 days at pH 9.
The first-order degradation model fit the data poorly, suggesting
degradation mechanisms other than hydrolysis. The major hydrolysis
degradate of "Tektamer 38" was identified as trans-l-bromo-2,4-
dicyanobutene. Hydrolysis degradates were tentatively identified as cis-1-
bromo-2,4-dicyanobutene and methylene glutaronitrile. Degradates were
detected with Rf 0.00 and 0.42 but were not identified. The information
available suggests that degradation is dependent on alkaline catalyzed
hydrolysis (MRID 55032).
Aerobic Aquatic Metabolism (GDLN 162-4). A single study has
been submitted. The study was not acceptable to fulfill the guideline
requirements because of inadequate identification of degradates. The
study, while supplemental, may be upgraded with submission of
information on identity of degradates at concentrations greater than 10%
of the applied dose. These data are not a guideline requirement for
dibromodicyanobutane's use pattern, but provide supplemental
information.
Radiolabeled "Tektamer 38" at an initial concentration of 10 jig/g
had a half-life of 0.874 days in flooded sandy loam soil. Intermediate
degradates were identified as 2-methleneglutaronitrile, making up 21.4%
of the initial measured dose at 12 hours post-treatment in soil and water
extracts, and (E) and (Z) isomers of l-bromo-2,4-dicyano-l-butene,
making up no more than 0.439% of the initial measured dose at 2 days
post-treatment in water extracts. Unidentified degradates (Rf=0.01 and
Rf=0.0 to 0.05) were also detected (79% of initial measured dose) in soil
and water extracts. A volatile degradate making up 10% of the initial
measured dose was identified as CO2. These results suggest that
degradation is rapid in sandy loam soil flooded with alkaline water. The
mechanisms of degradation appear to be controlled by alkaline catalyzed
hydrolysis and microbially mediated processes (MRID 41883901).
(2) Mobility
Leaching. Adsorption-Desorption (GDLN 163-1). A single unaged
batch equilibrium study was submitted that provides supplemental data
16
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because desorption coefficients were not reported and exaggerated
desorption was observed in the study. Aged mobility studies would be
needed to fulfill the aged portion of the data requirement. This study is not
a data requirement for this chemical's use pattern, but provides
supplemental information.
Radiolabeled "Tektamer 38", at 0.1 to 1.0 |ig/ml, had Freundlich
coefficients of 0.264 (Koc=528; l/n=1.331) in a sand, 0.351 (J^ =87.8;
l/n=1.046) in a sandy loam soil, 0.474 (Koc=72.9; l/n=0.9963) in a clay
loam soil, and 0.701 (Koc=33.4; l/n=1.086) in a silt loam soil. "Tektamer
38" degradation was observed during a 2-hour equilibration period. The
degradates (E) and (Z) isomers of l-bromo-2,4,dicyano-l-butene were
detected (6.16 to 75% of applied) by HPLC. Desorption coefficients were
not reported. However, the mean percent desorption of "Tektamer 38" was
125% for a sand, 107% for a sandy loam soil, 148% for a clay loam soil,
and 126% for a silt loam soil. These results suggest that the chemical will
be mobile in aquatic and soil environments (MRID 41883902).
3. Exposure and Risk Characterization
a. Ecological Exposure and Risk Characterization
The Agency requires only a limited set of ecotoxicology and environmental
fate studies for microbiocides. The information available indicates that
dibromodicyanobutane is slight toxic to birds on an acute oral and subacute
dietary basis and moderately toxic to aquatic invertebrates and estuarine/marine
animals. Dibromodicyanobutane is expected to degrade rapidly in aquatic
environments. A freshwater fish acute toxicity study has been required to
complete the data base.
The oil-related aquatic uses (oil recovery drilling muds/packer fluids,
secondary oil recovery injection water) are expected to result in minimal to no
exposure if proper procedures are employed in the disposal of the contaminated
materials.
While the hazard to aquatic organisms from dibromodicyanobutane has
been characterized, a quantitative risk assessment has not been conducted.
Discharge of industrial effluent containing dibromodicyanobutane residues to
aquatic environments must comply with NPDES permitting requirements of the
Office of Water..
b. Endangered Species
The Agency does not anticipate any exposure of concern to aquatic animals
and wildlife, providing that all dibromodicyanobutane products are handled and
applied as specified in the product labeling and that discharges to the environment
comply with all Federal disposal laws and NPDES.
17
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IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether products containing the active ingredient
are eligible for reregi strati on. The Agency has previously identified and required the submission
of the generic (i.e. active ingredient specific) data required to support reregi strati on of products
containing dibromodicyanobutane as an active ingredient. The Agency has completed its review
of these generic data, and has determined that the data are sufficient to support reregi strati on of
all products containing dibromodicyanobutane. Appendix B identifies the generic data
requirements that the Agency reviewed as part of its determination of reregi strati on eligibility of
dibromodicyanobutane, and lists the submitted studies that the Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess the
registered uses of dibromodicyanobutane and to determine that dibromodicyanobutane can be
used, as specified in this document, without resulting in unreasonable adverse effects to humans
and the environment. The Agency, therefore, finds that all products containing
dibromodicyanobutane as the active ingredient are eligible for reregi strati on. The reregi strati on
of particular products is addressed in Section V of this document.
The Agency made its reregi strati on eligibility determination based upon the target data
base required for reregistration, the current guidelines for conducting acceptable studies to
generate such data, published scientific literature, and the data identified in Appendix B.
Although the Agency has found that all uses of dibromodicyanobutane 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
dibromodicyanobutane, if new information comes to the Agency's attention or if the data
requirements for registration (or the guidelines for generating such data) change.
B. Determination of Eligibility Decision
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient
dibromodicyanobutane, the Agency has sufficient information on the health effects of
dibromodicyanobutane and on its potential for causing adverse effects in fish, wildlife and
the environment. The Agency has determined that dibromodicyanobutane 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 dibromodicyanobutane for all uses are eligible
for reregistration.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of dibromodicyanobutane, as specified
in this document, are eligible for reregistration.
18
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C. Labeling Rationale/Risk Mitigation Measures
1. Handler Safety Requirements
During reregistration, the Agency is reviewing existing worker protection
requirements for all occupational and residential uses.
a. Personal Protective Equipment for Occupational Use Products
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.
Just as the Agency developed standardized requirements for agricultural
workers with the implementation of the Worker Protection Standard (WPS) in
1994, it is now developing standardized requirements for occupational handlers
of industrial biocides since the Personal Protective Equipment requirements
developed for agricultural workers generally do not reflect the same kind of
exposures found in industrial use settings. The handler PPE requirements are
based on the acute toxicity characteristics of each end-use product. Comments on
these requirements should be addressed during the public comment period for
dibromodicyanobutane.
For occupational use products, the Agency has determined that handlers
(mixers/loaders/applicators, etc.) of all industrial biocides must wear long-sleeve
shirts, long pants and shoes and socks as minimum work attire. For industrial
biocide end-use products that are classified as toxicity category I or II for acute
dermal or skin irritation/sensitization, the Agency is requiring handlers to wear
chemical resistant gloves and an apron in addition to the minimum work attire.
For end-use biocide products classified as toxicity category I or II for eye
irritation, handlers must wear protective eyewear. For industrial biocide end-use
products classified as toxicity category I or II for acute inhalation toxicity,
handlers are required to wear a respirator. The type of respirator must be
established based on the acute toxicity category and the vapor pressure and must
be specified on the end-use product labeling.
19
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Table 6 - Personal Protective Work Attire for Industrial Biocide Handlers (Mixers/Loaders/Handlers)
Acute Dermal
Toxicity or
Skin Irritation
Potential
Eye Irritant
Acute
Inhalation
Toxicity
Toxicity
Category I
Long Sleeves
Long Pants
Shoes & Socks
Chemical
Resistant
Gloves &
Apron
Protective
Eyewear
Respirator
Toxicity
Category II
Long Sleeves
Long Pants
Shoes &
Socks
Chemical
Resistant
Gloves &
Apron
Protective
Eyewear
Respirator
Toxicity
Category III
Long Sleeves
Long Pants
Shoes & Socks
No minimum
No minimum
Toxicity
Category IV
Long Sleeves
Long Pants
Shoes & Socks
No minimum
No minimum
The Agency has determined that no active-ingredient-specific handler
safety requirements must be established due to the acute or other adverse effects
of dibromodicyanobutane. The handler safety requirements for end-use products
containing dibromodicyanobutane must be determined based on the acute toxicity
characteristics of the end-use product.
2. Engineering Control Requirements for Occupational Handlers
Primary Occupational Handlers: At this time, there are no engineering control
requirements, such as closed systems, currently required on labeling for end-use products
containing dibromodicyanobutane. None are being required as a result of the
reregi strati on evaluation of dibromodicyanobutane uses.
Secondary Occupational Handlers: At this time, the Agency believes that risks
from skin and eye sensitization would be acceptable without additional handler safety
requirements for secondary occupational handlers, since the dibromodicyanobutane in
such products as paints, inks and waxes is very diluted, usually far less than one percent.
3.
Homeowner-Use Products
All dibromodicyanobutane end-use pesticide products are intended only for
occupational use. The Agency believes that risks from skin and eye irritation secondary
occupational/homeowner handlers to such products as paints, inks and waxes containing
dibromodicyanobutane, would be acceptable without additional handler safety
requirements as any dibromodicyanobutane in these products is very diluted, usually far
less than one percent.
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4. Post-Application Safety Requirements
At this time, the Agency believes that risks from the skin and eye irritation
potential of dibromodicyanobutane would be acceptable for primary post-application
occupational exposures without additional human safety requirements, since post-
application skin and eye contact with the treated substances in commercial and industrial
settings is likely to be slight. At this time, EPA also believes that risks from the skin and
eye irritation potential of dibromodicyanobutane would be acceptable for secondary post-
application occupational and homeowner exposures without additional human safety
requirement, since the dibromodicyanobutane in such products as paint, waxes, and ink
is very diluted, usually far less than one percent and post-application skin and eye contact
with such products is likely to be minimal. Since the dibromodicyanobutane is classified
as toxicity category IV for acute inhalation toxicity, the Agency believes, at this time, that
risks from post-application inhalation exposure without a respirator requirement would
be acceptable.
5. Additional Labeling Requirements
The Agency is requiring specific label language addressing application restrictions,
user safety requirements and recommendations and skin sensitization. The label language
can be found in Section V.
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for the reregi strati on of both
manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregi strati on of dibromodicyanobutane for
the above eligible uses has been reviewed and determined to be substantially complete.
The hydrolysis study was upgradeable supplemental data. The registrant has been
required to provide the identity of the hydrolysis degradates because hydrolysis appears
to be the major route of degradation. This information is due to the Agency by July 31,
1996. Also, a freshwater fish acute toxicity study has been required and is due to the
Agency by March 31, 1997.
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 microbiocide/microbiostat/bacteriostat for use as an
additive for industrial adhesives, emulsions, resin/latex and polymer systems,
metalworking cutting fluids, secondary oil recovery injection water, drilling muds,
wet-end additives/industrial processing chemicals, specialty industrial products
21
-------
(includes fiber processing fluids, waxes, polishes, and inks), and latex and oil
paints.
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
complied with U.S. EPA submission requirements regarding support of
suchuse(s)."
Effluent Discharge Labeling Statements
Product labeling must include the statements pertaining to effluent discharge under
the NPDES permitting program (refer to PR Notice 93-10):
"Do not discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans or other waters unless in accordance with the requirements of a
National Pollutant Discharge Elimination system (NPDES) permit and the
permitting authority has been notified in writing prior to discharge. Do not
discharge effluent containing this product to sewer systems without previously
notifying the local sewage treatment plant authority. For guidance contact your
State Water Board or Regional Office of the EPA."
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 should be cited according to the instructions in the Requirement Status and
Registrants Response Form provided for each product.
22
-------
Labeling Requirements for End-Use Products
a. Occupational Labeling PPE Requirements for Pesticide Handlers
Sole-acti
2. ve ingredient end-use products that contain dibromo-dicyanobutane must be
revised to adopt the personal protective equipment requirements set forth in this
section. Any conflicting PPE requirements on their current labeling must be
removed.
Multiple-active-ingredient end-use products that contain dibromo-
dicyanobutane must compare the handler personal protective equipment
requirements, if any, set forth in this section to the PPE requirements on their
current labeling and retain the more protective.
Any necessary PPE for each dibromodicyanobutane 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 requirement for occupational uses of
dibromodicyanobutane end-use products are:
"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, add:
— "Protective eyewear."
If the end-use product is classified as toxicity category I or II for skin
irritation potential, add:
— "Chemical-resistant apron, and
— Chemical-resistant gloves*."
If the end-use product is classified as toxicity category I or II for acute
inhalation toxicity, a respirator requirement must be added. The type of respirator
must be specified in the statement and is based on the acute toxicity category and
the vapor pressure.
*For the glove statement, use the statement established for dibromodicyanobutane
through the instructions in Supplement Three of PR Notice 93-7. However, th e
corrosiveness and penetration of dibromodicyanobutane must be considered an d
appropriate chemical-resistant materials must be listed.
23
-------
Placement in Labeling
The personal protective equipment requirements must be placed on
the end-use product labeling in the location specified in PR Notice 93-7,
and the format and language of the PPE requirements must be the same as
is specified in PR Notice 93-7.
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 dibromodicyanobutane that are intended primarily
for occupational use.
Application Restrictions
"Do not use this product in a way that will contact workers or other
persons."
User Safety Requirements
Registrant: add the following statements only if gloves or protective
eyewear are required PPE on the end-use product:
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no
such instructions for washables, use detergent and hot water. Keep and
wash PPE separately from other laundry."
User Safety 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."
Skin Sensitizer Statement
"This product may cause skin sensitization reactions in
some people."
24
-------
Clarification of Oil Drilling Mud Use
To clarify the intent of the oil recovery drilling muds/packer fluids
use (as an aquatic or terrestrial non-food use pattern), the following
statement must be added to the labels for terrestrial non-food oil/gas
drilling muds and packer fluids:
"For use in terrestrial wells only"
And the following statement must be added to the precautionary labeling:
"Do not apply in marine and/or estuarine oil fields."
The following statement must be added to the labels for aquatic
non-food industrial oil/gas drilling muds and packer fluids:
"For use in offshore wells only."
For use in both terrestrial and offshore oil/gas drilling muds and
packer fluids, the following statement must be added:
"This product may be used for terrestrial and off-shore oil/gas
drilling muds and packer fluids."
Additional Directions for Use
Registrants must specify on labeling the complete directions for use
for each use pattern: site of application, type of application, timing of
application, equipment used for application, and the rate of application
(dosage)."
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling for 26
months from the date of the issuance of this Reregi strati on Eligibility Decision (RED). Persons
other than the registrant may generally distribute or sell such products for 50 months from the
date of the issuance of this RED. However, existing stocks time frames will be established
case-by-case, depending on the number of products involved, the number of label changes, and
other factors. Refer to "Existing Stocks of Pesticide Products; Statement of Policy"; Federal
Register. Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell dibromo-
dicyanobutane 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.
25
-------
26
-------
VI. APPENDICES
27
-------
28
-------
Report Run Date: 10/20/95 ) Time 12:59
PRD Report Date: 06/16/95
Case 2780[Dibromodicyanobutane]
LUIS 2.2 - Page:
APPENDIX A REPORT
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Chemical 111001[1,2-Dibromo-2,4-dicyanobutane]
14444444444444444444444444444444444444444
Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI un- Rate (AI Tex. ® Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED
ADHESIVES, INDUSTRIAL
Industrial preservative treatment, During SC/L
manufacture, Not on label, Not
Applicable, Not applicable for this use
COATINGS, INDUSTRIAL
Industrial preservative treatment, During SC/L
manufacture, Not on label, Not
Applicable, Not applicable for this use
COMMERCIAL/INDUSTRIAL WATER COOLING SYSTEMS
Water treatment (recirculating system), SC/L
Not on label, Not on label, Not
Applicable, Not applicable for this use
Use Group: INDOOR NON-FOOD
W 250 * NS NS NS NS NS
SC/L
SC/L
SC/L
SC/L
SC/L
SC/S
SC/S
W
W
W
W
W
W
W
95
100
100
102
119
98
100
W
W
W
W
W
W
W
1520
1000
2500
1530
1898
1960
2500
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Use Group: INDOOR NON-FOOD
W 250 * NS NS NS
SC/L
SC/L
SC/S
W 100
W 190
W 100
W 2500
W 712
W 2500
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 1898 * NS NS NS NS NS
CIS, C24
CIS, C24
C12
C12, CIS
CIS, C24
CIS, C24
CAH
C12, CIS
CIS, C24
C12, CIS
CIS, C24
C12, CIS
A08, CIS, C24
29
-------
Report Run Date: 10/20/95 ) Time 12:59
PRD Report Date: 06/16/95
Case 2780[Dibromodicyanobutane]
LUIS 2.2 - Page:
APPENDIX A REPORT
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Chemical 111001[1,2-Dibromo-2,4-dicyanobutane]
14444444444444444444444444444444444444444
Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI un- Rate (AI Tex. ® Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
EMULSIONS, RESIN/LATEX/POLYMER
Industrial preservative treatment, During SC/L
manufacture, Not on label, Not
Applicable, Not applicable for this use
Use Group: INDOOR NON-FOOD
W 250 * NS NS NS
SC/L
SC/L
SC/L
SC/L
SC/L
SC/S
W
W
W
W
W
W
95
100
100
102
119
98
W
W
W
W
W
W
1520
500
260
510
1898
490
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
METALWORKING CUTTING FLUIDS
Industrial preservative treatment, During SC/L
manufacture, Metering pump, Not
Applicable, Not applicable for this use
Industrial preservative treatment, During SC/L
manufacture, Not on label, Not
Applicable, Not applicable for this use
Use Group: INDOOR NON-FOOD
W 760 * NS NS NS
SC/L
SC/L
SC/L
SC/L
SC/L
SC/S
W
No
W
W
W
W
255
Calc
95
250
255
196
W 1020
No Calc
W 760
W 1000
W 1020
W 39200
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CIS, C24
CIS, C24
C12
C12, CIS
CIS, C24
CIS, C24
CAH
CIS, C24
CIS, C24
C12, CIS
CIS, C24
C12
CIS, C24
CAH
30
-------
Report Run Date: 10/20/95 ) Time 13:00
PRD Report Date: 06/16/95
Case 2780[Dibromodicyanobutane]
4444444444444444444444444444444444444
SITE Application Type, Application
Timing, Application Equipment )
LUIS 2.2 - Page:
APPENDIX A REPORT
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Chemical 111001[1,2-Dibromo-2,4-dicyanobutane]
Form(s) Min. Appl.
Rate (AI un-
less noted
otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI Tex. ® Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
(days) Interv Codes
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle
/crop
cycle
/year
[day(s)]
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
METALWORKING CUTTING FLUIDS (con't)
Preservative treatment, Not on label,
Metering pump, Not Applicable, Not
applicable for this use
SC/L
Preservative treatment, Not on label, Not SC/L
on label, Not Applicable, Not applicable
for this use
OIL RECOVERY DRILLING MUDS/PACKER FLUIDS
Make-up fluids treatment, Initial, Not on SC/L
label, Not Applicable, Not applicable for
this use
No Calc
Use Group: INDOOR NON-FOOD (con't)
W 949 * NS NS NS NS NS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
No Calc * NS NS NS NS NS
CIS, C24
CIS, C24
Make-up fluids treatment,
Subsequent/maintenance, Not on label, Not
Applicable, Not applicable for this use
SC/L
SC/S
SC/L
SC/L
SC/S
V 243
No Calc
No Calc
V 293
No Calc
V 485
No Calc
No Calc
V 585
No Calc
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Make-up fluids treatment, Initial, Not on SC/L No Calc
label, Not Applicable, Not applicable for
this use
SC/L V 243
SC/S No Calc
Use Group: TERRESTRIAL NON-FOOD CROP
No Calc * NS NS NS NS
V 485 * NS
No Calc * NS
NS
NS
NS NS NS
NS NS NS
NS
NS
CIS, C24
C12
C12
CIS, C24
C12
CIS, C24
C12
-------
Report Run Date: 10/20/95 ) Time 13:00
PRD Report Date: 06/16/95
Case 2780[Dibromodicyanobutane]
4444444444444444444444444444444444444
SITE Application Type, Application
Timing, Application Equipment )
LUIS 2.2 - Page:
APPENDIX A REPORT
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Chemical 111001[1,2-Dibromo-2,4-dicyanobutane]
Form(s) Min. Appl.
Rate (AI un-
less noted
otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI Tex. ® Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
(days) Interv Codes
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle
/crop
cycle
/year
[day(s)]
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
OIL RECOVERY DRILLING MUDS/PACKER FLUIDS (con't)
Make-up fluids treatment, SC/L
Subsequent/maintenance, Not on label, Not
Applicable, Not applicable for this use
SC/L
SC/S
PAINTS (IN-CAN)
Industrial preservative treatment, During SC/L
manufacture, Not on label, Not
Applicable, Not applicable for this use
SC/L
SC/L
SC/S
PAINTS, LATEX/OIL/VARNISH (APPLIED FILM)
Industrial preservative treatment, During SC/L
manufacture, Not on label, Not
Applicable, Not applicable for this use
SC/L
PULP/PAPER MILL WATER SYSTEMS
Water treatment, Continuous feed SC/L
(initial), Metering pump, Not Applicable,
Not applicable for this use
Water treatment, Continuous feed
(subsequent), Metering pump, Not
Applicable, Not applicable for this use
SC/L
No Calc
V 293
No Calc
W 190
W 255
W 196
No Calc
Use Group: TERRESTRIAL NON-FOOD CROP (con't)
No Calc * NS NS NS NS NS NS
V 585 * NS NS NS
No Calc * NS NS NS
Use Group: INDOOR NON-FOOD
W 760 * NS NS NS
W 712 * NS
W 765 * NS
W 784 * NS
NS
NS
NS
NS
NS
NS
NS NS
NS NS
NS NS
NS NS
NS NS
Use Group: INDOOR NON-FOOD
No Calc * NS NS NS NS NS
W 750 * NS NS NS NS NS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 50 * NS NS NS NS NS
NS
NS
NS
NS
NS
CIS, C24
C12
CIS, C24
CIS, C24
CIS, C24
CAH
C12, CIS
A30, CIS, C24
A30, CIS, C24
32
-------
Report Run Date: 10/20/95 ) Time 13:00
PRD Report Date: 06/16/95
Case 2780[Dibromodicyanobutane]
4444444444444444444444444444444444444
SITE Application Type, Application
Timing, Application Equipment )
LUIS 2.2 - Page:
APPENDIX A REPORT
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Chemical 111001[1,2-Dibromo-2,4-dicyanobutane]
Form(s) Min. Appl.
Rate (AI un-
less noted
otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI Tex. ® Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
(days) Interv Codes
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle
/crop
cycle
/year
[day(s)]
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
PULP/PAPER MILL WATER SYSTEMS (con't)
Water treatment, Initial, Not on label,
Not Applicable, Not applicable for this
use
Water treatment, Intermittent
(slug)(subsequent), Metering pump, Not
Applicable, Not applicable for this use
SC/L
SC/L
SC/S
SC/L
Water treatment, Not on label, Not on SC/L
label, Not Applicable, Not applicable for
this use
Water treatment, Subsequent/maintenance,
Not on label, Not Applicable, Not
applicable for this use
SECONDARY OIL RECOVERY INJECTION WATER
Water treatment, Intermittent
(slug)(subsequent), Metering pump, Not
Applicable, Not applicable for this use
Water treatment, Shock/slug, Metering
pump, Not Applicable, Not applicable for
this use
SC/L
SC/L
SC/S
SC/L
SC/L
W 120
W 30
W 5
W 40
W 10
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 50 * NS NS NS NS NS NS
W 200 * NS NS
W 50 * NS NS
W 50 * NS NS
W 1898 * NS NS
W 50 * NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
W 200 * NS NS NS NS NS
W 50 * NS NS NS NS NS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 494 * NS NS NS NS NS
W 496 * NS NS
NS
NS
NS NS NS NS
A08, C12, CIS
C12, CIS
A08, C12, CIS
A30, CIS, C24
A08, CIS, C24
A08, C12, CIS
C12, CIS
A08, C12, CIS
CIS, C24
SC/S
W 487 * NS NS
NS NS NS NS
-------
Report Run Date: 10/20/95 ) Time 13:00
PRD Report Date: 06/16/95
Case 2780[Dibromodicyanobutane]
LUIS 2.2 - Page:
APPENDIX A REPORT
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Chemical 111001[1,2-Dibromo-2,4-dicyanobutane]
14444444444444444444444444444444444444444
Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI un- Rate (AI Tex. ® Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
SPECIALITY INDUSTRIAL PRODUCTS
Industrial preservative treatment, During SC/L
manufacture, Not on label, Not
Applicable, Not applicable for this use
No Calc
Use Group: INDOOR NON-FOOD
No Calc * NS NS NS
WET-END ADDITIVES/INDUSTRIAL PROCESSING CHEMICALS
Industrial preservative treatment, During SC/L
manufacture, Not on label, Not
Applicable, Not applicable for this use
SC/L
SC/L
SC/L
SC/L
SC/S
[EMICAL£
SC/L
SC/L
SC/L
SC/L
SC/L
SC/S
SC/S
W
W
W
W
W
!>
W
W
W
W
W
W
W
95
100
102
119
98
50
95
100
102
750
98
100
W 760 *
W 1000 *
W 3060 *
W 949 *
W 2940 *
Use Group
W 250 *
W 2135 *
W 2500 *
W 255 *
W 1500 *
W 196 *
W 2500 *
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
: INDOOR NON- FOOD
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C12, CIS
CIS, C24
C12
CIS, C24
CIS, C24
CAH
CIS, C24
CIS, C24
C12, CIS
CIS, C24
C12
CAH
C12, CIS
34
-------
Report Run Date: 10/20/95 ) Time 13:01
PRD Report Date: 06/16/95
Case 2780[Dibromodicyanobutane]
LUIS 2.2 - Page: 7
APPENDIX A REPORT
Chemical 111001[1,2-Dibromo-2,4-dicyanobutane]
LEGEND
444444
Sort: Uses Eligible or Ineligible for Re-registration, Food/Feed or Non-Food/Non-Feed Uses, Alpha Site Name, Use Group Name, Alpha Application Type/Timing/Equipment
Description, Formulation, Maximum Application Rate Unit/Area Quantity, Minimum Application Rate, Maximum Number of Applications at Maximum Rate, Maximum Dose per Crop
Cycle or per Year, Minimum Interval Between Applications (Days), Restricted Entry Interval (Days), Allowed/Disallowed Geographical Areas, Use Limitations Codes.
HEADER ABBREVIATIONS
Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Microbial claims only.
noted otherwise)
Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.
noted otherwise)
Soil Tex. Max. Dose
Max. # Apps © Max. Rate
Max. Dose [(AI unless
noted otherwise)/A]
Min. Interv (days)
Restr. Entry Interv (days)
PRD Report Date
Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3
years" is expressed as "4/3 yr"
Maximum dose applied to a site over a single crop cycle or year. System calculated.
Minimum Interval between Applications (days)
Restricted Entry Interval (days)
LUIS contains all products that were active or suspended (and that were available from OPP Document Center) as of this date. Some products
registered after this date may have data included in this report, but LUIS does not guarantee that all products registered after this date have
data that has been captured.
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C : Coarse
M : Medium
F : Fine
O : Others
FORMULATION CODES
SC/L : SOLUBLE CONCENTRATE/LIQUID
SC/S : SOLUBLE CONCENTRATE/SOLID
ABBREVIATIONS
AN : As Needed
NA : Not Applicable
NS : Not Specified (on label)
UC : Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet,
briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part,
parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, --
APPLICATION RATE
DCNC
No Calc
W
V
U
cwt
nnE-xx
Dosage Can Not be Calculated
No Calculation can be made
PPM calculated by weight
PPM Calculated by volume
Unknown whether PPM is given by weight or by volume
Hundred Weight
nn times (10 power -xx); for instance, "1.234E-04" is equivalent to ".0001234"
-------
Report Run Date:
PRD Report Date:
10/20/95
06/16/95
) Time 13:01
- Page:
APPENDIX A REPORT
Case 2780[Dibromodicyanobutane]
USE LIMITATIONS CODES
Chemical 111001[1,2-Dibromo-2,4-dicyanobutane]
A08
A30
C12
CIS
C24
CAH
Preclean claim.
Preclean for heavily soiled areas.
Do not apply in marine and/or estuarine, oil fields, or discharge effluent into lakes, streams, ponds or public water. (NPDES license restriction)
Do not discharge effluent containing this pesticide into sewage systems without notifying the sewage treatment plant authority (POTW).
Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or public water. (NPDES license restriction)
Do not discharge into lakes, streams, ponds, or public water unless in accordance with NPDES Permit.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
GEOGRAPHIC CODES
CA : California
36
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregi strati on for active ingredients
within the case DIBROMODICYANOBUTANE covered by this Reregi strati on Eligibility Decision
Document. It contains generic data requirements that apply to DIBROMODICYANOBUTANE in all
products, including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in which they
appear in 40 CFR Part 158. the reference numbers accompanying each test refer to the test protocols set
in the Pesticide Assessment Guidelines, which are available from the National Technical Information
Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this column
lists the identifying number of each study. This normally is the Master Record Identification (MRID)
number, but may be a "GS" number if no MRID number has been assigned. Refer to the Bibliography
appendix for a complete citation of the study.
37
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38
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Dibromodicyanobutane
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1
6 1-2 A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-7
63-8
63-9
63-10
63-11
63-13
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
Stability
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
42592801
42592801
42592801
42592802
42592802
42592802
42592803
42592803
42592803
42592803
42592803
42592803
42592803
42592803
42592803
42592803
ECOLOGICAL EFFECTS
71-1A
7 1-2 A
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
ALL
ALL
39
77315
77316
-------
Data Supporting Guideline Requirements for the Reregistration of Dibromodicyanobutane
REQUIREMENT
72-1A
72-1C
72-2A
72-3A
72-3B
72-3C
72-4A
72-4B
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity -
Mollusk
Estuarine/Marine Toxicity -
Shrimp
Early Life Stage Fish
Life Cycle Invertebrate
USE PATTERN
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
CITATION(S)
63850
63850
63851,70890
41885301
41885302
41885303
41986701
41885304
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
82-1A
82-1B
82-2
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation -
Rabbit
Dermal Sensitization - Guinea Pig
90-Day Feeding - Rodent
90-Day Feeding - Non-rodent
21-Day Dermal - Rabbit/Rat
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
41885501
27554
25846, 42526401
25848
25847,41885502
105188,43183801
55028
55027, 92199020, 43540501
Cerven, 1990
40
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Data Supporting Guideline Requirements for the Reregistration of Dibromodicyanobutane
REQUIREMENT USE PATTERN CITATION(S)
83-3A Developmental Toxicity - Rat
83-3B Developmental Toxicity - Rabbit
84-2A Gene Mutation (Ames Test)
84-2B Structural Chromosomal
Aberration
84-4 Other Genotoxic Effects
85-1 General Metabolism
ENVIRONMENTAL FATE
160-5 Chemical Identity
161-1 Hydrolysis
162-4 Aerobic Aquatic Metabolism
163-1 Leaching/Adsorption/
Desorption
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
0126562,92199012
43540502
25091
125850
55029, 144412, 137288,128134
55031
42592803
55032, Upgrade required
41883901
41883902
41
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42
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GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in
the Reregi strati on Eligibility Document. Primary sources for studies in this bibliography have
been the body of data submitted to EPA and its predecessor agencies in support of past
regulatory decisions. Selections from other sources including the published literature, in
those instances where they have been considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of
published materials, this corresponds closely to an article. In the case of unpublished
materials submitted to the Agency, the Agency has sought to identify documents at a level
parallel to the published article from within the typically larger volumes in which they were
submitted. The resulting "studies" generally have a distinct title (or at least a single subject),
can stand alone for purposes of review and can be described with a conventional
bibliographic citation. The Agency has also attempted to unite basic documents and
commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically by
Master Record Identifier, or "MRID number". This number is unique to the citation, and
should be used whenever a specific reference is required. It is not related to the six-digit
"Accession Number" which has been used to identify volumes of submitted studies (see
paragraph 4(d)(4) below for further explanation). In a few cases, entries added to the
bibliography late in the review may be preceded by a nine character temporary identifier.
These entries are listed after all MRID entries. This temporary identifying number is also to
be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry consists
of a citation containing standard elements followed, in the case of material submitted to EPA,
by a description of the earliest known submission. Bibliographic conventions used reflect the
standard of the American National Standards Institute (ANSI), expanded to provide for
certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has chosen
to show a personal author. When no individual was identified, the Agency has shown
an identifiable laboratory or testing facility as the author. When no author or
laboratory could be identified, the Agency has shown the first submitter as the author.
b. Document date. The date of the study is taken directly from the document. When the
date is followed by a question mark, the bibliographer has deduced the date from the
evidence contained in the document. When the date appears as (19??), the Agency
was unable to determine or estimate the date of the document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to create or
enhance a document title. Any such editorial insertions are contained between square
brackets.
43
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d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following elements
describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the word
"under" is the registration number, experimental use permit number, petition
number, or other administrative number associated with the earliest known
submission.
(3) Submitter. The third element is the submitter. When authorship is defaulted to
the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the trailing
parentheses identifies the EPA accession number of the volume in which the
original submission of the study appears. The six-digit accession number
follows the symbol "CDL," which stands for "Company Data Library." This
accession number is in turn followed by an alphabetic suffix which shows the
relative position of the study within the volume.
44
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BIBLIOGRAPHY
MRID
CITATION
00025091 Tate, C.L.; Zwickey, R.E.; Kite, M.; et al. (1978) MPXP-38 Bacterial Mutagen Test
(Ames Test) November 29, 1978. Unpublished study received January 4, 1980
submitted by Calgon Corp., Water Management Division.
00025846 Hinz, J.P.; Re, T.A. (1978) Inhalation Toxicity of XP-38 solution (TN 835-252) in
Sprague-Dawley Rats: Laboratory No. 6070. Unpublished study received January 4,
1980 prepared by Food and Drug Research Laboratories, Inc.
00025847 Stevens, K.R. (1978) XP-38 Solution and Skin Irritation with Rabbits, Laboratory No.
6070. Unpublished study received January 4, 1980 prepared by Food and Drug
Research Laboratories, Inc.
00025848 Stevens, K.R. (1979) XP-38 Solution and Rabbit Eye Irritation: Laboratory No. 1-
6070. Unpublished study received January 4, 1980 prepared by Food and Drug
Research Laboratories, Inc.
00027554 Stevens, K.R. (1979) Report: No. 6070. Unpublished study received January 4, 1980
under No. 10445-24. Prepared by Food and Drug Research Laboratories, Inc.
00055027 Wolfe, G.W.; Dewey, J.M.; Weatherholtz, W.M.; et al. (1980) Thirteen-Week
Subchronic Dietary Administration in Dogs: Tektamer(R) 38: Project No. 994-124.
Final report; prepared by Hazleton Laboratories America, Inc. Unpublished study; 130
P-
00055028 Wolfe, G.W.; Mistretta, L.H.; Pence, D.H.; et al. (1980) Ninety Day Feeding Study in
Rats Exposed"in utero": Tektamer (R) 38: Project No. 994-125. Final report; prepared
by Hazleton Laboratories America, Inc. Unpublished study; 227 p.
00055029 Wolfe, G.W.; Twigg, C.J.; Kapp, R.W., Jr. (1980) Modified Dominant Lethal
Evaluation in Mice: Tektamer 38: Project No. 994-123. Final report prepared by
Hazleton Laboratories America, Inc.; 36 p.
00055031 Andrews, J.P.; Hill, J.T. (1980) Pharmacokinetic and Metabolic Evaluation of 14
C-Tektamer (R) -38 in Male Rats. Prepared by Hazleton Laboratories America, Inc.
Unpublished study; 37 p.
00055032 Calgon Corporation (1980) Hydrolysis Study-l,2-Dibromo-2,4-dicyanobutane.
(Compilation; unpublished study received Dec 5, 1980 under 10445-33;
CDL:243907-G)
00063850 Bentley, R.E. (1975) Acute Toxicity of MPXP-38 to Bluegill (Lepomis macrochirus)
and Rainbow Trout (Salmo gairdneri). Unpublished study received April 29, 1976:
Project No. 618-87 prepared by EG&G, Bionomics.
45
-------
BIBLIOGRAPHY
MRID
CITATION
00063851 LeBlanc, G.A. (1977) Acute Toxicity of MPXP-38 to the Water Flea (Daphnia
magna). Unpublished study received June 6, 1977 Project No. 618-87 prepared by
EG&G, Bionomics.
00070890 LeBlanc, G.A.; Surprenant, D.C. (1981) Acute Toxicity of Tektamer 38 to the Water
Flea (Daphnia magna). Report No. 81-1-808. Unpublished study received April 2,
1981 prepared by EG&G, Bionomics.
00077315 Fink, R. (1975) Final Report: Acute Oral LD50 Mallard Duck: Project No. 105-110.
Unpublished study received April 29, 1976 prepared by Truslow Farms, Inc.
00077316 Fink, R. (1975) Final Report: Eight-day Dietary LC50 Bobwhite Quail: Project No.
105-108. Unpublished study received April 29, 1976 prepared by Truslow Farms, Inc.
00105188 Calgon Corp. (1982) Dermal Sensitization Studies on Tektamer 38. Unpublished
study received June 14, 1982 under 10445-33.
00125850 Putman, D.; Moore, W. (1982) Activity of Tektamer 38 (T1752) in the in vivo
Cytogenetics Assay in Sprague-Dawley Rats: MA Study No. T1752.102001. Final
report. (Unpublished study received Feb 15, 1983 under 10445-33; prepared by
Microbiological Assoc., submitted by Calgon Corp., Pittsburgh PA; CDL:249565-A)
00126562 Gallagher, E.; Harris, S.; DeFrain, S.; et al. (1982) Final Report for a Teratology Study
of Tektamer 38 in Albino Rats: CAL/SAI 1082004. (Unpublished study received Dec
7, 1982 under 1044533; prepared by Science Applications, Inc., submitted by Calgon
Corp., Pittsburgh, PA; CDL:249004-A)
00128134 Thilagar, A.; Kumaroo, P.; Knight, R.; et al. (1982) Cytogenicity Study-Chinese
Hamster Ovary (CHO) Cells in vitro: Test Article Tektamer 38: Study No. T1752.338.
(Unpublished study received Dec 7, 1982 under 10445-33; prepared by
Microbiological Assoc., submitted by Calgon Corp., Pittsburgh, PA; CDL:249005-A)
00137288 Robertson, R.; Bokelman, D.; Bradley, M.; et al. (1983) Tektamer 38: Measurement of
Unscheduled DNA Synthesis in Human IMR-90 Fibroblasts: T #82-8505.
Unpublished study received April 8, 1983 prepared by Merck Sharp & Dohme
Research Laboratories.
00144412 Robertson, R. (1985) Tektamer 38: V-79 Mammalian Cell Mutagenesis: Preliminary
Draft: TT #84-8506, 84-8507 and TT #84-8510. Unpublished study prepared by
Merck Sharp & Dohme Research Laboratories. 44 p.
46
-------
BIBLIOGRAPHY
MRID
CITATION
41883901 Schmidt, J. (1990) "Aerobic Aquatic Metabolism of Carbon 14-Tektamer 38": Lab
Project Number: 38628. Unpublished study prepared by Analytical Bio-Chemistry
Laboratories, Inc. 591 p.
41883902 Williams, M.; Hargadine, S. (1990) "Soil/Sediment Adsorption-Desorption of
Tektamer 38": Lab Project Number: 38566. Unpublished Study prepared by
Analytical Bio-Chemistry Laboratories, Inc. 366 p.
41885301 Ward, T.; Boeri, R. (1991) Acute Flow-through Toxicity of Tektamer 38 to
Sheepshead Minnow, Cyprinodon variegatus: Lab Project Number: 9009-C.
Unpublished study prepared by Resource Analysts, Inc. 24 p.
41885302 Ward, T.; Boeri, R. (1991) Static Acute Toxicity of Tektamer 38 to Bivalve Mollusc
Embryos and Larvae: Lab Project Number: 9011-C. Unpublished study prepared by
Resource Analysts, Inc. 22 p.
41885303 Ward, T.; Boeri, R. (1991) Acute Flow-through Toxicity of Tektamer 38 to the Mysid,
Mysidopsis bahia: Lab Project Number: 9010-C. Unpublished study prepared by
Resource Analysts, Inc. 24 p.
41885304 Ward, T.; Boeri, R. (1991) Chronic Toxicity of Tektamer 38 to the Daphnid, Daphnia
magna: Lab Project Number: 9008-C. Unpublished study prepared by Resource
Analysts, Inc. 36 p.
41885501 Cerven, D. (1991) Tektamer 38: Single Dose Oral Toxicity in Rats/LD 50 in Rats:
Final Report: Lab Project Number: MB 90-106-A. Unpublished study prepared by
MB Research Laboratories, Inc. 19 p.
41885502 Cerven, D. (1991) Tektamer 38: Primary Dermal Irritation in Albino Rabbits: Final
Report: Lab Project Number: MB 90-106 C. Unpublished study prepared by MB
Research Laboratories, Inc. 9 p.
41986701 Ward, T.; Boeri, R. (1991) Early Life-Stage Toxicity of Tektamer 38 to the Rainbow
Trout, Oncorhyncus mykiss: Lab Project Number 90100-C: Calgon 900013.
Unpublished study prepared by Envirosystems Div., Resource Analysts Inc. 54 p.
42526401 Werley, M. (1992) Inhalation Toxicity in Rats: Tektamer 38: Lab Project Number
MB91-334E. Unpublished study prepared by MB Research Laboratories Inc., Temple
University Health Science Cener. 88 p.
42592801 Oslosky, S. (1992) Product Chemistry: l,2-dibromo-2,4-dicyanobutane. Unpublished
study prepared by Calgon Corp. 51 p.
47
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BIBLIOGRAPHY
MRID
CITATION
42592802 Oslosky, S. (1992) Analysis and Certificate of Product Ingredients:
l,2-dibromo-2,4-dicyanobutane. Unpublished study prepared by Calgon Corp. 20 p.
42592803 Johnson, H. (1992) Determination of Eleven Product Chemistry Parameters of
Tektamer 38: Lab Project Number: 1003-001. Unpublished study prepared by Twin
City Testing Corp. 64 p.
43183801 Berger, R. (1988) Human Photoxicity/Photoallergy Study: Tektamer 38: Lab Project
Number: 87/1836/74. Unpublished study prepared by Hill Top Research, Inc. 25 p.
43540501 Smith, P. (1994) Three Month Dietary Toxicity Study in Dogs With A Three Month
Recovery: Tektamer 38: Lab Project Number: 265-028. Unpublished study prepared
by Int'l Research and Development Corp. 518 p.
43540502 Dearlove, G. (1994) Developmental Toxicity (Embryo-Fetal Toxicity and Teratogenic
Potential) Study of DBDCB Administered Orally Via Stomach Tube to New Zealand
White Rabbits: Lab Project Number: 1603-001: 930012: ARGUS 1603-001.
Unpublished study prepared by Argus Research Labs, Inc. 274 p.
92199012 Carlson, P. (1990) Calgon Corp. Phase 3 Summary of MRID 00126562. Final Report
of Teratology Study of Tektamer 38 in Albino Rats. Prepared by Science Applications.
13 p.
92199020 Wolfe, G.; Weatherholtz, W.; Alsakar, R.;; et al. (1990) Calgon Corp. Phase 3
Reformat of MRID 00055027. Thirteen-Week Subchronic Dietary Administration in
Dogs Tektamer 38: Project No. 994-124. Prepared by Hazleton Laboratories America,
Inc. 133 p.
48
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
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 III 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
III-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 III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of your
49
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product(s) subject to this Notice will be subject to suspension. We have provided a list of all of
your products subject to this Notice in Attachment 2, Data Call-In Response Form, as well as a list
of all registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and
Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
and 2070-0057 (expiration date 03-31-96).
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 II - Data Required By This Notice
Section III - 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 VT - 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! 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 II. DATA REQUIRED BY THIS NOTICE
II-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.
50
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II-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.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical Information Service (NTIS),
Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (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 CFR § 158. Normally, the Agency will not extend deadlines for complying with
data requirements when the studies were not conducted in accordance with acceptable standards.
The OECD protocols are available from OECD, 2001 L Street, N.W., Washington, D.C. 20036
(Telephone number 202-785-6323; Fax telephone number 202-785-0350).
All new studies and proposed protocols submitted in response to this Data Call-In Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c¥2¥B) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or change the
requirements of any previous Data Call-In(s). or any other agreements entered into with the Agency
pertaining to such prior Notice. Registrants must comply with the requirements of all Notices to
avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
III-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 to failure to
comply with this Notice are presented in Section IV-A and IV-B.
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
51
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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 III-C. A discussion of options relating to requests
for data waivers is contained in Section III-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 III-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 III-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.
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III-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) I will generate and submit data within the specified time frame (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing study
that has been submitted but not reviewed by the Agency (Citing an Existing Study)
Option 1. Developing Data — 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 time to meet the requirements(s), you must submit a request to the Agency
which includes: (1) a detailed description of the expected difficulty and (2) a proposed schedule
including alternative dates for meeting such requirements on a step-by-step basis. You must explain
any technical or laboratory difficulties and provide documentation from the laboratory performing
the testing. While EPA is considering your request, the original deadline remains. The Agency will
respond to your request in writing. If EPA does not grant your request, the original deadline remains.
Normally, extensions can be requested only in cases of extraordinary testing problems beyond the
expectation or control of the registrant. Extensions will not be given in submitting the 90-day
responses. Extensions will not be considered if the request for extension is not made in a timely
fashion; in no event shall an extension request be considered if it is submitted at or after the lapse of
the subject deadline.
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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 registration(s), although you do not comply with the data
submission requirements of this Notice. EPA has determined that as a general policy, absent other
relevant considerations, it will not suspend the registration of a product of a registrant who has in
good faith sought and continues to seek to enter into a joint data development/cost sharing program,
but the other registrant(s) developing the data has refused to accept 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 in 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 in
response to this Notice, you must determine that the study satisfies the requirements imposed by this
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Notice. You may only submit a study that has not been previously submitted to the Agency or
previously cited by anyone. Existing studies are studies which predate issuance of this Notice. Do
not use this option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the required
date of submission. The Agency may determine at any time that a study is not valid and needs to be
repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data and
specimens from the study are available for audit and review and you must identify
where they are available. This must be done in accordance with the requirements of
the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160. As stated in 40
CFR 160.3(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 recorded 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 the Agency's
policy regarding acceptable protocols. If you wish to submit the study, you must, in
addition to certifying that the purposes of the PAG are met by the study, clearly
articulate the rationale why you believe the study meets the purpose of the PAG,
including copies of any supporting information or data. It has been the Agency's
experience that studies completed prior to January 1970 rarely satisfied the purpose of
the PAG and that necessary raw data 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.
If you know of a study pertaining to any requirement in this Notice which does not meet the
criteria outlined above but does contain factual information regarding unreasonable adverse effects,
you must notify the Agency of such a study. If such study is in the Agency's files, you need only
cite it along with the notification. If not in the Agency's files, you must submit a summary and copies
as required by PR Notice 86-5.
Option 5. Upgrading a Study — If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data submitted
and determine if the requirement is satisfied. If the Agency decides the requirement is not satisfied,
you may still be required to submit new data normally without any time extension. Deficient, but
upgradeable studies will normally be classified as supplemental. However, it is important to note
that not all studies classified as supplemental are upgradeable. If you have questions regarding the
classification of a study or whether a study may be upgraded, call or write the contact person listed in
Attachment 1. If you submit data to upgrade an existing study you must satisfy or supply
information to correct all deficiencies in the study identified by EPA. You must provide a clearly
articulated rationale of how the deficiencies have been remedied or corrected and why the study
should be rated as acceptable to EPA. Your submission must also specify the MRID number(s) of
the study which you are attempting to upgrade and must be in conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as unacceptable
and determined by the Agency as not capable of being upgraded.
This option 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.
III-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 in 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. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study as
required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task Forces,
failure to comply with the terms of an agreement or arbitration concerning joint data
development or failure to comply with any terms of a data waiver).
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6. Failure to submit supportable certifications as to the conditions of submitted studies,
as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or failure
of a registrant on whom you rely for a generic data exemption either to:
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 GeneTox Health Effects Test Guidelines) regarding the design, conduct, and
reporting of required studies. Such requirements include, but are not limited to, those relating
to test material, test procedures, selection of species, number of animals, sex and distribution
of animals, dose and effect levels to be tested or attained, duration of test, and, as applicable,
Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation of
any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting, the
completeness of results, and the adequacy of any required supporting (or raw) data, including,
but not limited to, requirements referenced or included in this Notice or contained in PR 86-5.
All studies must be submitted in the form of a final report; a preliminary report will not be
considered to fulfill the submission requirement.
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IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing stocks
of a pesticide product which has been suspended or cancelled if doing so would be consistent with
the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding 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 product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell, distribute,
or use existing stocks. Normally, the Agency will allow persons other than the registrant such as
independent distributors, retailers and end users to sell, distribute or use such existing stocks until the
stocks are exhausted. Any sale, distribution or use of stocks of voluntarily cancelled products
containing an active ingredient for which the Agency has particular risk concerns will be determined
on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by this
Notice will not result in the Agency granting any additional time to sell, distribute, or use existing
stocks beyond a year from the date the 90 day response was due unless you demonstrate to the
Agency that you are in full compliance with all Agency requirements, including the requirements of
this Notice. For example, if you decide to voluntarily cancel your registration six months before a 3
year study is scheduled to be submitted, all progress reports and other information necessary to
establish that you have been conducting the study in an acceptable and good faith manner must have
been submitted to the Agency, before EPA will consider granting an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT 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.
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SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet.
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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 in Attachment 1. If the voluntary cancellation or generic data exemption
option is chosen, only the Data Call-In Response 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,
Lois Rossi, Division Director
Special Review and
Reregistration Division
Attachments
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 and the Confidential Statement of
Formula Form
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DIBROMODICYANOBUTANE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing DIBROMODICYANOBUTANE.
This Product Specific Data Call-In Chemical Status Sheet contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregi strati on of
DIBROMODICYANOBUTANE. This attachment is to be used in conjunction with (1) the Product
Specific Data Call-In Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2),
(3) the Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA Acceptance
Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6) and (7) the Cost
Share and Data Compensation Forms in replying to this DIBROMODICYANOBUTANE Product
Specific Data Call-In (Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for
DIBROMODICYANOBUTANE are contained in the Requirements Status and Registrant's
Response. Attachment 3. The Agency has concluded that additional data on
DIBROMODICYANOBUTANE 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 DIBROMODICYANOBUTANE 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 Ernest Jones (703) 308-8069.
All responses to this Notice for the Product Specific data requirements should be submitted
to:
Ernest Jones
Chemical Review Manager Team 81
Product Reregi strati on Branch
Special Review and Reregi strati on Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: DIBROMODICYANOBUTANE
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMFOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancelyour 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 in 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 informationthat 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.
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMFOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier numberassigned by EPA in Item
3 This number must be used in the transmittal document for any dart
submissions in response to this Data Call-In Notice.
Item 4. 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, Subpart C.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. 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.
Item 7. 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.
Item 8. The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Documentmless EPA
determines that a longer time period is necessary.
Item 9 Enter only one of the following response codesfor each data requirementto
show how you intend to comply with the data requirements listed in this table.
Fuller descriptions of each option are contained in the Data Call-In Notice.
1. 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 Cmpensation Requirements" form (EPA
Form 8570-29) and (2) two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4)
2. 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 to another
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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 Daft
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 offerto 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 he 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 III-C.l.) apply as well. By the specified due date, I will also
submit: (1) a completed "Certification With Respect To Data Compensatin
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, I will submit an existing study that has not been submitted
previously to the Agency by anyone (Submitting an Existing Stud$. 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 III-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 (EA 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 Daft
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 option
outlined Option 5 in the Data Call-In Notice (Section III-C.l.) apply. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data CompensationRequirements" form (EPA Form 8570-29)and (2) two
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7.
completed and signed copies of the Confidential Statement of Formula
Form 8570-4)
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, an 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 MRID 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 CompensationRequirements" form (EPA Form 8570-29)and (2) two
completed and signed copies of the Confidential Statement of Formula (ER
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 informationthat 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.
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EPA'S BATCHING OF l,2-DIBROMO-2,4-DICYANOBUTANE PRODUCTS FB
MEETING REREGISTRATION ACUTE TOXICITY DATA REQUIREMENTS
In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregi strati on of products containing l,2-dibromo-2,4-dicyanobutane
as the active ingredient, the Agency has batched products which can be considered similar for
purposes of acute toxicity. Factors considered in the sorting process include each product's active
and inert ingredients (identity, percent composition and biological activity), type of formulation
(e.g., emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal
word, use classification, precautionary labeling, etc.). Note that the Agency is not describing
batched products as "substantially similar" since some products within a batch may not be
considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in the
preceding paragraph. Not with-standing the batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite
a single battery of six acute toxicological studies to represent all the products within that batch. It
is the registrant's option to participate in the process with all other registrants, only some of the other
registrants, or only their own products within a batch, or to generate all the required acute
toxicological studies for each of their own products. If a registrant chooses to generate the data for
a batch, he/she must use one of the products within the batch as the test material. If a registrant
chooses to rely upon previously submitted acute toxicity data, he/she may do so provided that the
data base is complete and valid by today's standards (see acceptance criteria attached), the
formulation tested is considered by EPA to be similar for acute toxicity, and the formulation has not
been significantly altered since submission and acceptance of the acute toxicity data. Regardless of
whether new data is generated or existing data is referenced, registrants must clearly identify the test
material by EPA Registration Number. If more than one confidential statement of formula (CSF)
exists for a product, the registrant must indicate the formulation actually tested by identifying the
corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI
Notice contains two response forms which are to be completed and submitted to the Agency within
90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant will meet
the data requirements for each product. The second form, "Requirements Status and Registrant's
Response," lists the product specific data required for each product, including the standard six acute
toxicity tests. A registrant who wishes to participate in a batch must decide whether he/she will
provide the data or depend on someone else to do so. If a registrant supplies the data to support a
batch of products, he/she must select one of the following options: Developing Data (Option 1),
Submitting an Existing Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an
Existing Study (Option 6). If a registrant depends on another's data, he/she must choose among: Cost
Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing Study (Option 6). If a
registrant does not want to participate in a batch, the choices are Options 1, 4, 5 or 6. However, a
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registrant should know that choosing not to participate in a batch does not preclude other registrants
in the batch from citing his/her studies and offering to cost share (Option 3) those studies.
PRS identified the following products for batching purposes:
Tektamer 38 = 98% a.i. (10445-33)
Tektamer 38 O.F. = 98% a.i. (10445-68)
Tektamer 38 Wet Cake = 85% a.i. (10445-102)
Tektamer 38 A.D. = 25% a.i. (10445-56)
Tektamer 38 O.A. = 25% a.i. (10445-67)
Tektamer 38 Liquid Concentrate = 25% a.i. (10445-22)
Tektamer 38 O.L. = 10% a.i. (10445-71)
Metasol CB 225-AD = 25% a.i. (10445-77)
Metasol CB 225-LC = 25% a.i. (10445-80)
Metasol CB-220 = 20% a.i. (10445-91)
Biochek 430 = 23.802% a.i. (10445-89)
Biochek 410 = 25% a.i. (10445-90)
Twelve products were found which contain l,2-dibromo-2,4-dicyanobutane (CAS No.
10445-33) as an active ingredient. Eight products have been placed into three "BATCH" categories.
Four Products were placed into the "NO BATCH" category.
Table 1
Batch
1
EPA Reg. No.
10445-33
10445-68
% active ingredient
98
98
Formulation Type
powder
powder
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Table 2
Batch
2
EPA Reg. No.
10445-56
10445-67
10445-77
% active ingredient
25.5%
25.0%
25.0%
Formulation Type
liquid
liquid
liquid
Table
Batch
3
EPA Reg. No.
10445-22
10445-80
10445-91
% active ingredient
25%
25%
20%
Formulation Type
liquid
liquid
liquid
The following table lists products that were either considered not to be similar or the Agency
lacked sufficient information for decision making and were not placed in any batch. The registrant
of these products is responsible for meeting the acute toxicity data requirements separately.
Tables (No Batch)
EPA Reg. No.
10445-102
10445-71
10445-89
10445-90
% active ingredient
85%
10%
23.8%
25%
Formulation Type
solid
liquid
liquid
liquid
PRS Recommendations:
Only acute toxicity studies supporting BATCH I with Category III and IV classifications may be
cited by the registrant to support any BATCH 2 product.
Acute toxicity data (generated, cited and/or submitted) from
BATCH 1 may be bridged to support 10445-102.
Acute toxicity data (generated, cited and/or submitted) from
BATCH 3 may be bridged to support 10445-71.
PRS was not able to batch or bridge to the following products: 10445-90 or 10445-89.
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Attachment a. List of All Registrants Sent This Data Call-In (inserjt
Notice
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed
copies of the form are required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible party
must be provided.
d. All applicable information which is on the product specific data submission must also
be reported on the CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids.
f Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently registered
source products must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
common names for the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be reported
under column 10 and must be exactly the same as on the source product's label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or grams.
In no case will volumes be accepted. Do not mix English and metric system units
(i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must represent pure
active form.
m. The upper and lower certified limits for ail active and inert ingredients must follow
the 40 CFR 158.175 instructions. An explanation must be provided if the proposed
limits are different than standard certified limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs become
obsolete for that specific formulation.
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r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
form Approved
OMB No. 2070-0106
2070-0057
Approval Expires 3 31 96
Public reporting burden 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-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Mame
Product Name
Company Number
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Name of Firm(s)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Date
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Form Approved
OMB No. 2070-0107,
2070-0057
Approval Expires
3-31-96
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
Product Name
Company Number
EPA Reg. No.
I Certify that:
1. For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) that 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 writing the
company(ies) that submitted data I have cited and have offered to: (a) Pay compensation for those data in accordance with sections
3(c)(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)
[ ] 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 or
reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
Signature
Date
Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
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The following is a list of available documents for DIBROMODICYANOBUTANE that my
further assist you in responding to this Reregi strati on 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 Reregi strati on Information System at 703-308-7224. They also are available
on the Internet on EPA's gopher server, GOPHER.EPA.GOV, or using ftp on
FTP.EPA.GOV, or using WWW (World Wide Web) on WWW.EPA.GOV., or
contact Ernest Jones at (703)-308-8069.
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 DIBROMODICYANOBUTANE.
The following documents are part of the Administrative Record for
DIBROMODICYANOBUTANE 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.Health and Environmental Effects Science Chapters.
2.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
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