United States
, Environmental Protection
Agency .
Prevention, Pesticides .
And Joxjc Substances
.'(7508W):, . '>, ;
EPA-738-F-96-027
December 1995
ORTHb^B|NZXl
CHLOROPHE
Pesticide
Reregistration
Use Profile
All pesticides sold or.distributed in ithe,United States ni.ust 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
pesticides which were first registered before November 1, 1984, be,
reregistered to ensure that they meet today's more stringent standards -'
- In^ evaluating pesticides for reregistration, EPA obtains and reviews a
complete sbt of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. .The Agency develops
any mitigatiw 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.
When a pesticide is eligible for reregistration, EPA explains the basis
for its decision in a JReregistrati on Eligibility Decision (RED) document. '
This fact sheet summarizes the information in the IlED document for
reregistration case 2045, Ortho-benzyl-para-chloropnenol. ' !>
Ortho-benzyl-para-chiorophenol and its salts are used as
disinfectants/antimicrobials for controlling Variety of bacteria, fungi, algae,
and viruses. The use sites include-swimming pool water related surfaces
such as decks, and other hard surface areas surrounding swimming po'ols
-refuse/solid waste sites, air washer water systems, evaporative condenser
water systems and industrial processing water, and commercial/industrial ,
water cooling systems. :
Ortho-benzyl-para-chlorophenol and its'salts. are alsp used as
.disinfectants for farm premises, poultry houses, food processing plants,
eating establishments, and federally inspected meat arid poultry processing
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plants. Labeling for disinfectants registered for use in federally inspected
meat, poultry, and egg processing plants, as well as for phenolic-based
products used as disinfectants in food preparation, storage, and serving
establishments/areas, requires that food products and packaging materials '
are removed or carefully covered prior to application and that a potable
water rinse is employed after treatment. Phenolic-based products
recommended for use as disinfectants on food contact surfaces in eating
establishments and homes are limited to sites such as counter tops, stoves,
arid refrigerators, which followed by a potable water rinse would allow their
classification as a nonfood use. Application of these products as
disinfectants on eating utensils, glassware, and similar items would be
considered a food use and would require, a tolerance or an exemption from
the requirements of a tolerance prior to approval, however specific label
directions are provided in Section V, of the RED document which result in
the classification of farm premise and poultry house disinfectants as non-
food use products.
Regulatory Ortho-benzyl-para-chlorophenol, potassium and sodium 2-benzyl-4-
HlStory chlorophenate salts were first registered in the United States in 1948 as
disinfectants. They are currently registered as disinfectants, bacteriostats,
sanitizers and microbiocides. Additionally, the salts are currently registered
for use as tuberculocides, viiiicides and fungicides.
There are currently 143 products registered by the Environmental
Protection Agency containing ortho-benzyl-para-chlorophenol active
ingredients.
Human Health Toxicity
Assessment
Ortho-benzyl-para-chlorophenol is Category III for acute oral and
dermal toxicity, and Category IV for acute inhalation toxicity. Ortho-
benzyl-para-chlorophenol is severely irritating to the eye (Category I), and
is corrosive with repeated contact to the skin. The requirement for a dermal
sensitization study was waived due to the corrosive nature of ortho-benzyl-
para-chlorophenol. In chronic studies, ortho-benzyl-para-chlorophenol
induces increases in kidney nephropathy and has been classified as a Group
C, possible human carcinogen. This was based on increases in renal tubule
combined adenomas/carcinomas in male B6C3F1 mouse and in renal
transitional cell carcinomas in female F344/N rat. However, renal tubular-
carcinomas in the mouse and renal transitional cell tumors in the rat are
rare.
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'.: Dietary Exposure- .- ' v.- ;'-'' -,- ' ----.;'.-'-^'._.. -.;'' ..: -;'".;'".; 'V'x """"
,, V. . No dietary ex^okre is expected from the pesticide uses of ortho- .
benzyl-pararchlorppfeenol sinc'e-no;^^food or feed uses are registered.
;, '', Ortrip-benzyl-para-chlprophenoi and its salts ^when registered for use;'.
as sanitizers.on'food-processing equipment and utensils, and on,other food-
contact articles are-underthe purview of FDA (21 GFR Part 178 1010 (20)).
EPA accepts FDA's approval and acceptance of the chemical (s) use pattern.
Occupational and Residential Exposure
The Agency, has determined that regulatory action regarding the
establishment of active ingredient-based minimum PPE requirements for
occupational handlers must be taken for ortho-benzyl-para-chlorophenol.
, , ,The Chemical Klanufacturer;s Asspeiatipn (CiyiA) exposure datarused to
assess the risk resulting from three of the use-scenarios were based on the
handlers in these use-spenariqs wearing chemical-resistant gloves.
.Therefore, chemicaUresistant gloves shall bfe required for occupational
handlers of ortho-benzyl-para-chlorophenol for the following use-scenarios-
.-, -. mixing and pouring'a soluble liquid, transferring (pumping) liquid, and
pouring powdered or flaked solid product. Since the chronic MOE for
hand-wiping (ungloved) was /ess than 300^ chemical resistant gloves are
, required to reduce/mitigate.the potential risk to applicators. For exposures
related to indoor fogging applications, EPA is requiring the use of a full- ~
face canister-style respirator to mitigate ocular and inhalation concerns.
; ,; The high-pressure spray application use-scenario, which is an ''''.-''-
intermediate exposure scenario, had an MOE of less than 100, The CMA
;e^xposure:data used to assess the ristfrom this use-scenario was based, in
_ some replicates, on the handlers wearing chemical-resistant gloves and
rainsuits, there are no additional PPE options available that would
adequately mitigate the'vrisk. Furthermore, there are no practicable '
engineering controls for this use-scenario. Due to uncertainties in the data '
- used to calculate exposure, the Agency will consider the high pressure
spray scenario conditionally acceptable until new-exposure, data are
available: '- ..' .\ .'"_.. .,' ' ':.'. ' - . . ..,'.' ... . ?." s,:'---.:
Human.Risk Assessment ?
Since orthoTbenzyl-para-chlorophenol has no food or feed uses,
dietary risk is not expected: , - " , ' ' -
Environmental Fate -.': '
'--. . ' -. J . '...---. - :.).' ' ' '- .;'-'".->- -- ,- <-.->. - -,-.y; -..."-, -,:- ---'T. ปv .:: ,---~f"-- ....
: The Agency expects that the registered uses of ortho-benzyl-para-
, ; chlorophenol should not result in significant exposure tp the environment.
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The environmental fate data indicated that the two salts rapidly degrade into
the acid in the environment Therefore, the data supporting the acid also
can be used to support the potassium and sodium salts.
Ecological Effects Risk Assessment
The Agency requires only a limited set of ecotoxicology and
environmental fate studies for microbiocides. The chemical, ortho-benzyl-
para-chlorophenol is nontoxic to birds and highly toxic to freshwater fish
and aquatic invertebrates. While the hazard to aquatic organisms from
ortho-benzyl-para-chlorophenol has been characterized, a quantitative risk
assessment has not been conducted. The risks to aquatic environments
from the uses of ortho-benzyl-para-chlorophenol are regulated under the
NPDES permitting program of the Office of Water. The Agency currently
requires that labels for all ortho-benzyl-para-chlorophenol products require
that discharges to aquatic environments comply with a NPDES permit.
Because terrestrial use of ortho-benzyl- para-chlorophenol and its.
potassium and sodium salts is limited to refuse/solid waste sites, exposure
to wildlife is not expected to be significant.
Additional Data EPA is requiring product-specific data including product chemistry
Required ancl information to upgrade the acute toxicity studies, and data to satisfy the
mammalian cells in culture forward gene mutation assay ( specifically a
mouse lymphoma assay, revised Confidential Statements of Formula
(CSFs), and revised labeling for reregi strati on of products containing
Ortho-benzyl-para-chlorophenol and its salts.
Product Labeling
Changes
Required
All end use products containing ortho-benzyl-para-chlorophenol and
it salts must comply with EPA's current pesticide product labeling
requirements. ,
t
PPE/Engineering Control Requirements for Pesticide Handlers
For sole-active-ingredient end-use products that contain ortho-
benzyl-para-chlorophenol, the product labeling must be revised to adopt the
handler personal protective equipment/engineering control requirements set
forth in this section. Any conflicting PPE requirements on the current
labeling must be removed.
For multiple-active-ingredient end-use products that contain ortho-
benzyl-para-chlorophenol, the handler personal protective
equipment/engineering control requirements set forth in this section must be
compared to the requirements on the current labeling and the more
protective must be retained. For guidance on which requirements are
considered more protective, see PR Notice 93-7.
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Minimum (Baseline) PPE/Engineering Control Requirements
- - , , : - ' \ _ --.;,';.- ' v . ^, -."_.".-.. y .'-.: , ' . vv _ -'
EPA is establishing active-ingredient-based minimum (baseline)
PPE/engirieering control requirements for ortho-benzyl-para-
chlprophenol end-use products that .are intended primarily for
occupational use for the following user-scenarios: (1) mixing and
pouring soluble liquids, (2) transferring (pumping) liquids, (6) hand-,
wiping, (7) pouring powdered or flaked formulations, and (8) applying
fogs to enclosed areas. The minimum (baseline) PPE for such
occupational uses of ortho-benzyl-para-chlorophenol end-use products
are:
' "Applicators and, other handlers must wear:.
, long-sleeve shirt and long pants, '...,.
: socks plus shoes, and
chemical-resistant gloves*. : .
"In addition, for applicators and-other handlers exposed to the
fogduring; fogging applications and until the fog has dissipated
and the-enclosed area has been thoroughly ventilated must wear:
, ~a full-face respirator with a canister approved for pesticides -
, (MSHA/NIOSH approval number prefix Te-14G)"
*For the glove statement, use the statement establi shed fofL .
, . ortho-benzyl-para-chlorophenol through the instructions in
; , ' Supplement Three of PR Notice 93-7:
- EPA is not establishing active-ingredient-based minirnum (baseline)
: PPE for occupational handlers in the following use-scenarios::-(4) low-
pressure spray, and"(5) mopping (ungloved).
In addition, for a comprehensive list of labeling, requirements,.:please
see the ortho-benzyl-para-chlorophenol RED document.
Regulatory The use of currently registered products containing ortho-benzyl-para-
ConclUSJOn chlorophenol in accordance with approved labeling will not pose
. unreasonable risks or adverse effects to humans or the environment.
Therefore, all uses of these products are eligible for reregistration.
-' . ; v Ortho-benzyl-para-chlorophenol products will be reregistered once
.the required product-specific data, revised Confidential Statements of
Formula, and revised labeling are received .and accepted by EPA.
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For More EPA is requesting public comments on the Reregi strati on Eligibility
Information Decision (RED) document for ortho-benzyl-para-chlorophenol during a 60-
day time period, as announced in a Notice of Availability published in the
Federal Register. To obtain a copy of the RED document or to submit
written comments, please contact the Pesticide Docket, Public Response
and Program Resources Branch, Field Operations Division (7506C), Office
of Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5805. '
Electronic copies of the RED and this fact sheet can be downloaded
from the Pesticide Special Review and Reregistration Information System
at 703-308-7224. They also are available on the Internet on EPA's gopher
server, GOPHER.EPA.GOV, or using ftp on FTP.EPA.GOV, or using
WWW (World Wide Web) on WWW.EPA.GOV.
Printed copies of the RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-489-8190, fax 513-489-8695.
Following the comment period, the ortho-benzyl-para-chlorophenol
RED document also will be available from the.National Technical
Information Service (NTIS), 5285 Port Royal Road, Springfield, VA
22161, telephone 703-487-4650. "
For more information about EPA's pesticide reregi strati on program,
the ortho-benzyl-para-chlorophenol RED, or reregistration of individual
, products containing ortho-benzyl-para-phlorophenol and its salts, please
contact the Special Review and Reregistration Division (7508W), OPP, US
EPA, Washington, DC 20460, telephone
703-308-8000.
For information about the health effects of pesticides, or for assistance
in recognizing and managing pesticide poisoning symptoms, please contact
the National Pesticides Telecommunications Network (NPTN). Call toll-
free 1-800-858-7378, between 9:30 am and 7:30 pm Eastern Standard
Time, Monday through Friday.
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. , . . . , .
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
' . '' . . ' - . ---...,
:,' : WASHINGTON, D;C.< 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL ~ ';'
: : - '; -v ' ','-' '^>'->:':-^ ^::-'--^'::'^
Dear Registrant: - ;: ,
-.'. -'.-';'-- ..-.;..->-'.;".- "-.. / ...-../ '. :,'""' - ,-'__ ... -
, I am pleased toiannpunce that;the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on. the pesticide chemical case ortho-benzyl-para-
chlorophenol which includes the active ingredients potassium 2-benzyH-para-chlorophenate
and sodium 2-benzyl-4-chlorophenate. The enclosed Reregistration Eligibility. Decision (RED)
contains the Agency's evaluation of the data base of these chemicals, its conclusions of the
potential human health and environmental risks of the current product uses, and its decisions
and .conditions under which these, uses and products will be eligible for reregistration. the -
RED includes me data and labeling requirements for products for reregistration. It may also
include requirements for additional data (generic) on the active ingredients to confirm the risk
assessments. . " , /' \ "\ ' ; \ ' r;' "' "" '^'" ----- ;' ;(.'.-. ; ' :
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 rurther instructions. You must follow all instructions and submit
complete and timely responses. ,The first set of required responses are due 90 days from
the receipt of this letter. The second set of required responses are due 8 months from the
receipt of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.
Please note that this RED was finalized and signed prior to August 3, 1996. On that
date, the Food Quality Protection Act .of 1996 ("FQPA";) became effective^ amending portions
of both the pesticide law (FIFRA) and the food anddrug law (FFDCA). This RED does not
address any issues raised by FQPA, and any tolerance-related statements in the RED did'not
take into account any changes in tolerance assessment procedures, requked under FQPA. To
the extent that this RED indicates that a change in any tolerance is necessary, that ''
determination will be reassessed by .the Agency under the standards set forth in FQPA before a
proposed tolerance is issued. To the extent that the RED does not indicate that a change in the
tolerance is necessary, that tolerance, too, will be reassessed in the future pursuant to the '
requirements of FQPA. Also note, this, sighed and-dated letter supercedes the signed but
undated letter included at the beginning of the bound document: ' . ,
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If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative
Nancy Tompkins at (703) 308-8172. Address any questions on required generic data to the
Special Review and Reregistration Division representative Veronica Dutch at 703-308-8585.
Sincerely yours,
oQ.
Lois A. Rossi, Director
Special Review
and Reregistration Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1. DATA CALL-IN (PCI) OR "90-DAY RESPQNSE"-If generic data are required for
reregistration, a DGI letter, will be enclosed describing such data. If product specific data
are required, laDCI letter will be enclosed listing such requirements. If both generic and
product specific data are'required, a combined Generic and Product Specific DCI lejter will
be enclosed describing such data. However, if you are aii 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. v
2. TIME EXTENSIONS AND DATA WAIVER REQUESTS-No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect,to actual data submissions. Requests for time extensions for product specific data
should be submitted in the 90-day response. Requests for data waivers must be submitted as
part of the 90-day response,. All data waiver and time extension requests must be accompanied
by a,full justification. All waivers and time extensions must be granted by EPA in order to go
into effect, -
3. APPLICATION FOR REREGISTRATIQN OR "8-MONTH RESPONSE"-Y6u 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 formsjisted 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^ ,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/REDsaysare ineligible for/refegistration. For further
labeling guidance, refer io the labeling section of the EPA publication "General Information
on Applying for Registratioain the U.S., Second Edition, August 1992" (available from the,
National Technical Information Service, publication #PB92-221811; telephone number 703-
487-4650). ... ; ^ V :: : :
c. Generic or Product Specific Data Submit all data in a format which complies
with PR. Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers.: Before citing these studies, you.must make sure that they meet
the Agency's acceptance criteria (attached to .the DCI). '
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d- Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 CFR ง158.175) 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 ง158.175(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 RERE6ISTRATIQN (8-MQNTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
i
6. EPA'S REVIEWS-ERA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8- >
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
ORTHO-BENZYL-P-CHLOROPHENOL
' , -'. --. LISTB '... ; , . -. .';''.'"
' ' '; ,: '.""' ;' ' ' CASE 2045 ; ''.' . '-' -
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS '
SPECIAL REVIEW AND REREGISTRATION DIVISION
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.'. .. ;"' ' - .:' v. TABLE OF CONTENTS '.: ^'" :'"".'v .'./""?' .."'"'-7'"_?':';V V '\.
O-be,nzyl-p-chIorophenolReregistration Eligibility Decision Team . .... . . . i
E^GUTTVE SUMMARY .... . .'.. .,. v.'..:.;. .;.;.". . v.;.';'..' '.-';' /:'_'vv7.'' -"--"r'V v'''1' "^-'V~~V'
I.' INTRODUCTIONS .7 ; :'. . ."...' .,/,.,,.". '.^.^.':'.'.^:. .,. ... '. V. vY/v'.v''"." "''-l' ' :'; '^-':;<
'H;-.. CASE OVERVIEW :. .". . . ., . .V",:; .'.-'.:, !'"... V.V! ;:'-.-';->;:.:. ?iVr ^v' '""'"2^ "'' -'
A. Chemical Overview . :...-. ..'. . . ... .... ...... 2 ;
B. UseProfile!......,.... f,.;!. ..?. .!'!/! ;! 2 "'*."'
C. Estimated Usage of Pesticidev.. 1 ; '. ";';."..- V; " "^ ' ].' ;'';['!;"].'' "^ [ "]| 16
D. Data Requirements ,-, ... . . , i .._.... . .... .... 17
E. Regulatory History ......:.;.. .V.:..;....... 17
m.' SCIE]yCE.ASSESSMENT , y,:.'.,. . .'-. . . /i-'.vV'.'."..'. . ." ;:': . '.'.;' . . 'j\V. .IS :;-;-.-.-;
A. Physical Chemistry Assessment ....... . . . . ..... ... ! 18 '
B. ..: Human Health Assessment . ;. . '*', . . . ;. ..: V !v ..!;;. 19
1. Toxicology Assessment ...,:...;....;....,.. . . V, 19
'.'.."." ป..: - Acute.Toxicity.-!":'.,;--;:.'.:".-."..-'-'. . .YV."'".:'.,''.''.'. '.'". ; .1 : 2Q ' '';:,":"-:: ;: '
b. ., SubchronicToxicity ;..........._......._.; .20
c.- Combined.Chronic Toxicity and Carcinogenicity .\ . . . . 21
d. Developmental Toxicity . ...... . . , . ...... 24
, e. Reproductive Toxicity ;. .... .... 25
f. Mutagenicity ........ . .x. . . . . .".'.':-..'. . . .... 25 - ;
, g.; Metabolism ......'..... ^ .......... ; ..; 26
, h. Dermal Penetration ; . ',,,.-..; . . . ... v V 26
: L Toxicological Endpoints of Concern Identified for Use in Risk
'-'','-. .Assessment . . . . . . . . . . .-.-.' . . . .'f... ..,. . [ .. 27
t ^- Exposure Assessment ../.;..,......... .;..... 2gV
a. Dietary Exposure .. .... . : . , . . . . ...........] ' 28
b. Occupational and Residential ....;!........... , 29
; :. " "'3. Risk Assessment , .. .^. , . .. /. .;.^ .... \\. ;. . ; 35 ' - - ' '
": v "'- ' '---'a'--. . ^Dietary- .--.-. . ,'.". .'....'.ซ'.'."'.'.''.-". .. . . :'.'. : - ''"''35 -'''' '~'
b. Occupational and Residential ....... . . . .... ... . ' .35
^C. Environmental Assessment ........... 38
1. Ecological Toxicity Data ..;........,.......;.. ^ '/ 38
i a. Toxicity to Terrestrial Animals . . . ; . . . :. ; .38,
b. Toxicity to Aquatic Animals .-"..,. . . ....'. . ... ... 49
c. Toxicity to Plants .'.\. .'....;....;.. -: ....->...... . 42
2.; Environmental Fate . .., . . ,;..... . I . . ; . -..'.::'. . ; ..... 42
a. Environmental Fate Assessment ................ 42
b- ^Enyironmerital Chemistry, Fate, and Transport . ;; 42
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3. Exposure and Risk Characterization . . 43
a. Ecological Exposure and Risk Characterization . . 43
IV. RISK MANAGEMENT AND REREGISTRATION DECISION ......... 44
A. Determination of Eligibility 44
B. Determination of Eligibility Decision .................: V 45
1. Eligibility Decision ^ . 45
2. Eligible and Ineligible Uses 45
C. Regulatory Position ............ .... . . 45
1. Labeling Rationale . 46
V. ACTIONS REQUIRED OF REGISTRANTS 48
A. Manufacturing-Use Products . ; ; 48
1. Additional Generic Data Requirements 48
2. Labeling Requirements for Manufacturing-Use Products ....... .50
B. End-Use Products ..'.../ 50
1. Additional Product-Specific Data Requirements ;....' . 50
2. Labeling Requirements for End-Use Products 51
C. Existing Stocks , . 58
VI. APPENDICES . . . . . 59
APPENDIX A. Table of Use Patterns Subject to Reregistration 60
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision *'.:...' ... 61
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Ortho-Benzyl-P-Chlorophenol 74
APPENDIX D. Product Specific Data Call-In 81
Attachment 1. Chemical Status Sheet 95
Attachment 2. Product Specific Data CaU-In Response Forms (Form A
inserts) Plus Instructions 96
Attachment 3. ' Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions
'' 99
Attachment 4. List of All Registrants Sent This Data Call-In (insert)
Notice . . . . 109
Attachment 5. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 112
Attachment 6. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 117
APPENDIX E. List of Available Related Documents ...........!!! 125
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O-benzyl-p-chlorophenol Reregistration .Eligibility1 Decision Team
Office of Pesticide Programs: "
Biological and Economic Analysis Division
PhyHss L. Johnson
Michele Gottrill
Biological Analysis Branch
Biological Analysis Branch
Environmental Fate and Effects Division
Sharlene Matten
William Erickson,
Dana Spatz
Health Effects Division .
Kathryri Boyle . ;
Pamela M. Hurley
Winston Dang
Registration Division
Robert Travaglini.
Sami Malak ;
Alfred Smith
Science Analysis and Coordination Staff
Ecological Effects Branch
" . Environmental Fate and Groundwater Branch
Risk Characterization and Branch)
Toxicology Branch I
Occupational and Residential Exposure Branch
, Antimicrobial Program Branch
Registration Support Branch
, Registration Support Branch
Special Review and Reregistration Division.
Veronica Dutch
Barbara Briscoe
Planning and Reregistratibn Branch
Planning and Reregistration Branch
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11
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ADI
AE
a.i.
ARC
CAS
CL .
CNS ;
CSFV
DFR
ORES,
DWEL
EEC
EP
EPA
FDA
FIFRA
FFDCA
FOB
GLC
GM ''
GRAS
HA
HOT
LD
'50
LEL
LOG
LOD
LOEL
MATC
MCLG
mg/L
MOE
>MP
MPI !
MRID
N/A
NOEC
NPDES
GLOSSARY OF TERMS AND ABBREVIATIONS
Acceptable Daily Intake. A now defunct term for reference dose (RfD). -'Y
Acid Equivalent " ' -
Active Ingredient . " ' , ' r - ''-*-: ''. . - ' ':. [,,,.' :' -:. ', -:-- - ^"
Anticipated Residue .Contribution ' , .,
Chemical Abstracts Service . ' . ..-'. /;
Cation , ' ' - '
Central Nervous System . , - ,
Confidential Statement of Formula
Dislodgeable Foliar Residue . ,
Dietary Risk Evaluation System . ^ . ' " '
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.k, :..'''"'.''- ;, .' -.-;." '. . . .' -'-':" ' .'....,'; .' _.. .
Estimated Envkonmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem. . . ....... , ..;-
End-Use Product ,
U.S. Environmental Protection Agency ., " - , .
Food and Drug Administration ''.'-'-' :
Federal Insecticide, Fungicide, and Rodenticide Act ..''.. ^ '
Federal Food, Drug, and Cosmetic Act
Functional Observation Battery ..'-'-'' .
Gas Liquid Chromatography " ...'' , - ,
Geometric Mean ^ ,
Generally Recognized as Safe as Designated by FDA
Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
Highest Dose Tested .; .
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. ' "
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 (oraC dermal, inhalation). It is
expressedas a weightofsubstariceper unit weight of animal, e.g., mg/kg. ,
Lethal Dose-low. Lowest Dose at which lethality occurs.
Lowest Effect Level : .; :- ".''/
Level of Concern . , . ;. V . ' .-
. Limit of Detection ' ; ' . . ,
Lowest Observed Effect Level . , ; .'..:--
Maximum Acceptable Toxicant Concentration '
Maximum Contaminant Level Goal (MCLG) The MCLG is used by the: Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
Micrograms Per Gram i ,
,'' Milh'grams Per Liter .
Margin of,Exposure , ... ~ ' , '
Manufacturing-Use Product - ' . , ^ . . .
.Maximum Permissible Intake -,
Master Record Identification (nuniber). EPA's system of recording and tracking studies submitted.
Not.Applicable - - ; . , _ ;
No effect concentration . , (
: National Pollutant Discharge Elimination System . ,
ill
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GLOSSARY OF TERMS AND ABBREVIATIONS
NOEL
NOAEL
OP
OPP
PADI
PAG
PAM
PHED
PHI
ppb
PPE
ppm
PRN
Q*i
RBC
RED
REI
RfD
RS
SLN
TC
TD
TEP
TGAI
TLC
TMRC
torr
FAOAVHO
WP
WPS
No Observed Effect Level
No Observed Adverse Effect Level
Organophosphate
Office of Pesticide Programs , '
Provisional Acceptable Daily Intake - . '
Pesticide Assessment Guideline
Pesticide Analytical Method
Pesticide Handler's Exposure Data
Preharvest Interval
Parts Per Billion
Personal Protective Equipment
Parts Per Million
Pesticide Registration Notice ''"",
The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RedBloodCell
Reregistration Eligibility Decision
Restricted Entry Interval
Reference Dose
Registration Standard ,
Special Local Need (Registrations Under Section 24 (c) of FIFRA)
Toxic Concentration. The concentration at which a substance produces a toxic effect.
Toxic Dose. The dose at which a substance produces a toxic effect.
Typical End-Use Product
Technical Grade Active Ingredient
Thin Layer Chromatography
Theoretical Maximum Residue Contribution
A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
Food and Agriculture Organization/World Health Organization :
Wettable Powder
Worker Protection Standard .
IV
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EXECUTIVE SUMMARY ';..'' ." . V ''.";'.'. *; /' ' ' ';'.'.__'.; ._. . .
'-. , .,,..-- v -.. "-... *'./
The Agency has determined that the uses of the active ingredient, ortho-benzyl-para-
chlorophenol (2-benzyl-4-chlorophenol), and its salts, potassium 2 benzyl-para-chlorophenate and
sodium 2-benzyl-4-chlorophenate, as prescribed in this document except, the enclosed area fogging
application will not-cause unreasonable risk to humans or the environment and all uses, are eligible
for reregistration. The Agency, is requiring handler exposure data on the fogging application and
cannot make an eligibility decision;on this method until these data are generated.
Ortho-benzyl-para-chlorophenol and its salts, are 'broad-spectrum disinfectants/anti-,
microbials for controlling a variety of bacteria, fungi,,algae, and viruses. The use patterns
include: indoor medical, indoor nonfood; indoor Tesidentialrterrestrials nonfood crop, and aquatic
nonfood industrial and residential. Outdoor use sites include swimming pool water related
surfaces such as decks, and other hard surface areas surrounding swimming pools for the acid and
both salts, refuse/solid waste sites for the acid,.air washer water systems for the sodium, salt,
evaporative condenser, water systems and industrial processing water for the potassium salt, and
commercial/industrial water cooling systems for both salts. ,
Ortho:benzyl-para-chlorophenol and its. salts are also registered for use as disinfectants for
farm premises, poultry houses, food processing plants, eating establishments, and federally
inspected meat and poultry processing plants. Dietary exposure is not expected from these use
patterns. Labeling for disinfectants registered'for use in federally inspected meat, poultry, and
egg/processing plants t as well as for phenolic-based, products used as disinfectants in food
preparation, storage, and serving establishments/areas, requires that food products and packaging
materials are removed or carefully covered prior to application and that a potable water rinse is
employed after treatment. Phenolic-based products recommended for use as disinfectants on food
contact surfaces in eating establishments and homes are' limited to sites such as counter tops,
stoves, and refrigerators, which Mowed by a potable water rinse would allow their classification
as a nonfood use. Application of these products as disinfectants on eating utensils, glassware, and
similar items would be considered a food use and would require a tolerance-or an exemption from
the requirements of a tolerance prior to approval'. Specific label directions are provided in Section
V, "Actions Required of-Registrants", which result in the classification of farm premise and
poultry house disinfectants as non-food use products.
Ortho-benzyl-para-chlorophenol and its salts when registered for use as sanitizers on food-
processing equipment and utensils, and on other food-contact articles are under the purview of
FDA (21 CFR; Part 178,1010 (20)). EPA accepts FDA's approval and acceptance of the
chemical(s) use pattern, ^ .
The product chemistry data base for^ortho-benzyl-pararchlorophenol is adequate for
reregistration. However, productchemistry data on the inorganic'""salts are required.
The Agency requires only a limited set of ecotoxicology and environmental fate studies
for microbiocides. The chemical, ortho-benzyl-para^chlorophenol, is nontoxic to birds and.highly
toxic to freshwater fish and aquatic invertebrates. While the hazard to aquatic organisms from
-------
ortho-benzyl-para-chlorophenol has been characterized, a quantitative risk assessment has not been
conducted. The risks to aquatic environments from the uses of ortho-benzyl-para-chlorophenol
are regulated under the NPDES permitting program of the Office of Water. The Agency
currently requires that labels for all ortho-benzyl -para-chlprophenol products require that
discharges to aquatic environments comply with a NPDES permit. Because terrestrial use of
ortho-benzyl- para-chlorophenol and its potassium and sodium salts is limited to refuse/solid waste
sites, exposure to wildlife is not expected to be significant.
The environmental fate data indicate that the two salts' rapidly degrade into the acid in the
environment. Therefore, the data supporting the acid also can be used to support the potassium
and sodium salts.
Ortho-benzyl-para-chlorophenol is Category El for acute oral and dermal toxicity, and
Category IV for acute inhalation toxicity. Ortho-benzyl-para-chlorophenol is severely irritating
to the eye (Category I), and is corrosive with repeated contact to the skin. The requirement for
a dermal sensitization study was waived due to the corrosive nature of ortho-benzyl-para-
chlorophenol. In chronic studies, ortho-benzyl-para-chlorophenol induces increases in kidney
nephropathy and has been classified as a Group C, possible human carcinogen.
There is a data gap for mutagenicity testing; Under the new mutagenicity guidelines a
mammalian cells in culture forward assay (specifically a mouse lymphoma assay) is needed in
order to completely satisfy the mutagenicity testing requirements.
The Agency has determined that regulatory action regarding the establishment of active
ingredient-based minimum PPE requirements for occupational handlers must be taken for ortho-
benzyl-para-chlorophenol. The Chemical Manufacturers Association (CMA) exposure data used
to assess the risk resulting from three of the use-scenarios were based on the handlers in these use-
scenarios wearing chemical-resistant gloves. Therefore, chemical-resistant gloves shall be, required
for occupational handlers of ortho-benzyl-para-chlorophenol for the following use-scenarios-
mixing and pouring a soluble liquid, transferring (pumping) liquid, and pouring powdered or
flaked solid product. Since the chronic MOE for hand-wiping (ungloved) was less than 300
chemical resistant gloves'are required to reduce/mitigate the potential risk to applicators For
exposures related to indoor fogging applications, EPA is requiring the use of a full-face canister-
style respirator to mitigate ocular and inhalation concerns.
i-
The high-pressure spray application use-scenario, which is an intermediate exposure
scenario, had an MOE of less than 100. Since the CMA exposure data used to assess the risk
from this use-scenario was based, in some replicates, on the handlers wearing chemical-resistant
gloves and rainsuits, there are no additional PPE options available that would adequately mitigate
the risk. Furthermore, there are no practicable engineering controls for this use-scenario
However, due to uncertainties in the data used to calculate exposure, the Agency will consider the
high pressure spray scenario conditionally acceptable until new exposure data are available.
VI
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At this time, EPA is not establishing active-ingredient-based minimum (baseline) PPE 'for
occupational handlers for the, following scenarios: (4) low-pressure spraying and (5) mopping.
The estimated exposures to and resulting risk from oftho-benzyl-para-chlorophenoi la these
occupational^use-scenarios.do not warrant establishing such PPE requirements.
The dermal and inhalation studies are required on handlers during fogging and high-
pressure spray applications in enclosed areas. V: . , ,
Before reregistering the products containing ortho-benzyl-para-chlprophenol and its salts,
the Agency is requiring that product specific data, revised Confidential Statements of Formula
(CSF) and revised labeling be submitted within eight months of the issuance of this document.
These data include product chemistry for each registration and acute toxicity testing. After
reviewing these: data and any revised labels and finding them acceptable in accordance with
Section 3(c)(5) of FIFRA, the Agency will Reregister a product. Those products which contain
other active ingredients will be eligible for reregistratipn only when the other active ingredients
are determined to be eligible for reregistfation.
vn
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I.
INTRODUCTION
In ,1988, the Federal Insecticide, Fungicide, aiuTRodenticide Act (FIFRA) was amended to
accelerate the reregistration of products with active ingredients registered prior to November 1,
1984. The. amended Act provides a,schedule for the reregistration process to be completed in nine
years. There are five phases to the reregistration process. The first four phases of the process
focus on identification of data requirements to support the reregistration of an active ingredient
and the generation and submission of data to fulfill.the requirements. The fifth phase is a review
by the U.S. Environmental Protection Agency (referred to as' "the Agency") of all data submitted
to support reregistration. ~. -'..;; ' ,
- FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregistration" before calling
in data" on products and either reregistering products or taking "other appropriate regulatory
action." Thus, reregistration involves a thorough review of the scientific data base underlying a
pesticide's registration, the purpose of the.Agency's review is to reassess the potential hazards.
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects "criterion .of, FIFRA. -.-'
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of ortho-benzyl-para-chlorophenol (the acid) which includes the active
ingredients potassium and sodium 2-benzyl-4-.ehlorophenate (the salts). The document consists of
six sections. Section I'is the introduction. Section II describes ortho-benzyl-para-chlorophenol
and,the salts, its uses, data requirements and regulatory history. Section III discusses the human
health and environmental assessment based pn the data available "to the Agency!, Section TVi
presents the reregistration decision for ortho-benzyl-para-chlorophenol. Section V discusses the
reregistration requirements for ortho-benzyl-para-chlorophenol. Finally, Section VI is/the
Appendices which support this Reregistration Eligibility Decision. Additional details concerning
the Agency's review of apph'cable data are available On request. , .
1
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H. CASE OVERVIEW
A. Chemical Overview
The following active ingredients are covered by this Registration Eligibility
Decision:
Common Name: Ortho-benzyl-para-cMorophenol/Chlorophen
Chemical Name: 2-benzyl-4-chlorophenol
CAS Registry Number: 120-32-1
OPP Chemical Code: 62201 ' ' ,
Empirical Formula: C13HnClO
Trade and Other Names: Preventol BP Technical
Basic Manufacturers): Bayer Inc. and NIPA Laboratories, Inc.
Chemical Name: Potassium 2-benzyl-4-para-chlorophenate
CAS Registry Number: 35471-49-9
OPP Chemical Code: 62202
Empirical Formula: C13HnCl O K
Chemical Name: Sodium 2-benzyl-4-chlorophenate
CAS Registry Number: 3184-65-4
OPP Chemical Code: 62203
Empirical Formula: C13HUC10 Na
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 ortho-benzyl-para-
chlorophenol and salts is in Appendix A.
For ortho-benzyl-para-chlorophenol:
TYPE OF PESTICIDE:
Disinfectant (limited, general, or medical), Tuberculocide, Virucide, Sanitizer, Fungicide
(mold/mildew), Fungicide/fungistat (Trichophyton), Microbiocide/microbiostat (slime-forming
bacteria, slime-forming fungi), Bacteriostat.
-------
-USE SITES:,
INDOOR NON-FOOD
+Agricultural/Farm Premises , _
+Agricultural/Farm Structures/Buildings and Equipment
Animal Kennels/Sleeping Quarters (Commercial)
*Ariimals (Laboratory/Research) : ; ; , . :
+Barns/Barnyards/Auction Barns ~
*+Calves ' -'. -' : ''.."...' .-:" "" '"- '.';"".'"'"<.";>'''""".". *~v"'
-------
#Meat Processing Plant Equipment (Food Contact)
#Meat Processing Plant Premises (Nonfood Contact)
Metalworking Cutting Fluids ,
* + Poultry (Egg/Meat)
*+Poultry (Meat) . ' ,
^Poultry Processing Plant Equipment (Food Contact)
Poultry Processing Plant Premises (Nonfood Contact) -
Refuse/Solid Waste Containers (Garbage Cans)
Rubber Products .
*Specialized Animals
Textiles/Textile Fibers/Cordage ~
INDOOR MEDICAL:
Barber/Beauty Shop Instruments (Shavers/Scissors)
Carpets (Hospital Sanitizer)
Diapers (Hospital Laundry) ' ,
Hospital Conductive Floors .
Hospital Critical Items (Surgical Instruments/Pacemakers)
Hospital Noncritical Items (Bedpans/Furniture)
Hospital Semicritical Items (Catheters/Inhalation Equipment)
Hospital/Medical Institutions Non-conductive Floors
Hospitals/Medical Institutions Critical Premises (Burn Wards)
Hospitals/Medical Institutions Patient Premises,
Hospitals/Medical Institutions Premises (Human/Veterinary)
Household Sickrooms Premises/Contents/Utensils
Human Waste (Typhoid Stools/Feces/Urine)
Laundry (Hospital) - / .
INDOOR RESIDENTIAL:
Bathroom Premises/Hard Surfaces -
*Birds
Carpets (Household Sanitizer)
Diaper Pails (Empty)
Household/Domestic Dwellings
Household/Domestic Dwellings Contents
Household/Domestic Dwellings Indoor Premises
Human Grooming Instruments (Brushes, Combs)
Laundry (Household/Coin-operated) '
* Indicates Premise treatment. Animal feeding/watering equipment treatment. Equipment treatment, or Transportation vehicle treatment.
+ Sec Section V, "Actions for Registrants", for labeling requirements to permit classification of this site as a non-food use.
# Labeling for disinfectants registered for use in federally inspected, meat, poultry, and egg processing plants, as well as for phenolic-
based products used as disinfectants on food contact surfaces of food preparation, storage, and serving establishments/areas, requires
that food products and packaging materials are removed or carefully covered prior to application and that a potable water rinse is
employed after treatment.
4
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Pet Living/Sleeping Quarters. .': . i ; - ^' ' : -.v.^". .'>,.; -";.'";-"- /.'.;'''-'.:.' : '-\-
Refuse/Solid;Waste Containers (Garbage Gaiis) ' ', '' ^ ; " ''--." :" ":'.\v:; ^ :::^
Refuse/Solid Waste Sites (Indoor) .[: ; "";;"'.-.':''.; '"''; .'.:'- ..: ' ,:- : .. 'S<~ '
iRefuse/Sqlid Waste Transportation Facilities/Handling Equipment ' "-V : '-' ' -
Residential Floors ^ f '-::; ;.;..-< .. -..-"'"...'v-\:A.'' '. -..',,; x-',', '' -,'
Toilet Bowls (Interior Surfaces) : - '-.".'.;" : .' ,' ^
toilet Tanks/Water Closets Water ". . ;,,'', ' -:-:'."',:'_': "]'''';. ';":*, .;'..''"",''", ('f'
Urinals (Interior Surfaces) . " . '. ' '. - ', :- '--,
AQUATIC NON-FOOD RESIDENTIAL: " 1 / ; : , r ;
Swimming Pool Water Related Surface Treatment ;. ' ^; ..' ;
TERRESTRIAL -NON-FOOD CROP:
Refuse/Solid Waste Sites (Outdoor) : --: ; , - , , J ' _ ; - ,
PESTS:-' ' ;'. :- .';; "''''.-'." ; '_;r -"";:,";.:.':s^'''';_[':"'', '^^:-;:;'^v-;^'-1"1 ""..'-- -V
Bacteriar,,/ , '..- ...;'...' .." ; '.',"'. -- 's' '-'. '-.- - --.-'./ .--;-:, -.- .;:_ ;
Mycobacterium tuberculosis, :Mycobacterium, bovis, Salmonella cholemesuis,- Staphylococcus
aureus, Pseudomonas aeruginosa, Pseudomonas cepacia, Pseudomonas maltophilia, Salmonella
arizonae, Salmonella enteritidis, Salmonella gallinarum, Salmonella pullorum, Salmonella sonnet,
Salmonella paratyphi, Salmonella .schottmuellerii Salmonella typhi . (Salmonella typhosa),
Salmonella typhimurium, Shigella dysentenae, Shigella flexneri, Staphylococcus epidermis,
Staphylococcus hyicus, Enterobacter aerogenes, Enterpcoccus sp., Enterococci group D sp.,
Enterococcus faecalis, Enterobacter chloacae, Escherichia coli, Proteus vulgaris, Proteus
mirabilis,Klebsiellapneumoniae,Neisseriac^
Streptococcus pyogenes, Streptococcus salivanus, Streptococcus hemolyticus, Streptococcus equi,
Streptococcus suis,^ Taylorettd equigenitalis^ Diplpcoccus pneumoniae, Corynebacterium
diptheriae, Providencia rettgeri, Alcaligenes faecalis, Bordetella brpnchiseptica, Mycoplasma
synpviae, Mycoplasma gallisepticum, Pasteurelld anatipestifer, Pasturella multocida,
Khodococcus equi, Brevibactenumainmpnidgenes,QAoi-c^ slime-forming bacteria,
ammonia-producing bacteria.. . ;'. '.-."'-..'. ,, , : '
. ''.',' ' '.' .'' ' ''.'' ' ' . .. " -,-'.'.'"-.' '"v..' -'"' ' '' .'' .
Fungi;- : .:' ''._ ', . " . ". , .-. :.-"."...':"..- ' ,. "''. . . .: .''..,'''''"
Trichophyton interdigitaies, Trichophyton mentagrophytes, frichophyton equinarum, Candida
albicans, Micr(osporum canis, Microsporum gypseum, Aspergillus niger,Aspergillus fumigatus,
Pennicillium glaucum, surnerfprming; fungi, mold and mildew.
Viruses:, . ,..'.'' : '.'..' '.'.-''.-." '' "; '".'"' ' '. '-'^. VV"-V:V..';/:\/v --;'-\!-\";^ >; '^-:'""-'";-;
Poh'o I virus,-Rhinpvirus, Feline Picornavirus, Avian,Reovirus, Mouse Hepatitis .virus,: Vaccinia
* .Indicates Premise treatment, Animal feeding/watering equipment treatment, Equipment treatment, or Transportation vehicle treatment.
+ SeeSectionV, "Actions for Registrants",:for labeling requirementsto permit classification of this site asa non-food use. '
# Labeling for disinfectants registered for use in/federally .inspected meat, poultry, and egg processing plants, as well as for phenolic- ..
based products used as disinfectants on food contact surf aces of food preparation, storage, and serving establishments/areas,:requires
; that food products and packaging materials are removed or carefully covered prior to application and that a potable water rinse is
employed after treatment. :- . . . '- -/ ; , ' . ,
-------
* virus, Herpes simplex Type 1, Herpes simplex Type 2, Pseudorabies, avian infectious bronchitis,
Avian Adenovirus, avian influenza, Avian Rotayirus, porcine transmissible gastroenteritis, '
Porcine Rotovirus, influenza Type A/Mich, Influenza A2/England, Influenza A2 (Japan, Asian,'
Hong Kong), Newcastle disease, mumps virus, HIV-1 (AIDS virus), Human Rhinovirus Type 38,
Feline Leukemia virus, Rubella, equine arteritis, Avian Laryngotracheitis virus, Parainfluenza
virus, Adenovirus Type 2, Canine Parvovirus, duck enteritis, Equine Herpes virus, Equine
Rotavirus, Feline Calicivirus, Feline Rhinotracheitis. , -
FORMULATION TYPES REGISTERED:
TYPE: Technical grade active ingredient, Manufacturing use, End use.
FORM: Emulsiflable concentrate, Soluble concentrate/liquid, Liquid - ready to use,
Pressurized liquid.
METHODS AND RATES OF APPLICATION:
TYPES OF TREATMENT:
Additive treatment, Animal feeding-watering equipment,-Barrier treatment, Brush-on, Conveyor
treatment,, Disposal treatment, Equipment treatment, Flush treatment, Fog, Heat treatment,
Immersion, Manual brush treatment, Mop, Pour-on, Indoor premise treatment, Premise
treatment, Rinse, Scrub, Shampoo, Sprinkle, Soak, Sponge-on, Spray, Surface treatment, Indoor
general surface treatment, Swab, Transportation vehicle treatment, .Wash, Water related surface
treatment, Wipe-on. .".
EQUIPMENT:
Aerosol can, Bowl mop, Brush, Cloth, Foaming apparatus, Mop, Pad, Mechanical scrubber,
Scrubber, Shampoo machine, Sponge, Sprayer, Compact sprayer, Mechanical sprayer, Pump
spray bottle, Swab, Tank, Washing machine.
TIMING: Final rinse, when needed.
RATE OF APPLICATION:
Indoor Non-food
Disinfectant for hard surfaces - 43 ppm to 2941 ppm active ingredient by volume, 97 ppm to
2657 ppm active ingredient by weight.
* Indicates Premise treatment, Animal feeding/watering equipment treatment, Equipment treatment, or Transportation vehicle treatment.
+ See Section V, "Actions for Registrants", for labeling requirements to permit classification of this site as a non-food use
S Labeling for disinfectants registered for use in federally inspected meat, poultry, and egg processing plants, as well as for phenolic-
based products used as disinfectants on food contact surfaces of food preparation, storage, and serving establishments/areas, requires
that food products and packaging materials are removed or carefully covered prior to application and that a potable water rinse is
employed after treatment. '
6 ' --. ' '. .-
-------
Sanitizer for laundry - 233. ppm active 'ingredient, by volume, 102 ppm to 278'ppm active
ingredient by weight. - '- ' : '.,>-,, ; /-;._ ' .^:
- ' -'' . ' . . -. '' .. ; . -. -."-..:; <;*:.. ?'./'< '-.;''.':'" "-..;';."", ""-'
Residual bacteriostatic activity for. odor-causing bacteria in laundry - 0.3 ppm .active; ingredient
by weight. .. - -. - ; ',: : - .:".';- ;;^:
Carpet sanitizer - 180 ppm to 1438 ppm active ingredient by volume.
Fungicide, (mold/mildew).-18,000 ppm'active ingredient byweight. : -
Indoor Medical ^ ,* , ' , \ ' ',-".. '
Disinfectant for hard surfaces - 202-ppm to 3820 ppm active ingredient by volume, 97 ppm to
STlS.ppm active ingredient by weight:
Diaper, sanitizer-102 ppm active ingredient by weight. ~ -
Carpet sanitizer ,L 523 ppm active ingredient by volume. .
Sanitary disposal of human waste - 769 ppm active ingredient by volume. - .
Indoor Residential : :
Disinfectant for hard surfaces - 202 .ppm to 2941 ppm active ingredient by volume, 97 ppm to
2657 ppm active ingredient by weight. [Toilet bowls and urinals (interior surfaces) 2.3 ppm to
26,000 ppm active ingredient by weight.]
Laundry sanitizer -105 ppm to 209 ppm active ingredient by volume.
Aquatic Non-food-Residential- ' 1 !
Disinfectant for water-related hard surfaces -769 ppm--1409 ppm active ingredient by volume,
1400 ppm active ingredient by weight. i "
Terrestrial Non-food > V i
Disinfectant for refuse/waste sites (outdoor) - 623 ppm active ingredient by volume.
* ' Indicates Premise treatment, Animal feeding/watering equipment treatment, Equipment treatment, or Transportation vehicle treatment.
+ See Section V, "Actions for Registrants", for labeling requirements to permit classification of this site as a non-food use.
# Labeling for disinfectants registered for use in federally inspected meat, poultry, and egg processing plants^ as well as for phenolic-
,based products used as disinfectants on food contact.surfaces of food preparation, storage, and serving establishments/areas, "requires
that food products and packaging materials are removed or carefully covered prior, to application and that a potable water rinse is,
employed after treatment. '' , : . ' ' " ,
' ' ' ' '" ' :' '
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For ortho-benzyl-para-chlorophenol, potassium salt:
TYPE OF PESTICIDE:
Bacteriostat, General disinfectant, Limited disinfectant, Medical disinfectant, Fungicide,
Fungicide/fungistat, Microbiocide/microbiostat (slime-forming bacteria and algae), Sanitizer,
Sanitizer (non-food use), Tuberculocide, Virucide.
USE SITES: ,
INDOOR NON-FOOD:
Agricultural/Farm Equipment/Shoe Baths
+Agricultural/Farm Premises
+Agricultural/Farm Structures/Buildings and Equipment '
Animal Kennels/Sleeping Quarters *
*Animals (Laboratory/Research) (Commercial)
+Barns/Barnyards/Auction Barns ,
*+Beef/Range/Feeder Cattle (Meat)
Commercial Transportation Facilities-Nonfeed/Nonfood
Commercial/Institutional/Industrial Premises/Equipment (Indoor)
*+Dairy Cattle (Lactating or Unspecified)
*-f-Dairy Cattle (Non-Lactating)
^Bating Establishments
#Eating Establishments Equipment/Utensils (Food Contact)
#Eating Establishments Food Handling Areas (Food Contact)
Eating Establishments Food Handling Areas (Nonfood Contact)
#Eating Establishments Food Serving Areas (Food Contact)
Eating Establishments Food Serving Areas (Nonfood Contact)
Egg Handling Equipment (Hatching)
Egg Handling Rooms (Hatching)
Egg Plants/Hatcheries/Brooder Rooms/Shoe Baths (Hatching)
#Food Marketing/Storage/Distribution Equipment/Utensils (Food Contact)
Greenhouse-Empty
*+Hog/Pig/Swine (Meat)
*Horses (Show/Race/Special/Ponies) ' ' "..""''
Laundry (Commercial)
*+Livestock
#Meat Processing Plant Equipment (Food Contact)
#Meat Processing Plant Premises (Nonfood Contact)
ป Indicates Premise treatment. Animal feeding/watering equipment treatment, Equipment treatment, or Transportation vehicle treatment.
+ Sec Section V. "Actions for Registrants". for labeling requirements to permit classification of this site as a non-food use.
# Labeling for disinfectants registered for use in federally inspected meat, poultry, and egg processing plants, as well as for phenolic-
biscd products used as disinfectants on food contact surfaces of food preparation, storage, and serving establishments/areas, requires
thai food products and packaging materials are removed or carefully covered prior to application and that a potable water rinse is
employed after treatment.
8
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Mushroom-Houses-Empty Premises/Equipment.
* + Poultry (Egg/Meat) . '.' . ''v / :"-""' '
* +Poultry (Meat). - - ;-. .:'*.:.'"'
#Poultry Processing Plant. Equipment-. (Food Contact)
#Ppultry Processing Plant Premises (Nonfood .Contact)
INDOOR MEDICAL: "'";' : / T,'.-
Hospital Conductive Floors
Hospital Critical Items .(Surgical Instruments/Pacernakers)
Hospital Janitorial Equipment . .-
Hospital Noncritical Items (Bedpans/Furniture)
Hospital Semicritical Items (Catheters/Inhalation Equipment)
Hospital/Medical Institutions Non-Conductive Floors
Hospitals/Medical Institutions Critical Premises (Burn-Wards)
Hospitals/Medical Institutions Noncritical Premises
Hospitals/Medical, Institutions'Patient Premises
Hospitals/Medical Institutions Premises (Human/Veterinary)
Laundry (Hospital)
Morgues/Mortuaries/Autopsy/Embalming Equipment
Morgues/Mortuaries/Autopsy/Embalming Room Premises
Vomitus ''.'.-"''
- - ^' ' " ' ,.',' ', "' ''- . '-
INDOOR RESIDENTIAL:
Bathroom Premises/Hard Surfaces
Household/Domestic Dwellings Indoor Premises
Human Footwear
Refuse/Solid Waste Containers (Garbage Cans) *
Toilet Bowls (Interior Surfaces) .!
Urinals (Interior Surfaces) - .
AQUATIC NON-FOOD IND0STRIAL:
Commercial/Industrial Water Cooling Systems
Evaporative Condenser Water Systems .
Industrial Processing Water
-------
AQUATIC NON-FOOD RESIDENTIAL: '
Swimming Pool Water Related Surface Treatment
PESTS: .
Bacteria: , .
Pseudomonas aeruginosa, Pseudomonas cichorii, Pseudomonas fluorescents (Biotype G),
Pseudomonas fragi, Pseudomonas putida, Pseudomonas solanacearum, Escherichia coli,
Erwinia caratovora, Erwinia chrysanthemi, Klebsiellapneumoniae, Mycobacterium
tuberculosis var. bovisBCG, Salmonella choleraesuis, Salmonella, enteritidis, Salmonella
pullorum, Salmonella gallinarum, Salmonella schottmuelleri, Salmonella typhosa, Sarcina
lutea, Aerobacter aerogenes, Serratia marcescens, Shigella dysenteriae, Shigella flexneri,
Streptococcus pyogenes, Agrobacterriium tumifaciens, Bordetella avium, Pasteurella
multocida, Staphylococcus aureus, Mycoplasma synoviae, Mycoplasma gallisepticum,
Xanthomonas pelargoni, Xanthomonas campestria, slime-forming bacteria, odor-causing
bacteria.
Fungi:
Trichophyton mentagrophytes, Trichophyton interdigitale, Verticillium fungicola, Vertidllium
albo-atrum, Mycogone pemiciosa, Tricoderma viride, Dactylium dendroides, Botrytis cinerea,
Fusarium oxysporum, Phytophthora cinnamomi, Phthium ultimum, Rhizoctonia solani, mold '
and mildew.
Algae:
Slime-forming algae.
Viruses:
HIV-1 (AIDS Virus), Avian Influenza virus, Avian Bronchitis virus, Avian laryngotracheitis
virus, Influenza A2/Hong Kong, Herpes simplex Type 1, Herpes simplex Type 2, Vaccinia
virus, Adenovirus Type 2, Adenovirus Type 3, Hog cholera virus.
* Indicates Premise treatment, Animal feeding/watering equipment treatment, Equipment treatment,
and/or Transportation vehicle treatment.
+ See Section V, "Actions for Registrants", for labeling requirements to permit classification of this site as
a non-food use.
# Labeling for disinfectants registered for use in federally inspected meat, poultry, and egg processing
plants, as well as for phenolic-based products used as disinfectants on food contact surfaces of food
preparation, storage, and serving establishments/areas, requires that food products and packaging
materials are removed or carefully covered prior to application and that a potable water rinse is employed
after treatment.
10
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FORMULATION TYPES REGISTERED:
TYPE:/' Enduse, v : '"': ';- .' - ..-H :; - . ' ' ': ''. ;'' -. \
FORM: , Granular, Wettable; powder, Emulsifiable concentrate, Soluble "
-' concentrate/liquid; , . . ' ^ "."'
METHODS AND RATES OF APPLICATION:
TYPES OF TREATMENT: , ; / \ ; ,1 i;
Water treatment;(recirculating system), Water related surface treatment, Wipe-on/wiper -
treatment, Shoe bath treatment, Surface treatment, Conveyor,treatment, Equipment treatment,
Premise treatment, Animal feeding/watering equipment, Equipment treatment, Transportation
vehicle treatment, Contact and/or surface treatment, Fog, Sprinkle, Mop, Scrub; Sponge-on,
Spray, Swab, Brush-on, Immersion, Soak, Wash.
EQUIPMENT: .. ( ' .. "' .'' ... . .' ', V ...-.'. ".^ . :''\'. -'.-: :,.';;- :-" ' -.
' ' ' '* ' - " -,-.--. _t "-,...;-,. ". . '__ .-/'; ' ', ' '. "''.''
Mop, High pressure sprayer. Mechanical sprayer,; Pressure sprayer, Hand 'held sprayer,
Cloth, Automatic scrubber, Brush, Scrubber, Sponge, Sprayer, Sprinkler can, Fogger, Bath,
Bowl mop,,Fogger. ;. ; .'"."'',.".' v .: '
' ' ' ' ' '.'''" . , * . .-.-''' . ' . ^ ." S* f '",,--'. '.7. -; ,- ; . _ . -- " - '',;.''-
.TIMING:-.,': ' . -. ''' '" "'' -''";.; ;' [['''' .' "'* '.' ' '/...'. ''''..':'
Initial, Subsequent/maintenance, Not specified. , > '''
RATE OF APPLICATION: :
Indoor Non-Food : ; /
Disinfectant for hard surfaces - 224 to 1075 ppm active ingredient by volume, 15 to 1345 ppm
active ingredient by weight. '
Disinfectant for commercial^ laundry - 520 ppm active ingredient by weight.
Sanitizing fog for hatchers and incubators -'340 to 4085 ppm'active ingredient by weight.
* Indicates Premise treatment, Animal feeding/watering equipment treatment. Equipment treatment,
and/or Transportation vehicle treatment.
+ See Section V, "Actions for Registrants", for labeling requirements to permit classification of this site as
a non-food use. , - _,.
# Labeling for disinfectants registered for use in federally inspected meat, poultry, and egg processing
plants, as well as for phenolic-based products used as disinfectants oh food contact surfaces of food
preparation, storage, and serving establishments/areas, requires that food products and packaging
materials are removed or carefully covered prior to application and that a potable water rinse is employed
after treatment. > , ' ,.- ; ' -,- ".'''
, ..; ' . , ^.;; .; n : " ' : :.-"..:"' .: -:"'':"'.' ' v":;
-------
Sanitizing fog for hatchery rooms - 14371 ppm active ingredient by weight.
Sanitizing fog for hard surfaces of livestock premises and equipment - 26767 ppm active
ingredient by volume. ,
Shoebath sanitizer - 224 ppm active ingredient by volume, 269 ppm active ingredient by
weight.
Indoor Medical
Disinfectant for hard surfaces - 310 to 813 ppm active ingredient by volume, 15 to 1345 ppm
active ingredient by weight.
Disinfectant for hospital laundry - 989 ppm active ingredient by volume, 623 to 1031 ppm
active ingredient by weight.
Bacteriostat for vomitus - 5760 ppm active ingredient by weight.
Indoor Residential '
Disinfectant for hard surfaces - 310 to 1075 ppm active ingredient by volume, 15 to 1345 ppm
active ingredient by weight.
Shoe sanitizer - 520 to 1031 ppm active ingredient by weight.
Disinfectant for toilet bowls - 1078 ppm active ingredient by volume, 4000 to 24000 ppm
active ingredient by weight.
Aquatic Non-Food Industrial '
Microbiocide/microbiostat - 13 to 53 ppm active ingredient by weight.
Aquatic Non-Food Residential
Disinfectant for water-related hard surfaces - 813 ppm active ingredient by volume.
* Indicates Premise treatment, Animal feeding/watering equipment treatment, Equipment treatment,
and/or Transportation vehicle treatment.
+ See Section V, "Actions for Registrants", for labeling requirements to permit classification of this site as
a non-food use.
# Labeling for disinfectants registered for use in federally inspected meat, poultry, and egg processing
plants, as well as for phenolic-based products used as disinfectants on food contact surfaces of food
preparation, storage, and serving establishments/areas, requires that food products and packaging
materials are removed or carefully covered prior to application and that a potable water rinse is employed
after treatment
12
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For ortho-benzyl-para-chlorophenol, sodium salt:
TYPE OF PESTICIDE:
' Medical disinfectant, General disinfectant, Fungicide/fungistat, Tuberculocide, Virucide,
Sanitizer, Fungicide, Microbiocide/microbiostat (slime^forming bacteria, fungi and algae),
Bacteriostat. . ' . . _ '.'. ~ - ' " .,. . ,,.. .'
INDOOR NON-FOOD , ^ :
Agricultural/Farm Equipment/Shoe Baths . -
+ Agricultural/Farm Premises r - , ;
Animal Kennels/Sleeping Quarters (Commercial)
* Animals (Laboratory/Research)
*+Beef/Range/Feeder Cattle. (Meat)
Carpets (Commercial Sanitizer) - , -
Commercial/Iiistitutional/Industrial Floors 'Y
Commercial/Institutional/Industrial Premises/Equip. (Indoor) ' '* -
*+ Dairy Cattle (Lactating or Unspecified) ,
*+ Dairy Cattle (Non-Lactating) . Y
#Eating Establishments . Y
#Eating Establishments Equipment/Utensils (Food Contact) ,
#Eating Establishments Food Handling Areas (Food Contact)
#Eating Establishments Food Serving Areas (Food Contact)Egg Handling Equipment
(Hatching) ' ''''. '"''.,',".. ': '
Egg Handling Rooms (Hatching) . . ,
Egg Plahts/Hatcheries/Brooder Rooms/Shbe Baths (Hatching) ;
#Feed Mills/Feed Processing Plants
#Food Processing Plant Equipment (Food Contact) ,
#Food Processing Plant Premises (Nonfood Contact)
Greenhouse-Empty > . ; . . :
^ *+Hog/Pig/Swine (Meat) , - . .'.' ' , :
*Horses (Show/Race/Special/Ponies)
*H- Livestock. . ,.-...- ','.. , ":. .'- ,'.,.' r.',^;,^- '" -..".'-' "'".'. ,'-'.'..' .. .'7
#Meat Processing Plant Equipment (Food Contact)
* Indicates Premise treatment, Animal feeding/watering equipment treatment, Equipment treatment,
and/or Transportation vehicle treatment. > , . . ' .
+ See Section V, "Actions for Registrants" , for labeling requirements to permit classification of this site as
a non-food use.' ~ , ; -; ,....,.,. . , ;1 ,
# Labeling for disinfectants registered for use in federally inspected meat, poultry, and egg processing
plants, as well as for phenolic-based products used as disinfectants on food contact surfaces of food
preparation,' storage, and serving establishments/areas, requires that food products and packaging materials
are removed or carefully covered prior to application and that a potable water rinse is employed after
'treatment.. - '" ' * ' ' -', '. '''. ' '"" ' ."'":'," : '": ' " . .' ""'..; ' " '-." '.''"','
" ' , '' 13 . '' J ''.'...'
-------
#Meat Processing Plant Premises (Nonfood Contact)
Mushroom Houses-Empty Premises/Equipment
*+Poultry (Egg/Meat)
^Poultry Processing Plant Equipment (Food Contact)
#Poultry Processing Plant Premises (Nonfood Contact)
*Specialized Animals
Textiles/Textile Fibers/Cordage
Upholstery (Hospital/Commercial)
INDOOR MEDICAL
Carpets (Hospital Sanitizer)
Hospital Conductive Floors
Hospital Critical Items (Surgical Instruments/Pacemakers)
Hospital Noncritical Items (Bedpans/Furniture)
Hospital/Medical Institutions Non-Conductive Floors
Hospitals/Medical Institutions Critical Premises (Burn Wards)
Hospitals/Medical Institutions Noncritical Premises
Hospitals/Medical Institutions Patient Premises
Hospitals/Medical Institutions Premises (Human/Veterinary)
Household Sickrooms Premises/Contents/Utensils
Laundry (Hospital)
INDOOR RESIDENTIAL
Bathroom Premises/Hard Surfaces
Filters (Air/Air Conditioner/Furnace)/Air Ducts
Household/Domestic Dwellings Contents
Household/Domestic Dwellings Indoor Premises
Refuse/Solid Waste Containers (Garbage Cans)
Refuse/Solid Waste Sites (Indoor)
Toilet Bowls (Interior Surfaces) ,
Toilet Tanks/Water Closets Water
Urinals (Interior Surfaces)
AQUATIC NON-FOOD INDUSTRIAL
Air Washer Water Systems
Commercial/Industrial Water Cooling Systems
AQUATIC NON-FOOD RESIDENTIAL
Swimming Pool Water Related Surface Treatment
14
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'.PESTS:' /;;- v ,'' '-. ' - '_ ..';;,..-'. v ;: ; -'/'':;"';.;,.:.:'r'.'V-/';-'.V-.;..." ;-::-^..\
Bacteria;-' ''.';'/..., ../.''" ...-.',." ,.-. !.--'-;,: '-:-'.'...'-...~":";:: .^-'^ '-:..-.'.-.. r : ^-::';/...!-.';.v -.-" -';/^',; ^- '".-''".
Alcaligenes sp.,^iplococcuspneumQniae Type. I, Escherichia coli, Ldctobacillus delbrueckli
subspecies lactis,Neissenacatarrhalis, Proteus ^yulgaris, Pasteurella multoada, Salmonella :
schottmuelleri, .Salmonella typhimurium, Serratiamarcescens,,Shigettaflexnen, S
sohnei, Streptococcus hemolyticus, Pseudomonas aeruginosa,Staphylococcusaureus^
Salmonella choleraesuis, Mycobacterium bovis, Pseufonipj^fluorescensfaiotypeE),:.
Pseudomonas solanacearum, Pseudomonas cichprii,Ervvmiacaraioyora, Ermniachrysantemi, '
Agrobacteriumtumifaciens,Xanthomoiws&
Aeromonashydrophild,;Bordetella;avium,Co^
pneumoniae, Mycoplasma gallisepticum, Pasteurella multocida, Salmonella enieritidis,
Salmonella pullorum, Gram positive and; gram negatiVe\bacteri^^S^erf6rming bacteria.
Trichophyton mentagrophytes,Verticillimnfung^icol^
viride.Dactylium dendroides, Botrytis cinerea, Phytdphthora,cinnamoni,Phthium ultimum,
Rhizoctonia solani, Vefticillium a/feofl/ram, Slime-forming fungi. ".
Slime-forming; algae. ^ t
Yeasts: : ".:..' ;-'"< .'.'": , .. -\ .' ,1;- '
Candida albicans, -Saccharomy ces cevevisiae.
Avian influenza Virus, Avian Bronchitis Virus i Avian Laryngotracheitis Virus, Avian Herpes
Virus 2, Hog Cholera Virus, Pseudorabies Virus , Influenza A2, Herpes Simplex, Adenovirus
Type 2, Vaccinia Virus, Adenovirus Type. 5, HIV- 1", Influenza A3/Hong Kong, Herpes
Simplex Type 2, Adenovirus Type 4, Herpes simplex WI-38.
FORMULATION TYPES REGISTERED;
TYPE: End use '~ -.;'-' :'. '';''; -' ( :' .";'; '..".--x i;-' "; ^-:^ ,;J ^^):''r'?-^^--, J-
FORM: Emulsifiable concentrate, Soluble concentrate/liquid, Liquid-Ready to use
15
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METHODS AND RATES OF APPLICATION:
TYPES OF TREATMENT: '"'
Mop, Sponge-on, Spray, Wipe-on/wiper treatment, Animal feeding/watering equipment
treatment, Equipment treatment, Premise treatment, Transportation vehicle treatment, Scrub,
Surface treatment, Brush-on, Soak, Rinse, Swab, Water treatment, Wash, Shampoo, Water
treatment (recirculating system), Indoor premise treatment, Shoe bath treatment, Immersion,
Water related surface treatment, Padding treatment.
EQUIPMENT:
Mop, Sponge, Sprayer, Cloth, Pressure sprayer, Brush, Bowl mop, Rag/Mechanical sprayer,
Carpet shampooer, Bath, By hand, Shampoo machine, Swab, Not specified.
TIMING:
Intermittent (slug) (initial), Intermittent (slug) (subsequent), Not specified.
RATE OF APPLICATION:
Indoor Non-food
341 to 4220 ppm active ingredient by volume, 329 to 2254 ppm active ingredient by weight.
Textiles/textile fibers/cordage-300,000 ppm active ingredient by weight. "
Indoor Medical
341 to 1274 ppm active ingredient by volume, 176 to 2254 ppm of active ingredient by
weight.
Indoor Residential " "
341 to 4000 ppm active ingredient by volume, 176 to 2395 ppm active ingredient by weight.
Aquatic Non-food Industrial
50 to 99 ppm active ingredient by volume.
Aquatic Non-food Residential
Water related surface treatment-494,ppm active ingredient by weight.
C. Estimated Usage of Pesticide ,
*
There are no non-proprietary data available regarding the usage of ortho-
benzyl-para-chlorophenol and its salts. Ortho-benzyl-para-chlorophenol and its salts
account for a substantial share of household disinfectant products used in the mid-
1980s. .
16
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D. Data Requirements v : '
> ; . ;.' / :'.- > : ': :,: '..-- -: /'.v - :t'.- -.-.v.r. A,;>:.V;v::X>v---?';" v.
The Agency issued: a Data Gall-In Notice (DCI) in 1987 to .registrants for
Subchronic and Chronic Toxicolpgical Data for Antimicrobial Active ingredients. On
June 10, 1991 a DCI Notice for ortho-benzyJ-para-chlorophenol was issued under
Phase IV -ofTth'e reregistration program and required submission of additional product
chemistry data. The DCI Notices for potassium 2-benzyl-4-para-chlorophenate and
sodium 2-benzyM-chlorophenate were issued On August 25, 1994 under. Phase IV of
the reregistration pr.bgram andrequired submission x>f additional ^product chemistry,
.' ehyironmental fate and toxicity data.; , ,:. - , r- .
E. Regulatory History
'.- The active ingredients prtho-benzyl-para-chlorophenol; and potassium and
sodium 2-benzyl-4-Hchl6rophenate'salts were first registered in the United States in 1948
as disinfectants. They are currently registered-as disinfectants, bacteriostats, sanitizers
arid microbiqcides for commereial/industrial water cooling systems, swimming pool
water related surfaces such as decks, and other^hard surface areas surrounding
. swimmirig'pools, food-preparation, storage and serving areas, nonfood areas such as
restroom facilities, and'medical/veterinary settings., Additionally $ the salts are
currently registered for use as tuberculocides, virucides and^fungicides on agricultural
farplipremisesl,and in mushroom houses and hospital/medical.institutions.
There are currendy 143 products registered by me Environmental Protection
Agency containing brtho-benzyl-para-chlorophenol active ingredients.
17
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SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
CHEMICAL IDENTITY:
Chemical Name:
Classification:
PPC#:
2-benzyl-4-chlorophenol
Disinfectant ''
062201
Common Names: Ortho-benzyl-para-chlorophenol/Chlorophen
Trade Name: Preventol BP Technical
Company: Bayer Inc. and NIPA Laboratories, Inc.
CAS Reg. No.: 120-32-1
Molecular Formula: Ci3HnClO
Molecular Weight: 218.7 .
Structural Formula: ,
Nominal Concentration... 98.0%
Upper Certified Limit. 100.0%
Lower Certified Limit... 95.0%
PHYSICAL AND CHEMICAL CHARACTERISTICS:
Color:
Physical State:
Odor:
Melting Point:
Boiling Point:
Bulk Density:
White to light gray.
Solid
Slightly phenolic
49ฐC
175ฐC
30.5 lbs./ft3
18
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Solubilities: ' Solvent grams, solute/100 _ .
:'". '.',(".." , V grams solvent
Methyl'ethyl ketone, 656
-' ... _ ' Ethyl alcohol. 644
Isopropyl alcohol 601
Ethylene glycol 422 '-
Benzene 219
: .Carbon tetrachloride; *" 92. '
Mineral oil , . ' 2.3 ."
Water " , 0.007
Vapor Pressure:
Dissociation Constant:
0.1 mbarat 100ฐC
pK= 10.8^0.2 at 20?C,
Octanol/Water .
Partition Coefficient:
PH:
Stability:
Log p = 4.3 ; K?w = 2 X lO4.
5.3 (in saturated aqueous solution).
Stable. Darkens with age. Non-corrosive to metals but complex
jeactions with transitional metals. Slow coloration under
sunlight, iA, \ " , ' , ;/
B. Human Health Assessment
.1. Toxicology Assessment
' ' - '~'''-. ' '",' ."',' ' \- ' ., : "-
. The toxicolbgical data base for ortho-benzyl-para-chlorophenol follows
the tiering pattern set forth for antimicrobials in the 1987 Data Call-in Notice
for Subchronic and Chronic lexicological Data for Antimicrobial Pesticide
Active Ingredients. Due to concerns about the economic effects of imposing
full lexicological data requirements (i.er, same as for a food use), ihe Agency
uses a tiered approach in which Tier 1, and Tier 2 tpxicity data alone, or in
combination \yith exposure data, indicate the, need for Tier 3 data. The
available data will support reregistration eligibility. This document also serves
as the decision on the need for not requiring Tier 3 data (chronic/carcinogenic
study, reproductive study, and metabolism study). : '",-.."
19
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a. Acute Toxicity
The requirement for a dermal sensitization study (GLN 81-6) was
waived because of the corrosive nature of ortho-benzyl-para-
chlorophenol. Of the five studies that were reviewed, only the acute
inhalation study was classified as acceptable. Table 1 summarizes the
results of the studies reviewed. (These data are Tier 1).
Table 1; Acute Toxicity Studies
STUDY
Acute Oral'
Acute Dermal'
Acute Inhalation
Primary Eye
Irritation*'
Primary Dermal ,
Irritation'*
Gim ,
,MRE>&o'.'
GLN 81-1/
00131367
GLN 81-2/
00130937
GLN 81-37
00130938
GLN 81-4/
00131368
GLN 81-57
00131369
RBS13LJ^
", f "
LDj,, males: 4462 rrig/kg
LDM females: 3852 mg/kg
LDso combined: 4147 mg/kg
. LDjj > 2000 mg/kg
LCs, males: 2.60 mg/L
LCjo females: 2.43 mg/L
LC50 combined: 2.50 mg/L
PIS score = 79 at 72 hours
severely irritating
PDII = 1.0 at 72 hours
, slightly irritating
- cAimaoRY
:
III
III
IV
I
IV
Each of these studies was classified as unacceptable, although the information available was sufficient to categorize the study. However,
each study can be upgraded to acceptable upon receipt of the purity of the test material and the identity of the vehicle.
Data pertaining to acute eye irritation and dermal irritation are not required to support the reregistration of the TGAI. These data are
presented for informational purposes.
b. Subchronic Toxicity
Ortho-benzyl-para-chlorophenol was tested in subchronic gavage
studies in both rats and mice (summarized in a single report). The
animals were dosed 5 days/week for 13 weeks at the following dose
levels: rats - 0 (control), 30, 60, 120, 240 or 480 mg/kg/day; mice- 0
(control), 500, 650, 800 or 1000 mg/kg/day.
In rats, the NOEL was set at 120 mg/kg/day. The'LOEL was set
at 240 mg/kg/day based on clinical signs of toxicity, changes in clinical
chemistries, decreases in thymus weights, increases in kidney weights,
chronic nephropathy and thymic lymphoid depletion.
In mice, a NOEL was not established because kidney lesions
were present at the lowest dose tested (LDT), 500 mg/kg/day. The
observed toxic effects included mortalities, clinical signs of toxicity,
increases in liver weights, decreases in kidney weights, renal lesions
(necrosis, casts, inflammation and regeneration of renal tubules) and
necrosis of thymic lymphocytes. '
20
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Both.studies were classified as core supplementary because .only .
minimal summary data tables were provided to support the text of the
report. The studies may^be upgraded if the tables are provided with
legends for clarification, and the individual animal data are provided.
For the mouse study, neither clinical biochemistry studies nor urinalysis
studies" were conducted (GLN 82-1; MRID 40376301, 41248202,
.41462401; this is Tier 2 data).;; . ' -. / ' ',..,
... In a 21-day dermal study, ortho-benzyl-para-chlorophenol was
tested on New Zealand rabbits at dose levels of 0 (control), 1, 5 or-25
mg/kg/day. The NOEL for systemic effects was set at 25,mg/kg/day,
the highest dose tested (HDT). The NOEL for skin effects was set at 1
mg/kg/day, and.therLOEL for skin effects was set at .5 mg/kg/day based
on acanthosis, hyperkeratosis, parakeratosis, dermatitis, and scabs.,
There were spme ulcerated areas in the 25 mg/kg/day dose group.
(GLN 82-2; MRID 41248201; this is Tier 1 dam).
c. Combined Chronic Toxkity and Carcinogenicity
Technical ortho-benzyl-para-chlorophenol (97%) was tested in a
.two-year gavage study with corn oil as the vehicle in male and female
F344/N rats at the following dose levels: 0 (control), 30, 60 or 120
mg/kg/day in males; 0 (control), 60, 120 or 240 mg/kg/day in females..
.Eighty rats/sex/dose level were.used for the study from which
10/sex/dpse were sacrificed at 3 months and 20/sex/dose were sacrificed
at 15 months (10 of these were used for clinical chemistry only).
In, males at dose levels of'30 mg/kg/day and higher, there were
increases in urinary coproporphyrin (179-321 % of control, which
increased with increasing dose); and increases in severity of
nephropathy. , ' ;
At dose levels/of 60 _mg/kg/day and higher, there were observed
increases in urinary protein (251-285%), urinary alkaline phosphatase
(185-225%), kidney weights (104-118%), hyperplasia of the,parathyroid
gland and fibrous osteodystrophy of the cranium and femur (although
neither effect was considered to be statistically significant) in males. In
females,, there were increases in yellow staining of the urogenital area
and-decreases in urinary N-acetyl-p-glucose amidase (32-59%, not dose-
related) and galactosidase (9-42%, not dose-related) activities. The
increase in hyperplasia of the parathyroid gland was attributed to renal
secondary hyperparathyroidism and the slight increase in fibrous
osteodystrophy of the cranium and femur were also ascribed, to and
21
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correlated with the increased severity of the nephropathy and the
development of secondary hyperparathyrbidism.
At dose levels of 120 mg/kg/day and higher, the following
effects were observed in males: decreases in urinary N-acetyl-p-glucose
amidase (54-62%) and galactosidase (30-51%) activities, increased
incidence of hyperplasia of the kidney tubule, and an increase in
transitional cell hyperplasia of the kidney, which can occur in the renal
pelvis epithelium as a component of severe nephropathy. In females
there were increases in kidney weights (107-119%).
At 240 mg/kg/day (HDT), the following effects were observed in
females: an increase in the number and severity of kidney nephropathy
and an increase in transitional cell hyperplasia of the kidney (no statistics
available). .
The systemic NOEL could not be established because of the
increased severity of kidney nephropathy in males at the lowest dose
tested (30 mg/kg/day). There was also an increase in urinary
coproporphyrin in males at this dose level. Therefore, the NOEL can be
assumed to be less than 30 mg/kg/day. The LOEL was set at 30
mg/kg/day, the lowest dose tested.
TWO transitional cell carcinomas of the kidneys were observed in
females, one in the mid-dose group and one in the high dose group.
These are considered to be rare tumors. None were observed in either
the control group or in any of the males. None of these tumors were
observed in any of 1,068 female historical controls.
Individual animal data were provided only for 'the neoplasms,
making it difficult to verify the information provided in summary tables
for the other parameters. Nevertheless, the study appeared to be
adequately conducted and had been subjected to a number of peer
reviews in connection with the National Toxicology Program (NTP).
The study was classified as Core Supplementary for a chronic feeding
study; however, this portion of the study'is still acceptable for
regulatory purposes. The study is classified as core minimum for the
carcinogenicity portion of the study. (GLN 83-5 is considered to be
satisfied, since the chronic study is considered acceptable for regulatory
purposes. MRID 42279301; This is Tier 3 data which were not required
by the Agency. This study was performed by NTP and submitted as
6(a)(2) data). ;-
22
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Technical ormo-benzyl-para-chlorophenol (97%) was tested in 'a
two-year .gavage study with corn Oil as the vehicle in groups of 70 male
, and, female B6C3Fj mice at the following dose levels: 0; (control), 120
(low), 240,(mid), or 480';(high) mg/kg/day. Three and 15 month " -
; evaluations, were included in the study Design in which 10/sex/dose were
sacrificed for evaluation. A systemic NOEL could not be set due to
treatment-related effects at the lowest dose tested. There was a do
related trend (an increase) in clinical findings. There was a statistically
significant decreasing trend in survival for both sexes. However, a
sufficient number of mice survived to termination to adequately
determine the carcinogenic potential. .
There appeared to be a definite effect on body weights at the high
,dose in both sexes (66% of the control value for males; and 70% of the .
control value for females by study termination). Dose-related decreases
in either absolute and/or relative kidney weights were observed (62-90 %
of controls in males, 72-89% of controls in females) at all dose levels.
These effects were more prevalent in males. Absolute and relative liver
weights in females were increased at various times, .most consistently at
the highest dose level (7-20% over controls for absolute and 46-48 %
over controls for relative weights at 15 months and at termination):
There were increases in the following treatment-related lesions at all
dose levels in both sexes: incidence and severity of kidney nephropathy,
hyperplasia and ulcer of the forestornach, mineralization of the glandular
stomach mucosa, and fibrous osteodystrophy. There were increases in
the following at the mid- and high dose levels: myocardial degeneration
and hyperplasia.of the renaltubule in males, and ulcers of the small
intestine in females. There were increases in the following at the high
' dose level:-ulcers-of the, small intestines in males, and depletion of
lymphoid and hematopoietic proliferation of. the spleen as well as
coagulative necrosis and inflammation in the liver in females.
Male mice had a significant dose-related increasing trend and
significant pair-wise comparisons of all dose groups with the controls,
for kidney renal tubule adenomas Nand/or adenocarcinomas combined.'
The incidences of these tumors in the study were above the historical
control incidences for all dose levels (5%, 10% and 9% for the low,
mid,-:and high dose groups, respectively, versus 0.4% in the^male.
historical controls for adenoma or carcinoma). There was also a
, significant difference in the pair-wise comparison of the 120 mg/kg/day
dose group with the controls for kidney renal tubule adenomas. The
highest dose level in this study was considered to be excessive. (MRID
422793'-02; this is Tier 3 data which were not required by the Agency.
The study-was performed by NTP and submitted as/6(a)(2) data).
23
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d. Developmental Toxicity
In a rat developmental toxicity study, ortho-benzyl-para-
chlorophenol was given to Sprague-Dawley rats at dose levels of 0
(control), 100, 300 or 900 mg/kg/day on days 6-15 of gestation.
Statistically significant decreases in body weight were observed at all
dose levels, decreases in mean food consumption were observed in the
mid- and high dose groups and increased water intake was observed in
the high dose group. Therefore, the maternal NOEL was considered to
be less than 100 mg/kg/day, the lowest dose tested. No developmental
effects were observed; therefore, the developmental NOEL was greater
than 900 mg/kg/day. (MRID 00143775; this is Tier 1 data).
In the second rat developmental toxicity study, ortho-benzyl-
para-chlorophenol was given by gavage to Wistar rats at dose levels of 0
(control), 15, 75 or 375 mg/kg/day on days 6-15 post coitum. At 375
mg/kg/day, 3 of the dams died. There was also decreased body weight
gain (47%), and corrected body weight gain (40%) when compared to
controls, as well as an increase in the number of animals with mucoid
feces. The NOEL for maternal toxicity was set at 75 mg/kg/day. The
LOEL was set at 375 mg/kg/day based on decreased body weight gain,
mortality and the increase in mucoid feces. At 375 mg/kg/day, there '
was a decrease in mean fetal weight (94% of control). The NOEL for
developmental toxicity was set at 75 mg/kg/day. The developmental
LOEL was set at 375 mg/kg/day based on a decrease in mean fetal
weight (MRID 00145836, 00161231; this is Tier 1 data):
* ' '
In the rabbit study, ortho-benzyl-para-chlorophenol was tested in
New Zealand White rabbits at the following dose levels: 0, 10, 30 or -
100 mg/kg/day. (These levels were determined by a dose-finding study
in which there was a 50% mortality rate in the 150 .mg/kg/day dose
group and a 100% mortality rate in the 200 and 300 mg/kg/day groups.
Therefore, 100 mg/kg/day was considered to be an adequate dose.) No
maternal toxicity was observed at any dose level. The maternal NOEL
is therefore greater than 100 mg/kg/day, the HOT. An increase in post-
implantation loss was observed in the high dose group when compared
with controls, which was outside the range of .the historical control data.
However, the litter sizes were comparable between the control and the
high dose group indicative of a minimal effect. The NOEL for
developmental toxicity was set at 30 mg/kg/day and the LOEL was set at
100 mg/kg/day. (MRID 00143774, 40988201, 41003901; this is Tier 2s
data).
24
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e. Reproductive Toxicity. ,*?
: ' These Tier 3 data are not required .based on the Agency's tiering
approach-for antimicrobials, A reproduction study is required if it is
determined thar" developmental toxicity and/or adverse effects on the
; reproductive organs were observed in the 9b-day dermal or inhalation
study",. For ortho-benzyl-para-ehlorophenol the available studies
included three developmental toxicity Studies; a 90-day subchronic
feeding study and a 21-day dermal study. The 21-day dermal study
showed dermal effects only. No systemic effects were observed. The
90 -day feeding study showed effects on the kidneys, thymus and liver.
The developmental toxieity studies indicated possible developmental
toxicity in the rabbit. There Was a non-statistically significant increase
in post-implantation loss in the. high dose group when compared to
controls. Although the NOEL for developmental toxicity was based on
this observation* this is not considered to be ahTeffect significant enough
to request a reproduction study because the number of corpora lutea per
doe, the number of implantation sites per dose and the liter size for all
the treated groups, including the high dose group, were larger than the
control .group. In addition, there was no indication of any mutagenic
effects for ortho-benzyl-para-ehlorophenol under the conditions of the
studies. -
f. Mutagenicity
Ortho-berizyl-para-chlorophenol:was tested for potential to induce
reverse mutations in Salmonella typhimurium strains TA1535, TA1537;
_TA98 and TA100. The exogenous metabolic activation mixes were
derived'from either hamster or rat liver S9 homogenates (all strains were
tested with each). The material was tested up to levels of cytotoxicity in
.all tested strains, ranging from 0.3 to 33 ^/plate without metabolic
activation and from 1 to 100 /zg/plate with metabolic activation. Ortho-
benzyl-para-chlorophenol failed to induce a mutagenic response^ either
with or without metabolic activation (MRIDA1287501; this is Tier 1
data).. : . : .-..': '.'"':.. ; : .':
Ortho-benzyl-para-chlorophenol was tested in an in vivo bone
marrow rnicronucleus assay in mice at dosing levels up to~and including
2000 mg/kg. The animals showed clear signs of toxicity, although there
was only slight evidence that the; test chemical reached the target Organ.
Ortho-benzyl-para-chlorophenol tested negatively under the conditions of
the study (MRID 41572801; This is tier 1 data).
25
-------
Non-activated and S9-activated cultures of Chinese hamster ovary
cells were exposed, to ortho-benzyl-para-chlorophenol at concentrations
of 0 (control), 4; 8, 15, 30 or 60 jtg/ml (-S9), or 0 (control), 1.3, 2.5,
5, 10 or 20 /xg/ml (+S9). They were then examined for structural
chromosome aberrations 20 hours after initiation of treatment. The
highest dose tested (HDT) caused excessive toxicity (complete
inhibition), but at no doses were there increased cytogenetic effects
(MRID 41287502; this is Tier 1 data),
There is a data gap for mutagenicity testing. Under the new
mutagenicity guidelines, a mammalian cells in culture forward gene
mutation assay (specifically a mouse lymphoma assay) is needed in order
to completely satisfy the mutagenicity testing requirements (GLN 84).
g. Metabolism
These Tier 3 data are not required based on the Agency's tiering
approach for antimicrobials. Metabolism studies are "required only if
the Agency determines that additional information on the metabolism of
the chemical is necessary to clarify unusual effects observed in chronic
or reproduction studies or to clarify issues concerning structure activity
relationships". For ortho-benzyl-para-chlorophenol, no issues were
identified that warrant the need for metabolism data.
h. Dermal Penetration
A dermal absorption study on a 5% ortho-benzyl-para-
chlorophenol formulation is available. This study has been classified as
acceptable.
The absorption study indicates that ortho-benzyl-para-
chlorophenol reacts in such a way that is typical of a chemical which
destroys the integrity of the stratum corium of the skin (MRID 433134-
01; this is Tier 2 data). Table 2 summarizes the results.
26
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Table 2: Dermal Absorption of ortho-benzyl-para-chlorophenol
''*',,-
% Absorption of 5% Formation From Several Dose ilevels at Various Time Points
DoseTirne
1 hour
. 4:hours
." JO hours
168 hours' -
, 5/ig/cm2'. , ' ',
, ,"'7.1% .
15.82%
23.93% '-'
26.10% ' ,.,-
50^g/cm2
>\ ,'6,19% r' ' ..;
14.69%
, ' 26.31% -
. 51.61%' " , ,-'
500/tg/cm2
5.42%
18.96%
29.15%.
..'"- .- 41.45%. .'. ;
Animals kept longer than 10 hours were washed at 10 hours^
The 168 hours, 50/ig/cm2 value was considered th&most appropriate to use. Therefore; the dermal absorption is 51.6%.
i. ToxicologiCal Endpoints of^^ Concern Identified for Use in Risk
' -";- Assessment ';'",''";'. .""'''"'.'- '' ^";-y-'.".--.; _ "- .-.
There is no registered food use pattern foi; prtho-benzyi-para-
chlorophenol. Should the use pattern change in the future, an RfD was
dqtermined to be 0.01 mg/kg/day by HED's RfD Peer Review,
Committee on Mafch23;4995.! This is;based pn the NOEL/qf less than '
30 mg/kg/day frorn the chronic gavage/carciriogenicity study in the rat
using a safety factor, of 3000 (100 to account for interspecies ,
extrapolation and iritraspecies variability; 10 to account for the lack of a
NOEL for rat study (using less than 30 mg/kg/day); and 3 to account for
the lack of a reproduction study or a chronic dog sttidy).
'Qrtho-benzyl-para-chlor.opherioi has not been reviewed by the
JointFAQ/WHOi Meeting on Pesticide Residues (JMPR).. , ;
The HED Garcinogenicity Peer Review Committee (CPRC) met
on March, 29, 1995 to discu.ss and evaluate" the weight-of-the-evidence.
The CPRC concluded? that ortho-benzyl-para:chiorophenoi should be
classified as Group C,,possible human carcinogen. This was based on
increases in renal tubule combined adenomas/carcinomas i_n the male
B6C3F1 mouse-and in renal transitional cell carcinomas in the female .
F344/Nrat>; Renal, tubularcarcinomas in the mouse and renal
transitional:cell tumors in .the rat are rare. The CPRC! recommended the.
RfD approach for estimating risk. . ' .
The following endpoints were determined by HED's Less Than
Lifetime Committee'on 4/7/95: . , -:. ' r
. An acute (1 day) dietary risk assessment is not required since
/^there is no food use pattern for prthp-benzyl-para-chlorophenol.
-------
A short term (1 - 7 days) occupational or residential risk
assessment is not required since the results from the 21-day dermal study
and the data from the other shorter term studies do not indicate a
tpxicological endpoint of concern which would suggest the need for a
risk assessment for workers exposed dermally to formulations of the
chemical. An intermediate term (1 week - several months) occupational
or residential risk assessment is required based on a subchronic 90-day
gavage study in rats (MRID 41248202). The NOEL was set at 120
mg/kg/day and the LOEL was set at 240 mg/kg/day based on clinical
signs of toxicity, changes in clinical chemistries, decreases in thymuS
weights, increases in kidney weights, chronic nephropathy and thymic
lymphoid depletion.
A chronic (longer than several months) occupational or
residential risk assessment is required based on a chronic gavage study
in rats (MRID 42279301). The NOEL was assumed to be less than 30
mg/kg/day. Therefore, a LOEL of 30 mg/kg/day (LTD) in the rat
chronic feeding study will be used.
For the intermediate occupational or residential risk assessments,
. an MOE of 100 is generally considered acceptable when based on animal
data. ;
However, for ortho-benzyl-para-chlorophenol an MOE of 300
shall be considered acceptable-for chronic occupational or residential
risk assessments due to the lack of a NOEL in the chronic rat savage
study. .
The 10 fold factor (which is used when there are data gaps in
setting the RfD) is not appropriate to include because there are no data
gaps for ortho-benzyl-para-chlorophenol based on the tiering data pattern
for antimicrobials. The 3 fold factor (which is used for lack of a NOEL
in the RfD calculation) is appropriate to include.
The dermal absorption factor is 51.6%.
Exposure Assessment
a. Dietary Exposure
Dietary exposure is not expected from the currently registered
use patterns of ortho-benzyl-para-chlorophenol and its salts. The U.S.
Department of Agriculture and the EPA have determined that
disinfectants always requiring a potable water rinse,, when applied to
28
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, surfaces-in federally inspected meat, poultry, and/egg processing plants,
do not present dietary exposure risks, (USpA, FSIS publication #1419,"'
"List pf Proprietary .Substances and Nonfood Compounds"). Labeling
for these-products, as. well'as, for phenolic-based products used .as.
/disinfectants in food preparation, storage,-and serving .
establishments/areas, requires that'foodproducts andpackaging ,,'
'materials are removed or carefully covered prior to application and that
_a potable water rinse is employed after treatment. Furthermore,.
phenolic based products recommended for use as disinfectants on food '-
.contact surfaces in eating establishments and homes are limited to sites
such.as counter tpps, stoves,and refrigerators,vwhich followed by a
potable water rinse would allow their classification as non-food use.
Application of these products as disinfectants on eating utensils, :
glassware, andI similar; items would be considered a food use and would,
require a tolerance or an exemption from the requirements of a tolerance
prior to approval. Specific label directions are provided, in Section V,
/".Actions Required of Registrants", to permit die classification of farm
premise and poultry house disinfectants as non-food use products.
The Food and Drug Administration (FDA) >and jflie.EPA have -
agreed in a Memorandum of Understanding (MOU) dated 1972 (36 FR;
24234) that FDA will have purview over, pesticides used'as food
sanitizers on food-processing: equipment and utensils, and on other food-
contact articles and EPA wiU register the vise pattern based on FDA's
; approvaUand acceptance (see 21 CFR,Part 178,1010 (20)).
b. Occupational and Residential
, ... " . , - -* .'.-''..,. " ' " . "._..._ -.-.' V '. : . - - - S ,'
, ...An occupational and/or residential exposure assessment is ,
required for an active ingredient .if (1) certain lexicological 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. : N ; . ; , .-.'.. ,- -\ '..'- '', "'."..'.
' Mixer/loader/applicator (M/L/A) exposure data for qrtho-benziyl-
para-chlorophenpl were required by^EPA as part of the reregistration
prQcess, since one tpxicplpgical criteria (i.e., 90-day oral toxicity study
indicated,chronic nephropathy and thymic lymphoid depletion) had been
triggered;. EPA has determined there are possible exposures to handlers
during use practices associated with prtho-benzyl-para-chlorophenol.
Specifically,-EPA is concerned abput .exposures to mixers, loaders^ and ;
applicators at commercial and iiadustrial sites and about pxposure to
homeowners w,ho handle ortho-benzyr-pararchlorophenol-contairiing
products, ,' ' :. . " '.'''-''.'
29
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. The criteria for conducting an, occupational/residential exposure
assessment were met: therefore, an exposure/risk assessment was
conducted using data obtained from CM A (Chemical Manufacturers
Association).
Occupational Exposure
Based on the use patterns and potential exposures, several major
exposure scenarios were identified for ortho-benzyl-para-chlorophenol.
These exposure scenarios are: (1).mixing and pouring a liquid which
involved transferring the liquid from the original container to a smaller
measuring and pouring container,-.- (2) transferring (pumping) liquid
products by metered or gravity flow, (3) use of a high'pressure spray,"
(4) use of a low pressure spray (ungloved), (5) floor mopping
(ungloved), (6) hand-wiping (ungloved) which often included the use of
finger pump dispensers, (7) pouring powdered or flaked solid product
from large shipping containers to smaller containers for measuring and
pouring, and (8) fogging enclosed areas.
The exposure data submitted by CMA used for use-scenarios (1)-
(7) in this assessment was obtained in response to an EPA Data Call-in.
The CMA Antimicrobial Exposure Assessment (MRID 41412201,
41742601, 42587501) was designed to assess potential dermal and'/or
inhalation exposures to M/L/As. Various industrial, commercial, and
consumer use sites and application methods were analyzed. Hpwever,
fogging of enclosed areas was not considered in the CMA Study.
For use-scenarios (l)-(7) it was necessary to calculate the amount
of active ingredient to which the M/L/A was exposed. Therefore, each
scenario assumed the use of an existing product to create a reasonable .
worst-case exposure scenario. The dilution ratios/mixing ratios
discussed in each scenario were taken from the product labels.
Scenario 1: Mixing and Pouring a Soluble Liquid.
The product assumed for this scenario was WRICO EGA with
23.5% active ingredient (EPA Reg. 1757-87), It was assumed that an
operator treated an industrial recirculating water system, The initial
dose was 25.6 fluid ounces of product per 1000 gallons of water. (The
dose would be repeated until control was evident.) Assuming 20,000
gallons of water were treated per exposure, a total of 512 ounces (4
gallons) of product would be needed. Four gallons of product equals
8.85 pounds of active ingredient for this initial treatment (4 gallons x
0.235 (23.5%) x 9.42 Ibs/gal = 8.85 Ibs). It was assumed that the
30
-------
'treatment was performed 50 timesJper year (once a week less two weeks
vacation)' thus indicating an intermfediate exposure scenario. ' , ,
Scenario 2: Transferring (Pumping) Liquid Products
The product assumed for this scenario is the same as that for
Scenario 1. Therefore, me :same assumptions were used.
._." ,'', , . -^;. . r ' ..." - '- -"',, - :. ,''' f .-.''. /
Scenario 3: High Pressure Spray
Exposure potential Is considered to'be high for mis scenario due
. to dripping and generated spray. The product assumed for this scenario
was MAGNAPHEN, 100 which is 8.99% active ingredient. (This is the
potassium salt of ortho-benzyl-para-chlorophenol; EPA Reg. 52779-15).
' One ounce of product was used per 3 gallons of water (1:400 dilution)
for high pressure spray applications. If 50 gallons of diluted product
were used per 1,000 square feet of surface area; then, 10.7 ounce,s of
product were used per 50 gallons, of water. Assuming a total of 10,000
square feet of a poultry house could be treated in a day, then a total of
167 ounces of .product would be used in a day. The 167 ounces of,
formulated product equals 1.12 pounds of active ingredient handled.
(167 oz/128 oz per gallon = 1.3 gallon of product needed. The density
is 9.6 Ibs per, gallon of product, 1.3 gallons x 9.6 Ibs/gal x 0.0899
(8.99%) = 1.12 Ib a.i. used.) It was assumed that the treatment was ,
performed 50 times per year (once a.week less two weeks vacation)thus
indicating an intermediate exposure scenario.
Scenario 4: Low Pressure Spray (ungloved)
The product assumed for this scenario was SANI-GLIDE with
1.4% active ingredient (EPA Reg. 1677-128). A.I % by volume (1 V*
ounce to 1 gallon of water) dilution of product in water was sprayed
through standard conveyor lubricant spray nozzles. If a total of 100
gallons of water were treated by adding 125 ounces of product, then
0.123 Ibs a.i. are handled (125/128 x-Q,014(l.4%) x 9 Ibs/gal = 0.123
Ibs a.i. used). It was assumed mat the treatment was;.performed 50 ""
times per year (oiice a week less two weeks vacation) thus indicating an
intermediate exposure scenario. .
Scenario 5: Floor INiopping (ungloved) -
The product assumed for this scenario was Tek-Trpl, a liquid
concentrate with,10% active ingredient (EPA Reg. 11725-7). One-half
ounce of product was" used, per gallon of water:(1:256 dilution).
Assuming an applicator used 10 gallons of diluted product, then a total.
of 5 ounces of product were used, which is.0.5 ounce of active
ingredient. A total of 0,035 pounds a.i. (0.5 oz/128 oz (gallon) x 9 Ibs
per gallon = 0.035 ib a.i.) was used. It was assumed that mopping was
-------
performed 250 times per year (each work day less two weeks vacation)
thus indicating a chronic exposure scenario.
Scenario 6: Hand-Wiping (ungloved)
The product assumed for this scenario is the same as that for
Scenario 5. Therefore, the same assumptions were used.
Scenario 7: Pouring Powdered or Flaked Solid Product
The product assumed for this scenario was TERGISYL with
active ingredient 7.45%. This is the potassium salt of ortho-benzyl-para-
chlorophenol; (EPA Reg. 675-16). One ounce of powder in a pre-
measured water soluble pouch was mixed with one gallon of water.
Assuming 100 gallons of water were treated, then a total of 100 ounces
(6.25 pounds) of product were used, which is (6.25 Ibs x 0.0745) 0.47
Ibs a.i. It was assumed that the treatment was performed 50 times per
year (once a week less two weeks vacation) thus indicating an
intermediate exposure scenario.
Scenario 8: Fogging in Enclosed Areas
The Agency does not have any exposure data for the fogging use-
scenario. Fogging of enclosed areas was not considered in the CMA
Study.
Table 3A: Exposure Estimates for Ortho-Benzyl Para-Chlor
Scenario
Mixing and Pouring a
Liquid
Transferring (Pumping)
Liquid Products
High Pressure Spray
Low Pressure Spray
(ungloved)
Pouring Powdered or
Flaked Solid Product
Fogging in Enclosed
Areas
Setting
or
Use
Cooling
Tower
Cooling
Tower
Disinfection
Disinfection
Preservative
Disinfection
UE
(iig/lb a.i.)
10230
90
299680
190560
479
No data
lbki.f
use
(each
8.85
8.85
1.12-
- Oil23
0.47
No data
phenol Intermediate Use Scenarios
, -Daily
Exposure ,
(Hjg/kg/Say)
1293 ,
'11
4795
335
3
No data
AtfuitetS
m
frg/fegfiito.?)
667
5.9
2474
173
1.7
No data
Adjusted
m
-------
The Unit Exposure' (UE) was .derived from .the CMA Study
(Amended.report, 1992). The UE is a combination of both dermal and
inhalation exposure values. The dermal exposure component of the
.UE was derived from the sum of dermal deposition measurements that
were taken at multiple body-locations. Measurements that were less than
the Level of Detection (non-detects) were included in the calculation at
one-half of the LOD. However, attempts to measure the inhalation
exposure component resulted in non-detectable values; Therefore, the
inhalation exposure component was added to the dermal exposure
component. .The inhalation exposure component is considered to be very
minimal in comparison to the dermal exposure for o-BCP.
In the CMA Study the clothing worn by workers was long sleeve
shirts, long pants and gloves with the exception of the low .pressure
spray, wiping and mopping scenarios for which the workers-did hot s
"wear gloves. . ,. ' ( , .'. , . , ..,-....
BW = Body Weight, which is 70 kg the default male value
DE (Daily ,Exposure,"ug/kg/day) = (UE X Ib ai/used) / BW
Adjusted DE = DE x the dermal exposure factor for orthp1
benzyl-para-chlorophenol, which is 0.516
/ f
Scenario
Floor Mopping
(ungloved)
Wiping:
(ungloved)
Sating--
orOse
Disinfection
Disinfection
- - ''
0E '
:?o
70
Dafly ;
Sxposatb
(DS/fcgjaayjf i
38
1461
;
ADD
(og/tg/day)
26
1001
Adjusted :
AT3D '
13
517
Affjusfcd.
ADD
img/kg/day)
001
3 .
0 SI
7
The Unit Exposure (UE) was derived from the CMA Study
(Amended report, 1992). The UE is a combination of both dermal and
inhalation exposure values: The dermal exposure component of the UE
was derived from the sum of dermal deposition measurements that were
taken at multiple body locations. Measurements that were less than the
Level of Detection (non-detects) were included in the calculation .at one-
half of the LOD. However, attempts to measure the inhalation exposure
component resulted in non-detectable values. Therefore, the inhalation
exposure component was added to the dermal exposure component. The
inhalation exposure component is considered to be minimal in .
comparison to the dermal exposure for prBCP. _.'
"...- In the CMA Study the clothing worn by workers was long sleeve
shirts, long pants and gloves with the exception of the low pressure
33
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spray, wiping and mopping scenarios for which the workers did not
wear gloves. "
EF = Exposure Frequency, which is the number of exposures
per year (For the purposes of this assessment, it was assumed that only
one exposure occurs during any one day.)
BW = Body Weight, which is 70 kg the default male value
DE (Daily Exposure, ug/kg/day) = (UE X Ib ai/used) / BW
ADD (Average Daily Dose, ug/kg/day) = ADE x EF / 365
Adjusted ADD = ADD x the dermal exposure factor for o-BCP, which
is 0.516
Occupational Post-Application Exposure
The Agency does not have the data necessary to estimate post
application exposure to ortho-benzyl-para-chlorophenol by workers
entering treated areas. However, the Agency, assumes that post
application exposures, would be significantly less than that of handlers
for use-scenarios (1),(2), (5),-(6), and (7). The Agency also assumes
that post-application exposures would be, less than that of applicators for
the high-pressure spray and low-pressure spray scenarios, provided entry
into treated areas does not occur immediately following the application,
i.e., until sprays have dried. However, the Agency has concerns about
post-application dermal and inhalation exposures to ortho-benzyl-para-
chlorophenol by workers entering enclosed areas following fogging
applications.
Residential/Homeowner Exposure
The two scenarios most applicable to the homeowner/residential
scenario are: floor mopping (ungloved) and hand-wiping (ungloved). It
was assumed that a homeowner would mop or wipe once or twice a
week (52 or 104 times a year) which is less than the 250 times a year for
an occupational handler. The diluted product that would be used by the
homeowner would contain less of the active ingredient than the product
used by an occupational handler. Additionally, a homeowner is likely to
use less than ten gallons per day.
Therefore, the Agency assumes that exposures to homeowners
who handle products containing ortho-benzyl-para-chlorophenol would
be considerably less than the estimated exposures and would not,
therefore, be significant.
34
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.-," . The Agency assumes that .post-application exposures for
; homeowners, such as walking on. a mopped floor, would be even less
, than the above estimated/assumed exposures.* ' -.-.
3. Risk Assessment -
* " ^ " "'",''' ' , '; ---"- ' '
a. Dietary
;, Based on the current use patterns and exposure profiles for ortho-
benzyl para-chlorophenol, residues in/on food and/or feed 'are not
,, expected to occur. Therefore, a dietary risk characterization is not \
' .required. ' . . - _ . .
b. Occupational and Residential
' ". As previously stated, the toxicological endpoint of concern for an
intermediate exposure is the. NOEL from a subchronic/90 day gavage
study, 120 mg/kg/day. The endpoint for a chronic exposure is the
LOEL from a chronic gavage study. 30 mg/kg/day.
The Margin, of Exposure (MOE) is a measure of how closely the
estimated exposure comes to the NOEL; The JylOE is,calculated using
the following formula:
MOE=-
NOEL
EXPOSURE
For calculating the intermediate MOE, the formula would be:
l '1.20 mg/kg/day
Adjusted DE mg/kg/day.
For calculating the chronic MOE, the formula-would be:
MOE=-
30 mg/kg/day
Adjusted ADD mg/kg/day - , ;'-....
35
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The MOEs calculated using the chronic formula can be
considered to be slightly over-estimated since a LOEL is being used in
the calculation. The NOEL, could not be determined, but would be less
than 30 mg/kg/day, and therefore yielding slightly smaller MOEs. The
risk could be considered as under-estimated; therefore for a chronic
exposure an MOE of less than 300 could trigger a risk concern.
Table 4: Occupational Margins of Exposure
Scenario ,,
; Mixing and Pouring a iquid
Transferring (Pumping) Liquid Products
High Pressure Spray
Low Pressure Spray (ungloved)
Floor Mopping (ungloved)
Wiping (ungloved)
Wiping (gloved)
Pouring Powdered or Flaked Solid
Product
Fogging in Enclosed Areas
> Setting of X3se
Cooling Tower
Cooling Tower
Disinfection
Disinfection '
Disinfection
Disinfection
Disinfection
Preservative
Disinfection
lateaaedlate
MOE'
180
20,338
48
694
ft/A
N/A
N/A
70,588
No data
Chroflfc MOE
N/A
N/A
N/A
N/A
2,255
58
581
N/A
No data
Of tho chronic MOEs. hand-wiping (ungloved), is less than 300. The chronic MOE is considered to be the most appropriate estimate
for the wiping and mopping scenarios since an exposure frequency of 250 was assumed. For the wiping scenario, gloves were not
worn during the CMA Assessment Study. If chemical resistant gloves were to be worn while wiping, then the MOE (gloved) can be
estimated as 581 assuming gloves provide a 90% protection factor.
All of these MOEs were calculated using the 70 kg default male
value. If these MOE calculations were to be performed using the 60 kg
default value for a female, then the MOEs would "be slightly smaller.
Since, all intermediate MOEs, except the high pressure spray, are
greater than 100 and all chronic MOEs are greater than 300, then MOEs
calculated using 60 kg should also exceed 100 for intermediate exposure
(except the high pressure spray), and 300 for chronic exposure.
I *V
As previously stated all intermediate MOEs, except the high
pressure spray, are greater than 100. The CMA Assessment Study
indicated that some of the exposure data for the high pressure spray
scenario was obtained from applicators that were wearing rainsuits.
Therefore, protection factors cannot be applied to improve the MOE
through the use of PPE. There are no engineering controls that are
practicable.
However, the Agency believes that the MOE of 48 for the high
pressure spray scenario can for the present be considered acceptable for
the following reasons:
36
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' ' ':.-/'' . ..'.>:'" ' , .'3 - '.-.'-'' '-. ' - ' ...... "'-:':, : ", ' -
(1), Use of .the daily exposure value-instead of an average daily dose could
over-estimate exposure. ' ; , *-' " '- -' ' :- " ' V
(2) The Agency does not have an appropriately designed study which would
yield \a lexicological endpoint of concern that mimics a use-scenario
- /which assumes product use of once a week for, a year.
(3) The lexicological effects that were demonstrated at the LOEL in the 90-
day study cannot be considered severe. . . . / '
.Thus, the Agency will consider the high pressure spray scenario
conditionallyacceptable until new exposure dataare available. New
exposure data are needed,because the current study references that
"Some applicators wore rainsuits",thus indicating that the data were
taken from both protected and unprotected applicators. Therefore, it is
not possible^ to extract an accurate exposure level. .
.,- ', ... - -./ i '...." i-..
The CMA Study does not providje data for the fogging
application scenario. Therefore, the Agency is requesting the registrant
, to provide applicator exposure data to confirm that application of this
product in a fogging device does not pose unreasonable risks to workers,
dirdugh dermal or inhalation exposures. In the interim, since the
Agency is particularly concerned about inhalation and ocular exposures
to applicators during fogging and other handlers who may enter the .
treated area before the fog -has dissipated, full-face respiratory protection
' > ' ' '.' will be required for such situations. '
Risk From Occupational Post-Application Exposures
, . ,It was previously stated that occupational post-application
exposure would, be significantiy less than that of handlersin many of the
exposure scenarios, such as use-scenarios (1, (2), (5), (6), and (7). The
MOEs for occupational handlers are considered to be acceptable.
Therefore, if the data were available to estimate me MOEs for post-
application workers; these MOEs'Should be even^^ higher, and therefore "
also acceptable. ; -
The Agency also assumes that post application"exposures would
be significantly less than/that'of-applicators' for the high-pressure spray
and low-pressure spray use-scenarios provided entry into treated areas
does not occur immediately following the application, i.e., until .sprays
have dried. In these use-scenarios prolonged skin contact by entering
workers with :treated surfaces (such as walls, benches, ,and floors) is
unlikely.
37
-------
However, the Agency is concerned about post-application dermal
and inhalation exposures to ortho-benzyl-para-chlorophenol by workers
entering an enclosed area following fogging applications. To mitigate
these risks, the Agency is requiring that the fog be completely dissipated
and the enclosed area be thoroughly ventilated before entry (other than
entry by trained and equipped handlers) is allowed.
Residential/Homeowner Risk
As previously stated, the two scenarios most applicable to the
homeowner/residential scenario are: floor mopping (ungloved) and '
hand-wiping (ungloved). Since EPA assumed that exposures to
homeowners would be significantly less than the estimated exposures to
occupational handlers, the MOEs for homeowner handlers should also
be greater than 100 for these two exposure scenarios. Therefore, the
Agency has determined that requiring homeowner users to wear
chemical-resistant gloves while wiping surfaces by hand with ortho-
benzyl-para-chlorophenol is not warranted. No active-ingredient based
personal protective equipment will be required for end-use products
primarily intended for homeowner use.
Since EPA assumes that post-application exposures to
homeowners would be significantly less than the estimated exposures to
occupational handlers or post-application workers, EPA estimates that
homeowner post-application exposures to ortho-benzyl-para-
chlorophenol would be acceptable without restrictions.
C. Environmental Assessment
1. Ecological Toxicity Data
The Agency has adequate data to assess the toxicity of the acid (ortho-
benzyl-para-chlorophenol) to nontarget organisms. No toxicity data exist for
either the potassium or sodium salts. The requirements for testing the inorganic
salts are waived because environmental fate data indicate that the two salts
rapidly degrade into the acid in the environment.
a. Toxicity to Terrestrial Animals .
(1) Birds, Acute and Subacute
To establish the toxicity of a microbiocide to birds, the
following tests are,required using technical-grade material: an
avian single-dose oral study (LD50) on one species, preferably
38
-------
mallardor- bobwhite quail; and,one subacute dietary study
"(LCjo,):. One study should use one ^pecies (Df^waterfowl,'.
preferably the mallard duclt-,- and the other study should use one
.species of upland gamebkd, preferably bobwhite quail. The '
registrant ^conducted .these studies, required for the acid-and both
'salts, only on the apid. The following tables present these study
results.
Sv. <. * v f .-.-. w *^^ -\ - ^ \ :. l.'"v"J """
; " "V,5 ,"" - - 7 ^ " A&SB Acute 6ralToxkfey findings " , "" -V% ' -" V \% * ^'"
Species ; ' ,\ : "
Northern. Bobwhite Quail '
%A.;I.
95 (acid)
LDs, (mg/kg)
'-^
>251'0.
Accession No.
(Author/Year)
252126
(Beavers 1983) :
Toxicity
Category ,
practically
nontoxic
Fulfills
Guideline,
Requirement*
Y . . ' '
ป ^ j ___,, __..__. .. f X&VIHI \wi.uuj ^>ui.viuiซj AUIAAIIWU. vjuiu^iiu^ UUL oUUlllUilol llliUiIIlaimU IS IlCCUvO
S=Supplemental (Study provided useful information but Guideline was not satisfied) N=Unacceptable (Study was iejected)/Nonconcur
\v! " ^ % ^ v ^ ""
"^ % a; , -- v
Species
Northern Bobwhite Quail ,
Mallard Duck ,
"A^^T^eปt*BSi^^K^cป%jraftfli^|S ^ - ^J, -, " s," " Vซ^
% A.I.
.95 (acid)
95 (acid)
LCj,, (ppm)
'>5620 '.-.
>5620
Accession No.
(Author/Year)
252303 .
(Beavers 1984) -
252304 . .
(Beavers 1984)
Toxicity
Category
practically
, nontoxic
practically
nontoxic ,
Fulfills Guideline
Requirement*
Y ; . ',:..' . ._
Y , .
P=Partial (Study partially fulfilled Guideline but additional information is needed
S= Supplemental (Study provided useful information but Guideline was not satisfied)
N=Unacceptable (Study waWejected)/Nonconcur, '
These results suggest that ortho-benzyl-para-chlorophenbl
is practically nontoxic to avian species on an acute oral and.
subacute dietary basis. Because the environmentaifate data
-.. indicate that the two salts rapidly degrade into the, acid in the
; environment,^^ the guideline requirements for: avian testing with
the inorganic salts are waived. Therefore, the guideline
requirements, are fulfilled. ... , :
'(2) Birds, Chronic
Avian reproduction studies are required when birds may
be,exposed repeatedly or. continuously through persistence,
bioaccumulatipn, or multiple applications, or if mammalian
reproduction tests indicate reproductive hazard. These conditions
do not apply to ortho.-benzyl-para-chl6rophenol and its potassium
and sodium,salts. Avian reproduction testing is not required,
-------
b.
(3) Mammals
Wild mammal testing is required on a case-by-case basis,
depending on several factors: results of the lower tier studies,
such as acute and subacute testing; the intended use pattern; and
pertinent environmental fate characteristics. In most cases,
however, an acute oral LD50 study is used to. determine toxicity
to mammals. For ortho-benzyl-para-chlorophenoland its
potassium and sodium salts, no acute mammal data are available.
(4) Insects
;'...
A honey bee acute contact LD50 study is required if the
proposed use will result in honey bee exposure. Because
applications of ortho-benzyl-para-chlorophenol and its potassium
and sodium salts are not likely to result in exposure to honey
bees, data are not required.
Toxicity to Aquatic Animals
(1) Freshwater Fish
To establish the toxicity of a microbiocide to freshwater^
fish, the minimum data required on the technical grade of the
active ingredient is one freshwater fish acute toxicity study. The
study should be conducted with either a cold-water species,
preferably the rainbow trout,, or a warm-water species;
preferably the bluegill sunfish. Data are required for the acid
and both inorganic salts.
Species
Rainbow trout
Bluegill sunfish
- ' ,
.ซ.
95 (acid)
95 (acid)
ฃซ5lปปstf*r^M 4
LCM (ppm)
0.72
0.33
-. * ^ ^ > * ' i.
"% *"
Accession No.
'(Author/Year)
251889
(Anonymous 1983)
251889
(Anonymous 1983)
C" '
Toxicity
Category
highly toxic
highly, toxic
Fulfills guideline '
requirement*
- v ; . ,-
Y
P-Partial (Study partially fulfilled Guideline but additional information is needed
SSupplemental (Study provided useful information but Guideline was not satisfied)
N"* Unacceptable (Study was rejected)/Nonconcur
The results of the 96-hour acute toxicity studies, using the
acid as the test material, indicate that ortho-benzyl-pafa-
40
-------
chlorophenoi is highly toxic to cold- and .warm-water fish. The ,
requirements.for testing the. inorganic salts are waived because
environmental; fate data indicate that the two salts rapidly degrade
into the acid in,the environment.'; - : "V . , ,, - ,
(2)-'/, Freshwater Invertebrates
The minimum testing required to assess the hazard of a
microbiocide to freshwater invertebrates is a freshwater, aquatic
'invertebrate toxicity test,-preferably using.first instar Daphnia
mdgna or early instar amphipods, stoneflies,, may flies, or
midges. Data are required for the acid and both inorganic- salts.
The table below shows the results of'these tests.- -
' ' ... i?rซsbwHfer Invertebrate Toxicfty Eiiufings ' '
Species
Daphnia magna
.'-.'"
%A.I.
" 95 (acid) ;
ECM (ppm)
0,59",.. '
Accession No.
(Author/Year)
251889
(Anonymous 1983) 7
Toxicity
Category
highly
toxic
Fulfills guideline
requirement*
Y. .-' '' ' ' 1
P=Partial '(Study partially fulfilled Guideline but ;additional.inforniation is heeded '-
S=Supplemental (Study .provided useful information but Guideline was not satisfied)
N^Unacceptable; (Study was'rejected)/Nonconcur; '"/,'.
There are sufficient inforrnation to characterize the acid as
as highly toxic to aquatic invertebrates. The guideline
requirement for testing the acid isifulfilled. the requirements
forstesting the inorganic salts are waived because environmental.
fate data indicate that the two salts rapidly degrade into the .acid
in the-environment,, ;',-"'"'.
(3) Estuarine and Marine Animals
, Acute toxicity testing with estuarine and marine
organisms is required when an end-use product is intended for
direct application, to the marine/estuarine environment or is
expected to reach this environment in significant concentrations.
Because of the use sites and nanir^e of the products, exposure of?
ortho-benzyl-para-chiorophenol and its potassium and sodium
"salts to marine/ estuarine organisms is not expected. Therefore,
data are not required. ' ' " >/
41
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c. Toxicity to Plants
(1) Terrestrial
Terrestrial plant testing (seedling emergence and
vegetative vigor) is required for herbicides which have terrestrial
non-food/feed or aquatic non-food (except residential) use
patterns and which have endangered or threatened plant species
associated with the site of application. These conditions do not
apply for ortho-benzyi-para-chlorophenol and its potassium and
sodium salts. Phytotoxicity tests are not required. '
2. Environmental Fate
a. Environmental Fate Assessment
The environmental fate data base for ortho-benzyl-para-
chlorophenol is adequate for reregistration. The environmental fate
assessment for ortho-benzyl-para-chlorophenol applies to both the
potassium (potassium 2-benzyl-4-chlorophenate) and sodium (sodium 2-
benzyl-4-chlorophenate) salt because the salts can be expected to rapidly
degrade to the acid (ortho-benzyl-para-chlorophenol) in the environment.
The registered uses of ortho-benzyl-para-chlorophenol should not
result in significant exposure to the environment. Orthp-benzyl-para-
chlorophenol is not expected to hydrolyze under environmental
conditions and existing data indicate that microbial degradation is likely
the predominant route of degradation.
b. Environmental Chemistry, Fate, and Transport
Phenolic compounds make up a major group of antimicrobial
chemical agents. These compounds are thought to act primarily by
denaturing cell proteins and damaging cell membranes. The
antimicrobial activity of phenolics is reduced at an alkaline pH and by
organic material. Low temperatures and the presence of soap also
reduce antimicrobial activity.
Orthd-benzyl-para-chlorophenol has a melting point of 45 ฐC and
a vapor pressure of < 1 torr at 139ฐC. It has a solubility of 70 ppm in
water and 6 x 106 ppm in isopropanol. The octanol/water partition
coefficient (log Kow) was estimated by the registrant to be 4.4 using the
method of Hansch and Leo, 1979.
. 42
-------
Ortho-benzyl-para-chlorophenQl is not expected to hydrqlyze
under environmental conditions and existing data indicate that microbial
degradation is likely the predominant route of degradation. Therefore
hydrolysis data 'are not required for this' chemical. The potassium
(potassium 2-benzyl-4-chlorophenate) and sodium (sodium 2Tbenzyl-4-
chlorophenate) salts are expected to rapidly degrade to the acid (ortho-
benzyl-para-chlorophenol) in the environment'
. - - ' ' s- '- -. " . -.' " "-' :' i .".--- -'V -_.'.. '-'-'.''-'.''
The biodegradation of oftho-6enzyl-para-chlorophenol was
reported by Monsanto Industrial Chemicals Co. in its Technical Bulletin,
No. IC/DP-502 for SANTOPHEN 1 (MRID #: 00130936), They
examined, the blodegradation in systems closely approximating those
which would be encountered by the product in nature, such as river
water, sewage and/activated sludge. These systems would be the
primary route for disposal of liquid disinfectant.compounds. The results
of the study indicated that, ortho-benzyl-para-chlprophenol is readily
biodegraded in river water, sewage and activated sludge..
* ;~ SttttSM-'' ,
/ River Water
Sewage .
Activated Sludge
\- ..
OrthoBeuzyI-|)aEa-Chlarqpba3orv
0.1 mg/L
0.5mg/L..
1.0 mg/L ; '
1.0 mg/L
.'.' 1.0 mg/L
, 100^t>B<3HAปAtlOK: '- '
6 days
' i ^y
' . 1 day
8hour;s(80%)
1 day,
3- Exposure and Risk Characterization
a. Ecological Exposure and Risk Characterization
(1) Exposure and Risk to Noritarget Organisms
;-,;'.;. The.Agency requires only a limited set of ecotoxicology
and environmental'fate studies for microbipcides. The chemical,
ortho-benzyl-para-chlorophenol, is nontoxic to birds and highly
toxic to freshwater fish and aquatic invertebrates. _
I' ; ' ' .'.,". '- ' .. ' ' " . , M '
.. The swimming pool water related surface use of ortho-
benzyl-para-chlorophenol may result in minimal to no exposure
. based upon the infrequent draining of the pools.
While the hazard to aquatic organisms from 2-benzyl 4-
v chlorophenol has been characterized, a quantitative risk
assessment has ,not been conducted. The Office of Pesticide
Programs has established a policy that risks to aquatic
43:
-------
environments are best characterized and regulated under the
NPDES permitting program of the Office of Water. The Agency
currently requires that labels for all ortho-benzyl-para-
chlorophenol products require that discharges to aquatic
environments comply with a NPDES permit.
Because terrestrial use of ortho-benzyl-para-chlorophenol
and its potassium and sodium salts is limited to refuse/solid waste
sites, exposure to wildlife is not expected to be significant.
s.
In addition, the environmental fate data indicate that the
two salts rapidly degrade into the acid in the environment.
Therefore, the data supporting the acid also can be used to
support the potassium and sodium salts.,
(2) Endangered Species
Based on the registered use patterns for 2-benzyl-4-
chlorophenol and the inorganic salts, risks to endangered species
are not anticipated.
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 ingredients are eligible for reregistration. The Agency has
previously identified and required the submission of the generic (i.e. active ingredient
specific) data required to support reregistration of products containing orthp-benzyl-
para-chlorophenol active ingredients. The Agency has completed its review of these
generic data, and has determined that the data are sufficient to support reregistration of
all products containing ortho-benzyl-para-chlorophenol. Appendix B identifies the
generic data requirements that the Agency reviewed as part of its determination of
reregistration eligibility of ortho-benzyl-para-chlorophenol, potassium-2-benzyl-4-
chlorophenate and sodium-2-benzyl-4-chlorophenate list 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 ortho-benzyl-para-chlorophenol and salts to determine that ortho-
benzyl-para-chlorophenol and salts can be used without resulting in unreasonable
adverse effects to humans and the environment. Therefore, the Agency concludes that
all products containing ortho-benzyl-para-chlorophenol and the active ingredients, for
44
-------
all uses ,are eligible for reregistration. ;_f he reregi'stration of particular products is
addressed in Section V of this'document/ ../-' : ' : f . '
The Agency made its .reregistration' eligibility determination based upon the
target data base required'for reregistration, the current guidelines for conducting
acceptable studies to generate such data, publisheUscientific literature, .etc, and the, data
identified/in Appendix B. Although the Agency has found that all uses of ortho-
benzyl-paraTchlorophenol potassium 2-benzyl-4-chlorophenate and sodiurn-2-benzyl-4-
chlorophenate 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 lortho-benzyl-para-chlorophenol
and salts,5 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 , 7
; ' Based on the reviews of the generic data for the active ingredient of
ortho-benzyl-para-chlorophenol and its salts, the Agency has sufficient -
information on the health effects ,of ortho-benzyl-para-chlorophenol and on its .
potential for causing adverse Affects in fish and wildlife and the environment.
The Agency has determined that products containing ortho-benzyl-para- .
chlorophenol and its salts labeled and used as specified in this Reregistration
Eligibility Decision, except the enclosed area fogging application will not pose
unreasonable risks or adverse effects to humans or the environment. Therefore,
the Agency concludes that all the uses of products containing ortho-benzyl-para-
chlorophenpl, potassium-2-benzyl-4-chlorophenate and sodium 2-benzyl-4-.
chlorophenate are eligible for reregistration. The Agency,is requiring handler .
exposure data on the fogging application and' cannot make an eligibility decision
on tiiis method until these data are generated, '
2. Eligible and Ineligible Uses .
The Agency has determined that all uses of products containing ortho-
benzyj-para-chlorbphenol, potassium -2-benzyl-4-chlorophenate,, and sodium-2-
benzyl-4-chlorophenate are eh'gible for reregistration. The Agency is requiring
handler exposure data on the fogging application and cannot make an eligibility
decision on this method until these data are generated.
C. Regulatory Position
The following is a summary of the regulatory positions and rationales for ortho-
benzyl-para-chlorophenol, potassmm-2-berizyl-4-chlorophenate and sodium-2-benzyl-4-
45
-------
chlorophenate. Where labeling .revisions are imposed, specific language is set forth in
Section V of this document.
1. Labeling Rationale
a. Occupational and Residential Labeling Rationale/Risk
Mitigation
For each end-use product, PPE requirements for pesticide
handlers are set during reregistration in one of two ways:
1. If the Agency has no special concerns about the acute effects or
other adverse effects of an active ingredient, the PPE for
pesticide handlers will be based on the acute toxicity of the end-
use product. For occupational-use products, PPE must be
established using the process described in PR Notice 93-7 or
more recent EPA guidelines.
2. If the Agency has special concerns about an active ingredient due
to very high acute toxicity or to certain other adverse effects,
such as allergic effects or delayed effects (cancer, developmental
toxicity, reproductive effects, etc.):
In the RED for that active ingredient, EPA may establish
minimum or "baseline" handler PPE requirements that
pertain to all or most end-use products containing that
active ingredient.
These minimum PPE requirements must be compared
with the PPE that would be designated on the basis of the
acute toxicity of the end-use product.
The more stringent choice for each type of PPE (i.e.,
bodywear, hand protection, footwear, eyewear, etc.) must
be placed ,on the label of the end-use product.
Personal protective equipment requirements usually are set by
specifying one or more pre-established PPE units - sets of items that are
almost always required together. For example, if chemical-resistant
gloves are required, then long-sleeve shirts, long pants, socks, and shoes
are assumed and are also included in the required minimum attire. If the
requirement is for two layers of body protection (coveralls over a long-
pr short-sleeve shirt and long of short pants), the minimum must also
include (for all handlers) chemical-resistant footwear and chemical-
resistant headgear for .overhead exposures and (for mixers, loaders, and
persons cleaning equipment) chemical-resistant aprons.
46
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Personal Protective Equipment/Engineering Controls for
Handlers ......
(1) Occupational-Use Products
The Agency has determined that regulatory action
regarding the establishment of active-irigredient-based minimum
PPE requirements for occupational handlers must be taken for
ortho-benzyl-para-chlorophenol. Many of the CMA exposure
studies used as data in this risk assessment ;were conducted with
the .handlers wearing chemical-resistant gloves. Therefore,
chemical-resistant gloves are required for occupational handlers
of ortho-benzyl para-chlorophenol,in the following use-scenarios:
Scenario (1) mixing and pourings liquid, Scenario (2)
>., transferring (meter-pumping) liquid, and Scenario (7) pouring
' powdered or flaked solid product formulations, Since the MOE
for:chronic exposures from ungloved hand-wiping applications
; (Scenario 6) was less than 300; chemical-resistant gloves are '.
, required to reduce/mitigate the potential risk to those applicators..
Finally, inhalation and ocular protection is required for persons
exposed to the fog during or-immediately following applications
\(Scenario8). ..'.-"'"'..'. .',--.
At this time, EPA ;is not establishing active-ingredient-
' based minimum (baseline) PPE for occupational handlers for the
following scenarios: .(Scenario 4) low-pressure spray and
(Scenario 5) mopping applications. The estimated exposures to
and resulting risks from ortho-benzyl-para-chlorophenol in these
occupational use-scenarios do not warrant establishing such PPE
requirements. . '
The'MOE from intermediate-term exposures during high-;
pressure spray applications (Scenario 3) could not be mitigated
with additional personal protective equipment or engineering
controls. However, as previously discussed, the Agency will
consider the high pressure ^spray scenario conditionally acceptable
until new exposure data are available. . K
... .. .. . ., , --^ . ...,- ^ i -. , -., j.. ^ .... ,''..'.' ' '-..
(2) Homeowner-Use Products
EPA is not establishing active-ingredient-based minimum
(baseline) PPE for homeowner handlers at this time. The^ '
assumed exposures to ortho-benzyl-para-chlorophenol in the use-.-
AT:.
-------
scenarios appropriate for a residential setting do not warrant
establishing such PPE requirements. .
c. Post-Application/Entry Restrictions
(1) Occupational-Use Products
Since the Agency has concerns about post-application
exposures to persons after softie occupational uses of ortho-
benzyl-para-chlorophehol, it is establishing entry restrictions for
those occupational uses. For specific requirements, refer to
Section V of this document, -
(2) Homeowner-Use Products
EPA is not establishing entry restrictions at this time for
homeowner uses of.ortho-benzyl-para-chlorophenol end-use
products, because of minimal exposure concerns.
d. Other Labeling Requirements
The Agency is also requiring other use and safety information to be
placed on the labeling of all end-use products containing ortho-benzyl-
para-chlorophenol. For the specific labeling statements, refer to Section
V of this document.
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for the
reregistration of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of o-benzyl-p-
chlorophenol for the above eligible uses has been reviewed and determined to
be substantially complete for reregistration. The following data are required for
the salts and are considered confirmatory:
61-1 Product Identity and Disclosure of Ingredients
61-2 Description of Beginning Materials and the Manufacturing Process
61-3 Discussion of the Formation of Impurities .
62-1 Preliminary Analysis ,
48
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Melting Point
Boiling Point.
Density
Solubility
Vapor Pressure
62-2 "Certification of Ingredient Limits -".',. '.-:
62-3 Analytical Methods to Verify Certified Limits;
.. 63-2. Color ;' :'-.. ; ' ; : : :
'.' 63-3 Physical State : '
63-4 Odor
63-5
63^6
63-7
63-8
63-9
63-10 Dissociation Co'nstant "_ . ~\
63-11 Qctanol/Water Partition Coefficient : .
1 " ,63-12 pH , ''..'" , ' ''.' ' :"' : , . ''. '' ; ;- '-- ..' .
, 63-13 Stability . :" , ; ^
The product chemistry data are adequate to support reregistration, however the
following confirmatory data are required on the potassium and sodium salts of orthd-benzyl-
para-chlorophenolr because it is expected that the chemical properties are very much like me
parent material^ An individual CSF is required for each product. .'''.-
Information to upgrade the acute oral, acute dermal, primary eye irritation, and
primary, dermal irritation studies (guidelines 81-1, 81-2, 81-4, and 81-5) to acceptable. -
The following study is required to. satisfy guideline 84: '
84-2(b) Mammalian cells in culture forward ,gene mutation assay (specifically a mouse'
lymphoma assay).
Additional Occupational/Residential Exposure Studies
Handler Studies
All registrants must submit additional handler exposure studies. Requirements for such
studies are addressed in subdivision U of the Pesticide Assessment Guidelines.
The required studies are necessary to provide data on handlers during fogging in
enclosed areas. They are: , , . ,- "
adermal exposure study (Guideline 231), arid '
an inhalation exposure study (Guideline 232)
These studies should be conducted concurrently; i.e., dermal and inhalation samples
should-be collected from the same handler and at the same site during;each trial.
The.requked confirmatory studies for reregistration are necessary to provide data on
handlers during high-pressure spray applications in enclosed areas. They are:
a dermal exposure "Study (Guideline 231),.and
49
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an inhalation exposure study (Guideline 232)
These studies should be conducted concurrently; i.e., dermal and inhalation samples
should be collected from the same handler and at the same site during each trial. Note: This
requirement is waived if the registrant reduces the application rate to a level where the MOE
for this exposure/risk scenario is greater than 100.
2. Labeling Requirements for Manufacturing-Use Products
To remain in complaince 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 an [fill blank with Insecticide,
Herbicide or the applicable term which describes the type of
pesticide use(s)] for the following use(s) [fill blank only with
those uses that are being supported by MP registrant."
An MP registrant may, at his/her discretion, add one of the following
statements to an MP label under
. "Directions for Use" to permit the reformulation of the product
for a specific use or all additional uses .supported by a formulator
or user group:
(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
such use(s)."
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility
50 '
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,has been made. The _ product _ specific data requirements ;are listed in Appendix
G, the Product Specific Data:CaU-In Notfee. - , ' ' ซ: v
, ., Registrants must, review previous data submissions to ensure that 'they
meet current EPA acceptance criteria (Appendix F; Attachment E) and if not,
commit to conduct new studies. If a Registrant believes ; that, previously
submitted date meet current testing standards,, then = study MRID numbers, should
.be piled according to the instructions in the Requirement Status and Registrants
Response Form provided for each, product. ' : , '
2. Labeling Requirements for End-Use Products
- - :- _ i --. h .^ . ' f '''''.'
Worker Protection. Standard ",/' - , ; : "
None of the uses, of orthp-benzyl-para-chlorophenol are within the scope
of the Agricultural Worker Protection /Standard (40 CFR part 170).
PPE/Engineering Control Requirements for Pesticide Handlers
For sole-actiye-ingredient end-use products that contain ortho-benzyl-
para-chlorophenol, the product labeling must be revised to adopt the handler , -
personal protective equipment/engineering control requirements set forth in this
section. Any conflicting PPE requirements on the current labeling must be
removed...... . ' ...-'-,' ' "', ':".'..-. '','"' "..'. - . ' '.".-',.' '','-' '.'..""
, ' , .'-'-'' ' ' ' ' ' '-',' , ' 'L ' ' ^ ' ' '."'" -' 5 "* ' ' ' % = "T ":''
r: For multiple-activeringredient end-use products that contain prtho-
benzyl-para-chlorophenol, the handler personal protective : ; ^
.equipment/engineering control requirements set forth in mis section must be
compared to the requirements on the current labeling and the more protective
must be retained. For guidance on which requirements are considered more
protective, see. PR Notice 93-7. , ^ . :
a. Products Intended Primarily for Occupational Use
Minimum (Baseline) PPE/Engmeering Coiitrbl Requirements
' " " ' ' ' ""
. . _ ,. _
, EPA is. establishing active-ingredient-based ^^ minimum (baseline) ; .. ..
PPE/engineering control requirements for prtho-benzyl-par.a-chlorpphenol end-
use products that are intended primarily for occupational use for theifpllqwing
'use-scenarios: (1) mixing and pouring soluble liquids, (2) transferrmg
(pumping) liquids, (6) handrwiping, (7) pouring powdered or flaked
formulations, and (8) applying fogs to enclosed areas. The minimum (baseline):
SPPE for such occupational uses of prtho-benzyl-para-chlorppheriol end-use
products are: j ^ ; . . / " ' . ' _... _ . -
51
-------
"Applicators and other handlers must wear:
long-sleeve shirt and long pants,
socks plus shoes, and
--chemical-resistant gloves*.
"In addition, for applicators and other handlers exposed to the fog during
fogging applications and until the fog has dissipated and the enclosed area has
been thoroughly ventilated must wear:
-a full-face respirator with a canister approved for pesticides (MSHA/NIOSH
approval number prefix TC-14G)"
*For the glove statement, use the statement established for ortho-benzyl-para-
chlorophenol through the instructions in Supplement Three of PR-Notice 93-7.
EPA is not establishing active-ingredient-based minimum (baseline) PPE
for occupational handlers in the following use-scenarios: (4) low-pressure
spray, and (5) mopping (ungloved).
Determining PPE Requirements for End-use Product Labels
The PPE, if any, that would be established on the basis of the acute
toxicity category of each end-use product must be compared to the active-
ingredient-based minimum (baseline) personal'protective equipment specified
above. The more protective PPE must be placed on the product labeling. (For
guidance on which PPE is considered more protective, see PR Notice 93-7.
Note: if the eye irritation potential of an end-use product is classified as
toxicity category I or H, protective eyewear is required on the labeling for all
handlers of that product.) '"'*',
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. Products Intended Primarily for Homeowner Use
Minimum (Baseline) PPE Requirements v
EPA is not establishing active-ingredient-based minimum (baseline) PPE
for homeowner handlers.
52
-------
Determining PPE Requirements for End-use Product Labels
- The PPE, ifany,-that Would be :estabiished p'n thevbasis of the acute -
toxicity category of each end-use product must be compared to the active-
ingredient-based minimum (baseh'ne) personal protective equipment specified
above. The moreprotective PPE must be placed on the product labeling: (For
guidance on which PPE is considered more protective, see PR Notice 93-7.
Placement in Labeling ; ..'-,
The personal protective equipment requirements, if any,; must be placed
on the end-use product labeling in the location specified in PR Notice 93-7, and
the formkt, and language of the PPE requirements must be the same as is .
specifiedin PR Notice 93-7. . -, -, :
i ' . _ v^-v::- - -, , " ..-,'. ^ i ,.,' ij -.,-', : ,,:- ^ ^. i ._.:': .._,.-'.,,", . ; ' .' ... .;, _ ," , ,
',. ' . i '. - - ..I1 '-'-' ';." , i ,""*- ,.--.. v ; ;. '; \ -" %> . ^ /'.'" ''. '-.,' \:" ,.--:' ",
Entry Restrictions
For sole-active-ingredient end-^use, products mat contain ortho-benzyl-
para-chlorophenol ,the product labeling must be revised to adopt the entry
restrictions set forth below. Any conflicting entry restrictions on me current
labeling must be removed, . - : '-,
For niultiiple-active-ingredieht end-use products that contain qrthV
benzyl-para-chlorophenol the entry restrictions set forth.in this section must be
compared to the entry restrictions on the current labeling and the.more
protective must be retained. A specific time period in hours or days is "
considered more protective,than "sprays have dried" or "dusts have settled.
c. Prpducts Intended Primarily for Occupational Use
Entry restrictions: .-',...''-.'-:".'.''- .' - ''-..-. . '" '.." '.'.' ..;" '. i;
For spray applications: : '-
"Following application as a low-pressure or high-pressure spray1, do not
enter or allow others to enter the treated area until sprays have dried."
.For fog applications: ,,' .;.-.-- .; L '
. "Thoroughly ventilate entire enclosed area following application. Do
not enter, allow^mer persons/to enter, house livestock, or use .
equipment in the treated area until yentilatipn is complete and any liquid
has been absorbed, set, or dried. For entry into fogged areas before
. ventilation is complete and the fog:has completely dissipated, all
53
-------
persons must wear the personal protective equipment, including a full-
face respirator, required in the precautionary statements section of this
labeling for applicators and other handlers."
d. Other Labeling Requirements
Products Intended Primarily for Occupational Use
The Agency is requiring the following labeling statements to be
located on all end-use products containing ortho-benzyl-para-
chlorophenol that are intended primarily for occupational use.
Application Restrictions - ป
For all spray applications:
"Do not apply this product in a way that will contact'
workers or other persons, either directly or through drift.
Only protected handlers may be in the area during
application."
For pour, pump, mop, and wipe applications:
"Do not apply this product in a way that will contact other,
persons. Only protected handlers may be in the area
during application."
"The type of food contact surface recommended for
disinfection must be identified, e.g., counter tops, stoves,
and refrigerators". ' . '
User Safety Requirements
{Registrants, add .this requirement if the end-use product labeling
contains PPE requirements other than long-sleeve shirt, long pants,
socks, and shoes.} '
"Follow manufacturer's instructions for
cleaning/maintaining PPE. If no such instructions for '
washables, use de.tergent 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.";
54 - - '
-------
"Users should remove clothing immediately if pesticide gets
inside> Then wash thoroughly and put on clean clothing." ,
1 ' ' _ ' ' - ",, -' '
{Registrants, add this recommendation if the end-use product labeling
'contains PPE requirements other than long-sleeve shirt, long pants,
socks, and; shoes.} ^ '.,.'' " ' . -,
. "Users should remove PPE immediately after handling this
product. Wash the outside of gloves before removing. As soon as
possible, wash thoroughly and change into clean clothing." '
The following label directions are required fdr.farm premises to
permit their classification as non-food use products:
. "Do not use in milking stalls, milking parlors, or milk houses"
(for phenolics, cresyjic acid, and pine oils recommended for
livestock premises). ;
-1.
2.
3.
4.
5.
6.
7.
8.
"Remove,all animals, poultry, and feed from premises, veliicles, ,
and enclosures." - ':'..
, , -.- . . . ' : ft ' '
"Remoye all litter and manure from floors, walls and surfaces,of
barns, pens,' stalls; chutes, and other facilities occupied or
traversed by animals or poultry.".
"Empty all troughs,: racks, and other feeding and watering
appliances." ''"'.;
"Thoroughly clean all surfaces^ with, soap or detergent and rinse
withwater." " : "'," ,
, , . ' ' ' ' - V ,.'.;,..'-"::.,'".,"'''.', _-, .., ' - -' ' : , .-.,._',
".Saturate all surfaces with the recommended solution for a period
of lO;minutes." _ . . ' . .. I . , ,
'_.'_., ."".;,..'.'.,.'. ' . " .! ' ', -,'i' \:
/'Immerse all halters, ropes, and other types of equipment used in
handling and restraining animals or poultry, as well as the.
cleaned forks, shovels, and scrapers used for removing litter and
manure, in the recommended use solution."
"Ventilate buildings, cars, boats, and other closed spaces in
which the product has been used. Do not house livestock or
poultry or employ equipment until, treatment has been absorbed,
set or dried." ..'-, ' . .-.''-,
,55 -
-------
9. "Thoroughly scrub all treated feed racks, mangers, troughs,
automatic feeders, fountains, and waterers with soap of
detergent, and rinse with'potable water before reuse."
The following label directions are required for farm
premises/poultry house disinfectants to permit their classification as npn-
food use products:
1. "Do not use in milking staUs,'milking parlors, or milk houses"
(for phenolics, cresylie acid, and pine oils recommended for
livestock premises).
2. "Remove all animals, poultry, and feed from premises, vehicles,
and enclosures."
3. "Remove all litter and manure from floors, walls and surfaces of
barns, pens, stalls, chutes, and other facilities occupied or
traversed by animals or poultry."
4. "Empty all troughs, racks, and other feeding and watering
appliances."
5. "Thoroughly clean all surfaces with soap or detergent and rinse
with water."
6. "Saturate all surfaces with the recommended solution for a period
of 10 minutes." '
7. "Immerse all halters, ropes, and other types of equipment used in
handling and restraining animals or poultry, as well as the
cleaned forks, shovels, and scrapers used for removing litter and
manure, in the recommended use solution."
8. "Ventilate buildings, cars, boats, and other closed spaces in
which the product has been used. Do not house livestock or
poultry or employ equipment until treatment has been absorbed,
set or dried."
9. "Thoroughly scrub all treated feed racks, mangers, troughs,
automatic feeders, fountains, and waterers with soap or
detergent, and rinse with potable water before reuse."
The following label directions are required for poultry house
disinfectants to permit their classification as non-food use products:
.56 '
-------
1,
2.
3.
4.
5.
7,
-"Remove all poultry: and feed, from premises,; vehicles,,and
'enclosures." "'_ .--:; ''"'''',' '""' ' ''*'.- :'
__: ."' = * 1 \ '.- r ,- ,..--.-_'. " .^jfe -- . ,, - f,- - --y-.-i _ ^ -_. - '' >b "M"-- .-'-- "-;, ' ' .*-''-"" ' T ;' '-
"Rem'ove all litter and manure from floors, walls, and surfaces of
facilities occupied or traversed by animals or poultry.";
"Empty all troughs, racks, and other feeding and watering
appliances.1' ; T,
"Thoroughly clean all surfaces with soap or detergent and rinse
with water." " , . ' .:'"
"Saturate all surfaces .with ,the recommetfded solution for a period
of 10 -minutes." , . . / :
"Immerse all types of equipment used in handling and restraining
poultry, as well as the cleaned forks, shovels," and scrapers used
for removing litter and manure, in the recommended use
solution." . . ~ ,
"Ventilate buildings, cars, boats, and other closed spaces in
which the product has been used. Do not house poultry or
employ equipment until treatment has been absorbed, set or
dried." '. -.' . ' . . "' ' '-..' - . -.
8. "Thoroughly^ scrub all/treated feed racks,:troughs, automatic
feeders, fountains, and waterers.with^SQap or detergent, and rinse
with potable water before reuse." ':-.'.
Products Intended Primaray for Home tlse
Application Restrictions ,
"Dp not apply .this product in a way that will contact any
person or pet. Keep people and pets out of the,area during
'application." v ''. /'. . ;, .- -.. " :
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." :
The labels and labeling of all products must comply with
EPA's current regulations and requirements as specified in 40
CFR ง156.10 and other applicable notices.
Effluent Discharge Labeling Statements
Refer to subsection A. above for labeling requirements
for effluent discharge.
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 Reregistration
Eligibility Decision (RED). Persons other than the registrant may generally distribute
or sell such products for 50 months from the date of the issuance of this RED.
However, existing stocks time frames will be established case-by-case, depending on
the number of products involved, the number of label changes, and other factors/Refer
to "Existing Stocks of Pesticide Products; Statement of Policy"; Federal Register
Volume 56, No. 123, June 26, 1991. ~~~ ~ .
The Agency has determined that registrants may distribute and sell ortho-
benzyl-p-chlorophenol 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.
58
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VI. APPENDICES
59-
-------
Appendix A (Table of Use Patterns Subject to Registration) is 631
pages in length. The Agency has not included this section as part
of the published version of the RED document. The entire
appendix A is available as outlined in Appendix E.
60
-------
GUIDE TO APPENDIX B
Appendix. B;contains listings of data requirements'which support the reregistration for active
ingredients within the case Ortho-Benzyl-P-Ghlorophenol, covered by this Reregistration Eligibility
Decision Document. It contains generic data .requirements that apply to Oitho-Benzyl-P-
Chlorophenol in allproducts, including data requirements for which a "typical formulation" is the
test substance. . -
The data table is organized in the folibwing format:. ;
1. Data Requirement (Column 1). The data requirements.are listed in the order in which
they appear hi 40 GFR 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 ; V . .
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 (MRIDy 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.
61
-------
62
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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 Reregistration Eligibility Document. Primary sources for studies in this
bibliography have been the body of data submitted to EPA and its predecessor agencies in
support of past regulatory decisions. Selections from other sources including the
published literature, in those instances where they have, been considered, are included.
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 ease 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.
74
-------
Title..' In some cases, it has been necessary; fqr the Agency; bibliographers to create
or enhance a document title. .Any such editorial msertiqnsjare'Qontained between ,
. square brackets.Y '. _- ' .''' '7 ;.; /_';'; /; '-^ ,' ,- '.":;-,-:'- -- :'-'xvW:V.^o ..-;-'
Trailing parentheses.- For studies submitted to the^Agency in tile past, the trailing
parentheses include (in addition to any self-explanatory text) the foUbwing elements
"describing the earliest known submission: ';; - / ; - ; V
(2)
(3)
(4)
Submission date, The date of the. earlies't Jfliown .submission appears
immediately following the word "received!"
>> -, . . .'" . . '",.-," r" ' '.;"" -.' -"""". '"..."""..,..". ',- -,".' ,,- "*,.,-'"-. ','.'-.. \ '"'.
Administrative number,; The next element immediately following the word
"under" is the registration number, experimental use permit number/
petition number,, or other admihistratiye number associated with; the earliest
known submission.
Submitter. The third element isthe submitter. When authors hip is
defaulted to the submitter,-this element is omitted.
Volume Identification (Accession .Numbers). The final element in the
trailing parentheses identifies the EPA accession number of,me volume in
which the original submission of the study appears! The six^ligit accession,
number follows the symbol "GDL," 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.
75
-------
BIBLIOGRAPHY
MRID
CITATION
00130937 Cummins, H.; Gardner, J. (1983) Ortho-benzyl Pafachlorophenol ...: Acute
Percutaneous Toxicity in the Rat: LSR Report No. 837 BTP017/237.
(Unpublished study received Aug 24, 1983 under 49403-2; prepared by Life
Science Research, Eng., submitted by NIPA Laboratories, Inc., Wilmington, DE;
CDL:251062-C)
^- - , '
00130938 Cummins, H.; Bannerman, M. (1983) Ortho-benzyl Parachlorophenol
(Chlorophen): Acute Inhalation Toxicity in the Rat: LSR Report No.
83/BTP030/296. (Unpublished study received Aug 24, 1983 under 49403-2;
prepared by Life Science Research, Eng., submitted by NIPA Laboratories, Inc.,
Wilmington, DE; CDL:251062-D)
00131367 Cummins, H.; Gardner, J. (1983) Ortho-benzyl Para-chlorophenol ...: Acute Oral
Toxicity in the Rat: LSR Report No. 83/BTP016/236. (Unpublished study received
Aug 24, 1983 under 49403-2; prepared by Life Science Research, Eng., submitted
by NIPA Laboratories^ Inc., Wilmington, DE; CDL:251062-B)
00131368 Cummins, H.; Gardner, J. (1983) Ortho-benzyl Parachlorophenol ...: Acute Eye
Irritation/Corrosion Test in Rabbits: LSR Report No. 83/BTP019/239.
(Unpublished study received Aug 24, 1983 under 49403-2; prepared by Life
Science Research, Eng., submitted by NIPA Laboratories, Inc., Wilmington, DE; "
CDL:251062-E) ' , .
00131369 Cummins, H.; Gardner, J. (1983) Ortho-benzyl Parachlorophenol...: Acute
Dermal Irritation/Corrosivity Test in Rabbits: LSR Report No. 83/BTP018/238.
(Unpublished study received Aug 24, 1983 under 49403-2; prepared by Life
Science Research, Eng., submitted by NIPA Laboratories, Inc., Wilmington, DE;
CDL:251062-G) , ...
00143774 Ross, F. (1985) Chlorophen: Effects of Oral Administration upon Pregnancy in the
Rabbit: Report Nos. 85/BTP033/161,85/BTP035/ 080. Unpublished study
prepared by Life Science Research. 60 p.
00143775 Willoughby,,C. (1985) Chlorophen: Teratology Study in the Rat: Report Nos.
85/BTP032/054, 84/BTP031/583. Unpublished study prepared by Life Science
Research. 82 p.
76
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MRID
BIBLIOGRAPHY
CITATION
00145836 , Becker,, H. (1984) Embryotoxicity (Including Teratogenicity) Study with Preventol
BP Technical in the Rat: Project Np. 035212, Unpublished study prepared by '"
,: Research ;& Consulting Company. lOlp, . ., . ' ,
00161231 vSachsse,;K.; Becker, H. (1985) Letter sent to whom it may concern dated Qct2,
1985: RCC Project 035212: Embryotoxicity (including teratogenicity) smdy with
. , Preventol BPTechnical in the rat: Date of "report: November 27, 1984. Prepared
by R^esearch and Consulting Co. AG- '353 p, .'-,'
40376301 Birnbaum, L.; Deskiri, RV;; Grumbem; S^; et al. (1986) Prechrbnic!tbxicity of
\ o-benzyl-p-chlorophenol in i rats and mice. Fundamental and Applied toxicology \
'' '' *> -" ' - ' ' ' ' " " - - ' ^ '. * ''<-' ;' ~ ' ^ ~ ".; ^ ^ ' ;^_ .^ '.'-',' -'._',_- '/t ' *: -' " ","
40988201 Ross, F, (1985) hlorophen: Effects of Oral Administration upon Pregnancy in
the Rabbit: Supplement to LSR Report No, 85/BTP033/ 161 : LSR Report No
85/BTP033/257. Unpublished study prepared by Life ScienceiResearch Limited,
:' ' . 67 p. ; : ' _ . ;'.- _;,',.. ,.-' . ;. _,.. . . ,. ,;.-, ,^.._- .,.'.;.,... . :,.. \..---::.'. .:.
41003901
the Rabbit: Supplement to LSR Report No, 85/BTP003/ 257. Unpublished study
, prepared by Life Science Research, Ltd. 19 p. , . ,
41248201 /Gummins,H;(198^)ProductToXicologyVNip^^^^
Parachlorophenol): 21-Day Percutaneous ^ Toxicity -Study in the R Rabbit: Project
,r ID NIPA-1989-4. Unpublished study prepared by Life Science Research Ltd 195
''"' ' ' ' '' '' ' ''
4124,8202 Birnbaum, L. etal. XI 986) Supplement to Prechronic Toxicity of :
OBenzyl-P-Chlorophenol in Rats and Mice: Project ID NIPA-1989-5. Unpublished
' study prepared by National Toxicology Program Battelle Columbus Division 142
; -. P-. ' :' "".. '..'-,':',-. '". -. .-..'.'.;:.. .". ' " .;. ';>-. -,; -;,;;-/;;'-.--- :./.-:?.^::f^ -./. .
41287501 Mortelmans, K. (1989). National Toxicology Program SalmoneUa Mutagemdty"
Tests: II. Results from the Testing of 270 Chemicals Including Ortho-Benzyl*
Parachlorphenol: Lab Project Number: NIPA/1989/6. .Unpublished study
prepared by; SRI International 40 p. . .
41287502 Gulati, D. (1989) National Toxicology Program: InMtro Cytogenetic Testing of ;
, / Ortho Benzyl Parachlorphenol: [Structural Chromosomal Aberration] : Lab Project
-------
BIBLIOGRAPHY
MRTO
CITATION
Number: NIPA/1989/7. Unpublished study prepared by Litton Bionetics, Inc. 10
p. ;
41412201 PopendorfVW.; Selim, M.; Kross, B. (1990) Chemical Manufacturers Association
Antimicrobial Exposure Assessment Study: Lab Project ID: Q626. Unpublished
study prepared by Univ. of Iowa, Institute of Agricultural Medicine and
Occupational Health. 209 p. Has different statistics when compared to 41742601
and 41761201.
41462401 Battelle (1990) Supplement No. 2: Prechronic Toxicity Study in Rats and Mice
(O-Benzyl-p-chlorophenol): Lab Project Number: NIPA1990-L Unpublished
study. 159 p. .
41572801 Edwards, C. (1990) Nipacide BGP (Ortho-benzyl Parachlorophenol): Assessment
of Clasio-genic Action on Bone Marrow Erythrocytes in the Micronucleus Test:
Lab Project Number: NIPA-1990-4. Unpublished study prepared by Life Science
Research Ltd. 38 p.
42279302 Hejtmancik, M.; Ryan, M.; Grumbein, S.; et al. (1988) Final Report on the
Chronic Gavage Study of o-Benzyl-p-Chlorophenol (CAS No. 120-32-1) in
B6C3F1 Mice to National Toxicology Program. Unpublished study prepared by
Battelle. 81 p.
43056901 National Institute of Health (1993) NTP Technical Report on the '' ;
Initiation/Promotion Study of o-Benzyl-p-Chlorophenol in Swiss (CD-I) Mice
(Mouse Skin Study): Draft Report: Lab Project Number: NTP TR 444: 93-3157. -
Unpublished study prepared by U.S. Dept. of Health and Human Services. 151 p.
43313401 Warren, D. (1994) Dermal Absorption of (carbon 14)-o-Benzyl-p-Chlorophenol
from a 5% Formulation: Lab Project Number: 94-722-XC: 7332. Unpublished
study prepared by Miles Inc. 60 p.
43322901 Putman, D.; Curry, P. (1994) Chromosome Aberrations in Chinese Hamster
Ovary (CHO) Cells: 2-benzyl-4-chlorophenol: Final Report: Lab Project Number:'
TC881.337: 93-C500-SW: 7342. Unpublished study prepared by Microbiological
Associates, Inc. 48 p. .,-..
43384201 U.S. Public Health Service, National Toxicology Program (1994) Toxicology and
Carcinogenesis Studies of o-Benzyl-pChlorophenol in F344/N Rats and B6C3F1
' 78 ' '
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MRID
BIBLIOGRAPHY
CITATION
Mice (Gavage Studies): NTP Technical Report Series No, 424 NTP TR 424- NIH
Pub. No. 94^155; 306 p. , ' "".>"'"' ""'-
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80
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UNITED STATES ENVIRONMENTAL PROtJECTIprSf AGENCY
WASHINGTON, D.CV 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;! 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 dataware 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 Illbelow, Your response must state:
1. Howyou 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
Hi-fi); or ~~~ , -~7~ . ; : . .. .,
3.
Why you believe EPA should not require your submission of product specific data
in the manner specified by.this Notice (see section in-D). -' '
If you do not. respond to this Notice, or if you do -not satisfy EPA -that you will comply
with its requirements or should be exempt or excused from.doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject, to this Notice in Attachment 2, 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); - . ;
81
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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 ffl - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable Adverse
Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 - Data Call-in Chemical Status Sheet
2 - Product-Specific Data Call-in Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the data
needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional, data necessary are product specific data. No additional
generic data requirements are being imposed. You have been sent this Notice because you
have product(s) containing the subject active ingredient.
\ '
SECTION H. DATA REQUIRED BY THIS NOTICE
H-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.
n-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. "
82 ' ' - '
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n-G.'.TESTING PROTOCOL . - -'~ : ':, , ^ ; .
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines fov those studies for which guidelines have
been established. ./__'. . / \-\ .. ' ; * ; . v
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 me Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform'to those
specified in the Pesticide ..Da'ta,Requirements regulation (40 CFRง 158.70). When using the
OECD protocols, they should fee modified as appropriate so that the data generated by the
study will satisfy the requirements of 40 CFR ง 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). . -
' ' ' * " -' "'-._ _ "."..,' ,, _ - i- -
All new studjes 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)]. ,
n-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
ISSUED'BY THE AGENCY : ' : ;
Unless otherwise noted herein, rthis Data Call-in does not in any way supersede or change
the requirements of any previous Data Call-In(sJ, 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 HI. COMPLIANCE WITH REQUIREIvlENTS OF THIS NOTICE
m-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 IVrB.
m-B. OPTIONS FOR RESPONDING TO THE AGENCY:. :
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the.product .spepific data requirements miposed by this notice
or (c) request a data, w^aiver(s). . , -,' --. f, ..
83
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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 II1-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.
m 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 IH-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"vaUd
options for fulfilling product specific data requirements.
3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section ni-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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m-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE ' "'v\-
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 .pptions 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)
(3)
(4)
(6)
I will generate and submit data within the specified time frame (Developing Data)
I have entered into an agreement with'one or more registrants to develop data
jointly (Cost Sharing) . '', ; s
I have .made offers to cost-share (Offers to Cost Share)
I am submitting an existing study that has not been submitted previously to the .
Agency by anyone (Submitting an Existing Study) :
I am submitting or citing data to upgrade a study classified by EPA as partially
' acceptable and upgradeable .(Upgrading a Study)
I am citing an existing study that EPA has classified as acceptable or an existing
study that has ;been submitted but not reviewed by the Agency (Citing an Existing
Study) . . . ;
Option 1, Developing Data - If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency-requirements as referenced herein
and in the- attachments. All data generated and submitted must comply with the Good
Laboratory Practice (GLP) rule (40 CFR Part 16Q), be conducted according to the Pesticide
Assessment Guidelines (PAG), and be in conformance with the, requirements of PR Notice 86-
1 * . . L . ' ' " ' , . --..-. . . .
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 ^egistration(s). , ; ""'',./
If you cannot submit the data/reports to .the Agency in the time required7by 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) aproposed
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
. ".. ' . . ' ' . '- '. . -".:.-" .;:-- 85 ' ' \.- ' ". ': . .'-' ; ; .- ' '".
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cases of extraordinary' testing problems beyond the expectation or control of the registrant.
Extensions will not be given in submitting the 90-day responses. Extensions will not be
considered if the request for extension is not made in a timely fashion; in no event shall an ,
extension request be considered if it is submitted at or after the lapse of the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data - 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 hi 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.
86
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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 Bother ^registrant must fulfill its
commitment to develop and submit the data as"required by,this Notice!; If the other .registrant;
fails to develop me dato'or for some,other reason is, subject to suspension, your registration1 as
well as that of the other registrant will 'normally be subject to mitiatibn of suspension
proceedings, unless ybu,commit to submit, and dp submit the required data in the,specified
time frame. In such cases, the Agency generally 'will not grant a time extension for submitting
the data. ' -\' " . '_ '.. ,. . ',', . -- ;' \ .;-../ ".'.' ' ' '".'-/ '" ' ' ': .->*-.
Option 4, Submitting an Existing Study If you choose to submit an existing study^ in
response to this Notice, you must determine that the study satisfies the requirements imposed
by this Notice. You may only submit a study that has not be'en 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
..'"'' ' ' - ' ' ' '' ' . ' ' ^ '.-.--- .- .. i .' ''" '-.'-'.-' ..'''.:.'.'.
You should be^aware that if me 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. . ; ; , - r
.To;meet the requirements pf^theDCINotice ^for ^submitting- an existing study, all of the
following three .criteria must be clearly met: '- : ",. .'.-;" '.'.
a.
b;
. 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 PracUce,(GLP). regulation, 40 CFR Part 160
As stated in 40 CFR 160.30) " '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 me reconstruction and
evaluation of the report
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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. _ '.
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 conforrhance 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.
88
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This,option should.also be used to cite data,that has b.een previously submitted to' upgrade
- a study, but has -not yet been reviewed bjyjhe Agency.: You must provide the MRID number of
the data submission as 'well..as the MRID number'.-of me studf'being upgraded. -
The,criteria for submitting an existing study, as specified in Option 4 above', apply to all
data, submissions, intended to .upgrade studiesV Additionally yojtf ^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 woulcj be "acceptable.", With respect to any studies for
which you wish to select this option you must prbyide'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 i
a completed copy of EPA .Form 8570-31, Certification with Respect to D.ata Compensation
Requirements: . .'' .;. ,"-.-. --. -j''. , .*. -:.'::;"/'.:;:",'-.;../*".;..,,*-"-; v/V; -.;;;...;
_ ._ ' <',' ' " ' " - ' ' '" ' \ ". .' , '. - - " ..----- ;/ .- /.: ' ,- ' ... " .' :' : V- .-
Registrant?i who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the. Data Gallon -Response Form and th6
Requirements 'Status and Registrant Is Response Form; as appropriate. " :
m-D REQUESTS FOR DATA WAIVERS ;: , . ,
If you request a .waiver for product specific-data because youRelieve it is
inappropriate, you must Attach a complete justification for/me: request, includihg 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 fnr prnrfnrt
chemistry, acute toxicity and efficacy (where appropriate) are required for all products arid the
Agency, would grant a w,aiver only under extraordinary circumstances. You should also be
aware that submitting a waiver request will not automatically extend the due date for the study
in question,, Waiver requests submitted without^adequate supporting rationale will be denied
.and the original due, date will remain; in force.
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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, tfte following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice. >
4. Failure to submit on the required schedule acceptable data as required by this
Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g.., any required action or
information pertaining to submission or citation of.existing studies or offers, .
arrangements, or arbitration on the sharing of costs or the formation of Task
Forces, failure to comply with the terms of an agreement or arbitration concerning
joint data development or failure to comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section ni-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 bost 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 .
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, c.. v otherwise take appropriate steps to meetihe requirements stated in this ' ."'.
' ' Notice, unless you.commit to submit and|o submit the:required data in the
.. .- , , specified time frame. " :; ' <: ~ ."'"'.'. ::;
' -' . . - ' .' -, .. , ' ' ' ,-' , ,. <. . ^ i .
9. ; Failure to take any required dr appropriate steps, not mentioned above, at any time
: following the issuance of this Notice/
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STTTDV TS ;
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 Gene.Tox 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 ahy.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. '
rV^-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 of cancelled if doing so would be
consistent with the purposes of the Act,
': . ' ' -'. '''' 'v .-.! --f: '' '''.. '" ' '
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-produces) only in
exceptional circumstances. If you believe such disposition:bf existing stocks of your product(s)
which may be suspended for failure to comply with this Notice should be permitted, you have '
theijurden of clearly demonstrating to EPA that granting such permission would be consistent
with the Act, You must also explain why an "existing.stocksrprovisionis 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.
i \
Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you
demonstrate to the Agency that you are in full compliance with all Agency requirements,
including the requirements of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3 year study is scheduled to be submitted, all progress
reports and other information necessary to establish that you have been conducting the study in
an acceptable and good faith manner must have been submitted to the Agency, before EPA will
consider granting an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS' .
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information
to the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies,
regarding unreasonable adverse effects on man or the environment. This requirement'
continues as long as the products are registered by the Agency. ,
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status
Sheet. "; ~
92
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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 r for
product specific data) and any other documents required by this Notice, and should be
submitted to the, contact person(s) identified in Attachment l"^ If the voluntary cancellation or
generic data exemption option is chosen, only the Data Call-in Response Formfeed he
submitted. . ~~ - '~ , ,. , . : /
The Office of Compliance Monitoring (QCM) 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 A. Rossi, Director
Special Review and
Reregistration Division
Attachments
1
2
-3".
4
, \
5
6
Data Gall-In Chemical Status Sheet - ^ '---"'-[_ "\ ..:...:.', ' .
Product-Specific Data Call-In Response Form
Requirements Status and Registrant's Response Form
EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration ~ ''... . . ... ~~~~~
List of Registrants Receiving This Notice "/';' ' .
Cost Share and Data Compensation Forms and the Confidential Statement of
Formula Form " .. ~~ ; . -..:-. ^--
93
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94
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ORTHO-BENZYL-P-CHLOROPHENOL DATA CALL-IN CHEMICAL STATUS
SHEET .. - . ; ;.. , !-..^\^.'._ : : ;-v, , ' - , . ' " ;;. .- -''..f: ' .:";'.
INTRODUCTION ^ :
You have been'sent this Product Specific Data Call Jii Notice because you have product(s)
containing Ortho-Benzyl-P-Chlorophenol.
This Product Specific Data Call-In Chemical Status Sheet, contains an .overview of "data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
Ortho-Benzyl-P-Chlorophenor. 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.ofregistrants receiving this DCI
(Attachment 6) and-..(?) .the .Cost Share and Data Compensation Forms in replying to'this ^
Ortho-Benzyl-P-Chlorophenol Product Specific Data CalHn (Attachment 7). Instructions and
guidance accompany each form. "'... ' \ ; - ,
r ' , I. " ' ' ' ' ' ' " '
DATA REQUIRED BY THIS NOTICE , , .. ~
' The additional data requirements needed to complete the database for Ortho-Benzyl-P- :
Chlorophenol are contained in the Requirements Status and Registrant's Response, Attachment
3. The Agency has concluded that additional data on Ortho-Benzyl-P-Chlorophenol 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
Ortho-Benzyl-P-Chlorophenol 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 Veronica Dutch at (703) 8585.
All responses to this-Notice for the Product Specific data requirements should be
submitted to: . ->-
Veronica Dutch , . /
Chemical Review Manager Team 81 , ;
Product Reregistration Branch ' ,
- Special Review and Reregistration Branch 7508W -
Office of Pesticide Programs ; ,
U.S?.Environmental Protection Agency . , '
Washington, D.C; 20460
RE; Ortho-Behzyl-PrChlorophenol ^,-
95
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes." If you choose this
option, you will not have to provide the data required by the Data Call-in Notice
and you will not have to complete any other forms. Further sale and distribution
of your product after the effective date of cancellation must be 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 7E (EUP) on this form, provide
the EPA registration numbers of your source(s); you would not complete the
"Requirements Status and Registrant's Response" form. Examples of such
products include repackaged products and Special Local Needs (Section 24c)
products which are identical to federally registered products.
Item 7a. For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes." If you are
requesting a data waiver, answer "yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with
Option 7 (Waiver Request) for each study for which you are requesting a waiver.
See Item 6 with regard to identical products and data exemptions. '
Items 8-11. Self-explanatory.
NOTE; You may provide additional information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already,
voluntarily canceled this product. For these cases, please supply all relevant
details so that EPA can ensure that its records are correct.
96
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98
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INSTRUCTIONS FOR COMPLETING THE REQUrREMENTS STATUS^ ANT>~
REGISTRANT'S RESPONSE FORM FORPRODUCTSPECIFIC DATA
Item 1-3
Item 4.
Item 6.
Item 7.
Item 8.
Item 9.
Completed-by EPA. Note the unique identifier number assigned by EPA. in Item
3. This number must be used in the transmittal document for: any data
submissions.in response to this Data CalWn Notice. : ,
The.guideline reference numbers of studies required to support the produces
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"thrdughi58.180, SubpartC, ; ' ',.-.'.-..""..'...
Item 5. ; The study title associated with, the guideline reference number is identified.
' '* "'' l '' '"
The use pattern(s) of the pesticide associated with the productspecific requirements
is (are) identified.* For most product specific data requirements, all use patterns
are covered by the data requirements, In the ease of efficacy data, the required
studies; only pertain to products which have the- use sites and/or pests /indicated. ',.
The substance ta,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. .':''".'.'-,'' ;"'"'" '"'""'. ',',-"./ -','/.,'. !.,'..;:. -~ Y^A;. V:?! .; V:'';: --\ , ,'::,:;,
The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Document unless EPA
determines that a longer time period is necessary ' ; !
Enter only one of the following response codes for each data requirement to
show how you intend to comply with the data requirements listed in this table.
'Fuller descriptions of each option are containedtin the Data CalHn Notice.
I will generate and submit data^by the specified due date (Developing Data). By
indicating that I have, chosen this, option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined in
the Data Call-in Notice. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form, 8570r29) and :(2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
I have entered into an agreement with one or more registrants to develop data
jointly .(Cost Sharing). lam 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
99
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to another product to qualify for this option. I certify that another party in the
agreement is committing to submit or provide the required data; if the required
study is not submitted on time, my product may be subject to suspension. By the
specified due date, I will also submit: (1) a completed "Certification With
Respect To Data Compensation Requirements" form (EPA Form 8570-29) and
(2) two completed and signed copies of the Confidential Statement of Formula
(EPA Form 8570-4).
3. I have made offers to share in the cost to develop data (Offers to Cost Share). I
understand that this option is available only for acute toxicity or certain efficacy
data and only if EPA indicates in an attachment to this Data Call-In Notice that my
product is similar enough to another product to qualify for this option. I am
submitting evidence that I have made an offer to another registrant (who has an
obligation to submit data) to share in the=cost of that data. I am also submitting a
completed "Certification of Offer to Cost Share in the Development Data"
form. I am including a copy of my offer and proof of the other registrant's .receipt
of that offer. I am identifying the party which is committing to submit or provide
the required data; if the required study is not submitted on time, my product may
be subject to suspension. I understand that other terms under Option 3 in the Data
Call-In Notice (Section ID-C. 1.) apply as well. By the specified due date, I will
also submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4).
4. By the specified due date, I will submit an existing study that has not been
submitted previously to the Agency by anyone (Submitting an Existing Study). I
certify that this study will meet all the requirements for submittal of existing data
outlined in Option 4 in the Data.CalHn Notice (Section III-Cl.) and will meet the ,
attached acceptance criteria (for acute,toxicity and product chemistry data). I will
attach the needed supporting information along with this response. I also certify
that I have determined that this study will fill the data requirement for which I have
indicated this choice. By the specified due date, I will also submit a completed
"Certification With Respect To Data Compensation Requirements" form (EPA
Form 8570-29) to show what data compensation option.I have chosen. By the
specified due date, I will also submit: (1) a completed "Certification With
Respect To Data Compensation Requirements" form (EPA Form 8570-29) and
(2) two completed and signed copies of the Confidential Statement of Formula
(EPA Form 8570-4).
5. By the specified due date, I will submit or cite data to upgrade a study classified by
the Agency as partially acceptable and upgradable (Upgrading a Study). I will
submit evidence of the Agency's review indicating that the study may be upgraded
and what information is required to do so. I will provide the MRID or Accession
number of the study at the due date. I understand that the conditions for this,
100 " '
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6.
. optioh outlined Option 5 in the Data Call-in Notice (Section HI-C. 1.) apply. By
the specified due date, I will also submit:':(!) a completed "Certification With -
Respect To, Data Compensation Requirements" form (EPA Form 8570-29) and
(2) two cdmp]teted;and signed copies of theConfidential Statement of Formula
(EPA Form 8570-4). ; _""';_ /",'.,", ,;, "Y ' '..'-{ v '.: .. ,: '"-.''".- .'.'
By the specified .due date, I will cite: an exisiirig'-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 anvciting 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'1 with one or more
other products Jor purposes of depending on the same data. I may also choose, this
option-if I am ;citin|;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:^(l) 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 (EPAForm 8570-4),
I request a waiver for this study because it is inappropriate fpr my product '
(Waiver Request). I, am attaching a complete justification
including technical reasons, .data and references to relevant EPA regiiiations,
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)(2XB):ofFIFRA. 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^ data as specified by the original data caU-in ^
notice .will.npt 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;.pf.Formula (EPA Form 8570-:4).
Items 10-13. Self-explanatory.';
NOTE:
You may provide additional information that does not fit op tiiis 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 Gompany or that you have already
rioi;
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voluntarily canceled this product. For these cases, please supply all relevant
details so that EPA can ensure that Its records are correct.
102
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EPA'S BATCHING OF O-BENZYL-P-CHLOROPHENOL PRODUCTS FOR 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 reregistration of products containing o-benzyl-p-chlorophenol 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. Notwithstanding the batching process, the Agency reserves the right
to require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute lexicological studies to represent all the products within that
batch. It is the 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 lexicological studies for each of their own products. If a regislrani chooses to
generate the data for a batch, he/she must use one of the producls 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 significantiy altered since submission and
acceptance of Ihe acute loxicity data. Regardless of whether new data is generated or existing
data is referenced, registrant must clearly identify the test material by EPA Registration
Number. If more than one confidential siatement of formula (CSF) exists for a product, the
registrant must indicate Ihe formulation aclually tested by identifying Ihe corresponding CSF.
In deciding how lo meet the producl specific dala requiremenls, registrants must follow
the directions given in the Data Call-In Notice and ils attachments appendecLto the RED. The
DCI Notice conlains iwo response forms which are lo be completed and submitted lo 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, "Requiremenls
Status and Registrants Response," lists the product specific data required for each product,
including the standard six acute toxicity tests, A registranl who wishes lo 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 Dala (Option 1), Submitting an Existing Study (Option 4),
Upgrading an Existing Study (Option 5) of Citing an Existing Study (Option 6). If a registrant
112 . : ' -""'
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depends on another's data, he/she must choose among- Cost Sharing (Option 2), Offers to
Cos^ Share (Option'3j); 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''$. However, a registrant should , -"
know that choosing not to participate in. a thatch does hot preclude other,registrants in the batch
-from citing his/her studies arid offering to cost share (Option 3) those studies. '
One hundred and six products were found which contain o-benzyl-p-chlorbphenol as an
active in'gredieiit. Theproducts have been placed into fifteen batches andla "no batch"
category in accordance with the..active and inert ingredients, type of formulation, pH and
current labeling; Table' 1 identifies the products in' each batch. Table 2 lists the.prpducts which
have been placed iiithe "no batch" category. . : :'.".:...... ,; ".
-The requirement for acute oral,, acute dermal and acute inhalation data has been waived
for all products addressed in this RED (i.e., all batched and "no batch" products listed below),
, with the exception of products in batch 14. Registrants with productsin batch 14 should
submit or cite appropriate acute oral., acute dermal and acute inhalation data. The, waiver of
acute oral, dermal and inhalation requirement is based on the condition that category in."
labeling will be employed"for these three routes, of exposure. If a registrant is not willing to V
use category HI labeling for these routes, product specific acute oral, dermal and inhalatidn
studies are needed. - ' " r . \- '
'- '" , - /;,.-"--' .': ." ;./.:/..'.' .-. .' . ". ;>;-'.. *.:-..'.^::. :- .', ':" ('-:.-^' '' ;^T-':.". ':':. v'"";
Furthermore, in accordance with 40CFR, any products'which are corrosive to skin or
have a pH above 11.5 or-below 2.0 are.not required to provide eye:and.skin irritation data. A
category I placement will be required for'such products on the basis of potential effects. ?
113
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Table 1
Batch
1
2
3
4
, 5
6
7
8
9
10
11
12
13
14
15
EPA Reg. No.
39967-5
49403-2
49403-3
1685-39
49403-4
2155-68
4313-11
1203-7
8047-1
1459-23
5747-7
572-293
2296-103
2296-105
1677-130
1677-135
675-19
777-10
421-409
48211-62
303-223
63281-5
303-225
47371-163
63281-4 '
11725-9
66171-2
2296-111
49403-6
421-350
421-349
675-1
1270-232
1270-233
% o-berizyl-p-chiorophenol '
95
95
; 95
4.7
6.9
'. 3.7
2.2 '
4.7
2.8
2.0
2.6 :
3.9
3.9 . ' ,
2.0
7.4
6.5
2.7
2.7
2.2
2.2
4.5 .'
3.4
9.1
9.1
9.1 ' " "
3.0
3.0
5.0
5.0
1.0.
0.15
0.01
- 0.09
0.09 ._ :
Formulation Type
Solid
Solid
Solid
Liq
Liq
Liq
Liq
ซ Liq
Liq
Liq
Liq
Liq
' . Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Spray
Spray
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 registrants of these producs are responsible for meeting the acute toxicity datas
requirements separately.
114
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Table 2 (No Batch)
::;::; -;!-:BPA:Reg.;;N&:-. ;;;
211-26 "...
303-26 x ;
' , 334-25 : : ,
v 402-96
402^113
421-16 V .
541-243
675-15 . .
675-27
.; . 675-43
675-46 ,
777-15
875-127
875-133 , ,
892-26
1043-36
1270-24V
1683-25
1769-72 ...
,, . . . 1769-194
1964rll
9167-8
1043-19
1057-61
, 1270-238
1270-243 . .
1459-18 '
1622-32
1677-128 ,
.1677-157
1683-24
1769-277
2296-102-
2296-106
2311-4 '
3525-126
4029-3 , '
4313-3
4313-21
4313-66 ~
4822-109
5197-45
,5741-22
% o-benzyl-p-chlorophenol -
, ' ', . ' ,-* 4.3
. . ' ..-.'- - ;, .6.1
.'-..-,' 3.7, , ' . ' ':','
..'. 3.9; "-. ... '
. 3.0 ,..
, ' . 4.9.. , . .
2.0
... 0.2 .
, 7.8 -._ ' '
. 5.0- '-.- '
-'-'.. 7.2.. : . . '
- -',' : " 4.5, ' ' .-. .......
, 0.8
. v . ' , 3.6 -.'~ . ' . : .
0.03 , -'.-;-
,, 5:2 . '.. ' ,
' , , 5.0. ...--
2,9 ,
4.0 . . .-
.- . . ' - . 3.0- , -
' 3.5 .-., ' ..-.'.
, ' . " 2.r .
, . -.---.- 0.08 -
' .- ..-, ' ' 3.0 . . ' . - ' .
. '' . - 5.7;. - - - . ;
' ' - 0.06," .'.... - '
3.4 .-' ' .
'" . . '3.5
1.4
, 2.5, ' . '
. - 1.2'- --
-'.''. 6.7 , ...
. ' 3.6:' ..-- .. ,; -
5.2 ......
- 4.6 , . . .
0.68. .---. .
..-.-. 5.0" . . . .--.' .-.
-2.6," " ' ,-.'.
4.9 '
.- ' -9.7 ' . ' .--..
-,-. . - 4.7 : ' ...
. 2.6.
0.07 , ...-.-
Formulation Type
Liq
Liq
Liq
.Liq
Liq ,
, Liq
, Liq
Liq.
Liq
' Liq
Liq
Liq ;
' Liq :
Liq
Liq
Liq
Liq ,
Liq
Liq ''.',
Liq ,
Liq
; Liq . '
Spray
Liq
Liq-
Spray
~Uq
Liq:
. Liq
Solid
Liq. .
Liq .....'
Liq
Liq
Liq. '
Liq ,
Liq ;
Liq
Liq .
' ' - Liq
Liq, ,
Liq ,
Spray
115
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EPA Reg. No.
5747-14
5813-32
6109-10
6484-4
8047-2
10693-4
10807-90
11725-7
11725-8
33176-6
34810-8
34810-17
34810-21 *
34810-28
39967-6
46851-1
46851-5
47371-162
48211-63
49403-5 **
49403-23
57125-9
63163-1
63281-1
63281-7
63281-8
65020-7
66171-1
67813-1
CA b-benzyl-p-chlorophendl .
2.6
3.0
9.2
0.85
4.9
3.14
3.0
10.0 '
6.5
0.08
5.7
6.0
0.02 ,
8.6
75.0
5.0
0.03
2.9
4.9
4.0
10.1
0.14
1.0
0.1
9.5
4.7
9.9
6.0
5.7
: '' : :;Pormuiation:Typei
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Spray
Liq
Liq
Liq
Liq
Liq
Liq
Liq
' Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
** Cin bo supported by all category III or category IV acute data generated with EPA Reg. No. 49403-6.
116
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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 siened
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 me telephone number of the responsible party'
. .: must be provided. . . x
d., All applicable information which is on the product specific data submission must
also be reported on the CSF. ." .'
e.
f.
i.
J-
k.
n.
All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids, '.' n
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 me trade names must be reported.
For the active ingredients, the percent purity of the source products must be
reported under column 10 and must be exactly the same as on the source product's
"*"-
All the weights in columns 13.a: and 13;b; mustl>e in pounds, Mlograms x>r
grams In no.case will volumes be accepted. Do not mix English and metric system
units (i.e., pounds and kilograms). ~ ' , . .,
All the items tinder column 13.b. must total 100 percent. /
1. All items under columns 14,*: and 14.5. for the active:ingredients must represent
pure active form. / , '
ro- llmitS for ail active and inert ingredients must foUow
tne 4U LFR 158.175 instructions. An explanation must be provided if the proposed
limits are different than standard certified limits. . : ' " ..
When new CSFs are submitted and approved, all previously -submitted CSFs;
become obsolete for that specific formulation. .' .
1-7
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118
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119
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120
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?/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 Expire* 3-31-84
1
Public reporting burden forthis collection of information is estimated to average 15 minutes oer resnonsa inri,,Hinr,
t,me for reviewtag instructions, searching existing data sources, gathering aXaWaSg KateTecTed and 9
22? MH3nd ? Viewina ,the collecticn ซ" information. Send comments regardingihe burden es JSK an other
%S!X^^
of Management and Budget. Paperwork Reduction^ Project
Please fill In blanks below.
'
Company Name
Product Name
Company Number
KVA
x. Nil.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
insectode. Fungicide and Rodenticide Act (FIFRA), if necessaryf However, my compSy^ woud prefer to
emer ,nto an agreement with one or more registrants to develop jointly or share in the 4tTd^etoPing
Th,s offer was made to the following firm(s) on the following
Name of Firm(ซ) ,
Certification:
Data ol Olhr
&,f > Z to rePresent,the comPany named above, and that the statements that I have made on
ttachments therem are true, accurate, and complete, .(acknowledge that any knowing false or
meleadmg statement may be .punishable by fine or Imprisonment or both under applfcable law
of Company's Authorized ReprasentatJve
Name and Tltl* (Plซaปซ Typป or Print)
Da to
EPA Form 8570-32 (5/91) Replaces EPA ftirm 8S80, which is. obsolete
121
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122
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United States Environmental Protection Agency
; Washington, DC 20460
CERTIFIpATION WIT^J RESPECT TO
DATA eOMpENSATION REQUIREMENTS
Form Approved
OMB No. 2070-01 07,
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 arid reviewing the
collection.pf 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 Prelection ' '
Agency, 401 M St./ S.W., Washington, DC 20460; and to the Office of Management and Budget,Paperwork Reduction Project
(2070-0.106), Washington, DC20503. : - . .;,.. , , J . . :' l
Please fill in blanks below. '":-.' ;.."._ ,.-' ' '.' '.'..,''....-' /.'./.: "/"/- V,^C ':;* '.- ' >:- v,' -.- '""''" .'>'"' ,'* '-:'..
Company Name , ' ' -. .. ;,.,.:, ^ ---';''' - ;;.'."- ;";^::"^ ',':-_', '--.^ '"', -"",.' ' ' '"-
ProductName .'. ,. ' :''".-,.'.,,:.]..'..- ''...'... . ' - -. - ../...-.'...'" T':/. -,'.. '"'. -::.--
. - , . . . ... . i .- ' - . ,. i -- ~' ,*' - '"-,-
- - - - ---,..-.. - . --, -- -. - , . - . _ r ^ ., .
Company Number
EPA Reg. No.
'- ' *"
I Certify that:
StMdy C',ted 'n SUp|J?rt Of-regisitration or reregistratiioh under-the Federal Insecticide, Fungicide and Rodenticide Act
Stesubra^? tnSe StUdy' ' am.the original data submitter, orrl haye obtained the writtenWmission: of the original
2. Thatforeach study cited in support of registration ofTeregistratjon under FlFRAthat is NOT an exclusive usestudy larn the;"
original data submitter, or I have obtained the written.permission^of the original data submitter.'orVhave notified in writing the
SURIn SS'Sfwro*^ซS' har/,,C;i*od and have offered to: (a);PaV 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 .sheeis, or indicated on'the attached
Requirements Status and Registrants' Response. Form," , .- . ,;. v ; ,, ,^- -;
3. That J. have previously complied:with section 3(c)(1^F) of FIFRA for the studies I have cited in support of registration or "^
reregistration under F'FRA. . . 'i; ,
Signature
Date
Mame and Title (Please Type or Print)
SENERAL OFFER TO^PAY; I hereby offer'and agree to pay compensation to other persons; with regard to the registration or
eregistratipn of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D). ': ;
Signature
Date
Jame and Title (Please Type or Print)
.Form 8570-31 (4-96) ~
123
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124
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r The following is a list of available ^documents for Ortho-Benzyl-P-Chlprophenpl that my,
further, assist you in ^responding to this Reregistration Eligibility Decision document.. These :
documents .may be'obtained by the following,methods;1. / ' . '"' '/ '; '- --
Electron^/'. .- . . V '_' :^ . .'/ '.'" / -^~i (~ "::'-'^'~:~-'^ ;;"'*-'-:'f-;:'.':'-\ '.''-.' -<': l: -.''>..".
File format: : Portable Document/Format (.PDF) Requires, Adobeฎ Acrobat or compatible:
reader. Electronic copies can be downloaded from the Pesticide Special
, . .Review and Reregistration information System at 703-308-7224. They also are
; /available on the Internet on EPA's gopher .server, GOPHER.EPA.GpV, or
using ftp on FTP,EPA.GOV, or using WWW (World Wide Web) on -
WWW,EPA:GQV., or contact Veronica Du^h.at (703)-8585. !//
: 1. "'/ PR Notice 86-5; _ '. ';:.- -: ;i "^--: ' :'"." .'' ,.\/-""' "7/"':"' ". -..;''';'""
2, PR Notice 91-2 (pertains to tihe Label Ingredient Statement). ,
3. A fuU copy of this RED doeument. , , -. . :
4. Acopy ofmefact sheetfdr'brtho-Benzyl-^ ' /
5. Appendix A, ' .- . /:. ; ; V'V -
The following documents ar? part;of the Administrative Record for drtho-Benzyl-P- .
Chlordphenol 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. . /, ,
l.Health^nd.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. . '--. - . ':., ' \ V
2. EPA Acceptance Criteria ." ' ;' . '"'''., -' -:i- '" ~ , .
::' 125
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