-------
14
Th® Offic® of Compliance Monitoring
of the
Sincerely yours.
.Daniel M. Barolo, Director
Special Review and
Reregistration Division
Attachments
Status fiftgo*-
Form
- Data Call-Tn
~ Data Call-in Resprmea
- Requirements status and
or Meeting Acute
'^^^^^^^^^^^^^—^^^^^^^^
EPA Acceptance
of Registrants
Specific Data Report
-------
ATTACHMENT A
Chemical Status Sheet
-------
ATTACHMENT A
CITRIC ACID: DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Data Call-In Notice because you have products containing
citric acid.
This attachment, the Data Call-in Chemical Status Sheet, contains a point of contact for
inquiries. This attachment is to be used in conjunction with (1) the Data Call-In Notice. (2)
Attachment B, the Data Call-in Response Form. (3) Attachment C, the Requirement Status and
Registrant's Response Form for product specific data, (4) Attachment D, EPA Grouping of
End-Use Products for Meeting Acute Toxicology Data Requirements for Reregistration. (5)
Attachment E, EPA Acceptance Criteria, (6) Attachment F, List of All Registrant^ sent this
Data Call-In Notice, and (7) Attachment G, the Cost Share and Data Compensation Forms for
product specific data, and Product Specific Data Report Form for use in replying to this citric
acid Data Call-In. Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for citric acid are
listed in the Requirements Status and Registrant's Response Form. Attachment C.
The Agency has concluded that product specific data are needed for citric acid. The
required additional data are listed in Attachment C.
Depending on the results of the studies required in this Notice, additional testing may
be required.
INQUIRIES AND RESPONSES TO THIS NQTTCE
If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Ruth Douglas at (703) 305-6600. All
responses to this Notice should be submitted to:
' Document Processing Desk (RED/RD/PM-32)
Office of Pesticide Programs
U.S. Environmental Protection Agency
401 M Street S.W.
Washington, D.C. 20460
RE: Citric acid
-------
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Napoleon Kotey at (703) 308-8523. All responses to
this Notice should be submitted to:
Chemical Review Manager Napoleon Kotey
Accelerated Reregistration Branch (H7508W)
Special Review and Reregistration Division
Office of Pesticide Programs
U.S. Environmental Protection Agency
401 M Street S.W.
Washington, D.C. 20460
RE; Citric acid
-------
ATTACHMENT B
PRODUCT SPECIFIC DATA CALL-IN RESPONSE FORMS (Form A)
PLUS INSTRUCTIONS
-------
SPECIFIC INSTRUCTIONS FOR COMPLETING
THE DATA CALL-IN RESPONSE FORM
Product specific Data.
This form is designed to be used to respond to call-ins for
generic and product specific data for the purpose of
reregistering pesticides under the Federal Insecticide Fungicide
and Rodenticide Act. Fill out this form each time you are
responding to a data call-in for which EPA has sent you the form
entitled "Requirements Status and Registrant's Response."
Items 1-4 will have been preprinted on the form. Items 5
through 7 must be completed by the registrant as appropriate.
Items 8 through 11 must be completed by the registrant before
submitting a response to the Agency.
Public reporting burden for this collection of information
is estimated to average 15 minutes per response, including time
for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding
the burden estimate or any other aspect of this collection of
information, including suggesting for reducing this burden, to
Chief, Information Policy Branch, PM-223, U.S. Environmental
Protection Agency, 401 M St., S.W., Washington, D.C. 20460; and
to the Office of Management and Budget, Paperwork Reduction
Project 2070-0107, Washington, D.C. 20503.
-------
62 Analysis and certification of Product Ingredients
GUIDANCE FOR SUMMARIZING STUDIES
2 Degree of accountability or closure in analyses in It. 11.
3. Chemical names of tcxic impurities which vere analyzed for
levels <0.1%.
*•
of method (.) in item 14.
5
Statement of precision and accuracy
analyzed in item #1
of how limits were determined.
.. Proposed -PP« certified limit for
lmits were determined
ferlfffelTim^ ,!f
latter) .
-------
63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active
ingredient being reregistered.
Does your study meet the following acceptance criteria?
"" - bb^=*^^^ -
Munsell color system
63-3 ^'i^^^oa of Physical state Provided using terms
- such as "solid, granular, volatile liquid
Based on visual inspection at about 20-25 C
63-4 Odor
verbal description of odor (or lack of it) using terms
luch as "garlic-like, characteristic of aromatic
compounds"
Observed at room temperature
63-5 Melting Point
Reported in C'
Any observed decomposition repprted
63-6 Boiling Point
— PrltSure iSder which B.P. measured reported
Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
registered products may be reported in Ibs/ft or
Ibs/gallon.]
-------
63-8 Solubility Hi stilled water and representative polar and
— SS^£^. S£SS5, those'used i" «*«**«**
2nd analytical methods for the pesticide
— £ S/SS SHo^er units li*e PP» acceptable if
sparingly soluble)
63-9 Vapor Pressure
— £asuredents2Lde
low to measure at 25" C)
by extrapolation from
if pressure too
conventional units
63-10 Dissociation Constant
Experimental method described ,creferablY
- Temperature of measurement specified {preferably
about 20 - 25' C)
63-11 octanol/water Partition Coefficient
""12^ folfoSin/dilutfon'or dispersion in distilled
water
63—13 Stability . - metal determined
— ISSililfat'norSaf andnelevated temperatures
Sensitivity to sunlight determined
-------
63 Physical and Chemical characteristics
GUIDANCE FOR SUMMARIZING STUDIES
Ihe fouowin, criteria.apply to «- technical ^e of the active
ingredient being reregistered.
1. Description of color.
2 Description of physical state.
point (in
ol nP^x S.; «- sP-i«o Cavity.
nc
7* indication of solubility.
8' indication of vapor pressure
ji SSSSS of SSSS^S-
11. indication of PH.
12. Description of stability.
-------
SUBDIVISION F
Guideline study Title
81-1 Acute Oral Toxicity in the Rat
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
81-3 Acute Inhalation Toxicity in the Rat
81-4 Primary Eye Irritation in the Rabbit
81-5 Primary Dermal Irritation Study
81-6 Dermal Sensitization in the Guinea Pig
-------
81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
Identify material tested (technical, end-use product, etc)
At least 5 young adult rats/sex/group
Dosing, single oral may be administered over 24 hrs.
Josef SJSST^iSE to^etermlne a toxicity category
or a limit dose (5000 mg/kg).
Individual observations at least once a day.
observation period to last at least 14 days, or until all
test animals appear normal whichever is longer.
individual daily observations.
individual body weights.
Gross necropsy on all animals.
Criteria marked with a * are supplemental and may not be required
for every study.
-------
81-1 Acute Oral Toxicity in the Rat
GUIDANCE FOR SUMMARIZING STUDIES
! The form of pesticide tested, e.g. solid, liquid, percent
S in technical, end-use product, etc.
2 The number of animals/dose/sex tested.
3'. Dosing route and regimen.
4. vehicle used
least 14 days. ,
7 summarization of body weights
r?f£S.nS. Acceptance crite.i,
-------
81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
"IB xdentify material tested (technical, end-use product, etc)
At Iea^_^0^nimal%bbit2r2^0-3.0 kg or guinea pigs 350-
450 gm.
Dosing, single dermal.
Dosing duration *t_least ^hours.^ vehicle is unknown.
to determine a toxicity category
'shaved at least 24 hours
of body surface area.
wii:n <* porous nonirritating cover
and to prevent ingestion.
_ 1 _ ^_ _ _ r* ft ^ \T
individual observations at least once a day
observation period to last at leasr x*
Individual body weights.
cross necropsy on all animals.
Criteria marked with a * are supplemental and may not be required
for every study.
-------
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
GUIDANCE FOR SUMMARIZING STUDIES
1 The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. The number of animals/sex/dose
3* Weight range of animals
4' verification of single, dermal exposure
5. Duration of dermal exposure
6. Statement of vehicle control
7 Doses tested and results
surface)
iS". occluslon'of test material on plication site
longer). .
12 summarization of body weights
13. Summarization of gross necropsy criteria
14 significance of changes from Acceptance Criteria
-------
81-3 Acute Inhalation Toxicity in the Rat
$ ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
,.__ Identify material y
2. Product is a gas, a solict wnicn » * v contains
~
l^ast 5ng adult rats/sex/group
3.
4.
* least 19% oxygen content.^ ^ relative humidity 40-60%.
f:EE £SS Hell°fconie'n"»tions of test .nateria! in
9. Honiior *««Jym^c^arti£ed£^or a^oKc^y category
10. Doses teste , su 1 ar.-i-.nal concentration of respirable
substance). .
11 Individual observations at
12" observation period to last
,,* individual body weights.
£4' cross necropsy on all animals.
-------
81-3 Acute Inhalation Toxicity in the Rat
GUIDANCE FOR SUMMARIZING STUDIES
!. The form.ofpesticide tested^e.g., solid, liquid, percent AI
f '4-1-1 i ntiaTability of test substance
3* The number of animals/sex/dose
^ SuSer0of0chaSeraaiirncnSges"our and the percent oxygen
' "'for SaSer air teuperature and relative humidity
9'. Results of ;f *°s°l P?rtic^e-size determina i^ attainable)
i?; ?nd!viduaieobservat!onsaoneday of'dosing and for at least 14
Jf . • _.C \^n/l*T tJOTrttl^S
12. sSSarization of body weights
-
13.
"14,
-------
81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
6.
7.
8,
*' de^alTrr™9at"oroVhaV7*pH of < 2 or >
34;— Dosln" Instiuation into the conjunotival sac of one eye
if a liquid; 0.1 ml or not more than 100 ing if
0r
21 days (whichever is shorter).
individual daily observations.
Criteria marked with a * are supplemental and may not be required
for every study.
-------
81-4 Primary Eye Irritation in the Rabbit
GUIDANCE FOR SUMMARIZING STUDIES
1 The form of pesticide tested, e.g., solid, liquid, percent AI
State^Steriaf'is^ttosive, cause severe dermal irritation
or has a pH of <2 or >11.5
3. Number of adult rabbits ^sted
4 state method of dosing, i.e., me»L.j.xo.«»*.j.*'»
conjunctival sac of one eye per animal
I'. NO!! wh^therStseoUdd or granular test material has been ground to
7. statfwSether eyes were washed andrt what time post
1 TISt 1_L 13. w lOll lIiOwi*>»^ _3J^.P-*^-i -r*>* T 4~ S»^ T OTl
State whether eyes were examined and graded for irritation
10. significance^ changes from Acceptance Criteria
-------
81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Does your study *eet the following acceptance criteria?
11.*
1.
pH of <2 or > ll.a.
3 6 adult animals.
4J ! Dosing, single dermal.
5*Dosing duration 4 hours. , t least 24 hours prior
—^^^~^^^~~ » _»_ * ^ •^ ^x ^^A f^UQfi ^!!L ^3 I 1 |J kJ tsti ci ** •*• *^**' "^
7> Application site aPProxP^£ a gauze patch held in place
T" SSrSSSFwasned with water, without trauma to
:ion site «,-Arted for irritation at 1,
. j ^-i^-o ova-mined and graaea iot xj.j-->-v-_ ^
10.
7a.i
{whichever is shorter).
individual daily observations.
criteria marKed with a * are supplemental and may not be retired
for every study.
-------
81-5 Primary Dermal Irritation Study
GUIDANCE FOR SUMMARIZING STUDIES
1. The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. State if material is corrosive, has a pH <2 or >11.5, or has a
dermal LD 50 <200 mg/kg
3. Number of adult animals tested
4. Amount applied
I! P^paraTion ^SilSSS^lt. (shaved or dipped at specified
time before dosing)
7. Area of application site
8 Method for occlusion of application site
I' Note removal of test material and if skin was washed with water
10'. State times post application when site was graded for
11. individual observations for day of dosing and individual
daily observations thereafter
12. Significance of changes from Acceptance Criteria.
-------
81-6 Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
dose your study meet the following acceptance criteria?
1 Identify material tested (technical, endTuse Product, etc)
l'-_ stuSy not required if material is corrosive or has a
3 one°of~therfollowing methods is utilized;
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehler test
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig
4p complete description of test
IS'-— ?:£rSSo£5 essentially as described in reference
6. -
document.
Positive-control included (may provide historical data
conducted within the last 6 months)
Criteria marked with a * are supplemental and may not be required
for every study.
-------
81-6 Dermal Sensitization in the Guinea Pig
GUIDANCE FOR SUMMARIZING STUDIES
1 The form of pesticide tested, e.g., solid, liquid, percent AI
in technical, end-use product, etc.
2. State if material is corrosive or has pH <2 or >11.5.
3. state specific method utilized
4 Complete description of specific method
5 Reference for the specific method employed
I'. Note" aSnerence of the protocol to that in the reference for
the specific method utilized
7. State the positive control tested
8. Significance of changes from Acceptance Criteria
-------
ATTACHMENT F
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
-------
Page
United States Environmental Protection Agency
Washington, D. C. 20460
- LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case i and Name: 4024 Citric acid, and salts
Additional Name
ECOLAB INC.
CANTOL INC
370 UABASHA ST. ECOLAB CENTER
2211 N AMERICAN STREET
ST PAUL UN
PHILADELPHIA PA
55102
19133
-------
ATTACHMENT G
COST SHARE AND DATA COMPENSATION FORMS
-------
United States Environmental Protection Agency
Washington, DC 20460
.WrtfCP/V CERTIFICATION WITH RESPECT TO
^^^^^^^f ^K ^1 ^^^^^^^fc ~~ — - - — •^ - • »^» ^ • • ** *• •
Form Approved
OMB No. 2070-0106
Approval Eiplroi 12-31-92
DATA COMPENSATION REQUIREMENTS
Public reporting burden for this collection of information is estimated to average 15 minutes P^6?^^'
time to reviewSxi instructions, searching existing data sources, gathering and mamta.n.ng the data needed, and
collection of information. Send comments regarding the burden est.mate or any other
.
intern-Bon, Mud* suggestions for reducing this bu,rden- to Chief
n o the
sp , ,
Branch PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC
ofSgemert l and Budget. Paperwork Reduction Project (2070-0106). Wash,ngton. DC 20503
Please (III In blanks below.
Company Nam*
EPA Reg.
Product Name
I Certify that:
1 For each study cited in support of registration or reregistration under the Federal Insecticide. Fungicide and
' R^emicide Abt (FlFRA) thaYis an exclusive use study, I am the original data submrtter, or I have obtamed the
written permission of the original data submitter to cite that study.
negotiation to determine which data are subject to the compensation requirement of FIFRA and the amount ot
compensation due, if any. The companies I have notified are:
[ ] The companies who have submitted the studies listed on the back of this form or attached
sheets, or indicated on the attached -Requirements Status and Registrants' Response Form,
3. That I have previously complied with section 3(c)(D(D) of FIFRA for the stydies I have cHed in support of
registration or reregistration under FIFRA. ^__
• ' " ~~ ~ I Oil*
Slgnitur*
Nam* «nd Tltlo (Plus* Typo or Print)
GENERAL OFFER TO PAY: ! hereby offer and agree to pay compensation to other persons with regard to the
reregistration of my products, to the extent required by FIFRA sections 3(C)(1)(D) and 3(cH2}(D).
D»t*
Signttur*
Ntmi ind T1U» (PU«* Typo or Print)
.^M.^•»*—^^•^P-B—^«—
'
EPA Form 8570-51 (4*00)
-------
?/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
Approval Expires 12-31-92
Public reporting burden for this collection of information Is estimated to average 15 minutes per response, including
time tor reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, lo Chief, Information Policy
Branch PM-223, U.S. Environmental Protection Agency, 401 M St.. S.W., Washington. DC 20460; and to the Office
of Management and Budget. Paperwork Reduction Project (2070-0106), Washington, DC 20503,
Please fill in blanks below.
Company Name
Product Name
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide. Fungicide and Rodenticide Act (FtFRA), if necessary. However, my company would prefer to
e.nter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c){2)(B){iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm{s) on the following
date(s):
Name of Flrm(»)
Date el Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company'* Authorized Representative
Date
Name and Title (Pleate Type or Print)
J
EPA Form 1570-32
-------
ruuiimanutl rroiecitan A
Washington, DC20460
V>ERA Product Specific
Data Report
Registration
Guideline No.
Testing not
required for my
product lifted
above
\ em complying with
Data Requirements bv
I 634
63-7
634
63-9
63-10
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
1 63-19
1 63-20
63-21'
Sec. 158.135
Toxicology
81-1
81-2
I 81-3
61-4
81-5
I 81-6
Boiling point
Density, bulk-density, or spec
Solubility
Vapor pressure
Dissociation constant
Octanof /water partition coeffic
PH
Stability
Oxidizing/reducing reaction
Rammability
Explod ability
Storage stability
Viscosity
Miscibility
Corrosion Characteristics
Dielectric breakdown voltage
Acute oral toxicity, rat
Acute dermal toxicity, rabbit /]
Acute inhalation toxicity, rat
Primary eye irritation, rabbit
Primary dermal irritation
Dermal sensitization
Citing MR ID No
Sec. 158.120
Product
Chemistry
Identity of Ingredients
Statement of composition
Discussion of formation of ingredients
Preliminary analysis
Certification of limits
methods for enforcement limit*
Submitting Data
(AflacfceoV
(Chtck t>»tow)
Form Approved
OMB #2070-0057
Expires 11-30-89
For EPA Use
Only)
Accession
numbers
• assigned
. .. . Certification
I certify that the statements I have made on this form and all attachments thereto are
true, accurate, and complete. I acknowledge that any knowinojy SsTor mfsfeadfna
statement may be punishable by fine or imprisonment orV^Srap^icableTaw 9
Typed Name and Title
Signature
EPA Form 8580-4 (Rev. 5-B8) Previous edition is obsolete
Date
-------
62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active
ingredient being reregistered. Use a table to present the
information in items 6, 7, and 8.
Does your study meet the following acceptance criteria?
1. Five or more representative samples (batches in case of
batch process) analyzed for each active ingredient and all
impurities present at > 0.1%
2. Degree of accountability or closure > ca 98%
3.Analyses conducted for certain trace toxic impurities at
lower than 0.1% (examples, nitrosamines in the case of
products containing dinitroanilines or containing secondary
or tertiary amines/alkanolamines plus nitrites;
polyhalogenated dibenzodioxins and dibenzofurans) [Note
that in the case of nitrosamines both fresh and stored
samples must be analyzed.]
4. complete and detailed description of each step in analytical
method used to analyze above samples
5. statement of precision and accuracy of analytical method
used to analyze above samples
6. Identities and quantities (including mean and standard
deviation) provided for each analyzed ingredient
7. Upper and lower certified limits proposed for each active
ingredient and intentionally added inert along with
explanation of how the limits were determined
8. Upper certified limit proposed for each impurity present at
>. 0.1% and for certain toxicologically significant
impurities at <0.1% along with explanation of how limit
determined
9. Analytical methods to verify certified limits of each
active ingredient and impurities (latter not required if
exempt from requirement of tolerance or if generally
recognized as safe by FDA) are fully described
10. ' Analytical methods (as discussed in #9) to verify certified
limits validated as to their precision and accuracy
-------
Page 1 of 1
United States Environmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested
Use additional sheet(s) if necessary.
1. Company name and Address 2. Case # and Name
ECOLAB INC. 4024 Citric acid, and salts
370 WABASHA ST. ECOLAB CENTER
ST PAUL MN 55102
4. EPA Product
Registration
1677-90
5. f wish to
cancel this
product regis-
tration volun-
tarily.
6. Generic Data
6a, I am claimimg a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
. t rat ion number listed below.
N.A.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N.A.
7. Product Specific
Form Approved
OHB No. 2070-0107
Approval Expire* 12-31-92
pn this form.
3. Date and Type of DC1
PRODUCT SPECIFIC
Data
7a. My product is a MUP and
I agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
8. Certification
I certify that the statements made on this form and all attachments are true, accurate, and complete.
1 acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company Contact
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
9. Date
11. Phone Number
-------
Page 1 of 1
United States Environmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested
Use additional sheet (s) if necessary.
1. Company name and Address H. Case # arid Name
ECOLAB INC. 4024 Citric acid, and salts
370 WABASHA ST. ECOLAB CENTER
ST PAUL MN 55102
4. EPA Product
Registration
1677-100
5. I wish to
cancel this
product regis-
tration volun-
tarily.
8. Certification
I certify that the statements made on th
I acknowledge that any knowingly false o
or both under applicable law.
Signature and Title of Company's Authori
6. Generic Data
6a. I am claimimg a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
N.A.
6b. t agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response.11
N.A.
is form and all attachments are true, accurate, and coqplete.
r misleading statement may be punishable by fine, imprisonment
zed Representative
7. Product Specific
Form Approved
OMB No. 2070-0107
Approval Expires 12-31-92
on this form.
3. Date and Type of DCI
PRODUCT SPECIFIC
Data
7a. «y product is a HUP and
I agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
10. Name of Company Contact
7b. My product is an EUP and
t agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
9. Date
11. Phone Number
-------
Page 1 of 1
United States Environmental Protection Agency Form Approved
Washington, D. C. 20460 OMB NO. 207o-o,or
DATA CALL-IN RESPONSE Approyal Expirc8 ^.^
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary. v
1. Company narae and Address 2. Case * and Name 3. Date and Type of DCI
CANTOL INC 4024 Citric acid, and salts PRODUCT SPECIFIC
2211 N AMERICAN STREET
PHILADELPHIA PA 19133
4. EPA Product
Registration
5664-4 -
5. I wish to
cancel this
product regis-
tration volun-
tarily.
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
. t rat ion number listed below.
N.A.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N.A.
7. Product Specific Data
7a. Hy product is a HUP and
I agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
\ .
7b. Hy product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
8. Certification °- Date
I certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
signature and Title of Company's Authorized Representative
10. Name of Company Contact H- phone Number
-------
Page 1 of 1
United States Environmental Protection Agency
Washington, D. C. 20460
-. LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case # and Name: 4024 Citric acid, and salts
Co. Nr. Company Name Additional Name Address City & State Zip
001677 ECOLAB INC. 370 WABASHA ST. ECOLAB CENTER ST PAUL MN 55102
005664 CANTOL INC 2211 N AMERICAN STREET PHILADELPHIA PA 19133
-------
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 (MP)
or 7b (EP) on this form, provide the EPA registration
numbers of your source(s) and complete and submit the
"Generic Data Exemption" form; 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 (MP) for which you
wish to maintain registration, you must agree to
satisfy the data requirements by responding "yes."
Itejn -7b. For each end use product (EP) 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 cancelled
this product. For these cases, please supply all
relevant details so that EPA can ensure that its
records are correct.
-------
ATTACHMENT C
PRODUCT SPECIFIC REQUIREMENT STATUS AND REGISTRANT'S RESPONSE
(FORMS B) PLUS INSTRUCTIONS
AND
PR NOTICE 86-5
-------
United States Environmental Protection Agency
Washington, D, C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Page 1 of 3
Form Approved
OK8 Bo. 2070-0107
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) If necessary.
1, Company name and Address
ECOLAB INC.
370 WABASHA ST. ECOLAB CENTER
ST PAUL MN 55102
2. Case # and Name
4024 Citric acid, and salts
EPA Reg. No. 1677-90
3. Date and Type of DCI
PRODUCT SPECIFIC
ID# 1677-RD-1899
4. Guideline
Requi rement
Number
5. Study Title
progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
9. Registrant
Response
Prod Chan - Regular Chemical
61-1
61-2(fa)
62-1
62-3
63-14
63-16
Product identity
i composition{1)
- .:;rria te
production 6 fo mutation
Discussion of formation of (1,3)
Preliminary analysis (1,4)
pCe^tif.feitf'(Sn'i.oJFii.tJuittia i-^y;^ :Cf^5j
Analytical method (1)
iij^j^leii-
Density
Oxidizing or reducing a tion (10)
ii'Fiattsbt'tltyi:
Explodability (12)
ABCDEFGHIJKLMNO
EP
EP:.
8 mos.
ABCDEFGHIJKLMNO
ABCbEFGHIJKLMNC)
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNb
ABCEFGHIJKLMNb
ABCDEFJSHiJKBQIp:
ABCbEFGHIJKLMNb
ABepEFGHIJKLMiKJ
ABcbEFGHIjkLMNO
EP
EP::;
EP
|fii
EP
$
EP
EP:::
EP
8 mos.
8 mos.
... ....
8 mos.
&;;;;;M^:i;
8 mos.
;8$iM
8 mos.
;&j;:fii6^ii;:;;
8 mos.
10. Certification
I certify that the statements mode on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
11. Date
12. Name of Company Contact
13. Phone Number
-------
United states Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Page 2 of 3
Form Approved
OMB No. 2070-0107
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully
Use additional sheet(s) if necessary.
the attached instructions and supply the information requested on this form.
1. Company name and Address
ECOLAB INC.
370 WABASHA ST. ECOLAB CENTER
ST PAUL MN 55102
2. Case * and Name
4024 Citric acid, and salts
EPA Reg. No. 1677-90
3. Date and Type of DCI
PRODUCT SPECIFIC
ID# 1677-RD-1899
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
9. Registrant
Response
63-18
|:i ;3tjara3*; it |W $£ |;t;|; ;jf-^ V:;-: ^: it:16) :•
Viscosity (13)
63-20
Corrosion characteristics (17)
? $$-t%y«£tr! i ic Wea&wi! ?mi$ aSe^^iS); '•.
'•afreaf&lVr:::-:::::':::
ABCDEFGHIJKLMNO
ABCDEFGHijKLMNO
ABCDIFGHIJKLMHO
ABCbEFGHIJKLMNO
81-2
81-3'
81-5
Acute dermal (1,2,37)
Acute inhalation toxicity-rat (3)
Primary dermal irritation (1,2)
••:# BjTwfeserHsi tf za t toft ;• ::^;h\ i.; •;; •; /•( 4) '•'•••; ^; t;
;. /tfiti 'iiilTcrbbii it Aocnts • - '. Publ ic - :
ABCDEPGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHUKLMNO
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
Health Uses
8 mos.
8 mos.
8 mos.
8 mos.
8
8 mos.
8 mos.
8 mos.
8 mos,
8 mos.
8 wos.
Initial to indicate certification as to information on this page
(full text of certification is on page one).
Date
-------
Page 3 of 3
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print fn ink. Please read carefully
Use additional sheet(s) if necessary.
1. Company name and Address
ECOLAB INC.
370 WABASHA ST. ECOLAB CENTER
ST PAUL MN 55102
4. Guideline
Requirement
Number
9X-2
the attached instructions and supply the information requested
2, Case # and Name
4024 Citric acid, and salts
EPA Reg. No. 1677-90
5. Study Title
Food Preparation and Eatfnfl
Establishments
AQAC germkidal and (1,Z,10)
detergent sanitizer
method
L
Progress
Reports
1
2
3
6. Use
Pattern
Initial to indicate certification as to information on this page
(full text of certification is on page one).
L
7. Test
Substance
on this form.
Form Approved
OMB No. 2070-0107
Approval Expires 12-31-92
3. Date and Type of OCI
PRODUCT SPECIFIC
ID# 1677-RD-1899
EP, ,
8. Time
Frame
8
mos.
9. Registrant
Response
Date
-------
Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case | and Name: 4024 Citric acid, and salts
Key: HP * manufacturing-use product; EP = end-use product; provided formulators purchase their active ingredient(s) from a registered source, they need not submit or cite
data pertaining to the purchased product.[NOTE: If a product is a 100 percent repackage of another registered product that is purchased, and any use for the product does
not differ from those of the purchased and registered source, users are not subject to any data requirements identified in the tables.]; TEP = typical end-use product;
TGAI » technical grade of the active ingredient; PAI = "pure" active ingredient; PAIRA = "pure" active ingredient, radiolabeled.
Use Categories Key:
A - Terrestrial food crop B - Terrestrial food feed crop C - Terrestrial nonfood crop D - Aquatic food crop E - Aquatic nonfood outdoor
F - Aquatic nonfood Industrial G - Aquatic nonfood residential H - Greenhouse food crop I - Greenhouse nonfood crop J - Forestry
K - Residential outdoor L - Indoor food H - Indoor nonfood N - Indoor Medical 0 - Indoor residential
Footnotes: [The following notes are referenced in column two (5. Study Title) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.)
Prod Chen - Regular Chemical
1 Requirements pertaining to product identity, composition, analysis, and certification of ingredients are detailed further in the following sections: *158.155 for
product identity and composition (61-1); *158.160, 158.16Z, and 158.165 for description of starting materials and manufacturing process (61-2); *158.167 for
discussion of formation of impurities (61-3); *156.170 for preliminary analysis (62-1); *158.175 for certification of limits (62-2); and M58.180 for enforcement
analytical methods (62-3).
2 A schematic diagram and/or brief description of the production process will suffice if the pesticide is not already under full scale production and an experimental
use permit is being sought. ,
3 If the pesticide is not already under full scale production and an experimental use permit is sought, e discussion of unintentional ingredients shall be submitted to
the extent this information is available.
4 Required to support the registration of each manufacturing-use product (including registered TGAIs) as well as end-use products produced by an integrated system.
Data on other end-use products will be required on a case-by-case basis. For pesticides in the development state, a rudimentary product analytical method and data
will suffice to support an experimental use permit.
5 Certified limits are not required for inert ingredients in products proposed for experimental use.
9 Required if test substances are dispersible with water.
10 Required if product contains an oxidizing or reducing agent.
11 Required if product contains combustible liquids.
12 Required if product is potentially explosive.
13 Required if product is a liquid.
14 Required if product is an emulsiftable liquid and is to be diluted with petroleum solvents.
15 Required if end-use product is liquid and is to be used around electrical equipment.
16 Basic manufactures are required to provide the Agency with a sample of each TGAI used to formulate a product when the new TGAI is first used as a formulating
ingredient in products registered under FIFRA. A sample of the active ingredient (PAI) suitable for use as an analytical standard is also required at this time.
Samples of end-use products produced by an integrated system must be submitted on a case-by-case basis. Material safety data sheets should accompany samples as
specified by OSHA in 29 CFR 1910.1200.
Acute Toxic - Regular Chenicat
1 Not required if test material is a gas or highly volatile.
2 Not required if test material is corrosive to skin or has pH less than 2 or greater than 11.5; such a product will be classified as Toxicity Category I on the basis
-------
Page 2 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 4024 Citric acid, and salts
Footnotes (cont.)J
of potential eye and dermal Irritation effects.
3 Required if the product consists of, or under conditions of use will result in, an inhalable material {e. g., gas, volatile substances, or aerosol/particulate).
* Required unless repeated dermal exposure does not occur under conditions of use.
36 Special testing (acute, subchronic, and/or chronic) is required for organophospates, and may be required for other choUnesterase inhibitors and other pesticides
which have demonstrated a potential to adversely affect the visual system. Registrants should consult with the agency for development of protocols and methodology
prior to initiation of studies. , . , . . . .,. _,
37 Testing of the EP dilution is required if it can be reasonably anticipated that the results of such testing may meet the criteria for restriction to use by certified
applicators specified in 40 CFR 152.170{b) or the criteria for initiation of special review specified in 40 CFR 154.7 (a)(1).
Efficacy - Antimicrobial Agent
1 Efficacy data for antimicrobial agents that claim to control pest microorganisms that may pose a threat to human must be submitted.
2 Generative product performance data are required to be developed and maintained in the registrant's file and must be submitted to the Agency on a case-by-case basis
for risk/benefit analyses such as for public interest findings and cases of special review.
10 Required for products to be used on food contact surfaces, which include quaternary ammonium compounds (OAC) chlorinated trtsodium phosphate, and anionic
detergent-acid formulations. ,
-------
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
""'
"*
** '""*"" 1'nStructions 9nd S(«*Y the information requested on this form.
Page 1 of 3
Form Approved
OMB Ho. 2070-0107
Approval Expires 12-31-92
1. Company name and Address
ECOLAB INC.
370 WABASHA ST. ECOLAB CENTER
ST PAUL MN 55102
4. Guideline
Requirement
Number
6i-i"""":':':':'::
(S1-2 (b)
62-1
62-3
63-7:
63-14
63-16
5. Study Title
Prod Chew - Regular Chemical
production & formulation
:';; >•;; -:t mpur.l t j «s.-;:;-.; ? .;•;•;; ?::; ::i;
Preliminary analysis
:;; Certif jeatl joVi" ^crf ffitft 1
Analytical method
.ijPhy&f ca I ::s tatif:; [ /;: •; {;; \ 'A
Density
Oxidizing or reducing
Explodability
FER
2. Case # and Name
4024 Citric acid, and salts
EPA Reg. No. 1677-100
anical
xnpositiond )
on of (1,3)
(1,4)
1 '$ £'#-7/fT;S )-;.- ::;."
(1)
c ion (10)
(12)
:'^:
• i'j! '.• '
Tr.
0
:;;;;
:;;••;
::•-
Progress
Reports
1
:i:i:i-;;
'.^y-
•:•::•>•
:;.;•:;:•
2
:4;;:;;:':
:: iV:.;'.
,::::>:•;.-.:.
:^K
3
;;|;;|;
'/"•••.::
-,<•<•';.?.
:rJ:;'
6. use
Pattern
ABCbEFGrilJKlMo
ABCDEFGHiJkLMNO
ABCDEFGHiJKLMNO
ABCDEEGHIJKLMNO:
ABCbEFGHIJkLMNO
ABCDEFGHIJKLMNO
ABCDEFGHiJKLMNO
ABCDEFGHIJKLMNO
ABC,DEFGHItrKLMW0
ABCDEFGHUKLMNO
7. Test
Substance
£p --•—---—
E'p •*••< •---• "l--J •
E- :.,,:,. --.-..-,::::,
3P'""" ":':::'":"'"'--':
3P'::::
EP' """!VI>:"
3. Date and Type of DCI
PRODUCT SPECIFIC
ID# 1677-RD-1900
0. Certification
certify that the statements made on this form and ell attachments are true, accurate, and complete
acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
12. Name of Company Contact
11. Date
8. Time
Frame
8 mos.
8 mos.
f-;-:^;;?!:.;;: :;i--:':-:::;.;
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
9. Registrant
Response
13. Phone Number
-------
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Page 2 of 3
Form Approved
OMB No. 2070-0107
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the
Use additional sheet(s) if necessary.
attached instructions and supply the information requested on this form.
1. Company name and Address
ECOLAB INC.
370 WABASHA ST. ECOLAB CENTER
ST PAUL MN 55102
Case # and Name
4024 Citric acid, and salts
EPA Reg. No. 1677-100
3. Date and Type of DCI
PRODUCT SPECIFIC
ID# 1677-RD-1900
4. Guideline
Requi rement
Number
5. Study Title
Progress
Reports
1 2 3
A. Use
Pattern
7. Test
Substance
8. Tine
Frame
9. Registrant
Response
63-18
63-20
81-2
: ' -v.-. •..'::::.'
81-3
81-5
•i Stolfigfl; isjatli i;i-ty:i; 5; >! I ?? 'l\
Viscosity
(133
Corrosion characteristics (17)
?j> if$e;
P Xc|itf :$e|i:; tostst tTr-t-itiiv! ::>;:; i;;:; ti*3(Sv3^ii;
Acute dermal (1,2,37)
:!:'•;:: :i:j-l^;fc| ^ i^bfef tff at ;| SIB *^ I ^;: g \ ;;-;;•; "& \
Acute inhalation toxicity-rat (3)
;:;|: Jl^ffiM^^I i*Hta;li<3^ i^bb^t i (z y i !^x£ i;
Primary dermal irritation (1,2)
ABqpffiF^alJ^LMNp
ABCDEFGHIJKLMNO
ABCJ^FGH|J^LHNQ
ABCbEFGHIjkLMNO
ABCDEFGHIJKLMNO
EP
EP
-fef f ii-aW:^ ^An^Tm cridbjat !• Ada-its' ^ Pub lie;
Health Uses
Medical, Dental. Hortuarv, and
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHIJKLWO
EP
EP
EP
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
Initial to indicate certification as to information on this page
(full text of certification is on page one).
Date
-------
Page 3 of 3
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully
Use additional sheet(s) if necessary.
1. Company name and Address
ECOLAB INC.
370 WABASHA ST. ECOLAB CENTER
ST PAUL MN 55102
4. Guideline
Requt rement
Nunber
91-2,3
91-2
91-2
the attached instructions and supply the information requested;
2. Case # and Name
4024 Citric acid, and salts
EPA Reg. No. 1677-100
5. Study Title
At i ted EfTvirohmcnts .KH • T- ':. :: ?£i " -: •• '• :- '::. • :: '; ;/- J
AOAC use-dilution method (1,2)
•" ' AOAC f
-------
Page1 of 2
, United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 4024 Citric acid, and salts
Key: MP "= manufacturing-use product; EP « end-use product; provided formulators purchase their active ingredient(s) from a registered source, they need not submit or cite
data pertaining to the purchased product.[NOTE: If a product is a 100 percent repackage of another registered product that Is purchased, and any use for the product does
not differ from those of the purchased and registered source, users are not subject to any data requirements Identified in the tables.]; TEP = typical end-use product;
TGAI = technical grade of the active ingredient; PAI = "pure" active ingredient; PAIRA = "pure" active ingredient, radiolabeled.
Use Categories Key:
A - Terrestrial food crop B - Terrestrial food feed crop C - Terrestrial nonfood crop D - Aquatic food crop E - Aquatic nonfood outdoor
F - Aquatic nonfood Industrial G - Aquatic nonfood residential H - Greenhouse food crop I - Greenhouse nonfood crop J - Forestry
K - Residential outdoor L - Indoor food K - Indoor nonfood N - Indoor Medical 0 - Indoor residential
Footnotes: [The following notes are referenced in column two (5. Study Title) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
Prod Che* - Regular Chenical
1 Requirements pertaining to product identity, composition, analysis, and certification of ingredients are detailed further in the following sections: *158,155 for
product identity ond composition (61-1); *158.160, 158.162, and 158.165 for description of starting materials and manufacturing process (61-2); *158.167 for
discussion of formation of impurities (61-3); *158.170 for preliminary analysis (62-1); M58.175 for certification of limits (62-2); and *15B.180 for enforcement
analytical methods (62-3).
2 A schematic diagram and/or brief description of the production process will suffice if the pesticide is not already under full scale production and an experimental
use permit is being sought.
3 If the pesticide is not already under full scale production end an experimental use permit is sought, a discussion of unintentional ingredients shall be submitted to
the extent this information is available.
4 Required to support the registration of each manufacturing-use product (including registered TGAIs) as well as end-use products produced by an integrated system.
Data on other end-use products will be required on a case-by-case basis. For pesticides in the development state, a rudimentary product analytical method and data
will suffice to support an experimental use permit.
5 Certified limits are not required for inert ingredients in products proposed for experimental use.
9 Required if test substances are dispersible with water.
10 Required if product contains an oxidizing or reducing agent.
11 Required if product contains combustible liquids.
12 Required if product is potentially explosive.
13 Required if product is a liquid.
H Required if product is an emulsffiable liquid and is to be diluted with petroleum solvents.
15 Required if end-use product is liquid and is to be used around electrical equipment.
16 Basic manufactures are required to provide the Agency with a sample of each TGAI used to formulate a product when the new TGAI is first used as a formulating
ingredient in products registered under FIFRA. A sample of the active ingredient (PAI) suitable for use as an analytical standard is also required at this time.
Samples of end-use products produced by an integrated system must be submitted on a case-by-case basis. Material safety data sheets should accompany samples as
specified by OSHA in 29 CFR 1910.1200.
Acute Toxic - Regular Chemical
1 Not required if test material is a gas or highly volatile.
2 Not required if test material is corrosive to skin or has pH less than 2 or greater than 11.5; such a product will be classified as Toxicity Category I on the basis
-------
Page 2 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case | and Name: 4024 Citric acid, and salts
Footnotes (cont.)i
of potential eye and dermal Irritation effects.
3 Required if the product consists of, or under conditions of use will result In, an inhalable material (e. g.r gas, volatile substances, or aerosol/partfculate).
4 Required unless repeated dermal exposure does not occur under conditions of use.
36 Special testing (acute, subchronic, and/or chronic) is required for organophospates, and may be required for other cholinesterase inhibitors and other pesticides
which have demonstrated a potential to adversely affect the visual system. Registrants should consult with the agency for development of protocols and methodology
prior to Initiation of studies.
37 Testing of the EP dilution is required If It can be reasonably anticipated that the results of such testing may meet the criteria for restriction to use by certified
applicators specified In 40 CFR 152.170(b> or the criteria for initiation of special review specified in 40 CFR 154.7 (a)(1).
Efficacy - Antimicrobial Agent
j;
1 Effiracy data for antimicrobial agents that claim to control pest microorganisms that may pose a threat to human must be submitted.
1 Cooperative product performance data are required to be developed and maintained in the registrant's file and must be submitted to the Agency on a case-by-case basis
for risk/benefit analyses such as for public interest findings and cases of special review.
10 Required for products to be used on food contact surfaces, which include quaternary ammonium compounds (OAC) chlorinated trisodium phosphate, and anionic
detergent-acid formulations.
-------
Page 1 of a
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Form Approved
OMB Ho. 2070-0107
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) ff necessary.
1. Company name and Address
CANTOL INC
2211 N AMERICAN STREET
PHILADELPHIA PA 19133
2. Case # and Name
4024 Citric acid, and salts
EPA Reg. NO. 5664-4
3. Date and Type of OCI
PRODUCT SPECIFIC
ID# 5664-RD-1901
4. Guideline
Requi rement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
9. Registrant
Response
61-2(b)
62-i'"V"'::"
62-3
63-7
63-14 :'"
63-16
Prod Chan - Regular Chemical
Product identity & composition(l)
production & formulation
Discussion of formation of (1,3)
if £f ;:•:•? jiifiiH it t ts; ^;! ?] & [ ;•;
Preliminary analysis (1,4)
Analytical method (1)
Density
ABCDEFGHIJKLMNO
AB^DEFGHiJKLMNO
EP
Oxidizing or reducing
ABCDEFGHIJKLMNO
ABCDEFGHiJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHtiJKLMNb:
ABCDEFGHIJKLMNO
ction (10)
Explodability
(12)
ABCDEFGHIJKLMNO
ABCDEFGHIiTKLMNO
ABCDEFGHIJKLMNO
EP:
EP
EP"
EP
EP"
8 mos.
liar;
8 mos
8 mos.
8 mos.
8 mos.
8 raos.
8 mos.
10. Certification
I certify that the statements made on this form and all attachments are true, accurate, and conplete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
11. Date
12. Name of Company Contact
13. Phone Number
-------
Page 2 of
United States Environmental Protection Agency Form Approved
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company name and Address 2. Case # and Name 3. Date and Type of DCI
CANTOL INC 4024 Citric acid, and salts PRODUCT SPECIFIC
2211 N AMERICAN STREET ID# 5664-RD-1901
PHILADELPHIA PA 19133 EPA Reg. No. 5664-4
A. Guideline
Requirement
Number
63-18'
63-2 O'"""""""" """"""""""
81-2
81-3" " """ "" ""
:8&r4':} :-:: !:x.i:iilliii:'::
81-5
5. Study Title
^^t^^ij^ltr^-^^^^"1^!^.^^-'^-' ^
Viscosity (13)
•! !; |:; Hi Sx ic s*v Regular Chenf ca t'i;'1: ';". ':• ;:.'::•-.; f; '" '-.• " '•
\ ;;';i.;;,:AciiJtflii srat| jtflji ji,e j:ty*fflt;';: « ;: H^X t '» ^i ^^ I -! :':
Acute dermal (1,2,37)
Acute inhalation toxicity-rat (3)
Primary dermal irritation (1,2)
: £f°f f cacy; •? Anti nicrobi a i Aqer^tig :" ^' ;PtibE i c : •. : :. ; '
Health Uses
Bathroom Surfaces-Premises
si;!;.;; ' M&&. '\i$& y Uiitlbh' • method !.:; i: Ci C 1 ; 2 ) - ' :";: ^ .• ; t: >:^
R
0
•;•;:.
Progress
Reports
1
>: /."'".;!":[
2
i!:::.-:-.;.:
3
: • :: ::-:: :•-•'
'.:•••'•: '!'•:!'
• - -.-.- . >
: ':::.:"•:
6. Use
Pattern
ABCDEHGHIJKLMNO
ABCDEFGHIJKLMNO
ABCDEFGHUKLMNO
ABCDEFGHijKLMNO
ABCDEFGHiJKLMNb
ABCDEFGHIJKLMNO
ABCDEF.GHIJ:KLMNO
:^-^':Mm&^MftO
7. Test
Substance
EP"'"""""""""""""" "'""
EP""""""""'""" " """:: :'
T
'- - '.-••*:'•• •'• ••••'••••••• •• ••• •• •• •• ; '•• ;• •• • '•, ••;•••; ;' :; •:• /•'; . •:• . •'•;
-Tp-T^'-.-'' -::-'-:- :•••••:••;••'••- :- ••• ':-••• '••;•: '•-£•• '••'•:':•• ': ;'.
^^::,,,,,,:,,:-,,:1:::::,:,:,,
EP"""""""""""
EP
8. Time
Frame
8 mos.
8 mos.
J ;8::::;mbW;
8 mos.
8 mos.
8 mos.
9. Registrant
Response
^^?.;:*;^f;"r"!
: v.:.'.: •: .'::H:: .:::l- ::- : -.:--.-.: -:'-:: :• :::'::--
IH .;:"•!:•.•:• •.-.'••' .•.-.• -• .;.-:• •:/.:;';...-:•/
^.•i ;'.:. • "'•,•.•:• •. ":-•.. : • ":'.• :i'./.' :> :. ;•
Initial to indicate certification as to information on this page Date
(full text of certification is on page one).
-------
Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case f and Name: 4024 Citric acid, and salts
Key: HP * manufacturing-use product; EP - end-use product; provided formulators purchase their active ingredient(s) from a registered source, they need not submit or cite
data pertaining to the purchased product.[NOTE: If a product is a 100 percent repackage of another registered product that is purchased, and any use for the product does
not differ from those of the purchased and registered source, users are not subject to any data requirements identified in the tables.]; TEP = typical end-use product;
TGA1 - technical grade of the active ingredient; PA1 = "pure" active ingredient; PAIRA = "pure" active ingredient, radiolabeled.
Use Categories Key:
A - Terrestrial food crop B - Terrestrial food feed crop C - Terrestrial nonfood crop D - Aquatic food crop E - Aquatic nonfood outdoor
F - Aquatic nonfood Industrial G - Aquatic nonfood residential H - Greenhouse food crop 1 - Greenhouse nonfood crop J - Forestry
K - Residential outdoor L - Indoor food M - Indoor nonfood N - Indoor Medical 0 - Indoor residential
Footnotes: [The following notes are referenced in column two (5. Study Title) of the REQUIREMENTS STATUS AMD REGISTRANT'S RESPONSE form.]
Prod Che* - Regular Chonical •-
1 Requirements pertaining to product identity, composition, analysis, and certification of ingredients are detailed further in the following sections: *158.155 for
product identity and composition (61-1); *158.160, 158.162, and 158.165 for description of starting materials and manufacturing process <61-2); *158.167 for
discussion of formation of impurities (61-3); *158.170 for preliminary analysis (62-1); *158.175 for certification of limits (62-2); and M58.180 for enforcement
analytical methods (62-3).
2 A schematic diagram and/or brief description of the production process will suffice if the pesticide fs not already under full scale production and an experimental
use permit is being sought.
3 If the pesticide is not already under full scale production and an experimental use permit is sought, a discussion of unintentional ingredients shall be submitted to
the extent this information is available.
4 Required to support the registration of each manufacturing-use product (including registered TGAIs) as well as end-use products produced by an integrated system.
Data on other end-use products will be required on a case-by-case basis. For pesticides in the development state, a rudimentary product analytical method and data
will suffice to support an experimental use permit.
5 Certified limits are not required for inert ingredients In products proposed for experimental use,
9 Required if test substances are dispersible with water.
10 Required if product contains an oxidizing or reducing agent.
11 Required if product contains combustible liquids.
12 Required if product is potentially explosive.
13 Required if product is a Liquid.
14 Required if product is an emulsifiable liquid and is to be diluted with petroleum solvents.
15 Required if end-use product is liquid and is to be used around electrical equipment.
16 Basic manufactures are required to provide the Agency with a sample of each TGAI used to formulate a product when the new TGAI is first used as a formulating
ingredient in products registered under FIFRA. A sample of the active ingredient (PAD suitable for use as an analytical standard is also required at this time.
Samples of end-use products produced by an integrated system must be submitted on a case-by-case basis. Material safety data sheets should accompany samples as
specified by OSHA in 29 CFR 1910.1200.
Acute Toxic - Regular Chemical
1 Not required if test material is a gas or highly volatile.
2 Not required if test material is corrosive to skin or has pH less than 2 or greater than 11.5; such a product will be classified as Toxicity Category I on the basis
-------
Page 2 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 4024 Citric acid, and salts
Footnotes (cont.):
of potential eye and dermal irritation effects.
3 Required if the product consists of, or under conditions of use will result fn, an inhalable material te. g., gas, volatile substances, or aerosol/paniculate).
4 Required unless repeated dermal exposure does not occur under conditions of use.
36 Special testing (acute, subchronic, and/or chronic) is required for organophospates, and may be required for other cholinesterase inhibitors and other pesticides
which have demonstrated a potential to adversely affect the visual system. Registrants should consult with the agency for development of protocols and methodology
prior to initiation of studies.
37 Testing of the EP dilution is required if it can be reasonably anticipated that the results of such testing may meet the criteria for restriction to use by certified
applicators specified in 40 CFR 152.170(b> or the criteria for initiation of special review specified (n 40 CFR 154.7 (a)(1).
Efficacy - Antimicrobial Agent
1 Efficacy data for antimicrobial agents that claim to control pest microorganisms that may pose a threat to human must be submitted.
2 Comparative product performance data are required to be developed and maintained in the registrant's file and must be submitted to the Agency on a case-by-case basis
for risk/benefit analyses such as for public interest findings and cases of special review.
10 Required for products to be used on food contact surfaces, which include quaternary ammonium compounds (QAC) chlorinated trisodium phosphate and anionic
detergent-acid formulations.
-------
SPECIFIC INSTRUCTIONS FOR COMPLETING
TEE REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE FORK
Product Specific Data
• This form Is designed to be used for registrants to respond
to call-ins for generic and product-specific data as part of
EPA's reregistratlon program under the Federal Insecticide
Fungicide and Rodenticide Act. Although the form is the same for
both product specific and generic data, instructions for
completing the forms differ slightly. Specifically, options for
satisfying product specific data requirements do not include (l)
deletion of uses or (2) request for a low volume/minor use
waiver. These instructions are for completion of product
specific data requirements.
EPA has developed this fora individually for each data call-
in addressed to each registrant, and has preprinted this fora
with a number of items. DO HOT use this form for any other
active ingredient.
Items 1 through 8 (inclusive) will have been preprinted on
the form. Vou must complete all other items on this form by
typing or printing legibly.
Public reporting burden for this collection of information
is estimated to average 30 minutes per response, including time
for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding
the burden estimate or any other aspect of this collection of
information, including suggesting for reducing this burden, to
Chief, Information Policy Branch, PM-223, U.S. Environmental
Protection Agency, 401 M St., S,W., Washington, D.C. 20460; and
to the Office of Management and Budget, Paperwork Reduction
Project 2070-0107, Washington, D.C. 20503.
-------
INSTRUCTIONS FOR 'COMPLETING THE "REQUIREMENTS STATUS
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPBClf 1C DATA
•»'*•«,
Ittn 1-3 Completed by EPA. Note the unique identifier number
assigned by EPA in Item 3. This number must be used in
•cne transmittal document for any data submissions in
Response to this Data Call-in Notice.
Itea 4.. The Guideline reference numbers of studies required to
product's continued registration are
Thesa «tti<»«lin«»f in addition to the
specified in the Notice, govern the conduct
.r*?ui3iftd •*««••• Note that series 61 and 62 in
40 CI* 158*155
vith the
Itea 6. The use pattern (s) ef the pesticide associated vith the
product specific requirements is (are) identified. For
aost product specific data requirements, all use pattern!
are covered by the data requirements. In the ca«™
efficacy data, the required studies only pertain to
product- which have the use sites and/or pests indicated?
Itea 7. The substance to be tested is identified by EPA; For
SS S?S*StCtf41C d?ta'v the Produ<=t as formulated for sale
°n * teSt substanc«' «xcept in rare
c«e.
Itea 8. The due date for submission of each study is identified.
It is normally based on 8 aontbs after issuance of thi
SJf Igisf "tlo» 1l11»ibilit3r Socum.it unless EPA SeteraineJ
that a longer time period is necessary. «»."«
Itea 9. Enter only 'one of the following response codes foreach
data r.qulg.a.pt to .how hov you intend to comgly
the data requirements listed in this table.
°Pti0n *" contain«d ^ the
I-vill generate and submit data by the specified due date
(Developing Data) . By indicating that I have chosen thi!
option, I certify that I will comply with Tall thJ
requirements pertaining to the conditions for submittal
of this study as outlined in the Data Call-in Notic"
cc
».quir«.at.» form. I ad.tand that «,«***.?,""?*
av.il.bl. »1, for .cut. '
-------
data and only if EPA indicates in an attachment to this
Notice that ay product is similar enough to another
product to qualify for this option. . I certify -that
another party in the agreement is committing to submit
or provide the required data; if the required study is
not submitted on time, ay product may be subject to
suspension. ' * " • •
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 ay product is slnilar enough to
another product to qualify for this option. I am
submitting evidence that I have Bade 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 aa including a copy of ay
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; it the required
study is not submitted on time, ay product may be subject
to suspension. I understand that other terms under
Option 3 in the Data Call-in Notice (Section III-C.l.)
apply as well.
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 aeet all the requirements
for submittal of existing data outlined in Option 4 in
the Data Call-In Notice (Section III-C.l.) and will meet
the attached acceptance criteria (for acute toxicity and
product chemistry data). I will attach the needed
supporting information along with this response. I also
certify that I have determined that this study will fill
the data requirement for which I have indicated this
choice.
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. X will provide the MRID or Accession
number of the ttudy at the due date. Z understand that
the conditions for this option outlined Option 5 in the
Data Call-In Notice (Section III-C.l.) apply.
i.
6. By the'specified due date, I will cite an existing study
that the Agency has classified as acceptable or an
existing study that has been submitted but not reviewed
by the Agency (Citing an Existing Study). If I am citing
-------
! another registrant's study, I understand that this option
•is available only for acute toxicity or certain efficacy
data and only if the cited study was conducted on my
product, an identical product or a product which EPA has
•"grouped" with one or more'other products for purposes
of depending on the same data. I may also choose this
ioption if I am citing my own data. In either case, I
will provide the KRID or Accession number (s) for the
cited data on a "Product Specific Data Report" fora er
in a similar format. If I cite another, registrant's
data, I will submit a completed "certification With
Respect To Bata Compensation Requirements" form.
7. 1 request a waiver for . this study because it is
inappropriate for my product (Waiver Request). I am
attaching a complete justification for this request,
including technical reasons, data and references to
relevant EPA regulations, guidelines or policies. [Note:
any supplemental data must be submitted in the format
required by P.R. Notice 86-5], I understand that this
is my only opportunity to state the reasons or provide
' Information in support of my request. If the Agency
approves my waiver request, I will not be required-to
supply the data pursuant to Section 3(c)(2)(B) of FIFRA.
If the Agency denies my waiver request, I must choose a
method of meeting the data requirements of this Notice
by the due date stated by this Notice. In this case, I
must, within 30 days of my receipt of the Agency's
written decision, submit a*revised "Requirements Status
and Registrant's Response" Form Indicating the option
chosen. • I also understand that the deadline for
submission of data as specified by the original data
call-In notice will hot change.
• . ^
Items 10-13. Self-explanatory.
You may provide additional information that does not fit
on this fora in a signed letter that accompanies this
fora. For example, you may wish to report that your
product has already been transferred to another company
or that you have already voluntarily cancelled this
product. For these cases, please supply all relevant
details so that £?A can ensure that its records are
* correct.
-------
\ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
/ WASHINGTON. O.C. 20460
JUL29I986
PR NOTICE 86-5 PMTICIOM A HO TOXIC «UMTAHCM
NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Attention: Persona responsible for Federal registration of
pesticides.
Subject: Standard format for data submitted under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA)
and certain provisions of the Federal Food, Drug,
and Coc-aetic Act (FFDCA).
I. Purpose
To require data to be submitted to the Environmental
Protection Agency (EPA) in a standard format. This Notice also
provides additional guidance about, and illustrations of, the
required formats.
II. Applicability
This PR Notice applies to all data that are submitted to EPA
to satisfy data requirements for granting or maintaining pesticide
registrations, experimental use permits, tolerances, and related
approvals under certain provisions of FIFRA and FFDCA. These
deta are defined in FIFRA SlO(d)d). This Notice does not apply
to commercial, financial, or production information, which are,
and must continue to be, submitted differently under separate
cover.
III. Effective Date
This notice is effective on November 1, 1986. Data formatted
according to this notice may be submitted prior to the effective
date. As of the effective date, submitted data packages that do
not conform to these requirements may be returned to the submitter
for .necessary revision.
IV. Background
On September 26, 1984, EPA published proposed regulations
in the Federal Register (49 FR 37956) which include Requirements
for Data Submission {40 CFR $158.32), and Procedures for Claims
of Confidentiality of Data (40 CFR 5158.33). These regulations
-------
y the format for data submitted to EPA under Section 3 of
l and Sections 408 and 409 of FFDCA, and procedures which
must be followed to make and substantiate claims of confiden-
- alitj. NO entitl -nts , -lata c .-f ide^iality are cnar^d,
either by the proposed regulation or by this notice.
OPP is making these requirements mandatory through this
Notice to gain resource-saving benefits from their use before the
entire proposed regulation becomes final. Adequate lead time is
being Provided for submitters to comply with the new requirements.
V. Relationship of this Hoti«« to Other OPP Policy and Guidance
While this Notice contains requirements for organizing and
-formatting submittals of supporting data, it does not address
the substance of test reports themselves. "Data reporting
guidance is now under development in OPP, and will specify how
the study objectives, protocol, observations, findings, and
conclusions are organized and presented within the study report.
The data reporting guidance will be compatible with submittal
format requirements described in this Notice.
OPP has also promulgated a policy (PR Notice 86-4 dated
Aoril 15, 1986) that provides for early screening of certain
applications for registration under FIFRA S3. The objective of
the screen is to avoid the additional costs ™d * ^Stlon" *
associated with handling significantly incomplete application
packages? As of the effective date of this Notice, the screen
will include in its criteria for acceptance of application
packages the data formatting requirements described herein.
OPP has als6 established a public docket which imposes dead-
lines for inserting into the docket documents submitted in con-
nection with Special Reviews and Registration Standards (see
40 CFR $154.15 and 5155.32). To meet these deadlines, OPP is
requiring an additional copy of any data submitted to the docket.
pleasirefer to Page 10 for more inf^mTtion about this requirement.
For several years, OPP has required that each application for
registration or olher action include a list of all applicable
data requirements and an indication of how each is satisfied—the
statement of the method of support for the application. Typically,
many refinements are satisfied by reference to data previously
submitted—either by the applicant or by another party. That re-
quirement is not altered by this notice, which applies only to
data submitted with an application.
VI. Format Requirements
' A more detailed discussion of these format requirements
follows the index on the next page, and samples of some of the
requirements are attached. Except for the language of the two
alternative forms of the Statement of Data Confidentiality Claims
(shown in Attachment 3) which cannot be altered, these samples
are illustrative. As long as the required information 10 }J«l«J»d
and clearly identifiable, the form of the samples may be altered
to reflect the submitter's preference.
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- INDEX -
Text Example
Page Page
A. Organization of the Submittal Package 3 17
B. Transmittal Document 4 11
C. Individual Studies 4
C.I Special Considerations for Identifying Studies. . 5
D. Organization of each Study Volume 6 17
D.I Study Title Page 7 12
D.2 Statement of Data Confidentiality Claims
(based on PIFRA S10(d}(l)) 8 13
D.3 Confidential Attachment 8 15 ,
D.4 Supplemental Statement of Data Confidentiality
Claims {other than those based on FIFRA $10(dHl)J 8 14
D.5 Good Laboratory Practice Compliance Statement . . 9 16
E. Reference to Previously Submitted Data 9
F. Physical Format Requirements & Number of Copies ... 9
G. Special Requirements for Submitting Data to the Docket 10
**************
A. Organization of Submittal Package
A 'subraittal package' consists of all studies submitted at
the same time for review in support of a single regulatory action,
along with a transmittal document and other related administrative
material (e.g. the method of support statement, EPA Forms 8570-1,
8570-4, 8570-20, etc.) as appropriate.
Data submitters must organize each submittal package as
described in this notice. The transmittal and any other admin-
istrative material must be grouped together in the first physical
volume. Each study included in the submittal package must then
be bound separately.
Submitters sometimes provide additional materials that are
intended to clarify, emphasize, or otherwise comment to help
Product Managers and reviewers better understand the submittal.
- If such materials relate to one study, they should be
included as an appendix to that study.
- If such materials relate to more than one study (as for
example a summary of all studies in a discipline) or to the
submittal in general, they must be included in the subraittal
package as a separate study (with title page and statement
of confidentiality claims).
-------
B. Transmittal Document
The first item in each submittal package must be a trans-
irif-l .'--rj.-..;..':. ~'-i-- •? . TV; • i identifies the £ubmUt?r or aM
joint submitters; the regulatory action in support of which the
package is being submitted—i.e., a registration application,
petition, experimental use permit (EUP), S3(c)(2)(B) data call-in,
S6(a){2) submittal, or a special review; the transmittal date;
and a list of all individual studies included in the package in
the order of their appearance, showing (usually by Guideline
reference number) the data requirement(s) addressed by each one.
The EPA-assigned number for the regulatory action {e.g. the
registration, EUP, or tolerance petition number) should be
included in the transmittal document as well, if it is known to
the submitter. See Attachment 1 for an example of an acceptable
transmittal document.
The list of included studies in the transmittal of a data
submittal package supporting a registration application should
be subdivided by discipline, reflecting the order in which data
requirements appear in 40 CFR 158.
The list of included studies in the transmittal of a data
submittal package supporting a petition for tolerance or an
application for an EUP should be subdivided into sections A, B,
C,.... of the petition or application, as defined in 40~CFR
180.7 and 158.125, (petitions) or Pesticide Assessment Guidelines,
Subdivision I (EUPs) as appropriate.
When a submittal package supports a tolerance petition and
an application for a registration or an EUP, list the petition"
studies first, then the balance of the studies. Within these
two groups of studies follow the instructions above.
C. Individual Studies
A study is the report of a single scientific investigation,
including all supporting analyses required for logical complete-
ness. A study should be identifiable and distinguishable by a
conventional bibliographic citation including author, date, and
title. Studies generally correspond in scope to a single Guide-
line requirement for supporting data, with some exceptions dis-
cussed in section C.I. Each study included in a submittal package
must be bound as a separate entity. (See comments on binding
studies on page 9.)
Each study must be consecutively paginated, beginning from
the title page as page 1. The total number of pages in the com-
plete study must be shown on the study title page. In addition
(to ensure that inadvertently separated pages can be reassociated
with the proper study during handling or review) use either of
the following:
- Include the total number of pages in the complete study
on each page (ie., 1 of 250, 2 of 250, ...250 of 250).
- include a company name or mark and study number on each
page of the study, e.g.. Company Name-1986-23. Never reuse
a study number for marking the pages of subsequent studies.
-------
When a single study is extremely long, binding it in multiple
volumes is permissible so long as the entire study is patinat "-P.,;.!* iciies, ana eacn volume is plainly identified by the
study'title and its position in the multi-volume sequence.
C.I special Considerations for Identifying Studies
Some studies raise special problems in study identification,
because they address Guidelines of broader than normal scope or
for other reasons.
a. safety Studies. Several Guidelines require testing for
safety in more than one species. In these cases each species
tested should be reported as a separate study, and bound
separately.
Extensive supplemental reports of pathology reviews, feed
analyses, historical control data, and the like are often assoc-
iated with safety studies. Whenever possible these should be
submitted with primary reports of the study, and bound with the
primary study as appendices. When such supplemental reports are
submitted independently of the primary report, take care to fully
_identify the primary report to which they pertain.
Batteries of acute toxicity tests, performed on the same end
use product and covered by a single title page, may be bound
together and reported as a single study,
b. Product Chemistry Studies. All product chemistry data
within a submittal package submitted in support of an end-use
product produced from registered manufacturing-use products
should be bound as a single study under a single title page.
product chemistry data submitted in support of a techni-
cal product, other manufacturing-use product, an experimental
use permit, an import tolerance petition, or an end-use prod-
uct produced from unregistered source ingredients, should be
bound as a single study for each Guideline series (61, 62,
and 63) for conventional pesticides, or for the equivalent
subject range for biorational pesticides. The first of the
three studies in a complete product chemistry submittal for
a biochemical pesticide would cover Guidelines 151-10, 151-11,
and 151-12; the second would cover Guidelines 151-13, 151-15,
and 151-16; the third would cover Guideline 151-17. The
first study for a microbial pesticide would cover Guidelines
151-20, 151-21, and 151-22? the second would cover Guidelines
151-23 and 151-25; the third would cover Guideline 151-26.
Note particularly that product chemistry studies are
likely to contain Confidential Business Information as defined
in FIFRA SlO(d)UHA), (B), or (C), and if so must be handled
as described in section D.3..of this notice.
-------
tigation still
or each analytical method,
a «
sing a single crop. wh?n "°5* **" and beet roots) residue
is ofs0 t ,
crop
b. reported as a .ln.1.
study.
D. organization of Each Study Volume
k complete
the list below, i0,^6
Several of these
in
are
"*
Study Title Page
Statement of Data
Confidentiality
Claims
Certification of Good
Laboratory practice
Flagging statements
Body of Study
Study Appendices
Cover Sheet to Confi-
dential Attachment
i
CBI Attachment
« ^plained in th. following
headed 'example' cite the
element is illustrated.
Example
Page 12
page 13
page 16
When Require^
Always
One of the two alternative
forms of this statement
is always required. '
If study reports laboratory
work subject to GLP require-
ments
For certain toxicology •tudi«. (JJh.n
flagging requirements are finalized.)
Always - with an English language
translation if required.
At submitter's option
If CBI is claimed under VlFRA
5lO(d)UHMr ,
-------
D.I Title Page
A title page is always required for each
page:
a Study title. The study title should be as descriptive as
possible!7 It must clearly identify the substancets) tested and
Correspond to the name of the data requirement as it appears
in the Guidelines.
b Data reouirement addressed. Include on the title page the
Guideline naSber(s) ot the specific requirement s) addressed by
the study.
c Author(s). Cite only individuals with primary intellectual
responsibility for the content of the study. Identify them
nllinly as authors, to distinguish them from the performing
la^atory, study sponsor, or other names that may also appear on
the title page.
d. Study Date. The title page must include a ,:
the study! If parts of the study were performed at different
use onlyPthe date of the latest element in the study.
e. Performing Labnr^ry identification. • If ^%?
work done by one or more laboratories, include on the «
the nlSe and address of the performing laboratory or lab oratories,
and the laboratory's internal project ™mb%r(?> J?ff^ £om'any
Clearly distinguish the laboratory's project identifier from any
other reference numbers provided by the study sponsor or submitter.
f. supplemental Submissions. If the study is a commentary on
or supplement to another previously submitted study, or if ^
Responds to EPA questions raised with respect to an /"J1" JJ^ly
^IsTsSt^^^
M-iiS SffltSi'S-llS; « S.-SSS;
title page).
g. Pacts of Publication. If the study is a repr int of a pub-
lished document, identity on the title page all relevant f^s
of publication, such as the journal title, volume, issue, inclusive
page numbers, and publication date.
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D.,. Statements of Data Confidentiality Claim* tmd.r PIf» SlO.dHl
* kto j efc- «.»._ ^«nf irtentiality Claims
tacn »u statement of Data Conr laentiai J.VJT
E.cn submitted study .
alternative forms of th« S"£T?!JJ0° !„ «158.33 (b) and (c).
d. - --
t
assert a claim of SIIMOMA; « ^3(en In either case, the
or to waive such a claim <*J^.33(c)^ in e jde the typed
statement must be signed and dated, «™ "« ^ not ^a^e CBI .
name and title of the <>"" "J^J^SSS. associated with petitions
y (see NOTE P9 »1.
3 Confidential Attachment
I£ th.
-
ie
-hich the passage
(See Attachment 5).
The confioenti.l Attachment to a st^V -« be "JJttf
sua n
=
with a specific «°","!r'id and with a reference to the
ibjrP:siS.?:)"5i "rS*""^" «• "hich the ^tia"ti
claim is based.
D.4. .u^l—n. Statement of Data Confidentiality Clai»s (See
Attachment 4)
-'^sM
apply.
() or c the
claim of confidentiality.
is
included in Attachment 4 on Pg 14.
and"title of the official who
t
8
-------
r 5 r-^d T»i*.-"atory Practice Compliance Statement
pies of these statements are shown in Attachment 6.
E Reference to Previously Submitted Data
the method of support for the application.
F. physical Format Requirements
all elements in the data submittal package must-be on uniform
* 1/9 ii ?l^nch white paper, printed on one side only in black
£SHb"r^
tt:^sx/£«sKi& sr. ys/2-ss nz^.«
paper, such as film or magnetic media.
Please be particularly attentive to the following points:
Do not include frayed or torn pages.
DO not include carbon copies, or copies in other than
black ink.
o
o
o Make sure that photocopies are clear, complete, and fully
readable.
Do not include oversize computer printouts or fold-out pages.
o Do not bind any documents with glue or binding tapes.
n Make sure that all pages of each study, including any attach-
° menls or appendices? Ire present and in correct seq.ence.
w,,mh*r of conies Required - All submittal-packages except
getting it into review.)
-------
Requirements for Submitting Data to the Docket
?he fourth copy hould be identical to the other three. When
of "'study submitted in support of an RS or SR are
ras^rov^
special preparation is required for the fourth copy.
o Remove the 'Supplemental Statement of Data Ccnf identiality
Claims' .
o Remove the 'Confidential Attachment'.
up
the fourth copy plainly on both its cover and its title
page with the phrase "Public Dock.t M.t. rial - contains no
information claimed as confidential .
V. For Further information
For further information contact William C. GrO8S®'9hfef '
information Services Branch, Program Management and Support
Division, (703-557-2613).
ames W. Akerman
ing Director,
Registration Division
Attachment 1.
Attachment 2.
Attachment 3.
Attachment 4.
Attachment 5.
Attachment 6.
Attachment 7.
»
Sample Transmittal Document
lan,ple Title Page for a Newly Submitted Study
statements of Data confidentiality Claims
lupplemental Statement of Data Confidentiality Claims
Samples of Confidential Attachments
Sample Good Laboratory Practice Statements
Format Diagrams for Submittal Packages and Studies
10
-------
ELEMENTS
ATTACHMENT 1.
TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
address of submitter (or- all joint submitters-)
1. «™» «nd
tBiith Chemical Corporation
„ 5S7B9
Chemical Corp. will act as sole agent for all submitters.
2. o^l.torv acti^ in sunnort of -*!«* this package is submitted
the EPA identification number (e.g. 359-EUP-67) if you
rtt "P
3. Transmittal date
4. List of submitted studies
vol 1. Administrative materials - forms,
pondence with Project Managers,, and so forth.
Vol 2. Title
of first study in the submittal (Guideline No.)
•
voi n. Title of nth study in the submittal (Guideline No.)
of the data.
Company Official:
Company Name:
Company Contact:
Name
Signature
Name
Phone
11
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ATTACHMENT 2.
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
Study Title
(Chemical name) - Magnitude of Residue on Corn
Data Requirement
Guideline 171-4
Author
John C. Davis
Study Completed On
January 5, 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Project ID
ABC 47-79
Page 1 of X
CX is the total number of pages In the study)
-------
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
NO da* of confidentiality ur*er FIFRA S10(d), or (C)
STATEMENT OF NO DATA CONFIFEtfTIALm CLAIMS
2. Claim
im of confidentiality under FIFPA |10(d)(l), or (C).
STATEMENT OF DK» CONFIDENTIALm CLAIMS
Conpany:
Ccnpany Agent
^ Wlicants tor
is OPP policy that no permanent tolerance,
, can be
13
-------
ATTACHMENT 4.
SUPPLE«ENTAL STATIST OF DATA CO-FIDENTIAUT*
t
Confidentiality Claims?
o. o.t.
be treated as confidential
necUon with those disclosures.
should be viewed as s
future,
14
•0 cit. th. r...on. why th. elt.d for
confidential treatment.
-------
EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
(confidential vgrd^r^rase that has been deleted fro* the study)
CKSS H^E «»_j_ w^«srsix^^r-"Si
indicated volume and page references.
DELETED WORDS OR PHRASE:.
pftGE LIRE REASON FOR THE DELETION
6 14 identity of Inert Ingredient
28 25 ;
100 19
FTFRA REFERENCE
SlO(dHlHC)
(CMf i*ntUl
that haw beer, delete erg, the studyl
indicated volume and page references.
Reproduce the deleted paragraph(s) here
DELETION
20
4-T7 Description of the quality control process
)
)
FIFRA REFERENCE
S10(d)(l)<0
BcMpteB XConfidential fiages that have been deleted fron the study)
,-r aiut,™ 7 This cross reference number noted on a place-holder
CRQSS.MH5BCE ttJMBER _7_ Tms cross^ ^ ^^ ^ ^ followir^ ^^ ^^
at the indicated volume and page references.
: are attached iimediately behind this page.
PP^ FOR THE DELETION FIFRA REFERENCE
Description of product manufacturing process S10(d)(1) (A)
15
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ATTACHMENT 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
This study meets the requirements for 40 CFR Part 160
Submitter „ .
Sponsor ___
Study Director
Example 2.
This study does not meet the requirements of 4C CFR
Part 160, and differs in the following ways:
1.
2.
3.
Submitter
Sponsor
Study Director
Example 3.
The submitter of this study was neither the sponsor of this
study nor conducted it, and does not know whether it has
been conducted in accordance with 40 CFR Part 160.
Submitter
16
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ATTACHMENT 7.
FORMAT OP THE SUBMITTAL PACKAGE
Transwittal Document.
Related Administrative Materials
(e.g., Method of Support Statement, etc.)
Other materials about the submittal
(e.g., summaries of groups of studies
"""^ aid in their review).
to
Studies, submitted as unique
physical entities, according
to the format below.
FORMAT OF SUBMITTED STUDIES
Study title page.
Statement of Confidentiality Claims.
GLP and flagging* statements - as appropriate,
Body of the study, with English
language translation if required.
Appendices to the study.
Title Page of the Confidential
I .. - Attachment.
LEGEND
I •'
confidential Attachment.
Supplemental Statement
of Confidentiality Claims,
* when flagging requirements
are finalized.
Documents which must be submitted as
appropriate to meet established requirements.
Documents submitted at submitter's option,
17
-------
ATTACHMENT D
EPA (TROUFIWU OF
-------
NOT TO BKKH EMD-ffiE HOODCTS
OOA RBQcnraMans
classificaUan, precautionary labeling, etc.).
each product
•
tt
Sring (Option 2) or Offers to C3ost Share (Option 3).
-------
I. EreKtee Products Contaiiung Citric Acid
X of Citric Acid I Other Active Ingredient*
1677-100
5664-4
20.0X - Citric Acid
22.5X - Phosphoric Acid
2.OX - Decanolc Acid
6.OX - OctanoJe Acid
4.6X - Citric Acid
16.4X • Phosphoric^
1.0X - Citric Acid
B.5X - Phosphoric Acid
5.OX - Sulfaoic Acid
3.0X - Oxalic Acid
1.0X - Gluconic Acid
1.2X • Sodium Xylene »ul;
Liquid
Liquid
at*
-------
ATTACHMENT E
EPA ACCEPTANCE CRITERIA
-------
- " SUBDIVISION D
Guideline Study Title
Series 63 Physical and Chemical
-------
61 Product Identity and Composition
ACCEPTANCE CRITERIA
D0es your study meet the following acceptance criteria?
1 Name of technical material tested (include product name and
* trade name, if appropriate) certified limits (upper and
2. ^me, nominal• ^^^YJ^ient and each intentionally-
3 Name and upper certit.ea limit for *-£ /^i^or
J- „ „* o.-L* DY -^7^,, /= a
it impurities (e.g.,
orossnt 3.t ^0»i* t _
ingredient and each intentlonaliy-
4^ 1*111-0086 01 tsa»-ii u^- -~.- J-iiy
•F-rn-m chemical Abstracts i:
5. Chemicax n^u^^rjjm^criem^^,^ Registry «—^ r— -----
each intentionally-
added inert^^^^ ^^ empirical formulas, molecular^
6.
Number if registered; for other
; Brand name, tr^Jc^^n°ror°S?rsheets by which
I ^s^^Xiil J-V^G'*- o^^***1^ j—^.* j VN*^*o /^^^TT^nf^Sl^L T_ Oil *
__—.^^— HV^T^I "i ^7™ QSSCITIC®^ WWIM^'^'^•*• *^-t-*^* r
properties or toxicity
8. Description of m^nuJajJUJ1bltch°or continuous process
Statement or wne^ner « .„„•__ materials and order
' Relative amounts of beginning materials.
' which they are added
reactions
-------
8. (continued)
Flow chart with chemical equations for each intended
chemical reaction
Duration of each step of process
Description of purification procedures
jjeow^. A-.f wi»»** ^**~r _ . ^ ««*«n v&
- • ,i . _ .e _*—. .^ mi** AC T~a IT^T) TLO a09U.J. ts
Description of purifica^ion proceau^
Description of measures taken to assure quality
product
Q Discussion of formation of
9'— chemical theory addre^ing^i) ^^ 0^^-r;^ctAnalyses
(see |3)
-------
61 Product Identity and Composition
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active
ingredient being reregistered. Items 1, 2, 3, and 5 can be
satisfied for most registered products by submission of the
Certified Statement of Formula Ingredients Page (EPA Form 8570-4).
Items 7 and 8 can be satisfied for most technical grade active
ingredients (TGAIs) by submission of a flow chart with chemical
equations for each intended chemical reaction. The flow chart
should include complete chemical structures and names for each
reactant and product of all the reactions.
1. Name of technical material (include product name and trade name,
if appropriate).
2. Description of each active and intentionally-added inert
ingredient, including name, concentration, and certified limits.
3. Name and upper limit for all impurities present at > 0.1% and
those toxicologically significant impurities present at <0.1%.
4. The purpose of each active and intentionally-added inert
ingredient.
5. Chemical name and Registry Number for each active and
intentionally-added inert ingredient (if available).
6. Molecular, structural, and empirical formulas, molecular weight,
and any experimental or internal code number for each active
ingredient.
7. Description of each beginning material in the manufacturing
process.
8. Description of manufacturing process.
9. Discussion of formation of impurities based on established
chemical theory.
-------