EPA 730-N-98-001
r
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
Fax-On-Demand
Telephone: (202)4014)527
Item: 6106
OFFICE OF
PREVENTION. PESTICiDES AND
• TOXIC SUBSTANCES
PESTICIDE REGISTRATION (PR) NOTICE 98-1
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDE PRODUCTS
ATTENTION:
SUBJECT:
Persons Responsible for Federal Registration andReregistration of Pesticide
Products . •
Self-Certification Of Product Chemistry Data
The Office of Pesticide Programs (OPP) of the Environmental Protection Agency (EPA) announces
a "self-certification'1 program for certain product chemistry data of manufacturing-use products (MP)
and end-use products (EP) produced by a non-integrated formulation system. This program is voluntary
and is intended to simplify and accelerate the processing of applications for registration and
reregistration while maintaining protection of public health and the environment.
Under the self-certification program, applicants will submit a one-page summary of the product's
physical/chemical properties, but will no longer be required to submit the study upon which the
summary is based. The registrants must, however, retain in their possession studies which are
conducted in substantial conformity with Agency guidelines and which must be submitted to EPA upon
request. , • . ., '
. No registrant is required to use the self-certification program. Applications for new registration
and reregistration .may continue to be submitted under normal review procedures.
This program will be effective for applications received" immediately after publication of this Notice.
I.
INTRODUCTION
Product chemistry data requirements for registration and reregistration of pesticide chemicals
include product identity/composition, manufacturing/formulation processes, analysis and certification
of product ingredients, and physical/chemical properties. These requirements are outlined in 40 CFR
158:150 to §158.190 for chemical pesticides (conventional), §158.690 for biochemical pesticides, and
§158.740 for microbial pesticides. Detailed guidance on how to conduct these studies is outlined in
OPPTS Test Guidelines Series 830- Product Properties (EPA publication 712-C-96-310, 8/96); OPPTS
Test Guidelines, Series 880 - Biochemical Test Guidelines; and OPPTS Test Guidelines, Series 885 -
Microbial Pesticides Test Guidelines, Overview of Microbial Pest Control Agents. It should be noted
that OPPTS Test Guidelines, Series 830 supersedes the Pesticide Assessment Guidelines, Subdivision-D,
Recycled/Recydable
'•'V PrlntKI with Soy>C«noU lr* on paper th*t
eom*n» st toot 56% recycled fiber
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Product Chemistry for chemical pesticides; and OPPTS Test Guidelines Series 880 and 885 for
Biochemical and Microbial Pesticides, respectively, supersedes the Pesticide Testing Guidelines,
Subdivision M for Microbial And Biochemical Pest Control Agents. In addition to a. review of data,
product chemistry review entails evaluation of the label and the Confidential Statement of Formula
(CSF). The requirements pertaining to the physical/chemical properties for
chemical pesticides are outlined in a table of 40 CFR 158.190.
II. PRODUCTS ELIGIBLE FOR SELF-CERTIFICATION
This PR Notice applies to applications for registration or reregistration of manufacturing-use and
end-use products of chemical, biochemical and microbial pesticide products produced by a "non-
integrated formulation system." To be eligible for self-certification a product must be formulated from
registered source(s). , .
This notice applies only to the self-certification of the information in support of the,physical/chemical
properties for these products (applicable studies in Series 830-6302 to 830-7950). Other requirements
pertaining to product chemistry are not within the scope of this policy (e.g., 40 CFR 158.150 to
158.180, applicable studies in Guideline Series 830-1550 to 830-1900, Good Laboratory Practice
Standard's (GLP) certification, confidentiality statement, labels and CSFs).
This Notice does not supersede any regulations. Consistent with PR Notice 92-5, applicants need
not submit summaries of color and odor of certain end-use products and, except as specified in PR
Notice 92-5, the Agency will not request data on these properties. Applicants are advised, however,
to summarize the results of color and odor for all MPs and the storage stability study for all MPs and
EPs and when requested, submit supporting data. Since PR Notice 92-5 calls for generating the
storage stability data for certain EPs to be submitted upon request, a summary of this data should be
included on the form.
HI. PROCEDURE FOR SELF-CERTIFICATION
Applicants for registration or reregistration of pesticide products participating in this program will
submit together with other requirements not within-the scope of this policy, conforming with PR Notice
86-5- (a) a title page; (b) a confidentiality statement consistent with 40 CFR Part 158.33;. (c) a GLP
statement- (d) a self-certification statement that the physical/chemical properties data was generated in
substantial conformity with OPPTS Test Guidelines Series 830, Product Properties, applicable to the
subject product, and in effect at the time of submission (EPA Form 8570-37); and (e) a summary of
applicable studies "in Series 830-6302 to 830-7950 pertaining to the physical/chemical properties on a
one-page form (EPA Form 8570-36,.page 1 of Attachment 1).
A blank copy of EPA form 8570-36 (Summary of the Physical/Chemical Properties) and instructions
are provided as Attachment 1 to this Notice (the form may be copied for use). Attachment 2 (EPA
Form 8570-37) is a self-certification'statement that must be completed and signed by the authorized
representative for a pesticide applicant. Attachment 3 (EPA Form 8570-38) is a sample filled-m form
showing how data summaries of some properties can be presented.
Electronic copies of EPA Form 8570-36 (Attachment 1) are available upon request. The form is
expandable to allow reporting the requirements for registration/reregistration on separate sheets
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identified by product's name and Reg. No./File Symbol No. The instructions can be copied on the back
of the form to save paper. Applicable data requirements in Series 830-6302 to 830-7950 pertaining to
the physical/chemical properties, whether generated by the applicant, shared or referenced data, .must
be cited on the form according to the instructions.
The GLP requirements of 40 CFR Part 160 and OPPTS Test Guidelines Series 830, Product
Properties (EPA publication 712-C-96--310, 8/96) apply to the data covered by this Notice. Applicants
wishing to participate in this program must submit a GLP compliance statement in accordance with 40
CFR Part 160.12(a) which:indicates that the data covered by this Notice were conducted in compliance
with all applicable GLP requirements set forth in 40 CFR 160. Note that under Sections 160.135(b),
with the exception of the storage stability study, certain GLP provisions are riot applicable to studies
covered by this Notice.
IV. EPA REQUESTS FOR SUPPORTING DATA
EPA may at its discretion request that applicants and registrants submit the supporting data to
ascertain that the studies were conducted in compliance with OPPTS. Test Guidelines Series 830,
Product Properties, and are consistent with the summary and GLP certification. If a registrant fails to
respond adequately to such a request, the Agency will treat the application 'as follows:
A. Applications for registration -
Normally, EPA will not request an applicant to submit the underlying studies, but will rely on the
data summary to evaluate the registration or reregistration. However, if the Agency requests the
studies, the applicant must submit the underlying product chemistry data within thirty (30) days of
registrants receipt of the Agency's request or within another specified time period agreed to by the
Agency. If the applicant fails to meet the deadline, the Agency will treat the application as incomplete
pursuant to 40 CFR 152.105. -
' B. Data Required Under Data Call-In Notice (DCI)
Normally, registrants required to satisfy the physical/chemical properties data as part of a. Data
Call-In Notice (DCI) in reregistration may satisfy the requirements by submitting the summary form
and other information set forth in this Notice (Part II above) in lieu of submitting the supporting data
itself. As noted above, however, the.Agency may request submission of the data and allow thirty (30)
' days (or within another specified time period agreed to by -the Agency) from registrant's receipt of the
Agency's notification for submission. The Agency will treat the failure to submit such supporting data
upon request as a failure to comply with the DCI and may suspend the registration under FIFRA Sec.
3(c)(2)(B). ..-'•', •'.'••:'.'..'- • "
C. .Data Requested as Part of an Audit . .-.,..-
EPA may request the submission of the underlying data as part of an audit to determine compliance
wiih EPA regulations and ensure that the supporting data are consistent with the summary and
GLP/self-certification statements submitted by the applicant or registrant. If a registrant fails to submit
such data upon request, EPA may suspend the registration as provided by the registrant's certification.
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V, REQUEST FOR RESPONSE . '
If, after review of the data summary under the self-certification program, or selective review of the
supporting data. EPA determines that:
The physical/chemical properties values are not adequately supported by the test data;
One or more of the reported product properties appears to be in error; or
The GLP certification is incorrect; then
EPA will request the applicant to submit to the Agency, within thirty (30) days (or within another
specified time period agreed to by the "Agency) of a registrant's receipt of the Agency's request, a
satisfactory response to the notification. EPA might request that the applicant:
Submit additional information if the submitted summaries are inadequate;
• i i • _
Explain why deviations from the guidelines were considered necessary;
Provide an explanation as to why the Agency should not pursue enforcement action; or
Provide an explanation as to why the Agency should not suspend the applicant's registration
pursuant to the registrant's certification or take other regulatory action.
VI. POSSIBLE TERMINATION OF THE SELF-CERTIFICATION PROGRAM
EPA may terminate the self-certification program at any time and will issue another PR Notice to
registrants if it does'so. Factors that could lead the Agency to terminate self-certification include a high
incidence of errors in the reported summary of the physical/chemical properties, non-participation by
applicants, or the program's failure to fulfill the needs of the Office of Pesticide Programs. For
example, if EPA finds that more time is required to assess the reported physical/chemical properties
than in reviewing the full data requirements, it would likely terminate the self-certification program.
Vli. PAPERWORK REDUCTION ACT NOTICE . .
The annual public burden for the collection of information associated with the self-certification
opportunity described in this PR-Notice has been approved'by the Office of Management and Budget
(OMB) under OMB Control No. 2070-0060 (EPA ICR # 277.10), OMB Control No. 2070-0107.(EPA
ICR # 1504.03), and OMB Control No. 2070-0057 (EPA ICR # 922.05), and is estimated at 1.25 hours
per response. The revised total burden to accomodate the voluntary electronic submission of CRP data
as described in this PR-Notice is estimated to be 1.25 hours per response. The Agency has therefore
adjusted the burden hours under OMB Control No. 2070-005 to account for the slight increase in
burden associated with making this information available electronically. According to the Paperwork
Reduction Act, "burden" means the fotal time, effort or financial resources expended by persons to
generate, maintain, retain or disclose or provide information to or for a Federal agency. For this
collection it includes the time needed to review instructions; to disclose and provide information, and
to transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person
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is not required to respond to, a collection of information unless it displays a currently valid OMB
control number The OMB control numbers for EPAvs regulations, after initial display in the final
rule, are listed in 40 CFR part 9, and appear on any related information collection instrument.
Send comments on.the Agency's need for this information, the-accuracy of the provided burden -.
estimates and any suggested methods for minimizing respondent burden, including through the use of
automated collection techniques to the Director, OPPE Regulatory Mormation Division,.VS..
Environmental Protection Agency (Mail Code 2137), 401 M Street, S.W, Washington D.C. 20460.
Include the OMB control number in any correspondence, but do not submit the requested information
to this address. The requested information should be submitted in accordance with the instructions in
.this PR Notice. ;
VIII. EFFECTIVE DATE . .
This policy will become effective for applications submitted immediately after publication of this
Notice Applications received before the effective date will not be eligible for self-certification because
of the burden associated with submitting and processing new requests for a change-over to self-
certification. ,
IX. ADDITION AI INFORMATION
If you have questions on the self-certification program, or want a copy of this Notice, please
contact: °
, Dr. Sami Malak , *
Office of Pesticide Programs (7505C) .
U.S! Environmental Protection Agency
401 MSt,. S. W.
Washington, D. C. 20460. .
Telephone: (703) 308-9365 " FAX: (703) 308-9382 .
e-mail: malak.sami@epamail. epa.gov
.cting Director
'rJbgrams
Anachments:'
1. Summary Table, EPA Form 8570-36. plus Instructions (one page each).
2. 'A Self-Certification Statement. EPA Form 8570-37 (one page).
3^ Filled-In Summary Table, EPA Form 8570-38 (one page).
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Form Approved OMB No. 2070-0060
UNITED STATES ENVIRONMENTAL PROTECTION AJ3EMCY
401 M Street, S.W.
WASHINGTON, D.C. 20460
Reduction Act Notice: The public reporting burden for this coMection of information s estimated to average 1 hour per
aS2TndTteuJSTmsponSfcr mZgMtfon and special review activities, including time for reading the instructor* and cornptet^g
m«rayfom« Send cc^^ntTregarding burden estimate or any other aspect of this collection of 'rrformation. mduding »>«£»>***
r^uooTtr* burden to; D.rector. OPPE Information Mangaement Division (2137), U.S. Environmental Protection Agency. 401 M Street,,S.W.,
Washington. DC 20460, Do not send the completed form to this address.
SUMMARY OF THE PHYSICAL/CHEMICAL PROPERTIES (PR Notice 98-1)
1. PRODUCT NAME:
2. Reg. No.
3. COMPANY NAME:
4. SUBMISSION DATE:
5. FIRST SUBMISSION [ ]
6. RESUBM1SS1ON [ ]
7. PESTICIDE TYPE:
10. REGISTRATION [ J
8. FORMULATED MANUFACTURING-USE PRODUCT [ 1 or 9. END-USE PRODUCT I 1
11. REREGISTKATION [ ]
13. PRODUCT MANAGER OR CHEMICAL REVIEW MANAGER J/NAME (IF KNOWN):
12. REREG CASE /
14. GUIDELINE REFERENCE
NO.(GRN)/nTLE
15. VALUE or QUALITATIVE DESCRIPTION/METHOD^) USED
WHERE APPLICABLE AND REFERENCES
16. MRID or REPORT NO.
Group B, Series 830-Physical and Chemical Properties (40 CFR 158.190)
•6302 Color
•6303 Physical State
-6304 Odor
-6314 Oxidation/Reduction:
Chemical Incompatibility
-6315 Flammabthty/Flame
Extension
•6316 Explodability
Dielectric Breakdown
Voltage
•7300 Densny/Relanve Density/
Bulk Density
•6317 Storage Stability
•6320 Corrosion Charactensncs
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rvcrpffrTTOrVS O* »nw TO COMP* *TF THF. SUMMARY FORM (PR NOTICE 98-1J
1. 3 to6&8 to 13: Self-explanatory. ' '• . '-•.,-.
2: Cite Registration Number * File Symbol Number.' Leave blank if un^wn or cite company num^r fol.owcd by a hyphen ard XXX. .
7- State whether your product is an insecticide, herbickte. f^
..
on the form for chemical pesticides. . '
^
scientific reason as per the footnotes to the Table in 40 CFR 158.190.. Snadies inpr ogr e:*can be completed with data
-a^^
full terms as footnotes to the Form.
Specific Instructions by Guideline Reference Number (GRN) > ; , •
GRNs 830*319, -6321/-7000, -7100 &-7300 should be conducted in compliance with ^PPTS Test Guidelines 'Series 830 Product Properties, or,
reported at 25 °C unless otherwise noted.
GRN 830-6302. -6303 & -63 17: Report qualitative description where applicable as per PR Notice ^92-5.
GRN's'830^315, -7000 & -7300: Reponed values on the form should be consistent with those given on the Confidential Statement of Formu.a (CSF).
GRN 830*303- Provide a brief description, e.g.. solid, granular, liquid, powder, aqueous solution, emulsion, volatile liquid, gas. etc. ,
-^^^^
e.g.. iron, aluminum. . .
CRN 83^3,7, **» b. »*««, for . n— , of on= y« »*, ^Z^g^^ZZSS*^ ?Z°&S
' <
-u r-uw svi.^17 indicate chanaes in the commercial packaging containers (fluorinated high
^
GRN 830-7100: Flow curves for non-Newtonian fluids on viscosity can be appended to the form.
GRN 830-7300: For soHds or powders, provide fte'bulk density in un.ts. e.g.. g/cc'or Ib/ff whichever is preferred. For liquids, provide the densu>
' '•-- - : •
in grams/ml or Ibs.'gal.
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Form Approved OMB No. 2070-0060
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
401 M Street, S.W. ..
WASHINGTON, D.C. 20460
Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 0.25
hours per response for registration and 0.25 hours per response for registration and special review activities, including time for reading the
mMructions and completing the necessary forms. Send comments regarding burden estimate or any other aspect of this collection of mforrnauon,
tncludmg suggestions for reducing the burden to: Director. OPPE Information Mangaement,Division (2137), U.S. Environmental Protectron
Agency. 401 M Street. S.W.. Washington. DC 20460. Do not send the completed form to this address. ___
SELF-CERTIFICATION STATEMENT FOR THE
PHYSICAL/CHEMICAL PROPERTIES (PR NOTICE 98-1)
Product Name:
Reg. No./File Symbol No.
(if known) or Company.No.
SELF-CERTIFICATION STATEMENT;
I certify that the reported information on the "Summary Form" represents a true and accurate record of
the test results of studies generated or owned by (Company Name): :
and that me values of the properties reported are
reliable. I further certify that such data was generated in substantial conformity with OPPTS Test Guidelines
Series 830 Product Properties, applicable to iny product, and in effect at the time of submission.
As a condition of registration, EPA may, by order, (1) withdraw a pending registration, (2) suspend the
registration of this product without opportunity for hearing, or (3) assess civil penalties provided for in
section 14 of FIFRA for violations of section 12(a)(2)(N) of FIFRA without opportunity for hearing, if I
have not submitted to EPA within thirty (30) days of receipt of a request by the Agency, or within a
specified time agreed to by the Agency, test results of studies summarized in the "Summary Form."
As a condition of registration, EPA may, by order, (1) withdraw a pending registration, (2) suspend the
registration of this product without opportunity for hearing, or (3) assess civil penalties provided for in
section 14 of FIFRA for violations of sections 12(a)(2)(N), 12(a)(2)(Q), or 12(a).(2)(R) of FIFRA without
opportunity for hearing, if T fail to provide to EPA within thirty (30) days of receipt of a notification of
error, of within a specified time agreed to by the Agency, information that EPA determines is required to
correct the error.
Type Applicant's Name: "
Title:
Telephone No.
Applicant's Signature:
Date:
=PA Form 8S?a-37
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SAMPLE FORM
Form Approved OMB No. 2070-0060
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
401 M Street, S.W.
WASHINGTON, D.C. 20460
Paperwork Reduction Act Notice: The public-reporting burden for this collection of information is estimated to average 1 hour per response
for RD and 1 hour per response for SRRD activities, including time for reading the instructions and completing the necessary forms^ Send comments regard,*?
burden estimate or £y other aspect of this collection of information, including suggestions for reducing the burden to: Director. OPPE Information Mangaeme.«
DivtsTon (2137). U.S Env.ronmental Protection Agency. 401 M Street. S.W.. Washington. DC 20460. Do no, send the completed form to th.s address.
SUMMARY FORM OF THE PHYSICAL/CHEMICAL PROPERTIES (PR Notice 98-1)
1. PRODUCT NAME:
2. Reg! No.
3. COMPANY NAME
4. SUBMISSION DATE:
4. First SUBMISSION [ J
5. RESUBMISSION ( ]
7. PESTICIDE TYPE:
10. REGISTRATION [ ]
8. FORMULATED MANUFACTURING-USE PRODUCT I ] OR 9. END-USE PRODUCT [ ]
11. REREGISTRATION [ 1
13. PRODUCT MANAGER OR CHEMICAL REVIEW MANAGER (K/NAME (IF KNOWN):
12. REREG CASE No.:
14. GUIDELINE REFERENCE
NO.(GRN)/nTLE
15. VALUE OR QUALITATIVE DESCRIPTION/METHOD(s)
USED WHERE APPLICABLE AND REFERENCES
.: MRID or REPORT NO.
Group B, Series 830-Physical and Chemical Properties (40 CFR 158.190)
-6302 Color
White.
PC0297-X1
^6303 Physical State
Liquid.
PC0297-X2
-6304
Odor
Odorless.
PC0297-X3
-6314 Oxidation/Reduction:
Chemical Incompatibility
No reaction was observed when the test substance was mixed, for one hour
at @ 20°C,' with zinc or iron powder: Ref. 44FR16267. 3/16/1979.
PC0397-X1
-6315 Flammability/.Flame
Extension
60°C, using MRI SOP No. PCA-515C. Flash Point - Pensky Martens
Closed Tester. •
PC0397-X2
-6316 Explodability
Not explosive based on structure and DSC test .to 200°C.
PC0397-X3
-6317 Storage Stability
No change in concentration of the active ingredients when stored for one
year under ambient warehouse conditions in corrimercial packaging material
composed of fluorinated High Density Polyethylene. Duplicate analysis of
three samples, using the enforcement method, gave >99% activity.
432167-03
-6319 Miscibility
Completely miscible with petroleum solvents.
.PC0497-X1
-6320 Corrosion Characteristics
No'evidence of corrosion of the container was observed when the test
substance was, stored for one year under ambient warehouse conditions in
commercial packagingmaterial composed of fluorinated High Density
Polyethylene: Ref. MRI SOP #LS-520. -
.432167-03
-6321 Dielectric Breakdown
Voltage
Not applicable. Not to be used around electrical equipment.
7000 pH
5.9 at 25°C in \% solution using a digital pH meter.
PC0497-X2
-7100 Viscosity.
45 centipoise at @ 25 °C using a Brookfield Digital Viscometer: Ref.
ALP-013-0. '. • - - .
PC0497-X3
-7300 Density/Relative Density/
. Bulk Density
1.965. @ 25°C using a specific gravity pycnometer: Ref. CIPAC
Handbook. Vol 1. -MT-3-Specific Gravity and Density. 1970."
PC0497-X4
:orm 8570-38 (UVlAN; 1998)
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