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-------
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APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
145
-------
146
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case mineral acids covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to mineral acids in all products,
including data requirements for which a "typical formulation" is the test substance.
{The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed hi the order in
which they appear hi 40 CFR Part 158. the reference numbers accompanying each test refer
to the test protocols set hi the Pesticide Assessment Guidelines, which are available from the
National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703)
487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the
data requirements apply. The following letter designations are used for the given use
patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in. its files,
this column lists the identify ing number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
147
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148
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APPENDIX C. Citations Considered to be Part of the
Data Base Supporting the Reregistration of Mineral Acids
157
-------
158
-------
GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all
studies considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere hi the Reregistration Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered,
are included.
2. UNITS OF ENTRY. The unit of entry hi this bibliography is called a "study". In
the case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes
of submitted studies (see paragraph 4(d)(4) below for further explanation). In a few
cases, entries added to the bibliography late hi the review may be preceded by a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is
needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, hi the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
159
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the date from the evidence contained in the document. When the date appears
as (19??), the Agency was unable to determine or estimate the date of the
document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
. ,>
d. Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any selfrexplanatory text) the
following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit
number, petition number, or other administrative number associated
with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume
in which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for
"Company Data Library." This accession number is hi turn followed
by an alphabetic suffix which shows the relative position of the study
within the volume.
160
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BIBLIOGRAPHY
MRID CITATION
Bogan, P. ES Research and Development Laboratory Static Acute Toxicitv
Fish Bioassay Complies with the State Water Resources Control Board.
Department of Fish and Game [unpublished study], 1981.
"Chemistry of N-Tack". Union Oil Co. of California [unpublished study],
1982.
Quality Criteria for Water. United States Environmental Protection Agency,
1976.
A Review of the Effects of pH on Freshwater Fish. European Inland Fisheries
Advisory Commission, 1969.
Robinson, S.; Sherman, H. Oral LD50 Test: G.B.S. Globular Sodium
Bisulfate Technical. Haskell Laboratory Report [unpublished study], 1967
prepared by E.I. du Pont de Nemours and Co., submitted by Drackett Co.,
Cincinnati, OH; CDL:250945-A)
SAX, N.I., and Lewis, R. J. SR, Dangerous Properties of Industrial
Materials. 7th Ed. Van Nostrand Reinhold, New York, 1989.
"Summary of Toxicity Data: Experimental Herbicide Formulation". ES Unilab
Research, Inc. [unpublished study], 1981.
Trent, L.; Hestand, R.; Carter, C. "Toxicity of Sulfuric Acid to Aquatic
Plants and Organisms." Journal of Aquatic Plant Management. 1978.
161
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162
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APPENDIX D. List of Available Related Documents
163
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164
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The following is a list of available documents related to mineral acids. It's purpose is
to provide a path to more detailed information if it is needed. These accompanying
documents are part of the Administrative Record for mineral acids and are included in the
EPA's Office-of Pesticide Programs Public Docket.
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Information System (LUIS) Report
3. Mineral Acids RED Fact Sheet
4. PR Notice 86-5 (included in this appendix)
5. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
165
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APPENDIX E. PR Notices 86-5 and 91-2
167
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168
-------
PR Notice 86-5
169
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170
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
July 29, 1986
OFFICE OF
PR NOTICE 86-5 PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
. .j, NOTICE TO PRODUCERS, FORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Attention: . Persons 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 Cosmetic 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 data are defined in FIFRA §10(d)(1). 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 §158.'33) . These regulations
171
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specify the format for data submitted to EPA under Section 3 of
FIPRA and Sections 408 and 409 of FFDCA, and procedures which
must be followed to make and substantiate claims of confiden-
tiality. No entitlements to data confidentiality are changed,
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 Notice 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
April 15, 1986) that provides for early screening of certain
applications for registration under FIFRA §3. The objective of
the screen is to avoid the additional costs and prolonged delays
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 also established a public docket which imposes
deadlines for inserting into the docket documents submitted in
connection with Special Reviews and Registration Standards (see
40 CFR §154.15 and §155.32). To meet these deadlines, OPP is
requiring an additional copy of any data submitted to the docket.
Please refer to Page 10 for more information about this
requirement.
For several years, OPP has required that each application
for registration or other 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 requirements are satisfied by reference to data
previously submitted--either by the applicant or by,another
party. That requirement 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 is
included and clearly identifiable, the form of the samples may be
altered- to reflect the submitter's preference.
172
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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. 1 Special Considerations for Identifying Studies . . 5
D. Organization of each Study Volume 6 17
, ,;
D- 1 Study Title Page 7 12
D. 2 Statement of Data Confidentiality Claims
(based on FIFRA §10 (d) (1) ) 8 13
D. 3 Confidential Attachment ....... 8 15
D. 4 Supplemental Statement of Data Confidentiality
Claims (other than those based on FIFRA §10(d)(1) ) 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 "submittal 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 submittal
package as- a separate study (with-title page and statement
of confidentiality claims).
173
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B. Transmittal Document
The first item in each submittal package must be a trans-
mittal document. This document identifies the submitter_or all
joint submitters; the regulatory action in support of which the
package is being submitted--i.e., a registration application,
petition, experimental use permit (EUP), §3(c)(2)(B) data
call-in, §6(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 (i.e., 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.
174
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When a single study is extremely long, binding it in mul-
tiple volumes is permissible so long as the entire study is pag-
inated in a single series, and each 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 .tf.n 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 technical
product, other manufacturing-use product, an experimental use
permit, an import tolerance petition, or an end-use product
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
§10(d)(1)(A), (B), or (C), and if so must be handled as described
in section D.3. of this notice.
175
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c. Residue Chemistry Studies. Guidelines 171-4, 153-3,
and 153-4 are extremely broad in scope; studies addressing
residue chemistry requirements must thus be defined at a level
below that of the Guideline code. The general principle,
however, of limiting a study to the report of a single inves-
tigation still applies fully. Data should be treated as a single
study and bound separately for each analytical method, each
report of the nature of the residue in a single crop or animal
species, and for each report of the magnitude of residues
resulting from treatment of a single crop or from processing a
single crop. When more than one commodity is derived from a
single crop (such as beet tops and beet roots) residue data on
all such commodities should be reported as a single study. When
multiple field trials are associated with a single crop, all such
trials should be reported as a single study.
D.
Organization of Each Study Volume
Each complete study must include all applicable elements in
the list below, in the order indicated. (Also see Page 17.)
Several of these elements are further explained in the following
paragraphs. Entries in the column headed "example"- cite the
page number of this notice where the element is illustrated.
Element
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
When Required Example
Always Page 12
One of the two alternative Page 13
forms of this statement
is always required
If study reports laboratory Page 16
work subject to GLP require-
ments
For 'certain toxicology studies (When
flagging requirements are finalized.)
Always - with an English language
translation if required.
At submitter's option
If CBI is claimed under FIFRA
§10 (d) (1) (A) , (B) , or (C)
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
If CBI is claimed under FIFRA
§10 (d) (1) (A) , (B) , or (C) Page 15
Only if confidentiality is Page 14
claimed on a basis other than
FIFRA. §10.(d) (l)-(A) -,, (B) , or (C).
176
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D.I. Title Page
A title page is always required for each submitted study,
published or unpublished. The title page must always be freely
releasable to requestors; DO NOT INCLUDE CBI ON THE TITLE PAGE.
An example of an acceptable title page is on page 12 of this
notice. The following information must appear on the title page:
a. Study title. The study title should be as descriptive as
possible It must clearly identify the substance(s) tested and
correspond to the name of the data requirement as it appears in
the Guidelines.
• >}
b. Data requirement addressed. Include on the title page the
Guideline number(s) of 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
plainly as authors, to distinguish them from the performing
laboratory, study sponsor, or other names that may also.appear on
the title page.
d. . Study. Date... The title page must include a single date for
the study. If parts of the study were performed at different
times, use only the date of the latest element in the study.
e. Performing Laboratory Identification. If the study reports
work done by one or more laboratories, include on the title page
the name and address of the performing laboratory or
laboratories, and the laboratory's internal project number(s) for
the work. 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 it
responds to EPA questions raised with respect to an earlier
study, include on the title page elements a. through d. for the
previously submitted study, along with the EPA Master Record
Identifier (MRID) or Accession number of the earlier study if you
know these numbers. (Supplements submitted in the same submittal
package as the primary study should be appended to and bound with
the primary .study. Do not include supplements to more than one
study under a single title page).
9- Facts of Publication. If the study is a reprint of a pub-
lished document, identity on the title page all relevant facts of
publication, such as the journal title, volume, issue, inclusive
page numbers, and publication date.
177
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D.2. Statements of Data Confidentiality Claims Under FIFRA
Each submitted study must be accompanied by one of the two
alternative forms of the statement of Data Confidentiality Claims
specified in the proposed regulation in §158.33 (b) and (c) (See
Attachment 3) . These statements apply only to claims of data
confidentiality based on FIFRA §10 (d) (1) (A) , (B) , or (C) . Use
the appropriate alternative form of the statement either to
assert a claim of §10 (d) (1) data confidentiality (§158. 33 (b)) or
to waive such a claim (§158 .33 (c) ) . In either case, the
statement must be signed and dated, and must include the typed
name .and title of the official who signs it. Do not make CBI
claims with respect to analytical methods associated with pet-
itions for tolerances or emergency exemptions (see NOTE Pg 13) .
D.3. Confidential Attachment
If the claim is made that a study includes confidential .
business information as defined by the criteria of FIFRA
§10 (D) (1) (A), (B) , or (C) (as described in D.2. above) all such
information must be excised from the body of the study and
confined to a separate study-specific Confidential Attachment.
Each passage of CBI so isolated must be identified by a reference
number cited within the body of the study at the point from which
the passage was excised (See Attachment 5) .
The Confidential Attachment to a study must be identified by
a cover' sheet fully identifying the parent study, and must be
clearly marked "Confidential Attachment." An appropriately
annotated photocopy of the parent study title page may be used as
this cover sheet. Paginate 'the Confidential Attachment
separately from the body of the study, beginning with page 1 of X
on the title page. Each passage confined to the Confidential
Attachment must be associated with a specific cross reference to
the page(s) in the main body of the study on which it is cited,
and with a reference to the applicable passage (s) of FIFRA
§10 (d) (1) on which the confidentiality claim is based.
D.4. Supplemental Statement of Data Confidentiality Claims (See
Attachment 4)
If you wish to make a claim of confidentiality for any
portion of a submitted study other than described by FIFRA §10 (d)
(1) (A) , (B) , or (C) , the following provisions apply:
- The specific information to which the claim applies must
be clearly marked in the body of the study as subject to a
claim of confidentiality.
- A Supplemental Statement of Data Confidentiality Claims
must be submitted, identifying each passage claimed confi-
dential and describing in detail the basis for the claim.
A list of the points to address .in- :such a statement is
included in Attachment 4 on Pg 14 .
- The Supplemental Statement of Data Confidentiality Claims
must be signed and dated and must include the typed name and
title of the official who signed it .
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D.5. Good Laboratory Practice Compliance Statement
This statement is required if the study contains laboratory
work subject to GLP requirements specified in 40 CFR 160. Sam-
ples of these statements are shown in Attachment 6.
E. Reference to Previously Submitted Data
DO NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it. A copy
of the title page plus the MRID number (if known) is sufficient
to allow us to retrieve the study immediately for review. This
prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study. References to pre-
viously submitted studies should not be included in the transmit-
tal document, but should be incorporated into the statement of
the method of'support for the application.
F. Physical Format Requirements
All elements in the data submittal package must be on
uniform 8 1/2 by 11 inch white paper, printed on one side only in
black ink, with high contrast and good resolution. Bindings for
individual studies,, must .be secure, but easily removable to permit
disassembly for microfilming. Check with EPA for special
instructions before submitting data in any medium other than
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.
• Make sure that photocopies are clear, complete, and
fully readable.
• Do not include oversize computer printouts or fold-out
pages.
• Do not bind any documents with glue or binding tapes.
• Make sure that all pages of each study, including any
attachments or appendices, are present and in correct
sequence.
Number of Copies Required - All submittal packages except
those associated with a Registration Standard or Special Review
(See Part G below) must be provided In three complete, identical
copies. (The'proposed regulations specified.two copies; three
are now being required to expedite and reduce the cost of
processing data into the OPP Pesticide Document Management System
and getting it-into review.) . «-,,. .,,t,.r .„,.,
179
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G.
Special Requirements for Submitting Data to the Docket
Data submittal packages associated with a Registration- Stan-
dard or Special Review must be provided in four copies, from one
of which all material claimed as CBI has been excised. This
fourth copy will become part of the public docket for the RS or
SR case. If no claims of confidentiality are made for the study,
the fourth copy should be identical to the other three. When
portions of a study submitted in support of an RS or SR are
claimed as CBI, the first three copies will include the CBI
material as provided in section D of this notice. The following
special preparation is required for the fourth copy.
Remove the "Supplemental Statement of Data
Confidentiality Claims".
Remove the "Confidential Attachment".
Excise from the body of the study any information you
claim as confidential, even if it does not fall within
the scope of FIFRA §10(d)(1)(A), (B), or (C). Do not
close up or paraphrase text remaining after this
excision.
Mark the fourth copy plainly on both its cover and its
title page with the phrase "Public Docket Material -
contains no information claimed as confidential".
V.
For Further Information
For further information contact John Carley, Chief,
Information Services Branch, Program Management and Support
Division, (703) 305-5240.
«m«s W. Aktrmin
Actins Dirtotoe,
Attachment 1,
Attachment 2,
Attachment 3.
Attachment 4.
Attachment 5,
Attachment 6,
Attachment 7
Sample Transmittal Document
Sample Title Page for a Newly Submitted Study
Statements of Data Confidentiality Claims
Supplemental Statement of Data Confidentiality
Claims
Samples of Confidential -Attachments
Sample Good Laboratory Practice Statements
Format Diagrams for Submittal Packages and Studies
180
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ATTACHMENT 1
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
1. Name and address of submitter (or all joint submitters**)
+Smith Chemical Corporation Jones Chemical Company
1234 West Smith Street -and- 5678 Wilson Blvd
Cincinnati, OH 98765 ' Covington, KY 56789
, ,*
+Smith Chemical Corp will act as sole agent for all submitters.
2. Regulatory action in support of which this package is
submitted
Use the EPA identification number (e.g. 359-EUP-67) if you know
it. Otherwise describe the type of request (e.g. experimental
use permit, data,call-in - of xx-xx-xx date).
3. Transmittal date
4. List of submitted studies
Vol 1. Administrative materials - forms, previous corres-
pondence with Project Managers, and so forth.
Vol 2. Title of first study in the submittal (Guideline
No.)
Vol n Title of nth study in the submittal (Guideline
No.)
* Applicants commonly provide this information in a tran-
smittal letter. This remains an acceptable practice so
long as all four elements are included.
* Indicate which of the joint submitters is empowered to
act on behalf of all joint submitters in any matter
concerning data compensation or subsequent use or
release of the data.
Company Official:,
"' Name Signature
Company Name :
Company Contact:
Name Phone
181
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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 Pro*! ect ID
ABC 47-79
Page 1 of X
(X is the total number of pages in the study)
182
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ATTACHMENT 3
STATEMENTS OF DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under FIFRA §10(d)(1)(A),(B), or
(C) .
STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
No claim of confidentiality is made for any information
contained in this study on the basis of its falling within
the scope of FIFRA 6§10(d)(1)(A), (B), or (C).
Company
Company Agent:
Title
Typed Name
Date:
Signature
2. Claim of confidentiality under FIFRA §10 (d) (1) (A)-, (B) , or
(C) .
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
Information claimed confidential on the basis of its falling
within the scope of FIFRA §10(d)(1)(A), (B), or (C) has been
removed to a confidential appendix, and is cited by
cross-reference number in the body of the study.
Company:
Company Agent:
Title
Typed Name
Date:
Signature
NOTE: Applicants for permanent or temporary tolerances should
note that it is OPP policy that no permanent tolerance, temporary
tolerance, or request, for an emergency exemption incorporating an
analytical method, can be approved unless the applicant waives
all claims of confidentiality for the .analytical method. 'These
analytical methods are published in the FDA Pesticide Analytical
Methods Manual, and therefore cannot be claimed as confidential.
OPP implements this policy by returning submitted analytical
methods, for which confidentiality claims have been made, to the
submitter, to obtain the confidentiality.waiver before they can
be processed.
183
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ATTACHMENT 4
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described
by FIFRA §10(d)(1)(A), (B), or (C), but for which you claim
confidential treatment on another basis, the following informa-
tion ,must be included within a Supplemental Statement of Data
Confidentiality Claims:
• Identify specifically by.page and line number(s) each
portion of the study for which you claim
confidentiality.
• Cite the reasons why the cited passage qualifies for
confidential treatment.
• Indicate the length of time--until a specific date or
event, or permanently--for which the information should
be treated as confidential.
• Identify the measures taken to guard against undesired
disclosure of this information.
• Describe the extent to which the information has been
disclosed, and what precautions have been taken in con-
nection with those disclosures.
• Enclose copies of any pertinent determinations of
confidentiality made by EPA, other Federal agencies, of
courts -concerning this information.
• If you assert that disclosure of this information would
be likely to result in substantial harmful effects to
you, describe those harmful effects and explain why
they should be viewed as substantial.
• If you assert that the information in voluntarily sub-
mitted, indicate whether you believe disclosure of this
information might tend to lessen the availability to
EPA of similar information in the future, and if so,
how.
184
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ATTACHMENT 5
EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
Example 1. (Confidential word or phrase that has been deleted
from the study)
CROSS REFERENCE NUMBER 1. This cross reference number is used in the study
in place of the following words or phrase at the
indicated volume and page references.
DELETED WORDS OR PHRASE:.
•R<-Viy1 Q-no
6
12
100
LINE REASON FOR THE DELETION
14
25
19
Identity of Inert Ingredient
FIFRA REFERENCE
§10 (d) (1) (C)
Example 2. (Confidential paragraph(s) that have been deleted from the study)
CROSS REFERENCE NUMBER 5. This cross reference number is used in the study
in place of the following paragraph(s)•at the
indicated volume and page references.
DELETED PARAGRAPH(S):
Reproduce the deleted paragraph(s) here
)
PAGE LINES REASON FOR THE DELETION FIFRA REFERENCE
20. 2-17 Description of the quality control process §10(d)(1)(C)
Example 3. (Confidential pages that have been deleted from the study)
CROSS REFERENCE NUMBER 2 This cross reference number noted on a place-
holder page is used in place of the following
whole pages at the indicated volume and page
references.
DELETED PAGE(S): are attached immediately behind this page.
PAGE LINES REASON FOR THE DELETION FIFRA REFERENCE
20. 2-17 Description of the product manufacturing process §10(d)(1)(A)
185
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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 40 CFR Part 160, and differs
in the following ways:
X. [ 2
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
186
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ATTACHMENT 7.
FORMAT OF THE SUBMITTAL PACKAGE
LEGEND
Transmittal Document.
Related Administrative Materials
te.g., Method of Support statement, etc.)
Other materials about the submittal
Ifl'2:-rt """""J*8 of groups of studies
to aid in their review).
Studies, submitted a» unique
physical entities, according
to the format below.
FORMAT Of SUBMITTED STUDIES
^^^••MM^^^PVMMHM^^^
Study title page.
Statement of Confidentiality Claims.
GLP and flagging* statements - as appropriate.
Body of the study, with English
language translation if required.
1--T
Appendices to the study.
.Title Page of the Confidential
Attachment.
Confidential Attachment.
Supplemental Statement
of Confidentiality Claims,
* When flagging requirements
are finalised.
Documents which must be submitted as
appropriate to meet established requirements.
Documents submitted at submitter's option.
187
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188
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PR Notice 91-2
189
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190
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
PR NOTICE 91-2
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDES
ATTENTION: Persons Responsible for Federal Registration of
Pesticide Products.
SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement
I. PURPOSE:
The purpose of this notice is to clarify the Office of
Pesticide Program's policy with respect to the statement of
percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(s)
specified in the ingredient statement on the label must be stated
as the nominal concentration of such ingredient(s), as that term
is defined in 40 CFR 158.153 (i) . Accordingly, the Agency has
established the nominal concentration as the only acceptable
label claim for the amount of active ingredient in the product.
II. BACKGROUND
For_some time the Agency has accepted two different methods
of identifying on the label what percentage is claimed for the
ingredient(s) contained in a pesticide. Some applicants claimed a
percentage which represented a level between the upper and the
lower certified limits. This was referred to as the nominal
concentration. Other applicants claimed the lower limit as the
percentage of the ingredient(s) that would be expected to be
present in their product at the end of the product's shelf-life.
Unfortunately, this led to a great deal of confusion among the
regulated industry, the regulators, and the consumers as to
exactly how much of a given ingredient was in a given product.
The Agency has established the nominal concentration as the only
acceptable label claim for the amount of active ingredient in the
product.
Current regulations require that the percentage listed in
the active ingredient statement be as precise as possible
reflecting good manufacturing practices 40 CFR 156.10(g)(5). The
certified limits required for each active ingredient are intended
to encompass any such "good manufacturing practice" variations 40
191
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CFR 158.175(c)(3).
The upper and lower certified limits, which must be proposed
in connection with a product's registration, represent the •
amounts of an ingredient that may legally be present 40 CFR
158.175. The lower certified limit is used as the enforceable
lower limit for the product composition according to FIFRA
section 12(a)(1)(C), while the nominal concentration appearing on
the label would be the routinely achieved concentration used for
calculation of dosages and dilutions.
The nominal concentration would in fact state the greatest
degree of accuracy that is warranted with respect to actual
product! composition because the nominal concentration would be
the amount of active ingredient typically found in the product.
It is important for registrants to note that certified
limits for active ingredients are not considered to be trade
secret information under FIFRA section 10(b). In this respect the
certified limits will be routinely provided by EPA to States for
enforcement purposes, since the nominal concentration appearing
on the label may not represent the enforceable composition for
purposes of section 12(a)(1)(C).
III. REQUIREMENTS
As described below under Unit V. " COMPLIANCE SCHEDULE," all
currently registered products as well as all applications for new
registration must comply with this Notice by specifying the
nominal concentration expressed as a percentage by weight as the
label claim in the ingredient(s) statement and equivalence
statements if applicable (e.g., elemental arsenic, metallic zinc,
salt of an acid). In addition, the requirement for performing
sample analyses of five or more representative samples must be
fulfilled. Copies of the raw analytical data must be submitted
with the nominal ingredient label claim. Further information
about the analysis requirement may be found in the 40 CFR
158.170. All products are required to provide certified limits
for each active, inert ingredient, impurities of toxicological
significance(i.e., upper limit(s) only) and on a case by case
basis as specified by EPA. These limits are to be set based on
representative sampling and chemical analysis(i.e., quality
control) of the product.
The format of the ingredient statement must conform to 40
CFR 156-Labeling Requirements For Pesticides and Devices.
After July 1,\997, all pesticide ingredient Statements must
be changed to nominal concentration.
192
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IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore,
the certified lower limits may not be lower then the minimum
level to achieve efficacy. This is extremely important for
products which are intended to control pests which threaten the
public health, e.g., certain antimicrobial and rodenticide
products. Refer to 40 CFR 153.640.
i i,*
in those cases where efficacy limits have been established,
the Agency will not accept certified lower limits which are below
that level for the shelf life of the product.
V. COMPLIANCE SCHEDULE
As described earlier, the purpose of this Notice is to make
the registration process more uniform and more manageable for
both the agency and the regulated community. It is the Agency's
intention to implement the requirements of this notice as
smoothly as possible so as not to disrupt or delay the Agency's
high priority programs, i.e., reregistration, new chemical, or
fast track (FIFRA section 3(c)(3)(B). Therefore,
applicants/registrants are expected to comply with the
requirements of this Notice as follows:
(1) Beginning July 1, 1991, all new product registrations
submitted to the Agency are to comply with the
requirements of this Notice.
(2) Registrants having products subject to reregistration
under FIFRA section 4(a) are to comply with the
requirements of this Notice when specific products are
called in by the Agency under Phase V of the
Reregistration Program.
193
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(3) All other products/applications that are not subject to
(1) and (2) above will have until July 1, 1997, to
comply with this Notice. Such applications should note
"Conversion to Nominal Concentrations on the
application form. These types Or amendments will not be
handled as "Fast Track" applications but will be
handled as routine requests.
VI. FOIL FURTHER INFORMATION
Contact Tyrone Aiken for information or questions concerning
this notice on (703) 308-7031.
J.O __/f ,
•*—• si - f*-.-S^j- _j*t
E. tdndaay, Director
Division (H-7505
194
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APPENDIX F. Generic Data Call-in
195
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196
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GENERIC DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient(s) identified in Attachment 1 of this Notice, the Data Call-in Chemical Status Sheet.
to submit certain data as noted herein to the U.S. Environmental Protection Agency (EPA, the
Agency). These data are necessary to maintain the continued registration of your product(s)
containing this active ingredient(s). Within 90 days after you receive this Notice you must
respond as set forth in Section III below. Your response must state:
1. how you will comply with the requirements set forth in this Notice and its Attachments
1 through 4; or,
2. why you believe you are exempt from the requirements listed in this Notice and hi
Attachment 3, Requirements Status and Registrant's Response Form, (see section IH-B);
or,
3. why you believe EPA should not require your submission of data hi the manner specified
by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2, Data Call-in Response Form, as well
as a list of all registrants who were sent this Notice (Attachment 4).
The authority for this Notice is section 3(c)(2)(B) of. the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
197 .
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(expiration date 12-31-92).
This Notice is divided into six sections and five Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
.Section n - Data Required By This Notice
Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable
Adverse Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
Attachment 1 - Data Call-In Chemical Status Sheet
Attachment 2 - Data Call-In Response Form
Attachment 3 - Requirements Status And Registrant's Response Form
Attachment 4 - List Of All Registrants Sent This Data Call-In Notice
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient(s) and reevaluated the
data needed to support continued registration of the subject active ingredient(s). This
reevaluation identified additional data necessary to assess the health and safety of the continued
use of products containing this active ingredient(s). You have been sent this Notice because you
have product(s) containing the subject active ingredient(s).
SECTION II. DATA REQUIRED BY THIS NOTICE
A. DATA REQUIRED
The data required by this Notice are specified hi Attachment 3, Requirements
Status and Registrant's Response Form. Depending on the results of the studies required
hi this Notice, additional testing may be required.
B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements
specified in Attachment 3, Requirements Status and Registrant's Response Form, within
the time frames provided.
198
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C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test
standards outlined in the Pesticide Assessment Guidelines for those studies for which
guidelines have been established.
i!>
These EPA Guidelines are available from the National Technical Information
Service (NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel-
703-487-4650).
Protocols approved by the Organization for Economic Cooperation and
Development (OECD) are also acceptable if the OECD-recommended test standards
conform to those specified hi the Pesticide Data Requirements regulation (40 CFR §
158.70). When using the OECD protocols, they should be modified as appropriate so
that the data generated by the study will satisfy the requirements of 40 CFR § 158.
Normally, the Agency will not extend deadlines for complying with data requirements
when the studies were not conducted in accordance with acceptable standards. The
OECD protocols are available from OECD, 1750 Pennsylvania Avenue N.W.,
Washington, D.C. 2Q006.
All new studies and proposed protocols submitted hi response to this Data Call-In
Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)] .
D. REGISTRANTS RECEIVING PREVIOUS SECTION 3fc)(2)rm NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not hi any way supersede
or change the requirements of any previous Data Call-Intel, or any other agreements
entered into with the Agency pertaining to such prior Notice. Registrants must comply
with the requirements of all Notices to avoid issuance of a Notice of Intent to Suspend
their affected products.
SECTION HI. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice must be submitted to
the Agency within 90 days after your receipt of this Notice. Failure to adequately
respond to this Notice within 90 days of your receipt will be a basis for issuing a Notice
of Intent to Suspend (NOIS) affecting your products. This and other bases for issuance
199
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of NOIS due to failure to comply with this Notice are presented in Section IV-A and IV-
B.
B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice are: 1) voluntary cancellation, 2) delete
use(s), (3) claim generic data exemption, (4) agree to satisfy the data requirements
.imposed by this Notice or (5) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option,
the Delete Use(s) option or the Generic Data Exemption option is presented below. A
discussion of the various options available for satisfying the data requirements of this
Notice is contained hi Section III-C. A discussion of options relating to requests for data
waivers is contained hi Section O-D.
There are two forms that accompany this Notice of which, depending upon your
response, one or both must be used in your response to the Agency. These forms are
the Data-Call-in Response Form (Attachment 2) and the Requirements Status and
Registrant's Response Form (Attachment 3). The Data Call-In Response Form must be
submitted as part of every response to this Notice. Please note that the company's
authorized representative is required to sign the first page of the Data Call-In Response
Form and Requirements Status and Registrant's Response Form (if this form is required)
and initial any subsequent pages. The forms contain separate detailed instructions on the
response options. Do not alter.the printed material. If you have questions or need
assistance hi preparing your response, call or write the contact person identified hi
Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice
by requesting voluntary cancellation of your product(s) containing the active
ingredients) that is the subject of this Notice. If you wish to voluntarily cancel
your product, you must submit a completed Data Call-in Response Form.
indicating your election of this option. Voluntary cancellation is item number 5
on the Data Call-In Response Form. If you choose this option, this is the only
form that you are required to complete.
If you choose to voluntarily. cancel your product, further sale and
distribution of your product after the effective date of cancellation must be hi
accordance with the Existing Stocks provisions of this Notice which are contained
hi Section IV-C.
2. Use Deletion - You may avoid the requirements of this Notice by
eliminating the uses of your product to which the requirements apply. If you
wish to amend your registration to delete uses, you must submit the Requirements
Status and Registrant's Response Form, a completed application for amendment,
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a copy of your proposed amended labeling, and all other information required for
processing the application. Use deletion is option number 7 on the Requirements
Status and Registrant's Response Form. You must also complete a Data Call-In
Response Form by signing the certification, item number 8. Application forms for
amending registrations may be obtained from the Registration Support and
Emergency Response Branch, Registration Division, (703) 308-8358.
If you choose to delete the use(s) subject to this Notice or uses subject to
specific data requirements, further sale, distribution, or use of your product after
one year from the due date of your 90 day response, must bear an amended label.
3. Generic Data Exemption - Under section 3(c)(2)(D) of FIFRA, an
applicant for registration of a product is exempt from the requirement to submit
or cite generic data concerning an active ingredient(s) if the active higredient(s)
in the product is derived exclusively from purchased, registered pesticide products
containing the active ingredient(s). EPA has concluded, as an exercise of its
discretion, that it normally will not suspend the registration of a product which
would qualify and continue to qualify for the generic data exemption in section
3(c)(2)(D) of FIFRA. To qualify, all of the following requirements must be met:
a. The active ingredient(s) hi your registered product must be present
solely because of incorporation of another registered product which
contains the subject active ingredient(s) and is purchased from a source
not connected with you; and,
b. every registrant who is the ultimate source of the active
ingredients) in your product subject to this DCI must be in compliance
with the requirements of this Notice and must remain in compliance; and
c. you must have provided to EPA an accurate and current
"Confidential Statement of Formula" for each of your products to which
this Notice applies.
To apply for the Generic Data Exemption you must submit a completed
Data Call-In Response Form. Attachment 2 and all supporting documentation.
The Generic,Data Exemption is item number 6a on the Data Call-In Response
Form. If you claim a generic data exemption you are not required to complete
the Requirements Status and Registrant's Response Form. Generic Data
Exemption cannot be selected as an option for product specific data.
If you are granted a Generic Data Exemption, you rely on the efforts of
other persons to provide the Agency with the required data. If the registrant(s)
who have committed to generate and submit the required data fail to take
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appropriate steps to meet the requirements or are no longer in compliance with
this Data Call-In Notice, the Agency will consider that both they and you are not
in compliance and will normally initiate proceedings to suspend the registrations
of both your and their product(s), unless you commit to submit and do submit the
required data within the specified time. In such cases the Agency generally will
not grant a time extension for submitting the data.
, ,\ 4. Satisfying the Data Requirements of this Notice - There are various
options available to satisfy the data requirements of this Notice. These options
are discussed in Section ffl-C of this Notice and comprise options 1 through 6 on
the Requirements Status and Registrant's Response Form and option 6b and 7 on
the Data Call-In Response Form. If you choose option 6b or 7, you must submit
both forms as well as any other information/data pertaining to the option chosen
to address the data requirement.
5. Request for Data Waivers. Data waivers are discussed in Section III-D
of this Notice and are covered by options 8 and 9 on the Requirements Status and
Registrant's Response Form. If you choose one of these options, you must
submit both forms as well as any other information/data pertaining to the option
chosen to address the data requirement.
C. SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy
the data requirements (i.e. you select option 6b and/or 7), then you must select one of
the six options on the Requirements Status and Registrant's Response Form related to
data production for each data requirement. Your option selection should be entered
under item number 9, "Registrant Response." The six options related to data production
are the first six options discussed under item 9 hi the instructions for completing the
Requirements Status and Registrant's Response Form. These six options are listed
immediately below with information in parentheses to guide registrants to additional
instructions provided in this Section. The options are:
1. I will generate and submit data within the specified time frame
(Developing Data),
2. I have entered into an agreement with one or more registrants to develop
data jointly (Cost Sharing),
3. I have made offers to cost-share (Offers to Cost Share),
4. I am submitting an existing study that has not been submitted previously
to the Agency by anyone (Submitting an Existing Study),
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5. I am submitting or citing data, to upgrade a study classified by EPA as
partially acceptable and upgradeable (Upgrading a Study),
6. I am citing an existing study that EPA has classified as acceptable or an
existing study that has been submitted but not reviewed by the Agency
(Citing an Existing Study).
Option 1. Developing Data —
If you choose to develop the required data it must be hi conformance with
Agency deadlines and with other Agency requirements as referenced herein and
in the attachments. All data generated and submitted must comply with the Good
Laboratory Practice (GLP) rule (40 CFR Part 160), be conducted according to the
Pesticide Assessment Guidelines (PAG), and be in conformance with the
requirements of PR Notice 86-5. In addition, certain studies require Agency
approval of test protocols in advance of study initiation. Those studies for which
a protocol must be submitted have been identified in the Requirements Status and
Registrant's Response Form and/or footnotes to the form. If you wish to use a
protocol which differs from the options discussed in Section II-C of this Notice,
you must submit a detailed description of the proposed protocol and your reason
for wishing to use it. The Agency may choose to reject a protocol not specified
in Section II-C. If the Agency rejects your protocol you will be notified in
writing, however, you should be aware that rejection of a proposed protocol will
not be a basis for extending the deadline for submission of data.
A progress report must be submitted for each study within 90 days from
the date you are required to commit to generate or undertake some other means
to address that study requirement, such as making an offer to cost-share or
agreeing to share in the cost of developing that study. A 90-day progress report
must be submitted for all studies. This 90-day progress report must include the
date the study was or will be initiated and, for studies to be started within 12
months of commitment, the name and address of the laboratory(ies) or individuals
who are or will be conducting the study.
In addition, if the time frame for submission of a final report is more than
1 year, interim reports must be submitted at 12 month intervals from the date you
are required to commit to generate or otherwise address the requirement for the
study. In addition to the other information specified hi the preceding paragraph,
at a minimum, a brief description of current activity on and the status of the study
must be included as well as a full description of any problems encountered since
the last progress report.
The time frames in the Requirements Status and Registrant's Response
Form are the time frames that the Agency is allowing for the submission of
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completed study reports or protocols. The noted deadlines run from the date of
the receipt of this Notice by the registrant. If the data are not submitted by the
deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected registration(s).
If you cannot submit the data/reports to the Agency hi the tune required
by this Notice and intend to seek additional tune to meet the requirement(s), you
must submit a request to the Agency which includes: (1) a detailed description
of the expected difficulty and (2) a proposed schedule including alternative dates
for meeting such requirements on a step-by-step basis. You must explain any
technical or laboratory difficulties and provide documentation from the laboratory
performing the testing. While EPA is considering your request, the original
deadline remains. The Agency will respond to your request hi writing. If EPA
does not grant your request, the original deadline remains. Normally, extensions
can be requested only hi cases of extraordinary testing problems beyond the
expectation or control of the registrant. Extensions will not be given in
submitting the 90-day responses. Extensions will not be considered if the request
for extension is not made hi a timely fashion; hi no event shall an extension
request be considered if it is submitted at or after the lapse of the subject
deadline.
Option 2. Agreement to Share in Cost to Develop Data —
If you choose to enter into an agreement to share hi the cost of producing
the required data but will not be submitting the data yourself, you must provide
the name of the registrant who will be submitting the data. You must also
provide EPA with documentary evidence that an agreement has been formed.
Such evidence may be your letter offering to join hi an agreement and the other
registrant's acceptance of your offer, or a written statement by the parties that an
agreement exists. The agreement to produce the data need not specify all of the
terms of the final arrangement between the parties or the mechanism to resolve
the terms. Section 3(c)(2)(B) provides that if the parties cannot resolve the terms
of the agreement they may resolve then: differences through binding arbitration.
Option 3. Offer to Share in the Cost of Data Development —
If you have made an offer to pay in an attempt to enter into an agreement
or amend an existing agreement to meet the requirements of this Notice and have
been unsuccessful, you may request EPA (by selecting this option) to exercise its
discretion not to suspend your registration(s), although you do not comply with
the data submission requirements of this Notice. EPA has determined that as a
general policy, absent other relevant considerations, it will not suspend the
registration of a product of a registrant who has hi good faith sought and
continues to seek to enter into a joint data development/cost sharing program, but
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the other registrant(s) developing the data has refused to accept your offer. To
qualify for this option, you must submit documentation to the Agency proving
that you have made an offer to another registrant (who has an obligation to submit
data) to share hi the burden of developing that data. You must also submit to the
Agency a completed EPA Form 8570-32, Certification of Offer to Cost Share in
the Development of Data. In addition, you must demonstrate that the other
registrant to whom the offer was made has not accepted your offer to enter into
a cost sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that offer (such as a certified mail receipt). Your offer
must, in addition to anything else, offer to share in the burden of producing the
data upon terms to be agreed or failing agreement to be bound by binding
arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must not qualify this
offer. The other registrant must also inform EPA of its election of an option to
develop and submit the data required by this Notice by submitting a Data Call-In
Response Form and a Requirements Status and Registrant's Response Form
committing to develop and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not
withdraw your offer to share hi the burdens of developing the data. In addition,
the other registrant must fulfill its commitment to develop and submit the data as
required by this Notice. If the other registrant fails to develop the data or for
some other reason is subject to suspension, your registration as well as that of the
other registrant will normally be subject to initiation of suspension proceedings,
unless you commit to submit, and do submit the required data hi the specified
time frame. In such cases, the Agency generally will not grant a time extension
for submitting the data.
Option 4. Submitting an Existing Study —
If you choose to submit an existing study hi response to this Notice, you
must determine that the study satisfies the requirements imposed by this Notice.
You may only submit a study that has not been previously submitted to the
Agency or previously cited by anyone. Existing studies are studies which predate
issuance of this Notice. Do not use this option if you are submitting data to
upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not
acceptable, the Agency will require you to comply with this Notice, normally
without an extension of the required date of submission. The Agency may
determine at any time that a study is not valid and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing
study, all of the following three criteria must be clearly met:
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a. You must certify at the time that the existing study is submitted
that the raw data and specimens from the study are available for audit and
review and you must identify where they are available. This must be
done hi accordance with the requirements of the Good Laboratory Practice
(GLP) regulation, 40 CFR Part 160. As stated in 40 CFR 160.3(7) " raw
data means any laboratory worksheets, records, memoranda, notes, or
exact copies thereof, that are the result of original observations and
activities of a study and are necessary for the reconstruction and
evaluation of the report of that study. In the event that exact transcripts
of raw data have been prepared (e.g., tapes which have been transcribed
verbatim, dated, and verified accurate by signature), the exact copy or
exact transcript may be substituted for the original source as raw data.
Raw data may include photographs, microfilm or microfiche copies,
computer printouts, magnetic media, including dictated observations, and
recorded data from automated instruments." The term "specimens",
according to 40 CFR 160.3(7), means "any material derived from a test
system for examination or analysis."
b. Health and safety studies completed after May 1984 must also
contain all .GLP-required quality assurance and quality control
information, pursuant to the requirements of 40 CFR Part 160.
Registrants must also certify at the time of submitting the existing study
that such GLP information is available for post-May 1984 studies by
including an appropriate statement on or attached to the study signed by
an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for
the Guideline relevant to the study provided hi the FIFRA Accelerated
Reregistration Phase 3 Technical Guidance and that the study has been
conducted according to the Pesticide Assessment Guidelines (PAG) or
meets the purpose of the PAG (both available from NTIS). A study not
conducted according to the PAG may be submitted to the Agency for
consideration if the registrant believes that the study clearly meets the
purpose of the PAG. The registrant is referred to 40 CFR 158.70 which
states the Agency's policy regarding acceptable protocols. If you wish to
submit the study, you must, hi addition to certifying that the purposes of
the PAG are met by the study, clearly articulate the rationale why you
believe the study meets the purpose of the PAG, including copies of any
supporting information or data. It has been the Agency's experience that
studies completed prior to January 1970 rarely satisfied the purpose of the
PAG and that necessary raw data are usually not available for such
studies.
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If you submit an existing study, you must certify that the study
meets all requirements of the criteria outlined above.
If EPA has previously reviewed a protocol for a study you are
submitting, you must identify any action taken by the Agency on the
protocol and must indicate, as part of your certification, the manner in
which all Agency comments, concerns, or issues were addressed hi the
final protocol and study.
If you know of a study pertaining to any requirement in this Notice
. which does not meet the criteria outlined above but does contain factual
information regarding unreasonable adverse effects, you must notify the
Agency of such a study. If such a study is hi the Agency's files, you
need only cite it along with the notification. If not hi the Agency's files,
you must submit a summary and copies as required by PR Notice 86-5.
Option 5. Upgrading a Study —
If a study has been classified as partially acceptable and upgradeable, you
may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the
requirement is not satisfied, you may still be required to submit new data
normally without any tune extension. Deficient, but upgradeable studies will
normally be classified as supplemental. However, it is important to note that not
all, studies, classified as supplemental are upgradeable. If you have questions
regarding the classification of a study or whether a study may be upgraded, call
or write the contact person listed hi Attachment 1. If you submit data to upgrade
an existing study you must satisfy or supply information to correct all deficiencies
hi the study identified by EPA. You must provide a clearly articulated rationale
of how the deficiencies have been remedied or corrected and why the study
should be rated as acceptable to EPA. Your submission must also specify the
MRID number(s) of the study which you are attempting to upgrade and must be
hi conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study
classified as unacceptable and determined by the Agency as not capable of being
upgraded. .
This option should also be used to cite data that has been previously
submitted to upgrade a study, but has not yet been reviewed by the Agency. You
must provide the MRID number of the data submission as well as the MRID
number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4
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above, apply to all data submissions intended to upgrade studies. Additionally
your submission of data intended to upgrade studies must be accompanied by a
certification that you comply with each of those criteria as well as a certification
regarding protocol compliance with Agency requirements.
Option 6. Citing Existing Studies —
tv if you choose to cite a study that has been previously submitted to EPA,
that study must have been previously classified by EPA as acceptable or it must
be a study which has not yet been reviewed by the Agency. Acceptable
toxicology studies generally will have been classified as "core-guideline" or "core
minimum." For ecological effects studies, the classification generally would be
a rating of "core." For all other disciplines the classification would be
"acceptable." With respect to any studies for which you wish to select this option
you must provide the MRID number of the study you are citing and, if the study
has been reviewed by the Agency, you must provide the Agency's classification
of the study.
If you are citing a study of which you are not the original data submitter,
you must submit a completed copy of EPA Form 8570-31, Certification with
Respect to Data Compensation Requirements.
D. REQUESTS FOR DATA WAIVERS
There are two types of data waiver responses to this Notice. The first is a request
for a low volume/minor use waiver and the second is a waiver request based on your
belief that the data requirements) are inapplicable and do not apply to your product.
1. Low Volume/Minor Use Waiver - Option 8 nn the Requirements Status
and Registrant's Response Form. Section 3(c)(2)(A) of FIFRA requires EPA to
consider the appropriateness of requiring data for low volume, minor use
pesticides. In implementing this provision EPA considers as low volume
pesticides only those active ingredient(s) whose total production volume for all
pesticide registrants is small. In determining whether to grant a low volume,
minor use waiver the Agency will consider the extent, pattern and volume of use,
the economic incentive to conduct the testing, the importance of the pesticide, and
the exposure and risk from use of the pesticide. If an active ingredient(s) is used
for both high volume and low volume uses, a low volume exemption will not be
approved. If all uses of an active ingredient(s) are low volume and the combined
volumes for all uses are also low, then an exemption may be granted, depending
on review of other information outlined below. An exemption will not be granted
if any registrant of the active ingredient(s) elects to conduct the testing. Any
registrant receiving a low volume minor use waiver must remain within the sales
figures in their forecast supporting the waiver request in order to remain qualified
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for such waiver. If granted a waiver, a registrant will be required, as a condition
of the waiver, to submit annual sales reports. The Agency will respond to
requests for waivers in writing.
To apply for a low volume, minor use waiver, you must submit the
following information, as applicable to your product(s), as part of your 90-day
response to this Notice:
a. Total company sales (pounds and dollars) of all registered
product(s) containing the active ingredient(s). If applicable to the active
ingredient(s), include foreign sales for those products that are not
registered in this country but are applied to sugar (cane or beet), coffee,
bananas, cocoa, and other such crops. Present the above information by
year for each of the past five years.
b. Provide an estimate of the sales (pounds and dollars) of the active
higredient(s) for each major use site. Present the above information by
year for each of the past five years.
c. Total direct production cost of product(s) containing the active
ingredient(s) by year for the past five years. Include information on raw
material cost, direct labor cost, advertising, sales and marketing, and any
other significant costs listed separately.
d. Total indirect production cost (e.g. plant overhead, amortized plant
and equipment) charged to product(s) containing the active ingredient(s)
by year for the past five years. Exclude all non-recurring costs that were
directly related to the active ingredient(s), such as costs of initial
registration and any data development.
e. A list of each data requirement for which you seek a waiver.
Indicate the type of waiver sought and the estimated cost to you (listed
separately for each data requirement and associated test) of conducting
the testing needed to fulfill each of these data requirements.
f. A list of each data requirement for which you are not seeking any
waiver and the estimated cost to you (listed separately for each data
requirement and associated test) of conducting the testing needed to fulfill
each of these data requirements.
g. For each of the next ten years, a year-by-year forecast of company
sales (pounds and dollars) of the active ingredients), direct production
costs of product(s) containing the active ingredient(s) (following the
parameters in item c above),'indirect production costs of product(s)
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containing the active ingredient(s) (following the parameters in item d
above), and costs of data development pertaining to the active
ingredient(s).
h. A description of the importance and unique benefits of the active
ingredient(s) to users. Discuss the use patterns and the effectiveness of
the active ingredient(s) relative to registered alternative chemicals and
, ,\ non-chemical control strategies. Focus on benefits unique to the active
ingredient(s), providing information that is as quantitative as possible. If
you do not have quantitative data upon which to base your estimates, then
present the reasoning used to derive your estimates. To assist the Agency
hi determining the degree of importance of the active ingredient(s) in
terms of its benefits, you should provide information on any of the
following factors, as applicable to your product(s):
(1) documentation of the usefulness of the active ingredient(s)
in Integrated Pest Management, (b) description of the beneficial impacts
on the environment of use of the active ingredient(s), as opposed to its
registered alternatives, (c) information on the breakdown of the active
ingredient(s) after use and on its persistence in the environment, and (d)
description of its usefulness against a pest(s) of public health significance.
Failure to submit sufficient information for the Agency to make a determination
regarding a request for a low volume minor use waiver will result hi denial of the request
for a waiver.
2. Request for Waiver of Data —Option 9 on the Requirements Status and
Registrant's Response Form. This option may be used if you believe that a
particular data requirement should not apply because the corresponding use is no
longer registered or the requirement is inappropriate. You must submit a
rationale explaining why you believe the data requirements should not apply.
You must also submit the current label(s) of your product(s) and, if a current
copy of your Confidential Statement of Formula is not already on file you must
submit a current copy.
You will be informed of the Agency's decision in writing. If the Agency
determines that the data requirements of this Notice do not apply to your
produces), you will not be required to supply the data pursuant to section
3(c)(2)(B). If EPA determines that the data are required for your productCs"). you
must choose a method of meeting the requirements of this Notice within the time
frame provided by this Notice. Within 30 days of your receipt of the Agency's
written decision, you must submit a revised Requirements Status and Registrant's
Response Form indicating the option chosen.
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IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
i, \
A. NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this
Notice due to failure by a registrant to comply with the requirements of this Data Call-In
Notice, pursuant to FIFRA section 3(c)(2)(B). Events which may be the basis for
,iss,uance of a Notice of Intent to Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your
receipt of this Notice.
2. Failure to submit on the required schedule an acceptable proposed or final
protocol when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on
a study as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by
this Notice.
5. Failure to take a required action or submit adequate information pertaining
to any option chosen to address the data requirements (e.g., any required
action or information pertaining to submission or citation of existing
studies or offers, arrangements, or arbitration on the sharing of costs or
the formation of Task Forces, failure to comply with the terms of an
agreement or arbitration concerning joint data development or failure to
comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of
submitted studies, as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom,you have tendered an offer to share in
the cost of developing data and provided proof of the registrant's receipt
of such offer, or failure of a registrant on whom you rely for a generic
data exemption either to:
a. inform EPA of intent to develop and submit the data required by
this Notice on a Data Call-in Response Form and a Requirements Status
and Registrant's Response Form: or,
b. fulfill the commitment to develop and submit the data as required
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by this Notice; or,
c. otherwise take appropriate steps to meet the requirements stated in
this Notice, unless you commit to submit and do submit the required data
hi the specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at
,i any time following the issuance of this Notice.
B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required
time) is unacceptable and constitutes a basis for issuance of a Notice of Intent to
Suspend. The grounds for suspension include, but are not limited to, failure to meet any
of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test
Guidelines) regarding the design, conduct, and reporting of required studies.
Such requirements include, but are not limited to, those relating to test material,
test procedures, selection of species, number of animals, sex and distribution of
animals, dose and effect levels to be tested or attained, duration of test, and, as
applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the
incorporation of any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner
of reporting, the completeness of results, and the adequacy of any required
supporting (or raw) data, including, but not limited to, requirements referenced
or included in this Notice or contained in PR 86-5. All studies must be submitted
in the form of a final report; a preliminary report will.not be considered to fulfill
the submission requirement.
•3u ' ''
C. EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of
existing stocks of a pesticide product which has been suspended or cancelled if doing so
would be consistent with the purposes of the Federal Insecticide, Fungicide, and
Rodenticide Act.
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The Agency has determined that such disposition by registrants of existing stocks
for a suspended registration when a section 3(c)(2)(B) data request is outstanding would
generally not be consistent with the Act's purposes. Accordingly, the Agency anticipates
granting registrants permission to sell, distribute, or use existing stocks of suspended
product(s) only in exceptional circumstances. If you believe such disposition of existing
stocks of your product(s) which may be suspended for failure to comply with this Notice
should be permitted, you have the burden of clearly demonstrating to EPA that granting
.such permission would be consistent with the Act. You must also explain why an
"existing stocks" provision is necessary, including a statement of the quantity of existing
stocks and your estimate of the time required for their sale, distribution, and use. Unless
you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this
Notice and your product is hi full compliance with all Agency requirements, you will
have, under most circumstances, one year from the date your 90 day response to this
Notice is due, to sell, distribute, or use existing stocks. Normally, the Agency will allow
persons other than the registrant such as independent distributors, retailers and end users
to sell, distribute or use such existing stocks until the stocks are exhausted. Any sale,
distribution or use of stocks of voluntarily cancelled products containing an active
ingredient(s) for which the Agency has particular risk concerns will be determined on
case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period
required by this Notice will not result hi the Agency granting any additional tune to sell,
distribute, or use existing stocks beyond a year from the date the 90 day response was
due unless you demonstrate to the Agency that you are in full compliance with all
Agency requirements, including the requirements of this Notice. For example, if you
decide to voluntarily cancel your registration six months before a 3 year study is
scheduled to be submitted, all progress reports and other information necessary to
establish that you have been conducting the study in an acceptable and good faith manner
must have been submitted to the Agency, before EPA will consider granting an existing
stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE UNREASONABLE
ADVERSE EFFECTS
i& >'
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information
to the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or me environment. This requirement continues as long
as the products are registered by the Agency.
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SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person listed hi Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-In Response Form (Attachment 2) and
a completed Requirements Status and Registrant's Response Form (Attachment 3) and any other
documents required by this Notice, and should be submitted to the contact person identified in
Attachment 1. If the voluntary cancellation or generic data exemption option is chosen, only the
Data Call-In Response Form need be submitted.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated hi response to this Notice.
Sincerely yours,
Daniel M. Barolo, Director
Special Review
and Reregistration Division
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Attachment 1. Chemical Status Sheet
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Mineral Acids DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Callln Notice because you have product(s)
containing mineral acids.
Thijs Generic Data Call-In Chemical Status Sheet, contains an overview of data required
by this notice, and point of contact for inquiries pertaining to the reregistration of mineral acids.
This attachment is to be used hi conjunction with (1) the Generic Data Call-In Notice, (2) the
Generic Data Call-In Response Form (Attachment B), (3) the Requirements Status and
Registrant's Form (Attachment C), (4) a list of registrants receiving this DCI (Attachment D),
(5) the EPA Acceptance Criteria (Attachment E), and (6) the Cost Share and Data Compensation
Forms hi replying to this mineral acids Generic Data Call-In (Attachment F). Instructions and
guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for mineral
acids are contained in the Requirements Status and Registrant's Response. Attachment C. The
Agency has concluded that additional product chemistry data on mineral acids are needed. These
data are needed to fully complete the reregistration of all eligible mineral acids products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Kathryn Scanlon at (703) 308-8178.
All responses to this Notice for the generic data requirements should be submitted to:
Kathryn Scanlon, Chemical Review Manager
Accelerated Reregistration Branch
Special Review and Registration Division (H7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Mineral Acids
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Attachment 2. Generic DCI Response Forms Inserts (Form
A) plus Instructions
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SPECIFIC INSTRUCTIONS FOR THE GENERIC DATA CALL-IN RESPONSE FORM
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."
ftejms 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.
INSTRUCTIONS
Item 1. This item identifies your company name, number and address.
Item 2. This item identifies the ease number, ease name, EPA chemical number
and chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the EPA product registrations relevant to the data
call-in. Please note that you are also responsible for informing the
Agency of your response regarding any product that you believe may be
covered by this data call-in but that is not listed by the Agency in Item 4.
You must bring any such apparent omission to the Agency's attention
within the period required for submission of this response form.
Item 5. Cheek this item for each product registration you wish to cancel
voluntarily. If a registration number is listed for a product for which you
previously requested voluntary cancellation, indicate in Item 5 the date of
that request. You do not need to complete any item on the Requirements
Status and Registrant's Response Form for any product that is voluntarily
cancelled.
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Item 6a. Check this item if this data call-in is for generic data as indicated in Item
3 and if you are eligible for a Generic Data Exemption for the chemical
listed in Item 2 and used in the subject product. By electing this
exemption, you agree to the terms and conditions of a Generic Data
Exemption as explained hi the Data Call-In Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA
, .» registration Number of each registered source of that active ingredient that
you use hi your product.
Typically, if you purchase an EPA-registered product from one or more
other producers (who, with respect to the incorporated product, are in
compliance with this and-any other outstanding Data Call-In Notice), and
incorporate that product into all your products, you may complete this
item for all products listed on this form If, however, you produce the
active ingredient yourself, or use any unregistered product (regardless of
the fact that some of your sources are registered), you may not claim a
Generic Data Exemption and you may not select this item.
Item 6b. Check this Item if the data call-in is a generic data call-in as indicated in
Item 3 and if you are agreeing to satisfy the generic data requirements of
this data call-in. Attach the Requirements Status and Registrant's
Response Form that indicates how you will satisfy those requirements.
Item 7a. Check this item if this call-in if a data call-in as indicated in Item 3 for a
manufacturing use product (MUP), and if your product is a manufacturing
use product for which you agree to supply product-specific data. Attach
the Requirements Status and Registrants' Response Form that indicates
how you will satisfy those requirements.
Item 7b. Check this item if this call-in is a data call-in for an end use product
(EUP) as indicated hi Item 3 and if your product is an end use product for
which you agree to supply product-specific data. Attach the Requirements
Status and Registrant's Response Form that indicates how you will satisfy
those requirements.
Item 8. This certification statement must be signed by an authorized representative
of your company and the person signing must include his/her title.
Additional pages used hi your response must be initialled and dated in the
space provided for the certification.
Item 9. Enter the date of signature.
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Item 10. Enter the name of the person EPA should contact with questions regarding
your response.
Item 11. Enter the phone number of your company contact.
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Attachment 3. Requirements Status and Registrants'
Response Forms Inserts (Form B) plus Instructions
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SPECIFIC INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANTS RESPONSE FORM
Generic Data
This form is designed to be used for registrants to respond to call-in- for generic and
product-specific data as part of EPA's reregistration 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 (1) deletion of uses or (2) request
for a low volume/minor use waiver. These instructions are for completion of generic data
requirements.
EPA has developed this form individually for each data call-in addressed to each registrant, and
has preprinted this form with a number of items. DO NOT use this form for any other active
ingredient.
Items 1 through 8 (inclusive) will have been preprinted on the form. You 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 2070-010?'
Washington, D.C. 20503.
INSTRUCTIONS
Item 1. This item identifies your company name, number, and address.
Item 2. This item identifies the case number, case name, EPA chemical number and
chemical name. .
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the guideline reference numbers of studies required to support
the product(s) being reregistered. These guidelines, in addition to requirements
specified hi the Data Call-In Notice, govern the conduct of the required studies.
Item 5. This item identifies the study title associated with the guideline reference number
and whether protocols and 1, 2, or 3-year progress reports are required to be
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Item 6.,
submitted in connection with the study. As noted in Section III of the Data
Call-In Notice, 90-day progress reports are required for all studies.
If an asterisk appears in Item 5, EPA has attached information relevant to
this guideline reference number to the Requirements Status and
Registrant's Response Form.
This item identifies the code associated with the use pattern of the pesticide. A
brief description of each code follows:
A.
B.
C.
D.
E.
F.
G.
H.
I.
J.
K.
L.
M.
N.
O.
Terrestrial food
Terrestrial feed
Terrestrial non-food
Aquatic food
Aquatic non-food outdoor
Aquatic non-food industrial
Aquatic non-food residential
Greenhouse food
Greenhouse non-food crop
Forestry
Residential
Indoor food
Indoor non-food
Indoor medical
Indoor residential
Item 7.
This item identifies the code assigned to the substance that must be used for
testing. A brief description of each code follows.
EP
MP
MP/TGAI
PAI
PAI/M
PAI/PAIRA
%
PAIRA
PAIRA/M
PAIRA/PM
TEP
TEP *
End-Use Product
Manufacturing-Use Product
Manufacturing-Use Product and Technical Grade
Active Ingredient
Pure Active Ingredient
Pure Active.Ingredient and Metabolites
Pure Active Ingredient or Pure Active Ingredient
Radiolabelled-
Pure Active Ingredient Radiolabelled
Pure Active IngredientRadiolabelled and Metabolites
Pure Active Ingredient Radiolabelled and Plant
Metabolites
Typical End-Use Product
Typical End-Use Product, Percent Active Ingredient
Specified
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TEP/MET Typical End-Use Product and Metabolites
TEP/PAI/M Typical End-Use Product or Pure Active Ingredient
and Metabolites
TGAI/PAIRA Technical Grade Active Ingredient or Pure Active
Ingredient Radiolabelled
TGAI Technical Grade Active Ingredient
TGAI/TEP Technical Grade Active Ingredient or Typical
, f End-Use Product
TGAI/PAI Technical Grade Active Ingredient or Pure Active
Ingredient
MET Metabolites
IMP Impurities
DEGR Degradates
*See: guideline comment
Item 8. This item identifies the tune frame allowed for submission of the study or
protocol identified in item 2. The time frame runs from the date of your receipt
of the Data Call-In Notice.
Item 9. Enter the appropriate Response Code or Codes to show how you intend to comply
with each data requirement. Brief descriptions of each code follow. The Data
Call-In Notice contains a fuller description of each of these options.
1. (Developing Data) I will conduct a new study and submit it within the
time frames specified in item 8 above. By indicating that I have chosen
this option, I certify that I will comply with all the requirements
pertaining to the conditions for submittal of this study as outlined in the
Data Call-in Notice and that I will provide the protocol and progress
reports required hi item 5 above.
2. (Agreement to Cost Share) I have entered into an agreement with one or
• more registrants to develop data jointly. By indicating that I have chosen
this option, I certify that I will comply with all the requirements
pertaining to sharing in the cost of developing data as outlined in the Data
Call-In Notice. .
•"£ * .
3. (Offer to Cost Share) I have made an offer to enter into an agreement with
one or more registrants to develop data jointly. I am submitting a copy of
the form "Certification of Offer to Cost Share hi the Development of
Data" that describes this offer/agreement. By indicating that I have
chosen this option, I certify that I will comply with all the requirements
pertaining to making an.offer to share in the cost of developing data as
outlined hi the Data Call-In Notice.
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4. (Submitting Existing Data) I am submitting an existing study that has
never before been submitted to EPA. By indicating that I have chosen this
option, I certify that this study meets all the requirements pertaining to the
conditions for submittal of existing data outlined in the Data Call-In
Notice and I have attached the needed supporting information along with
this response.
, ,v 5. (Upgrading a Study) I am submitting or citing data to upgrade a study that
EPA has classified as partially acceptable and potentially upgradeable. By
indicating that I have chosen this option, I certify that I have met all the
requirements pertaining to the conditions for submitting or citing existing
data to upgrade a study described hi the Data Call-In Notice. I am
indicating on attached correspondence the Master Record Identification
Number (MRID) that EPA has assigned to the data that I am citing as well
as the MRID of the study I am attempting to upgrade.
6. (Citing a Study) I am citing an existing study that has been previously
classified by EPA as acceptable, core, core minimum, or a study that has
not yet been reviewed by the Agency. I am providing the Agency's
classification of the study.
7. (Deleting Uses) I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
8. (Low Volume/Minor Use Waiver Request) I have read the statements
concerning low volume-minor use data waivers hi the Data Call-In Notice
and I request a low-volume minor use waiver of the data requirement. I
am attaching a detailed justification to support this waiver request
including, among other things, all information required to support the
request. I understand that, unless modified by the Agency in writing, the
data requirement as stated in the Notice governs.
9. (Request for Waiver of Data) I have read the statements concerning data
waivers other than low volume minor-use data waivers in the Data Call-in
Notice and I request a waiver of. the data requirement. I am attaching an
identification of the basis for this waiver and a detailed justification to
support this waiver request. The justification includes, among other
things, all information required to support the request. I understand that,
unless modified by the Agency in writing, the data requirement as stated
in the Notice governs.
Item 10. This item must be signed by an authorized representative of your company. The
person signing must include his/her title, and must initial and date all other pages
of this form.
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Item 11. Enter the date of signature.
Item 12. Enter the name of the person EPA should contact with questions regarding your
response.
Item 13. Enter the phone number of your company contact.
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Attachment 4. List of Registrants) sent this DCI (Insert)
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APPENDIX G. Product Specific Data Call-In
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DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet, to
submit certain product specific data as noted herein to the U.S. Environmental Protection
Agency (EPA, the Agency). These data are necessary to maintain the continued registration of
your product(s) containing this active ingredient. Within 90 days after you receive this Notice
you must respond as set forth in Section III below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments A through G; or
2. Why you believe you are exempt from the requirements listed in this Notice and
in Attachment 3, Requirements Status and Registrant's Response Form, (see
section III-B); or
3. Why you believe EPA should not require your submission of product specific
data in the manner specified by this Notice (see section HI-D)..
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your produces) subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2, Data Call-in Response Form, as well
as a list of all registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
(expiration date 12-31-92).
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This Notice is divided into six sections and seven Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
.Section HI- Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable Adverse
Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - EPA Acceptance Criteria
6 - List of Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms, and Product Specific Data Report
Form
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the data
needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional
generic data requirements are being imposed. You have been sent this Notice because you have
product(s) containing the subject active ingredient.
SECTION H. DATA REQUIRED BY THIS NOTICE
n-A. DATA REQUIRED
The product specific data required by this Notice are specified hi Attachment 3,
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required hi this Notice, additional testing may be required.
n-B. SCHEDULE FOR SUBMISSION OF DATA
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You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided.
H-C. TESTING PROTOCOL
All, Sadies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD
protocols, they should be modified as appropriate so that the data generated by the study will satisfy
the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for complying
with data requirements when the studies were not conducted in accordance with acceptable
standards. The OECD protocols are available from OECD, 1750 Pennsylvania Avenue N W
Washington, D.C. 20006. ' "
All new studies and proposed protocols submitted in response to this Data Call-in Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
n-D- REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)fm NOTTCF.S
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-in does not in anv wav supersede or change the
requirements of any previous Data Call-TnfsV or any other agreements entered into with the Agency
pertaining to such prior Notice. Registrants must comply with the requirements of all Notices to
avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
in-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific data must
be submitted to the Agency within 90 days after your receipt of this Notice. Failure to adequately
respond to this Notice within 90 days of your receipt will be a basis for issuing a Notice of Intent
to Suspend (NOIS) affecting your products. This and other bases for issuance of NOIS due to
failure to comply with this Notice are presented hi Section IV-A and IV-B.
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m-B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or
(c) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option is presented
below., A discussion of the various options available for satisfying the product specific data
requirements of this Notice is contained hi Section IH-C. A discussion of options relating to
requests for data waivers is contained hi Section ffl-D.
There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used hi your response to the Agency. These forms are the Data-Call-in
Response Form, and the Requirements Status and Registrant's Response Form. Attachment 2 and
Attachment 3. The Data Call-In Response Form must be submitted as part of every response to this
Notice. In addition, one copy of the Requirements Status and Registrant's-Response Form must
be submitted for each product listed on the Data Call-In Response Form unless the voluntary
cancellation option is selected or unless the product is identical to another (refer to the instructions
for completing the Data Call-In Response Form hi Attachment 2). Please note that the company's
authorized representative is required to sign the first page of the Data Call-In Response Form and
Requirements Status and Registrant's Response Form (if this form is required) and initial any
subsequent pages. The forms contain separate detailed instructions on the response options. Do not
alter the printed material. If you have questions or need assistance in preparing your response, call
or write the contact person(s) identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your produces) containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must submit a completed Data Call-In
Response Form, indicating your election of this option. Voluntary cancellation is item number 5
on the Data Call-In Response Form. If you choose this option, this is the only form that you are
required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your product
after the effective date of cancellation must be hi accordance with the Existing Stocks provisions
of this Notice which are contained hi Section IVrC.
2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of this Notice. These options are
discussed in Section ni-C of this Notice and comprise options 1 through 6 on the Requirements
Status and Registrant's Response Form and item numbers 7a and 7b on the Data Call-In Response
Form. Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
product specific data requirements.
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3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section III-D of this Notice and are covered by option 7 on the Requirements Status
and Registrant's Response Form. If you choose one of these options, you must submit both forms
as well as any other information/data pertaining to the option chosen to address the data
requirement.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
• •.>
If you acknowledge on the Data Call-In Response Form that you agree to satisfy the product
specific data requirements (i.e. you select item number 7a or 7b), then you must select one of the
six options on the Requirements Status and Registrant's Response Form related to data production
for each data requirement. Your option selection should be entered under item number 9,
"Registrant Response." The six options related to data production are the first six options discussed
under item 9 in the instructions for completing the Requirements Status and Registrant's Response
Form. These six options are listed immediately below with information in parentheses to guide
registrants to additional instructions provided hi this Section. The options are:
(1) I will generate and submit data within the specified time frame (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study)
Option 1. Developing Data - If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein and
in the attachments. All data generated and submitted must comply with the Good Laboratory
Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide Assessment
Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.
The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports. The noted
deadlines run from the date of the receipt of this Notice by the registrant. If the data are not
submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected registration(s).
If you cannot submit the data/reports to the Agency hi the tune required by this Notice and
intend to seek additional time to meet the requirements^), you must submit a request to the Agency
which includes: (1) a detailed description of the expected difficulty and (2) a proposed schedule
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including alternative dates for meeting such requirements on a step-by-step basis. You must explain
any technical or laboratory difficulties and provide documentation from the laboratory performing
the testing. While EPA is considering your request, the original deadline remains. The Agency
will respond to your request in writing. If EPA does not grant your request, the original deadline
remains. Normally, extensions can be requested only hi cases of extraordinary testing problems
beyond the expectation or control of the registrant. Extensions will not be given in submitting the
90-day responses. Extensions will not be considered if the request for extension is not made hi a
timely fashion; hi no event shall an extension request be considered if it is submitted at or after the
lapse of the subject deadline.
Option 2. Agreement to Share in Cost to Develop Data ~ Registrants may only choose this
option for acute toxicity data and certain efficacy data and only if EPA has indicated in the attached
data tables that your product and at least one other product are similar for purposes of depending
on the same data. If this is the case, data may be generated for just one of the products in the
group. The registration number of the product for which data will be submitted must be noted hi
the agreement to cost share by the registrant selecting this option. If you choose to enter into an
agreement to share in the cost of producing the required data but will not be submitting the data
yourself, you must provide the name of the registrant who will be submitting the data. You must
also provide EPA with documentary evidence that an agreement has been formed. Such evidence
may be your letter offering to join hi an agreement and the other registrant's acceptance of .your
offer, or a written statement by the parties that an agreement exists. The agreement to produce the
data need not specify all of the terms of the final arrangement between the parties or the mechanism
to resolve the terms. Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the
agreement they may resolve their differences through binding arbitration.
Option 3. Offer to Share in the Cost of Data Development - This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer
to pay hi an attempt to enter hito an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration^), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general policy,
absent other relevant considerations, it will not suspend the registration of a product of a registrant
who has hi good faith sought and continues to seek to enter into a joint data development/cost
sharing program, but the other registrant(s) developing the data has refused to accept your offer.
To qualify for this option, you must submit documentation to the Agency proving that you have
made an offer to another registrant (who has an obligation to submit data) to share in the burden
of developing that data. You must also submit to the Agency a completed EPA Form 8570-32,
Certification of Offer to Cost Share hi the Development of Data, Attachment 7. In addition, you
must demonstrate that the other registrant to whom the offer was made has not accepted your offer
to enter into a cost sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that offer (such as a certified mail receipt). Your offer must, in addition to
anything else, offer to share hi the burden of producing the data upon terms to be agreed or failing
agreement to be bound by binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must
not qualify this offer. The other registrant must also inform EPA of its election of an option to
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develop and submit the data required by this Notice by submitting a Data Call-in Response Form
and a Requirements Status and Registrant's Response Form committing to develop and submit the
data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your offer
to share in the burdens of developing the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant fails
to devejon the data or for some other reason is subject to suspension, your registration as well as
that of the other registrant will normally be subject to initiation of suspension proceedings, unless
you commit to submit, and do submit the required data in the specified time frame. In such cases,
the Agency generally will not grant a time extension for submitting the data.
Option 4. Submitting an Existing Study - If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed by
this Notice. You may only submit a study that has not been previously submitted to the Agency
or previously cited by anyone. Existing studies are studies which predate issuance of this Notice.
Do not use this option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the required
date of submission. The Agency may determine, at any time that a study is not valid and needs to
be repeated.
To meet the requirements of the.DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data and
specimens from the study are available for audit and review and you must identify
where they are available. This must be done in accordance with the requirements
of the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160. As stated in
40 CFR 160.3(j) " 'raw data' means any laboratory worksheets, records,
memoranda, notes, or exact copies thereof, that are the result of original
observations and activities of a study and are necessary for the reconstruction and
evaluation of the report of that study. In the event that exact transcripts of raw data
have been prepared (e.g., tapes which have been transcribed verbatim, dated, and
verified accurate by signature), the exact copy or exact transcript may be substituted
for the original source as raw data. 'Raw data' may include photographs, microfilm
or microfiche copies, computer printouts, magnetic media, including dictated
observations, and recorded data from automated instruments." The term
"specimens", according to 40 CFR 160.3(k), means "any material derived from a
test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality" control information, pursuant to the
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requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study signed
by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
, ,» Technical Guidance and that the study has been conducted according to the Pesticide
Assessment Guidelines (PAG) or meets the purpose of the PAG (both available from
NTIS). A study not conducted according to the PAG may be submitted to the
Agency for consideration if the registrant believes that the study clearly meets the
purpose of the PAG. The registrant is referred to 40 CFR 158.70 which states the
Agency's policy regarding acceptable protocols. If you wish to submit the study, you
must, in addition to certifying that the purposes of the PAG are met by the study,
clearly articulate the rationale why you believe the study meets the purpose of the
PAG, including copies of any supporting information or data. It has been the
Agency's experience that studies completed prior to January 1970 rarely satisfied the
purpose of the PAG and that necessary raw data are usually not available for such
studies.
If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.
If you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such study is in the Agency's files, you
need only cite it along with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
Option 5. Upgrading a Study — If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement is
not satisfied, you may still be required to submit new data normally without any time extension.
Deficient, but upgradeable studies will normally.be classified, as supplemental. However, it is
important to note that not all studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a study may be upgraded, call or write
the contact person listed in Attachment 1. If you submit data to upgrade an existing study you must
satisfy or supply information to correct all deficiencies in the study identified by EPA. You must
provide a clearly articulated rationale of how the deficiencies have been remedied or corrected and
why the study should be rated as acceptable to EPA. Your submission must also specify the MRID
number(s) of the study which you are attempting to upgrade and must be in conformance with PR
Notice 86-5. . , . „„,
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Do not submit additional data for the purpose of upgrading a study classified as unacceptable
and determined by the Agency as not capable of being upgraded.
This option should also be used to cite data that has been previously submitted to upgrade
a study, but has not yet been reviewed by .the Agency. You must provide the MRID number of
the data submission as well as the MRID number of the study being upgraded.
(The criteria for submitting an existing study, as specified in Option 4 above, apply to all
data submissions intended to upgrade studies. Additionally your submission of data intended to
upgrade studies must be accompanied by a certification that you comply with each of those criteria
as well as a certification regarding protocol compliance with Agency requirements.
Option 6. Citing Existing Studies - If you choose to cite a study that has been previously
submitted to EPA, that study must have been previously classified by EPA as acceptable or it must
be a study which has not yet been reviewed by the Agency. Acceptable toxicology studies
generally will have been classified as "core-guideline" or "core minimum." For all other
disciplines the classification would be "acceptable." With respect to any studies for which you wish
to select this option you-must provide the MRID number of the study you are citing and, if the
study has been reviewed by the Agency, you must provide the Agency's classification of the study.
If you are citing a study of which you are not the original data submitter, you must submit
a completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements. "
Registrants who select one of the above 6 options must meet all of the-requirements
described in the instructions for completing the Data Call-in Response Form and the Requirements
Status and Registrant's Response Form, as appropriate.
III-D REQUESTS FOR DATA WATVF.KS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request, including technical reasons
data and references to relevant EPA regulations, guidelines or policies. (Note: any supplemental
data must be submitted in the format required by PR Notice 86-5). This will be the only
opportunity to state the reasons or provide information hi support of your request If the Agency
^Pp.^% 7°fCTwaiver re
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IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-In Notice, pursuant to
FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task Forces,
failure to comply with the terms of an agreement or arbitration concerning joint data
development or failure to comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted studies,
as required by Section ni-C of this Notice.
7. Withdrawal of an offer to share hi the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or failure
of a registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this Notice
on a Data Call-in Response Form and a Requirements Status and Registrant's
Response Form:
b. fulfill the commitment to develop and submit the data as required by this
Notice; or
c. otherwise take appropriate step's to meet the requirements stated in this
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Notice, unless you commit to submit and do submit the required data in the
specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this. Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required tune) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds for
suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified hi the Data Call-In Notice or other documents incorporated
by reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data
Reporting Guidelines, and GeneTox Health Effects Test Guidelines) regarding the design,
conduct, and reporting of required studies. Such requirements include, but are not limited
to, those relating to test material, test procedures, selection of species, number of animals,
sex and distribution of animals, dose and effect levels to be tested or attained, duration of
test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation of
any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting,
the completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or contained
in PR 86-5. All studies must be submitted in the form of a final report; a preliminary
report will not be considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing stocks
of a pesticide product which has been suspended or cancelled if doing so would be consistent with
the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not be
consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended produces) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may be
suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act. You
must also explain why an "existing stocks" provision' is "necessary, including a statement of the
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quantity of existing stocks and your estimate of the time required for their sale, distribution, and
use. Unless you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell, distribute,
or use existing stocks. Normally, the Agency will allow persons other than the registrant such as
independent distributors, retailers and end users to sell, distribute or use such existing stocks until
the stocks are exhausted. Any sale, distribution or use of stocks of voluntarily cancelled products
containing an active ingredient for which the Agency has particular risk concerns will be
determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result hi the Agency granting any additional tune to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you demonstrate
to the Agency that you are in full compliance with all Agency requirements, including the
requirements of this Notice. For example, if you decide to voluntarily cancel your registration six
months before a 3 year study is scheduled to be submitted, all progress reports and other
information necessary to establish that you have been conducting the study in an acceptable and
good faith manner must have been submitted to the Agency, before EPA will consider granting an
existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any tune after a
pesticide is registered a registrant has additional factual information regarding unreasonable adverse
effects on the environment by the pesticide, the registrant shall submit the information to the
Agency. Registrants must notify the Agency of any factual information they have, from whatever
source, including but not limited to interim or preliminary results of studies, regarding unreasonable
adverse effects on man or the environment. This requirement continues as long as the products are
registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed hi Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-In Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for product
specific data) and any other documents required by this Notice, and should be submitted to the
contact person(s) identified in Attachment. 1. .If. the- voluntary cancellation or generic data
exemption option is chosen, only the Data Call-In Response Form need be submitted.
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The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS),. EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Daniel M. Barolo, Director
Special Review and
Reregistration Division
Attachments
1 -
2 -
3 -
4 -
5 -
6 -
7 -
Data Call-in Chemical Status Sheet
Product-Specific Data Call-In Response Form
Requirements Status and Registrant's Response Form
EPA Grouping of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
EPA Acceptance Criteria
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms, and Product Specific Data Report Form
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248
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Attachment 1. Chemical Status Sheet
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MINERAL ACIDS DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have
produces) containing mineral acids.
This Product Specific Data Call-In Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
mineral acids. This attachment is to be used in conjunction with (1) the Product Specific Data
Call-In Notice, (2) the Product Specific Data Call-In Response Form (Attachment B), (3) the
Requirements Status and Registrant's Form (Attachment C), .(4) EPA's Grouping of End[-]Use
Products for Meeting Acute Toxicology Data Requirement (Attachment D), (5) the EPA
Acceptance Criteria (Attachment E), (6) a list of registrants receiving this DCI (Attachment F)
and (7) the Cost Share and Data Compensation Forms in replying to this mineral acids Product
Specific Data Call[-]In (Attachment G). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for mineral acids are
contained in the Requirements Status and Registrant's Response. Attachment C. The Agency
has concluded that additional data on mineral acids are needed for specific products. These data
are required to be submitted to the Agency within the time frame listed. These data are needed
to fully complete the reregistration of all eligible mineral acids products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of mineral acids, please contact
Kathryn Scanlon at (703) 308-8178.
If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Frank Rubis (703) 308-8184
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Accelerated Reregistration Branch, Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Mineral Acids
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Attachment 2. Product Specific Data Call-In Response
Forms (Form A inserts) Plus Instructions
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252
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INSTRUCTIONS FOR COMPLETING THE "DATA CALL-IN RESPONSE" FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes". If you choose this
option, you will not have to provide the data required by the Data Call-In Notice and
you will not have to complete any other forms. Further sale and distribution of your
. •} product after the effective date of cancellation must be in accordance with the
Existing Stocks provision of the Data Call-In Notice (Section IV-C).
Item 6. Not applicable since this form calls in product specific data only. However, if your
product is identical to another product and you qualify for a data exemption, you
must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide the
EPA reregistration numbers of your source (s); you would not complete the
requirements status and registrant's response" form. Examples of such products
include repackaged products and Special Local Needs (Section 24c) products which
are identical to federally registered products.
Item 7a. For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes." if you are
requesting a data waiver, answer "yes" here; hi 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 hi a signed letter
that accompanies this form. For example, you may wish to report that your product has
already been transferred to another 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.
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Attachment 3. Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and
Instructions
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256
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
Item 1-3. Completed by EPA. Note the unique identifier number assigned by EPA in item 3.
This number must be used in the transmittal document for any data submissions in
response to this Data Call-In Notice.
Item 4. The guidelines reference numbers of studies required to support the product's
, .}. continued registration are identified. These guidelines, in addition to the
; requirements specified in the Notice, govern the conduct of the required studies.
Note that series 61 and 62 in product chemistry are now listed under 40 CFR
158.155 through 158.180, Subpart c.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use patters (s) of the pesticide associated with the product specific requirements
is (are) identified. For most product specific data requirements, all use patterns are
covered by the data requirements. In the case of efficacy data, the required studies
only pertain to products which have the use sites and/ or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except hi rare
cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Documents unless EPA
determines that a longer time period is necessary.
Item 9. Enter Only one of the following response codes for each data requirement to show
how you intend to comply with the data requirements listed hi this table. Fuller
descriptions of each option are contained in the Data Call-In Notice.
1. I will generate and submit data by the specified due date (Developing Data).
By indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined hi
the Data Call-In Notice.
2. I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing). I am submitting a copy of this agreement. I understand that
this option is available on for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this notice that my product is similar. Enough to
another product to qualify for this option. I certify that another party in the
agreement is committing to submit or provide,the required data; if the required study
is not submitted on time, my product, my be .subject to suspension.
3. I have made offers to share hi the cost to develop data (Offers to Cost Share).
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I understand that this option is available only for acute toxicity or certain efficacy
data and only if EPA indicates in an attachment to this Data Call-In Notice that my
product is similar enough to another product to qualify for this option. I am
submitting evidence that I have made an offer to another registrant (who has an
obligation to submit data) to share in the cost of that data. I am also submitting a
completed " Certification of offer to Cost Share in the Development Data" form.
I am including a copy of my offer and proof of the other registrant's receipt of that
offer. I am identifying the parry which is committing to submit or provide the
require data; if the required study is not submitted on time, my product may be
subject to suspension. I understand that other terms under Option 3 in the Data
Call-In Notice (Section m-C.l.) apply as'well.
4. By the specified due date, I will submit an existing study that has not been
submitted previously to the Agency by anyone (submitting an Existing Study). I
certify that this study will meet all the requirements for submittal of existing data
outlined in option 4 in the Data 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 upgrade (upgrading a study).
I will submit evidence of the Agency's review indicating that the study may be
upgraded and what information is required to do so. I will provide the MRID or
Accession number of the study at the due date. I understand that the conditions for
this Option outlined Option 5 in the Data Call-In Notice (Section III-C.l.) apply.
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 option if I am citing
my own data. In either .case, I will provide.the MRID or Accession number (s)
number (s) for the cited data on a "Product Specific Data Report" form or in a
similar format. If I cite another registratrant's data, I will submit a completed
"Certification With Respect To Data Compensation Requirements" form.
7. I request a waiver for this study because it is inappropriate for my product
(Waiver Request). I am attaching a complete justification for this request, including
technical reasons, data and references to relevant EPA regulations, guidelines or
policies. [Note: any supplemental data must,be submitted in the format required by
P.R. Notice 86-5]. I understand that this is my only opportunity to state the reasons
or provide information in support of my request. If the Agency approves my waiver
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£3^M£^^^^^^^«-*"»-
Items 10-13. Self-explanatory.
letter that accompanies this form. ^^^^^^^^^S^^t^ this
are correct.
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Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
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EPA'S BATCHING OF MINERAL ACID PRODUCTS FOR MEETING ACUTE TOXICITY
DATA REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxicity data requirements for reregistration of products containing mineral acids
(phosphoric acid, hydrogen chloride, sodium bisulfate and sulfuric acid) as the active ingredient,
the Agency has batched products which can be considered similar for purposes of acute toxicity.
Factors considered in the sorting process include each product's active and inert ingredients
(identity, .percent composition and biological activity), type of formulation (e.g., emulsifiable
concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal word, use
classification, precautionary labeling, etc.). Note that the Agency is not describing batched
products as "substantially similar" since some products within a batch may not be considered
chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described
in the preceding paragraph. Notwithstanding the batching process, the Agency reserves the right
to require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute toxicological studies to represent all the products within that
batch. It is the registrants' option to participate in the process with all other registrants, only
some of the other registrants, or only their own products within a batch, or to generate all the
required acute toxicological studies for each of their own products. If a registrant chooses to
generate the data for a batch, he/she must use one of the products within the batch as the test
material. If a registrant chooses to rely upon previously submitted acute toxicity data, he/she
may do so provided that the data base is complete and valid by today's standards (see acceptance
criteria attached), the formulation tested is considered by EPA to be similar for acute toxicity,
and the formulation has not been significantly altered since submission and acceptance of the
acute toxicity data. Regardless of whether new data is generated or existing data is referenced,
registrants must clearly identify the test material by EPA Registration Number. If more than one
confidential statement of formula (CSF) exists for a product, the registrant must indicate the
formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow
the directions given in .the Data Call-In Notice and its attachments appended to the RED. The
DCI Notice contains two response.forms.which.are.to be completed and submitted to the Agency
within 90 days of receipt. The first form, "Data Call-in Response," asks whether the registrant
will meet the data requirements for each product. The second form, "Requirements Status and
Registrant's Response," lists the product specific data required for each product, including the
standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide
whether he/she will provide the data or depend on someone else to do so. If a registrant
supplies the data to support a batch of products, he/she must select one of the following options:
Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing
Study (Option 5) or Citing an Existing Study (Option 6),. If a registrant depends on another's
data, he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or
Citing an Existing Study (Option 6). If a registrant does not want to participate in a batch, the
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choices are Options 1, 4, 5 or 6. However, a registrant should know that choosing not to
participate in a batch does not preclude other registrants hi the batch from citing his/her studies
and offering to cost share (Option 3) those studies.
Two hundred and seven products were found which contain mineral acids as the active
ingredient. The products have been placed into twenty-two batches and a "no batch" category
in accordance with the active and inert ingredients, type Of formulation and current labeling.
Tables 1-4 identify the products hi each batch. Table 5 lists the products which have been placed
in the ,"np batch" category.
Table 1
Batch
1
2
3
EPA Reg. No.
1124-69
4170-40
4170-53
5741-3
7378-12
8155-7
10292-18
1072-10
3640-66
4524-27
11715-35
1072-18
1839-153
3862-18
4524-41
4875-10
'% Active Ingredient
Phosphoric acid 20.5
Ammonium chloride 0.25
Phosphoric acid 20.0
Ammonium chloride 0.05
Phosphoric acid 20.0
Ammonium chloride 0.05
Phosphoric acid 25.0
Ammonium chloride 0.05 ,
Phosphoric acid 16.0
Ammonium chloride 0.21
Phosphoric acid 20.0
Ammonium chloride 0.1
Phosphoric acid 20.0
Ammonium chloride 0.1
Phosphoric acid 30.0
Ammonium chloride 10.0
Phosphoric acid 30.0
Ammonium chloride 10.0
Phosphoric acid 30.0
Ammonium chloride 10.0
Phosphoric acid 30.0
Ammonium chloride 10.0
Phosphoric acid 6.8
Nonylphenoxypolyethoxy-ethanol
iodine complex 1.75
Phosphoric acid 5.9
Nonylphenoxypolyethoxy-ethanol
iodine complex 1.75
Phosphoric acid 9.0
Nonylphenoxypolyethoxy-ethanol
iodine complex 1.75
Phosphoric acid 8.0
Nonylphenoxypolyethoxy-ethanol
iodine complex 1.75
Phosphoric- acid "6.5
Nonylphenoxypolyethoxy-ethanol
iodine complex 1.6
Formulation Type
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq.
Li<1
Liq
264
-------
Batch
• *
EPA Reg. No.
7546-13
8616-7
8781-4
9152-20
% Active Ingredient
Phosphoric acid 7.0
Butoxypolypropoxypolyethoxy-
ethanol- iodine complex 16.0
Phosphoric acid 6.0
Nonylphenoxypolyethoxy-ethanol
iodine complex 9.2
Phosphoric acid 6.5
Nony I phenoxypo lyethoxy- ethano I
iodine complex 18.6
Phosphoric acid 6.0
Nonylphenoxypolyethoxy-ethanol
iodine complex 1.75
Formulation Type
Liq
Liq
Liq
Liq
265
-------
Batch
4
, J
5
6
7
EPA Reg. No.
527-121
875-112
1677-138
3276-18
4462-9
4524-30
6931-2
10634-15
25293-1
50600-3
1622-33
1769-244
875-136
875-137
833-58
875-85
5870-34
34859-6
% Active Ingredient
Phosphoric acid 16.0
Nonylphenoxypolyethoxyethanol-
iodine complex 18.0
Phosphoric acid 12.0
Nonylphenoxypolyethoxyethanol-
iodine complex 8.75
Phosphoric acid 15.0.
Nonylphenoxypolyethoxyethanol -
iodine complex 1.75
Phosphoric acid 13.5
Alkyl-omega-hydroxypoly(oxy-
ethylene)- iodine complex 15.7
Phosphoric acid 16.0
Nonylphenoxypolyethoxyethanol-
iodine complex 6.4
Octylphenoxypolyethoxyethanol-
iodine complex 12.6
Phosphoric acid 16.0
Nonylphenoxypolyethoxyethanol-
iodine complex 1.75
Phosphoric acid 15.0
Nonylphenoxypolyethoxyethanol-
iodine complex 20.0
Phosphoric acid 16.0
Nonylphenoxypolyethoxyethanol-
iodine complex 1.75
Phosphoric acid 16.0
Nonylphenoxypolyethoxyethanol-
iodine complex 18.0
Phosphoric acid 16.0
Nonylphenoxypolyethoxyethanol -
iodine complex 18.0
Phosphoric acid 2.5
Nonylphenoxypolyethoxyethanol-
iodine complex 1.4
Phosphoric acid 3.4
Nonylphenoxypolyethoxyethanol-
iodine complex 9.0
Phosphoric acid 56.2
Dodecy I benzene sulfonic acid 3.4
Phosphoric acid 54.6
Dodecy I benzene sulfonic acid 4.5
Isopropanol 10.0
Phosphoric acid 30.0
Dodecylbenzene sulfonic acid 5.0
Phosphoric acid 30.0
Dodecylbenzene sulfonic acid 5.0
Phosphoric acid 30.0
Dodecylbenzene sulfonic acid 5.2
Phosphoric 'acid 30.0
Dodecylbenzene sulfonic acid 5.0
Formulation Type
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
266
-------
Batch
8
9
. i>
10
11
EPA Reg. No.
1677-22
1677-58
1677-150
19713-299
1020-13
1677-56
2686-15
5174-11
6931-4
7546-4
9152-18
1769-228
4959-29
45447-10
% Active Ingredient
• Phosphoric acid 6.5
But oxypo lypropoxypo I yet h oxy-
ethanol-iodine complex 1.75
Phosphoric acid 6.5
But oxypo 1 ypropoxypo I yethoxy-
ethanol- iodine complex 1.75
Phosphoric acid 48.7
Dodecy I benzene sulfonic acid 17.4
Phosphoric acid 48.7
Dodecylbenzene sulfonic acid 17.4
Phosphoric acid 21.0
Dodecylbenzene sulfonic acid 2.75
Phosphoric acid 22.0
Dodecylbenzene sulfonic acid 2.75
Phosphoric acid 20.0
Dodecylbenzene sulfonic acid 5.0
Isopropanol 1.0
Phosphoric acid 23.4
Dodecylbenzene sulfonic acid 3.17
Phosphoric acid 21.0
Phosphoric acid 20.0
Dodecylbenzene sulfonic acid 5.0
Phosphoric acid 22.5
Dodecylbenzene sulfonic acid 5.0
Phosphoric acid 56.9
Dodecylbenzene sulfonic acid 10.7
Isopropanol 10.0
Phosphoric acid 50.0
Dodecylbenzene sulfonic acid 15.0
Phosphoric acid 57.0
Dodecylbenzene sulfonic acid 15.5
Isopropanol 8.5
Formulation Type
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Table 2
Batch
^•i^M^B
12
EPA Reg. No.
^Mf^MH^^^M^MH
99-83
421-349
421-350
675-1
675-8
% Active Ingredient
Hydrogen chloride 23.0
Ammonium chloride 0.05
Hydrogen chloride 27.64
Ammonium chloride 0.2
o-faenzyl p-chlorophenol 0.15
Hydrogen chloride 25.82
Ammonium chloride 0.2
o-benzyl p-chlorophenol 1.0
Hydrogen chloride 23.0
Ammonium chloride 0.05
o-benzyl p-chlorophenol 0.01
Hydrogen chioride 19.0
Ammonium chloride 0.05
Formulation Type
Liq
Liq
Liq
Liq
Liq
267
-------
Bitch
, ,)
EPA Reg. No.
1459-24
1622-35
1839-105
1839-148
3862-89
4170-52
5741-11
6836-84
7378-10
8155-3
8370-2
9367-5
10693-2
39272-2
48211-31
% Active Ingredient
Hydrogen chloride 25.0
Ammonium chloride 0.22
Hydrogen chloride 23.0
Ammonium chloride 0.5
Hydrogen chloride 20.0
Ammonium chloride 1.5
Hydrogen chloride 23.0
Ammonium chloride 0.25
Hydrogen chloride 23.0
Ammonium chloride 0.75
Hydrogen chloride 23.0
Ammonium chloride 0.05
Hydrogen chloride 23.0
Ammonium chloride 0.05
Hydrogen chloride 20.3
Ammonium chloride 0.7
Hydrogen chloride 24.0
Ammonium chloride 0.21
Hydrogen chloride 23.0
Ammonium chloride 0.05
Hydrogen chloride 24.0
Ammonium chloride 0.25
Hydrogen chloride 24.7
Ammonium chloride 0.3
Hydrogen chloride 23.0
Ammonium chloride 0.2
Hydrogen chloride 27.64
Ammonium chloride 0.22
Hydrogen chloride 20.32
Ammonium chloride 0.75
Formulation Type
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Batch
EPA Reg. No.
% Active Ingredient
Formulation Type
13
334-361
421-339
675-34
777-29
1839-104
2230-56
4170-39
Hydrogen chloride 9.0
Ammonium chloride 0.36
Hydrogen chloride 9.49
Ammonium chloride 0.2
Hydrogen chloride 8.0
Ammonium chloride 1.0
Hydrogen chloride 9.5
Ammonium chloride 0.75
Hydrogen chloride 8.0
Ammonium chloride 1.0
Hydrogen chloride 9.5
Ammonium chloride 0.06
Hydrogen chloride 9.0
Ammonium chloride 0.05
Liq
Liq
Liq
Liq
Liq
Liq
Liq
268
-------
Batch
' *
EPA Reg. No.
4170-54
4822-410
5664-18
6836-85
7378-3
8155-4
8325-27
8370-1
9367-36
11694-27
39272-3 .
48211-26
% Active Ingredient
: Hydrogen chl'oride 9.0
Ammonium chloride 0.05
Hydrogen chloride 9.25
Ammonium chloride 0.6
Hydrogen chloride 9.6
Ammonium chloride 1.5
Hydrogen chloride 9.6
Ammonium chloride 0.75
I Hydrogen chloride 7.5
Ammonium chloride 0.6
Hydrogen chloride 9.0
Ammonium chloride 0.05
Hydrogen chloride 8.0
Ammonium chloride 1.0
Hydrogen chloride 8.0
Ammonium chloride 0.25
Hydrogen chloride 9.6
Ammonium chloride 0.75
Hydrogen chloride 9.0
Ammonium chloride 0.2
Hydrogen chloride 9.49
Ammonium chloride 0.22
Hydrogen chloride 9.6
Ammonium chloride 0.75
Formulation Type
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
269
-------
Batch
14
15
, £
16
17
18
EPA Reg. No.
47371-87
47371-172
334-281
4000-70
4000-71
8503-10
257-131
303-61
334-285
491-103
1203-25
1270-29
2155-30
4000-69
15567-1
2528-36
5741-17
257-332
8155-6
X Active Ingredient
Hydrogen chloride 17.75
Ammonium chloride 1.44
Hydrogen chloride 16.5
Ammonium chloride 1.44
Hydrogen chloride 9.45
Hydrogen chloride 9.5
Hydrogen chloride 9.4
Hydrogen chloride 9.8
Hydrogen chloride 23.0
Hydrogen chloride 23.0
Hydrogen chloride 23.7
Hydrogen chloride 24.0
Hydrogen chloride 23.0
Hydrogen chloride 23.0
Hydrogen chloride 24.0
Hydrogen chloride 23.0
Hydrogen chloride 23.0
Hydrogen chloride 9.55
Ammonium chloride 0.2
Hydrogen chloride 9.5
Ammonium chloride 0.5
Hydrogen chloride 9.0
Ammonium chloride 1.2
Hydrogen chloride 9.5
Ammonium chloride 0.1
Formulation Type
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Lid
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Table 3
Batch
19
20
21
EPA Reg. Mo.
777-50
4822-407
475-191
475-198
475-142
475-177
475-225
% Active Ingredient
Sodium bisulfate 62.0
Sodium bisulfate 62.0
Sodium bisulfate 62.0
Sodium bisulfate 62.0
Sodium bisulfate 81.0
Sodium bisulfate 75.0
Sodium bisulfate 81.0
Formulation Type
Solid
Solid
Solid
Solid
Solid
Solid
Solid
270
-------
Table 4
Batch
22
' D*
EPA Reg. No.
567-8
57559-1
62589-1
65878-1
66602-1
67217-1
X Active Ingredient
Sulfuric acid 93.0
Sulfuric acid 93.0
Sulfuric acid 93.0
Sulfuric acid 93.0
Sulfuric acid 93.0
Sulfuric acid 93.0
Formulation Tvoe
Solid
Solid
Solid
Solid
Solid
The following, table lists products that were either, considered not to be similar or the Agency
lacked sufficient information .for decision making and were not placed in any batch. Registrants of these
products are responsible for meeting the acute toxicity data requirements separately for each product.
Table 5 (No Batch)
EPA Reg. No.
52-111
150-61
334-303
402-92
421-237
421-391
475-69
475-195
475-196
475-199
475-350
550-152
602-294
675-39
% Active Ingredient
Hydrogen chloride 0.11
Nonylphenoxypolyethoxyethano 1 -
iodine complex 8.74
Polyethoxypolypropoxyethanol-
iodine complex 9.1
Phosphoric acid 45.0
Dodecylbenzene sulfonic acid 10.6
Hydrogen chloride 9.5
Nonylphenoxypolyethoxyethanol-
iodine complex 3.0
Hydrogen chloride 7.23
Phosphoric acid 24.75
Sulfamic acid 0.5
Ammonium chloride 1.5
Phosphoric acid
Nonylphenoxypolyethoxyethanol-
iodine complex 0.875
Phosphoric acid 25.0
Hydrogen chloride 7.0
Oxalic acid 2.0
Sodium bisulfate 68.0
Sodium bisulfate 50.0
Hydrogen chloride 7.0
Ammonium chloride 0.2
Hydrogen chloride 8.35
Phosphoric acid 30.0
Ammonium chloride 10.0
Phosphoric acid 9.0
Nonylphenoxypolyethoxyethanol-
iodine complex 27.6
Phosphoric acid 0.85 . '". "
Hydrogen peroxide 6.0
Formulation Type
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Solid
Solid
Liq
Liq
Liq
Liq
Liq
271
-------
EPA Reg. No.
833-65
833-66
875-88
875*-90
875-96
875-97
875-100
875-115
875-153
875-156
875-157
875-168
1370-204
1317-68
1677-89
1677-90
1677-95
1677-100
1677-132
1677-152
1769-161
1839-60
1913-12
% Active Ingredient
Phosphoric acid 15.0
Sulfonated oleic acid 5.0
Phosphoric acid 6.5
Nonylphenoxypolyethoxyethanol-
iodine complex 1.75
Hydrogen chloride 5.48
Phosphoric acid 5.2 Iodine 1.75
Phosphoric acid 15.0
Phosphoric acid 15.75
Iodine 1.75
Phosphoric acid 18.75
Iodine 1.75
Phosphoric acid 59.8
Phosphoric acid 0.632
Nonylphenoxypolyethoxyethanol -
iodine complex 17.6
Hydrogen chloride 4.71
Phosphoric acid 22.5
Phosphoric acid 6.0
Nonylphenoxypolyethoxyethanol-
iodine complex 16.7
Potassium iodide 2.0
Hydrogen chloride 12.58
Phosphoric acid 4.49
Phosphoric acid 6.75
Iodine 1.76
Hydrogen chloride 5.5
Phosphoric acid 22.5
Phosphoric acid 22.0
Nonylphenoxypolyethoxyethanol-
iodine complex 18.0
Phosphoric acid 25.0
Polyethoxypolypropoxyethanol-
iodine complex 3.5
Phosphoric acid 23.8
Citric acid 20.0
Phosphoric acid 25.5 ,
Phosphoric acid 17.4
Phosphoric acid 29.3
Polyethoxypolypropoxyethanol -
iodine complex 4.3
Phosphoric acid 37.5
Hydrogen chloride 18.5
Ammonium chloride 1.5
Phosphoric acid 8.5
Ammonium chloride 1.0 '•
Hydrogen chloride 9.25
Ammonium chloride 0.6
Formulation Type
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
„., _ Lic!'
Liq
272
-------
EPA Reg. No.
2230-43
2230-55
2230-58
2344-4
3573-26
3862-119
% Active Ingredient
Hydrogen chloride 10.4
Ammonium chloride 0.42
Phosphoric acid 14.62
Ammonium chloride 0.2
Hydrogen chloride 23.9
Ammonium chloride 0.45
Phosphoric acid 25.73
Dodecylbenzene sulfonic acid 3.36
Hydrogen chloride 15.0
Phosphoric acid 6.0
Ammonium chloride 1.0
/
'Phosphoric acid 20.0
Ammonium chloride 0.05
Formulation Type
Liq
Liq
Liq
Liq
Liq
Liq
EPA Reg. No.
4000-91
4524-22
4822-54
4822-408
4822-409
4959-9
4959-21
4959-23
4959-36
4959-41
4959-42
5197-34
5389-12
5741-23
5813-13
% Active Ingredient
Hydrogen chloride 8.0
Ammonium chloride 2.5
Phosphoric acid 45.0
Hydrogen chloride 14.4
. Sodium bisulfate 75.0
Sodium bisulfate 81.0
Phosphoric acid 40.0
Iodine. 1.6
Phosphoric acid 11.5
Nonylphenoxypolyethoxyethanol-
iodine complex 1.75
Phosphoric acid 15.95
Nonylphenoxypolyethoxyethanol-
iodine complex 1.75
Phosphoric acid 24.7
Polyethoxypolypropoxyethanol-
iodine complex 3.5
Phosphoric acid 8.5
Sulfuric acid 9.5
Propionic acid 10.0
Nonanoic acid 3.0
Phosphoric acid 28.5
. Nonanoic acid 3.0
Propionic acid 10.0
Hydrogen chloride 23.83
Ammonium chloride 0.08
Phosphoric acid 11.25
Dodecylbenzene sulfonic acid 1.0
Phosphoric acid 12.0
Ammonium chloride 0.5
Hydrogen chloride 8.0
Ammonium chloride 0.5
Formulation Type
Liq
Liq
Liq
Solid
Solid
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
273
-------
EPA Reg. No.
••••••••MiiMHB
5991-31
6718-21
6836-39
6836-42
7546-5
8155-19
8370-4
8503-6
10292-10
10292-20
10693-9
10807-105
10807-139
11292-3 .
13215-1
13215-3
15567-4
15567-5
15567-8
35495-14
35900-10
35900-11
47371-86
47371-150
57125-5
X Active Ingredient
•^^^•••••^•ii^^^^^^^^^^^^^^^^^^^^^^^^^
Phosphoric acid 45.0
Dodecylbenzene sulfonic acid 13.73
Sodium bisulfate 74.4
Hydrogen chloride 8.0
Ammonium chloride 2.5
Hydrogen chloride 17.5
Ammonium chloride 2.5
Phosphoric acid 15.0
Ammonium chloride 5.0
Hydrogen chloride 14.5
Phosphoric acid 18.75
Ammonium chloride 0.25
Hydrogen chloride 23.0
Ammonium chloride 0.06
Hydrogen chloride 9.5
Ammonium chloride 0.6
Phosphoric acid 2.0
Hydrogen chloride 6.0
Phosphoric acid 10.0
Nonylphenoxypolyethoxyethanol-
iodine complex 6.4
Hydrogen chloride 9.5
Octylphenoxypolyethoxyethanol-
Hydrogen chloride 9.6
Ammonium chloride 0.75
Hydrogen chloride 21.8
Phosphoric acid 45.0
Hydrogen chloride 18.0
Hydrogen chloride 8.5
Hydrogen chloride 8.5
Hydrogen chloride 14.5
Phosphoric acid 30.0
Dodecylbenzene sulfonic acid 25.6
Phosphoric acid 75.5
Phosphoric acid 0.13
Hydrogen chloride 8.16
Ammonium chloride 1.44
Hydrogen chloride 9.45
Ammonium chloride- 1.44 ••-••-. •-•-""
Hydrogen chloride 14.5
Ammonium chloride 0.1
Formulation Type
•••••••^B
Liq
Solid
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Solid
Liq
Liq
Liq
Liq
liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
Liq
274
-------
EPA Reg. No.
61181-1
% Active Ingredient
Phosphoric acid 6.8 '-'
Iodine 1.75
Formulation Type
.Liq
275
-------
276
-------
Attachment 5. EPA Acceptance Criteria
277
-------
278
-------
SUBDIVISION D
Guideline Study Title
Series 61 Product Identity and Composition
Series 62 Analysis and Certification of Product Ingredients
Series 63 ,\ Physical and Chemical Characteristics
279
-------
61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Name of technical material tested (include product name and trade name, if appropriate).
, ,t
2. Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each
intentionally-added inert ingredient.
3. Name and upper certified limit for each impurity or each group of impurities present at .>. 0.1% by
weight and for certain lexicologically significant impurities (e.g., dioxins, nitrosamines) present at
<0.1%.
4. Purpose of each active ingredient and each intentionally-added inert.
5. Chemical name from Chemical Abstracts index of Nomenclature and Chemical Abstracts Service (CAS)
Registry Number for each active ingredient and, if available, for each intentionally-added inert.
6. Molecular, structural, and empirical formulas, molecular weight or weight range, and any company
assigned experimental or internal code numbers for each active ingredient.
7. Description of each beginning material in the manufacturing process.
EPA Registration Number if registered; for other beginning materials, the following:
Name and address of manufacturer or supplier.
Brand name, trade name or commercial designation.
Technical specifications or data sheets by which manufacturer or supplier describes composition,
properties or toxicity.
8. Description of manufacturing process.
Statement of whether batch or continuous process.
Relative amounts of beginning materials and order in which they are added.
Description of equipment.
Description of physical conditions (temperature, pressure, humidity) controlled in each step and
the parameters that are maintained.
Statement of whether process involves intended chemical reactions.
Flow chart with chemical equations for each intended chemical reaction.
Duration of each step of process.
Description of purification procedures.
Description of measures taken to assure quality of final product.
9. Discussion of formation of impurities based on established chemical theory addressing (1) each impurity
which may be present at >, 0.1% or was found at >_ 0.1% by product analyses and (2) certain
lexicologically significant impurities (see #3).
280
-------
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 lexicologically
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.
281
-------
63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered.
Docs your study meet the following acceptance criteria?
63-2 Color %
' Verbal description of coloration (or lack of it)
Any intentional coloration also reported in terms of Munsell color system
63-3 Physical State
Verbal description 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 such as "garlic-like, characteristic of aromatic
compounds"
Observed at room temperature
63-5 Melting Point
Reported in °C
Any observed decomposition reported
63-6 Boiling Point
Reported in °C
Pressure under which B.P. measured reported
Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25° C
Density of technical grade active ingredient reported in g/ml or the specific gravity of liquids reported
With reference to water at 20° C. [Note: Bulk density of registered products may be reported in lbs/ft3
or Ibs/gallon.]
63-8 Solubility
Determined in distilled water and representative polar and non-polar solvents, including those used hi
formulations and analytical methods for the pesticide
Measured at about 20-25° C
Reported in g/100 ml (other units like ppm acceptable if-sparingly soluble)
63-9 Vapor Pressure
Measured at 25° C (or calculated by extrapolation from measurements made at higher temperature if
pressure too low to measure at 25° C)
Experimental procedure described
Reported in mm Hg (ton) or other conventional units
63-10 Dissociation Constant
Experimental method described
282
-------
Temperature of measurement specified (preferably about
20-25 °C)
63-11 Octanol/water Partition Coefficient
Measured at about 20-25° C
Experimentally determined and description of procedure provided (preferred method-45 Fed. Register
77350)
Data supporting reported value provided
63-12 pH j
' Measured at about 20-25° C
Measured .following dilution or dispersion in distilled water
63-13 Stability
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined
283
-------
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 hi the Rabbit
81-5 , Primary Dermal Irritation Study
81-6 Dermal Sensitization in the Guinea Pig
284
-------
81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At feast 5 young adult rats/sex/group.
3. bo'sing, single oral may be administered over 24 hrs.
4." Vehicle control if other than water.
5. Doses tested, sufficient to determine a toxicity category or a limit dose (5000 mg/kg).
6. Individual observations at least once a day.
7. Observation period to last at least 14 days, or until all test animals appear normal whichever is longer.
8. Individual daily observations.
9. Individual body weights.
10. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
285
-------
81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Fig
ACCEPTANCE CRITERIA
Docs your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. A^ least 5 animals/sex/group.
3.* Rats 200-300 gm, rabbits 2.0-3.0 kg or guinea pigs 350-450 gm.
4. Dosing, single dermal.
5. Dosing duration at least 24 hours.
6.* Vehicle control, only if toxicity of vehicle is unknown.
7. Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg).
8. Application site clipped or shaved at least 24 hours before dosing.
9. Application site at least 10% of body surface area.
10. Application site covered with a porous nonirritating cover to retain test material and to prevent
ingestion.
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study. '
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81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use
'orcontains particles of inhalable size for man (aerodynamic diameter 15 urn or less).
3. At least 5 young adult rats/sex/group.
4. Dosing, at least 4 hours by inhalation.
5. Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
6. Chamber temperature, 22° C (±2°), relative humidity 40-60%.
7. Monitor rate of air flow.
8. Monitor actual concentrations of test material in breathing zone.
9. Monitor aerodynamic particle size for aerosols.
10. Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of
respirable substance).
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
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81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Docs your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive, causes severe
dermal irritation or has a pH of <2 or >11.5.
3. 6 adult rabbits.
4. Dosing, instillation into the conjunctiva! sac of one eye
per animal.
5. Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or paniculate substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24 hours.
8. Eyes examined and graded for irritation before dosing and
at 1, 24, 48 and 72 hr, then daily until eyes are normal
or 21 days (whichever is shorter).
9.* Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
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81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a pH of <2 or J>_11.5.
3. 6 adult animals.
4. Dosing, single dermal.
5. Dosing duration 4-hours.
6. Application site shaved or clipped at least 24 hours prior to dosing.
7. Application site approximately 6 cm2.
8- Application site covered with a gauze patch held hi place with nonirritating tape.
9. Material removed, washed with water, without trauma to application site.
10- Application site examined and graded for irritation at 1, 24, 48 and 72 hr, then daily until normal or 14
days (whichever is shorter).
11.* Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
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81-6 Dermal Sensitization in the Guinea Fig
ACCEPTANCE CRITERIA
Docs your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a
pH o(.<2 or >11.5.
3. One of the following 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.
4. Complete description of test.
5.J Reference for test.
6. Test followed essentially as described in reference document.
7. Positive control included (may provide historical data conducted within the last 6 months).
Criteria marked with an * are supplemental and may not be required for every study.
290
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Attachment 6. List of All Registrants Sent This Data Call-In (insert)
Notice
291
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292
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Attachment 7. Cost Share Data Compensation Form, and Confidential
Statement of Formula Form
293
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed
copies of the form are required. Following are basic instructions:
a. All the blocks on the form must be filled hi and answered completely.
.*
b^ ,11 If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible party
must be provided.
d. All applicable information which is on the product specific data submission must
also be reported on the CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids.
f. Flashpoint must be in degrees Fahrenheit and flame extension in niches.
g. For all active, ingredients, the EPA Registration Numbers for the currently
registered source products must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
common names for the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be
reported under column 10 and must be exactly the same as on the source
product's label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or
grams. In no case will volumes be accepted. Do not mix English and metric
system units (i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must represent
pure active form.
m. The upper and lower certified limits for ail active and inert ingredients must
follow the 40 CFR 158.175 instructions. An explanation must be provided if the
proposed limits are different than standard certified limits.
n. When new CSFs are submitted and approved, all previously'submitted CSFs
become obsolete for that specific formulation.
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unmo stat., Enviroomtntal Prottctlon Agtnly
EPA
Washington. DC 2046O
WITH RESPECT TO
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300
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APPENDIX A. MEMORANDUM OF UNDERSTANDING
BETWEEN THE FOOD AND DRUG ADMINISTRATION,
PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH
AND HUMAN SERVICES AND THE ENVIRONMENTAL
PROTECTION AGENCY
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Memorandum of Understanding
Between
The Food and Drug Administration, Public Health Service,
Department of Health and Human Services
and
The Environmental Protection Agency
Notice Regarding Matters of Mutual Responsibility - Regulation of Liquid Chemical Germicides Intended
for Use on Medical Devices
I. PURPOSE
This Memorandum of Understanding (MOU) between the Food and Drug Administration (FDA) and the
Environmental Protection Agency (EPA) clarifies jurisdiction between the two agencies in the regulation
of certain liquid chemical germicides. These liquid chemical germicides are devices under the Federal
Food, Drug, and Cosmetic Act (FD&C Act) and pesticides under the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA). This MOU also embodies the agreement of the two agencies to undertake certain
rulemakings hi order to eliminate duplicative regulation of certain types of liquid chemical germicides. This
MOU includes the agencies' interim agreement to simplify and coordinate their regulatory and enforcement
activities hi shared areas of jurisdiction affecting these types of products pending the conclusion of these
rulemakings.
H. STATUTORY AUTHORITIES
A. FDA Authorities
The FD&C Act grants FDA authority to regulate devices as defined in 21 U.S.C. §321(h). Under section
321(h), the term "device" includes an instrument, apparatus, implement, machine, contrivance, implant,
in vitro reagent, or other similar or related article, including any component, part, or accessory that is
intended to cure, mitigate, treat, or prevent disease in man, or is intended to affect the structure or any
function of the body of man. Liquid chemical germicides intended for use in conjunction with a variety of
articles that fit within the statutory definition of "device," such as operating instruments, medical examining
tables, hospital scales, and other hospital equipment, also fall within the definition of "device", because
they are considered accessories to these devices.
Unless liquid chemical germicides used hi conjunction with devices were commercially distributed prior
to May 28, 1976,1 manufacturers of these products, under 21 U.S.C. §360(k) [section 510(k) of the
FD&C Act] are required to submit a premarket notification to FDA before they market their products.
Before these products can be legally marketed, FDA must grant marketing clearance by (1) issuance of an
order in response to a section 510(k) submission which exempts the device from the FD&C Act's premarket
approval requirements, or (2) approval of a premarket approval application. In granting marketing clearance
by issuance of a section 510(k) order exempting a liquid chemical germicide from premarket approval,
FDA must find that the device is "substantially equivalent," as the term is defined in 21 U.S.C.
§360c(i)(l)(A), to a predicate device that does not require premarket approval. Section 513 of the FD&C
Act authorizes FDA to exempt products from premarket notification requirements for which there is a
1 Devices marketed prior to May 28, 1976 are grandfathered from the FD&C Act's
premarket notification requirements. Neither FDA nor EPA are aware of any currently
marketed products that are exempt under this grandfather provision. Should any exist, they are
not covered by this Memorandum of Understanding.
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reasonable assurance of safety and effectiveness. At present, no chemical germicides that are used with
devices have been exempted from premarket notification requirements.
In regulating liquid chemical germicides used with devices, FDA is exercising its responsibilities under the
FD&C Act for ensuring that devices are safe and effective for their intended uses. The FD&C Act provides
enforcement authority to FDA to pursue regulatory actions, including seizure, injunction, prosecution, and
civil penalties.
B. EPA Authorities
Liquid chemical germicides, including those regulated as devices, are also under the authority of the EPA
under FEFRA. Before a pesticide product may be lawfully sold or distributed in commerce, the product
must be registered by EPA pursuant to FIFRA section 3, or otherwise exempted from the requirements of
FIFRA. A registration is a license allowing a pesticide product to be sold and distributed for specified uses
in accordance with specified use instructions, precautions, and other terms and conditions. Liquid chemical
sterilants are included among the various types of antimicrobial products that are currently subject to
FIFRA.
A pesticide product may be registered or remain registered only if it meets the statutory standard for
registration. Among other things, a pesticide must perform its intended pesticidal function without causing
"unreasonable adverse effects on the environment" (FIFRA section 3(c)(5)). "Unreasonable adverse effects
on the environment" is defined as "any unreasonable risk to man or the environment, taking into account
the economic, social, and environmental costs and benefits of the use of [the] pesticide" (FIFRA section
2(bb)).
The burden of demonstrating that a pesticide product satisfies the statutory criteria for registration is at all
times on the proponents of initial or continued registration. FIFRA section 6 provides EPA with various
regulatory tools that the Administrator may use if it appears that the product no longer satisfies the statutory
criteria for registration. If appropriate, EPA may require modifications to the terms and conditions of
registration, such as deletion of particular uses or revisions to labeling, as an alternative to regulatory
outcomes such as cancellation, suspension, or emergency suspension. FIFRA also provides enforcement
authority to EPA to pursue actions, including issuance of stop sale, use, or removal orders when there is
reason to believe a pesticide is in violation of FIFRA. Additionally, EPA has authority to seek the
assessment of civil administrative penalties as well as institute seizure and criminal actions for violations
of FIFRA.
FIFRA section 25(b) authorizes the Administrator to exempt pesticides from FIFRA through regulation if
the Administrator determines that the pesticide is "adequately regulated by another Federal agency" or is
"of a character which it is unnecessary to be subject to this Act hi order to carry out the purposes of this
Act." '
m. REGULATORY RESPONSIBILITIES AND DEFINITIONS
For the purposes of this agreement, liquid chemical germicides that are used in conjunction with medical
devices are divided into two product categories: (1) sterilants and (2) general purpose disinfectants.
Sterilants, for purposes of this agreement, means those chemical germicides used to reprocess reusable
critical and semicritical devices2. Critical devices are devices that are introduced directly into the human
2
This definition is consistent with the definition of these terms used by the Centers for
Disease Control and Prevention (CDC). Block, S.S. 1991. Disinfection, Sterilization and-
Preservation. 4th Edition. Philadelphia, Lea & Febiger.
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body, either into or in contact with the bloodstream or normally sterile areas of the body. These critical
devices must be sterile. Semicritical devices are those which contact intact mucous membranes but which
do not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body. For these
devices, sterilization is desirable but not mandatory. These devices must be subjected at least to a high level
disinfection3 process using a sterilant, but for a shorter time than that required for sterilization.
The second category of liquid chemical germicides are general purpose disinfectants. General purpose
disinfectants, for purposes of this agreement, means those chemical germicides used to reprocess noncritical
devices and medical equipment surfaces4. Noncritical devices and medical equipment surfaces must be
subjected to intermediate or low level disinfection5.
FDA's priority is to confirm the efficacy and safety of sterilants used to reprocess critical and semicritical
devices which pose the greatest risk of disease transmission. This includes assuring that they do not
adversely affect device performance or pose a hazard to the patient/user. Historically, EPA has assessed
the effective performance of all chemical germicides and addressed health and safety issues their use.
The FD&C Act and FIFRA have overlapping regulatory schemes for liquid chemical germicides used on
devices. The objective of this MOU is to minimize redundant regulation of these products by FDA and
EPA while assuring that the safety and efficacy requirements of both statutes are met. This affects
three areas: data requirements for obtaining approval, procedures for obtaining approval, and compliance.
In determining whether the FD&C Act's and FIFRA's statutory and regulatory requirements are met, EPA
and FDA will utilize the data requirements and performance standards referenced hi FDA's current
Guidance on the Content and Format of Premarket Notification Submission for Liquid Chemical
Germicides, FDA premarket notification regulations at 21 CFR Part 807, Subpart E, EPA data
requirements regulations at 40 CFR Part 158, and EPA's Subdivision G, Product Performance Guidelines.
Since the EPA registration requirements for general purpose disinfectants parallel the requirements
necessary to receive marketing clearance for general purpose disinfectants under section 510(k) of the
FD&C Act, fulfillment of EPA's registration requirements fulfills FDA's section 510(k) requirements for
those products.
The EPA efficacy data requirements for liquid chemical sterilants, including those with high level
disinfectant uses, are fulfilled by FDA's section 510(k) requirements or premarket approval requirements
Therefore, premarket clearance by FDA fulfills certain EPA registration requirements for liquid chemical
sterilants, insofar as efficacy and product performance are concerned. FDA premarket clearance does not
satisfy EPA's chemistry, toxicology^ and ecological effects requirements.
IV. AGREEMENT
•—j »- -
3 "High level disinfectant" and "high level disinfection" are terms of are used by the public
health community. FDA recognizes "high level disinfectant" as a separate or subcategory of
sterilants. EPA does not register "high level disinfectants" as separate antimicrobial pesticides,
but instead may register uses of germicides that correspond with uses hi FDA's "high level
disinfection" category.
4 This definition is consistent with the definition of the temi'used by CDC.
5 "Low and intermediate level disinfectants" are terms of art used by the public health
community. FDA recognizes "low and intermediate level disinfection" as subcategories of
general purpose disinfectants. EPA does not register low level and intermediate level
disinfectants, but has corresponding germicide classes.
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iiie Administrator of the Environmental Protection Agency and the Commissioner of the Food and Drug
Administration agree that until exemptions referred to in Section V occur, the following division of
responsibility will govern the activities of the agencies in the regulation of liquid chemical germicides that
are intended for use on devices:
A. Regulatory Responsibilities
1. FDA will be primarily responsible for the premarket review of safety and efficacy requirements for
liquid chemical germicides that are sterilants6 intended for use on critical or semicritical devices.
Examples of critical devices are laparoscopes, surgical instruments, heart-lung oxygenators, and
transfer forceps. Examples of semicritical devices are gastrointestinal endoscopes, endotracheal
tubes, cystoscopes, anesthesia breathing circuits, and vaginal specula. FDA will also be primarily
responsible for premarket review of contact lens solutions.
2. EPA will be primarily responsible for premarket review of liquid chemical germicides that are
general purpose disinfectants7 intended for use on devices other than critical or semicritical devices.
Examples of noncritical devices are wheel chairs, medical beds, stands, certain operating room
surfaces, medical lamps, dental units, and stethoscopes.
3. FDA marketing clearance through the section 510(k) process or approval through the premarket
approval process of sterilants will satisfy certain requirements for registration under FIFRA Section
3. Upon submission to EPA by the applicant of an order issued by FDA granting marketing
clearance or approval for a liquid chemical germicide that is a sterilant, EPA will consider the
efficacy data requirements for registration to be satisfied, and will promptly determine whether the
other requirements for registration are satisfied.
4. EPA registration of liquid chemical germicides that are used as disinfectants for devices, except
sterilants, will satisfy the criteria necessary to .establish substantial equivalence as defined in 21
U.S.C. §360c(i)(l)(A). For this category of liquid chemical germicides, submission by the
manufacturer to FDA of a copy of the EPA correspondence granting registration will satisfy FDA's
requirement for a premarket notification under 21 U.S.C. §360(k). Upon receipt of this information
from the manufacturer of a liquid chemical germicide in this category, FDA will issue an order
finding the product substantially equivalent to a predicate device that does not require premarket
approval. This order will allow the device to be legally marketed without an approved FDA
premarket approval application.
5. As part of the EPA registration process, EPA will require registrants of liquid chemical germicides
other than sterilants that have received FDA premarketing clearance or approval to put the
following statement on their product labels:
6 If a liquid chemical sterilant product has subordinate claims such as tuberculocidal or
virucidal, these claims also will be regulated by FDA.
7 Procedures described in Paragraph 4 only apply to liquid chemical germicide products that
do not contain any. sterilant claims. If a liquid chemical germicide product contains both
sterilant and general purpose disinfectant claims, registration will proceed according to the
procedures described in Paragraph 3. If the registrant of a general purpose disinfectant product
registered by EPA subsequently applies for registration of a sterilant claim, registration of that
product must proceed under procedures described in Paragraph 3 and the existing EPA
registration will become void upon FDA's clearance of the product.
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This product is not to be used on any surface or instrument that (1) is introduced directly
into the human body, either into or in contact with the bloodstream or normally sterile areas
of the body, or (2) contacts intact mucous membranes but which does not ordinarily
penetrate the blood barrier or otherwise enter normally sterile areas of the body."
B. Compliance Responsibilities
1. FDA will be responsible for all sampling and all efficacy testing of liquid chemical sterilants
intended for use on critical and semicritical devices and for instituting appropriate enforcement
and/or regulatory action against any products that do not comply with the FD&C Act.
Upon request, EPA will provide FDA with copies of the latest accepted labeling and the name and
location of the production site for each product FDA intends to sample.
n voi 1 U-S'C- § 331j' 21 U'S-C- §36°MC>> 42 U.S.C. §263g(d), 42
U.S.C. 263i(e), and 21 C.F.R. Part 20, FDA will share all safety and efficacy test results labeling
changes, and upon EPA request, any other information obtained during FDA enforcement/regulatory
actions relating to liquid chemical sterilants. EPA may use this information to determine whether
the registrant has complied with FIFRA. On the basis of this information, EPA may determine that
further regulatory action under FIFRA, including cancellation of the product's registration is
warranted. '
2. EPA will be responsible for the sampling and efficacy testing of all general purpose chemical
germicides that are intended for use on devices other than critical and semicritical devices and for
instituting appropriate enforcement and/or regulatory action against any such chemical germicide
that does not comply with FIFRA. EPA will refer labels and other evidence concerning inefficacious
liquid chemical germicides intended for use on medical devices other than critical or semicritical
to bDA for complementary action under the FD&C Act.
3 . Each agency will provide assistance upon request to support compliance activities and litigation by
the other Agency in cases involving liquid chemical germicides that are intended for use on devices
Assistance will be requested in accordance with applicable procedures, statutory and regulatory
- requirements including compliance with regulations of 21 CFR Part 20, through the liaison officers
listed below. Assistance may include provision of sampling, inspection and audit data exoert
witnesses, certified statements, and affidavits. '
Each Agency may consult with the other at any time to determine if the initiation of regulatory
and/or enforcement action against a liquid chemical germicide in lieu of or concurrently with the
other agency's action is appropriate.
This Memorandum of Understanding has no effect on any pending investigations or enforcement
or regulatory actions undertaken by EPA pursuant to FIFRA or by FDA pursuant to the FD&C Act.
C. Coordination of Activities
To ensure the continued coordinated regulatory, compliance, and enforcement activities for liquid chemical
nfrCFPA'ntep 6T?n deViCeS' an EPA/FDA ^teragency committee is established. The Directors
of the EPA s Registration Division and the Compliance- Division, Office of Prevention Pesticides aM
Toxic Substances and of FDA's Center for Devices and Radiological Health, Office o? Compute a^d
SurveiUance will serve as joint chairpersons who will designate their respective agency members of foe
committee. The committee will meet at a minimum of twice each fiscal year.
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V. FUTURE RULEMAKINGS TO ELIMINATE DUPLICATIVE AGENCY REVIEW
EPA will initiate a rulemaking proceeding under section 25(b) of FIFRA to exempt liquid chemical sterilant
products from regulation under FIFRA. EPA believes that the efficacy data requirements and product
performance standards for liquid chemical sterilants are fulfilled by FDA's section 510(k) requirements or
premarket approval requirements. When such exemption becomes effective, FDA and EPA will cease to
follow procedures described hi Paragraph IV, A. 3. and these products will be subject solely to the
regulatory and enforcement requirements and procedures of FDA, and EPA will no longer register such
products. To the extent EPA receives information regarding such products, it will share such information
with FDA.
FDA wilj initiate a rulemaking proceeding to classify liquid chemical germicides used on devices under
section 513 of the FD&C Act. FDA believes that EPA's requirements under FIFRA for liquid chemical
germicides that are intended for use on medical devices that are not critical or semicritical devices parallel
the FD&C Act's requirements under section 510(k) of the Act. Accordingly, FDA will recommend to its
classification advisory panel that liquid chemical germicides intended for use on devices that are not critical
or semicritical devices be exempted from premarket notification requirements under section 510(k) of the
FD&C Act. When any such exemption becomes effective, FDA and EPA will cease to follow the
procedures in paragraph IV. A. 4. To the extent FDA obtains any information regarding such products,
it will share the information with EPA.
VI. NAME AND ADDRESS OF PARTICIPATING PARTIES
A. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
B. Environmental Protection Agency
401 M Street, S.W.
Washington, D.C. 20460
Vn. LIAISON OFFICERS
A. For the Food and Drag Administration
Sterilization and Toxicology Project Officer
(currently: Dr. Virginia Chamberlain)
Office of Compliance and Surveillance
Center for Devices and Radiological Health
1390 Piccard Drive
Rockville, MD 20850
Telephone: (301)427-1131
For the Environmental Protection Agency:
Antimicrobial Program Branch Chief
(currently: Juanita Wills)
Registration Division
Antimicrobial Program Branch (H7505C)
401 M Street, S.W.
Washington, DC 20460
• Telephone: (703) 305-6661
"•
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VIII. PERIOD OF AGREEMENT
This agreement becomes effective upon acceptance by both parties. It may be modified by
mutual written consent or terminated by either party upon a thirty (30) day advance written
notice to the other party. The parties agree to evaluate the agreement every three (3) years, at
which time either party would have the option of renewing, modifying, or canceling the
agreement.
AKO ACCEPTED FOR TK£ APPROVED AND ACCEPTED FOR THE
ENVIRONMENTAL PROTECTION AGENC* FOOD AND D3UG ADKINISTBATIOK
3*1 tl e Acting Ass^gfaat frlwinfflcrator Ti Cl e Associate Camssioner for Rggul ato:
Date June U~ 1993 _ Date June 4. 1993
309
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