Structured Product Labeling (SPL)
Draft Implementation Guide with
Validation Procedures and User Guide
(DRAFT)
** This is a draft document. Its purposes are not intended
for use of building an XML Schema document for later
submission to EPA. **
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Table of Contents
1	Introduction	8
1.1	Organization	8
1.2	Document Information (Package Information Section)	9
1.3	Document ID Numbering	9
1.4	Validation Procedures	9
2	Overview of SPL Technical Conformance Criteria	11
2.1	HL7 SPL Header	11
2.1.0	General	11
2.1.1	XML References	11
2.1.2	Document Information	12
2.1.3	Author Information	13
2.2	HL7 SPL Body	14
2.2.0	General	14
2.2.1	Sections and Subsections	14
2.2.2	Document Inputs	16
3	Pesticide Product Label	23
3.1	Pesticide Product Labeling SPL Header	23
3.1.0	Section in General	23
3.1.1	Document Type	23
3.1.2	Author Information	23
3.2	Pesticide Product Labeling SPL Body	24
3.2.0	Section in General	24
3.2.1	Pesticide Product Label sections in General	25
3.3	Restricted Use Pesticide (RUP) Section	26
3.3.0	Section in General	26
3.3.1	RUP Statement (Section Text)	26
3.4	Ingredient Statement Section	26
3.4.0	Section in General	26
3.4.1	Ingredient Statement (Section Text)	26
3.4.2	Identified Inert Statement Sub-Section (3565732)	28
3.4.3	Deterioration/Expiration Statement Sub-Section (3144196)	29
3.5	Child Hazard Warning/Signal Word Section	29
3.5.0	Section in General	29
3.5.1	Child Hazard Warning/Signal Word Statement (Section Text)	29
3.6	Product Profile	31
3.6.0	Section in General	31
3.6.1	Product Profile Statement (Section Text)	31
3.7	Precautionary Statements	34
3.7.0	Section in General	34
3.7.1	First Aid (3144200)	 35
3.7.2	Hazards to Humans and Domestic Animals (3144205)	 35
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3.7.3	Personal Protective Equipment (PPE) (3144206)	 36
3.7.4	Engineering Controls Statement (3144207)	 36
3.7.5	User Safety Requirements (3144208)	 37
3.7.6	User Safety Recommendations (3144209)	 38
3.7.7	Environmental Hazards (3144210)	 38
3.7.8	Physical and Chemical Hazards (3144212)	 39
3.8	Directions for Use	39
3.8.0	Section in General	39
3.8.1	Directions for Use Statement (Section Text)	39
3.8.2	Agricultural Use Requirements (3144215)	40
3.8.3	Non Agricultural Use Requirements (3144216)	41
3.8.4	Resistance Management (3144217)	41
3.8.5	Spray Drift (314423 0)	42
3.8.6	Rotational Crop Intervals (3144229)	42
3.8.7	Seed Bag Labeling Requirements (3144214)	43
3.8.8	Storage and Disposal Subsection (3144244)	43
3.8.9	Product Application Instructions/Information Subsection (3144218)	44
3.8.10	Use Site Application Instructions Subsection	45
3.9	Warranty/Disclaimer Statement	50
3.9.0	Section in General	50
3.9.1	Warranty and Disclaimer Statement (Section Text)	50
3.10	Marketing/Advertising Claims	50
3.10.0	Section in General	50
3.10.1	Marketing and Advertising Claims Statement (Section Text)	50
3.11	Additional Documentation and Labeling	52
3.11.0 Section in General	52
4 Use Index	54
4.1	Use Index SPL Header	54
4.1.0	Section in General	54
4.1.1	Document Type	54
4.1.2	Author Information	55
4.2	Use Index SPL Body	56
4.2.0	Section in General	56
4.2.1	Use Index Sections	57
4.3	Product Level	59
4.3.0	Section in General	60
4.3.1	Product Identification	60
4.3.2	Product Level Use Restrictions/Limitations	64
4.4	Site Level (+)	96
4.4.0	Section in General	96
4.4.1	Use Site Attributes	97
4.4.2	Use Site Yearly/Crop Cycle Rate (+)	99
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4.4.3 Use Site Level Restrictions/Limitations (+)	102
4.5 S cenari o Level (+)	135
4.5.0	Section in General	135
4.5.1	ScenarioRate	135
4.5.2	Scenario Attributes	149
4.5.3	Use Scenario Level Restrictions/Limitations	154
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Table of Figures
Figure 1: XML References XML Code Snippet	12
Figure 3: Author Information XML Code Snippet	13
Figure 4: SPL Body XML Code Snippet	14
Figure 5: Sections XML Code Snippet	14
Figure 6: Section Text XML Code Snippet	14
Figure 7: Sub-Section XML Codes Snippet	15
Figure 8: Section Text XML Snippet	16
Figure 9: Font Effects XML Snippet	17
Figure 10: Font Effects (Continued) XML Snippet	17
Figure 11: Font Effects (Continued 2) XML Snippet	17
Figure 12: List XML Code Snippet	19
Figure 13: Recent Major Change in Text Example XML Code Snippet	21
Figure 14: Images XML Code Snippet	22
Figure 15: Pesticide Product Label Document Type XML Code Snippet	23
Figure 16: Product Labeling Author Information XML Code Snippet	24
Figure 17: Pesticide Product Label Sections in General Code Snippet	25
Figure 18: RUP Section XML Code Snippet	26
Figure 19: Active Ingredient XML Code Snippet	28
Figure 20: Identified Inert Statement Sub-section XML Code Snippet	29
Figure 21: Deterioration/Expiration Statement XML Code Snippet	29
Figure 22: Child Hazard Warning/Signal Word XML Code Snippet	31
Figure 23: Product Profile XML Code Snippet	34
Figure 24: Precautionary Statements XML Code Snippet	35
Figure 25: FIRST Aid Sub-Section XML Code Snippet	35
Figure 26: Hazards to Humans and Domestic Animals Sub-Section XML Code Snippet
	36
Figure 27: PPE Sub-Section XML Code Snippet	36
Figure 28: Engineering Controls Statement Sub-Section XML Code Snippet	37
Figure 29: User Safety Requirements Code Snippet	37
Figure 30: Use Safety Recommendations XML Code Snippet	38
Figure 31: Environmental Hazards Sub-section XML Code Snippet	39
Figure 32: Physical and Chemical Hazards Sub-section XML Code Snippet	39
Figure 33: Directions for Use Section XML Code Snippet	40
Figure 34: Agricultural Use Requirements Sub-section XML Code Snippet	41
Figure 35: Non Agricultural Use Requirements Sub-section XML Code Snippet	41
Figure 36: Resistance Management Sub-section XML Code Snippet	42
Figure 37: Spray Drift Management Sub-section XML Code Snippet	42
Figure 38: Rotational Crop Interval Sub-section XML Code Snippet	43
Figure 39: Seed Bag Labeling Requirements Sub-section XML Code Snippet	43
Figure 40: Storage and Disposal Sub-section XML Code Snippet	44
Figure 42: Product Application Instructions/Information Sub-section XML Code Snippet
	45
Figure 43: Use Site Application Instructions Sub-section XML Code Snippet	47
Figure 44: Use Site Application Instructions Sub-section XML Code Snippet (Continued)
	48
Figure 47: Pesticide Action - Plant Regulator XML Code Snippet	50
Figure 48: Warranty/Disclaimer Section XML Code Snippet	50
Figure 49: Marketing/ Advertising Claims Section XML Code Snippet	52
Figure 50: Additional Documentation and Labeling Section XML Code Snippet	53
Figure 51: Use Index Document Type XML Code Snippet	54
Figure 52: Author Information XML Code Snippet	56
Figure 53: Document Information XML Code Snippet	57
Figure 54: Use Index Sections XML Code Snippets	58
Figure 55: Use Index Sections XML Code Snippets (Continued)	59
Figure 56: Product Level Section XML Code Snippet	60
Figure 57: Product Identification XML Code Snippet	60
Figure 58: Product Number XML Code Snippet	60
Figure 59: Active Ingredient and Percent Factoring Term XML Code Snippet	62
Figure 60: Product Density XML Code Snippet	63
Figure 61: Mass Product per Miscellaneous Application XML Code Snippet	64
Figure 62: : Product Level Use Restrictions/Limitations XML Code Snippet	65
Figure 63: Geographic Area XML Code Snippet	65
Figure 64: Food Site Relationship XML Code Snippet	66
Figure 65: Maximum A.I. Rate Across Products XML Code Snippet	68
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Figure 66: Rotational Crop XML Code Snippet	69
Figure 67: Applicator Class Restrictions XML Code Snippet	70
Figure 68: PPE/Engineering Control XML Code Snippet	71
Figure 69: Re-Entry Interval XML Code Snippet	72
Figure 70: MRI XML Code Snippet	73
Figure 71: PHI XML Code Snippet	74
Figure 72: Pre-Grazing/Pre-Feeding Interval XML Code Snippet	76
Figure 73: Pre-Slaughter Interval XML Code Snippet	77
Figure 74: Buffered Area XML Code Snippet	78
Figure 75: Maximum Release Height XML Code Snippet	79
Figure 76: Maximum Wind Speed XML Code Snippet	80
Figure 77: Application Temperature XML Code Snippet	81
Figure 78: ASABE Droplet Size XML Code Snippet	82
Figure 79: Soil Incorporation Depth and Time XML Code Snippet	83
Figure 80: Restricted Soil Type XML Code Snippet	84
Figure 81: Minimum Percent Soil Organic Matter XML Code Snippet	85
Figure 82: Minimum Age of Animal To Be Treated XML Code Snippet	86
Figure 83: Minimum Weight of Animal To Be Treated XML Code Snippet	87
Figure 84: Pollinator Protection Statement XML Code Snippet	88
Figure 85: Bulletins Live XML Code Snippet	88
Figure 86: Water Protection Statement XML Code Snippet	89
Figure 87: Secondary Manufacturing XML Code Snippet	90
Figure 88: Restricted Use Site Location XML Code Snippet	91
Figure 89: Restricted Application Target XML Code Snippet	92
Figure 90: Restricted Application Type XML Code Snippet	93
Figure 91: Restricted Application Equipment XML Code Snippet	94
Figure 92: Restricted Application Timing XML Code Snippet	95
Figure 93: Site Level Section XML Code Snippet	97
Figure 94: Use Site Attributes XML Code Snippet	99
Figure 95: Use Site Yearly Rate XML Code Snippet	101
Figure 96: Use Site Level Restrictions/Limitations XML Code Snippet	102
Figure 97: Geographic Area XML Code Snippet	103
Figure 98: Food Site Relationship XML Code Snippet	104
Figure 99: Maxium Al Rate Across Products XML Code Snippet	106
Figure 100: Rotational Crop XML Code Snippet	107
Figure 101: Applicator Class Restrictions XML Code Snippet	108
Figure 102: PPE/Engineering Control XML Code Snippet	109
Figure 103: Re-Entry Interval XML Code Snippet	110
Figure 104: MRI XML Code Snippet	111
Figure 105: PHI XML Code Snippet	112
Figure 106: PGI/PFI XML Code Snippet	113
Figure 107: PSI XML Code Snippet	115
Figure 108: Buffered Areas XML Code Snippet	116
Figure 109: Maximum Release Height XML Code Snippet	117
Figure 110: Maximum Wind Speed XML Code Snippet	118
Figure 111: Application Temperature XML Code Snippet	119
Figure 112: ASABE Droplet Size XML Code Snippet	120
Figure 113: Soil Incorporation Depth and Time XML Code Snippet	121
Figure 114: Restricted Soil Type XML Code Snippet	122
Figure 115: Minimum Percent Soil Organic Matter XML Code Snippet	123
Figure 116: Minimum Age of Animal To Be Treated XML Code Snippet	124
Figure 117: Minimum Weight of Animal To Be Treated XML Code Snippet	125
Figure 118: Pollinator Protection Statements XML Code Snippet	126
Figure 119: Bulletins Live XML Code Snippet	126
Figure 120: Water Protection Statement XML Code Snippet	127
Figure 121: Secondary Manufacturing XML Code Snippet	128
Figure 122: Use Site Location XML Code Snippet	129
Figure 123: Restricted Application Target XML Code Snippet	130
Figure 124: Restriced Application Type XML Code Snippet	131
Figure 125: Restriced Application Equipment XML Code Snippet	132
Figure 126: Restricted Application Timing XML Code Snippet	133
Figure 127: Scenario Level Section XML Code Snippet	135
Figure 128: Scenario Rate XML Code Snippet	136
Figure 129: Single Application Rate Range XML Code Snippet	139
Figure 131: Acre Rate XML Code Snippet	141
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Figure 132: Minimum Diluent Volume XML Code Snippet	142
Figure 133: Residence/Contact Time XML Code Snippet	143
Figure 134: Maximim Number of Applications XML Code Snippet	144
Figure 135: Maximum Application Rate Range XML Code Snippet	147
Figure 136: Maximum Application Rate Range XML Code Snippet (Continued)	148
Figure 137: Maximum Number of Crop Cycles per Year XML Code Snippet	149
Figure 138: Scenario Attributes XML Code Snippet	149
Figure 139: Form As Applied XML Code Snippet	150
Figure 140: Application Target XML Code Snippet	150
Figure 141: Application Type XML Code Snippet	151
Figure 142: Application Equipment XML Code Snippet	151
Figure 143: Application Timing (Site Status) XML Code Snippet	152
Figure 144: Application Timing (Time of Day) XML Code Snippet	153
Figure 145: Application Timing (Timing of Pest) XML Code Snippet	154
Figure 146: Use Scenario Level Restrictions/Limitations XML Code Snippet	155
Figure 147: Geographic Area XML Code Snippet	156
Figure 148: Food Site Relationship XML Code Snippet	157
Figure 149: Maximum Al Rate Across Products XML Code Snippet	158
Figure 150: Rotational Crop XML Code Snippet	159
Figure 151: Applicator Class Restrictions XML Code Snippet	160
Figure 152: PPE/Engineering Control XML Code Snippet	161
Figure 153: REI XML Code Snippet	162
Figure 154: MRI XML Code Snippet	163
Figure 155: PHI XML Code Snippet	164
Figure 156: PGI/PFI XML Code Snippet	165
Figure 157: PSI XML Code Snippet	166
Figure 158: Buffered Areas XML Code Snippet	167
Figure 159: Maximum Release Height XML Code Snippet	168
Figure 160: Maximum Wind Speed XML Code Snippet	169
Figure 161: Application Temperature XML Code Snippet	170
Figure 162: ASABE Droplet Size XML Code Snippet	171
Figure 163: Soil Incorporation Depth and Time XML Code Snippet	172
Figure 164: Restricted Soil Type XML Code Snippet	173
Figure 165: Minimum Percent Soil Organic Matter XML Code Snippet	174
Figure 166: Minimum Age of Animal To Be Treated XML Code Snippet	175
Figure 167: Minimum Weight of Animal To Be Treated XML Code Snippet	176
Figure 168: Pollinator Protection Statements XML Code Snippet	177
Figure 169: Bulletins Live XML Code Snippet	177
Figure 170: Water Protection Statement XML Code Snippet	178
Figure 171: Secondary Manufacturing XML Code Snippet	179
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1 Introduction
The Environmental Protection Agency's (EPA) SmartLabel Project is an electronic
system for submission of Pesticide Product Labels, related use information, and tolerance
data. The SmartLabel system allows pesticide manufacturers to develop and submit
Pesticide Product Labels and related use information to EPA for review in an electronic
format instead of as paper or PDF files.
SmartLabel strives to make the label review process more efficient by creating a standard
template for registrant supplied submission of Pesticide Product Label content to EPA, in
combination with formatted label use information, allowing for quicker reviews and
easier comparisons to previous label versions. Additionally, the data submitted through
SmartLabel allows the Agency to set up a searchable database of standardized label
content and use data for all products, which can be used in support of risk assessments
and registration decisions. This standardized formatting of information also facilitates
information sharing between EPA and other agencies.
This document provides an introduction to the SmartLabel Model, as well as guidance on
how to extract pesticide information into the Structured Product Label (SPL) model for
submission to EPA. It is intended that the companion document on the SmartLabel
Vocabulary Guide Version 3.xlsx is used in concurrence with this guidance.
Additionally, information on technical conformance criteria is included to provide the
blueprint for the coding utilized in the SPL Extensible Markup Language (XML) model.
The Agency hosts a SPL Builder on EPA's Central Data Exchange (CDX). The
SmartLabel SPL Builder is the Agency's publicly offered tool to build, validate, and
submit structured XML files to EPA for review and registration. Other tools may be
programed to build and validate SmartLabel XML files by external groups using the
technical specifications provided in this document. Files created using external builders
must pass validation and be submitted through the Agency's CDX portal. EPA's CDX
SmartLabel Builder User Guide should be used in conjunction with this document when
using the CDX builder to enter, validate, and submit information to the Agency.
In summary, this document provides the information necessary to understand the
technical coding for the builder tool as well as instruction on the submission of a label in
the XML format via entry into the Label Content, Use Index, and Tolerance documents.
1.1 Organization
The body of this document is divided into three parts. The first part of this document
(Section 2) provides an overview of the standard/model used and the general technical
conformance criteria that are applicable to the header and body of the SmartLabel
document independent of the exchanged information; i.e., the blueprint for the XML
form. The second part of the document (Section 3) describes the standard/model used and
the technical conformance criteria used to enter information into the Pesticide Product
Label. The third part of the document (Section 4) describes the standard/model used and
the technical conformance criteria used to enter information into the Use Index.
Each section of the document is broken into subsections that represent data
elements/structured content text blocks or groups of data elements/structured content text
blocks. Each subsection is organized as follows:
(# for location in model) Subsection Title
[Description of subsection data element/structured content]
Entry Type: description of entry type, if any, and name of picklist, if any.
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1.2	Document Information (Package Information Section)
	Document Name is an optional field on the 'Document Information' screen of
the builder application. Its value is not added to the XML schema and it is not
submitted. Saving locally will capture this value in the .zip filename instead of the
default "Document ID" filename.
	Company Name identifies the name of the organization registered with EPA and
associated with the pesticide product. It is linked with the Company Number
below listed; both of which are populated from the CDX account of the user who
created the SmartLabel package. See section 2.1.3 Author Information below.
	Registration Number is a unique identifier for each registered pesticide product.
It is separated into two parts comprised of an EPA Company Number and
Product Number. While both numbers are captured together on the' Document
Information' screen of the SmartLabel builder application, each number is stored
in its own location in the respective XML documents. See sections 3.6.1.1
Product Number and 4.3.1.1 Product Number for more information on
Product Numbers.
	EPA Company Number is a unique identifier assigned by EPA to the registered
organization listed under Company Name. It is populated from the CDX account
of the user who created the SmartLabel package. See section 2.1.3 Introduction
below.
	Product Number is a unique identifier assigned by EPA to the registered
pesticide product. This number is combined with an EPA Company Number to
form a Registration Number unique to each registered pesticide product. While
this number is entered on the Document Information screen of the SmartLabel
builder application, it is captured in the Product Profile section of the Pesticide
Product Label document and Product Identification section of the Use Index
document. See sections 3.6.1.1 Product Number and 4.3.1.1 Product Number
for more information.
1.3	Document ID Numbering
	[Document Type] . [Section] . [Sub-section] . [Data Element] . [Validation Error
ID]
	Section = screen in the Label Doc or Section = Level in the Use Index Doc
	In the Label document, section statements are synonymous with 'Sub-section';
e.g., 'Ingredient Statement' applies to that sub-section but also to the statement
made in the respective section text area.
	In the Use Index document, 'Section' is synonymous with the level; e.g., Product
Level, Site Level, Scenario Level.
1.4	Validation Procedures
Detailed validation procedures are presented with most sub-sections and are clearly
marked with the heading "Validation Procedures." These procedures can be used by
human readers as check-lists to verify their submission is correct. Additionally, the
validation procedures are written as specific and operational so that they may be checked
by systems processing SmartLabel documents. Therefore, some validation procedures
contain information that refers specifically to SmartLabel standards. Validation
procedures that are meant to be used as a check-list when entering information are
specified in black text. while SPL technical conformance criteria that are needed to
program the XML builder are specified in grey text. Validation rules typically include
information such as: if a section is required, the number of times a section can be used (0
through # = not required, 1 = required but not duplicable, 1 through # = may be
duplicated # number of times), what type of data can be entered (text, number, picklist),
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picklist that may be used, terms that may be selected, and other relevant information for
data entry and programing. Each validation message has an ID number. These validation
messages and ID numbers are generally stable over time but may change between
versions of the document. Although rare, new validations may be inserted between
existing versions. Normally however, new validations are appended to the end of their
respective sub-sections.
Validation Rules:
Linked validation ID number Human readable text stating specific cause of validation
denoting location of error	error
XML Code Snippet:
[box containing xml code for subsection, which can be used to program alternate SmartLabel
xml builders]	
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2 Overview of SPL Technical Conformance Criteria
SPL is a Health Level Seven (HL7) standard based on Clinical Document Architecture
and HL7 Reference Information Model (RIM) accredited by the American National
Standards Institute (ANSI) for the exchange of product information. SPL documents
include both a header and body. The header includes information about the document
such as the type of document, author, and versioning. The body of the document includes
product information and labeling content in both structured text and data element
formats. EPA's Office of Pesticide Programs (OPP) uses SPL documents to exchange
SmartLabel information regarding pesticide products.
This document provides guidance on how to extract pesticide information into structured
models for submission to EPA, and technical conformance criteria for SPL documents
used by EPA's OPP to create the XML builder.
SPL history and background information can be found on the HL7 website:
http://www.hl7.org/implement/standards/product brief.cfm?product id=401
A reference implementation guide can be found on the HL7 website:
http://www.hl7.org/documentcenter/private/standards/SPL/V3IG SPL R5 INFORM 20
1 IMAY.pdf
2.1 HL7SPL Header
2.1.0 General
The following validation rules apply generally to all SmartLabel files submitted to EPA.
Validation Procedures:
2.1.0.1.1
2.1.0.1.2
2.1.0.1.3
2.1.0.1.4
2.1.0.1.5
2.1.0.1.6
2.1.0.1.7
2.1.0.1.8
2.1.0.1.9
2.1.0.1.10
2.1.0.1.11
XML is well formed and valid against the schema
There are no data elements and attributes in addition to those
described in this document. Certain exceptions apply to this rule,
notably any default attribute that validating schemas would create
are by default part of the document. These need not be stated, but
cannot reasonably be forbidden.
There are no spaces in codes
Codes do not have a codeSystemName attribute
Display names are case insensitive.
There are no spaces in id extensions
Letters in Globally Unique Identifiers (GUID) are lower case
There are no empty or incomplete elements except, in certain
circumstances, code, title, text, and time (an id has a root, a code has
a codeSystem)
Characteristics have a class code of "OBS" or no class code at all
There is no confidentiality code on anything but inactive ingredients,
registrant, and assigned establishments outside establishment
registrations
If there is a confidentiality code, then the code is "B" and the
codeSystem is 2.16.840.1.113883.5.25
2.1.1 XML References
This information includes the location of the current style sheet for EPA's view of the
SPL and the location of the current schema. The start of the SPL file is the same for
every SPL document and is as follows:
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Validation Procedures:
XML reference is for version 1.0 and encoding "UTF-8"
2.1.1.1.2	There is an xml-stylesheet reference to
https://cdxnodengn.epa.gov/cdx-
SmartLabel/public/stylesheet/spl.xsl
2.1.1.1.3	The schemaLocation of the urn:hl7-org:v3 namespace is provided
as https://cdxnodengn.epa.gov/cdx-
SmartLabel/public/schema/SPL.xsd
2.1.1.1.4	There are no processing instructions other than the XML and xml-
stylesheet declarations
2.1.1.1.5	There are no comments
2.1.1.1.6	SPL file name is the document id followed by ".zip"
2.1.1.1.7	A submission contains only the SPL file whose name ends in ".zip"
and, if appropriate, associated labeling files whose name ends in
".pdf" or image files whose name ends in ".jpg" or ".jpeg"
2.1.1.1.8	All files associated with the SPL document are referenced from
that SPL document
Figure 1: XML References XML Code Snippet


2.1.2 Document Information
This information provides basic information for the identity of the particular
document, its type, title, date, and versioning as a member of a document set.
	The  is a Globally Unique Identifier (GUTD) and is unique for each
version of the document. Letters used in a GUTD are lower case.
	The  provides information on the document type.
	The  data element is used for the document title, if necessary. Images are
not included in the title. Multiple lines may be used in the title with each line
separated by the line break <br/> tag. (Note: all titles can also be as follows: <title
medi aTyp e=" text/x-hl 7-titl e+xml" >).
	The <effectiveTime> provides a date reference to the SPL version including the
year, month and day as yyyymmdd.
	The <setld> is a GUID for the document that remains constant through all
versions/revisions of the document.
	The <versionNumber> is an integer greater than zero that provides a sequence to
the versions of the document. This date is automatically populated when the
document is created and should be updated when a new version of the document
is submitted.
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Validation Procedures:
2.1.2.1.1	There is one Document ID per Document Type
2.1.2.1.2	Document ID is a Globally Unique Identifier (GUID) captured as
<id root> under <document>
2.1.2.1.3	Document ID does not have an extension
2.1.2.1.4	Document ID must be unique and cannot match any other ID
within the document
2.1.2.1.5	Document ID (id root) must be unique across all documents
within EPAs database
2.1.2.1.6	Each document type has a code
2.1.2.1.7	Each document type code and displayName comes from
codeSystem 2.16.840.1.113883.6.275.1
2.1.2.1.8	Each document type displayName must match the respective
code
2.1.2.1.9	There are no figures in the title
2.1.2.1.10	There is an "Effective Date" captured as <effectiveTime>
2.1.2.1.11	Effective Date has the precision of four digit year, two digit
month, and two digit day in the format YYYYMMDD
2.1.2.1.12	There is one Set ID captured as <setld>
2.1.2.1.13	Set ID must be a Globally Unique Identifier (GUID)
2.1.2.1.14	Set ID does not match any other <setld> within the document
2.1.2.1.15	There is one document Version captured as <versionNumber>
2.1.2.1.16	Version value must be a whole number greater than 0 (zero)
2.1.3 Author Information
This section provides basic information about the business responsible for the product,
including the Company Name and Company Number. See section 1.2 Document
Information (Package Information Section) for additional information.
	The <name> (also known as Company Name), identifies the name of the
organization registering the product using the company name registered with the
agency that is associated with the company number entered below.
	The <id extension> (also known as Company Number) identifies the organization
registering the product using EPA registered company numbers. These are
identifiers with the root 2.16.840.1.113883.6.275.1 and an extension.
Validation Procedures:
2.1.3.1.1	There is one EPA Company Number captured as <id extension/>
2.1.3.1.2	EPA Company Number has a root of 2.16.840.1.113883.6.275.1
2.1.3.1.3	There is one Company Name is captured as <name>
Figure 2: Author Information XML Code Snippet
<document>
<author>
<assignedEntity>
<representedOrganization>
<id extension="EPA Company Number" root="2.16.840.1.113883.6.275.l"/>
<name>"EPA Company Name"</name>
</representedOrganization>
</assignedEntity>
</author>
</document>
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2.2 HL7 SPL Body
2.2.0	General
The body of an SPL document can include structured text (e.g., product labeling),
structured values (e.g., percent active ingredient), and/or specific data elements from
picklists (e.g., active ingredients).
Figure 3: SPL Body XML Code Snippet
<documerit> <!-- SPL header material -->
<comporient>
<structuredBody> <!-- SPL body material -->
<componerit>
<section>
2.2.1	Sections and Subsections
The following is a representative coding for a section.
Figure 4: Sections XML Code Snippet
<component>
<sectiori>
<id root="62abedf9-6bde-4787-beb0-abd214307427"/>
<code code-'section ID"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="section display riame"/>
<title>Directions for Use
labeling text



Sections and subsections have an id, title, and code. The Section Names list provides
the codes used for sections and subsections.
The ,  (if necessary), and the order of the sections and subsections in the
SPL are used to render the labeling contents.
In the SPL schema, the <structuredBody> element contains multiple <component>
elements, and each <component> contains a <section>.
Sections are used to aggregate paragraphs into logical groupings. The order in which
sections appear in an SPL document is the order the sections will appear when
rendered using the standard style sheet.
Figure 5: Section Text XML Code Snippet
<section>
<!-- this section's id, codes -->
<text>
<!-- actual text content in "narrative block" markup -->
</text>
Each section has a unique identifier (<id>), an <effectiveTime>, a Section Names code
(<code>) and a <title>.
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The human readable content of labeling is contained within the <text> element in the
<section>. The <section> can be nested to form sub-sections. The schema for
subsections in an SPL document requires that the nested <section> tag first be nested
inside a <component> tag. Use nested sections to relate paragraphs. The section tag
applies to all of the nested sections.
Figure 6: Sub-Section XML Codes Snippet
<section>
<!-- this section's id, codes -->
<text>
<!-- actual text content in "narrative block" markup -->
</text>
<component>
<section>
<!-- subsection content -->
</section>
</component>
<component>
<section>
<!-- subsection content -->
</section>
</component>
</section>
Using the following principles for markup of text information improves access to
information in labeling:
	Capture the section heading using the <title> element rather than placing the text
of the title within the <text> element. This allows computer systems to properly
use and display this information.
	Capture the section heading even when the printed label does not include a
heading.
	Link different parts of the labeling using the ID attribute to the <section> element.
For example, <section ID="Rest_Use_Pest_Section"> serves as the target of a
<linkHtml> element. Linking to the ID attribute of a section allows the link to
'reference' the section entirely, e.g., for retrieval of a whole section in a non-
browser interface.
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Validation Procedures:
2.2.1.1.1	Each section has zero to many subsections
2.2.1.1.2	Each section and subsection has a <section ID> captured as <id root>
and does not have an extension
2.2.1.1.3	<section ID> (id root) must be a Globally Unique Identifier (GUID)
2.2.1.1.4	<section ID> (id root) cannot match any other IDs in the document
2.2.1.1.5	<section ID> (id root) does not match any ID other than the ID of the
same section previously submitted
2.2.1.1.6	Each section and subsection has a section UID corresponding to a
section name captured as code "value"
2.2.1.1.7	Section UID (code "value") comes from codeSystem
2.16.840.1.113883.6.275.1
2.2.1.1.8	Each section and sub-section has a name captured as displayName
"value"
2.2.1.1.9	Section UID (code "value") and displayName "value" are from
codeSystem 2.16.840.1.113883.6.275.1 and must match
2.2.1.1.10	Each section optionally has an effectiveTime with at least the
precision of day in the format YYYYMMDD
2.2.1.1.11	There are no figures in the <title> for a section or subsection
2.2.2 Document Inputs
2.2.2.1 Text
The human readable text content of SmartLabel documents is contained within the <text>
element. The actual content is contained within a <paragraph>, <table>, and/or <list>. If
a section consists only of nested sections, the <text> tag is not included. Elements that
can be used within the <text> element to capture the human readable content of an SPL
document include paragraphs (<paragraph>), lists (<list>), tables (<table>) and images
(<renderMultimedia>). Elements permitted as children of the <text> element, used as
children of the <paragraph> element or within <table> and <list> include superscripts
(<sup>), subscripts (<sub>), links (<linkHtml>), line breaks (<br>), footnotes
(<footnote>), footnote references (<footnoteRef>). Images may be included in the
content of labeling using the <renderMultiMedia> tag. This tag may be used as a direct
child of <text> for 'block' images or as a child of <paragraph> for inline images.
Figure 7: Section Text XML Snippet
<section>
<text>
<paragraph>Lorem ipsum dolor sit amet, consectetur adipisicing elit, sed do eiusmod
tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis
nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute
irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur.
Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit
anim id est laborum.</paragraph>
<paragraph>At vero eos et accusamus et iusto odio dignissimos ducimus qui blanditiis
praesentium voluptatum deleniti atque corrupti quos dolores et quas molestias
excepturi sint occaecati cupiditate non provident, similique sunt in culpa qui officia
deserunt mollitia animi, id est laborum et dolorum fuga.</paragraph>
</text>
</section>
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2.2.2.2 Font Effects
There are certain aspects of the rendering of a SPL document that must be specified in
the source to ensure that labeling content is correctly formatted when rendered. For
example:
Figure 8: Font Effects XML Snippet
<text>
<paragraph>The next snippet <content styleCode="bold italics">will appear as bold
italics</content> in the rendering.</paragraph>
Will be rendered as:
The next snippet will appear as bold italics in the rendering.
The <content styleCode="> can also be nested, for example:
The next snippet will appear as bold italics in the rendering.
The <content styleCode="> can also be nested, for example:
Figure 9: Font Effects (Continued) XML Snippet
<text>
<paragraph>
<content styleCode="bold italics"> will appear as bold italics</content>
Can also be represented as:
Figure 10: Font Effects (Continued 2) XML Snippet
<text>
<paragraph>
<content styleCode="bold"xcontent styleCode="italics"> will appear as bold
italics.</contentx/content>
The values for <styleCode> for font effects are bold, italics, and underline. To assist
visually impaired users, the <styleCode="emphasis"> is used to prompt computer
screen reader programs to emphasize text such as text in a box warning. The bold,
italics, and underline font effects may be used together with each other and the
emphasis styleCode. For example, <content styleCode="bold"><content
styleCode="emphasis"> </content></content> will appear as bold and will be
emphasized by screen reader programs.
A special styleCode is used for recent major changes (see below).
2.2.2.3 Symbols and Special Characters
Special characters can be included in the text. Superscripts and subscripts are
accomplished using the <sup> and <sub> tags. Because the SPL encoding utilizes
UTF-8, any Unicode character can be included. Unicode references may also be
inserted as either &#dddd; where dddd is the Unicode value in decimal notation or
� where dddd is the Unicode value in hexadecimal notation. The font used in
the standard style sheet is a Unicode font; assuring that most Unicode characters will
be rendered correctly if viewed by a browser supporting this font. The only prohibited
characters in XML that cannot be directly used are less-than "<" because SPL XML
tags begin with it, and ampersand "&" because XML entity references begin with it.
Use of these two symbols must be replaced by the XML entity references <. and
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& respectively. For example, "<paragraph> The mean for group 1 was < 13.
</paragraph>" will render as "The mean for group 1 was <13." and "D&C Yellow
#10" will render as "D&C Yellow #10".
2.2.2.4	Footnotes
The SPL schema includes a specific footnote element, <footnote>. Footnotes are
rendered automatically by the standard SPL style sheet. <footnoteRef> is used to refer
to another (usually earlier) footnote. For example, "<footnote ID="testNote">This is
the footnote content</footnote>" will generate the following footnote at the
appropriate end of a section, " This is footnote content".
The <footnoteRef> element with the appropriate IDREF attribute, e.g., <footnoteRef
IDREF="testNote"/> will display the footnote reference in the text corresponding to
the footnote with the same ID, e.g., in this example footnote 6.
Footnotes are rendered by the default style sheet using Arabic numbers (e.g., 1, 2 3,).
Within tables, footnotes are rendered using footnote marks in the series: * f J  ]} # 4
V ~ *, effectively separating numbered footnotes within general text and footnotes
within tables. Footnotes within tables are rendered at the bottom of the table.
2.2.2.5	Lists
All lists are marked using the <list> tag, and each item in a list is marked with an
<item> tag. The 'listType' attribute identifies the list as ordered (numbered) or
unordered (bulleted). The default numbering and bulleting are controlled by the style
sheet.
Lists featuring a standard set of specialized markers (standard specialized lists) can be
created using the styleCode attribute with the <list> element. Options available for
ordered lists are:
	Arabic (List is ordered using Arabic numerals: 1, 2, 3)
	LittleRoman (List is ordered using little Roman numerals: i, ii, iii)
	BigRoman (List is ordered using big Roman numerals: I, II, III)
	LittleAlpha (List is order using little alpha characters: a, b, c)
	BigAlpha (List is ordered using big alpha characters: A, B, C)
For example: <list listType="ordered" styleCode="LittleRoman">
For unordered lists the following options exist:
	Disc (List bullets are simple solid discs: )
	Circle (List bullets are hollow discs: o)
	Square (List bullets are solid squares: )
For example: <list listType="unordered" styleCode="Disc">
In addition to the standard specialized lists, user-defined characters are also permitted
as markers by nesting <caption> within the <item> tag. Note that any character, XML
entity, or Unicode symbol, may be used in the <caption>, and that the <caption> for
each <item> are not restricted to the same character.
For example: <item><caption>*</caption> the asterisk is used as item marker here.
<item>
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XML Code Snippet:
Figure 11: List XML Code Snippet
<text>
<paragraph>Lorem ipsum dolor sit amet, consectetur adipisicing elit, sed do eiusmod
tempor incididunt ut labore et ...</paragraph>
<list listType="ordered" styleCode="BigRoman">
<item>Lorem ipsum dolor sit amet,</item>
<item>consectetur adipisicing slit</item>
</list>
<paragraph>At vero eos et accusamus et iusto ...</paragraph>
</text>
2.2.2.6 Tables
Tables can be created with the full structure (header (e.g., for column names), body
(e.g., for table rows) and footer (e.g., for table footnotes). The element <tbody> is
required for an SPL table while the elements <thead> and <tfoot> are optional in the
SPL schema. The structure will display a standard typographical table with rules
between the caption (table title) and head, the head and body, and the body and
<tfoot>. If a <tfoot> element is included and footnotes are present in a table, then
footnotes are rendered after the existing content of the <tfoot> element.
It is recommended to always start with a standard table (i.e., <thead> and <tbody>
elements) and test to see whether the rendering is unambiguous and interpretable. It is
important that the table communicate labeling content not that it duplicates the
presentation in word processed or typeset versions of the package insert. In the
unusual situation where additional formatting is needed, the rule styleCode specified
or certain attributes may be used to modify the table.
The rule codes are as follows (Note that the control names are case sensitive).
	Rule on left side of cell is Lrule
	Rule on right side of cell is Rrule
	Rule on top of cell is Toprule
	Rule on bottom of cell is Botrule
Note: More than one rule control may be used in a cell, e.g., <td styleCode
code="Botrule Lrule">Cell content </td>.
Rule control codes should be used only when necessary for the interpretability of the
table. Use of these codes may result in overriding the default rules for tables. Rather
than setting the rule for each cell, table rules may also be controlled according to entire
rows or columns by use of the styleCode attributes with <col>, <colgroup>, <thead>,
<tfoot>, <tbody> and <tr> elements.
To make row groups appear with horizontal rules, use the styleCode attribute
"Botrule" with the appropriate <tr> element. The Botrule value is rarely needed on the
<td> element.
The preferred method for using vertical rules is to define colgroup with
styleCode="Lrule" or "Rrule" (or both). Only if this does not yield the desired vertical
rule should the Lrule or Rrule code value with styleCode attributes on the <td> or <th>
element itself be used. Note: In general, vertical rules should not be used. Good
typography for tables means using few vertical rules.
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To merge cells vertically and horizontally, the rowspan and colspan attributes should
be used on the <td>element.
To determine the width of a table, the width attribute may be used on the <table>
element and to determine the width of a table column, the width attribute may be used
on the <col> and <colgroup> elements.
For horizontal alignment, the preferred method for aligning cell content within the
margins is to use <col align=".. "/> in the <colgroup> element, though this can be used
in the <colgroup> element as well. Valid values for align are "left", "center", "right",
"justify" (for full justification of contents within the cells), and "char" (for character
alignment within the cells). Using the <col align=".. "/> markup ensures that the
contents for all cells in the column share the same alignment.
For vertical alignment, the align attribute can be used within cells. For cases in which
the cell alignment must be different from other cells in the column, align is also
available as an attribute on the other table elements, including <td>.
Markup for table footnote is rendered in the <tfoot> tag. This element does not need to
be included in SPL; the standard style sheet will include a <tfoot> tag if a <footnote>
element is present within either the <thead> or <tbody> sections. A <tfoot> section
should be included in SPL only if there is additional information other than footnotes
that needs to be rendered in this section.
For table text spacing, in some instances, the use of a "tab" or text indentation is
desirable in a given table cell. In an SPL document, this effect is achieved by using the
nonbreaking space ( ) as if it were a "tab" space. As the following snippet of
XML shows, two nonbreaking spaces were used to offset the word "Male" from the
margin: <td>  Male</td>. The nonbreaking space can also be used to
keep text in a table from breaking inappropriately due to browser resizing.
2.2.2.7	Hypertext Links
SPL offers hypertext linking capabilities generally similar to those found in the HTML
specification.
Links are specified by the <linkHtml> construct, where the value for the href attribute
of <linkHtml> (the target of the link) is the ID attribute value of a <section>,
<paragraph>, <table>, <list>, <content>, <renderMultimedia> element. The style
sheet does not support the styleCode attribute of the <linkHtml> element; if a
styleCode is needed for a link, this should be coded via the <content> element within
the link as with other text.
2.2.2.8	Major Changes in Labeling Text
SPL offers a notation to identify recent major changes in the labeling text including
table elements <table> and table data <td>. The recent major text is tagged using the
<content styleCode= "xmChange">.
Validation Procedures:
2.2.2.8.1	Text is enclosed under <paragraph>, <list>, or <table> elements
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Figure 12: Recent Major Change in Text Example XML Code Snippet
<text>This is an example of text that is not changed.<content
styleCode="xmChange">This is an example of text that is a recent major
change</content>This is an example of changed text that is not considered a recent
major change</text>
2.2.2.9 Images
The SPL schema uses <observationMedia> elements to identify graphic files to be
rendered at the locations where they are referenced by <renderMultiMedia> elements
in the <section>. In other words, an image in an SPL will be rendered wherever it is
referenced by the renderMultimedia markup, no matter where the observationMedia
markup appears. The referencedObject attribute of the renderMultiMedia element
identifies the corresponding observationMedia instance by means of its ID identifier
such as <renderMultiMedia referencedObject="MMl"/>.
The <observationMedia> element does not contain the graphics file, but instead points
at the file. The <reference> value is the file name. The file name should not include
spaces. The observationMedia identifies the graphic media type; e.g., ".jpg" or ".jpeg".
In addition, the observationMedia element includes the text description of the image
used by screen reader software for visually impaired users. This is included in the
<text> child of <observationMedia>. Note also that observationMedia is always
contained within a <component> element as illustrated.
For image placement, if an image is a block image (i.e., should appear in its own
space), insert the renderMultimedia tag between <paragraph> elements. If an image is
inline (i.e., should appear alongside text), insert the renderMultimedia tag in the text of
a <paragraph> as appropriate. Inline images are expected to be uncommon and
basically represent symbols that cannot be represented by Unicode characters. In
addition, <caption> are not applicable for inline images since these are not offset from
the surrounding text.
The SPL style sheet does not resize or change the resolution of graphics files. Thus, all
images are rendered in the browser as-is, with all characteristics of the actual graphic
file itself. It is very important that the graphic file is edited to dimensions appropriate
for its presentation within the browser to ensure that a graphic will appear as desired.
If not, the appearance of the graphic may not be consistent with the narrative content
and reduce the readability of the file. Images should be Joint Photographic Experts
Group (JPEG)/JPG file type with appropriate pixels per inch for viewing the standard
style sheet using a web browser.
Validation Procedures:
2.2.2.9.1	There is <text> associated with an image.
2.2.2.9.2	Image mediaType is "image/jpeg" or "image/jpg".
2.2.2.9.3	Image <value> xsi:type is "ED".
2.2.2.9.4	Image <reference> value is the filename for a valid image.
2.2.2.9.5	Size of image file is less than 1 MB.
2.2.2.9.6	Image file must be JPEG with name extension ".jpg" or ".jpeg".
2.2.2.9.7	Image components are referenced at least once in the text of any
section.
2.2.2.9.8	Image reference in <text> has an image <observationMedia> element
with a matching ID in the same document.
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Figure 13: Images XML Code Snippet
<section>
<text>
<paragraph>...</paragraph>
<renderMultiMedia referencedObject="MMl"/>
<paragraph>...</paragraph>
</text>
<component>
<observationMedia ID="MM1">
<text>descriptive text</text>
<value xsi:type="ED" mediaType="image/jpeg">
<refererice value="pesticide-01.jpg"/>
</value>
</observationMedia>
</component>
</section>
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3 Pesticide Product Label
The goal of the Label Content document is to capture and display the master label content
in a structured and queryable format.
This document captures data in text boxes, as terms from a picklist, and/or value unit
combinations. If a picklist is used, the name of the picklist will be listed in the "Entry
type" field of each subsection. The items in each picklist and their definitions are
compiled on the SmartLabel website:
httns://www. en a. eov/nesticide-reeistration/nesticide-SmartTMhel-nilot-documents This
document and the definitions it contains can be used as a reference when filling out the
Label Content to help the user select the correct term. If a term to fit your needs cannot
be found, please contact SmartLabeKa)eva. sov for assistance determining the correct
term. If an appropriate term cannot be found, a new term can be established and added
to the vocabulary. Because new terms will likely be added on a semi-regular basis,
please periodically refer to the SmartLabel website for the most current listing of
vocabularies and definitions.
3.1 Pesticide Product Labeling SPL Header
3.1.0 Section in General
This section provides basic information for the identity of the Pesticide Product Labeling
document, its type, title, date, and versioning as a member of a document set. This
information is captured in the Document Information section of the application and stored
as part of the Pesticide Product Labeling XML schema. See section 1.2 Document
Information above.
3.1.1 Document Type
This is the header name of the SmartLabel document providing general subject matter of
the Pesticide Product Label.
Entry type: "Document type" picklist selection.
Validation Procedures
3.1.1.0.1
3.1.1.0.2
There is one Pesticide Product Label "Document Type" with a code of
3565715.
There is one Pesticide Product Label "Document Type" with a displayName of
"Pesticide Product Label".
Figure 14: Pesticide Product Label Document Type XML Code Snippet
<document>
<code code="3565715"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="Pesticide Product Label"/>
3.1.2 Author Information
This is the Company Name of the organization associated with the registered pesticide
product. See above sections 1.2 Document Information and 2.1.3 Author Information.
3.1.2.1 Company Name
Identifies the organization registering the product using the company name registered
with the agency that is associated with the below entered company number.
Entry type: Text.
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Validation Procedures
3.1.2.1.1	There is one Company Name (author) captured as <name> under
<representedOrganization>.
3.1.2.1.2	Only <id> and <name> should be present under
<representedOrganization>.
3.1.2.1.3	Company Name matches the name in the EPA Company Number list.
3.1.2.2 Company Number
Identifies the organization registering the product using EPA registered company
numbers. These ntifiers with the root 2.16.840.1.113883.6.275.1 and an extension.
Entry type: Value.
Validation Procedures
3.1.2.2.1	There is one EPA Company Number captured as <id extension> under
<representedOrganization>.
Figure 15: Product Labeling Author Information XML Code Snippet
<document>
<author>
<assignedEntity>
<representedOrganization>
<id root="2.16.840.1.113883.6.275.2" extension="EPA Company Number"/>
<name>EPA Company Name</name>
3.2 Pesticide Product Labeling SPL Body
3.2.0 Section in General
The Master Label content is included in the Content of Labeling. The Content of
Labeling is divided into sections and subsections. A section or subsection may be
associated with data elements.
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Validation Procedures:
3.2.0.0.1 Each section has zero to many subsections.
3.2.0.0.2 Each section and subsection has a <section ID> captured as <id root>
and does not have an extension.
3.2.0.0.3 <section ID> (id root) must be a Globally Unique Identifier (GUID).
3.2.0.0.4 <section ID> (id root) cannot match any other IDs in the document.
3.2.0.0.5 <section ID> (id root) does not match any ID other than the ID of the
same section previously submitted.
3.2.0.0.6 Each section and subsection has a section UID corresponding to a
section name and captured as code "value".
3.2.0.0.7 Section UID (code "value") comes from codeSystem
2.16.840.1.113883.6.275.1.
3.2.0.0.8 Each section and sub-section has a name captured as displayName
"value" in the Pesticide Product Label XML schema; e.g., "Directions
for Use".
3.2.0.0.9 Section UID (code "value") and displayName "value" are from
codeSystem 2.16.840.1.113883.6.275.1 and must match.
3.2.0.0.10 Each section optionally has an effectiveTime with at least the precision
of day in the format YYYYMMDD.
3.2.0.0.11 There are no figures in the <title> for a section or subsection.
Figure 16: Pesticide Product Label Sections in General Code Snippet
<document>
<structuredBody>
<component>
<section ID="Section Link">
<id root="Section UUID"/>
<code code-' codeSystem="2.16.840.1.113883.6.275.1"
displayName="...">
<title>Title

... Section Text (Narrative Block Markup)...


3.2.1 Pesticide Product Label sections in General
The Pesticide Product Label document is divided into sections. Each section of the
Pesticide Product Label document can contain zero to many subsections. Information
regarding the types of data provided in each section and the respective subsections is
noted in Section 3 Pesticide Product Label of this Implementation Guide. Only data
elements (e.g., section text areas) containing inputs inside the Pesticide Product Label of
the application builder are added to the XML schema to be submitted.
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3.3 Restricted Use Pesticide (RUP) Section
3.3.0 Section in General
The content of this section describes if a Pesticide Product has the potential to cause
unreasonable adverse effects to the environment and/or injury to applicators or
bystanders without added restrictions. In general, it describes why the product is
considered RUP and provides a summary statement of the terms of the restriction.
	Example: "Due to Acute Toxicity and Toxicity to Birds and Mammals, for retail sale
to and use only by Certified Applicators or persons under their direct supervision and
only for those uses covered by the Certified Applicator's certification."
	Reference: 40 CFR Part 156, including the requirements set out in 40 CFR 156.10(j)
(2) described further in PR Notice 93-1, and Label Review Manual (LRM): Chapter
6.
3.3.1 RUP Statement (Section Text)
If a product is classified as a RUP, information regarding that classification is found in
the Pesticide Product Label RUP section text area provided here. If this section applies to
the product, enter the appropriate text in this section text area. If this section does not
apply to the product, leave the section text area blank.
Entry type: Text.
Validation Procedures:
3.3.1.0.1 There is one Restricted Use Pesticide section with a code of 3144193 and a
displayName of "Restricted Use Pesticide".
3.3.1.0.2 Restricted Use Pesticide section  and displayName must match.
3.3.1.0.3 Restricted Use Pesticide section has no sub-sections.
3.3.1.0.4 If the product is not considered a RUP, then leave text element blank ("text"
can be null).
Figure 17: RUP Section XML Code Snippet
<section ID="Section Link">
<id root="Section UUID"/>
<code code="3144193"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="Restricted Use Pesticide"/>
<title>Restricted Use Pesticide


3.4 Ingredient Statement Section
3.4.0	Section in General
The content of this section provides information regarding the ingredients contained in a
pesticide product. In addition to inputs made to the Ingredient Statement section text area,
information is also provided per the respective sub-sections including: Active
Ingredients, Identified Inert Statement, and Deterioration/Expiration Statement.
3.4.1	Ingredient Statement (Section Text)
Enter the appropriate text in this section text area if this section applies to a product. If
this section does not apply to a product, leave this section text area blank.
Entry type: Text.
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Validation Procedures:
3.4.1.0.1 There is one Ingredient Statement section with a code of 3144198 and
a displayName of "Ingredient Statement".
3.4.1.0.2 Ingredient Statement section  and displayName must match.
3.4.1.1 Active Ingredients
This sub-section identifies and characterizes the active ingredients contained in a product
captured as EPA Registry Name and Systematic Name including: a listing of active
ingredient(s) and their respective nominal concentrations (expressed as a percentage); and
information regarding concentrations of equivalence of the active ingredients, identified
in this document as Factoring Term (e.g., elemental metallics, acid equivalents, or other
moieties).
	Percent Active Ingredient is the strength of an active ingredient expressed as a
percentage. For products which express the strength of an active ingredient as a
range, input the high number of the range. For products which express the strength of
an active ingredient as a qualified value (e.g., <) enter the value identified on the
label.
	Factoring Term Ingredient can be optionally specified for certain chemical types.
The Factoring Term value is a number describing the amount of a formulation that
theoretically could be converted back to the corresponding or parent active ingredient
per the total weight of the formulated product.
	Percent Factoring Term is the amount of a formulation that theoretically could be
converted back to the corresponding or parent active ingredient per the total weight of
the formulated product.
	Multiple Active Ingredients can be entered.
	Reference: 40 CFR 156.10(g) and LRM: Chapter 5.
Entry type: Substance picklist selection and value.
Validation Procedures
ID Numbers Validation Error Messages
3.4.1.1.1	There is at least one or more Active Ingredient(s) with name and code
provided under <ingredientSubstance>.
3.4.1.1.2	There is one Percent Active Ingredient per Active Ingredient with a unit
code of 3627136 and a displayName of
3.4.1.1.3	Percent Active Ingredient value is a number.
3.4.1.1.4	There is zero or one Factoring Term per Active Ingredient with name
and code provided under <activeMoiety>.
3.4.1.1.5	There is one Percent Factoring Term per Factoring Term with a unit
code of 3627136 and a displayName of
3.4.1.1.6	Percent Factoring Term value is a number.
27
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</pre><hr><pre>
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Figure 18: Active Ingredient XML Code Snippet
<sectiori ID="Section Lirik">
<id root="Section UUID"/>
<code code="3144198"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="lngredient Statement"/>
<titl e> I n gredi e nt Statem e nt</titl e>
<text/>
<effectiveTime value="YYYYMMDD"/>
<subject>
<manufacturedProduct>
<manufacturedProduct>
<ingredient classCode="ACTIB">
<quantity>
<numerator nullFlavor="OTH">
translation code="3627136"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="%" value="{Percent Value}"/>
</numerator>
<denominator value="1"/>
</quantity>
<ingredientSubstance>
<code code="SRS Internal Tracking Number"
codeSystem="2.16.840.1.113883.6.275"/>
<name>SRS Systematic Name</name>
<name use="OR">EPA Registry Name</name>
<!- Percent Factoring Term >
<activeMoiety>
<quantity>
<numerator xsi:type="PQ" nullFlavor="OTH">
translation code="3627136"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="%" value="{Percent Value}"/>
</numerator>
denominator value="1"/>
</quantity>
<activeMoiety>
<code code="{Molecule Code}"
codeSystem="2.16.840.1.113883.6.275""/>
<name>{Molecule Name}</name>
</activeMoiety>
</activeMoiety>
</i n g redi e ntS u bsta n ce>
</ingredient>
3.4.2 Identified Inert Statement Sub-Section (3565732)
This label sub-section includes statements which identify toxic ingredients, petroleum
distillates, sodium nitrite, or other compounds which are required to be disclosed. If this
sub-section applies to a product, enter the appropriate text in this sub-section text area. If
this sub-section does not apply to the product, leave the sub-section text area blank.
 Reference: LRM Chapter 5.
Entry type: Text.
Validation Procedures:
3.4.2.0.1
3.4.2.0.2
3.4.2.0.3
There is one Identified Inert Statement sub-section with a code of
3565732 and a displayName of "Identified Inert Statement".
Identified Inert Statement sub-section <title> must match the
displayName.
If Identified Inert Statement is not applicable to the product, leave
the <text> element blank.
28
(DRAFT)
</pre><hr><pre>
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Figure 19: Identified Inert Statement Sub-section XML Code Snippet
<sectiori ID="Section Link">
<id root-'Section UUID"/>
<code code-'3565732"
codeSystem-'2.16.840.1.113883.6.275.1"
displayName-'Identified Inert Statement'7>
<title>ldentified Inert Statement


3.4.3 Deterioration/Expiration Statement Sub-Section (3144196)
This label sub-section includes statements regarding the deterioration of a product during
storage. In cases where it is determined that a pesticide formulation changes chemical
composition significantly over time, the product must bear a statement in this sub-section
of the label. If this sub-section applies to the product, enter the appropriate text in this
sub-section text area. If this sub-section does not apply to the product, leave the sub-
section text area blank.
	Examples: "Not for sale or use after (date)" or "Degrades with age.
	Reference: 40 CFR 156.10(g)(6)(i); LRM Chapter 5.
Entry type: Text.
Validation Procedures:
3.4.3.0.1
3.4.3.0.2
3.4.3.0.3
lessag
There is one Deterioration/Expiration Statement sub-section with a
code of 3144196 and a displayName of "Deterioration/Expiration
Statement".
Deterioration/Expiration Statement sub-section  must match
the displayName.
If Deterioration/Expiration Statement is not applicable to the
product, leave the <text> element blank.
Figure 20: Deterioration/Expiration Statement XML Code Snippet
<section ID="Section Link">
<id root-'Section UUID"/>
<code code-'3144196"
codeSystem="2.16.840.1.113883.6.275.1"
displayName-'Deterioration/Expiration Statement"/>
<title>Deterioration/Expiration Statement


3.5 Child Hazard Warning/Signal Word Section
3.5.0 Section in General
This content section and sub-sections include statements and images regarding the Child
Hazard Warning and the Signal Word. Free text and images regarding the Child Hazard
Warning are added in the section text area for possible contact with children during
distribution, storage, and/or use. Associated Signal Word and Signal Word Qualifiers are
added by selecting inputs from the respective, pre-determined EPA lists.
 Example: Child Hazard Warning free text may include "Keep out of Reach of
Children" with an image of a skull and cross-bones in the section text area. The
associated Signal Word may include "Danger" with a Signal Word Qualifier of
"Poison [skull and cross-bones]".
3.5.1 Child Hazard Warning/Signal Word Statement (Section Text)
If a pesticide product label should contain statements regarding child safety, including
KOROC, free text should be entered in the section text area. Images may or may not be
accompany the text. If this section does not apply to the product, leave the section text
area blank.
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Entry type: Text.
Validation Procedures:
3.5.1.0.1
3.5.1.0.2
There is one Child Hazard Warning/Signal Word section with a code of
3567150 and a displayName of "Child Hazard Warning/Signal Word".
Child Hazard Warning/Signal Word section  must match the
displayName.
3.5.1.1 Signal Word
This label attribute is the selection of a signal word from a defined set of terminology.
 Reference: LRM Chapter 7 and 10; 40 CFR 156.206(e).
Entry type: "Signal Word' picklist selection.
Validation Procedures:
Error Messages
3.5.1.1.2
3.5.1.1.3
Signal Word is required and cannot be null.
Signal Word code and displayName must come from the list "Signal
Word" (1004401) and are captured under <asSpecializedKind>.
Signal Word codeSystem is 2.16.840.1.113883.6.275.1.
3 .5.1.2 Signal Word Qualifier
This label attribute is the optional selection of a term to accompany the signature
word (e.g., Peligro).
 Reference: LRM Chapter 7 and 10; 40 CFR 156.206(e).
Entry type: "Signal Word Qualifier" picklist selection.
Validation Procedures:
Error Messages
3.5.1.2.2
3.5.1.2.3
3.5.1.2.4
There is zero or one Signal Word Qualifier per Signal Word.
Signal Word Qualifier code and displayName must come from the list
"Signal Word Qualifier" and are captured under <qualifier>.
Signal Word Qualifier codeSystem is 2.16.840.1.113883.6.275.1.
There is zero or one "image" included in the "Child Hazard
Warning/Signal Word" section.
30
(DRAFT)
</pre><hr><pre>
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Figure 21: Child Hazard Warning/Signal Word XML Code Snippet
<component>
<section I D="Lac57fb2d-2975-42ee-a868-e3c5020ba88a">
<id root="ac57fb2d-2975-42ee-a868-e3c5020ba88a"/>
<code code="3567150"
codeSystem-'2.16.840.1.113883.6.275.1"
displayName-'Child Hazard Warning/Signal Word"/>
<title>Child Hazard Warning/Signal Word



















	
3.6 Product Profile
3.6.0	Section in General
This content section includes information that is unique to a pesticide product and that
generally appears on the front page of a pesticide product label, including: Primary Brand
Name, Alternate Brand Name(s), Product Number, EPA Company Number, Company
Name, Pesticide Classification, Net Contents or Net Weight, and Batch Code. This
section includes the paragraph or phrase typically found under the product name of the
label describing the type of product, formulation, its uses, pests it controls, and other
categories or descriptors (e.g., resistance management category). NOTE: not all
information captured in this section is provided from the Product Profile screen of the
SmartLabel builder application. See above Section 1.2 Document Information for
additional information.
3.6.1	Product Profile Statement (Section Text)
Free text entered in the Product Profile section text area includes statements and/or
phrases typically found under the product name describing the type of product, its
formulation, its uses, pests it controls, and other categories or descriptors (e.g., resistance
management category). This content section may also include other descriptors for the
product that are NOT contained in the Ingredient Statement, Precautionary Statements,
Directions for Use, Warranty/Disclaimer Statement, or Marketing/Advertising Claims
sections.
Entry type: Text.
Validation Procedures:
3.6.1.0.1	There is one Product Profile section with a code of 3144190 and a
displayName of "Product Profile".
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3.6.1.0.2	Product Profile section  must match the displayName.
3.6.1.1 Product Number
This is a unique number assigned to the product by EPA. This number is
combined with the EPA Company Number to form a unique identifier for each
registered pesticide product, known as the EPA Registration Number. While
this number exists in the Product Profile section per the Pesticide Product Label
XML schema, it is captured with the Package Information of the 'Document
Information' section of the application. See above Section 1.2 Document
Information for additional information.
Entry type: Numeric text.
Validation Procedures:
3.6.1.1.1	There must be one and only one Product Number per Pesticide
Product Label.
3.6.1.2 Primary Brand Name
Primary Brand Name is the product brand name and it is required. There may
only be one Primary Brand Name associated with a registered pesticide product. It
cannot match any Alternate Brand Name(s), should any be listed.
Entry type: Text.
Validation Procedures:
3.6.1.2.1	There must be one and only one Primary Brand Name per Pesticide
Product Label.
3.6.1.3 Packaged Form
Describes the physical state and attributes of the product as packaged. If the
product is a liquid, the type of liquid (e.g., Solution, Suspension, Emulsion, or
Gel/Grease/Paste) is selected. If the product is a solid, the type of solid (e.g.,
Granule, Dust/Powder, Crystalline, Solidified Agar, Impregnated Material, or
Pellet/Tablet/Rodlet/Briquette) is selected. If the product is packaged as a gas,
then Gas/Vapor is selected. For example:
	A Water Dispersible Granule product is packed as a "granule" which is
associated with the broader term "solid".
	A Wettable Powder product is packed as a "dust/powder" which is associated
with the broader term "solid".
	A Suspension Concentrate is packaged as a "suspension" which is associated
with the broader term "liquid".
Entry type: "Physical Form" picklist selection.
Validation Procedures:
3.6.1.3.1	There must be one and only one Packaged Form per Pesticide
Product Label.
3.6.1.3.2	Packaged Form is from the list "Physical Form" and captured as
<formCode>.
32
(DRAFT)
</pre><hr><pre>
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3.6.1.4 Pesticide Classification(s)
Describes a product according to the type of pest targeted and the function of a
pesticide against the pest (e.g., fungicide, herbicide, disinfectant).
Entry type: "Pesticide Classifications'' picklist selection.
Validation Procedures:
3.6.1.4.1
3.6.1.4.2
Error Messages
There is at least one to many Pesticide Classification(s) per Pesticide
Product Label.
Pesticide Classification(s) is from the list "Pesticide Classifications".
3.6.1.5 Alternate Brand Name(s)
Includes any names associated with the registered pesticide product, other than
the Primary Brand Name, under which this product may be sold. There may be
zero to many Alternate Brand Names.
Entry type: Text.
Validation Procedures:
3.6.1.5.2
3.6.1.5.3
There are zero to many Alternate Brand Name(s) per Pesticide
Product Label.
Alternate Brand Name(s) must be unique and cannot be duplicated.
Alternate Brand Name(s) cannot match the Primary Brand Name.
33
(DRAFT)
</pre><hr><pre>
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Xml Code Snippet:
Figure 22: Product Profile XML Code Snippet
<section ID="Sectiori Link">
<id root="Section UUID"/>
<code code="3144190"
codeSystem="2.16.840.1.113883.6.275.1"
displayName=" Product Profile"/>
<title>Product Profile






Primary Brand Name


Alternate Brand Name



Alternate Brand Name














3.7 Precautionary Statements
3.7.0 Section in General
The content for this label section is contained within the subsections. It includes the
statement "Keep Out of Reach of Children." Sometimes a modified statement may be
more appropriate (see CFR Part 156.66 (b)). In those instances, the alternative statement
may be entered into the free text box for approval by the Agency.
34
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Validation Procedures:
3.7.0.0.1	There is one Precautionary Statements section with a code of 3144199
and a displayName of "Precautionary Statements".
3.7.0.0.2	Precautionary Statements section  must match the displayName.
XML Code Snippet:
Figure 23: Precautionary Statements XML Code Snippet
<section ID="Section Linl<">
<id root="Section UUID"/>
<code code="3144199" codeSystem="2.16.840.1.113883.6.275.1"
displayName=" Precautionary Statements"/>
<title>Precautionary Statements

3.7.1 First Aid (3144200)
Includes required and optional first aid statements for the four routes of exposure.
Starting with the highest toxicity category, enter each route of exposure (e.g., "If
Swallowed") and its required language. This section also includes general information
used when calling a poison control center, doctor, or National Pesticides Information
Center. Additionally, this section includes the Note to Physician with specific medical
treatment directions for a medical professional to follow in situations of exposure. If this
section applies to a product, enter the appropriate text in this section text area. If this
section does not apply to a product, leave the section text area blank.
 Reference: 40 CFR 156.68; LRM Chapter 7.
Entry type: Text.
Validation Procedures
3.7.1.0.1	There is one First Aid sub-section with a code of 3144200 and a
displayName of "First Aid".
3.7.1.0.2	First Aid sub-section  must match the displayName.
Figure 24: FIRST Aid Sub-Section XML Code Snippet
<section \D="Section Link">
<id root="Section UUID"/>
<code code="3144200"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="First Aid"/>
<title>First Aid


3.7.2 Hazards to Humans and Domestic Animals (3144205)
Includes "Precautionary Statements", a product's signal word, and statement(s) that
describe a particular hazard, route of exposure, and precautions to be taken. These
statements are determined by the acute toxicology assessment and must be written
verbatim. If this section applies to a product, enter the appropriate text in this section text
area. If this section does not apply to a product, leave the section text area blank.
 Reference: 40 CFR 156.70; LRM Chapter 7.
Entry type: Text.
35
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Validation Procedures
3.7.2.0.1	There is one Hazards to Humans and Domestic Animals sub-section
with a code of 3144205 and a displayName of "Hazards to Humans and
Domestic Animals".
3.7.2.0.2	Hazards to Humans and Domestic Animals sub-section  must
match the displayName.
Figure 25: Hazards to Humans and Domestic Animals Sub-Section XML Code Snippet
<section ID="Secf/'on Link">
<id root-'Section UUID"/>
<code code="3144205"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="Hazards to Humans and Domestic Animals"/>
<title>Hazards to Humans and Domestic Animals


3.7.3 Personal Protective Equipment (PPE) (3144206)
Lists all of the required PPE. This includes requirements for clothing, respiratory
protection, and protective eyewear for uses covered under the Worker Protection
Standard (WPS) as well as label-required baseline work clothes for end-use occupational
use products (non-WPS). If this section applies to a product, enter the appropriate text in
this section text area. If this section does not apply to a product, leave the section text
area blank.
 Reference: 40 CFR 170.240; LRM Chapter 10.
Entry type: Text.
Validation Procedures:
3.7.3.0.1
3.7.3.0.2
There is one Personal Protective Equipment sub-section with a code of
3144206 and a displayName of "Personal Protective Equipment".
Personal Protect Equipment sub-section  must match the
displayName.
Figure 26: PPE Sub-Section XML Code Snippet
<section ID="Section Linl<">
<id root="Section UUID"/>
<code code="3144206"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="Personal Protective Equipment"/>
<title>Personal Protective Equipment


3.7.4 Engineering Controls Statement (3144207)
Describes any reductions or modifications to handler PPE requirements that may be made
in the presence of certain engineering controls (e.g., closed systems, enclosed cabs, lock
and load containers). Engineering controls may be required by a regulatory assessment or
by the acute toxicity profile. If this section applies to a product, enter the appropriate text
in this section text area. If this section does not apply to a product, leave the section text
area blank.
36
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	Example: When handlers use closed systems, enclosed cabs, or aircraft, in a manner
that meets the requirements listed in the WPS for agricultural pesticides [40 CFR
170.240 (d) (4-6)], the handler PPE requirements may be reduced or modified as
specified in the WPS.
	Reference: 40 CFR 170.240 (d) (4-6). LRM Chapter 10.
Entry type: Text.
Validation Procedures:
ID Numbers Validation Error Messages	|
3.7.4.0.1	There is one Engineering Controls Statement sub-section with a code of
3144207 and a displayName of "Engineering Controls Statement".
3.7.4.0.2	Engineering Controls Statement sub-section  must match the
displayName.
Figure 27: Engineering Controls Statement Sub-Section XML Code Snippet
<section ID="Section Linl<">
<id root="Section UUID"/>
<code code="3144207"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="Engineering Controls Statement"/>
<title>Engineering Controls Statement


3.7.5 User Safety Requirements (3144208)
Includes label language for maintaining PPE and handling contaminated PPE, as well as
any specific user safety requirements described in RED and other Agency documents that
this section is required for all occupational use products, both WPS and non-WPS. If this
section applies to a product, enter the appropriate text in this section text area. If this
section does not apply to a product, leave the section text area blank.
	Example: "Follow manufacturer's instructions for cleaning/maintaining PPE. If no
such instructions for washables exist, use detergent and hot water. Keep and wash
PPE separately from other laundry."
	Reference: 40 CFR 170.240, 40 CFR156.200-212. LRM Chapter 10.
Entry type: Text.
Validation Procedures:
3.7.5.0.1	There is one User Safety Requirements sub-section with a code of
3144208 and a displayName of "User Safety Requirements".
3.7.5.0.2	Use Safety Requirements sub-section  must match the
displayName.
Figure 28: User Safety Requirements Code Snippet
<section ID="Section Link">
<id root-'Section UUID"/>
<code code="3144208"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="User Safety Requirements"/>
<title>User Safety Requirements


37
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3.7.6 User Safety Recommendations (3144209)
This label section includes user safety information and additional recommendations for
users of products that fall within the scope of the WPS. These statements are required for
all WPS products, but are also required for many non-WPS occupational use products
based upon regulatory assessments. If this section applies to a product, enter the
appropriate text in this section text area. If this section does not apply to a product, leave
the section text area blank.
	Example: "Users should remove PPE immediately after handling this product. Wash
the outside of gloves before removing. As soon as possible, wash thoroughly and
change into clean clothing."
	Reference: PR Notice 93-7, Supplement Three. LRM Chapter 10.
Entry type: Text.
Validation Procedures:
3.7.6.0.1
3.7.6.0.2
There is one Use Safety Recommendations sub-section with a code of
3144209 and a displayName of "User Safety Recommendations".
User Safety Recommendations sub-section  must match the
displayName.
Figure 29: Use Safety Recommendations XML Code Snippet
<section ID="Section Linl<">
<id root="Section UUID"/>
<code code="3144209"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="User Safety Recommendations"/>
<title>User Safety Recommendations


3.7.7 Environmental Hazards (3144210)
Provides precautionary information on potential hazards to the environment from
transport, use, storage, and/or spill of the product based on environmental fate and
toxicity data. These hazards may be to water, soil, air, and/or to animals or plants. This
section may also contain other mandatory environmental label statements (e.g., Aquatic
Weed Control Statement, Irrigation Water Statement, Mosquito Control Statement,
Endangered Species Bulletins, Point Discharge Statement, and Seed Treatment
Statement). If this section applies to a product, enter the appropriate text in this section
text area. If this section does not apply to a product, leave the section text area blank.
 Reference: 40 CFR 156.80-85; LRM Chapter 8.
Entry type: Text.
Validation Procedures:
3.7.7.0.1	There is one Environmental Hazards sub-section with a code of
3144210 and a displayName of "Environmental Hazards".
3.7.7.0.2	Environmental Hazards sub-section  must match the
displayName.
38
(DRAFT)
</pre><hr><pre>
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Figure 30: Environmental Hazards Sub-section XML Code Snippet
<section ID="Secf/'on Link">
<id root="Section UUID"/>
<code code="3144210" codeSystem="2.16.840.1.113883.6.275.1"
displayName="Environmental Hazards"/>
<title>Environmental Hazards


3.7.8 Physical and Chemical Hazards (3144212)
Includes language and symbols regarding physical and/or chemical hazards for the
product, as well as the various required precautions identified in the product chemistry
review. If this section applies to a product, enter the appropriate text in this section text
area. If this section does not apply to a product, leave the section text area blank.
	Example: "Combustible. Do not use or store near heat or open flame."
	Reference: 40 CFR 156.78. LRM Chapter 9.
Entry type: Text.
Validation Procedures:
3.7.8.0.1	There is one Physical and Chemical Hazards sub-section with a code of
3144212 and a displayName of "Physical and Chemical Hazards".
3.7.8.0.2	Physical and Chemical Hazards sub-section  must match the
displayName.
Figure 31: Physical and Chemical Hazards Sub-section XML Code Snippet
<section ID="Secf/on Link">
<id root-'Section UUID"/>
<code code="3144212" codeSystem="2.16.840.1.113883.6.275.1"
displayName="Physical and Chemical Hazards"/>
<title>Physical and Chemical Hazards


3.8 Directions for Use
3.8.0 Section in General
The content for this label section is contained within the main section and its sub-
sections. Information presented here in a clear, concise, and effective manner describes
how a product can legally be used and how a product must not be used. It is critical to
distinguish the statements that are intended to be enforceable from those that are included
for informational purposes.
 Reference 40 CFR 156.10(i).
3.8.1 Directions for Use Statement (Section Text)
Include the statement "It is a violation of Federal law to use this product in a manner
inconsistent with its labeling." Other statements relating to misuse are acceptable for
residential/household-use products (e.g., "Read the Label First"). These additional
statements can appear on the label following the required misuse statement above noted.
Other products may require additional language (e.g., "Do not apply this product in a way
that will contact workers or other persons, either directly or through drift.", "Only
39
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protected handlers may be in the area during application,", or "For any requirements
specific to your state or tribe, consult the state or tribal agency responsible for pesticide
regulation.")
 Reference: LRM Chapter 11.
Entry type: Text.
Validation Procedures:
3.8.1.0.1
3.8.1.0.2
3.8.1.0.3
3.8.1.0.4
lessag
There is one Directions for Use section with a code of 3144213 and
displayName of "Directions for Use".
Directions for Use section  must match the displayName.
The following statement must be present in the Directions for Use
statement section <text>: "IT IS A VIOLATION OF FEDERAL LAW TO USE
THIS PRODUCT IN A MANNER INCONSISTENT WITH ITS LABELING."
If product is a RUP, then the text "Restricted Use Pesticide" should
appear in the Directions for Use section <text>.
Figure 32: Directions for Use Section XML Code Snippet
<section ID="Secf/'on Link">
<id root-'Secf/'on UUID"/>
<code code="3144213" codeSystem="2.16.840.1.113883.6.275.1"
displayName="Directions for Use"/>
<title>Directions for Use

lt is a violation of Federal law to use this product in a manner
inconsistent with its	labeling.


3.8.2 Agricultural Use Requirements (3144215)
Includes all text associated with the Agricultural Use Requirements box, including early
entry PPE and Restricted Entry Interval (REI) information. If this section applies to a
product, enter the appropriate text in this section text area. If this section does not apply
to a product, leave the section text area blank.
 Reference: WPS-required language can be found in CFR 156.206.
Entry type: Text.
Validation Procedures:
3.8.2.0.1
3.8.2.0.2
lessag
There is one Agricultural Use Requirements sub-section with a code of
3144215 and a displayName of "Agricultural Use Requirements".
Agricultural Use Requirements sub-section  must match the
displayName.
40
(DRAFT)
</pre><hr><pre>
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Figure 33: Agricultural Use Requirements Sub-section XML Code Snippet
<section ID="Secf/'on Link">
<id root="Section UUID"/>
<code code="3144215" codeSystem="2.16.840.1.113883.6.275.1"
displayName="Agricultural Use Requirements"/>
<title>Agricultural Use Requirements


3.8.3 Non Agricultural Use Requirements (3144216)
Includes any applicable use requirements that are not within the scope of WPS. Enter the
statement, "The requirements in this box apply to uses of this product that are NOT
within the scope of the WPS for agricultural pesticides (40 CFR Parti 70)," as well as any
entry restrictions, notification requirements, or other statements and instructions that
apply to the non-WPS uses on the label. If this section applies to a product, enter the
appropriate text in this section text area. If this section does not apply to a product, leave
the section text area blank.
 This section only needs to be entered if a label includes both WPS and non-WPS use
sites.
Entry type: Text.
Validation Procedures:
3.8.3.0.1	There is one Non Agricultural Use Requirements sub-section with a
code of 3144216 and a displayName of "Non Agricultural Use
Requirements".
3.8.3.0.2	Non Agricultural Use Requirements sub-section  must match the
displayName.
Figure 34: Non Agricultural Use Requirements Sub-section XML Code Snippet
<section ID="Secf/'on Link">
<id root="Section UUID"/>
<code code="3144216" codeSystem="2.16.840.1.113883.6.275.1"
displayName="Non Agricultural Use Requirements"/>
<title>Non Agricultural Use Requirements


3.8.4 Resistance Management (3144217)
Provides details on precautions, directions, and restrictions related to resistance
management of the chemistries of the product and frequently references the
IRAC/HRAC/FRAC groups or Integrated Pest Management (IPM) practices. If
"Biopesticide: Plant Incorporated Protectant" is selected for the Pesticide Category, then
this section must be included. If this section applies to a product, enter the appropriate
text in this section text area. If this section does not apply to the product, leave a section
text area blank.
Entry type: Text.
Validation Procedures:
3.8.4.0.1
Error Messages
There is one Resistance Management" sub-section with a code of
3144217 and a displayName of "Resistance Management".
41
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3.8.4.0.2
Resistance Management sub-section  must match the
displayName.
Figure 35: Resistance Management Sub-section XML Code Snippet
<section ID="Secf/'on Link">
<id root="Section UUID"/>
<code code="3144217" codeSystem="2.16.840.1.113883.6.275.1"
displayName="Resistance Management"/>
<title>Resistance Management


3.8.5 Spray Drift (3144230)
Includes any mandatory spray drift prevention language as well as any advisory language
that is applicable to a product. If this section applies to a product, enter the appropriate
text in this section text area. If this section does not apply to a product, leave the section
text area blank.
Entry type: Text.
Validation Procedures:
3.8.5.0.1	There is one Spray Drift Management sub-section with a code of
3144230 and a displayName of "Spray Drift Management".
3.8.5.0.2	Spray Drift Management sub-section  must match the
displayName.
Figure 36: Spray Drift Management Sub-section XML Code Snippet
<section ID="Secf/'on Link">
<id root-'Section UUID"/>
<code code="3144230" codeSystem="2.16.840.1.113883.6.275.1"
displayName="Spray Drift Management"/>
<title>Spray Drift Management


3.8.6 Rotational Crop Intervals (3144229)
Includes statements regarding the timing of planting for subsequent food/feed crops or
cover crops following failure/harvest of a treated crop. Also contains relevant information
on grazing/harvest restrictions. Plant-back intervals are typically expressed in days or
months. It is recommended that this information is displayed in a table for ease of use. If
this section applies to a product, enter the appropriate text in this section text area. If this
section does not apply to a product, leave the section text area blank.
Entry type: Text.
Validation Procedures:
3.8.6.0.1	There is one Rotational Crop Intervals sub-section with a code of
3144229 and a displayName of "Rotational Crop Intervals".
3.8.6.0.2	Rotational Crop Intervals sub-section  must match the
displayName.
42
(DRAFT)
</pre><hr><pre>
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Figure 37: Rotational Crop Interval Sub-section XML Code Snippet
<section ID="Secf/on Link">
<id root="Section UUID"/>
<code code="3144229" codeSystem="2.16.840.1.113883.6.275.1"
displayName="Rotational Crop lntervals"/>
<title>Rotational Crop lntervals


3.8.7 Seed Bag Labeling Requirements (3144214)
Contains instructions to the applicator/seed treater regarding labeling requirements for
bags containing treated seed. If this section applies to a product, enter the appropriate text
in this section text area. If this section does not apply to a product, leave the section text
area blank.
	If it applies, Seed Bag Labeling must include the specific language required under the
Federal Seed Act:
(1)	A word or statement indicating that the seeds have been treated;
(2)	The commonly accepted coined, chemical (generic), or abbreviated chemical
name of any substance used in such treatment;
(3)	If the substance used in such treatment in the amount remaining with the seeds
is harmful to humans or other vertebrate animals, an appropriate caution statement
provided by the Secretary of Agriculture as adequate for the protection of the
public, such as "Do not use for food or feed or oil purposes."
	Seed bag labeling may also include statements requested by EPA that are intended to
provide the end-user of the treated seed with precautionary and hazard information,
planting requirements, disposal instructions, and other restrictions (e.g., PPE for the
planter, minimum planting depth, seeding rate restrictions, plant-back restrictions,
excess seed disposal instructions).
Entry type: Text.
Validation Procedures:
3.8.7.0.1
3.8.7.0.2
There is one Seed Bag Labeling Requirements sub-section with a code
of 3144214 and a displayName of "Seed Bag Labeling Requirements".
Seed Bag Labeling Requirements sub-section  must match the
displayName.
Figure 38: Seed Bag Labeling Requirements Sub-section XML Code Snippet
<section ID="Secf/'on Link">
<id root-'Section UUID"/>
<code code="3144214" codeSystem="2.16.840.1.113883.6.275.1"
displayName="Seed Bag Labeling Requirements"/>
<title>Seed Bag Labeling Requirements


3.8.8 Storage and Disposal Subsection (3144244)
Contains information on storage, pesticide disposal, and container handling/disposal. This
subsection has further data elements, see details in Section 3.8.8.1 Container Type
below.
	All products, except for residential/household-use products, must bear the following
statement: "Do not contaminate water, food, or feed by storage or disposal."
	All products must contain storage statements, which may be chemical-specific (as
identified by EPA in the LRM) or non-chemical specific.
43
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	Pesticide disposal instructions include information on how to dispose of leftover
pesticide. Pesticide disposal and container handling statements are generally specific
to the uses of the product contained and the type of container itself. For
residential/household-use products, pesticide disposal and container handling
statements may be combined.
	Container handling instructions include information on whether the container is
refillable or non-refillable, a reuse statement, a recycling/reconditioning statement,
and information on how to remove residues from emptied pesticide containers and
what to do with the pesticide container after it is emptied. Plant-incorporated
protectants, pesticidal articles not exempted from Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) by  152.25(a), transport vehicles, and products listed in
156.140(a) (5) are not required to have refillable/non-refillable and reuse statements.
	Reference LRM Chapter 13.
Entry type: Text.
Validation Procedures:
3.8.8.0.1	There is one Storage and Disposal" sub-section with a code of 3144244
and a displayName of "Storage and Disposal".
3.8.8.0.2	Storage and Disposal sub-section  must match the displayName.
Figure 39: Storage and Disposal Sub-section XML Code Snippet
<section ID="Secf/'on Link">
<id root-'Section UUID"/>
<code code="3144244" codeSystem="2.16.840.1.113883.6.275.1"
displayName="Storage and Disposal"/>
<title>Storage and Disposal


3.8.8.1 Container Type
Identifies the types of containers in which a product is packaged.
Entry type: "FormCode" picklist selection.
Validation Procedures:
3.8.8.1.1	Storage and Disposal sub-section has at least one "Container Type"
captured as  under .
3.8.9 Product Application Instructions/Information Subsection (3144218)
Includes any product application instructions that are consistent across all labeled use
sites not described in the above sections. Information in this sub-section includes:
directions to users for opening the package (e.g., shake before using and specific child-
resistant packaging instructions); application methods and equipment instructions (e.g.,
aerial, ground, chemigation); environmental conditions (e.g., soil temperature, soil type,
air temperature); product restrictions; product advisory statements; and tank mix and
compatibility (includes instructions for diluting and/or mixing the product with other
chemicals prior to application). If this section applies to a product, enter the appropriate
text in this section text area. If this section does not apply to a product, leave the section
text area blank.
 Reference Chapter 11, Section 11-22 of the LRM.
44
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Entry type: Text.
Validation Procedures:
3.8.9.0.1	There is one Product Application Instructions/Information sub-section
with a code of 3144218 and a displayName of "Product Application
Instructions/Information".
3.8.9.0.2	Product Application Instructions/Information sub-section  must
match the displayName.
Figure 40: Product Application Instructions/Information Sub-section XML Code Snippet
<section ID="Secf/on Link">
<id root-'Section UUID"/>
<code code="3144218" codeSystem="2.16.840.1.113883.6.275.1"
displayName="Product Application lnstructions/lnformation"/>
<title>Product Application lnstructions/lnformation


3.8.10 Use Site Application Instructions Subsection
This label section includes application instructions specific to a use site, such as
application rate, number of applications, reapplication interval, application timing, target
pest, site-specific restrictions, etc.
Entry type: Text.
Validation Procedures:
3.8.10.0.1
3.8.10.0.2
lessag
There is at least one or more Use Site Application Instructions sub-
sections with a code of 3144234 and a displayName of "Use Site
Application Instructions".
Use Site Application Instructions sub-section  must match the
displayName.
 Use Site Application Instructions Data Elements are consistent across all labeled
use sites not described in the above sections. Information in this section includes:
directions to the users for opening the package (e.g., shake before using and specific
child-resistant packaging instructions); application methods and equipment
instructions (e.g., aerial, ground, chemigation); environmental conditions (e.g., soil
temperature, soil type, air temperature); product restrictions; product advisory
statements; and tank mix and compatibility (including instructions for diluting and/or
mixing the product with other chemicals prior to application). Refer to Section 11-22
of the LRM for more information on what to include in this section.
3.8.10.1 Use Site/Commodity
Identifies the use site. For crop use sites, the list includes all crops and crop groups. For
non-crop use sites, the list is comprised of higher level categories. See the "Crop Use
Sites" and "Non-Crop Use Sites" lists in the SmartLabel Vocabulary Guide Version
3.xlsx document for guidance.
 Pesticide Action - Identifies a pesticide's intended use (e.g., Action Against Pest,
Action Against Plant Disease, Plant Regulator) at the named Use
Site(s)/Commodities.
Entry type: "Use Site/Commodity" picklist selection.
45
(DRAFT)
</pre><hr><pre>
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Validation Procedures:
3.8.10.1.1	There is at least one to many "Use Site/Commodity" entries.
3.8.10.1.2	Use Site(s)/Commodity has a code of 3810088 and a displayName of
"Use Site/Commodity".
3.8.10.1.3	Use Site/Commodity displayName must match the code.
3.8.10.1.4	If there is a Use Site/Commodity entry listed then there must be a
<value> element with code and displayName.
3.8.10.1.5	Use Site/Commodity <value> code must come from the list "Registered
Use Site" under codeSystem 2.16.840.1.113883.6.275.1.
3.8.10.1.6	Use Site/Commodity <value> code must match the displayName.
3.8.10.1.7	There is at least one Pesticide Action associated with Use
Site/Commodity.
3.8.10.1.8	Pesticide Action has an effect code.
3.8.10.1.9	Pesticide Action code must come from the list "Pesticide Action" under
codeSystem is 2.16.840.1.113883.6.275.1.
3.8.10.1.10	Pesticide Action code must match the displayName.
3.8.10.2 Use Site Location
Gives a broad category-based description of where a pesticide treatment takes place (e.g.,
Agricultural (indoor), Agricultural (outdoor), Medical/Hospital/Veterinary Facility
(indoor), etc.). The Use Site and Use Site Location work together to fully define where
pesticide application occurs.
Entry type: "Use Site Location" picklist selection.
Validation Procedures:
3.8.10.2.1	There is at least one to many Use Site Location(s).
3.8.10.2.2	Use Site Location(s) is captured as code and displayName under
<approachSiteCode>.
46
(DRAFT)
</pre><hr><pre>
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Figure 41: Use Site Application Instructions Sub-section XML Code Snippet
<section ID="Sectiori Link">
<id root="Section UUID"/>
<code code="3144218" codeSystem="2.16.840.1.113883.6.275.1"
displayName="Product Application lnstructions/lriformation"/>
<title>Product Application lnstructions/lnformation




-------
Figure 42: Use Site Application Instructions Sub-section XML Code Snippet (Continued)








3.8.10.3 Action(s) Against Pest
Specifies that the pesticide's effect against a target pest. The selection of an action
indicates the expected outcome of the pesticide when applied to said target pest; e.g.,
Attract, Kill, Prevent, or Repel.
	Pesticide Action identifies if an intended pesticide use at the named Use
Site(s)/Commodities is an Action Against Pest, Action Against Plant Disease, or
Plant Regulator Function.
	Target Pest identifies the specific pest(s) for which a pesticide may be used to
prevent, destroy, repel, or mitigate.
	Pest Stage identifies the development stage(s) of a target pest when a pesticide
should be applied.
48
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Entry type: "Actions Against Pesf picklist selection.
Validation Procedures:
J I Ml
3.8.10.3.1
3.8.10.3.2
3.8.10.3.3
3.8.10.3.4
3.8.10.3.5
3.8.10.3.6
3.8.10.3.7
3.8.10.3.8
If Pesticide Action is "Action Against Pest" then there must be a Target
Pest element.
Target Pest codes are from the list "Target" under codeSystem
2.16.840.1.113883.6.275.
Target Pest displayName must match the code.
Target Pest must have at least one or more Pest Stage(s) under
.
Pest Stage has a code of 1004703 and a displayName of "Pest Stage".
If there is a Pest Stage then there must be a  element with code
and displayName.
Pest Stage  codes are from the list "Pest Stage" under
codeSystem 2.16.840.1.113883.6.275.1.
Pest Stage  displayName must match the code.
3.8.10.4 Action(s) Against Plant Disease
Specifies that the effect of a pesticide is against a target plant disease. The selection of an
action here indicates the expected outcome of the pesticide is to treat an existing plant
disease and/or prevent the emergence of one.
	Pesticide Action identifies if an intended use of a pesticide at the named Use
Site(s)/Commodities is an Action Against Pest, Action Against Plant Disease, or
Plant Regulator Function.
	Plant Disease identifies the specific plant disease(s) for which a pesticide may be
used.
Entry type: "Actions Against Plant Disease" picklist selection.
Validation Procedures:
J IV
3.8.10.4.1
Error Messages
If Pesticide Action is "Action Against Plant Disease" then there must be
a Plant Disease element.
3.8.10.4.2	Plant Disease codes are from the list "Plant Disease" under codeSystem
2.16.840.1.113883.6.275.1.
3.8.10.4.3	Plant Disease displayName must match the code.
3.8.10.5 Plant Regulator Function
Specifies that the effect of a pesticide is intended for plant regulation.
	Pesticide Action identifies if the intended use of a pesticide at the named Use
Site(s)/Commodities is an Action Against Pest, Action Against Plant Disease, or
Plant Regulator Function.
	Plant Regulator Function describes the intent of a pesticide as accelerating or
retarding growth, or altering plant behavior or the produce of the plant.
Entry type: "Plant Regulator Function" picklist selections.
Validation Procedures:
3.8.10.5.1
3.8.10.5.2
3.8.10.5.3
If Pesticide Action is "Plant Regulator Function" then there must be a
Plant Regulator Function element.
Plant Regulator Function codes are from the list "Plant Regulator
Function" under codeSystem 2.16.840.1.113883.6.275.1.
Plant Regulator Function displayName must match the code.
49
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Figure 43: Pesticide Action - Plant Regulator XML Code Snippet








	
3.9 Warranty/Disclaimer Statement
3.9.0	Section in General
The content for this label section is language describing the warranty and disclaimer
statement, and/or terms of use for a pesticide product.
3.9.1	Warranty and Disclaimer Statement (Section Text)
If this section applies to a product, enter the appropriate text in this section text area. If
this section does not apply to a product, leave the section text area blank.
 Reference: LRM Chapter 12.
Entry type: Text.
Validation Procedures:
3.9.1.0.1	There is one Warranty/Disclaimer section with a code of 3144249 and a
displayName of "Warranty/Disclaimer".
3.9.1.0.2	Warranty/Disclaimer section  must match the displayName.
Figure 44: Warranty/Disclaimer Section XML Code Snippet
<section \D="Section Link">
<id root-'Section UUID"/>
<code code="3144249" codeSystem="2.16.840.1.113883.6.275.1"
displayName="Warranty/Disclaimer"/>
<title> Warranty/Disclaimer 


3.10 Marketing/Advertising Claims
3.10.0	Section in General
The content for this label section is a statement of something as a fact or an assertion on
the label open to challenge which is accepted by EPA.
3.10.1	Marketing and Advertising Claims Statement (Section Text)
This section contains a comprehensive numbered list of optional language used to market
a product or make claims about the effectiveness or characteristics of a product. If this
section applies to a product, enter the appropriate text in this section text area. If this
section does not apply to a product, leave the section text area blank.
 Reference: LRM Chapter 12.
50
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Entry type: Text.
Validation Procedures:
3.10.1.0.1 There is one Marketing/Advertising Claims section with a code of
3144194 and a displayName of "Marketing/Advertising Claims".
3.10.1.0.2 Marketing/Advertising Claims section  must match the
displayName.
3.10.1.1 Certifications and Seals
Identifies third party seals or certifications displayed on the label and the associated
text (e.g., 'Good housekeeping seal of approval').
Entry type: "Certifications and Seals'' picklist selection.
Validation Procedures:
3.10.2.0.1
3.10.2.0.2
3.10.2.1.1
3.10.2.1.2
3.10.2.1.3
3.10.2.1.4
Jatior
There is one Certification(s) and Seal(s) sub-section with a code of
3852212 and a displayName of "Certification(s) and Seal(s)".
Certification(s) and Seal(s) sub-section <title> must match the
displayName.
There is zero to many Certification(s) and Seal(s) captured as code and
displayName under <approval>.
If there is a certification and/or seal then there is text associated with
the <approval>.
Certification(s) and Seal(s) codeSystem is 2.16.840.1.113883.6.275.1.
Certification(s) and Seal(s) displayName must match the code.
51
(DRAFT)
</pre><hr><pre>
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Figure 45: Marketing/ Advertising Claims Section XML Code Snippet
<section ID="Section Link">
<id root="Section UUID"/>
<code code="3144194" codeSystem="2.16.840.1.113883.6.275.1"
displayName="Marketing/Advertising Claims"/>
<title>Marketing/Advertising Claims




-------
at the point of sale with the product which provide expanded use patterns or specific
instructions for geographic locations/application equipment/pests controlled or other
variable.
 Reference: LRM Chapter 18.
Entry Type: PDF document upload from a user's local machine. Document
uploads are saved to the 'Attachment' folder in the ZIP file.
Validation Procedures
3.11.0.0.1
3.11.0.0.2
3.11.0.0.3
3.11.0.0.4
3.11.0.0.5
3.11.0.0.6
There is one Additional Documentation and Labeling section with a
code of 3144228 and a displayName of "Additional Documentation and
Labeling".
Additional Documentation and Labeling section  must match the
displayName.
There is zero to many document or label attachment references in the
Additional Documentation and Labeling section.
Additional Documentation and Labeling attachments must have a "text"
element with mediaType and "reference".
Additional Documentation and Labeling "reference" value must be the
same as the valid filename of the respective attachment.
Additional Documentation and Labeling filename extension must match
the mediaType ".pdf" or ".PDF".
Figure 46: Additional Documentation and Labeling Section XML Code Snippet
<section ID="Section Link">
<id root="Section UUID"/>
<code code="3144228" codeSystem="2.16.840.1.113883.6.275.1"
displayName="Additional Documentation and Labeling"/>
<title>Additional Documentation and Labeling








reference value="20150304_5fa97bf5-28a2-48fl-8955-f56012d296be.pdf"/>







reference value="20141215_4bca97bf5-28a2-48fl-8955-f56012d296be.pdf"/>



53
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4 Use Index
The goal of a Use Index document is to capture and display the unique use patterns
registered for each label in a queryable, tabular format that can easily be compared across
registrations. This is accomplished by translating narrative use patterns in the Product
Labeling document and capturing them as combinations of discrete, predefined picklist
terms and value entries. A Use Index can then be used as a tool to review and assess a
Pesticide Product Label registration.
This document captures data as terms from a picklist, and/or value unit combinations. If
a picklist is used, the name of the picklist will be listed in the "Entry type" field of each
sub-section. The items in each picklist and their definitions are compiled on the
SmartLabel website:
httns://www.ena.pov/nesticide-repistration/nesticide-SmartLahel-nilot-documents.
This document and the definitions it contains can be used to aid the user select the correct
term when filling out a Use Index document. If a term to fit your needs cannot be found,
please contact SmartLaheKa)ena.eov for assistance determining the correct term. If an
appropriate term cannot be found, a new term can be established and added to the
vocabulary. Please periodically refer to the SmartLabel website for the most current
listing of vocabularies and definitions as new terms will be added on a semi-regular basis.
4.1 Use Index SPL Header
4.1.0 Section in General
This section provides basic information for the identity of a Use Index document, its type,
title, date, and versioning as a member of a document set. This information is captured in
the Document Information section of the application and stored as part of the Use Index
XML schema. See above Section 1.2 Document Information for additional information.
4.1.1 Document Type
This is the header name of the SmartLabel document containing data on the general
subject matter of a label; i.e., Use Index.
Entry type: "Document type" picklist selection.
Validation Procedures:
4.1.1.0.1
4.1.1.0.2
4.1.1.0.3
4.1.1.0.4
4.1.1.0.5
There is one Use Index "Document Type" with a code of 3810133 and
a displayName of "Use Index".
Use Index code comes from EPA's Document Type list.
Use Index codeSystem is 2.16.840.1.113883.6.275.1.
Use Index displayName matches the code.
If a document with the same set id was previously submitted then
this document and the previous document are of the same type.
Figure 47: Use Index Document Type XML Code Snippet







54
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4.1.2 Author Information
This provides basic information about the business responsible for the registered
pesticide product, including the Company Name and EPA Company Number. See
above Section 1.2 Document Information (Package Information Section) for
additional information.
4.1.2.1	Company Name
Identifies the name of the organization registering the pesticide product using the
Company Name registered with EPA. It is associated with the EPA Company Number
and is populated from the CDX account of the user who created the SmartLabel
document. See above Section 1.2 Document Information (Package Information
Section) for additional information.
Entry type: Text.
Validation Procedures:
ID Numbers Validation Error Messages	j
4.1.2.1.1	There is one Company Name (author) captured as  under
.
4.1.2.1.2	Only  and  should be present under
.
4.1.2.1.3	Company Name matches the name in the EPA Company Number list.
4.1.2.2	EPA Company Number
Identifies the organization associated with a pesticide product using a registered EPA
Company Number. This identifier has a root of 2.16.840.1.113883.6.275.1 and
extension. It is associated with the Company Name and is populated from the CDX
account of the user who created the SmartLabel document. See above Section 1.2
Document Information (Package Information Section) for additional information.
Entry type: Value.
Validation Procedures:
4.1.2.2.1	There is one EPA Company Number captured as  under
.
55
(DRAFT)

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Figure 48: Author Information XML Code Snippet
Author information is used to identify the business responsible for the product,
represented here by the EPA registered Company Name and Company number. The
Company Name is the name registered with EPA, and the Company number is the unique
1-6 digit number assigned to the company by the EPA (product number is entered in
another section)





{Company Name}



4.2 Use Index SPL Body
4.2.0 Section in General
The body of a Use Index document includes structured text (e.g., Company Name),
structured values (e.g., Percent Active Ingredient), and/or specific data elements from
pick-lists (e.g., Use Site Locations).
Sections and sub-sections have id, title, and code. The Section Names list provides the
codes used for sections and sub-sections.
Refer to Section 2.2 HL7 SPL Body of this document for specific information about
how each structured XML section is coded.
Validation Procedures:
ID Numbers Validation Error Messages	1
4.2.0.0.1	Section codes must come from the list "Use Index Section Names".
4.2.0.0.2	Use Index codeSystem is 2.16.840.1.113883.6.275.1.
4.2.0.0.3	Use Index displayName must match the code.
4.2.0.0.4	Use Index  and displayName must match.
56
(DRAFT)
</pre><hr><pre>
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Figure 49: Document Information XML Code Snippet
<document>
<structuredBody>
<component>
<section>
<!-- other elements -->
<code code="{Section Code}" codeSystem="2.16.840.1.113883.6.275.1"
displayName="{Section DisplayName}">
<title>Company Name





4.2.1 Use Index Sections The SPL Body sections of a Use Index document are interpreted as a hierarchy. There are three main sections (levels) in the hierarchy; as below depicted: Product Level describes the registration and the restrictions/limitations that apply to all use sites and methods of application. Site Level describes the place that the pesticide is intended to be applied, and the restrictions/limitations that apply to all application methods at the site. Scenario Level describes the methods with which an application can be made to the site using a specified rate pattern, and the restrictions/limitations that apply to those application methods. Information entered at a higher level applies to all levels that fall below it in the model. Thus, all information entered at the Product level applies to all Use Sites and all Scenarios; and information entered at the Use Site level applies to all Scenarios for that Use Site. Information must be entered only at the lowest level of differentiation, so as not to contradict information entered at higher levels (including rates and limitations). Entry of data for the same field at multiple levels will result in a validation error. Therefore, the user should give thought to where a given data element falls in the hierarchy before they extract information from the label. The Use Index document contains only data elements. No sections within a Use Index document contain text or narrative. A skeletal XML snippet is shown below. Validation Procedures: )n Error Messages nnn M Dr/-,rl. . /-+ I 4.2.1.0.1 4.2.1.0.2 4.2.1.0.3 There is one "Product Level" section per Use Index document. There is one or more "Site Level" section(s) per Use Index document. There is one or more "Scenario Level" section(s) per Site Level section. 57 (DRAFT)

-------
Figure 50: Use Index Sections XML Code Snippets








Product Level
Product ldentification
Product Level Use Restrictions/Limitations
58 (DRAFT)

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Figure 51: Use Index Sections XML Code Snippets (Continued)

Site Level
Use Site Attributes
Use Site Yearly Rate
Use Site Level Restrictions/Limitations
Scenario Level
Scenario Rate
Product Level 59 (DRAFT)

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4.3.0 Section in General
The Product Level section is a header section that contains the Product Identification and
Product Level Use Restrictions/Limitations sub-sections. Information entered in the
Product Level sub-sections applies to all Use Sites and Scenarios.
Validation Procedures:
4.3.0.0.1
4.3.0.0.2
4.3.0.0.3
4.3.0.0.4
4.3.0.0.5
There is one "Product Level" section.
Product Level section  and displayName must match.
Product Level section link is optional.
If the Product Level section link is provided then the section link is a
unique string within the Use Index document.
Product Level section id is a unique UUID within the Use Index
document.
Figure 52: Product Level Section XML Code Snippet
<component>
<section ID="{Section Linl<}">
<id root-'{Section ld}"/>
<code code="3810084" codeSystem="2.16.840.1.113883.6.275.1"
displayName="Product Level"/>
<title>Product Level
4.3.1 Product Identification
This sub-section identifies the product and is used to link a Use Index document with a
Pesticide Product Label document for the same product. It provides basic information to
identify and characterize the particular product including registration number, active
ingredients and their percentages, and other physical characteristics of certain types of
product.
Validation Procedures:
lessag
4.3.1.0.1	There is one "Product Identification" section with code 3810085.
4.3.1.0.2	Product Identification section  and displayName must match.
4.3.1.0.3	Product Identification section link is optional.
4.3.1.0.4	If Product Identification section link is provided then the section link is a
unique string within the Use Index document.
4.3.1.0.5	Product Identification <section ID> is a unique UUID within the Use
Index document.
Figure 53: Product Identification XML Code Snippet
<component>
<section ID="{Section Linl<}">
<id root-'{Section ld}"/>
<code code="3810085" codeSystem="2.16.840.1.113883.6.275.1"
displayName="Product ldentification"/>
<title>Product ldentification
Figure 54: Product Number XML Code Snippet
Product ldentification





60
(DRAFT)

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4.3.1.1 Product Number
This is a unique number assigned to a product by EPA. This number is combined
with the EPA Company Number to form a unique identifier, known as the EPA
Registration Number, for each registered pesticide product. While this number
exists here per the Use Index XML schema, it is captured with the Package
Information in the Document Information section of the application; Refer to
Section 1.2 Document Information (Package Information Section) above for
more information.
Entry type: Numeric text.
Validation Procedures:
4.3.1.1.1
4.3.1.1.2
Error Messages
Product Number is required and cannot be null.
Product Number is assigned to the pesticide product by EPA and is part
of the Registration Number.
4.3.1.2 Active Ingredients
Identifies and characterizes the active ingredients contained in a product captured
as EPA Registry Name and Systematic Name including: a listing of active
ingredient(s) and their respective nominal concentrations (expressed as a
percentage); as well as any information regarding concentrations of equivalence
of the active ingredients, identified in this document as Factoring Term (e.g.,
elemental metallics, acid equivalents, or other moieties).
	Percent Active Ingredient is the amount of active ingredient per the total
amount of the formulated product.
	Factoring Term Ingredient optionally identifies ingredients of certain
types of chemicals that theoretically could be converted back to the
corresponding or "parent" active ingredient.
	Percent Factoring Term is the amount of a formulation that theoretically
could be converted back to the corresponding or parent active ingredient
per the total weight of the formulated product.
	Multiple Active Ingredients can be entered.
	Each Active Ingredient can contain zero or one Factoring Term
Ingredients.
Entry type: Picklist selection and value.
Validation Procedures:
4.3.1.2.1
4.3.1.2.2
4.3.1.2.3
4.3.1.2.4
4.3.1.2.5
3.4.1.1.6
Error Messages
There is at least one or more Active Ingredient(s) with name and code
provided under .
There is one Percent Active Ingredient per Active Ingredient with a unit
code of 3627136 and a displayName of
Percent Active Ingredient  is a number.
There is zero or one Factoring Term Ingredient per Active Ingredient
with name and code provided under .
There is one Percent Factoring Term per Factoring Term Ingredient
with a unit code of 3627136 and a displayName of
Percent Factoring Term value is a number.
61
(DRAFT)

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Figure 55: Active Ingredient and Percent Factoring Term XML Code Snippet
Product ldentification








translation code="3627136"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="%" value="{Percent Value}"/>





SRS Systematic Name
EPA Registry Name




translation code="3627136"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="%" value="{Percent Value}"/>





{Molecule Name}




4.3.1.3 Product Density
Identifies the weight of active ingredient per volume/mass of product. Both values and
units are entered here.
Entry type: Value unit, per value unit.
Validation Procedures:
:
Error Messages
4.3.1.3.1	Product Density is optional.
4.3.1.3.2	Product Density numerator value is a number.
4.3.1.3.3	Product Density denominator value is a number.
4.3.1.3.4	Product Density numerator units must be "pound".
4.3.1.3.5	Product Density denominator units must be "gallon".
62
(DRAFT)

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Figure 56: Product Density XML Code Snippet
Product ldentification









translation value="{Mass Quantity}"
displayName="{Unit DisplayName"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>


translation value="{Volume Quantity}"
displayName-'{Unit DisplayName"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>




4.3.1.4 Mass Product per Miscellaneous Application
The Mass Product per Miscellaneous Application identifies the mass of product per each
miscellaneous application unit as deployed (e.g., mass of active ingredient per: bait
station, per ear tag, per water soluble package, etc.). This information must be supplied if
miscellaneous application units are used in any of the rate sections at the site or scenario
level(s). Both values and units are entered.
See unit definitions in the SmartLabel Vocabulary Guide Version 3.xlsx for a
complete listing of Miscellaneous Application Units.
Entry type: Value unit, per value unit.
Validation Procedures:
4.3.1.4.1
4.3.1.4.2
4.3.1.4.3
4.3.1.4.4
4.3.1.4.5
Mass Product per Miscellaneous Application is required if
"Miscellaneous Application Units" are used in any of the rate sections at
the Site or Scenario level(s).
Mass Product per Miscellaneous Application numerator value is a
number.
Mass Product per Miscellaneous Application denominator value is a
number.
Mass Product per Miscellaneous Application numerator units must be
"Standard Weight/Mass".
Mass Product per Miscellaneous Application denominator units must
be "Miscellaneous Application".
63
(DRAFT)

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Figure 57: Mass Product per Miscellaneous Application XML Code Snippet
Product ldentification









translation value="{Mass Product}"
displayName="{Unit DisplayName" code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>

denominator xsi:type="PQ" nullFlavor="OTH">
translation value="{Misc Application Value}"
displayName="{Unit DisplayName" code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>




4.3.2 Product Level Use Restrictions/Limitations
Identifies Product Level Restrictions/Limitations, which are applicable to all use sites and
scenarios. If a restriction/limitation differs between sites, it should be entered only at the
site level. If a restriction/limitation differs between scenarios of a given site, it should be
entered only at the scenario level. Entry of data for the same field at multiple levels will
result in a validation error. Restrictions/Limitations should only be recorded in the Use
Index if the label explicitly restricts or limits the identified data element in legally
enforceable language. Statements that include terms like "should" or "for best results" are
not legally enforceable, and should not be recorded.
Multiple entries are possible for many Restrictions/Limitations. In this document, data
elements that may have multiple entries are marked with a (+) after their title.
Additionally, the validation rules for each element indicate if entry is optional and the
number of entries that can be entered.
Leaving a data element blank indicates that the respective restriction does not apply at
this level.
Validation Procedures:
'
4.3.2.0.1
4.3.2.0.2
4.3.2.0.3
4.3.2.0.4
4.3.2.0.5
bers
if I- I -	p	n <
Validation Error Messages
There is one "Product Level Use Restrictions/Limitations" section with
code 3810086.
Product Level Use Restrictions/Limitations section  and
displayName must match.
Product Level Use Restrictions/Limitations section link is optional.
If Product Level Use Restrictions/Limitations section link is provided
then the section link is a unique string within the Use Index document.
Product Level Use Restrictions/Limitations section id is a unique UUID
within the Use Index document.
64
(DRAFT)
</pre><hr><pre>
-------
Figure 58: : Product Level Use Restrictions/Limitations XML Code Snippet
<component>
<section ID="{Section Link}">
<id root="{Section ld}"/>
<code code="3810086" codeSystem="2.16.840.1.113883.6.275.1"
displayName="Product Level Use Restrictions/Limitations"/>
<title>Product Level Use Restrictions/Limitations
4.3.2.1 Geographic Area(s) Allowed (+)
Identifies restrictions associated with geographic location, at the state and county
level, by listing areas where application is allowed. This is a required field at
either the Product, Site, or Scenario level for each method. If applications of the
product are not restricted to any particular geographic area, enter "United States".
If application is not allowed in a particular area, enter all areas except the
prohibited area.
Entry type: "Geographic Area" picklist selection.
Validation Procedures:
There is at least one or more Geographic Areas per Scenario. A Scenario
is considered to have a Geographic Area if it is provided at the Product,
Site, or Scenario Level.
4.3.2.1.2	If Geographic Area is provided at the Site or Scenario Level, then it
should not also provided at the Product Level.
4.3.2.1.3	Geographic Area has a code of 1005202 and a displayName of
"Geographic Area".
4.3.2.1.4	Geographic Area displayName must match the code.
4.3.2.1.5	If there is Geographic Area listed then there must be a  element
with code and displayName.
4.3.2.1.6	Geographic Area  code and displayName must come from the
list "Geographic Area".
4.3.2.1.7	Geographic Area  displayName must match the code.
Figure 59: Geographic Area XML Code Snippet
Product Level Use Restrictions/Limitations















65
(DRAFT)

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4.3.2.2 Use Site Food Relationship
Identifies if applications are intended to come in contact with food or feed, which
may indicate the need for a pesticide tolerance or a certain kind of regulatory risk
assessment. This information is required for agricultural crops at either the
Product, Site, or Scenario levels for each method to establish whether crops may
be used as food or feed (including Bearing), or may not be used as food or feed
(including Non-Bearing/Dormant, Grown for Seed). If the product labeling for
non-agricultural sites explicitly prohibits applications that may contact food or
feed, then "Non-Food/Non-Feed Stream" should be entered.
See definitions in the SmartLabel Vocabulary Guide Version 3.xlsx for further
guidance.
Entry type: "Use Site Food Relationship" picklist selection.
Validation Procedures:
4.3.2.2.1	There is one Use Site Food Relationship per Scenario. A Scenario is
considered to have a Use Site Food Relationship if it is provided at the
Product, Site, or Scenario Level.
4.3.2.2.2	If Use Site Food Relationship is provided at the Site or Scenario Level,
then it should not also be provided at the Product Level.
4.3.2.2.3	Use Site Food Relationship has a code of 1005021 and a displayName of
"Use Site Food Relationship".
4.3.2.2.4	Use Site Food Relationship displayName must match the code.
4.3.2.2.5	If there is Use Site Food Relationship listed then there must be a
 element with code and displayName.
4.3.2.2.6	Use Site Food Relationship  code and displayName must come
from the list "Use Site Food Relationship".
4.3.2.2.7	Use Site Food Relationship  displayName must match the code.
Figure 60: Food Site Relationship XML Code Snippet
Product Level Use Restrictions/Limitations














4.3.2.3 Maximum A.I. Rate Across Products
Identifies the maximum amount of active ingredient or, in some cases, the
maximum amount of a chemical class that may be applied to a given area across
products that contain the same active ingredient. This restriction is often stated on
66
(DRAFT)

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labels as "Do not apply more than [x amount] of product per [year or crop cycle]
from this or any other product containing this active ingredient".
Entry type: Value unit, per value unit, per "Application Rate Measurement
Period" picklist selection.
Validation Procedures:
4.3.2.3.1
4.3.2.3.2
4.3.2.3.3
4.3.2.3.4
4.3.2.3.5
4.3.2.3.6
4.3.2.3.7
4.3.2.3.8
There is zero or one "Maximum Al Rate Across Products per Time".
If Maximum Al Rate Across Products per Time is provided at the
Site or Scenario Level, then it should not also provided at the
Product Level.
Maximum Al Rate Across Products per Time numerator value is a
number.
Maximum Al Rate Across Products per Time denominator value is a
number.
Maximum Al Rate Across Products per Time numerator units must
be one of the following: "Standard Weight/Mass", "Standard
Volume/Capacity", "Miscellaneous Application Unit",
"Concentration", "Non-Standard Volume/Capacity".
Maximum Al Rate Across Products per Time denominator units
must be one of the following: "Standard Area", "Standard Length",
"Standard Weight/Mass", "Standard Volume/Capacity", "Time",
"Non-Standard Volume/Capacity", "Non-standard - Target (with
area rate limit)", "Non-Standard Weight/Mass", "Miscellaneous -
Target".
Maximum Al Rate Across Products per Time  is from
the list "Application Rate Measurement Period".
If there is a Maximum Al Rate Across Products per Time numerator
value then there must also be a denominator value.
67
(DRAFT)

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Figure 61: Maximum A.I. Rate Across Products XML Code Snippet
Product Level Use Restrictions/Limitations













translation value="{Maximum Rate}"
displayName="{Unit DisplayName"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>


translation value="{Per Quantity}"
displayName="{Unit DisplayName"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>







4.3.2.4 Rotational Crop
Identifies if any rotational crop restrictions apply to this specific product. This is a
presence/absence indicator. If any restrictions to rotation plantings appear on the label,
including what may be planted following the current crop, or the length of time that must
pass before a crop can be planted in the area, then Rotational Crop should be selected.
Entry type: Presence/absence selection (absence selected as default).
68
(DRAFT)

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Validation Procedures:
4.3.2.4.1	There is zero or one "Rotational Crop" requirements.
4.3.2.4.2	If Rotational Crop is provided at the Site or Scenario Level, then it
should not also be provided at the Product Level.
Figure 62: Rotational Crop XML Code Snippet
Product Level Use Restrictions/Limitations











4.3.2.5 Applicator Class Restrictions (+)
Identifies those individuals or groups of individuals who are allowed to apply the
product, if only certain classes of applicator are allowed. The existence of an Application
Class Restriction, by definition, indicates all other applicators not identified are restricted
from using the product.
Entry type: "Applicator Class Restrictions'' picklist selection.
Validation Procedures:
4.3.2.5.1	There is zero to many "Applicator Class Restrictions".
4.3.2.5.2	If Applicator Class Restrictions is provided at the Site or Scenario Level,
then it should not also be provided at the Product Level.
4.3.2.5.3	Applicator Class Restrictions has a code of 1004442 and a displayName
of "Applicator Class Restrictions".
4.3.2.5.4	Applicator Class Restrictions displayName must match the code.
4.3.2.5.5	If there is Applicator Class Restrictions listed then there must be a
 element with code and displayName.
4.3.2.5.6	Applicator Class Restrictions  code and displayName must come
from the list "Applicator Class Restrictions".
4.3.2.5.7	Applicator Class Restrictions  displayName must match the
code.
69
(DRAFT)

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Figure 63: Applicator Class Restrictions XML Code Snippet
Product Level Use Restrictions/Limitations














4.3.2.6 PPE/Engineering Controls (+)
This indicates the PPE and/or engineering controls required for use of the product.
Information captured here is not limited to information in the Agricultural Use box on the
label. It is intended to capture requirements for PPE/Engineering Controls that appear
anywhere on the label.
Entry type: "PPE/Engineering ControF picklist selection.
Validation Procedures:
4.3.2.6.1	There is zero to many "PPE/Engineering Controls" requirements.
4.3.2.6.2	If PPE/Engineering Controls is provided at the Site or Scenario Level,
then it should not also be provided at the Product Level.
4.3.2.6.3	Personal Protection Equipment (PPE)/Engineering Controls has a code
of 1005024 and a displayName of "PPE/Engineering Controls".
4.3.2.6.4	PPE/Engineering Controls displayName must match the code.
4.3.2.6.5	If there is PPE/Engineering Controls listed then there must be a 
element with code and displayName.
4.3.2.6.6	PPE/Engineering Controls  code and displayName must come
from the list "PPE/Engineering Controls".
4.3.2.6.7	PPE/Engineering Controls  displayName must match the code.
70
(DRAFT)

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Figure 64: PPE/Engineering Control XML Code Snippet
Product Level Use Restrictions/Limitations














4.3.2.7 Re-Entry Interval (REI)
Identifies the minimum period of time after a pesticide application when entry into the
treated area is restricted; i.e., minimum period of time before worker re-entry. It includes
WPS and non-WPS re-entry intervals.
Entry type: Value unit.
Validation Procedures:
4.3.2.7.1
4.3.2.7.2
4.3.2.7.3
4.3.2.7.4
4.3.2.7.5
Error Messages
There is zero to one "Re-Entry Interval" requirements.
If Re-Entry Interval is provided at the Site or Scenario Level, then it
should not also be provided at the Product Level.
Re-Entry Interval restriction occurs after application.
( value must be "3".)
Re-Entry Interval - Time value is a number.
Re-Entry Interval - Units must be units of time.
71
(DRAFT)

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Figure 65: Re-Entry Interval XML Code Snippet
Product Level Use Restrictions/Limitations













translation value="{Period of time value}"
displayName-'{Unit DisplayName}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>




4.3.2.8 Minimum Retreatment Interval (MRI)
Identifies the minimum period of time after an application that must pass before a product
can be reapplied to the same area or target.
Entry type: Value unit.
72
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Validation Procedures:
4.3.2.8.1	There is zero to one "Minimum Retreatment Interval" requirements.
4.3.2.8.2	If Minimum Retreatment Interval is provided at the Site or Scenario
Level, then it should not also be provided at the Product Level.
4.3.2.8.3	Minimum Retreatment Interval is required if more than one application
is allowed or if the single application rate is not equal to the crop
cycle/yearly rate.
4.3.2.8.4	Minimum Retreatment Interval restriction occurs after application.
( value must be "3".)
4.3.2.8.5	Minimum Retreatment Interval - Time value is a number.
4.3.2.8.6	Minimum Retreatment Interval - Units must be units of time.
Figure 66: MRI XML Code Snippet
Product Level Use Restrictions/Limitations













translation value="{Minimum period of time}"
displayName="{Unit DisplayName}"
code-'{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>




4.3.2.9 Pre-Harvest Interval Restrictions (PHI) (+)
Identifies the minimum period of time that must pass after an application before
crop/commodity harvest. This data element may be blank if the final application is
restricted to occur at or before a crop growth stage that is typically 30 days or more
before harvest.
Entry type: "PHI Category" (Pre-Harvest Interval) picklist selection, and value
unit.
Validation Procedures:
4.3.2.9.1	There is zero to many "Pre-Harvest Interval Restrictions" requirements.
4.3.2.9.2	If Pre-Harvest Interval Restrictions is provided at the Site or Scenario
Level, then it should not also be provided at the Product Level.
4.3.2.9.3	Pre-Harvest Interval Restrictions occur after application.
( value must be "3".)
73
(DRAFT)

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4.3.2.9.4	Pre-Harvest Interval Restrictions has a code of 1005028 and a
displayName of "PHI Category".
4.3.2.9.5	Pre-Harvest Interval Restrictions displayName must match the code.
4.3.2.9.6	If there is Pre-Harvest Interval Restrictions listed then there must be a
 element with code and displayName.
4.3.2.9.7	Pre-Harvest Interval Restrictions  code and displayName must
come from the list "PHI Category".
4.3.2.9.8	Pre-Harvest Interval Restrictions  displayName must match the
code.
4.3.2.9.9	Pre-Harvest Interval Restrictions - Time value is a number.
4.3.2.9.10	Pre-Harvest Interval Restrictions - Units must be units of time.
Figure 67: PHI XML Code Snippet
Product Level Use Restrictions/Limitations














translation value-'{"Interval Time"}"
displayName="{"Unit of Measure Display name"}"
code="{"UoM Code"}"
codeSystem="2.16.840.1.113883.6.275. l"/>









translation value="5"
displayName="pound"
code="3627071"
codeSystem="2.16.840.1.113883.6.275. l"/>






	
4.3.2.11 Pre-Slaughter Interval (PSI) (+)
Identifies the minimum period of time after an application that must pass before an
identified group of animals that have contacted the product can be slaughtered for food or
feed.
Entry type: "Pre-Slaughter Interval (PSI) Category" picklist selection, and value
unit.
Validation Procedures:
4.3.2.11.1	There is zero to many "Pre-Slaughter Interval Restrictions"
requirements.
4.3.2.11.2	If Pre-Slaughter Interval Restrictions is provided at the Site or Scenario
Level, then it should not also be provided at the Product Level.
4.3.2.11.3	Pre-Slaughter Interval Restrictions occur after application.
( value must be "3".)
4.3.2.11.4	Pre-Slaughter Interval Restrictions has a code of 1005027 and a
displayName of "PSI Category".
4.3.2.11.5	Pre-Slaughter Interval Restrictions displayName must match the code.
76
(DRAFT)

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4.3.2.
4.3.2.
4.3.2.
4.3.2.
4.3.2.
11.6
11.7
11.8
11.9
11.10
11.11
If there is Pre-Slaughter Interval Restrictions listed then there must be a
 element with code and displayName.
Pre-Slaughter Interval Restrictions  code and displayName must
come from the list "PSI Category".
Pre-Slaughter Interval Restrictions  displayName must match
the code.
There is zero or one Pre-Slaughter Interval Restrictions - Time per Pre-
Slaughter Interval Restriction.
Pre-Slaughter Interval Restrictions - Time value is a number.
Pre-Slaughter Interval Restrictions - Units must be units of time.
Figure 69: Pre-Slaughter Interval XML Code Snippet
Product Level Use Restrictions/Limitations
















translation value="{Pre-Slaughter Interval}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="{Unit DisplayName}"/>




4.3.2.12 Buffered Area(s) (+)
Identifies the minimum distance that is required between the area where a pesticide
product is applied and the specific area to be protected from the pesticide application.
Entry type: "Buffered Area" picklist selection, and value unit.
Validation Procedures:
4.3.2.12.1	There is zero to many "Buffered Area(s)" preconditions.
4.3.2.12.2	If Buffered Area(s) is provided at the Site or Scenario Level, then it
should not also be provided at the Product Level.
4.3.2.12.3 Buffered Area(s) checkpoint code is "T".
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4.3.2.12.4	Buffered Area(s) has a code of 1004980 and a displayName of "Buffered
Area".
4.3.2.12.5	Buffered Area(s) displayName must match the code.
4.3.2.12.6	If there is Buffered Area(s) listed then there must be a  element
with code and displayName.
4.3.2.12.7	Buffered Area(s)  code and displayName must come from the
list "Buffered Area".
4.3.2.12.8	Buffered Area(s)  displayName must match the code.
4.3.2.12.9	Buffered Area(s) - Distance value is a number.
4.3.2.12.10	Buffered Area(s) - Units must be "Standard Length" units.
Figure 70: Buffered Area XML Code Snippet
Product Level Use Restrictions/Limitations
















translation value="{Buffered Area value}"
displayName-'{Unit DisplayName}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>



4.3.2.13 Max Release Height
Identifies the maximum distance between the point of release from the application
equipment and the top of crop or ground.
Entry type: Value unit.
Validation Procedures:
4.3.2.13.1
4.3.2.13.2
4.3.2.13.3
4.3.2.13.4
4.3.2.13.5
There is zero or one "Maximum Release Height" preconditions.
If Max Release Height is provided at the Site or Scenario Level, then it
should not also be provided at the Product Level.
Max Release Height checkpoint code is "T".
Max Release Height - Height value is a number.
Max Release Height - Units must be "Standard Length" units.
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Figure 71: Maximum Release Height XML Code Snippet
Product Level Use Restrictions/Limitations












translation value="{Release Height}"
displayName="{Unit DisplayName}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>



4.3.2.14 Max Wind Speed
Identifies the maximum wind speed allowed during application.
Entry type: Value unit.
Validation Procedures:
4.3.2.14.1
4.3.2.14.2
4.3.2.14.3
4.3.2.14.4
4.3.2.14.5
Error Messages
There is zero or one "Maximum Wind Speed" preconditions.
If Max Wind Speed is provided at the Site or Scenario Level, then it
should not also be provided at the Product Level.
Max Wind Speed checkpoint code is "T".
Max Wind Speed - Speed value is a number.
Max Wind Speed - Units must be units of speed.
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Figure 72: Maximum Wind Speed XML Code Snippet
Product Level Use Restrictions/Limitations












translation value="{Wind Speed}"
displayName-'{Unit DisplayName}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>



4.3.2.15 Application Temperature
Identifies the minimum and/or maximum temperatures at which application(s) may be
made.
Entry type: Value unit, value unit.
Validation Procedures:
4.3.2.15.1	There is zero or one "Application Temperature" preconditions.
4.3.2.15.2	If Application Temperature is provided at the Site or Scenario Level,
then it should not also be provided at the Product Level.
4.3.2.15.3	Application Temperature checkpoint code is "B".
4.3.2.15.4	Application Temperature - Min Temp value is a number.
4.3.2.15.5	Application Temperature - Max Temp value is a number.
4.3.2.15.6	Application Temperature - Units (Min Temp/Max Temp) must be
temperature units.
4.3.2.15.7	Application Temperature - Units must match when both limits are
provided.
4.3.2.15.8	"Min Temp" and "Max Temp" do not need to be provided together.
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Figure 73: Application Temperature XML Code Snippet
Product Level Use Restrictions/Limitations













translation value="{Minimum Temperature}"
displayName="{Unit DisplayName}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>


translation value="{Maximum Temperature}"
displayName="{Unit DisplayName}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>




4.3.2.16 American Society of Agricultural and Biological Engineers
(ASABE) Droplet Size (+)
Identifies restrictions associated with the application droplet size according to the
ASABE 572 standard. Droplet sizes that are acceptable for application should be
selected. This must be entered for broadcast applications using aerial or ground
equipment.
Entry type: "ASABE Droplet Size" picklist selection, and value unit.
Validation Procedures:
4.3.2.16.1
4.3.2.16.2
4.3.2.16.3
4.3.2.16.4
4.3.2.16.5
4.3.2.16.6
4.3.2.16.7
There is zero to many "ASABE Droplet Size" requirements.
If ASABE Droplet Size is provided at the Site or Scenario Level, then it
should not also be provided at the Product Level.
ASABE Droplet Size is required when Application Type = "broadcast",
Form as Applied = "liquid formations" and/or Application Equipment =
"Aerial"' or "Groundboom".
ASABE Droplet Size has a code of 1004962 and a displayName of
"ASABE Droplet Size".
ASABE Droplet Size displayName must match the code.
If there is ASABE Droplet Size listed then there must be a 
element with code and displayName.
ASABE Droplet Size  code and displayName must come from the
list "ASABE Droplet Size".
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4.3.2.16.8
ASABE Droplet Size  displayName must match the code.
Figure 74: ASABE Droplet Size XML Code Snippet
Product Level Use Restrictions/Limitations















4.3.2.17 Soil Incorporation Depth and Time
Identifies the minimum soil incorporation depth that is required for the application, and
the maximum amount of time that must pass before incorporation takes place. If soil
incorporation occurs at the time of application, a time of "0" minutes should be entered.
Entry type: Value unit, value unit.
Validation Procedures:
4.3.2.17.1
4.3.2.17.2
4.3.2.17.3
4.3.2.17.4
4.3.2.17.5
4.3.2.17.6
lessag
There is zero or one "Soil Incorporation Depth and Time" observations.
If Soil Incorporation Depth and Time is provided at the Site or Scenario
Level, then it should not also be provided at the Product Level.
Soil Incorporation Depth and Time restriction occurs after application.
( value must be "3".)
If soil incorporation occurs at the time of application then "Time" is "0"
and "Units" are "minutes".
If there is a soil incorporation "Time" then there should also be a soil
incorporation "Depth".
Soil Incorporation Depth and Time - Units must be units of time and
"Standard Length", respectively.
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Figure 75: Soil Incorporation Depth and Time XML Code Snippet
Product Level Use Restrictions/Limitations











translation value="{Maximum time after application}"
displayName="{Unit DisplayName}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>










translation code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="{Unit DisplayName"
value="{Minimum Depth}"/>






4.3.2.18 Restricted Soil Type (+)
Identifies any soil type(s) to which the product should not be applied using the prescribed
methods.
Entry type: "Soil Type" picklist selection, and value unit.
Validation Procedures:
ID Numbers Validation Error Messages
4.3.2.18.1	There is zero to many "Restricted Soil Type(s)" preconditions.
4.3.2.18.2	If Restricted Soil Type(s) is provided at the Site or Scenario Level, then it
should not also be provided at the Product Level.
4.3.2.18.3	Restricted Soil Type(s) checkpoint code is "B".
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4.3.2.18.4
4.3.2.18.5
4.3.2.18.6
4.3.2.18.7
4.3.2.18.8
Restricted Soil Type(s) has a code of 1004961 and a displayName of
"Soil Type".
Restricted Soil Type(s) displayName must match the code.
If there is Restricted Soil Type(s) listed then there must be a 
element with code and displayName.
Restricted Soil Type(s)  code and displayName must come from
the list "Soil Type".
Restricted Soil Type(s)  displayName must match the code.
Figure 76: Restricted Soil Type XML Code Snippet
Product Level Use Restrictions/Limitations
















4.3.2.19 Minimum Percent Soil Organic Matter
Identifies the minimum percent soil organic matter to which application(s) may be made.
Entry type: Value unit.
Validation Procedures:
4.3.2.19.1
4.3.2.19.2
4.3.2.19.3
4.3.2.19.4
4.3.2.19.5
There is zero or one "Minimum Percent Soil Organic Matter"
preconditions.
If Minimum Percent Soil Organic Matter is provided at the Site or
Scenario Level, then it should not also be provided at the Product Level.
Minimum Percent Soil Organic Matter  code is "B".
Minimum Percent Soil Organic Matter - Value is a number.
Minimum Percent Soil Organic Matter has a unit code of 3627136 and a
displayName of
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Figure 77: Minimum Percent Soil Organic Matter XML Code Snippet
Product Level Use Restrictions/Limitatioris












translation code="3627136"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="%"
value="{Percent Soil Organic Matter}"/>



4.3.2.20 Minimum Age of Animal To Be Treated
Identifies the minimum age of animals to which application(s) may be made.
Entry type: Value unit.
Validation Procedures:
4.3.2.20.1
4.3.2.20.2
4.3.2.20.3
4.3.2.20.4
4.3.2.20.5
Error Messages
There is zero or one "Minimum Age of Animal To Be Treated"
preconditions.
If Minimum Age of Animal To Be Treated is provided at the Site or
Scenario Level, then it should not also be provided at the Product Level.
Minimum Age of Animal To Be Treated  code is "B".
Minimum Age of Animal To Be Treated - Age value is a number.
Minimum Age of Animal To Be Treated - Units must be units of time.
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Figure 78: Minimum Age of Animal To Be Treated XML Code Snippet
Product Level Use Restrictions/Limitations












translation value="{Minimum Age}"
displayName="{Units DisplayName}"
code="{Minimum Age units}"
codeSystem="2.16.840.1.113883.6.275. l"/>



4.3.2.21 Minimum Weight of Animal To Be Treated
Identifies the minimum weight of animals to which application(s) may be made.
Entry type: Value unit.
Validation Procedures:
4.3.2.21.1
4.3.2.21.2
4.3.2.21.3
4.3.2.21.4
4.3.2.21.5
Error Messages
There is zero or one "Minimum Weight of Animal To Be Treated"
preconditions.
If Minimum Weight of Animal To Be Treated is provided at the Site or
Scenario Level, then it should not also be provided at the Product Level.
Minimum Weight of Animal To Be Treated  code is "B".
Minimum Weight of Animal To Be Treated - Weight value is a number.
Minimum Weight of Animal To Be Treated - Units must be "Standard
Weight/Mass" units.
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Figure 79: Minimum Weight of Animal To Be Treated XML Code Snippet
Product Level Use Restrictions/Limitations












translation value="{Minimum Weight}"
displayName="{Units DisplayName}"
code="{Minimum Age units}"
codeSystem="2.16.840.1.113883.6.275. l"/>



4.3.2.22 Pollinator (+)
Identifies specific label restrictions to application based on pollinator protection. The
statements selected from the picklist and those that appear on the label may not be
identical, but must have the same general meaning.
Entry type: "Pollinator Protection Statements'' picklist selection.
Validation Procedures:
Error Messages
:
4.3.2.22.1	There is zero to many "Pollinator Protection Statement(s)"
requirements.
4.3.2.22.2	If Pollinator Protection Statement(s) is provided at the Site or Scenario
Level, then it should not also be provided at the Product Level.
4.3.2.22.3	Pollinator Protection Statement(s) has a code of 1005022 and a
displayName of "Pollinator Protection Statements".
4.3.2.22.4	Pollinator Protection Statement(s) displayName must match the code.
4.3.2.22.5	If there is Pollinator Protection Statement(s) listed then there must be a
 element with code and displayName.
4.3.2.22.6	Pollinator Protection Statement(s)  code and displayName must
come from the list "Pollinator Protection Statements".
4.3.2.22.7	Pollinator Protection Statement(s)  displayName must match
the code.
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Figure 80: Pollinator Protection Statement XML Code Snippet
Product Level Use Restrictions/Limitations














4.3.2.23	Bulletins Live
Identifies if there is an Endangered Species County Level Bulletin indicator on a label.
This is a presence/absence indicator. If a Bulletins Live statement appears on a label, then
Bulletins Live should be selected.
Entry type: Presence/absence selection (absence selected as default).
Validation Procedures:
ID Numbers Validation Error Messages	|
4.3.2.23.1	There is zero or one "Bulletins Live" requirements.
4.3.2.23.2	If Bulletins Live is provided at the Site or Scenario Level, then it should
not also be provided at the Product Level.
Figure 81: Bulletins Live XML Code Snippet
Product Level Use Restrictions/Limitations











4.3.2.24	Applications to Water (+)
Identifies specific label restrictions related to the treatment of a volume of water
including flooded field applications and other water bodies. The statements selected from
the picklist and those that appear on a label may not be identical, but must have the same
general meaning.
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Entry type: "Water Protection Statements'' picklist selection.
Validation Procedures:
4.3.2.24.1	There is zero to many "Water Protection Statement(s)" requirements.
4.3.2.24.2	If Water Protection Statement(s) is provided at the Site or Scenario
Level, then it should not also be provided at the Product Level.
4.3.2.24.3	Water Protection Statement(s) has a code of 1005023 and a
displayName of "Water Protection Statements".
4.3.2.24.4	Water Protection Statement(s) displayName must match the code.
4.3.2.24.5	If there is Water Protection Statement(s) listed then there must be a
 element with code and displayName.
4.3.2.24.6	Water Protection Statement(s)  code and displayName must
come from the list "Water Protection Statements".
4.3.2.24.7	Water Protection Statement(s)  displayName must match the
code.
4.3.2.24.8	Water Protection Statement(s) - Value is a number.
4.3.2.24.9	Water Protection Statement(s) - Units must be provided.
Figure 82: Water Protection Statement XML Code Snippet











translation code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="{Unit DisplayName}"
value="{Some Value}"/>




	
4.3.2.25 Secondary Manufacturing
Identifies if there are any restrictions which limit further manufacturing of the treated
material; e.g., restricting treated plastics in the manufacture of toys. This is a
presence/absence indicator. If any restrictions limiting secondary manufacturing appear
on the label, then Secondary Manufacturing should be selected.
Entry type: Presence/absence selection (absence selected as default).
Validation Procedures:
4.3.2.25.1
4.3.2.25.2
Error Messages
There is zero or one "Secondary Manufacturing" requirements.
If Secondary Manufacturing is provided at the Site or Scenario Level,
then it should not also be provided at the Product Level.
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Figure 83: Secondary Manufacturing XML Code Snippet
Product Level Use Restrictions/Limitations











4.3.2.26 Restricted Use Site Location(s) (+)
Identifies if applications are not permitted in specific Use Site Locations. Locations
entered as restricted at the Product Level cannot be entered as permitted in the site
attribute sections at lower levels of the model. Generally, elements that are not positively
entered in the attributes section of this document are considered to be disallowed. This
restriction should only be entered if the text of the label explicitly prohibits use in a
particular use site location.
Entry type: "Use Site Location" picklist selection.
Validation Procedures:
4.3.2.26.1
4.3.2.26.2
4.3.2.26.3
4.3.2.26.4
4.3.2.26.5
4.3.2.26.6
Error Messages
There is zero to many "Restricted Use Site Location(s)" preconditions.
If Restricted Use Site Location(s) is provided at the Site or Scenario
Level, then it should not also be provided at the Product Level.
Restricted Use Site Location(s)  code is "B".
Restricted Use Site Location(s) has a code of 1004663 and a
displayName of "Use Site Location".
Restricted Use Site Location(s) displayName must match the code.
If there is Restricted Use Site Location(s) listed then there must be a
 element with code and displayName.
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Figure 84: Restricted Use Site Location XML Code Snippet
Product Level Use Restrictions/Limitations
















4.3.2.27 Restricted Application Target(s) (+)
Identifies if applications are not permitted to specific targets. Targets entered as restricted
at the Product Level cannot be entered as permitted in scenario attribute sections at lower
levels of the model. Generally, elements that are not positively entered in the attributes
section of this document are considered to be disallowed. This restriction should only be
entered if the text of the label explicitly prohibits this type of application.
Entry type: "Application Target' picklist selection.
Validation Procedures:
Error Messages
4.3.2.27.1	There is zero to many "Restricted Application Target(s)" preconditions.
4.3.2.27.2	If Restricted Application Target(s) is provided at the Site or Scenario
Level, then it should not also be provided at the Product Level.
4.3.2.27.3	Restricted Application Target(s)  code is "B".
4.3.2.27.4	Restricted Application Target(s) has a code of 1004682 and a
displayName of "Application Target".
4.3.2.27.5	Restricted Application Target(s) displayName must match the code.
4.3.2.27.6	If there is Restricted Application Target(s) listed then there must be a
 element with code and displayName.
4.3.2.27.7	Restricted Application Target(s)  code and displayName must
come from the list "Application Target".
4.3.2.27.8	Restricted Application Target(s)  displayName must match the
code.
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Figure 85: Restricted Application Target XML Code Snippet
Product Level Use Restrictions/Limitations
















4.3.2.28 Restricted Application Type(s) (+)
Identifies if applications are not permitted using specific application types. Application
types entered as restricted at the Product Level cannot be entered as permitted in scenario
attribute sections at lower levels of the model. Generally, elements that are not positively
entered in the attributes section of this document are considered to be disallowed. This
restriction should only be entered if the text of the label explicitly prohibits this type of
application.
Entry type: "Application Type" picklist selection.
Validation Procedures:
Error Messages
4.3.2.28.1	There is zero to many "Restricted Application Type(s)" preconditions.
4.3.2.28.2	If Restricted Application Type(s) is provided at the Site or Scenario
Level, then it should not also be provided at the Product Level.
4.3.2.28.3	Restricted Application Type(s)  code is "B".
4.3.2.28.4	Restricted Application Type(s) has a code of 1004920 and a
displayName of "Application Type".
4.3.2.28.5	Restricted Application Type(s) displayName must match the code.
4.3.2.28.6	If there is Restricted Application Type(s) listed then there must be a
 element with code and displayName.
4.3.2.28.7	Restricted Application Type(s)  code and displayName must
come from the list "Application Type".
4.3.2.28.8	Restricted Application Type(s)  displayName must match the
code.
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Figure 86: Restricted Application Type XML Code Snippet
Product Level Use Restrictions/Limitations
















4.3.2.29 Restricted Application Equipment (+)
Identifies if applications are not permitted using specific equipment. Equipment entered
as restricted at the Product Level cannot be entered as permitted in scenario attribute
sections at lower levels of the model. Generally, elements that are not positively entered
in the attributes section of this document are considered to be disallowed. This restriction
should only be entered if the text of the label explicitly prohibits this type of application.
Entry type: "Application Equipment' picklist selection.
Validation Procedures:
4.3.2.29.1
4.3.2.29.2
4.3.2.29.3
4.3.2.29.4
4.3.2.29.5
4.3.2.29.6
4.3.2.29.7
4.3.2.29.8
There is zero to many "Restricted Application Equipment"
preconditions.
If Restricted Application Equipment is provided at the Site or Scenario
Level, then it should not also be provided at the Product Level.
"Restricted Application Equipment"  code is "B".
Restricted Application Equipment has a code of 1004922 and a
displayName of "Application Equipment".
Restricted Application Equipment displayName must match the code.
If there is Restricted Application Equipment listed then there must be a
 element with code and displayName.
Restricted Application Equipment  code and displayName must
come from the list "Application Equipment".
Restricted Application Equipment  displayName must match the
code.
93
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Figure 87: Restricted Application Equipment XML Code Snippet
Product Level Use Restrictions/Limitations
















4.3.2.30 Restricted Application Timing (+)
Identifies if applications are not permitted during specific timings (e.g., "Time of Day",
"Timing of Pest", "Use Site Status"). Timings entered as restricted at the Product Level
cannot be entered as permitted in scenario attribute sections at lower levels of the model.
Generally, elements that are not positively entered in the attributes section of this
document are considered to be disallowed. This restriction should only be entered if the
text of the label explicitly prohibits this type of application.
Entry type: "Application Timing (Time of Day)", "Application Timing (Timing of
Pest) and/or "Application Timing (Use Site Status)" picklist selection.
Validation Procedures:
ID Numbers Validation Error Messages
4.3.2.30.1	There is zero to many "Restricted Application Timing (Use Site Status)",
"Restricted Application Timing (Time of Day)", and/or "Restricted
Application Timing (Timing of Pest)" preconditions.
4.3.2.30.2	If Restricted Application Timing is provided at the Site or Scenario Level,
then it should not also be provided at the Product Level.
4.3.2.30.3	Restricted Application Timing  code is "B".
4.3.2.30.4	Restricted Application Timing (Time of Day) has a code of 1004921 and
a displayName of "Application Timing (Time of Day)".
4.3.2.30.5	Restricted Application Timing (Timing of Pest) has a code of 1005020
and a displayName of "Application Timing (Timing of Pest)".
4.3.2.30.6	Restricted Application Timing (Use Site Status) has a code of 1004960
and a displayName of "Application Timing (Use Site Status)".
4.3.2.30.7	Restricted Application Timing displayName must match the code.
4.3.2.30.8	If there is Restricted Application Timing listed then there must be a
 element with code and displayName.
4.3.2.30.9	Restricted Application Timing (Time of Day)  code and
displayName must come from the list "Application Timing (Time of
Day)".
4.3.2.30.10	Restricted Application Timing (Timing of Pest)  code and
displayName must come from the list "Application Timing (Timing of
Pest)".
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4.3.2.30.11 Restricted Application Timing (Use Site Status)  code and
displayName must come from the list "Application Timing (Use Site
Status)".
4.3.2.30.12 Restricted Application Timing  displayName must match the
code.
Figure 88: Restricted Application Timing XML Code Snippet
Product Level Use Restrictions/Limitations





























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4.4 Site Level (+)
4.4.0 Section in General
The Site Level section is a header section to contain the sub-sections defined herein and
the Scenario Level sub-sections. The Site Level section can be cloned/repeated to create
many site level sections within a Product Level section. Adding a new or cloning an
existing Site Level section will add/clone all sub-sections contained within the respective
Site Level.
Each site is defined as a place with the combination of Use Site Attributes (Use Sites and
Use Site Locations) to which the product may be applied with the same maximum yearly
or crop cycle rate (from all Scenarios combined). Changes to the overall maximum yearly
rate allowed for a site require the creation of a new site. However, differences in the rate
that can be applied from any one method can be recorded at the Scenario Level.
Differences in restrictions associated with a particular application method can also be
recorded at the Scenario Level.
The system is flexible in that if all of the Site Level rate and restriction elements are
identical, then multiple Site Attributes (Use Sites and Use Site Locations) may be listed
under a single Site Level. Likewise, if a label has more complicated application
instructions, then additional Sites Levels can be added to isolate caveats to the maximum
use. This may also include Geographic Restrictions when rates differ based on
geography. Before entering information to define a site, look across the product
application instructions to determine if there are unique use parameters. For example, if
there are different maximum yearly application rates associated with applications to turf
in residential and agricultural settings, then a separate site is entered for each.
Conversely, if the parameters for all Use Sites and Use Site Locations remain unchanged
for Site Yearly/Crop Cycle Rate and Site Level Restrictions/Limitations, then a single
Site Level can be used to capture all the details. It is important to remember, however,
that all combinations of selections must be permitted.
There may be one to many Site Level sections. Each Site Level section must have at least
one scenario. Each Site Level section should contain parameters unique to the respective
Use Site and Use Site Location combinations selected. For example:
 Site Level 1
	Use Site Attributes
	Use Site "A"
	Use Site Location "a"
	Use Site Location "b"
	Use Site Yearly/Crop Cycle Rate "1"
	Use Site Level Restrictions/Limitations "xxx"
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 Site Level 2
	Use Site Attributes
	Use Site "B"
	Use Site "C"
	Use Site Location "a"
	Use Site Location "c"
	Use Site Yearly/Crop Cycle Rate "2"
	Use Site Level Restrictions/Limitations "yyy"
Information entered in the Site Level subsections applies to all Scenarios associated with
that Site Level.
Validation Procedures:
4.4.0.0.1	There is at least one or more "Site Level" section(s) per Use Index
document.
4.4.0.0.2	Site Level section  and displayName must match.
4.4.0.0.3	Site Level section link is optional.
4.4.0.0.4	If Site Level section link is provided then the section link is a unique
string within the Use Index document.
4.4.0.0.5	Site Level <section ID> is a unique UUID within the Use lndex>
document.
Figure 89: Site Level Section XML Code Snippet
<component>
<section ID="{Section Link}">
<id root-'{Section ld}"/>
<code code="3810087" codeSystem="2.16.840.1.113883.6.275.1"
displayName="Site Level"/>
<title>Site Level
4.4.1 Use Site Attributes
The Use Site Attributes section is a sub-section of the Site Level section. The site
attributes listed below describe in detail to what and where a product can be applied.
Multiple site attributes can be entered if ALL subsequent application information applies
to all combinations of the attributes.
Validation Procedures:
.. ivunibers Validation Error Messa;
4.4.1.0.1	There is one "Use Site Attributes" sub-section per Site Level section.
4.4.1.0.2	Use Site Attributes section  and displayName must match.
4.4.1.0.3	Use Site Attributes section link is optional.
4.4.1.0.4	If Use Site Attributes section link is provided then the section link is a
unique string within the Use Index document.
4.4.1.0.5	Use Site Attributes <section ID> is a unique UUID within the Use Index
document.
4.4.1.0.6	Use Site Attributes section must have a code and displayName.
4.4.1.1 Use Site/Commodity (+)
Identifies the person, place, or thing being treated. For crop use sites, the list
includes all crops and crop groups. For non-crop use sites, the list is comprised of
higher level categories. See the "Crop Use Sites" and "Non-Crop Use Sites" lists
in the SmartLabel Vocabulary Guide Version 3.xlsx document for guidance.
Entry type: "Use Site/Commodity" picklist selection.
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</pre><hr><pre>
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Validation Procedures:
IU IMl
4.4.1.1.1
4.4.1.1.2
4.4.1.1.3
4.4.1.1.4
4.4.1.1.5
4.4.1.1.6
There is at least one to many "Use Site(s)/Commodities".
Use Site(s)/Commodities has a code of 3810088 and a displayName of
"Use Site/Commodity".
Use Site(s)/Commodities displayName must match the code.
If there is Use Site(s)/Commodities listed then there must be a <value>
element with code and displayName.
Use Site(s)/Commodities <value> code must come from the list
"Registered Use Site" under codeSystem 2.16.840.1.113883.6.275.1.
Use Site(s)/Commodities <value> code must match the displayName.
4.4.1.2 Use Site Location(s) (+)
The Use Site Location gives a broad category-based description of where the
person, place, or thing being treated (Use Site) can be found (e.g., Agricultural
(indoor), Agricultural (outdoor), Medical/Hospital/Veterinary Facility (Indoor),
etc.). The Use Site and Use Site Location work together to fully define where
pesticide application occurs.
Entry type: "Use Site Location" picklist selection.
Validation Procedures:
lidation Error Messages
There is at least one to many "Use Site Location(s)".
Use Site Location(s) cannot be restricted in the Product Level section.
Use Site Location(s) code is from the list "Use Site Location".
Use Site Location(s) displayName must match the code.
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</pre><hr><pre>
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Figure 90: Use Site Attributes XML Code Snippet
<component>
<section ID="{Section Link}">
<id root="{Section ld}"/>
<code code="3810088" codeSystem="2.16.840.1.113883.6.275.1"
displayName="Use Site Attributes"/>
<title>Use Site Attributes










{Use Site DisplayName}







4.4.2 Use Site Yearly/Crop Cycle Rate (+)
Use Site Yearly/Crop Cycle Rate is a sub-section of the Site Level section containing
Maximum Number of Applications per Site per Time and Maximum Site Application
Rate per Time.
Each Site Level must include either a Maximum Number of Applications per Site per
Time, a Maximum Site Application Rate per Time, or both elements. If both Maximum
Number of Applications per Site per Time and Maximum Site Application Rate per Time
are given, enter information as either per year or per crop cycle, not both. If the site
maximum number of applications or the maximum application rate are expressed in terms
of per crop cycle, the maximum number of crop cycles per year must be recorded in the
Maximum Number of Crop Cycles per Year field at the Scenario Level; see Section
4.5.1.9_Maximum Number of Crop Cycles per Year below.
Validation Procedures:
4.4.2.0.1	There is one "Use Site Yearly/Crop Cycle Rate" sub-section per Site
Level section.
4.4.2.0.2	Use Site Yearly/Crop Cycle Rate section  and displayName must
match.
4.4.2.0.3	Use Site Yearly/Crop Cycle Rate section link is optional.
4.4.2.0.4	If Use Site Yearly/Crop Cycle Rate section link is provided then the
section link is a unique string within the Use Index document.
99
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</pre><hr><pre>
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4.4.2.0.5
Use Site Yearly/Crop Cycle Rate <section ID> is a unique UUID within
the Use Index document.
4.4.2.1 Maximum Number of Applications per Site per Time
Identifies the maximum number of applications that can be applied per year or per
crop cycle to the use site from all scenarios combined.
Entry type: value per "Application Rate Measurement Period" picklist selection.
Validation Procedures:
4.4.2.1.1
4.4.2.1.2
4.4.2.1.3
4.4.2.1.4
4.4.2.1.5
At least one, "Maximum Number of Applications per Site per Time" or
"Maximum Site Application Rate per Time", must be provided per Site
Level section.
Maximum Number of Applications per Site per Time - Number value is a
number.
Maximum Number of Applications per Site per Time - Per Time is "Year"
or "Crop Cycle".
Maximum Number of Applications per Site per Time value cannot
exceed the value for Product Level Use Restrictions/Limitations.
Maximum Number of Applications per Site per Time <methodCode> is
from the list "Application Rate Measurement Period".
4.4.2.2 Maximum Site Application Rate per Time
Identifies the maximum quantity of a product that can be applied per year or per
crop cycle to the use site from all scenarios combined.
Entry type: Value unit per value unit, per "Application Rate Measurement
Period" picklist selection.
Validation Procedures:
4.4.2.2.1
4.4.2.2.2
4.4.2.2.3
4.4.2.2.4
Error Messages
4.4.2.2.5
4.4.2.2.6
Maximum Site Application Rate per Time numerator value is a number.
Maximum Site Application Rate per Time denominator value is a
number.
Maximum Site Application Rate per Time numerator units must be one
of the following: "Standard Weight/Mass"; " Standard
Volume/Capacity"; "Miscellaneous Application Unit"; "Concentration";
"Non-Standard Volume/Capacity".
Maximum Site Application Rate per Time denominator units must be
one of the following: "Standard Area"; "Standard Length"; "Standard
Weight/Mass"; "Standard Volume/Capacity"; "Time"; "Non-Standard
Volume/Capacity"; "Non-standard - Target (with acreage rate limit)";
"Non-Standard Weight/Mass"; "Miscellaneous - Target".
Maximum Site Application Rate per Time <methodCode> is from the list
"Application Rate Measurement Period".
If there is a Maximum Site Application Rate per Time numerator value
then there must also be a denominator value.
100
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</pre><hr><pre>
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Figure 91: Use Site Yearly Rate XML Code Snippet
<component>
<section ID="{Section Link}">
<id root="{Section ld}"/>
<code code="3810089" codeSystem="2.16.840.1.113883.6.275.1"
displayName-'Use Site Yearly Rate"/>
<title>Use Site Yearly Rate












translation value="{Maximum Rate}"
displayName="{Unit DisplayName}"
code="3627132"
codeSystem="2.16.840.1.113883.6.275. l"/>


translation value="{Per Quantity}"
displayName-'{Unit DisplayName}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275.1"/>








101
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4.4.3 Use Site Level Restrictions/Limitations (+)
Identifies Use Site Level Restrictions/Limitations that are applicable to all scenarios for a
respective site. If a restriction/limitation differs between scenarios of a given site, it
should be entered only at the scenario level for that site. Restriction/limitation
information cannot be entered at multiple levels. Restrictions/limitations should only be
recorded in a Use Index if the label explicitly restricts or limits the identified data
element in legally enforceable language. Statements that include terms like "should" or
"for best results" are not legally enforceable, and should not be recorded.
Multiple entries are possible for many restrictions/limitations. In this document, data
elements that may have multiple entries are marked with a (+) after their title.
Additionally, the validation rules for each element indicate if entry is optional and the
number of entries that can be entered.
Leaving a data element blank indicates that the respective restriction does not apply at
this level.
Validation Procedures:
4.4.3.0.1
4.4.3.0.2
4.4.3.0.3
4.4.3.0.4
4.4.3.0.5
There is one "Use Site Level Restrictions/Limitations" section per Site
Level section.
Use Site Level Restrictions/Limitations section  and displayName
must match.
Use Site Level Restrictions/Limitations section link is optional.
If Use Site Level Restrictions/Limitations section link is provided then
the section link is a unique string within the Use Index document.
Use Site Level Restrictions/Limitations <section ID> is a unique UUID
within the Use Index document.
Figure 92: Use Site Level Restrictions/Limitations XML Code Snippet
<component>
<section ID="{Section Linl<}">
<id root-'{Section ld}"/>
<code code="3810090" codeSystem="2.16.840.1.113883.6.275.1"
displayName="Use Site Level Restrictions/Limitations"/>
<title>Use Site Level Restrictions/Limitations
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4.4.3.1 Geographic Area(s) Allowed (+)
Identifies restrictions associated with geographic location, at the state and county level,
by listing areas where application is allowed. This is a required field at either the Product,
Site, or Scenario level for each method. If applications to a specific site are not restricted
to any particular geographic area, enter "United States". If application is not allowed in a
particular area, enter all areas except the prohibited area.
Entry type: "Geographic Area" picklist selection.
Validation Procedures:
4.4.3.1.1	There is at least one "Geographic Area" per Scenario. The Scenario is
considered to have a Geographic Area if it is provided at the Product,
Site, or Scenario Level.
4.4.3.1.2	If Geographic Area is provided at the Product or Scenario Level, then it
should not also provided at the Site Level.
4.4.3.1.3	Geographic Area has a code of 1005202 and a displayName of
"Geographic Area".
4.4.3.1.4	Geographic Area displayName must match the code.
4.4.3.1.5	If there is Geographic Area listed then there must be a  element
with code and displayName.
4.4.3.1.6	Geographic Area  code and displayName must come from the
list "Geographic Area".
4.4.3.1.7	Geographic Area  displayName must match the code.
Figure 93: Geographic Area XML Code Snippet
Product Level Use Restrictions/Limitations















4.4.3.2 Use Site Food Relationship
Identifies if application(s) are intended to come in contact with food or feed, which may
indicate the need for a pesticide tolerance or a certain kind of regulatory risk assessment.
This information is required for agricultural crops at either the Product, Site, or Scenario
levels for each method to establish whether crops may be used as food/feed or may not be
used as food/feed. If the product labeling for non-agricultural sites explicitly prohibits
applications that may contact food or feed, then "Non-Food/Non-Feed Stream" should be
entered.
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See definitions in the SmartLabel Vocabulary Guide Version 3.xlsx for further
guidance.
Entry type: "Use Site Food Relationship" picklist selection.
Validation Procedures:
4.4.3.2.1	There is one "Use Site Food Relationship" per Scenario. A Scenario is
considered to have a Use Site Food Relationship if it is provided at the
Product, Site, or Scenario Level.
4.4.3.2.2	If Use Site Food Relationship is provided at the Product or Scenario
Level, then it should not also be provided at the Site Level.
4.4.3.2.3	Use Site Food Relationship has a code of 1005021 and a displayName of
"Use Site Food Relationship".
4.4.3.2.4	Use Site Food Relationship displayName must match the code.
4.4.3.2.5	If there is Use Site Food Relationship listed then there must be a
 element with code and displayName.
4.4.3.2.6	Use Site Food Relationship  code and displayName must come
from the list "Use Site Food Relationship".
4.4.3.2.7	Use Site Food Relationship  displayName must match the code.
Figure 94: Food Site Relationship XML Code Snippet
Product Level Use Restrictions/Limitations














4.4.3.3 Maximum Active Ingredient Rate Across Products per Time
Identifies the maximum amount of active ingredient or, in some cases, the maximum
amount of a chemical class that may be applied to a given area across products that
contain the same active ingredient. This restriction is often stated on labels as "Do not
apply more than [x amount] of product per [year or crop cycle] from this or any other
product containing this active ingredient".
Entry type: Value unit, per value unit, per "Application Rate Measurement
Period" picklist selection.
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Validation Procedures:
4.4.3.3.1
4.4.3.3.2
4.4.3.3.3
4.4.3.3.4
4.4.3.3.5
4.4.3.3.6
4.4.3.3.7
4.4.3.3.8
There is zero or one "Maximum Al Rate Across Products per Time".
If Maximum Al Rate Across Products per Time is provided at the
Product or Scenario Level, then it should not also provided at the Site
Level.
Maximum Al Rate Across Products per Time numerator value is a
number.
Maximum Al Rate Across Products per Time denominator value is a
number.
Maximum Al Rate Across Products per Time numerator units must be
one of the following: "Standard Weight/Mass", "Standard
Volume/Capacity", "Miscellaneous Application Unit", "Concentration",
"Non-Standard Volume/Capacity".
Maximum Al Rate Across Products per Time denominator units must be
one of the following: "Standard Area", "Standard Length", "Standard
Weight/Mass", "Standard Volume/Capacity", "Time", "Non-Standard
Volume/Capacity", "Non-standard - Target (with area rate limit)", "Non-
Standard Weight/Mass", "Miscellaneous - Target".
Maximum Al Rate Across Products per Time  is from the
list "Application Rate Measurement Period".
If there is a Maximum Al Rate Across Products per Time numerator
value then there must also be a denominator value.
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Figure 95: Maxium AI Rate Across Products XML Code Snippet
Product Level Use Restrictions/Limitations













translation value="{Maximum Rate}"
displayName="{Unit DisplayName"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>


translation value="{Per Quantity}"
displayName="{Unit DisplayName"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>







4.4.3.4 Rotational Crop
Identifies if any rotational crop restrictions apply to this specific product. This is a
presence/absence indicator. If any restrictions to rotation plantings appear on the label,
including what may be planted following the current crop, or the length of time that must
pass before a crop can be planted in the area, then Rotational Crop should be selected.
Entry type: Presence/absence selection (absence selected as default).
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Validation Procedures:
4.4.3.4.1	There is zero or one "Rotational Crop" requirements.
4.4.3.4.2	If Rotational Crop is provided at the Product or Scenario Level, then it
should not also provided at the Site Level.
Figure 96: Rotational Crop XML Code Snippet
Product Level Use Restrictions/Limitations











4.4.3.5 Applicator Class Restrictions (+)
Identifies those individuals or groups of individuals who are allowed to apply the
product, if only certain classes of applicator are allowed. The existence of an Application
Class Restriction, by definition, indicates all other applicators not identified are restricted
from using the product.
Entry type: "Applicator Class Restrictions'' picklist selection.
Validation Procedures:
4.4.3.5.1	There is zero to many "Applicator Class Restrictions".
4.4.3.5.2	If Applicator Class Restrictions is provided at the Product or Scenario
Level, then it should not also provided at the Site Level.
4.4.3.5.3	Applicator Class Restrictions has a code of 1004442 and a displayName
of "Applicator Class Restrictions".
4.4.3.5.4	Applicator Class Restrictions displayName must match the code.
4.4.3.5.5	If there is Applicator Class Restrictions listed then there must be a
 element with code and displayName.
4.4.3.5.6	Applicator Class Restrictions  code and displayName must come
from the list "Applicator Class Restrictions".
4.4.3.5.7	Applicator Class Restrictions  displayName must match the
code.
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Figure 97: Applicator Class Restrictions XML Code Snippet
Product Level Use Restrictions/Limitations














4.4.3.6 PPE/Engineering Controls (+)
This indicates the PPE and/or engineering controls required for use of the product.
Information captured here is not limited to information in the Agricultural Use box on the
label. It is intended to capture requirements for PPE/Engineering Controls that appear
anywhere on the label.
Entry type: "Personal Protection Equipment (PPE)/Engineering ControF
picklist selection.
Validation Procedures:
ibers
4.4.3.6.1	There is zero to many "PPE/Engineering Controls" requirements.
4.4.3.6.2	If PPE/Engineering Controls is provided at the Product or Scenario Level,
then it should not also provided at the Site Level.
4.4.3.6.3	Personal Protection Equipment (PPE)/Engineering Controls has a code
of 1005024 and a displayName of "PPE/Engineering Controls".
4.4.3.6.4	PPE/Engineering Controls displayName must match the code.
4.4.3.6.5	If there is PPE/Engineering Controls listed then there must be a 
element with code and displayName.
4.4.3.6.6	PPE/Engineering Controls  code and displayName must come
from the list "PPE/Engineering Controls".
4.4.3.6.7	PPE/Engineering Controls  displayName must match the code.
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Figure 98: PPE/Engineering Control XML Code Snippet
Product Level Use Restrictions/Limitations















4.4.3.7 REI
Identifies the minimum period of time after a pesticide application when entry into the
treated area is restricted; i.e., minimum period of time before worker re-entry. It includes
WPS and non-WPS re-entry intervals.
Entry type: Value unit.
Validation Procedures:
4.4.3.7.1
4.4.3.7.2
4.4.3.7.3
4.4.3.7.4
4.4.3.7.5
ation Error Messages
There is zero to one "Re-Entry Interval" requirements.
If Re-Entry Interval is provided at the Product or Scenario Level, then it
should not also provided at the Site Level.
Re-Entry Interval restriction occurs after application.
( value must be "3".)
Re-Entry Interval - Time value is a number.
Re-Entry Interval - Units must be units of time.
109
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Figure 99: Re-Entry Interval XML Code Snippet
Product Level Use Restrictions/Limitations













translation value="{Period of time value}"
displayName="{Unit DisplayName}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>




4.4.3.8 MRI
Identifies the minimum period of time after an application that must pass before the
product can be reapplied to the same area or target.
Entry type: Value unit.
Validation Procedures:
4.4.3.8.1
4.4.3.8.2
4.4.3.8.3
4.4.3.8.4
4.4.3.8.5
4.4.3.8.6
There is zero to one "Minimum Retreatment Interval" requirements.
If Minimum Retreatment Interval is provided at the Product or Scenario
Level, then it should not also provided at the Site Level.
Minimum Retreatment Interval is required if more than one application
is allowed or if the single application rate is not equal to the crop
cycle/yearly rate.
Minimum Retreatment Interval restriction occurs after application.
( value must be "3".)
Minimum Retreatment Interval - Time value is a number.
Minimum Retreatment Interval - Units must be units of time.
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Figure 100: MRI XML Code Snippet
Product Level Use Restrictions/Limitations













translation value="{Minimum period of time}"
displayName-'{Unit Display Name}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>




4.4.3.9 Pre-Harvest Interval (PHI) (+)
Identifies the minimum period of time that must pass after an application before
crop/commodity harvest. This data element may be blank if the final application is
restricted to occur at or before a crop growth stage that is typically 30 days or more
before harvest.
Entry type: "Pre-Harvest Interval (PHI) Category" picklist selection, and value
unit.
Validation Procedures:
Error Messages
4.4.3.9.1	There is zero to many "Pre-Harvest Interval Restrictions" requirements.
4.4.3.9.2	If Pre-Harvest Interval Restrictions is provided at the Product or
Scenario Level, then it should not also provided at the Site Level.
4.4.3.9.3	Pre-Harvest Interval Restrictions occur after application.
( value must be "3".)
4.4.3.9.4	Pre-Harvest Interval Restrictions has a code of 1005028 and a
displayName of "PHI Category".
4.4.3.9.5	Pre-Harvest Interval Restrictions displayName must match the code.
4.4.3.9.6	If there is Pre-Harvest Interval Restrictions listed then there must be a
 element with code and displayName.
4.4.3.9.7	Pre-Harvest Interval Restrictions  code and displayName must
come from the list "PHI Category".
4.4.3.9.8	Pre-Harvest Interval Restrictions  displayName must match the
code.
4.4.3.9.9	Pre-Harvest Interval Restrictions - Time value is a number.
4.4.3.9.10	Pre-Harvest Interval Restrictions - Units must be units of time.
Ill
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Figure 101: PHI XML Code Snippet
Product Level Use Restrictions/Limitations

















translation value="{PHI Value}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="{Unit DisplayName}"/>




4.4.3.10 Pre-Grazing Interval (PGI)/Pre-Feeding Interval (PFI)
Restrictions (+)
Identifies the minimum period of time that must pass after an application before an
identified group of animals may graze in treated areas or may be fed treated material.
Entry type: "Pre-Grazing Interval (PGI)/Pre-Feeding Interval (PFI) Category"
picklist selection, and value unit.
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Validation Procedures:
4.4.3.10.1	There is zero to many "Pre-Grazing/Pre-Feeding Interval Restrictions"
requirements.
4.4.3.10.2	If Pre-Grazing/Pre-Feeding Interval Restrictions is provided at the
Product or Scenario Level, then it should not also be provided at the
Site Level.
4.4.3.10.3	Pre-Grazing/Pre-Feeding Interval Restrictions occurs after application.
( value must be "3".)
4.4.3.10.4	Pre-Grazing/Pre-Feeding Interval Restrictions has a code of 1005026
and a displayName of "PGI Category".
4.4.3.10.5	Pre-Grazing/Pre-Feeding Interval Restrictions displayName must match
the code.
4.4.3.10.6	If there is Pre-Grazing/Pre-Feeding Interval Restrictions listed then
there must be a  element with code and displayName.
4.4.3.10.7	Pre-Grazing/Pre-Feeding Interval Restrictions  code and
displayName must come from the list "PGI Category".
4.4.3.10.8	Pre-Grazing/Pre-Feeding Interval Restrictions  displayName
must match the code.
4.4.3.10.9	There is zero or one animal "Weight" or "Age" per Pre-Grazing/Pre-
Feeding Interval Restriction.
4.4.3.10.10	Pre-Grazing/Pre-Feeding Interval Restrictions animal "Weight" value is
a number.
4.4.3.10.11	Pre-Grazing/Pre-Feeding Interval Restrictions animal "Age" value is a
number.
4.4.3.10.12	There is zero or one Pre-Grazing/Pre-Feeding Interval Restrictions -
Time per Pre-Grazing/Pre-Feeding Interval Restriction.
4.4.3.10.13	Pre-Grazing/Pre-Feeding Interval Restrictions - Time value is a number.
4.4.3.10.14	Pre-Grazing/Pre-Feeding Interval Restrictions - Units must be units of
time or weight, respectively.
Figure 102: PGI/PFI XML Code Snippet
113
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translation value-'{"Interval Time"}"
displayName="{"Unit of Measure Display name"}"
code="{"UoM Code"}"
codeSystem="2.16.840.1.113883.6.275. l"/>









translation value="5"
displayName="pound"
code="3627071"
codeSystem-'2.16.840.1.113883.6.275. l"/>






	
4.4.3.11 Pre-Slaughter Interval (PSI) (+)
Identifies the minimum period of time after an application that must pass before an
identified group of animals that have contacted the product can be slaughtered for food or
feed.
Entry type: "Pre-Slaughter Interval (PSI) Category" picklist selection, and value
unit.
Validation Procedures:
4.4.3.11.1
4.4.3.11.2
4.4.3.11.3
4.4.3.11.4
4.4.3.11.5
4.4.3.11.6
There is zero to many "Pre-Slaughter Interval Restrictions"
requirements.
If Pre-Slaughter Interval Restrictions is provided at the Product or
Scenario Level, then it should not also be provided at the Product Level.
Pre-Slaughter Interval Restrictions occur after application.
( value must be "3".)
Pre-Slaughter Interval Restrictions has a code of 1005027 and a
displayName of "PSI Category".
Pre-Slaughter Interval Restrictions displayName must match the code.
If there is Pre-Slaughter Interval Restrictions listed then there must be a
 element with code and displayName.
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4.4.3.11.1 There is zero to many "Pre-Slaughter Interval Restrictions"
requirements.
4.4.3.11.7	Pre-Slaughter Interval Restrictions  code and displayName must
come from the list "PSI Category".
4.4.3.11.8	Pre-Slaughter Interval Restrictions  displayName must match
the code.
4.4.3.11.9	There is zero or one Pre-Slaughter Interval Restrictions - Time per Pre-
Slaughter Interval Restriction.
4.4.3.11.10	Pre-Slaughter Interval Restrictions - Time value is a number.
4.4.3.11.11	Pre-Slaughter Interval Restrictions - Units must be units of time.
Figure 103: PSI XML Code Snippet
Product Level Use Restrictions/Limitations

















translation value="{Pre-Slaughter Interval}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="{Unit DisplayName}"/>




4.4.3.12 Buffered Area(s) (+)
Identifies the minimum distance that is required between the area where a product is
applied and the specific area to be protected from the pesticide application.
Entry type: "Buffered Area" picklist selection, and value unit.
Validation Procedures:
4.4.3.12.1	There is zero to many "Buffered Area(s)" preconditions.
4.4.3.12.2	If Buffered Area(s) is provided at the Product or Scenario Level, then it
should not also provided at the Site Level.
4.4.3.12.3 Buffered Area(s)  code is "T".
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4.4.3.12.1 There is zero to many "Buffered Area(s)" preconditions.
4.4.3.12.4	Buffered Area(s) has a code of 1004980 and a displayName of "Buffered
Area".
4.4.3.12.5	Buffered Area(s) displayName must match the code.
4.4.3.12.6	If there is Buffered Area(s) listed then there must be a  element
with code and displayName.
4.4.3.12.7	Buffered Area(s)  code and displayName must come from the
list "Buffered Area".
4.4.3.12.8	Buffered Area(s)  displayName must match the code.
4.4.3.12.9	Buffered Area(s) - Distance value is a number.
4.4.3.12.10	Buffered Area(s) - Units must be "Standard Length" units.
Figure 104: Buffered Areas XML Code Snippet
Product Level Use Restrictions/Limitations
















translation value="{Buffered Area value}"
displayName="{Unit DisplayName}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>



4.4.3.13 Max Release Height
Identifies the maximum distance between the point of release from the application
equipment and the top of crop or ground.
Entry type: Value unit.
Validation Procedures:
lessag
4.4.3.13.1	There is zero or one "Maximum Release Height" preconditions.
4.4.3.13.2	If Max Release Height is provided at the Product or Scenario Level, then
it should not also provided at the Site Level.
4.4.3.13.3	Max Release Height  code is "T".
4.4.3.13.4	Max Release Height - Height value is a number.
4.4.3.13.5	Max Release Height - Units must be "Standard Length" units.
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Figure 105: Maximum Release Height XML Code Snippet
Product Level Use Restrictions/Limitations












translation value="{Release Height}"
displayName="{Unit DisplayName}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>



4.4.3.14 Max Wind Speed
Identifies the maximum wind speed allowed during application.
Entry type: Value unit.
Validation Procedures:
4.4.3.14.1
4.4.3.14.2
4.4.3.14.3
4.4.3.14.4
4.4.3.14.5
Error Messages
There is zero or one "Maximum Wind Speed" preconditions.
If Max Wind Speed is provided at the Product or Scenario Level, then it
should not also provided at the Site Level.
Max Wind Speed  code is "T".
Max Wind Speed - Speed value is a number.
Max Wind Speed - Units must be units of speed.
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Figure 106: Maximum Wind Speed XML Code Snippet
Product Level Use Restrictions/Limitations












translation value="{Wind Speed}"
displayName="{Unit DisplayName}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>



4.4.3.15 Application Temperature
Identifies the minimum and/or maximum temperature(s) at which application(s) may be
made.
Entry type: Value unit, value unit.
Validation Procedures:
lessap
4.4.3.15.1	There is zero or one "Application Temperature" preconditions.
4.4.3.15.2	If Application Temperature is provided at the Product or Scenario Level,
then it should not also provided at the Site Level.
4.4.3.15.3	Application Temperature  code is "B".
4.4.3.15.4	Application Temperature - Min Temp value is a number.
4.4.3.15.5	Application Temperature - Max Temp value is a number.
4.4.3.15.6	Application Temperature - Units (Min Temp/Max Temp) must be
temperature units.
4.4.3.15.7	Application Temperature - Units must match when both limits are
provided.
4.4.3.15.8	"Min Temp" and "Max Temp" do not need to be provided together.
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Figure 107: Application Temperature XML Code Snippet
Product Level Use Restrictions/Limitations













translation value="{Minimum Temperature}"
displayName="{Unit DisplayName}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>


translation value="{Maximum Temperature}"
displayName="{Unit DisplayName}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>




4.4.3.16 ASABE Droplet Size (+)
Identifies restrictions associated with the application droplet size according to the
ASABE 572 standard. Droplet sizes that are acceptable for application should be
selected. This must be entered for broadcast applications using aerial or ground
equipment.
Entry type: "ASABE Droplet Size" picklist selection, and value unit.
Validation Procedures:
ibers Validation Error Mc
4.4.3.16.1	There is zero to many "ASABE Droplet Size" requirements.
4.4.3.16.2	If ASABE Droplet Size is provided at the Product or Scenario Level, then
it should not also provided at the Site Level.
4.4.3.16.3	ASABE Droplet Size is required when Application Type = "broadcast",
Form as Applied = "liquid formations" and/or Application Equipment =
"Aerial"' or "Groundboom".
4.4.3.16.4	ASABE Droplet Size has a code of 1004962 and a displayName of
"ASABE Droplet Size".
4.4.3.16.5	ASABE Droplet Size displayName must match the code.
4.4.3.16.6	If there is ASABE Droplet Size listed then there must be a 
element with code and displayName.
4.4.3.16.7	ASABE Droplet Size  code and displayName must come from the
list "ASABE Droplet Size".
4.4.3.16.8	ASABE Droplet Size  displayName must match the code.
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Figure 108: ASABE Droplet Size XML Code Snippet
Product Level Use Restrictions/Limitations















4.4.3.17 Soil Incorporation Depth and Time
Identifies the minimum soil incorporation depth that is required for the application, and
the maximum amount of time that must pass before incorporation takes place. If the
incorporation is done during application, enter the time as "0" minutes.
Entry type: Value unit, value unit.
Validation Procedures:
4.4.3.17.1
4.4.3.17.2
4.4.3.17.3
4.4.3.17.4
4.4.3.17.5
4.4.3.17.6
lessaE
There is zero or one "Soil Incorporation Depth and Time" observations.
If Soil Incorporation Depth and Time is provided at the Product or
Scenario Level, then it should not also provided at the Site Level.
Soil Incorporation Depth and Time restriction occurs after application.
( value must be "3".)
If soil incorporation occurs at the time of application then "Time" is "0"
and "Units" are "minutes".
If there is a soil incorporation "Time" then there should also be a soil
incorporation "Depth".
Soil Incorporation Depth and Time - Units must be units of time and
"Standard Length", respectively.
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Figure 109: Soil Incorporation Depth and Time XML Code Snippet
Product Level Use Restrictions/Limitations











translation value="{Maximum time after application}"
displayName="{Unit DisplayName}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>










translation code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="{Unit DisplayName"
value="{Minimum Depth}"/>






4.4.3.18 Restricted Soil Type (+)
Identifies any soil type(s) to which the product should not be applied using the prescribed
methods.
Entry type: "Soil Type" picklist selection, and value unit.
Validation Procedures:
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4.4.3.18.1	There is zero to many "Restricted Soil Type(s)" preconditions.
4.4.3.18.2	If Restricted Soil Type(s) is provided at the Product or Scenario Level,
then it should not also provided at the Site Level.
4.4.3.18.3	Restricted Soil Type(s)  code is "B".
4.4.3.18.4	Restricted Soil Type(s) has a code of 1004961 and a displayName of
"Soil Type".
4.4.3.18.5	Restricted Soil Type(s) displayName must match the code.
4.4.3.18.6	If there is Restricted Soil Type(s) listed then there must be a 
element with code and displayName.
4.4.3.18.7	Restricted Soil Type(s)  code and displayName must come from
the list "Soil Type".
4.4.3.18.8	Restricted Soil Type(s)  displayName must match the code.
Figure 110: Restricted Soil Type XML Code Snippet
Product Level Use Restrictions/Limitations
















4.4.3.19 Minimum Percent Soil Organic Matter
Identifies the minimum percent soil organic matter to which application(s) may be made.
Entry type: Value unit.
Validation Procedures:
4.4.3.19.1
4.4.3.19.2
4.4.3.19.3
4.4.3.19.4
4.4.3.19.5
There is zero or one "Minimum Percent Soil Organic Matter"
preconditions.
If Minimum Percent Soil Organic Matter is provided at the Product or
Scenario Level, then it should not also provided at the Site Level.
Minimum Percent Soil Organic Matter  code is "B".
Minimum Percent Soil Organic Matter - Value is a number.
Minimum Percent Soil Organic Matter has a unit code of 3627136 and a
displayName of
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Figure 111: Minimum Percent Soil Organic Matter XML Code Snippet
Product Level Use Restrictions/Limitations












translation code="3627136"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="%"
value="{Percent Soil Organic Matter}"/>



4.4.3.20 Minimum Age of Animal To Be Treated
Identifies the minimum age of animals to which application(s) may be made.
Entry type: Value unit.
Validation Procedures:
:
Error Messages
4.4.3.20.1	There is zero or one "Minimum Age of Animal To Be Treated"
preconditions.
4.4.3.20.2	If Minimum Age of Animal To Be Treated is provided at the Product or
Scenario Level, then it should not also provided at the Site Level.
4.4.3.20.3	Minimum Age of Animal To Be Treated  code is "B".
4.4.3.20.4	Minimum Age of Animal To Be Treated - Age value is a number.
4.4.3.20.5	Minimum Age of Animal To Be Treated - Units must be units of time.
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Figure 112: Minimum Age of Animal To Be Treated XML Code Snippet
Product Level Use Restrictions/Limitations












translation value="{Minimum Age}"
displayName="{Units DisplayName}"
code="{Minimum Age units}"
codeSystem="2.16.840.1.113883.6.275. l"/>



4.4.3.21 Minimum Weight of Animal To Be Treated
Identifies the minimum weight of animals to which application(s) may be made.
Entry type: Value unit.
Validation Procedures:
4.4.3.21.1
4.4.3.21.2
4.4.3.21.3
4.4.3.21.4
4.4.3.21.5
Error Messages
There is zero or one "Minimum Weight of Animal To Be Treated"
preconditions.
If Minimum Weight of Animal To Be Treated is provided at the Product
or Scenario Level, then it should not also provided at the Site Level.
Minimum Weight of Animal To Be Treated  code is "B".
Minimum Weight of Animal To Be Treated - Weight value is a number.
Minimum Weight of Animal To Be Treated - Units must be "Standard
Weight/Mass" units.
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Figure 113: Minimum Weight of Animal To Be Treated XML Code Snippet
Product Level Use Restrictions/Limitations












translation value="{Minimum Weight}"
displayName-'{Units DisplayName}"
code="{Minimum Age units}"
codeSystem="2.16.840.1.113883.6.275. l"/>



4.4.3.22 Pollinator (+)
Identifies specific label restrictions to application based on pollinator protection. The
statements selected from the picklist and those that appear on the label must not be
identical, but must have the same general meaning.
Entry type: "Pollinator Protection Statements'' picklist selection.
Validation Procedures:
4.4.3.22.1	There is zero to many "Pollinator Protection Statement(s)"
requirements.
4.4.3.22.2	If Pollinator Protection Statement(s) is provided at the Product or
Scenario Level, then it should not also provided at the Site Level.
4.4.3.22.3	Pollinator Protection Statement(s) has a code of 1005022 and a
displayName of "Pollinator Protection Statements".
4.4.3.22.4	Pollinator Protection Statement(s) displayName must match the code.
4.4.3.22.5	If there is Pollinator Protection Statement(s) listed then there must be a
 element with code and displayName.
4.4.3.22.6	Pollinator Protection Statement(s)  code and displayName must
come from the list "Pollinator Protection Statements".
4.4.3.22.7	Pollinator Protection Statement(s)  displayName must match
the code.
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Figure 114: Pollinator Protection Statements XML Code Snippet
Product Level Use Restrictions/Limitations














4.4.3.23	Bulletins Live
Identifies if there is an Endangered Species County Level Bulletin indicator on the label.
This is a presence/absence indicator. If a Bulletins Live statement appears on the label,
then Bulletins Live should be selected.
Entry type: Presence/absence selection.
Validation Procedures:
ID Numbers Validation Error Messages	|
4.4.3.23.1	There is zero or one "Bulletins Live" requirements.
4.4.3.23.2	If Bulletins Live is provided at the Product or Scenario Level, then it
should not also provided at the Site Level.
Figure 115: Bulletins Live XML Code Snippet
Product Level Use Restrictions/Limitations











4.4.3.24	Applications to Water (+)
Identifies specific label restrictions related to the treatment of a volume of water
including flooded field applications and other water bodies. The statements selected from
the picklist and those that appear on the label may not be identical, but must have the
same general meaning.
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Entry type: "Water Protection Statements'' picklist selection.
Validation Procedures:
4.4.3.24.1	There is zero to many "Water Protection Statement(s)" requirements.
4.4.3.24.2	If Water Protection Statement(s) is provided at the Product or Scenario
Level, then it should not also provided at the Site Level.
4.4.3.24.3	Water Protection Statement(s) has a code of 1005023 and a
displayName of "Water Protection Statements".
4.4.3.24.4	Water Protection Statement(s) displayName must match the code.
4.4.3.24.5	If there is Water Protection Statement(s) listed then there must be a
 element with code and displayName.
4.4.3.24.6	Water Protection Statement(s)  code and displayName must
come from the list "Water Protection Statements".
4.4.3.24.7	Water Protection Statement(s)  displayName must match the
code.
4.4.3.24.8	Water Protection Statement(s) - Value is a number.
4.4.3.24.9	Water Protection Statement(s) - Units must be provided.
Figure 116: Water Protection Statement XML Code Snippet











translation code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="{Unit DisplayName}"
value="{Some Value}"/>




	
4.4.3.25 Secondary Manufacturing
Identifies if there are any restrictions which limit further manufacturing of the treated
material; e.g., restricting treated plastics in the manufacture of toys. This is a
presence/absence indicator. If any restrictions limiting secondary manufacturing appear
on the label then Secondary Manufacturing should be selected.
Entry type: Presence/absence selection.
Validation Procedures:
ID Numbers Validation Error Messages	j
4.4.3.25.1	There is zero or one "Secondary Manufacturing" requirements.
4.4.3.25.2	If Secondary Manufacturing is provided at the Product or Scenario
Level, then it should not also provided at the Site Level.
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Figure 117: Secondary Manufacturing XML Code Snippet
Product Level Use Restrictions/Limitations











4.4.3.26 Restricted Use Site Location (+)
Identifies if applications are not permitted in specific Use Site Locations. Locations
entered as restricted at the Site Level cannot be entered as permitted in scenario attribute
sections at lower levels of the model. Generally, elements that are not positively entered
in the attributes section of this document are considered to be disallowed. This restriction
should only be entered if the text of the label explicitly prohibits this type of application.
Entry type: "Use Site Location" picklist selection.
Validation Procedures:
4.4.3.26.1	There is zero to many "Restricted Use Site Location(s)" preconditions.
4.4.3.26.2	If Restricted Use Site Location(s) is provided at the Product or Scenario
Level, then it should not also be provided at the Site Level.
4.4.3.26.3	Restricted Use Site Location(s)  code is "B".
4.4.3.26.4	Restricted Use Site Location(s) has a code of 1004663 and a
displayName of "Use Site Location".
4.4.3.26.5	Restricted Use Site Location(s) displayName must match the code.
4.4.3.26.6	If there is Restricted Use Site Location(s) listed then there must be a
 element with code and displayName.
4.4.3.26.7	Restricted Use Site Location(s)  code and displayName must
come from the list "Use Site Location".
4.4.3.26.8	Restricted Use Site Location(s)  displayName must match the
code.
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Figure 118: Use Site Location XML Code Snippet
Product Level Use Restrictions/Limitations
















4.4.3.27 Restricted Application Target (+)
Identifies if applications are not permitted to specific targets. Targets entered as restricted
at the Site Level cannot be entered as permitted in scenario attribute sections at lower
levels of the model. Generally, elements that are not positively entered in the attributes
section of this document are considered to be disallowed. This restriction should only be
entered if the text of the label explicitly prohibits this type of application.
Entry type: "Application Target" picklist selection.
Validation Procedures:
4.4.3.27.1	There is zero to many "Restricted Application Target(s)" preconditions.
4.4.3.27.2	If Restricted Application Target(s) is provided at the Product or Scenario
Level, then it should not also be provided at the Site Level.
4.4.3.27.3	Restricted Application Target(s)  code is "B".
4.4.3.27.4	Restricted Application Target(s) has a code of 1004682 and a
displayName of "Application Target".
4.4.3.27.5	Restricted Application Target(s) displayName must match the code.
4.4.3.27.6	If there is Restricted Application Target(s) listed then there must be a
 element with code and displayName.
4.4.3.27.7	Restricted Application Target(s)  code and displayName must
come from the list "Application Target".
4.4.3.27.8	Restricted Application Target(s)  displayName must match the
code.
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Figure 119: Restricted Application Target XML Code Snippet
Product Level Use Restrictions/Limitations
















4.4.3.28 Restricted Application Type (+)
Identifies if applications are not permitted using specific application types. Application
types entered as restricted at the Site Level cannot be entered as permitted in scenario
attribute sections at lower levels of the model. Generally, elements that are not positively
entered in the attributes section of this document are considered to be disallowed. This
restriction should only be entered if the text of the label explicitly prohibits this type of
application.
Entry type: "Application Type" picklist selection.
Validation Procedures:
4.4.3.28.1	There is zero to many "Restricted Application Type(s)" preconditions.
4.4.3.28.2	If Restricted Application Type(s) is provided at the Product or Scenario
Level, then it should not also be provided at the Site Level.
4.4.3.28.3	Restricted Application Type(s)  code is "B".
4.4.3.28.4	Restricted Application Type(s) has a code of 1004920 and a
displayName of "Application Type".
4.4.3.28.5	Restricted Application Type(s) displayName must match the code.
4.4.3.28.6	If there is Restricted Application Type(s) listed then there must be a
 element with code and displayName.
4.4.3.28.7	Restricted Application Type(s)  code and displayName must
come from the list "Application Type".
4.4.3.28.8	Restricted Application Type(s)  displayName must match the
code.
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Figure 120: Restriced Application Type XML Code Snippet
Product Level Use Restrictions/Limitations
















4.4.3.29 Restricted Application Equipment (+)
Identifies if applications are not permitted using specific equipment. Equipment entered
as restricted at the Site Level cannot be entered as permitted in scenario attribute sections
at lower levels of the model. Generally, elements that are not positively entered in the
attributes section of this document are considered to be disallowed. This restriction
should only be entered if the text of the label explicitly prohibits this type of application.
Entry type: "Application Equipment' picklist selection.
Validation Procedures:
4.4.3.29.1
4.4.3.29.2
4.4.3.29.3
4.4.3.29.4
4.4.3.29.5
4.4.3.29.6
4.4.3.29.7
4.4.3.29.8
There is zero to many "Restricted Application Equipment"
preconditions.
If Restricted Application Equipment is provided at the Product or
Scenario Level, then it should not also provided at the Site Level.
"Restricted Application Equipment"  code is "B".
Restricted Application Equipment has a code of 1004922 and a
displayName of "Application Equipment".
Restricted Application Equipment displayName must match the code.
If there is Restricted Application Equipment listed then there must be a
 element with code and displayName.
Restricted Application Equipment  code and displayName must
come from the list "Application Equipment".
Restricted Application Equipment  displayName must match the
code.
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Figure 121: Restriced Application Equipment XML Code Snippet
Product Level Use Restrictions/Limitations
















4.4.3.30 Restricted Application Timing (+)
Identifies if applications are not permitted during specific timings. Timings entered as
restricted at the Site Level cannot be entered as permitted in scenario attribute sections at
lower levels of the model. Generally, elements that are not positively entered in the
attributes section of this document are considered to be disallowed. This restriction
should only be entered if the text of the label explicitly prohibits this type of application.
Entry type: "Application Timing (Time of Day)", "Application Timing (Timing of
Pest) and/or "Application Timing (Use Site Status)" picklist selection.
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Validation Procedures:
4.4.3.30.1 There is zero to many "Restricted Application Timing (Use Site Status)",
"Restricted Application Timing (Time of Day)", and/or "Restricted
Application Timing (Timing of Pest)" preconditions.
4.4.3.30.2	If Restricted Application Timing is provided at the Product or Scenario
Level, then it should not also be provided at the Site Level.
4.4.3.30.3	Restricted Application Timing Code code is "B".
4.4.3.30.4	Restricted Application Timing (Time of Day) has a code of 1004921 and
a displayName of "Application Timing (Time of Day)".
4.4.3.30.5	Restricted Application Timing (Timing of Pest) has a code of 1005020
and a displayName of "Application Timing (Timing of Pest)".
4.4.3.30.6	Restricted Application Timing (Use Site Status) has a code of 1004960
and a displayName of "Application Timing (Use Site Status)".
4.4.3.30.7	Restricted Application Timing displayName must match the code.
4.4.3.30.8	If there is Restricted Application Timing listed then there must be a
 element with code and displayName.
4.4.3.30.9	Restricted Application Timing (Time of Day)  code and
displayName must come from the list "Application Timing (Time of
Day)".
4.4.3.30.10	Restricted Application Timing (Timing of Pest)  code and
displayName must come from the list "Application Timing (Timing of
Pest)".
4.4.3.30.11	Restricted Application Timing (Use Site Status)  code and
displayName must come from the list "Application Timing (Use Site
Status)".
4.4.3.30.12	Restricted Application Timing  displayName must match the
code.
Figure 122: Restricted Application Timing XML Code Snippet
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Product Level Use Restrictions/Limitations






































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4.5 Scenario Level (+)
4.5.0 Section in General
The Scenario Level section is a sub-section of a Site Level and is a header section to
contain the child sections below defined. The Scenario Level section can be
repeated/cloned to create many scenarios within a Site Level section.
A scenario describes specific instructions for how to use the product. Each scenario is
defined using a Scenario Rate pattern (including both single and yearly rates) and all the
Scenario Attributes (target, timing, type, equipment, and associated restrictions) by which
that rate can be applied.
While most of the rates on labels are presented in terms of a particular pest, the goal of
the Scenario Level is to capture the maximum overall rate for the application method at a
particular site. The system is flexible in that if all of the Scenario Rate elements are
identical, then multiple Scenario Attributes may be listed as a single scenario. Likewise,
if a label has more complicated application instructions, then additional scenarios can be
added to isolate caveats to the maximum use. This may also include use of the
"Geographic Restrictions" when rates differ based on geography. Before entering
information to define a scenario, look across the application instructions for the site to
determine if there are unique use parameters. For example, if there are different
application rates associated with a pre-plant, soil in-furrow application versus a post
emergent foliar application, then a separate scenario is entered for each. Conversely, if
the parameters do not change with variations in equipment, timing, application type, or
target, then a single scenario can capture all the details. It is important to remember,
however, that all combinations of selections must be permitted.
Information entered in the Scenario Level subsections applies to all combinations of the
Scenario Attributes listed.
Validation Procedures:
4.5.0.0.1	There is at least one "Scenario Level" section per Site Level section.
4.5.0.0.2	Scenario Level section  and displayName must match.
4.5.0.0.3	Scenario Level section link is optional.
4.5.0.0.4	If Scenario Level section link is provided then the section link is a unique
string within the Use Index document.
4.5.0.0.5	Scenario Level <section ID> is a unique UUID within the Use Index
document.
Figure 123: Scenario Level Section XML Code Snippet
<component>
<section ID="{Section Linl<}">
<id root-'{Section ld}"/>
<code code="3810091" codeSystem="2.16.840.1.113883.6.275.1"
displayName="Scenario Level"/>
<title>Scenario Level
4.5.1 Scenario Rate
Describes single and yearly/crop cycle maximum rate parameters that can be applied
using a set of Scenario Attributes. Only one set of maximum single and yearly/crop cycle
rates may be entered for each Scenario. Differences in these values (except minimum
rate) trigger a new Scenario. Each Scenario must contain a single maximum application
rate, and at least one number of application per year/crop cycle or maximum rate per
year/crop cycle.
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Validation Procedures:
4.5.1.0.1	There is one "Scenario Rate" sub-section per Scenario Level section.
4.5.1.0.2	Scenario Rate section  and displayName must match.
4.5.1.0.3	Scenario Rate section link is optional.
4.5.1.0.4	If Scenario Rate section link is provided then the section link is a unique
string within the Use Index document.
4.5.1.0.5	Scenario Rate <section ID> is a unique UUID within the Use Index
document.
4.5.1.0.6	Scenario Rate must be less than the Use Site Yearly/Crop Cycle Rate
when Unit of Measure codes are the same.
Figure 124: Scenario Rate XML Code Snippet
<component>
<section ID="{Section Link}">
<id root-'{Section ld}"/>
<code code="3810092" codeSystem="2.16.840.1.113883.6.275.1"
displayName="Scenario Rate"/>
<title>Scenario Rate
4.5.1.1 Single Application Minimum Rate
The single application rate is entered in as a numerical range of pesticide quantity
per an area, volume, time, or target of application. The value range is represented
as the Single Application Minimum Rate and the Single Application Maximum
Rate. For the purposes of this document, the single application rate is the quantity
of product that can be applied per day (24 hours) to the respective site using the
scenario. Minimum values are only required for scenarios that require efficacy
data (such as public health uses).
While rates on labels are frequently presented in terms of a particular pest, the
goal of the Single Application Rate Range is to capture the minimum and
maximum overall rate a product can be applied with a particular combination of
Scenario Attributes.
Typically, conventional pesticide use rates are expressed in terms of amount of
product per area treated. However, some rates will require non-area based units;
e.g., "per 100 pounds of seed", "per animal", "per volume", "per second", etc.
Similarly, antimicrobial use rates will typically be expressed in terms of amount
of product per amount of treated material. However, some rates may be expressed
as concentration; e.g., "parts per million", "parts per billion", "%" based on total
product weight", etc. In these cases, the denominator of the rate should be entered
as per "1" "target concentration no area needed".
Additionally, rates may be expressed as a finished spray (maximum amount of
product per minimum volume of diluent, with the maximum total solution applied
per area) by using both the "Single Application Rate" and "Minimum
Diluent/Carrier or Maximum Finish Spray Volume per Area" data entry points.
To do this, the "Single Application Rate" is entered as a spray solution
concentration, where the denominator of the rate represents the minimum quantity
of diluent that the entered quantity of product may be mixed with. The "Minimum
Diluent/Carrier or Maximum Finish Spray Volume per Area" data element below
is then used to record the maximum amount of spray solution that can be applied
per area. If the denominator of the rate entered in the "Single Application Rate"
data field is a volume, and the Application Target is not water or treated material,
then it will be assumed that the value is in terms of the finish spray.
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Entry type: Value unit, value unit.
Validation Procedures:
4.5.1.1.1	There is zero or one "Single Application Minimum Rate" per Scenario
Level section.
4.5.1.1.2	Single Application Minimum Rate xsi:type is "RTO_PQ_PQ".
4.5.1.1.3	Single Application Minimum Rate numerator value is a number.
4.5.1.1.4	Single Application Minimum Rate denominator value is a number.
4.5.1.1.5	Single Application Minimum Rate numerator units must match Single
Application Maximum Rate numerator units when both are provided.
4.5.1.1.6	Single Application Minimum Rate denominator units must match Single
Application Maximum Rate denominator units when both are provided.
4.5.1.1.7	Single Application Minimum Rate numerator units must be one of the
following: "Standard Weight/Mass"; "Standard Volume/Capacity";
"Miscellaneous Application Unit"; "Concentration"; "Non-Standard
Volume/Capacity".
4.5.1.1.8	"Single Application Minimum Rate" denominator units must be one of
the following: "Standard Area"; " Standard Length"; "Standard
Weight/Mass"; "Standard Volume/Capacity"; "Time"; "Non-Standard
Volume/Capacity"; "Non-standard - Target (with acreage rate limit)";
"Non-Standard Weight/Mass".
4.5.1.1.9	If there is a Single Application Minimum Rate numerator value then
there must also be a denominator value.
4.5.1.2 Single Application Maximum Rate
The single application rate is entered in as a numerical range of pesticide quantity
per an area, volume, time, or target of application. The value range is represented
as the Single Application Minimum Rate and the Single Application Maximum
Rate. For the purposes of this document, the single application rate is the quantity
of product that can be applied per day (24 hours) to the respective site using the
scenario. Minimum values are only required for scenarios that require efficacy
data (such as public health uses).
While rates on labels are frequently presented in terms of a particular pest, the
goal of the Single Application Rate Range is to capture the minimum and
maximum overall rate a product can be applied with a particular combination of
Scenario Attributes.
Typically, conventional pesticide use rates will be expressed in terms of amount
of product per area treated. However, some rates will require non-area based
units; e.g., "per 100 pounds of seed", "per animal", "per volume", "per second",
etc.
Similarly, antimicrobial use rates will typically be expressed in terms of amount
of product per amount of treated material. Some rates, however, may be expressed
as concentration; e.g., "parts per million", "parts per billion", "%" based on total
product weight", etc. In these cases, the denominator of the rate should be entered
as per "1" "target concentration no area needed".
Additionally, rates may be expressed as a finished spray (maximum amount of
product per minimum volume of diluent, with the maximum total solution applied
per area) by using both the "Single Application Rate" and "Minimum
Diluent/Carrier or Maximum Finish Spray Volume per Area" data entry points.
To do this, the "Single Application Rate" is entered as a spray solution
concentration, where the denominator of the rate represents the minimum quantity
137
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of diluent that the entered quantity of product may be mixed with. The "Minimum
Diluent/Carrier or Maximum Finish Spray Volume per Area" data element below
is then used to record the maximum amount of spray solution that can be applied
per area. If the denominator of the rate entered in the "Single Application Rate"
data field is a volume, and the Application Target is not water or treated material,
then it will be assumed that the value is in terms of the finish spray.
Entry type: Value unit, value unit.
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Validation Procedures:
4.5.1.2.2
4.5.1.2.3
4.5.1.2.4
4.5.1.2.5
4.5.1.2.6
"Single Application Maximum Rate" is required per each Scenario Level
section.
Single Application Maximum Rate numerator value is a number.
Single Application Maximum Rate denominator value is a number.
Single Application Maximum Rate numerator units must be one of the
following: "Standard Weight/Mass"; "Standard Volume/Capacity";
"Miscellaneous Application Unit";" Concentration"; "Non-Standard
Volume/Capacity".
Single Application Maximum Rate denominator units must be one of
the following: "Standard Area"; "Standard Length"; "Standard
Weight/Mass"; "Standard Volume/Capacity"; "Time"; "Non-Standard
Volume/Capacity"; "Non-standard - Target (with acreage rate limit)";
"Non-Standard Weight/Mass"; "Miscellaneous - Target".
If there is a Single Application Maximum Rate numerator value then
there must also be a denominator value.
Figure 125: Single Application Rate Range XML Code Snippet
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Scenario Rate








translation value="{Minimum Rate}"
code-'{Unit Code}"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="{Unit DisplayName}"/>

denominator xsi:type="PQ" nullFlavor="OTH">
translation value="{Per Quantity}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="{Unit DisplayName}"/>




denominator xsi:type="PQ" nullFlavor-'OTH">
translation value="{Per Quantity}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="{Unit DisplayName}"/>










translation value="{Maximum Rate}"
code-'{Unit Code}"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="{Unit DisplayName}"/>


translation value="{Per Quantity}"
code-'{Unit Code}"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="{Unit DisplayName}"/>




4.5.1.3 Acre Rate for Non-Standard Target Measures
Identifies the mass of product that can be applied per day (24 hours) using this scenario
when non-standard target units are used for the Single Application Rate. For example, if a
rate is expressed as "amount of product per insect mound", per acre rate is needed to
clarify the extent of allowable use. This information must be supplied if "Non-Standard
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Target" application units are used for Single Application Rate (see units terminology in
the SmartLabel Vocabulary Guide Version 3.xlsx for a complete listing of these
units). Non-standard target application units may not be used for yearly or crop cycle
application rates.
Entry type: Value unit, value unit.
Validation Procedures:
4.5.1.3.1
4.5.1.3.2
4.5.1.3.3
4.5.1.3.4
4.5.1.3.5
4.5.1.3.6
4.5.1.3.7
4.5.1.3.8
There is zero or one "Acre Rate for Non-Standard Target Measures"
characteristics per Scenario Level section.
Acre Rate for Non-Standard Target Measures xsi:type is "RTO_PQ_PQ".
Acre Rate for Non-Standard Target Measures is required if Single
Application Maximum Rate units are "Non-standard - Target (with
acreage rate limit)".
Acre Rate for Non-Standard Target Measures numerator value is a
number.
Acre Rate for Non-Standard Target Measures denominator value is a
number.
Acre Rate for Non-Standard Target Measures numerator units must be
one of the following: "Standard Weight/Mass"; "Standard
Volume/Capacity"; "Miscellaneous Application Unit"; "Concentration";
"Non-Standard Volume/Capacity".
Acre Rate for Non-Standard Target Measures denominator units must
be one of the following: "Standard Area"; "Standard Length"; "Standard
Weight/Mass"; "Standard Volume/Capacity"; "Time"; "Non-Standard
Volume/Capacity"; "Non-standard - Target (with acreage rate limit)";
"Non-Standard Weight/Mass"; "Miscellaneous - Target".
If there is an Acre Rate for Non-Standard Target Measures numerator
value then there must also be a denominator value.
Figure 126: Acre Rate XML Code Snippet
Scenario Rate








translation value="{Acre Rate}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="{Unit DisplayName}"/>

4.5.1.4 Minimum Diluent/Carrier or Maximum Finish Spray
Amount per Area
Identifies either the minimum volume of diluent/carrier or the maximum amount of finish
spray solution that can be used per treated area. The amount entered may represent a
liquid carrier or a solid carrier; e.g., "dry bulk fertilizer". When Form as Applied in the
Scenario Attributes subsection is a liquid and nothing is entered in this field it signifies
that the product does not need to be diluted prior to application; i.e., the product is in a
ready-to-use form.
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Entry type: Value unit, value unit.
Validation Procedures:
4.5.1.4.1	There is zero or one "Minimum Diluent/Carrier or Maximum Finish
Spray Volume per Area" per Scenario Level section.
4.5.1.4.2	Minimum Diluent/Carrier or Maximum Finish Spray Volume per Area
xsi:type is "RTO_PQ_PQ".
4.5.1.4.3	Minimum Diluent/Carrier or Maximum Finish Spray Volume per Area is
required when "Form as Applied" is a liquid.
4.5.1.4.4	Minimum Diluent/Carrier or Maximum Finish Spray Volume per Area
numerator value is a number.
4.5.1.4.5	Minimum Diluent/Carrier or Maximum Finish Spray Volume per Area
denominator value is a number.
4.5.1.4.6	Minimum Diluent/Carrier or Maximum Finish Spray Volume per Area
numerator units must be one of the following: "Standard/Volume
Capacity"; " Standard Weight/Mass".
4.5.1.4.7	Minimum Diluent/Carrier or Maximum Finish Spray Volume per Area
denominator units must be one of the following: "Standard Area";
"Standard Length"; "Standard Weight/Mass"; "Standard
Volume/Capacity"; "Non-Standard Volume/Capacity"; "Non-standard -
Target (with acreage rate limit)"; "Non-Standard Weight/Mass";
"Miscellaneous - Target".
Figure 127: Minimum Diluent Volume XML Code Snippet
Scenario Rate









translation value="{Minimum Diluent}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="{Unit DisplayName}"/>

denominator xsi:type="PQ" nullFlavor="OTH">
translation value="{Per Quantity}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="{Unit DisplayName}"/>




4.5.1.5 Residence/Contact Time
Identifies the minimum time required for the dosage to remain in place. This value is
generally associated with efficacy.
Entry type: Value unit.
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Validation Procedures:
4.5.1.5.1	There is zero or one "Residence/Contact Time" per Scenario Level
section.
4.5.1.5.2	Residence/Contact Time xsi:type is "PQ".
4.5.1.5.3	Residence/Contact Time is required for products where contact time is
required for efficacy.
4.5.1.5.4	Residence/Contact Time - Min Time value is a number.
4.5.1.5.5	Residence /Contact Time - Units must be time units.
Figure 128: Residence/Contact Time XML Code Snippet
Scenario Rate








translation value="{Minimum Time}"
displayName="{Unit DisplayName}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>



4.5.1.6 Maximum Number of Applications per Scenario per Time
Identifies the maximum number of times the product can be applied per year/crop cycle
for this scenario. This value may not exceed the maximum number of applications
allowed for the respective Use Site using all Scenarios combined, as indicated in
Maximum Number of Applications per Site per Time.
Enter information here and for "Maximum Application Rate per Scenario per Time" as
either per year or per crop cycle; not both.
If "Maximum Number of Applications per Scenario per Time" or "Maximum
Application Rate per Scenario per Time" are expressed in terms of "per Crop Cycle",
then "Maximum Number of Crop Cycles per Year" must also be provided.
Entry type: Value per "Application Rate Measurement Period" picklist selection.
Validation Procedures:
4.5.1.6.1
4.5.1.6.2
4.5.1.6.3
4.5.1.6.4
At least one, "Maximum Number of Applications per Scenario per Time"
or "Maximum Application Rate per Scenario per Time", must be
provided.
Maximum Number of Applications per Scenario per Time xsi: type is
"PQ".
Maximum Number of Applications per Scenario per Time - Number
value is a number.
Maximum Number of Applications per Scenario per Time - Per Time
units must be "Year" or "Crop Cycle".
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4.5.1.6.1	At least one, "Maximum Number of Applications per Scenario per Time"
or "Maximum Application Rate per Scenario per Time", must be
provided.
4.5.1.6.5	Maximum Number of Applications per Scenario per Time
 is from the list "Application Rate Measurement Period".
4.5.1.6.1	At least one, "Maximum Number of Applications per Scenario per Time"
or "Maximum Application Rate per Scenario per Time", must be
provided.
4.5.1.6.2	Maximum Number of Applications per Scenario per Time xsi: type is
"PQ".
Figure 129: Maximim Number of Applications XML Code Snippet
Scenario Rate















4.5.1.7 Minimum Application Rate per Scenario per Time
The maximum yearly/crop cycle application rate is entered in as a numerical range with a
given unit per value with a unit. The value range represents the minimum and maximum
cumulative application rate. Minimum values are only required for scenarios that require
efficacy data (such as public health uses).
Typically, conventional pesticide use rates will be expressed in terms of amount of
product per area treated. However, some rates will require non-area based units; e.g., "per
100 pounds of seed", "per animal", "per volume", "per second", etc.
Similarly, antimicrobial use rates will typically be expressed in terms of amount of
product per amount of treated material. Some rates, however, may be expressed as
concentration; e.g., "parts per million", "parts per billion", "%" based on total product
weight", etc. In these cases, the denominator of the rate should be entered as per "1"
"target concentration no area needed".
Enter information here and for "Maximum Number of Applications per Scenario per
Time" as either per year or per crop cycle; not both.
144
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If "Maximum Number of Applications per Scenario per Time" or "Maximum
Application Rate per Scenario per Time" are expressed in terms of "per Crop Cycle",
then "Maximum Number of Crop Cycles per Year" must also be provided.
Entry type: Value unit per value unit "Application Rate Measurement Period"
picklist selection.
Validation Procedures:
4.5.1.7.1	There is zero or one "Minimum Application Rate per Scenario per Time"
per Scenario Level section.
4.5.1.7.2	Minimum Application Rate per Scenario per Time xsi: type is
"RTO_PQ_PQ" and nullFlavor is "OTH".
4.5.1.7.3	Minimum Application Rate per Scenario per Time numerator units must
match Maximum Application Rate per Scenario per Time numerator
units when both are provided.
4.5.1.7.4	Minimum Application Rate per Scenario per Time denominator units
must match Maximum Application Rate per Scenario per Time
denominator units when both are provided.
4.5.1.7.5	Minimum Application Rate per Scenario per Time numerator value is a
number.
4.5.1.7.6	Minimum Application Rate per Scenario per Time denominator value is
a number.
4.5.1.7.7	Minimum Application Rate per Scenario per Time numerator units must
be one of the following: "Standard Weight/Mass"; "Standard
Volume/Capacity"; "Miscellaneous Application Unit"; "Concentration";
"Non-Standard Volume/Capacity".
4.5.1.7.8	Minimum Application Rate per Scenario per Time denominator units
must be one of the following: "Standard Area"; "Standard Length";
"Standard Weight/Mass"; "Standard Volume/Capacity"; "Time"; "Non-
Standard Volume/Capacity"; "Non-standard - Target (with acreage rate
limit)"; "Non-Standard Weight/Mass"; "Miscellaneous - Target".
4.5.1.7.9	Minimum Application Rate per Scenario per Time  is
from the list "Application Rate Measurement Period".
4.5.1.7.10	If there is a Minimum Application Rate per Scenario per Time
numerator value then there must also be a denominator value.
4.5.1.8 Maximum Application Rate per Scenario per Time
The maximum yearly/crop cycle application rate is entered in as a numerical range with a
given unit per value with a unit. The value range represents the minimum and maximum
cumulative application rate. Minimum values are only required for scenarios that require
efficacy data (such as public health uses).
Typically, conventional pesticide use rates will be expressed in terms of amount of
product per area treated. However, some rates will require non-area based units; e.g., "per
100 pounds of seed", "per animal", "per volume", "per second", etc.
Similarly, antimicrobial use rates will typically be expressed in terms of amount of
product per amount of treated material. However, some rates, may be expressed as
concentration; e.g., "parts per million", "parts per billion", "%" based on total product
weight", etc. In these cases, the denominator of the rate should be entered as per "1"
"target concentration no area needed".
Enter information here and for "Maximum Number of Applications per Scenario per
Time" as either per year or per crop cycle; not both.
145
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If "Maximum Number of Applications per Scenario per Time" or "Maximum
Application Rate per Scenario per Time" are expressed in terms of "per Crop Cycle",
then "Maximum Number of Crop Cycles per Year" must also be provided.
Entry type: Value unit per value unit "Application Rate Measurement Period"
picklist selection.
Validation Procedures:
4.5.1.8.1	Maximum Application Rate per Scenario per Time xsi: type is
"RTO_PQ_PQ" and nullFlavor is "OTH".
4.5.1.8.2	Maximum Application Rate per Scenario per Time numerator value is a
number.
4.5.1.8.3	Maximum Application Rate per Scenario per Time denominator value is
a number.
4.5.1.8.4	Maximum Application Rate per Scenario per Time numerator units
must be one of the following: "Standard Weight/Mass"; "Standard
Volume/Capacity"; "Miscellaneous Application Unit"; "Concentration";
"Non-Standard Volume/Capacity".
4.5.1.8.5	Maximum Application Rate per Scenario per Time denominator units
must be one of the following: "Standard Area"; "Standard Length";
"Standard Weight/Mass"; "Standard Volume/Capacity"; "Time"; "Non-
Standard Volume/Capacity"; "Non-standard - Target (with acreage rate
limit)"; "Non-Standard Weight/Mass"; "Miscellaneous - Target".
4.5.1.8.6	Maximum Application Rate per Scenario per Time  is
from the list "Application Rate Measurement Period".
4.5.1.8.7	If there is a Maximum Application Rate per Scenario per Time
numerator value then there must also be a denominator value.
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Figure 130: Maximum Application Rate Range XML Code Snippet
Scenario Rate














translation value="{Minimum Rate}"
displayName="{Unit DisplayName}"
code-'3627132"
codeSystem="2.16.840.1.113883.6.275. l"/>


translation value="{Per Quantity}"
displayName="{Unit DisplayName}"
code-'{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>









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Figure 131: Maximum Application Rate Range XML Code Snippet (Continued)
displayName="Maximum Application Rate"/>


translation value="{Maximum Rate}"
displayName="{Unit DisplayName}"
code="3627132"
codeSystem-'2.16.840.1.113883.6.275. l"/>


translation value="{Per Quantity}"
displayName="{Unit DisplayName}"
code="{Unit Code}"
codeSystem-'2.16.840.1.113883.6.275. l"/>





4.5.1.9 Maximum Number of Crop Cycles per Year
Identifies the number of crop cycles per annual (12 month) period. This indicator is
necessary when rates at the Site Level or Scenario Level are based on a crop cycle rather
than per year.
Entry type: Value unit per value unit "Application Rate Measurement Period"
picklist selection.
Validation Procedures:
ID Numbers Validation Error Messages	|
4.5.1.9.1	There is zero or one "Maximum Number of Crop Cycles per Year" per
Scenario Level section.
4.5.1.9.2	Maximum Number of Crop Cycles per Year is required if rates are given
per "crop cycle" on the label for this site.
4.5.1.9.3	Maximum Number of Crop Cycles per Year - Number value is a number.
4.5.1.9.4	Maximum Number of Crop Cycles per Year has a unit code of 3627146
and a displayName of "year".
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Figure 132: Maximum Number of Crop Cycles per Year XML Code Snippet
Scenario Rate













translation code="3627146"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="year"
value-'{Max Num Crop Cycles Value}"/>



4.5.2 Scenario Attributes
Identifies the method(s) in which a single set of rate parameters can be applied. Multiple
scenario attributes can be entered for each rate parameter set if all of the use pattern
parameters and restrictions/limitations are identical.
Validation Procedures:
4.5.2.0.1	There is one "Scenario Attributes" sub-section per Scenario Level
section.
4.5.2.0.2	Scenario Attributes section  and displayName must match.
4.5.2.0.3	Scenario Attributes section link is optional.
4.5.2.0.4	If Scenario Attributes section link is provided then the section link is a
unique string within the Use Index document.
4.5.2.0.5	Scenario Attributes <section ID> is a unique UUID within the Use Index
document.
Figure 133: Scenario Attributes XML Code Snippet
<component>
<section ID="{Section Link}">
<id root-'{Section ld}"/>
<code code="3810093" codeSystem="2.16.840.1.113883.6.275.1"
displayName="Scenario Attributes"/>
<title>Scenario Attributes
4.5.2.1 Form as Applied
Identifies the product form at the time of application. This value may be the same or
different from Form as Packaged, depending on whether the product is mixed before
application or undergoes a physical state change during application.
Entry type: "PhysicalForm" picklist selection.
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Validation Procedures:
4.5.2.1.1
4.5.2.1.2
4.5.2.1.3
4.5.2.1.4
"Form as Applied" is required per each Scenario Level section.
There is one Form as Applied .
Form as Applied  is from the list "Physical Form".
Form as Applied displayName must match the code.
Figure 134: Form As Applied XML Code Snippet
Scenario Attributes










4.5.2.2 Application Target (+)
Identifies what is physically treated during application/where application of the product is
directed; e.g., foliage/plant, soil, human/animal, etc.
Entry type: "Application Target" picklist selection.
Validation Procedures:
ID Numbers Validation Error Messages
4.5.2.2.1	There is at least one to many "Application Target(s)" per Scenario Level
section.
4.5.2.2.2	Application Target(s)  is from the list "Application
Target".
4.5.2.2.3	Application Target(s) displayName must match the code.
4.5.2.2.4	Application Target(s) cannot be restricted at the Product or Site Level.
Figure 135: Application Target XML Code Snippet
Scenario Attributes





4.5.2.3 Application Type (+)
Identifies the specific method(s) for product application; e.g., broadcast, dip treatment,
material incorporation, etc.
Entry type: "Application Type" picklist selection.
Validation Procedures:
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4.5.2.3.1
4.5.2.3.2
4.5.2.3.3
4.5.2.3.4
There is at least one to many "Application Type(s)" per Scenario Level
section.
Application Type(s)  is from the list "Application Type".
Application Type(s) displayName must match the code.
Application Type(s) cannot be restricted at the Product or Site Level.
Figure 136: Application Type XML Code Snippet
Scenario Attributes





4.5.2.4 Application Equipment (+)
Identifies the type(s) of equipment used during product application; e.g., helicopter,
trap/bait station, total-release fogger, etc.
Entry type: "Application Equipment" picklist selection.
Validation Procedures:
4.5.2.4.1
4.5.2.4.2
4.5.2.4.3
4.5.2.4.4
4.5.2.4.5
4.5.2.4.6
Error Messages
There is at least one to many "Application Equipment" characteristics
per Scenario Level section.
Application Equipment xsi: type is "SXCM_CD", meaning a set of codes.
Application Equipment code 1004922 is from the list "Application
Equipment".
Application Equipment displayName must match the code.
Application Equipment operator attribute is "I", meaning inclusive.
Application Equipment cannot be restricted at the Product or Site Level.
Figure 137: Application Equipment XML Code Snippet
Scenario Attributes










4.5.2.5 Application Timing (Site Status) (+)
Identifies when pesticide application occurs in relation to the use site; e.g., "At
transplant", "During bloom", "Dormant", etc. If timing is determined solely by pest
pressure enter "All crop/site stages possible (e.g., timing determined solely by pest
151
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pressure)" and then enter the specific pest related timing in Application Timing (Timing
of Pest).
Entry type: "Application Timing (Site Status) " picklist selection.
Validation Procedures:
:
Error Messages
4.5.2.5.1	There is at least one to many "Application Timing (Site Status)"
characteristics per Scenario Level section.
4.5.2.5.2	Application Timing (Site Status) xsi: type is "SXCM_CD", meaning a set
of codes.
4.5.2.5.3	Application Timing (Site Status) code 1005020 is from the list
"Application Timing (Site Status)".
4.5.2.5.4	Application Timing (Site Status) displayName must match the code.
4.5.2.5.5	Application Timing (Site Status) operator attribute is "I", meaning
inclusive.
4.5.2.5.6	Application Timing (Site Status) cannot be restricted at the Product or
Site Level.
Figure 138: Application Timing (Site Status) XML Code Snippet
Scenario Attributes










4.5.2.6 Application Timing (Time of Day) (+)
Identifies when pesticide application occurs in relation to the time of day; e.g., "After
sunrise", "Evening", "After dark", etc.). This information is not required. Only enter this
information if it is explicitly stated on the label.
Entry type: "Application Timing (Time of Day) " picklist selection.
Validation Procedures:
4.5.2.6.1	There is zero to many "Application Timing (Time of Day)" characteristics
per Scenario Level section.
4.5.2.6.2	Application Timing (Time of Day) xsi: type is "SXCM_CD", meaning a set
of codes.
4.5.2.6.3	Application Timing (Time of Day) code 1004960 is from the list
"Application Timing (Time of Day)".
4.5.2.6.4	Application Timing (Time of Day) displayName must match the code.
4.5.2.6.5	Application Timing (Time of Day) operator attribute is "I", meaning
inclusive.
4.5.2.6.6	Application Timing (Time of Day) cannot be restricted at the Product or
Site Level.
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Figure 139: Application Timing (Time of Day) XML Code Snippet
Sceriario Attributes










4.5.2.7 Application Timing (Timing of Pest) (+)
Identifies when a pesticide product should be applied in relation to the targeted pest; e.g.,
"After weed emergence", "When pest occurs", "When damage from pest is observed",
etc. This is required if "All crop/site stages possible (e.g., timing determined solely by
pest pressure)" is entered for Application Timing (Site Status). Otherwise, the
information is not required and should only be entered if it is explicitly stated on the
label.
Entry type: "Application Timing (Timing of Pest) " picklist selection.
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Validation Procedures:
4.5.2.7.2
4.5.2.7.3
4.5.2.7.4
4.5.2.7.5
4.5.2.7.6
4.5.2.7.7
There is zero to many "Application Timing (Timing of Pest)"
characteristics per Scenario Level section.
Application Timing (Timing of Pest) xsi: type is "SXCM_CD", meaning a
set of codes.
Application Timing (Timing of Pest) is required when "All crop stages
possible (e.g., timing determined solely by pest pressure)" is selected
for Application Timing (Site Status).
Application Timing (Timing of Pest) code 1004921 is from the list
"Application Timing (Timing of Pest)".
Application Timing (Timing of Pest) displayName must match the code.
Application Timing (Timing of Pest) operator attribute is "I", meaning
inclusive.
Application Timing (Timing of Pest) cannot be restricted at the Product
or Site Level.
Figure 140: Application Timing (Timing of Pest) XML Code Snippet
Scenario Attributes










4.5.3 Use Scenario Level Restrictions/Limitations
Identifies only Scenario Level Restrictions/Limitations. Restrictions/limitations are
entered at this level if they differ between scenarios. Restriction/limitation information
cannot be entered at multiple levels. Restrictions/limitations should only be recorded in
the Use Index if the label explicitly restricts or limits the identified data element in
legally enforceable language. Statements that include terms like "should" or "for best
results" are not legally enforceable, and should not be recorded.
Multiple entries are possible for many restrictions/limitations. In this document, data
elements that may have multiple entries are marked with a (+) after their title.
Additionally, the validation rules for each element indicate if entry is optional and the
number of entries that can be entered.
Leaving a data element blank indicates that the respective restriction does not apply at
this level.
Validation Procedures:
4.5.3.0.1
4.5.3.0.2
4.5.3.0.3
There is one "Use Scenario Level Restrictions/Limitations" sub-section
per Scenario Level section.
Use Scenario Level Restrictions/Limitations section  and
displayName must match.
Use Scenario Level Restrictions/Limitations section link is optional.
154
(DRAFT)
</pre><hr><pre>
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4.5.3.0.1	There is one "Use Scenario Level Restrictions/Limitations" sub-section
per Scenario Level section.
4.5.3.0.4	If Use Scenario Level Restrictions/Limitations section link is provided
then the section link is a unique string within the Use Index document.
4.5.3.0.5	Use Scenario Level Restrictions/Limitations <section ID> is a unique
UUID within the Use Index document.
Figure 141: Use Scenario Level Restrictions/Limitations XML Code Snippet
<component>
<section ID="{Section Link}">
<id root="{Section ld}"/>
<code code="3810094" codeSystem="2.16.840.1.113883.6.275.1"
displayName="Use Scenario Level Restrictions/Limitations"/>
<title>Use Scenario Level Restrictions/Limitations
4.5.3.1 Geographic Area(s) Allowed (+)
Identifies restrictions associated with geographic location, at the state and county level,
by listing areas where application is allowed. This is a required field at either the Product,
Site, or Scenario level for each method. If applications for a specific scenario are not
restricted to any particular geographic area, enter "United States". If application is not
allowed in a particular area, enter all areas except the prohibited area.
Entry type: "Geographic Area" picklist selection.
Validation Procedures:
4.5.3.1.1	There is at least one "Geographic Area" per Scenario. The Scenario is
considered to have a Geographic Area if it is provided at the Product,
Site, or Scenario Level.
4.5.3.1.2	If Geographic Area is provided at the Product or Site Level, then it
should not also be provided at the Scenario Level.
4.5.3.1.3	Geographic Area has a code of 1005202 and a displayName of
"Geographic Area".
4.5.3.1.4	Geographic Area displayName must match the code.
4.5.3.1.5	If there is Geographic Area listed then there must be a  element
with code and displayName.
4.5.3.1.6	Geographic Area  code and displayName must come from the
list "Geographic Area".
4.5.3.1.7	Geographic Area  displayName must match the code.
155
(DRAFT)

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Figure 142: Geographic Area XML Code Snippet
Product Level Use Restrictions/Limitations















4.5.3.2 Use Site Food Site Relationship
Identifies if applications are intended to come in contact with food or feed, which may
indicate the need for a pesticide tolerance or a regulatory risk assessment. This
information is required for agricultural crops at either the Product, Site, or Scenario levels
for each method to establish whether crops may be used as food/feed or may not be used
as food/feed. If the product labeling for non-agricultural sites explicitly prohibits
applications that may contact food or feed, then "Non-Food/Non-Feed Stream" should be
entered.
See definitions in the SmartLabel Vocabulary Guide Version 3.xlsx for further
guidance.
Entry type: "Use Site Food Relationship" picklist selection.
156
(DRAFT)

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Validation Procedures:
There is one "Use Site Food Relationship" per Scenario. A Scenario is
considered to have a Use Site Food Relationship if it is provided at the
Product, Site, or Scenario Level.
4.5.3.2.2	If Use Site Food Relationship is provided at the Product or Site Level,
then it should not also be provided at the Scenario Level.
4.5.3.2.3	Use Site Food Relationship has a code of 1005021 and a displayName of
"Use Site Food Relationship".
4.5.3.2.4	Use Site Food Relationship displayName must match the code.
4.5.3.2.5	If there is Use Site Food Relationship listed then there must be a
 element with code and displayName.
4.5.3.2.6	Use Site Food Relationship  code and displayName must come
from the list "Use Site Food Relationship".
4.5.3.2.7	Use Site Food Relationship  displayName must match the code.
Figure 143: Food Site Relationship XML Code Snippet
Product Level Use Restrictions/Limitations














4.5.3.3 Maximum Active Ingredient Rate Across Products per Time
Identifies the maximum amount of active ingredient or, in some cases, the maximum
amount of a chemical class that may be applied to a given area across products that
contain the same active ingredient. This restriction is often stated on labels as "Do not
apply more than [x amount] of product per [year or crop cycle] from this or any other
product containing this active ingredient".
Entry type: Value unit, per value unit, per "Application Rate Measurement
Period" picklist selection.
Validation Procedures:
J I Ml
4.5.3.3.1
4.5.3.3.2
4.5.3.3.3
4.5.3.3.4
There is zero or one "Maximum Al Rate Across Products per Time".
If Maximum Al Rate Across Products per Time is provided at the
Product or Site Level, then it should not also be provided at the
Scenario Level.
Maximum Al Rate Across Products per Time numerator value is a
number.
Maximum Al Rate Across Products per Time denominator value is a
number.
157
(DRAFT)

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4.5.3.3.1	There is zero or one "Maximum Al Rate Across Products per Time".
4.5.3.3.5	Maximum Al Rate Across Products per Time numerator units must be
one of the following: "Standard Weight/Mass", "Standard
Volume/Capacity", "Miscellaneous Application Unit", "Concentration",
"Non-Standard Volume/Capacity".
4.5.3.3.6	Maximum Al Rate Across Products per Time denominator units must be
one of the following: "Standard Area", "Standard Length", "Standard
Weight/Mass", "Standard Volume/Capacity", "Time", "Non-Standard
Volume/Capacity", "Non-standard - Target (with area rate limit)", "Non-
Standard Weight/Mass", "Miscellaneous - Target".
4.5.3.3.7	Maximum Al Rate Across Products per Time  is from the
list "Application Rate Measurement Period".
4.5.3.3.8	If there is a Maximum Al Rate Across Products per Time numerator
value then there must also be a denominator value.
Figure 144: Maximum Al Rate Across Products XML Code Snippet
Product Level Use Restrictions/Limitations












translation value="{Maximum Rate}"
displayName-'{Unit DisplayName"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>

denominator xsi:type="PQ" nullFlavor="OTH">
translation value="{Per Quantity}"
displayName-'{Unit DisplayName"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>







158
(DRAFT)

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4.5.3.4 Rotational Crop
Identifies if any rotational crop restrictions apply to this specific product. This is a
presence/absence indicator. If any restrictions to rotation plantings appear on the label,
including what may be planted following the current crop, or the length of time that must
pass before a crop can be planted in the area, then Rotational Crop should be selected.
Entry type: Presence/absence selection (absence selected as default).
Validation Procedures:
4.5.3.4.1	There is zero or one "Rotational Crop" requirements.
4.5.3.4.2	If Rotational Crop is provided at the Product or Site Level, then it should
not also be provided at the Scenario Level.
Figure 145: Rotational Crop XML Code Snippet
Product Level Use Restrictions/Limitations











4.5.3.5 Applicator Class Restrictions (+)
Identifies those individuals or groups of individuals who are allowed to apply the
product, if only certain classes of applicator are allowed. The existence of an Application
Class Restriction, by definition, indicates all other applicators not identified are restricted
from using the product.
Entry type: "Applicator Class Restrictions'" picklist selection.
Validation Procedures:
ID Numbers Validation Error Messages
4.5.3.5.1	There is zero to many "Applicator Class Restrictions".
4.5.3.5.2	If Applicator Class Restrictions is provided at the Product or Site Level,
then it should not also be provided at the Scenario Level.
4.5.3.5.3	Applicator Class Restrictions has a code of 1004442 and a displayName
of "Applicator Class Restrictions".
4.5.3.5.4	Applicator Class Restrictions displayName must match the code.
4.5.3.5.5	If there is Applicator Class Restrictions listed then there must be a
 element with code and displayName.
4.5.3.5.6	Applicator Class Restrictions  code and displayName must come
from the list "Applicator Class Restrictions".
4.5.3.5.7	Applicator Class Restrictions  displayName must match the
code.
159
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Figure 146: Applicator Class Restrictions XML Code Snippet
Product Level Use Restrictions/Limitations














4.5.3.6 Personal Protection Equipment (PPE)/Engineering Control
(+)
This indicates the PPE and/or engineering controls required for use of the product.
Information captured here is not limited to information in the Agricultural Use box on the
label. It is intended to capture requirements for PPE/Engineering Controls that appear
anywhere on the label.
Entry type: "PPE/Engineering ControF picklist selection.
Validation Procedures:
4.5.3.6.1	There is zero to many "PPE/Engineering Controls" requirements.
4.5.3.6.2	If PPE/Engineering Controls is provided at the Product or Site Level,
then it should not also be provided at the Scenario Level.
4.5.3.6.3	Personal Protection Equipment (PPE)/Engineering Controls has a code
of 1005024 and a displayName of "PPE/Engineering Controls".
4.5.3.6.4	PPE/Engineering Controls displayName must match the code.
4.5.3.6.5	If there is PPE/Engineering Controls listed then there must be a 
element with code and displayName.
4.5.3.6.6	PPE/Engineering Controls  code and displayName must come
from the list "PPE/Engineering Controls".
4.5.3.6.7	PPE/Engineering Controls  displayName must match the code.
160
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Figure 147: PPE/Engineering Control XML Code Snippet
Product Level Use Restrictions/Limitations















4.5.3.7 REI
Identifies the minimum period of time after a pesticide application when entry into the
treated area is restricted; i.e., minimum period of time before worker re-entry. It includes
WPS and non-WPS re-entry intervals.
Entry type: Value unit.
Validation Procedures:
4.5.3.7.1
4.5.3.7.2
4.5.3.7.3
4.5.3.7.4
4.5.3.7.5
Error Messages
There is zero to one "Re-Entry Interval" requirements.
If Re-Entry Interval is provided at the Product or Site Level, then it
should not also be provided at the Scenario Level.
Re-Entry Interval restriction occurs after application.
( value must be "3".)
Re-Entry Interval - Time value is a number.
Re-Entry Interval - Units must be units of time.
161
(DRAFT)

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Figure 148: REI XML Code Snippet
Product Level Use Restrictions/Limitations













translation value="{Period of time value}"
displayName-'{Unit Display Name}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>




4.5.3.8 MRI
Identifies the minimum period of time after an application that must pass before the
product can be reapplied to the same area or target.
Entry type: Value unit.
Validation Procedures:
4.5.3.8.1
4.5.3.8.2
4.5.3.8.3
4.5.3.8.4
4.5.3.8.5
4.5.3.8.6
There is zero to one "Minimum Retreatment Interval" requirements.
If Minimum Retreatment Interval is provided at the Product or Site
Level, then it should not also be provided at the Scenario Level.
Minimum Retreatment Interval is required if more than one application
is allowed or if the single application rate is not equal to the crop
cycle/yearly rate.
Minimum Retreatment Interval restriction occurs after application.
( value must be "3".)
Minimum Retreatment Interval - Time value is a number.
Minimum Retreatment Interval - Units must be units of time.
162
(DRAFT)

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Figure 149: MRI XML Code Snippet
Product Level Use Restrictions/Limitations













translation value="{Minimum period of time}"
displayName-'{Unit DisplayName}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>




4.5.3.9 Pre-Harvest Interval (PHI) (+)
Identifies the minimum period of time that must pass after an application before
crop/commodity harvest. This data element may be blank if the final application is
restricted to occur at or before a crop growth stage that is typically 30 days or more
before harvest.
Entry type: "Pre-Harvest Interval (PHI) Category" picklist selection, and value
unit.
Validation Procedures:
Error Messages
4.5.3.9.1	There is zero to many "Pre-Harvest Interval Restrictions" requirements.
4.5.3.9.2	If Pre-Harvest Interval Restrictions is provided at the Product or Site
Level, then it should not also be provided at the Scenario Level.
4.5.3.9.3	Pre-Harvest Interval Restrictions occur after application.
( value must be "3".)
4.5.3.9.4	Pre-Harvest Interval Restrictions has a code of 1005028 and a
displayName of "PHI Category".
4.5.3.9.5	Pre-Harvest Interval Restrictions displayName must match the code.
4.5.3.9.6	If there is Pre-Harvest Interval Restrictions listed then there must be a
 element with code and displayName.
4.5.3.9.7	Pre-Harvest Interval Restrictions  code and displayName must
come from the list "PHI Category".
4.5.3.9.8	Pre-Harvest Interval Restrictions  displayName must match the
code.
4.5.3.9.9	Pre-Harvest Interval Restrictions - Time value is a number.
4.5.3.9.10	Pre-Harvest Interval Restrictions - Units must be units of time.
163
(DRAFT)

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Figure 150: PHI XML Code Snippet
Product Level Use Restrictions/Limitations

















translation value="{PHI Value}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="{Unit DisplayName}"/>




4.5.3.10 PGI/Pre-Feeding Interval (PFI) (+)
Identifies the minimum period of time that must pass after an application before an
identified group of animals may graze in treated areas or may be fed treated material.
Entry type: "Pre-Grazing Interval (PGI)/Pre-Feeding Interval Category"
picklist selection, and value unit.
Validation Procedures:
4.5.3.10.1
4.5.3.10.2
4.5.3.10.3
4.5.3.10.4
4.5.3.10.5
4.5.3.10.6
4.5.3.10.7
4.5.3.10.8
There is zero to many "Pre-Grazing/Pre-Feeding Interval Restrictions"
requirements.
If Pre-Grazing/Pre-Feeding Interval Restrictions is provided at the Site
Level, then it should not also be provided at the Product Level.
Pre-Grazing/Pre-Feeding Interval Restrictions occurs after application.
( value must be "3".)
Pre-Grazing/Pre-Feeding Interval Restrictions has a code of 1005026
and a displayName of "PGI Category".
Pre-Grazing/Pre-Feeding Interval Restrictions displayName must
match the code.
If there is Pre-Grazing/Pre-Feeding Interval Restrictions listed then
there must be a  element with code and displayName.
Pre-Grazing/Pre-Feeding Interval Restrictions  code and
displayName must come from the list "PGI Category".
Pre-Grazing/Pre-Feeding Interval Restrictions  displayName
must match the code.
164
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There is zero to many "Pre-Grazing/Pre-Feeding Interval Restrictions"
requirements.
There is zero or one animal "Weight" or "Age" per Pre-Grazing/Pre-
Feeding Interval Restriction.
Pre-Grazing/Pre-Feeding Interval Restrictions animal "Weight" value is
a number.
Pre-Grazing/Pre-Feeding Interval Restrictions animal "Age" value is a
number.
There is zero or one Pre-Grazing/Pre-Feeding Interval Restrictions -
Time per Pre-Grazing/Pre-Feeding Interval Restriction.
Pre-Grazing/Pre-Feeding Interval Restrictions - Time value is a number.
Pre-Grazing/Pre-Feeding Interval Restrictions - Units must be units of
time or weight, respectively.
Figure 151: PGI/PFI XML Code Snippet









translation value="5"
displayName="pound"
code="3627071"
codeSystem-'2.16.840.1.113883.6.275. l"/>






		
4.5.3.11 Pre-Slaughter Interval (PSI) (+)
Identifies the minimum period of time after an application that must pass before an
identified group of animals that have contacted the product can be slaughtered for food or
feed.
Entry type: "Pre-Slaughter Interval (PSI) Category" picklist selection, and value
unit.
4.5.3.10.1
4.5.3.10.9
4.5.3.10.10
4.5.3.10.11
4.5.3.10.12
4.5.3.10.13
4.5.3.10.14
165
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Validation Procedures:
:
4.5.3.11.1	There is zero to many "Pre-Slaughter Interval Restrictions"
requirements.
4.5.3.11.2	If Pre-Slaughter Interval Restrictions is provided at the Site Level, then it
should not also be provided at the Product Level.
4.5.3.11.3	If Pre-Slaughter Interval Restrictions is provided at the Scenario Level,
then it should not also be provided at the Product Level.
4.5.3.11.4	Pre-Slaughter Interval Restrictions occur after application.
( value must be "3".)
4.5.3.11.5	Pre-Slaughter Interval Restrictions has a code of 1005027 and a
displayName of "PSI Category".
4.5.3.11.6	Pre-Slaughter Interval Restrictions displayName must match the code.
4.5.3.11.7	If there is Pre-Slaughter Interval Restrictions listed then there must be a
 element with code and displayName.
4.5.3.11.8	Pre-Slaughter Interval Restrictions  code and displayName must
come from the list "PSI Category".
4.5.3.11.9	Pre-Slaughter Interval Restrictions  displayName must match
the code.
4.5.3.11.10	There is zero or one Pre-Slaughter Interval Restrictions - Time per Pre-
Slaughter Interval Restriction.
4.5.3.11.11	Pre-Slaughter Interval Restrictions - Time value is a number.
4.5.3.11.12	Pre-Slaughter Interval Restrictions - Units must be units of time.
Figure 152: PSI XML Code Snippet
Product Level Use Restrictions/Limitations

















translation value="{Pre-Slaughter Interval Time}"
code="{Unit Code}"
codeSystem-'2.16.840.1.113883.6.275.1"
displayName="{Unit DisplayName}"/>




166
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4.5.3.12 Buffered Area(s) (+)
Identifies the minimum distance that is required between the area where a product is
applied and the specific area to be protected from the pesticide application.
Entry type: "Buffered Area" picklist selection, and value unit.
Validation Procedures:
:
Error Messages
4.5.3.12.1	There is zero to many "Buffered Area(s)" preconditions.
4.5.3.12.2	If Buffered Area(s) is provided at the Product or Site Level, then it
should not also be provided at the Scenario Level.
4.5.3.12.3	Buffered Area(s)  code is "T".
4.5.3.12.4	Buffered Area(s) has a code of 1004980 and a displayName of "Buffered
Area".
4.5.3.12.5	Buffered Area(s) displayName must match the code.
4.5.3.12.6	If there is Buffered Area(s) listed then there must be a  element
with code and displayName.
4.5.3.12.7	Buffered Area(s)  code and displayName must come from the
list "Buffered Area".
4.5.3.12.8	Buffered Area(s)  displayName must match the code.
4.5.3.12.9	Buffered Area(s) - Distance value is a number.
4.5.3.12.10	Buffered Area(s) - Units must be "Standard Length" units.
Figure 153: Buffered Areas XML Code Snippet
Product Level Use Restrictions/Limitations
















translation value="{Buffered Area value}"
displayName-'{Unit DisplayName}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>



4.5.3.13 Max Release Height
Identifies the maximum distance between the point of release from the application
equipment and the top of crop or ground.
167
(DRAFT)

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Entry type: Value unit.
Validation Procedures:
4.5.3.13.1
4.5.3.13.2
4.5.3.13.3
4.5.3.13.4
4.5.3.13.5
There is zero or one "Maximum Release Height" preconditions.
If Max Release Height is provided at the Product or Site Level, then it
should not also be provided at the Scenario Level.
Max Release Height  code is "T".
Max Release Height - Height value is a number.
Max Release Height - Units must be "Standard Length" units.
Figure 154: Maximum Release Height XML Code Snippet
Product Level Use Restrictions/Limitations












translation value="{Release Height}"
displayName="{Unit DisplayName}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>



4.5.3.14 Max Wind Speed
Identifies the maximum wind speed allowed during application.
Entry type: Value unit.
Validation Procedures:
ibers
4.5.3.14.1
4.5.3.14.2
4.5.3.14.3
4.5.3.14.4
4.5.3.14.5
lidation Error Messages

There is zero or one "Maximum Wind Speed" preconditions.
If Max Wind Speed is provided at the Product or Site Level, then it
should not also be provided at the Scenario Level.
Max Wind Speed  code is "T".
Max Wind Speed - Speed value is a number.
Max Wind Speed - Units must be units of speed.
168
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Figure 155: Maximum Wind Speed XML Code Snippet
Product Level Use Restrictions/Limitations












translation value="{Wind Speed}"
displayName="{Unit DisplayName}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>



4.5.3.15 Application Temperature
Identifies the minimum and/or maximum temperatures at which application(s) may be
made.
Entry type: Value unit, value unit.
Validation Procedures:
4.5.3.15.1	There is zero or one "Application Temperature" preconditions.
4.5.3.15.2	If Application Temperature is provided at the Product or Site Level, then
it should not also be provided at the Scenario Level.
4.5.3.15.3	Application Temperature  code is "B".
4.5.3.15.4	Application Temperature - Min Temp value is a number.
4.5.3.15.5	Application Temperature - Max Temp value is a number.
4.5.3.15.6	Application Temperature - Units (Min Temp/Max Temp) must be
temperature units.
4.5.3.15.7	Application Temperature - Units must match when both limits are
provided.
4.5.3.15.8	"Min Temp" and "Max Temp" do not need to be provided together.
169
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Figure 156: Application Temperature XML Code Snippet
Product Level Use Restrictions/Limitations













translation value="{Minimum Temperature}"
displayName="{Unit DisplayName}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>


translation value="{Maximum Temperature}"
displayName="{Unit DisplayName}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>




4.5.3.16 ASABE Droplet Size (+)
Identifies restrictions associated with the application droplet size according to the
ASABE 572 standard. Droplet sizes that are acceptable for application should be
selected. This must be entered for broadcast applications using aerial or ground
equipment.
Entry type: "ASABE Droplet Size" picklist selection, and value unit.
Validation Procedures:
ibers Validation Error Mc
4.5.3.16.1	There is zero to many "ASABE Droplet Size" requirements.
4.5.3.16.2	If ASABE Droplet Size is provided at the Product or Site Level, then it
should not also be provided at the Scenario Level.
4.5.3.16.3	ASABE Droplet Size is required when Application Type = "broadcast",
Form as Applied = "liquid formations" and/or Application Equipment =
"Aerial"' or "Groundboom".
4.5.3.16.4	ASABE Droplet Size has a code of 1004962 and a displayName of
"ASABE Droplet Size".
4.5.3.16.5	ASABE Droplet Size displayName must match the code.
4.5.3.16.6	If there is ASABE Droplet Size listed then there must be a 
element with code and displayName.
4.5.3.16.7	ASABE Droplet Size  code and displayName must come from the
list "ASABE Droplet Size".
4.5.3.16.8	ASABE Droplet Size  displayName must match the code.
170
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Figure 157: ASABE Droplet Size XML Code Snippet
Product Level Use Restrictions/Limitations















4.5.3.17 Soil Incorporation Depth and Time
Identifies the minimum soil incorporation depth that is required for the application, and
the maximum amount of time that must pass before incorporation takes place. If the
incorporation is done during application, enter the time as "0" minutes.
Entry type: Value unit, value unit.
Validation Procedures:
There is zero or one "Soil Incorporation Depth and Time" observations.
If Soil Incorporation Depth and Time is provided at the Product or Site
Level, then it should not also be provided at the Scenario Level.
4.5.3.17.3	Soil Incorporation Depth and Time restriction occurs after application.
( value must be "3".)
4.5.3.17.4	If soil incorporation occurs at the time of application then "Time" is "0"
and "Units" are "minutes".
4.5.3.17.5	If there is a soil incorporation "Time" then there should also be a soil
incorporation "Depth".
4.5.3.17.6	Soil Incorporation Depth and Time - Units must be units of time and
"Standard Length", respectively.
171
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Figure 158: Soil Incorporation Depth and Time XML Code Snippet
Product Level Use Restrictions/Limitations











translation value="{Maximum time after application}"
displayName="{Unit DisplayName}"
code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275. l"/>










translation code="{Unit Code}"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="{Unit DisplayName"
value="{Minimum Depth}"/>






4.5.3.18 Restricted Soil Type(s) (+)
Identifies any soil type(s) to which the product should not be applied using the prescribed
method(s).
Entry type: "Soil Type" picklist selection, and value unit.
Validation Procedures:
172
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4.5.3.18.1	There is zero to many "Restricted Soil Type(s)" preconditions.
4.5.3.18.2	If Restricted Soil Type(s) is provided at the Product or Site Level, then it
should not also be provided at the Scenario Level.
4.5.3.18.3	Restricted Soil Type(s)  code is "B".
4.5.3.18.4	Restricted Soil Type(s) has a code of 1004961 and a displayName of
"Soil Type".
4.5.3.18.5	Restricted Soil Type(s) displayName must match the code.
4.5.3.18.6	If there is Restricted Soil Type(s) listed then there must be a 
element with code and displayName.
4.5.3.18.7	Restricted Soil Type(s)  code and displayName must come from
the list "Soil Type".
4.5.3.18.8	Restricted Soil Type(s)  displayName must match the code.
Figure 159: Restricted Soil Type XML Code Snippet
Product Level Use Restrictions/Limitations
















4.5.3.19 Minimum Percent Soil Organic Matter
Identifies the minimum percent soil organic matter to which application(s) may be made.
Entry type: Value unit.
Validation Procedures:
4.5.3.19.1
4.5.3.19.2
4.5.3.19.3
4.5.3.19.4
4.5.3.19.5
There is zero or one "Minimum Percent Soil Organic Matter"
preconditions.
If Minimum Percent Soil Organic Matter is provided at the Product or
Site Level, then it should not also be provided at the Scenario Level.
Minimum Percent Soil Organic Matter  code is "B".
Minimum Percent Soil Organic Matter - Value is a number.
Minimum Percent Soil Organic Matter has a unit code of 3627136 and a
displayName of
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Figure 160: Minimum Percent Soil Organic Matter XML Code Snippet
Product Level Use Restrictions/Limitatioris












translation code="3627136"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="%"
value="{Percent Soil Organic Matter}"/>



4.5.3.20 Minimum Age of Animal To Be Treated
Identifies the minimum age of animals to which application(s) may be made.
Entry type: Value unit.
Validation Procedures:
4.5.3.20.1
4.5.3.20.2
4.5.3.20.3
4.5.3.20.4
4.5.3.20.5
There is zero or one "Minimum Age of Animal To Be Treated"
preconditions.
If Minimum Age of Animal To Be Treated is provided at the Product or
Site Level, then it should not also be provided at the Scenario Level.
Minimum Age of Animal To Be Treated  code is "B".
Minimum Age of Animal To Be Treated - Age value is a number.
Minimum Age of Animal To Be Treated - Units must be units of time.
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Figure 161: Minimum Age of Animal To Be Treated XML Code Snippet
Product Level Use Restrictions/Limitations












translation value="{Minimum Age}"
displayName="{Units DisplayName}"
code="{Minimum Age units}"
codeSystem="2.16.840.1.113883.6.275. l"/>



4.5.3.21 Minimum Weight of Animal To Be Treated
Identifies the minimum weight of animals to which application(s) may be made.
Entry type: Value unit.
Validation Procedures:
4.5.3.21.1
4.5.3.21.2
4.5.3.21.3
4.5.3.21.4
4.5.3.21.5
Error Messages
There is zero or one "Minimum Weight of Animal To Be Treated"
preconditions.
If Minimum Weight of Animal To Be Treated is provided at the Product
or Site Level, then it should not also be provided at the Scenario Level.
Minimum Weight of Animal To Be Treated  code is "B".
Minimum Weight of Animal To Be Treated - Weight value is a number.
Minimum Weight of Animal To Be Treated - Units must be "Standard
Weight/Mass" units.
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Figure 162: Minimum Weight of Animal To Be Treated XML Code Snippet
Product Level Use Restrictions/Limitations












translation value="{Minimum Weight}"
displayName="{Units DisplayName}"
code="{Minimum Age units}"
codeSystem="2.16.840.1.113883.6.275. l"/>



4.5.3.22 Pollinator (+)
Identifies specific label restrictions to application based on pollinator protection. The
statements selected from the picklist and those that appear on the label must not be
identical, but must have the same general meaning.
Entry type: "Pollinator Protection Statements'' picklist selection.
Validation Procedures:
4.5.3.22.1	There is zero to many "Pollinator Protection Statement(s)"
requirements.
4.5.3.22.2	If Pollinator Protection Statement(s) is provided at the Product or Site
Level, then it should not also be provided at the Scenario Level.
4.5.3.22.3	Pollinator Protection Statement(s) has a code of 1005022 and a
displayName of "Pollinator Protection Statements".
4.5.3.22.4	Pollinator Protection Statement(s) displayName must match the code.
4.5.3.22.5	If there is Pollinator Protection Statement(s) listed then there must be a
 element with code and displayName.
4.5.3.22.6	Pollinator Protection Statement(s)  code and displayName must
come from the list "Pollinator Protection Statements".
4.5.3.22.7	Pollinator Protection Statement(s)  displayName must match
the code.
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Figure 163: Pollinator Protection Statements XML Code Snippet
Product Level Use Restrictions/Limitations














4.5.3.23 Bulletins Live
Identifies if there is an Endangered Species County Level Bulletin indicator on the label.
This is a presence/absence indicator. If a Bulletins Live statement appears on the label,
then Bulletins Live should be selected.
Entry type: Presence/absence selection.
Validation Procedures:
4.5.3.23.1
4.5.3.23.2
ation Error Messages
There is zero or one "Bulletins Live" requirements.
If Bulletins Live is provided at the Product or Site Level, then it should
not also be provided at the Scenario Level.
Figure 164: Bulletins Live XML Code Snippet
Product Level Use Restrictions/Limitations











4.5.3.24 Applications to Water (+)
Identifies specific label restrictions related to the treatment of a volume of water
including flooded field applications and other water bodies. The statements selected from
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the picklist and those that appear on the label may not be identical, but must have the
same general meaning.
Entry type: "Water Protection Statements'' picklist selection.
Validation Procedures:
Error Messages
4.5.3.24.1	There is zero to many "Water Protection Statement(s)" requirements.
4.5.3.24.2	If Water Protection Statement(s) is provided at the Product or Site
Level, then it should not also be provided at the Scenario Level.
4.5.3.24.3	Water Protection Statement(s) has a code of 1005023 and a
displayName of "Water Protection Statements".
4.5.3.24.4	Water Protection Statement(s) displayName must match the code.
4.5.3.24.5	If there is Water Protection Statement(s) listed then there must be a
 element with code and displayName.
4.5.3.24.6	Water Protection Statement(s)  code and displayName must
come from the list "Water Protection Statements".
4.5.3.24.7	Water Protection Statement(s)  displayName must match the
code.
4.5.3.24.8	Water Protection Statement(s) - Value is a number.
4.5.3.24.9	Water Protection Statement(s) - Units must be provided.
Figure 165: Water Protection Statement XML Code Snippet











translation code-'{Unit Code}"
codeSystem="2.16.840.1.113883.6.275.1"
displayName="{Unit DisplayName}"
value="{Some Value}"/>




	
4.5.3.25 Secondary Manufacturing
Identifies if there are any restrictions which limit further manufacturing of the treated
material; e.g., restricting treated plastics in the manufacture of toys. This is a
presence/absence indicator. If any restrictions limiting secondary manufacturing appear
on the label then Secondary Manufacturing should be selected.
Entry type: Presence/absence selection.
Validation Procedures:
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4.5.3.25.1	There is zero or one "Secondary Manufacturing" requirements.
4.5.3.25.2	If Secondary Manufacturing is provided at the Product or Site Level,
then it should not also be provided at the Scenario Level.
Figure 166: Secondary Manufacturing XML Code Snippet
Product Level Use Restrictions/Limitations











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