Docket Number EPA-HQ-OPP-20 15-0061 

www.regulations.gov 

Tetraconazole Preliminary Work Plan 

Registration Review: Initial Docket 

Case Number 7043 

Approved by: 

Date: 

September 2015 

Gbh~ r v~~::n 

Richard P. Keigwin, Jr. 

Director 

Pesticide Re-evaluation Division 
Tetraconazole Preliminary Work Plan- Table of Contents 

OVERVIEW .................................................................................... .... ............... ....... ................ ..... 4 

ANTICIPATED DATA NEEDS ..... ............ ......... .... .... .................................................................. 5 

STATUTORY AND REGULATORY AUTHORITY ..................... .......................... ............ .... .... 6 

CHEMICAL FACTS .... ........ .... .... .... .... ............. .... .... .... .... .... .... .... ........... ............... ................ ....... 6 

USE AND USAGE INFORMATION ............................................................................................ 7 

RECENT ACTIONS .. .... .... .... .... ........ ......... .... .... .... .... .... .... .... .... ....... .... ....... .................................. 8 

ANTICIPATED RISK ASSESSMENTS FOR REGJSTRA TION REVIEW ................................ 8 

TIMELINE ... .... .... .... .... ....................................................................................... .......................... 11 

NEXT STEPS ............................................................................... .... .... ... .... .... ........... .................. 11 

Appendix - Additional Areas Considered in the Tetraconazole Registration Review ............. 12 

References: 

This Preliminary Work Plan summarizes the Environmental Protection Agency's current position 

based on the following documents: 

1. Registration Review: Preliminary Problem Formulation for Environmenlal Fate 

Ecological Risk, Endangered Species, and Drinking Water Exposure Assessments/or 

Tetraconazole. He Zhong, Ph.D., and Christopher M. Koper, M.S. August 26,2015. 

2. Tetraconazole, Human Health Risk Assessment Scoping Document in Support of 

Registration Review. Anwar Y. Dunbar, Ph .. D., Thomas Bloem, and James Miller. August 

26, 2015. 

3. Tetraconazole: Tier I (Scoping) Review of Human Incidents. Elizabeth Evans and Shanna 

Recore. May 21 , 2015. 

4. BEAD Chemical Profile (BCP) for Registralion Review: Tetraconazole (120603). Leonard 

Yourman, Rafael A. Prieto, and Michelle Ranville. May 6, 2015. 

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5. Tetraconazofe (120603). Screening Level Usage Analysis (SLUA). November 5, 2014. 

6. Environmental Fare and Effects Division Label Data Report Spreadsheet: PC Code: 

120603. November 5, 2014. 

7. Health Effects Division Alaster Label Report Spreadsheet: PC Code 120603. November 5, 

2014. 

These and other supporting documents for the tetraconazole registration review case may be 

found in the docket EPA-HQ-OPP-2015-0061 at http://www.regulations.gov. 

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OVERVIEW 

The docket for tetraconazole is now open, initiating the first public comment period for this 

registration review (docket number EPA-HQ-OPP-2015-0061). Tetraconazole is a 

demethylation inhibiting (DMI) fungicide registered for use on soybeans, sugar beets, corn 

(field, pop), peanuts, and pecans, to control Cercospora blight, frogeye leaf spot, powdery 

mildew, brown spot, and anthracnose. It is also registered for some crops in the crop subgroups 

13-07F (small fruit vine climbing subgroup, except fuzzy kiwifmit) and 13-07G (low growing 

berry subgroup, excluding cranberry). Currently, there are no registered non-agricultural uses for 

tetraconazole. This Preliminary Work Plan (PWP) document explains what EPA's Office of 

Pesticide Programs knows about tetraconazole, highlighting anticipated data and assessment 

needs, identifying the types of information that would be especially useful to the Agency in 

conducting the review, and providing an anticipated timeline for completing the registration 

review for tetraconazole. 

The registration review process was designed to include a public participation component to 

solicit input from interested stakeholders. The Agency intends, by sharing this information in the 

docket, to inforn1 the public of what it knows about tetraconazole and what types of new data or 

other information would be helpful for the Agency to receive as it moves toward a decision on 

tetraconazole. The Agency encourages all interested stakeholders to review the PWP and 

Appendix and to provide comments and additional information that will help the Agency's 

decision-making process for this chemical. In addition to general areas on which persons may 

wish to comment, there are some areas identified in the PWP and Appendix about which the 

Agency specifically seeks comments and information. Interested stakeholders could include: 

environmental non-profit or interest groups; pesticide manufacturers; agricultural labor or 

commodity groups; commercial, institutional, residential, and other users of pesticides; or the 

public at large. 

The Preliminary Work Plan begins by listing the anticipated data needs for tetraconazole. Next, 

it discusses the statutory and regulatory authority for Registration Review. Then the document 

provides chemical facts, use and usage information, recent actions, the anticipated risk 

assessments, and a projected registration review timeline for tetraconazole. Finall y, the 

Appendix to this document includes identification and discussion of some areas that are 

considered generally in Registration Review along with some additional chemical case-specific 

information. 

4 
ANTICIPATED DATA NEEDS 

Table I below summarizes anticipated data needs for tetraconazole. For additional discussion of 

the anticipated data needs, see the Registration Review: Preliminary Problem Formulation for 

Environmental Fate Ecological Risk, Endangered Species, and Drinking Water Exposure 

Assessments for Tetraconazole and Tetraconazole, Human Health Risk Assessment Scoping 

Document in Support of Registration Review. 

Table 1: Anticipated Data Needs for the Tetraconazole Registration Review 

Estimated 

Guideline Timeframe 

Number• Study Title 

Test Material (Months from 

receipt of DCI) 

Anticipated Data Needs for the Parent Tetraconazole 

835.4200 Anaerobic soil metabolism2 TGAI 24 

835.4400 Anaerobic aquatic metabolism3 TGAJ 12 

860.1380 Storage stability in soil and water TGAI 12 

850.6100 Environmenta l ChemistryMethods and TGAl 12 Associated Independent Laboratory Validation 

850. 1350 Aquatic invertebrate life cycle (sa ltwater) TGAI 12 

850.1 400 Fish early-life stage (saltwater) TGAJ 12 

850.4100 Terrestrial plant toxicity, seedling emergence TEP 12 

850.4150 Terrestria l plant toxicity, vegetative vigor TEP 12 

850.1500 Fish life cycle (freshwater) TGAI 24 

850.4500 Algal toxicity (freshwater green alga, freshwater TGAI 12 

and marine diatom) 

850.4550 Cyanobacteria (Anabaenajlos-aquae) toxicity TGAl 12 

850.2100 A vi an oral toxicity (passerine) TGAI 12 

875.2100 Dislodgeable foliar residue and turf transferable TGAI 12 

residues 

Whole sediment-chronic (Two freshwate r 

Non- amphipods, Hyalella azteca and Chironomus 

TGAI 12 guideline tentans, and one estuarine/marine amphipod, 

Leptocheirus plumulosus). 

Non- Honeybee adult chronic oral toxicity TGAI 12 

guideline 

Non- Honeybee larval acute and chronic oral toxicity TGAI 12 guideline 

1 On June 27, 2012, EPA announced certain revisions in harmonized guideline series 850 - Ecological Effects Tests 

- including renumbering and other designations or changes for some guideline studies. See "Final Test 

Guidelines; OCSPP 850 Series; Notice of Availability" 77 FR 38282, June 27, 20 12. 

http://www .regu lations.gov/#! documentDetai I; D=EP A-HQ-OPPT -2009-0 I 54-0028 2 Four soil systems 

3 One additional water/sediment system 

5 
Table 1: Anticipated Data Needs for the Tetraconazole Registration Review 

Estimated 

Guideline Timeframe 

Number1 Study Title Test Material (Months from 

receipt ofDCI) 

·"-

Non- Residues in pollen and nectar4 TEP 24 guideline 

Non- Semi-field testing for pollinators4 TEP 24 

guideline 

850.3040 Field testing for pollinators4 TEP 24 

TGAI = technical grade active ingred1ent; TEP = typical end-use product; 

STATUTORY AND REGULATORY AUTHOIUTY 

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All 

pesticides distributed or sold in the United States (U.S.) generally must be registered by the 

Environmental Protection Agency (EPA or the Agency), based on scientific data showing that 

they will not cause unreasonable risks to human health or the environment when used as directed 

on product labeling. The registration review program is intended to make sure that, as the ability 

to assess risk evolves and as policies and practices change, all registered pesticides continue to 

meet the statutory standard of no unreasonable adverse effects to human health or the 

environment. Changes in science, public policy, and pesticide use practices will occur over time. 

Through the registration review program, the Agency periodically reevaluates pesticides to make 

sure that as change occurs, products in the marketplace can be used safely. Information on this 

program is provided on EPA's website.

5 

The Agency is implementing the registration review program pursuant to Section 3(g) of the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and will review each registered 

pesticide every 15 years to determine whether it continues to meet the FIFRA standard for 

registration. The regulations governing registration review begin at 40 CFR 155.40. The 

Agency will consider benefits information and data as required by FIFRA. The public phase qf 

registration review begins when the initial docket is opened for each case. The docket is the 

Agency's opportunity to state what it knows about the pesticide and what additional risk analyses 

and data or inforn1ation it believes are needed to make a registration review decision. After 

reviewing and responding to comments and data received in the docket during this initial 

comment period, the Agency will develop a Final Work Plan (FWP) and anticipated schedule for 

the registration review of tetraconazole. 

CHEMICAL FACTS 

Table 2 provides a summary of the chemical facts for tetraconazole. 

4 Pending rei view of lower Tier studies. 

5 http://www.epa.gov/oppsrrd 1/registration_review/ 

6 
Table 2: Chemical Facts for Tetraconazole 

PC code 120603 

Case Number 7043 

CAS Number 112281-77-3 

Year first registered 1993 

Pesticide Type Fungicide 

Chemical class triazole 

Reregistration Eligibility Tetraconazole was registered after November 1984; therefore, it 

Decision (RED) was not subject to reregistration. 

Tolerance Reassessment Tetraconazole was registered after November 1984; therefore, it 

Eligibility Decision (TRED) was not subject to tolerance reassessment. 

Cumulative group No cumulative risk assessment is required at this time since the 

Agency has not made a determination regarding a common 

mode of action. 

40 CFR Citation Tolerances are established in 40 CFR 180.557. 

Dual-use Conventional pesticide uses only. 

Non-pesticidal uses No non-pesticidal uses. 

Pesticide Re-evaluation Veronica Dutch, dutch.veronica@epa.gov, (703-308-8585 

Division, Chemical Review 

Manager 

Registration Division, Hope Johnson, Johnson.Hope@epa.gov, (703)-305-541 0 

Product Manager 

USE AND USAGE INFORMATION 

Table 3 summarizes the use and usage information for tetraconazole. Please see the BEAD 

Chemical Profile (BCP) for Registration Review: Tetraconazole (120603, in the registration 

review docket for more details. 

Table 3: Tetraconazole Use and Usage Information 

Summary of Use Tetraconazole is a broad spectrum systemic fungicide with 

protective, curative, and eradicative properties. Tetraconazole is a 

conazole containing compound and a triazole systemic fungicide 

which acts primarily by interfering with cell growth, particularly the 

ability to build cell walls, through inhibition of ergosterol 

biosynthesis in cell membranes. 

Use Sites Use sites for tetraconazole are soybeans, sugar beets, corn (field, 

pop), peanuts, pecans, and berries. The predominant use sites are 

soybean and sugar beets (98+% of total usage). 

Summary of Usage Average usage (2008-20 12) was approximately 77,000 pounds of 

active ingredient applied annually on 1.1 million acres. 

Formulation Type(s) Tetraconazole is formulated as an emulsifiable concentrate. 

Application Method(s) Products can be applied broadcast by ground or air, by chemgation 

or sprinkler irrigation, or with a high volume or low volume 

sprayer. 

7 
Table 3: Tctraconazolc Usc and Usage Information 

Technical Registrant(s) Sipcam Agro USA, Inc., and Isagro (S.P.A.) 

No. of Registrations 13 Section 3 products6 

Restricted Use No 

Guidance for Commcntcrs: Additional areas of use and usage related information requested 

for this registration review, and of particular interest to EPA, are described below. 

• The label for EPA Registration # 60063-12 for peanuts, pecan, and sugar beets does not list 

maximum application rate per year or the maximum number of applications per year. 

• Seasonal, rather than yearly application information, is provided for some uses on the labels 

of EPA Registration #s 80289-1 8 and 80289-8. The number of applications and the 

maximum application rate on an annual basis are needed for the risk assessment. 

• Soybean use: the label for EPA Registration # 7969-361 does not prohibit application to 

soybean after the R5 crop stage. For all products except EPA Registration #s 7969-361 and 

I 0163-332. The labels for some products have no information on a minimum retreatment 

interval for control of soybean rust; available field trial data were developed with a minimum 

retreatment interval of 10 days. 

Without this information, EPA will need to rely on conservative assumptions to conduct its risk 

assessments, and doing so may lead to overestimates of actual risk. The Agency is willing to 

work with registrants to clarify infonnation on tetraconazole product labels. 

• In addition, usage information for small vine fruits and pecans (including lbs active 

ingredient applied on an annual basis, total area treated, typical application rates, target 

pests, and state usage data) will be useful for the Agency's assessments of tetraconazole. 

RECENT ACTIONS 

There are no recent actions for tetraconazole. 

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW 

The most recent occupational assessment for tetraconazole was completed in April 2011, and the 

most recent aggregate risk assessment for tetraconazole was completed in April 2015. The most 

recent ecological and environmental fate risk assessment was completed in 2014. Findings and 

conclusions from these risk assessments are summarized in Tetraconazole. Human Health Risk 

Assessment Scoping Document in Support of Registration Review and Registration Review: 

Preliminary Problem Formulation for Environmental Fate Ecological Risk, Endangered Species, 

and Drinking Water Exposure Assessments for Tetraconazole. 

During registration review, the Agency anticipates the need to conduct a comprehensive 

ecological risk assessment, including an endangered species assessment, for all uses of 

6 Section 3 product labe ls can be obtained from the Pesticide Product Label System (PPLS) website 

(http://oaspub.epa.gov/pestlabl/ppls.home). 

8 
tetraconazole. For human health, EPA anticipates the need to re-evaluate toxicity endpoints/dose 

selection, and to conduct revised dietary and occupational risk assessments. The need for spray 

drift and volatilization risk assessments for tetraconazole also will be considered. If 

toxicological endpoints or points of departure are revised based on the data that are anticipated to 

be required for registration review, they will be considered in the new assessments, as will any 

changes to the standard operating procedures or default exposure assumptions. 

Table 4 below summarizes the anticipated registration review risk assessments based on the 

EFED Problem Formulation and HED Scoping Document. 

9 
Table 4: Anticipated Risk Assessments for the Tetraconazole Registration Review 

Type of Risk Assessment Conduct? Notes 

Ecological and Environmental Fate -

Comprehensive ecological y The Agency will conduct a comprehensive ecological 

including endangered species assessment, including an endangered species 

assessment. 

Incidents Will For a discussion of reported ecological incidents for 

check for tetraconazole, see page 14 of the Problem F orrnulation. 

updates There are currently no ecological incidents reported for 

tetraconazole. 

Human Health> 

Dietary 

Food y As part of the registration review, the dietary risk 

assessment may be revisited. 

Drinking water y Concentrations in drinking water will be reevaluated as 

part of registration review. 

Occupational 

Handlers (mixers, loaders, y Occupational handler and post-application dermal and 

applicators) inhalation assessments wi ll be revised to reflect all 

Post-application y potential exposure scenarios, updated policies, exposure 

data, and any updated toxicological PODs. 

Residential 

Handlers N Tetraconazole is not used in residential settings, so a 

residential handler assessment is not needed. 

Post-application N Tetraconazole is not used in residential settings. A 

conventional residential post-application assessment is 

not needed. The need for drift and volatility 

assessments will be considered during registration 

review. 

Other 

Aggregate y A revised aggregate assessment may be required to 

reflect revised dietary exposure estimates and/or 

changes to the toxicological PODs. 

Cumulative N Tetraconazole is a member of of the triazole-containing 

class of pesticides. Structural similarities do not 

constitute a common mechanism of toxicity and there is 

currently no evidence to indicate that members of this 

class share a common mechanism of toxicity. 

Tolerances y The Agency will revisit the tolerances during 

registration review. 

Incidents Will For a discussion of reported human incidents for 

check for tetraconazole, see page 11 of the Seeping Document and 

updates the Tetraconazole: Tier 1 (Scoping) Review of Human 

Incidenls. 

10 
Guidance for Commcnters: Additional ecological information requested for this 

registration review, and of particular interest to EPA, is described below. 

• Aggregated incidents not already reported to the Agency. 

• Water monitoring data. 

Guidance for Commcntcrs: Additional human health information requested for this 

registration review, and of particular interest to EPA, is described below. 

• Human health incidents not previously reported to the Agency. 

TIM ELINE 

EPA has created the following estimated timeline for the completion of the tetraconazole 

registration review in Table 5 below. 

Table 5: Projected Tetraconazole Registration Review Timcline 

Activities Estimated Date 

Opening the Docket 

Open Docket and 60-day Public Comment Period September-20 15 

Close Public Comment November-20 15 

Case Development 

Final Work Plan February-20 16 

Issue DCI April-June -201 6 

Data Submission April-June -2018 

60-day Public Comment Period for Draft Risk October-December-20 19 

Assessments 7 

Registration Review Decision 

60-day Public Comment Period for Proposed July-Septembcr-2020 

Registration Review Decision 

Registration Review Decision and Begin Post-Decision 2021 

Follow-up 

Total (years) 6 

NEXT STEPS 

After the 60-day publi c comment period closes, the Agency will review and respond to any 

comments received in a timely manner and then issue a Final Work Plan for the registration 

review of tetraconazolc. 

7 The regulations governing Registration Review generally require the Agency to provide a public comment period 

of at least 30 calendar days for draft risk assessments; see 40 CFR Part 155.53(c). For conventional pesticides, the 

Agency plans to provide a 60 calendar day public comment period generally for draft risk assessments. 

I I 
Appendix- Additional Areas Considered in theTetraconazole Registration 

Review 

PUBLIC COMMENTS AND FEEDBACK: 

Guidance for Commenters: The areas below highlight topics of special interest to the Agency 

where your comments, data submissions, or reference to sources of additional information could 

be of particular use. 

Trade Irritants: 

Through the registration review process, the Agency intends to solicit information on trade 

irritants and, to the extent feasible, take steps toward facilitating irritant resolution. The Agency 

will work to harmonize tolerances and international maximum residue limits (MRLs) and may 

modify tolerance levels to do so, when possible. Growers and other stakeholders are asked to 

comment on any trade irritant issues resulting from Jack of MRLs or disparities between U.S. 

tolerances and MRLs in key export markets, providing as much specificity as possible regarding 

the nature of the concern. 

Water Quality: 

Tetraconazole is not identified as a cause of impairment for any water bodies listed as impaired 

under section 303(d) of the Clean Water Act.8 In addition, no Total Maximum Daily Loads 

(TMDL) have been developed for tetraconazole.9 More information on impaired water bodies 

and TMDLs can be found at the Agency's websitc. 10 The Agency invites submission of water 

quality data for this pesticide. To the extent possible, data should conform to the quality 

standards in Appendix A of the OP P Standard Operating Procedure: Inclusion of Impaired 

Water Body and Other Water Quality Data in OPP 's Registration Review Risk Assessment and 

Management Process'' in order to ensure they can be used quantitatively or qualitatively in 

pesticide risk assessments. 

Environmental Justice: 

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all 

people, regardless of race, color, national origin, or income, in the development, implementation, 

and enforcement of environmental laws, regulations, and policies. To help address potential 

environmental justice issues, the Agency seeks information on any groups or segments of the 

population who, as a result of their location, cultural practices, or other factors, may have 

atypical, unusually high exposure to tetraconazolc compared to the general population. Please 

comment if you are aware of any sub-populations that may have atypical, unusually high 

exposure compared to the general population. 

8 http://iaspub.epa.gov/tmdl waters I 0/anains nation cv.causc detail 303d?p cause group id=885 9http://iaspub.epa.gov/tmdl waters I 0/artains nation.tmdl pollutant detail?p pollutant group id=885&p pollutant 

group name=PESTICIDES 

IO !J..!.m:!/www.epa.gov/owow/tmdl/ 11 http://www.epa.gov/oppsrrd I /registration review/water gualitv sop.htm 

12 
ENDANGERED SPECIES: 

A risk assessment that supports a complete endangered species determination has not been 

conducted for tetraconazole. The ecological risk assessment planned during registration review 

will allow the Agency to determine whether use of tetraconazole has "no effect" or "may affect" 

federally listed threatened or endangered species (listed species) or their designated critical 

habitats. When an assessment concludes that a pesticide's use "may affect" a listed species or its 

designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife Service 

and/or National Marine Fisheries Service (the Services), as appropriate. 

ENDOCRINE DISRUPTOR SCREENING PROGRAM: 

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse 

outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and 

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

susceptible to endocrine influence, including effects on endocrine target organ histopathology, 

organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, 

and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and 

chronic studies that assess growth, developmental and reproductive effects in different 

taxonomic groups. As part of its most recent registration decision for tetraconazole, EPA 

reviewed these data and selected the most sensitive endpoints for relevant risk assessment 

scenarios from the existing hazard database. However, as required by FFDCA section 408(p), 

tetraconazole is subject to the endocrine screening part of the Endocrine Disruptor Screening 

Program (EDSP). 

EPA has developed the EDSP to determine whether certain substances (including pesticide 

active and other ingredients) may have an effect in humans or wildlife similar to an effect 

produced by a "naturally occurri ng estrogen, or other such endocrine effects as the Administrator 

may designate. " The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier I consists of a battery of I I screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact withE, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 

establish a dose-response relationship between the dose and theE, A, or T effect. 

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between 

October 2009 and February 20 I 0, EPA issued test orders/data call-ins for the first group of 67 

chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A second list 

of chemicals identified for EDSP screening was published on June 14, 2013 12 and includes some 

pesticides scheduled for registration review and chemicals found in water. Neither of these lists 

12 See http://www.regulations.gov/#!documentDetaii;D=EPA-HO-OPPT-2009-0477-0074 for the final second list of 

chemicals. 

13 
should be construed as a list of known or likely endocrine disruptors. Tetraconazole does not 

appear on either list. 

For furthe r information on the status of the EDSP, the policies and procedures, the lists of 

chemicals, future lists, the test guidelines and the Tier I screening battery, please visit our 

website. 13 

HUMAN STUDIES: 

Occupational 

Past tetraconazole risk assessments rely in part on data from studies in which adult human 

subjects were intentionall y exposed to a pesticide to determine their dermal and inhalation 

exposure. Many such studies, involving exposure to many different pesticides, comprise generic 

pesticide exposure databases such as the Pesticide Handlers Exposure Database (PHED) and the 

Agricultural Reentry Task Force (ARTF) Database. EPA has reviewed all the studies supporting 

these multi-pesticide generic exposure databases, and has found no clear and convincing 

evidence that the conduct of any of them was either fundamentally unethical or significantly 

deficient relative to the ethical standards prevai I ing at the time the research was conducted. All 

applicable requirements of EPA's Rule for the Protection of Human Subjects ofResearch (40 

CFR Pa11 26) have been satisfied, and there is no regulatory barrier to continued reliance on 

these studies. 

13 hrrp://www.epa.gov/endo/ 

14