80 FR 30997 - Monsanto Co.; Availability of Preliminary Plant Pest Risk Assessment and Draft Environmental Assessment of Maize Genetically Engineered for Protection Against Corn Rootworm and Resistance to Glyphosate

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service

Federal Register Volume 80, Issue 104 (June 1, 2015)

Page Range		30997-30998
FR Document		2015-13164

We are advising the public that the Animal and Plant Health Inspection Service is making available for public comment a preliminary plant pest risk assessment and draft environmental assessment for maize designated as event MON 87411, which has been genetically engineered for protection against corn rootworm and resistance to the herbicide glyphosate.

Federal Register, Volume 80 Issue 104 (Monday, June 1, 2015)

[Federal Register Volume 80, Number 104 (Monday, June 1, 2015)]
[Notices]
[Pages 30997-30998]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-13164]


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Notices
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains documents other than rules 
or proposed rules that are applicable to the public. Notices of hearings 
and investigations, committee meetings, agency decisions and rulings, 
delegations of authority, filing of petitions and applications and agency 
statements of organization and functions are examples of documents 
appearing in this section.

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Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / 
Notices

[[Page 30997]]



DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2014-0007]


Monsanto Co.; Availability of Preliminary Plant Pest Risk 
Assessment and Draft Environmental Assessment of Maize Genetically 
Engineered for Protection Against Corn Rootworm and Resistance to 
Glyphosate

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public that the Animal and Plant Health 
Inspection Service is making available for public comment a preliminary 
plant pest risk assessment and draft environmental assessment for maize 
designated as event MON 87411, which has been genetically engineered 
for protection against corn rootworm and resistance to the herbicide 
glyphosate.

DATES: We will consider all comments that we receive on or before July 
1, 2015.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0007.
     Postal Mail/Commercial Delivery: Send your comment to 
Docket No. APHIS-2014-0007, Regulatory Analysis and Development, PPD, 
APHIS, Station 3A-03.8, 4700 River Road Unit 118, Riverdale, MD 20737-
1238.
    Supporting documents for this petition and any comments we receive 
on this docket may be viewed at http://www.regulations.gov/#!docketDetail;D=APHIS-2014-0007 or in our reading room, which is 
located in room 1141 of the USDA South Building, 14th Street and 
Independence Avenue SW., Washington, DC. Normal reading room hours are 
8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure 
someone is there to help you, please call (202) 799-7039 before coming.
    Supporting documents for this petition are also available on the 
APHIS Web site at http://www.aphis.usda.gov/biotechnology/petitions_table_pending.shtml under APHIS Petition Number 13-290-01p.

FOR FURTHER INFORMATION CONTACT: Dr. John Turner, Director, 
Environmental Risk Analysis Programs, Biotechnology Regulatory 
Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; 
(301) 851-3954, email: [email protected]. To obtain copies 
of the petition, contact Ms. Cindy Eck at (301) 851-3892, email: 
[email protected].

SUPPLEMENTARY INFORMATION: Under the authority of the plant pest 
provisions of the Plant Protection Act (7 U.S.C. 7701 et seq.), the 
regulations in 7 CFR part 340, ``Introduction of Organisms and Products 
Altered or Produced Through Genetic Engineering Which Are Plant Pests 
or Which There Is Reason to Believe Are Plant Pests,'' regulate, among 
other things, the introduction (importation, interstate movement, or 
release into the environment) of organisms and products altered or 
produced through genetic engineering that are plant pests or that there 
is reason to believe are plant pests. Such genetically engineered (GE) 
organisms and products are considered ``regulated articles.''
    The regulations in Sec.  340.6(a) provide that any person may 
submit a petition to the Animal and Plant Health Inspection Service 
(APHIS) seeking a determination that an article should not be regulated 
under 7 CFR part 340. APHIS received a petition (APHIS Petition Number 
13-290-01p) from the Monsanto Company (Monsanto) of St. Louis, MO, 
seeking a determination of nonregulated status of maize (Zea mays) 
designated as event MON 87411, which has been genetically engineered 
for protection against corn rootworm and resistance to the herbicide 
glyphosate. The Monsanto petition states that information collected 
during field trials and laboratory analyses indicates that MON 87411 
maize is not likely to be a plant pest and therefore should not be a 
regulated article under APHIS' regulations in 7 CFR part 340.
    According to our process \1\ for soliciting public comment when 
considering petitions for determinations of nonregulated status of GE 
organisms, APHIS accepts written comments regarding a petition once 
APHIS deems it complete. In a notice \2\ published in the Federal 
Register on March 7, 2014 (79 FR 13035-13036, Docket No. APHIS-2014-
0007), APHIS announced the availability of the Monsanto petition for 
public comment. APHIS solicited comments on the petition for 60 days 
ending on May 6, 2014, in order to help identify potential 
environmental and interrelated economic issues and impacts that APHIS 
may determine should be considered in our evaluation of the petition. 
APHIS received 423 comments on the petition. Issues raised during the 
comment period include the contamination of conventional crop 
production, the potential for disruption of trade due to the presence 
of unwanted genetically engineered commodities in exports, the 
potential for negative impacts to plant fitness and the environment, 
and health concerns. APHIS has evaluated the issues raised during the 
comment period and, where appropriate, has provided a discussion of 
these issues in our draft environmental assessment (EA).
---------------------------------------------------------------------------

    \1\ On March 6, 2012, APHIS published in the Federal Register 
(77 FR 13258-13260, Docket No. APHIS-2011-0129) a notice describing 
our public review process for soliciting public comments and 
information when considering petitions for determinations of 
nonregulated status for GE organisms. To view the notice, go to 
http://www.regulations.gov/#!docketDetail;D=APHIS-2011-0129.
    \2\ To view the notice, the petition, and the comments we 
received, go to http://www.regulations.gov/#!docketDetail;D=APHIS-
2014-0007.
---------------------------------------------------------------------------

    After public comments are received on a completed petition, APHIS 
evaluates those comments and then provides a second opportunity for 
public involvement in our decisionmaking process. According to our 
public review process (see footnote 1), the second opportunity for 
public involvement follows one of two approaches, as described below.
    If APHIS decides, based on its review of the petition and its 
evaluation and analysis of comments received during the 60-day public 
comment period on the petition, that the petition involves a GE 
organism that raises no substantive new issues, APHIS will follow 
Approach 1 for public involvement.

[[Page 30998]]

Under Approach 1, APHIS announces in the Federal Register the 
availability of APHIS' preliminary regulatory determination along with 
its EA, preliminary finding of no significant impact (FONSI), and its 
plant pest risk assessment (PPRA) for a 30-day public review period. 
APHIS will evaluate any information received related to the petition 
and its supporting documents during the 30-day public review period.
    If APHIS decides, based on its review of the petition and its 
evaluation and analysis of comments received during the 60-day public 
comment period on the petition, that the petition involves a GE 
organism that raises substantive new issues, APHIS will follow Approach 
2. Under Approach 2, APHIS first solicits written comments from the 
public on a draft EA and preliminary PPRA for a 30-day comment period 
through the publication of a Federal Register notice. Then, after 
reviewing and evaluating the comments on the draft EA and preliminary 
PPRA and other information, APHIS will revise the PPRA as necessary and 
prepare a final EA and, based on the final EA, a National Environmental 
Policy Act (NEPA) decision document (either a FONSI or a notice of 
intent to prepare an environmental impact statement). For this 
petition, we are using Approach 2.
    As part of our decisionmaking process regarding a GE organism's 
regulatory status, APHIS prepares a PPRA to assess the plant pest risk 
of the article. APHIS also prepares the appropriate environmental 
documentation--either an EA or an environmental impact statement--in 
accordance with NEPA, to provide the Agency and the public with a 
review and analysis of any potential environmental impacts that may 
result if the petition request is approved.
    APHIS has prepared a preliminary PPRA and has concluded that maize 
designated as event MON 87411, which has been genetically engineered 
for protection against corn rootworm and resistance to the herbicide 
glyphosate, is unlikely to pose a plant pest risk. In section 403 of 
the Plant Protection Act, ``plant pest'' is defined as any living stage 
of any of the following that can directly or indirectly injure, cause 
damage to, or cause disease in any plant or plant product: A protozoan, 
a nonhuman animal, a parasitic plant, a bacterium, a fungus, a virus or 
viroid, an infectious agent or other pathogen, or any article similar 
to or allied with any of the foregoing.
    APHIS has also prepared a draft EA in which we present two 
alternatives based on our analysis of data submitted by Monsanto, a 
review of other scientific data, field tests conducted under APHIS 
oversight, and comments received on the petition. APHIS is considering 
the following alternatives: (1) Take no action, i.e., APHIS would not 
change the regulatory status of maize designated as event MON 87411, or 
(2) make a determination of nonregulated status of maize designated as 
event MON 87411.
    The EA was prepared in accordance with (1) NEPA, as amended (42 
U.S.C. 4321 et seq.), (2) regulations of the Council on Environmental 
Quality for implementing the procedural provisions of NEPA (40 CFR 
parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 
1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).
    In accordance with our process for soliciting public input when 
considering petitions for determinations of nonregulated status for GE 
organisms, we are publishing this notice to inform the public that 
APHIS will accept written comments on our draft EA and our preliminary 
PPRA regarding the petition for a determination of nonregulated status 
from interested or affected persons for a period of 30 days from the 
date of this notice. Copies of the draft EA and the preliminary PPRA, 
as well as the previously published petition, are available as 
indicated under ADDRESSES and FOR FURTHER INFORMATION CONTACT above.
    After the comment period closes, APHIS will review all written 
comments received during the comment period and any other relevant 
information. After reviewing and evaluating the comments on the draft 
EA and the preliminary PPRA and other information, APHIS will revise 
the PPRA as necessary and prepare a final EA. Based on the final EA, 
APHIS will prepare a NEPA decision document (either a FONSI or a notice 
of intent to prepare an environmental impact statement). If a FONSI is 
reached, APHIS will furnish a response to the petitioner, either 
approving or denying the petition. APHIS will also publish a notice in 
the Federal Register announcing the regulatory status of the GE 
organism and the availability of APHIS' final EA, PPRA, FONSI, and our 
regulatory determination.

    Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 
CFR 2.22, 2.80, and 371.3.

    Done in Washington, DC, this 22nd day of May 2015.
Kevin Shea,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2015-13164 Filed 5-29-15; 8:45 am]
BILLING CODE 3410-34-P

30997

Notices Federal Register
Vol. 80, No. 104

Monday, June 1, 2015

This section of the FEDERAL REGISTER room hours are 8 a.m. to 4:30 p.m., According to our process 1 for
contains documents other than rules or Monday through Friday, except soliciting public comment when
proposed rules that are applicable to the holidays. To be sure someone is there to considering petitions for determinations
public. Notices of hearings and investigations, help you, please call (202) 799–7039 of nonregulated status of GE organisms,
committee meetings, agency decisions and before coming. APHIS accepts written comments
rulings, delegations of authority, filing of Supporting documents for this regarding a petition once APHIS deems
petitions and applications and agency
statements of organization and functions are
petition are also available on the APHIS it complete. In a notice 2 published in
examples of documents appearing in this Web site at http://www.aphis.usda.gov/ the Federal Register on March 7, 2014
section. biotechnology/petitions_table_ (79 FR 13035–13036, Docket No.
pending.shtml under APHIS Petition APHIS–2014–0007), APHIS announced
Number 13–290–01p. the availability of the Monsanto petition
DEPARTMENT OF AGRICULTURE FOR FURTHER INFORMATION CONTACT: Dr. for public comment. APHIS solicited
John Turner, Director, Environmental comments on the petition for 60 days
Animal and Plant Health Inspection Risk Analysis Programs, Biotechnology ending on May 6, 2014, in order to help
Service Regulatory Services, APHIS, 4700 River identify potential environmental and
[Docket No. APHIS–2014–0007] Road Unit 147, Riverdale, MD 20737– interrelated economic issues and
1236; (301) 851–3954, email: impacts that APHIS may determine
Monsanto Co.; Availability of john.t.turner@aphis.usda.gov. To obtain should be considered in our evaluation
Preliminary Plant Pest Risk copies of the petition, contact Ms. Cindy of the petition. APHIS received 423
Assessment and Draft Environmental Eck at (301) 851–3892, email: comments on the petition. Issues raised
Assessment of Maize Genetically cynthia.a.eck@aphis.usda.gov. during the comment period include the
Engineered for Protection Against SUPPLEMENTARY INFORMATION: Under the contamination of conventional crop
Corn Rootworm and Resistance to authority of the plant pest provisions of production, the potential for disruption
Glyphosate the Plant Protection Act (7 U.S.C. 7701 of trade due to the presence of
et seq.), the regulations in 7 CFR part unwanted genetically engineered
AGENCY: Animal and Plant Health commodities in exports, the potential
340, ‘‘Introduction of Organisms and
Inspection Service, USDA. for negative impacts to plant fitness and
Products Altered or Produced Through
ACTION: Notice. Genetic Engineering Which Are Plant the environment, and health concerns.
Pests or Which There Is Reason to APHIS has evaluated the issues raised
SUMMARY: We are advising the public during the comment period and, where
that the Animal and Plant Health Believe Are Plant Pests,’’ regulate,
among other things, the introduction appropriate, has provided a discussion
Inspection Service is making available of these issues in our draft
for public comment a preliminary plant (importation, interstate movement, or
release into the environment) of environmental assessment (EA).
pest risk assessment and draft After public comments are received
environmental assessment for maize organisms and products altered or
on a completed petition, APHIS
designated as event MON 87411, which produced through genetic engineering
evaluates those comments and then
has been genetically engineered for that are plant pests or that there is
provides a second opportunity for
protection against corn rootworm and reason to believe are plant pests. Such
public involvement in our
resistance to the herbicide glyphosate. genetically engineered (GE) organisms
decisionmaking process. According to
and products are considered ‘‘regulated
DATES: We will consider all comments our public review process (see footnote
articles.’’
that we receive on or before July 1, 1), the second opportunity for public
The regulations in § 340.6(a) provide
2015. involvement follows one of two
that any person may submit a petition
approaches, as described below.
ADDRESSES: You may submit comments to the Animal and Plant Health If APHIS decides, based on its review
by either of the following methods: Inspection Service (APHIS) seeking a of the petition and its evaluation and
• Federal eRulemaking Portal: Go to determination that an article should not analysis of comments received during
http://www.regulations.gov/ be regulated under 7 CFR part 340. the 60-day public comment period on
#!docketDetail;D=APHIS-2014-0007. APHIS received a petition (APHIS the petition, that the petition involves a
• Postal Mail/Commercial Delivery: Petition Number 13–290–01p) from the GE organism that raises no substantive
Send your comment to Docket No. Monsanto Company (Monsanto) of St. new issues, APHIS will follow
APHIS–2014–0007, Regulatory Analysis Louis, MO, seeking a determination of Approach 1 for public involvement.
and Development, PPD, APHIS, Station nonregulated status of maize (Zea mays)
3A–03.8, 4700 River Road Unit 118, designated as event MON 87411, which 1 On March 6, 2012, APHIS published in the
Riverdale, MD 20737–1238. has been genetically engineered for Federal Register (77 FR 13258–13260, Docket No.
Supporting documents for this protection against corn rootworm and APHIS–2011–0129) a notice describing our public
petition and any comments we receive resistance to the herbicide glyphosate. review process for soliciting public comments and
information when considering petitions for
Lhorne on DSK2VPTVN1PROD with NOTICES

on this docket may be viewed at The Monsanto petition states that determinations of nonregulated status for GE
http://www.regulations.gov/ information collected during field trials organisms. To view the notice, go to http://
#!docketDetail;D=APHIS-2014-0007 or and laboratory analyses indicates that www.regulations.gov/#!docketDetail;D=APHIS-
in our reading room, which is located in MON 87411 maize is not likely to be a 2011-0129.
2 To view the notice, the petition, and the
room 1141 of the USDA South Building, plant pest and therefore should not be comments we received, go to http://
14th Street and Independence Avenue a regulated article under APHIS’ www.regulations.gov/#!docketDetail;D=APHIS-
SW., Washington, DC. Normal reading regulations in 7 CFR part 340. 2014-0007.

VerDate Sep<11>2014 14:50 May 29, 2015 Jkt 235001 PO 00000 Frm 00001 Fmt 4703 Sfmt 4703 E:\FR\FM\01JNN1.SGM 01JNN1

30998 Federal Register / Vol. 80, No. 104 / Monday, June 1, 2015 / Notices

Under Approach 1, APHIS announces in Monsanto, a review of other scientific Done in Washington, DC, this 22nd day of
the Federal Register the availability of data, field tests conducted under APHIS May 2015.
APHIS’ preliminary regulatory oversight, and comments received on Kevin Shea,
determination along with its EA, the petition. APHIS is considering the Administrator, Animal and Plant Health
preliminary finding of no significant following alternatives: (1) Take no Inspection Service.
impact (FONSI), and its plant pest risk action, i.e., APHIS would not change the [FR Doc. 2015–13164 Filed 5–29–15; 8:45 am]
assessment (PPRA) for a 30-day public regulatory status of maize designated as BILLING CODE 3410–34–P
review period. APHIS will evaluate any event MON 87411, or (2) make a
information received related to the determination of nonregulated status of
petition and its supporting documents maize designated as event MON 87411. DEPARTMENT OF AGRICULTURE
during the 30-day public review period.
If APHIS decides, based on its review The EA was prepared in accordance Food and Nutrition Service
of the petition and its evaluation and with (1) NEPA, as amended (42 U.S.C.
analysis of comments received during 4321 et seq.), (2) regulations of the Agency Information Collection
the 60-day public comment period on Council on Environmental Quality for Activities: Proposed Collection;
the petition, that the petition involves a implementing the procedural provisions Comment Request—USDA National
GE organism that raises substantive new of NEPA (40 CFR parts 1500–1508), (3) Hunger Clearinghouse Database
issues, APHIS will follow Approach 2. USDA regulations implementing NEPA Forms FNS 543 and FNS 543–A
Under Approach 2, APHIS first solicits (7 CFR part 1b), and (4) APHIS’ NEPA AGENCY: Food and Nutrition Service
written comments from the public on a Implementing Procedures (7 CFR part (FNS), USDA.
draft EA and preliminary PPRA for a 30- 372). ACTION: Notice.
day comment period through the
publication of a Federal Register notice. In accordance with our process for
SUMMARY: In accordance with the
Then, after reviewing and evaluating the soliciting public input when Paperwork Reduction Act of 1995, this
comments on the draft EA and considering petitions for determinations notice invites the general public and
preliminary PPRA and other of nonregulated status for GE organisms, other public agencies to comment on
information, APHIS will revise the we are publishing this notice to inform this proposed information collection.
PPRA as necessary and prepare a final the public that APHIS will accept This is a revision of a currently
EA and, based on the final EA, a written comments on our draft EA and approved collection for the purpose of
National Environmental Policy Act our preliminary PPRA regarding the collecting information from
(NEPA) decision document (either a petition for a determination of organizations fighting hunger and
FONSI or a notice of intent to prepare nonregulated status from interested or poverty.
an environmental impact statement). affected persons for a period of 30 days DATES: Written comments must be
For this petition, we are using Approach from the date of this notice. Copies of
2. received on or before July 31, 2015.
the draft EA and the preliminary PPRA, ADDRESSES: Comments are invited on:
As part of our decisionmaking process as well as the previously published
regarding a GE organism’s regulatory (a) Whether the proposed collection of
petition, are available as indicated information is necessary for the proper
status, APHIS prepares a PPRA to assess
under ADDRESSES and FOR FURTHER performance of the functions of the
the plant pest risk of the article. APHIS
INFORMATION CONTACT above. agency, including whether the
also prepares the appropriate
environmental documentation—either After the comment period closes, information shall have practical utility;
an EA or an environmental impact APHIS will review all written comments (b) the accuracy of the agency’s estimate
statement—in accordance with NEPA, received during the comment period of the burden of the proposed collection
to provide the Agency and the public and any other relevant information. of information, including the validity of
with a review and analysis of any After reviewing and evaluating the the methodology and assumptions that
potential environmental impacts that comments on the draft EA and the were used; (c) ways to enhance the
may result if the petition request is preliminary PPRA and other quality, utility, and clarity of the
approved. information, APHIS will revise the information to be collected; and (d)
APHIS has prepared a preliminary PPRA as necessary and prepare a final ways to minimize the burden of the
PPRA and has concluded that maize EA. Based on the final EA, APHIS will collection of information on those who
designated as event MON 87411, which are to respond, including use of
prepare a NEPA decision document
has been genetically engineered for appropriate automated, electronic,
(either a FONSI or a notice of intent to
protection against corn rootworm and mechanical, or other technological
prepare an environmental impact
resistance to the herbicide glyphosate, is collection techniques or other forms of
unlikely to pose a plant pest risk. In statement). If a FONSI is reached, information technology.
section 403 of the Plant Protection Act, APHIS will furnish a response to the Comments may be sent to: Tony
‘‘plant pest’’ is defined as any living petitioner, either approving or denying Craddock, Jr., Food and Nutrition
stage of any of the following that can the petition. APHIS will also publish a Service, U.S. Department of Agriculture,
directly or indirectly injure, cause notice in the Federal Register 3101 Park Center Drive, Room 941,
damage to, or cause disease in any plant announcing the regulatory status of the Alexandria, VA 22302. Comments may
or plant product: A protozoan, a GE organism and the availability of also be submitted via email to Tony
nonhuman animal, a parasitic plant, a APHIS’ final EA, PPRA, FONSI, and our Craddock, Jr. at tony.craddock@
Lhorne on DSK2VPTVN1PROD with NOTICES

bacterium, a fungus, a virus or viroid, an regulatory determination. fns.usda.gov. Comments will also be
infectious agent or other pathogen, or Authority: 7 U.S.C. 7701–7772 and 7781– accepted through the Federal
any article similar to or allied with any 7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and eRulemaking Portal. Go to http://
of the foregoing. 371.3. www.regulations.gov and follow the
APHIS has also prepared a draft EA in online instructions for submitting
which we present two alternatives based comments electronically. Comments
on our analysis of data submitted by will also be accepted through the

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Document Created: 2015-12-15 15:18:32
Document Modified: 2015-12-15 15:18:32

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		We will consider all comments that we receive on or before July 1, 2015.
Contact		Dr. John Turner, Director, Environmental Risk Analysis Programs, Biotechnology Regulatory Services, APHIS, 4700 River Road Unit 147, Riverdale, MD 20737-1236; (301) 851-3954, email: [email protected] To obtain copies of the petition, contact Ms. Cindy Eck at (301) 851-3892, email: [email protected]
FR Citation		80 FR 30997

80 FR 30997 - Monsanto Co.; Availability of Preliminary Plant Pest Risk Assessment and Draft Environmental Assessment of Maize Genetically Engineered for Protection Against Corn Rootworm and Resistance to Glyphosate

DEPARTMENT OF AGRICULTUREAnimal and Plant Health Inspection Service

Federal Register Volume 80, Issue 104 (June 1, 2015)

DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service