[Federal Register Volume 84, Number 181 (Wednesday, September 18, 2019)]
[Notices]
[Pages 49111-49114]
[FR Doc No: 2019-20229]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-4187]

A New Era of Smarter Food Safety; Public Meeting, Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public meeting entitled ``A New Era of Smarter
Food Safety'' to get input from a broad cross-section of stakeholders
on a modern approach the Agency is taking to strengthen its protection
of the food supply. The purpose of this meeting is to foster a dialogue
with our domestic and international regulatory and public health
partners, industry, consumers, academia, and others. The input received
at this meeting, and in comments submitted to the docket, will be used
to shape an FDA Blueprint for a New Era of Smarter Food Safety. This
Blueprint will outline how this modern approach will address public
health challenges, ranging from being able to trace sources of
contaminated foods, to using new predictive analytics tools like
artificial intelligence to assess risks, and help prioritize the
Agency's work and resources.

DATES: The public meeting will be held on October 21, 2019, from 8:30
a.m. to 5 p.m. Submit either electronic or written comments on this
public meeting by November 20, 2019. See the SUPPLEMENTARY INFORMATION
section for registration date and information.

ADDRESSES: The public meeting will be held at the Hilton Washington DC/
Rockville Hotel and Executive Meeting Center, 1750 Rockville Pike,
Rockville, MD 20852. For more information on the hotel see https://www.fda.gov/food/news-events-cfsan/workshops-meetings-webinars-food-and-dietary-supplements.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before November 20, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of November 20, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket
No.FDA-2019-N-4187 for ``A New Era of Smarter Food Safety.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked

as ``confidential'' will not be disclosed except in accordance with 21
CFR 10.20 and other applicable disclosure law. For more information
about FDA's posting of comments to public dockets, see 80 FR 56469,
September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    For questions about registering for the meeting or to register by
phone: Mark Gifford, SIDEM, 1775 Eye St. NW, Suite 1150, Washington, DC
20006, telephone:<PHONE_NUMBER>, Fax:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    For general questions about the meeting or for special
accommodations due to a disability: Juanita Yates, Center for Food
Safety and Applied Nutrition (HFS-009), Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740, telephone:<PHONE_NUMBER>,
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On April 30, 2019, FDA released a joint statement from Acting FDA
Commissioner Ned Sharpless, M.D., and Deputy Commissioner for Food
Policy and Response Frank Yiannas on the New Era of Smarter Food
Safety. (https://www.fda.gov/news-events/press-announcements/statement-acting-fda-commissioner-ned-sharpless-md-and-deputy-commissioner-frank-yiannas-steps-usher). This is a modern approach to food safety that
incorporates the use of new and emerging technologies, considers the
challenge of evolving business models, and works to support the
development of food safety cultures throughout the global supply chain.
The New Era of Smarter Food Safety will enhance the Agency's ongoing
efforts to implement the FDA Food Safety Modernization Act (FSMA) by
creating a more digital, traceable, and safer system to help protect
consumers from contaminated food.
    FDA continues to build a modernized regulatory framework that can
help ensure the safety of the food supply, including innovations in
food ingredients and processes. At the same time, FDA will leverage the
use of new and emerging technologies to strengthen predictive
capabilities, support the implementation of preventive controls, and
speed outbreak response.
    Today's technology-focused world has changed the way our society
operates, creating a highly complex and globally interconnected
landscape. The food system has evolved from a system that sources foods
from around the corner to a system that brings in foods from around the
world and travels an ever-changing ``last mile'' with the emergence of
direct-to-home delivery models. Technology and market forces have
redefined how foods go from farm to table as shown by the expansion of
e-commerce and the use of new technologies to track foods and their
storage conditions along the supply chain.
    There will be significant innovation in the agriculture, food
production, and food distribution systems in the next 10 years, which
will continue to provide an even greater variety of food sources, food
ingredients, and delivery conveniences for American consumers. With
this ever-changing landscape, FDA must continue preparing to take
advantage of new opportunities and address potential risks.
    Since FSMA was signed into law in 2011, FDA has proposed and
finalized critical regulations that have established science- and risk-
based standards for the production, importation, and transportation of
foods. FDA has also had great success leveraging technology to advance
food safety, especially in the use of new analytical tools like Whole
Genome Sequencing. However, a lot has changed since 2011.
    When it comes to food traceability, many in the food system still
utilize a largely paper-based based system of taking one step forward
to identify where the food has gone and one step back to identify the
source. The use of new and evolving digital technologies envisioned in
the New Era of Smarter Food Safety will play a pivotal role in tracing
the origin of a contaminated food to its source in minutes, or even
seconds, instead of days or weeks. Access to information during an
outbreak about the origin of contaminated food will facilitate more
timely root cause analyses and enable FDA to prevent future
contamination incidents.
    The Agency will look at technologies and approaches that include
those being used in society and business sectors all around us, such as
distributed ledgers, sensors, the Internet of Things, and artificial
intelligence. FDA will assess how these technologies could create a
more digital, transparent, and safe food system while also addressing
consumer demands for quick access to information about where their
foods come from, how they are produced, and if the food is the subject
of an ongoing recall.
    As consumers are increasingly asking for food to be delivered to
their homes, there are new methods, packaging materials, temperature
control approaches, and delivery models in the e-commerce system. These
evolving business models present food safety challenges, as well as
novel considerations around regulatory framework and oversight at the
federal, state, territorial, and local level.
    The New Era of Smarter Food Safety is about more than technology.
It is also about working within and outside of FDA to foster a food
safety culture that transcends borders between the public and private
sector, as well as geographic and commodity divides. The New Era of
Smarter Food Safety is also about enhancing existing processes to make
them more effective and efficient. FDA looks forward to participation
in this effort by food companies and technology firms of all sizes, as
well as state, territorial, local, and federal agencies and other
stakeholders.

II. Topics for Discussion at the Public Meeting

    The public meeting will begin with a plenary session, followed by
breakout sessions that will discuss key topics relating to the New Era
of Smarter Food Safety. These topics will include technologies and data
streams that have the potential to greatly reduce the time it takes to
trace the origin of a contaminated food to its source and how we might
best use this information. We will talk about how we can use lessons
learned from outbreaks to better inform and enhance our prevention
efforts.
    No matter how consumers get their food, whether they are ordering
online or at their favorite restaurant, they deserve to have confidence
in the safety of the food supply. We will talk about advancing the
safety of both new business models, such as e-commerce and home
delivery of foods, and traditional business models, such as retail food
establishments. Perhaps the most fundamental topic that we will address
is the need to support and strengthen food safety culture throughout
the supply chain from farms to facilities through retail, which is the
foundation of food safety management.
    We encourage public comments and presentations at the public
meeting. In submitting comments, data, and

information to the docket, please identify available references for the
data and information, as well as the general category area and, if
appropriate, the specific question listed below. We are starting with
several focus areas: Traceability, smarter tools and approaches for
prevention, the challenges of new business models and retail food
safety, and support for the development of food safety cultures.

A. New and Evolving Digital Technologies Will Play a Pivotal Role in
Tracing the Origin of a Contaminated Food to Its Source in Minutes, or
Even Seconds, Instead of Days or Weeks

    1. What are the most significant actions FDA could undertake to
enable industry to enhance traceability across the entire global food
supply chain?
    2. How could FDA make it more likely that companies utilize new
technologies to enhance the traceability of their products?
    3. What can FDA do to facilitate and expedite outbreak-related
communications between government agencies, industry, and consumers?
    4. Are there mechanisms FDA could employ to incentivize adoption of
real-time, end-to-end food traceability throughout the food sector?
    5. What are the challenges to creating a more digital, traceable
global food supply, and how might FDA approach this in a manner that
creates shared value for all participants?

B. To Fully Realize a Preventive Controls System That Rapidly
Incorporates New Knowledge, We Must Also Ask if We Can We Make
Processes and Communications More Effective, Efficient, and in Some
Cases, Simpler

    1. What are the most significant actions FDA could undertake to
promote and support the use of smarter tools for prevention?
    2. What predictive analytical tools and data streams are best
suited to helping identify a potential contamination event?
    3. What further steps can be taken to advance the safety of
domestic and foreign commodities that have been the subject of frequent
contamination incidents?
    4. In what ways can FDA support the use of environmental
assessments and root cause analyses in industry prevention efforts?
    5. Are there changes that FDA can and should make in the way in
which it conducts environmental assessments and root cause analyses,
and reports its findings to industry, to better facilitate their use in
industry prevention efforts?

C. Evolving Business Models Present Food Safety Challenges as Well as
Novel Considerations Around Regulatory Framework and Oversight at the
Federal, State, Territorial, and Local Level

    1. What are the most significant actions FDA could undertake to
help ensure the safety of foods delivered under a variety of new
business models, such as e-commerce?
    2. What research is available or should be conducted to understand
the potential health risks posed by foods provided by new business
models, such as e-commerce?
    3. Are there specific collaborations between FDA and industry that
would help to ensure the safety of these foods?
    4. What are the most significant actions that FDA, state,
territorial, and local agencies, and industry could take to change
practices in the retail food industry that present risks to public
health?

D. We Want To Do More To Use and Leverage Proven Organizational Culture
and Behavioral Science Principles and Techniques To Enhance
Organizational and Employee Compliance With Desired Food Safety
Practices and Behaviors

    1. What are the most significant actions FDA could undertake to
foster and support the development of food safety cultures globally?
    2. How can FDA encourage and support companies in the development
of food safety cultures throughout the supply chain?
    3. What are the obstacles to creating food safety cultures
throughout the supply chain?
    4. Are there changes that FDA can and should take in how it
approaches food safety to place further emphasis on prevention?
    Approximately two weeks before the meeting, we will post the public
meeting agenda and additional meeting materials on the internet at:
https://www.fda.gov/food/news-events-cfsan/workshops-meetings-webinars-food-and-dietary-supplements. In addition to the opportunity to comment
at the public meeting, there will be an opportunity for interested
stakeholders to submit written comments following the meeting.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the
following website: https://www.fda.gov/food/news-events-cfsan/workshops-meetings-webinars-food-and-dietary-supplements. Please
provide complete contact information for each attendee, including name,
title, affiliation, address, email, and telephone.
    Registration is free and based on space availability. Persons
interested in attending this public meeting must register by 11:59 p.m.
Eastern Time on October 11, 2019. Early registration is recommended
because seating is limited; therefore, FDA may limit the number of
participants from each organization. Registrants will receive
confirmation when they have been accepted. If time and space permit,
onsite registration on the day of the public meeting will be provided
beginning at 8 a.m. We will let registrants know if registration closes
before the day of the public meeting.
    For questions about registering for the meeting or to register by
phone, please contact Mark Gifford (see FOR FURTHER INFORMATION
CONTACT).
    If you need special accommodations due to a disability, please
contact Juanita Yates, (see FOR FURTHER INFORMATION CONTACT) no later
than October 2, 2019.
    Requests for Oral Presentations: During online or telephone
registration you may indicate if you wish to present during a public
comment session or participate in a specific session, and which
topic(s) you wish to address. We will do our best to accommodate
requests to make public comments. Individuals and organizations with
common interests are urged to consolidate or coordinate their
presentations, and request time for a joint presentation, or submit
requests for designated representatives to participate in the focused
sessions. Following the close of registration, we will determine the
amount of time allotted to each presenter and the approximate time each
oral presentation is to begin, and will select and notify participants.
All requests to make oral presentations must be received by October 2,
2019. No commercial or promotional material will be permitted to be
presented or distributed at the public meeting. Persons notified that
they will be presenters are encouraged to arrive at the meeting room
early and check in at the on-site registration table. Actual
presentation times may vary based on how the meeting progresses in real
time.
    Persons attending FDA's meetings are advised that FDA is not
responsible for providing access to electrical outlets.
    Streaming Webcast of the public meeting: This public meeting will
also be webcast. Webcast participants are asked to preregister at
https://www.fda.gov/food/news-events-cfsan/workshops-meetings-webinars-food-and-dietary-supplements.

    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/food/news-events-cfsan/workshops-meetings-webinars-food-and-dietary-supplements.

    Dated: September 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20229 Filed 9-17-19; 8:45 am]
 BILLING CODE 4164-01-P


Wyeth’s response to Section 114 letter.

Confidential Business Information located at EPA headquarters 1310 L St NW.


[Federal Register Volume 76, Number 98 (Friday, May 20, 2011)]
[Rules and Regulations]
[Page 29153]
[FR Doc No: 2011-12410]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 878

[Docket No. FDA-2006-N-0045; Formerly Docket No. 2006N-0109]

Medical Devices; Reclassification of the Topical Oxygen Chamber
for Extremities; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a final
rule that appeared in the Federal Register of April 25, 2011 (76 FR
22805). The document announced that FDA is reclassifying the topical
oxygen chamber for extremities (TOCE) from class III to class II. The
document published inadvertently used outdated contact information.
This document corrects that error.

DATES: Effective May 25, 2011.

FOR FURTHER INFORMATION CONTACT: Charles N. Durfor, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G424, Silver Spring, MD 20993-0002, 301-
796-6438.

SUPPLEMENTARY INFORMATION: In FR Doc. 2011-9899 appearing on page 22805
in the Federal Register of Monday, April 25, 2011, the following
correction is made: 1. On page 22805, in the third column, the FOR
FURTHER INFORMATION CONTACT section is corrected to read as follows:

FOR FURTHER INFORMATION CONTACT: Charles N. Durfor, Center for
Devices and Radiological Health, Food and Drug Administration, Bldg.
66, Rm. G424, 10903 New Hampshire Ave., Silver Spring, MD 20993-
0002,<PHONE_NUMBER>.

    Dated: May 17, 2011.
 Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-12410 Filed 5-19-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 86, Number 31 (Thursday, February 18, 2021)]
[Notices]
[Page 10113]
[FR Doc No: 2021-03334]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4563-DR; Docket ID FEMA-2021-0001]

Alabama; Amendment No. 5 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Alabama (FEMA-4563-DR), dated September 20, 2020, and
related determinations.

DATES: This amendment was issued January 13, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Alabama is hereby amended to include the following
area among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of September 20, 2020.

    Monroe County for Public Assistance.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Robert J. Fenton,
Senior Official Performing the Duties of the Administrator, Federal
Emergency Management Agency.
[FR Doc. 2021-03334 Filed 2-17-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 79, Number 44 (Thursday, March 6, 2014)]
[Proposed Rules]
[Page 12681]
[FR Doc No: 2014-04633]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

========================================================================

Federal Register / Vol. 79, No. 44 / Thursday, March 6, 2014 /
Proposed Rules

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 60, 70, 71 and 98

[EPA-HQ-OAR-2013-0495; FRL-9907-42-OAR]
RIN 2060-AQ91

Standards of Performance for Greenhouse Gas Emissions From New
Stationary Sources: Electric Utility Generating Units

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of extension of public comment period.

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SUMMARY: The EPA is announcing that the period for providing public
comments on the January 8, 2014, proposed ``Standards of Performance
for Greenhouse Gas Emissions From New Stationary Sources: Electric
Utility Generating Units'' and on the February 26, 2014, notice of data
availability soliciting comment on the provisions in the Energy Policy
Act of 2005, is being extended by 60 days.

DATES: Comments. The public comment period for the proposed rule
published January 8, 2014 (79 FR 1352) and the notice of data
availability published on February 26, 2014 (79 FR 10750), is being
extended by 60 days to May 9, 2014, in order to provide the public
additional time to submit comments and supporting information.

ADDRESSES: Comments. Written comments on the proposed rule may be
submitted to the EPA electronically, by mail, by facsimile or through
hand delivery/courier. Please refer to the proposal (79 FR 1352) for
the addresses and detailed instructions.
    Docket. Publicly available documents relevant to this action are
available for public inspection either electronically at http://www.regulations.gov or in hard copy at the EPA Docket Center, Room
3334, 1301 Constitution Ave. NW., Washington, DC. The Public Reading
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. A reasonable fee may be charged for copying.
The EPA has established the official public docket No. EPA-HQ-OAR-2013-
0495.
    Worldwide Web. The EPA Web site containing information for this
rulemaking is: http://www2.epa.gov/carbon-pollution-standards.

FOR FURTHER INFORMATION CONTACT: Dr. Nick Hutson, Energy Strategies
Group, Sector Policies and Programs Division (D243-01), U.S. EPA,
Research Triangle Park, NC 27711; telephone number<PHONE_NUMBER>,
facsimile number<PHONE_NUMBER>; email address<EMAIL_ADDRESS>or
Mr. Christian Fellner, Energy Strategies Group, Sector Policies and
Programs Division (D243-01), U.S. EPA, Research Triangle Park, NC
27711; telephone number<PHONE_NUMBER>, facsimile number (919) 541-
5450; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comment Period

    The EPA is extending the public comment period for an additional 60
days. The public comment period will end on May 9, 2014, rather than
March 10, 2014. This will ensure that the public has sufficient time to
review and comment on all of the information available, including the
proposed rule, the notice of data availability and other materials in
the docket.

List of Subjects

40 CFR Part 60

    Environmental protection, Administrative practice and procedure,
Air pollution control, Intergovernmental relations, Reporting and
recordkeeping requirements.

40 CFR Part 70

    Environmental protection, Administrative practice and procedure,
Air pollution control, Intergovernmental relations, Reporting and
recordkeeping requirements.

40 CFR Part 71

    Environmental Protection, Administrative practice and procedure,
Air pollution control, Reporting and recordkeeping requirements.

40 CFR Part 98

    Environmental protection, Greenhouse gases and monitoring,
Reporting and recordkeeping requirements.

    Dated: February 25, 2014.
Mary Henigin,
Acting Director, Office of Air Quality Planning and Standards.
[FR Doc. 2014-04633 Filed 3-5-14; 8:45 am]
BILLING CODE 6560-50-P


                                                    United States
ENVIRONMENTAL PROTECTION AGENCY
                                        Washington, DC 20460
                                    Office of Atmospheric Programs
                        Application for Recognition of Certification Bodies  by EPA under the ENERGY STAR[(R)] Program

  This form is an application for recognition of Certification Bodies (CBs) by the U.S. EPA under the ENERGY STAR program. To serve as an EPA-recognized CB for the ENERGY STAR program, please fill out and submit this form to EPA by following the instructions below. Upon confirmation of EPA recognition, you may begin to operate as an EPA-recognized CB for the ENERGY STAR program.
  Instructions:
 Read and understand the "Conditions and Criteria for Recognition of Certification Bodies for the ENERGY STAR Program," the full text of which is included under Section VI.
 Complete the form. All fields are required unless stated otherwise.
 Sign the form by either:
 Inserting your digital signature; or
 Printing out the form, signing it by hand, and scanning it into PDF format.
 Email the completed form with the required attachment to<EMAIL_ADDRESS>        I. 	Certification Body Information Organization Name: Organization URL:
        Address 1 (e.g., street address):
        Address 2 (e.g., suite #):
        City:
        State:
        Zip/Postal Code: Country:
        Primary contact first name:
        Primary contact last (family) name:
        Job title of primary contact:
        Email:
        Phone:
        If mailing address of primary contact is different from the organization address, please provide it here:
        Address 1 (e.g., street address):
        Address 2 (e.g., suite #):
        City:
        State:
        Zip/Postal Code: Country:
        The following secondary contact information section is optional.
        Secondary contact first name:
	Secondary contact last (family) name:
        Job title of secondary contact:
        Email:
        Phone:
        If mailing address of secondary contact is different from the organization address, please provide it here:
        Address 1 (e.g., street address):
        Address 2 (e.g., suite #):
        City:
        State:
        Zip/Postal Code: Country:
 General Requirements: Consistent with "Conditions and Criteria for Recognition of Certification Bodies for the
        ENERGY STAR Program," an EPA-recognized, accredited CB must maintain accreditation to ISO/IEC Guide 65,
        "General requirements for bodies operating product certification systems," by a signatory to the International Accreditation Forum (IAF) Multilateral Recognition Agreement (MLA) that covers accreditation of product certification bodies and operates in accordance with ISO/IEC 17011.
 Name of Accreditation Body:
 Accreditation effective date:
 Accreditation expiration date (if applicable):
 A digital copy of the CB's accreditation certificate and scope of accreditation is included with this application (check box to confirm).
 Additional remarks (optional):
 Scope of Accreditation: Below, please select each ENERGY STAR product category for which the CB named herein is accredited to operate its product certification system. Since EPA-recognition is per product category, EPA will recognize this CB only for products listed on its Scope of Accreditation. If in the future you wish to certify products not checked below, please resubmit this form with the additional products checked and your updated Scope of Accreditation. Products listed in italics are currently undergoing specification development; they are included here to provide interested CBs with notice of forthcoming ENERGY STAR product categories.
                                    ENERGY STAR Product Categories
               Appliances
  Electronics and Office Equipment (continued)
 Clothes Washers
 Dishwashers
 Refrigerators and/or Freezers
Telephony
Televisions
Uninterruptible Power Supplies
           Heating and Cooling
Boilers
Central Air Conditioners and Air-Source Heat Pumps
Commercial Water Heaters
Dehumidifiers
Furnaces
Geothermal Heat Pumps
Light Commercial HVAC
Room Air Cleaners and Purifiers
Room Air Conditioners
Residential Water Heaters - Solar
Enterprise Storage
Small Network Equipment
                           Commercial Food Service
Commercial Dishwashers
Commercial Fryers
Commercial Griddles
Commercial Hot Food Holding Cabinets
Commercial Ice Machines
Commercial Ovens
Commercial Refrigerators and Freezers
Commercial Steam Cookers
Residential Water Heaters - Non-Solar
Climate Controls
      Electronics and Office Equipment
Audio/Video
Battery Charging Systems (BCSs)
Computers
Displays
Enterprise Servers
Imaging Equipment
Set-top Boxes & Cable Boxes
                              Lighting and Fans
Ceiling Fans
Compact Fluorescent Lamps (includes GU24)
Decorative Light Strings
Integral LED Lamps (Decorative)
Integral LED Lamps (Omnidirectional/Directional)
LED package, module or array (IES LM-80-2008)
Luminaires: Halogen (Directional)
Luminaires: Halogen (Non-directional)
Luminaires: High Intensity Discharge Ballasts

                  Additional product categories on next page
Lighting and Fans (continued) Luminaires: High Intensity Discharge (Directional)
                                                       Home Building Materials
 Roof Products
Luminaires: High Intensity Discharge Lamps
                                         Other
Luminaires: High Intensity Discharge (Non-Directional and Subcomponents)
Luminaires: Fluorescent Ballasts
Luminaires: Fluorescent (Directional)
Luminaires: Fluorescent Lamps
 Pool Pumps
Vending Machines
Water Coolers
Lab-grade Refrigerators/Freezers
         Luminaires: Fluorescent (Non-Directional and  subcomponents)
         Luminaires: Solid State (Directional)
         Luminaires: Solid State (Non-Directional)
         Residential Ventilating Fans

 Required Documentation: Attach to this application a manual or procedural guide that describes your certification program, as well as any other documents necessary to demonstrate that your organization meets the "Conditions and Criteria for Recognition of Certification Bodies for the ENERGY STAR Program" (the complete text of which is in Section VI of this application). Complete the table below by citing in the "Applicant's Reference Document(s)" column the attached document that fulfills the ENERGY STAR requirement noted at left.  To facilitate application review, please record the exact file name that is used in the attachment, and highlight the applicable text within the document or note in the table its exact location.
                                 ENERGY STAR
                               Requirements for
                             Certification Bodies
                           Applicant's Reference
                                 Document(s)
          (example: File123.pdf, relevant info in Section 6, page 9)
                                   Remarks
                              Internal Use Only

                              Conforms (Yes/No)
2 a): Description of the CB's data review cycle time.

2 b) ii: Description of procedure to verify partner claims as to which models are part of a family and which model may be a
representative model from a family (please indicate N/A if you certify no applicable product categories).

3 a) i: Description of the verification testing program.

3 a) i (2): Description of the procedure for determining the number of models subject to verification testing.

3 a) i (3): Description of the procedure for selecting products for verification testing.

3 a) i (4): Description of the procurement procedure for products selected for verification testing.

 Rev. Mar - 2013
                                 ENERGY STAR
                               Requirements for
                             Certification Bodies
                           Applicant's Reference
                                 Document(s)
          (example: File123.pdf, relevant info in Section 6, page 9)
                                   Remarks
                              Internal Use Only

                              Conforms (Yes/No)
3 b) i: Description of procedure for re-evaluating products in event of design changes.

3 c): Description of challenge testing procedure.

3 d): Description of procedure for resolving discrepancies that result from re-testing.

                 Appendix A: Requirements for CBs Operating a
                           Witnessed or Supervised
 Manufacturer's Testing Lab
                               (W/SMTL) Program
         (please note "NA" if you do not operate such a program)

1 a): Description of initial and ongoing auditing process of WMTLs/SMTLs to ensure compliance with ISO/IEC 17025.

1 e): Description of proficiency testing procedure.

2): Description of WMTL program.

3): Description of SMTL program.

                                 ENERGY STAR
                               Requirements for
                             Certification Bodies
                           Applicant's Reference
                                 Document(s)
          (example: File123.pdf, relevant info in Section 6, page 9)
                                   Remarks
                              Internal Use Only

                              Conforms (Yes/No)
3 a) and 3 b): Description of process for establishing confidence in an SMTL.

 Declaration:
         By checking this box, I declare that I have read and agree to the terms of "Conditions and Criteria for
      Recognition of Certification Bodies for the ENERGY STAR Program," and the information submitted via this form is, to the best of my knowledge, accurate and associated with the Certification Body named herein. I understand that the ENERGY STAR program will associate all information in this form with this Certification Body. I understand that if any of the submitted information is found to be inaccurate, the Certification Body will be removed from the list of EPA-recognized Certification Bodies. I understand that intentionally submitting false information to the U.S. government is a criminal violation of the False Statements Act, Title 18 U.S.C. section 1001.
      Failure to operate a certification program according to these Conditions and Criteria will be grounds for loss of EPA recognition. Should EPA decide to cease recognition of a CB, EPA will inform both the CB and its accreditation body of the decision and provide specifics of the errors or issues that EPA identified.
      CBs that lose recognition may re-apply after six months. This time frame allows the CB to develop procedures that remedy the deficiencies identified by EPA and be re-assessed by its accreditation body. In the interest of conserving government resources and barring special circumstances, additional applications are limited to two, each a minimum of six months apart.
      I further declare that the Certification Body named herein will not use any ENERGY STAR mark for any purpose at any time.
      You are required to provide your signature by either:
 Inserting your digital signature in the box below, or,
 Printing out the form, signing the signature box below by hand, and scanning the form into PDF format.
      Responsible Corporate Official/Signatory:
      Printed Name:
      Job Title:
      Date:

VI.	Conditions and Criteria for Recognition of Certification Bodies for the ENERGY STAR Program
In order to be recognized as a Certification Body (CB) for the ENERGY STAR Program, a CB shall agree in writing to the following requirements:
    General Requirements and Responsibilities
 Maintain accreditation to ISO/IEC Guide 65, "General requirements for bodies operating product certification systems," or ISO/IEC 17065, "Conformity Assessment: Requirements for bodies certifying products, processes, and services," by a signatory to the International Accreditation Forum (IAF) Multilateral Recognition Agreement (MLA) that covers accreditation of product certification bodies and operates in accordance with ISO/IEC 17011.
      Note: The IAF expects ISO/IEC 17065 to be in effect and replace Guide 65 by September 15, 2015. Currently recognized and applicant CBs accredited to ISO/IEC Guide 65 will transition to ISO/IEC 17065 according to the schedule determined by their accreditation body, however they must keep EPA informed of their progress and projected date that this accreditation will be final.
      Noteworthy elements of ISO/IEC Guide 65 and ISO/IEC 17065 include requirements that the CB shall: i)	Operate in a non-discriminatory manner so as not to impede or inhibit access by applicants.
          Make its services accessible to all applicants whose activities fall within its declared field of operation, independent of the size or membership status of the applicant.
          Ensure that the relationship between it and each organization providing test data does not compromise the CB's independence.
          Be responsible for decisions relating to its granting, maintaining, suspending, and withdrawing of certification, and make these decisions impartially.
          Decide whether or not to certify a product on the basis of the information gathered during the evaluation process.
          Have a legally enforceable agreement for the provision of certification activities to its clients. Contract and agreements for certification shall take into account the responsibilities of the parties.
          Provide, regularly update, and make available upon request by EPA a directory of the products it has certified, and their suppliers.
 Demonstrate to EPA's satisfaction adequate availability of personnel to the Agency and the ability to provide requested information in a timely manner.
 Apply the same conditions to the review of test reports from all EPA-recognized laboratories from which the CB has agreed to accept data, regardless of the ownership of the laboratory.
 Make available in written format to current or prospective clients all relevant aspects of the CB's certification program, and submit this information to EPA upon request. At a minimum, these shall include:
 A copy of the form or template which serves as the legally enforceable agreement for the provision of certification activities to the CB's client; and,
 A description of the certification program.
 Make available in written format to EPA a description of the management of competencies of personnel involved in the certification process.
 Maintain test reports for certified products for at least the longer of five years or the duration of certification, and permit EPA to examine any information used in making certification decisions, including test data.
 Participate in meetings with EPA as EPA deems necessary to discuss changes to ENERGY STAR product specifications or third-party certification requirements relevant to certified products. EPA and the CB will jointly determine whether the meeting should take place remotely (for example, by telephone) or in-person.
 Forward any questions related to ENERGY STAR product specifications, including test methods and eligibility criteria, to EPA for resolution, and abide by the decisions of EPA relative to the resolution of those questions.
 Allow EPA, at its discretion, to audit product certification and verification activities.
 Notify EPA and any ENERGY STAR partner whose product(s) the CB has certified, of any suspension or withdrawal of the CB's accreditation or recognition.
 Not use its own mark to indicate that a product is ENERGY STAR qualified.
 Comply with EPA written policies, including FAQs, directives, and other written instructions.
    ENERGY STAR Qualification
 Provide EPA with a description of the CB's data review cycle time in order to allow the estimation of its potential impact on ENERGY STAR partners' product introduction cycles.
 Abide by the Standard Operating Procedure for Certification of Products to ENERGY STAR Specifications. Noteworthy elements of the SOP include:
 Determine qualification by assessing whether the product meets the performance parameters described in the relevant ENERGY STAR product specification. This assessment shall comprise a review of the test report of each model intended for ENERGY STAR qualification.
 In the case of ENERGY STAR product specifications that permit the qualification of a group of models based on the test report of a representative model, the CB shall have a procedure to verify ENERGY STAR partner claims as to:
 Which models are part of a single family; and,
 Which model may be considered a representative model of that family.iii) Confirm that all data in the test report originated from a laboratory EPA has recognized for the relevant ENERGY STAR specification. EPA-recognized laboratories include the following:
 All laboratories EPA has formally recognized as currently meeting the "Conditions and Criteria for Recognition of Laboratories for the ENERGY STAR Program." The terms of this document include accreditation to ISO/IEC 17025 by an EPA-recognized Accreditation Body. EPA maintains an online list of these laboratories. Therefore, confirming data have originated with such a laboratory shall consist of confirming the presence of the laboratory on this list.
 All laboratories participating in the CB's witnessed or supervised manufacturers' testing laboratory (WMTL/SMTL) program per the requirements described in Appendix A. The terms of this include assessment to ISO/IEC 17025 by an EPA-recognized CB. Ensuring data have originated with such a laboratory shall consist of the CB confirming the presence of the laboratory on its internal list of
            WMTLs/SMTLs.
 Report accurate and complete product data on certified products to EPA using XML-based web services. CBs should refer to product-specific XML schema to ensure they are collecting all necessary data fields. Also, CBs must be able to successfully complete a test submission using the relevant XML service for any new product category before they may expand their EPA recognition to that category.
    ENERGY STAR Verification
 Verification Testing
 Operate an ENERGY STAR partner-funded verification testing procedure that fulfills the verification testing requirements enumerated as follows:
 Ensure products meet all product performance parameters as described in the relevant ENERGY STAR product specification.
 Number of products:
 On a twelve-month cycle, test at least 10% of all ENERGY STAR qualified models, per product specification, that the CB has certified or registered. The CB shall document its testing cycle schedule within its quality system documentation.
 When determining the number of models subject to verification testing, the CB shall consider product families as defined in the relevant product specification.
 EPA may advise the CB to modify the number of models tested in subsequent years. The minimum number of products tested may differ by product specification.
 Products shall be selected by the CB according to the following general guidelines:
 When the CB is ready to select models for a round of verification testing, it shall contact EPA for Agency selections and include these selections in that round of testing; (b) EPA and the CB shall select models in consideration of the following:
 Whether an ENERGY STAR partner has experienced a previous verification testing failure, and has other models qualified to that product specification;
 Referrals from third parties such as consumers, consumer groups or regulatory agencies regarding the accuracy of ratings; and,
               (c) Models with high sales volumes if this data is available. The remaining models to be tested shall be randomly selected; although, the more recently a model has undergone verification or challenge testing, the less likely it should be selected in this random selection process.
 Procurement of unit(s) for testing:
 The CB shall procure or obtain the unit(s) for testing, prioritizing the source of those units in the following order (from most to least favored)  (i) Off-the-shelf (i.e., from the open market);
 Warehouse (i.e., from a storage depot); or
 Off-the-line (i.e., from the manufacturing facility).
               NOTE: Consistent with Directive 2011-06, off-the-line testing is only appropriate where procuring products from the shelf or from a warehouse is not feasible. Examples include where the selected product is prohibitively expensive to purchase and/or transport, is made-to-order, or is otherwise unavailable through normal retail channels.
 The CB shall be responsible for obtaining the unit for testing, and shall not allow the ENERGY STAR partner to choose the testing sample.
 Partners whose products are selected for verification testing are required to:
 In the case of off-the-shelf procurement, provide a list of at least three locations where a unit(s) of the product(s) to be tested may be obtained; or
 In the case of warehouse or off-the-line procurement, provide access to the CB to select a unit(s) of the product(s) for testing.
 Comply with verification testing requests in a timely manner.
 The CB shall report to EPA any partners that do not comply with verification testing requirements.
 Location of verification testing:
 Verification testing shall be performed at an EPA-recognized, third-party laboratory; or,
 If the unit is obtained off-the-line from the manufacturing facility, the verification testing may be performed at an EPA-recognized, first-party  laboratory provided that qualified CB personnel witness the test.
 Re-evaluation in the Event of Significant Changes
 Have procedures to re-evaluate product performance in the event of changes that could affect the ENERGY STAR qualification status of a product the CB has certified.[3] Consistent with this, the CB shall:
 Require the ENERGY STAR partner responsible for a product the CB has certified to inform the CB about any changes to that product that could result in it no longer meeting the requirements of the relevant ENERGY STAR product specification.
 Require, and evaluate the results of, retesting of the product's relevant performance. c)	Challenge Testing
 Have in place a challenge testing procedure, and contractual provisions for challenge testing, that includes a process for establishing if a challenge has merit.
 The CB shall not oblige the challenger to convey the details of the challenge to the challengee.
 Upon the failure of a product to meet the performance requirements of the relevant ENERGY STAR product specification, the CB shall notify the ENERGY STAR partner and EPA within two business days. d)	Changes in Product Performance:
 Have in place a procedure to resolve discrepancies between data resulting from product re-testing, that is, verification testing, re-evaluation in the event of significant changes, or challenge testing, and the data previously certified by the CB.
 Report to EPA any changes in product performance, including new test data.
 If the changes do not impact the ability of the product to qualify for ENERGY STAR, the CB shall report the relevant data to EPA on the same schedule as information on newly certified products.
 If initial test results indicate the product does not meet the performance requirements of the relevant ENERGY STAR product specification, the CB shall notify EPA within two business days, and report to EPA the test results that are relevant to ENERGY STAR qualification. If EPA considers the test results final, the CB shall, in addition to the preceding steps, decertify the product for ENERGY STAR, likewise within two business days.
 A CB may notify a manufacturer of a model's verification or challenge testing failure only upon or after notifying EPA of the failure.

Appendix A: Requirements for the operation of a Witnessed Manufacturers' Testing Laboratory (WMTL) or Supervised Manufacturers' Testing Laboratory (SMTL) program
A CB, per ISO/IEC Guide 65 or ISO/IEC 17065, may operate a testing program to accept test data from a manufacturer's first-party laboratory that participates in a WMTL or a SMTL program only if the CB adheres to the requirements enumerated below. Note, the CB shall not enroll as a WMTL any laboratory EPA has formally recognized as currently meeting the "Conditions and Criteria for Recognition of Laboratories for the ENERGY STAR Program," since this recognition obviates the need to establish confidence in the laboratory via the level of witnessing inherent to a WMTL program. Instead, the CB shall enroll such a laboratory as an SMTL, and the procedure the CB follows to do so shall entail fewer steps than in the case of non-accredited laboratories.
To operate a testing program to accept test data from a manufacturer's first-party laboratory that participates in a WMTL or a SMTL program, the CB shall:
1)	General Requirements:
 Ensure through an on-site initial assessment and periodic auditing that the WMTL or SMTL is able to demonstrate its facilities are in compliance with all relevant requirements of ISO/IEC 17025 and the applicable test method(s), and that the laboratory personnel conducting the testing have the necessary competence and expertise. Consistent with this, the CB shall have and follow written procedures for evaluating laboratory facilities; environmental controls; personnel and training; testing and calibration equipment types and accuracy; calibration procedures; written test procedures, set-up, measurement technique(s) and documentation systems; quality assurance programs; and other elements as required in the relevant ENERGY STAR product specification;
 Document and maintain reports of its assessments and periodic auditing of the WMTLs/SMTLs in the programs it operates;
 Have and follow procedures to monitor the impartiality of WMTLs/SMTLs on an ongoing basis. Document review, consistent with the requirements of ISO/IEC 17025, shall include but may not be limited to the following:
 Organization chart showing that the responsibilities, authorities, and inter-relationships of all personnel who manage, perform or verify laboratory results are free from influence that may adversely affect the quality of their work;
 Dates of internal audits, audit findings, and any corrective actions taken; iii) Any customer complaints and corrective action taken;
          Original testing records containing sufficient information for repeatability, including the names of staff who participated;
          Evidence that mechanisms for reporting and responding to attempts to exert undue influence on test results are in place; and,
          Other measures as appropriate to ensure the impartial conduct of laboratory staff.
 Maintain records that demonstrate the test data originating with the WMTL/SMTL are unbiased.
 Operate proficiency testing when EPA/DOE deems it necessary to ensure consistent results between the WMTL/SMTL and an EPA-recognized third-party laboratory.
 Provide EPA with a list of each WMTL/SMTL enrolled in its program to test products for ENERGY STAR, and updates to this list on an ongoing basis.
 Assume full responsibility for the validity of the test results. 2)	Requirements specific to the operation of a WMTL program:
 Supervise and check all critical aspects of the tests;
 Witness the final data acquisition;
 Ensure that the CB personnel who witness the test(s) have the necessary competence and expertise to carry out tests to the relevant ENERGY STAR product specification; and,
 Ensure that all tests are carried out by personnel of the WMTL in accordance with the applicable requirements. 3)	Requirements specific to the operation of an SMTL program:
 Witness testing and all other elements that contribute to the establishment of confidence in the SMTL's quality processes;
 As the CB gains experience with and confidence in the SMTL, supervision may gradually shift away from witnessing tests;
 At least once per year, audit the SMTL's procedures on-site against the requirements of ISO/IEC 17025 and the applicable test method(s). During visits, the CB shall: i)	Supervise product testing; and,
	ii)	Review relevant test reports in progress; and,
	d)	Maintain records of:
 The dates and elements of performed supervision, including what tests were observed; and,
 Observations made and advice provided to the SMTL during visits.
End of text of "Conditions and Criteria for Recognition of Certification Bodies for the ENERGY STAR Program"
The public reporting and recordkeeping burden for this collection of information is estimated to average 6.7 hours per response. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, Collection Strategies Division, U.S. Environmental Protection Agency (2822T), 1200 Pennsylvania Ave., NW, Washington, D.C. 20460. Include the OMB control number in any correspondence. Do not send the completed form to this address.