MEMORANDUM
DATE:		February 20, 2013
SUBJECT:  	European Wood Heating Technology Survey Explanation of Data for Solid Wood Stoves and Boilers
FROM:	Alden West, EC/R Inc.
		Glenn Meganck, EC/R Inc.
TO: 		Gil Wood, EPA/OAQPS
      David Cole, EPA/OAQPS

The Excel(TM) spreadsheet (included as an attachment in this e-mail) provides data for solid wood stoves and boilers from the European Wood-Heating Technology Survey (EWHTS). Both the stoves and boilers tables are provided in the format presented in the EWHTS and as a "sortable" table.  A PM emission rate in grams per hour (g/hr) was calculated by multiplying the nominal load (MBtu/hr  -  converted to MMBtu/hr) by the TSP emissions (lb/MMBTU  -  converted to g/MMBTU).
The data in the European Wood-Heating Technology Survey are useful for development of the Residential Wood Heaters NSPS although not all of the data are directly comparable to some of the data previously compiled for the NSPS. Some differences should be kept in mind:  (1) The EWHTS provides emissions data as "dust" or "total suspended particulate (TSP)," which is defined as particles with a diameter of 45 micrometers (um) or less, while the NSPS data is provided as particulate matter (PM), defined as particles with a diameter less than either 10 um (PM10) or 2.5 um (PM2.5). Both measures need clarification; the EWTHS test method does not use a dilution tunnel and thus the EWHTS "dust" does not include the condensibles [products of incomplete combustion] that would be measured by EPA Method 28. This difference is believed to be very small for the higher combustion efficiency heaters that have less products of incomplete combustion. Although neither the EWHTS test methods nor EPA Method 28 distinguishes between TSP and PM10 and PM2.5, studies have shown that over 85% of residential wood smoke emissions are PM2.5 or less. (2) The EWHTS provides data for European solid wood boilers, which often are low-pressurized systems whereas many current U.S. hydronic heaters are not pressurized.         (3) The EWHTS provides data on stoves that burn wood in Austria, Denmark, Germany, Norway and Sweden; some of the tree species in these countries are different than those in the United States and therefore may have somewhat different emission characteristics when burned.  (4) The EWHTS characterizes wood heaters based on "nominal load" (MBtu/hr).  Although nominal load is believed to be similar to the "maximum capacity" as defined by NSPS Burn Rate Category 4, both EPA Method 28 and EN303-05 currently allow the manufacturers to specify the rated output capacity goal for the tests. This may not be a significant difference since most manufacturers use the highest value the heater can achieve for the durations specified in the owner's manual.
It should also be noted that the EWHTS ranked the top performing wood stoves based on the efficiency of the stove and CO emissions (as an indicator of combustion quality), whereas the top performers in the NSPS data are currently ranked solely based on PM emissions (grams per hour).  Therefore, if wood stoves in the EWHTS data have low PM emissions they may still be excluded from the EWHTS "top performers" if they are inefficient or generate high CO emissions from incomplete combustion. Also, it should be noted that forced-air furnaces are not included in the EWHTS because European manufacturers and consumers consider forced-air furnaces to be an inferior technology/system compared to the other systems that can perform better.
Also, note that the efficiencies in the EWHTS tables are for gross combustion values, i.e., using the high heating value of the wood burned rather than the net combustion values, i.e., using lower heating value of the wood as typically advertised in Europe. The NSPS is expected to require testing and reporting of the gross values.


[Federal Register Volume 84, Number 145 (Monday, July 29, 2019)]
[Proposed Rules]
[Pages 36563-36564]
[FR Doc No: 2019-16040]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Part 571

[Docket No. NHTSA-2019-0036]
RIN 2127-AM00

Removing Regulatory Barriers for Vehicles With Automated Driving
Systems; Extension of Comment Period

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation (DOT).

ACTION: Advance notice of proposed rulemaking (ANPRM); Extension of
comment period.

-----------------------------------------------------------------------

SUMMARY: In response to a request from the public, NHTSA is announcing
a 30-day extension of the comment period on the ANPRM on Removing
Regulatory Barriers for Vehicles with Automated Driving Systems. The
comment period for the ANPRM was originally scheduled to end on July
29, 2019. It will now end on August 28, 2019.

DATES: The comment period for the ANPRM published on May 28, 2019 at 84
FR 24433 is extended. Written comments on the ANPRM must be received on
or before August 28, 2019 in order to be considered timely.

ADDRESSES: Comments must be submitted by one of the following methods:
     Federal eRulemaking Portal: go to http://www.regulations.gov. Follow the

online instructions for submitting comments.
     Mail: Docket Management Facility, M-30, U.S. Department of
Transportation, West Building, Ground Floor, Rm. W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery or Courier: West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue SE, between 9 a.m. and 5 p.m. Eastern
Time, Monday through Friday, except Federal holidays.
     Fax:<PHONE_NUMBER>.
    Regardless of how you submit your comments, they must include the
docket number identified in the heading of this notice.
    Not that all comments received, including any personal information
provided, will be posted without change to http://www.regulations.gov.
Please see the ``Privacy Act'' heading below.
    You may call the Docket Management Facility at<PHONE_NUMBER>.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or the street
address listed above. We will continue to file relevant information in
the docket as it becomes available.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (Volume 65, Number 70; Pages 19477-78) or you may visit
http://dms.dot.gov.

FOR FURTHER INFORMATION CONTACT: David Hines, Director, Office of Crash
Avoidance Standards, Telephone:<PHONE_NUMBER>. Facsimile: (202) 366-
7002. Sara Bennett, Attorney-Advisor, Vehicle Rulemaking and
Harmonization, Office of Chief Counsel, Telephone<PHONE_NUMBER>.
Facsimile:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: On May 28, 2019, NHTSA published an ANPRM to
obtain public comments on the near- and long-term challenges of testing
and verifying compliance with existing crash avoidance (100-series)
Federal Motor Vehicle Safety Standards for Automated Driving System-
Dedicated Vehicles that lack traditional manual controls necessary for
a human driver to maneuver the vehicle and other features intended to
facilitate operation of a vehicle by a human driver, but that are
otherwise traditional vehicles with typical seating configurations. The
ANPRM stated that the closing date for comments is July 29, 2019.
    On July 15, 2019, NHTSA received a request from the American Public
Transportation Association (APTA) for a 60-day extension of the comment
period. The request can be found in the docket for the ANPRM identified
in the heading of this notice. NHTSA has considered this request and
believes that a 30-day extension beyond the original due date
appropriately balances NHTSA's interest in providing the public with
sufficient time to comment on the complex and novel questions raised in
the ANPRM, with its interest in safely addressing regulatory barriers
in a timely manner. This is to notify the public that NHTSA is
extending the comment period on the ANPRM, and allowing it to remain
open until August 28, 2019.
    We note that, in addition to requesting an extension of the ANPRM
comment period, APTA also requested NHTSA hold a public meeting or
webinar on the issues raised in the ANPRM. NHTSA is considering whether
to hold a public meeting or webinar on the issues raised in the ANPRM,
and will decide whether to do so once the agency has considered the
comments received during the full extended comment period.

    Authority: Delegation of authority at 49 CFR 1.95 and 501.5.

Heidi Renate King,
Deputy Administrator, National Highway Traffic Safety Administration.
[FR Doc. 2019-16040 Filed 7-26-19; 8:45 am]
 BILLING CODE 4910-59-P


[Federal Register: December 28, 2005 (Volume 70, Number 248)]
[Notices]
[Page 76814-76815]
[DOCID:fr28de05-107]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application To Amend Recreation Plan and Soliciting
Comments, Motions To Intervene, and Protests

December 21, 2005.
    Take notice that the following application has been filed with the
Commission and is available for public inspection:
    a. Application Type: Amendment of License.
    b. Project No.: 7161-053.
    c. Date Filed: October 14, 2005.
    d. Applicant: Douglas County, Oregon.
    e. Name of Project: Galesville Project.
    f. Location: The project is located on Cow Creek in Douglas County,
Oregon. This project occupies federal lands administered by the Bureau
of Land Management.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791 (a) 825(r)
and 799 and 801.

    h. Applicant Contact: Mr. W. Brian Connors, Hydroelectric Plant
Manager, Douglas County Public Works Department, 1036 SE Douglas, Room
219, Roseburg, Oregon 97470,<PHONE_NUMBER>.
    i. FERC Contacts: Any questions on this notice should be addressed
to Mr. Jon Cofrancesco at<PHONE_NUMBER>, or e-mail address:
<EMAIL_ADDRESS>
    j. Deadline for filing comments and or motions: January 23, 2006.
    All documents (original and eight copies) should be filed with: Ms.
Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington DC 20426. Please include the project
number (P-7161-053) on any comments or motions filed. Comments,
protests, and interventions may be filed electronically via the
Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and the
instructions on the Commission's Web site under the ``e-Filing'' link.
The Commission strongly encourages e-filings.
    k. Description of the Application: On October 14, 2005, Douglas
County (licensee) filed an application to amend the project's
recreation plan to provide for a campground adjacent to Galesville
reservoir. Specifically, the licensee proposes to construct a
campground with seven rustic cabin sites and 19 sites for recreational
vehicles on a narrow strip of land between the county road and the
reservoir adjacent to an existing developed picnic area and boat
launch.
    l. Location of the Application: The filing is available for review
at the Commission in the Public Reference Room, located at 888 First
Street, NE., Room 2A, Washington, DC 20426, or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''

link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, please
contact FERC Online support at<EMAIL_ADDRESS>or toll free
(866) 208 3676 or TTY, contact<PHONE_NUMBER>.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210,
385.211, 385.214. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    o. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'', or ``MOTION TO INTERVENE'', as
applicable, and the Project Number of the particular application to
which the filing refers. A copy of any motion to intervene must also be
served upon each representative of the Applicant specified in the
particular application.
    p. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.
    q. Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See, 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site at http://www.ferc.gov

under the ``e-Filing'' link.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-7936 Filed 12-27-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 162 (Wednesday, August 21, 2013)]
[Notices]
[Pages 51719-51721]
[FR Doc No: 2013-19875]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9900-13-ORD; Docket ID No. EPA-HQ-ORD-2011-0391]

Draft Toxicological Review of Benzo[a]pyrene: In Support of the
Summary Information in the Integrated Risk Information System (IRIS)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of public comment period and public meeting.

-----------------------------------------------------------------------

SUMMARY: EPA is announcing a 60-day public comment period for the
external review draft human health assessment titled ``Toxicological
Review of benzo[a]pyrene: In Support of Summary Information on the
Integrated Risk Information System (IRIS)'' (EPA/635/R-13/138) and the
draft peer review charge questions. The draft assessment was prepared
by the National Center for Environmental Assessment (NCEA) within the
EPA Office of Research and Development (ORD). EPA is releasing this
draft assessment and peer review charge questions for the purpose of
public comment. This draft assessment is not final as described in
EPA's information quality guidelines, and it does not represent and
should not be construed to represent Agency policy or views. The draft
assessment will also be discussed at the first bi-monthly IRIS public
meeting scheduled for October 23-24, 2013.

DATES: The public comment period begins, August 21, 2013, and ends
October 21, 2013. Technical comments should be in writing and must be
received by EPA by October 21, 2013.
    Discussion of the draft toxicological review of benzo[a]pyrene will
be included on the agenda of the bi-monthly IRIS public meeting to be
held on October 23-24, 2013, at EPA offices in Arlington, Virginia.
Information on this meeting, including meeting location, time, and
registration and participation procedures are available at the IRIS Web
site (http://www.epa.gov/iris/publicmeeting/).

FOR FURTHER INFORMATION CONTACT: For general information about IRIS
public meetings, please contact Christine Ross, IRIS Staff,
Environmental Protection Agency, National Center for Environmental
Assessment (NCEA), Mail Code 8601P; telephone:<PHONE_NUMBER>; facsimile:
703-347-8689; or<EMAIL_ADDRESS>For information
regarding the subject matter of a specific meeting, please contact the
EPA representative identified on the IRIS public meeting Web site
(http://www.epa.gov/iris/publicmeeting/).

ADDRESSES: The draft ``Toxicological Review of benzo[a]pyrene: In
Support of Summary Information on the Integrated Risk Information
System (IRIS)'' is available primarily via the Internet on the NCEA
home page under the Recent Additions and Publications menus at http://www.epa.gov/ncea. A limited number of paper copies are available from
the Information Management Team, NCEA; telephone:<PHONE_NUMBER>;
facsimile:<PHONE_NUMBER>. If you request a paper copy, please provide
your name, mailing address, and the document title.
    Discussion of the draft toxicological review of benzo[a]pyrene will
be included on the agenda of the bi-monthly IRIS public meeting to be
held on October 23-24, 2013, at EPA offices in Arlington, Virginia.
Detailed information regarding meeting location, time, and registration
and participation procedures will be available at the IRIS Web site
(http://www.epa.gov/iris/publicmeeting/).

SUPPLEMENTARY INFORMATION:

I. Information About IRIS

    EPA's IRIS Program is a human health assessment program that
evaluates quantitative and qualitative risk information on effects that
may result from exposure to chemical substances found in the
environment. Through the IRIS Program, EPA provides the highest quality
science-based human health assessments to support the Agency's
regulatory activities and decisions to protect public health. The IRIS
database contains information for more than 500 chemical substances
that can be used to support the first two steps (hazard identification
and dose-response evaluation) of the human health risk assessment
process. When supported by available data, IRIS provides health effects
information and toxicity values for health effects (including cancer
and effects other than cancer). Government and others combine IRIS
toxicity values with exposure information to characterize public health
risks of chemical substances; this information is then used to support
risk management decisions designed to protect public health.

II. Bi-Monthly Public Meeting

    In addition to the 60-day public comment period announced in this
notice, the draft assessment will be discussed at the first bi-monthly
IRIS public meeting scheduled for October 23-24, 2013. Information on
this meeting, including meeting location, time, and registration and
participation procedures, will be available at the IRIS Web site
(http://www.epa.gov/iris/publicmeeting/). The purpose of the IRIS
public meeting is to allow all interested parties to present scientific
and technical comments on the draft IRIS health assessment and charge
questions to EPA and other interested parties attending the meeting.
The public comments provided in response to this notice, and at the
IRIS public meeting, will be considered by the Agency prior to
submitting the draft assessment to the SAB for peer review.

III. Peer Review

    After consideration of public comments by EPA, the draft assessment
will be sent to the EPA's Science Advisory Board (SAB) Chemical
Assessment Advisory Committee (CAAC) for peer review. The EPA SAB is a
body established under the Federal Advisory Committee Act with a broad
mandate to advise the Agency on scientific matters. The public comment
period and bi-monthly public meeting announced in this notice are
separate processes from the SAB/CAAC peer review. The SAB will schedule
one or more public peer review meetings, which will be announced in a
separate Federal Register Notice at a later date.

IV. How To Submit Technical Comments to the Docket at http://www.regulations.gov

    Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2011-
0391 by one of the following methods:
     http://www.regulations.gov: Follow the on-line
instructions for submitting comments
     Email<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: Office of Environmental Information (OEI) Docket
(Mail Code: 28221T), U.S. Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, DC 20460. The phone number is 202-
566-1752.
     Hand Delivery: The OEI Docket is located in the EPA
Headquarters Docket Center, EPA West Building, Room 3334, 1301
Constitution Ave. NW., Washington, DC. The EPA Docket Center's Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>. Deliveries are only accepted during the
docket's normal hours of operation, and special arrangements should be
made for deliveries of boxed information. If you provide comments by
mail or hand delivery, please submit one unbound original with pages
numbered consecutively, and three copies of the comments. For
attachments, provide an index, number pages consecutively with the
comments, and submit an unbound original and three copies.
    Instructions for submitting comments to the EPA Docket: Direct your
comments to Docket ID No. EPA-HQ-ORD-2011-0391. Please ensure that your
comments are submitted within the specified comment period. Comments
received after the closing date will be marked ``late,'' and may only
be considered if time permits. It is EPA's policy to include all
comments it

receives in the public docket without change and to make the comments
available online at http://www.regulations.gov, including any personal
information provided, unless a comment includes information claimed to
be confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through http://www.regulations.gov or email. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an email comment directly to EPA without
going through http://www.regulations.gov, your email address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to
technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.
    All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the OEI Docket in the
EPA Headquarters Docket Center.

FOR FURTHER INFORMATION CONTACT: For information on the federal docket,
contact the Office of Environmental Information Docket; telephone: 202-
566-1752; facsimile:<PHONE_NUMBER>; or email<EMAIL_ADDRESS>    For information on the bi-monthly IRIS public meeting please
contact Christine Ross, IRIS Staff, National Center for Environmental
Assessment, (8601P), U.S. EPA, 1200 Pennsylvania Avenue NW.,
Washington, DC 20460; telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>;
or email<EMAIL_ADDRESS>    If you have questions about the document, contact Kathleen
Newhouse, National Center for Environmental Assessment (NCEA);
telephone:<PHONE_NUMBER>; facsimile:<PHONE_NUMBER>; or email<EMAIL_ADDRESS>
    Dated: August 15, 2013.
Abdel M. Kadry,
Acting Director, National Center for Environmental Assessment.
[FR Doc. 2013-19875 Filed 8-20-13; 8:45 am]
BILLING CODE 6560-50-P


Comment Info: =================

General Comment:Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they are saving my life. I wish to provide you with my personal story, I used to smoke 1 pack a day and now with the help of e-cigarettes I might smoke  half a pack of regular cigarettes a day. My total count per day is dropping each week with the help of the e-cigarette and i hope to only be vaping by the end of the month. If you take away e-cigarettes what will I have then, I would have to go back to health crunching regular cigarette which I have a hard time quitting without the e-cig.  I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.


[Federal Register Volume 81, Number 85 (Tuesday, May 3, 2016)]
[Rules and Regulations]
[Pages 26466-26468]
[FR Doc No: 2016-09768]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 112

[Docket No. FDA-2011-N-0921]
RIN 0910-AG35

Standards for the Growing, Harvesting, Packing, and Holding of
Produce for Human Consumption; Technical Amendment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is amending a
final rule that published in the Federal Register of November 27, 2015.
That final rule established science-based minimum standards for the
safe growing, harvesting, packing, and holding of produce, meaning
fruits and vegetables grown for human consumption. The rule sets forth
procedures, processes, and practices that minimize the risk of serious
adverse health consequences or death, including those reasonably
necessary to prevent the introduction of known or reasonably
foreseeable biological hazards into or onto produce and to provide
reasonable assurances that the produce is not adulterated on account of
such hazards. FDA established these standards as part of our
implementation of the FDA Food Safety and Modernization Act. The final
rule published with some editorial and inadvertent errors. This
document corrects those errors.

DATES: Effective May 3, 2016.

FOR FURTHER INFORMATION CONTACT: Samir Assar, Center for Food Safety
and Applied Nutrition (HFS-317), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, November
27, 2015 (80 FR 74354), FDA published the final rule ``Standards for
the Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption'' with some editorial and inadvertent errors. This action
is being taken to correct inadvertent errors in the preamble to the
final rule and to improve the accuracy of the provisions added to the
Code of Federal Regulations.
    On page 74357, the table with the heading ``COMPLIANCE DATES'' is
corrected to read as follows:

                                                                    Compliance Dates
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                        Covered activities involving all      Farms eligible for a qualified exemption (if applicable)
                                 Covered activities   other covered produce (i.e., subject -------------------------------------------------------------
                                  involving sprouts      to part 112, except subpart M)
                                    covered under   ---------------------------------------  Compliance date
      Size of covered farm        subpart M (i.e.,     Compliance date                       for retention of   Compliance date     Compliance date for
                                   subject to all        for certain      Compliance date        records          for modified    all other requirements
                                   requirements of        specified        for all other        supporting       requirement in    in Sec.  Sec.   112.6
                                      part 112)      agricultural water     requirements      eligibility in          Sec.               and 112.7
                                                        requirements                         Sec.   112.7(b)      112.6(b)(1)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                   Time periods starting from the effective date of this                                          Time periods starting
                                                            rule                                                                   from the effective
                                                                                date of this rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Very small business............  3 years (January    6 years (January    4 years (January   Effective date of  January 1, 2020..  4 years for farms not
                                  26, 2019).          26, 2022).          26, 2020).         rule (January                         producing sprouts
                                                                                26, 2016).                            (January 26, 2020)/3
                                                                                years for farms
                                                                                producing sprouts
                                                                                (January 26, 2019).
Small business.................  2 years (January    5 years (January    3 years (January   .................  .................  3 years for farms not
                                  26, 2018).          26, 2021).          26, 2019).                                               producing sprouts
                                                                                (January 26, 2019)/2
                                                                                years for farms
                                                                                producing sprouts
                                                                                (January 26, 2018).
All other businesses...........  1 year (January     4 years (January    2 years (January   .................  .................  N/A.
                                  26, 2017).          26, 2020).          26, 2018).
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Section 112.3 is revised to collapse paragraphs (a), (b), and (c)
into a single paragraph.
    The definition of ``farm'' is revised to use the same indent
numbering as in the definition of ``farm'' under 21 CFR 1.227
established in the final rule, ``Current Good Manufacturing Practice,
Hazard Analysis, and Risk-Based Preventive Controls for Human Food''
(80 FR 55908; September 17, 2015).
    The definition of ``covered activity'' is revised to replace the
reference to 21 CFR part 110 with a reference to 21 CFR part 117.
    The definition of ``harvesting'' is revised consistent with the
revision to the definition of ``harvesting'' in Sec.  1.227 as
published in ``Current Good Manufacturing Practice, Hazard Analysis,
and Risk-Based Preventive Controls for Human Food; Technical
Amendment'' (81 FR 3714; January 22, 2016).
    The definition of ``packing'' is revised to remove a duplicative
reference to section 201(r) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321(r)) and to add the term ``re-packing'' in multiple
places, so that the definition is consistent with the definition of
``packing'' in Sec.  117.3 as published in ``Current Good Manufacturing
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human
Food; Technical Amendment'' (81 FR 3714);
    The definitions of ``small business'' and ``very small business''
are revised to remove paragraph references that are no longer needed
due to the rearrangement of Sec.  112.3 into a single section and to
follow the structure of the other definitions in Sec.  112.3.
    In the definition of ``qualified end-user,'' paragraphs (i) and
(ii) are redesignated as paragraphs (1) and (2).
    Section 112.55(b) is revised to add a liquid weight basis for
sampling, consistent with table 18 in the final rule ``Standards for
the Growing, Harvesting, Packing, and Holding of Produce for Human
Consumption'' (80 FR 74354 at 74475) and discussion under Comment 291
in the same document (80 FR 74354 at 74472 to 74473).

List of Subjects in 21 CFR Part 112

    Foods, Fruits and vegetables, Incorporation by reference, Packaging
and containers, Recordkeeping requirements, Safety.

PART 112--STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND
HOLDING OF PRODUCE FOR HUMAN CONSUMPTION

0
1. The authority citation for 21 CFR part 112 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 342, 350h, 371; 42 U.S.C. 243,
264, 271.

0
2. Amend Sec.  112.3 by:
0
a. Removing paragraphs (a) and (b) and (c) introductory text and adding
introductory text;
0
b. In the definition of ``Qualified end-user'', redesignating
paragraphs (i) and (ii) as paragraphs (1) and (2);
0
c. Revising the definitions of ``Covered activity'', ``Farm'',
``Harvesting'', and ``Packing''; and
0
d. Adding in alphabetical order the definitions of ``Small business''
and ``Very small business''.
    The revisions and additions read as follows:

Sec.  112.3  What definitions apply to this part?

    The definitions and interpretations of terms in section 201 of the
Federal Food, Drug, and Cosmetic Act apply to such terms when used in
this part. The following definitions also apply:
* * * * *
    Covered activity means growing, harvesting, packing, or holding
covered produce on a farm. Covered activity includes manufacturing/
processing of covered produce on a farm, but only to the extent that
such activities are performed on raw agricultural commodities and only
to the extent that such activities are within the meaning of ``farm''
as defined in this chapter. Providing, acting consistently with, and
documenting actions taken in compliance with written assurances as
described in Sec.  112.2(b) are also covered activities. This part does
not apply to activities of a facility that are subject to part 117 of
this chapter.
* * * * *
    Farm means:
    (1) Primary production farm. A primary production farm is an
operation under one management in one general (but not necessarily
contiguous) physical location devoted to the growing of crops, the
harvesting of crops, the raising of animals (including seafood), or any
combination of these activities. The term ``farm'' includes operations
that, in addition to these activities:
    (i) Pack or hold raw agricultural commodities;
    (ii) Pack or hold processed food, provided that all processed food
used in such activities is either consumed on that farm or another farm
under the same management, or is processed food identified in paragraph
(1)(iii)(B)(1) of this definition; and
    (iii) Manufacture/process food, provided that:
    (A) All food used in such activities is consumed on that farm or
another farm under the same management; or
    (B) Any manufacturing/processing of food that is not consumed on
that farm or another farm under the same management consists only of:
    (1) Drying/dehydrating raw agricultural commodities to create a
distinct commodity (such as drying/dehydrating grapes to produce
raisins), and packaging and labeling such commodities, without
additional manufacturing/processing (an example of additional
manufacturing/processing is slicing);
    (2) Treatment to manipulate the ripening of raw agricultural
commodities (such as by treating produce with ethylene gas), and
packaging and labeling treated raw agricultural commodities, without
additional manufacturing/processing; and
    (3) Packaging and labeling raw agricultural commodities, when these
activities do not involve additional manufacturing/processing (an
example of additional manufacturing/processing is irradiation); or
    (2) Secondary activities farm. A secondary activities farm is an
operation, not located on a primary production farm, devoted to
harvesting (such as hulling or shelling), packing, and/or holding of
raw agricultural commodities, provided that the primary production
farm(s) that grows, harvests, and/or raises the majority of the raw
agricultural commodities harvested, packed, and/or held by the
secondary activities farm owns, or jointly owns, a majority interest in
the secondary activities farm. A secondary activities farm may also
conduct those additional activities allowed on a primary production
farm as described in paragraphs (1)(ii) and (iii) of this definition.
* * * * *
    Harvesting applies to farms and farm mixed-type facilities and
means activities that are traditionally performed on farms for the
purpose of removing raw agricultural commodities from the place they
were grown or raised and preparing them for use as food. Harvesting is
limited to activities performed on raw agricultural commodities, or on
processed foods created by drying/dehydrating a raw agricultural
commodity without additional manufacturing/processing, on a farm.
Harvesting does not include activities that transform a raw
agricultural commodity into a processed food as defined in section
201(gg) of the Federal Food, Drug, and Cosmetic Act. Examples of
harvesting include cutting (or otherwise separating) the edible portion
of the raw agricultural

commodity from the crop plant and removing or trimming part of the raw
agricultural commodity (e.g., foliage, husks, roots or stems). Examples
of harvesting also include cooling, field coring, filtering, gathering,
hulling, shelling, sifting, threshing, trimming of outer leaves of, and
washing raw agricultural commodities grown on a farm.
* * * * *
    Packing means placing food into a container other than packaging
the food and also includes re-packing and activities performed
incidental to packing or re-packing a food (e.g., activities performed
for the safe or effective packing or re-packing of that food (such as
sorting, culling, grading, and weighing or conveying incidental to
packing or re-packing)), but does not include activities that transform
a raw agricultural commodity into a processed food as defined in
section 201(gg) of the Federal Food, Drug, and Cosmetic Act.
* * * * *
    Small business means a farm that is subject to any of the
requirements of this part and, on a rolling basis, the average annual
monetary value of produce (as defined in this section) the farm sold
during the previous 3-year period is no more than $500,000; and the
farm is not a very small business as defined in this section.
* * * * *
    Very small business means a farm that is subject to any of the
requirements of this part and, on a rolling basis, the average annual
monetary value of produce (as defined in this section) the farm sold
during the previous 3-year period is no more than $250,000.
* * * * *

0
3. In Sec.  112.55, revise paragraph (b) to read as follows:

Sec.  112.55  What microbial standards apply to the treatment processes
in Sec.  112.54?

* * * * *
    (b) Salmonella species are not detected using a method that can
detect three MPN Salmonella species per 4 grams (or milliliter, if
liquid is being sampled) of total solids; and less than 1,000 MPN fecal
coliforms per gram (or milliliter, if liquid is being sampled) of total
solids.

    Dated: April 21, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09768 Filed 5-2-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: December 5, 2005 (Volume 70, Number 232)]
[Rules and Regulations]
[Page 72372-72373]
[DOCID:fr05de05-13]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

17 CFR Parts 229 and 239

[Release Nos. 33-8518A; 34-50905A; File No. S7-21-04]

Asset-Backed Securities

AGENCY: Securities and Exchange Commission.

ACTION: Final rule; technical amendments.

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SUMMARY: This document contains corrections to final rules which were
published in the Federal Register on Friday, January 7, 2005 (70 FR
1506). The rules relate to the registration, disclosure and reporting
requirements for asset-backed securities under the Securities Act of
1933 and the Securities Exchange Act of 1934.

DATES: Effective Date: December 5, 2005. The Compliance Dates are the
same as in Release No. 33-8518.

FOR FURTHER INFORMATION CONTACT: Katherine W. Hsu, Special Counsel,
Office of Rulemaking, at<PHONE_NUMBER>, Division of Corporation
Finance, U.S. Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549.

SUPPLEMENTARY INFORMATION: On December 22, 2004, the Commission adopted
changes to address comprehensively the registration, disclosure, and
reporting requirements for asset-backed securities under the Securities
Act of 1933 (``Securities Act'') and the Securities Exchange Act of
1934.\1\ Items 1100 and 1105 \2\ of Regulation AB \3\ and General
Instruction I.B. to Form S-3 \4\ under the Securities Act in the final
regulations, as published, contain errors that need correction. We are
also correcting language in paragraph 4 of the certification for asset-
backed issuers required by paragraph (b)(31)(ii) of Item 601 \5\ of
Regulation S-K \6\ to conform to the corresponding provisions in Item
1123 \7\ of Regulation AB.
---------------------------------------------------------------------------

    \1\ See Release No. 33-8518 (Dec. 22, 2004) [70 FR 1506].
    \2\ 17 CFR 229.1100 and 17 CFR 229.1105.
    \3\ 17 CFR 229.1100 et seq.
    \4\ 17 CFR 239.13.
    \5\ 17 CFR 229.601.
    \6\ 17 CFR 229.10 et seq.
    \7\ 17 CFR 229.1123.
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Text of Amendments

List of Subjects in 17 CFR Parts 229 and 239

    Reporting and recordkeeping requirements, Securities.

0
In accordance with the foregoing, Title 17, Chapter II of the Code of
Federal Regulations is amended as follows:

PART 229--STANDARD INSTRUCTIONS FOR FILING FORMS UNDER SECURITIES
ACT OF 1933, SECURITIES EXCHANGE ACT OF 1934 AND ENERGY POLICY AND
CONSERVATION ACT OF 1975--REGULATION S-K

0
1. The authority citation for part 229 continues to read in part as
follows:

    Authority: 15 U.S.C. 77e, 77f, 77g, 77h, 77j, 77k, 77s, 77z-2,
77z-3, 77aa(25), 77aa(26), 77ddd, 77eee, 77ggg, 77hhh, 77iii, 77jjj,
77nnn, 77sss, 78c, 78i, 78j, 78l, 78m, 78n, 78o, 78u-5, 78w, 78ll,
78mm, 79e, 79j, 79n, 79t, 80a-8, 80a-9, 80a-20, 80a-29, 80a-30, 80a-
31(c), 80a-37, 80a-38(a), 80a-39, 80b-11, and 7201 et seq.; and 18
U.S.C. 1350, unless otherwise noted.

Sec.  229.601  [Amended]

0
2. Section 229.601 is amended by adding the phrase ``in all material
respects'' after the words ``servicing agreement(s)'' in both places
that those words appear in paragraph (4) of the Certifications section
that follows the introductory language in paragraph (b)(31)(ii).

Sec.  229.1100  [Amended]

0
3. Section 229.1100 is amended by revising the heading to the
instruction to paragraph (c)(2) that reads ``Instruction to Item
1101(c)(2)'' to read ``Instruction to Item 1100(c)(2)''.

Sec.  229.1105  [Amended]

0
4. Section 229.1105 is amended by revising the phrase ``weighted
average initial pool balance'' in the second sentence of paragraph
(a)(3)(iii) to read ``weighted average initial loan balance''.

PART 239--FORMS PRESCRIBED UNDER THE SECURITIES ACT OF 1933

0
5. The authority citation for part 239 continues to read in part as
follows:

    Authority: 15 U.S.C. 77f, 77g, 77h, 77j, 77s, 77z-2, 77sss, 78c,
78l, 78m, 78n, 78o(d), 78u-5, 78w(a), 78ll(d), 79e, 79f, 79g, 79j,
79l, 79m, 79n, 79q, 79t, 80a-8, 80a-24, 80a-26, 80a-29, 80a-30, and
80a-37, unless otherwise noted.

0
6. Form S-3 is amended by revising paragraph (b) of General Instruction
I.B.5. to read as follows:

    Note: The text of Form S-3 does not, and this amendment will
not, appear in the Code of Federal Regulations.

Form S-3

* * * * *
General Instructions
I. Eligibility Requirements for Use of Form S-3
* * * * *

B. Transaction Requirements * * *

5. Offerings of Investment Grade Asset-Backed Securities

    (a) * * *
    (b) Securities relating to an offering of asset-backed securities
registered in accordance with paragraph (a) of this General Instruction
I.B.5 where those securities represent an interest in or the right to
the payments of cash flows of another asset pool and meet the
requirements of Securities Act Rule 190(c)(1) through (4) (17 CFR
230.190(c)(1) through (4)).
* * * * *

    Dated: November 29, 2005.
Jonathan G. Katz,
Secretary.
[FR Doc. 05-23614 Filed 12-2-05; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 79, Number 78 (Wednesday, April 23, 2014)]
[Notices]
[Pages 22693-22694]
[FR Doc No: 2014-09188]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0247]

Food and Drug Administration Transparency Initiative: Increasing
Public Access to the Food and Drug Administration's Compliance and
Enforcement Data; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: As part of the Transparency Initiative, the Food and Drug
Administration (FDA) is announcing the availability of a report
entitled ``Food and Drug Administration Transparency Initiative:
Increasing Public Access to FDA's Compliance and Enforcement

Data.'' This report summarizes findings and recommendations from eight
FDA working groups established to enhance the transparency and public
accessibility of the Agency's compliance and enforcement data.

FOR FURTHER INFORMATION CONTACT: Daniel W. Sigelman, Office of the
Commissioner, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 32, rm. 4254, Silver Spring, MD 20993,<PHONE_NUMBER>, FAX: 301-
847-8616, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a
report entitled ``FDA Transparency Initiative: Increasing Public Access
to FDA's Compliance and Enforcement Data.'' FDA is responsible for a
broad range of compliance and enforcement activities. Increasing the
transparency of these activities enhances the public's understanding of
the Agency's decisions and promotes accountability of the Agency and
the regulated industry.
    On October 3, 2011, FDA issued a report entitled, ``Food and Drug
Administration Transparency Initiative: Draft Proposals for Public
Comment to Increase Transparency by Promoting Greater Access to the
Agency's Compliance and Enforcement Data.'' The report advanced eight
draft proposals for making FDA's publicly available compliance and
enforcement data more accessible and user-friendly (available at:
http://www.fda.gov/downloads/AboutFDA/Transparency/TransparencyInitiative/UCM273145.pdf). Following extensive public
comment on the report and internal FDA deliberation, the FDA
Commissioner adopted all eight draft proposals, committing FDA to
exploring numerous avenues for increasing the transparency and public
accessibility of its compliance and enforcement data (see 77 FR 5027,
February 1, 2012, and http://www.fda.gov/AboutFDA/Transparency/TransparencyInitiative/ucm289638.htm).
    To develop plans for addressing the eight initiatives, FDA
established eight working groups with representatives from all of FDA's
centers and several of its offices. Each group was asked to draft a
report on its initiative and to include recommendations for moving
forward. These efforts culminated in the preparation of this report,
which summarizes the eight initiatives and the recommendations from the
relevant working groups for enhancing the transparency and public
accessibility of FDA's compliance and enforcement data.

    Dated: April 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09188 Filed 4-22-14; 8:45 am]
BILLING CODE 4164-01-P