Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm; Availability; Reopening of the Comment Period, 15894-15895 [2013-05730]
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15894
Federal Register / Vol. 78, No. 49 / Wednesday, March 13, 2013 / Proposed Rules
emcdonald on DSK67QTVN1PROD with PROPOSALS
thermal shock that may occur from
water, sleet, snow, soldering, or
welding.
III. Comparison Methodology
In the 2008 analysis, DOE reviewed
each of the five sets of shipment data
that were collected in consultation with
NEMA and applied two curve fits to
generate unit sales estimates for the five
lamp types after calendar year 2006.
One curve fit applied a linear regression
to the historical data and extended that
line into the future. The other curve fit
applied an exponential growth function
to the shipment data and projected unit
sales into the future. For this
calculation, linear regression treats the
year as a dependent variable and
shipments as the independent variable.
The linear regression curve fit is
modeled by minimizing the differences
among the data points and the best
curve-fit linear line using the least
squares function.5 The exponential
curve fit is also a regression function
and uses the same least squares function
to find the best fit. For some data sets,
an exponential curve provides a better
characterization of the historical data,
and, therefore, a better projection of the
future data.
For 3-way incandescent lamps, 2,601–
3,300 lumen general service
incandescent lamps, and shatterresistant lamps, DOE found that the
linear regression and exponential
growth curve fits produced nearly the
same estimates of unit sales (i.e., the
difference between the two forecasted
values was less than 1 or 2 percent).
However, for rough service and
vibration service lamps, the linear
regression curve fit projected lamp unit
sales would decline to zero for both
lamp types by 2018. In contrast, the
exponential growth curve fit projected a
more gradual decline in unit sales, such
that lamps would still be sold beyond
2018, and it was, therefore, considered
the more realistic forecast. While DOE
was satisfied that either the linear
regression or exponential growth
spreadsheet model generated a
reasonable benchmark unit sales
estimate for 3-way incandescent lamps,
2,601–3,300 lumen general service
incandescent lamps, and shatterresistant lamps, DOE selected the
exponential growth curve fit for these
lamp types for consistency with the
selection made for rough service and
5 The least squares function is an analytical tool
that DOE uses to minimize the sum of the squared
residual differences between the actual historical
data points and the modeled value (i.e., the linear
curve fit). In minimizing this value, the resulting
curve fit will represent the best fit possible to the
data provided.
VerDate Mar<15>2010
14:48 Mar 12, 2013
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vibration service lamps.6 DOE examines
the benchmark unit sales estimates and
actual sales for each of the five lamp
types in the following section and also
makes the comparisons available in a
spreadsheet online: https://
www1.eere.energy.gov/buildings/
appliance_standards/product.aspx/
productid/63.
IV. Comparison Results
A. Rough Service Lamps
For rough service lamps, the
exponential growth forecast projected
the benchmark unit sales estimate for
2012 to be 5,780,000 units. The NEMAprovided shipment data reported
shipments of 6,045,000 rough service
lamps in 2012. As this finding exceeds
the estimate by only 4.6 percent, DOE
will continue to track rough service
lamp sales data and will not initiate
regulatory action for this lamp type at
this time.
B. Vibration Service Lamps
For vibration service lamps, the
exponential growth forecast projected
the benchmark unit sales estimate for
2012 to be 3,019,000 units. The NEMAprovided shipment data reported
shipments of 1,077,000 vibration service
lamps in 2012. As this finding is only
35.7 percent of the estimate, DOE will
continue to track vibration service lamp
sales data and will not initiate
regulatory action for this lamp type at
this time.
C. Three-Way Incandescent Lamps
For 3-way incandescent lamps, the
exponential growth forecast projected
the benchmark unit sales estimate for
2012 to be 50,131,000 units. The NEMAprovided shipment data reported
shipments of 28,854,000 3-way
incandescent lamps in 2012. As this
finding is only 57.6 percent of the
estimate, DOE will continue to track 3way incandescent lamp sales data and
will not initiate regulatory action for
this lamp type at this time.
D. 2,601–3,300 Lumen General Service
Incandescent Lamps
For 2,601–3,300 lumen general
service incandescent lamps, the
exponential growth forecast projected
the benchmark unit sales estimate for
2012 to be 33,979,000 units. The NEMAprovided shipment data reported
shipments of 12,373,000 2,601–3,300
lumen general service incandescent
lamps in 2012. As this finding is 36.4
6 This selection is consistent with the 2010 and
2011 comparisons. See DOE’s 2008 forecast
spreadsheet models of the lamp types for greater
detail of the estimates.
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percent of the estimate, DOE will
continue to track 2,601–3,300 lumen
general service incandescent lamp sales
data and will not initiate regulatory
action for this lamp type at this time.
E. Shatter-Resistant Lamps
For shatter-resistant lamps, the
exponential growth forecast projected
the benchmark unit sales estimate for
2012 to be 1,663,000 units. The NEMAprovided shipment data reported
shipments of 1,455,000 shatter-resistant
lamps in 2012. As this finding is only
87.5 percent of the estimate, DOE will
continue to track shatter-resistant lamp
sales data and will not initiate
regulatory action for this lamp type at
this time.
V. Conclusion
None of the shipments for rough
service lamps, vibration service lamps,
3-way incandescent lamps, 2,601–3,300
lumen general service incandescent
lamps, or shatter-resistant lamps crossed
the statutory threshold for a standard.
DOE will monitor the situation for these
five currently exempted lamp types and
will reassess 2013 sales by March 31,
2014, in order to determine whether an
energy conservation standards
rulemaking is required, consistent with
42 U.S.C. 6295(l)(4)(D)–(H).
Issued in Washington, DC, on March 5,
2013.
Kathleen B. Hogan,
Deputy Assistant Secretary for Energy
Efficiency, Energy Efficiency and Renewable
Energy.
[FR Doc. 2013–05770 Filed 3–12–13; 8:45 am]
BILLING CODE 6450–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 117
[Docket No. FDA–2012–N–1258]
Draft Qualitative Risk Assessment of
Risk of Activity/Food Combinations for
Activities (Outside the Farm Definition)
Conducted in a Facility Co-Located on
a Farm; Availability; Reopening of the
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notification; reopening of the
comment period.
ACTION:
The Food and Drug
Administration (FDA or ‘‘we’’) is
reopening the comment period for a
document entitled ‘‘Draft Qualitative
Risk Assessment of Risk of Activity/
SUMMARY:
E:\FR\FM\13MRP1.SGM
13MRP1
Federal Register / Vol. 78, No. 49 / Wednesday, March 13, 2013 / Proposed Rules
Food Combinations for Activities
(Outside the Farm Definition)
Conducted in a Facility Co-Located on
a Farm’’ (the draft RA) that we made
available for public comment in the
Federal Register of January 16, 2013.
We are reopening the comment period
to update comments and to receive any
new information.
Submit either electronic or
written comments by May 16, 2013.
DATES:
Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Jenny Scott, Center for Food Safety and
Applied Nutrition (HFS–300), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–2166.
SUPPLEMENTARY INFORMATION:
emcdonald on DSK67QTVN1PROD with PROPOSALS
I. Background
In the Federal Register of January 16,
2013 (78 FR 3824), we published a
notification with a 30-day comment
period announcing the availability of,
and requesting comment on, a
document entitled ‘‘Draft Qualitative
Risk Assessment of Risk of Activity/
Food Combinations for Activities
(Outside the Farm Definition)
Conducted in a Facility Co-Located on
a Farm.’’ The purpose of the draft RA is
to provide a science-based risk analysis
of those activity/food combinations that
would be considered low risk. We
conducted this draft RA to satisfy
requirements of the FDA Food Safety
Modernization Act (FSMA) to conduct a
science-based risk analysis and to
consider the results of that analysis in
rulemaking that is required by FSMA. In
the Federal Register of January 16, 2013
(78 FR 3646), we announced that we
had used the results of the draft RA to
propose to exempt certain food facilities
(i.e., those that are small or very small
businesses that are engaged only in
specific types of onfarm manufacturing,
processing, packing, or holding
activities identified in the draft RA as
low-risk activity/food combinations)
from the proposed requirements of the
Federal Food, Drug, and Cosmetic Act
for hazard analysis and risk-based
preventive controls (the proposed
preventive controls rule). Interested
persons were originally given until
February 15, 2013, to comment on the
draft RA.
VerDate Mar<15>2010
14:48 Mar 12, 2013
Jkt 229001
II. Request for Comments
Following publication of the
notification announcing the availability
of, and requesting comment on, the draft
RA, we received three requests to allow
interested persons additional time to
comment. The requesters asserted that
the time period of 30 days was
insufficient to respond fully to FDA’s
specific requests for comments and to
allow potential respondents to
thoroughly evaluate and address
pertinent issues. Two requesters
considered that the comment period for
the draft RA should conform to the
comment period of the proposed
preventive controls rule. (One of these
requesters further requested that the
comment period conform to that of
another proposed rule published in the
Federal Register of January 16, 2013 (78
FR 3504; the proposed produce safety
rule) and other major rulemakings that
FDA would be conducting under FSMA
but were not yet published.) For similar
reasons, another requestor considered
that the comment period should be
extended by another 120 days, to June
14, 2013.
We have considered the requests and
are reopening the comment period for
the draft RA until May 16, 2013, which
conforms to the comment periods of the
proposed preventive controls rule and
the proposed produce safety rule. We
believe that this extension allows
adequate time for interested persons to
submit comments without significantly
delaying the associated rulemaking in
the proposed preventive controls rule.
III. How To Submit Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
Dated: March 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–05730 Filed 3–12–13; 8:45 am]
BILLING CODE 4160–01–P
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15895
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R04–OAR–2009–0140; FRL–9789–6]
Approval and Promulgation of Air
Quality Implementation Plans: North
Carolina; Control Techniques
Guidelines and Reasonably Available
Control Technology
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA is proposing to approve
several State Implementation Plan (SIP)
revisions submitted to EPA by the State
of North Carolina, through the North
Carolina Department of Environment
and Natural Resources (NC DENR), to
address the nitrogen oxides (NOx)
reasonably available control technology
(RACT) requirements for the North
Carolina portion of the CharlotteGastonia-Rock Hill, North CarolinaSouth Carolina 1997 8-hour ozone
nonattainment area (hereafter referred to
as the ‘‘bi-state Charlotte Area’’). The bistate Charlotte Area for the 1997 8-hour
ozone national ambient air quality
standards (NAAQS) includes six full
counties and one partial county in
North Carolina; and one partial county
in South Carolina. Additionally, EPA is
proposing to approve in part, and
conditionally approve in part, several
SIP revisions to address the volatile
organic compounds (VOC) RACT
requirements which include related
control technology guidelines (CTG)
requirements. Together, these SIP
revisions establish the RACT
requirements for sources located in the
North Carolina portion of the bi-state
Charlotte Area. In a separate
rulemaking, EPA has already taken
action on RACT and CTG requirements
for the South Carolina portion of the bistate Charlotte Area. EPA has evaluated
the proposed revisions to North
Carolina’s SIP, and has made the
preliminary determination that they are
consistent, with the exception of
applicability for some CTG VOC
sources, with statutory and regulatory
requirements and EPA guidance.
DATES: Comments must be received on
or before April 12, 2013.
ADDRESSES: Submit your comments,
identified by Docket ID No. EPA–R04–
OAR–2009–0140 by one of the following
methods:
1. www.regulations.gov: Follow the
on-line instructions for submitting
comments.
2. Email: R4–RDS@epa.gov.
SUMMARY:
E:\FR\FM\13MRP1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 49 (Wednesday, March 13, 2013)]
[Proposed Rules]
[Pages 15894-15895]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-05730]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 117
[Docket No. FDA-2012-N-1258]
Draft Qualitative Risk Assessment of Risk of Activity/Food
Combinations for Activities (Outside the Farm Definition) Conducted in
a Facility Co-Located on a Farm; Availability; Reopening of the Comment
Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification; reopening of the comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or ``we'') is reopening
the comment period for a document entitled ``Draft Qualitative Risk
Assessment of Risk of Activity/
[[Page 15895]]
Food Combinations for Activities (Outside the Farm Definition)
Conducted in a Facility Co-Located on a Farm'' (the draft RA) that we
made available for public comment in the Federal Register of January
16, 2013. We are reopening the comment period to update comments and to
receive any new information.
DATES: Submit either electronic or written comments by May 16, 2013.
ADDRESSES: Submit electronic comments to https://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Jenny Scott, Center for Food Safety
and Applied Nutrition (HFS-300), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740, 240-402-2166.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 16, 2013 (78 FR 3824), we
published a notification with a 30-day comment period announcing the
availability of, and requesting comment on, a document entitled ``Draft
Qualitative Risk Assessment of Risk of Activity/Food Combinations for
Activities (Outside the Farm Definition) Conducted in a Facility Co-
Located on a Farm.'' The purpose of the draft RA is to provide a
science-based risk analysis of those activity/food combinations that
would be considered low risk. We conducted this draft RA to satisfy
requirements of the FDA Food Safety Modernization Act (FSMA) to conduct
a science-based risk analysis and to consider the results of that
analysis in rulemaking that is required by FSMA. In the Federal
Register of January 16, 2013 (78 FR 3646), we announced that we had
used the results of the draft RA to propose to exempt certain food
facilities (i.e., those that are small or very small businesses that
are engaged only in specific types of onfarm manufacturing, processing,
packing, or holding activities identified in the draft RA as low-risk
activity/food combinations) from the proposed requirements of the
Federal Food, Drug, and Cosmetic Act for hazard analysis and risk-based
preventive controls (the proposed preventive controls rule). Interested
persons were originally given until February 15, 2013, to comment on
the draft RA.
II. Request for Comments
Following publication of the notification announcing the
availability of, and requesting comment on, the draft RA, we received
three requests to allow interested persons additional time to comment.
The requesters asserted that the time period of 30 days was
insufficient to respond fully to FDA's specific requests for comments
and to allow potential respondents to thoroughly evaluate and address
pertinent issues. Two requesters considered that the comment period for
the draft RA should conform to the comment period of the proposed
preventive controls rule. (One of these requesters further requested
that the comment period conform to that of another proposed rule
published in the Federal Register of January 16, 2013 (78 FR 3504; the
proposed produce safety rule) and other major rulemakings that FDA
would be conducting under FSMA but were not yet published.) For similar
reasons, another requestor considered that the comment period should be
extended by another 120 days, to June 14, 2013.
We have considered the requests and are reopening the comment
period for the draft RA until May 16, 2013, which conforms to the
comment periods of the proposed preventive controls rule and the
proposed produce safety rule. We believe that this extension allows
adequate time for interested persons to submit comments without
significantly delaying the associated rulemaking in the proposed
preventive controls rule.
III. How To Submit Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
Dated: March 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05730 Filed 3-12-13; 8:45 am]
BILLING CODE 4160-01-P
