Nexira; Filing of Food Additive Petition; Amendment, 53801-53802 [2012-21639]
Download as PDF
<![CDATA[
sroberts on DSK5SPTVN1PROD with PROPOSALS
Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Proposed Rules
a warning. Because individual magnets
are easily shared among children, many
end users of the product are likely to
have had no exposure to any warning.
Unreasonable risk. As noted
previously, we have determined that an
estimated 1,700 ingestions of magnets
from magnet sets were treated in
emergency departments during the
period from January 1, 2009 to
December 31, 2011. Injuries resulting
from such ingestions of magnets can be
severe and life-threatening. The risk
posed by these magnets may not be
appreciated by caregivers and children,
as they may assume, mistakenly, that
the consequences of ingesting magnets
would be similar to ingesting any other
small object. However, once ingested,
these strong magnets are mutually
attracted to each other and exert
compression forces on the trapped
gastrointestinal tissue.
We estimate that the societal costs of
resulting injuries could amount to $25
million annually. This would be the
expected benefits that could result from
the proposed rule. The costs of the
proposed rule would consist of the lost
profits of firms that produce and sell
magnet sets, plus the lost use value that
consumers would experience when the
product is no longer available. We
estimate these costs to be about $7.5
million in lost profits and some
unknown quantity of lost utility.
Considering the injuries associated with
magnet sets and the resulting societal
costs, balanced against the likely impact
that the proposed rule would have on
firms producing and selling the product,
and the impact on consumers who
would lose the utility of the product, we
conclude, preliminarily, that magnet
sets pose an unreasonable risk of injury.
Additionally, we conclude that the
proposed rule is reasonably necessary to
reduce that risk.
Public interest. This proposed rule is
in the public interest because it may
reduce magnet-related deaths and
injuries in the future. A rule prohibiting
certain magnet sets from the chain of
commerce will mean that children will
have less access to this product, thereby
reducing the number of incidents of
children swallowing the magnets and
the resulting cost to society of treating
these injuries.
Voluntary standards. Currently, there
is no voluntary standard for magnetic
sets. A group of magnet set importers
and distributors have requested the
formation of a voluntary standard by
ASTM International for the labeling and
marketing of these products. The
companies have requested the formation
of a voluntary standard to: (1) Provide
for appropriate warnings and labeling
VerDate Mar<15>2010
16:15 Aug 31, 2012
Jkt 226001
on packages of these magnet sets, and
(2) establish guidelines for restricting
the sale of these magnet sets to, or for
the use of children, such as by not
selling to stores that sell children’s
products exclusively, and by not selling
magnet sets in proximity to children’s
products. Such a voluntary standard
would have many of the same
limitations as a labeling standard.
Relationship of benefits to costs.
Based on reports to the CPSC, ingestions
of small magnets contained in magnet
sets have caused multiple, high severity
injuries that require surgery to remove
the magnets and repair internal damage.
Although there is some uncertainty
concerning the benefits that would
result from the proposed rule, we
estimate that benefits of the rule might
amount to about $25 million annually.
The costs of the proposed rule, in terms
of reduced profits for firms and lost
utility by consumers, are also uncertain.
However, based on annual estimates
available for the 2009–2011 study
period, these costs could amount to
about $7.5 million in lost profits and
some unknown quantity of lost utility.
We believe that there would be a
reasonable relationship between the
anticipated benefits and costs of the
proposed rule.
Least burdensome requirement. We
have considered several alternatives to
the proposed rule prohibiting certain
magnet sets. We conclude that none of
these alternatives would adequately
reduce the risk of injury. Alternative
performance requirements might allow a
different flux index for magnets
contained in magnetic sets.
Theoretically, this might allow some
current products to continue to be
produced. However, it is unclear
whether a different flux index would
permit products that have the desired
physical qualities to make them
enjoyable to adults would reduce
adequately the characteristics that make
these strong magnets hazardous to
children. Some type of special storage
containers or other packaging
requirements might be possible.
However, it is unlikely that consumers
would use such containers, particularly
if they wish to keep the magnets out of
the container and maintain whatever
shape they have constructed with the
magnets. We have considered the
possibility of requiring rigorous
warnings on the products or in the
instructions for the products. However,
magnet sets currently on the market
provide warnings concerning the
potential hazard to children. It is
unlikely that even strengthened
warnings would substantially reduce
the incidence of magnet ingestions. This
PO 00000
Frm 00023
Fmt 4702
Sfmt 4702
53801
is particularly true for incidents
involving older children and
adolescents. Moreover, children who are
old enough to understand the warnings
still may not abide by them. Some type
of sales restriction limiting the location
where magnet sets could be sold might
be possible. However, even with
restrictions on sales, ingestions are still
likely to occur as children encounter
these magnets in the home, at school, or
in other locations when adults have
bought them and they are available to
children. Finally, the Commission could
continue to address the hazard from
magnet sets through corrective actions,
i.e., recalls of the product. However,
such action would do nothing to
prevent additional companies from
continuing to enter the market and
import magnet sets into the country.
The Commission has the option of
taking no regulatory action. Although it
is possible that, with increased
awareness of the hazard over time, some
reduction in ingestions could occur, the
magnitude of any such reduction in
incidents is uncertain and would likely
be smaller than if the Commission
issues the proposed rule.
Dated: August 28, 2012.
Todd A. Stevenson,
Secretary, U.S. Consumer Product Safety
Commission.
[FR Doc. 2012–21608 Filed 8–31–12; 8:45 am]
BILLING CODE 6355–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 172
[Docket No. FDA–2011–F–0765]
Nexira; Filing of Food Additive
Petition; Amendment
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of petition.
The Food and Drug
Administration (FDA) is amending the
filing notice for a food additive petition
filed by Nexira proposing that the food
additive regulations be amended to
provide for the expanded safe use of
acacia gum (gum arabic) in foods.
DATES: Submit either electronic or
written comments on the petitioner’s
environmental assessment by October 4,
2012.
ADDRESSES: Submit electronic
comments to https://www.regulations.
gov. Submit written comments to the
Division of Dockets Management (HFA–
SUMMARY:
E:\FR\FM\04SEP1.SGM
04SEP1
53802
Federal Register / Vol. 77, No. 171 / Tuesday, September 4, 2012 / Proposed Rules
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Ellen Anderson, Center for Food Safety
and Applied Nutrition (HFS–265), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740–
3835, 240–402–1309.
In a notice
published in the Federal Register on
December 20, 2011 (76 FR 78866), FDA
announced that a food additive petition
(FAP 1A4784) had been filed by Nexira,
c/o Keller and Heckman LLP, 1001 G St.
NW., Suite 500 West, Washington, DC
20001. The petition proposes to amend
the food additive regulations in
§ 172.780 Acacia (gum arabic) (21 CFR
172.780) to provide for the expanded
safe use of acacia gum (gum arabic) in
food.
Under 21 CFR 171.1(c)(H), either a
claim of categorical exclusion under 21
CFR 25.30 or § 25.32 (21 CFR 25.32) or
an environmental assessment under 21
CFR 25.40 is required to be submitted in
a food additive petition. A claim of
categorical exclusion under § 25.32(k)
was submitted with the petition, which
applies to substances added directly to
food that are intended to remain in food
through ingestion by consumers and
that are not intended to replace
macronutrients in food. The Agency
reviewed the claim of categorical
exclusion submitted by the petitioner
and stated in the original filing notice
its determination that, under § 25.32(k),
the proposed action was of a type that
does not individually or cumulatively
have a significant effect on the human
environment, and therefore, neither an
environmental assessment nor an
environmental impact statement is
required.
However, upon further review of the
petition, the Agency has decided that
the food additive may act to replace
macronutrients in food and, therefore,
the categorical exclusion in § 25.32(k) is
not applicable for the proposed action.
The Agency informed the petitioner of
this decision, who subsequently
submitted an environmental assessment.
The potential environmental impact
of this petition is being reviewed. To
encourage public participation
consistent with regulations issued under
the National Environmental Policy Act
(40 CFR 1501.4(b)), the Agency is
placing the environmental assessment
submitted with the petition that is the
subject of this notice on public display
at the Division of Dockets Management
(see DATES and ADDRESSES) for public
review and comment.
sroberts on DSK5SPTVN1PROD with PROPOSALS
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
16:15 Aug 31, 2012
Jkt 226001
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. 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.
FDA will also place on public display
any amendments to, or comments on,
the petitioner’s environmental
assessment without further
announcement in the Federal Register.
If, based on its review, the Agency finds
that an environmental impact statement
is not required, and this petition results
in a regulation, the notice of availability
of the Agency’s finding of no significant
impact and the evidence supporting that
finding will be published with the
regulation in the Federal Register in
accordance with 21 CFR 25.51(b).
Dated: August 28, 2012.
Dennis M. Keefe,
Director, Office of Food Additive Safety,
Center for Food Safety and Applied Nutrition.
[FR Doc. 2012–21639 Filed 8–31–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF TRANSPORTATION
Federal Highway Administration
23 CFR Part 172
[FHWA Docket No. FHWA–2012–0043]
RIN 2125–AF44
Procurement, Management, and
Administration of Engineering and
Design Related Services
Federal Highway
Administration (FHWA), U.S.
Department of Transportation (DOT).
ACTION: Notice of proposed rulemaking
(NPRM); request for comments.
AGENCY:
The FHWA proposes to
update the regulations governing the
procurement, management, and
administration of engineering and
design related services directly related
to a highway construction project and
reimbursed with Federal-aid highway
program (FAHP) funding. The intent is
to make the regulations consistent with
prior changes in legislation and other
applicable regulations. These revisions
also address certain findings and
recommendations for the oversight of
consultant services contained in
national review and audit reports.
DATES: Comments must be received on
or before November 5, 2012. Late
SUMMARY:
PO 00000
Frm 00024
Fmt 4702
Sfmt 4702
comments will be considered to the
extent practicable.
ADDRESSES: Mail or hand deliver
comments to the U.S. Department of
Transportation, Dockets Management
Facility, Room W12–140, 1200 New
Jersey Avenue SE., Washington, DC
20590, or submit electronically at
https://www.regulations.gov or fax
comments to (202) 493–2251. All
comments should include the docket
number that appears in the heading of
this document. All comments received
will be available for examination and
copying at the above address from 9
a.m. to 5 p.m., e.t., Monday through
Friday, except Federal holidays. Those
desiring notification of receipt of
comments must include a selfaddressed, stamped postcard or you
may print the acknowledgment page
that appears after submitting comments
electronically. You may review DOT’s
complete Privacy Act Statement in the
Federal Register published on April 11,
2000 (Volume 65, Number 70, Page
19477–78), or you may visit https://
dms.dot.gov.
FOR FURTHER INFORMATION CONTACT: Mr.
Jon Obenberger, Preconstruction Team
Leader, FHWA Office of Program
Administration, (202) 366–2221, or via
email at jon.obenberger@dot.gov, or Mr.
Steven Rochlis, Attorney Advisor,
FHWA Office of the Chief Counsel,
(202) 366–1395, or via email at
steve.rochlis@dot.gov. Office hours for
the FHWA are from 8 a.m. to 4:30 p.m.,
e.t., Monday through Friday, except
Federal holidays.
SUPPLEMENTARY INFORMATION:
Electronic Access and Filing
This document and all comments
received may be viewed online through
the Federal eRulemaking portal at:
https://www.regulations.gov. The Web
site is available 24 hours each day, 366
days this year. Please follow the
instructions. Electronic submission and
retrieval help and guidelines are
available under the help section of the
Web site.
An electronic copy of this document
may also be downloaded by accessing
the Office of the Federal Register’s home
page at: https://www.archives.gov/
federal-register/, or the Government
Printing Office’s Web page at: https://
www.gpo.gov/fdsys.
Background
The FHWA proposes to modify
existing regulations for the
administration of engineering and
design related service contracts to
ensure consistency and compliance
with prior changes in authorizing
E:\FR\FM\04SEP1.SGM
04SEP1
]]>Agencies
[Federal Register Volume 77, Number 171 (Tuesday, September 4, 2012)]
[Proposed Rules]
[Pages 53801-53802]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-21639]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 172
[Docket No. FDA-2011-F-0765]
Nexira; Filing of Food Additive Petition; Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of petition.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the filing
notice for a food additive petition filed by Nexira proposing that the
food additive regulations be amended to provide for the expanded safe
use of acacia gum (gum arabic) in foods.
DATES: Submit either electronic or written comments on the petitioner's
environmental assessment by October 4, 2012.
ADDRESSES: Submit electronic comments to https://www.regulations.gov.
Submit written comments to the Division of Dockets Management (HFA-
[[Page 53802]]
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ellen Anderson, Center for Food Safety
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1309.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register on December 20, 2011 (76 FR 78866), FDA announced that a food
additive petition (FAP 1A4784) had been filed by Nexira, c/o Keller and
Heckman LLP, 1001 G St. NW., Suite 500 West, Washington, DC 20001. The
petition proposes to amend the food additive regulations in Sec.
172.780 Acacia (gum arabic) (21 CFR 172.780) to provide for the
expanded safe use of acacia gum (gum arabic) in food.
Under 21 CFR 171.1(c)(H), either a claim of categorical exclusion
under 21 CFR 25.30 or Sec. 25.32 (21 CFR 25.32) or an environmental
assessment under 21 CFR 25.40 is required to be submitted in a food
additive petition. A claim of categorical exclusion under Sec.
25.32(k) was submitted with the petition, which applies to substances
added directly to food that are intended to remain in food through
ingestion by consumers and that are not intended to replace
macronutrients in food. The Agency reviewed the claim of categorical
exclusion submitted by the petitioner and stated in the original filing
notice its determination that, under Sec. 25.32(k), the proposed
action was of a type that does not individually or cumulatively have a
significant effect on the human environment, and therefore, neither an
environmental assessment nor an environmental impact statement is
required.
However, upon further review of the petition, the Agency has
decided that the food additive may act to replace macronutrients in
food and, therefore, the categorical exclusion in Sec. 25.32(k) is not
applicable for the proposed action. The Agency informed the petitioner
of this decision, who subsequently submitted an environmental
assessment.
The potential environmental impact of this petition is being
reviewed. To encourage public participation consistent with regulations
issued under the National Environmental Policy Act (40 CFR 1501.4(b)),
the Agency is placing the environmental assessment submitted with the
petition that is the subject of this notice on public display at the
Division of Dockets Management (see DATES and ADDRESSES) for public
review and comment.
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. 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. FDA will
also place on public display any amendments to, or comments on, the
petitioner's environmental assessment without further announcement in
the Federal Register. If, based on its review, the Agency finds that an
environmental impact statement is not required, and this petition
results in a regulation, the notice of availability of the Agency's
finding of no significant impact and the evidence supporting that
finding will be published with the regulation in the Federal Register
in accordance with 21 CFR 25.51(b).
Dated: August 28, 2012.
Dennis M. Keefe,
Director, Office of Food Additive Safety, Center for Food Safety and
Applied Nutrition.
[FR Doc. 2012-21639 Filed 8-31-12; 8:45 am]
BILLING CODE 4160-01-P
