Requirements for Child-Resistant Packaging: Products Containing Specified Imidazolines Equivalent to 0.08 Milligrams or More; Extension of Stay of Enforcement, 69044-69046 [2014-27378]
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Federal Register / Vol. 79, No. 224 / Thursday, November 20, 2014 / Rules and Regulations
(a) Response required. A response is
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reporting requirements of the BE–10,
Benchmark Survey of U.S. Direct
Investment Abroad—2014, contained
herein, whether or not they are
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about reporting in this survey, either by
sending them a report form or by
written inquiry, must respond in writing
pursuant this section. This may be
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(1) Certifying in writing, by the due
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(3) Filing the properly completed BE–
10 report (comprising Form BE–10A and
Form(s) BE–10B, BE–10C, and/or BE–
10D) by May 29, 2015, or June 30, 2015,
as required.
(b) Who must report. (1) A BE–10
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person is a U.S. Reporter in this survey.
(3) Reports are required even if the
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inactivated during the U.S. person’s
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(4) The amount and type of data
required to be reported vary according
to the size of the U.S. Reporters or
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affiliates, whether they are majorityowned or minority-owned by U.S. direct
investors. For purposes of the BE–10
survey, a ‘‘majority-owned’’ foreign
affiliate is one in which the combined
direct and indirect ownership interest of
all U.S. parents of the foreign affiliate
exceeds 50 percent; all other affiliates
are referred to as ‘‘minority-owned’’
affiliates.
(c) Forms to be filed. (1) Form BE–10A
must be completed by a U.S. Reporter.
If the U.S. Reporter is a corporation,
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13:14 Nov 19, 2014
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Form BE–10A is required to cover the
fully consolidated U.S. domestic
business enterprise. It must also file
Form(s) BE–10B, C, and/or D for its
foreign affiliates, whether held directly
or indirectly.
(2) Form BE–10B must be filed for
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operating revenues excluding sales
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year.
(3) Form BE–10C must be filed:
(i) For each majority-owned foreign
affiliate for which any one of the three
items listed in paragraph (c)(2) of this
section was greater than $25 million but
for which none of these items was
greater than $80 million (positive or
negative), at any time during the
affiliate’s 2014 fiscal year, and
(ii) For each minority-owned foreign
affiliate for which any one of the three
items listed in (c)(2) of this section was
greater than $25 million (positive or
negative), at any time during the
affiliate’s 2014 fiscal year.
(4) Form BE–10D must be filed for
majority- or minority-owned foreign
affiliates for which none of the three
items listed in paragraph (c)(2) of this
section was greater than $25 million
(positive or negative) at any time during
the affiliate’s 2014 fiscal year. Form BE–
10D is a schedule; a U.S. Reporter
would submit one or more pages of the
form depending on the number of
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(d) Due date. A fully completed and
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BE–10A and Form(s) BE–10B, C, and/or
D (as required) is due to be filed with
BEA not later than May 29, 2015, for
those U.S. Reporters filing fewer than
50, and June 30, 2015, for those U.S.
Reporters filing 50 or more, foreign
affiliate Forms BE–10B, C, and/or D. If
the U.S. person had no foreign affiliates
during its 2014 fiscal year, it must file
a BE–10 Claim for Not Filing by May 29,
2015.
[FR Doc. 2014–27421 Filed 11–19–14; 8:45 am]
BILLING CODE 3510–06–P
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CONSUMER PRODUCT SAFETY
COMMISSION
16 CFR Part 1700
[CPSC Docket No. CPSC–2012–0005]
Requirements for Child-Resistant
Packaging: Products Containing
Specified Imidazolines Equivalent to
0.08 Milligrams or More; Extension of
Stay of Enforcement
Consumer Product Safety
Commission.
ACTION: Extension of stay of
enforcement.
AGENCY:
This document announces the
Commission’s decision to extend the
conditional stay of enforcement of
special packaging requirements for overthe-counter and prescription products
containing the equivalent of 0.08
milligrams or more of a specified
imidazoline (tetrahydrozoline,
naphazoline, oxymetazoline, or
xylometazoline) in a single package.
Firms that meet the conditions of the
stay have until June 10, 2015 to comply
with the special packaging
requirements.
SUMMARY:
The stay of enforcement of
special packaging requirements for
specified imidazoline products expires
on June 10, 2015.
FOR FURTHER INFORMATION CONTACT:
Carol Afflerbach, Senior Compliance
Officer, Division of Regulatory
Enforcement, Office of Compliance and
Field Operations, Consumer Product
Safety Commission, 4330 East West
Highway, Bethesda, MD 20814;
telephone (301) 504–7529; email:
cafflerbach@cpsc.gov.
SUPPLEMENTARY INFORMATION:
DATES:
I. Background
On December 10, 2012 (77 FR 73294),
the Commission issued a rule requiring
special packaging (also called childresistant or CR packaging) for any overthe-counter or prescription products
containing the equivalent of 0.08
milligrams or more of a specified
imidazoline (tetrahydrozoline,
naphazoline, oxymetazoline, or
xylometazoline) in a single package. 16
CFR 1700.14(a)(3). The rule included an
effective date of 1 year after publication
of the rule in the Federal Register
(making the effective date December 10,
2013); however, in consideration of
concerns raised in comments on the
proposed rule, the Commission allowed
manufacturers of imidazoline products
subject to the rule to avail themselves of
a 1-year conditional stay of enforcement
(77 FR 73300). Firms meeting the
E:\FR\FM\20NOR1.SGM
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Federal Register / Vol. 79, No. 224 / Thursday, November 20, 2014 / Rules and Regulations
conditions for the stay of enforcement
would have until December 10, 2014 to
comply with the rule. The final rule
preamble set forth the conditions that a
firm would need to satisfy to obtain the
1-year conditional stay of enforcement:
• Provide notice to the Commission
of intent to receive the benefit of the
conditional stay of enforcement, which
includes a detailed timeline setting forth
the steps necessary for the firm to
produce CR packaging for its products
and a range of time anticipated for
completion of each step; and
• Submit quarterly status reports
during the 1-year stay of enforcement
for each affected product, providing the
following information:
Æ Proposed packaging specifications;
Æ estimated initial production date;
Æ progress made and/or steps
completed during the quarterly
reporting period; and
Æ reports of any incidents or
exposures involving the firm’s
imidazoline-containing products subject
to the rule.
Id.
Eleven manufacturers of imidazoline
products covered by the rule and one
contract packager timely notified the
Commission of their intent to avail
themselves of the 1-year conditional
stay of enforcement; to date, these
manufacturers and the packager have
met the reporting requirements of the
conditional stay. The 1-year conditional
stay is due to expire on December 10,
2014.
rmajette on DSK2VPTVN1PROD with RULES
II. Requests for Extension of the
Conditional Stay of Enforcement
Twelve companies provided timely
notice and met the conditions for the 1year conditional stay of enforcement.
Eight of these 12 firms have notified the
Commission that they likely will not be
able to comply with the requirements of
the rule by December 10, 2014 for
certain of their imidazoline products;
for that reason these firms are seeking
an extension of the conditional stay.
Four of the 12 firms expect to have their
products in compliant packaging before
the expiration of the conditional stay.
Five additional manufacturers of
imidazoline products covered by the
rule that did not provide timely notice
of their intent to avail themselves of the
conditional stay have contacted the
Commission regarding the stay of
enforcement. These firms are not
covered by the 1-year conditional stay of
enforcement, and therefore not eligible
for the 6-month extension of the
conditional stay.
The 17 firms that have contacted the
Commission regarding the conditional
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stay of enforcement account for a
substantial share of the imidazoline
products on the market subject to the
rule.
A. Manufacturers of Ophthalmic-Use
Products Covered by the Stay of
Enforcement
Five firms that manufacture
imidazoline-containing products
intended for ophthalmic use timely
notified the Office of Compliance and
Field Operations (Compliance) of their
intent to avail themselves of the 1-year
conditional stay of enforcement. These
five firms produce 35 different eye drop
products. One of these firms expects to
meet the CR packaging requirements for
its products before the expiration of the
1-year conditional stay. The other four
firms have notified the Commission that
they require additional time to meet the
CR packaging requirements for their
products.
The four firms that manufacture
imidazoline products for ophthalmic
use have provided detailed explanations
of the difficulties encountered in
developing or obtaining CR packaging
for their products, such as:
• Multiple prototype packages failing
the child-resistant and senior-friendly
test requirements when produced for
testing purposes;
• prototype packages passing the
child-resistant and senior-friendly test
requirements, but then failing the test
requirements when mass-produced;
• mass production problems
encountered by a third party contract
packager;
• inability to obtain sufficient
quantities of special packaging to permit
timely mass production of imidazoline
products in CR packaging; and
• intent to conduct final protocol
testing of packaging supplied by third
party package suppliers before
beginning distribution of ophthalmic
imidazoline products.
B. Manufacturers of Nasal Products
Covered by the Stay of Enforcement
Imidazoline-containing products that
are intended to relieve nasal congestion
use either a squeeze-to-spray or
metered-pump-to spray delivery system.
Seven manufacturers of nasal products
provided timely notice to the
Commission of their intent to avail
themselves of the conditional stay of
enforcement and have satisfied the other
conditions of the stay. These seven
firms include one contract packager that
supplies products for 28 different
distributors/private labelers, who, in
turn, supply products to retailers who
sell store brand nasal products. These
seven firms manufacture 156 different
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69045
nasal decongestant products—118
products are packaged in a squeezespray bottle, and 38 are packaged in
pump-spray bottles. Four of these seven
firms do not expect to be able to
produce compliant products by
December 10, 2014.
The firms that manufacture
imidazoline products for nasal use have
provided detailed explanations of the
difficulties encountered in developing
or obtaining CR packaging for their
products, such as:
• Mass production problems
encountered by a third party contract
packager;
• possible incompatibility of
manufacturing lines with the mass
production of new package designs;
• intent to conduct final protocol
testing of packaging supplied by third
party package suppliers before
beginning distribution of nasal
imidazoline products;
• inability to obtain sufficient
quantities of special packaging to permit
timely mass production of imidazoline
products in CR packaging.
III. Incident and Injury Data
As discussed more extensively in the
Federal Register notice for the final
rule, CPSC staff reviewed several
sources for information on adverse
health effects from ingestion of
imidazolines. One source reviewed by
CPSC staff is the National Electronic
Injury Surveillance System (NEISS).1
Another incident data source reviewed
in connection with the final rule is the
Children and Poisoning (CAP) system
maintained by the CPSC’s Directorate
for Health Sciences. The CAP is a subset
of NEISS records containing additional
information obtained through NEISS
involving children under 5 years old.2
The final rule noted that an analysis
of the CAP database revealed a total of
198 emergency-room treated injuries
associated with household products
containing imidazolines involving
children under 5 years old from January
1, 1997 to December 31, 2011—an
average of 13 cases per year.
CPSC staff searched the CAP database
for incidents involving household
products that typically contain
imidazolines and children under 5 years
old for the period from December 2012
1 NEISS is a statistically valid injury surveillance
and follow-back database that the Commission
maintains of consumer product-related injuries
occurring in the United States. Injury data are
gathered from the emergency departments (ED) of
96 hospitals selected as a probability sample of all
5,000+ U.S. hospitals with emergency departments.
2 CAP includes data on each pediatric poisoning,
chemical burn, or ingestion case reported from a
NEISS hospital, as well as data on some ingestions
that could lead to poisoning.
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69046
Federal Register / Vol. 79, No. 224 / Thursday, November 20, 2014 / Rules and Regulations
rmajette on DSK2VPTVN1PROD with RULES
(when the final rule for imidazolines
was published) through September 8,
2014, to update the injury and incident
data discussed in the final rule. This
search revealed 79 cases involving
decongestants/nose drops, nose sprays,
nose drops, and naphazoline eye drops.
These cases were reviewed for incidents
involving imidazolines used in nose
drops, nose sprays and eye drops, and
17 cases were identified—13 involving
eye drops, and four involving nasal
drops or spray. One of these cases
involved a 3-year old female who
ingested eye drops and was
hospitalized. The remaining patients
were treated and released, except for
one child who left the emergency room
without being seen by medical
personnel. Fifteen of the 17 cases
occurred during the 12-month period
from December 2012 to December 2013,
the one year period prior to the effective
date of the rule. Two cases occurred
during the most recent 9-month period
during which the stay of enforcement
was in effect. Neither of the two most
recent cases resulted in the
hospitalization of the child. Moreover,
the narratives describing these two cases
did not provide sufficient information to
determine whether the incident
products were in CR packaging, or
whether the circumstances of the
incident suggest that CR packaging
would likely have prevented the
ingestion.
CPSC staff also searched the
Consumer Product Safety Risk
Management System (CPSRMS) for
reports of incidents received by the
Commission involving household
products containing imidazolines. The
search was conducted on September 9,
2014, and included all incidents for
which reports had been received from
December 2012 to September 9, 2014.
One report involving eye drops that was
received arose from an investigation of
one of the 17 NEISS cases mentioned
above. No other reports involving eye
drops, nasal sprays, or nasal drops were
received during this time period.
IV. Extension of Stay of Enforcement
Twelve firms that manufacture and/or
package imidazoline-containing
products covered by the final rule
provided timely notice to the
Commission of their intent to avail
themselves of the conditional stay of
enforcement authorized in the final rule.
These firms have also met the other
conditions of the stay, i.e., providing
quarterly status reports during the 1year stay of enforcement that include
the information specified in the final
rule. As discussed above, eight of these
firms have advised CPSC staff that they
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13:14 Nov 19, 2014
Jkt 235001
likely will be unable to package some of
their imidazoline products in CR
packaging by the date that the current
conditional stay of enforcement is set to
expire. Four of the five firms that
manufacture ophthalmic products and
that have met the requirements to
participate in the stay have advised staff
that the firms need additional time to
produce their products in CR packaging.
Four of seven firms that manufacture
nasal products and that have met the
requirements to participate in the stay
have advised staff that the firms need
additional time to produce either
squeeze spray or metered pump spray
bottles for their imidazoline products.
A review of injury data reveals a
significant reduction in NEISS cases
since the effective date of the final rule.
Although there was an average of
approximately 13 NEISS cases of
imidazoline ingestions by children
under 5 years of age, per year, from
January 1997 to December 2013, two
cases were found for the most recent 9month period. Furthermore, there have
been no CPSRMS reports of incidents
involving household products
containing imidazolines since
publication of the final rule.
The Commission finds that the
circumstances described above warrant
an extension of the conditional stay of
enforcement. All but one of the eight
firms covered by the conditional stay of
enforcement that have requested
additional time to comply with the rule
have advised Compliance staff that their
products will comply with the rule by
May 2015 at the latest. Therefore, we
have determined that the duration of the
extension of the conditional stay of
enforcement will be 6 months from the
date of the expiration of the conditional
stay, or June 10, 2015. The stay will
apply only to firms that are subject to
the current conditional stay of
enforcement and that continue to meet
the reporting conditions set forth in the
final rule preamble as explained above.
One firm covered by the stay of
enforcement has told Compliance staff
that the firm’s products will not comply
with the final rule by May 2015. The
Office of Compliance will consider
requests for an additional temporary
extension of the stay of enforcement on
a case-by-case basis, if a firm covered by
the extended stay of enforcement
anticipates difficulties meeting the June
10, 2015 date. A request for time beyond
June 10, 2015 must be submitted to the
Office of Compliance before the
expiration of the extended conditional
stay of enforcement. The request must
specify the period of time needed to
produce CR packaging, explain the
reasons why additional time is needed,
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and provide a timeline or schedule
outlining the steps the firm will take to
comply with the final rule.
Dated: November 14, 2014.
Todd A. Stevenson,
Secretary, Consumer Product Safety
Commission.
[FR Doc. 2014–27378 Filed 11–19–14; 8:45 am]
BILLING CODE 6355–01–P
DEPARTMENT OF COMMERCE
International Trade Administration
19 CFR Part 351
[Docket No.: 141104924–4924–01]
RIN 0625–AB01
Enforcement and Compliance; Change
of Electronic Filing System Name
International Trade
Administration, Department of
Commerce.
ACTION: Final rule.
AGENCY:
The International Trade
Administration’s Enforcement and
Compliance Unit publishes this rule to
announce a change in the name of
Enforcement and Compliance’s
electronic filing system from ‘‘IA
ACCESS’’ to ‘‘ACCESS.’’ Consistent
with this action, this rule makes
appropriate conforming changes in part
351 of title 19 of the Code of Federal
Regulations. This action is being taken
to ensure that the regulations reflect the
change in nomenclature from Import
Administration to Enforcement and
Compliance.
SUMMARY:
This rule is effective November
24, 2014.
FOR FURTHER INFORMATION CONTACT:
Laura Merchant, IT Manager,
Enforcement and Compliance,
Telephone (202) 482–0367; Shana
Hofstetter, Attorney, Office of Chief
Counsel for Trade Enforcement and
Compliance, Telephone: (202) 482–
3414.
DATES:
On
October 1, 2013, as part of an internal
consolidation within the International
Trade Administration, the name of the
Import Administration was changed to
Enforcement and Compliance to reflect
the unit’s new operational mandate.1
This rule updates the regulations to
reflect the new name of Enforcement
and Compliance’s electronic filing
system from ‘‘IA ACCESS’’ to
‘‘ACCESS’’. This rule changes all
SUPPLEMENTARY INFORMATION:
1 See Import Administration; Change of Agency
Name, 78 FR 62417 (Oct. 22, 2013).
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]]>Agencies
[Federal Register Volume 79, Number 224 (Thursday, November 20, 2014)]
[Rules and Regulations]
[Pages 69044-69046]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-27378]
=======================================================================
-----------------------------------------------------------------------
CONSUMER PRODUCT SAFETY COMMISSION
16 CFR Part 1700
[CPSC Docket No. CPSC-2012-0005]
Requirements for Child-Resistant Packaging: Products Containing
Specified Imidazolines Equivalent to 0.08 Milligrams or More; Extension
of Stay of Enforcement
AGENCY: Consumer Product Safety Commission.
ACTION: Extension of stay of enforcement.
-----------------------------------------------------------------------
SUMMARY: This document announces the Commission's decision to extend
the conditional stay of enforcement of special packaging requirements
for over-the-counter and prescription products containing the
equivalent of 0.08 milligrams or more of a specified imidazoline
(tetrahydrozoline, naphazoline, oxymetazoline, or xylometazoline) in a
single package. Firms that meet the conditions of the stay have until
June 10, 2015 to comply with the special packaging requirements.
DATES: The stay of enforcement of special packaging requirements for
specified imidazoline products expires on June 10, 2015.
FOR FURTHER INFORMATION CONTACT: Carol Afflerbach, Senior Compliance
Officer, Division of Regulatory Enforcement, Office of Compliance and
Field Operations, Consumer Product Safety Commission, 4330 East West
Highway, Bethesda, MD 20814; telephone (301) 504-7529; email:
cafflerbach@cpsc.gov.
SUPPLEMENTARY INFORMATION:
I. Background
On December 10, 2012 (77 FR 73294), the Commission issued a rule
requiring special packaging (also called child-resistant or CR
packaging) for any over-the-counter or prescription products containing
the equivalent of 0.08 milligrams or more of a specified imidazoline
(tetrahydrozoline, naphazoline, oxymetazoline, or xylometazoline) in a
single package. 16 CFR 1700.14(a)(3). The rule included an effective
date of 1 year after publication of the rule in the Federal Register
(making the effective date December 10, 2013); however, in
consideration of concerns raised in comments on the proposed rule, the
Commission allowed manufacturers of imidazoline products subject to the
rule to avail themselves of a 1-year conditional stay of enforcement
(77 FR 73300). Firms meeting the
[[Page 69045]]
conditions for the stay of enforcement would have until December 10,
2014 to comply with the rule. The final rule preamble set forth the
conditions that a firm would need to satisfy to obtain the 1-year
conditional stay of enforcement:
Provide notice to the Commission of intent to receive the
benefit of the conditional stay of enforcement, which includes a
detailed timeline setting forth the steps necessary for the firm to
produce CR packaging for its products and a range of time anticipated
for completion of each step; and
Submit quarterly status reports during the 1-year stay of
enforcement for each affected product, providing the following
information:
[cir] Proposed packaging specifications;
[cir] estimated initial production date;
[cir] progress made and/or steps completed during the quarterly
reporting period; and
[cir] reports of any incidents or exposures involving the firm's
imidazoline-containing products subject to the rule.
Id.
Eleven manufacturers of imidazoline products covered by the rule
and one contract packager timely notified the Commission of their
intent to avail themselves of the 1-year conditional stay of
enforcement; to date, these manufacturers and the packager have met the
reporting requirements of the conditional stay. The 1-year conditional
stay is due to expire on December 10, 2014.
II. Requests for Extension of the Conditional Stay of Enforcement
Twelve companies provided timely notice and met the conditions for
the 1-year conditional stay of enforcement. Eight of these 12 firms
have notified the Commission that they likely will not be able to
comply with the requirements of the rule by December 10, 2014 for
certain of their imidazoline products; for that reason these firms are
seeking an extension of the conditional stay. Four of the 12 firms
expect to have their products in compliant packaging before the
expiration of the conditional stay.
Five additional manufacturers of imidazoline products covered by
the rule that did not provide timely notice of their intent to avail
themselves of the conditional stay have contacted the Commission
regarding the stay of enforcement. These firms are not covered by the
1-year conditional stay of enforcement, and therefore not eligible for
the 6-month extension of the conditional stay.
The 17 firms that have contacted the Commission regarding the
conditional stay of enforcement account for a substantial share of the
imidazoline products on the market subject to the rule.
A. Manufacturers of Ophthalmic-Use Products Covered by the Stay of
Enforcement
Five firms that manufacture imidazoline-containing products
intended for ophthalmic use timely notified the Office of Compliance
and Field Operations (Compliance) of their intent to avail themselves
of the 1-year conditional stay of enforcement. These five firms produce
35 different eye drop products. One of these firms expects to meet the
CR packaging requirements for its products before the expiration of the
1-year conditional stay. The other four firms have notified the
Commission that they require additional time to meet the CR packaging
requirements for their products.
The four firms that manufacture imidazoline products for ophthalmic
use have provided detailed explanations of the difficulties encountered
in developing or obtaining CR packaging for their products, such as:
Multiple prototype packages failing the child-resistant
and senior-friendly test requirements when produced for testing
purposes;
prototype packages passing the child-resistant and senior-
friendly test requirements, but then failing the test requirements when
mass-produced;
mass production problems encountered by a third party
contract packager;
inability to obtain sufficient quantities of special
packaging to permit timely mass production of imidazoline products in
CR packaging; and
intent to conduct final protocol testing of packaging
supplied by third party package suppliers before beginning distribution
of ophthalmic imidazoline products.
B. Manufacturers of Nasal Products Covered by the Stay of Enforcement
Imidazoline-containing products that are intended to relieve nasal
congestion use either a squeeze-to-spray or metered-pump-to spray
delivery system. Seven manufacturers of nasal products provided timely
notice to the Commission of their intent to avail themselves of the
conditional stay of enforcement and have satisfied the other conditions
of the stay. These seven firms include one contract packager that
supplies products for 28 different distributors/private labelers, who,
in turn, supply products to retailers who sell store brand nasal
products. These seven firms manufacture 156 different nasal
decongestant products--118 products are packaged in a squeeze-spray
bottle, and 38 are packaged in pump-spray bottles. Four of these seven
firms do not expect to be able to produce compliant products by
December 10, 2014.
The firms that manufacture imidazoline products for nasal use have
provided detailed explanations of the difficulties encountered in
developing or obtaining CR packaging for their products, such as:
Mass production problems encountered by a third party
contract packager;
possible incompatibility of manufacturing lines with the
mass production of new package designs;
intent to conduct final protocol testing of packaging
supplied by third party package suppliers before beginning distribution
of nasal imidazoline products;
inability to obtain sufficient quantities of special
packaging to permit timely mass production of imidazoline products in
CR packaging.
III. Incident and Injury Data
As discussed more extensively in the Federal Register notice for
the final rule, CPSC staff reviewed several sources for information on
adverse health effects from ingestion of imidazolines. One source
reviewed by CPSC staff is the National Electronic Injury Surveillance
System (NEISS).\1\ Another incident data source reviewed in connection
with the final rule is the Children and Poisoning (CAP) system
maintained by the CPSC's Directorate for Health Sciences. The CAP is a
subset of NEISS records containing additional information obtained
through NEISS involving children under 5 years old.\2\
---------------------------------------------------------------------------
\1\ NEISS is a statistically valid injury surveillance and
follow-back database that the Commission maintains of consumer
product-related injuries occurring in the United States. Injury data
are gathered from the emergency departments (ED) of 96 hospitals
selected as a probability sample of all 5,000+ U.S. hospitals with
emergency departments.
\2\ CAP includes data on each pediatric poisoning, chemical
burn, or ingestion case reported from a NEISS hospital, as well as
data on some ingestions that could lead to poisoning.
---------------------------------------------------------------------------
The final rule noted that an analysis of the CAP database revealed
a total of 198 emergency-room treated injuries associated with
household products containing imidazolines involving children under 5
years old from January 1, 1997 to December 31, 2011--an average of 13
cases per year.
CPSC staff searched the CAP database for incidents involving
household products that typically contain imidazolines and children
under 5 years old for the period from December 2012
[[Page 69046]]
(when the final rule for imidazolines was published) through September
8, 2014, to update the injury and incident data discussed in the final
rule. This search revealed 79 cases involving decongestants/nose drops,
nose sprays, nose drops, and naphazoline eye drops. These cases were
reviewed for incidents involving imidazolines used in nose drops, nose
sprays and eye drops, and 17 cases were identified--13 involving eye
drops, and four involving nasal drops or spray. One of these cases
involved a 3-year old female who ingested eye drops and was
hospitalized. The remaining patients were treated and released, except
for one child who left the emergency room without being seen by medical
personnel. Fifteen of the 17 cases occurred during the 12-month period
from December 2012 to December 2013, the one year period prior to the
effective date of the rule. Two cases occurred during the most recent
9-month period during which the stay of enforcement was in effect.
Neither of the two most recent cases resulted in the hospitalization of
the child. Moreover, the narratives describing these two cases did not
provide sufficient information to determine whether the incident
products were in CR packaging, or whether the circumstances of the
incident suggest that CR packaging would likely have prevented the
ingestion.
CPSC staff also searched the Consumer Product Safety Risk
Management System (CPSRMS) for reports of incidents received by the
Commission involving household products containing imidazolines. The
search was conducted on September 9, 2014, and included all incidents
for which reports had been received from December 2012 to September 9,
2014. One report involving eye drops that was received arose from an
investigation of one of the 17 NEISS cases mentioned above. No other
reports involving eye drops, nasal sprays, or nasal drops were received
during this time period.
IV. Extension of Stay of Enforcement
Twelve firms that manufacture and/or package imidazoline-containing
products covered by the final rule provided timely notice to the
Commission of their intent to avail themselves of the conditional stay
of enforcement authorized in the final rule. These firms have also met
the other conditions of the stay, i.e., providing quarterly status
reports during the 1-year stay of enforcement that include the
information specified in the final rule. As discussed above, eight of
these firms have advised CPSC staff that they likely will be unable to
package some of their imidazoline products in CR packaging by the date
that the current conditional stay of enforcement is set to expire. Four
of the five firms that manufacture ophthalmic products and that have
met the requirements to participate in the stay have advised staff that
the firms need additional time to produce their products in CR
packaging. Four of seven firms that manufacture nasal products and that
have met the requirements to participate in the stay have advised staff
that the firms need additional time to produce either squeeze spray or
metered pump spray bottles for their imidazoline products.
A review of injury data reveals a significant reduction in NEISS
cases since the effective date of the final rule. Although there was an
average of approximately 13 NEISS cases of imidazoline ingestions by
children under 5 years of age, per year, from January 1997 to December
2013, two cases were found for the most recent 9-month period.
Furthermore, there have been no CPSRMS reports of incidents involving
household products containing imidazolines since publication of the
final rule.
The Commission finds that the circumstances described above warrant
an extension of the conditional stay of enforcement. All but one of the
eight firms covered by the conditional stay of enforcement that have
requested additional time to comply with the rule have advised
Compliance staff that their products will comply with the rule by May
2015 at the latest. Therefore, we have determined that the duration of
the extension of the conditional stay of enforcement will be 6 months
from the date of the expiration of the conditional stay, or June 10,
2015. The stay will apply only to firms that are subject to the current
conditional stay of enforcement and that continue to meet the reporting
conditions set forth in the final rule preamble as explained above.
One firm covered by the stay of enforcement has told Compliance
staff that the firm's products will not comply with the final rule by
May 2015. The Office of Compliance will consider requests for an
additional temporary extension of the stay of enforcement on a case-by-
case basis, if a firm covered by the extended stay of enforcement
anticipates difficulties meeting the June 10, 2015 date. A request for
time beyond June 10, 2015 must be submitted to the Office of Compliance
before the expiration of the extended conditional stay of enforcement.
The request must specify the period of time needed to produce CR
packaging, explain the reasons why additional time is needed, and
provide a timeline or schedule outlining the steps the firm will take
to comply with the final rule.
Dated: November 14, 2014.
Todd A. Stevenson,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2014-27378 Filed 11-19-14; 8:45 am]
BILLING CODE 6355-01-P
