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[Federal Register Volume 79, Number 224 (Thursday, November 20, 2014)]
[Rules and Regulations]
[Pages 69044-69046]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-27378]

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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

AGENCY: Consumer Product Safety Commission.

ACTION: Extension of stay of enforcement.

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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: 
[email protected].

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\
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    \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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    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
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