69044 Federal Register / Vol. 79, No. 224 / Thursday, November 20, 2014 / Rules and Regulations 

(a) Response required. A response is 

required from persons subject to the 

reporting requirements of the BE–10, 

Benchmark Survey of U.S. Direct 

Investment Abroad—2014, contained 

herein, whether or not they are 

contacted by BEA. Also, a person, or 

their agent, that is contacted by BEA 

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 

accomplished by: 

(1) Certifying in writing, by the due 

date of the survey, to the fact that the 

person had no direct investment within 

the purview of the reporting 

requirements of the BE–10 survey; 

(2) Completing and returning the 

‘‘BE–10 Claim for Not Filing’’ by the due 

date of the survey; or 

(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 

report is required of any U.S. person 

that had a foreign affiliate—that is, that 

had direct or indirect ownership or 

control of at least 10 percent of the 

voting stock of an incorporated foreign 

business enterprise, or an equivalent 

interest in an unincorporated foreign 

business enterprise, including a 

branch—at any time during the U.S. 

person’s 2014 fiscal year. 

(2) If the U.S. person had no foreign 

affiliates during its 2014 fiscal year, a 

‘‘BE–10 Claim for Not Filing’’ must be 

filed by the due date of the survey; no 

other forms in the survey are required. 

If the U.S. person had any foreign 

affiliates during its 2014 fiscal year, a 

BE–10 report is required and the U.S. 

person is a U.S. Reporter in this survey. 

(3) Reports are required even if the 

foreign business enterprise was 

established, acquired, seized, 

liquidated, sold, expropriated, or 

inactivated during the U.S. person’s 

2014 fiscal year. 

(4) The amount and type of data 

required to be reported vary according 

to the size of the U.S. Reporters or 

foreign affiliates, and, for foreign 

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, 

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 

each majority-owned foreign affiliate for 

which any of the following three 

items—total assets, sales or gross 

operating revenues excluding sales 

taxes, or net income after provision for 

foreign income taxes—was greater than 

$80 million (positive or negative) at any 

time during the affiliate’s 2014 fiscal 

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 

affiliates that are required to be filed on 

this form. 

(d) Due date. A fully completed and 

certified BE–10 report comprising Form 

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 

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 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. 

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 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 


rmajette on DSK2VPTVN1PROD with RULES
Federal Register / Vol. 79, No. 224 / Thursday, November 20, 2014 / Rules and Regulations 69045 

1NEISS 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. 

2CAP 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. 

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. 

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 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 


rmajette on DSK2VPTVN1PROD with RULES
69046 Federal Register / Vol. 79, No. 224 / Thursday, November 20, 2014 / Rules and Regulations 

1See Import Administration; Change of Agency 

Name, 78 FR 62417 (Oct. 22, 2013). 

(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 

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 

AGENCY: International Trade 

Administration, Department of 

Commerce. 

ACTION: Final rule. 

SUMMARY: 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. 

DATES: 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. 

SUPPLEMENTARY INFORMATION: 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 


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