52220 Federal Register / Vol. 77, No. 168 / Wednesday, August 29, 2012 / Rules and Regulations 

1The Commission voted 4–0 to approve 

publication of this rule. Chairman Inez M. 

Tenenbaum filed a statement concerning this action 

which may be viewed on the Commission’s Web 

site at http://www.cpsc.gov/library/foia/ballot/ 

ballot12/playyards.pdf or obtained from the 

Commission’s Office of the Secretary. 

September 15, 2011 is amended as 

follows: 

Paragraph 6002 Class E airspace designated 

as surface areas. 

* * * * * 

ANM MT E2 Lewistown, MT [Modified] 

Lewistown Municipal Airport, MT 

(Lat. 47°02′57′′N., long. 109°28′00′′W.) 

Within a 6.8-mile radius of the Lewistown 

Municipal Airport. This Class E airspace area 

is effective during the specific dates and 

times established in advance by a Notice to 

Airmen. The effective date and time will 

thereafter be continuously published in the 

Airport/Facility Directory. 

Paragraph 6005 Class E airspace areas 

extending upward from 700 feet or more 

above the surface of the earth. 

* * * * * 

ANM MT E5 Lewistown, MT [Modified] 

Lewistown Municipal Airport, MT 

(Lat. 47°02′57′′N., long. 109°28′00′′W.) 

That airspace extending upward from 700 

feet above the surface within 9.3-mile radius 

of the Lewistown Municipal Airport, and 

within 4.5 miles each side of the Lewistown 

Municipal Airport 269° bearing extending 

from the 9.3-mile radius to 14.5 miles west 

of the airport, and within 2.5 miles south and 

4 miles north of the Lewistown Municipal 

Airport 258° bearing extending from the 9.3- 

mile radius to 20.5 miles west of the airport; 

that airspace extending upward from 1,200 

feet above the surface bounded by a line 

beginning at lat. 47°21′00′′N., long. 

110°33′00′′W.; to lat. 47°30′00′′N., long. 

110°00′00′′W.; to lat. 47°16′00′′N., long. 

109°44′00′′W.; to lat. 47°11′33′′N., long. 

108°46′00′′W.; to lat. 46°43′40′′N., long. 

108°48′22′′W.; to lat. 46°43′40′′N., long. 

109°32′14′′W., to lat. 46°32′19′′N., long. 

109°32′14′′W.; to lat. 46°32′19′′N., long. 

110°06′30′′W.; thence to the point of origin. 

Issued in Seattle, Washington, on August 

17, 2012. 

John Warner, 

Manager, Operations Support Group, Western 

Service Center. 

[FR Doc. 2012–21164 Filed 8–28–12; 8:45 am] 

BILLING CODE 4910–13–P 

CONSUMER PRODUCT SAFETY 

COMMISSION 

16 CFR Part 1221 

[CPSC Docket No. CPSC–2011–0064] 

RIN 3041–AC92 

Safety Standard for Play Yards 

AGENCY: Consumer Product Safety 

Commission. 

ACTION: Final rule. 

SUMMARY: Section 104(b) of the 

Consumer Product Safety Improvement 

Act of 2008 (CPSIA), also known as the 

‘‘Danny Keysar Child Product Safety 

Notification Act,’’ requires the United 

States Consumer Product Safety 

Commission (Commission, CPSC, us, or 

we) to promulgate consumer product 

safety standards for durable infant or 

toddler products. These standards are to 

be ‘‘substantially the same as’’ 

applicable voluntary standards or more 

stringent than the voluntary standard if 

the Commission concludes that more 

stringent requirements would further 

reduce the risk of injury associated with 

the product. In this rule, we are issuing 

a safety standard for play yards in 

response to the CPSIA.1

DATES: This rule is effective on February 

28, 2013 and will apply to all play yards 

manufactured or imported on or after 

that date. The incorporation by 

reference of the publication listed in 

this rule is approved by the Director of 

the Federal Register as of February 28, 

2013. 

FOR FURTHER INFORMATION CONTACT: 

Justin Jirgl, Compliance Officer, Office 

of Compliance and Field Investigations, 

U.S. Consumer Product Safety 

Commission, 4330 East-West Highway, 

Bethesda, MD 20814; email: 

jjirgl@cpsc.gov. 

SUPPLEMENTARY INFORMATION: 

A. Background: Section 104(b) of the 

Consumer Product Safety Improvement 

Act 

The Consumer Product Safety 

Improvement Act of 2008 (CPSIA, Pub. 

L. 110–314) was enacted on August 14, 

2008. Section 104(b) of the CPSIA 

requires the Commission to promulgate 

consumer product safety standards for 

durable infant and toddler products. 

These standards are to be ‘‘substantially 

the same as’’ applicable voluntary 

standards or more stringent than the 

voluntary standard if the Commission 

concludes that more stringent 

requirements would further reduce the 

risk of injury associated with the 

product. The term ‘‘durable infant or 

toddler product’’ is defined in section 

104(f)(1) of the CPSIA as a durable 

product intended for use, or that may be 

reasonably expected to be used, by 

children under the age of 5 years. Play 

yards are one of the products 

specifically identified in section 

104(f)(2)(F) as a durable infant or 

toddler product. 

In the Federal Register of September 

20, 2011 (76 FR 58167), we published a 

notice of proposed rulemaking (NPR) for 

play yards, incorporating by reference 

ASTM F406–11, ‘‘Standard Consumer 

Safety Specification for Non-Full-Size 

Baby Cribs/Play Yards,’’ with three 

clarifications. ASTM F406 is the safety 

standard for both non-full-size cribs and 

play yards. In the proposed rule for play 

yards, we indicated which sections of 

the ASTM standard apply to play yards, 

and we excluded the provisions of 

ASTM F406 that apply to non-full-size 

cribs. 

The ASTM subcommittee on play 

yards developed a newer edition of this 

standard, ASTM F406–12a, which 

includes the three clarifications we 

proposed in the NPR. ASTM F406–12a 

also contains two clarifications that 

were suggested in comments we 

received from the public in response to 

the NPR. Those two clarifications: (1) 

Added a preload to the mattress vertical 

displacement test; and (2) exempted 

from the top rail configuration 

requirement play yards with upwardfolding top rails. 

In this document, we are issuing a 

safety standard for play yards, which 

incorporates by reference ASTM F406– 

12a and provides a 6-month (from the 

date of publication) effective date for the 

mandatory play yard standard. 

B. The Product 

ASTM F406–12a defines a ‘‘play 

yard’’ as a ‘‘framed enclosure that 

includes a floor and has mesh or fabric 

sided panels primarily intended to 

provide a play or sleeping environment 

for children. It may fold for storage or 

travel.’’ Play yards are intended for 

children who are less than 35 inches 

tall, who cannot climb out of the 

product. Some play yards include 

accessory items that attach to the 

product, including mobiles, toy bars, 

canopies, bassinets, and changing 

tables. 

C. Incident Data 

The preamble to the NPR (76 FR 

58168) summarized the data for 

incidents related to play yards reported 

to us from early November 2007 through 

early April 2011. The final rule is based 

on the data provided in the NPR, as well 

as updated data on incidents related to 

play yards reported to us from April 

2011 through December 31, 2011. 

From April 10, 2011, through 

December 31, 2011, we received 

information on 41 play yard-related 

incidents. Fifteen of the 41 incidents 

were fatal. Of the remaining 26 

incidents, eight resulted in injuries to 

the child. 

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Federal Register / Vol. 77, No. 168 / Wednesday, August 29, 2012 / Rules and Regulations 52221 

Eleven of the 15 fatal incidents are 

attributable to an unsafe sleep 

environment, such as the presence of 

soft bedding. For one fatality, very little 

information was supplied to us and, we 

were unable to determine the cause of 

the death. Three of the 15 fatalities were 

play yard related. One child died when 

the bassinet accessory being used as a 

sleep environment was assembled 

without key structural elements, which 

resulted in a dangerous tilt of the sleep 

surface. The child slid into the corner of 

the bassinet and suffocated. In another 

incident, a child was attempting to 

climb out of a play yard and, while 

holding onto a separate bassinet nearby, 

the canopy of the bassinet fell forward 

and caught him on the back of the neck, 

suffocating him. A third child 

suffocated when he got his head stuck 

in a torn opening between the floor and 

the mesh side of the play yard. 

The recent incidents have hazard 

patterns similar to those reported in the 

NPR, and include: 

• Eleven incidents, all resulting in 

fatalities, were the result of unsafe sleep 

environments and unsafe sleep 

practices. 

• Ten incidents were caused by 

broken or detached component parts, 

such as loose wheels and loose 

hardware, which resulted in the 

instability or collapse of the product. 

There were three injuries reported in 

this category. 

• Five incidents were related to the 

mesh or fabric sides of the play yard, 

such as stitching that unraveled, tears in 

the fabric, and mesh holes that were too 

large. There were two injuries and one 

fatality reported in this category. 

• Four incidents were caused by 

hazardous accessories, such as broken 

or detached components from a mobile 

or a tent accessory. There was one 

injury reported in this category. 

• Three incidents were related to the 

mattress pad or floor of the play yard, 

including reports that the fasteners 

designed to keep the floor board in 

place failed. There were no injuries 

reported in this category. 

• Three incidents were due to the 

side rail of the play yard collapsing. 

There were no injuries in this category. 

• Two incidents were the result of the 

child being able to climb out of the play 

yard. There was one injury and one 

fatality reported in this category. 

• One incident, which resulted in a 

fatality, can be attributed to assembly 

issues in the bassinet accessory of a play 

yard. In this incident, the bassinet was 

missing key structural elements meant 

to support the accessory. The sleep 

surface of the bassinet tilted, and the 

child slid into the corner and 

suffocated. 

• One incident was the result of a 

child nearly choking on a sticker that 

was a component of the play yard. 

• For one reported fatality associated 

with a play yard, there was insufficient 

information to determine the cause. 

D. Response to Comments on the 

Proposed Rule 

The preamble to the NPR invited 

comments concerning all aspects of the 

proposed rule. We received comments 

from 23 individuals or organizations. 

Many of the comments contained more 

than one issue. Thus, we organized our 

responses by issue, rather than 

responding to each individual 

commenter. Each comment and 

response is numbered below to help 

distinguish between different 

comments. The number assigned to each 

comment is purely for organizational 

purposes and does not signify the 

comment’s value or importance, or the 

order in which it was received. All of 

the comments can be viewed on: 

www.regulations.gov, by searching 

under the docket number for this 

rulemaking, CPSC–2011–0064. 

1. Generally Unsupportive of 

Regulations 

(Comment 1)—One commenter does 

not support government regulation of 

this, or any, consumer product and 

asserts that the free market will ‘‘weed 

out those manufacturers of unsafe 

products.’’ 

(Response 1)—The CPSIA requires 

that we promulgate mandatory 

regulations for durable infant or toddler 

products, including play yards. This 

final rule fulfills a statutory obligation 

given to us by Congress. Accordingly, 

issuance of a play yard mandatory 

standard is consistent with the statutory 

requirements of the CPSIA. 

2. The Definition of ‘‘Play Yard’’ 

(Comment 2)—One commenter notes 

a possible loophole in the ASTM F406 

definition of ‘‘play yard’’ because 

materials other than mesh or fabric 

could be used to form the walls. 

According to the commenter, this would 

allow a manufacturer to circumvent the 

mandatory play yard rule. 

(Response 2)—Play yards with sides 

made of materials that are not flexible 

would be considered rigid-sided 

products. These products would be 

classified as full-size- or non-full-size 

cribs, subject to more severe 

requirements under 16 CFR part 1219 

(full-size cribs) or 16 CFR part 1220 

(non-full-size cribs). It would be less 

burdensome to produce a mesh- or 

fabric-sided product. Accordingly, we 

do not believe that a play yard 

manufacturer would attempt to evade 

the play yard standard requirements by 

making a rigid-sided product. 

3. ASTM Voluntary Standard as the 

Basis for the Mandatory Standard 

(Comment 3)—Three commenters 

note that the ASTM standard might not 

be the best basis for the mandatory play 

yard rule. Each commenter asserts that 

because we do not have data to indicate 

whether the fatalities and injuries were 

caused by play yards not in compliance 

with the current ASTM standard, we 

cannot be sure that incorporating by 

reference the ASTM standard will result 

in safer play yards. 

(Response 3)—The CPSIA requires 

that we base our mandatory standard for 

play yards on a voluntary standard. We 

chose the ASTM standard because it is 

the most widely used play yard 

standard in the United States. The 

ASTM committees that produce the 

durable infant and toddler product 

standards represent a cross-section of 

stakeholders, including manufacturers, 

retailers, testing laboratories, 

independent consultants, 

representatives from consumer 

advocacy groups, representatives from 

Health Canada, as well as CPSC staff. 

The creation of an ASTM standard 

involves analyzing CPSC incident data 

in detail, assessing other standards 

(including international standards), and 

testing products. The ASTM standard 

upon which we are basing the 

mandatory regulation addresses the 

known hazards of play yards and it is 

the most stringent standard available. 

Therefore, we believe that it is an 

appropriate standard upon which to 

base the play yard mandatory rule. 

4. Injury Rates 

(Comment 4)—One commenter 

indicates that ‘‘the extremely low 

incidence of injury puts into question 

the need for regulation at all, outside of 

the CPSIA mandate, as there probably is 

no heinous market failure.’’ 

(Response 4)—The standard is based 

on careful analysis of incidents, injuries, 

and fatalities associated with play yards. 

Injury rates, when available, are an 

important part of that analysis. In this 

case, however, even if we agreed with 

the commenter that the injury rate is too 

low, that does not negate the 

requirement for the issuance of a play 

yard mandatory standard, which fulfills 

a statutory obligation given to us by 

Congress. However, we disagree with 

the commenter and believe that the 

incidents, injuries, and fatalities justify 

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52222 Federal Register / Vol. 77, No. 168 / Wednesday, August 29, 2012 / Rules and Regulations 

the issuance of a play yard mandatory 

standard. 

5. American Baby Group Data 

(Comment 5)—One commenter says 

that the ‘‘record demonstrates that the 

Commission relies solely upon 

information provided by a 2005 survey 

by American Baby Group for all market 

data,’’ and that ‘‘affected parties may 

challenge the rule by claiming that the 

Commission’s actions are based on old, 

inaccurate data.’’ 

(Response 5)—The commenter is 

incorrect in assuming that the 2005 

American Baby Group survey (2006 

Baby Products Tracking Study) was the 

sole source of market information we 

considered in the rulemaking process. 

The Baby Products Tracking Study was 

used to provide an estimate of the 

magnitude of the play yard market. The 

initial regulatory flexibility analysis 

recognized the limitations of this data, 

both for its age and potentially biased 

sampling methods. 

However, we also used market 

research—conducted independently—to 

perform the regulatory flexibility 

analysis. This research provided 

information on the number of firms 

supplying play yards to the U.S. market, 

their type, their size, and their location. 

We also researched, independently, the 

number of products supplied by each 

firm, each firm’s compliance with the 

voluntary standard, as well as details 

about accessories sold with each play 

yard. It is this information, along with 

input from our staff and play yard 

manufacturers, which led to the 

conclusions of the initial regulatory 

flexibility analysis. 

6. Small Business Impact 

(Comment 6)—One commenter 

expresses concerns about how 

effectively the CPSC complied with the 

requirements of the Regulatory 

Flexibility Act (RFA). The commenter 

asserts that the proposed rule will have 

a significant impact on all small firms. 

(Response 6)—The economic impact 

of the mandatory play yard standard 

proposed in the NPR would not be 

significant for play yard suppliers who 

already are in compliance with the 

ASTM play yard standard. Many play 

yard manufacturers and importers have 

a history of making adjustments to their 

play yards to remain in compliance with 

the ASTM standard, and they likely 

would continue to comply in the 

absence of a mandatory standard. Firms 

with a history of voluntary compliance 

would have few, if any, costs associated 

with the proposed rule, regardless of 

their size. 

The initial regulatory flexibility 

analysis recognized that the impact on 

firms that supply noncompliant play 

yards to the U.S. market potentially 

could be significant. However, because 

the CPSIA requires that we promulgate 

a mandatory standard that is 

substantially the same as, or more 

stringent than, the voluntary standard, 

the CPSC is limited in how it can 

minimize the economic impact on small 

firms that are not in compliance with 

the standard. 

7. International Standards 

(Comment 7)—We received two 

comments regarding international play 

yard standards. One commenter 

expresses the concern that our play yard 

mandatory standard could impact trade 

agreements and emphasizes the 

importance of standards harmonization 

as a way to avoid this. Another 

commenter states that international 

harmonization should be a priority. 

(Response 7)—When drafting the NPR 

for play yards, we reviewed, compared, 

and considered a variety of play yard 

standards, including the Canadian 

standard, the European standard, and 

the Australian/New Zealand standard. 

There are differences among all of the 

international standards. Thus, even if 

we adopt part, or all, of one of the 

standards listed here, we still would not 

have complete international 

harmonization. We are aware of the 

utility of having harmonized standards 

in a global marketplace, and we will 

continue to strive to achieve this 

harmonization, whenever possible. 

8. Adequacy of Testing 

(Comment 8)—One commenter states 

that the proposed test methods for play 

yards, which do not include any cyclic 

tests (tests that involve hundreds or 

thousands of testing cycles in order to 

evaluate a product’s durability), are 

insufficient because play yards are set 

up and taken down more often than 

cribs. 

(Response 8)—Cyclic testing is timeconsuming and expensive. For play 

yards, we have found that using very 

heavy loads applied for one testing 

cycle (instead of cyclic testing that 

would require relatively lighter loads 

and testing cycles that are repeated 

hundreds or thousands of times) can 

simulate a lifetime of use. The tests 

found in the play yard standard were 

developed over time, and they have 

been found to be reliable indicators of 

when a play yard could present a 

hazard. 

9. Quality Control 

(Comment 9)—One commenter states 

that the CPSC should establish a 

mandatory set of production and 

manufacturing inspection standards for 

the industry. 

(Response 9)—The CPSC’s role is to 

monitor the results of the manufacturing 

process, not participate in the process 

itself. We monitor the manufacturing 

process in several ways. First, we are 

able to act preventatively by issuing 

mandatory standards and requiring 

children’s products be third party tested 

by an accredited laboratory. Second, we 

have the ability to act if the 

manufacturing process fails and a 

product is sold that does not meet a 

mandatory standard or is defective and 

presents a substantial risk of injury to 

the public. 

10. Effective Date 

(Comment 10)—Several commenters 

weigh in on the appropriate effective 

date for the proposed rule. One 

commenter, representing numerous 

juvenile product manufacturers, 

supports the proposed 6-month effective 

date. One manufacturer says: ‘‘from an 

industrial point of view, 6 months of 

fulfilling a new legislation is very short’’ 

and, therefore, suggests a 12-month 

effective date. Two other commenters 

also feel that the effective date should 

be longer. One suggests that it is 

‘‘doubtful that a six month grace period 

would provide sufficient protection for 

the small businesses that the RFA 

intends to protect,’’ while the other says 

that an effective date ‘‘6 months after 

publication of the final rule’’ is 

‘‘seemingly arbitrary’’ and that other 

alternatives ‘‘may encourage more 

compliance.’’ 

One commenter, representing several 

consumer advocacy groups, 

recommends: ‘‘an effective date of 90 

days after publication in the Federal 

Register.’’ Their rationale is twofold. 

First, ‘‘the changes to the voluntary 

standard proposed by CPSC are minor,’’ 

the commenter opines. Second, the 

commenter adds: ‘‘it affects only 

product manufactured after that date, 

not sold by that date,’’ and 

‘‘manufacturers and retailers have large 

inventories of children’s products and 

will be able to sell noncompliant 

product for years after the effective date. 

The sooner new products meet the 

standard, the better for the infants and 

toddlers who will be using them.’’ 

(Response 10)—We consider 6 months 

sufficient time for suppliers to come 

into compliance with the proposed rule. 

Although a longer effective date would 

allow small entities to spread their costs 

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Federal Register / Vol. 77, No. 168 / Wednesday, August 29, 2012 / Rules and Regulations 52223 

out over a longer period of time, 6 

months is common in the industry. For 

example, 6 months is the amount of 

time the Juvenile Products 

Manufacturers Association allows for 

products in their certification program 

to shift to a new standard. On the other 

hand, a shorter effective date could put 

a substantial burden on firms, 

particularly those whose play yards 

currently do not meet the requirements 

of the voluntary ASTM standard. 

We share concerns about 

noncompliant products being available 

for years beyond the effective date. 

However, the number and severity of 

play yard incidents does not seem to 

warrant a shorter effective date than that 

used for other durable infant products, 

particularly given that ongoing 

compliance activities would continue to 

be used to pull unsafe play yards from 

the market. 

11. Bassinet and Cradle Accessory 

Misassembly 

(Comment 11)—One commenter states 

that incidents arise from products that 

appear to be set up correctly but are 

actually misassembled. The commenter 

recommends that we add language to 

the mandatory play yard standard to 

address this hazard, by requiring 

products with consumer-assembled 

components be designed to prevent 

misassembly. If that is not possible, the 

commenter suggests that clear visual 

indicators be included to alert 

consumers that the accessory has not 

been assembled correctly. 

(Response 11)—Many play yards are 

sold with accessories that attach to the 

product, such as bassinets, changing 

tables, and mobiles. Bassinet accessories 

are unique among play yard accessories 

because bassinet accessories are 

intended to be used as a sleeping 

environment, and infants are meant to 

be left unsupervised in them for 

extended periods of time. Serious 

injuries or fatalities can result if a play 

yard bassinet accessory has been 

assembled without key structural 

elements, such as rods, tubes, bars, and 

hooks, which keep the sleep surface flat 

and level. A tilt in the sleeping surface 

of the bassinet can result in an infant 

getting into a position where he or she 

is unable to breathe and is at risk of 

suffocation. 

It is possible that the omission of key 

structural elements initially may not be 

visually evident to the consumer. If the 

misassembled accessory supports an 

infant without a catastrophic and 

obvious change to the sleep surface, 

then a consumer may continue to use 

the accessory and place a child in 

danger inadvertently. 

We considered adding a provision to 

the play yard final rule to address the 

hazards associated with play yard 

bassinet accessories that can be 

assembled while missing key structural 

elements. However, we have chosen, 

instead, to publish an NPR in today’s 

issue of the Federal Register, in which 

we propose a requirement and a test 

method to address bassinet accessory 

misassembly in play yards. 

12. Play Yards With Upward Folding 

Side Rails 

(Comment 12)—One commenter, a 

play yard manufacturer, states that play 

yards with side rails that fold upward 

should be excluded from the top rail 

configuration requirement. The 

commenter notes that most play yards 

form a dangerous V-shape if the side rail 

latch mechanisms are not locked 

properly. The commenter states that his 

firm’s play yards are designed 

differently than the ‘‘typical’’ play yard, 

in that the top rail folds upward, which 

forms a non-dangerous upside down Vshape. If a child were to put their weight 

on the top rail by leaning on it, their 

weight would actually lock the top side 

rail further, rather than unlock it. The 

commenter requests that the play yard 

standard exempt play yards that fold 

upward from the top rail configuration 

requirement because they will not 

expose a child to a dangerous V-shape. 

(Response 12)—We agree with the 

commenter. The top rail configuration 

requirements, found in section 7.10 of 

ASTM F406–12a, are intended to 

address entrapment hazards associated 

with side rails folding and creating a Vshape. If a child’s neck is caught in the 

V-shape, the child could suffocate. The 

exemption for play yards with upward 

folding side rails has already been 

added to ASTM F406–12a. By 

incorporating by reference ASTM F406– 

12a, we support the inclusion of this 

clarification in the play yard mandatory 

standard. 

13. Unsafe Sleep Environment 

(Comment 13)—Five commenters 

raise concerns about the addition of soft 

bedding, such as blankets, pillows, and 

quilted covers, which can create an 

unsafe sleep environment for an infant. 

Some commenters suggest methods to 

educate the public about this issue, 

including: Publishing a safety guide, 

providing public outreach through 

traditional and social media, and 

offering information on the Web site: 

www.saferproducts.gov, in addition to: 

www.cpsc.gov. 

(Response 13)—We agree that this is 

an extremely serious issue, and we are 

dedicated to public outreach and 

education campaigns that could prevent 

infant fatalities caused by unsafe sleep 

environments and practices. Safety 

guides, blogs, and videos addressing 

safe sleep are already available on the 

agency’s Web site at: www.cpsc.gov. 

Additionally, we use traditional media 

channels, as well as popular social 

media outlets, such as Twitter, YouTube 

and Flickr, to disseminate information 

to the public about unsafe sleep 

environments and practices. 

(Comment 14)—One commenter 

recommends that graphics or pictograms 

depicting the dangers of unsafe sleep 

environments be added to the existing 

warnings in the play yard standard in 

order to enhance their effectiveness. 

(Response 14)—We believe that 

graphics depicted on warnings are 

useful and potentially can enhance the 

effectiveness of warnings. However, the 

development of an effective pictogram 

warning takes considerable testing to 

ensure that the graphic is not confusing 

or counterintuitive or does not lessen 

the effectiveness of current warnings. 

We continue to evaluate warnings on 

play yards and other children’s products 

and will revise such warnings, as 

necessary. 

14. Clearance Around Play Yards 

(Comment 15)—One commenter is 

concerned about outside objects, such as 

window blind cords and computer 

cords, which can fall into the play yard 

and potentially strangle a child. The 

commenter feels that requiring a 

minimum clearance of 24 inches around 

a play yard would prevent children 

from reaching out and pulling window 

blind cords or other hazardous objects 

into the play yard. 

(Response 15)—For children who are 

too young to climb out of the play yard, 

a minimum clearance of about 3 feet 

usually would suffice. However, once a 

child can climb out of the play yard, 

this minimum clearance has limited 

utility. For this reason, we feel that the 

existing required warning on play yards, 

advising parents to stop using the 

product once the child can climb out, is 

the most effective way to prevent these 

incidents. The ASTM standard also 

includes warnings that address the 

hazards of strings, cords, and window 

blind cords that may fall into the play 

yard. 

15. Play Yard Covers 

(Comment 16)—One commenter is 

concerned about fatalities that have 

occurred when caregivers place 

improvised covers on the play yard in 

an attempt to keep children in the 

product. In some instances, children 

were killed when attempting to climb 

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52224 Federal Register / Vol. 77, No. 168 / Wednesday, August 29, 2012 / Rules and Regulations 

out of the play yard because they 

became trapped between the cover and 

the play yard side rail. The commenter 

feels that perhaps, there is a ‘‘market 

failure in providing adequate, and 

adequately priced, covers.’’ The 

commenter also suggests that play yard 

covers could be subject to mandatory 

regulations. 

(Response 16)—Before a child can 

stand and reach a cover, the cover likely 

presents little risk. Once the child can 

reach it, the cover itself becomes a 

hazard. We are aware of two fatal 

incidents associated with covers and 

tents that can be affixed on top of play 

yards and cribs. In one incident, a child 

was able to tear the tent fabric and 

strangle in the loose strands. In the 

other incident, the child was able to 

deform the tent poles and become 

trapped beneath the mattress and the 

inverted poles. Because of these 

incidents, we recommend that 

consumers avoid using tents and covers 

on play yards and cribs. We believe that 

the following existing warning in 

section 9.4.2.6 of ASTM F406–12a is 

sufficient to address this hazard: ‘‘Child 

can become entrapped and die when 

improvised netting or covers are placed 

on top of product. Never add such items 

to confine child in product.’’ 

16. Risks Associated With Children 

Climbing Out of a Play Yard 

(Comment 17)—One commenter feels 

that the CPSC has ‘‘unnecessarily 

disregarded the idea to make the play 

yard walls higher’’ as a way to prevent 

children from climbing out of the 

product. 

(Response 17)—A designer of a play 

yard faces limited options for 

preventing children from climbing out 

of the product. The play yard is 

essentially a lidless box. Play yards that 

prevent climbing out would require 

either higher sides or lids to be effective. 

Both designs could introduce other 

problems that potentially are of more 

concern than the problem of climbing 

out of the play yard. For instance, 

making the sides higher increases the 

difficulty caregivers have placing their 

children, especially the youngest ones, 

into the play yard. This could increase 

the use of alternative sleeping 

arrangements, such as allowing children 

to sleep in adult beds, which can have 

serious hazards associated with them. 

Introducing a lid or some other kind of 

cover to a play yard creates more 

movable parts and the potential for 

mechanical failures that could lead to 

entrapment, entanglement, or 

strangulation. 

We have been unable to identify a 

performance requirement for inclusion 

in the play yard standard that would 

effectively reduce incidents of children 

climbing out of play yards without 

simultaneously introducing other 

potential hazards. The current ASTM 

standard contains a warning advising 

parents to stop using the product once 

a child can climb out of the play yard. 

We feel that this is the most effective 

way to prevent injuries associated with 

children being able to climb out of play 

yards. 

17. Standing/Choking Deaths 

(Comment 18)—In the NPR, we 

reported that two toddlers were killed in 

separate incidents while standing up in 

a play yard. It is believed that they 

leaned forward against the side rail 

(perhaps to reach an object that the 

child had thrown outside the play yard), 

lost consciousness, or suffocated when 

the pressure from the side rail 

compressed their airway. One 

commenter asks that we continue to 

investigate these deaths and address this 

hazard. 

(Response 18)—We are very 

concerned about these deaths. At this 

time, we are unable to explain how 

these children died; and thus, we are 

unable to comment on whether there are 

changes that could be made to play yard 

designs that would prevent fatalities 

like this from occurring. We have 

reached out to medical professionals 

and are continuing to collect 

information that might assist us in 

understanding the deaths and 

determining whether there is an 

engineering solution that could prevent 

them. 

18. Hazards Related to Accessories 

(Comment 19)—One commenter notes 

that the accessories that come with play 

yards can be dangerous. Specifically, 

the commenter feels that changing table 

attachments should come with 

restraints. 

(Response 19)—There are strong 

arguments against changing table 

attachments having restraints, including 

the concern that the presence of 

restraints will give the consumer a false 

sense of security about the accessory. 

Restraints might lead to the caregiver 

walking away while the infant is left on 

the table. More troubling is the concern 

that parents mistakenly will use 

changing tables as a sleep environment, 

which is not the intended use of the 

product and can be very dangerous. 

Thus, we cannot recommend that 

changing tables have restraints. 

(Comment 20)—One commenter 

requests that play yard accessories, such 

as changing tables and bassinets, be 

banned completely. Failing this, the 

commenter asks that these products be 

required to lock in place so that they 

cannot be manipulated by infants and 

toddlers. The commenter’s 13-monthold daughter died when her head 

became trapped between a non-locking 

changing table attachment and side rail 

of a play yard. 

(Response 20)—The current ASTM 

standard includes a requirement to 

address this hazard. It can be found in 

section 5.15 of ASTM F406–12a, titled, 

Entrapment in Accessories. The 

requirement was added in 2005. The 

standard requires that accessories not 

separate from a play yard when an 

infant-size head probe is pushed against 

the attachment from inside the play 

yard with 25 pounds of force. The 

pushing direction is varied to evaluate 

the security of the attachment to the 

play yard better. We feel that this test 

is adequate to address the hazard the 

commenter mentions, and we are not 

recommending any further action. 

(Comment 21)—One commenter states 

that the cyclic testing required for rigidsided products, contained in section 8.5 

of ASTM F406–12a, should be required 

for mesh-sided products, such as play 

yards. The commenter states that a 

cyclic test would better assess the 

integrity of play yard accessory 

attachment points used to secure 

bassinets and changing tables to the side 

rails of play yards. The commenter 

recommends that the cyclic testing in 

section 8.5 of the ASTM standard be 

repeated with and without the 

attachments installed. The commenter 

states that it appears that many 

incidents reported to the CPSC occur 

when the accessory became unattached 

at one or more attachment points and 

that additional durability testing will 

ensure that the attachment points will 

hold through a lifetime of use. 

(Response 21)—The purpose of the 

cyclic testing requirement, found in 

section 8.5, is to evaluate the attachment 

security of threaded fasteners, such as 

screws, used in rigid-sided products, 

specifically full- and non-full-size cribs. 

Of the accessories mentioned by the 

commenter, bassinet play yard 

accessories are of the greatest concern 

because they are intended to be used 

while an infant is sleeping 

unsupervised. The majority of play yard 

bassinet accessories are structureless, 

fabric shells that attach to the top rails 

of play yards. Because they have no 

structure of their own they will be 

substantially unaffected by this kind of 

cyclic testing. The attachment 

components in play yards typically 

consist of plastic clips, hook-and-loop 

(Velcro) straps, or snaps sewn into soft 

material around the inner perimeter of 

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the play yard. These attachment means 

are substantially different than the 

threaded fasteners this test is intended 

to evaluate. Thus, we feel that cyclic 

testing would not adequately test the 

durability of attachment points in play 

yard accessories. 

We identified five incidents where the 

attachment points of a play yard 

bassinet accessory failed. None of the 

incidents resulted in an injury to the 

child. Three incidents were caused by 

weak fabric or poor stitching. These 

hazards are addressed in the ASTM 

standard for play yards at sections 7.7 

and 7.8, which address the durability of 

fabric and the strength of seams. The 

other two incidents were caused by 

separated hook-and-loop (Velcro) 

closures. On one, the closure failed to 

secure during the consumer’s first use of 

the product and permitted the sleep 

surface to tilt slightly. The consumer 

noticed the problem immediately. We 

have evaluated the incident and 

determined that it can be attributed, 

most likely, to poor quality control in 

the manufacturing process. In the other 

incident, the hook-and-loop closure, 

used as a back-up means of attachment, 

wore out over time. The concern is that 

if the primary attachment were to fail, 

the worn hook-and-loop closure might 

permit the sleep surface to tilt. 

However, in this case, because the hookand-loop closure was a secondary 

means of attachment, the product did 

not cause an injury or incident. 

We share the commenter’s concern 

about the robustness of bassinet and 

cradle attachments, but we do not agree 

that requiring cyclic testing for the 

attachment points will address those 

concerns. At this point, we cannot 

recommend a performance requirement 

and test method that would reduce the 

risk of injury associated with this 

hazard. Incoming data will be 

monitored to ensure that any emerging 

trends are identified. 

19. Mattress Vertical Displacement Test 

Repeatability 

(Comment 22)—One commenter feels 

that the consistency of the mattress 

vertical displacement test could be 

improved by adding a provision that 

accounts for slack in the mattress. 

(Response 22)—The change the 

commenter suggests will improve 

testing consistency for vertical mattress 

displacement by ensuring that free 

movement of fabric is taken up before 

establishing the initial clamp position 

reference point. It has already been 

approved by ASTM members and was 

published in ASTM F406–12. It is also 

contained in F406–12a. By 

incorporating by reference ASTM F406– 

12a, we support the inclusion of this 

clarification in the play yard mandatory 

standard. 

20. Impact on Play Yard 

(Comment 23)—One commenter states 

that small children have ‘‘wobbly legs 

and can fall down’’ and sustain an 

injury because the play yard is not 

secured firmly to the floor, or it might 

be placed on an unlevel floor. The 

commenter suggests securing play yards 

to the surface of hard floors with suction 

cups. 

(Response 23)—Our incident data 

suggest that most children who are 

injured by falling in a play yard simply 

lose their balance. Thus, we disagree 

that children fall in play yards because 

the products are not secured firmly to 

the floor. However, even if that were the 

case, we disagree that suction cups will 

provide an improved attachment to hard 

surfaces. The length of time for which 

the suction effect can be maintained 

depends significantly on the porosity, 

flatness, and cleanliness of the floor 

surface. Furthermore, play yards 

typically are set up and taken down 

multiple times and are used on a 

multitude of indoor surfaces, including 

carpet, hardwood, and tile, as well as 

outdoor surfaces, such as grass or dirt. 

A consumer would not only have to 

inspect the suction cups for cleanliness 

and physical deformation before each 

use, but also remember to remove and 

install the suction cups, as needed, 

depending upon the floor surface. 

Therefore, we feel that requiring suction 

cups is not an adequate means of 

preventing injuries to children who fall 

in play yards. 

21. Warnings Statements 

(Comment 24)—One commenter notes 

that the ASTM standard does not 

require multilingual warnings, and they 

ask us to consider requiring them. The 

commenter argues that the use of 

multilingual warnings reasonably could 

be expected to reduce play yard injuries 

by educating caregivers who do not 

speak or read English. 

(Response 24)—We are not opposed to 

the use of multilingual labels. Many 

manufacturers already use multilingual 

warnings, although currently, they are 

not required. We feel that play yard 

manufacturers are in the best position to 

determine who uses their product and 

decide when to create labels and 

instructional materials in other 

languages. 

(Comment 25)—One commenter feels 

that the warning label on play yards 

requiring adult supervision while the 

child uses the product is unreasonable 

because you cannot reasonably expect a 

parent to supervise a child who is 

sleeping in a play yard. 

(Response 25)—The warning label 

that this commenter refers to can be 

found in section 9.4.2.11 of ASTM 

F406–12a, and it advises caregivers: 

‘‘(a)lways provide the supervision 

necessary for the continued safety of 

your child. When used for playing, 

never leave child unattended.’’ This 

warning is intended to address the use 

of play yards as a play environment, not 

as a sleep environment. We agree with 

the commenter that a caregiver is not 

expected to continuously supervise a 

child who is sleeping in a play yard. 

This warning is intended for caregivers 

who are using the product as a play 

environment. 

22. Package and Product Marking To 

Indicate Compliance With the 

Mandatory Rule 

(Comment 26)—One commenter 

recommends that products be marked 

clearly to enable a consumer to 

determine if the product was 

manufactured after the play yard 

mandatory standard became effective. 

This would enable consumers to discern 

easily which products comply with the 

mandatory rule, and which were 

manufactured before the standard 

became effective. 

(Response 26)—A date code is already 

required to be on the product, under 

section 9.1.1.2 of ASTM F406–12a. In 

addition, future changes to the standard 

may come into effect. Because it is not 

practicable to delineate every change to 

the standard through a new mark on the 

product, we decline to take action. 

E. Summary of ASTM F406–12a and 

Description of the Final Rule 

For the play yard final rule, we are 

incorporating by reference ASTM F406– 

12a. The final rule excludes sections of 

ASTM F406–12a that apply to non-fullsize cribs exclusively. In this section, 

we: (1) summarize the requirements of 

ASTM F406–12a; and (2) describe the 

final rule, listing the excluded 

provisions of ASTM F406–12a that only 

apply to non-full-size cribs. 

1. Summary of ASTM F406–12a 

In the NPR (76 FR 58169 through 

58170), we described, in detail, the key 

provisions of ASTM F406–11 that apply 

to play yards. ASTM F406–12a differs 

from ASTM F406–11 in the following 

ways: 

• It includes the three changes to the 

play yard standard we proposed in the 

NPR, specifically two clarifications to 

the testing method used to measure the 

strength of the play yard floor, and one 

change to the Top Rail to Corner Post 

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Attachment Test that would allow 

testers to choose the shape and area of 

the clamping surface, within a specified 

range. We reviewed the language that 

ASTM adopted and, while not exactly 

the same as the wording we proposed in 

the NPR, we believe it provides better 

clarity than what we proposed. By 

incorporating by reference ASTM F406– 

12a, we support the inclusion of these 

clarifications in the play yard 

mandatory standard. 

• On its own initiative, the ASTM 

committee clarified the Top Rail to 

Corner Post Attachment Test, as well as 

the accompanying explanatory graphics. 

By incorporating by reference ASTM 

F406–12a, we support the inclusion of 

these clarifications in the play yard 

mandatory standard. 

• A preload was added to the 

Mattress Vertical Displacement Test in 

order to improve testing consistency by 

ensuring that free movement of fabric is 

taken up before establishing the initial 

clamp position reference point. We also 

received a comment to the NPR 

suggesting this change. By incorporating 

by reference ASTM F406–12a, we 

support the inclusion of this 

clarification in the play yard mandatory 

standard. 

• An exemption was included in the 

Top Rail Configuration requirement to 

exclude play yards with side rails that 

fold upward. The side rails of most play 

yards move downward vertically. If the 

side rail latch mechanisms are not 

locked properly, they can form a 

dangerous V-shape. If the child’s neck is 

caught in the V-shape, the child could 

suffocate. Play yards with side rails that 

fold upward, however, do not create this 

risk. We also received a comment to the 

NPR suggesting this change. By 

incorporating by reference of ASTM 

F406–12a, we support the inclusion of 

this clarification in the play yard 

mandatory standard. 

2. Description of the Final Rule 

The final play yard rule incorporates 

by reference ASTM F406–12a, with 

several exclusions for provisions that 

apply to non-full-size cribs only. In the 

Federal Register of December 28, 2010 

(75 FR 81766), we issued a final rule on 

safety standards for non-full-size cribs. 

Thus, the final rule excludes provisions 

of ASTM F406–12a that apply to nonfull-size cribs, including the following: 

• Section 5.17 of ASTM F406–12a, 

containing the requirements for 

mattresses in rigid-sided products; 

• Section 5.19 of ASTM F406–12a, 

containing a provision to prevent 

misassembly in non-full-size cribs; 

• Section 5.20 of ASTM F406–12a, 

containing record keeping requirements 

for non-full-size cribs; 

• The entirety of section 6 of ASTM 

F406–12a, containing the performance 

requirements for rigid-sided products; 

• Sections 8.1 through 8.10.5 of 

ASTM F406–12a, containing the test 

methods for rigid-sided products; 

• A portion of section 9.4.2.10 of 

ASTM F406–12a, containing warning 

label requirements for nonrectangular 

cribs; and 

• Section 10.1.1.1 of ASTM F406– 

12a, containing instructional literature 

requirements for non-full-size cribs. 

F. Effective Date 

The Administrative Procedure Act 

(APA) generally requires that the 

effective date of a rule be at least 30 

days after publication of the final rule. 

5 U.S.C. 553(d). 

We are providing a 6-month effective 

date, as proposed in the NPR. This will 

give suppliers sufficient time to come 

into compliance with the mandatory 

standard. 

G. Regulatory Flexibility Act 

1. Introduction 

The Regulatory Flexibility Act (RFA), 

5 U.S.C. 601–605, requires that final 

rules be reviewed for their potential 

economic impact on small entities, 

including small businesses. Section 604 

of the RFA requires that we prepare a 

final regulatory flexibility analysis when 

promulgating final rules. The final 

regulatory flexibility analysis must 

describe the impact of the rule on small 

entities and identify any alternatives 

that may reduce the impact. 

Specifically, the final regulatory 

flexibility analysis must contain: 

1. A succinct statement of the need 

for, and objectives of, the rule; 

2. A summary of the significant issues 

raised by the public comments in 

response to the initial regulatory 

flexibility analysis, a summary of the 

assessment of the agency of such issues, 

and a statement of any changes made in 

the proposed rule as a result of such 

comments; 

3. A description of, and an estimate 

of, the number of small entities to which 

the rule will apply, or an explanation of 

why no such estimate is available; 

4. A description of the projected 

reporting, recordkeeping, and other 

compliance requirements of the rule, 

including an estimate of the classes of 

small entities that will be subject to the 

requirement, and the type of 

professional skills necessary for 

preparation of the report or record; and 

5. A description of the steps that the 

agency has taken to minimize the 

significant economic impact on small 

entities, consistent with the stated 

objectives of applicable statutes, 

including a statement of the factual, 

policy, and legal reasons for selecting 

the alternative adopted in the final rule, 

and why each one of the other 

significant alternatives to the rule 

considered by the agency that affect the 

impact on small entities was rejected. 

2. The Market 

There are 21 domestic firms known to 

be producing or selling play yards in the 

United States. Ten are domestic 

manufacturers, and 11 are domestic 

importers. Under the U.S. Small 

Business Administration (SBA) 

guidelines, a manufacturer of play yards 

is small if it has 500 or fewer 

employees, and an importer is 

considered small if it has 100 or fewer 

employees. Based on these guidelines, 

nine domestic manufacturers and 10 

domestic importers known to supply 

play yards to the U.S. market are small 

businesses. The remaining domestic 

entities are one large manufacturer and 

one large importer. There are also three 

foreign firms supplying play yards to 

the U.S. market. There may be 

additional unknown small 

manufacturers and importers operating 

in the U.S. market. 

The Juvenile Products Manufacturers 

Association (JPMA) runs a voluntary 

certification program for juvenile 

products. Certification under the JPMA 

program is based on the most recent 

ASTM voluntary play yard standard, 

typically with a 6-month delay. Six of 

the nine small manufacturers produce 

play yards that are certified as 

compliant with the ASTM voluntary 

play yard standard by the JPMA. Of the 

importers, three import play yards that 

have been certified as compliant with 

the ASTM voluntary standard. One 

additional importer claims compliance 

with the ASTM standard but is not 

JPMA certified. 

3. Impact of the Standard on Small 

Businesses 

a. Costs of Complying With the 

Voluntary Standard 

The extent to which each firm will be 

impacted by the play yard mandatory 

standard depends upon whether the 

firm’s play yards currently comply with 

the ASTM voluntary standard. Small 

firms whose play yards already comply 

with the voluntary standard will not 

incur any new costs. Many of these 

firms are active in the ASTM standard 

development process, and compliance 

with the voluntary standard is part of an 

established business practice. Thus, it is 

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likely that most of the firms that already 

comply with the ASTM standard would 

continue to do so, even in the absence 

of a mandatory regulation. 

b. Small Domestic Manufacturers 

Six of the small manufacturers 

produce play yards known to comply 

with the voluntary standard. Small 

firms whose play yards already comply 

with the voluntary standard will not 

incur any new costs. For the three 

manufacturing firms whose play yards 

may not be compliant with the 

voluntary standard, the costs could be 

more significant. Meeting the existing 

voluntary standard could require 

manufacturers to redesign their product. 

The impact on manufacturers who 

produce noncompliant play yards may 

be mitigated if the costs are treated as 

new product expenses and amortized 

over time. 

This scenario also assumes that the 

three firms whose play yards are not 

JPMA certified do not meet the 

voluntary standard. In fact, we have 

identified many instances in which a 

juvenile product not certified by the 

JPMA complies with the ASTM 

voluntary standard. To the extent that 

these firms already may supply play 

yards that meet the ASTM voluntary 

standard, the costs incurred would be 

lower. 

c. Small Domestic Importers 

Four of the 10 small importers 

produce play yards known to comply 

with the voluntary standard. Three are 

certified by the JPMA, and one 

additional firm claims compliance with 

the ASTM standard. Small firms whose 

play yards already comply with the 

voluntary standard will not incur any 

new costs. 

The costs to the six importers whose 

play yards may not be compliant with 

the voluntary standard could be more 

significant. Importers of play yards 

would need to find an alternate source 

if their existing supplier does not come 

into compliance with the standard. 

Purchasing compliant, higher quality 

play yards could increase the cost of the 

product. 

This will not be an option for two of 

the noncompliant play yard importers 

because they specialize in the 

importation of play yards from a 

specific foreign company. Thus, finding 

an alternative supply source is probably 

not an option for them. These firms 

could respond to the rule by 

discontinuing the import of play yards. 

The impact of this decision could be 

mitigated by replacing play yards with 

a different infant or toddler product. 

Deciding to import an alternative infant 

or toddler product would be a 

reasonable and realistic way to offset 

any lost revenue. 

As with manufacturers, to the extent 

that some of the firms believed to 

supply noncompliant play yards 

actually may supply play yards that 

meet the ASTM voluntary standard, the 

costs incurred would be lower. 

4. Alternatives 

An alternative that could minimize 

the economic impact on small business 

is providing an effective date longer 

than 6 months. However, the JPMA, 

which represents many play yard 

manufacturers, felt that a 6-month 

effective date was adequate to allow 

suppliers to come into compliance with 

the mandatory standard. We agree. 

Therefore, we have chosen a 6-month 

effective date for the play yard 

mandatory standard. 

5. Issues Raised by Public Comment 

We received several comments from 

the public in response to the initial 

regulatory flexibility analysis, including 

comments regarding the use of market 

data, the impact on small businesses, 

and the appropriate effective date. A 

summary of those comments and our 

responses can be found in part D of this 

preamble, titled, ‘‘Response to 

Comments on the Proposed Rule.’’ 

6. Conclusion of the Final Regulatory 

Flexibility Analysis 

The impact of the final play yard rule 

on firms supplying non-ASTMcompliant play yards could be 

significant. However, the requirements 

of the final rule address known play 

yard hazard patterns and will help 

reduce injuries and deaths. We are 

providing a 6-month effective date as 

proposed in the NPR. This will give 

suppliers sufficient time to come into 

compliance with the mandatory 

standard and spread the costs over a 

longer period of time. 

H. Environmental Considerations 

The Commission’s regulations address 

whether we are required to prepare an 

environmental assessment or an 

environmental impact statement. Our 

rules generally have ‘‘little or no 

potential for affecting the human 

environment,’’ and therefore, are 

exempt from any requirement to prepare 

an environmental assessment or impact 

statement. 16 CFR 1021.5(c)(1). This 

rule falls within the categorical 

exemption. 

I. Paperwork Reduction Act 

This rule contains information 

collection requirements that are subject 

to public comment and review by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995. The preamble to the 

proposed rule (76 FR 58173 through 

58174) discussed the information 

collection burden of the proposed rule 

and specifically requested comments on 

the accuracy of our estimates. Briefly, 

sections 9 and 10 of ASTM F406–12a 

contain requirements for marking, 

labeling, and instructional literature. 

These requirements fall within the 

definition of ‘‘collection of 

information,’’ as defined in 44 U.S.C. 

3502(3). 

OMB has assigned control number 

3041–0152 to this information 

collection. We did not receive any 

comments regarding the information 

collection burden of this proposal. 

However, the final rule makes 

modifications regarding the information 

collection burden because the number 

of estimated suppliers subject to the 

information collection burden is now 

estimated to be 24 firms rather than the 

nine firms initially estimated in the 

proposed rule. 

Accordingly, the estimated burden of 

this collection of information is 

modified as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN

16 CFR section Number of 

respondents 

Frequency of 

responses 

Total annual 

responses 

Hours per 

response 

Total burden 

hours 

1221.2(a) .............................................................................. 24 3 72 1 72 

There are 24 known firms supplying 

play yards to the U.S. market. All 24 

firms are assumed to use labels already 

on both their products and their 

packaging, but they might need to make 

some modifications to their existing 

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52228 Federal Register / Vol. 77, No. 168 / Wednesday, August 29, 2012 / Rules and Regulations 

labels. The estimated time required to 

make these modifications is about 1 

hour per model. Each entity supplies an 

average of three different models of play 

yards; therefore, the estimated burden 

associated with labels is 1 hour per 

model × 24 entities × 3 models per 

entity = 72 hours. We estimate the 

hourly compensation for the time 

required to create and update labels is 

$28.36 (U.S. Bureau of Labor Statistics, 

‘‘Employer Costs for Employee 

Compensation,’’ September 2011, Table 

9, total compensation for all sales and 

office workers in goods-producing 

private industries: http://www.bls.gov/ 

ncs/). Therefore, the estimated annual 

cost to industry associated with the 

labeling requirements is $2,041.92 

($28.36 per hour × 72 hours = 

$2,041.92). There are no operating, 

maintenance, or capital costs associated 

with the collection. 

In compliance with the Paperwork 

Reduction Act of 1995 (44 U.S.C. 

3507(d)), we have submitted the 

information collection requirements of 

this final rule to the OMB. 

J. Preemption 

Section 26(a) of the Consumer 

Product Safety Act (CPSA), 15 U.S.C. 

2075(a), provides that where a consumer 

product safety standard is in effect and 

applies to a product, no state or political 

subdivision of a state may establish or 

continue in effect a requirement dealing 

with the same risk of injury, unless the 

state’s requirement is identical to the 

federal standard. Section 26(c) of the 

CPSA also provides that states or 

political subdivisions of states may 

apply to the Commission for an 

exemption from this preemption under 

certain circumstances. Section 104(b) of 

the CPSIA refers to the rules to be 

issued under that section as ‘‘consumer 

product safety rules,’’ thus, implying 

that the preemptive effect of section 

26(a) of the CPSA would apply. 

Therefore, a rule issued under section 

104 of the CPSIA will invoke the 

preemptive effect of section 26(a) of the 

CPSA when the rule becomes effective. 

K. Certification 

Once in effect, the final rule on play 

yards will make it unlawful for anyone 

to manufacture, distribute, or import a 

play yard into the United States that is 

not in conformity with the standard. 15 

U.S.C. 2068(1). Pursuant to section 

14(a)(2) of the CPSA, play yards must be 

certified by the manufacturer to the final 

standard based on testing conducted by 

a CPSC-accepted third party conformity 

assessment body. The third party testing 

and certification requirement for play 

yards will not be in effect until we issue 

a final notice of requirements (NOR). 

The final NOR establishes requirements 

for how third party conformity 

assessment bodies can become accepted 

by us to test play yards to the final rule. 

A proposed NOR for play yards was 

published in the Federal Register on 

May 24, 2012, as part of an NPR titled, 

‘‘Requirements Pertaining to Third Party 

Conformity Assessment Bodies.’’ 77 FR 

31086. When the final rule is effective 

and the NOR is final, third party 

conformity assessment bodies can apply 

to us for acceptance of their 

accreditation to test play yards. Play 

yard manufacturers will be required to 

certify products to the final play yard 

rule based on third party testing once 

we have accepted the accreditation of 

such laboratories. 

List of Subjects in 16 CFR Part 1221 

Consumer protection, Imports, 

Incorporation by reference, Infants and 

children, Labeling, Law enforcement, 

Safety and toys. 

Therefore, the Commission amends 

Title 16 of the Code of Federal 

Regulations by adding part 1221 to read 

as follows: 

PART 1221—SAFETY STANDARD FOR 

PLAY YARDS 

Sec. 

1221.1 Scope. 

1221.2 Requirements for play yards. 

Authority: The Consumer Product Safety 

Improvement Act of 2008, Pub. L. 110–314, 

section 104, 122 Stat. 3016 (August 14, 2008). 

§ 1221.1 Scope. 

This part establishes a consumer 

product safety standard for play yards 

manufactured or imported on or after 

February 28, 2013. 

§ 1221.2 Requirements for play yards. 

(a) Except as provided in paragraph 

(b) of this section, each play yard must 

comply with all applicable provisions of 

ASTM F406–12a, Standard Consumer 

Safety Specification for Non-Full-Size 

Baby Cribs/Play Yards, approved on 

May 1, 2012. The Director of the Federal 

Register approves this incorporation by 

reference in accordance with 5 U.S.C. 

552(a) and 1 CFR part 51. You may 

obtain a copy from ASTM International, 

100 Bar Harbor Drive, P.O. Box 0700, 

West Conshohocken, PA 19428; http:// 

www.astm.org. You may inspect a copy 

at the Office of the Secretary, U.S. 

Consumer Product Safety Commission, 

Room 820, 4330 East-West Highway, 

Bethesda, MD 20814, telephone 301– 

504–7923, or at the National Archives 

and Records Administration (NARA). 

For information on the availability of 

this material at NARA, call 202–741– 

6030, or go to: http://www.archives.gov/ 

federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

(b) Comply with the ASTM F406–12a 

standard with the following exclusions: 

(1) Do not comply with section 5.17 

of ASTM F406–12a. 

(2) Do not comply with section 5.19 

of ASTM F406–12a. 

(3) Do not comply with section 5.20 

of ASTM F406–12a. 

(4) Do not comply with section 6, 

Performance Requirements for RigidSided Products, of ASTM F406–12a, in 

its entirety. 

(5) Do not comply with sections 8.1 

through 8.10.5 of ASTM F406–12a. 

(6) Instead of complying with section 

9.4.2.10 of ASTM F406–12a, comply 

with only the following: 

(i) 9.4.2.10 For products that have a 

separate mattress that is not 

permanently fixed in place: Use ONLY 

mattress/pad provided by manufacturer. 

(ii) [Reserved]. 

(7) Do not comply with section 

10.1.1.1 of ASTM F406–12a. 

Dated: August 23, 2012. 

Todd A. Stevenson, 

Secretary, Consumer Product Safety 

Commission. 

[FR Doc. 2012–21168 Filed 8–28–12; 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–2009–F–0570] 

Food Additives Permitted for Direct 

Addition to Food for Human 

Consumption; Vitamin D2 Bakers Yeast 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

food additive regulations to provide for 

the safe use of vitamin D2 bakers yeast 

as a source of vitamin D2 and as a 

leavening agent in yeast-leavened baked 

products at levels not to exceed 400 

International Units (IU) of vitamin D2

per 100 grams (g) in the finished food. 

This action is in response to a petition 

filed by Lallemand, Inc. (Lallemand). 

DATES: This rule is effective August 29, 

2012. Submit either electronic or 

written objections and requests for a 

hearing by September 28, 2012. See 

section VII of this document for 

information on filing objections. 

mstockstill on DSK4VPTVN1PROD with RULES