[Federal Register Volume 61, Number 61 (Thursday, March 28, 1996)]
[Rules and Regulations]
[Pages 13931-13947]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-7301]



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DEPARTMENT OF TRANSPORTATION
46 CFR Part 160

[CGD 94-110]
RIN 2115-AE96


Recreational Inflatable Personal Flotation Device Standards

AGENCY: Coast Guard, DOT.

ACTION: Final rule.

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SUMMARY: The Coast Guard is adopting a final rule that establishes 
structural and performance standards for inflatable personal flotation 
devices (PFDs) for recreational boaters, as well as the procedures for 
Coast Guard approval of inflatable PFDs. These standards allow for 
approval of inflatable PFDs which are more amendable to continuous wear 
by recreational boaters than inherently buoyant PFDs, thereby 
encouraging use of PFDs by the boating public and saving lives.

DATES: This rule is effective on September 24, 1996.

ADDRESSES: Unless otherwise indicated, documents referred to in this 
preamble are available for inspection or copying at the office of the 
Executive Secretary, Marine Safety Council (G-LRA/3406), U.S. Coast 
Guard Headquarters, 2100 Second Street SW., room 3406, Washington, DC 
20593-0001, between 8 a.m. and 3 p.m., Monday through Friday, except 
Federal holidays.

FOR FURTHER INFORMATION CONTACT:
Mr. Robert L. Markle, U.S. Coast Guard, Marine Safety and Environmental 
Protection Directorate, telephone (202) 267-6446, facsimile (202) 267-
1069, or electronic mail ``mvi-3/G-M[email protected]''. A copy of 
this final rule may be obtained by calling the Coast Guard's toll-free 
Customer Infoline, 1-800-368-5647. In Washington, DC, call (202) 267-
0780.

SUPPLEMENTARY INFORMATION:

Regulatory History

    On November 9, 1993, the Coast Guard published an Advance Notice of 
Proposed Rulemaking (ANPRM) entitled ``Inflatable Personal Flotation 
Devices'' in the Federal Register (58 FR 59428). On June 23, 1995, the 
Coast Guard published an interim rule (IR) entitled ``Inflatable 
Personal Flotation Device Standards'' in the Federal Register (60 FR 
32836). This IR became effective on July 24, 1995. Due to requests, a 
public meeting, announced in the August 2, 1995, Federal Register (60 
FR 39268), was held at Coast Guard Headquarters on August 28, 1995. On 
October 10, 1995, the Coast guard published a notice in the Federal 
Register (60 FR 52631, October 10, 1995) extending the comment period 
on the IR from October 23, 1995, to November 6, 1995, to allow 
discussion of the rule at the National Boating Safety Advisory Council 
(NBSAC) meeting on October 30-31, 1995. Additionally, minor editorial 
changes reflecting Coast Guard organizational changes were made to the 
regulations established by the IR by a final rule published September 
29, 1995, in the Federal Register (60 FR 50455).

[[Page 13932]]

    In addition to this rulemaking project, a separate rulemaking 
project (CGD 93-055) resulted in the publication of a Notice of 
Proposed Rulemaking (NPRM) which proposed complementary rules governing 
the carriage, use, registration, and defect notification for inflatable 
PFDs for recreational boats (June 23, 1995), Federal Register (60 FR 
32861)). Additional procedures for approval of inflatable PFDs, and 
other types of PFDs, were included in the NPRM. These provisions were 
proposed separately because they affect other types of PFDs besides 
inflatables. The Final Rule for this project (CGD 93-055) is being 
published elsewhere in today's Federal Register.
    This rule, establishing minimum safety standards for inflatable 
PFDs, is being made effective 180 days after publication in the Federal 
Register pursuant to 46 U.S.C. 4302(b). Although the IR was effective 
30 days after its publication, it provided a new category for approval 
of PFDs, and did not change any existing approval procedures. Since 
this Final Rule changes regulations now in effect, it could affect 
persons who relied upon regulations in the IR which are now being 
changed. For this reason, the 180 day delay in the effective date under 
46 U.S.C. 4302(b) applies. This should not affect the progress of 
manufacturers' design and testing, and therefore should not result in 
delay in getting approved devices to market. Manufacturers can proceed 
with design and testing during this period.

Public Meeting

    A number of initial comments to the IR expressed confusion about 
the basis and applicability of the ``Life-Saving Index'' (LSI) used in 
the IR as an alternative path for approval. The LSI is a probability 
based risk assessment tool designed to evaluate a PFD design's overall 
lifesaving potential. Based on comments, the Coast Guard held a public 
meeting and training seminar to aid interested persons in understanding 
and applying the LSI analysis process. The meeting was attended by six 
PFD manufacturers, two inflation system manufacturers, an official from 
a boat owners association, a member of the public from the National 
Boating Safety Advisory Council (NBSAC), and representatives from 
Underwriters Laboratories (UL), the only laboratory currently 
recognized to perform the approval tests for inflatable PFD devices. A 
summary and video tape of the meeting are available as part of the 
public docket for inspection and copying where indicated under 
ADDRESSES. During the meeting, Coast Guard personnel discussed the 
history of this rulemaking, with emphasis on the development of the LSI 
and its role and usefulness in evaluating the overall lifesaving 
potential of various PFD designs. There was also a discussion of the 
PFD information pamphlet which accompanies the sale of inflatable PFDs 
and provides important information to the potential consumer before a 
PFD is purchased. Specific details of the meeting are discussed below 
in the appropriate sections.

Approval History

    Under the IR, Coast Guard approval of inflatable PFDs and component 
materials has been possible since July 24, 1995. To this date, four 
manufacturers have started the approval process for at least 6 models 
of inflatable PFDs, but no device has yet received final approval. 
Additionally, no inflator or inflation chamber material has been 
completely tested to be accepted by the Coast Guard as meeting the 
requirements of the UL 1191 consensus standard for component materials 
incorporated by reference into the Coast Guard regulations. Although a 
number of manufacturers have completed preliminary testing of prototype 
designs of PFDs, sample PFDs for final testing have not been 
constructed. This is due to a lack of accepted component materials 
since a sample PFD undergoing final testing for Coast Guard approval 
must be constructed of the same or equivalent materials that will be 
used in commercially available manufactured products to ensure that the 
final products meet the approval standards.

Regulatory Information

    The two main standards adopted by the IR and retained in this 
rulemaking are Underwriters Laboratories (UL) standards for inflatable 
PFDs and PFD components (UL 1180 and 1191, respectively). These 
standards were developed in accordance with the American National 
Standards Institute (ANSI) procedure for voluntary industry standards. 
In accordance with the ANSI procedures, interested parties were 
provided with an opportunity to participate in the development of the 
standards. The public was also given an opportunity to comment on the 
adoption of approval standards for inflatable PFDs in the ANPRM 
published on November 9, 1993 (58 FR 59428), and the IR published on 
June 23, 1995 (60 FR 32836). The ANPRM advised of the intention to use 
an industry consensus standard and encouraged interested, knowledgeable 
persons to participate in the ANSI standards making process. On 
February 24, 1994, notice was published in the Federal Register (59 FR 
9015) of the Coast Guard's participation in the first consensus 
standards meeting with UL. This notice again invited interested 
technical experts knowledgeable in the field to participate in the 
meeting and process. Comments received in response to the ANPRM and IR 
were generally in favor of development of structural and performance 
standards for inflatable personal flotation devices and procedures for 
Coast Guard approval of inflatable PFDs. The UL standard (UL 1180) is 
complete, with the exception of several reserved sections.

Background and Purpose

    The regulations in this final rule are intended to allow approval 
of PFDs which may be more appealing to recreational boaters than 
currently approved PFDs, thereby increasing the percentage of PFDs 
actually used by the boating public and saving lives. However, the 
Coast Guard notes that the currently approved inherently buoyant PFDs 
have an excellent lifesaving record. The Coast Guard boating statistics 
show that while boating activity was increased several fold, the number 
of fatalities has dropped from about 1,800 to 800 per year over the 
past 25 years, and this decrease is in part due to use of these 
inherently buoyant PFDs. The Coast Guard also notes that inherently 
buoyant PFDs are more appropriate for non-swimmers than inflatable 
PFDs. Non-swimmers may panic when they enter the water, and may 
therefore not be able to manually or orally inflate an inflatable PFD. 
Moreover, there are a number of boating applications for which 
inflatable PFDs are not suitable, as listed in the PFD information 
pamphlet. Therefore, inherently buoyant PFDs will continue to play a 
vital role in boating safety programs for the public.

Advisory Committee and Other Consultations

    In developing these regulations the Coast Guard consulted with the 
National Boating Safety Advisory Council (NBSAC) and the National 
Association of State Boating Law Administrators (NASBLA). In May 1994, 
NBSAC passed a resolution recommending approval for Type I, II, III, 
IV, and V inflatable PFDs. PFDs differ in Type based on the environment 
in which they are designed to perform and their intended use. The 
various Types of PFDs are described in more detail in the IR. In 1988, 
1993 and 1994, NASBLA also passed resolutions urging that approvals for 
inflatable PFDs be

[[Page 13933]]
granted as soon as possible. Additionally, the National Transportation 
Safety Board has recommended that the Coast Guard approve inflatable 
PFDs.
    NBSAC formed a subcommittee to study the implementation of the 
various types of approvals that might be granted by the Coast Guard and 
developed an ``inflatable PFD objectives statement'' and ``performance 
goals''. Copies of these documents are included in the docket file for 
this rulemaking. The documents identified a number of goals that NBSAC 
determined to be appropriate in the effort to set standards for the 
manufacture and approval of inflatable PFDs. In November 1994, the full 
council passed a resolution supporting the objectives statement and 
goals.
    After publication of the IR, NBSAC and NASBLA again considered the 
issue of inflatable PFD approval and passed resolutions recommending 
approval of inflatable PFDs. Both resolutions, though, objected to the 
modifications to the UL 1180 standard that the Coast Guard included in 
the IR. The details of the most recent deliberations and the 
resolutions are discussed with the appropriate comments below and the 
resolutions are included in the docket file for this rulemaking.

Inflatable PFD Studies

    As discussed in the IR, the Coast Guard has sponsored two studies 
on the suitability of inflatable PFDs in the recreational boating 
environment: a 1981 Inflatable PFD Field Test, Report No. CG-M-84-1 and 
a 1993 study conducted by the BOAT/U.S. Foundation for Boating Safety. 
Each study involved the use of about 500 inflatable PFDs in a 
recreational boating environment. Copies of these studies are included 
in the docket file for this rulemaking. Initial review of these studies 
indicated that inflatable PFDs could not be approved without extensive 
servicing requirements or conditions on approval. However, as discussed 
below, developments in inflatable PFDs have allowed the Coast Guard to 
establish the approval standards for inflatable PFDs adopted in this 
final rule.

New Developments in Inflatable PFDs and UL Standards

    New developments in the manufacture of inflatable PFDs, along with 
work done by UL in this area since the testing was conducted in the 
above studies, have improved the chances that inflatable PFDs will work 
when used and maintained by the average boater. The problems revealed 
by the two studies discussed above have been addressed in the UL 
standard. Consequently, PFDs meeting the requirements of the new UL 
standard, along with certain additional requirements included in this 
final rule, should not have the problems that prevented the Coast Guard 
from approving recreational inflatable PFDs in the past.
    The Coast Guard is issuing a final rule for approval of inflatable 
PFDs at this time based on the need for more wearable PFDs, boater 
demand for alternatives and the development of more ``user 
serviceable'' inflatable PFDs. With these user serviceable PFDs there 
is a good chance that the user of the PFD will (1) recognize when the 
PFD needs servicing and (2) be able to perform the servicing correctly. 
These improved PFDs are equipped with inflation mechanisms (inflators) 
that are more user-friendly than previous models. User-friendly 
features are often referred to as mechanisms that are designed with 
``good human factors''. Good human factors relate to the ease with 
which boaters can determine when their inflatable PFD needs rearming 
and the ease with which they can correctly rearm the PFD. Good human 
factors design will decrease the incidence of unarmed inflatable PFDs 
that were evident in the studies discussed above.
    The UL standard defines two different performance levels for 
inflators. For an inflator to meet the requirements of the UL standard, 
a high percentage of test subjects must be able to correctly identify 
whether an inflator is properly armed and to be able to rearm the 
device with no training other than use of the owner's manual provided 
by the manufacturer and toll-free calls to a manufacturer's help line, 
if one is available. The performance level assigned is based on the 
percentage of passing test results. At this time, an inflator capable 
of being accepted at the highest level is not available at a reasonable 
cost, but at least one such inflator is under development. The 
characteristics of the higher performing inflators (use code 1F) are 
described in item 1 of the discussion of specific comments below. If 
properly maintained, inflatable PFDs with the lower level performing 
inflation mechanisms provide high reliability, though the probability 
of proper maintenance (maintainability) remains a key component of 
ensuring their effectiveness. The information pamphlet and owner's 
manual required to accompany the sale of inflatable PFDs will emphasize 
the need for proper maintenance of these devices. Additionally, the 
inflatable PFD label will include warnings to check that the unit is 
fully armed before donning and to perform a service test at least once 
each year.

Discussion of Comments and Changes

    Seventy comments were received from fifty-seven individuals and 
organizations in response to the interim final rule (IR) published June 
23, 1995. Thirty-eight of those commenting were boaters, nine were PFD 
and component manufacturers or PFD consultants, and seven were from 
organizations or associations representing manufacturers, boaters, 
cities or state boating law enforcement. The remaining three groups 
commenting were laboratories or dealers. A number of manufacturers and 
organizations commented more than once. The Coast Guard has reviewed 
all of the comments and revised the rule as appropriate. The comments 
have been grouped by general and specific issues, and are discussed 
below.

General Comments

    None of the comments opposed Coast Guard approval of inflatable 
PFDs; 49 comments urged the Coast Guard to approve inflatable PFDs as 
soon as possible.
    Boaters submitted the largest number of comments. Nearly all of 
their comments supported Coast Guard approval of inflatable PFDs as 
soon as possible, and many of them indicated that boaters would be 
inclined to wear an inflatable PFD more frequently than a currently 
approved PFD. Many of these comments either explicitly or implicitly 
cited the published views of a boating organization, which opposed many 
of the IR provisions. Two comments also specifically favored the use of 
inflatables for Coast Guard Auxiliary patrols because of their 
increased wearability. Additionally, one comment pointed out the 
potential increased safety benefit of greater flotation of inflatable 
PFDs when compared to presently approved inherently buoyant PFDs.
    Wear Rates and Wearability: Ten comments noted that they favored 
the use of inflatable PFDs because of their comfort (i.e., easy to 
wear, not as hot, less bulky, and greater maneuverability when 
performing operations aboard a boat). Six commenters indicated that 
they currently owned yoke style inflatable PFDs that they were pleased 
with. Eight commenters, including all but one of the above owners, 
indicated they currently wear a PFD continuously. Eight more comments 
indicated that the writer would wear an inflatable if approved and 
available. In addition,

[[Page 13934]]
several comments from boaters indicated that they were not opposed to a 
requirement that inflatables be worn to be considered as approved 
devices. Approval of a PFD signifies that the PFD can be counted 
towards the ``carriage requirements'' (33 CFR 175, Subpart B) which 
requires boats to have on board specified quantities and Types of 
approved PFDs. This totals 21 comments whose writers either presently 
wear or would wear inflatable PFDs if they were approved. Three 
comments from boaters indicated that they opposed any condition that 
required PFDs to be worn to meet the carriage requirements.
    Four comments indicated the belief that inflatable PFDs would save 
lives because people would be more apt to wear them. This view was 
bolstered by two comments which noted that 80 percent of drownings 
occur as a result of people not wearing PFDs, as opposed to wearing the 
wrong kind of PFD, and that these accidents were usually sudden events 
that precluded the donning of a PFD after recognizing the event was 
about to happen. Five other comments indicated that if an impact on 
boating accident drownings is expected, there needs to be an incentive 
to increase wear rate of PFDs, such as requiring that PFDs be worn to 
count as meeting the carriage requirements, particularly on small 
boats. The Coast Guard recognizes that increased wear of PFDs is 
essential to increase the number of lives saved.
    Maintainability: Two comments noted that inflatable PFDs have been 
in military use since the beginning of World War II. One of these 
comments noted using Navy-issue inflatables in World War II and 
questioned why the Coast Guard would delay the approval of inflatables 
for the boating community, when a perfectly satisfactory inflatable PFD 
was available 50 years ago. The Coast Guard notes that inflatables used 
by the military both in the past and currently are not maintained by 
the individual user, but rather by trained professionals. As discussed 
in the ANPRM and IR, ensuring that inflatable PFDs are maintainable by 
the user has been one of the key concerns for introduction of 
inflatables to recreational boating. As previously mentioned, lack of 
proper maintenance adversely affects reliability due to the probability 
that some PFDs will not be rearmed or will be rearmed improperly. Due 
to the importance of this aspect of inflatable PFD use, the Coast Guard 
emphasizes that users should check their inflation mechanisms 
frequently.
    Non-swimmers and Children: Six comments from boaters expressing 
support for approval of inflatable PFDs indicated that their support 
was based on concerns about the safety of family members who were 
either children or poor swimmers. These comments suggested that 
children and poor swimmers would be more likely to wear an inflatable 
PFD than other types of currently approved PFDs due to an inflatable 
PFD's increased comfort and more desirable appearance. These comments 
concern the Coast Guard because they suggest that the desire for a more 
comfortable device may lure people to use inflatable PFDs 
inappropriately. The Coast Guard notes that the consensus committee 
preparing the UL 1180 Standard, incorporated into this rule, 
specifically pointed out that PFDs approved under the standard are not 
suitable for non-swimmers or children. Additionally, this issue was 
specifically raised in the ANPRM and IR of this rulemaking. The Coast 
Guard emphasizes that under this rule, inflatable PFDs cannot be 
approved for children and that non-swimmers should be strongly 
discouraged from choosing this type of lifesaving device.
    Approval of inflatable PFDs for children is not now considered 
appropriate by the Coast Guard and UL consensus standard committee due 
to concerns about a child's ability to take the necessary steps to 
initiate inflation in an emergency or perform backup inflation in case 
the primary system fails. The Coast Guard notes that the issue of 
inflatable devices for children may be revisited after more experience 
is gained with approval of inflatable PFDs for adults.
    As for the use of inflatable PFDs by non-swimmers, as noted in the 
IR, the Coast Guard acknowledges that there is no practical way that 
law enforcement officials can conduct a field assessment of swimming 
abilities, and thus there are no regulations restricting the use of 
inflatable PFDs by non-swimmers. However, because of the unique risks 
associated with these devices, the labeling and information pamphlet 
for these PFDs are required to explicitly state that the devices are 
not recommended for use by non-swimmers.
    Terminology: One comment suggested that the barrier between 
wearable inflatables and many potential consumers is that the use of 
the word ``approved'' by the Coast Guard to denote devices which have 
met the stated requirements, and that the term ``approved'' is not the 
most accurate or effective term. The comment suggested substituting 
``recognized as a required device'' or ``meets Coast Guard minimum 
carriage requirements'' for the term ``approved''. The Coast Guard has 
not adopted this suggestion. As previously discussed in the IR, the 
Coast Guard acknowledges that the term ``approved'' may cause some 
confusion and misperceptions to the public. However, both the terms 
suggested by the comment may cause even more confusion. The term 
``approved'' is well recognized by the public and has been used by the 
Coast Guard for over 50 years to denote that a lifesaving device meets 
Coast Guard minimum safety standards. The term ``recognized as a 
required device'' may confuse the boating public as to the implications 
of a device being ``recognized'' versus ``approved''. As for the phrase 
``meets the Coast Guard minimum carriage requirements'', in addition to 
possible confusion over the implications of a new term, the phrase is 
not being adopted because it may cause boaters to mistakenly believe 
that the carriage requirements are met by merely having that one 
device. In almost all cases, this is not true and to meet the carriage 
requirements, boaters may have to have several devices aboard their 
vessel.
    Inflatable PFD Costs/Affordability: Thirteen comments from eleven 
boaters, one dealer, and a boat club addressed the issue of ensuring 
the approval of reasonably-priced inflatable PFDs. Comments on this 
issue were solicited in the initial ANPRM and were discussed in the IR. 
One comment acknowledged that Coast Guard approval of inflatable PFDs 
may bring costs down by increasing sales and competition. On the other 
hand, several of these comments indicated the belief that the Coast 
Guard's modifications to the UL 1180 standard would substantially 
increase the cost of approved inflatable PFDs without saving 
significantly more lives. Five of these comments specifically indicated 
the view that increased testing costs due to Coast Guard additions to 
the UL standard would keep manufacturers from seeking approval while 
another comment was concerned that Coast Guard approval would merely 
lead to the availability of limited products at high prices. Four 
comments thought that boaters would be less able to afford the PFDs 
made under the Coast Guard modifications than inflatable PFDs that only 
met the UL standard. Several others were simply concerned that the cost 
of inflatables would deter many boaters from buying an inflatable PFD. 
Two commenters specifically noted that they have been wearing the yoke 
style PFD with harness and found that

[[Page 13935]]
although many boaters inquired about the devices, the high cost seemed 
to be a deterrent to most boaters. One of these comments noted also 
that the rearming kits are fairly expensive.
    Four comments urged the Coast Guard to make the regulations for 
inflatables stringent for safety purposes, but not to the point so as 
to drive the prices ``out of sight''. One of these comments expressed 
concern that the manufacturers would pass on the expense of additional 
approval requirements to the consumer, making the resultant PFDs 
unaffordable. The comment stated that safety of the boating public 
should be a high priority for the government and that the Coast Guard's 
requirements should result in an easy-to-wear, affordable, and 
comfortable inflatable lifejacket that meets the carriage requirements.
    A number of PFD and component material manufacturers' comments also 
addressed cost. These comments objected to the IR's required use of use 
code 1F inflators, in place of the LSI evaluation. The objections 
centered on the fact that currently, the only use code 1F inflator 
which could be accepted would be disposable, and therefore 
prohibitively expensive to maintain. At the time the IR was published, 
the Coast Guard believed that use code 1F inflators would be available 
at a reasonable cost. Unfortunately, since that time, no affordable use 
code 1F inflator has been produced. However, while the IR did encourage 
use of 1F inflators, it did not require them for approval.
    Additionally, several manufacturers objected to some of the costs 
of testing associated with the requirements added by the Coast Guard to 
the UL requirements. These objections are discussed further with the 
specific comments below.
    The Coast Guard notes that the lowest priced PFDs permitted by the 
UL standard are eligible for approval under the IR and this final rule. 
Less expensive PFDs that differ from UL 1180 may also be approved under 
the equivalency provisions contained in the IR and which are being 
retained in the final rule. The additional testing costs imposed by the 
Coast Guard modifications to the UL standard requirements under the IR 
are minimal and will decrease under this final rule. In addition, the 
lifesaving benefits of the additional provisions retained in this final 
rule outweigh the associated costs as discussed under ``Regulatory 
Evaluation.''
    Comments on specific requirements are discussed below under 
``Specific Comments and Major Areas of Revision''.
    IR Consistency with UL Standards: Nine comments from manufacturers, 
manufacturing organizations, and boating organizations and various 
comments from boaters requested that the Coast Guard amend the 
requirements for approval of inflatable PFDs contained in the IR so as 
to make them more consistent or, in the case of a few comments, 
identical with the requirements of UL 1180 and UL 1191 standards.
    A number of comments objected to the perceived delay in making 
Coast Guard-approved inflatable PFDs available to recreational boaters. 
These comments expressed the opinion that these delays were caused by 
the Coast Guard requirements contained in the two UL standards adopted, 
UL 1180 and 1191. The general consensus of these comments was that the 
increased safety benefits of having approved inflatables available and 
worn by boaters would outweigh any potential increase in safety 
benefits resulting from the manufacture of inflatable PFDs that met the 
IR's additional requirements. One comment suggested that the IR places 
too much emphasis on ensuring that the vests are 100 percent perfect, 
and other comments cited overregulation as the major obstacle to having 
the vests approved.
    The Coast Guard notes that though a number of manufacturers have 
completed preliminary testing of designs, no inflatable PFD has yet 
been submitted for final testing and approval. This delay has been 
caused by the lack of accepted component materials (inflators of any 
use code and inflation chamber material) which are needed to produce 
any device submitted to the Coast Guard for final approval. The interim 
rule did not impose any additional requirements to the UL 1191 
consensus standard, which sets the acceptance standards for component 
materials.
    Several comments indicated that changes to the UL standard embodied 
in the IR were not consistent with the promises the Coast Guard made to 
the industry. The Coast Guard notes the statements in the ANPRM and 
meeting notice for the first consensus committee meeting which clearly 
define the Coast Guard's intentions and commitments in entering into 
the rulemaking process with the aim of using an industry consensus 
standard. These documents show that the Coast Guard anticipated the 
possible need for additions or modifications to the consensus standard 
to meet the minimum level of safety deemed necessary and clearly stated 
that such modification or additions would be incorporated into the 
final approval standards if necessary.
    Two of the comments discussed above requested that the final rule 
base Coast Guard approval on the requirements of UL 1180 with 
additional requirements limited to product marking and point-of-sale 
consumer information. UL commented that they expected the rule to 
contain a limited number of requirements supplemental to the UL 1180 
and UL 1191 such as a USCG information pamphlet and PFD production 
quality control related requirements. UL also recommended that the 
Coast Guard make additional modifications and additions to the first 
edition of the 1180 standard, such as making trade-offs between 
requirements for donning and secureness of fit, revising the added 
visibility looking to the side test, and adding warning markings. The 
individual changes suggested are discussed below.
    Two comments included resolutions requesting that the Coast Guard 
rescind those portions of the interim rule that impose additional 
requirements for Coast Guard approval beyond those imposed by UL 1180. 
As noted above, one of these resolutions was passed by the National 
Association of State Boating Law Administrators (NASBLA) which noted 
that its membership is deeply concerned that additional requirements 
beyond the UL 1180 standard may jeopardize the development and approval 
of fully inflatable PFDs. NASBLA recommended that the Coast Guard amend 
the IR to reflect only those standards currently in the incorporated UL 
standards.
    The second resolution was submitted by the PFD Manufacturers 
Association (PFDMA), which represents manufacturers of PFDs and 
component materials. PFDMA and supporters commented that the Coast 
Guard should rescind almost all portions of the IR which impose 
additional requirements to the UL standards. However, the comments did 
note that the Coast Guard approval regulations do need to address 
labeling and information pamphlet requirements, areas which UL 1180 
either does not address or does not do so adequately. The Coast Guard 
notes that two sections of the UL standard are ``Reserved'', those 
dealing with production quality control requirements and with the 
information pamphlet. As a result, the Coast Guard's requirements in 
these areas are the only requirements for those items.
    NBSAC, an advisory committee charged with advising the Coast Guard 
on boating safety issues, approved a resolution, by a vote of 10 to 8, 
that

[[Page 13936]]
recommended that the Coast Guard requirements for approval of 
inflatable PFDs congruent with the consensus standard embodied in UL 
1180 without exception or additional requirements. However, in a 
written survey of the NBSAC members, immediately following the meeting 
which adopted the resolution, many of the members indicated support for 
the Coast Guard's modifications to the UL standards. The Coast Guard 
therefore intends to raise some of these issues in the consensus 
committee when UL reopens UL 1180 and UL 1191 for revision.
    Several comments from individuals favored the Coast Guard's 
modifications to the UL standards. One comment opposed the idea of 
merely adopting the UL standard by stating that it is not desirable to 
set a rigid pass/fail criteria for approval of any device in the form 
of an adopted consensus standard that fixes for a long period 
requirements based on currently available technology and designs. The 
comment continued by explaining that the Coast Guard's approval process 
should encourage and reward improvements in reliability and 
effectiveness above the level of what is feasible today at a reasonable 
cost. According to the comment, this approach would lead manufacturers 
into entering a desirable, continuing race to produce more comfortable 
and affordable PFDs, and that an industry consensus standard alone 
cannot provide such an incentive. Additionally, one comment from a PFD 
design consultant expressed the view that by having a clearly defined 
alternative to strict compliance with UL 1180, innovative and consumer 
responsive products would be more likely to make it to market. The 
Coast Guard notes that both the IR and this final rule allow for the 
possibility of approval of alternative designs that do not conform to 
the promulgated standards. As a result, manufacturers have had, and 
continue to have, the option of receiving approval for innovative 
inflatable PFD designs. The Coast Guard recognizes that trade-offs must 
be made between absolute safety and making inflatable PFDs both 
affordable and available to recreational boaters who would not 
typically wear currently approved devices and who are prepared to 
accept the increased care and servicing requirements needed to maintain 
reliability.
    UL Standard Conflicts and Shortcomings: Comments from UL and 
manufacturers indicated that there were areas in the UL standard that 
need revisions or improvement as discussed below. Most of these changes 
are in areas addressed by the IR but some deal with conflicting 
requirements or requirements that are believed by some manufactures to 
be set unintentionally too high within the UL standard.
    One comment stated that even without the most objectionable 
provisions of the IR, that is the LSI and ``Approved Only When Worn'' 
provisions, the standard as recommended by the consensus standard 
committee was problematic in many areas. The comment expressed the view 
that the UL standards were difficult and unrealistic in many areas, but 
might be ``fixable''. The commenter also expressed the belief that as 
large and complex as the UL documents were, they would likely have 
contradictions or deficiencies requiring correction consistent with the 
specification's stated goals. The commenter expected that, for example, 
the sections of the UL standard that conflicted with the use of 
disposable inflation mechanisms would be modified, and that the goal of 
having disposable inflators as an option would not be abandoned.
    Missing Standards for Wearability and Approval Type: The Coast 
Guard notes that the UL standard calls for the USCG to set approval 
type for inflatable PFDs based on a PFD's performance, serviceability, 
and status indicators, but does not establish how these characteristics 
are to be used. As discussed at the first consensus standards meeting 
in March 1994, the Coast Guard indicated that its approval type would 
be determined after the characteristics of the PFDs were identified by 
the standards. As stated in the ANPRM ``[t]he consensus standard may 
not address all the issues and characteristics essential to the Coast 
Guard,'' and alternatives ``remaining unresolved will presented * * * 
for comment.''
    As initially drafted, the UL standard had a test for the projected 
wear rate that a PFD design would provide. This provision, which was 
referred to as ``wearability'', was deleted from the standard at the 
final standards committee meeting. The consensus committee was informed 
by the Coast Guard that the lack of a wearability standard would have 
to be justified or otherwise addressed. The committee failed to do so. 
Therefore, in the IR the Coast Guard provided conditional approval, 
requiring a device to be worn to meet carriage requirements, in 
addition to the UL standard as one way to address the lack of a 
wearability standard. One comment indicated that unconditional approval 
based on what is available today is undesirable and others supported 
the IR's conditional approval as discussed above. The lack of a 
wearability standard within the consensus standard will require the 
Coast Guard to closely monitor accident statistics and revise the rules 
if necessary. Conditional approval is discussed further below.
    Based on the above comments and on internal discussions within the 
Coast Guard detailed below, the Coast Guard is minimizing the additions 
and modifications to UL 1180 required for Coast Guard approval but 
retaining those which in the Coast Guard's judgment are essential to 
safety. The Coast Guard is retaining the two provisions of the IR for 
which the UL standard had reserved sections. These two areas, the PFD 
information pamphlet and production quality control, as mentioned 
above, were discussed by several commenters.
    Nearly all the provisions being deleted from the IR may, in the 
future, further the lifesaving goals adopted by NBSAC and the Coast 
Guard as discussed in the IR. Therefore, those provisions will be 
proposed by the Coast Guard for inclusion in UL 11180. This will allow 
the Coast Guard to pursue the incorporation of these changes in concert 
with the industry and other interested parties, as many comments 
indicated the desire to proceed.
    The Coast Guard notes that the PFDMA had expressed an interest in 
working with the Coast Guard, Underwriters Laboratories (UL), and 
others to revise the interim rule based on comments and resolutions 
which have been forwarded. As mentioned above, the Coast Guard does 
intend to continue to work with the consensus standards committee with 
the goal of incorporating as many of the provisions being deleted from 
the IR by this rulemaking as possible into UL 1180.
    The comments on specific provisions of the regulation and the 
revisions made by this rulemaking are discussed below.
    Timeline for approval: Two comments discussed the validity of the 
stated goal of the Coast Guard in the IR to have significant numbers of 
approved inflatable PFDs available to the public for the 1996 boating 
season. One comment noted that for approved inflatables to be available 
for the 1996 boating season, achievable and well defined requirements 
needed to be in place well in advance of the October 23, 1995, comment 
deadline for the IR. Another comment stated that it is highly unlikely 
that manufacturers will be able to make significant number of 
inflatable PFDs available to the public in 1996. The comment explained 
that because of the many unanticipated problems associated with meeting 
the requirements of the IR, manufacturers

[[Page 13937]]
would have to return to the design phase to re-engineer their products 
before submitting them for approval. According to the comment, when 
this process is completed, 1996 will probably be over. The comment 
projected that unless requirements are substantially changed, the 
regulation established by the IR would not result in inflatable PFDs 
becoming more than 3 percent of the total PFDs sold by the year 2007. 
The comment also stated that the Coast Guard and NBSAC goal of saving 
210 lives by increasing the wear rate to 66 percent is desirable but 
not a rational projection resulting from the IR.
    The Coast Guard shares the concerns regarding making approved 
inflatable PFDs available as soon as possible, however, it must balance 
that concern with the need to ensure that Coast Guard standards for 
approved inflatable PFDs will achieve a reasonable balance between 
safety and cost. The Coast Guard notes that nothing currently prevents 
the sale of non-approved inflatable PFDs to the public.

Specific Comments and Major Areas of Revision

    The major areas of comment and revision to the IR standard are 
separated into categories and discussed below. For those areas in which 
the Coast Guard is deleting requirements from the IR, the Coast Guard 
intends to suggest that most of the deleted requirements be considered 
for inclusion in a revised version of the UL 1180 standard. 
Additionally, the Coast Guard intends to suggest the requirements from 
the IR which are being retained be considered for inclusion in a 
revised version of the UL 1180 standard. If the UL 1180 standard is 
revised to include the changes, the rules will be revised to delete 
these provisions from the subpart and update the incorporation by 
reference to cite the revised standard.

1. Lifesaving Index (LSI) and Use Code 1F Inflator [Sections 160.076-5, 
-7, -9, -13(c)(10), -21(e), -23(a)(1), -27, and -37(b)(4 & 5)]

    As the IR's approval requirements concerning use code 1F inflators 
and the LSI are interdependent, they are being discussed as one 
category.
    IR Requirement: Under the requirements for inflatable PFDs in the 
IR, the Coast Guard requires that, except for inflatable PFDs equipped 
with inflators with 1F use codes, an LSI analysis be performed to 
evaluate the overall lifesaving potential of an inflatable PFD 
submitted for approval. A use code 1F inflator, which has a cylinder 
seal indicator, provides a visible indication to the user of the 
cylinder status. The same readily visible indication of inflation 
cylinder status is not available with use code 2F and 3F inflators. The 
LSI analysis, therefore, was provided as an alternative to allow other 
reliability and wearability factors to compensate for the lack of 
visible cylinder status indication. Under the IR, the Approval Type (I, 
II, III, or V) given to any particular PFD design, except for those 
with 1F inflators, would depend on the results of the LSI analysis. If, 
as a result of the LSI analysis, it was determined that a conditional 
approval would be appropriate for a particular PFD, the most likely 
condition for approval would be the requirement that a PFD would be 
required to be worn to count toward the PFD carriage requirement.
    Comments on Use Code 1F Inflator Requirement: Thirteen commenters 
specifically discussed the requirements related to inflation system 
indicators with a 1F use code. Of these, four comments favored the IR's 
requirements regarding the use of a 1F inflator. One cylinder 
manufacturer described the IR as a great step towards saving lives and 
commended the Coast Guard and UL for properly addressing the gas 
cylinder issue by including indicators within the inflator mechanism. 
Another comment favoring use code 1F inflator requirements did so by 
reasoning that the Coast Guard's approval process should encourage and 
reward improvements in reliability and effectiveness beyond what is 
feasible today at reasonable cost and therefore should have a built in 
mechanism, such as the requirement for the LSI analysis and 1F 
inflators to encourage technological advances. Three comments, 
including one of the above, expressed hope that the Coast Guard's 
regulations would require approved PFDs to have an easy way to check 
the CO2 cartridge to ensure it was charged, such as fire 
extinguisher gauges or push-and-release pop-out pins. Use code 1F 
inflators include indicators that satisfy this need.
    The remaining nine commenters that discussed inflators disagreed 
with the IR's emphasis on cylinder indication to increase operational 
reliability of inflatable PFDs. Seven comments suggested that the Coast 
Guard withdraw the requirement to either have a use code 1F inflator or 
utilize the LSI analysis, for all but Type I inflatable PFDs. Four of 
these comments indicated that there is lack of current technology to 
provide full cylinder indication at a reasonable cost. These comments 
reasoned either that use code 1F inflators remain beyond state-of-the-
art and therefore their use should not be required or that the use code 
1F requirement may possibly delay the production of Coast Guard 
approved inflatable PFDs. One comment added that the highest level of 
cylinder indicator was not necessary because the requirements for 
redundant inflation systems and for swimming ability, adequately 
compensates for the remote possibility of primary inflation system 
failure. The Coast Guard notes that a ``recommendation'' against use by 
non-swimmers is not equivalent to a ``requirement'' and that, as 
discussed above, any swimming requirement would be unenforceable.
    One comment cautioned the Coast guard with regard to drawing 
conclusions from the informal study at NASBLA's annual meeting 
discussed in the IR, where only 2 out of 18 participants were able to 
correctly identify the serviceability of 4 older style inflation 
mechanisms. The comment remainded the Coast Guard that the newer styles 
of inflators are designed so that it is easier to determine when an 
inflator has already been fired. The comment also cautioned the Coast 
Guard not to presume that all systems were represented in the field 
study, and that no mechanism is completely foolproof, including one 
with a cylinder seal indicator.
    The Coast Guard remains concerned with the inflation systems used 
on inflatable PFDs. The design of the inflation mechanism is important 
because proper maintenance plays a crucial role in ensuring the 
reliability of an inflatable PFD. If the status of the inflator 
mechanism is easy to check, then it is more likely that a boater will 
check the status often and correctly. A recent Coast Guard study of the 
causes of marine casualties indicated that 80% or more of all marine 
casualties are caused by human error and that these were often induced 
by inadequate attention to human factors in the design and performance 
standards for equipment. The Coast Guard's findings on this subject are 
reported in the ``Prevention Through People'' quality action team 
report, the Notice of Availability of which was published in the 
February 16, 1996, Federal Register (61 FR 6283).
    Comments on PFD Life-Saving Index Evaluation: Twelve commenters 
specifically noted reservations about the ``Life-Saving Index'' (LSI), 
while three comments expressed unqualified support of this alternative 
approval path, generally because of the flexibility and encouragement 
of improvements thought to be fostered by the LSI requirement. 
Additionally, the October 30, 1995, NBSAC resolution discussed

[[Page 13938]]
above favored continued development of the LSI for possible future use.
    The three comments which supported the LSI concept thought that the 
LSI might be the most potentially beneficial portion of the IR, with 
one stating that it would ``allow approval of unique and novel designs 
that offer lifesaving potential equal to or greater than that of 
approved devices * * * these designs may prove to be very comfortable, 
affordable and popular with the boating public.'' The comment continued 
that promoting innovation in design actually allows the end user to 
have a voice in what can be used to meet Coast Guard requirements.
    Another comment which supported the LSI expressed pleasure with the 
results of the NBSAC member survey for retaining the LSI, in which 9 
out of 14 respondents indicated that they favored retaining the LSI as 
a clearly defined alternative to strict compliance to UL 1180. The 
comment continued that through the LSI, innovative and consumer 
responsive products will be able to make it to market, and that without 
the LSI, inflatable PFDs will be static in design. Also the comment 
indicated that if the LSI were eliminated, the Coast Guard would be 
limiting the ability of manufacturers of innovative PFDs to fairly 
compete with current products. As mentioned above, the Coast Guard 
notes that both the IR and this final rule allow for the possibility of 
approval of alternative designs that do not conform to the promulgated 
standards. As a result, manufacturers have had, and continue to have, 
the option of receiving approval for innovative inflatable PFD designs.
    One comment which supported the overall concept of the LSI objected 
to the LSI scheme if inflatable PFDs of low reliability or 
effectiveness receive the same Coast Guard approval status as other 
PFDs. If this were to occur, the comment continued, the boating public 
should be notified of the reduced reliability of the device at the 
point of sale.
    On the other hand, most comments received by the Coast Guard 
expressed reservations about the LSI analysis as presented in the IR. 
Six of these comments expressing concerns noted that LSI concepts have 
merit in a broad application, but indicated apprehension about its 
application to individual items.
    Five comments specifically requested that the Coast Guard delete 
the LSI from the IR. One of these comments also stated that, as opposed 
to the LSI, what the industry needs is a realistic standard of 
performance, keyed to individual product types. Another comment stated 
that the LSI and conditional approval provisions added by the IR to the 
UL standard will hamper the Coast Guard's desire for a flow of 
innovative, new products.
    Two comments and a number of participants in the public meeting 
stated that mandating the use of the LSI as an alternative to having 
the use code 1F inflation mechanism, is unacceptable. These comments 
criticized the LSI saying the validity of the LSI elements chosen and 
weights which have been applied, do not appear statistically valid, 
uniformly applied, or adequately defined. Another comment noted that 
adequate development of the LSI process would likely require an ad hoc 
committee effort.
    A concern expressed at the public meeting on the LSI and in several 
comments, related to the IR's provisions for an annual review of the 
LSI. This concern focused on the fear that an annual review could 
potentially subject manufacturers to revocation of approval and the 
resulting possible liability. In addition, several other comments and 
meeting participants cautioned that the LSI factors will become moving 
targets that will unnecessarily invite litigation against manufacturers 
as factors and weights are changed.
    Two comments noted that approval classification, i.e., the USCG 
Type designation for a PFD, should coincide directly with UL 1180 
``performance type'' without requiring an LSI evaluation for approval 
of any specific PFD model. These comments reasoned that because the 
performance required by UL 1180 is significantly higher than required 
for any other recreational use PFD, there is no need to ensure the 
lifesaving potential of a device through the LSI. The Coast Guard notes 
that while the UL standard requires in-water performance and other 
increases, it also permits a decrease in reliability compared to 
inherently buoyant PFDs. The Coast Guard believes that the increase in 
wearability expected by many commenters will be needed in addition to 
the UL performance increases for the lifesaving potential of most 
inflatable PFDs to equal that of inherently buoyant PFDs.
    Final rule requirements: The requirement that a device either have 
a use code 1F inflator or be subjected to the LSI evaluation for 
approval was based on two studies, one conducted by BOAT/U.S. from 1990 
to 1993 and one conducted by the Coast Guard with the USCG Auxiliary 
from 1979 to 1981. Both of these studies concluded that inflatable PFDs 
without visible indicators of the state of inflation cylinder charge 
would not be properly maintained by a substantial percentage of typical 
users. The maintenance deficiencies reported in the studies were of 
such a nature that the devices would not operate as intended. The Coast 
Guard was concerned that if a substantial percentage of lower-
performing inflatables were not properly maintained, as the studies 
suggest, the widespread use of these types of devices could actually 
lead to an increase in drowning fatalities. In addition, the Coast 
Guard was concerned that as the lower-performing devices would be the 
least expensive, and therefore most accessible to boaters, the risk of 
improper maintenance would be compounded. The use of the LSI as an 
approval evaluation tool was intended to ensure that the inherent 
lesser reliability of inflatable PFDs, coupled with the lower in-water 
effectiveness and the additional reduction in reliability for lower-
performing devices due to human error as observed in the studies, would 
be offset by other features or approval conditions on the PFD.
    Most of the comments received on the IR, as discussed above, 
opposed the use of the LSI as an approval evaluation tool. The comments 
cited the untested, and potentially subjective, nature of the LSI. As 
discussed above, these comments strongly urged the adoption of the UL 
1180 consensus standard for approval of inflatable PFDs without any 
additions or modifications except to address those areas in which UL 
1180 is incomplete or inadequate. This view was supported by 
resolutions of NBSAC, NASBLA, and PFDMA.
    After careful review of all of the comments, the Coast Guard has 
reconsidered its previous interpretation of the study results the NBSAC 
recommendation, and of the improvements to PFD inflation hardware which 
occurred as a result of the development of UL 1180 and 1191. Upon 
reconsideration, the Coast Guard noted that the correlation of the 
study results to actual use patterns in the market may not be entirely 
conclusive. In particular, the different methodologies of the Coast 
Guard Auxiliary and BOAT/U.S. Foundation studies yielded somewhat 
different results, calling into question the relative validity of those 
methodologies in assessing the behaviors of the overall boating 
population. The Coast Guard notes that many comments received from 
boaters, as discussed below under ``Approval Type'', suggest that wear 
rates for approved inflatables would be higher than was observed in the 
studies. Additionally, the inflators on the PFDs used in the studies 
did not incorporate

[[Page 13939]]
the performance improvements mentioned above. Furthermore, the comments 
from PFD manufacturers indicated that the IR requirement for conducting 
an LSI analysis for devices with 2F and 3F inflators, which was based 
upon the Coast Guard's initial interpretation of the studies, would 
severely hamper the efforts of PFD manufacturers to bring inflatable 
PFDs to market thereby delaying the safety gains considered possible as 
a result of introducing approved inflatable PFDs.
    In the absence of conclusive evidence that the use of the LSI to 
evaluate inflatable PFDs with use code 2F and 3F inflators is necessary 
to avoid undesirable outcomes as the result of approval of inflatable 
PFDs for recreational use, the Coast Guard has removed the LSI from 
this final rule as a required evaluation tool for approval of all PFDs 
not having a use code 1F inflator. As suggested in many comments, this 
final rule provides for approval of inflatable PFDs with use code 1F, 
2F, or 3F inflators in accordance with the requirements of the UL 1180 
consensus standard, supplemented only as needed to address the portions 
of UL 1180 which are acknowledged as being incomplete or having 
significant safety implications. The Coast Guard believes that the 
potential benefit of increased PFD wear as the result of approval of 
inflatable PFDs for recreational boaters, in conjunction with the 
inflatable PFD performance improvements established in UL 1180, 
outweigh the potential risk of PFD failures due to human error. 
Nevertheless, the Coast Guard is strongly encouraging PFD manufacturers 
to emphasize the need for proper maintenance in their marketing and 
instructional materials. As inflatable PFDs are introduced to the 
recreational boating market, the Coast Guard will carefully monitor 
casualty data to ensure that appropriate adjustments are made to the UL 
standards or requirements in the event of negative outcomes.
    The Coast Guard notes that it has used the LSI to aid its 
evaluation and analysis of PFD rulemaking projects since 1985, but this 
is the first regulatory project in which it was to be used as an 
approval evaluation tool. The Coast Guard's intent in inserting this 
requirement was to provide more flexibility for design approval. 
Although it is no longer required as an approval evaluation tool, the 
Coast Guard anticipates that the LSI will be used in the future as an 
evaluation tool for novel designs not specifically covered by UL 1180 
and to evaluate rule changes, establish policy, and make equivalency 
interpretations. Additionally, the Coast Guard will continue 
development of the LSI as was suggested by a number of the comments 
discussed above, and the October 30, 1995, NBSAC resolution which 
favored continued development of the LSI for possible future use. 
Therefore the following sections are revised or deleted accordingly: 
Secs. 160.076-5, -7(a)(1), -9(b), -13(c)(10), -21(e), -23(a)(1), -27, 
and -37(b)(4 & 5).
    Future action: The uncertainty the LSI caused for manufacturers 
needs to be addressed in order for the probabilistic risk based 
assessment embodied in the LSI to be a truly viable alternate approval 
path. The Coast Guard will propose to develop the LSI as a consensus 
standard with participation of industry. If the LSI can be developed 
adequately to be a viable alternative path, it may be proposed as part 
of the approval process for PFDs in the future. As noted above, the 
Coast Guard will carefully monitor the effect of deleting the LSI and 
approving PFDs with either use code 1F, 2F or 3F inflators.

2. Approval Type [Sections 160.076-7, -9, and -39(c)]

    IR Requirement: Under the approval requirements for inflatable PFDs 
in the IR, the Coast Guard provided the option of approving inflatable 
PFDs as Type V PFDs, which either would require that the PFD be worn to 
count towards the carriage requirement, or would have other conditions 
appropriate to their intended use. In the latter case, conditional 
approvals would be allowed for special PFDs designed for special 
circumstances, such as those for diving with recreational submersibles. 
Approval of this special category of devices is not addressed by the UL 
standard.
    Comments on Conditional Approval and Approved Only When Worn:
    Five comments indicated the need for an incentive, such as a 
condition that a PFD only be approved as meeting the carriage 
requirements if it is worn, to increase PFD wear rates. After noting 
that 80% of drownings occur because the victim is not wearing a PFD, 
one of these comments concluded that any regulation relating to PFDs 
should require that PFDs be worn, particularly on small boats, if the 
Coast Guard expects to have an impact on boating accident drownings. 
Several comments from boaters indicated that they were not opposed to a 
requirement for inflatables to be worn, and as discussed above, there 
were 21 comments that either favor required wear, presently wear, or 
would wear inflatable PFDs.
    One of the comments requested that approval of all inflatable PFDs 
be conditional on the PFD being worn and noted that approvals that are 
contingent on the device being worn may increase use, grant boaters 
access to approved devices, allow the industry to sell approved 
devices, and allow price and comfort to drive the market. Another 
comment from a manufacturer that also favored conditional approval for 
all inflatable PFDs, not just Type V, noted that the condition would 
benefit and promote: wear among those who purchase an inflatable PFD, 
better care and maintenance of the inflation among those who wear it, 
and redundancy in personal lifesaving equipment aboard vessels where 
space is not limited.
    One comment suggested adding the condition ``in presence of 
perceived danger'' to the ``approved only when worn'' provision to make 
the conditional approval more acceptable and reasonable. It is the 
Coast Guard's view that for most accidents danger is often unperceived, 
and that such a requirement would, instead of encouraging increased 
wear, result in boaters wearing PFDs less often under the mistaken 
belief that the need for them was limited to situations when imminent 
danger is apparent. Additionally, as with a swimming ability 
requirement, it would not be feasible for law enforcement personnel to 
enforce such a condition.
    Two comments that favored required wear, noted that to get more 
comfortable PFDs on the market and achieve wider use than currently 
approved PFDs, it may be necessary for the Coast Guard to relax the 
standards of reliability and effectiveness. One of these comments 
indicated that reduced ``reliability or effectiveness'' in combination 
with the condition that a PFD is ``approved only when worn'' should be 
an available approval option to permit manufacturers to reduce the cost 
of a device.
    On the other hand, several comments from manufacturers and from 
boaters indicated that they were opposed to any requirement for 
inflatables to be worn. Three comments from boaters indicated that they 
opposed any condition that required PFDs to be worn to meet the 
carriage requirements. One stated that the introduction of the 
``Approved Only When Worn'' concept is curious in light of the results 
of another Coast Guard interim rule which set approval standards for 
hybrid inflatable life jackets (50 FR 33923; August 22, 1985) which had 
adopted the same requirement. A hybrid PFD uses a mixture of inherently 
buoyant material and inflation to provide flotation. In the commenter's 
opinion the effect of the action was the ``kiss of death'' for hybrid

[[Page 13940]]
PFDs. In addition, the comment noted that if this requirement was truly 
justified for inflatables, then it is equally justified for inherently 
buoyant vests. The Coast Guard notes that there are two significant 
differences between the hybrid PFDs and inflatables: comfort and price. 
Hybrid PFDs do not provide as much improvement in comfort, and hence 
increased wearability, as inflatables because of their greater bulk and 
body coverage. Additionally, inflatables only have one means of 
buoyancy, and therefore will be less expensive than hybrids and 
represent a much smaller incremental increase above the cost of an 
inherently buoyant PFD. The Coast Guard also notes that the option of 
approving hybrid PFDs without the requirement that they be worn to be 
considered approved has been available since February 1995. Since that 
time only one manufacturer has sought approval without this condition. 
This fact appears to confirm that the approval condition is not the 
sole reason for the lack of retail success of hybrid PFDs.
    Final rule requirements: The Coast Guard adopted the option of 
conditional approval in the IR for inflatable PFDs without use code 1F 
inflators but, as discussed above in the discussion of the use code 1F 
inflators and the LSI, the Coast Guard is deleting the use code 1F 
inflator provision as imposing conditional approval from the final rule 
for PFDs meeting UL 1180 because of the potential impediment that the 
conditions may have on the sales of devices to recreational boaters.
    In this final rule, conditional approval is being used only for 
PFDs which do not comply with the UL standards and which are intended 
to be used in some special application or manner, such as diving with a 
``wet'' submersible vessel, i.e., a vessel designed to propel a person 
using SCUBA, or partially wet submersible vessel. The Coast Guard 
believes that such designs can provide boaters with an effective 
lifesaving alternative only if the user understands the PFD's 
limitations and is used accordingly. Conditional approval serves these 
ends and may make more affordable alternatives available to users who 
wish to have an approved supplemental PFD on board for occasional use 
or who are willing to comply with the approval conditions to have the 
device count as a replacement PFD to meet the carriage requirements. 
The lack of a wearability standard within the consensus standard or 
conditional approval in the regulations will require the Coast Guard to 
closely monitor accident statistics and revise the rules if necessary. 
Therefore, the following sections are revised or deleted accordingly: 
Secs. 160.076-7, -9, and -39(c).

3. Repack Evaluation (Section 160.076-25(c)(2))

    IR Requirement: UL 1180 does not address repacking. Under the IR, 
however, an inflatable PFD being tested for approval must pass an 
evaluation in which test subjects demonstrate that they can repack the 
PFD, or refold the yoke-style design so that it will function properly 
when donned and used again. After being repacked the PFD must be ready 
for donning and manual inflation in or out of the water, and for oral 
inflation in the water. There is no time limit associated with the 
test. The test is not required for devices the manufacturer requires to 
be professionally serviced.
    Comments: One manufacturer commented that the requirement for a 
repack evaluation test is a good improvement, because most designs 
currently available are very difficult to repack. However, a second 
comment stated that the requirement that each test subject perform 
three repack evaluations is excessive and adds expense. The comment 
noted that a single repack evaluation would adequately address the 
necessary safety considerations. The Coast Guard notes that as the 
requirement is written in the IR, the PFD's suitibility for use in the 
specific test conditions noted above must be assessed after the 
repacking. The Coast Guard believes that all of these conditions can be 
properly evaluated after the test subject performs only one repack. 
Therefore, only one repack evaluation is needed for approval, but a 
follow-up assessment must be conducted by the test laboratory to ensure 
that all of the cited UL 1180 conditions are evaluated.
    Final rule requirements: The Coast Guard is retaining the repack 
evaluation requirement in Sec. 160.076-25(c)(2), but is making 
editorial revisions to clarify that only one repack evaluation is 
required. Inflatable PFDs that pass this test will have a higher in-
service operational reliability than designs not meeting the 
requirement because they will be less likely to be repacked or refolded 
such that inflation lanyards and the like are inaccessible for 
emergency use or unusable without disassembly.

4. 45-Sec. Average Donning Time, Donning Relaxation, and Reporting 
Subject Disqualification [Section 160.076-25(c)(1)]

    IR Requirements: A 45-second average donning time requirement was 
included in the IR in addition to the UL 1180 imposed 60-second maximum 
limit for each subject. Additionally, unusual problems with the 
reference vest used for the donning time test are required to be 
reported to the Coast Guard, as this is a new reference vest that has 
not been previously used for testing purposes. A longer donning time is 
permitted for designs requesting approval with conditions which are not 
yet addressed in UL 1180.
    Comments: Except for the NBSAC survey discussed above, comments on 
the average donning time test were not favorable and advocated 
elimination of this requirement. One comment noted that in 
administering a donning time test, consideration should be given to the 
trade-off that exists between the simplicity of donning a PFD and the 
secureness of the device during water entry. The comment suggested that 
the Coast Guard eliminate the 45-second average donning time 
requirement and only require the 60-second maximum in UL 1180. Another 
comment indicated that the average time requirement has reduced the 
time limit from 60 to 45 seconds, and did not understand why an 
inflatable PFD should be donned faster than an inherently buoyant PFD. 
The Coast Guard notes that the 45-second average donning time 
requirement is actually a second requirement in addition to the UL 1180 
60-second maximum donning time requirement. The requirement is not a 
significant reduction in donning time but a change in the method of 
evaluating the test results.
    Final rule requirements: The average donning requirement was added 
in the IR as a supplement to the 60-second maximum time requirement 
contained in the UL 1180 standard, in order to effectively measure 
donning-time performance of PFDs. Historically, nearly all designs of 
inherently buoyant and hybrid PFDs that pass a 60-second maximum 
requirement, have been shown to pass a 45-second average requirement as 
well. The Coast Guard inserted the average requirement in the IR 
because, overall it is a better tool for assessing whether designs are 
improving or whether they are getting more difficult to don. No 
reasonable PFD design would be denied approval solely as a result of 
the average requirement. Unless PFDs are required to be worn, donning 
is a critical part of the survival process.
    However, the average donning time test provides limited additional 
safety and may slow the availability of inflatable PFDs to boaters. 
Therefore, the Coast Guard is deleting the average donning time test 
requirements contained in the IR at Sec. 160.076-25(c)(1)

[[Page 13941]]
but retaining the requirement that a PFD meet the 60-second maximum 
donning time requirement in UL 1180.

5. Average Freeboard for Type II and Freeboard Reporting (Section 
160.076-25(c)(3)(i) and -25(c)(4)(i))

    IR Requirement: UL 1180 contains both an average and minimum 
freeboard requirement for performance types I and III PFDs, but only 
contains a minimum freeboard requirement for performance type II PFDs. 
To make the requirements consistent for all types of PFDs, the IR 
contained an average freeboard requirement for approval Type II PFDs. 
As part of the IR, freeboard is required to be measured and reported in 
order that PFD performance trends can be effectively monitored by the 
Coast Guard.
    Comments: One comment stated that the 4.25 inch average freeboard 
requirements for Type II PFDs contained in the IR is excessive based on 
the 3.25 inch per subject minimum freeboard requirement, contained in 
UL 1180. The commenter informed the Coast Guard that they had never 
seen an average freeboard requirement applied and were not aware of any 
body of data to support its use. As mentioned above, the Coast Guard 
notes that the UL 1180 standard has both minimum and average freeboard 
requirements already in place for performance type I and III PFDs and 
that the performance type II requirements are the exception.
    Final rule requirements: Although UL 1180 contains both average and 
minimum freeboard requirements for type I and II PFDs, the UL standards 
committee could not come to an agreement on the average requirement for 
performance type II PFDs and therefore omitted the average requirement 
for type IIs only. As a result, UL 1180 only contains a minimum 
freeboard requirement for Type II PFDs and no average requirement. 
Although adequate for safety, a minimum requirement is not conducive to 
monitoring trends, comparing performance, or promoting continuous 
improvement.
    The Coast Guard is deleting the average freeboard requirement for 
Type II PFDs as well as the freeboard reporting requirement, and will 
ask UL to voluntarily measure and calculate average freeboard and 
report the results to the Coast Guard. As a result, although the safety 
of any individual PFD will not be effected, until the UL standard can 
be updated, an inconsistency will remain between the freeboard 
evaluation method of performance type II PFDs versus types I and III.

6. Wearer's View from PFD (Section 160.076-25(c)(3)(ii) and -
25(c)(4)(ii))

    IR Requirement: The IR requirements ensure that the inflated PFD 
does not unduly interfere with the wearer's ability to see in front and 
to the sides (``side mark view'') without having to tread water. The UL 
standard does not address these issues.
    Comments: Three comments addressed these provisions. One comment 
suggested that the side mark view evaluation be performed at 20 feet, 
rather than the 3 m (10 ft) requirement in the IR, to make it 
consistent with other standards and regulations which use this type of 
PFD performance requirement. The Coast Guard notes that the approval 
requirements for hybrid and commercial inflatable PFDs require that 
this evaluation occur at 3 m rather than 20 feet (46 CFR Part 160.077 
and 160.176). In addition, the comment indicated that the in-water 
performance evaluation relating to front and side views should only be 
conducted with the device positioned in its intended wear condition. 
The comment indicated that if the PFD shifts during water entry it 
should not be judged a failure for inadequacy of vision; it does not 
matter if unconscious people have their vision restricted. However, the 
comment agreed that the remaining in-water requirements (e.g., turns, 
freeboard, etc.) are applicable to both conscious and unconscious 
users. In addition, the comment requested that the front mark view 
requirement not apply to Type III PFDs.
    The second comment also discussed the IR requirement that the water 
surface be visible to the subject when looking to the side. The comment 
suggested that this only apply to Type I devices and even then not 
rigidly. The comment added that a relaxed head position without 
constant visibility of the lowest point on the horizon is not an unsafe 
condition. Another comment stated that the IR requirement for static 
measurements of the side mark view, freeboard, and retroreflective 
material location creates an excessive amount of testing and continues 
to increase the cost of approval.
    Final rule requirements: The Coast Guard is deleting both of the 
wearer view requirements contained in Sec. 160.076-25(c)(3)(ii) and -
25(c)(4)(ii) as these provisions add limited additional safety and may 
slow inflatable PFDs from being available to boaters.

7. Retroreflective Tape and Light Visibility (Section 160.076-
25(c)(3)(iii))

    IR Requirement: Any retroreflective tape or light provided on the 
PFD is required to be visible while worn in the water. The Coast Guard 
instituted these requirements to ensure that the retroreflective 
material is effective for search and rescue purposes. The Coast Guard 
believes that it would be an unnecessary expense and misleading to the 
user to provide these materials at locations that do not aid search and 
rescue. The UL 1180 standard does not address these provisions.
    Comments: One comment opposed the requirement in Sec. 160.076-
25(e)(3)(iii) that requires 75 percent of the reflective material to be 
above the water line. The comment noted that this type of requirement, 
and others like it, do not encourage improved performance. Instead, a 
minimum surface area of reflective material above the water line should 
be required. The comment added that manufacturers should be encouraged, 
not discouraged to provide more reflective material.
    Final rule requirements. The Coast Guard is deleting the additional 
requirements relating to retroreflective material above those required 
in UL 1180. UL practice is to require manufacturers to ensure that the 
minimum area needed for effective search and rescue is covered with 
retroreflective material if the device is sold as one that will aid in 
search and rescue, or if sold for use on commercial vessels. Therefore, 
the Coat Guard expects that most PFDs with such material tested by UL 
will meet this requirement.

8. Chamber Material Physical Properties, Production Oversight, 
Production Tests, and Manufacturer's Records Sections 160.076(b) & (c), 
-25(d)(2), -29, -31, and -33]

    IR Requirement: To set a baseline, the IR requires that tests be 
conducted on materials taken from prototypes of PFDs tested for 
approval. There are no pass/fail criteria associated with these tests 
during approval, but they provide baseline data essential for 
production quality control limits and for use at a later date if the 
manufacturer proposes changes in materials. The production oversight 
and tests established by the IR also cover all the usual elements of a 
quality control program including the division of production units into 
lots, running various tests on each lot, establishing and retaining 
certain records, and establishing criteria for product acceptance and 
resolution of problems.
    Comments on inflation chamber properties: One comment indicated 
that Sec. 160.076-25(d)(2), which requires testing of inflation chamber 
properties from the tested prototype PFD, should

[[Page 13942]]
be revised to permit PFD manufacturers to bypass the inflation chamber 
properties tests by using material from the same lot, or equivalent, as 
that evaluated for the compartment material manufacturer. The comment 
did not define equivalent, and the Coast Guard knows of no way to 
determine equivalence other than by testing these physical properties. 
However, other methods of demonstrating equivalence can be considered.
    Another comment opposed this requirement because of the difficulty 
and questionable value of remaining within close limits of minimum 
design on all components and assembly parameters in an inflatable PFD 
used for approval testing. The comment went on to say that production 
lots of components occasionally dip below the assumed safe level, and 
that both wide deviations within relatively small lots as well as 
testing errors on a specific sample are possible. This comment points 
out the competing demands of economical production and assurance that a 
produced product is adequately represented by the samples which have 
been tested for safety during the approval process.
    Comments on Lot numbering: One comment indicated that the 
Sec. 160.076-29(d) requirement to change PFD lot numbers whenever an 
incoming component lot number changes, would create a hardship for 
manufacturers. Another comment indicated that changes in lot numbers 
for component lot changes should only be required for changing lots of 
fabric and inflation mechanisms. Additionally, one comment noted that 
the suggestion that PFDs be manufactured in batches and given 
sequential serial numbers is burdensome and unnecessary. The comment 
suggested that this method of numbering be an available option, but not 
a requirement. The Coast Guard notes that the lot numbering 
requirements in the IR are the same as for other kinds of PFDs and that 
in the IR providing sequential serial numbers is an option, not a 
requirement.
    Comments on production tests: One comment questioned why 
Sec. 160.76-29(e)(2) requires two sets of samples for every fifth lot, 
and indicated that the tests conducted by the inspectors should replace 
the tests conducted by manufacturers for these lots. The Coast Guard 
notes that these provisions are the same as for other PFDs and are 
based on the quality assurance concept of counter checking the primary 
quality control provider's results.
    One comment indicated that Sec. 160.076-29(e)(4) (vi) and (5)(iii) 
requires testing without regard to production schedules. The Coast 
Guard notes that these paragraphs are notes to the manufacturer's and 
inspector's sampling plan tables and thus only apply to testing when 
there is production in process, as the comment indicated should be the 
case.
    One comment indicated that the seam strength test in Sec. 160.076-
31(c)(2) is redundant with the over-pressure and air retention tests. 
The Coast Guard notes that in fact the latter tests provide no 
meaningful measure against which production control limits for the 
material or process can be set because they are simply pass/fail tests 
and thus cannot be used to monitor or predict developing problems. Seam 
strength offers a measure that can show trends and thereby indicate 
when to intervene to prevent problems.
    Comments on supervision: One comment indicated that Sec. 160.076-
31(d)(3) which requires that the examiner not be supervised by someone 
who is responsible for meeting production schedules would sometimes 
initially cause problems in production start-up. The Coast Guard notes 
that such start-up conflicts are expected and are handled on a case by 
case basis, by waiving the requirement until the product line is 
established.
    Comments on records retention: One comment questioned why 
Sec. 160.076-33(a) requires the records for inflatable PFDs to be 
retained longer than for inherently buoyant PFDs. Another comment 
questioned why Sec. 160.076-33(b)(4)(ii) requires dates of purchase and 
receipt of components to be recorded in addition to the component lot 
number. The comment indicated the lot number provides the necessary 
tracking information.
    Final rule requirements: Performance of approval tests on 
production inflation chamber materials as required by the IR, avoids 
the necessity and cost for manufacturers to retest a PFD design in the 
event of a material change. The results of these types of material 
tests indicate the level of quality that the materials used in 
production must achieve to ensure production PFDs are capable of 
passing the UL 1180 approval tests. The production requirements section 
of UL 1180 is ``Reserved''. Production oversight is a fundamental 
component for all approval processes. The IR provisions require 
essentially the same production oversight as for other kinds of PFDs. 
Therefore, the Coast Guard is retaining the baseline material and 
production tests to establish the quality of the fundamental element of 
an inflatable PFD's ability to provide durable flotation. Under the IR 
and the final rule, manufacturers are provided the option of qualifying 
several alternate inflation chamber materials, while still being 
prevented from unwittingly submitting a ``lab queen'' for initial 
approval. Inflation chamber material properties as well as production 
oversight and tests, as with all PFDs, are essential quality control 
provisions that ensure production units comply with specifications of 
the tested prototypes.
    As to the lot numbering requirements, though the IR requirements 
are being retained in this final rule the Coast Guard will work with UL 
and the PFD industry to establish equivalent numbering systems, and if 
such a requirement is adopted into the UL standard the Coast Guard will 
delete the requirement for the Coast Guard regulations.
    The Coast Guard is retaining the records and recordkeeping 
provisions in the final rule as published in the IR, because records 
are an essential element to its oversight responsibilities. The UL 
standard does not address these provisions. As the Coast Guard gains 
experience with regulated use and user servicing of inflatables, the 
Coast Guard believes that long-term records are necessary to allow for 
tracking of defects during the initial period of approval. 
Additionally, a more extensive record retention will benefit 
manufacturers by limiting the scope of any necessary defect 
notification solely to affected units. Inherently buoyant PFDs have a 
shorter records retention period than those for inflatables because of 
their ``self inspecting'' qualities of the PFDs as discussed in the 
ANPRM. The Coast Guard interprets the subpart lot recordkeeping 
requirement as being complied with if the component lot number provides 
the manufacturer with the other required information.

9. Waterproof Marking Durability [Section 160.076-31(c)(8)]

    IR Requirement: The IR requires a waterproof marking test that is 
moderately more stringent than the test required for other kinds of 
PFDs.
    Comments: One comment indicated that Sec. 160.076-31(c)(8), 
waterproof marking test, should not require elevated temperature and 
mild detergent since the same is not required for other PFDs.
    Final rule requirements: The Coast Guard agrees that all PFD 
marking should be tested in the same manner, but had established the 
test in the IR because the impermanence of markings is a common 
complaint on presently approved PFDs, and because the modified test is 
no challenge to current technology. However, to avoid excessive 
differences between this and other Coast

[[Page 13943]]
Guard regulations and UL requirements, the waterproof marking 
requirement in the IR is beign revised in this final rule to make the 
test consistent with that applicable to other PFDs.

10. Inflator Marking [Sections 160.076-21(f) and -39(d)(1)(ii)]

    IR Requirement: The IR requires that both inflators and PFDs be 
marked with the model number of the inflator used for approval testing.
    Comments: PFDMA, the industry association, and one manufacturer 
acknowledged in comments the need for the Coast Guard to address PFD 
marking issues as the UL standard does not completely address these 
concerns.
    Final rule requirements: The Coast Guard is retaining the marking 
requirements in the final rule to aid in enforcement of the 
serviceability requirements in Title 33 Part 175. Additionally, these 
provisions are to discourage boaters from switching to less reliable 
and less capable after-market inflators after purchasing a PFD, and to 
minimize the possibility of a boater being harmed as a result of an 
unauthorized modification to an approved PFD. The provision will also 
help to prevent inadvertent voiding of approval.

11. Adhesive Requirements [Section 160.076-21(d)]

    IR Requirement: The IR requires that any adhesive used in the PFD 
must meet a simple performance standard. The UL standard is not 
specific in this area.
    Final rule requirements: The Coast Guard has decided to drop this 
restriction from the final rule. Currently, adhesives are not 
extensively used in most inflatable PFDs produced. The Coast Guard 
included the requirement in the IR because adhesives have been used in 
the past and may possibly come into use again. Even without the Coast 
Guard requirement, if adhesives are used in a PFD submitted for 
approval, the adhesive will still need to be evaluated for suitability 
in the intended application according to section 1.4 of UL 1180, which 
provides general testing standards for components and materials 
different from the standard.

12. Inflation Discomfort [Section 160.076-23(a)(2)]

    IR Requirement: PFDs must not be so uncomfortable during inflation 
or after inflation so as to cause distress or panic to the user.
    Final rule requirements: The Coast Guard is removing this 
requirement from the final rule. The UL 1180 Standard partially covers 
this area in section 6.11.4, which requires the PFD to have acceptable 
comfort up to 90% of the maximum inflation pressure. If after a design 
is approved, the Coast Guard determines that some boaters are 
experiencing distress upon inflation, the need for additional 
requirements in this area will be reevaluated.

13. Textile Cut Edges [Section 160.076-239b)]

    IR Requirement: Textile cut edges must be finished to minimize 
premature unraveling failures. This is a durability and product value 
issue and not a safety issue.
    Final rule requirements: The Coast Guard is removing this 
requirement from the final rule. As a result, some products will need 
to be removed from service sooner than if the requirement were in 
effect; however, a shortened life span should not be catastrophic or 
life threatening.

14. Pamphlet Requirements [Section 160.076-35]

    IR Requirement: An information pamphlet must be provided which is 
similar in format to that required for inherently buoyant and hybrid 
PFDs, but which covers the features of inflatable PFDs.
    Comments: In comments, PFDMA and three manufacturers acknowledged 
the need for this information pamphlet section. They provided no 
specific comments or suggested improvements to the requirements. The UL 
comments indicate that they expected the Coast Guard to fill in these 
requirements until the UL standard could be completed. The general 
consensus of the attendees at the public meeting, discussed above, was 
support of the approach to the pamphlet published in the IR.
    Final rule requirements: All Coast Guard-approved PFDs are required 
by 33 CFR 181 to be provided with a PFD pamphlet. The UL standard has a 
section reserved for this item. Without requirements specific to 
inflatable PFDs in this section, the pamphlet for inherently buoyant 
PFDs specified in 33 CFR 181 would be required. This result would add 
no benefit to the public as that pamphlet fails to address inflatable 
PFDs. Therefore, the Coast Guard is retaining the requirement regarding 
the information pamphlet in the final rule as published in the IR. 
Proper selection guidance is critical for a potential inflatable PFD 
consumer to make an informed purchase decision.

15. Owner's manual [Section 160.076-37 (b)(1), (b)(2), (b)(3), (b)(4), 
and (b)(5)]

    IR Requirement: In addition to the UL 1180 requirements for the 
type of information to be provided in an owner's manual, the IR 
requires five additional issues to be addressed: (1) instructions to 
inform users to partially deflate a PFD to ease climbing out of the 
water; (2) service life disclosure; (3) warning against misuse that 
could be hazardous; (4) explanation of the meaning of any approval 
conditions; and (5) estimate of user's chances of survival if approval 
conditions are or are not met.
    Comments: Several comments addressed this issue. One manufacturer 
acknowledged the need for the IR's owner's manual section. Two comments 
indicated that the requirement is Sec. 160.076-37(b)(2), to state the 
expected service life in owners manual, was not prudent due to enormous 
diversity of usage conditions. One of these comments went on to say 
that the components which will be used in the first inflatable PFDs are 
newly developed to meet the new standard and have no historical data to 
justify any claims of expected service life. Additionally, a comment 
from UL indicated that the example in Sec. 160.076-37(b)(3), which 
requires a warning against wearing a PFD with automatic inflation under 
restrictive clothing, should be revised to indicate that such a warning 
be provided with all inflatable PFDs since any inflatable PFD worn 
under clothing is hazardous.
    Final rule requirements: During the development of UL 1180, PFD 
manufacturers were divided on the service life disclosure issue, and 
the UL committee could not reach a consensus on the issue. Because the 
IR provisions requiring additional information to be included in 
owner's manual add limited additional safety benefits and may delay 
designs being available to boaters, those provisions are being deleted 
in the final rule. The UL standard still requires an owner's manual to 
be included and manufacturers who choose to, can include the material 
which would have been required by the IR.

16. PFD Markings [Section 160.076-39 (c), (d), and (f)]

    IR Requirement: In addition to the UL 1180 marking requirements for 
PFDs and component materials, the IR requires several additional 
marking items including information about use on commercial vessels, 
the approved inflator model, and warnings of foreseeable hazards. 
Additionally, conditional approval markings are permitted for 
manufacturers seeking such approval.
    Comments; General: The PFDMA acknowledged that, in general, the 
Coast Guard's marking provisions in the IR

[[Page 13944]]
were necessary. The Association provided no specific comments.
    Comments; Marking size: There were two comments on the size of the 
marking required on the inflation handle of a manual inflator. Both 
comments indicated that smaller marking would be adequate.
    Comments; Use on Commercial Vessels: There were two comments on the 
requirements in Sec. 160.076-39(d)(1)(i) which require markings on an 
approved PFD to state that the PFDs are ``NOT APPROVED FOR USE ON 
COMMERCIAL VESSELS.'' Both comments believed that there was a high 
likelihood that the marking would be misinterpreted as prohibiting use 
of these recreational inflatable PFDs on commercial vessels. One 
comment noted that the marking would create the misperception in the 
minds of many crew members of commercial vessels, that they are not 
allowed to wear inflatable PFDs. The comment stated that as a result, 
the marking will be a disservice to thousands of men and women on board 
commercial vessels. Further, the comment noted, it will greatly 
diminish the stated objective of getting people to take the preventive 
measure of actually wearing a PFD and advocated that all inflatable 
PFDs be marked ``Meets USCG Carriage Requirements Only When Worn.''
    The other comment also favored use of the devices on uninspected 
vessels with certain conditions. This comment stated that for 
uninspected passenger vessels for hire, there appears to be no basis 
for allowing inflatable PFDs in lieu of inherently buoyant PFDs unless 
they are worn by the passengers during the voyage.
    Comments; Reliability Disclosure: One of the comments discussed 
above also requested that inflatable PFDs be marked with their 
reliability (after five years of typical service), for the consumer's 
information at the point of sale. The comment indicated that 
comparative figures for inherently buoyant PFDs should be allowed. The 
comment also suggested that the inflatable PFD should be marked with an 
indication of its reliability and effectiveness when worn.
    Final rule requirements: Based on the comments the Coast Guard is 
revising the marking requirements in the final rule to require the PFDs 
to be marked ``NOT APPROVED TO MEET CARRIAGE REQUIREMENTS ON COMMERCIAL 
VESSELS.'' This will make it clear that Type I, II, or III inflatable 
PFDs may be used as additional equipment on uninspected commercial 
vessels, in the same fashion as most other recreational PFDs. This 
would allow crew members to use these inflatables in addition to Type V 
PFDs permitted to be used on these vessels in accordance with their 
labels. In a future rulemaking the Coast Guard intends to consider 
revising 46 CFR part 25 to address use of these PFDs to meet certain 
commercial vessel carriage requirements and to address the associated 
maintenance responsibilities and perhaps wear requirements as suggested 
in the comments.
    The Coast Guard has decided not to require markings concerning 
reliability of the PFD on the PFD label as requested because, among 
other things, it cannot be adequately explained in a brief statement. 
This information may be addressed in the information pamphlet or the 
owner's manual. The pamphlet is intended for point of sale information. 
In this final rule, the Coast Guard is not requiring this information 
to be provided either on the label or in the owner's manual because the 
rating would depend on how the PFD is used and cared for or would 
require the development of a standardized typical service life which is 
not available at this time.
    As to the other comments on marking requirements in Sec. 160.076-
39, the Coast Guard is deleting paragraphs (d)(2) and (f) regarding 
foreseeable misuse and manual inflation handle marking, as these 
provisions add limited additional safety and may delay designs being 
available to boaters.

Editorial Corrections

    In addition to the above changes, a number of editorial changes are 
being made in the final rule to conform the text of the rule to the new 
organization of the Coast Guard. Additionally, the production test and 
inspection sampling plan tables in Sec. 160.076-29 are corrected in two 
areas. The lot size headings are relocated to not confuse them with the 
number of samples per lot. Also, in the notes to the tables the symbols 
``/@'' are replaced with ``Sec. ''.

Incorporation by Reference

    The following material is incorporated by reference in 
Sec. 160.076-11: Fully Inflatable Recreational Personal Flotation 
Devices (UL 1180), first edition, May 15, 1995; Components for Personal 
Flotation Devices (UL 1191), May 16, 1995; Marine Buoyant Devices (UL 
1123), February 17, 1995; American Society for Testing and Materials, 
ASTM D 751-79, Standard Methods of Testing Coated Fabrics, 1979; ASTM D 
1434-75, Gas Transmission Rate of Plastic Film and Sheeting, 1975; and 
Federal Standards, Federal Test Method Standard No. 191A, July 20, 
1978. Copies of the material are available for inspection where 
indicated under ``ADDRESSES.'' Copies of the material are available 
from the sources listed in Sec. 160.076-11.
    The Director of the Federal Register has approved the material in 
Sec. 160.076-11 for incorporation by reference under 5 U.S.C. 552 and 1 
CFR part 51. The material is available as indicated in that section.

Regulatory Evaluation

    This rule is not a significant regulatory action under section 3(f) 
of Executive Order 12866 and does not require an assessment of 
potential costs and benefits under section 6(a)(3) of that order. It 
has not been reviewed by the Office of Management and Budget under that 
order. It is not significant under the regulatory policies and 
procedures of the Department of Transportation (DOT) (44 FR 11040; 
February 26, 1979).
    A Regulatory Evaluation under paragraph 10e of the DOT regulatory 
policies and procedures has been prepared and is available in the 
docket for inspection or copying where indicated under ADDRESSES. The 
Evaluation is summarized as follows.
    The requirements of this final rule open up a new marketing 
opportunity for inflatable PFD manufacturers by allowing them to obtain 
Coast Guard approval of recreational inflatable PFDs, if they so 
choose. The final rule will also allow boaters to purchase and use 
inflatable PFDs on their boats, if they wish to do so. Manufacturers 
may still make and sell unapproved inflatable PFDs, and boaters may 
continue to use such PFDs as additional equipment. Manufacturers who 
wish to obtain approval will have to pay for the approval testing at 
the recognized laboratory, pay the cost of the required quality control 
and oversight, and provide the information pamphlet and manuals 
required by this rule.
    The estimated total initial approval cost per inflatable PFD design 
is expected to be approximately $18,500, excluding the cost of 
inflation system acceptance which could be amortized over several 
designs of PFDs. This cost is almost entirely due to tests required by 
the industry consensus standard, which are not included in the cost 
imposed by this rule. Costs to approve other types of PFDs are 
approximately $6,000, excluding component acceptance costs. The 
additional cost to approve inflatable PFDs could easily be absorbed in 
the cost of the units produced. The cost increase per device would be 
small considering the number of devices which could be produced under 
authorization of each approval

[[Page 13945]]
certificate. The Coast Guard anticipates that it will approve 36 
inflatable PFD designs within the first 10 years after issuing this 
rule.
    Production inspection costs imposed by these regulations will be 
approximately $1,000 for the largest size lot of inflatable PFDs 
permitted. This cost is similar to that incurred for other types of 
approved PFDs.
    The retail cost, per device, is expected to be between $50 and $200 
for inflatable PFDs. Currently approved PFDs range in price from $7-
$200.
    If 500,000 units per year are produced, costs for the requirements 
imposed over those imposed by the industry consensus standard is 
estimated to be $618,000 annually to the industry.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), the 
Coast Guard must consider the economic impact on small entities of a 
rule for which a general notice of proposed rulemaking is required. 
``Small entities'' may include (1) small businesses and not-for-profit 
organizations that are independently owned and operated and are not 
dominant in their fields and (2) governmental jurisdictions with 
populations of less than 50,000.
    As the requirements of this final rule open up a new marketing 
opportunity for inflatable PFD manufacturers by allowing them to obtain 
Coast Guard approval of recreational inflatable PFDs, a general notice 
of proposed rulemaking was not required. The Coast Guard has 
nevertheless reviewed this rule for its potential impact on small 
entities. The final rule will also allow boaters to purchase and use 
inflatable PFDs on their boats. As discussed above, the economic impact 
of the new requirements is expected to be minimal.
    Therefore, the Coast Guard certifies that this rule will not have a 
significant economic impact on a substantial number of small entities.

Collection of Information

    This rule contains collection-of-information requirements. The 
Coast Guard has submitted the requirements to the Office of Management 
and Budget (OMB) for review under section 3504(h) of the Paperwork 
Reduction Act (44 U.S.C. 3501 et seq.), and OMB has approved them. The 
section numbers are Secs. 160.076-13, 160.076-21, 160.076-29, 160.076-
31, 160.076-33, 160.076-35, and 160.076-39 and the OMB approval number 
is OMB Control Number 2115-0619.

Federalism

    The Coast Guard has analyzed this rule under the principles and 
criteria contained in Executive Order 12612 and has determined that 
this rule does not have sufficient federalism implications to warrant 
the preparation of a Federalism Assessment. This rulemaking establishes 
procedures for Coast Guard approval of inflatable PFDs. The authority 
to establish these requirements are committed to the Coast Guard by 
Federal statutes. Furthermore, since PFDs are manufactured and used in 
the national marketplace, safety standards for PFDs should be national 
in scope to avoid burdensome variances. Therefore, the Coast Guard 
intends this rule to preempt State action on the same subject matter.

Environment

    The Coast Guard considered the environmental impact of this rule 
and concluded that under paragraph 2.B.2 of Commandant Instruction 
M16475.1B, this rule is categorically excluded from further 
environmental documentation. This rule has no environmental impact 
other than reducing the volume of unicellular plastic foam being used 
in inherently buoyant PFDs. A ``Categorical Exclusion Determination'' 
is available in the docket for inspection or copying where indicated 
under ADDRESSES.

List of Subjects in 46 CFR Part 160

    Marine safety, Reporting and recordkeeping requirements, 
Incorporation by reference.

    Accordingly, the interim rule amending 46 CFR part 160, which was 
published at 60 FR 32836 on June 23, 1995, is adopted as final with the 
following changes:

PART 160--LIFESAVING EQUIPMENT

    1. The authority citation for part 160 is revised to read as 
follows:

    Authority: 46 U.S.C. 2103, 3306, 3703 and 4302; E.O. 12234, 45 
FR 58801, 3 CFR, 1980 Comp., p. 277; 49 CFR 1.46.

    2. Section 160.076-5 is amended by revising the definition of 
``Commandant'', and removing the definition of ``LSI'' to read as 
follows:


Sec. 160.076-5  Definitions.

* * * * *
    Commandant means the Chief of the Lifesaving and Fire Safety 
Standards Branch, U.S. Coast Guard Marine Safety and Environmental 
Protection Directorate. Address: Commandant (G-MMS-4), U.S. Coast Guard 
Headquarters, 2100 Second St. SW., Washington, DC 20593-0001; phone: 
202-267-1444; facsimile: 202-267-1069; electronic mail: ``mvi-3/G-
M[email protected]''.
* * * * *
    3. In Sec. 160.076-7, paragraph (a) is revised to read as follows:


Sec. 160.076-7  PFD approval Type.

    (a) An inflatable PFD may be approved without conditions as a Type 
I, II, or III PFD for persons over 36 kg (80 lb) if it meets the 
requirements of this subpart.
* * * * *
    4. In Sec. 160.076-9, paragraph (b) is revised to read as follows:


Sec. 160.076-9  Conditional approval.

* * * * *
    (b) PFDs not meeting the performance specifications for type I, II, 
or III PFDs in UL 1180 may be classified as Type V, conditionally 
approved PFDs, when the Commandant determines that the performance or 
design characteristics of the PFD make such classification appropriate.
    5. In Sec. 160.076-11, paragraph (b) is revised to read as follows:


Sec. 160.076-11  Incorporation by reference.

* * * * *
    (b) The materials approved for incorporation by reference in this 
subpart, and the sections affected are as follows:

American Society for Testing and Materials (ASTM)

100 Barr Harbor Drive, West Conshohocken, PA 19428-2959.
ASTM D 751-79 Standard Methods of Testing Coated Fabrics, 1979, 
160.076-25;
ASTM D 1434-75 Gas Transmission Rate of Plastic Film and Sheeting, 
1975, 160.076-25.

Federal Standards

    Naval Publishing and Printing Center, Customer Service, 700 Robbins 
Avenue, Philadelphia, PA 19120.
    In Federal Test Method Standard No. 191A (dated July 20, 1978) the 
following methods:

(1) Method 5100, Strength and Elongation, Breaking of Woven Cloth; Grab 
Method, 160.076-25;
(2) Method 5132, Strength of Cloth, Tearing; Falling-Pendulum Method, 
160.076-25;
(3) Method 5134, Strength of Cloth, Tearing; Tongue Method, 160.076-25.

Underwriters Laboratories (UL)

    Underwriters Laboratories, Inc., P.O. Box 13995, Research Triangle 
Park, NC 27709-3995 (Phone (919) 549-1400; Facsimile: (919) 549-1842)


[[Page 13946]]

UL 1123, ``Marine Buoyant Devices'', February 17, 1995, 160.076-35;
UL 1180, ``Fully Inflatable Recreational Personal Flotation Devices'', 
May 15, 1995, 160.076-7; 160.076-21; 160.076-23; 160.076-25; 160.076-
29; 160.076-31; 160.076-37; 160.076-39.
UL 1191, ``Components for Personal Flotation Devices'', May 16, 1995, 
160.076-21; 160.076-25; 160.076-39.


Sec. 160.076-13  [Amended]

    6. In Sec. 160.076-13 paragraph (c)(10) is removed.


Sec. 160.076-21  [Amended]

    7. In Sec. 160.076-21 paragraphs (d) and (e) are removed and 
paragraph (f) is redesignated as paragraph (d).
    8. In Sec. 160.076-23, paragraphs (a)(2) and (b) are removed, 
paragraph (a)(3) is redesignated as (a)(2), and paragraph (a)(1) is 
revised to read as follows:


Sec. 160.076-23  Construction and performance requirements.

    (a) * * *
    (1) Meet the requirements in UL 1180 applicable to the PFD 
performance type for which approval is sought; and
* * * * *
    9. In Sec. 160.076-25, paragraph (c) is revised to read as follows:


Sec. 160.076-25  Approval testing.

* * * * *
    (c) Each test subject participating in the tests in UL 1180, 
section 6 shall in addition, demonstrate that the test subject can 
repack the PFD such that it can be used in the donning tests and manual 
activation tests required by--
    (1) Section 6.2.3 of UL 1180; and
    (2) Sections 6.4.1, and 6.4.2 of UL 1180, if the test engineer 
cannot verify that the manual and oral inflators are properly stowed.
* * * * *


Sec. 160.076-27  [Removed and reserved]

    10. Sec. 160.076-27 is removed and reserved.


Sec. 160.076-29  [Amended]

    11. In Sec. 160.076-29, Tables 160.076-29A and 160.076-29B are 
revised to read as follows:
* * * * *

                                 Table 160.076-29A--Manufacturer's Sampling Plan                                
----------------------------------------------------------------------------------------------------------------
                                                              Number of Samples Per Lot (Lot size)              
                                               -----------------------------------------------------------------
                                                  1-100     101-200    201-300    301-500    501-750    751-1000
----------------------------------------------------------------------------------------------------------------
Tests:                                                                                                          
    Inflation Chamber Materials...............                                                                  
(5) See Note (a)                                                                                                
    Seam Strength.............................          1          1          2          2          3          4
    Over-pressure (b)(c)......................          1          2          3          4          6          8
    Air Retention.............................                                                                  
(5) EVERY DEVICE IN THE LOT                                                                                     
    Buoyancy and Inflation Medium Retention...          1          2          3          4          6          8
    Tensile Strength..........................                                                                  
(5) See Note (d)                                                                                                
Detailed Product Examination..................          2          2          3          4          6          8
Retest Sample Size (b)........................  .........  .........         13         13         20         20
Final Lot Inspection..........................                                                                  
(5) EVERY DEVICE IN THE LOT                                                                                     
----------------------------------------------------------------------------------------------------------------
Notes to Table.                                                                                                 
(a) See Sec.  160.076-29(e)(4)(i).                                                                              
(b) See Sec.  160.076-29(e)(4)(ii).                                                                             
(c) See Sec.  160.076-29(e)(4)(iii).                                                                            
(d) See Sec.  160.076-29(e)(4)(iv).                                                                             


                                  Table 160.076-29B--Inspector's Sampling Plan                                  
----------------------------------------------------------------------------------------------------------------
                                                              Number of Samples Per Lot (Lot size)              
                                               -----------------------------------------------------------------
                                                  1-100     101-200    201-300    301-500    501-750    751-1000
----------------------------------------------------------------------------------------------------------------
Tests:                                                                                                          
    Over-pressure (a).........................          1          1          2          2          3          4
    Air Retention.............................          1          1          2          2          3          4
    Buoyancy & Inflation Medium Retention.....          1          1          2          2          3          4
    Tensile Strength..........................                                                                  
(5) See Note (b)                                                                                                
    Waterproof marking........................                                                                  
(5) See Note (c)                                                                                                
Detailed Project Examination..................          1          1          1          2          2          3
Retest Sample Size (a)........................         10         10         13         13         20         20
Final Lot Inspection..........................         10         15         20         25         27         30
----------------------------------------------------------------------------------------------------------------
Notes to Table:                                                                                                 
(a) See Sec.  160.076-29(e)(5)(i).                                                                              
(b) See Sec.  160.076-29(e)(5)(ii).                                                                             
(c) See Sec.  160.076-29(e)(5)(iii).                                                                            

* * * * *
    12. In Sec. 160.076-31, paragraph (c)(8) is revised to read as 
follows:


Sec. 160.076-31  Production tests and examinations.

* * * * *
    (c) * * *
    (8) Waterproof Marking Test. Each sample must be completely 
submerged in fresh water for at least 30 minutes. The sample must then 
be removed, immediately placed on a hard surface, and the markings 
vigorously rubbed with the fingers for 15 seconds. If the printing 
becomes illegible, the sample must be rejected.
* * * * *
    13. In Sec. 160.076-37, paragraph (b) is revised to read as 
follows:


Sec. 160.076-37  Owner's manual.

* * * * *

[[Page 13947]]

    (b) Manual contents. Each owner's manual must contain the 
information specified in section 11 of UL 1180, and, if the PFD is 
conditionally approved, an explanation of the meaning of, and reasons 
for, the approval conditions.
    14. In Sec. 160.076-39, paragraph (d)(2) is removed and reserved, 
paragraphs (c) and (d)(1)(i) are revised and paragraph (f) is removed 
to read as follows:


Sec. 160.076-39  Marking.

* * * * *
    (c) A Type V, conditionally approved, inflatable PFD must be marked 
with the approval conditions specified on the approval certificate.
    (d) * * *
    (1) * * *
    (i) ``NOT APPROVED TO MEET CARRIAGE REQUIREMENTS ON COMMERCIAL 
VESSELS.''
* * * * *
    Dated: March 20, 1996.
J.C. Card,
Rear Admiral, U.S. Coast Guard, Chief, Office of Marine Safety, 
Security and Environmental Protection.
[FR Doc. 96-7301 Filed 3-27-96; 8:45 am]
BILLING CODE 4910-14-M