[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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