(a) This subpart contains requirements for production follow-up inspections for inflatable recreational personal flotation devices (PFDs) approved prior to January 6, 2025.

(b) Inflatable PFDs approved under this subpart rely partially or entirely upon inflation for buoyancy.

(c) PFDs approved under this subpart are intended to meet the carriage requirements for wearable PFDs for recreational vessels and uninspected recreational submersible vessels, in accordance with 33 CFR 175.15 and 175.17.

As used in this part:

Commandant means the Chief of the Lifesaving and Fire Safety Standards Division. Address: Commandant (CG-ENG-4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE., Washington, DC 20593-7509; telephone 202-372-1392 or fax 202-372-1924.

Conditional approval means a PFD approval which has condition(s) with which the user must comply in order for the PFD to be counted toward meeting the carriage requirements for the vessel on which it is being used.

First quality workmanship means construction which is free from any defect materially affecting appearance or serviceability.

Inflation medium means any solid, liquid, or gas that, when activated, provides inflation for buoyancy.

Inspector means a recognized laboratory representative assigned to perform, supervise or oversee the duties described in §§ 160.076-29 and 160.076-31 of this subpart or any Coast Guard representative performing duties related to the approval.

MOU means memorandum of understanding which describes the approval functions a recognized independent laboratory performs for the Coast Guard, and the recognized independent laboratory's working arrangements with the Coast Guard.

Performance type means the in-water performance classification of the PFD.

PFD means personal flotation device as defined in 33 CFR 175.13.

Plans and specifications means the drawings, product description, construction specifications, and bill of materials submitted in accordance with § 160.076-13 for approval of a PFD design.

Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the Coast Guard Headquarters and at the National Archives and Records Administration (NARA). Contact Commandant (CG-ENG-4), Attn: Lifesaving and Fire Safety Division, U.S. Coast Guard Stop 7509, 2703 Martin Luther King Jr. Avenue SE, Washington, DC 20593-7509. For information on the availability of this material at NARA, visit www.archives.gov/federal-register/cfr/ibr-locations or email [email protected]. The material may be obtained from UL, 333 Pfingsten Road, Northbrook, IL 60062-2002; phone (847) 272-8800; website: www.ul.com.

(a) ANSI/CAN/UL 9595:2021, Standard for Safety Factory Follow-Up on Personal Flotation Devices (PFDs), First Edition, June 4, 2020 (including revisions through September 9, 2021) (“ANSI/CAN/UL 9595”); IBR approved for § 160.076-29(a).

(b) [Reserved].

(a) A conditionally approved inflatable PFD may be used to meet the Coast Guard PFD carriage requirements of 33 CFR part 175 only if the PFD is used in accordance with any requirements on the approval label. PFDs marked “Approved only when worn” must be worn whenever the vessel is underway and the intended wearer is not within an enclosed space if the PFD is intended to be used to satisfy the requirements of 33 CFR part 175. Note: Additional approved PFDs may be needed to satisfy the requirements of 33 CFR part 175 if “Approved only when worn” PFDs are not worn.

(b) PFDs not meeting the performance specifications in UL 1180 (incorporated by reference, see § 160.076-11) may be conditionally approved when the Commandant determines that the performance or design characteristics of the PFD make such classification appropriate.

As provided in § 159.005-15 of this chapter, the Commandant may suspend or terminate the approval of an inflatable PFD design if the manufacturer fails to comply with this subpart or the recognized laboratory's accepted procedures or requirements.

(a) The manufacturer must submit any proposed changes in design, material, or construction to the recognized laboratory and the Commandant for approval before changing PFD production methods.

(b) Determinations of equivalence of design, construction, and materials may be made only by the Commandant or a designated representative.

The approval and production oversight functions that this subpart requires to be conducted by a recognized laboratory must be conducted by an independent laboratory recognized by the Coast Guard under subpart 159.010 of part 159 of this chapter to perform such functions. A list of recognized independent laboratories is available from the Commandant and online at http://cgmix.uscg.mil.

(a) Production tests and inspections must be conducted in accordance with ANSI/CAN/UL 9595 (incorporated by reference, see § 160.076-5) or an alternative follow-up procedure accepted by the Commandant. The Commandant may prescribe additional production tests and inspections necessary to maintain quality control and to monitor compliance with the requirements of this subpart.

(b) Production oversight must be performed by the same laboratory that performs the approval tests unless the Commandant determines that the employees of an alternative laboratory have received training and have access to the same information as the inspectors of the laboratory that conducted the approval testing.

(c) In addition to responsibilities set out in part 159 of this chapter and the accepted Laboratory Follow-up Procedures, each manufacturer of an inflatable PFD and each recognized laboratory inspector shall comply with the following, as applicable:

(1) Manufacturer. Each manufacturer must—

(i) Perform all required tests and examinations on each PFD lot before any required inspector's tests and inspection of the lot;

(ii) Follow established procedures for maintaining quality control of the materials used, manufacturing operations, and the finished product;

(iii) Implement a continuing program of employee training and a program for maintaining production and test equipment;

(iv) Admit the inspector to any place in the factory where work is done on PFDs or component materials, and where parts or completed PFDs are stored;

(v) Have an inspector observe the production methods used in producing the first PFD lot and observe any revisions in production methods made thereafter; and

(vi) Allow the inspector to take samples of completed PFDs or of component materials for tests required by this subpart and for tests relating to the safety of the design.

(2) Recognized laboratory oversight. An inspector from a recognized laboratory shall oversee production in accordance with the MOU. During production oversight, the inspector shall not perform or supervise any production test or inspection unless—

(i) The manufacturer has a valid approval certificate; and

(ii) The inspector has first observed the manufacturer's production methods and any revisions to those methods.

(3) The inspector must perform or supervise testing and inspection of at least one in each five lots of PFDs produced.

(4) During each inspection, the inspector must check for compliance with the manufacturer's quality control procedures.

(d) PFD lots. A lot number must be assigned to each group of PFDs produced. Lots must be numbered serially. A new lot must be started whenever any change in materials or a revision to a production method is made, and whenever any substantial discontinuity in the production process occurs. Changes in lots of component materials must be treated as changes in materials. The lot number assigned, along with the approval number, must enable the PFD manufacturer, by referring to the records required by this subpart, to determine the supplier of the components used in the PFD and the component supplier's identifying information for the component lot.

(e) Samples. For the tests, examinations, and inspections required by § 160.076-31, inspectors and manufacturers shall select samples as provided in this paragraph.

(1) Samples shall be selected at random from a lot in which all PFDs or materials in the lot are available for selection. Except as provided in § 160.076-31(c), samples must be selected from completed PFDs.

(2) Different samples must be selected for the manufacturer's and inspector's tests, except, if the total production for any five consecutive lots does not exceed 250 PFDs, the manufacturer's and inspector's tests may be run on the same sample(s) at the same time.

(f) Facilities and equipment—(1) General. The manufacturer must provide the test equipment and facilities necessary for performing production tests, examinations, and inspections, unless Commandant has accepted testing at a location other than the manufacturer's facility.

(2) Calibration. The manufacturer must have the calibration of all test equipment checked at least every six months by a weights and measures agency or the equipment manufacturer, distributor, or dealer.

(3) Facilities. The manufacturer must provide a suitable place and the necessary equipment for the inspector to use in conducting or supervising tests. For the final lot inspection, the manufacturer must provide a suitable working environment and a smooth-top table for the inspector's use.

(a) Samples used in testing must be selected in accordance with the sampling plan accepted by the Commandant.

(b) On each sample selected—

(1) The manufacturer must conduct the tests specified in the follow-up program accepted by the Commandant;

(2) The recognized laboratory inspector must conduct or supervise the tests specified in the follow-up program accepted by the Commandant; and

(3) In addition to meeting the requirements of this section, each test result must meet the requirements, if any, contained in the approved plans and specifications.

(c) Final lot examination and inspection—(1) General. On each PFD lot that passes production testing, the manufacturer must perform a final lot examination and, on every fifth lot, a laboratory inspector must perform a final lot inspection. Each final lot must demonstrate—

(i) First quality workmanship;

(ii) That the general arrangement and attachment of all components, such as body straps, closures, inflation mechanisms, tie tapes, and drawstrings, are as specified in the approved plans and specifications;

(iii) Compliance with the marking requirements in § 160.076-39; and

(iv) That the information pamphlet and owner's manual required by § 160.076-35 and 160.076-37, respectively, are securely attached to the device, with the pamphlet selection information visible and accessible prior to purchase.

(2) Accept/reject criteria. Each nonconforming PFD must be rejected. If three or more nonconforming PFDs are rejected for the same kind of defect, lot examination or inspection must be discontinued and the lot rejected.

(3) Manufacturer examination. This examination must be conducted by a manufacturer's representative who is familiar with the approved plans and specifications, the functioning of the PFD and its components, and the production testing procedures. This person must not be responsible for meeting production schedules or be supervised by someone who is. This person must prepare and sign the record required by 159.007-13(a) of this chapter and 160.076-33(b).

(4) Independent laboratory inspection. (i) The inspector must discontinue lot inspection and reject the lot if examination of individual PFDs or the records for the lot shows noncompliance with either this section or the laboratory's or the manufacturer's quality control procedures.

(ii) If the inspector rejects a lot, the inspector must advise the Commandant or the recognized laboratory within 15 days.

(iii) The inspector must prepare and sign the inspection record required by 159.007-13(a) of this chapter and 160.076-33(b). If the lot passes, the record must include the inspector's certification that the lot passed inspection and that no evidence of noncompliance with this section was observed.

(d) Disposition of rejected PFD lot or PFD. (1) A rejected PFD lot may be resubmitted for testing, examination or inspection if the manufacturer first removes and destroys each defective PFD or, if authorized by the Commandant, reworks the lot to correct the defect.

(2) Any PFD rejected in a final lot examination or inspection may be resubmitted for examination or inspection if all defects have been corrected and reexamination or reinspection is authorized by the Commandant.

(3) A rejected lot or rejected PFD may not be sold or offered for sale under the representation that it meets this subpart or that it is Coast Guard-approved.

(a) Each manufacturer of inflatable PFDs shall keep the records of production inspections and tests as required by § 159.007-13 of this chapter, except that they must be retained for at least 120 months after the month in which the inspection or test was conducted.

(b) In addition to the information required by § 159.007-13 of this chapter, the manufacturer's records must also include the following information:

(1) For each test, the serial number of the test instrument used if more than one test instrument was available.

(2) For each test and inspection, the identification of the samples used, the lot number, the approval number, and the number of PFDs in the lot.

(3) For each lot rejected, the cause for rejection, any corrective action taken, and the final disposition of the lot.

(4) For all materials used in production the—

(i) Name and address of the supplier;

(ii) Date of purchase and receipt;

(iii) Lot number; and

(iv) Where required by § 164.019-5 of this chapter, the certification received with standard components.

(5) A copy of this subpart.

(6) A copy of the approved plans and specifications.

(7) The approval certificate obtained in accordance with § 2.75-1 and 2.75-5 of this chapter.

(8) Certificates evidencing calibration of test equipment, including the identity of the agency performing the calibration, date of calibration, and results.

(c) A description or photographs of procedures and equipment used in testing required by § 159.007-13(a)(4) of this chapter, is not required if the manufacturer's procedures and equipment meet the requirements of this subpart.

(d) The records required by paragraph (b)(4) of this section must be kept for at least 120 months after preparation. All other records required by paragraph (b) of this section must be kept for at least 60 months after the PFD approval expires or is terminated.

A pamphlet or placard accepted by the Commandant must be attached to each inflatable PFD sold or offered for sale in such a way that a prospective purchaser can read the pamphlet prior to purchase. The pamphlet or placard text and layout must be submitted to the Commandant for approval. The text must be printed in each pamphlet or placard exactly as approved by the Commandant. Additional information, instructions, or illustrations must not be included within the approved text and layout. Sample pamphlet text and layout may be obtained by contacting the Commandant. This pamphlet or placard may be combined with the manual required by § 160.076-37 if PFD selection and warning information is provided on the PFD packaging in such a way that it remains visible until purchase.

(a) General. The manufacturer must provide an owner's manual with each inflatable PFD sold or offered for sale.

(b) Manual contents. The manual must contain the information as approved by the Commandant. If the PFD is conditionally approved, an explanation of the meaning of and reasons for the approval conditions must be included.

Each inflatable PFD must be marked as approved by the Commandant. At a minimum, all labels must include—

(a) Size information, as appropriate;

(b) The Coast Guard approval number;

(c) Manufacturer's contact information;

(d) Model name/number;

(e) Lot number, manufacturer date; and

(f) Any limitations or restrictions on approval or special instructions for use.