(a) Each approval issued under this subpart contains the following conditions:
(1) Upon the request of the Associate Administrator, the applicant or holder must allow the Associate Administrator or the Associate Administrator's designee to inspect the applicant's pressure receptacle manufacturing and testing facilities and records, and must provide such materials and pressure receptacles for analyses and tests as the Associate Administrator may specify. The applicant or holder must bear the cost of the initial and subsequent inspections, analyses, and tests.
(2) Each holder must comply with all of the terms and conditions stated in the approval letter issued under this subpart.
(b) In addition to the conditions specified in Sec. 107.713, an approval may be denied or if issued, suspended or terminated if the Competent Authority of the country of manufacture fails to initiate, maintain or recognize an IIA approved under this subpart; fails to recognize UN standard packagings manufactured in accordance with this subchapter; or implements a condition or limitation on United States citizens or organizations that is not required of its own citizenry. [71 FR 33874, June 12, 2006]
Sec. Appendix A to Part 107--Standard Operating Procedures for Special
Permits and Approvals
This appendix sets forth the standard operating procedures (SOPs) for processing an application for a special permit or an approval in conformance with 49 CFR parts 107 and 171 through 180. It is to be used by PHMSA for the internal management of its special permit and approval programs.
The words ``special permit'' and ``approval'' are defined in Sec. 107.1. PHMSA receives applications for: (1) Designation as an approval or certification agency, (2) a new special permit or approval, renewal or modification of an existing special permit or an existing approval, (3) granting of party status to an existing special permit, and (4) in conformance with Sec. 107.117, emergency processing for a special permit. Depending on the type of application, the SOP review process includes several phases, such as Completeness, Publication, Evaluation, and Disposition.
Special Permit and Approval Evaluation Review Process----------------------------------------------------------------------------------------------------------------
Non-
Special permit classification Classification Registration
approval approval approval----------------------------------------------------------------------------------------------------------------1. Completeness............................. X X X X2. Publication.............................. X ...............3. Evaluation...............................a. Technical................................ X X Xb. Safety Profile........................... X X ............... X4. Disposition..............................a. Approval................................. X X X Xb. Denial................................... X X X Xc. Reconsideration/Appeal................... X X X X----------------------------------------------------------------------------------------------------------------
An approval for assessing an applicant's ability to perform a function that does not involve classifying a hazardous material is described as a non-classification approval and certifies that: An approval holder is qualified to requalify, repair, rebuild, and/or manufacture cylinders stipulated in the HMR; an agency is qualified to perform inspections and other functions outlined in an approval and the HMR; an approval holder is providing an equivalent level of safety or safety that is consistent with the public interest in the transportation of hazardous materials outlined in the approval; and a radioactive package design or material classification fully complies with applicable domestic or international regulations. An approval for assessing the hazard class of a material is described as a classification approval and certifies that explosives, fireworks, chemical oxygen generators, self-reactive materials, and organic peroxides have been classed for manufacturing and/or transportation based on requirements stipulated in the HMR. Registration approvals include the issuance of a unique identification number used solely as an identifier or in conjunction with approval holder's name and address, or the issuance of a registration number that is evidence the approval holder is qualified to perform an HMR-authorized function, such as visually requalifying cylinders. This appendix does not include registrations issued under 49 CFR part 107, subpart G.
1. Completeness. PHMSA reviews all special permit and approval applications to determine if they contain all the information required under Sec. 107.105 (for a special permit), Sec. 107.117 (for emergency processing) or Sec. 107.402 (for designation as a certification agency) or Sec. 107.705 (for an approval). If PHMSA determines an application does not contain all the information needed to evaluate the safety of the actions requested in the application, the Associate Administrator may reject the application. If the application is rejected, PHMSA will notify the applicant of the deficiencies in writing. An applicant may resubmit a rejected application as a new application, provided the newly submitted application contains the information PHMSA needs to make a determination.
Emergency special permit applications must comply with all the requirements prescribed in Sec. 107.105 for a special permit application, and contain sufficient information to determine that the applicant's request for emergency processing is justified under the conditions prescribed in Sec. 107.117.
2. Publication. When PHMSA determines an application for a new special permit or a request to modify an existing special permit is complete and sufficient, PHMSA publishes a summary of the application in the Federal Register in conformance with Sec. 107.113(b). This provides the public an opportunity to comment on a request for a new or a modification of an existing special permit.
3. Evaluation. The evaluation phase consists of two assessments, which may be done concurrently, a technical evaluation and a safety profile evaluation. When applicable, PHMSA consults and coordinates its evaluation of applications with the following Operating Administrations (OAs) that share enforcement authority under Federal hazardous material transportation law: Federal Aviation Administration, Federal Motor Carrier Safety Administration, Federal Railroad Administration, and United States Coast Guard. PHMSA also consults other agencies with hazardous material subject-matter expertise, such as the Nuclear Regulatory Commission and the Department of Energy.
(a) Technical evaluation. A technical evaluation considers whether the proposed special permit or approval will achieve a level of safety at least equal to that required under the HMR or, if a required safety level does not exist, considers whether the proposed special permit is consistent with the public interest in that it will adequately protect against the risks to life and property inherent in the transportation of hazardous material. For a classification approval, the technical evaluation is a determination that the application meets the requirements of the regulations for issuance of the approval. If formal coordination with another OA is included as part of the evaluation phase, that OA is responsible for managing this process within the applicable OA. The OA reviews the application materials and PHMSA's technical evaluation, and may provide their own evaluation, comments and recommendations. The OA may also recommend operational controls or limitations to be incorporated into the special permit or approval to improve its safety.
(b) Safety profile evaluation. Each applicant for a special permit or non-classification approval is subject to a safety profile evaluation to assess if the applicant is fit to conduct the activity authorized by the special permit or approval application. PHMSA will coordinate the safety profile evaluations with the appropriate OA if a proposed activity is specific to a particular mode of transportation, if the proposed activity will set new precedent or have a significant economic impact, or if an OA requests participation. PHMSA does not conduct initial safety profile reviews as part of processing classification approvals, which include fireworks, explosives, organic peroxides, and self-reactive materials. Additionally, cylinder approvals and certification agency approvals do not follow the same minimum safety profile review model.
(i) Automated Review. An applicant for a special permit or approval which requires a safety profile evaluation, but does not include coordination with an OA, is subject to an automated safety profile review. If the applicant passes the initial automated review, the applicant is determined to be fit. If the applicant fails the initial automated review, the applicant is subject to a safety profile evaluation. An applicant that fails a safety profile evaluation may be determined to be unfit. To begin this review, PHMSA or the applicant enters the applicant's information into the web-based Hazardous Materials Information System (HMIS) or Hazmat Intelligence Portal (HIP), or other future application processing technology that provide an integrated information source to identify hazardous material safety trends through the analysis of incident and accident information, and provide access to comprehensive information on hazardous materials incidents, special permits and approvals, enforcement actions, and other elements that support PHMSA's regulatory program. PHMSA then screens the applicant to determine if, within the four years prior to submitting its application, the applicant was involved in any incident attributable to the applicant or package where two or more triggers for a safety profile review or five or more triggers for on-site inspection enforcement case referral events occurred.
(1) The trigger events are listed in the following table: ------------------------------------------------------------------------
Trigger for on-site inspection
(1) Any incident that involved a death (1) Evidence that an applicant
or injury;. is at risk of being unable to
comply with the terms of an
application, including those
listed below.(2) Two or more incidents involving a (2) An on-site inspection at
Sec. 172.504(e) (placarding) Table 1 the recommendation of the
hazardous material; fitness coordinator if the
following criteria applies--
Any incident listed under
automated review in paragraph
3(b)(i) of this appendix is
attributable to the applicant
or package, other than driver
error.(3) Three or more incidents involving a (3) If, during an inspection,
bulk packaging, or an applicant that evidence is found in the four
is acting as an interstate carrier of years prior to submitting its
hazardous materials under the terms of application that an applicant
the special permit or an approval; or has not implemented sufficient
corrective actions for prior
violations, or is at risk of
being unable to comply with
the terms of an application
for a special permit or
approval, an existing special
permit or approval, or the
HMR, then PHMSA will determine
that the applicant is unfit to
conduct the activities
requested in an application or
authorized special permit or
approval.(4) Any incident that involved: (4) Incorrect or missing: (a)
Incorrect package selection; leaking Markings, (b) labels, (c)
packages; not following closure placards, or (d) shipping
instructions; failure to test papers.
packages, if applicable; and failure
to secure packages, including
incorrect blocking and/or bracing.------------------------------------------------------------------------* The Fitness Coordinator assesses and applies these triggers.
(2) If an applicant is acting as an interstate carrier of hazardous materials under the terms of the special permit, they will be screened in an automated manner based upon criteria established by FMCSA, such as that contained in its Safety and Fitness Electronic Records (SAFER) system, which consists of interstate carrier data, several states' intrastate data, interstate vehicle registration data, and may include operational data such as inspections and crashes.
(ii) Safety profile evaluation. A fitness coordinator, as defined in Sec. 107.1, conducts a safety profile evaluation of all applicants meeting any of the criteria listed earlier in this appendix under ``automated review,'' and all applicants whose safety profile evaluations are subject to coordination with an OA, as described in introductory paragraph 3(b) of this appendix. In a safety profile evaluation, PHMSA or the OA performs an in-depth evaluation of the applicant based upon items the automated review triggered concerning the applicant's four-year performance and compliance history prior to the submission of the application. Information considered during this review may include the applicant's history of prior violations, insufficient corrective actions, or evidence that the applicant is at risk of being unable to comply with the terms of an application for an existing special permit, approval, or the HMR. PHMSA performs the review or coordinates with the OAs, if necessary, if two or more modes of transportation are requested in the application, and coordinates this review with the OA(s) of the applicable mode(s). The applicable OA performs the review if one mode of transportation is requested in the application. If necessary, the fitness coordinator will attempt to contact the applicant for clarifying information. If the information provided is sufficient, an on-site inspection may not be necessary. After conducting an evaluation, if the fitness coordinator determines that the applicant may be unfit to conduct the activities requested in the application, the coordinator will forward the request and supporting documentation to PHMSA's Field Operations Division, or a representative of the Department, such as an authorized Operating Administration representative, to perform an on-site inspection. After the safety profile evaluation is completed, if the applicant is not selected for an on-site inspection, the applicant is determined to be fit. On-site inspections are not required for fitness determinations from modal administrations according to their own procedures.
(iii) On-Site Inspection. (A) The factors in paragraph 3(b)(i) and 3(b)(ii) are used as evidence that an applicant is at risk of being unable to comply with the terms of an application, including those listed below. PHMSA's Field Operations Division or representative of the Department, such as an Operating Administration representative, will conduct an on-site inspection at the recommendation of the fitness coordinator if one of the following criteria applies:
(1) Any incident listed under automated review in paragraph 3(b)(i) of this appendix is attributable to the applicant or package, other than driver error;
(2) Insufficient Corrective Actions, as defined in Sec. 107.1, in any enforcement case for a period of four years prior to submitting the application, except when re-inspected with no violations noted; or
(3) Items noted by an IIA on a cylinder requalifier inspection report, except when re-inspected with no violations noted.
(B) If, during an inspection, the PHMSA investigator or a representative of the Department finds evidence in the four years prior to submitting its application that an applicant has not implemented sufficient corrective actions for prior violations, or is at risk of being unable to comply with the terms of an application for a special permit or approval, an existing special permit or approval, or the HMR, then PHMSA will determine that the applicant is unfit to conduct the activities requested in an application or authorized special permit or approval.
(a) Special Permit. If an application for a special permit is issued, PHMSA provides the applicant, in writing, with a special permit and an authorization letter if party status is authorized.
(b) Approval. If an application for approval is issued, PHMSA provides the applicant, in writing, with an approval, which may come in various forms, including:
(1) An ``EX'' approval number for classifying an explosive (including fireworks; see Secs. 173.56, 173.124, 173.128, and 173.168(a));
(2) A ``RIN'' (requalification identification number) to uniquely identify a cylinder requalification, repair, or rebuilding facility (see Sec. 180.203);
(3) A ``VIN'' (visual identification number) to uniquely identify a facility that performs an internal or external visual inspection, or both, of a cylinder in conformance with 49 CFR part 180, subpart C, or applicable CGA Pamphlet or HMR provision;
(4) An ``M'' number for identifying packaging manufacturers (see Sec. 178.3); or
(5) A ``CA'' (competent authority) for general approvals (see Secs. 107.705, 173.185, and 173.230).
(c) Denial. An application for a special permit or approval may be denied in whole or in part. For example, if an application contains sufficient information to successfully complete its technical review but the Associate Administrator determines the applicant is unfit, the application will be denied. If an application for a special permit or an approval is denied, PHMSA provides the applicant with a brief statement, in writing, of the reasons for denial and the opportunity to request reconsideration (see Secs. 107.113(g), 107.402, and 107.709(f)).
(d) Reconsideration and Appeal. (1) Special Permit. If an application for a special permit is denied, the applicant may request reconsideration as provided in Sec. 107.123 and, if the reconsideration is denied, may appeal as provided in Sec. 107.125. Applicants submitting special permit reconsiderations and appeals must do so in the same manner as new applications, provided the new submission is sufficiently complete to make a determination.
(1) Special Permit. If an application for a special permit is denied, the applicant may request reconsideration as provided in Sec. 107.123 and, if the reconsideration is denied, may appeal as provided in Sec. 107.125. Applicants submitting special permit reconsiderations and appeals must do so in the same manner as new applications, provided the new submission is sufficiently complete to make a determination.
(2) Approval. If an application for an approval is denied, the applicant may request reconsideration as provided in Sec. 107.715 and, if the reconsideration is denied, may appeal as provided in Sec. 107.717. Applicants submitting approval reconsiderations and appeals must do so in the same manner as new applications, provided the new submission is sufficiently complete to make a determination.
Effective Date Note: At 80 FR 54438, Sept. 10, 2015, appendix A was added to part 107, effective Nov. 9, 2015.