49 C.F.R. § 229.311 – Review of SAs.

(a) Prior to the initial planned use of a product subject to this subpart, a railroad shall inform the Associate Administrator for Safety/Chief Safety Officer, FRA, 1200 New Jersey Avenue SE., Mail Stop 25, Washington, DC 20590 of the intent to place this product in service. The notification shall provide a description of the product, and identify the location where the complete SA documentation described in § 229.307, the testing records contained in § 229.313, and the training and qualification program described in § 229.319 is maintained.
(b) FRA may review or audit the SA within 60 days of receipt of the notification or anytime after the product is placed in use. If FRA has not notified the railroad of its intent to review or audit the SA within the 60-day period, the railroad may assume that FRA does not intend to review or audit, and place the product in use. FRA reserves the right, however, to conduct a review or audit at a later date.
(c) A railroad shall maintain and make available to FRA upon request all railroad or vendor documentation used to demonstrate that the product meets the safety requirements of the SA for the life-cycle of the product.
(d) After a product is placed in service, the railroad shall maintain a database of all safety-relevant hazards encountered with the product. The database shall include all hazards identified in the SA and those that had not been previously identified in the SA. If the frequency of the safety-relevant hazards exceeds the threshold set forth in the SA, then the railroad shall:
1. (1) Report the inconsistency by mail, facsimile, email, or hand delivery to the Director, Office of Safety Assurance and Compliance, FRA, 1200 New Jersey Ave. SE., Mail Stop 25, Washington, DC 20590, within 15 days of discovery;
2. (2) Take immediate countermeasures to reduce the frequency of the safety-relevant hazard(s) below the threshold set forth in the SA; and
3. (3) Provide a final report to FRA's Director, Office of Safety Assurance and Compliance, on the results of the analysis and countermeasures taken to reduce the frequency of the safety-relevant hazard(s) below the calculated probability of failure threshold set forth in the SA when the problem is resolved. For hazards not identified in the SA the threshold shall be exceeded at one occurrence.