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Federal Register / Vol. 86, No. 230 / Friday, December 3, 2021 / Rules and Regulations apart from that appropriated by Congress for ACs ongoing operations.
Another commenter asked for the contingency requirements to be more prescriptive. Specifically, the commenter wanted APHIS to require entities to create contingency plans for the potential death of an owner and heat waves.
The regulations require a regulated entity to identify emergencies or disasters that could reasonably be anticipated and that would be detrimental to the well-being of their animals. We expect that, for most entities, it would be difficult to reasonably anticipate death.
If an entity determines that they are located in an area prone to heat waves that could be reasonably anticipated to be harmful to their animals, they would need to address heat waves in their contingency plans. However, an entity located in an extremely temperate climate may assess climatic conditions and determine a heat wave to be unlikely. APHIS believes that regulated entities themselves are best suited to make such determinations, and therefore will not provide a one-sizefits-all list of emergencies or disasters that all entities must plan for.
Another commenter requested explicit acknowledgement that plans developed for compliance with The Guide for the Care and Use of Laboratory Animals The Guide comply with this rules contingency plan regulations.
Contingency plans developed using The Guide are acceptable so long as they fulfill the requirements laid out in the regulations.
The commenter also requested assurance that APHIS will not view deviations from contingency plans in emergency situations as violations, but as on-the-ground efforts to tailor the plan to specific events and opportunities to improve the contingency plan.
APHIS agrees with the commenter that the actual response may vary from the written contingency plan in an emergency situation, and that these variations can serve as a basis for updating and improving a contingency plan. If an entity varies its response from its written contingency plan in order to better meet the needs of an unfolding emergency situation, this would not necessarily be viewed as a violation. In such situations, APHIS
would determine whether or not a violation has occurred on a case-by-case basis, based on whether the deviation furthers the purpose of the regulation, which is to safeguard the health and
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welfare of animals in the event of possible emergencies or disasters.
One commenter suggested requiring regulated entities to submit their contingency plans to USDA for review.
We are making no changes in response to the commenter. Submitting a plan to APHIS is not the sole means to demonstrate that a plan has been developed and satisfies the requirements of the regulations, and would impose a significant resource constraint on AC to receive and compile the plans and ensure their confidentiality. Rather, AC will ensure compliance with this rule through reviewing the entitys plan during announced and unannounced inspections. We believe that this method of enforcing the requirements provides sufficient assurance that the contingency planning requirements are being met while minimizing regulatory burden on entities and more efficiently allocating agency resources.
One commenter urged APHIS to take further action to ensure that an entitys contingency plans are kept confidential.
APHIS will not maintain the plans.
Therefore, this rule does not raise confidentiality concerns.
Training A commenter wrote that the regulatory text should overtly state that it is up to the regulated entity to determine who needs to be trained and how.
The entity is responsible for including all personnel encompassed by the plan in the training and is responsible for the content and delivery of the training. We do not believe it is necessary to add this statement into the regulatory text, as the regulations do not state or imply otherwise.
The commenter also asked that the regulatory text clarify that only substantive changes to a contingency plan would necessitate updated training.
We agree with the commenter that non-substantive changes, which could include revisions as minor as reordering of instructions or grammatical corrections, do not necessitate updated training, and have made this change in 2.38l3 and 2.134c. Our intent was that only substantive changes, that is, changes that materially alter the plan, would require updated training.
The commenter also asked that the 60- or 30-day training deadlines that we proposed be extended to 90 days for both initial and subsequent training of personnel.
We are making no changes in response to this comment. Training required by the regulations entails
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familiarizing personnel with their roles and responsibilities as outlined in the contingency plan. APHIS believes the deadlines in the proposed rule 60 days for initial training and 30 days for new employees and updates to the contingency plan are sufficient time to provide this basic training, and the commenter did not provide information suggesting this basic training could not be accomplished within that time period.
As noted above, we proposed to remove a requirement from the stayed final rule that facilities as well as dealers, exhibitors, intermediate handlers, and carriers document their personnels participation in requisite trainings. Seven commenters disagreed with our proposed removal and asked for it to be reinstated.
APHIS does not believe that requiring entities to keep training records would significantly increase compliance with the training requirements, but it would increase burden on regulated entities.
Rather than require documentation, we will evaluate compliance with the training requirement through discussions with the licensee or registrant during announced and unannounced inspections. APHIS AC
successfully enforces other training requirements in this manner, and is confident that this model will work for the regulations promulgated in this rule as well. Therefore, we are making no change in response to the commenters.
Economic Analysis Two commenters stated that our estimates for the time it will take entities to create contingency plans and train personnel are too low.
Our estimates are averages based on the varying sizes of the entities and the optional fillable template the agency is providing. Some entities may require less time, and some will require more.
Additionally, based on the comments received, it appears that most entities will not be formulating their plans de novo. Several commenters who were regulated entities themselves opined that it would be difficult for a regulated entity to remain operational without at least some contingency planning, and a few commenters stated that the regulated entities they represented already have contingency plans in place that meet the requirements of the rule.
Indeed, one of the commenters who stated that our estimates were too low also stated that the entities that it represents already have plans in place and should not incur new costs as a result of the rule.
Based on the comments received, we believe that the 1-to-2-hours for plan
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