Lesson 4: How the Process Works
Topic 7: Address Comments
In this topic, you will learn about step seven of the U.S. market access process: Addressing comments.
Objectives:
- Describe the general approach APHIS uses to respond to comments
- Explain APHIS’ policy against ex parte communication after the close of the comment period and how it relates to the open process described earlier
After the comment period closes, APHIS reviews the comments, identifies the issues raised in the comments, and develops responses. The overall goals for the comment response process are to be comprehensive, fair, and impartial.
APHIS addresses comments based on the issues that are raised in the comments, not based on the identity of the commenter. Every issue that commenters raise must be addressed. In final actions, APHIS typically does not identify the commenters who have made comments, instead using phrases like “One commenter stated…” or “Several commenters requested…”. In some cases, the nature of a comment makes it necessary to identify the comment. For example, the NPPO of an exporting country might comment that it is unrealistic for the NPPO to enforce a certain requirement.
In addition, USDA has a policy against ex parte communication after the close of the comment period. Ex parte communication occurs when one member of the public has an opportunity to communicate with the agency outside of the open commenting process described earlier. For example, after the close of the comment period, an industry group might want to meet with APHIS to discuss how APHIS is planning to respond to specific comments about pest risk and, perhaps, to provide additional information. However, other commenters, as well as the general public, would not be aware of this meeting because it would take place outside of the open commenting process. For this reason, APHIS does not have such meetings. If, after the close of the comment period, it becomes apparent that APHIS needs more information on an issue, APHIS will reopen the comment period as described earlier. This approach allows every interested member of the public to consider the issue and provide any relevant information.
APHIS might take any of several actions in response to comments. APHIS might disagree with a point raised by a commenter and explain why in the final rule or notice. APHIS might agree with a point but disagree that it necessitates changes to the risk analysis or the proposed action. APHIS might make changes to the risk analysis but conclude that they do not affect the proposed action. APHIS might conclude that some changes to the proposed action are necessary, or that the proposed action needs to be withdrawn for further consideration. APHIS’ policy of responding carefully to all issues raised on the proposed rule or notice helps to fulfill the SPS Agreement’s requirements for transparency and justifying actions on the basis of a risk assessment.
During the country consultation phase of preparing the PRA, which is described elsewhere in this training, APHIS and the exporting country might discuss any mitigation that could be employed and come up with a combination that works for both the exporting country and APHIS. However, if an exporting country requests further changes to mitigations during the public comment period, APHIS might not be able to make them without taking public comment on the changes, thus delaying the process. This is due to the open nature of the U.S. regulatory system.
For example, during country consultation, an exporting country could determine that a pest-free area is unworkable and instead request that it be allowed to establish pest-free places of production. APHIS could review the request and make the change. However, during the comment period, the primary reviewer of the proposed action is the public, not APHIS. In this case, APHIS would need to notify the public of the change in proposed mitigations and take comment on them before finalizing the action.
Any comment on the proposed action will be considered. However, APHIS typically does not consider comments outside the scope of the proposed action. Let us consider an example. APHIS proposes to allow the importation of apples from a country, and these apples would be subject to a previously approved treatment for fruit flies. A commenter states that apples should not be allowed to be imported because there are plenty of apples available in the United States. APHIS would not consider that comment because it is outside the scope of the proposed action (and, indeed, APHIS’ statutory authority).
Another commenter states that the importation of the apples should be allowed but that the cold treatment should be modified to require fewer days of cold treatment because it is impractical to treat apples for the period specified in the treatment. Because the treatment was previously approved, and APHIS was not proposing to change the treatment as part of the action, APHIS typically would not change the treatment in response to this comment. However, depending on the evidence the commenter supplied to support the conclusion that the cold treatment would still be effective with fewer days of treatment, APHIS might propose to change the treatment in a separate action.
Another commenter states that certain areas of the country are actually free of fruit flies, so cold treatment should not be required for apples originating from those areas. Recognizing an area as free of fruit flies is a separate process from authorizing the importation of a commodity from those areas, so APHIS would propose to recognize those areas as free of fruit flies in a separate action if the evidence indicated that APHIS should do so.
However, a comment that stated that fruit flies do not affect commercially produced apples in the country or a comment that stated that there are other pests in the country that are associated with apples and that could not be mitigated by cold treatment would need to be addressed in the final action. APHIS might not agree with these comments, but APHIS would need to explain its reasons for disagreeing, based on the scientific evidence, the risk assessment published with the proposed rule or notice, and APHIS’ experience mitigating pest risk.
In this topic, you learned about how APHIS addresses comments, including what kinds of comments it can and cannot respond to within the context of a rule or notice.
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