martes, 21 de noviembre de 2017

FDA Law Blog - Please Wait: AMS (Again) Delays the Effective Date of Organic Livestock and Poultry Practices Rule Questioning Its Statutory Authority and the Rule’s Benefit Analysis

Posted: 20 Nov 2017 06:03 PM PST
On November 14, 2017, the USDA Agricultural Marketing Service (AMS) announced that it will further delay and reconsider the Organic Livestock and Poultry Practices (OLPP) regulations.  This is not the first delay of the effective date for the OLPP regulations.
The OLPP final rule amends the organic livestock and poultry production requirements of the organic regulations by adding provisions for (1) livestock handling and transport for slaughter; (2) avian living conditions; and (3) expanding and clarifying existing requirements covering livestock care and production practices and mammalian living conditions. The final rule was issued on January 19, 2017, in the last 24 hours of the Obama administration. The effective date for the rule was March 20, 2017.  However, in March, consistent with the memorandum “Regulatory Freeze Pending Review,” AMS delayed the effective date by 60 days.
Next, on May 10, 2017, nine days before the new effective date, AMS announced a further delay of the effective date; this time by six months, until November 14, 2017, because “significant policy and legal issues addressed within the final rule warranted further review by USDA.”  Concurrently, AMS issued a proposed rule requesting comments on the course of action for the final rule.. AMS asked comments on four possible options:
  1. Let the rule become effective on November 14, 2017.
  2. Suspend the rule indefinitely to allow time to consider whether to implement, modify or withdraw the final rule.
  3. Delay the effective date of the rule further, beyond the effective date of November 14, 2017.
  4. Withdraw the rule.
AMS received more than 47,000 comments. More than 40,000 comments (34,600 of which apparently were submitted as form letters) selected “Option 1: Implement,” 28 comments supported “Option 4: Withdraw,” some comments supported “Option 2: Suspend”; and only one comment selected “Option 3: Delay.” In light of these results, the announcement of another six months delay is somewhat surprising.
So why did AMS decide to delay the effective date yet again? According to the announcement in the Federal Register, AMS has concluded that “important questions regarding [its] statutory authority to promulgate the OLPP rule and the likely costs and benefits of [the] rule” need to be more fully assessed. AMS now questions whether it has the authority, under the Organic Food Production Act (OFPA), to issue regulations “reflecting a stand-alone concern for animal welfare.” It asserts that it has concluded that “OFPA’s reference to additional regulatory standards ‘for the care’ of organically produced livestock is limited to health care practices.” In addition, AMS is uncertain that the OLPP is consistent “with USDA regulatory policy principles . . . . because the requirements in [the] rule may not represent the most innovative and least burdensome tools for achieving regulatory ends.” AMS also is concerned that due to an error in the calculation of the benefits, it may have overestimated the benefits of the final rule. In light of these questions and uncertainties, AMS does not want to proceed with the implementation of the rule. Instead, a delay to allow for careful reconsideration is warranted.
Presumably, AMS will issue a proposed rule for comments on the revised cost benefit analysis and AMS’s interpretation of its (limited) authority under the OFPA in the near future.
Meanwhile, a September 2017 lawsuit by the Organic Trade Association challenging AMS’s repeated delays of the effective date as violations of the Administrative Procedures Act and the OFPA remains pending. As a result of the delay of the effective date, that proceeding also is delayed.

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