Warning
Info
Warning
Info
LSD+
LSD+ gives you access to over 50,000 case briefs, more than anyone else. Start your free 14-day trial today. Read as much content as you want during your trial, and you can cancel any time and keep access for the full 14 days.
United States Court of Appeals for the Second Circuit - 568 F.2d 240
Contributed by LegalWriter
The Food and Drug Administration did not promulgate valid regulations when it did not disclose the scientific basis and key considerations underlying the regulations.
Issue
In conducting informal notice-and-comment rulemaking, can the Food and Drug Administration promulgate a final rule without revealing the scientific evidence behind the rule and without responding to comments received?
Conclusion
No. The Administrative Procedure Act mandates that an agency must provide a concise general statement of its rulemaking when it conducts informal notice-and-comment rulemaking. The Food and Drug Administration did not provide a concise general statement for its time-temperature-salinity rules because the agency did not reveal its scientific basis or answer key questions. The time-temperature-salinity rules are invalid because they were not promulgated under a valid rulemaking procedure.
LSD+ exclusive
Rule
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat.
Analysis
Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum
Facts
- The Food and Drug Administration (FDA) tried to mitigate the risk of botulism poisoning from fish consumption by promulgating time-temperature-salinity (TTS) requirements for all species of fish. Before the TTS regulations were adopted, the FDA had an
- informal notice-and-comment period.
- Some comments, including those submitted by the Nova Scotia Food Products Corporation protested that the broad applicability of the TTS requirements were inappropriate for some fish species. While the FDA did not respond to these comments, the FDA’s final TTS regulation was
- slightly different
- from its proposed rule. The FDA did
- not
- disclose the scientific evidence its final rule was based on. After the TTS regulations were promulgated, the FDA found that Nova Scotia Corporation was violating the TTS requirements for whitefish. The FDA sought an injunction against Nova Scotia Corporation to prevent it from processing whitefish until it had complied with the TTS regulations. The district court granted the injunction and the corporation appealed to the Second Circuit. Nova Scotia Corporation claimed that the FDA had an
- inadequate administrative record
- of the TTS regulations because the FDA did not reveal its scientific evidence or answer the comments it received.
LSD+ exclusive
Holding
- Hey! This is the holding for Pennoyer v. Neff. It probably isn't the holding for the brief you're looking at. Join LSD+ for full access.
- A named property within the court's jurisdiction is attached to satisfy an unrelated claim, despite the owner of said property being a non-resident of the state.
- A named property within the court's jurisdiction is attached as the basis for the suit (e.g., to quiet title), despite the owner of said property being a non-resident of the state.
- An individual is sued who is a resident of the state, or who has been served with process while physically located within the state.
- jurisdiction - Neff is neither a resident, nor was served while within the state. Service by publication may be valid for an
- proceeding, where the owner would be made aware of the suit due to their property being seized, but not for
- jurisdiction - the action was on the basis of a suit to receive payment owed, and did not relate directly to a property within the state.
- jurisdiction, as the Oregon property was not attached to the initial suit, but rather was added in after the suit happened - note that Neff did not even purchase the property until after the suit had concluded.
- Accordingly, the Oregon court did not have jurisdiction over the initial suit between Neff and his lawyer.
- Enforcement of a judgment without jurisdiction denies due process!
- Additionally, although judgments rendered by other states are entitled to full faith and credit, if that state did not have jurisdiction to render the judgment, it loses such entitlement.
LSD+ exclusive
Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. . Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua
Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Excepteur sint occaecat cupidatat non proident, . Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat
Join LSD+
Energize your law school studying with LSD+ for only $19 per month. Join over 40,000 applicants who have used LSD to crush admissions and empower yourself to crush 1L and beyond. With LSD+, you’ll get immediate access to many nice things including:
- Full-access to over 50,000 case briefs
- LSD’s DeepDive tool to read the case at different levels of summarization
- Highlight-to-define to get easy to understand definitions in real time as you study
- Social learning with LSD community case high points
- Instantly brief over 6,000,000 cases with LSD’s cutting edge AI briefing tool
- 14-day free trial