## Facts

- OSHA issued a 1991 Bloodborne Pathogens Standard regulating removal of contaminated needles, permitting removal only in limited circumstances and requiring that any permitted removal be done with a mechanical device or a one-handed technique.
- Blood-drawing equipment included a needle, a blood tube holder, and a blood tube; manufacturers offered reusable holders designed to allow one-handed needle release into a sharps container.
- For years after 1991, OSHA did not cite employers for using reusable blood tube holders, effectively tolerating that practice under the standard.
- MetWest (Quest Diagnostics) typically supplied phlebotomists with reusable blood tube holders.
- In 2003, OSHA issued a compliance directive/guidance stating that the use of reusable blood tube holders with contaminated needles generally violated the 1991 standard.
- In 2004, OSHA cited MetWest based on that guidance; an ALJ upheld the citation and the Occupational Safety and Health Review Commission affirmed.

## Issues

1. Whether OSHA’s 2003 guidance reflected a material change from a settled interpretation of the 1991 needle-removal regulation.
2. Whether such a change, if substantive, required notice-and-comment rulemaking under the Administrative Procedure Act before it could be enforced through an OSHA citation.
3. Whether MetWest could be cited based on an interpretation that had not been adopted through required APA procedures.

## Decision

- The D.C. Circuit granted MetWest’s petition for review and vacated the citation.
- The court held OSHA could not enforce, via citation, the 2003 guidance’s materially different interpretation of the 1991 regulation without first using notice-and-comment rulemaking.
- The court treated OSHA’s long-standing non-enforcement and prior approach toward reusable holders as reflecting a settled interpretive position that the 2003 guidance reversed.
- Because the guidance imposed new compliance obligations and exposure to liability, it functioned as a substantive change rather than a mere clarification.

## Legal Principles

- When an agency has adopted a definitive interpretation of a regulation and later significantly revises it, the revision is treated as legislative in effect and generally must be adopted through APA notice-and-comment procedures.
- A guidance document may not be used to impose new binding duties or change regulated parties’ legal obligations where the agency’s prior, settled approach allowed the challenged practice.
- Regulated parties are entitled to fair notice before being penalized based on a materially new agency interpretation of an existing regulation.

## Conclusion

The court vacated OSHA’s citation against MetWest because OSHA attempted to enforce a materially new interpretation of the bloodborne-pathogens needle-removal rule announced in guidance, without first conducting APA notice-and-comment rulemaking.


MetWest, Inc. v. Sec’y of Labor, 560 F.3d 506 (D.C. Cir. 2009)