United States Court of Appeals
FOR THE DISTRICT OF COLUMBIA CIRCUIT
Argued November 17, 2008 Decided April 3, 2009
No. 08-1061
METWEST INC., A SUBSIDIARY OF QUEST DIAGNOSTICS
INCORPORATED, DOING BUSINESS AS QUEST DIAGNOSTICS,
PETITIONER
v.
SECRETARY OF LABOR,
RESPONDENT
On Petition for Review of a Final Order
of the Administrative Review Board
Brent I. Clark argued the cause for petitioner. With him on
the briefs were James L. Curtis, and Elizabeth L. Ash. Lawrence
P. Postol entered an appearance.
Jonathan L. Snare, Attorney, U.S. Department of Labor,
argued the cause for respondent. On the brief were Joseph M.
Woodward, Associate Solicitor, Charles F. James, Counsel for
Appellate Litigation, and Scott Glabman, Senior Appellate
Attorney.
Before: GINSBURG and HENDERSON, Circuit Judges, and
RANDOLPH, Senior Circuit Judge.
2
Opinion for the Court filed by Senior Circuit Judge
RANDOLPH
RANDOLPH, Senior Circuit Judge: The main question in this
petition for judicial review of a decision of the Occupational
Safety and Health Review Commission is whether MetWest,
Inc. can be held liable for violating a regulation governing the
removal of needles from equipment used to extract blood.
Relying on Alaska Professional Hunters Association, Inc. v.
FAA, 177 F.3d 1030 (D.C. Cir. 1999), and other decisions of this
court, the company claims that the Occupational Safety and
Health Administration (OSHA) improperly altered the
interpretation of its regulation without engaging in notice and
comment rulemaking.
I.
In 1991, OSHA promulgated safety standards aimed at
preventing the transmission of bloodborne pathogens in the
workplace. See Occupational Exposure to Bloodborne
Pathogens, 56 Fed. Reg. 64,004 (Dec. 6, 1991). Several of these
standards apply specifically to phlebotomists – the medical
professionals who draw blood from patients at hospitals,
doctors’ offices, nursing homes, and clinics. The safety standard
at issue in this case regulates the removal of needles after blood
has been drawn.
The basic blood-drawing device consists of three parts: the
needle, the blood tube holder, and the blood tube. The needle
extends out of the front of the blood tube holder, a plastic device
similar to a syringe but with an open back end. The blood tube,
typically a glass tube with a rubber top, fits into the open back
end of the blood tube holder. When the tube is inserted into this
open end, its rubber top is pierced by the “back end” of the
needle, which sticks out slightly into the back of the blood tube
holder. The phlebotomist inserts the needle into the patient’s
3
arm; blood enters the needle and travels through it into the blood
tube. When the tube is filled, the phlebotomist withdraws the
needle from the patient’s arm and removes the blood tube from
the holder. The next step is to discard the needle.
Originally, phlebotomists removed used needles with a
“two-handed” technique – they placed a plastic cap over the
front of the needle and then unscrewed it manually. By the time
OSHA promulgated its safety standards in 1991, medical
suppliers had developed reusable blood tube holders that
allowed for “one-handed” needle removal – the phlebotomist
pressed a button on the blood tube holder and released the
needle into a safe container. Although this method still exposed
phlebotomists to a risk of needlesticks from the back end of the
used needle, it was considered far safer than the original two-
handed removal techniques. During the 1990s, medical
suppliers also developed and marketed “single-use” blood tube
holders. These devices became widely available and widely
used beginning in 2003. With the single-use tube holder the
phlebotomist does not remove the needle after use; he simply
discards the holder and its attached needle into a safe container.
Single-use holders are more costly than reusable holders, but
they reduce the chances of injury due to “back end”
needlesticks.
OSHA’s 1991 regulation provides that “[c]ontaminated
needles and other contaminated sharps shall not be bent,
recapped or removed unless the employer can demonstrate [1]
that no alternative is feasible or [2] that such action is required
by a specific medical or dental procedure.” 29 C.F.R.
§ 1910.1030(d)(2)(vii)(A) (emphasis added). Even if the
employer demonstrates that bending, recapping, or removing the
needle qualifies under one of these exceptions, the process
“must be accomplished through the use of a mechanical device
or a one-handed technique.” Id. § 1910.1030(d)(2)(vii)(B).
Initially, OSHA declined to enforce this section against
4
employers who supplied their employees with reusable blood
tube holders. OSHA followed this course even though such
holders required manual needle removal. In October 2003, the
agency issued a guidance document stating that using reusable
blood tube holders likely violated 29 C.F.R.
§ 1910.1030(d)(2)(vii). Occupational Safety & Health Admin.,
Disposal of Contaminated Needles and Blood Tube Holders
Used for Phlebotomy (Oct. 15, 2003). The guidance document
also made clear that single-use holders were the safest type of
blood tube holder and were, as of 2003, widely used in the
phlebotomy industry. Id. OSHA’s current policy is to enforce
the provisions of 29 C.F.R. § 1910.1030(d)(2)(vii).
MetWest’s parent company operates roughly 2,000 clinical
testing facilities in the United States, only 400 of which employ
single-use blood tube holders. MetWest typically supplies its
phlebotomists with reusable holders. In February 2004, an
OSHA compliance officer inspected a MetWest facility in
Denver, Colorado. The officer issued the facility a citation for
allowing its employees to remove needles from reusable blood
tube holders in violation of 29 C.F.R. § 1910.1030(d)(2)(vii)(A).
After an Administrative Law Judge and the Occupational Safety
and Health Review Commission upheld the citation, MetWest
filed this petition for judicial review.
MetWest contends that OSHA, in several guidance
documents and other interpretations issued during the 1990s,
interpreted 29 C.F.R. § 1910.1030(d)(2)(vii) to permit the
removal of needles from reusable blood tube holders in all
circumstances. Then OSHA’s 2003 guidance document and its
enforcement policy changed the interpretation. Relying on a
line of cases in this circuit, notably Alaska Professional Hunters,
177 F.3d at 1034, MetWest argued that OSHA had effectively
amended its rule without the notice and comment rulemaking
required by the Administrative Procedure Act, 5 U.S.C. § 553.
5
The first problem with MetWest’s argument is that OSHA
has never interpreted 29 C.F.R. § 1910.1030(d)(2)(vii) to allow
the use of reusable blood tube holders in all situations. The
guidance documents OSHA issued in the 1990s do not purport
to establish such a sweeping rule. Each of the documents
merely indicates that one-handed removal may be permitted
when it is medically required or when no feasible alternative
exists.1 We have held that conditional or qualified statements,
1
A guidance document issued in March 1992 stated in
pertinent part: “Bending, recapping, or removing contaminated
needles by hand is prohibited as a general practice. However, certain
circumstances may exist in which these actions are necessary; e.g.
when . . . removing the needle from a phlebotomy collection
apparatus.” Office of Health Compliance Assistance, OSHA
Instruction CPL 2-2.44C at 19 (Mar. 6, 1992). A February 1, 1993
document used nearly identical language, stating that while removing
needles is prohibited, removal using a “one hand [] method . . . may
be necessary when . . . removing the needle from a phlebotomy
collection apparatus such as a vacutainer.” Occupational Safety &
Health Admin., Most Frequently Asked Questions Concerning the
Bloodborne Pathogens Standard (Feb. 1, 1993). A March 9, 1993
letter to a reusable blood tube holder manufacturer again states that the
use of such devices “may be necessary” and concludes: “we believe
that [the product’s] intended use does not appear to violate the
requirements of 29 CFR 1910.1030. . . . Please bear in mind that
OSHA does not endorse or approve products and that the final
determination regarding compliance is made in the workplace by
direct compliance officer observation of employee work practices and
taking into account all factors pertaining to the use of such a device at
the particular worksite.” Occupational Safety & Health Admin., Letter
to Alan A. Wanderer, M.D. (Mar. 9, 1993). In a 1999 instruction on
enforcement procedures, OSHA restated that needle removal may be
necessary in some circumstances. It also instructed its compliance
officers that, in evaluating one-handed removal procedures, they
“should determine if the circumstances warrant needle removal. If
they do not, paragraph (d)(2)(vii)(A), which prohibits needle removal
6
including statements that something “may be” permitted, do not
establish definitive and authoritative interpretations. See, e.g.,
Darrell Andrews Trucking, Inc. v. Fed. Motor Carrier Safety
Admin., 296 F.3d 1120, 1126 (D.C. Cir. 2002); Hudson v. FAA,
192 F.3d 1031, 1035 (D.C. Cir. 1999); compare Envtl. Integrity
Project v. EPA, 425 F.3d 992, 998 (D.C. Cir. 2005). None of
the policy statements MetWest cites come close to the “express,
direct, and uniform interpretation present in Alaska Professional
Hunters.” Ass’n of Am. R.Rs. v. Dep’t of Transp., 198 F.3d 944,
950 (D.C. Cir. 1999).
We have also held that so long as a new guidance document
“can reasonably be interpreted” as consistent with prior
documents, it does not significantly revise a previous
authoritative interpretation. Air Transp. Ass’n of Am. v. FAA,
291 F.3d 49, 57–58 (D.C. Cir. 2002) (quotation omitted). All of
the documents MetWest cites are consistent with each other and
with the text of 29 C.F.R. § 1910.1030(d)(2)(vii). The only
logical reading of § 1910.1030(d)(2)(vii) is that it bans all
needle removal unless an employer can demonstrate that no
other alternative to removal is feasible, in which case removal
is permitted using the one-handed technique. OSHA’s guidance
documents have always indicated that employers permitting
their employees to remove needles should “demonstrate that no
alternative . . . is feasible” by including a “written justification
(supported by reliable evidence)” in their exposure control
plans.2 Occupational Safety & Health Admin., Directive CPL
unless no alternative is feasible or it is required by a specific medical
procedure, should be cited.” Occupational Safety & Health Admin.,
Directive CPL 2-2.44D, Enforcement Procedures for the Occupational
Exposure to Bloodborne Pathogens (Nov. 5, 1999).
2
Employers are required to “establish a written Exposure
Control Plan designed to eliminate or minimize employee exposure”
7
2-2.44D, Enforcement Procedures for the Occupational
Exposure to Bloodborne Pathogens at 22 (Nov. 5, 1999). This
requirement, included in the first guidance document on the
regulation, remained nearly unchanged in the last guidance
document issued before MetWest’s 2004 citation. See Office of
Health Compliance Assistance, OSHA Instruction CPL 2-2.44C
at 19 (Mar. 6, 1992); Occupational Safety & Health Admin.,
Disposal of Contaminated Needles and Blood Tube Holders
Used for Phlebotomy (Oct. 15, 2003). The only meaningful
difference between OSHA’s early guidance documents and its
later ones is that the later documents explicitly state that
compliance officers should “review [the laboratory’s] exposure
control plan” for a “determination that no alternative is feasible”
if laboratory employees are still removing needles from reusable
blood tube holders. Occupational Safety & Health Admin.,
Directive CPL 2-2.69, Enforcement Procedures for the
Occupational Exposure to Bloodborne Pathogens (Nov. 27,
2001). This change in enforcement policy was to be expected,
as the availability of single-use blood tube holders increased
significantly between 1992 and 2004, eventually providing a
“feasible” alternative to reusable holders and rendering one-
handed removal unnecessary and therefore prohibited under
§ 1910.1030(d)(2)(vii).
Even if OSHA had interpreted 29 C.F.R.
§ 1910.1030(d)(2)(vii) to permit the use of reusable blood tube
holders in all circumstances, this case would still not fit within
the framework of Alaska Professional Hunters. We there held
that an agency’s practice of advising affected entities – in a prior
agency adjudication and the consistent advice of agency officials
over a 30-year period – that a regulation did not apply to them
established “an authoritative departmental interpretation” that
could not be changed without notice and comment. 177 F.3d at
under 29 C.F.R. § 1910.1030(c).
8
1034–35.3 A fundamental rationale of Alaska Professional
Hunters was the affected parties’ substantial and justifiable
reliance on a well-established agency interpretation.4 Id. at
1035; see also Ass’n of Am. R.Rs., 198 F.3d at 950. People in
the lower 48 states had pulled up stakes and moved to Alaska.
They and others within Alaska had opened hunting and fishing
“lodges and built up businesses dependent on aircraft, believing
their flights were [not] subject to” certain commercial flight
regulations. Alaska Prof’l Hunters, 177 F.3d at 1035.5 Forcing
guide pilots to comply with regulations developed for
commercial airlines would have driven Alaska’s hunting and
3
The advice came from the FAA’s Alaskan regional office
rather than central headquarters in Washington, D.C. We viewed this
of no moment because, during the relevant period, the FAA had
decentralized its operations. Alaska Prof’l Hunters, 177 F.3d at
1032, 1035.
4
This is a crucial part of the analysis. To ignore it is to
misunderstand Alaska Professional Hunters to mean that an agency’s
initial interpretation, “once informally adopted, freezes the state of
agency law, which cannot subsequently be altered without
notice-and-comment rulemaking.” Peter L. Strauss, Publication Rules
in the Rulemaking Spectrum: Assuring Proper Respect for an
Essential Element, 53 Admin. L. Rev. 803, 844 (2001); see also
William Funk, A Primer on Nonlegislative Rules, 53 Admin. L. Rev.
1321, 1329–30 (2001); Richard W. Murphy, Hunters for
Administrative Common Law, 58 Admin. L. Rev. 917, 921–23 (2006).
5
Their reliance on the FAA’s advice was, as we said,
“justifiable.” The Assistant Chief Counsel’s new interpretation of the
administrative decision on which the Alaska region had relied was, for
reasons we explained, “quite implausible.” Alaska Prof’l Hunters,
177 F.3d at 1034.
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fishing tourism operations out of business.6 Furthermore, during
this 30-year span, the “guide pilots and lodge operators had no
opportunity to participate in the development of the . . .
regulations” that the FAA had abruptly decided to apply to
them. As a result, they were deprived of any opportunity to
request changes or exceptions to accommodate the unique
circumstances of Alaskan air travel.7 Id. at 1035–36.
The situation here is not comparable. OSHA never
established an authoritative interpretation of its regulation on
which MetWest justifiably relied to its detriment. The agency
reiterated its long-standing policy and announced that it would
enforce that policy as reflected in its regulation. This meant that
MetWest and others would have to switch from reusable blood
tube holders to disposable ones. The feasability of their doing
so is clear. MetWest’s parent company owns 400 patient service
centers that already employ single-use holders. Alaska
Professional Hunters thus does not apply, and OSHA was not
required to engage in notice and comment rulemaking before it
ramped up its enforcement of 29 C.F.R. § 1910.1030(d)(2)(vii).
6
Congress, recognizing this fact, responded to our decision by
specifically exempting Alaskan guide pilots from the FAA’s
commercial flight regulations. See Pub. L. 106-181, § 732, 114 Stat.
61, 169 (Apr. 5, 2000).
7
FAA regulations have frequently treated Alaska differently
than the rest of the United States, and the participation of Alaskan
guide pilots and lodge operators very likely would have affected the
commercial flight regulations at issue in Alaska Professional Hunters.
See 177 F.3d at 1035–36 & n.8.
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II.
MetWest has one more argument: it may continue to use
reusable blood tube holders despite the plain language of 29
C.F.R. § 1910.1030(d)(2)(vii), because the Needlestick Safety
and Prevention Act, Pub. L. No. 106-430, 114 Stat. 1901 (2000),
requires employers to “document annually consideration and
implementation of appropriate commercially available and
effective safer medical devices designed to eliminate or
minimize occupational exposure.” Pub. L. No. 106-430,
§ 3(4)(B), 114 Stat. at 1903. MetWest argues that this language
allowed it to “select reusable blood tube holders over other
devices” if it thought – as it claims it did – that reusable holders
were the safest medical devices available. Pet’r Br. at 27.
The Needlestick Act does not vest employers with the
power and discretion to determine the safest medical device for
each of their facilities regardless of the applicable regulations.
MetWest cannot substitute its own unsupported judgment about
blood tube holders for that of OSHA. See Fluor Daniel v.
Occupational Safety & Health Review Comm’n, 295 F.3d 1232,
1240 (11th Cir. 2002). Adopting MetWest’s interpretation leads
to the untenable proposition that Congress barred OSHA from
preemptively banning any medical device. Further, if MetWest
truly believed that reusable blood tube holders were safer than
the single-use holders mandated by § 1910.1030(d)(2)(vii), it
could have applied for a variance from the regulation pursuant
to 29 U.S.C. § 655(d).
For the foregoing reasons, the petition for review is denied.
So ordered.