Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-caDC-08-01061/USCOURTS-caDC-08-01061-0/pdf.json

Parties Involved:
METWEST INC.
Petitioner
Secretary of Labor
Respondent

Document Text:

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.

USCA Case #08-1061 Document #1174035 Filed: 04/03/2009 Page 1 of 10
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

USCA Case #08-1061 Document #1174035 Filed: 04/03/2009 Page 2 of 10
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 twohanded 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

USCA Case #08-1061 Document #1174035 Filed: 04/03/2009 Page 3 of 10
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.

USCA Case #08-1061 Document #1174035 Filed: 04/03/2009 Page 4 of 10
5

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

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,

USCA Case #08-1061 Document #1174035 Filed: 04/03/2009 Page 5 of 10
6

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”

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

USCA Case #08-1061 Document #1174035 Filed: 04/03/2009 Page 6 of 10
7

under 29 C.F.R. § 1910.1030(c).

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 onehanded 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

USCA Case #08-1061 Document #1174035 Filed: 04/03/2009 Page 7 of 10
8

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.

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

USCA Case #08-1061 Document #1174035 Filed: 04/03/2009 Page 8 of 10
9

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.

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).

USCA Case #08-1061 Document #1174035 Filed: 04/03/2009 Page 9 of 10
10

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.

USCA Case #08-1061 Document #1174035 Filed: 04/03/2009 Page 10 of 10