Context Over Text: Pennsylvania Supreme Court Upholds DOH’s Two‑Lab Testing Rule Under the Medical Marijuana Act (Wecht, J., dissenting)

Introduction

In Green Analytics North, LLC v. Department of Health, the Supreme Court of Pennsylvania addressed whether the Department of Health (DOH) exceeded its rulemaking authority under the Medical Marijuana Act (the “Act”) by mandating that growers/processors use two different independent laboratories to conduct required testing—one for harvest testing and a different one for final processing testing. The statutory fulcrum is Section 704(a) of the Act, which provides that a “grower/processor shall contract with one or more independent laboratories” and requires tests “at harvest and at final processing.” The challenged regulation, 28 Pa. Code § 1171a.29(c)(2), requires that the second test be performed by a laboratory “other than the one” that conducted the harvest test.

The DOH, as Appellant, defended its “Two-Lab Requirement” as a reasonable, safety-driven regulation adopted within its delegated power. A coalition of laboratories and medical marijuana operators (including Green Analytics North d/b/a Steep Hill PA, Hanging Gardens, Pennsylvania Medical Solutions, Curaleaf PA, AES Compassionate Care, Standard Farms, and Parea Biosciences) opposed the rule, arguing it contradicts the statute’s plain text, which expressly permits contracting with “one or more” laboratories.

The Court’s majority (opinion not provided here) approved the DOH’s regulation. Justice Wecht, joined by Justice Brobson, dissented. The dissent contends that the majority allowed “context” and policy aims to override unambiguous statutory text, thereby authorizing an agency to promulgate a regulation that eliminates a statutorily permitted option.

Summary of the Opinion

Although only the dissent is reproduced, its critique reveals the majority’s core holding: that DOH’s Two-Lab Requirement is valid under the Court’s regulatory validity framework from Tire Jockey Services, Inc. v. Department of Environmental Protection, 915 A.2d 1165 (Pa. 2007). The majority, as characterized by the dissent, reasoned that Section 704(a)’s “one or more” phrase, read in the broader statutory context and in light of the Act’s policy goals (promoting patient safety and facilitating high-quality research), does not preclude a regulation mandating two different laboratories for the two required tests. The majority thus concluded that the regulation falls within DOH’s granted power and is reasonable.

Justice Wecht’s dissent takes the opposite view. It argues that:

The statute’s plain language is unambiguous and permits growers/processors to fulfill their testing obligation by contracting with “one” laboratory (or more).
By requiring two laboratories, DOH eliminates the “one” option that the legislature expressly allowed, creating a facial conflict between statute and regulation.
Under Tire Jockey, a regulation that contradicts its enabling statute fails at the first prong—“adopted within the agency’s granted power”—and should be invalidated without resort to broader contextual or policy analysis.
Even on policy grounds, DOH’s rationale (accuracy, anti-fraud, diversion prevention, research quality) is not clearly served by a two-lab mandate, especially given the apples-to-oranges nature of harvest-versus-final-product comparisons.

Analysis

1) Precedents and Statutes Cited

The dissent draws heavily on several interpretive and administrative law anchors:

Tire Jockey Servs., Inc. v. Dep’t of Env’t Prot., 915 A.2d 1165 (Pa. 2007): Establishes the three-part test for legislative rulemaking validity: (a) adopted within the agency’s granted power; (b) issued pursuant to proper procedure; and (c) reasonable. The dissent emphasizes the primacy of prong (a): a regulation must not conflict with the enabling statute.
Slippery Rock Area Sch. Dist. v. Unemployment Comp. Bd. of Rev., 983 A.2d 1231 (Pa. 2009): Agencies cannot adopt binding regulations inconsistent with their enabling statutes; all regulations must be consistent with the statute.
Popowsky v. Pa. Pub. Util. Comm’n, 910 A.2d 38 (Pa. 2006): Reinforces the consistency requirement between regulation and statute.
Statutory Construction Act of 1972.
- 1 Pa.C.S. § 1903(a): Words and phrases should be construed according to rules of grammar and common usage unless defined or used in a technical sense.
- 1 Pa.C.S. § 1921(b), (c): When statutory words are clear and free from ambiguity, the letter of the statute is not to be disregarded under the pretext of pursuing its spirit; extrinsic aids and policy considerations are available only when text is not explicit.
Pennsylvania Human Relations Comm’n v. St. Joe Minerals Corp., 382 A.2d 731 (Pa. 1978): Courts interpret what the Legislature said, not what it might or should have said.
Commonwealth v. Lehman, 311 A.3d 1034 (Pa. 2024) (quoting Miller v. Cnty. of Centre, 173 A.3d 1162 (Pa. 2017)): Plain language is the best indication of legislative intent.

The substantive statutory provisions at issue:

35 P.S. § 10231.704(a): “A grower/processor shall contract with one or more independent laboratories to test the medical marijuana produced by the grower/processor.” The Department “shall approve a laboratory” and require testing “at harvest” and “at final processing.”
28 Pa. Code § 1171a.29(c)(1)–(2): An approved laboratory must test samples from a harvest batch/lot before use in production, and “an approved laboratory other than the one that tested the harvest batch or harvest lot shall test samples from each process lot” before sale.
35 P.S. § 10231.102: The Act’s policy declarations, including patient safety and support for high-quality research.

2) The Dissent’s Legal Reasoning

The dissent’s analysis has three main pillars.

a) Plain Text Controls When Unambiguous

Justice Wecht views Section 704(a) as clear: the statute expressly authorizes a grower/processor to contract with one laboratory (or more than one). The subject of the sentence is the grower/processor; the mandate is directed to that entity; and the word “one” necessarily must remain a permissible option. By eliminating that option, DOH’s regulation “contravenes” the statute.

The dissent rejects the majority’s appeal to “context” because the majority (in the dissent’s telling) never identified an ambiguity in the operative words—“one or more”—and neither a statutory definition nor a technical meaning applies here. Under the Statutory Construction Act, resort to context and policy is reserved for ambiguous text. Thus, the dissent warns, the majority’s “context” analysis lacks a limiting principle and in effect licenses agencies and courts to disregard plain text.

b) Tire Jockey’s First Prong Is Dispositive

Because the regulation, in the dissent’s view, contradicts Section 704(a), it fails Tire Jockey’s first requirement—being “adopted within the agency’s granted power.” The dissent would end the analysis there: agencies cannot promulgate a regulation that takes away what the statute plainly permits. No amount of policy rationalization can cure a textual conflict.

c) Policy Rationales Do Not Do the Work the Majority Claims

Even on policy’s own terms, the dissent is skeptical. The majority emphasizes accuracy, independence, research quality, and diversion prevention. The dissent counters:

Accuracy and independence: The statute already requires the use of independent labs. Requiring a second lab does not self-evidently increase accuracy of the final product test, particularly when harvest and final products are materially different (e.g., plant material versus processed oils, pills, or edibles), making direct comparison “apples to oranges.”
Anti-fraud: The Department’s theory is that two labs enable cross-checking to detect false reporting. But if the final-product test is by a second (potentially unscrupulous) lab, the harvest test results may not expose that wrongdoing because the matrices differ. The regulation could even introduce new risk by compelling use of a second lab that the operator would not otherwise choose.
Research quality: High-quality research depends on accurate characterization of the final product administered in studies; it is unclear why split-lab testing enhances that aim as compared to a single independent lab testing both stages.
Diversion prevention: Because testing addresses samples rather than entire lots, a two-lab rule does not plausibly prevent diversion of bulk product. The dissent finds the majority’s diversion rationale especially unmoored from the mechanics of sampling and testing.

For the dissent, these gaps illustrate the hazard of privileging policy over text: courts risk endorsing speculative rationales untethered to the statute’s words or to the regulation’s actual mechanisms.

3) The Majority’s Approach as Reflected in the Dissent

While the majority’s opinion is not provided, the dissent’s references reveal its contours:

The majority looks “to the rest of the Act,” particularly the statement of policies in Section 102 and the Act’s enabling provisions, to conclude that the DOH may require two different labs to advance safety and research goals.
It characterizes a strict textual focus on “one or more” as “simplistic sophistry” and warns against an “obsessive focus” on dictionary meanings divorced from context.
It reasons that two-lab testing is reasonably related to accurate labeling, safe patient use, valid research protocols, and deterring diversion—thus satisfying Tire Jockey’s “within power” and “reasonable” prongs.

The resulting precedent, as framed by the dissent, is that statutory context and express policy aims can support an agency regulation that is stricter than what the statute’s bare words might appear to allow, even when the statute says “one or more.”

4) Likely Impact

This decision carries significant doctrinal and practical consequences.

a) Doctrinal: Text vs. Context in Pennsylvania Statutory Interpretation

Expanded role for “context” in agency rulemaking cases: Agencies defending regulations may lean more heavily on statutory policy declarations and cross-provisions to justify rules that go beyond (or narrow) the flexibility the text seems to confer on regulated parties.
First-prong elasticity under Tire Jockey: The majority’s reasoning, as described by the dissent, may be cited to argue that prong (a) tolerates stricter rules that “further” statutory goals even if they remove an option the statute literally permits.
Separation-of-powers friction: The dissent warns that this approach risks writing a “blank check” to agencies and may prompt more challenges alleging that agencies have crossed from filling gaps to contradicting text.

b) Industry Operations and Compliance

Operational changes: Growers/processors must plan for two independent labs—one for harvest batches/lots and a different one for process lots—affecting logistics, contracts, and timelines.
Cost and market effects: Requiring two labs can increase costs and may reshape the laboratory services market, especially in regions with limited lab availability.
Quality assurance systems: Operators and labs will need to refine chain-of-custody, sampling, and data comparison protocols to extract any compliance or QA value from split-lab testing.

c) Litigation Strategy

For agencies: Anchor regulations in explicit statutory policy statements and enabling grants; demonstrate a concrete safety or reliability nexus.
For challengers: Focus on pinpointing conflicts where a regulation removes a statutory option; argue that context cannot override unambiguous text; document practical incoherence (e.g., “apples-to-oranges” comparisons) to undercut “reasonableness.”
For the Legislature: If the Court’s reading diverges from legislative expectations, clarifying amendments (e.g., specifying “one lab may conduct both tests” or “the Department may require different labs for each test”) can realign text and policy.

Complex Concepts Simplified

“One or more”: A common legal phrase meaning at least one, and possibly more. The dissent argues that when a statute uses this phrase to describe a regulated party’s duty, an agency may not eliminate “one” as a compliant choice.
Legislative vs. interpretive rules: Legislative rules (like the DOH regulation here) are adopted under explicit delegated authority and have the force of law if valid under Tire Jockey. Interpretive rules advise how an agency reads a statute and generally lack binding effect on courts.
Tire Jockey test: A Pennsylvania framework assessing whether a regulation is (a) within the agency’s granted power, (b) procedurally proper, and (c) reasonable.
Plain meaning rule (1 Pa.C.S. § 1921(b)): If statutory language is clear, courts apply it as written and do not rely on policy or extrinsic evidence to alter that meaning.
Statutory context: The whole-act view, including policy statements and related provisions. The majority (per the dissent) invoked context to support the two-lab rule; the dissent cautions context cannot override unambiguous text absent ambiguity.
Diversion: Unlawful redirection of regulated substances (here, medical marijuana) into illegal channels. The dissent doubts that split-lab testing of samples meaningfully deters diversion.
Harvest batch vs. final processing: The Act requires tests at both stages. The dissent emphasizes that these materials can be very different (raw plant vs. processed product), complicating cross-lab comparisons.

Conclusion

Green Analytics North v. DOH stakes out an important boundary—contested in a forceful dissent—between text and context in Pennsylvania administrative law. The majority, as recounted by the dissent, treats Section 704(a)’s “one or more” language as compatible with a Department mandate that the two required tests be conducted by different laboratories, citing the Act’s safety and research aims and the DOH’s enabling authority under Tire Jockey.

Justice Wecht’s dissent insists that the regulation cannot stand because it eliminates a statutory option unambiguously preserved by the General Assembly: compliance via “one” independent laboratory. In his view, the regulation fails Tire Jockey at the threshold and should not be salvaged by policy appeals or whole-act context when the text is clear. He also questions whether the asserted benefits—accuracy, anti-fraud, diversion control, and research quality—are meaningfully advanced by split-lab testing of different product forms.

Going forward, agencies and litigants will test how far the “context” rationale extends: When does a safety-driven, gap-filling regulation legitimately “further” a statute, and when does it impermissibly contradict it? For the medical marijuana sector, the Two-Lab Requirement now stands, with operational and compliance consequences. For Pennsylvania administrative law more broadly, the case signals a live tension—highlighted by the dissent—about the judiciary’s role in safeguarding legislative text against expansive agency interpretations in the name of statutory purpose.