I. Introduction: The Power of Silence

Public policy is not made only in hearings, courtrooms, or legislative chambers. It is also made in the quiet—through agency memos that never get drafted, rulemakings that never open, enforcement actions that never arrive, and standards that never materialize. Silence, repeated long enough and widely enough, becomes a form of law. It acquires the weight of custom and the force of habit. And when that silence involves “scientific” tools—testing methods, screening instruments, predictive models—it acquires something even more potent: the aura of objectivity.

That is how a device cleared for one limited purpose can become the basis for hiring and firing decisions it was never authorized to influence. That is how a contested methodology can be dressed in the language of neutrality, marched into personnel systems, and used to decide, without real scrutiny, who works, who advances, and who is removed. That is how people—applicants, probationers, junior employees—become the test subjects of a regime no one ever openly approved.

In theory, our regulatory structure is designed to prevent exactly this sort of end-run around democratic controls. Congress assigns duties to agencies. Agencies promulgate rules. Courts review. The public comments. And science, if it is to have coercive force, is examined, bounded, and translated into standards. In practice, institutions often do something else: they let the market outrun the law, allow administrative ambiguity to stand in for guidance, and then absorb private practices as if they were public policy. When that happens, the burden of proof shifts—away from the institutions that deploy the tools and onto the people harmed by them.

The dynamics are painfully familiar. A laboratory markets a test as cutting-edge. A large employer adopts it to signal vigilance. A regulator, facing limited resources and political risk, declines to intervene. Early objections are dismissed as anecdotal. The test’s footprint grows; forms appear, boxes get added to investigative checklists, and what was novel is suddenly standard. After a few years, “we’ve always done it this way” becomes a defense, not a confession. And somewhere in this chain, the people most affected—often those with the least leverage—lose their jobs or never get them, and are told the system is scientifically neutral.

The story of hair drug testing is a clear illustration. It is a case study in how a contested practice moved from experimental claim to personnel policy without the guardrails that make public power legitimate. The crucial mechanism was not a sweeping statute or an aggressive rule. It was the quieter mechanism of omission: a regulator’s refusal to draw a line; an employer’s willingness to treat that non-line as permission; a vendor’s eagerness to fill the vacuum with marketing and certitude. That is how science becomes policy without oversight—by exploiting the gap between what the public thinks “approved” means and what the law actually authorizes.

This essay is not narrowly about a device or a single agency. It is about the architecture of administrative silence—how it forms, why it persists, and whom it privileges. It is about how power moves when the state chooses not to speak. It is about the civil rights consequences that predictably follow when a tool with known reliability problems and documented racial disparities is allowed to govern livelihoods under the false banner of neutrality. And it is about what it takes to break that silence—not with slogans, but with legal instruments that force agencies to put their position in writing and on the record.

To understand the cost, one must first understand the translation that happens when scientific language enters bureaucratic systems. Inside laboratories, claims about sensitivity, specificity, contamination, and detection windows are contested, hedged, and revised. Inside personnel systems, those claims are converted into checkboxes, thresholds, and yes/no decisions. What was probabilistic becomes dispositive. What was a confidence interval becomes a career judgment. The administrative file rarely captures the scientific debate; it captures only the conclusion. And because the conclusion arrives stamped with the patina of “science,” it is presumed objective unless the worker can prove otherwise.

This presumption is backward. The coercive use of a scientific tool in employment should require the employer—and, where applicable, the state—to demonstrate that the tool is authorized for the purpose at hand, that it operates within defined limits, and that it does not systemically discriminate. The default should be scrutiny, not deference. Yet when oversight recedes, the default flips. The worker is told to take it up with the lab, or to find an expert, or to accept the result. That is not neutrality; that is power operating behind the screen of jargon.

What makes this arrangement so durable is that no single actor must accept responsibility. Vendors point to regulators—“If it were a problem, the agency would say so.” Regulators point to employers—“We did not mandate its use.” Employers point to the market—“Everyone uses it.” In the circularity of these deflections, the practice consolidates. And every year that passes without an explicit prohibition is treated as a year of tacit approval, a year that can be cited on a slide deck or in a policy memo as evidence of legitimacy.

The legal system, for its part, is often asked to adjudicate harms long after the administrative facts have hardened. Plaintiffs must explain not only why a testing method is unreliable or discriminatory, but why the absence of agency action is not itself proof that the method is acceptable. This is the perverse leverage of silence: it is simultaneously nothing—a failure to act—and a powerful something—the predicate of a status quo.

The antidote is speech, but not performative speech. It is legally operative speech: a formal agency response, a published standard, a binding articulation of scope and limits. When an agency is compelled to answer, the fog lifts. The marketplace loses its favorite defense: that if something were wrong, the state would have told us. And the people harmed have something they seldom receive in administrative law—a document that clarifies where authority ends and liability begins.

This is why mechanisms that force agencies to speak are not bureaucratic niceties; they are civil rights tools. They convert ambiguity into record. They transform a pattern of harm into a paper trail that can be used in courtrooms, oversight hearings, and policy reform. They also reset the presumption: the question is no longer whether the worker can overcome science, but whether the employer can justify turning contested science into coercive policy.

Silence, in other words, is not an absence of power. It is a method of exercising it. And in the context of employment and public safety, where the state’s decisions determine who works and who doesn’t, silence can be as coercive as any mandate. The first step toward accountability is recognizing silence as policy, not as a gap between policies.

II. The Birth of Policy Without Oversight

Policy, at its most legitimate, emerges through a structured process: a problem is defined, solutions are debated, evidence is gathered, rules are promulgated, and the public—those affected—has the chance to speak. But some of the most consequential policies in American life have never been written down as such. They emerge in a quieter way: through absence, through the passivity of regulators, through the self-interest of institutions willing to treat ambiguity as opportunity.

This is how the science-to-policy pipeline without oversight works. It does not begin with a legislative act or an agency determination. It begins with a technical claim—a new testing method, a novel screening device, an algorithmic model—marketed not as a law, but as a tool. The claim is simple: the science is ready, the science is neutral, the science can help. And once that claim enters bureaucratic systems—especially those obsessed with speed, efficiency, and liability protection—it becomes policy before anyone ever votes on it.

The dynamic was fully visible in the rise of hair drug testing, though the pattern itself is far older. A device cleared by the U.S. Food and Drug Administration (FDA) for one limited purpose—an enzyme immunoassay for serum, plasma, saliva, and urine—was quietly repurposed for a different one: hair. This was not accomplished through a public hearing or a rulemaking; it happened through marketing materials, sales presentations, and interoffice memoranda. What began as a vendor’s commercial ambition slipped almost frictionlessly into personnel policy.

In the late 1980s, drug testing in the workplace became a political imperative. President Reagan’s Executive Order 12564 pushed for “drug-free workplaces” across the federal government, and private employers followed suit. The Substance Abuse and Mental Health Services Administration (SAMHSA), responsible for setting standards for federally regulated testing, moved carefully: it adopted urine testing as the gold standard but repeatedly declined to adopt hair testing. SAMHSA cited unresolved concerns about environmental contamination, the lack of standardized cutoffs, and troubling racial disparities in results.

Yet this deliberate federal restraint did not slow the market. It redirected it. Instead of pursuing formal approval, vendors leaned on the silence: “If it were a problem,” they told employers, “the government would have said so.” That line—the soft power of implied permission—became more valuable than any regulation.

Large employers, especially in law enforcement and transportation, seized on the supposed advantages of hair testing. Unlike urine, hair testing could be sold as a “look back” tool, reaching further into an applicant’s past and projecting a more aggressive posture on drug enforcement. It also offered something administrators prize: simplicity. The test’s output was binary, the collection process clean, the result clothed in technical language. Crucially, the legal risk appeared low because no regulator had explicitly said “no.”

What followed was not a single policy decision, but thousands of micro-decisions: procurement officers signing contracts, HR units updating manuals, lawyers drafting clauses, investigators checking boxes. Each decision was small enough to escape notice, but together they formed a system: a testing regime with no legal mandate but all the practical force of law.

The regulator’s silence did not stop the growth of this practice—it accelerated it. For employers, silence is a form of legal insulation. If the government has not prohibited something, adopting it can be cast as due diligence. For vendors, silence is an open field. They can frame their product as innovative and compliant without ever facing the evidentiary burden that formal approval would impose. For agencies, silence means avoiding political risk; they neither bless nor ban. In this triangle, silence is not a void. It is a productive condition.

The hair testing regime spread most aggressively in policing, where the cultural and institutional appetite for “certainty” has always exceeded the evidentiary basis for the tools used. But the same structure has been replicated in other domains: psychological screening protocols applied by non-licensed personnel, sealed record access practices at odds with statute, algorithmic “risk assessments” with no public testing or disclosure. In each case, the mechanism of power is the same: a tool that has not been vetted through democratic or regulatory processes takes on the practical authority of policy because the people with the least power are least able to challenge it.

This process thrives in institutional settings where risk is defined asymmetrically. Employers worry about the reputational cost of hiring “the wrong person” but not about the civil rights cost of excluding the right ones. Agencies fear political backlash for appearing “soft,” not for violating due process in the name of “science.” Vendors build their profit models on being one step ahead of regulators. And workers—especially those from marginalized communities—bear the burden of disproving what was never proven in the first place.

Silence, in this sense, is not a passive failure. It is a strategic allocation of risk. The regulator avoids political heat. The employer avoids liability. The vendor makes money. And the worker—the applicant, the probationary officer, the nurse, the teacher, the construction worker—absorbs the entire weight of a testing regime that no one ever formally authorized.

The legal system is poorly equipped to address this kind of problem ex post. By the time a plaintiff challenges an adverse employment action, the administrative infrastructure around the tool is fully built. Policies are in manuals. Procedures are routinized. HR directors testify, “We’ve used this test for years.” And because no agency has ever articulated the test’s limits, courts confront a vacuum that looks, from a distance, like consensus.

What has taken shape is a shadow policymaking process, one that moves faster than law, relies on ambiguity for cover, and entrenches itself through repetition. Its hallmark is not open defiance of regulation, but quiet evasion of it. Its currency is the assumption of legitimacy, and its cost is borne entirely by the people subjected to it.

This is how science becomes policy without oversight: not with a bang, but with a murmur. Not through conflict, but through a choreography of silence.

III. How Science Becomes Law Without Legislation

When most people imagine how new policy takes shape, they think of legislation, rulemaking, or court decisions—formal processes with notice, debate, and record. But some of the most enduring and coercive policies are born through a different mechanism: institutional adoption. It is less visible, but no less powerful. A tool moves from the laboratory to the market, from the market to the bureaucracy, and from the bureaucracy to the personnel file. At no point is there a vote. At no point is there a published rule. Yet the outcome is the same: a de facto legal regime with real human consequences.

The mechanism is elegantly simple.

Step one: vendor marketing. A company develops or repurposes a tool—a test, a model, an algorithm—and markets it to large employers as a cutting-edge solution to a politically charged problem. The claim is never just technical; it is moral and managerial. “Our technology helps ensure drug-free workplaces.” “Our test protects the integrity of your workforce.” “Our model ensures objectivity.” These are not regulatory assurances—they are rhetorical ones. The Psychemedics Corporation pitch for hair testing followed this script exactly: the science, they said, could look back months instead of days, making it harder for applicants to “game” the system.

Step two: bureaucratic convenience. For agencies like the New York City Police Department—and for hospitals, schools, and security contractors—the allure is not just the promise of accuracy, but the simplicity. Hair testing is clean, quick, and binary. It comes with neatly packaged results that can be dropped into a personnel file without protracted interpretation. Unlike urine testing, which requires strict chain-of-custody protocols and is subject to evolving federal standards, hair testing offers administrators something they value even more than certainty: control without oversight. It can be used in ways that are internally standardized but externally unexamined.

Step three: policy normalization. Once a handful of influential agencies adopt a practice, its perceived legitimacy grows. New adopters can say, “This is what the NYPD uses,” or “This is standard in transportation,” or “This is common in healthcare.” HR manuals are quietly updated. Procurement contracts are extended. Investigative checklists add new boxes. An unapproved scientific method becomes, through repetition, a personnel infrastructure.

This pipeline works because regulatory silence functions as a permission structure. If the FDA has not explicitly barred hair testing, employers assume they are on safe ground. If SAMHSA has not issued a formal standard, administrators treat that absence not as a warning but as a blank canvas. Silence becomes evidence of acceptability, even though it is nothing of the kind. It is the absence of scrutiny dressed up as a shield.

This was the trajectory of hair testing. But the pattern is not unique to drug testing. It is the same pattern that underlies other quietly embedded practices inside public agencies and large employers.

Consider the NYPD’s psychological screening process. Over the years, the department has relied heavily on evaluations conducted by personnel who are not licensed psychologists, in direct tension with New York Education Law § 7605 and related provisions. The practice emerged not through explicit rulemaking but through institutional drift. Psych holds became a routine administrative device to stall or eliminate candidates without triggering formal disqualifications. And because no state regulator forcefully intervened, the practice was absorbed into normal operations, as if it had legal sanction.

Or consider sealed record misuse. Statutes such as New York Criminal Procedure Law § 160.50 and § 160.55 are clear: sealed records should not be used for employment decisions. Yet law enforcement agencies have, for years, quietly accessed and factored sealed matters into candidate assessments. The justification was not legal but administrative: “this is what we’ve always done.” Again, silence from oversight bodies—and in some cases judicial deference to “operational necessity”—allowed the practice to ossify into policy.

These examples reveal the same architecture. The absence of an explicit legal boundary does not create neutrality. It creates opportunity—opportunity for employers and agencies to adopt practices that expand their discretionary control. Over time, those practices develop their own internal justifications. “It’s in the manual.” “It’s standard.” “It’s objective.” The fact that none of this has ever been authorized—or even meaningfully reviewed—fades into the background.

And once an institution has built its hiring and discipline apparatus around a tool, dislodging it becomes far harder than adopting it ever was. Adoption requires no rulemaking. Reversal often requires litigation, discovery, media scrutiny, or legislative intervention. By the time the legal system engages, the practice is entrenched.

This is why “science” becomes law without legislation. It is not because the science is unassailable, but because institutions find it useful. Because regulators find it convenient not to intervene. Because courts, encountering a mature practice, are reluctant to upend it retroactively. And because the people most affected—applicants, employees, disproportionately from marginalized communities—lack the resources to challenge a system that presents itself as neutral.

This is not a glitch in administrative governance. It is a feature. Bureaucracies have always relied on tools that offer the appearance of objectivity without the burden of external accountability. In the mid-twentieth century, that tool might have been a subjective character reference. In the twenty-first, it is a lab test or an algorithm. The shape changes, but the power dynamic remains the same.

IV. Building Power Through Administrative Ambiguity

The reason this pattern endures is not only because silence is profitable for vendors and convenient for employers. It is also because ambiguity itself is a source of bureaucratic power.

Clear rules invite challenge. They can be tested, appealed, and enforced. Ambiguity, by contrast, diffuses responsibility and concentrates discretion. It lets institutions act as if they are bound by objective standards while retaining maximum flexibility behind the scenes.

Nowhere is this clearer than inside the New York City Police Department, whose candidate assessment system reveals how administrative ambiguity hardens into control.

One of the department’s most potent tools is the “psychological hold.” On paper, a psych hold is not a disqualification. It is a “temporary” administrative status that allows the department to suspend a candidate’s processing while awaiting additional information—college transcripts, medical records, employment verification. In practice, however, the hold often functions as a de facto disqualification, lingering indefinitely while the candidate is told nothing definitive.

This ambiguity benefits the department in several ways. It allows the agency to avoid triggering formal appeal rights. It creates a buffer against scrutiny, because no one can appeal a “non-decision.” And it lets the department control candidate flow with minimal accountability. The ambiguity is not incidental; it is instrumental.

The same logic governs background check extensions. Candidates may be told their investigation is ongoing, with no clear timetable for completion. This ambiguity places the entire burden on the candidate to “wait it out,” often for months or years, while the department incurs no formal obligations. Once again, the absence of a hard rule operates as a shield.

The downstream effect of these ambiguous administrative categories is blacklisting by attrition. A candidate who has been on hold too long, or caught in investigative limbo, is effectively branded unfit, even if no formal finding is ever made. This status often follows the individual beyond the agency in question. Other employers, especially in law enforcement and security, may be informed—formally or informally—that the candidate was “psych held” or “under investigation,” a stigma that functions like a disqualification without ever triggering due process.

This architecture of ambiguity is not unique to NYPD. It is found in school districts that place teachers on “administrative reassignment” for indefinite periods. It is found in hospitals that sideline nurses based on “pending concerns.” It is found in the private sector, where background screening reports carry ambiguous “flags” that never quite amount to findings but destroy employment prospects all the same.

Administrative law theory has long recognized that discretion expands in the gaps between rules. When silence is policy, power consolidates. Regulators can disclaim responsibility—“we didn’t tell them to do this.” Employers can disclaim malice—“we’re just following procedure.” Vendors can disclaim liability—“we only provide the tool.” And workers are left with nowhere to direct their challenge because no one actor owns the decision.

This fragmentation is by design. It insulates the system from legal accountability. It also helps perpetuate structural inequities. Ambiguity and silence do not affect everyone equally. Those with resources, connections, or legal counsel may eventually navigate or challenge the system. Those without are absorbed by it.

In this way, administrative ambiguity does not merely mirror existing hierarchies—it amplifies them. It allows employers to act with the coercive force of law while escaping the legal obligations that should accompany such power. It allows regulators to appear neutral while enabling exclusionary practices. And it allows vendors to monetize the gap between what the law says and what institutions do.

The doctrinal literature calls this “administrative drift” or “informal governance.” But its lived reality is simpler: silence is not a vacuum. It is a structure of control. It is the soft infrastructure through which science becomes policy, policy becomes power, and power is exercised without ever being formally granted.

This is why the issue of hair testing cannot be reduced to a laboratory debate about contamination thresholds or detection windows. It is a case study in how ambiguous, unauthorized tools can become the backbone of personnel systems that shape entire professions. And it is why any meaningful accountability effort must target not just the tool itself, but the architecture of silence and ambiguity that sustains it.

V. The Human Cost: Frankie Palaguachi’s Story — and Thousands Like Him

Frankie Palaguachi’s story does not begin with a legal theory. It begins with a detective who had already devoted years of his life to law enforcement. Like so many others in his position, Frankie entered the New York City Police Department not as an outsider seeking entry, but as a sworn officer who had earned his position through service and performance. He had passed every test required of him long ago. He had built a career, carried a shield, and served the people of New York. What he did not anticipate was that an unapproved laboratory test—one never authorized by the United States Food and Drug Administration for use on hair—would be used to erase that career, not through a finding of guilt, but through a test that was never lawfully sanctioned for its purpose.

Frankie was ordered to submit to hair testing as part of the department’s drug screening protocol. Like most officers, he was never briefed on the regulatory backstory — the critical distinction between FDA clearance and approval, the intended-use limitations, or the absence of any federal standard governing hair testing. What he did know was that the department treated the test as infallible. A positive result was not the beginning of a process; it was the end of one.

The test came back positive. Frankie — a detective with a spotless disciplinary record and years of service — immediately denied any drug use and moved forcefully to challenge the result. He voluntarily submitted to three independent drug tests, each of which came back negative. He invoked the law, not supposition: he challenged the enzyme immunoassay (EIA) hair test under the Frye standard, argued that the department had failed to meet the validation requirements set forth in Uniform Guidelines on Employee Selection Procedures (UGESP), and pointed out that the agency ignored Rule 7.01, which requires employers relying on selection procedures with adverse impact to produce proper technical validation.

The department’s response was silence and evasion. It refused to disclose the laboratory methodology, ignored the absence of scientific reliability under Frye, disregarded the mandatory validation standards under UGESP, and never produced the legally required confirmation studies demonstrating the test’s job-relatedness or predictive validity. It also refused to credit Frankie’s three negative tests or provide any meaningful administrative hearing. Instead, the unapproved test result was treated as dispositive, as if it carried the force of law.

Frankie’s career was not ended by evidence or legal process. It was ended by the calculated use of regulatory silence — by a department that bypassed the very legal standards designed to protect against unreliable, discriminatory testing.

This is the architecture at work:

• Step one: FDA silence. The agency never authorized the use of the immunoassay device on hair samples but also never explicitly prohibited it. That silence became the foundation for institutional adoption.

• Step two: agency adoption. The NYPD incorporated hair testing into its hiring and disciplinary process in 1996, as if it were legally sanctioned. Internally, it became standard procedure. Externally, it was justified as “scientifically sound.”

• Step three: employment exclusion. A single positive result — from a test whose reliability has been challenged for decades — was used to end Frankie’s career before it started.

• Step four: lack of recourse. No formal process existed for challenging the decision. No standard governed the methodology. No appeal rights attached to a “test result.”

Frankie’s case is not an aberration. It is a template. Over the past three decades, thousands of applicants — disproportionately people of color, disproportionately from working-class backgrounds — have been eliminated from law enforcement, healthcare, transportation, and security-sector jobs based on hair testing results. The overwhelming majority never saw a lab report, never had a hearing, and never learned that the test itself was never authorized for that use.

I have seen this pattern repeat in countless variations. A promising applicant disqualified with no recourse. A veteran employee terminated after a “surprise” positive test. A worker flagged and quietly blacklisted across multiple employers. The bureaucratic language is always the same: “test result,” “objective standard,” “policy.” What is missing from that language is the truth about the legal and scientific foundation on which these life-altering decisions rest.

Hair testing does not reliably distinguish between ingestion and environmental exposure. In urban environments, or in communities where drug use occurs in proximity, innocent people can return “positive” results because their hair — especially if melanin-rich — binds drug metabolites from the surrounding environment. The science of the test’s limitations is well established. The legal authorization for its use does not exist. And yet, the test continues to function as a gatekeeper to employment.

Frankie did what few others have the resources or courage to do. He challenged the practice, filing a formal Citizen Petition with the FDA — forcing the agency to confront the question it has avoided for decades: How can a test be used to decide careers when it was never authorized for that purpose? That petition is not just about Frankie’s job. It is about every applicant who never had the chance to fight.

The cruelty of this system is not its loudness, but its quiet precision. No one held a press conference to exclude Frankie. No one drafted a law that said he could not be hired. No one passed a rule authorizing a racially biased test. The decision happened in silence, on a lab bench, in an HR file, in a memo that never had to cite authority. It happened because silence had already been mistaken for law.

VI. Civil Rights by Default: How Inaction Discriminates

Regulatory inaction is often portrayed as neutral — a mere absence of enforcement, a lack of priority, a technical oversight. But when inaction surrounds a practice that is both scientifically contested and racially skewed, it becomes a civil rights problem. Not in theory. In outcome.

A. Disparate Racial Impact

The racial bias embedded in hair testing is not speculative. It is documented. Multiple studies — including those published in the Journal of Analytical Toxicology — have confirmed that melanin-rich hair binds drug metabolites more readily than lighter hair. That means Black and Brown applicants are more likely to produce positive results than white applicants at equal or even lower exposure levels. This is not a marginal disparity; it is a structural one.

This disparity was one of the central reasons SAMHSA refused to adopt hair testing into federal drug testing standards. The agency recognized that environmental contamination and melanin bias made the test inherently unreliable as a disciplinary or hiring tool. But SAMHSA’s decision to exclude the test was not matched by FDA enforcement to restrict its use. That gap — the space between exclusion and enforcement — became the territory in which discriminatory practices flourished.

When employers adopt hair testing without legal authorization, they are not just violating regulatory boundaries. They are creating a racially disparate barrier to employment. Title VII of the Civil Rights Act does not require discriminatory intent. A practice with a disparate impact that is not job-related and consistent with business necessity violates the law. Hair testing’s racial bias makes it almost tailor-made for disparate impact claims.

B. Disparate Economic Impact

Racial disparity intersects with economic vulnerability. The applicants most likely to be subjected to hair testing are those seeking positions in law enforcement, healthcare, transportation, construction, and security — industries that employ large numbers of working-class Black and Brown individuals. These are not executive roles with layers of legal protection. These are frontline jobs where a single adverse test can erase years of effort and permanently scar a record.

Unlike applicants for elite positions, these candidates often lack access to attorneys, expert witnesses, or alternative pathways. When a test result is treated as final, the burden of challenging it falls entirely on individuals with the least capacity to do so. The system’s ambiguity protects institutions while exposing individuals.

C. Due Process Erosion

The erosion of procedural protections compounds the discriminatory impact. Hair testing operates without a formal federal standard, without uniform laboratory protocols, and without meaningful avenues for appeal. Most employers treat a “positive” as dispositive. They do not disclose test data. They do not permit independent verification. They do not provide hearings. And they do not bear the burden of proving that the test is scientifically reliable or legally authorized.

This flips fundamental administrative and constitutional principles on their head. In a fair system, the state or employer must justify the use of a coercive tool. In this system, the worker must disprove a test the state never authorized.

Title VII, state civil rights laws, and administrative due process doctrines were designed to guard against exactly this kind of hidden discrimination. The problem is that these doctrines often collide with entrenched bureaucratic practices that are presumed legitimate simply because they are longstanding. But longevity is not legality. A discriminatory practice does not become lawful because it is old.

VII. The Legal Fiction of “FDA Approved”

The entire edifice of hair testing as an employment practice rests on a fiction: that the test is “FDA approved.” It is not.

The enzyme immunoassay (EIA) device used by Psychemedics Corporation was cleared through the FDA’s 510(k) process under 21 C.F.R. § 862.3870, which covers immunoassay systems for detecting drugs in serum, plasma, saliva, and urine. Hair was not part of the clearance. The intended use was explicit and narrow.

510(k) clearance itself is not “approval.” It is a determination of substantial equivalence to a legally marketed device for a specified use. It does not involve rigorous premarket review of safety and effectiveness. It does not authorize expanded applications beyond the cleared scope. And yet, through a combination of vendor marketing and bureaucratic repetition, the term “FDA approved” entered agency vernacular.

Psychemedics and similar vendors did not need to falsify anything. They only needed to allow the misunderstanding to persist. Agencies like the NYPD then repeated the language to applicants, investigators, and lawyers. Over time, the fiction hardened. In hearings, depositions, and policy documents, hair testing was referred to as “FDA approved” as casually as if it were written into statute.

This fiction is more than sloppy language. It is a legal shield. When challenged, employers point to the supposed FDA imprimatur to argue that their practices are presumptively valid. But when pressed on the specifics — what was cleared, for what purpose, under what regulatory authority — the foundation collapses. The FDA never approved hair testing. It never reviewed its reliability in detecting ingestion versus contamination. It never set cutoffs. It never issued guidance authorizing its use in employment contexts.

The fiction has real consequences. It creates a presumption of legitimacy in administrative hearings. It discourages applicants from challenging their disqualifications. It allows agencies to outsource accountability to a regulator that never actually approved the practice. And it turns a vendor’s marketing language into the functional equivalent of law.

This is why the Palaguachi Citizen Petition matters. It forces the FDA to say out loud what it has avoided saying for decades: that the device was never authorized for hair testing. Once that statement exists in the administrative record, the fiction collapses. And when the fiction collapses, so too does the shield it has provided to employers, agencies, and vendors who built their power on silence.

VIII. When Regulatory Silence Becomes Institutional Architecture

Silence, once accepted as permission, does not remain inert. It becomes infrastructure. What begins as a vendor’s marketing claim becomes a departmental practice, then a policy manual, and eventually a disciplinary system that treats an unapproved tool as unquestionable fact.

The progression is predictable:

• Vendor to department. A company markets a tool — in this case, hair testing — to agencies as a modern, objective, and “legally defensible” solution. The Psychemedics Corporation marketing pitch leaned on the ambiguity created by the United States Food and Drug Administration: it never said hair testing was approved, but it didn’t have to. Silence did the work.

• Department to policy. Once a department like the New York City Police Department adopts the test, it becomes embedded in administrative procedures. Forms are revised. Investigative checklists expand. Language like “mandatory drug screening” or “hair testing protocol” is inserted into personnel instructions.

• Policy to disciplinary system. Over time, these procedures gain the weight of institutional memory. Officers and applicants alike are told, “This is how we’ve always done it.” A positive hair test is treated as per se proof of wrongdoing — not because it ever had legal authority, but because policy inertia transformed silence into an administrative rule.

The entrenchment of these practices is what makes them so resistant to change. They are not written as experimental or provisional; they are written as standard operating procedure. Undoing them requires more than a memo. It requires unwinding a structure that has been woven into the operational fabric of entire agencies.

Several forces reinforce that inertia:

• Collective bargaining agreements that lock in disciplinary processes built on these tests.

• Risk aversion within agencies, which view deviation from established practice as legal exposure rather than legal compliance.

• Bureaucratic self-interest, where administrators value tools that offer them control without oversight.

The consequences of this entrenchment are profound. By the time an individual like Frankie challenges the test, the practice is no longer viewed as “a testing method.” It is viewed as the backbone of policy. Even in litigation, the agency stands behind the test not on the strength of its scientific validation or regulatory approval, but on the fact of its own usage: “We’ve done this for decades.”

Longevity becomes a defense. But as history has shown repeatedly — from racially exclusionary hiring practices to discredited forensic methods — longevity does not equal legality. Silence becomes a form of law not because it is codified, but because it is repeated.

IX. Citizen Petitions as a Break Point

The most powerful feature of regulatory silence is that it protects itself. As long as the agency says nothing, vendors and employers can point to the void as proof of legitimacy. But there is a legal mechanism designed to pierce that silence: the 21 C.F.R. § 10.30 Citizen Petition.

Unlike lawsuits, which fight over consequences after the fact, a Citizen Petition forces an agency to speak. Once filed, the FDA must respond in writing. It cannot ignore the petition. It must either grant, deny, or acknowledge the request, and its response must enter the public administrative record.

This is why the Palaguachi Citizen Petition is strategically significant. It is not merely a challenge to a single test result. It is a demand for regulatory accountability. It compels the FDA to confront a question it has sidestepped for decades:

How can an EIA device cleared only for serum, plasma, saliva, and urine under 21 C.F.R. § 862.3870 lawfully be used for hair testing?

The answer to that question — whatever it is — will no longer live in the realm of silence. It will live in a formal document subject to judicial review, legislative oversight, and public scrutiny.

This is more than administrative housekeeping. It is the conversion of silence into speech, ambiguity into record, assumption into fact. That record then becomes a foundation for civil rights litigation, policy reform, and public accountability. If the FDA acknowledges that hair testing was never authorized, every employer and agency relying on it loses their shield.

Frankie’s petition is thus not an act of personal vindication alone. It is a structural intervention. It is a forcing mechanism that can begin to dismantle a decades-old architecture built entirely on silence.

X. The Broader Pattern: Not Just Hair Testing

Hair testing is a case study, not an anomaly. The same pattern — science presented as objective, regulators silent, agencies adopting it as policy — can be seen across multiple domains.

A. Psychological Screening Practices

The NYPD and other law enforcement agencies have long relied on psychological evaluations conducted by non-licensed personnel, in tension with New York Education Law § 7605 and related provisions. These screenings carry enormous weight in hiring decisions but are often based on unvalidated instruments and opaque interpretations. Regulatory bodies have not meaningfully intervened, allowing psychological “fitness” assessments to function as gatekeeping tools without legal guardrails.

B. Sealed Records Misuse

State law — including New York Criminal Procedure Law § 160.50 and § 160.55 — explicitly prohibits the use of sealed criminal records in employment decisions. Yet agencies have quietly accessed and factored sealed matters into candidate assessments for years. This practice was never authorized; it was normalized through administrative routine and oversight inaction.

C. Algorithmic Surveillance and Predictive Policing

In the private and public sectors alike, algorithmic tools now shape hiring, promotion, surveillance, and policing. Few of these systems have been subjected to meaningful validation or regulatory review. They operate in the same gap hair testing exploited: technical complexity, regulatory silence, and administrative eagerness to embrace tools that promise efficiency.

Across these domains, the structure is the same:

1. Science (or something packaged as science) enters the marketplace.

2. Regulatory silence creates a permission structure.

3. Administrative adoption converts silence into policy.

4. Systemic exclusion follows — often along racial, economic, or social lines.

This is how entire bureaucratic regimes are built without legislation. Science becomes policy. Policy becomes power. And power is exercised without public consent or legal authorization.

XI. A Civil Rights Reckoning: When Silence Stops Speaking for the State

For decades, administrative silence has functioned as a proxy for law. Agencies like the NYPD have used unapproved scientific tools as if they bore the imprimatur of federal authority. Vendors have profited. Regulators have stood back. And workers — disproportionately Black, Brown, and working-class — have paid the price.

But silence can be broken. Once the FDA speaks, the legal terrain changes.

Administrative silence is not neutral. It is power. And power wielded without accountability has legal and constitutional consequences. Title VII of the Civil Rights Act, state civil rights statutes, and administrative due process principles do not exempt silent discrimination. A practice that has a disparate impact and no valid job-related justification is unlawful, whether or not the agency spoke it into being.

Citizen Petitions are one pathway to accountability. Litigation is another. But lasting reform will require political will:

• Legislators willing to demand enforcement.

• Regulators willing to set clear boundaries.

• Courts willing to recognize silence as a source of discriminatory harm.

For too long, agencies have been able to hide behind the absence of explicit prohibition. That era must end. Silence is not a shield. It is evidence — evidence of abdication, of institutional convenience, and of structural discrimination.

XII. Conclusion: Science, Power, and the Price People Pay

Frankie Palaguachi’s story is not unique. It is a window into a larger system that has allowed science to become policy without oversight. A single unapproved hair test was used to override his service, his reputation, and his due process rights. But behind that test stands a deeper architecture — decades of regulatory silence, institutional entrenchment, and civil rights harm.

When science is used to exclude people from jobs, careers, and livelihoods, the burden of proof must rest with those who wield the tool, not with those subjected to it. Silence cannot be allowed to carry the force of law.

The path forward is clear:

• Transparency from regulators.

• Enforcement of legal validation requirements.

• Civil rights accountability for institutions that weaponize unapproved tools.

• Litigation and petitions that force agencies to speak, to draw lines, and to own the consequences of their silence.

Science without oversight is not neutral. It is a tool of power. And power exercised in silence is precisely what civil rights law was built to confront.

Frankie’s petition is more than an individual challenge. It is a declaration that silence no longer controls the narrative. It is a step toward restoring accountability to a system that has hidden behind technical language for far too long.