Toxic Waste. No Permit. Three Years.
What Frontida Did, and For How Long
Frontida BioPharm, LLC packages prescription pharmaceutical solids under contract at its Philadelphia facility. In the course of doing that work, it generates hazardous waste. Federal law under the Resource Conservation and Recovery Act (RCRA) is unambiguous: if you store hazardous waste without a permit, you are breaking the law. Frontida broke that law across multiple categories for at least three years.
- No hazardous waste storage permit exists for 7722 Dungan Road. Frontida registered as a Small Quantity Generator (SQG) of hazardous waste with Pennsylvania regulators back in 1989 and received RCRA ID No. PAD002277150. An SQG registration is not a storage permit. They are different things with different legal requirements.
- Frontida accepted hazardous waste from its own “Orthodox” facility, which is classified as a Large Quantity Generator (LQG). Under federal rules, only Very Small Quantity Generators can consolidate waste with an LQG. Frontida is an SQG. This means every single transfer from Orthodox to the Dungan Road facility was an unpermitted deposit of hazardous material.
- From March 1, 2020 to at least March 1, 2023, Frontida shipped hazardous waste between its two facilities with no Uniform Hazardous Waste Manifests. These paper trail documents are not optional. They are the federal government’s mechanism for tracking dangerous materials from origin to disposal. Three years. Zero manifests.
- Also from March 2020 through the inspection date, Frontida failed to conduct required weekly inspections of its hazardous waste accumulation area. This is a basic operational requirement designed to catch leaks, spills, and deteriorating containers before they become community health emergencies. It was skipped for three years straight.
- The EPA conducted its Compliance Evaluation Inspection on March 1, 2023. What its inspector found in the building that day was a facility operating as if the hazardous waste regulations simply did not apply to it.
The hazardous waste sitting in that facility was not theoretical or symbolic. The EPA identified specific materials and classified them under federal waste codes with real-world chemical and physical hazards attached.
- D001: Ignitable waste. This classification covers materials that can catch fire under certain conditions. Waste aerosol cans and IPA-contaminated wipes both fall here.
- D002: Corrosive waste. Materials that can chemically burn or degrade other materials, including human skin, at a pH below 2 or above 12.5.
- F003: Spent non-halogenated solvents. This specifically includes isopropyl alcohol (IPA), which Frontida used in its operations and allowed to accumulate on wipes that workers were disposing of as ordinary trash.
- The full list of waste found on site included: Rejected Powders Waste (pharmaceutical materials that failed quality control), Waste Aerosol Cans, Waste Lamps (fluorescent, containing mercury), Waste Batteries, and IPA-Contaminated Wipes.
The Non-Financial Ledger: What This Actually Means for People
The legal document in front of you is written in the detached language of regulatory enforcement. Paragraph numbers. Code citations. Docket references. It is designed to process a violation, assign a dollar amount, and close the file. What it does not do is account for what it feels like to work in a pharmaceutical facility where your employer cannot explain what it is doing with the aerosol cans you’re using every day.
On March 1, 2023, when EPA inspectors arrived at 7722 Dungan Road, they found facility representatives who told them, on the record, that they were “unsure how waste aerosol cans are managed by the Facility.” Not “our records are in a different office.” Not “let us pull that documentation.” Unsure. About containers classified as D001 ignitable hazardous waste. About materials that, handled incorrectly, can rupture, combust, or release toxic propellants into an enclosed workspace. The workers using those cans had no idea where they went when they were empty.
That is the daily reality the financial penalty does not capture. The workers at Frontida’s Dungan Road facility showed up to package prescription drugs, which is skilled, regulated, safety-sensitive work. They were doing their jobs in a facility where IPA-contaminated wipes, classified as hazardous solvent waste under federal code F003, were being thrown away as ordinary garbage. Every person who touched those wipes, every person who breathed the air in that waste storage area during three years of uninspected accumulation, was exposed to conditions that the law considers hazardous enough to require a permit and weekly monitoring. None of them got a vote on that. None of them were told.
Meanwhile, 200 containers of rejected pharmaceutical material sat in something called a “Reject Cage” for unspecified periods of time with no hazardous waste determination made on any of them. Two hundred containers. Some of them could have been entirely harmless. Some of them could have contained materials that required immediate classification and controlled disposal. Nobody checked. The EPA says so explicitly in its inspection findings.
Fluorescent lamps containing mercury sat in six open, unlabeled containers with no accumulation start dates. Mercury is a neurotoxin with no safe level of exposure. Six containers. Open. Unlabeled. In a workplace. And when the EPA finally settled the entire matter, it did so for $13,750. That works out to roughly $12.50 per worker if the facility employed a hundred people. Probably less than what Frontida spends on printer toner in a slow month.
The people living in Northeast Philadelphia’s Burholme neighborhood, where this facility sits, were never part of this settlement negotiation. They are not a party to Docket No. RCRA-03-2025-0065. Nobody asked them whether they were comfortable with three years of unpermitted hazardous waste storage operating two blocks from their homes. They found out the same way everyone else did: after the fact, if they found out at all.
Legal Receipts: Verbatim From the EPA File
The following quotes are pulled directly from EPA Docket No. RCRA-03-2025-0065, filed April 21, 2025. These are not summaries or paraphrases. Every word is from the government’s own record.
“On March 1, 2023, Respondent operated the Facility without a permit by accepting HW from its Orthodox facility, which is a Large Quantity Generator (‘LQG’) of HW. Consolidation of HW by mutually owned facilities is only allowable, with certain exceptions and requirements, by Very Small Quantity Generators to LQGs. Respondent is an SQG that accepted and stored HW from an LQG without a permit.” EPA Region 3, Expedited Settlement Agreement, Paragraph 10(a)(1)
- This confirms the core permit violation: Frontida had no legal authority to accept hazardous waste from its Orthodox facility. The regulatory exception the EPA cites only applies to Very Small Quantity Generators (VSQGs), and Frontida is classified as an SQG, one tier up from that.
- The phrase “accepted and stored HW from an LQG without a permit” is the government’s formal confirmation that Frontida was operating an unpermitted hazardous waste storage site, which is a federal violation under 42 U.S.C. § 6925(a).
“From March 1, 2020 to at least March 1, 2023, Respondent failed to conduct weekly inspections of its HW accumulation area as required by 25 Pa. Code § 262a.10.” EPA Region 3, Expedited Settlement Agreement, Paragraph 10(a)(2)
- The phrase “at least” is doing significant legal work here. The EPA is saying the documented violation window runs three years, but the agency is not committing to that as a firm start date. The actual start of non-compliance may be earlier.
- Weekly inspections are not a bureaucratic formality. They exist to catch fires, leaks, container failures, and unauthorized materials before they cause harm. Skipping them for 156 consecutive weeks is a structural failure of the facility’s safety operation.
“Reject Cage Material – Facility representatives stated that rejected material is accumulated in the Reject Cage for an unspecified period of time before a HW determination is made. The Inspector observed approximately 200 rejected material containers in the Reject Cage at the time of the Inspection for which a HW determination had not been made.” EPA Region 3, Expedited Settlement Agreement, Paragraph 10(b)(i)
- “Unspecified period of time” is Frontida’s own characterization. The company had no defined process for determining whether its rejected pharmaceutical materials were hazardous. It was storing unknown quantities of unknown-classification waste indefinitely.
- 200 containers is not a handful of items pushed to the side. This represents systematic, facility-wide accumulation of unclassified material. Federal law requires the hazardous waste determination to happen at the point of generation, not at some future unspecified moment.
“Waste Aerosol Cans – the Inspector observed in-use aerosol cans at the Facility at the time of the Inspection. The Facility representatives indicated they were unsure how waste aerosol cans are managed by the Facility and unsure how previously generated waste aerosol cans had been disposed.” EPA Region 3, Expedited Settlement Agreement, Paragraph 10(b)(ii)
- The company’s own representatives told a federal inspector that they did not know what their facility does with its D001 ignitable waste. This is the exact type of hazardous material that, when improperly disposed of, can rupture, ignite, or release toxic chemicals in a landfill or municipal waste stream.
- “Unsure how previously generated waste aerosol cans had been disposed” means the EPA has no verified record of where that waste went. It could have gone anywhere.
“IPA-contaminated Wipes – At the time of the Inspection, Facility representatives stated that IPA-contaminated wipes are disposed as nonhazardous waste and did not provide any HW determination documentation for the waste stream.” EPA Region 3, Expedited Settlement Agreement, Paragraph 10(b)(iii)
- Isopropyl alcohol is classified under EPA hazardous waste code F003, “spent non-halogenated solvents.” Wipes saturated in IPA are not ordinary trash. Disposing of them as regular waste means they bypassed the entire hazardous waste tracking, transport, and disposal infrastructure that RCRA mandates.
- The lack of any HW determination documentation means there is no record showing Frontida ever properly evaluated this waste stream. For a pharmaceutical facility generating this waste routinely, that is a sustained, deliberate omission.
“Respondent sent one (1) manifest (Manifest #024947115JJK) to EPA via email on September 1, 2023. The manifest documented a shipment of D001 HW on May 17, 2023 and was observed to not be signed by the designated facility. There is no record of an exception report being filed after 45 days had passed from the time of shipment.” EPA Region 3, Expedited Settlement Agreement, Paragraph 10(c)
- Frontida produced exactly one hazardous waste manifest under pressure from the EPA inspection. That single document was unsigned and procedurally deficient.
- When a hazardous waste shipment’s manifest is not returned by the receiving facility within 45 days, federal law requires the generator to file an exception report. Frontida’s shipment left on May 17, 2023. As of the settlement, no exception report had ever been filed.
Societal Impact Mapping
Public Health
A pharmaceutical facility in a residential Philadelphia neighborhood stored improperly classified hazardous waste for at least three years. The documented exposure risks are specific and material.
- Mercury exposure from open, unlabeled fluorescent lamp containers. Mercury is a neurotoxin. Inhalation of mercury vapor causes neurological damage, particularly in developing brains. Six open containers of universal waste lamps sat in the facility with no labels, no dates, and no sealed containment. Any worker in proximity was potentially exposed.
- Ignitable waste from D001-classified aerosol cans with no documented disposal path. When pressurized aerosol cans classified as ignitable hazardous waste are disposed of as ordinary trash, they enter the municipal solid waste stream and can rupture or ignite during compaction or incineration, releasing toxic propellants and creating fire hazards at waste handling facilities.
- IPA-contaminated wipes discarded as nonhazardous waste. Isopropyl alcohol, code F003, is a flammable solvent. Wipes saturated with it, disposed of in regular waste, can generate flammable vapor concentrations in enclosed trash containers, storage areas, and garbage trucks.
- No weekly inspections for three years means no early detection of leaks or spills. RCRA’s weekly inspection mandate exists because hazardous waste containers degrade. Drums corrode. Bags tear. Without weekly checks, a slow leak from any one of the dozens of containers in the accumulation area could go undetected for weeks or months, contaminating the building and potentially adjacent soil or drainage.
- Two hundred unclassified containers in the Reject Cage posed an unknown but documented risk. Because Frontida never made hazardous waste determinations on rejected pharmaceutical material, the EPA cannot confirm what chemicals or compounds those containers held, or whether any of them required special handling that workers were not given.
Economic Inequality
The fine Frontida paid to settle this case tells the story of a two-tier enforcement system: one for people, one for corporations.
- $13,750 is the total penalty for five categories of RCRA violations spanning at least three years at a facility operated by a pharmaceutical contract packaging company. An individual American faces federal criminal prosecution under 42 U.S.C. § 6928(d) for knowingly treating, storing, or disposing of hazardous waste without a permit. The penalty for that is up to five years in federal prison per violation. Frontida paid $13,750 and admitted nothing.
- The settlement was handled through an “Expedited Settlement Agreement Pilot,” a streamlined process explicitly designed to resolve cases quickly with reduced penalties. Frontida’s violations were serious enough to require EPA intervention. They were apparently not serious enough to go through standard enforcement.
- The facility operates in Philadelphia’s Northeast, a working-class and middle-class neighborhood. Residents of wealthier communities have historically been more successful at preventing industrial hazardous waste facilities from operating near their homes, or at securing faster, more aggressive enforcement when violations occur. The people nearest to 7722 Dungan Road did not get that.
- Frontida’s parent company, Adare Pharma Solutions, operates in the pharmaceutical contract services sector, a high-margin industry serving major drug manufacturers. The $13,750 fine represents a business cost so trivial it does not appear as a line item in any meaningful corporate accounting. It creates no structural incentive to invest in compliance systems that might have cost far more than the penalty.
- Workers at the facility were exposed to improperly managed hazardous materials and received no documented benefit from the settlement. The $13,750 went to the U.S. Treasury. Not to affected workers. Not to a community remediation fund. Not to a medical monitoring program for employees who worked in proximity to the unlabeled, open waste containers found on inspection day.
The “Cost of a Life” Metric
What Now? Who Is Responsible and What Can You Do
Frontida BioPharm signed this settlement through Joseph Jefferson, Sr. Director of Packaging Operations, using an Adare Pharma Solutions email address. The corporate parent is the relevant actor here: Adare Pharma Solutions controls the operational decisions, the compliance budgets, and the executive accountability at these facilities.
Watchlist: Who Oversees This
- U.S. EPA Region 3 (Philadelphia): The enforcing agency in this case. Contact: Rebecca Serfass, Sr. Inspector/Enforcement Officer, Serfass.Rebecca@epa.gov. If you have knowledge of ongoing violations, this is the direct contact on record.
- Pennsylvania Department of Environmental Protection (PADEP): Pennsylvania administers its own federally authorized hazardous waste program. PADEP received prior notice of this enforcement action. You can file a complaint with PADEP’s Southeast Regional Office for any ongoing concerns at this facility.
- U.S. Department of Justice (DOJ): RCRA Section 3008(d) authorizes criminal prosecution for knowing violations of hazardous waste laws, including unpermitted storage. EPA referred no criminal matters in this settlement, but DOJ’s Environment and Natural Resources Division (ENRD) accepts public referrals.
- Occupational Safety and Health Administration (OSHA): Workers exposed to unlabeled, open containers of mercury-containing lamps, ignitable aerosols, and solvent-contaminated wipes have OSHA protections. OSHA’s Philadelphia Area Office handles workplace hazard complaints for this facility’s jurisdiction.
- Philadelphia City Council and the Mayor’s Office of Sustainability: Philadelphia has its own environmental justice frameworks. Local representatives for Northeast Philadelphia’s districts can be contacted to demand enhanced inspection frequency at pharmaceutical facilities in residential areas.
What You Can Do Right Now
- If you work at or near this facility: You have the right to report hazardous waste concerns to OSHA and EPA without retaliation. Document what you observe (dates, descriptions, locations). The EPA’s confidential tip line for RCRA violations is available through epa.gov/enforcement/report-environmental-violations.
- If you live in the Burholme/Fox Chase area of Northeast Philadelphia: Contact your City Council member and request a formal briefing on industrial compliance in your district. Ask specifically about permit status and inspection history for facilities on Dungan Road.
- Push for stronger penalties: The $13,750 settlement reflects EPA’s Expedited Settlement Agreement Pilot, a fast-track program that trades thoroughness for speed. Contact EPA Region 3’s Enforcement and Compliance Assurance Division, Director Karen Melvin, and demand that pharmaceutical facilities face standard (not expedited) penalty calculations commensurate with three-year violation windows.
- Support environmental justice organizations operating in Philadelphia: Groups like PennEnvironment, the Clean Air Council, and the Philadelphia Environmental Justice Advisory Commission amplify community voices in exactly these enforcement gaps. Volunteer. Donate. Share this investigation with them directly.
- Mutual aid and neighbor organizing: Form or join a neighborhood watch focused on industrial compliance. Attend PADEP public comment periods for any permit applications from Frontida, Adare Pharma Solutions, or affiliated entities in Philadelphia. A facility that tried to operate without a hazardous waste storage permit for three years has no business receiving regulatory favors in the future without community scrutiny.
The source document for this investigation is attached below.
You can read this Expedited Settlement Agreement between the EPA and Frontida (Adare) by visiting the EPA’s website: https://yosemite.epa.gov/OA/RHC/EPAAdmin.nsf/Filings/C65F6629B20A15FB85258C730078F4DF/$File/Frontida%20BioPharm%20LLC_RCRA%20C%20ESA_April%2021%202025.pdf
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