Responsible Management of Pharmaceutical Industry Waste

The pharmaceutical manufacturing industry is growing quickly and, as a result, so too are the by-products and waste it generates.  With tighter regulations and an increased focus on corporate social responsibility, companies in the sector are understandably concerned about managing their environmental impact.

An important aspect of an industry-leading environmental program is proper waste management.  Not only is waste management crucial to minimizing environmental impact, but it also significantly reduces liabilities and risk associated with off-spec or even dangerous products ending up in secondary markets.

Responsible waste management starts at the source

“Proper waste management in the pharmaceutical sector involves more than just the recycling or destruction and disposal of materials,” said Todd Smith, Vice President of Environmental Solutions for Central Canada at Terrapure.  “It is critically important to be able to monitor and track waste every step of the way, beginning  at the customer’s site, through transportation and ultimately the final disposal at a regulated waste management facility.’’

Today, Global Positioning Satellite (GPS) technology allows every detail to be monitored – from bottles and cartons to drums and skids.  All material is inventoried before reaches the waste management facility and undergoes a final set of tests in the lab before the destruction process can begin.  In addition, leading waste management companies are introducing barcoding technology to be able to further monitor and report on the type and amount of a customer’s waste, as well as where and at what stage of processing or disposal it is at any given time.

A carefully executed and documented destruction process

The typical destruction process involves the following steps:

Shredding and grinding

First, solids such as pills, bottles, boxes and other packaging material must be separated from the liquids.  Solids are then shredded and grinded to a particulate specification that meets the customer’s exact needs.  For example, for those customers who require it, some waste management companies can guarantee that shredding and grinding will ensure unrecognizable text on bottles or other packaging.

Co-mingling solids

To provide additional security, all shredded and ground by-products are gathered and co-mingled with other non-hazardous materials to ensure they are not able to be retrieved.  From there, materials are sent to an incinerator for final disposal, for a threefold destruction process.

Fuel blending

Some waste management companies specialize in the blending of pharmaceutical materials with residual heat value, such as off-spec or expired consumer products and liquid industrial wastes, and transforming them into alternate fuel for use by industry.

Incineration

For those materials that are not able to be recovered for their heat value, incineration is the final stage of disposal, allowing for the complete destruction and disposal of non-hazardous pharmaceutical liquids and solids.

Audit Preparation

Pharmaceutical manufacturers are required to provide extensive reporting and auditing material to regulatory bodies, including Health Canada’s Therapeutic Products Directorate (TPD) and the United States Food and Drug Administration (USFDA). Proper waste management also calls for accurate and timely paperwork.  Certificates of destruction and all supplementary paperwork for shipment, including waste management termination and other administrative documents, need to be delivered to the manufacturer as quickly as possible.

“Today, waste management and environmental solutions companies are no longer just providing a service; they are their customers’ partners and this is especially true for pharmaceutical manufacturers who are subject to stringent audits,” adds Terrapure’s Smith.  “Knowing how important audit materials are for pharmaceutical customers, our team prides itself on delivering these documents within just three days and helping them navigate the audit process by being available 24/7.”

Pharmaceutical manufacturers can benefit from working with an experienced partner in their pursuit of an effective solution that minimizes the environmental impact of their waste streams and provides the utmost in security and disposal for regulated materials.

An expert environmental solutions provider will strategically evaluate and characterize their various waste streams to help both the environment and their business’s bottom line, ensure a safe and efficient destruction process, and support them in their regulated audit processes.

About the Author

Terrapure Environmental, a leading Canadian environmental solutions provider, offers a thorough waste destruction and disposal process that provides pharmaceutical manufacturers peace of mind knowing their waste streams will not be a risk to their reputation or bottom line.

Canadian TDG Training – From “Adequate” to “Competent”

Transport Canada has released for comment a White Paper, Training in the Transportation of Dangerous Goods: A White Paper, outlining the changes it is proposing to the training requirements for individuals responsible for transporting dangerous goods in and out of Canada.

“Competency” to be Proven

Concerns have been expressed, often post-incident, as to the sufficiency and quality of training of company dangerous goods representatives. The White Paper represents a fundamental training threshold shift from mandating ‘adequately trained’ representatives to demonstrable ‘competent persons’ Included within these certification changes will be:

  • competency-based training and assessments (CBTA), including performance expectations based on an individual’s job functions;
  • standards and guidelines to supplement the CBTA framework; and
  • standardized dangerous goods testing administered by the public sector.

These changes will mean that company dangerous goods representatives will need to meet demonstrated testing standards in order to quality or remain tasked with dangerous goods administration. Companies may look upon these testing changes as better due diligence protections than past self-reporting of training “adequacy”.

Transport Canada is also proposing the mandating of employee skills necessary to perform dangerous goods-related job-related functions, as well as performance criteria for assessing the outcome.

More Coordination with Provinces / Territories

The training changes are part of a larger effort by Transport Canada to better coordinate with provincial and territorial governments, which also have some jurisdiction over dangerous goods transportation requirements. It’s less clear if a long-term move towards harmonization, as has occurred with WHMIS, might be in store for dangerous goods movements.

About the Author

Jonathan Cocker heads Baker & McKenzie’s Environmental Practice Group in Toronto, as part of the Global Environment and Climate Change practice, ranked as a Band 1 practice by Chambers and the largest environmental law practice globally.  Mr. Cocker provides advice and representation to multinational companies on a variety of environment, health and safety matters, including product content, dangerous goods transportation, regulated wastes, food and drug safety, extended producer responsibilities and contaminated lands matters.  He appears before both environmental health and safety (EHS) tribunals and civil courts across Canada. Mr. Cocker is a frequent speaker and writer on EHS matters, is a participant in a number of EHS national and international industry groups and is an author of the upcoming Encyclopedia of Environmental Law.

Ontario Association of Emergency Managers

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Phasellus viverra nulla ut metus varius laoreet. Quisque rutrum. Aenean imperdiet. Etiam ultricies nisi vel augue. Curabitur ullamcorper ultricies nisi. Nam eget dui. Etiam rhoncus. Maecenas tempus, tellus eget condimentum rhoncus, sem quam semper libero, sit amet adipiscing sem neque sed ipsum. Nam quam nunc, blandit vel, luctus pulvinar, hendrerit id, lorem. Maecenas nec odio et ante tincidunt tempus. Donec vitae sapien ut libero venenatis faucibus.

Clean-up Incentives Proposed for Brownfield Owners

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Phasellus viverra nulla ut metus varius laoreet. Quisque rutrum. Aenean imperdiet. Etiam ultricies nisi vel augue. Curabitur ullamcorper ultricies nisi. Nam eget dui. Etiam rhoncus. Maecenas tempus, tellus eget condimentum rhoncus, sem quam semper libero, sit amet adipiscing sem neque sed ipsum. Nam quam nunc, blandit vel, luctus pulvinar, hendrerit id, lorem. Maecenas nec odio et ante tincidunt tempus. Donec vitae sapien ut libero venenatis faucibus.

Northern Ontario Refinery and President Fined $1.5 Million for Environmental Offences

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Phasellus viverra nulla ut metus varius laoreet. Quisque rutrum. Aenean imperdiet. Etiam ultricies nisi vel augue. Curabitur ullamcorper ultricies nisi. Nam eget dui. Etiam rhoncus. Maecenas tempus, tellus eget condimentum rhoncus, sem quam semper libero, sit amet adipiscing sem neque sed ipsum. Nam quam nunc, blandit vel, luctus pulvinar, hendrerit id, lorem. Maecenas nec odio et ante tincidunt tempus. Donec vitae sapien ut libero venenatis faucibus.

Revisions to Hazardous Waste Rules in the U.S.

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Phasellus viverra nulla ut metus varius laoreet. Quisque rutrum. Aenean imperdiet. Etiam ultricies nisi vel augue. Curabitur ullamcorper ultricies nisi. Nam eget dui. Etiam rhoncus. Maecenas tempus, tellus eget condimentum rhoncus, sem quam semper libero, sit amet adipiscing sem neque sed ipsum. Nam quam nunc, blandit vel, luctus pulvinar, hendrerit id, lorem. Maecenas nec odio et ante tincidunt tempus. Donec vitae sapien ut libero venenatis faucibus.

Global Warming’s Effects on Far North Hazardous Waste Site

As first reported by Brown University, researchers recently published a study that indicates that climate change is poised to release hazardous wastes at an abandoned United States military base in Greenland.

The work has led Vittus Qujaukitsoq, Greenland’s minister of industry, labor, and trade and foreign affairs, to publicly demand that Denmark prepare to clean up the base and compensate residents who live near it. In his statement, Qujaukitsoq refers to the study, which appears in Geophysical Research Letters.

Camp Century, Greenland, circa 1959
Camp Century, Greenland, circa 1959
According to the October 13th edition of the Danish newspaper Berlingske, Qujaukitsoq also demanded renegotiation of the Danish-American defense agreement in Greenland. Søren Espersen, member of Danish parliament and chairman of Denmark’s foreign policy committee, strongly objected to this demand, the newspaper reports.

In the study, Jeff Colgan, associate professor of political science and international and public affairs at Brown University’s Watson Institute, and colleagues discuss both the historic and climatic context of the base and anticipated the potential for political acrimony.

“Our study highlights that Camp Century now possesses unanticipated political significance in light of anthropogenic climate change,” the researchers write. “The potential remobilization of wastes that were previously regarded as properly sequestered, or preserved for eternity is an instance, possibly the first, of a potentially new pathway to political dispute associated with climate change.”

During the Cold War, the US government and Denmark signed a treaty to jointly defend Greenland, a Danish territory, from Soviet attack, Colgan says. Camp Century was established in Greenland in 1959 and was intended “to test the feasibility of building nuclear missile launch sites close enough to reach the Soviet Union,” according to an article in New Security Beat by Colgan and his coauthor William Colgan of York University in Ontario. Camp Century shuttered after eight years, in 1967.

“The base was abandoned with minimal decommissioning,” the researchers write in the Geophysical Research Letters study, “as engineering design of the era assumed that the base would be ‘preserved for eternity’ by perpetual snowfall.” According to the study, the Army Corps of Engineers removed the base’s nuclear reactor core but left the camp’s infrastructure and all other waste behind.

According to the study, waste left at the site includes diesel fuel, polychlorinated biphenyls (PCBs), biological waste including grey water and sewage in unlined sumps, and radiological waste in the form of coolant for the portable nuclear generator at the base.

Since the camp was decommissioned, Jeff Colgan says, “falling snow has buried the camp roughly 115 feet further underneath the ice.” Climatic projections, however, “predict increased surface melting in northwestern Greenland through 2100,” according to the study.

Colgan and Colgan point out that climate change has warmed the Arctic more than any other region on Earth. They and their coauthors predict that the waste, which they found covers 136 acres, could begin to reemerge in 2090.

“The PCBs are likely the biggest concern for animal and human health, if they are remobilized into surface waters,” according to Colgan and Colgan, who add that the pollutants could reach the ocean, disrupt marine ecosystems, and accumulate in the food chain.

“It is very understandable that Greenland’s government wants clarity on who is responsible for the pollution and whether they will accept the eventual costs of environmental remediation,” Jeff Colgan says, but “as we emphasized in the study, there is no environmental risk in the near-term, and likely the pollution will stay buried in the ice for several decades at least.

“Right now, what’s needed is monitoring and research to assess if and when clean-up actions are necessary.”

Brownfield Conference in Newark, New Jersey

The 8th Northeast Sustainable Communities Workshop is scheduled for March 15th2017 in Newark, New Jersey.  Sponsored by the Brownfield Coalition of the Northeast, the workshop will is entitled Driving Revitalization Sustainably: identifying sustainable goals and strategies for revitalizing their communities and brownfields,

The conference brings together experts and attendees to discuss the most current and state-of-the-art approaches and strategies are unique and typically heard at other events.  Past workshops have been attended by representatives from government, higher education, professional organizations, and laboratories, as well as attorneys, developers, contractors, and consultants.

The goals of the workshop are to break new ground, offer new ideas, and posit new concepts on the topics of sustainability, collaboration and leverage, contamination, resiliency, brownfields, technology, and their impact on community revitalization.

The workshop is known to for using PowerPoint presentations sparingly, having speakers that are concise, yet informative; and providing plenty of time in each session for dialogue between attendees, speakers, and moderators.

To register for the March 15, 2017 visit the workshop website.

Guide on Long-Term Contaminant Management Using Institutional Controls

The U.S. Interstate Technology Regulatory Council (ITRC) recently published a guidance document on Long-Term Contaminant Management Using Institutional Controls (IC-1).  The guidance document was developed in response to the recent growth in the number of contaminated sites in the U.S. that are being managed through the use of institutional controls (ICs).

ICs are a form of land use controls that provide protection from exposure to contaminants on a site.  In contrast to engineered site remedies, ICs consist of government controls, proprietary controls, enforcement or permit mechanisms, and informational devices that limit land or resource use (thus protecting human health by controlling how the property is used).

The guidance manual includes a survey of current state practices for ICs, best practices for developing and managing ICs.  As part of the manual, there is a downloadable tool that can be used to document critical information about an IC.  This tool can help to create a lasting record of the site that includes the regulatory authority, details of the IC, the responsibilities of all parties, a schedule for monitoring the performance of the IC, and much more relevant information.  The tool generates an editable Long Term Stewardship (LTS) plan in Microsoft Word.

Real-Time Mapping of Chlorinated Solvent DNAPL in the Subsurface

A report United States Environmental Security Technology Certification Program (U.S. ESTCP) recently released a report that describes the testing of a new direct-push optical screening tool for high-resolution three-dimensional (3D) subsurface mapping of chlorinated solvent dense non-aqueous phase liquids (DNAPLs) in unlithified sediments. 

Unlithified sediments are sediments that have not undergone lithification, a process whereby sediments are transformed into solid rocks.  The sediments are still in loose form and have not become compacted by pressure.

 The tool was field-tested at a formerly used defense facility in Massachusetts in fall 2013 (Geoprobe® delivery) and again in March 2014 (CPT delivery).  The new tool, a laser-induced fluorescence (LIF) technology referred to as “DyeLIF,” was developed and validated during this project and is now commercially available. 

The DyeLIF probe functions by injecting an aqueous delivery fluid containing a proprietary hydrophobic dye through a small injection port that is situated below the LIF window.  As the probe is advanced through the subsurface, the injected dye contacts the soil and quickly partitions into any present DNAPL. Standard LIF tooling is used to detect the dye-labeled chlorinated solvent DNAPLs.  The fluorescent signature of un-solvated and solvated dye is sufficiently different.

The U.S. ESTCP is U.S. Department of Defense’s (U.S. DoD) environmental technology demonstration and validation program.  The Program was established in 1995 to promote the transfer of innovative technologies that have successfully established proof of concept to field or production use.  U.S. ESTCP demonstrations collect cost and performance data to overcome the barriers to employ an innovative technology because of concerns regarding technical or programmatic risk, the so-called “Valley of Death.”

Chlorinated solvents are among the most common organic contaminants detected in groundwater at US. DoD sites.  The sources of these contaminants are often historical releases of DNAPLs. Unfortunately, chlorinated solvent DNAPL source zones are difficult to locate using conventional subsurface characterization technologies.  Laser-induced fluorescence (LIF) tools are currently available for real-time, high-resolution mapping of petroleum hydrocarbon and coal tar-based NAPL source zones.  These LIF tools do not work with chlorinated solvent DNAPLs because chlorinated solvents lack the aromatic structure responsible for the laser-induced fluorescence in coal tars and petroleum hydrocarbons.  

The objective of the field demonstration was to provide a field-scale demonstration of the new DyeLIF tool for high-resolution subsurface mapping of chlorinated DNAPLs.  The real-time, high-resolution profiles generated from the DyeLIF were then compared to profiles from high resolution vertical soil sampling with subsequent dye shake tests and quantitative laboratory VOC analysis. 

No major implementation issues were identified during the field demonstrations.  However, a key limitation for any direct-push technology is suitability of the geological conditions for direct-push probing, i.e. absence of cobbles or other conditions that would cause tool damage and preclude advancing the probes.