Both the California Transparency in Supply Chains Act and the UK Modern Slavery Act require companies that are (i) doing business in California and in the UK, respectively, and (ii) exceeding specified volume or revenue thresholds, to disclose their efforts to ensure that slavery and human trafficking are not occurring in their businesses or supply chains. This statement is made in accordance with, and relates to the fiscal year ended December 31, 2020 and includes the activities of OraSure Technologies, Inc. (“OraSure”) and its wholly-owned subsidiaries, DNA Genotek, Inc. (“DNAG”), ), Diversigen, Inc. (“Diversigen”)and Novosanis N.V. (“Novosanis”) (collectively the “Company”). The Company is committed to being fully compliant with all laws including those prohibiting human trafficking and slavery.
The Company is comprised of two business segments: OraSure and DNAG. The operations of Diversigen and Novosanis are included in the DNAG segment. OraSure, located in Bethlehem, Pennsylvania, operates the diagnostics segment, is a leader in the development, manufacture and distribution of point of care diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. Its first-to-market, innovative products include rapid tests for the detection of antibodies to HIV and HCV on the OraQuick® platform, and oral fluid laboratory tests for detecting various drugs of abuse. OraSure’s portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research and academic institutions, distributors, government agencies, physicians’ offices, commercial and industrial entities and consumers. OraSure’s products enable healthcare providers to deliver critical information to patients, empowering them to make decisions to improve and protect their health. Given that OraSure’s HIV and HCV products contain critical components,
DNAG, located in Ottawa, Canada, is the Company’s molecular collection segment which consists of the manufacture and sale of specimen collection kits that are used to collect, stabilize, transport and store samples of genetic material for molecular testing in the consumer genetic, clinical genetic, academic research, pharmacogenomics, personalized medicine, microbiome and animal genetics markets. Diversigen provides microbiome laboratory testing and analytical services and Novosanis sells a device for the collection of first void urine samples in humans.
The Company is committed to conducting business in a lawful and ethical manner and is opposed to human trafficking and slavery. It is the Company’s expectation that its suppliers will also conduct their business in such a manner and will comply fully with all laws and regulations, including those prohibiting slavery and human trafficking. The Company assesses its risk of human trafficking as low for the following reasons.
The Company aims to work with suppliers who are committed to the same strict principles and high ethical standards as the Company. Prior to entering into contracts with manufacturing suppliers, the Company evaluates suppliers for suitability as a business partner, and in particular, compliance with applicable laws and regulations. The Company’s supplier approval activities are based on an assessment of capabilities, quality and on-site inspections of supplier facilities. However, the Company does not conduct a specific verification process to evaluate the risks of slave labor or human trafficking by its suppliers and verifications are not conducted by third parties.
The Company has a limited number of suppliers and many of them are long-term. Further, the Company’s contracts with suppliers prohibit suppliers from sub-contracting their responsibilities. Moreover, the vast majority of the Company’s suppliers are located in the United States, Canada or Western Europe and are subject to the labor, health and safety laws in these jurisdictions including prohibitions on human trafficking and slavery. We believe the use of a limited number of suppliers primarily located in the United States, Canada and Western Europe and which are not permitted to subcontract their responsibilities reduces the risk of slave labor or human trafficking in the Company supply chain.
Once a supplier is selected, the Company utilizes contract terms, quality agreements, and regular supplier assessments and/or audits to confirm the supplier’s compliance with the Company’s performance and quality expectations, as well as applicable laws and regulations. The Company has the right to audit its suppliers and generally conducts assessments and/or on-site audits of suppliers to assess compliance with these requirements. Supplier audits are generally conducted by OraSure and/or DNAG employees and are typically announced. The Company audits of suppliers do not include a specific assessment of potential slavery and human trafficking activities. The Company classifies suppliers based on the criticality of the components or raw materials purchased. Suppliers that provide critical components or raw materials are monitored and audited on a more frequent basis than non-critical suppliers. The Company develops supplier audit and supplier assessment lists on a yearly basis based on this classification and typically conducts approximately 75 audits and/or assessments of suppliers every year. Depending on the criticality of the product being supplied, assessments range from self-assessments that are sent to the Company suppliers to provide up-to-date information on their quality systems, to desktop assessments where the supplier’s quality performance is evaluated by a Company auditor, to on-site audits that can range anywhere from one to several days, depending on the scope and size of the supplier. The Company maintains an approved vendor listing that lists suppliers that have been registered and qualified in accordance with the Company’s procedural requirements. This listing is reviewed on an annual basis when the yearly assessment/audit lists are developed.
If the Company determines that a supplier has failed to meet applicable requirements, the Company may take action with respect to that supplier, including requiring corrective actions, canceling outstanding orders or eliminating such supplier from the supply chain. In addition, the Company will cooperate fully with federal, state and foreign agencies that are responsible for enforcing the applicable laws and regulations.
The Company’s relationships with suppliers are based on lawful, efficient and fair practices. Although the Company contracts with suppliers do not include a specific provision related to human trafficking and slavery laws, the Company obligates its suppliers by contract to comply with all applicable laws and regulations, which includes compliance with labor, employment health and safety and other requirements and suppliers promise as part of the contract to comply with those requirements.
The Company provides annual compliance training to all staff and has global compliance policies requiring all Company personnel to comply with all applicable laws and regulations. Additionally, all employees are required to acknowledge and adhere to the Company’s Code of Business Conduct and Ethics, which includes a requirement to comply with all applicable laws. Any employee who fails to abide by the Company’s compliance policies may be subject to disciplinary action, including termination. Compliance with laws would include compliance with laws regarding slavery and human trafficking.
The Company has designated OraSure’s General Counsel as the Compliance Officer responsible for the overall administration of the Code of Business Conduct and Ethics. A procedure is in place to permit employees to report known or suspected violations of laws or other actions contrary to the Code of Business Conduct and Ethics. Reports of violations by employees may be made anonymously. The Company has adopted a policy that no adverse action will be taken against any employee who reports a violation in good faith or who participates in the investigation of a violation. The Company is dedicated to the principles of the Code of Business Conduct and Ethics and believes it will help prevent slavery and human trafficking within its supply chains.