1. INTRODUCTION

Gene synthesis companies manufacture synthetic DNA and other nucleic acid sequences for scientific research, biotechnology, medicine and industrial applications. However, these services may also create biosecurity risks if synthetic sequences are used to reconstruct dangerous pathogens, produce toxins or bypass biological safety controls. China regulates these risks through its national biosafety framework, biotechnology research controls, pathogenic microorganism regulations and relevant technical standards.

A key distinction is that China's general biosafety legislation establishes broad legal duties, but these duties should not automatically be interpreted as a single, comprehensive, publicly established mandatory sequence-screening rule for every gene synthesis company. The precise obligations depend on the activity, biological material, customer, applicable technical standards and relevant administrative requirements.

2. PRINCIPAL LEGAL FRAMEWORK

A. Biosecurity Law of the People's Republic of China, 2020

The Biosecurity Law, effective from 15 April 2021, is the central legislation governing biotechnology-related security risks. Articles 34–39 address biotechnology research, development and application, risk classification, risk prevention and the traceability of specified biological factors and equipment. <Link url="https://en.npc.gov.cn.cdurl.cn/2020-10/17/c_703568.htm" title="Read the Biosecurity Law"/>.

Article 35 requires entities conducting biotechnology research, development and application to assume responsibility for security, implement risk-prevention measures, provide training, conduct inspections and maintain reporting procedures. Article 36 establishes a risk-based classification system, while Article 38 requires qualifying high-risk and medium-risk research activities to be undertaken by legally established entities subject to applicable approval or filing requirements. <Cite refs={["turn171464search3","turn171464search5"]}/>

For gene synthesis companies, these provisions support institutional responsibility for assessing risks and preventing misuse. Nevertheless, the precise legal obligation to screen each customer or sequence must be established by reference to the applicable implementing rules and standards.

B. Regulations on Pathogenic Microorganisms

China's regulations governing pathogenic microorganisms and laboratory biosafety may apply when a synthesis company handles, stores, transports or supplies regulated biological materials. Relevant requirements can include appropriate containment, authorised handling, traceability and restrictions on transfers.

Synthetic DNA must be distinguished from a live pathogen: an order for a nucleic acid sequence does not automatically constitute possession or transfer of a viable microorganism. Nevertheless, its intended use and biological significance may create separate biosafety and biosecurity concerns.

C. Technical Standards and Industry Screening Practices

China has adopted technical standards relevant to nucleic acid synthesis quality management. GB/T 43629.1-2023 addresses the production and quality control of synthetic oligonucleotides. A separate national standard project concerning the production and quality control of synthetic gene fragments, genes and genomes has also been listed by the national standards authority. <Cite refs={["turn171464search1","turn171464search12"]}/>

The legal effect of a standard depends on whether it is mandatory, voluntary or incorporated into a binding regulatory or contractual requirement. Therefore, a company must verify the current status and scope of the particular standard instead of assuming that every technical recommendation is compulsory.

3. CORE SCREENING REQUIREMENTS FOR GENE SYNTHESIS COMPANIES

A. Sequence Screening

Sequence screening involves evaluating requested synthetic nucleic acids for potential association with pathogens, toxins or other sequences of biosecurity concern. A responsible screening programme should identify potentially dangerous orders and subject them to appropriate review before synthesis or delivery.

Companies should distinguish a genuine biological risk from a superficial sequence match. Scientific context, sequence function and the reliability of screening results may all be relevant. However, the precise screening databases, thresholds and procedures required under Chinese law must be determined from applicable rules rather than assumed from international guidance.

B. Customer Verification

Customer screening evaluates whether an order is consistent with the customer's identity, institutional affiliation, research purpose and legitimate authority to obtain the requested material. Companies should maintain appropriate records and escalate suspicious or unexplained orders for further review.

C. Order Review and Escalation

Where an order raises significant biosecurity concerns, companies should apply a documented review process. Depending on the circumstances, this may involve seeking clarification, consulting biosafety personnel, declining the order or making reports where legally required. A company should not treat a successful automated screening result as a complete substitute for risk assessment.

D. Record-Keeping and Accountability

Companies should maintain proportionate records of orders, customer verification, screening outcomes, review decisions and relevant communications. Records should support traceability, internal audits and cooperation with competent authorities, subject to applicable data-protection requirements.

4. RELEVANT CASE LAWS

1. United States v. Regenerative Sciences, LLC, 741 F.3d 1314 (D.C. Cir. 2014) — Analogous authority.

The US Court of Appeals for the District of Columbia Circuit upheld the application of federal drug regulation to a particular cultured-cell treatment. Although the case did not concern gene synthesis screening, it demonstrates that biotechnology activities may remain subject to regulatory controls despite being presented as specialised scientific services. It does not establish a screening obligation under Chinese law.

2. Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013) — Analogous authority.

The US Supreme Court held that naturally occurring DNA is not patent-eligible merely because it has been isolated, while synthetically created complementary DNA may be patent-eligible subject to the Court's reasoning. The judgment concerned patent eligibility, not biosecurity screening. Its relevance is limited to illustrating the legal distinction between biological material and engineered genetic products.

3. Vellore Citizens' Welfare Forum v. Union of India, (1996) 5 SCC 647 — Comparative and analogous authority.

The Supreme Court of India recognised the precautionary principle in environmental law. By analogy, this principle supports preventive risk assessment when biotechnology presents potentially serious or irreversible hazards. The judgment is not binding on Chinese authorities and does not itself impose gene synthesis screening requirements in China.

4. He Jiankui genome-editing case, China (2019) — Directly relevant to biotechnology governance, but not a gene-screening precedent.

A Chinese court convicted He Jiankui for illegally conducting human embryo gene-editing activities and sentenced him to imprisonment and a fine. The case illustrates the consequences of violating applicable biotechnology and medical-research requirements. It did not establish a general judicial rule requiring gene synthesis companies to screen every customer or sequence.

5. ENFORCEMENT AND COMPLIANCE IMPLICATIONS

The Biosecurity Law provides for administrative and other legal consequences for violations within its scope. Article 74, for example, provides substantial penalties for prohibited biotechnology research, development or application activities. Whether that provision applies to a particular synthesis company depends on the conduct and statutory elements involved; it should not be treated as an automatic penalty for every screening failure. <Cite refs={["turn171464search5","turn171464search6"]}/>

Companies operating in China should therefore maintain written biosecurity policies, establish appropriate customer and order-review procedures, assess relevant biological risks, train staff, preserve traceability records and verify any applicable licensing, reporting or technical-standard requirements. International suppliers should separately assess the laws of their home jurisdictions and export-control obligations.

6. CONCLUSION

China's gene synthesis governance rests on a combination of national biosafety legislation, biotechnology risk classification, pathogenic microorganism controls and technical standards. The Biosecurity Law supplies an important foundation for institutional responsibility and risk prevention, but the existence and scope of a specific mandatory sequence-screening or customer-verification duty must be established from the applicable Chinese instruments. The cited judicial decisions provide comparative or contextual guidance rather than direct precedents governing gene synthesis company screening. Effective compliance consequently requires careful legal classification, documented risk assessment and verification of current regulatory requirements.