; (ii) a partner of a partnership; or (iii) any employee or other agent of a corporation, association, or partnership having duties such that the conduct of such employee or agent may fairly be assumed to represent the policy of the corporation, association, or partnership; and (B) includes persons having management responsibility for— (i) submissions to a Federal agency regarding the development or approval of any product; (ii) production, quality assurance, or quality control of any product; or (iii) research and development of any product; (2) the term product means a product or service of a business entity that enters or will enter interstate commerce; (3) the term business entity means any corporation, company, association, firm, partnership, or other business entity or a sole proprietor; (4) the term business practice means a method or practice of manufacturing, assembling, designing, researching, importing or distributing a product that enters or will enter interstate commerce, conducting, providing or preparing to provide a service that enters or will enter interstate commerce, or otherwise carrying out business operations related to products or services that enter or will enter interstate commerce; (5) the term serious danger , used with respect to a product or business practice, means a danger, not readily apparent to the average person, that the normal or reasonably foreseeable use of, or the exposure of a human being to, that product or business practice may cause death or serious bodily injury to a human being; (6) the term serious bodily injury means an impairment of physical condition, including as result of trauma, repetitive motion or disease, that— (A) creates a substantial risk of death; or (B) causes— (i) serious permanent disfigurement; (ii) unconsciousness; (iii) extreme pain; or (iv) permanent or protracted loss or impairment of the function of any bodily member, organ, bodily system, or mental faculty