40 CFR 439.0 - Applicability.

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§ 439.0 Applicability.
(a) This part applies to process wastewater discharges resulting from the research and manufacture of pharmaceutical products, which are generally, but not exclusively, reported under SIC 2833, SIC 2834 and SIC 2836 (1987 Standard Industrial Classification Manual).
(b) Although not reported under SIC 2833, SIC 2834 and SIC 2836, discharges from the manufacture of other pharmaceutical products to which this part applies include (but are not limited to):
(1) Products manufactured by one or more of the four types of manufacturing processes described in subcategories A, B, C or D of this part, and considered by the Food and Drug Administration to be pharmaceutical active ingredients;
(2) Multiple end-use products (e.g., components of formulations, chemical intermediates, or final products) derived from pharmaceutical manufacturing operations and intended for use primarily in pharmaceutical applications;
(3) Pharmaceutical products and intermediates not subject to other categorical limitations and standards, provided the manufacturing processes generate process wastewaters that are similar to those derived from the manufacture of pharmaceutical products elsewhere (an example of such a product is citric acid);
(4) Cosmetic preparations that are reported under SIC 2844 and contain pharmaceutical active ingredients, or active ingredients that are intended for the treatment of a skin condition. (These preparations do not include products such as lipsticks or perfumes that serve to enhance appearance, or provide a pleasing odor, but do not enhance skin care. Also excluded are deodorants, manicure preparations, shaving preparations and non-medicated shampoos that do not function primarily as a skin treatment.)
(c) The provisions of this part do not apply to wastewater discharges resulting from the manufacture of the following products, or as a result of providing one or more of the following services:
(1) Surgical and medical instruments and apparatus reported under SIC 3841;
(2) Orthopedic, prosthetic, and surgical appliances and supplies reported under SIC 3842;
(3) Dental equipment and supplies reported under SIC 3843;
(4) Medical laboratory services reported under SIC 8071;
(5) Dental laboratory services reported under SIC 8072;
(6) Outpatient care facility services reported under SIC 8081;
(7) Health and allied services reported under SIC 8091, and not classified elsewhere;
(8) Diagnostic devices other than those reported under SIC 3841;
(9) Animal feed products that include pharmaceutical active ingredients such as vitamins and antibiotics, where the major portion of the product is non-pharmaceutical, and the resulting process wastewater is not characteristic of process wastewater from the manufacture of pharmaceutical products;
(10) Food and beverage products fortified with vitamins or other pharmaceutical active ingredients, where the major portion of the product is non-pharmaceutical, and the resulting process wastewater is not characteristic of process wastewater from the manufacture of pharmaceutical products;
(11) Pharmaceutical products and intermediates subject to the provisions of 40 CFR part 414, provided their manufacture results in less than 50 percent of the total flow of process wastewater that is regulated by 40 CFR part 414 at the facility.
[63 FR 50424, Sept. 21, 1998]

Title 40 published on 2014-07-01

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