[Code of Federal Regulations]
[Title 40, Volume 29]
[Revised as of July 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR439.0]

[Page 397]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 439_PHARMACEUTICAL MANUFACTURING POINT SOURCE CATEGORY
--Table of Contents
 
Sec. 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]