the surface of the part. This operation generates oily wastewater that contains metal fines and dust.

Laminating involves applying a material to a substrate using heat and pressure.

Mechanical and Vapor Plating involves applying a metallic coating to a part. For mechanical plating, the part is rotated in a drum containing a water-based solution, glass beads, and metal powder. In vapor plating, a metallic coating is applied by atomizing the metal and applying an electric charge to the part, which causes the atomized (vapor phase) metal to adhere to the part. Wastewater generated in this operation includes spent solutions from the process bath and rinse water. Typically, the wastewater contains high concentrations of the applied metal.

Metallic Fiber Cloth Manufacturing involves weaving thin metallic fibers to create a mesh cloth.

Metal Spraying (Including Water Curtain) involves applying a metallic coating to a part by projecting molten or semimolten metal particles onto a substrate. Coatings can be sprayed from rod or wire stock or from powdered material. The process involves feeding the material (e.g., wire) into a flame where it is melted. The molten stock then is stripped from the end of the wire and atomized by a high-velocity stream of compressed air or other gas that propels the material onto a prepared substrate or part. Metal spraying coatings are used in a wide range of special applications, including: insulating layers in applications such as induction heating coils; electromagnetic interference shielding; thermal barriers for rocket engines; nuclear moderators; films for hot isostatic pressing; and dimensional restoration of worn parts. Metal spraying is sometimes performed in front of a "water curtain” (a circulated water stream used to trap overspray) or a dry filter exhaust hood that captures the overspray and fumes. With water curtain systems, water is recirculated from a sump or tank. Wastewater is generated when the sump or tank is discharged periodically. Metal spraying typically is not followed by rinsing. Painting-Immersion

(Including Electrophoretic, "E-coat”) involves applying an organic coating to a part using processes such autophoretic and electrophoretic painting.

(1) Autophoretic Painting involves applying an organic paint film by electrophoresis when a part is immersed in a suitable aqueous bath.

(2) Electrophoretic Painting is coating a part by making it either anodic or cathodic in a bath that is generally an aqueous emulsion of the organic coating material.

(3) Other Immersion Painting includes all other types of immersion painting such as dip painting

Water is used in immersion paint operations as a carrier for paint particles and to rinse the part. Aqueous painting solutions and rinses typically are treated through an ultrafiltration system. The concentrate is returned to the painting solution, and the permeate is reused as rinse water. Sites typically discharge a bleed stream to treatment. The painting solution and rinses are batch discharged periodically to treatment.

Photo Imaging is the process of exposing a photoresist-laden printed wiring board to light to impact the circuitry design to the board. Water is not used in this operation.

Photo Image Developing is an operation in which a water-based solution is used to develop the exposed circuitry in a photoresistladen printed wiring board. Wastewater generated in this operation includes spent process solution and rinse water.

Photoresist Application is an operation that uses heat and pressure to apply a photoresist coating to a printed wiring board. Water is not used in this operation.

Photoresist Strip involves removing organic photoresist material from a printed wiring board using an acid solution.

Phosphor Deposition is the application of a phosphorescent coating to a part. Wastewater generated in this unit operation includes water used to keep the parts clean and wet while the coating is applied, and rinse water used to remove excess phosphorescent coating from the part.

Physical Vapor Deposition involves physically removing a material from a source through evaporation or sputtering, using the energy of the vapor particles in a vacuum or partial vacuum to transport the removed material, and condensing the removed material as a film onto the surface of a part or other substrate.

Plasma Arc Machining involves removing material or shaping a part by a high-velocity jet of high-temperature, ionized gas. A gas (nitrogen, argon, or hydrogen) is passed through an electric arc, causing the gas to become ionized, and heated to temperatures exceeding 16,650 °C (30,000 °F). The relatively narrow plasma jet melts and displaces the material in its path. Because plasma arc machining does not depend on a chemical reaction between the gas and the part, and because plasma temperatures are extremely high, the process can be used on almost any metal, including those that are resistant to oxygen-fuel gas cutting. The method is used mainly for profile cutting of stainless steel and aluminum alloys. Although plasma arc machining typically is a dry process, water is used for water injection plasma arc torches. In these cases, a constricted swirling flow of water surrounds the cutting arc. This operations also may be performed immersed in a water bath. In both cases, water is used to stabilize the arc, to cool the part, and to contain smoke and fumes.

Plastic Wire Extrusion involves applying a plastic material to a metal wire through an extrusion process.

Salt Bath Descaling involves removing surface oxides or scale from a part by immersing the part in a molten salt bath or hot salt solution. Salt bath descaling solutions can contain molten salts, caustic soda, sodium hydride, and chemical additives. Molten salt baths are used in a salt bath-water quenchacid dip sequence to remove oxides from stainless steel and other corrosion-resistant alloys. In this process, the part typically is immersed in the molten salt, quenched with water, and then dipped in acid. Oxidizing, reducing, or electrolytic salt baths can be used depending on the oxide to be removed. Wastewater generated during salt bath descaling includes spent process solutions, quenches, and rinses.

Shot Tower—Lead Shot Manufacturing involves dropping molten lead from a platform on the top of a tower through a sieve-like device and into a vat of cold water.

Soldering involves joining metals by inserting a thin (capillary thickness) layer of nonferrous filler metal into the space between them. Bonding results from the intimate contact produced by the metallic bond formed between the substrate metal and the solder alloy. The term soldering is used where the melting temperature of the filler is below 425 °C (800 °F). Some soldering operations use a solder flux, which is an aqueous or nonaqueous material used to dissolve, remove, or prevent the formation of surface oxides on the part. Except for the use of aqueous fluxes, soldering typically is a dry operation; however, a quench or rinse sometimes follows soldering to cool the part or remove excess flux or other foreign material from its surface. Recent developments in soldering technology have focused on fluxless solders and fluxes that can be cleaned off with water.

Solder Flur Cleaning involves removing residual solder flux from a printed circuit board using either an alkaline or alcohol cleaning solution.

Solder Fusing involves coating a tin-lead plated circuit board with a solder flux and then passing the board through a hot oil. The hot oil fuses the tin-lead to the board and creates a solder-like finish on the board.

Solder Masking involves applying a resistive coating to certain areas of a circuit board to protect the areas during subsequent processing.

Sputtering is a vacuum evaporation process in which portions of a coating material are physically removed from a substrate and deposited a thin film onto a different substrate.

Stripping (Paint) involves removing a paint (or other organic) coating from a metal basis material. Stripping commonly is performed as part of the manufacturing process to re

cover parts that have been improperly coated or as part of maintenance and rebuilding to restore parts to a usable condition. Organic coatings (including paint) are stripped using thermal, mechanical, and chemical means. Thermal methods include burn-off ovens, fluidized beds of sand, and molten salt baths. Mechanical methods include scraping and abrasive blasting (as defined in "Abrasive Blasting" in appendix B of this part). Chemical paint strippers include alkali solutions, acid solutions, and solvents (e.g., methylene chloride). Wastewater generated during organic coating stripping includes process solutions (limited mostly to chemical paint strippers and rinses).

Stripping (Metallic Coating) involves removing a metallic coating from a metal basis material. Stripping is commonly part of the manufacturing process to recover parts that have been improperly coated or as part of maintenance and rebuilding to restore parts to a usable condition. Metallic coating stripping most often uses chemical baths, although mechanical means (e.g., grinding, abrasive blasting) also are used. Chemical stripping frequently is performed as an aqueous electrolytic process. Wastewater generated during metallic coating stripping includes process solutions and rinses. Stripping solutions become contaminated from dissolution of the base metal. Typically, the entire solution is discharged to treatment. Rinsing is used to remove the corrosive film remaining on the parts.

Thermal Infusion uses heat to infuse metal powder or dust onto the surface of a part. Typically, thermal infusion is a dry operation. In some cases, however, water may be used to remove excess metal powder, metal dust, or molten metal.

Ultrasonic Machining involves forcing an abrasive liquid between a vibrating tool and a part. Particles in the abrasive liquid strike the part, removing any microscopic flakes on the part.

Vacuum Impregnation is used to reduce the porosity of the part. A filler material (usually organic) is applied to the surface of the part and polymerized under pressure and heat. Wastewater is generated in this unit operation when rinse water is used to remove residual organic coating from the part.

Vacuum Plating involves applying a thin layer of metal oxide onto a part using molten metal in a vacuum chamber.

Water Shedder involves applying a dilute water-based chemical compound to a part to accelerate drying. This operation typically is used to prevent a part from streaking when excess water remains on the part.

Wet Air Pollution Control involves using water to remove chemicals, fumes, or dusts that are entrained in air streams exhausted from process tanks or production areas. Most frequently, wet air pollution control devices are used with electroplating, cleaning, and coating processes. A common type of wet air pollution control is the wet packed scrubber consisting of a spray chamber that is filled with packing material. Water is continuously sprayed onto the packing and the air stream is pulled through the packing by a fan. Pollutants in the air stre are absorbed by the water droplets and the air is released to the atmosphere. A single scrubber often serves numerous process tanks; however, the air streams typically are segregated by source into chromium, cyanide, and acid/alkaline sources. Wet air pollution control can be divided into several suboperations, including:

(1) Wet Air Pollution Control for Acid Alkaline Baths;

(2) Wet Air Pollution Control for Cyanide Baths;

(3) Wet Air Pollution Control for Chromium-Bearing Baths; and

(4) Wet Air Pollution Control for Fumes and Dusts.

Wire Galvanizing Flux involves using flux to remove rust and oxide from the surface of steel wire prior to galvanizing. This provides long-term corrosion protection for the steel wire.

PART 439—PHARMACEUTICAL MANUFACTURING

POINT SOURCE CATEGORY

GENERAL

new

Sec. 439.0 Applicability. 439.1 General definitions. 439.2 General monitoring requirements. 439.3 General pretreatment standards. 439.4 General limitation or standard for pH.

Subpart D-Mixing/Compounding and

Formulation

Subpart A-Fermentation Products 439.10 Applicability. 439.11 Special definitions. 439.12 Effluent limitations attainable by the

application of the best practicable control technology currently available

(BPT). 439.13 Effluent limitations attainable by the

application of the best conventional pol

lutant control technology (BCT). 439.14 Effluent limitations attainable by the

application of best available technology

economically achievable (BAT). 439.15 New source performance standards

(NSPS). 439.16 Pretreatment standards for existing

sources (PSES). 439.17 Pretreatment standards for new

sources (PSNS).

439.40 Applicability. 439.41 Special definitions. 439.42 Effluent limitations attainable by the

application of the best practicable control technology currently available

(BPT). 439.43 Effluent limitations attainable by the

application of the best conventional pol

lutant control technology (BCT). 439.44 Effluent limitations attainable by the

application of best available technology

economically achievable (BAT). 439.45 New source performance standards

(NSPS). 439.46 Pretreatment standards for existing

sources (PSES). 439.47 Pretreatment standards

for

new sources (PSNS).

Subpart E-Research

Subpart B-Extraction Products 439.20 Applicability. 439.21 Special definitions.

439.50 Applicability. 439.51 Special definitions. 439.52 Effluent limitations attainable by the

application of the best practicable control technology currently available (BPT).

APPENDIX A TO PART 439_TABLES

AUTHORITY: 33 U.S.C. 1311, 1314, 1316, 1317, 1318. 1342 and 1361.

SOURCE: 48 FR 49821, Oct. 27, 1983, unless otherwise noted.

GENERAL

$ 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 nonpharmaceutical, 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 nonpharmaceutical, 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]

$ 439.1 General definitions.

As used in this part:

(a) The general definitions, abbreviations and methods of analysis in 40 CFR part 401 shall apply.

(b) Bench-scale operation means the laboratory testing of materials, methods, or processes on a small scale, such as on a laboratory worktable.

(c) Cyanide (T) means the parameter total cyanide.

(d) In-plant monitoring point means a location within a plant, where an individual process effluent can be exclusively monitored before it is diluted or mixed with other process wastewaters en route to the end-of-pipe.

(e) Marimum daily means the highest allowable discharge of wastewater pollutants during a calender day or any 24 hour period that reasonably represents a calender day for purposes of sampling.

(f) Maximum monthly average means the highest allowable average of daily discharges of wastewater pollutants over a calendar month, and is calculated as the sum of all daily values measured during a calendar month divided by the number of daily values measured during that month.

(g) mg/L means milligrams per liter or parts per million (ppm)

(h) Minimum level means the level at which an analytical system gives recognizable signals and an acceptable calibration point.

(i) Nitrification capability means the capability of a POTW treatment system to oxidize ammonia or ammonium salts initially to

nitrites (via Nitrosomonas bacteria) and subsequently to nitrates (via Nitrobacter bacteria). Criteria for determining the nitrification capability of a POTW treatment system are: bioassays confirming the presence of nitrifying bacteria; and analyses of the nitrogen balance demonstrating a reduction in the concentration of ammonia or ammonium salts and an increase in the concentrations of nitrites and nitrates.

(j) Non-detect (ND) means centration value below the minimum level that can be reliably measured by the analytical method.

(k) Pilot-scale operation means processing equipment being operated at an intermediate stage between laboratory-scale and full-scale operation for the purpose of developing a new product or manufacturing process.

(1) POTW means publicly owned treatment works (40 CFR 403.3).

(m) Process wastewater, as defined at 40 CFR 122.2 and for the purposes of this part, does not include the following:

(1) Trimethyl silanol, any active anti-microbial materials, process wastewater from imperfect fermentation batches, and process area spills. Discharges containing such materials are not subject to the limitations and standards of this part.

(2) Non-contact cooling water, utility wastewaters, general site surface runoff, groundwater (e.g., contaminated groundwaters from on-site or off-site groundwater remediation projects), and other non-process water generated on site. Discharges of such waters and wastewaters are not subject to the limitations and standards of this part.

(n) Non-conventional pollutants means parameters that are neither conventional pollutants (40 CFR 401.16), nor “toxic" pollutants (40 CFR 401.15).

(0) Surrogate pollutant means a regulated parameter that, for the purpose of compliance monitoring, is allowed to serve as a surrogate for a group of specific regulated parameters. Plants would be allowed to monitor for a surrogate pollutant(s), when the other parameters for which it stands are receiving the same degree of treatment as the surrogate pollutant(s) and all of the parameters discharged are in the same treatability class(es) as their respective surrogate pollutant(s). Treatability classes have been identified in Appendix A of this part for both steam stripping and biological treatment technologies, which are the respective technology bases for PSES/PSNS and BAT/NSPS limitations controlling the discharge of regulated organic parameters.

(p) Xylenes means a combination of the three isomers: 0-xylene, m-xylene, and p-xylene. (63 FR 50425, Sept. 21, 1998; 64 FR 48104, Sept. 2, 99, as amended 68 FR 12270, Mar. 13, 2003]

a

con

$ 439.2 General monitoring require

ments. (a) Permit compliance monitoring is required for each regulated pollutant generated or used at a pharmaceutical manufacturing facility, except where the regulated pollutant is monitored as