3.3 Pharmaceuticals & Cosmetics
Categories 25 and 1897
3.3.1 Introduction
Emissions reported in this category are from the pharmaceuticals and cosmetics industry. The emissions consist of both point (Category 25) and area (Category 1897) source emissions.
Pharmaceuticals manufacturing plants are those producing and/or blending chemicals for use in the formulation and production of pharmaceutical products. These consist of the manufacture, packaging, and sales of chemicals used as medication for humans and animals. Sources of emissions at pharmaceutical plants may come from batch process equipment, such as reactors, distillation units, extractors, centrifuges, filters, crystallizers, dryers, and storage and transfer. Emissions are comprised of volatile organic compound (VOC) emissions.
Several different products are manufactured at Cosmetics products facilities. Organic chemicals are used as raw materials and solvents; such as ethanol, acetone, isopropanol, etc. are used. Solvent is recovered where convenient, and as a means of cost effectiveness. Emissions from these operations are almost entirely non-methane organic solvents.
There is a wide variety of products manufactured from these two industries, which may also include non-pharmaceuticals for preventive medicine and health-enhancement, medicated and non-medicated cosmetics, and food additives. The manufacturing of pharmaceuticals and cosmetics products produces mostly organic emissions (ROG and TOG).
3.3.2 Methodology
Point Sources
Point Sources are operations that emit air pollution into the atmosphere at a fixed location within a facility, for which the Air District has issued a permit to operate, e.g. refinery cooling towers. These could also be a collection of similar equipment / sources located across multiple facilities, e.g. reciprocating engines.
During the permit to operate (PTO) issuance process, the BAAQMD collects information from the operating facility and/or determines from published literature, e.g. EPA’s AP-42, characteristics of a source including maximum throughput, emission factors for emitted pollutants, and control factors associated with downstream abatement devices. These characteristics are then stored for future use in the BAAQMD’s internal database. Facilities that hold a permit to operate are required to renew this permit periodically (this period varies based on facility and source type). Upon renewal, the facilities are requested to provide any updates to source characteristics as well as the source throughput for the last 12 months. This throughput, in combination with the emission factors and controls factors stored in the internal database, are used to estimate annual emissions at the source level. These source level emissions are then sorted and aggregated into categories.
Further speciation and quality assurance of emissions are performed as a part of the inventory process. The BAAQMD staff also perform a systematic crosswalk between CEPAM’s source category classification (Emission Inventory Code - EICs) and the District’s source category classification (category identification number - cat_ids), which ensures consistency in the annual emissions reporting process (CEIDARS) to California Air Resources Board. The last part of the inventory development process includes forecasting and back casting, and aggregation into sub-sectors and sectors for documentation purposes. For those years where no data is available, emissions data are backcasted to year-1990, as well as forecasted to year-2040 using either interpolation or another mathematical approach (see Trends section). Finally, emissions trends spanning from year 1990-2040 for each category and pollutant are evaluated for anomalies that are then investigated and addressed.
Category 25 is considered a point source category and follows the above methods for emissions estimates. To limit and reduce emissions from this category, District’s Regulation 8, Rule 24, Pharmaceutical and Cosmetic Manufacturing Operations Rule 13 emissions from various pharmaceutical and cosmetics manufacturing operation was adopted in July 1984.
Area Sources
Category 1897 is considered an area source category since it covers facilities / emission sources that are not directly permitted by the District, and hence not systematically cataloged. Emissions for area source categories are determined using the formula:
Current Year Emissions = Base Year Emission X Growth Profile, and,
Base Year Emission = Throughput X Control Factor X Emission Factor
where,
- throughput or activity data for applicable base year(s) is determined using a top-down approach (e.g. state-, national-level data);
- emission factor is derived from general literature, specific literature and reports, and/or source testing results provided by Air District staff;
- control factor (if applicable) is determined by District and state rules and regulations in effect;
- and, historical backcasting and forecasting of emissions is based on growth profiles as outlined in the Trends section of this chapter
More details on throughput, county distribution, emission factors and controls is provided in the following subsections.
It is assumed there are a number of other smaller pharmaceutical and cosmetics manufacturers not included in the District internal database. Subtracting the point source usage from the total solvent usage estimate yields an area source solvent usage.
(a) Activity Data / Throughput
The amount of solvent usage by pharmaceutical manufacturers is estimated based on the U.S. Dept. of Commerce “Current Industrial Reports”, and the “Census of Manufacturers” 14. It is assumed that solvent usage of the cosmetics industry is included within this estimate. Using a dollar per gallon of alcohol, the dollar estimate of alcohol consumed by this sector is converted into gallons. This throughput is projected for Bay Area use with an annual growth rate of 0.8 % from the base year in the report (1993), and is assumed to be the total solvent usage by the pharmaceutical and cosmetics industries put together.
(b) County Distribution / Fractions
The ratio of each county’s population was used to distribute emission into counties. For area source categories, the “American Community Survey” census data was used to derive county fractions.
(c) Emission Factors
The average solvent density was assumed to be 6.6 lbs./gal. An uncontrolled emission factor of 330 lbs./1000 gallons is derived based on an assumed 5% organic evaporative loss due to the spent solvent.
(d) Control Factors
District [Rule 8-24], limiting organic compounds emissions from various pharmaceutical and cosmetics manufacturing operation took effect in July 1984 with an estimated 42% overall control.
(e) Speciation
The speciation applied to TOG to determine ROG is consistent with the size fractions of speciation profiles developed by the California Air Resources Board (CARB) and published on their emissions inventory web-page 15.
3.3.3 Changes in Methodology
There are no changes in the methodology to estimate emissions in the current base year inventory compared to the previous base year inventory (year 2011).
3.3.4 Emissions
A summary of emissions by category, county, and year are available via the associated data dashboard for this inventory publication.
3.3.5 Trends
In the absence of future rules and controls which are unknown at this point in time, the growth in activity of the pharmaceutical and cosmetic industry is expected to correlate with emissions derived from it. The expected long term growth of the pharmaceutical and cosmetic industry is expected to increase at roughly one percent per annum.
(a) Historical Emissions / History
Historical emissions for point source emissions (category 25) are derived from source-specific throughputs provided by the permitted facility, compiled/reported emission factors, and regulation-based control factors. This information is archived in the BAAQMD’s internal database which is queried to retrieve the data for historical and current years. Interpolation techniques to account for missing data are used when necessary, this is the case for years 1991-1992.
Historical emissions from area source emissions (category 1897) were estimated by using the estimated solvent usage by the industry. As previously mentioned, historical emission has significantly decreased since the adoption of District Regulation 8, Rule 24 1, which limits organic compound emissions from pharmaceutical and cosmetic manufacturing operations.
(b) Future Projections / Growth
For a given category or a group of related categories, future emissions estimates were developed using a growth profile based on data available from a handful of resources. These resources include employment- and population-based growth projections generated by the Association of Bay Area Governments16, fixed-percentage growth assumptions consistent with historical emissions data trends, and specific growth profiles derived using relevant regional or sub-national data sources (e.g. county-specific wine production data from the Wine Institute for wine fermentation categories, California crude oil distillation capacity data from the Energy Information Administration for refinery categories, and California Energy Commission natural gas usage projection data for residential and commercial natural gas combustion categories). For this category, the growth profile follows the pharmaceutical manufacturing profile which forecasts growth to be approximately 0.8 percent per annum.
\[ \text{PE} = \text{Gr} * \text{Ci} * \text{Ei} \] \(PE\) = projected emissions of pollutant i in a past or future year
\(Gr\) = growth rate by economic profile of industry or population
\(Ci\) = control factor of pollutant i based on adopted rules and regulations
\(Ei\) = base year emissions of pollutant i
Emissions for area source category 1897 through the year 2040 are projected to follow similarly to that of point source category 24. According to estimated growth prediction of pharmaceutical and cosmetic products industry, approximately 0.8% or roughly one percent per year of growth is expected in future years spanning out to the next two decades.
3.3.6 Uncertainties
Throughputs for this category are reported by all pharmaceutical and cosmetic manufacturing facilities via the BAAQMD permit system requirement on a year by year basis and are assumed to reflect the most current data available at the time. Throughput data that are taken based on source test is considered the most accurate, followed by engineering calculations such as mass/material balance, and then published data via literature such as AP-42. The emission factor is estimated using historical data and could change or be improved as new data is published.
3.3.7 Contact
Author: Tan Dinh
Reviewer: Abhinav Guha, Yuan Du
Last Update: November 06, 2023
3.3.8 References & Footnotes
BAAQMD. 1994. Reg 8-24. https://www.baaqmd.gov/rules-and-compliance/rules/reg-8-rule-24-pharmaceutical-and-cosmetic-manufacturing-operations↩︎
U.S. Dept. of Commerce. Reports; [accessed 2023 March 08]. (https://www.commerce.gov/data-and-reports/reports?q=/data-and-reports/reports&title=&page=0)↩︎
CARB. 2022. ORGPROF; https://ww2.arb.ca.gov/speciation-profiles-used-carb-modeling↩︎
Plan Bay Area 2040. ABAG 2017. http://2040.planbayarea.org/files/2020-02/Final_Plan_Bay_Area_2040.pdf↩︎