In recent years, regulators and policy-makers have become concerned about the potential impact of exhaust emissions on human health. The Environmental Protection Agency has promulgated strict regulations for the amount of carbon monoxide, unburned hydrocarbons, oxides of nitrogen and particulate matter that an engine is allowed to emit. This has resulted in large reductions in the amount of these compounds entering our atmosphere. In addition, the EPA enforces ambient air standards across the country and holds those regions that are not in compliance with these standards responsible for developing plans to correct the non-compliance. As an additional safeguard, the EPA requires that producers of fuels and fuel additives (F/FA) intended for use in motor vehicles register their products. The authorization for this registration process is provided in sections 211(b) and 211(e) of the Clean Air Act and the F/FA regulations are sometimes referred to as the 211 regulations. The regulations are described in detail in 40 CFR Part 79.
Fuels that are not sold into on-road markets are exempt from 40 CFR Part 79. These include fuels sold as heating oil, farming, construction, marine, power generation, and other off-road uses. To qualify for this exemption, a biodiesel producer can never provide biodiesel to anyone using it in a licensed vehicle used on-road all or part of the time. Cooperatives or producers using biodiesel in their own vehicles must register their fuels.
All motor vehicle fuel and fuel additive manufacturers are required to register each product they sell; offer for sale; or introduce into commerce, with the EPA.
The most significant obstacle to registration is that producers are required to submit data that shows the Health Effects associated with the use of their product in an engine. In most cases, very expensive testing is required to produce these data.
Testing Requirements
The testing requirements can be organized into three tiers. Tier 1 is the first step of data collection. It starts with a comprehensive literature review of the publications that have investigated the health effects of the exhaust from engines fueled with the fuel to be registered.
The second step of Tier 1 is an emissions characterization. This requires testing of engines following a protocol that goes well beyond the usual emissions certification test. The protocol requires speciation of hydrocarbon emissions (identification of individual chemical compounds), measurement of the amounts of the polynuclear aromatic hydrocarbons (PAHs) and nitro-PAHs.
Tier I data in the public domain (generated outside of the National Biodiesel Board dataset) can be referenced so long as the engine, testing methods and other criteria involved in the test meet the EPA’s standards. Anyone pursuing a Tier I data should check with EPA in person and read the 40CFR79 regulations to determine what is appropriate to submit.
To date, a complete body of emission data that meets Tier I criteria have not been conducted independently from NBB and are not available for reference. For example, DOE’s Northwest Regional Biomass Energy Program submitted Tier I data to the EPA but the data were rejected because the wrong engine was used in the test.
Tier 2 consists of a test of laboratory rats that are exposed for 90 days to the exhaust of engines fueled with the fuel (subchronic exposure). After 90 days, the rats are dissected and examined for evidence of carcinogenicity (tendency to cause cancer), mutagenicity (tendency to cause genetic mutations-conducted on diesel particulate extract), teratogenicity (tendency to cause fetal abnormalities), reproductive toxicity (inability to reproduce), and neurotoxicity (nervous system problems).
The NBB is the only organization to date to submit Tier II data to the EPA. Only members of NBB can access this data for registration purposes. All other manufacturers will need to either join NBB for their coverage, or conduct their own independent tests.
Tier 3 is additional testing that EPA may require after the results of Tier 1 and Tier 2 testing have been submitted. If EPA believes that additional testing is needed to confirm the results of Tier 1 and Tier 2, or if new testing is justified, they can require it as part of Tier 3.
Special Provisions
The cost of the testing to satisfy Tier 1, 2, and 3 is very large. The National Biodiesel Board has stated that their total cost was $2.2 million. In recognition of the high potential costs for this testing, the EPA included several provisions intended to ease the burden of the program. These provisions include the ability for manufacturers to group together and share costs and waivers for small businesses. A manufacturer may make use of jointly-submitted testing and analysis for a product that conforms to the same grouping criteria as the tested product. However, previous submitters (NBB in this case) are entitled to reimbursement for an appropriate portion of its costs incurred to report the information.
The grouping below is not solely intended for the evaluation of shared costs and waivers, but also dictates the testing required by the manufacturer. The grouping system established by the EPA divides the candidate fuels into 3 groups: baseline fuels, non-baseline fuels, and atypical fuels. These fuels are defined as follows:
Baseline fuels – satisfy all of the following criteria.
1) Contains no elements other than carbon, hydrogen, oxygen, nitrogen, and/or sulfur.
2) Contain less than 1.0% oxygen by weight.
3) Contain less than 0.05% sulfur by weight.
4) Possess the characteristics of diesel fuel as specified by ASTM standard D 975-93.
5) Derived only from conventional petroleum, heavy oil deposits, coal, tar sands, and/or oil sands.
Non-baseline fuels – These fuels satisfy the criteria for the baseline fuel except that they contain more than 1% oxygen and may be derived from sources that are not fossil-based.
Atypical fuels – The definition of atypical fuel is that it contains elements other than carbon, hydrogen, oxygen, nitrogen, and/or sulfur. However, EPA also indicates that fuels that do not fall into the baseline or non-baseline categories should also be considered to be atypical.
Biodiesel only contains carbon, hydrogen, and oxygen, so it satisfied requirement 1). However, B100 contains about 11% oxygen so 2) is not satisfied and B100 cannot be considered to be baseline. Further, while B100 does have a sulfur content of less than 0.05%, it does not conform to ASTM D 975 and is not derived from conventional petroleum or the other sources listed.
The non-baseline category would appear to be a better fit for biodiesel. It allows the fuel to contain more than 1% oxygen and to be from other than fossil sources. In fact, biodiesel (B100) is specifically identified as a non-baseline fuel in one area of the Code of Federal Regulations [40 CFR 79.56(e)(4)(ii)(B)(2)(iv)(A)], so it would appear that it was the intent of the original writers of the regulations that there is a biodiesel group that is considered as a non-baseline group. However, the EPA has subsequently determined that B100 does not qualify as non-baseline since it does not satisfy some of the parameters specified in ASTM D 975.
Excluding biodiesel from consideration as a non-baseline fuel based on the differences from ASTM D 975 is a decision that is likely to be challenged. The areas where biodiesel does not conform with D 975, such as the 90% distillation temperature, are primarily included in the standard to allow distinctions to be made between different grades of diesel fuel such as No. 1 and No. 2. They are not relevant to the question of whether a fuel is suitable for use in a diesel engine. The only property in D 975 that pertains to the suitability of the fuel is the cetane number and biodiesel easily meets the minimum value of 40 given in the standard.
Due to the deviations with D 975, the EPA has categorized biodiesel as an atypical fuel. While biodiesel does not satisfy the primary requirement of atypical fuels, which is that it should contain elements other than carbon, hydrogen, oxygen, nitrogen, and/or sulfur, the EPA considers fuels to be atypical if they do not fit in the baseline or non-baseline categories [40 CFR 79.56 (e)(2)(iii)].
Small Business Provisions
To further ease the impact of the testing costs on small producers, the F/FA regulations state that fuel manufacturers of baseline and non-baseline fuels with annual sales of less than $50 million, only need to submit the basic registration data. These companies are not required to submit Tier 1 and Tier 2 data. However, since EPA does not consider biodiesel to be a non-baseline fuel, small biodiesel producers are not eligible for this exemption.
Small producers of atypical fuels can also qualify for an exemption but the limiting size is only $10 million. These producers are also still required to submit Tier 1 data although Tier 2 can be waived. Collecting Tier 1 data can still be quite expensive, requiring between $100,000 and $250,000.
NBB Health Effects Data
The National Biodiesel Board (NBB), using funds from the National Soybean Checkoff Program, has sponsored a program to develop Tier 1 data. NBB and the Department of Energy co-sponsored a program to develop Tier 2 data. This test program has been described in a number of publications [1-4].
The EPA has accepted the NBB data and registered several new biodiesel producers. These producers are considered to be part of NBB’s group, and with NBB’s permission, are allowed to use its data.
The EPA regulations recognize that groups that submit Health Effects data are entitled to reimbursement from groups that submit later requests that reference the earlier data. Before the EPA will consider the later registration requests, the group must submit documentation that the original submitter has been notified and reimbursement has been arranged. The entitlement to compensation remains in effect for 15 years following the original submission. Any person who violates the registration requirements is subject to a civil penalty set up by the EPA, which may be up to $25,000 per violation plus the monetary savings which may have resulted from the violation. Each day of a continuing offense is a separate violation.
The NBB has made their Health Effects data available to all their members at no charge. Non-members must pay $100,000 plus twice the volume dues paid by NBB members on gallons produced for access to the data.
NBB Membership
The National Biodiesel Board is a trade association that has been formed to promote the common business interests of its members and to promote the use of biodiesel as a fuel that meets ASTM standards.
The National Biodiesel Board has two classes of Voting Director membership:
1)
Feedstock producers or feedstock producer organizations;
2) Biodiesel processors or biodiesel marketers.
The board also has non-voting associate memberships available to individuals and organizations that do not fall into one of the categories for voting membership.
The NBB charges annual dues that depend on whether you are in the feedstock class or the biodiesel processor/marketer class.
The dues for a feedstock producer or feedstock producer organization are currently $10,000/year. Several organizations can split the dues but they only receive one Voting Director position. Dues for a Biodiesel processor or marketer are a minimum of $5,000/year but primarily depend on annual sales.
Table 2 shows how the actual dues are calculated from the sales volume.
The annual dues are
billed at the start of each fiscal year (October 1). The volume dues must be paid quarterly based on quarterly sales reports submitted to NBB.
NBB may audit a member’s books to confirm that they are correctly reporting their volumes.
Table 2. Voting Director; Biodiesel Producer/Marketer - Volume Dues
| Volume produced or marketed (gallons/yr)
|
Volume dues
|
|
|
|
| 0 to 1,000,000
|
$0.01/ gallon ($5,000 minimum annual dues)
|
| 1,000,001 to 5,000,000
|
$0.0075/gallon
|
| 5,000,001 to 10,000,000
|
$0.0050/gallon
|
| 10,000,001 to 15,000,000
|
$0.0025/gallon
|
| Amounts over 15,000,000 |
$0.0010/gallon |
Sample Calculation:
Suppose a processor sells 65 million gallons of biodiesel.
$10,000 + $30,000 + $25,000 + $12,500
+ $50,000 = $127,500 annual dues
NBB Fuel Accreditation
NBB has initiated a fuel accreditation program that will allow fuel producers to claim that they are an “accredited” producer. This is intended to ensure that biodiesel producers
follow good business practices and provide fuel that meets the ASTM standard. While guidelines for the accreditation process are still under development, they are expected to involve ISO 9000 – type inspections (paid for by producer) and periodic fuel testing.
References
1. Koo-Oshima, S., N. Hahn, and J. Van Gerpen, “Comprehensive Health and Environmental Effects of Biodiesel as an Alternative Fuel,” presented at the Fall meeting of the Society for Risk Analysis, Paris, France, Oct. 11-14, 1998.
2. Sharp, C.A., S.A. Howell, J. Jobe, “The Effect of Biodiesel Fuels on Transient Emissions from Modern Diesel Engines, Part I Regulated Emissions and Performance,” Society of Automotive Engineers Paper No. 2000-01-1967, 2000.
3. Sharp, C.A., S.A. Howell, J. Jobe, “The Effect of Biodiesel Fuels on Transient Emissions from Modern Diesel Engines, Part II Unregulated Emissions and Chemical Characterization,” Society of Automotive Engineers Paper No. 2000-01-1968, 2000.
4. Finch, G.L., et al., “Effects of Subchronic Inhalation Exposure of Rats to Emissions from Diesel Engine Burning Soybean Oil-Derived Biodiesel Fuel,” submitted to Toxicological Sciences, Dec., 2001.
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