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EPA
Registration
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. |