-------
Description of Codes Used in "Tables of Critical Documents"
AC Academia performed the work.
C A contract was used as the funding mechanism.
CA a cooperative agreement was used as the funding mechanism.
ENP Peer review was done by an external group in a non-public manner, such as a refereed journal
or three external experts hired by EPA
FACA Peer review was publicly done by a Federal advisory committee, like the Science Advisory
Board or National Research Council. Some FACAs provide both peer advisement and peer
review; we tried to distinguish between these when possible.
G A grant was used as the funding mechanism.
I EPA in-house resources were the funding mechanism, i.e., Federal salaries and expenses.
IAG An interagency agreement was used as the funding mechanism.
A
Peer review was done by independent internal EPA reviewers, such by the risk assessment
forum or by EPA Office of Research and Development (ORD) of a program office document.
IO EPA ORD performed the work. This includes reports with an ORD cover, white papers, or
memorandums clearly produced by ORD, unless there was an indication that the report had
been prepared for EPA by a contractor.
IP EPA program office performed the work. This includes reports with a program office cover, white
papers, or memorandums clearly produced by the program office, unless there was an indication
that the report had been prepared for EPA by a contractor.
N No independent peer review was done, according to what we were told or had good reason to
infer.
O Other. For who funded the work, this includes reports funded by: state, local, and foreign
governments; an industry; professional or trade organizations; environmental and other public
interest groups; and non-governmental research institutes with no academic affiliation. For
funding mechanism, this was typically in-house research by these same entities.
OEP Peer review was done by some other public review process by external experts, such as a
committee of the National Research Council.
OF Another Federal agency besides EPA performed or funded the work.
OG Other (non-Federal) government entity performed the work.
ORD EPA Office of Research and Development funded the work.
PO EPA program office funded the work.
PS Private sector performed the work. This includes reports prepared by a contractor for EPA or
another organization, or reports prepared by an industry, professional or trade organization,
environmental and other public interest group, or a non-governmental research institute with no
academic affiliation.
U Unknown entity performed or funded the work, unknown funding mechanism was used, or it was
unknown whether a peer review was done.
-------
Table Of Contents
age
Case 1 Municipal Waste Combustors A-1
Case 2 Synthetic Chemicals Monitoring A-5
Case 3 Acid Rain Permits A-15
Case 4 Land Disposal Restrictions A-19
Case 5 Reformulated Gasoline A-30
Case 6 Great Lakes Water Quality A-35
Case 7 Municipal Solid Waste Landfills A-50
Case 8 Biotechnology A-55
Case 9 Pulp and Paper (Air) A-66
Case 10 Pulp and Paper (Water) A-71
Case 11 Disinfectants and Byproducts A-75
Case 12 Polychlorinated Biphenyls A-84
Case 13 Regional Ozone A-88
Case 14 Nonroad Diesel Engines A-102
Case 15 Plant-Incorporated Protectants A-105
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Case 1
Municipal Waste Combustors
Rule Title: Standards of Performance for New Stationary Sources; Municipal Waste Combustors
Citation for Final Rule: 56 Federal Register 5488 (February 11, 1991)
EPA Start Action Notice: 2424
Brief description of the rule
The Administrator determined that emissions from municipal waste Combustors (MWC) cause or
contribute significantly to air pollution that may reasonably be anticipated to endanger public
health or welfare. Therefore, under section 11 l(b) of the Clean Air Act and section 129 of the
Clean Air Act Amendments of 1990, this rule was promulgated to limit air emissions from MWC.
The emission limits were set at levels achievable by the best demonstrated system of continuous
emission reduction, considering costs, nonair quality health and environmental impacts, and
energy requirements. The emissions regulated included: MWC organics; MWC acid gases; MWC
metals; and nitrogen oxides.
The rule applied to each new, modified or reconstructed MWC unit having a capacity to combust
over 225 megagrams a day (250 tons per day). Thus, MWC units of this size for which construc-
tion, modification, or reconstruction started after December 20, 1989, much comply with the rule.
In addition, the rule included combustor operating standards, and provisions for certification of
key MWC personnel and training of other MWC personnel.
EPA excluded from the rule provisions in the proposal to: separate reusable materials, divert
household batteries before incineration, and prohibit the burning of lead-acid vehicle batteries.
Brief description of science input to the rule
The scientific aspects of the rule centered on identifying and measuring what was emitted from
municipal waste Combustors, and the effect of these emissions on human health and the environ-
ment. Also, the best demonstrated technologies had to be identified and evaluated, particularly
with regard to their cost and how they affected emissions.
Description of critical documents
EPA issued a Report to Congress in June 1987 that was a compilation of the available information
on MWCs, including industry characteristics, emission data, health risks, control technologies,
and costs of control. This report was prepared by the EPA Office of Solid Waste and Emergency
Response in conjunction with the Office of Air and Radiation and the Office of
A-1 Report 2003-P-00003
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Research and Development. Much of the information in it came from eight technical reports
prepared by EPA or its contractors. This Report to Congress provided the technical basis for the
decision to regulate emissions from MWCs. [See Reference 1.]
Besides the Report to Congress, the support for the promulgated regulation included two
documents prepared by the program office; one was the updated regulatory and economic impact
analysis of the regulation and the other summarized the comments received on the proposed
regulation. These analysis evaluated the alternatives considered and the Agency's basis for
selecting the one that was proposed and promulgated. The summary of comments was the basis
for changes in the standard between proposal and promulgation. [See References 2 and 3.]
The regulations require compliance and performance testing. These testing methodologies were
developed by EPA, by the American Society of Mechanical Engineers (ASME), or by work
groups with staff from one or both of these organizations, and tested in the field. More specifi-
cally, ORD's Atmospheric Research and Exposure Assessment Laboratory developed some of
these methods. [See References 12 and 15.]
Besides published literature and specific source test reports, EPA used three methods to obtain
current information about operator training, facility design and operation, and emissions data.
The first was to request such information from facilities. [See Reference 13.] The second was to
visit facilities; an EPA contractor may have represented EPA on the visit. [See Reference 14.]
The third was the Municipal Waste Combustion Multipollutant Study that was jointly funded by
the program office and ORD, as well as others such as Environment Canada. For this study, EPA
conducted 10 emission testing programs at 6 municipal waste combustor facilities. Quality
Assurance / Quality Control Project Plans were prepared before the majority of the testing
programs; for at least one site, an external QA/QC program was conducted. [See Reference 15.]
The collected information described above was either put into a database or used to characterize
"model" facilities. These, in turn, were used by Agency staff or contractors to prepare a series of
other documents that were needed for the previously-mentioned Report to Congress or regulatory
and economic impact analysis. [See References 4 through 11.]
Table of critical documents
Ref. JDocument/Study
1 JU.S.EPA, June 1987, "Municipal
jWaste Combustion Study Report to
JCongress", Washington, DC,
iEPA/530-SW-87-021a
2 JU.S. EPA, November 1 990, "Air Pol-
jlutant Emission Standards and Guide-
jlines for Municipal Waste Combustors:
JRevision and Update of Economic
ilmpact Analysis," RTP, NC,
JEPA-450/3-91-003
Who Performed
It (Category)
IP
IP
Who Funded
u It (Category) j
PO
PO
Funding
Mechanism
I
I
Peer
Review?
FACA
U
A-2
Report 2003-P-00003
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Ref. JDocument/Study
3 ;U.S. EPA, January 1991, "Municipal
jWaste Combustion: Background Infor-
jmation for Promulgated Standards
land Guidelines - Summary of Public
JComments and Responses", RTP,
JNC, EPA-450/3-91-004
4 jU.S.EPA, June 1987, "Municipal
jWaste Combustion Study Assessment
jof Health Risks Associated With Mu-
jnicipal Waste Combustion Emissions",
JWashington, DC,
JEPA/530-SW-87-021g
5 ill. S. EPA, August 1989, "Municipal
jWaste Combustion Assessment:
jTechnical Basis For Good Combustion
JPractice", RTP, NC,
iEPA-600/8-89-063
6 jU.S.EPA, August 1 989, "Municipal
jWaste Combustion Assessment:
JCombustion Control at New Facilities",
JRTP, NC, EPA-600/8-89-057
7 jU.S.EPA, August 1989, "Municipal
jWaste Combustors - Background In-
jformation for Proposed Standards:
JControl of NOx Emissions", RTP, NC,
iEPA-450/3-89-27d
8 jU.S.EPA, August 1989, "Municipal
jWaste Combustors - Background In-
jformation for Proposed Standards:
JPost-Combustion Technology Perfor-
jmance", RTP, NC, EPA-450/3-89-27c j
9 jU.S.EPA, August 1989, "Municipal
JWaste Combustors - Background In-
jformation for Proposed Standards:
|1 1 1 (b) Model Plant Description and
JCost Report", RTP, NC,
iEPA-450/3-89-27b
10 jU.S. EPA, January 1991, "Municipal
jWaste Combustion: Background Infor-
imation for Materials Separation,"
JRTP, NC, EPA-450/3-90-021
11 jMemorandum from Rayburn M. Morri-
json (EPA), Baseline Risk Analysis to
jSupport Municipal Waste Combustor
jNew Source Performance Standard
land Emission Guideline Development,
ito The Files, dated November 22,
11989.
12 jU.S. EPA, June 1988, "Guidelines For
jStack Testing Of Municipal Waste
JCombustion Facilities",
JEPA-600/8-88-06
Who Performed
..J-UCategpryl..,
IP
IP
PS
PS
PS
PS
PS
PS
IP
IP, IO, OG
Who Funded
J^CategoryL
PO
PO, ORD
ORD
ORD
PO
PO
PO
PO
PO
PO, ORD, O
Funding
Mechanism
I
I
C
C
C
C
C
C
I
u
Peer
Review?
U
ENP
U
N
U
U
U
U
U
U
A-3
Report 2003-P-00003
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Ref. JDocument/Study
13 j Information provided by industry in
jresponse to Clean Air Act section 114
iletters from EPA.
14 ilnformation obtained during site visits
ito MWCs.
1 5 JU.S. EPA, September 1 989, "Munici-
jpal Waste Combustion Multipollutant
JStudy", RTP, NC
Who Performed
..J-UCategpryl..,
PS
PS
PS
Who Funded
J^CategoryL
0
PO
PO, ORD
Funding
Mechanism
U
C
C
Peer
Review?
U
U
U
Methodology
The majority of the documents identified as critical were described or specifically identified by the
primary contact. He did this via e-mails, an interview, and telephone conversations with members
of the pilot study team.
With this information, we went to the air docket (A-89-08) and found the documents. In
addition, we picked up a few documents we considered critical from the docket that the primary
contact had not identified. With one exception, all the critical documents came from the docket.
Miscellaneous Other Information
The promulgated rule omitted three requirements that had been proposed: a 25 percent reduction
in the weight of waste material combusted because of recycling; separation of household batteries;
and a prohibition on burning lead acid batteries. The reason recycling was not made mandatory
was primarily cost rather than science. The Agency was uncertain about the net financial cost
estimate, recycling would have reduced the flexibility of local government, landfills were not
required to recycle, and there was not enough evidence that energy and environmental benefits
could be achieved. Concerning household batteries, the Agency could not show that battery
separation would significantly effect the amount of mercury emissions. The prohibition on lead
acid batteries was dropped because the Agency decided there was already a strong regulatory
mechanism in place to discourage combustion of lead batteries.
A-4
Report 2003-P-00003
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Case 2
Synthetic Chemicals Monitoring
Rule Title: National Primary Drinking Water Regulations - Synthetic Organic Chemicals and
Inorganic Chemicals; Monitoring for Unregulated Contaminants; National Primary Drinking
Water Regulations Implementation; National Secondary Drinking Water Regulations.
Citation for Final Rule: 56 Federal Register 3526 (January 30, 1991)
EPA Start Action Notice: Unknown
Brief description of the rule
EPA promulgated maximum contaminant level goals (MCLGs) and National Primary Drinking
Water Regulations (NPDWRs) for 26 synthetic organic chemicals (SOCs) and 7 inorganic
chemicals (lOCs). The NPDWRs consist of maximum contaminant levels (MCLs) or treatment
techniques for the SOCs and lOCs and include monitoring, reporting, and public notification
requirements for these compounds. This rule includes the best available technology (BAT) upon
which the MCLs are based and the BAT for the purpose of issuing variances. EPA also promul-
gated secondary MCLs (SMCLs) for two contaminants and one-time monitoring requirements for
approximately 30 SOCs and lOCs that are not regulated by NPDWRs.
The Safe Drinking Water Act (SDWA), as amended in!986, requires EPA to publish "maximum
contaminant level goals" (MCLGs) for contaminants which, in the judgment of the Administrator,
"may have an adverse effect on the health of persons and which [are] known or anticipated to
occur in public water systems" (section 1412(b)(3)(A)). MCLGs are to be set at a level at which
"no known or anticipated adverse effects on the health of persons occur and which allows an
adequate margin of safety" (section 1412(b)(4)). At the same time EPA publishes an MCLG,
which is a non-enforceable health goal, it must also promulgate a National Primary Drinking
Water Regulation (NPDWR) which includes either (1) a maximum contaminant level (MCL), or
(2) a required treatment technique (sections 1401(1), 1412(a)(3), and 1412(b)(7)(A)). A
treatment technique may be set only if it is not "economically or technologically feasible" to
ascertain the level of a contaminant (sections 1401(1) and 1412(b)(7)(A)). An MCL must be set
as close to the MCLG as feasible (section 1412(b)(4)). "Feasible" means "feasible with the use of
the best technology, treatment techniques and other means which the Administrator finds are
available, after examination for efficacy under field conditions and not solely under laboratory
conditions (taking cost into consideration)" (section 1412(b)(5)). NPDWRs also include
monitoring, analytical and quality assurance requirements, specifically, "criteria and procedures to
assure a supply of drinking water which dependably complies with such maximum contaminant
levels." (Section 1401(1)(D)). Section 1445 of SDWA also authorizes EPA to promulgate
monitoring requirements.
A-5 Report 2003-P-00003
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Brief description of science input to the rule
Establishment of an MCLG depends on the evidence of carcinogenicity from drinking water
exposure or the Agency's reference dose (RfD), for each specific contaminant. Decisions on
cancer classifications are made by the Cancer Risk Assessment Verification Endeavor group, and
decisions on EPA reference doses (using non-cancer endpoints only) are made through the
Agency Reference Dose work group. Decisions by both groups represent policy decisions for the
Agency and are used by the respective regulatory programs as the basis for regulatory decisions.
Both are published in the Agency's Integrated Risk Information System (IRIS).
The RfD is an estimate, with an uncertainty spanning perhaps an order of magnitude, of a daily
exposure to the human population (including sensitive subgroups) that is likely to be without an
appreciable risk of deleterious health effects during a lifetime. The RfD is derived from a no- or
lowest-observed-adverse-effect level (a NOAEL or LOAEL, respectively) that has been identified
from a subchronic or chronic scientific study of humans or animals. The NOAEL or LOAEL is
then divided by an uncertainty factor to derive the RfD. Uncertainty factors range from 10-1000,
based on the type of evidence (e.g., human vs animal). From the RfD, a drinking water equivalent
level (DWEL) is calculated by multiplying the RfD by an assumed adult body weight (generally 70
kg) and then dividing by an average daily water consumption of 2 L per day. The DWEL assumes
the total daily exposure to a substance is from drinking water exposure. The MCLG is determined
by multiplying the DWEL by the percentage of the total daily exposure contributed by drinking
water (generally assumed to be 20 percent, unless other exposure data for the chemical are
available).
For chemicals suspected as carcinogens, the assessment for non-threshold toxicants consists of the
weight of evidence of carcinogenicity in humans, using bioassays in animals and human epidemio-
logical studies as well as information that provides indirect evidence (i.e., mutagenicity and other
short-term test results). The objectives of the assessment are (1) to determine the level or strength
of evidence that the substance is a human or animal carcinogen and (2) to provide an upper bound
estimate of the possible risk of human exposure to the substance in drinking water.
Category I contaminants are those which EPA has determined there is strong evidence of
carcinogenicity from drinking water ingestion and the MCLG is set at zero. Category II
contaminants are those which EPA has determined that there is limited evidence for carcinogenic-
ity from drinking water ingestion. The MCLG for Category II contaminants is calculated using
the RfD/DWEL with an added margin of safety to account for cancer effects or are based on a
risk range of 10"5 to 10"6 when data are inadequate to derive an RfD. Category III contaminants
are those which there is inadequate evidence of carcinogenicity by drinking water ingestion. For
Category III contaminants, the MCLG is established using the RfD. The science issues with
respect to the MCLGs thus involve health risk assessments that deal with all the above aspects for
each of the pollutants.
The statutory standard for "best available technology" (BAT) under 1412(b)(5) represented a
change from the provision prior to 1986, and EPA read the rule to allow EPA to select a
technology that was not necessarily in widespread use, or had not been tested for each specific
contaminant, as long as it has been field tested beyond the laboratory. EPA thus derived the
MCLs based on an evaluation of (1) the availability and performance of various technologies for
A-6 Report 2003-P-00003
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removing the contaminant, and (2) the costs of applying those technologies. For Category I
contaminants, the Agency also evaluated the health risks that are associated with various levels of
the contaminants, with the goal of ensuring that the maximum risk at the MCL falls within the 10"4
to 10"6 risk range. EPA made an engineering assessment of technologies capable of removing a
contaminant from drinking water, and developed occurrence documents for each pollutant. To
determine the "best" technologies, EPA reviewed the available data to determine which ones had
the highest removal efficiencies, were compatible with other water treatment processes, and were
not limited to a particular geographic region. Based on the removal capabilities of the various
technologies, EPA calculated the level of each contaminant that is achievable by their application
to large systems with relatively clean raw water sources.
The feasibility of setting an MCL at a precise level is also influenced by laboratory ability to
reliably measure the contaminant in drinking water. EPA derives practical quantitation levels
(PQLs) which reflect the level that can be measured by good laboratories under normal operating
conditions within specified limits of precision and accuracy. This factor is critically important in
determining the MCL for contaminants for which EPA sets the MCLG at zero, a number which
by definition can be neither measured nor attained. Limits of analytical detection require that the
MCL be set at some level greater than the MCLG for these contaminants. In these cases, EPA
examined the reduction capability of BAT and the accuracy of analytical techniques as reflected in
the PQL to establish the appropriate MCL level. Only the analytical procedures specified in the
final rule can be used for compliance monitoring after the rule is promulgated. The rule also dealt
with laboratory certification requirements. The science inputs with respect to BAT and PCLs
thus have to do with engineering data and judgement and analytical chemistry and quality
assurance.
In developing the compliance monitoring requirements for the contaminants in this rule, EPA
considered (1) the likely source of drinking water contamination, (2) differences between ground
and surface water systems, (3) how to collect samples that are representative of consumer
exposure, (4) sample collection and analysis costs, (5) the use of historical monitoring data to
identify vulnerable systems and subsequently specify monitoring requirements for vulnerable
systems, (6) the limited occurrence of some contaminants, and (7) the need for States to tailor
monitoring requirements to system- and area-specific conditions. The science inputs to compli-
ance monitoring generally have to do with sampling statistics, but do not appear to have had
much impact relative to cost and practical constraints on monitoring.
EPA proposed monitoring requirements for approximately 110 "unregulated" organic chemicals
and six inorganic chemicals divided into two priority groups. EPA adopted a monitoring scheme
that requires all systems to monitor for the highest priority organics, unless a vulnerability
assessment determines the system is not vulnerable. Any science issues reflected the concern
about the chemicals on the two lists. The rule also required one-time monitoring of 30 unregu-
lated organic and inorganic contaminants.
EPA proposed secondary maximum contaminant levels (SMCLs) based on taste and odor
detection levels for seven organic chemicals (o-dichlorobenzene, p-dichlorobenzene, ethylben-
zene, pentachlorophenol, styrene, xylene, and toluene) and for silver and aluminum. These
organic chemicals had reported taste or odor detection levels lower than the proposed (or final)
A-7 Report 2003-P-00003
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MCLs. EPA believed it appropriate to set SMCLs for these compounds to protect against
aesthetic effects (such as odor) which could be present at levels below the proposed MCLs. EPA
dropped the organics SMCLs but retained the existing odor SMCL of 3 Total Odor Number
(TON). EPA finalized an SMCL for aluminum (due to discoloration of water) with the precise
level for each system being determined by the State. Furthermore, EPA deleted an MCL for silver
and finalized an SMCL to protect against skin discoloration or argyreia from lifetime exposure.
Science issues with respect to SCMLs have to do with the effects of the contaminants on tastes,
odors, colors, and cosmetic effects.
Description of critical documents
This rule established primary MCLs for 33 chemicals, secondary MCLs for two chemicals, and
monitoring requirements for 30 chemicals. Most of the referenced documents had been removed
from the docket and archived. Consequently, we decided to concentrate on the criteria docu-
ments for all the chemicals. In addition, we reviewed the documents referenced in two of the
criteria document (nitrate/nitrite and 1,2 dichloropropane), which we chose at random. We also
looked at the occurrence document for Chromium. The results for the referenced documents may
not be characteristic of those for the other 31 chemicals.
There is no overall background information document for the rule. The preamble to the proposed
rule [Reference 1] explains the basis for the various regulations, and the preamble to the final rule
[Reference 2] contains the response to comments, but the preambles seldom explicitly reference
the items in the docket. We therefore had to infer the importance of the other referenced
documents.
The first group of other referenced documents supporting the final rule are the occurrence
documents. There are five occurrence documents for the metals prepared under contract to
OGDW by Wade Miller Assoc [Reference 3], a draft final report on the occurrence and human
exposure to pesticides [Reference 4], and a draft final report on the occurrence of the remaining
organics [Reference 5]. The occurrence documents are critical in determining the cost-effective-
ness of the rule, because they serve as the baseline against which reductions in risk are deter-
mined.
There are 33 health criteria documents associated with the final rule [References 6-36]. Seven-
teen of the criteria documents carried forward to the final rule, and sixteen criteria documents
were revised between proposal and final. The documents were produced either under the
supervision of the Criteria and Standards Division (CSD) of the Office of Drinking Water or the
ORD Environmental Criteria and Assessment Office (ECAO). Both groups relied largely on
contractors to develop the documents, with various degrees of involvement by internal scientists.
The ECAO documents identify who worked on the documents, and who the peer reviewers were
(including their affiliations), while the CSD documents did not indicate the reviewers, or often the
contractors who contributed.
It was difficult to determine whether the analytical methods cited were critical, inasmuch as water
suppliers were given the option to choose among EPA methods manuals (developed by what was
then EMSL-Cincinnati, an ORD laboratory), and manuals by the U.S. Geological
A-8 Report 2003-P-00003
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Survey, the American Society of Testing and Materials, the American Public Health Association,
and in some cases, the manufacturer of the instrument. However, the only method allowed for
asbestos fibers was developed by ORD's Athens laboratory [Reference 37].
The key technologies and cost document was Technologies and Costs for the Removal of
Synthetic Organic Chemicals from Potable Water Supplies. U.S. EPA ODW [Reference 38].
Treatment techniques for the removal of inorganic contaminants from drinking water regulations.
ORD EPA-600-8-77-005 [Reference 39] appears to be the comparable document for inorganics.
There are numerous addenda listed to Draft Regulatory Impact Assessments for Inorganic and
Synthetic Organic Chemicals, all apparently produced by ODW.
Moving on to other critical references, we looked at two health assessments, nitrate/nitrite
developed by CSD, and 1,2-dichloropropane, developed by ORD/ECAO. We also looked at the
occurrence document for Chromium.
The Drinking Water Criteria Document for Nitrate/Nitrite [Reference 12] was prepared by Life
Systems, Inc., a subcontractor to ERG, who prepared many of the Criteria Documents for CSD.
Although many references were included, basically two epidemiological studies conducted in the
early 1950's [References 40 and 41] yielded the lowest NOEL and LOAEL, and nine later studies
all yielded higher values, so the RfD was based on the two earlier studies, making them critical.
Most of the later studies were conducted in parts of the world that had quite high nitrate/nitrite
levels in water supplies, and most appear to have been funded by foreign governments or
international health organizations.
Bosch, et al (1950) [Reference 40] had the most extensive data on methemoglobinemia in
Minnesota, where some of the highest nitrate concentrations in drinking water are found.
Methemoglobinemia is a disease in infants caused by nitrite binding hemoglobin and causing
cyanosis or "blue baby" syndrome. Walton et al. (1951) [Reference 41] used data from a survey
letter sent to all of the States by the American Public Health Association, to identify the lowest
nitrate/nitrite concentrations associated with methemoglobinemia,. Most of the cases of
methemoglobinemia occurred in three states (MN, IL, and NE), and only 5 cases (5% of the
sample) were associated with the 10-20ug/L N concentrations, the lowest range in the survey.
The Drinking Water Committee of EPA's science advisory board reviewed this report, and asked
that the discussion of the basis for this RfD be expanded and that the study be reviewed by a
statistician - the final discussion was expanded to eleven lines, and apparently no review was
conducted. Lukens (1987) [Reference 42] was cited to show that 10% of nitrate is reduced to
nitrite in infants stomachs, making that the most sensitive criterion upon which to base the MCL.
The Criteria Document for 1,2 dichloropropane [Reference 22] was prepared by ECAO,
Cincinnati by Syracuse Research Corp. and several staff of the ORD ECAO. The scientific
reviewers were a member of EPA's Carcinogen Assessment Group and two ODW staffers. This
report was indicative of the difficulty of establishing MCLGs. The Summary states:
"The data base for the toxicity of 1.2-dichloropropane is limited, consisting of a number of
studies from the older literature and the NTP (1986) report of toxicology and carcino-
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genesis studies. No drinking water criteria have been recommended due to the inadequacy
of the available toxicological studies."
However, based on the National Toxicology Program (1986) report [Reference 43], criteria for
cancer risks could be established using EPA's 1986 Cancer Risk Guidelines [Reference 44] for
10E-4 to 10E-6 risk levels, which were used to set the MCLG and MCLs. Also, based on Ames
Test data, the chemical was elevated from group C to B2, so these data significantly affected the
cancer risk levels. Of four sources cited, only two could be found, DeLorenzo et al. (1977) and
Stolzenburg and Hine (1980) [References 45and 46].
A review of the occurrence document for Chromium [Reference 3] indicted several sources for
the occurrence data: a report by Pacific Northwest Laboratory (1984) Chemical attenuation rates,
coefficients, and constants in leachate migration. V.I. A critical Review [Reference 47]; EPA
(1979) Water-related environmental fate of 129 priority pollutants. EPA 440/4-79-029a [Refer-
ence 48]; and Britton (1983) National Stream Quality Assessment Network [Reference 49].
There also are references to several studies by ODW: the 100 city study (1964), Community
Water Supply Studies (1969 and 1978), rural water supply study (1978-80) and the National
Inorganics and Radionuclides Survey [Reference 50]. The latter survey caused the occurrence
studies for the inorganics to be revised between 1987 and 1990.
Table of critical documents
Ref. I Document/Study
1 jSynthetic Organic Chemicals,
jlnorganic Chemicals, and Microorgan-
iisms: Proposed Rule. 50 FR 46936.
11985
2 jNational Primary Drinking Water Reg-
julations - Synthetic Organic Chemi-
jcals and Inorganic Chemicals; Moni-
jtoring for Unregulated Contaminants;
jNational Primary Drinking Water Reg-
julations Implementation; National
JSecondary Drinking Water Regula-
tions 56 FR 3526 1991
3 jOccurrence and Exposure
jAssessment for Cadmium (Cop-
jper/Mercury/Nitrate/Nitrite/Selenium)
Jin Public Water Drinking Supplies.
JEPA ODW, 1 990. (5 reports)
4 jDraft Final Report on the Occurrence
land Human Exposure of to Pesticides
Jin Drinking Water, Food, and Air in the
iU.S.A. EPA ODW 1990
5 jOccurrence of Synthetic Organic
JChemicals in Drinking Water. Food,
land Air. EPA ODW 1987.
6 iDrinking Water Criteria Document for
JAsbestos (ECAO-CIN-422) April 1988 ,
Who Performed
u It? (Category) j
IP
IP
PS
IP
PS
10
Who Funded
It? (Category) j
PO
PO
PO
PO
PO
ORD
Funding
Mechanism
I
I
C
I
C
C
Peer
Review?
N
N
N
U
N
II
A-10
Report 2003-P-00003
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Ref. i Document/Study
8 jFinal Draft for the Drinking Water Cri-
iteria Document on Barium
l(TR-832-92) Dec 1987
9 jFinal Draft for the Drinking Water Cri-
iteria Document on Cadmium
!(TR-832-93) Dec 1986
10 JThe Drinking Water Criteria Document
Jon Chromium (TR-1 242-64) Oct 1990 ^
1 1 JDrinking Water Criteria Document for
Mercury (ECAO-CIN-025) July 1988
12 JDrinking Water Criteria Document on
i Nitrate/Nitrite (TR-1 242-60) Dec 1990 H
13 JThe Drinking Water Criteria Document
Jon Selenium (TR-1 242-65) Oct 1 990
1 4 jFinal Draft for the Drinking Water Cri-
iteria Document on Acrylamide
j(TR-832-104A) July 1987
15 JQuantification of Toxicological Effects
ifor Arochlor May 1 990
16 JDrinking Water Criteria Document for
JAIdicarb (ECAO-CIN-420) Jan 1 988
17 JDrinking Water Criteria Document for
iAtrazine May 1990
18 JThe Drinking Water Criteria Document
ion Carbofuran (TR-1 242-59)
19 JDrinking Water Criteria Document for
iHeptachlor, Heptachlor Epoxide and
JGhlordane (ECAO-CIN-406) Aug 1990j
20 JDrinking Water Criteria Document for
il,2 dibromo-3-Chloropropane (DBCP)
j(ECAO-CIN-410) Mar 1988
21 jDraft Criteria Document for
jortho-Dichlorobenzene,
jmeta-Dichlorobenzene and
jpara-Dichlorobenzene June 1988
22 iCriteria Document for 1 ,2 dichloropro-
jpane (ECAO-CIN-404) Aug 1 990
23 JDrinking Water Criteria Document for
pichloroethylenes Dec 1990
24 jFinal Draft for the Drinking Water Cri-
jteria Document for 2,4-
iDichlorophenoxyacetic acid (2,4-D)
i(ECAO-CIN-418)Mar1988
25 JDrinking Water Criteria Document for
iEpichlorohydrin (ECAO-CIN-413) Feb
il987
26 iDrinking Water Criteria Document for
JEtlrylbenzene (ECAO-CIN-430)
Who Performed
JttlCategory}..,
PS
PS
PS
IP
PS
PS
PS
PS
10
PS
PS
PS
PS
u
PS
PS
PS
IO
PS
Who Funded
"^Category).,
PO
PO
PO
ORD
PO
PO
PO
PO
ORD
PO
PO
ORD
ORD
PO
ORD
PO
ORD
ORD
ORD
Funding
Mechanism
I
C
C
I
C
C
C
C
I
C
C
C
C
u
C
C
C
C
C
Peer
Review?
U
U
U
ENP
FACA
U
U
U
N
U
U
ENP
II
U
II
U
ENP
ENP
ENP
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Report 2003-P-00003
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Ref. I Document/Study
27 jDrinking Water Criteria Document for
JEthylene Dibromide (EDB) (ECAO-
JCIN-412) July, 1987
28 JDrinking Water Criteria Document for
ilindane (ECAO-CIN-402) Oct 1990
29 JDrinking Water Criteria Document for
iMethoxychlor (ECAO-CIN-425)
30 jDrinking Water Criteria Document for
JPolychlorinated Biphenyls
j(ECAO-CIN-41 4) April 1 988
31 JDrinking Water Criteria Document for
iStyrene (ECAO-CIN-409) Jan 1991
32 JTetrachloroethylene - Quantification of
jToxicological Effects Dec 1990
33 JDrinking Water Criteria Document for
'Toluene (ECAO-CIN-408) July 1990
34 jDrinking Water Criteria Document for
JToxaphene (ECAO-CIN-426) Feb
11987
35 jDrinking Water Criteria Document for
J2(2,4,5-Trichlorophenoxy) Propionic
JAcid (ECAO-CIN-41 9) Sept 1 987
36 JDrinking Water Criteria document for
jXylenes (ECAO-CIN-41 6) June 1987
37 jAnalytical methods for the determina-
ition of asbestos fibers in water. EPA -
1600/4-83-043
38 Technologies and Costs for the
jremoval of synthetic organic chemi-
icals from potable water supplies. U.S.
IEPA ODW
39 Treatment techniques for the removal
jof inorganic contaminants from drink-
ling water regulations. ORD
iEPA-600-8-77-005.
40 Bosch, etal (1950) J. AWWA 42:161.
41 jWaltonetal. (1951) Survey of litera-
jture relating to infant methemoglobin-
iemia due to nitrate contaminated wa-
iter. Am. J. Pub. Health. 41 : 986-996.
42 jLukens, J. 1987. The legacy of well-
j-water methemoglobinemia, JAMA
1257:2793-2795
43 JNTP(1986). NTP Technical Report
jno 263 on the toxicology and carcino-
jgenicity studies of 1 ,2-dichloropropane
iin F344/N rats and B6C3F1 mice (ga-
jvage study). NIH Rept. No 83-2519
Who Performed
JttlCategory}..,
PS
PS
PS
AC
PS
U
PS
PS
PS
PS
PS
IP
10
OG
OG
AC
OF
Who Funded
.^..(Category)^
ORD
ORD
ORD
ORD
ORD
PO
ORD
ORD
ORD
ORD
ORD
PO
ORD
O
OF
U
OF
Funding
Mechanism
C
C
C
C
C
U
C
C
C
C
C
C
I
G
0
U
C
Peer
Review?
ENP
ENP
N
ENP
ENP
U
ENP
ENP
ENP
II
II
U
ENP
ENP
ENP
ENP
FACA
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Report 2003-P-00003
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Ref. I Document/Study
44 JU.S. EPA Guidelines for Carcinogen
iRisk Assessment. 51 FR 33992.
45 jDeLorenzo, et al. 1977. Mutagenicity
jof pesticides containing 1 ,2 -
idichloropropane. Cancer Res. 37:
11915-1917.
46 iStolzenburg and Mine (1980)
jMutagenicity of 2- and 3- carbon
jhalogenated compounds in the
jSalmonella/mammalian microsome
jtest. Environ. Mutagen. 2: 59-66
47 i Battelle, Pacific Northwest Labs,
J1984. Chemical attenuation rates,
jcoefficients, and constants in leachate
jmigration. V.1. A critical Review.
^Prepared for EPRI Project #21 98-1 .
48 JU.S. EPA 1979. Water-related envi-
jronmental fate of 129 priority
jpollutants. 2 vols. Office of Water
JPIanning and Stds. EPA
i440/4-79-029a&b
49 jBritton (1983) National Stream Qual-
jity Assessment Network. U.S.G.S.
iOpen File Rept. 80-594
50 JVarious ODW Surveys
Who Performed
J.t?.lCategory}..H
IP/IO
AC
AC
OF
IP/PS
OF
U
Who Funded
Jt?.(Categpn/).H
PO/ORD
O
0
O
PO
OF
PO
Funding
Mechanism
I
C
G
C
C
I
U
Peer
Review?
FACA
ENP
ENP
U
ENP
U
U
Methodology
We received two replies to the questionnaire. The primary contact indicated that his job had been
to pull the entire rule together, but that he did not have detailed knowledge about each of the 33
chemicals regulated in the rule. A senior OW official also indicated that his memory was pretty
hazy on the rule. We approached the rule by going directly to the docket, identifying the major
technical support documents, and then reading several of the occurrence papers and criteria
documents. Because most of the referenced documents had been archived, we generally searched
for these sources in the EPA library in Research Triangle Park and the University of North
Carolina Library system, and even did some searches through interlibrary loans. It was often very
difficult to locate the referenced documents.
Miscellaneous Other Information
Our experience with this rule led us to wonder how the NTP (a toxicology program of the
National Institutes of Environmental Health Sciences with a multi-agency steering committee,
including the Administrator of EPA) worked. More specifically, given the fact that many of the
chemicals that EPA regulates require that standards be set under several (or even many) different
statutes, does EPA or NTP have an organized strategy to reduce the uncertainty in the toxicology
of these compounds? An interview with an EPA senior scientist familiar with both the NTP and
EPA's efforts said that for a time, EPA actually discouraged NTP from its activities, because
A-13
Report 2003-P-00003
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EPA was requiring industry to conduct toxicology studies as part of TSCA and FIFRA reviews.
This came about in part because EPA was being "outspent" by industry (e.g., EPA would conduct
a toxicology study, and then industry would spend three times as much on further studies to cast
doubt on the validity of the original tests). He also said that the administrative requirements of
rule-makings, which typically costs $150K/rule, were taking substantial funding away from
toxicology. EPA has since dropped it's opposition to NTP testing, but the program typically
focuses more on NIH priorities. The staffer also said that in the early 1990's, an EPA branch chief
tried to organize a cross-agency group to prioritize chemicals for toxicology testing, but that it
failed due to lack of support by the Assistant Administrators.
We were advised that we should also look at how the process of NPDWR formulation had
changed since 1991. Actually, we also did a 1998 NPDWR rule in the pilot. Just as we were
finishing this study, the Office of Ground Water and Drinking Water announced its preliminary
decision not to revise NWPDRs for 68 chemical contaminants. EPA stated that the 68 chemical
NPDWRs should not be revised at this time for one of the following reasons:
> 36 NPDWRs were undergoing EPA health risk assessments. These assessments are not
expected to be complete in time to make its final revise/not revise decisions.
> 17 NPDWRs remained appropriate and any new information available to EPA supports
retaining the current regulatory requirements.
*• 12 NPDWRs had new health, technological, or other information that indicated a potential
revision to MCLG and/or MCL; however, EPA believed any potential revision would
result in minimal gain in the level of public health protection and/or provide negligible
opportunity for significant cost-savings.
> 3 NPDWRs data gaps or research needs that needed to be addressed before EPA could
make definitive regulatory decisions. When the data gaps have been resolved, EPA plans
to consider the results in the next review cycle.
Agency Comments and OIG Response
As part of the comments from the Office of Water, the Office of Ground Water and Drinking
Water suggested specific changes related to synthetic chemical monitoring. Since the changes
clarified our meaning or improved factual accuracy, we revised Case 2 as suggested by the Office
Water.
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Case 3
Acid Rain Permits
Rule Title: Acid Rain Permits, Allowance System, Emissions Monitoring, Excess Emissions and
Appeals Regulations Under Title IV of the Clean Air Amendments of 1990
Citation for Final Rule: 58 Federal Register 3590 (January 11, 1993)
EPA Start Action Notice: 2886
Brief description of the rule
Title IV of the Clean Air Act (CAA), as amended November 15, 1990, required EPA to establish
an Acid Rain Program to reduce the adverse effects of acidic deposition. Prior to publication of
acid rain proposed regulations, EPA solicited ideas and comments from organizations and
individuals that would be affected by acid rain rules. The resulting Acid Rain Advisory Commit-
tee (ARAC) was formed and included 44 members that represented stakeholder groups that
included: utility companies, emissions control equipment vendors, State Public Utility Commis-
sioners, academicians, coal companies, State air pollution control agencies, labor, and environ-
mental groups. There were six ARAC public meetings attended by hundreds of people and the
discussions and input from those stakeholders was helpful in drafting proposed rules. During the
public comment period for the proposed rule, stakeholders communicated over 7,800 individual
comments focused on over 850 major and minor issues.
The emission of concern for this rule was sulfur dioxide (SO2). SO2 emissions, along with
Nitrogen Oxide (NOx, regulated in a later EPA rule) are released into the atmosphere from the
burning of fossil fuels, primarily coal and oil. Once in the air, SO2 and NOx may undergo various
chemical reactions, resulting in transformation of the emissions into sulfates, nitrates, sulfuric acid
and nitric acid. These compounds can fall to earth near the emission sources of SO2 and NOx or
be transported hundreds of miles. Acid rain is also referred to as acidic deposition and these
compounds can be either dry (gases, aerosols, and particles) or wet (precipitation such as rain,
fog, or snow). SO2 and NOx emissions and their byproducts damage ecosystems and man-made
materials, are suspected of posing a threat to human health, and reduce visibility.
The centerpiece of the Acid Rain Program Rule is a unique trading system in which allowances
(each authorizing the emission of up to one ton of SO2) are bought and sold at prices determined
in a free market. Existing utility sources are allocated allowances based on their historic fuel use
and the emissions limitations specified in the Act. Utility units are required to limit SO2 emissions
to the number of allowances they hold, but since allowances are fully transferrable, utilities may
meet their emissions control requirements in the most cost-effective manner possible.
In order to operate, each affected source must apply for a permit in which the source certifies that
it will hold a sufficient number of allowances to cover its SO2 emissions, and specifies the
A-15 Report 2003-P-00003
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source's planned method of compliance. Each affected source must install a system to continu-
ously monitor the emissions and to collect, record, and report emissions data to ensure that source
compliance results in achieving nationally mandated reductions in SO2 and NOx. If an affected
unit exceeds its emissions limitation for either SO2 or NOx, the Act requires the affected
(violating) sources to pay penalties and, for SO2, to forfeit the excess SO2 allowances.
Brief description of science input to the rule
To prepare the rule, EPA needed to determine the precision, accuracy, and reliability of continu-
ous emissions monitoring systems (CEM). Specifically, EPA needed to determine that continuous
emissions monitors work (measuring the amount of gas flow) and how well the monitors worked
(measuring the concentration of gas). Also, EPA needed to determine what companies are to do
when the continuous emissions monitors are not working (devising a way to determine what's
going out when the monitors are not working).
Description of critical documents
The key support for this rule was the CEM technology development to determine that CEMs
would measure the amount of gas flow and the concentration of the gas flow. [See References 6,
11-12]. Additional support for the final rule were technical documents pertaining to performance
evaluations that measured emissions from CEMs and reviewed the monitoring systems at power
plants which helped determine emissions limitations and calculations when CEMs are not
working. [See References 7-10]. Survey results from vendors of flow monitoring and gas
monitoring equipment were helpful in developing the emissions monitoring technology. [See
References 1-2]. An equipment user survey on flow monitoring was useful in CEM technology
development, as well as technical information on velocity stratification. [See References 3-4].
Finally, a limited amount of data gathered showed a correlation between boiler parameters and
stack volumetric flow rates. [See Reference 5].
Table of critical documents
Ref. I Document/Study
1 jEntropy Environmentalists, Inc.
|November26, 1990. Draft Sum-
jmary Report: Flow Monitor Vendor
jSurvey Results.
2 jEntropy Environmentalists, Inc.
jDecember21, 1990. Draft Sum-
jmary Report: Gas Monitor Vendor
jSurvey Results.
3 jEntropy Environmentalists, Inc.
jJanuary 11, 1991. Draft Summary
JReport: Flow Monitoring Equip-
jment User Survey.
4 jEntropy Environmentalists, Inc.
JFebruary 28, 1991. Draft: Velocity
jStratification.
Who Performed
It (Category) j
PS
PS
PS
PS
Who Funded
It (Category) j
ORD, PO
ORD, PO
ORD, PO
PO
Funding
Mechanism
C
C
C
C
Peer Re-
view?
FACA
FACA
FACA
FACA
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Report 2003-P-00003
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Ref. I Document/Study
5 jEntropy Environmentalists, Inc.
jMarch 1991. Draft: Determination
jof Flue Gas Flow Rates Using
iBoiler Parameters.
6 JU.S.E.P.A. April 1991. Protocol
jforthe Field Validation of Emission
JConcentrations from Stationary
jSources. OAQPS & AREAL.
7 jEntropy Environmentalists, Inc.
JMay1991. Draft: Flow Monitor
jPerformance Evaluation, Kurz
J455T Mass Velocity Monitor,
JSoutheast Resource Recovery Fa-
jcility, Long Beach, CA
8 jEntropy Environmentalists, Inc.
jMay 31 , 1 991 . Technical Guidance
ion Selected Flow Monitoring Pro-
jcedures and Equipment, Report 1,
jFlow Monitor Performance Evalua-
tion, Central Illinois Public Service
iCompany.
9 jEntropy Environmentalists, Inc.
jJune 14, 1991. Draft: Flow Moni-
jtor Performance Evaluation, Big
JRivers Electric Corp., D.B. Wilson
jStation, Central City, Kentucky,
jand United Services, Inc., Ultra
JFlow 100 Ultrasonic Flow Rate
iMonitor.
10 jEntropy Environmentalists, Inc.
jJuly 31, 1991. Draft: Flow Monitor
jPerformance Evaluation, Kansas
jCity Power and Light La Cygne
JGenerating Station, La Cygne,
iKansas.
1 1 JEPA Proposed Rule for Acid Rain
jProgram: Permits, Allowance Sys-
jtem, Continuous Monitoring, and
JExcess Emissions. December 3,
J1991
1 2 jRegulatory Impact Analysis of the
jProposed Acid Rain Implementa-
tion Regulations. September 16,
11991
Who Performed
....It.CC.ategp/yL..,
PS
IO, IP
PS
PS
PS
PS
IP
PS
Who Funded
.!t..(Cate.goryL
PO
ORD, PO
ORD, PO
ORD, PO
ORD, PO
ORD, PO
PO
PO
Funding
Mechanism
C
I
C
C
C
C
I
C
Peer Re-
view?
FACA
FACA
FACA
FACA
FACA
FACA
FACA
FACA
A-17
Report 2003-P-00003
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Methodology
Originally, we went to the air docket and identified some documents we considered critical to the
continuous emissions monitoring part of the rule. We then met with the primary contact on two
occasions and he identified the science documents he considered critical. Using the information
provided by the primary contact, we went to the docket and pulled the documents identified.
The primary contact also suggested obtaining minutes of the advisory board minutes to get a
better understanding of the rulemaking, which we did. The primary contact did not disagree with
those chosen as critical when he reviewed the summary.
Miscellaneous Other Information
Of the approximately 26 million tons of SO2 emitted annually from all sources in the U.S. in 1980,
approximately 17 million tons of SO2 were emitted by electric utilities. Title IV of the Act
required EPA to establish an Acid Rain Program and a national emissions cap of 8.95 million tons
per year on electric utility SO2 emissions to be implemented in two phases. Phase I began in 1995
and affected 263 units at 110 mostly coal-burning electric utility plants located in 21 eastern and
mid-western states. An additional 182 units joined Phase I of the program as substitution or
compensating units, bringing the total of Phase I affected units to 445. Phase II, which began in
the year 2000, tightened the annual emissions limits imposed on these large, higher emitting plants
and also set restrictions on smaller, cleaner plants fired by coal, oil, and gas, encompassing over
2,000 units in all. The program affects existing utility units serving generators with an output
capacity of greater than 25 megawatts and all new utility units. In 2001, Acid Rain Program
affected sources emitted 10.6 million tons of SO2 — nearly 7 million tons below 1980 levels,
which is an approximately 40% reduction.
Agency Comments and OIG Response
In their comments on the draft report, staff from the Office of Air and Radiation suggested
specific changes related to acid rain permits. Since these changes improved the factual accuracy
of the report, we changed Case 3 as suggested.
A-18 Report 2003-P-00003
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Case 4
Land Disposal Restrictions
Rule Title: Land Disposal Restrictions: Phase II (Universal Treatment Standards, and Treatment
Standards for Organic Toxicity Characteristic Wastes and Newly Listed Wastes); Phase III
(Decharacterized Wastewaters, Carbamate Wastes and Spent Potliners); and Phase IV (Treatment
Standards for Wood Preserving Wastes, and Treatment Standards for Metal Wastes, and Zinc
Micronutrient Fertilizers, and Carbamate Treatment Standards, and K088 Treatment Standards)
Citation for Final Rule: 59 Federal Register 47982 (September 19, 1994), 61 Federal Register
15565 (April 8, 1996), 63 Federal Register 28555 (May 26, 1998), and 64 Federal Register 25408
(May 11, 1999)
EPA Start Action Notice: Unknown
Brief description of the rule
The Hazardous and Solid Waste Amendments (HSWA), RCRA section 3004(m) required EPA to
develop treatment standards for hazardous waste to substantially diminish the toxicity or mobility
of hazardous wastes. As instructed by Congress, the standards were based on the best
demonstrated available technology instead of risk.
Once a hazardous waste is prohibited from land disposal, the statute provides only two options
for legal land disposal: meet the treatment standard for the waste prior to land disposal, or dispose
of the waste in a land disposal unit that has been found to satisfy the statutory no-migration test.
A no-migration unit is one from which there will be no migration of hazardous constituents for as
long as the waste remains hazardous. (RCRA section 3004(d), (e), (g) (5).
The treatment standards may be expressed as either constituent concentration levels or as specific
methods of treatment. For purposes of the restriction, land disposal includes any placement of
hazardous waste in a landfill, surface impoundment, waste pile, injection well, land treatment
facility, salt dome formation, salt bed formation, or underground mine or cave. (RCRA section
3004(k). Land Disposal Restrictions (LDR) were needed to minimize short and long-term threats
to human health and the environment.
For wastes identified or listed as hazardous waste after the 1984 HSWA, Congress required EPA
to promulgate LDR treatment standards within six months of the date that the listing or
identification became final. EPA did not meet this statutory deadline for all of the wastes
identified or listed after the 1984 amendments. As a result, a suit was filed by the Environmental
Defense Fund (EDF). EPA and EDF signed a consent decree that established a schedule for
adopting prohibitions and treatment standards for newly identified or listed wastes. As a result,
the following rules were promulgated subject to a demanding court-ordered schedule. The Phase
II rule basically established treatment standards for newly listed coke by-product and chlorotuene
production wastes, and for the D018-D043 TC wastes (TC wastes identified as hazardous
A-19 Report 2003-P-00003
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because of the presence of organic hazardous constituents), with some exceptions. The Phase III
rule amends the treatment standards for initially characteristic wastewaters managed in centralized
wastewater management systems containing land disposal units. The amended treatment
standards require treatment that destroys, immobilizes, or removes the hazardous constituents
present in the initially characteristic wastewaters. The Phase IV rule deals with treatment of
wood preserving wastes, paperwork reduction, TC metal wastes, and mineral processing wastes.
Brief description of science input to the rule
To prepare these rules, EPA needed to obtain technology performance information to determine
the best demonstrated available technologies and the universal treatment standards that applied to
the various wastes.
Description of critical documents
The treatment standards for the LDR Phase II-IV rules were technology based, not risk based.
Therefore, the critical documents consisted of treatment performance analyses, treatment capacity
analyses, and economic analysis documents. [See References 1, 2, 4, 7, 10, 13, 17, 24, 36, 58,
60, 61, 63, 70, 73, and 78-85]. The rest of the support were appendices on analytical methods,
treatment performance databases, and other technological and cost information for the various
hazardous wastes.
Table of critical documents
Ref. I Document/Study
1 jDOCID..: F-1994-CS2F-S0026 Final
JBest Demonstrated Available
Technology (BOAT), Background
jDocument for Wastes from the
JProduction of Chlorinated Aliphatic
iHydrocarbons F024
2 JDOCID..: F-1994-CS2F-S0028 ..: Final
jBest Demonstrated Available
jTechnology (BOAT), Background
jDocument For Universal Standards,
jVolume A: Universal Standards For
jNonwastewater Forms of Listed
JHazardous Wastes Rorg.. U.S. EPA
iOffice of Solid Waste
3 JDOCID..: F-1994-CS2F-S0028.A
JAttachment A: Analytical Methods For
jConstituents Selected For Regulation
jUnder Universal Standards
Who Performed
It (Category)
PS
PS
PS
Who Funded
t It (Category) j
PO
PO
PO
Funding
Mechanism
C
C
C
Peer
Review?
N
N
N
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Report 2003-P-00003
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Ref. j Document/Study
4 JDOCID..: F-1994-CS2F-S0046..:
jFinal, Best Demonstrated Available
JTechnology (BOAT), Background
iDocument For Universal Standards,
jVolume B: Universal Standards For
jWastewater Forms of Listed
iHazardous Wastes
5 JDOCID..: F-1994-CS2F-S0046.A
jAppendix A: Analytical Methods for
iConstituents for Regulation under Uni-
iversal Standards
6 JDOCID..: F-1994-CS2F-S0046.B
jAppendix B: Method Detection Limits
JBased on Epa-approved Analytical
iMethods
7 JDOCID..: F-1994-CS2F-S0047 ..:
jFinal, Best Demonstrated Available
JTechnology (BOAT), Background
iDocument for Coking Wastes
JK141-K145, K147, and K148
8 JDOCID..: F-1994-CS2F-S0047.A
jAppendix A: Treatment Performance
jDatabase and Methodology for
^Identifying Universal Standards for
JConstituents in Nonwastewater Forms
jofK141-145, K1 47, and K1 48 Wastes j
9 JDOCID..: F-1994-CS2F-S0047.B
jAppendix B: Treatment Performance
jDatabase and Methodology for
^Identifying Universal Standards for
JConstituents in Wastewater Forms of
JK141-145, K147, and K148 Wastes
10 JDOCID..: F-1994-CS2F-S0048..:
jFinal, Best Demonstrated Available
JTechnology (BOAT), Background
iDocument For Chlorinated Toluene
jWastes K149, K150, And K151
11 JDOCID..: F-1994-CS2F-S0048.A
JAppendix A: Treatment Performance
jDatabase And Methodology For
identifying Universal Standards For
iConstituents in Nonwastewater Forms
iof K149, K150, And K151 Wastes
12 JDOCID..: F-1994-CS2F-S0048.B
jAppendix B: Treatment Performance
iDatabase and Methodology for
identifying Universal Standards for
iConstituents in Wastewater Forms of
JK1 49, K1 50, and K1 51 Wastes
Who Performed
..J.Upatego.ryl ..,
PS
PS
PS
PS
PS
PS
PS
PS
PS
Who Funded
^(Category),
PO
PO
PO
PO
PO
PO
PO
PO
PO
Funding
Mechanism
C
C
C
C
C
C
C
C
C
Peer
Review?
N
N
N
N
N
N
N
N
N
A-21
Report 2003-P-00003
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Ref. ! Document/Study
13 JDOCID..: F-1994-CS2F-S0049..:
jFinal, Best Demonstrated Available
jTechnology, Background Document
JFor Organic Toxicity Characteristic
jWastes D018-D043 And Addendum to
jNon-wastewater Forms of Pesticide
JToxicity Characteristic Wastes
ID012-D017
14 JDOCID..: F-1994-CS2F-S0049.A
JAppendix A: Treatment Performance
iDatabase And Methodology For
jldentifying Universal Standards For
JConstituents in Nonwastewater Forms
iof D018-D043 Wastes
15 JDOCID..: F-1994-CS2F-S0049.B
JAppendix B: Treatment Performance
iDatabase And Methodology For
jldentifying Universal Standards For
JConstituents in Wastewater Forms of
ID018-D043 Wastes
16 JDOCID..: F-1994-CS2F-S0049.C
JAppendix C: TRI Release Data
jCorresponding to the Organic TC
JConstituents Regulated in D012-D043
iWastes for 1987-1 990
17 JDOCID..: F-1994-CS2F-S0074..:
jBackground Document for Capacity
JAnalysis for Land Disposal Restrictions
jPhase II - Universal Treatment Stan-
jdards, and Treatment Standards for
JOrganic Toxicity Characteristic Wastes
jand Other Newty Listed Wastes (Final) j
18 JDOCID..: F-1994-CS2F-S0074.E
JAppendix E: Data on Newly Identified
iTC Organic Mixed Radioactive Wastes
19 JDOCID..: F-1994-CS2F-S0074.F
JAppendix F: Data on Deep Well
j Injected Wastes
20 JDOCID..: F-1994-CS2F-S0075 . Reg-
julatory Impact Analysis of Land
jDisposal Restrictions For Newly
identified Wastes And Hazardous Soil
i(Phase II LDRs), Final Rule
21 JDOCID..: F-1994-CS2F-S0075.B
JAppendix B: Analysis of UTS Impacts,
jWastestreams With Changing
Treatment Standards
22 JDOCID..: F-1994-CS2F-S0075.C
JAppendix C: Percentage (By Volume)
iof TC Wastes Assigned to Treatment
jTechnologies (Including Average)
Who Performed
..J.Upatego.ryl ..,
PS
PS
PS
PS
PS
PS
PS
PS
PS
PS
Who Funded
^(Category) ^
PO
PO
PO
PO
PO
PO
PO
PO
PO
PO
Funding
Mechanism
C
C
C
C
C
C
C
C
C
C
Peer
Review?
N
N
N
N
N
N
N
N
N
N
A-22
Report 2003-P-00003
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Ref. I Document/Study
23 JDOCID..: F-1994-CS2F-S0075.D
JAppendix D: Unit Costs Used in Phase
jll Rule TC Analysis
24 JDOCID..: F-1994-CS2F-S0075.E
JAppendix E: Cost of Affected Tc
jWaste by Tc Code and Physical Form
25 JDOCID..: F-1994-CS2F-S0075.F
JAppendix F: Example Calculations for
JEstimating Emissions (Human Health
jBenefits - Air Pathway)
26 JDOCID..: F-1994-CS2F-S0075.G
JAppendix G: Baseline and Post-reg-
julatory Leachate Concentrations for
jCarcinogenic Constituents
27 JDOCID..: F-1994-CS2F-S0075.H
JAppendix H: Gems/gams Modeling
jAnalysis
28 JDOCID..: F-1994-CS2F-S0075.I ..:
JAppendix I: Waste Minimization Com-
imercial TSD Analysis
29 JDOCID..: F-1994-CS2F-S0075.K
JAppendix K: Sensitivity Analysis of
JGround-water Population Risk
jAssumptions
30 JDOCID..: F-1996-PH3F-S0001..: Reg-
julatory Impact Analysis of the Phase III
jLand Disposal Restriction Final Rule
31 JDOCID..: F-1996-PH3F-S0001. A
JAppendix A: Results of Screening
JAnalyses of the Organic Chemical
jlndustry
32 JDOCID..: F-1996-PH3F-S0001.B
JAppendix B: Results of Screening
JAnalyses of the Petroleum Refining
jlndustry
33 JDOCID..: F-1996-PH3F-S0001.C
JAppendix C: Results of Screening
JAnalyses of the Pesticides Industry
34 JDOCID..: F-1996-PH3F-S0001.D
JAppendix D: Results of Screening
JAnalyses of the Inorganic Chemical
jlndustry
35 JDOCID..: F-1996-PH3F-S0001.E
JAppendix E: Results of Screening
JAnalyses of the Iron and Steel Industry
iDocdate: 19960215
36 JDOCID..: F-1996-PH3F-S0001.F
JAppendix F: Summary of Analyses for
jSteam Electric Generators
Who Performed
..J.Upatego.ryl ...
PS
PS
PS
PS
PS
PS
PS
PS
PS
PS
PS
PS
PS
PS
Who Funded
^(Category),
PO
PO
PO
PO
PO
PO
PO
PO
PO
PO
PO
PO
PO
PO
Funding
Mechanism
C
C
C
C
C
C
C
C
C
C
C
C
C
C
Peer
Review?
N
N
N
N
N
N
N
N
N
N
N
N
N
N
A-23
Report 2003-P-00003
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Ref. I Document/Study
37 JDOCID..: F-1996-PH3F-S0001.G
jAppendixG: Results of Screening
JAnalyses of the Electronics and
jElectrical Components Industry
38 JDOCID..: F-1996-PH3F-S0001.H
JAppendix H: Results of Screening
JAnalyses of the Food Industry
39 JDOCID..: F-1996-PH3F-S0001 .1 ..:
JAppendix 1: Results of Screening
JAnalyses of Metal Products And
JMachinery And Electroplating/metal
jFinishing
40 JDOCID..: F-1996-PH3F-S0001.J ..:
JAppendix J: Results of Screening
JAnalyses of The Pulp And Paper
jlndustry
41 JDOCID..: F-1996-PH3F-S0001.K
JAppendix K: Results of Screening
JAnalyses of the Pharmaceutical
jlndustry
42 JDOCID..: F-1996-PH3F-S0001.L
JAppendix L: Results of Screening
iAnalyses of Industrial Laundries
43 JDOCID..: F-1996-PH3F-S0001.M
JAppendix M: Results of Screening
JAnalyses of the Leather Treating
jlndustry
44 JDOCID..: F-1996-PH3F-S0001.N
JAppendix N: Results of Screening
iAnalyses of Federal Facilities
45 JDOCID..: F-1996-PH3F-S0001.0
JAppendix O: Results of Screening
iAnalyses of the Transportation
jEquipment Cleaning Industry
46 JDOCID..: F-1996-PH3F-S0001.P
JAppendix P: Approach and Results of
jthe Screening Analyses of The
jBiennial Report Survey (BRS)
47 JDOCID..: F-1996-PH3F-S0001.Q
JAppendix Q: Cost Methodology for the
JOrganic Chemical and Petroleum
jRefining Industries
48 JDOCID..: F-1996-PH3F-S0001.R
JAppendix R: Economic Impact
iCalculations
49 JDOCID..: F-1996-PH3F-S0001.S
JAppendix S: Risk Assessment
jEquations
Who Performed
...J.UP.ategoryl ...
PS
PS
PS
PS
PS
PS
PS
PS
PS
PS
PS
PS
PS
Who Funded
^(Category),
PO
PO
PO
PO
PO
PO
PO
PO
PO
PO
PO
PO
PO
Funding
Mechanism
C
C
C
C
C
C
C
C
C
C
C
C
C
Peer
Review?
N
N
N
N
N
N
N
N
N
N
N
N
N
A-24
Report 2003-P-00003
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Ref. I Document/Study
50 JDOCID..: F-1996-PH3F-S0001.il
JAppendix U: Analysis of the Effect of
jthe Hazardous Waste Identification
jRule (HWIR) on the Affected Universe
jforthe Petroleum Refining and
jOrganic Chemicals Industries
51 JDOCID..: F-1996-PH3F-S0003 ..:
JAddendum to the Regulatory Impact
jAnalysis of the Phase III Land Disposal
jRestriction Final Rule: Revised Risk
JAssessment for Spent Aluminum
iPotliners
52 JDOCID..: F-1996-PH3F-S0003.A
JAppendix A: Central Tendency Risk
JCalculations and High End Risk
iCalculations - Tables
53 JDOCID..: F-1996-PH3F-S0007 ..:
JBackground Document for Capacity
jAnalysis for Land Disposal Restrictions
jPhase III - Decharacterized Waste-
jwaters, Carbamate Wastes, and Spent
jPotliners (Final Rule); Volume 1:
JCapacity Analysis Methodology and
i Results
54 JDOCID..: F-1996-PH3F-S0008 ..:
jBackground Document For Capacity
jAnalysis For Land Disposal
JRestrictions Phase III -
jDecharacterized Wastewaters,
jCarbamate Wastes, And Spent
iPotliners (Final Rule); Volume 2:
^Appendix A (Part 1)
55 JDOCID..: F-1996-PH3F-S0008.A
JAttachment A: (Part 1) Detailed
jAnalyses of the Required Treatment
jCapacity for Industries Generating
jlgnitable, Corrosive, Reactive, And/or
jOrganic Toxicity Characteristic Wastes
JManaged in Clean Water Act or Clean
jWater Act-equivalent Systems
56 JDOCID..: F-1996-PH3F-S0009 ..:
jBackground Document for Capacity
jAnalysis for Land Disposal Restrictions
jPhase III - Decharacterized Waste-
jwaters, Carbamate Wastes, and Spent
iPotliners (Final Rule); Volume 3:
JAppendix A (Part 2) - Appendix F
Who Performed
..J.Upatego.ryl ...
PS
PS
PS
PS
PS
PS
PS
Who Funded
^(Category),
PO
PO
PO
PO
PO
PO
PO
Funding
Mechanism
C
C
C
C
C
C
C
Peer
Review?
N
N
N
N
N
N
N
A-25
Report 2003-P-00003
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Ref. I Document/Study
57 JDOCID..: F-1996-PH3F-S0009.A
jAppendix A: (Part 2) Detailed Analyses
jof the Required Treatment Capacity
jfor Industries Generating Ignitable,
jCorrosive, Reactive, And/or Organic
jToxicity Characteristic Wastes
JManaged in Clean Water Act or Clean
jWater Act-equivalent Systems
58 JDOCID..: F-1996-PH3F-S0009.B
jAppendix B: Data on Wastewater
Treatment Capacity
59 JDOCID..: F-1996-PH3F-S0009.D
jAppendix D: Additional Data
jSupporting the K088 Capacity Analysisj
60 JDOCID..: F-1996-PH3F-S0009.E
jAppendix E: Wastewater and
JNon-wastewater Quantities of D003
iWastes(1993BRS)
61 JDOCID..: F-1996-PH3F-S0009.F
jAppendix F: Case Study Report for
jCapacity Analysis of LDR Phase III
iDecharacterized Wastewater
62 JDOCID... F-1996-PH3F-S0013 ..:
jFinal; Best Demonstrated Available
JTechnology (BOAT) - Background
jDocument for Spent Potliners from
jPrimary Aluminum Reduction - K088
JRorg...: U.S. EPA, Office of Solid
iWaste
63 JDOCID..: F-1996-PH3F-S0013.A
jAppendix A: Treatment Performance
jDatabase and Methodology for
jldentifying Universal Treatment
jStandards for Constituents in
iNonwastewater Forms of K088
64 JDOCID..: F-1996-PH3F-S0013.B .
jAppendix B: Draft Annotated Index for
jthe Administrative Record: Final Best
jDemonstrated Available Technology
j(BDAT) Treatment Standards, Phase
65 JDOCID..: F-1998-2P4F-S0015 ..:
jTechnical Background Document:
jHuman Health and Environmental
JDamages from Mining and Mineral
jProcessing Wastes
66 JDOCID..: F-1998-2P4F-S0015.A ..:
jAppendix A: Mining Waste Releases
jand Contaminants for Selected
jFacilities
Who Performed
..J.Upatego.ryl ..,
PS
PS
PS
PS
PS
PS
PS
PS
PS
PS
Who Funded
^(Category) ^
PO
PO
PO
PO
PO
PO
PO
PO
PO
PO
Funding
Mechanism
C
C
C
C
C
C
C
C
C
C
Peer
Review?
N
N
N
N
N
N
N
N
N
N
A-26
Report 2003-P-00003
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Ref. I Document/Study
67 JDOCID..: F-1998-2P4F-S0015.B ..:
jAppendix B: Memorandum to RCRA
pocket F-95-PH4A-FFFFF Discussing
JNatural Resource Damages from
jMining Operations
68 JDOCID..: F-1998-2P4F-S0015.C ..:
jAppendix C: Documentation Regarding
JReleases from Mineral Processing
jPhosphogypsum Storage
69 JDOCID..: F-1998-2P4F-S0016 ..: Final
Technical Background Document:
'Identification and Description of
JMineral Processing Sectors and Waste
iStreams
70 JDOCID..: F-1998-2P4F-S0043 ..:
jTechnical Background Document:
jCapacity Analysis for Land Disposal
jRestrictions - Phase IV: Newly
'Identified Toxicity Characteristic Metal
JWastes and Mineral Processing
iWastes, (Final Rule)
71 JDOCID..: F-1998-2P4F-S0047..:
iTechnical Background Document: Soil
jTreatability Analysis: Analysis of Treat-
lability Data for Contaminated Soil
Treatment Technologies, Final Report
72 JDOCID..: F-1998-2P4F-S0063 ..: Reg-
julatory Impact Analysis: Application of
jPhase IV Land Disposal Restrictions to
JNewly Identified Mineral Processing
iWastes
73 JDOCID..: F-1998-2P4F-S0064 ..: Reg-
julatory Impact Analysis: Phase IV
JLand Disposal Restrictions - TC Metals
iWastes, Final Report
74 jGuidebook for QA/QC Procedures for
jSubmission of Data for the Land
jDisposal Restrictions Program
75 jMethodology for Developing Best
JDemonstrated Available (BOAT)
Treatment Standards
76 JSW-846 On-line Test Methods for
jEvaluating Solid Waste Physi-
ical/chemical Methods
77 JDOCID..: F-1998-2P4F-S0044..:
iTechnical Background Document:
jBackground Document for Analysis of
jthe Land Disposal Restrictions - Phase
JIV: Underground Injection Data and
ilssues.
Who Performed
..J.Upatego.ryl ..,
PS
PS
PS
PS
PS
PS
PS
IP
IP
IP
PS
Who Funded
^(Category),
PO
PO
PO
PO
PO
PO
PO
PO
PO
PO
PO
Funding
Mechanism
C
C
C
C
C
C
C
I
I
I
C
Peer
Review?
N
N
N
N
N
N
N
N
N
N
N
A-27
Report 2003-P-00003
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Ref. I Document/Study
78 jDOCID..: F-1998-2P4F-S0046..:
JTechnical Background Report: Site-
jWide Soils Remedy Report, Koppers
jCompany, Inc., Superfund Site
j(Feather River Plant), Oroville, CA
79 jDOCID..: F-1998-2P4F-S0054..:
JTechnical Background Document:
iTechnology Screening Guide for
jTreatment of CERCLA Soils and
JSIudges
80 JDOCID..: F-1998-2P4F-S0058..:
JTechnical Background Document:
JApplication of the Phase IV Land
jDisposal Restrictions to Contaminated
jMedia: Costs, Cost Savings, and
JEconomic Impacts
81 jDOCID..: F-1998-2P4F-S0059..:
JTechnical Background Document:
jTreatability Analysis of Completed
jDemonstration Projects, (1995 EPA
JSite Program)
82 jDOCID..: F-1998-2P4F-S0068..:
jMemorandum to the Record Regarding
jDevelopment of Metal Treatment
JStandards
83 JDOCID..: F-1998-2P4F-S001 10..:
jProposed Best Demonstrated
JAvailable Technology (BOAT)
jBackground Document for Toxicity
jCharacteristic Metal Wastes D004-
JD011
84 jDOCID..: F-1998-2P4F-S00129..:
JTechnical Resource Document:
jSolidification/Stabilization and its
JApplication to Waste Materials,
!(EPA/530-R-93-012)
85 jDOCID..: F-1998-2P4F-S00146..:
jTreatment Technology Background
JDocument
Who Performed
...JKP.ategory). ^
PS
PS
PS
PS
IP
PS
PS
PS
Who Funded
^(Category),
PO
PO
PO
PO
PO
PO
ORD
PO
Funding
Mechanism
C
C
C
C
I
C
C
C
Peer
Review?
N
N
N
N
N
N
N
N
Methodology
The primary contact sent e-mails identifying, either specifically or generally, science documents
she considered critical. This list was developed in consultation with a team of program office staff
involved in the rulemaking. Using this information, we went to the docket and pulled the
documents identified. We also met and talked on the phone with the primary contact about the
rule and the critical documents.
A-28
Report 2003-P-00003
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Agency Comments and OIG Response
In commenting on the draft report, staff from the Office of Solid Waste and Emergency Response
suggested specific changes related to the land disposal restrictions. In addition, they identified
nine additional critical documents. We made the suggested changes to Case 4, evaluated the
additional technical background documents identified by the program office, and appropriately
added them to the table of critical documents.
A-29 Report 2003-P-00003
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Case 5
Reformulated Gasoline
Rule Title: Regulation of Fuels and Fuel Additives: Standards for Reformulated and Conventional
Gasoline
Citation for Final Rule: 59 Federal Register 7716 (February 16, 1994)
EPA Start Action Notice: 2959
Brief description of the rule
EPA had established a National Ambient Air Quality Standard for ozone. To help achieve this
standard, EPA required under section 21 l(k) of the amended Clean Air Act that gasoline sold in
certain areas be reformulated to reduce vehicle emissions of toxic and ozone-forming compounds.
These areas were the nine largest metropolitan areas with the most severe summertime ozone
levels and other ozone nonattainment areas that opt into the program. In addition, the rule
prohibited conventional gasoline sold in the rest of the country from becoming more polluted than
it was in 1990.
The rule was implemented in phases. Retail sale of reformulated gasoline began on January 1,
1995, as did the provisions for the "simple model" certification, the anti-dumping program for
conventional gasoline, and the associated enforcement procedures. During this phase (Phase I)
from 1995 through 1999, either volatile organic compounds (VOC) and toxics had to be reduced
by 15 percent of baseline emissions, or that of a formula fuel, whichever was more stringent. The
baseline was emissions from 1990 model year vehicles. Certification of reformulated gasoline by
the "complex model" began January 1, 1998. The Phase II performance standards became
effective on January 1, 2000. Thus, for the year 2000 and beyond, the VOC and toxics
performance standards must be no less than that of the formula fuel or a 25 percent reduction
from baseline emissions, whichever is more stringent. The Phase II standards also required, under
section 21 l(c) of the Clean Air Act, a reduction in emissions of oxides of nitrogen (i.e., NOx).
Brief description of science input to the rule
The rule was required as part of the Clean Air Act Amendments of 1990; that section of the
amendments was a replacement recommended by the oil industry for language in the proposed
law that would have required alternative fuel vehicles and infrastructure. The oil industry
provided information that much larger emission benefits could be achieved earlier by
reformulating gasoline rather than changing to alternative fuels. EPA carried out the rulemaking
through a regulatory negotiation with the industry. In this process EPA, the oil industry, the auto
industry, and other stakeholders provided available information on the impacts of gasoline
changes on emissions, and (more importantly) committed to, throughout the rulemaking process,
collecting the additional data needed to more accurately quantify the impacts.
A-30 Report 2003-P-00003
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Given the short timeline provided in the law for compliance with the reformulated gasoline
provisions, the participants in the negotiations agreed that initial compliance would be based upon
a model developed from the data available at the time (i.e., the "simple model"). A more
"complex model" was then developed for the final rule on the basis of the much larger set of data
available and required for compliance beginning in 1998. The results from this model was then
further used in other models to confirm that the emission reductions from the fuel changes would
in fact result in ozone level reductions. There were also studies on the relationships of various
emissions to the formation of ozone. EPA pulled together the information needed to support the
rule.
Description of critical documents:
One of the major technical documents supporting the rule was the regulatory impact analysis. It
provided background information on the rule and addressed comments received on the proposal.
See Reference 1.
Which emissions should be addressed and why was considered during development of the rule.
Before the rule was proposed, EPA had already done some work on the health risks associated
with emissions from automobiles. See Reference 2. Further, the relationship of various emissions
needed to form ozone was evaluated. See References 3 and 4.
Several organizations tested emissions from automobiles using different kinds of gasoline. The
earliest were done by an industry consortium, but EPA and others also did testing. See
References 5 through 11. The emission information was used to establish the baselines with
which the reformulated gasoline would be compared. In addition, the information was used in
models to determine how the different gasolines would effect the formation of ozone. See
References 12 and 13.
EPA also used the emission information to improve the Mobile Source Emission Factor Model
(see Reference 14); it can estimate the impact of the reformulated gasoline program on emissions
and is used by states to prepare emission inventories.
Furthermore, EPA used the emission information for developing the models to determine
compliance with the law during the two phases in which the rule would be implemented. During
the first phase, which took effect in 1995, the "simple model" would be used to certify that a
gasoline met applicable emission reduction standards. The simple model allowed certification
based on a fuel's oxygen, benzene, heavy metal and aromatics content and Reid Vapor Pressure
(RVP). In accordance with the regulatory negotiation agreement, EPA proposed the "complex
model" to supplant the simple model for certifying compliance with these standards. Certification
under the complex model took effect in 1998. EPA considered the "simple" and "complex
models" more accurate, faster, cheaper, and more practical to use than actual vehicle testing in
predicting the emission effects of fuel modifications.
The emission information showed that NOx emission reductions could be achieved through fuel
changes. Consequently, although section 21 l(k) only required that NOx not increase because of
the reformulated gasoline, the rule required a reduction in NOx.
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Finally, the cost of using reformulated gasoline was considered. See References 15 through 19.
This information became part of the regulatory impact analysis.
Table of critical documents
Ref. JDocument/Study
1 jU.S. EPA, December 1993, "Final
JRegulatory Impact Analysis For
iReformulated Gasoline"
2 jAdler, J.A., Carey, P.M., 1989, "Air
JToxics Emissions and Health Risks
jfrom Mobile Sources", In: Air & Waste
jManagement Associations 82nd
JAnnual Meeting and Exhibition,
lAnaheim, CA, June 25-30, 1989.
3 JMilford, J.B., Russell, A.G., and
JMcRae, G.J., 1989, "A New Approach
jto Photochemical Pollution Control:
jlmplications of Spatial Patterns in
jPollutant Responses to Reductions in
jNitrogen Oxides and Reactive Organic
JGas Emissions," Environment Science
Technology, vol. 23, pp. 1290-1301
4 jFinlayson-Pitts, B.J. and J.N. Pitts, Jr.,
J1993, "Atmospheric Chemistry of
jTropospheric Ozone Formation:
jScientific and Regulatory
ilmplications," Air and Waste, Vol. 43,
JAugust, pp. 1091-1100
5 jAuto/Oil Air Quality Improvement
jResearch Project (AQIRP), 1990,
J1991, 1992, various technical bulletins
jshowing results of emission testing
6 jBoekhaus, K.L. et al, 1991, Society of
jAutomotive Engineers, Technical
|Paper911628, "Reformulated
jGasoline for California: EC-Premium
JEmission Control Gasoline and
jBeyond", In: Future Transportation
jTechnology Conference and
JExposition, Portland, OR, August 5-7,
J1991, Warrendale, PA
7 iCalifornia Air Resources Board, July
J1991, "Evaluation Of The Effects Of
Lowering Gasoline Volatility From 7.8
IRVP to 7.0 RVP: A Work Plan"
8 jU.S. EPA, November 1992, "Emission
JTesting of Reformulated Gasoline"
j(Note: Also published as SAE
jTechnical Paper 941 973.)
Who Performed
It (Category)
IP
IP
AC
AC
PS
PS
OG
PS
Who Funded
It (Category) j
PO
PO
O
U
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0
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PO
Funding
Mechanism
I
I
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ENP
ENP
ENP
ENP
ENP
U
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Ref. JDocument/Study
9 j"Exhaust VOC Emission Inventory By
jVehicle Emitter Class Following
implementation of an Enhanced
inspection and Maintenance (I/M)
jProgram", Memorandum from EPA
jstaff (Christian Lindhjem and David
JBrzezinski) to EPA Air Docket
iA-92-12, June 24, 1993
10 jSociety Of Automotive Engineers,
J1994, "Reformulated Gasoline Effects
jon Exhaust Emissions: Phase II:
jContinued Investigation of the Effects
jof Fuel Oxygenate Content,
jOxygenate Type, Volatility, Sulfur,
JOIefins and Distillation Parameters",
iSAE Technical Paper 941974
1 1 jSociety Of Automotive Engineers,
J1995, "Reformulated Gasoline Effects
jon Exhaust Emissions: Phase II:
investigation on the Effects of Sulfur,
jOlefins, Volatility, and Aromatics and
jthe Interactions Between Olefins and
JVolatility or Sulfur", SAE Technical
jPaper 950782
12 jSystems Applications International,
jSeptember 1992, "Modeling The
jEffects Of Reformulated Gasolines On
jOzone And Toxics Concentrations In
JThe Baltimore And Houston Areas",
\San Rafael, CA
13 jSillman, S., Samson, P. J., and
JMasters, J.M., 1993, "Ozone
jProduction in Urban Plumes Trans-
jported over Water: Photochemical
jModel and Case Studies in the
jNortheastern and Midwestern United
JStates," J. Geo. Res., vol. 98, number
JD7, pp. 12,687-12,699
14 JU.S. EPA, May 1994, "Mobile Source
iEmission Factor Model"
1 5 JAuto/Oil AQIRP, January 1 992,
'"Estimated Costs Of Modifying
JGasoline Properties", Economic
Bulletin No. 2
16 Turner, Mason & Company, April
J1992, "Costs Of Alternate Gasoline
JReformulations Results Of U.S.
jRefining Study"
1 7 JU.S. EPA, October 1 992 "Draft
JReport, Evaluation and Costing of
jNOx Controls for Existing Utility
jBoilers in the NESCAUM Region"
Who Performed
It (Category)
IP
PS
IP
PS
AC
IP
PS
PS
PS
Who Funded
..KCategpry) ^
PO
PO
PO
PO
0
PO
0
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Funding
Mechanism
I
C
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C
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I
0
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C
Peer
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U
ENP
ENP
U
ENP
U
ENP
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U
A-33
Report 2003-P-00003
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Ref. JDocument/Study
18 JBonner& Moore Management
jScience, December 1992, rough draft,
j"Study of the Effects of Sulfur and
JOIefins on the Cost of Producing
iReformulated Gasoline"
19 |Bonner& Moore Management
jScience, June 1993, "Study of the
jEffects of Fuel Parameter Changes on
jVOC Emissions and on the Cost of
JProducing Reformulated Gasoline"
Who Performed
It (Category)
PS
PS
Who Funded
JJL(
-------
CaseG
Great Lakes Water Quality
Rule Title: Water Quality Guidance for Great Lakes System
Citation for Final Rule: 60 Federal Register 15366 (March 23, 1995)
EPA Start Action Notice: 3203
Brief description of the rule
In 1986, the Governors of the eight Great Lakes States signed the Great Lakes Toxic Substances
Control Agreement, pledging the States' cooperation in studying, managing and monitoring the
Great Lakes as an integrated ecosystem. EPA and the Great Lakes States initiated the Great
Lakes Water Quality Initiative in 1989 to address the environmental concerns identified in the
Governors Agreement, and to provide a forum to develop uniform water quality criteria and
implementation procedures for the basin. The participants planned to use the results of this effort
as a basis for revising State water quality standards and permit programs pursuant to sections
303(c) and 402 of the Clean Water Act (CWA). The Great Lakes Critical Programs Act (CPA)
of 1990 (P.L. 101-596) codified the ongoing Initiative effort into the CWA. Section 101 of the
CPA (CWA section 118(c)(2)) required EPA to publish water quality guidance for the Great
Lakes System which conformed with the objectives and provisions of the Great Lakes Water
Quality Agreement (GLWQA) and was no less restrictive than provisions of the CWA and
National water quality criteria and guidance.
Section 118(c)(2) required EPA to publish proposed and final water quality guidance on minimum
water quality standards, antidegradation policies, and implementation procedures for the Great
Lakes System. The Guidance consisted of water quality criteria for 29 pollutants to protect
aquatic life, wildlife, and human health, and detailed methodologies to develop criteria for
additional pollutants; implementation procedures to develop more consistent, enforceable water
quality-based effluent limits in discharge permits, as well as total maximum daily loads of
pollutants that could be allowed to reach the Great Lakes and their tributaries from all sources;
and antidegradation policies and procedures. Illinois, Indiana, Michigan, Minnesota, New York,
Ohio, Pennsylvania, and Wisconsin had to adopt provisions consistent with the Guidance into
their water quality standards and NPDES permit programs by March 1997, or EPA would
promulgate the provisions for them.
Brief description of science input to the rule
Three committees were formed under the Initiative. A Steering Committee, consisting of
directors of water programs from EPA's National and Regional offices and the Great Lakes
States' environmental agencies, discussed policy, scientific and technical issues and directed the
work of the Technical Work Group. The Technical Work Group, consisting of technical staff
from the Great Lakes States environmental agencies, EPA, the U.S. Fish and Wildlife Service
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and the U.S. National Park Service, prepared proposals on scientific guidance for submission to
the Steering Committee. A Public Participation Work Group, consisting of representatives from
environmental groups, municipalities, industry and academia, observed the deliberations of the
other two groups, advised them of the public's concerns, and kept its various constituencies
apprized of Initiative activities. In 1992, internal EPA teams actually wrote the rule language and
technical support documents.
The rule covered a wide range of pollutants, including the "bioaccumulative chemicals of
concern" (BCCs) that were widely believed to be causing poor reproductive success and
deformities in gulls and increased risk of cancer and the potential for systemic or non-cancer
effects such as kidney damage in people consuming fish from the lakes (risks as high as 2.5 x
10"3). Toxicological data from more than 100 contaminants found in the lakes showed the
potential for acute of chronic effects on aquatic life, wildlife, or human health, including PCBs,
DDT, dioxin, chlordane, and mirex.
Against this background, ambient water quality criteria for the six Great Lakes States differed by
as much as an order of magnitude for many of the pollutants of concern. Wide variation also
existed in procedures for translating water quality criteria into discharge permits, e.g., in
procedures for the granting of mixing zones, interpretation of background levels of pollutants,
consideration of pollutants present in intake waters, controls for pollutants present in
concentrations below the level of detection, and determination of appropriate levels for pollutants
discharged in mixtures with other pollutants. Also, when addressing accumulation of chemicals by
fish some States considered accumulation through multiple steps in the food chain (bioaccumu-
lation), while others considered only the single step of concentration from the water column
(bioconcentration). Further disparities existed in deriving numeric values for implementing
narrative water quality criteria, different practices in deciding what pollutants need to be
regulated in a discharge, what effect detection limits have on compliance determinations, and how
to develop whole effluent toxicity limitations.
The guidance provided numeric criteria (both acute and chronic) to protect aquatic life for 15
pollutants and a two-tier methodology to derive criteria or values for new pollutants. Tier I
criteria (similar to the existing 304(a) CWA guidance), were to be based on laboratory toxicology
data for at least eight families representing different habitats and taxonomic groups. Tier II values
could be derived from acceptable toxicity tests on a single family, but must use uncertainty
factors. States were allowed to substitute whole effluent toxicity (WET) testing in lieu of Tier II
values, if they could show that the parameter will attain the narrative water quality standard that
protects aquatic life. On fmalization, the aquatic criteria for metals were changed from total
recoverable metals to dissolved metals, using conversion factors to convert the former to the
latter (59 FR 44678).
The final Guidance contained numeric human health criteria for 18 pollutants, as well as
methodologies to derive cancer and non-cancer human health criteria for additional pollutants
(two pollutant were dropped from the proposal because they did not meet the more restrictive
minimum data requirements for bioaccumulation factors (BAFs) used in the final Guidance).
Chronic criteria were derived to reflect long-term consumption of food and water from the Great
Lakes System. The proposed and final Guidance established 10"5 as the risk level to be used for
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carcinogens. The final Guidance included a Great Lakes-specific fish consumption rate of 15
g/day, based upon several fish consumption surveys from the Great Lakes, including a study by
West et al. (59 FR 44678). This rate differed from the national average consumption value of 6.5
g/day rate used in the National water quality criteria guidelines.
Commenters argued that a 15 g/day assumption would not adequately protect populations that
consume greater than this amount (e.g., low-income minority anglers and Native Americans), and
that such an approach therefore would be inconsistent with Executive Order 12898 regarding
environmental justice (59 FR 7629). EPA held that the human health criteria methodology,
including the fish consumption rate, would provide adequate health protection for the public,
because if fish are contaminated at the level permitted by criteria derived under the final Guidance,
individuals eating up to 10 times (i.e., 150 grams per day) the assumed fish consumption rate
would still be protected at the 10"4 risk level. Available data indicated that, even among low-
income minorities who as a group consume more fish than the population on average, the
overwhelming majority (approximately 95 percent) consume less than 150 grams per day (West,
et al.). The final Guidance required that States and Tribes modify the human health criteria on a
site-specific basis to provide additional protection appropriate for highly exposed sub-populations
greater than 10"4. The final Guidance also requires States and Tribes to adopt provisions to
protect human health from the potential adverse effects of mixtures of pollutants in effluents,
specifically including mixtures of carcinogens.
In developing bioaccumulation factors, the final Guidance used BAFs predicted from biota-
sediment accumulation factors (BSAFs) in addition to field-measured BAFs, and used a food
chain multiplier (FCM) to account for biomagnification when using measured or predicted
bioconcentration factors (BCFs). The final Guidance uses a 3.10 percent lipid value for trophic
level 4 fish and 1.82 percent for trophic level 3 fish. These values are based on an analysis of the
West et al. study and data from State fish contaminant monitoring programs. The final Guidance
placed a cap of 30,000 on the combined product of uncertainty factors that may be applied in the
derivation of non-cancer Tier II values and a combined uncertainly factor of 10,000 for Tier I
criteria. The likely maximum combined uncertainty factor for Tier I criteria in most cases is 3,000.
The proposed Guidance used an 80 percent relative source contribution (RSC) from surface water
pathways for BCCs and a 100 percent RSC for all other pollutants in deriving noncancer criteria.
The RSC concept is applied in the National drinking water regulations and is intended to account,
at least in part, for exposures from other sources for those bioaccumulative pollutants for which
surface water pathways are likely to be major contributors to human exposure. The final Guidance
used the more protective 80 percent RSC for all pollutants in deriving noncancer criteria. This
change was made because of concern that for non-BCCs as well as BCCs, there may be other
sources of exposures for noncarcinogens.
The final Guidance contained numeric criteria to protect wildlife from four pollutants and a
methodology to derive Tier I criteria for additional BCCs. They were EPA's first water quality
criteria specifically for the protection of wildlife. The methodology was based largely on the
noncancer human health paradigm, but focused on reproduction and population survival rather
than the survival of individuals. The methodology incorporated pollutant-specific effect data for a
variety of mammals and birds and species-specific exposure parameters for two mammals and
three birds representative of mammals and birds resident in the Great Lakes basin. The decision
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to restrict wildlife criteria to BCCs was consistent with comments made by the EPA Science
Advisory Board (EPA-SAB-EPEC-ADV-94-001). Commenters were concerned that the
mercury criterion for wildlife was not scientifically appropriate. After review of all comments and
a reevaluation of all the data, the mercury criterion for wildlife was increased from 180 pg/L to
1300 pg/L. EPA believed the 1300 pg/L would be protective of wildlife in the Great Lakes
System. In developing bioaccumulation factors, the proposed Guidance used a 7.9 percent lipid
value for fish consumed by wildlife. The final Guidance used a 10.31 percent lipid value for
trophic level 4 fish and 6.46 for trophic level 3 fish. These values were based on the actual prey
species consumed by the wildlife species specified in the methodology, and are used to estimate
the BAFs for the trophic levels which those species consume, and were based on the preferential
consumption patterns of wildlife and cross-referenced with fish weight and size and appropriate
percent lipid. This approach was believed to be a more accurate reflection of the lipid content of
the fish consumed by wildlife species than the approach used in the proposal.
EPA guidelines for the derivation of human health water quality criteria use BCFs, which measure
only uptake from water, when field-measured BAFs are not available. EPA believed, however,
that the BAF is a better predictor of the concentration of a chemical in fish tissues in the Great
Lakes because it considered uptake of contaminants from all routes of exposure. The proposed
Guidance included a hierarchy of three methods for deriving BAFs for non-polar organic
chemicals: field-measured BAFs; predicted BAFs derived by multiplying a laboratory-measured
BCF by a food-chain multiplier; and BAFs predicted by multiplying a BCF calculated from the log
Kow by a food-chain multiplier. For inorganic chemicals, the proposal would have required either
a field-measured BAF or laboratory-measured BCF. Based on comments received, the final
Guidance modified the proposed hierarchy by adding a predicted BAF based on a BSAF as the
second method in the hierarchy. BSAFs may be used for predicting BAFs from concentrations of
chemicals in surface sediments. In addition, the final Guidance used a model to assist in
predicting BAFs that includes both benthic and pelagic food chains, thereby incorporating
exposures of organisms to chemicals from both the sediment and the water column. The model
used in the proposal only included the pelagic food chain, and therefore did not account for
exposure to aquatic organisms from sediment.
The proposed Guidance used the total concentration of a chemical in the ambient water when
deriving BAFs for organic chemicals. EPA requested comments on deriving BAFs in terms of the
freely dissolved concentration of the chemical in the ambient water. Based on comments received
from the proposal and the document, the final Guidance uses the freely dissolved concentration of
a chemical instead of the total concentration in the derivation of BAFs for organic chemicals in
order to improve the accuracy of extrapolations between water bodies.
The proposed Guidance would have required that pollutants with human health BAFs greater than
1000 receive increased attention and more stringent controls within the Great Lakes System.
These pollutants are termed BCCs. EPA identified 28 BCCs in the proposed Guidance. The
additional controls for BCCs are specified in certain of the implementation procedures and the
antidegradation procedures, and are discussed further in the SID. The final Guidance identified
22 BCCs to be targeted for special controls instead of the 28 in the proposed Guidance. Six
BCCs were deleted from the proposed list because of concern that the methods used to estimate
the BAFs may not account for metabolism or degradation of the pollutants in the environment.
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EPA has traditionally developed numeric water quality criteria on a single pollutant basis, but
most potential environmental hazards involve mixtures of two or more pollutants. The individual
pollutants in such mixtures can act or interact in various ways which may affect the magnitude and
nature of risks or effects on human health, aquatic life, and wildlife. WET tests address
interactive effects of mixtures on aquatic organisms. EPA's 1986 "Guidelines for the Health Risk
Assessment of Chemical Mixtures" set forth principles and procedures for human health risk
assessment of chemical mixtures, but there were no technical guidelines on how to assess effects
on wildlife from chemical mixtures. Regulatory language was proposed for two options, each
with separate provisions for aquatic life, wildlife and human health. One approach was developed
by the Initiative Committees, modified to delete the application of toxicity equivalency factors
(TEFs) for PCBs to wildlife; the other was developed by EPA. Neither approach addressed the
possible toxicologic interactions between pollutants in a mixture (e.g., synergism or antagonism)
because of the limited data available on these interactive effects. In the absence of contrary data,
both approaches recommended that the risk to human health from individual carcinogens in a
mixture be considered additive, and that a 10"5 risk level be adopted as a cap for the cancer risk
associated with mixtures. Both approaches also proposed using TEFs to assess the risk to
humans and wildlife from certain chemical classes. The TEF approach converts the concentration
of individual components in a mixture of chemicals to an "equivalent" concentration expressed in
terms of a reference chemical. Both approaches used the 17 TEFs for dioxins and furans. The
final Guidance includes a general requirement for States and Tribes to adopt an additivity
provision to protect human health from the potential additive adverse effects from both the
noncarcinogenic and carcinogenic components of chemical mixtures in effluents and required the
use of the 17 TEFs included in the proposed Guidance to protect human health from the potential
additive adverse effects in effluents.
The proposal attempted to develop a single, consistent approach for developing TMDLs, but
there are no critical scientific or technical references in the corresponding section of the
Supplementary Information Document. The regulations allowed States and Tribes the flexibility
to control for WET with either numeric or narrative criteria, and allowed the States and Tribes to
adopt 0.3 TUa and 1.0 TUc, either as numeric criteria or as an equivalent numeric interpretation
of narrative criteria, and allowed the use of acute mixing zones for the application of the acute
criteria, but again without citing scientific references.
Critical science inputs thus involved available toxicology data on humans and aquatic life for the
pollutants for which criteria were established by the final rule; new criteria and a methodology
developed by the Initiative Committees to specifically protect wildlife; incorporation of new data
on the bioavailability of metals into the aquatic life criteria and methodologies; incorporation of
Great Lakes-specific data on fish consumption rates and fish lipid contents into the human health
criteria; and a methodology to determine the bioaccumulation properties of individual pollutants.
Description of critical documents
The major supporting documents underlying the rule fall into two groups. EPA prepared the
Final Water Quality Guidance for the Great Lakes System: Supplementary Information Document
(SID) [Reference 1] to provide a detailed discussion (with references) of EPA's reasons for
issuing the final Guidance, analysis of comments and issues, description of specific
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changes made to the proposed Guidance, and further description of the final Guidance. EPA also
prepared the Regulatory Impact Analysis (RIA) [Reference 2], which documents in Chapter 6 the
risk levels faced by populations consuming fish and other aquatic biota in the region (the risk
levels were key to setting the criteria). The RIA is heavily scientifically referenced. Finally, the
Response to Comments [Reference 64] was identified by one of the Region scientists as
explaining the critical science issues.
Other major supporting documents were developed by teams of EPA staff from the Office of
Water, ORD, and the Regions, and they provide the detailed treatments of each issue summarized
in the SID. The first three cover the development of criteria for wildlife and aquatic life,
respectively: Great Lakes Water Quality Initiative Criteria Technical Support Document for
Wildlife Criteria [Reference 3], Great Lakes Water Quality Initiative Criteria Documents for the
Protection of Wildlife - DDT, Mercury, 2,3,7,8-TCDD, PCBs [Reference 4], and Great Lakes
Water Quality Initiative Criteria Document for the Protection of Aquatic Life in Ambient Water
[Reference 5]. The Great Lakes Water Quality Initiative Technical Support Document for the
Procedure to Determine Bioaccumulation Factors. [Reference 6] develops the approach to
bioaccumulation factors that serve as the core of a common approach for the Great Lakes States.
The Great Lakes Water Quality Initiative Criteria Document for the Protection of Human Health.
[Reference 7] sets forth the basis for the human health criteria for people eating fish and wildlife
from the Great Lakes basin.
Several papers and reports about specific compounds of concern were identified by various
respondents as critical "early mover" science. Because the documents were dated after the CPA,
they could not have played a critical role in passage of the Act that required the guidance to be
issued. That said, several of these documents stand out in the Background chapter of the SID as
creating or sustaining concern about toxics in the Great Lakes. A report by Environment Canada.
(1991) Toxic chemicals in the Great Lakes and associated effects. Vols I & II. [Reference 8]
summed up the information then known about toxics problems in the Great Lakes Basin. Papers
by Colborn (1991), Gilbertson et al. (1991), Giesey et al. (1994), Mora et al. (1993), and Tillet et
al. (1992) all showed evidence of harm to birds from various toxics in the Great Lakes
[References 9-13]; Colborn at al (1990) showed that the primary route of human exposure was
fish consumed from the lake [Reference 14], and Swain (1991) and Fein et al.. (1984) [References
15-16] showed some potential for adverse pregnancy outcomes in the Basin using epidemiological
studies. Also, a series of papers by Devault et al. [References 17-21] pointed to the fact that
declining contaminant residues in fish tissue had been leveling off by the early 1990s.
Respondents identified a large number of critical references in support of development offish and
wildlife criteria. Respondents indicated that the rule relied heavily in its approach on EPA's 1992
Framework for Ecological Risk Assessment [Reference 22]. Respondents identified several
papers as being critical to the development of a model to establish bioavailability factors, which
also were cited in the SID (Eadie 1990, Thomann and Conneley 1984, Thomann 1989, Gobas
1993, MacKay 1992) [References 23-27], and Oliver and Niimi (1983, 1988) and Niimi (1985)
[References 28-30], who provided real-world lake data against which to test the model. Niimi
(1988) also was used to derive composite DDT and metabolite BAF values for aquatic trophic
levels 3 and 4, based on weighting the BAF for DDT, DDE, and DDD (derived for the
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dissolved fraction), in accordance with the fraction of each compound in the Great Lakes fish
species. A paper by DeWolf et al. (1992) [Reference 53] was cited by ORD scientists as
introducing a critical lipid-normalizing adjustment for BCFs, and another by Chin and Gschwand
(1992) [Reference 54] that developed a critical equation for determining the fraction of the
chemical that is freely dissolved in the water. Both were cited in Reference 6, but not the SID. A
report by Host et al. (1991) [Reference 60] was cited by program scientists as important in
establishing the basis for "adjustment factors" to be used to develop aquatic life criteria when a
limited suite of toxicological data for the chemical in question was available. The model
development is unique in that it appears to have been developed through a collaboration of
researchers working at a number of institutions funded through diverse funding sources. The
EPA report, Interim Report on Data and Methods for Assessment of 2,3,7,8-Tetrachlordibenzo-
p-dioxin Risks to Aquatic Life and Associated Wildlife [Reference 31] was cited as the conceptual
basis for the definitions, derivation methods, and application methods for BAFs.
Program and ORD scientists identified two critical papers that provided the background for
guidance on the Tier I and Tier II water quality criteria. The Tier I approach was based on
Stephan et al. (1985) [Reference 56]. The Tier II approach was cited as Host, GE, Regal, RR,
and Stephan, CE. Analyses of Acute and Chronic Data for Aquatic Life. 3-16-95., and although it
was referred to in the SID, it was not cited in the references. The Program office scientist also
cited a draft report, Results of simulation tests concerning the percent dissolved metal in
freshwater toxicity tests (Stephan 1994) [Reference 57] as critical in determining the percent
dissolved metal in freshwater toxicity tests. This draft paper is cited in the SID.
Of the 24 references in the Human Health Chapter of the SID, respondents identified only two
reports by West et al (1989, 1993). While two other papers on fish consumption and the West
(1989) paper were used to identify a regional fish consumption estimate in the proposal, the West
1993) study [Reference 32], because it included an entire year of data and split fish into trophic
levels, proved definitive. This report increased the estimates offish consumption in the Great
Lakes region by a factor of two (and thus reduced the allowable contamination levels by a factor
of two), and also was used to specify the mix of trophic level fish in the diet (higher trophic level
fish have higher tissue values for bioaccumulative contaminants).
The evaluator carefully read the Health Effects Chapter of the SID and identified several other
references that appear to be critical. Dedrick (1973), Freirich et al. (1986), and Pinkel (1958)
[References 33-35] are cited in support of a 2/3 surface area scaling factor for converting effects
on test organisms to humans (against a proposal to use a 3/4 body weight scaling factor). EPA's
Exposure Factors Handbook (1989) [Reference 36] is cited several times, in support of default
body weights and water consumption. Although several papers are cited, the tap water study of
Ershow and Cantor (1989) [Reference 37] seems to have done the most to persuade EPA that the
2.0 L/day default value was appropriate. The program office scientist also said, "we used several
data sources such as the Ceasars and Acquire databases, to develop aquatic life criteria. We used
information in the IRIS database to develop Human Health criteria. We also used several state
databases to determine percent lipid values offish (needed to develop BAFs)." These databases
were from the fish contaminant monitoring programs in Michigan, Wisconsin, Ohio, Indiana, New
York and Minnesota. No explicit sources were identified in the Health Document; the sources
were in the TSD for bioaccumulation factors.
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Responding to comments on various criteria values for human health, the SID cited Norback and
Weltman (1985) [Reference 38] in support of the slope factor for cancer risk from PCBs,
Bowman et al. (1989) [Reference 39] on non-cancer risks from TCDD, and the Sauer (1990)
reevaluation of the data of Kociba et al. (1978) [References 40 and 41] on TCDD cancer criteria.
Although not identified by respondents, the SID references the EPA Risk Assessment Forum
report, Interim Procedures for Estimating Risks Associated with Exposures to Mixtures of
Chlorinated Dibenzo-p-Dioxins and -Dibenzofurans and 1989 Update (EPA 1989) [Reference 53]
in support of the additivity approach for toxic equivalency factors for human health.
ORD scientists working on the Technical Committee identified a number of documents critical to
the development of Wildlife criteria. Many, but not all, were referenced in the Wildlife Chapter of
the SID. Allometric equations from Nagy (1987) [Reference 42] were used to determine food
and water ingestion rates when species-specific data were not available, but also allowed the use
of the approach in EPA (1993) [Reference 36]. A study by Dunning (1984) [Reference 60], cited
in Reference 5, was used to adjust the factors for body weights in different bird species, and a
study by Calder and Braun (1983) [Reference 61] cited in Reference 3 provided a critical
allometric equation for estimating drinking water ingestion rates in different species. The
dose/response curve for the avian TD for mercury depended on data from a series of studies by
Heinz, of which three were cited by the ORD scientists (1976a, 1976b, and 1979) [References 43-
45], and Wobeser et al. (1976) [Reference 46] was cited to defend the uptake factor for mercury
in mammals. A study by Anderson (1975) [Reference 47] was cited by the ORD scientists and
the SID in defense of deriving water quality criteria for DDT and its metabolites, and as was
Baune and Norstrum (1989) and Aulerich and Ringer (1977) [References 48 and 49] for
biomagnification factors for PCBs and 2,3,7,8 TCDD, and Nosek et al. (1992) [Reference 50] for
avian uptake factors for 2,3,7,8 TCDD. ORD scientists identified a pheasant study by Dahlgren et
al. (1972) [Reference 58] that was used to derive the avian wildlife value for PCBs, and a study
by Murray et al. (1979) [Reference 59], that was used to develop the mammalian wildlife value
for 2,3,7,8-TCDD.
ORD scientists cited two reports by EPA's Science Advisory Board (EPA 1992, 1994)
[References 51 and 52] as being critical. The 1992 SAB evaluation of the then nascent guidance
indicated concern with the wildlife criteria concepts being formulated around the perceived
requirements of the noncancer human health paradigm, which might be inadequate for wildlife.
EPA made several changes in response to the SAB's commentary in the proposed Guidance (58
FR 20882). The 1994 SAB commentary (EPA1994) found that, with the changes, it promised to
be an innovative and valuable new method for understanding the fate and effects of contaminants
in the environment, which led to EPA believing the approach to be appropriate.
Finally, the primary contact for the region identified two reports as particularly important in
independently confirming the ability of the States in the region to afford the rule, which is
important because water quality criteria do consider costs. The reports are, Great Lakes Water
Quality Initiative: Cost Effective Measures to Enhance Environmental Quality and Regional
Competitiveness (1993) and Great Lakes Water Quality Initiative, Cost Effectiveness Update
(1995) [References 62 and 63].
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Table of critical documents
Ref. JDocument/Study
1 JFinal Water Quality Guidance for the
jGreat Lakes System: Supplementary
jlnformation Document (SID).
JEPA-820-B-95-001 , U.S. EPA Office of
iWater. March 1995
2 ;RCG/Hagler Bailly. 1993. Regulatory
jlmpact Analysis of the Proposed Great
jLakes Water Quality Guidance - Final
jReport. Prepared by R.S. Raucher, E.
JTrabka, and A. Dixon for the U.S. EPA.
iApril 15.
3 jGreat Lakes Water Quality Initiative
jTechnical Support Document for Wildlife
JCriteria. EPA-820-B-95-009. U.S. EPA
iOffice of Water. March 1995
4 jGreat Lakes Water Quality Initiative
iCriteria Documents for the Protection of
jWildlife DDT, Mercury, 2,3,7,8-TCDD,
JPCBs. EPA-820-B-95-008. U.S. EPA
iOffice of Water. March 1995
5 jGreat Lakes Water Quality Initiative
JCriteria Document for the Protection of
jAquatic Life in Ambient Water.
JEPA-820-B-95-004. U.S. EPA Office of
iWater. March 1995
6 JGreat Lakes Water Quality Initiative
jTechnical Support Document for the Pro-
jcedure to Determine Bioaccumulation
JFactors. EPA-820-B-95-005. U.S. EPA
iOffice of Water. March 1995
7 jGreat Lakes Water Quality Initiative
JCriteria Document for the Protection of
JHuman Health. EPA-820-B-95-006. U.S.
iEPA Office of Water. March 1995
8 JEnvironment Canada. (1991) Toxic
jchemicals in the Great Lakes and
jassociated effects. Vol. II. Effects.
jCanada. Department of Fisheries and
{Oceans, Health and Welfare.
9 jColborn, T.I. 1991. Epidemiology of
JGreat Lakes bald eagles. J. Toxicol.
Environ. Health Toxicol. 33:395-453.
10 jGilbertson, M., T. Kubiak, J. Ludwig, and
JG. Fox. 1991. Great Lakes embryo
jmortality, edema, and deformities
jsyndrome (GLEMEDS) in colonial fish-
jeating birds: similarity to chick-edema
jdisease. J. Toxicol. Environ. Health, 33:
J455-520.
Who Performed
..J.Upatego.ryl ..,
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Report 2003-P-00003
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Ref. JDocument/Study
11 JGiesy, J.P., J.P. Ludwig, and D.E. Tillitt.
J1994. Deformities in birds of the Great
jLakes region: Assigning causality.
JEnviron. Sci. Technol., 28(3):
I128A-135A.
12 JMora, M.A., H.J. Auman, J.P. Ludwig,
JJ.P. Giesy, D.A. Verbrugge, and M.E.
jLudwig. 1993. Polychlorinated
jbiphenyls and chlorinated insecticides in
jplasma of Caspian terns: relationships
jwith age, productivity, and colony site
jtenacity in the Great Lakes. Arch.
Environ. Contam. Toxicol. 24: 320-331.
13 JTillitt, D.E., G.T. Ankley, J.P. Giesy, J.P.
JLudwig, H. Kurita-Matsuba, D.V.
jWeseloh, P.S. Ross, C.A. Bishop, L.
jSileo, K.L. Stromborg, J. Larson, and T.
JKubiak. 1992. Polychlorinated biphenyl
jresidues and egg mortality in
jdouble-crested cormorants from the
JGreat Lakes. Env. Toxicol. Chem. 1 1 :
11281-1288.
14 jColborn, I.E., Davidson, A., Green S.N.,
jHodge, R.A., Jackson, C.I., and Liroff,
JR.A. 1990. Great Lakes, Great Legacy?
jWashington, D.C.: The Conservation
jFoundation; and Ottawa, Ontario: The
ilnstitute for Research on Public policy;
i174.
15 ;Swain,W.R. 1991. Effects of organ-
jchlorine chemicals on the reproductive
joutcomes of humans who consumed
jcontaminated Great lakes fish: an
iepidemiologic consideration. J. Toxicol.
Environ. Health 33: 587-639.
16 jFein, G.G., J.L. Jacobson, S.W.
jJacobson, P.M. Schwartz, and J.K.
jDowler. 1984b. Prenatal exposure to
jpolychlorinated biphenyls: Effects on
ibirth size and gestational age. J.
iPediatr. 105(2): 315-320.
17 JDeVault, D.S., W.A. Willford, R.J.
jHesselberg, D.A. Nortrupt, D.A. Rund-
jberg, A.K. Alwan, and C. Bautista. 1986.
jContaminant trends in lake trout
j(Salvelinus namaycush) from the upper
JGreat Lakes. Arch. Environ. Contam.
iToxicol. 15:349-356
18 JDeVault, D.S., J.M. Clark, G. Lahvis, and
JJ. Weishaar. 1988. Contaminants and
jtrends in fall run coho salmon. J. Great
Lakes Res. 14:23-33.
Who Performed
..J.Upatego.ryl ..,
AC
AC
AC
PS
PS
AC
IP
IP
Who Funded
JLCCjtego.ry.L
o
o
0
o
0
ORD
PO/OF
PO
Funding
Mechanism
U
U
U
U
G
CA
I
I
Peer
Review?
N
ENP
ENP
U
ENP
ENP
ENP
ENP
A-44
Report 2003-P-00003
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Ref. JDocument/Study
19 JDeVault, D.S. 1993a. Data on
jcontaminant trends in Lake Trout
i(Unpublished). Contains data for
i1 984-1 990.
20 JDeVault, D.S. 1993b. Data on
jcontaminant trends in fall run coho
isalmon (Unpublished). Contains data for
i1 986-1 990
21 JDeVault, David S., and R. Hesselberg.
J1994. Contaminant trends in lake trout
land walleye from the St. Lawrence Great
{Lakes. (Final Draft
22 jU.S. Environmental Protection Agency.
|1 992. Framework for Ecological Risk
JAssessment. Washington D.C.
IEPA/630/R-92/001 .
23 JEadie, B.J., N.R. Morehead, and P.F.
jLandrum. 1990. "Three-phase
jpartitioning of hydrophobic organic
jcompounds in Great Lakes waters."
iChemosphere, 20, 161-178.
24 JThomann, R.V. and J.P. Connolly. 1984.
jModel of PCB in the Lake Michigan lake
itroutfood chain. Environ. Sci. Technol.
i1 8: 65-71.
25 JThomann, R.V. 1989. Bioaccumulation
jModel of Organic Chemical Distribution
Jin Aquatic Food Chains. Environ. Sci.
iTechnol. 23:699-707
26 JGobas, F.A.P.C. 1993, "A model for
jpredicting the bioaccumulation of
jhydrophobic organic chemicals in
jaquatic food-webs: application to Lake
{Ontario." Ecological Modelling, 69, 1-17^
27 jMackay, D. 1982. Correlation of
ibioconcentration factors. Environ. Sci.
iTechnol. 16:274-278.
28 jOliver, E.G. and A.J. Niimi. 1983.
JBioconcentration of chlorobenzenes from
jwater by rainbow trout: correlations with
jpartition coefficients and environmental
iresidues. Environ. Sci. Technol.
i1 7:287-291.
29 jOliver, E.G. and A.J. Niimi. 1988.
jTrophodynamic analysis of polychlor-
jinated biphenyl congeners and other
jchlorinated hydrocarbons in the lake
iOntario ecosystem. Environ. Sci.
{Technol. 22:388-397.
Who Performed
..J.Upatego.ryl ...
IP
IP
IP/OF
IP/IO
OF
AC
AC
AC
AC
OG
OG
Who Funded
JLCCjtego.ry.L
PO
PO
PO
ORD
OF
ORD
OF
O
PO/0
O
0
Funding
Mechanism
I
I
I
I
0
CA
G
U
U
O
0
Peer
Review?
U
U
U
FACA
ENP
ENP
ENP
ENP
ENP
ENP
ENP
A-45
Report 2003-P-00003
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Ref. JDocument/Study
30 JNiimi, A.J. 1985. Use of laboratory
jstudies in assessing the behavior of
jcontaminants in fish inhabiting natural
iecosystems. Water Poll. Res. J. Canada
120:79-88.
31 JU.S. EPA. 1993. Interim Report on Data
jand Methods for Assessment of
|2,3,7,8-Tetrachlordibenzo-p-dioxin Risks
ito Aquatic Life and Associated Wildlife.
IEPA/600/R-93/055
32 iWest, P., M. Fly, R. Marans, F. Larkin
jandD. Rosenblatt. 1993. 1991-1992
jMichigan Sport Anglers Fish
jConsumption Study. Final report to the
jMichigan Great Lakes Protection Fund,
jMichigan Dept. of Natural Resources.
jUniversity of Michigan, School of Natural
jResources. Natural Resources Sociology
JResearch Lab. Technical Report #6.
JMay1993.
33 JDedrick, R.L. 1973. Animal Scale Up. J.
iPharamcokin. Biopharm. 1:435-461.
34 jFreireich, E.J., E.A. Gehan, D.P. Rail,
JL.H. Schmidt, and H.E. Skipper. 1966.
jQuantitative comparison of toxicity of
janticancer agents in mouse, rat,
ihamster, dog, monkey and man. Cancer
jChemother. Rep. 50:219-244.
35 jPinkel, D.. 1958. The use of body
jsurface area as a criterion of drug
idosage in cancer chemotherapy. Cancer
iRes. 18:853-856.
36 JU.S. Environmental Protection Agency.
J1989. Exposure Factors Handbook,
jWashington, DC, Office of Health and
JEnvironmental Assessment.
iEPA/600/8-89/043.
37 JErshow, A.G. and K.P. Cantor, 1989.
Total Water and Tapwater Intake in the
jUnited States: Population-Based
JEstimates of Quantities and Sources,
{National Cancer Institute, Bethesda, MD. j
38 JNorback, D. and R.H. Weltman. 1985.
jPolychlorinated biphenyl induction of
jhepatocellular carcinomas in the
jSprague-Dawley rat. Environ. Health
{Perspectives. 60:97-105
Who Performed
..J.Upatego.ryl ..,
OG
IO
AC
OF
OF/AC
AC
IO
OF
AC
Who Funded
JLCCjtego.ry.L
0
ORD
0
OF
OF
OF
ORD
OF
OF
Funding
Mechanism
0
I
C
O
U
G
I
O
G
Peer
Review?
ENP
ENP
U
ENP
ENP
ENP
U
U
ENP
A-46
Report 2003-P-00003
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Ref. JDocument/Study
39 JBowman, R.E., et al. 1989. Chronic
jdietary intake of
J2,3,7,8-tetrachlorodibenzo-p-dioxin
j(TCDD) at 5 or 25 parts per trillion in the
jmonkey: TCDD kinetics and dose-effect
iestimate of reproductive toxicity.
JGhemosphere. 18(1-6); 243-252.
40 iSauer, R.M. 1990. Pathology Working
jGroup: 2,3,7,8-Tetrachlorodibenzo-p-
jdioxin in Sprague-Dawley rats. Pathco,
line. Submitted to the Maine Scientific
{Advisory Panel
41 jKociba, R.J. et al. 1978. Results of a
jtwo-year chronic toxicity and oncogen-
jicity study of
|2,3,7,8-tetrachlorodibenzo-p-dioxin in
irats. Toxicol. Applied Pharmacol.
146:279-303.
42 JNagy, K. A. 1987. Field Metabolic Rate
land Food Requirement Scaling in
JMammals and Birds. Ecological
{Monographs. 57(2): 111-128.
43 JHeinz, G.H. 1976a. Methylmercury:
jsecond-year feeding effects on mallard
ireproduction and duckling behavior. J.
IWildl. Manage. 40(1): 82-90.
44 JHeinz, G.H. 1976b. Methylmercury:
jsecond-year reproductive and behavioral
ieffects on mallard ducks. J. Wild I.
{Manage. 40(4): 710-715
45 JHeinz, G.H. 1979. Methylmercury:
jreproductive and behavioral effects on
ithree generations of mallard ducks. J.
iWildl. Manage. 43: 394-401.
46 iWobeser, G., N.D. Nielsen, and B.
jSchiefer. 1976. Mercury and mink: II.
jExperimental methyl mercury
iintoxication. Can. J. Comp. Med. 40:
134-45
47 iAnderson, D.W., J.R. Jehl, R.W. Rise-
jbrough, L.A. Woods, L.R. Deweese, and
jW.G. Edgecombe. 1975. Brown
jpelicans: improved reproduction off the
isouthern California coast. Science 190:
I806-808.
48 JBraune, B.M. and R.J. Norstrom. 1989.
jDynamics of organochlorine compounds
jin herring gulls: III. Tissue distribution
land bioaccumulation in Lake Ontario
jgulls. Environ. Toxicol. Chem. 8:
{957-968
Who Performed
..J.Upatego.ryl ..,
AC/PS
PS
PS
AC
OF
OF
OF
AC
OF
OG
Who Funded
JLCCjtego.ry.L
ORD/OF
U
0
OF
OF
OF
OF
O
OF
O
Funding
Mechanism
G
U
0
C/G
0
O
0
O
O
O
Peer
Review?
ENP
U
ENP
ENP
ENP
ENP
ENP
ENP
ENP
ENP
A-47
Report 2003-P-00003
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Ref. JDocument/Study
49 JAulerich, R.J. and R.K. Ringer. 1977.
jCurrent status of PCB toxicity to mink,
land effect on the reproduction. Arch.
Environ. Contam. Toxicol. 6: 279-292.
50 JNosek, J.A., S.R. Craven, J.R. Sullivan,
;J.R. Olson, and R.E. Peterson. 1992.
I Metabolism and disposition of
|2,3,7,8-tetrachlorodibenzo-p-dioxin in
jring-necked pheasant hens, chicks, and
ieggs. J. Toxicol. Environ. Health. 35:
1153-164.
51 JU.S. Environmental Protection Agency.
J1992. An SAB report: Evaluation of the
jguidance for the Great Lakes Water
JQuality Initiative. Washington D.C.
iEPA-SAB-EPEC/DWC-93-005.
52 jU.S. Environmental Protection Agency.
J1994. Advisory on the development of a
inational wildlife criteria program.
{Washington D.C. EPA-SAB-EPEC-ADV j
53 jEPA 1989. Interim Procedures for
JEstimating Risks Associated with
Exposures to Mixtures of
54 jDeWolfW, de Bruijn JHM, Seinen W,
JHermansJLM. 1992. Influence of
jbiotransformation on the relationship
jbetween bioconcentration factors and
joctanol-water partition coefficients.
Environ. Sci. Technol. 26:1197-1201.
55 jChin, Y., and P.M. Gschwend. 1992.
j"Partitioning of polycyclic aromatic
jhydrocarbons to marine porewater
iorganic colloids." Environ. Sci. Technol.,
{26, 1621-1626.
56 jStephan C.E., D.I. Mount, D.J. Hansen,
;J.H. Gentile, G.A. Chapman, and W.A.
JBrungs. 1985. Guidelines for deriving
jnumerical National water quality criteria
jforthe protection of aquatic organisms
land their uses. Office of Research and
Development.
57 jDraft Report: Results of Simulation
jTests Concerning the Percent Dissolved
I Metal in Freshwater Toxicity Tests
{(Stephan, 8/1994
58 JDahlgren, R.B., R.L. Linder, and C.W.
jCarlson. 1972. Polychlorinated
jbiphenyls: their effects on penned
jpheasants. Environ. Health Perspectives
H:89-101.
Who Performed
..J.Upatego.ryl ...
AC
AC
OF
OF
IP
AC
AC
IO
10
AC
Who Funded
JLCCjtego.ry.L
0
o
0
o
0
o
OF/ORD
ORD
ORD
O
Funding
Mechanism
G/0
G
0
O
0
U
G
I
I
G
Peer
Review?
ENP
ENP
FACA
FACA
FACA
ENP
ENP
N
N
ENP
A-48
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Ref. JDocument/Study
59 JMurray, F.J., F.A. Smith, K.D. Nitschke,
jC.G. Huniston, R.J. Kociba and B.A.
jSchwetz. 1979. Three-generation
^reproduction study of rats given
|2,3,7,8-tetrachlorodobenzo-p-dioxin
I(TCDD) in the diet. Toxicol. Appl.
iPharmacol. 50:241-252.
60 jDunning, J.B. 1984. Body Weights of
J686 North American Birds. Monograph
{#1 . Western Bird Banding Association.
61 jCalderlll, W. A. and E. J. Braun. 1983.
jScaling of Osmotic Regulation in
JMammals and Birds. American Journal
ipf Physiology. 244:601-606.
62 JThe Great Lakes Water Quality Initiative:
jCost Effective Measures to Enhance
jEnvironmental Quality and Regional
JCompetitiveness (DRI/McGraw-Hill,
{September 1 993)
63 jGreat Lakes Water Quality Initiative,
JCost Effectiveness Update
l(DRI/McGraw-Hill, June 1995)
64 jGreat Lakes Water Quality Guidance:
JResponse to Comments
Who Performed
...J.UP.ategoryl ..,
PS
PS
AC
PS
PS
IP
Who Funded
JLCCjtego.ry.L
0
o
OF
o
0
PO
Funding
Mechanism
0
O
G
C
C
I
Peer
Review?
ENP
U
ENP
U
U
N
Methodology
We had an excellent response from the ORD scientists involved in the rule, who identified a large
number of very specific documents, mostly associated with the fish and wildlife criteria. We also
had very helpful responses from the primary contacts from the program and regional offices who
identified additional documents pertaining to health risks and economics, and who also vetted the
ORD scientists' responses. It is noteworthy however that all of the respondents failed to identify
two of the major technical support documents. In any case, all of the technical support
documents were available in electronic format. This allowed easy searching of the TSDs for the
references provided by the respondents, which in turn not only made the significance of these
documents clear, but also helped the evaluator to identify additional critical documents. Of all the
rules in the pilot study, this one is probably is the most complete of the scientifically complex
rules.
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Case 7
Municipal Solid Waste Landfills
Rule Title: Standards of Performance for New Stationary Sources and Guidelines for Control of
Existing Sources: Municipal Solid Waste Landfills
Citation for Final Rule: 61 Federal Register 9905 (March 12, 1996)
EPA Start Action Notice: 2535
Brief description of the rule
The standards and emission guidelines implemented section 111 of the Clean Air Act and were
based on the Administrator's determination that municipal solid waste (MSW) landfills caused, or
contributed significantly to, air pollution that may reasonably be anticipated to endanger public
health or welfare. The intended effect of the standards and guidelines was to require certain
MSW landfills to control emissions to the level achievable by the best demonstrated system of
continuous emission reduction, considering costs, nonair quality health, and environmental and
energy impacts.
The emissions of concern were methane and non-methane organic compounds (NMOC), which
include volatile organic compounds (VOC), hazardous air pollutants (FLAPs), and odorous
compounds. VOC emissions contribute to ozone formation which can result in adverse effects to
human health and vegetation. The health effects of FLAPs can include cancer, respiratory irritation
and damage to the nervous system. Methane emissions contribute to global climate change and
can result in fires and explosions when they accumulate in structures in or off the landfill site.
The requirements varied depending on the size of the new or existing landfill. Landfills less than
2.5 million megagrams (Mg) or 2.5 million cubic meters must file a design capacity report. Those
landfills bigger than that must calculate the annual NMOC emission rate. If the emission rate is
greater than 50 Mg/yr, the landfill must install controls that are to remain in effect until the
emission rate drops below that level. Specifically, using the best demonstrated technology, these
landfills must have a well-designed and well-operated gas collection system and a control device
capable of reducing NMOC in the collected gas by 98 weight-percent. In addition, there were
record keeping and reporting requirements for these landfills.
Brief description of science input to the rule
To prepare the rule, EPA needed information about: the universe of landfills; what they emit and
how much; the effect of the emissions; and the options and costs related to controlling the
emissions. In addition, using some of the above information, the Agency developed a model to
estimate emissions.
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Description of critical documents
The key support for the final rule summarized the regulatory and cost impacts, alternatives, and
comments that were the basis for changes to the rule between the proposal and promulgation.
See Reference 1. However, an earlier Report to Congress was the basis for the decision that a
rule was needed. See Reference 2. The proposed rule was supported by a regulatory impact
analysis and an economic impact analysis. These analysis considered alternatives and related
costs. See References 3 and 6.
Absent actual information on emissions, facility operators must use a model to determine if
controls are necessary. Thus, developing the model was essential to the rule. Early studies
evaluated the decomposition of waste material to determine the type and amount of gas
generated. See References 7, 8, 9, 10 and 17. Such information was pulled together (Reference
12) and a rate of generation was calculated (References 13 and 16). This rate was needed to
project either overall emissions or those from a particular landfill.
Actual emission information was needed for the model. EPA collected such information from
various sources and put it into a database (Reference 14). Information about the actual number of
landfills was also needed; in fact such a survey was required by a 1984 law and conducted. See
Reference 15. From such information the national impacts of the proposed standards and
guidelines could be estimated, justifying the need for the rule.
The model was developed by EPA, through contractors. They fine-tuned and tested it. See
References 18 and 19. The result was the Landfill Gas Emissions Model (LandGEM), Reference
20.
Because the emission controls required by the rule had to be the best demonstrated technology,
the Agency needed information on the available technology. This came mostly from the industry.
See References 21 through 25. However, EPA evaluated the effects of some options, such as
identifying the emissions from burning the collected gas. See Reference 11.
Some health information (see Reference 4) and other cost information was also collected (see
Reference 5). The latter further supported the need for the rule and the former that cost was
considered.
Table of critical documents
Ref. JDocument/Study
1 iU.S. EPA, December 1995, "Air
jEmissions from Municipal Solid Waste
Landfills Background Information for
jFinal Standards and Guidelines", RTP,
'IMC, EPA-453/R-94-02
Who Performed
It (Category)
PS
Who Funded
u It (Category) j
PO
Funding
Mechanism
C
Peer
Review?
U
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Ref. JDocument/Study
2 JU.S. EPA, October 1 988, "Report to
jCongress Solid Waste Disposal in the
jllnited States, Volume II (Chapter 4)",
JWashington, DC,
IEPA/530-SW-88-011B
3 JU.S. EPA, April 1 994, "Regulatory
jlmpact Analysis of Air Pollutant
JEmission Standards and Guidelines for
Municipal Solid Waste Landfills"
4 JHang, W.L., Rogers, S., 1982,
^'Environmental and Public Health
jlmplications of the Port Washington
Landfill", New York Public Interest
^Research Center, Inc.
5 jJansen, G.R., May 1986, "The Eco-
jnomics of Landfill Gas Projects", In:
jProceedings from the GRCDA 9th
ilnternational Landfill Gas Symposium,
Publication #GLFG-1 3
6 jResearch Triangle Institute, October
J1993, "Economic Analysis of Air
JPollution Regulations: Landfills", RTP,
JNC
7 JU.S. EPA, 1 977, "Recovery of Landfill
JGas at Mountain View, Engineering
iSite Study", EPA-530/SW-587d
8 JDeWalle, F.B., Chain, E.S.K.,
jHammerberg, E., June 1978, "Gas
jProduction from Solid Waste in
Landfills", Journal of the Environmental
iEngineering Division
9 jSouth Coast Air Quality Management
JDistrict, July 1982, "Landfill Gas
iEmissions, Report of the Task Force"
10 jEmcon Associates, 1982, "Methane
JGeneration and Recovery from
jLandfills", Ann Arbor Science
1 1 JU.S. EPA, September 1 985,
i"Compilation of Air Pollutant Emission
jFactors, Volume 1: Stationary Point
land Area Sources", AP-42, Fourth
JEdition, RTP, NC
12 JU.S. EPA, August 1986, "Critical
jReview and Summary of Leachate and
JGas Production from Landfills",
jCincinnati, OH, EPA-600/S2-86-073
13 JJ. Hargrove, W. G. Vogt, and E. T.
jConrad, SCS Engineers, to A.
JGeswein, OSWER:OSW, Novem-
jber 17, 1986, "Gas emission rates from
jsolid waste landfills"
Who Performed
..J.Upatego.ryl ..,
IP
IP
PS
PS
PS
PS
AC
OG, PS
PS
IP
PS
PS
Who Funded
^(Category),
PO
PO
0
O
PO
PO
ORD
U
0
PO
ORD
PO
Funding
Mechanism
I
I
U
U
c
G
G
U
U
I
CA
C
Peer
Review?
U
U
U
U
U
U
ENP
U
U
U
U
U
A-52
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Ref. JDocument/Study
14 JP. Carrico, W. G. Vogt, and E. T.
jConrad, SCS Engineers, to A.
jGeswein, OSWER:OSW, Octobers,
J1986, "Data base for landfill gas trace
iconstituents"
1 5 JU.S. EPA, September 1 988, "National
jSurvey of Solid Waste (Municipal)
JLandfill Facilities", Washington, DC,
JEPA/530-SW88-034,
16 |R. Pelt, Radian Corporation, to
jMunicipal Solid Waste Landfill Project
JFile, May 6, 1991, "Calculation of the
jMethane Generation Rate Constant, k" j
17 JR. Pelt, Radian Corporation, to MSW
jLandfills Project File, May 6, 1991,
j"Selection of Nonmethane Organic
jCompound Concentrations"
18 jRadian Corporation, undated,
'"Development of an Empirical Model of
JMethane Emissions from Landfills",
IRTP, NC
19 jRadian Corporation, undated, "Analysis
jof Factors Affecting Methane Gas
jRecovery From Six Landfills", RTP, NCj
20 jRadian International & Eastern
jResearch Group, 1998, "User's Manual
JLandfill Gas Emissions Model"
j(LandGEM)
21 ;Van Heuit, R.E., August 1 983,
j"Extraction, Metering and Monitoring
jEquipment for Landfill Gas Control and
jRecovery Systems", In: Proceedings
jof the GRCDA6th International Landfill
jGas Symposium
22 JLove, D.L., May 1986, "Overview Of
jProcess Options And Relative Eco-
jnomics", In: Proceedings from the
JGRCDA 9th International Landfill Gas
^Symposium, Publication #GLFG
23 jSchell, W.J., Houston, C.D., May 1986,
i"Membrane Systems for Landfill Gas
jRecovery", In: Proceedings from the
JGRCDA 9th International Landfill Gas
jSymposium, Publication #GLFG-1 3
24 jAir Products and Chemicals, Inc., 1987,
!"Landfill Gas Treatment Experience
jwith the GEMINI-S System"
25 JU.S. EPA, June 1 992, "Landfill Gas
jEnergy Utilization: Technology Options
land Case Studies", EPA-600/R-92-116
Who Performed
..J.Upatego.ryl ..,
PS
PS
PS
PS
PS
PS
PS
PS
PS
PS
PS
PS
Who Funded
^(Category),
PO
PO
PO
PO
ORD
ORD
PO
O
0
O
0
ORD
Funding
Mechanism
C
C
C
C
C
C
C
U
U
U
U
C
Peer
Review?
U
U
U
U
U
U
U
U
U
U
U
U
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Report 2003-P-00003
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Methodology
Through e-mail or an interview with a member of the pilot study team, the primary contact and a
program scientist (now with ORD) described some of the critical documents. According to the
scientist, all critical documents were in the docket. Using these descriptions, we went to the
docket (A-88-09) and pulled the documents described. We also pulled some documents we
believed might be critical. The primary contact did not disagree with those chosen as critical
when she reviewed the initial summary.
Miscellaneous Other Information
The emission standards and guidelines for municipal solid waste landfills was not as high a priority
for the Agency, unlike the similar limits for municipal waste combustors. The Agency's Report to
Congress on solid waste disposal was released in October 1988. However, the notice on the
proposed standards and guidelines for landfills was not published until May 1991, which was 32
months later. On the other hand, the proposed rule on the combustors was published in July
1987, immediately following the related Report to Congress in June 1987. A program official
credited the Agency's Landfill Methane Outreach Program as the motivation for the landfill
emission rule.
The program office and ORD both contributed to the science needed for the rule, with research
from as early as the late 1970s. At that time, ORD's Municipal Environmental Research
Laboratory in Cincinnati had an ongoing program to evaluate municipal waste, landfill leachate,
and gas management. In 1990 ORD's Air and Energy Engineering Research Laboratory began a
program to improve global landfill emission estimates, which contributed to the emission model.
A-54 Report 2003-P-00003
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CaseS
Biotechnology
Rule Title: Microbial Products of Biotechnology
Citation for Final Rule: 62 Federal Register 17910 (April 11, 1997)
EPA Start Action Notice: 2326
Brief description of the rule
This rule establishes a part in the Code of Federal Regulations for microbial products of
biotechnology subject to the Toxic Substances Control Act (TSCA), 40 C.F.R. Part 725. This
rule establishes procedures the Agency will use to conduct premanufacture review of certain new
microbial products of biotechnology. The procedures are comparable to those for traditional
chemical substances but are tailored to address the specific characteristics of these
microorganisms. Microorganisms subject to this rule are used commercially for such purposes as
production of industrial enzymes and other specialty chemicals; agricultural practices (e.g.,
biofertilizers); and break-down of chemical pollutants in the environment, but not as foods, drugs,
or pesticides, which are regulated under different statutes. The rule was designed to ensure that
EPA can adequately identify and regulate risk associated with microbial products of
biotechnology without unnecessarily hampering the biotechnology industry.
The rule implements EPA's screening program for new microorganisms under Section 5 of
TSCA, creates a number of exemptions for their general commercial use, and codifies EPA's
approach to related research and development (R&D).
For screening purposes, the rule continues the interpretation of "new" microorganism first put
forth by EPA in 1986 (51 FR 23302), i.e., "a microorganism that is formed by the deliberate
combination of genetic material originally isolated from organisms of different taxonomic genera1.
The term ...includes a microorganism which contains a mobile genetic element which was first
identified in a microorganism in a genus different from the recipient microorganism, [but not] a
microorganism which contains introduced genetic material consisting of only well-characterized,
non-coding regulatory regions from another genus." EPA believes that intergeneric
microorganisms have a sufficiently high likelihood of expressing new traits or new combinations
of traits to be termed "new" and warrant review. Microorganisms that are not intergeneric would
not be "new", and thus would not be subject to reporting under this rule.
The rule creates a reporting vehicle specifically designed for microorganisms, the Microbial
Commercial Activity Notice (MCAN). Persons intending to use intergeneric microorganisms for
commercial purposes in the United States must submit an MCAN to EPA at least 90 days before
1 A genus (pi. genera) is a level in a classification system based on the relatedness of organisms.
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such use. In general, EPA has 90 days to review the submission in order to determine whether
the intergeneric microorganism may present an unreasonable risk to human health or the
environment.
This rule establishes two exemptions from the requirement to submit a MCAN under Section
5(h)(4) of TSCA for new microorganisms introduced into general commerce. In the Tier I
exemption, if three criteria are met, manufacturers are only required to notify EPA that they are
manufacturing a new microorganism that qualifies for this exemption 10 days before commencing
manufacture, and to keep certain records (i.e., they are not required to wait for EPA approval).
To qualify for the Tier I exemption, a manufacturer must use one of the ten recipient organisms
listed in the rule, and must implement specific physical containment and control technologies. In
addition, the DNA introduced into the recipient microorganism must be well-characterized,
limited in size, poorly mobilizable, and free of certain sequences. A manufacturer, who otherwise
meets the conditions of the Tier I exemption, may modify the specified containment restrictions,
but must submit a Tier II exemption notice. The Tier II exemption requires manufacturers to
submit an abbreviated notice describing the modified containment, and provides for a 45-day
period, during which EPA would review the proposed containment. The manufacturer may not
proceed under this exemption until EPA approves the exemption.
Rather than submitting a MCAN during research and development, manufacturers may qualify for
one of several exemptions under section 5(h)(3) if they are conducting research and development
activities solely within a contained structure. For contained research conducted by researchers
who are required to comply with the National Institutes of Health (NIH) Guidelines for Research
Involving Recombinant DNA Molecules (1994), EPA has established a complete exemption from
EPA review and reporting and recordkeeping requirements. For all other manufacturers
conducting contained research and development activities EPA has established a parallel
exemption. The exemption specifies factors which the technically qualified individual must
consider in selecting the appropriate containment. The manufacturer is required to keep records
to document compliance with the containment requirements, but is exempt from almost all other
TSCA section 5 reporting requirements.
If the research involves testing of microorganisms in the environment, the organization may
choose to submit to EPA a TSCA Experimental Release Application (TERA). EPA's review
period is 60 days, although EPA may extend the period for good cause. EPA must approve the
test before the researcher may proceed, even if the 60-day period expires. EPA's approval is
limited to the conditions outlined in the TERA notice or approval. For researchers conducting
small-scale field tests with Bradyrhizobium japonicum and Rhizobium meliloti, the final rule
creates an exemption from EPA review, providing certain conditions are met. The field testing
must occur on no more than 10 terrestrial acres; the introduced genetic material must comply with
certain restrictions; and appropriate containment measures must be selected to limit dissemination.
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Brief description of science input to the rule
There was a great deal of attention paid to the safety of genetically engineered organisms in the
two decades preceding fmalization of this rule. In 1976, the National Institutes of Health
published its Guidelines for Research Involving Recombinant DNA Molecules. The
Biotechnology Science Coordinating Committee (BSCC) of the Domestic Policy Council
Working Group on Biotechnology announced a coordinated policy for dealing with biotechnology
across the various agencies with a regulatory role (e.g., FDA, USDA, and EPA) in the Federal
Register as 51 FR 23302, on June 26, 1986. The policy, while not a science document, adopted
the government-wide definition of intergeneric microorganisms adopted under this rule. The
Committee also published Principles for Federal Oversight of Biotechnology: Planned
Introduction Into the Environment of Organisms With Modified Hereditary Traits, as 55 FR
31118, on July 31, 1990
EPA's FACA, the Biotechnology Science Advisory Committee (BSAC), began holding meetings
in 1986 to brainstorm or review BSCC or EPA proposals on topics including substantially
changing the approach to identifying the "scope" of organisms that might trigger the need for
review, clarifying the types of transfers of genetic material and scale of release that would trigger
a pre-manufacturing review, definitions of pathogens (gene transfers to or from pathogenic
microorganisms were considered to be riskier than those among non-pathogens), and more
generally what factors should be considered in assessing the risks from "new" microorganisms.
Review of the minutes and from these meetings reflects a deep understanding of the potential
issues involved by arguably the best microbiologists and microbial ecologists in the country, and
they also illustrate the complexity of coming up with a scientifically sound approach that is
effective and legally defensible.
The National Institutes of Health Recombinant DNA Advisory Committee considered the safety
of release of genetically modified organisms into the environment (see Sharpies, F.E. , 1987.
Regulation of products of biotechnology. Science 235: 1329-1332, and Davis, B.D. 1987.
Bacterial domestication. Science 235: 1329, 1332-1335 for points of view of two of the
committee members). The Ecological Society of America (ESA) also convened a panel of
scientists to consider the issue. Their report is summarized in Tiedje, et al. 1989. "The planned
introduction of genetically engineered organisms: Ecological considerations and
recommendations." Ecology 70(2):298-315.
ORD also had a substantial research program in biotechnology in the 1980s. In a presentation to
the BSAC in April 1987, the Assistant Administrator for Research and Development indicated
that ORD had a budget of $7 million for R&D in biotechnology, approximately 80% of which was
in external research grants, primarily directed at developing "widely accepted methods in ...
microbial ecology." ORD projects aimed at evaluating monitoring strategies for planned field
releases were presented to the BSAC at the July 1987 and January 1988 meetings. ORD reported
on several biotechnology workshops at the January 1989 meeting. At the December 1989
meeting, ORD presented a progress report on 53 projects that had been conducted under the
program. The "primary foci of these studies [were] on detection and enumeration, survival and
colonization, and genetic exchange." Several studies funded by ORD were included in the docket
for the proposed rule.
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EPA from the start indicated that it intended to regulate microorganisms as chemicals under
TSCA, to screen "new" microorganisms under section 5(a)(l)(A), and to use the intergeneric
definition of new organisms put forward in the 1986 BSSC Coordinated Framework. There was
considerable debate about this definition. Sharpies (1987), Davis (1987), and Tiedje et al (1989)
considered the issue of whether microorganisms that involved intragenenc transfers of coding
DNA, or transfers of "well-characterized, non-coding sequences" were inherently low-risk, and
thus not worthy of screening by EPA or other Departments, and concluded that there was
inadequate science to support that assumption. At the February 1987 BSAC meeting, a
manufacturer presented an issue paper recommending that well-characterized, non-coding
regulatory sequences be exempt, but a microbial ecologist on the committee who had been
studying genetic exchange in soil dwelling Bacillus species said that manipulation of these
elements may be the most powerful capability of biotechnology and there was no reason to
assume they were safe. At the April 27 meeting, a different member said "microbial taxonomy is
somewhat arbitrary and is a weak regulatory instrument, because it is based on phytogeny rather
than evolutionary relatedness. It is questionable that taxonomic classification is related to risk."
The BSAC Chair agreed. At the July 17, 1987, meeting, the BSAC decided to review an issue
paper on the exemption of "genetic material consisting of well-characterized, non-coding
regulatory sequences" because it "raised interesting ecological issues which should be fully
considered."
However, under section 5(a)(l)(A), there is no presumption of risk associated with "new"
chemicals or microorganisms. Existing microorganisms under the proposed rule would have been
regulated under the Significant New Use Rule (SNUR) provisions of section 5(a)(l)(B), which
involves a determination of any increase or change in the type, magnitude, or duration of exposure
to humans or ecosystems. In the final rulemaking, however, EPA reserved but did not
promulgate new SNUR language for microorganisms. Consequently, much of the discussion and
debate involving the risks of intrageneric gene transfers or the comparative safety of well-
characterized non-coding DNA in the aforementioned activities had no direct impact on the final
rulemaking. What counted was novelty, not risk.
EPA dealt with this issue explicitly in determining that for this final rule, it would not reconsider,
as requested by commenters #8 and 18, whether EPA should continue to exclude microorganisms
that result from the addition of material that is well-characterized and contains only non-coding
regulatory regions. Under section 5 of TSCA, EPA determines whether a chemical substance is
"new", independently of the determination that the chemical substance or microorganism may
present risks. In defining "new microorganism", EPA focused on the potential for expression of
new traits or new combinations of traits. Where only well-characterized, non-coding regulatory
material is transferred, no distinctly new traits are likely to be introduced. Instead, quantitative
changes in existing traits in the recipient microorganism may occur. EPA recognized that the
insertion of well-characterized, non-coding regulatory regions may result in expression of
previously cryptic regions, but the genetic material in cryptic regions is present in the recipient
and could be expressed in other members of the recipients species at any time naturally. A
microorganism expressing such material as a consequence of the insertion of well-characterized,
non-coding regulatory regions would thus not be "new" under TSCA.
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There are only two documents cited in support of the idea of the science behind defining "new"
microorganisms under the rule. One of those simply serves to identify the taxonomy of
microorganisms (as opposed to the novelty of intergeneric organisms as defined), and the other
deals with the taxonomy of viruses. During a presentation on ORD's research program, one
reviewer commented that, although "much progress had been made in the considering genetic,
ecologic, and evolutionary issues, .... the information was still insufficient to give a definitive
answer on what merited review." The preamble acknowledges that some genera of bacteria are
much more diverse than others, so that in a diverse genus, species may be as genetically different
as different genera in other groups of bacteria. The rulemakers argued in response to comments
that advances in bacterial taxonomy would reduce this problem over time. As the Environmental
Defense Fund commented (while acknowledging that there are problems with an intergeneric
scope), "no one has proposed a clearly superior scope, despite years of discussion and debate.
Adoption of the intergeneric scope by EPA at this time is logical." The BSAC also commented
favorably on the entire proposed rule package.
Some of the science debates and research findings undoubtedly informed the data requirements
associated with an MCAN, but there are no references to any particular science sources in the
preambles of the proposed or final rules. For example, EPA responded to a comment on the
proposed rule: "EPA's MCAN requirements at 725.155 and 725.160 were based entirely on
TSCA 5(b) and 5(d)(l)," and "The MCAN information requirements closely parallel those for
PMNs and differ only to the extent necessary to accommodate the specific characteristics of
microorganisms."
For an example of how the Premanufacture Notices were modified for microorganisms:
Section 725.155(d) requires submission of microorganism identity information.
This corresponds to TSCA 8(a)(2)(A) which requires chemical identity and
molecular structure information. For intergeneric microorganisms, the equivalent
of chemical identity would include the taxonomic designations (genus and species)
of the recipient microorganism and the donor(s) of the introduced genetic material
as well as certain phenotypic and genotypic information. Many taxonomic
designations at the species level define phenotypically and genotypically diverse
groups of microorganisms. Therefore, supplemental information on phenotypic
and genotypic traits is necessary to identify as precisely as possible a specific
microorganism for Inventory listing.
The response later added:
The purpose of the MCAN is to supply EPA with information necessary to identify
and list the new microorganism on the TSCA Inventory and to determine whether
the microorganism would pose an unreasonable risk to human health or the
environment. In keeping with that objective, EPA has revised 725.155(b) to
explicitly include the statement that the submitter include all reasonably
ascertainable information that will permit EPA to make a reasoned evaluation of
the human health and environmental effects of the microorganism. If EPA finds
that the information submitted in the MCAN is insufficient for EPA to complete
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its review, it may request the submitter to provide the additional information
during the 90-day review period, or EPA will take action under TSCA 5(e), where
appropriate, to regulate the substance pending submission of the information.
Based on interviews with program staff, much of the science that would be relied upon in
determining safety or risk of intergeneric microorganisms would be brought to bear in the
application and review process. Although this science was not specifically identified in the
rulemaking, it is clear that the part of the rulemaking creating subsections 725.155 (Information to
be included in the MCAN) and 725.160 (Submission of health and environmental effects data)
required substantial scientific input.
By far the major science inputs to the rulemaking itself involved specifications for the exemptions
for new microorganisms in section 5(h)(3) and section 5(h)(4). These exemptions involved the
conditions under which new microorganisms would be exempt from notification, depending on
whether they were used in contained facilities or released to the environment, and whether they
were used for commercial purposes or for research and development. The rationale for the
exemptions is best laid out in the preamble to the proposed rule (59 FR 45526).
The approach for research exemptions under 5(h)(3) was modified from that used for traditional
new chemicals, which covers "small quantities" of a chemical used for research. Whereas small
quantities of traditional chemicals are diluted in the environment, a small innoculum (initial
"dose") of microorganisms that escaped from a research experiment could establish itself and
grow to a larger size or amount. For R&D in confined structures, EPA developed performance-
based standards for containment and record-keeping and notification of employees aimed at
understanding the number of microorganisms used in a particular setting and the efficacy of
various control measures in reducing this number to a number with a reduced probability of
establishment in the natural environment, and thus would not be expected to result in
unreasonable risk if they should escape. The science cited to support 5(h)(3) concerned the
general experience of plant and animal ecologists with the size of population determining
probability of establishment.
Section 5(h)(4) exemptions allow EPA to exempt a new chemical substance from all or part of the
requirements of section 5 if it is determined that the activities involving the substance will not
present an unreasonable risk of injury to health or the environment. Although reasonable risk is
not defined, section 6(c) provides that consideration be given to factors such as harmful effects,
degree of exposure, potential benefits of the substance, substitutability, and ascertainable
economic consequences of regulatory action. EPA established five types of exemptions for R&D
and one for commercial use. Science is cited in support of two of the R&D situations: allowing
researchers to follow the NIH guidelines in one case, and field tests of two new microorganisms,
Bradyrhizobium japonicum and Rhizobium meliloti, as an example of a finding of no
unreasonable risk for microorganisms proposed for exemption from TERA reporting. There are a
substantial number of science citations in support of Tiered exemptions for commercial
applications, relating both to ten specific recipient microorganisms exempted in the rule, the
characteristics of genetic material that may be exempted from transfer to exempted recipient
microorganisms, and the standards for limiting releases from the facility.
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Description of critical documents
There is no specific technical support document for the rule, and the scientific arguments in
support of the rule are contained in the preamble to the proposed rule (Reference 1), the preamble
to the final rule (Reference 2), and in EPA (1997) Microbial Products of Biotechnology Final
Regulation under the Toxic Substances Control Act -A Summary of the Public's Comments And
The Agency's Response. (Reference 3). These three documents explain and defend the inter-
generic and non-coding criteria for "new" microorganisms triggering the need for an MCAN, the
reasons for the information requirements in the MCAN, and the exemptions for research and
certain other microorganisms for use in general commerce. Review of the regulatory impact
analysis for the rule did not reveal any technical content not contained elsewhere in the preambles
and Response to Comments.
The preamble to the proposed rule cites six documents to support the idea that successful
establishment of new organisms in the environment generally increases with the size of innoculum
(i.e., the number of initial invaders). Of these documents four refer to higher organisms, in which
the size of the initial population is suggested to depend on greater genetic variability in the
invaders, which would not be the case with carefully maintained culture of microorganisms. We
have included Tiedje et al (Reference 5), which references the aforementioned documents in the
preamble, as well as some references dealing with microorganisms, and Schroth (Reference 6),
which deals specifically with bacteria.
Tiered exemptions for organisms in general commercial use require introduced genetic material to
be (1) limited in size, (2) well-characterized, (3) free of certain sequences, and (4) poorly
mobilizable. The first criterion is defined as only "those segments required to perform the intended
function," and the second by identifying certain characteristics of the genetic sequences, but no
specific science document is cited. With respect to the third criterion, the preamble specifies that
genes known to code for certain toxins classified by Gill (References 7 and 8) as being of high
potency would preclude an exemption. The preamble also states that genes that might contribute
to multigenic toxins or pathogenicity would not preclude exemption, because a large number of
genes would be required to express the trait, but no specific science document is cited. Several
science documents are brought to bear on the fourth criterion. Poorly mobilizable is defined as
having a transfer frequency of 10"8 transfer events per donor or less. Sayre et al (1991), Kokjohn
(1989), Stotsky (1989), Sayre et al. (1989), and Jeffrey et al. (1990) (References 9-13) are cited
as evidence that transfers of genes among microorganisms in the environment through processes
such as conjugation, transformation, and transduction occur at this frequency or higher, and
Lewin (1987) and Maki et al. (1983) (References 14 and 15) are cited to show that spontaneous
mutations also occur at least this rate. Basically, this limit not only represents a baseline
frequency at which change occurs in genetic material in nature, but it also sets a technical limit for
measurability. Finally, Ippen-Ihler (1989) (Reference 16) is cited as supporting that this frequency
is attainable with current techniques.
The NIH Guidelines for Research Involving Recombinant DNA Molecules (USDA 1994)
(Reference 17) provided the framework for research in contained facilities in the rule. Radian
Corporation (1996) and EPA (1991) (References 18 and 19) were cited to support the
requirement for a six order of magnitude reduction of microbes in waste and other materials
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leaving a contained research facility. Battelle 1988 (Reference 20) was cited to support EPA's
position that "features known to be effective in minimizing viable microbial populations in
aerosols and exhaust gases" was a more appropriate requirement than specifically requiring HEPA
filters. The requirement for six log reduction of microbial populations in waste, and features
known to minimize microbial populations in aerosols and exhaust gases are both among the
criteria that have to be satisfied for an organism used in a contained facility to be exempt from the
MCAN review (in addition to the recipient organism being on the approved list and conditions
placed upon the type of genetic material introduced).
The original PMNs for Bacillus japonicum and Rhizobium meliloti are cited in support of the
exemption for field testing involving these microorganisms, and we have included one as an
example (Reference 21). For each of the ten microorganisms identified for tiered exemptions in
the rulemaking, there is a decision document that ties all of the science together to support the
exemption. An example for A niger is included for the rule (Reference 4). Each of these
decision documents is supported by a risk assessment, also prepared by the program office staff.
Each risk assessment in turn is supported by four additional documents, a health risk assessment,
an environmental hazard assessment (dealing with plant and animal effects), an exposure
assessment, and an organism profile. We have included examples of these documents for A niger
in the critical documents for this rule (References 22-25). Each of these secondary documents
contains references to the scientific literature, which we were unable to include due to time
constraints.
Table of critical documents
Ref I Document/Study
1 jMicrobial Products of
JBiotechnology - 59 FR 45526 -
jProposal Preamble
2 jMicrobial Products of
JBiotechnology- 62 FR 17910 -
iFinal Preamble
3 jMicrobial Products of
JBiotechnology Final Regulation
junderthe Toxic Substances
jControl Act - A Summary of the
jPublic's Comments And The
JAgency's Response. US EPA.
JMarch26, 1997
4 JFinal Decision Document: TSCA
jSection 5(h)(4) Exemption for
jAspergillus niger.
Who Performed It
L (Category) j
IP
IP
IP
IP
Who Funded It
(Category) j
PO
PO
PO
PO
Funding
Mechanism
I
I
I
I
Peer
Review?
FACA
N
N
FACA
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Ref I Document/Study
5 JTiedje, J., Colwell, R.K.,
JGrossman, Y.L., Hodson, R.E.,
JLenski, R.E., Mack, R.N., Regal,
;P.J. 1989. The planned
introduction of genetically
jengineered organisms: Ecological
jconsiderations and
irecommendations. Ecology
J70(2):298-315.
6 jSchroth, M.N. 1983. Bacteria as
jbiocontrol agents of plant disease.
jPages 362-369 in Klug, M.J.
jReddy, C.A., eds. Current Per-
jspectives in Microbial Ecology.
JAmerican Society for Microbiology,
Washington, DC.
7 JGill, D.M. 1982. Bacterial toxins: a
jtable of lethal amounts.
JMicrobiological Reviews 46(1): 86-
J94.
8 JGill, D.M. 1987. "Bacterial Toxins:
jdescription. Laskin, A.I.
JLechevalier, H.A., eds. pp. 3-18 in
jCRC Handbook of Microbiology,
|2nd edition, Volume VIII, Toxins
JEnzymes. CRC Press, Boca
JRaton, FL.
9 j Sayre, P.G. and Miller, R.V. 1991.
JBacterial mobile genetic elements:
jlmportance in assessing the
jenvironmental fate of genetically
iengineered sequences. Plasmid
126:151-171.
10 JKokjohn, T.A. 1989. Transduction:
jmechanism and potential for gene
jtransfer in the environment, pp 73-
J97 in Levy, S.B. and Miller, R.V.,
jeds. Gene Transfer in the
JEnvironment. McGraw-Hill: New
lYork
1 1 i Stotzky, G. 1 989. "Gene transfer
iamong bacteria in soil. pp. 165-
J222 in Levy, S.B. and Miller, R.V.,
jeds. Gene Transfer in the
iEnvironment. McGraw-Hill: New
JYprk
Who Performed It
t (Category) j
AC
AC
AC
AC
IP, AC
AC
AC
Who Funded It
.....(category).....
0
U
U
O
PO, U
ORD
ORD
Funding
Mechanism
C
U
U
C
I, U
CA
CA
Peer
Review?
ENP
U
ENP
N
ENP
N
N
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Ref I Document/Study
12 jSaye, D.J. Miller, R.V. 1989. "The
jaquatic environment: consideration
jof horizontal gene transmission in
la diversified habitat. Pages 223-
J259 in Levy, S.B. and Miller, R.V.,
jeds. Gene Transfer in the
JEnvironment. McGraw-Hill: New
JYork
13 iJeffrey, W., Paul, J., and Stewart,
jG. 1990. "Natural transformation
jof a Marine Vibrio Species by
JPIasmid DNA. Microbial Ecology
i1 9:259-268.
14 j Lewin, B., ed. 1987. Pages 55-56
Jin "Genes, Third Edition. John
iWiley Sons, New York
15 jMaki, H., Horiucki, T., and
jSekiguchi, M. 1983. "Structure
jand expression of the DNAQ
jmutator and RNase H genes of
jEscherichia coli: Overlap of the
jpromoter regions. Proceedings of
ithe National Academy of Sciences
180:7137-7141
16 ilppen-lhler, K. 1989. "Bacterial
iConjugation. Pages 33-72 in Levy,
JS.B. and Miller, R.V., eds. 1989.
JGene Transfer in the Environment.
iMcGraw-Hill: New York.
17 JU.S. Department of Health Human
jServices, National Institutes of
JHealth (NIH). 1994. Guidelines
jfor Research Involving
jRecombinant DNA Molecules (NIH
JGuidelines) (59 FR 34496, July 5,
1 1994)
18 jRadian Corp. 1996. Review of past
jpremanufacture notices for
jpotential containment criteria for
ithe 5(h)(4) exemptions in the
jproposed biotechnology rule. U.S.
JEPA, Office of Pollution
JPrevention and Toxics,
unpublished. Washington, D.C.
19 JU.S. EPA Office of Toxic Sub-
jstances. 1991. Analysis of
jenvironmental releases and
joccupational exposure in support
jof proposed TSCA 5(h)(4)
jexemption.
Who Performed It
, (Category) H
AC
AC
AC
AC
AC
OF
PS
IP
Who Funded It
.....(categorxJ...^
ORD
ORD, OF
0
O
U
OF
PO
PO
Funding
Mechanism
CA
G, CA
C
G
U
U
C
I
Peer
Review?
N
ENP
N
ENP
N
U
U
N
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Ref I Document/Study
20 JBattelle. 1988. Final Report on
jBiosafety in Large-Scale rDNA
jProcessing Facilities. 4 volume
jset. U.S. EPA, Risk Reduction
jEngineering Laboratory,
JCincinnati, OH.
21 JPMN Application for Rhizobium
imelitoli
22 JDynamac. 1991. Human health
jassessment of the possible
jrisk for use Aspergillus niger as a
jrecipient microorganism,
^Unpublished
23 JKough, J. 1991. Environmental
jassessment for the use of A.
jniger as a recipient
imicroorganism. Unpublished, U.S.
IEPA
24 jVersar. 1991. Screening level
jexposure assessment of
jAspergillus species for 5(h)(4)
jexemption under the proposed
jbiotech rule. Unpublished
25 JDynamac. 1990. Organism Profile:
\A. niger. Unpublished
Who Performed It
t (Category). ,
OF
PS
PS
IP
PS
PS
Who Funded It
.....(category)....,
ORD
O
PO
PO
PO
PO
Funding
Mechanism
IAG
O
C
I
C
C
Peer
Review?
U
FACA
U
U
U
U
Methodology
The
OIG had no response from any of the respondents during the development of this case study.
information was developed by reading the rule and preamble, the major technical support
documents, the ESA report (Tiedje 1989), the regulatory impact analysis, the response to
comments report, and the reports and minutes from the BSAC meetings in the docket. The
reference lists for the major technical support document and response to comments, as well as
research papers cited in the docket table of contents were identified, and scanned for content,
funding sources, etc. Research funded by ORD and identified by acquisition number were tracked
back to the original decision memos in the Grants Administration Division files (most turned out
to be competitively awarded).
Agency Comments and OIG Response
During the internal agency review, the primary contact and other program officials involved in the
rule identified some significant misunderstandings of the screening (MCAN) process in the
original draft, and pointed out additional areas where science played a critical role in exclusions
under section 5(h)(4). The scientific underpinnings for the exclusions were identified only in the
preamble to the proposed rule, which we had not examined earlier. Consequently, we made
substantial changes to the list of critical documents during fmalization of this report.
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Case9
Pulp and Paper (Air)
Rule Title: National Emission Standards for Hazardous Air Pollutants for Source
Category: Pulp and Paper Production
Citation for Final Rule: 63 Federal Register 18504 (April 15, 1998)
EPA Start Action Notice: 3105
Brief description of the rule
EPA promulgated effluent limitations guidelines and standards under the Clean Water Act (CWA)
for a portion of the pulp, paper, and paperboard industry, and national emission standards for
hazardous air pollutants (NESHAP) under the Clean Air Act (CAA) as amended in!990 for the
pulp and paper production source category. This summary deals only with the NESHAP.
Prior to 1990, the Clean Air Act directed EPA to regulate toxic air pollutants based on the risks
each pollutant posed to human health. The Act directed EPA to identify all pollutants that caused
"serious and irreversible illness or death," and to develop standards to reduce emissions of these
pollutants to levels that provided an "ample margin of safety" for the public. During the 1970s
and 1980s, EPA became involved in many legal, scientific, and policy debates over which
pollutants to regulate and how stringently to regulate them. In 20 years, EPA regulated only
seven pollutants (asbestos, benzene, beryllium, inorganic arsenic, mercury, radionuclides, and
vinyl chloride).
In 1990, Congress amended section 112(b) of the Clean Air Act to mandate a more practical
approach to reducing emissions of toxic air pollutants. It lists 189 HAPs and directs EPA to
develop rules to control all new and existing major sources of HAP (facilities that emit 10 tons of
any single HAP or 25 tons of total HAPs). In the first phase, EPA develops regulations, MACT
standards, requiring sources to meet specific emissions limits that are based on emissions levels
already being achieved by many similar sources in the country. In the second phase, EPA applies
a risk-based approach to assess how these technology-based emissions limits are reducing health
and environmental risks. This rule reflect the first phase of the NESHAP process for the pulp and
paper sector, which was identified in a list published by EPA in 1992 as a major source of 14
major HAPs, including methanol, chlorinated compounds, formaldehyde, benzene, and xylene
When developing a MACT standard for a particular source category, EPA looks at the level of
emissions currently being achieved by the best-performing similar sources through clean
processes, control devices, work practices, or other methods. These emissions levels set a
baseline (referred to as the "MACT floor") for the new standard. At a minimum, a MACT
standard must achieve, throughout the industry, a level of emissions control that is at least
equivalent to the MACT floor (EPA can establish a more stringent standard if it makes
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economic, environmental, and public health sense). This NESHAP was expected to reduce
baseline emissions of HAPs by 65 percent or 139,000 Mg/yr.
Brief description of science input to the rule
The MACT floor is established differently for existing sources and new sources. For existing
sources, the MACT floor must equal the average emissions limitations currently achieved by the
best-performing 12 percent of sources in that source category, if there are 30 or more existing
sources. If there are fewer than 30 existing sources, then the MACT floor must equal the average
emissions limitation achieved by the best-performing five sources in the category. For new
sources, the MACT floor must equal the level of emissions control currently achieved by the best-
controlled similar source. Wherever feasible, EPA writes the final MACT standard as an
emissions limit (i.e., as a percent reduction in emissions or a concentration limit that regulated
sources must achieve) to provide flexibility for industry to determine the most effective way to
comply with the standard.
The (engineering) science involved in this first phase of a NESHAP thus involves gathering data
on emissions of each HAP from the various potential emissions points in the pulp and paper
production process, making some determination of how to classify these processes to determine if
different MACTs are appropriate for different processes, identifying the best-performing source
and the best-performing 12% sources (for existing-source MACTs); determining whether to set
the MACT as a technology or an emissions limit; identifying appropriate compliance monitoring
methods; and determining whether a more stringent MACT is justified. There is no requirement
to either show a harmful effect (HAPs are designated in the CAAA of 1990, and there is a
separate process for revising the list), or to show achievement of an ambient standard downwind
of the source.
With respect to monitoring, EPA had proposed that method 308 be used to monitor methanol
emissions, but commenters held that EPA should not use an un-validated method. EPA validated
the method before fmalization
Description of critical documents
One of the major technical support documents was the original background information document
(BID), Pulp, Paper, and Paperboard Industry -Background Information for Promulgated Air
Emission Standards, Manufacturing Processes at Kraft, Sulfite, Soda, Semi-Chemical Mills,
Mechanical, and Secondary and Non-wood Fiber Mills, EPA-453/R-93-050a 1973 [Reference
1]. This document characterized and classified the industrial sources in this category and their
background emissions; identified the applicable control technologies; proposed model process
units, control options, and their corresponding environmental impacts and control costs; and
presented the database system used to calculate the environmental impacts. The revision of this
BID for the final rule [Reference 2] is essentially a response to comments, and presents changes to
the rule since proposal, rather than re-presenting the material in the proposal BID. Another major
support document was the Economic Analysis for the National Emission Standards for
Hazardous Air Pollutants for Source Category: Pulp and Paper Production; Effluent Limitations
Guidelines, Pretreatment Standards, and New Source
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Performance Standards: Pulp, Paper, and Paperboard Category—Phase 1 EPA Contract No. 68-
C3-0302 1997 [Reference 3], which laid out the cost-benefit analysis for the rule. This is critical for
a NESHAP, which allows a MACT lower than the typical 12% floor if justified by the cost-benefit
ratio.
Several of the critical documents centered around development of the emissions factors for the
industry (emissions factors are critical, because they are the basis for setting the MACT floor).
The Chemical Pulping Emission Factor Development Document [Reference 4], prepared by ERG
for EPA's Office of Air Quality Planning and Standards (OAQPS), represents the integration data
from a number of studies conducted by contractors working for EPA or the regulated industry.
Rather than cite these individually, they include five reports on the EPA "five mill" study, one by
Entropy Environmentalists and four by Roy F. Weston working under contract to OAQPS
[Reference 4]; a memo from J.L. Shumaker, International Paper, to P. Lassiter, July 27, 1994,
[Reference 5] summarizing HAP emissions test data for 11 International Paper mills, conducted
by Roy F. Weston under contract to International Paper; NCASI Technical Bulletins 701 and 702
[References 6 and 7], which summarized test data from chemical wood pulp mills and kraft mill
condensates; a ten-volume summary of test data from the NCASI "16 mill study" [Reference 8];
and a report by Roy F. Weston on the Texas Mill study conducted under contract to the Texas
Paper Industry [Reference 10]. Two additional reports by Radian under contract to EPA
[References 9 and 10] document the chemical recovery combustion sources at kraft and sulfite
mills, respectively.
The technical arguments in Reference 2 are difficult for the non-specialist to follow, but the key
issue is that many changes were made to the proposed rule based on data submitted by industry,
and many of the references in Reference 2 are to memoranda from Radian and ERG, to the
primary contact or to the OAQPS person identified as the recipient of comments on the rule. For
purposes of the science pilot, we did not feel it necessary to go into detail on these, since the
critical technical inputs all fall into the same categories (private sector firms under contract either
to EPA or industry).
Table of critical documents
Ref. I Document/Study
1 jPulp, Paper, and Paperboard Industry
j- Background Information for
jPromulgated Air Emission Standards,
jManufacturing Processes at Kraft,
jSulfite, Soda, Semi-Chemical Mills,
JMechanical, and Secondary and
jNon-wood Fiber Mills,
JEPA-453/R-93-050a: October 1993 ,
Who Performed
It (Category)
IP
Who Funded
t It (Category) j
PO
Funding
Mechanism
C
Peer
Review?
N
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Ref. I Document/Study
2 jPulp, Paper, and Paperboard Industry
j- Background Information for
jPromulgated Air Emission Standards,
JManufacturing Processes at Kraft,
jSulfite, Soda, Semi-Chemical Mills,
jMechanical, and Secondary and
JNon-wood Fiber Mills,
JEPA-453/R-93-050b, October 1997
3 JEconomic Analysis for the National
jEmission Standards for Hazardous Air
jPollutants for Source Category: Pulp
land Paper Production; Effluent
jLimitations Guidelines, Pretreatment
jStandards, and New Source
jPerformance Standards: Pulp, Paper,
land Paperboard Category — Phase 1
JEPA Contract No. 68-C3-0302 .
jOctober27, 1997
4 jChemical Pulping Emission Factor
jDevelopment Document. Revised
JDraft Report, July 1997. Eastern
jResearch Group.
5 JEPA Five Mill Study - Five reports
i(docketll-A-17to21)
6 iJ.L. Shumaker, International Paper, to
JP. Lassiter, EPA:CPB. July 27, 1994.
JHAP emissions test data for 1 1
^International Paper mills. (Docket IV)
7 JNCASI Technical Bulletin, No. 701 .
jCompilation of 'Air Toxic' and Total
jHydrocarbon Emissions Data for
JSources at Chemical Wood Pulp Mills.
iVolumes I and II. October 1995
8 JNCASI Technical Bulletin No. 702.
jAcetaldehyde, Acetone, Methanol and
JMethyl Ethyl Ketone Contents of Kraft
iMill Condensates. October 1995.
9 JNCASI ten volume summary of test
jreports (16-mill study) Various NCASI
Technical Bulletins (Docket IV)
10 JTexas mill study (6 volumes) con-
jducted by Roy F. Weston under
jcontract to the Texas Paper Industry
! (Docket II)
Who Performed
..J.UCategpryI..H
IP
PS
IP
PS
PS
PS
PS
PS
PS
Who Funded
Jt. (c.?.te.gpry).H
PO
PO
PO
PO
0
O
0
O
0
Funding
Mechanism
C
C
C
C
C
O
0
O
C
Peer
Review?
N
N
N
N
N
N
N
N
N
Methodology
We received no detailed responses to the questionnaires, but the primary contact directed us to
the docket and made a few general comments about how NESHAPs are developed. This
summary was developed by reading the major support documents and other documents identified
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on the pulp and paper rule web page. We then considered whether the documents referenced in
these documents were also critical.
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Case 10
Pulp and Paper (Water)
Rule Title: Effluent Limitation Guidelines, Pretreatment Standards, and New Source Performance
Standards for the Pulp, Paper, and Paperboard Point Source Category
Citation for Final Rule: 63 Federal Register 18504 (April 15, 1998)
EPA Start Action Notice: 3105
Brief description of the rule
The EPA Office of Water, in 1988, initiated a revision of the effluent limitations guidelines for the
pulp and paper industry under authority of the Clean Water Act (CWA) in response to a Consent
Decree on regulating dioxins. The intent of the Consent Decree with the Environmental Defense
Fund/National Wildlife Federation was for EPA to address discharges of toxic pollutants from
pulp mills and to conduct a multiple pathway risk assessment considering sludges, water effluent,
and products made from pulp products. The Clean Water Act requires periodic reviews of
existing effluent guidelines and Section 304(m) drives the process for selecting both new and
previously regulated industries. Early in the process EPA decided to integrate the development of
the effluent guidelines with standards under the Clean Air Act (CAA) for controlling emissions of
hazardous air pollutants (HAPs) by maximum achievable control technology (MACT). The
integrated rules became known as the pulp and paper air and water Cluster Rules.
The water rule limits the discharge of pollutants into navigable waters of the U.S. and the
introduction of pollutants into publicly owned treatment works by existing and new pulp, paper,
and paperboard mills in the subpart B and E subcategories. The pollutants of concern are
chlorinated organic compounds from chlorine bleaching, particularly dioxins and furans,
adsorbable organic halides (AOX), chloroform, and chlorinated phenolics. These pollutants have
been determined to be human carcinogens and human system toxicants, and many are extremely
toxic to aquatic life.
The primary focus of this rule is to eliminate or reduce the formation of the pollutants by pollution
preventing process changes and internal controls. For this rule, EPA determined that the effluent
limitations and standards based on Best Available Technology Economically Achievable (BAT)
should be complete substitution of chlorine dioxide for elemental chlorine as the key process
technology. EPA also determined that the technology basis for New Source Performance
Standards for toxics and non-conventional pollutants is the BAT Model Technology with the
addition of oxygen delignification and/or extended cooking. Finally, the rule includes a voluntary
advanced technology incentives program to move mills well beyond the rule's regulatory baseline
toward the minimum impact mill of the future. These process changes also contribute to
controlling emissions of HAPs.
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Brief description of science input to the rule
To prepare the rule, EPA needed information about: the universe of pulp and paper mills; what
pollutants the mills discharge in effluents; available technologies to eliminate or reduce the
formation of pollutants; data on the cost and performance of these technology options; and
analyses to determine the effluent reduction benefits and economic impacts of these options.
Description of critical documents
The key support for the final rule summarized the technologies tested, the analysis for determining
pollutants in effluent discharges, and cost impacts. [See References 1 - 6]. Another key support
was the summarization of field sampling results of technologies other than pulping and bleaching
technologies, sampling effluents and analyses of 365 specific compounds. [See References 1,8].
Another key support was a document on the technical support for the voluntary advanced
technology incentives program. [See Reference 7].
Additional information that was important to the development of the rule was background
information on dioxin releases from pulp and paper mills. Additional technical information on
pulp and paper mill discharges and treatment techniques and treatment results was used for rule
development. [See references 9 - 14]. The rule itself summarized data gathering activities and
reasons for changes after proposal in response to comments.
Table of critical documents
Ref. I Document/Study
1 jSupplemental Technical Development
jDocument for Effluent Limitations
jGuidelines and Standards for the Pulp,
JPaper, and Paperboard Point Source
jCategory j
2 jEconomic Analysis for the National
jEmissions Standards for Hazardous Air
jPollutants for Source Category: Pulp
jand Paper Production; Effluent
JLimitations Guidelines, Pretreatment
jStandards, and New Source
jPerformance Standards for the Pulp,
JPaper, and Paperboard Industry-Phase
jl
3 jAnalytical Methods for the
JDetermination of Pollutants in Pulp and
JPaper Industry Wastewater
4 JAssessment of Final Effluent
JLimitations Guidelines for the
jPapergrade Sulfite and Bleached
JPapergrade Kraft and Soda
jSubcategories of the Pulp, Paper, and
jPaperboard Industry
Who Performed
It (Category) ^
IP
IP
IP
IP
Who Funded
Jt (Category)^
PO
PO
PO
PO
Funding
Mechanism
C
C
C
C
Peer
Review?
N
N
N
N
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Ref. I Document/Study
5 JStatistical Support Document for the
jPulp and Paper Industry: Subpart B
6 Technical Support Document for Best
jManagement Practices for Spent
JPulping Liquor Management, Spill
jPrevention, and Control
7 jTechnical Support Document for the
JVoluntary Advanced Technology
jlncentives Program
8 jSummary Report for Pulp and Paper
jMill Sampling Program. June 1996.
9 JU S E P A /Paper Industry Cooperative
iDioxin Study. March 1988
10 jU.S.E.P.A/Paper Industry Cooperative
JDioxin Study: The 104 Mill Study. May
i1990. Technical Bulletin No. 590.
11 JNCASI Report: Examination of Data
jRelevant to EPA's Proposed Effluent
jLimitations Guideline for Chloroform at
JBIeached Papergrade Kraft
jSubcategory Mills. February 1996.
12 JNCASI Technical Bulletin No. 71 1 :
jLoading and Treatability of Adsorbable
JOrganic Halide (AOX) in Kraft Bleach
iPlant Effluents. April 1996.
13 ;ERG Memo to EPA on Docket
JReferences to the Relationship
jBetween AOX and Concentrations of
jOther Pollutants; and to AOX as an
JAppropriate Measure of BAT
^Performance. July 29, 1996.
14 JNCASI Report: Progress in Reducing
jthe TCDD/TCDF Content of Effluents,
jPulps, and Wastewater Treatment
jSludges from the Manufacturing of
JBIeached Chemical Pulp. 1996NCASI
iDioxin Profile. May 1997.
Who Performed
..J.UCategoryJ...H
IP
IP
IP
IP
IP
PS
PS
PS
PS
PS
Who Funded
JL(9. ategory) ,
PO
PO
PO
PO, ORD
PO
O
0
O
PO
O
Funding
Mechanism
C
C
I
C
O
u
0
O
C
O
Peer
Review?
N
N
N
II
N
N
N
N
N
N
Methodology
The primary contact e-mailed us a detailed response on the rule and generally identified science
documents he considered critical. Using the information provided by the primary contact, we
went to the docket and pulled documents that we thought were critical. We met with the primary
contact to get a better understanding of the rule. The primary contact did not disagree with those
chosen as critical when he reviewed the summary.
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Miscellaneous Other Information
According to the primary contact, the Cluster Rules were not "peer reviewed" within the structure
of the process for which ORD has the Agency lead responsibility. However, the entire rule-
making project from start to finish, including data and information sources, underwent in-depth
scrutiny by the industry and many other stakeholders inside and outside of government, primarily
through our notice and comment process driven by the Administrative Procedures Act (APA).
Moreover, the Cluster Rules (and all of the effluent guidelines) were developed through an open
process. For the Cluster Rules, in addition to extensive coordination with the industry on all data
gathering, five public meetings were held prior to proposal, and two public meetings after
proposal. Innumerable individual meetings also were held with industry, environmentalists, and
other stakeholders throughout the process. EPA also published a notice of availability of
additional information between proposal and promulgation for both the air and water rules. EPA
received thousands of public comments (many linear feet). All of these comments have responses
in the record included in many volumes.
The primary contact believed this rulemaking process must be substantially more rigorous than the
Agency's "peer review" process. Among the most important reasons why it must be substantially
more rigorous is that the primary product of this process is enforceable numerical permit
limitations and standards, implemented under a statute (CWA) with provision for penalties, which
therefore must be firmly grounded on fact and science. In addition, the rules are often litigated.
Without a very strong record including comments and responses, EPA risks remands by the
courts. At this writing the effluent guideline portion of the Cluster Rules is in the final stages of
litigation.
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Case 11
Disinfectants and Byproducts
Rule Title: National Primary Drinking Water Regulations: Stagel Disinfectant and Disinfection
Byproducts
Citation for Final Rule: 63 Federal Register 69389 (December 16, 1998)
EPA Start Action Notice: 2772
Brief description of the rule
The Stage I Disinfection Byproducts Rule finalized maximum residual disinfectant level goals
(MRDLGs) for chlorine, chloramines, and chlorine dioxide; maximum contaminant level goals
(MCLGs) for four trihalomethanes, two haloacetic acids, bromate, and chlorite. The rule also
established National Primary Drinking Water Regulations (NPDWRs) which consist of maximum
residual disinfectant levels (MRDLs) or maximum contaminant levels (MCLs) or treatment
techniques for the above mentioned disinfectants and their byproducts. Monitoring, reporting,
and public notification requirements for these compounds are also included in the NPDWRs.
Potential health risks of people exposed to disinfectants and disinfection byproducts (DBFs)
include cancer and adverse reproductive and developmental effects. EPA believed that the rule
would provide public health protection for households not covered by previous drinking water
rules for disinfection byproducts. The rule also provided first time protection from exposure to
haloacetic acids, chlorite (a major chlorine dioxide byproduct) and bromate (a major ozone
byproduct).
EPA's most significant concern in developing regulations for disinfectants and DBFs was the need
to ensure that adequate treatment be maintained for controlling risks from microbial pathogens.
EPA initiated a negotiated rulemaking which included representatives of State and local health
and regulatory agencies, public water systems, elected officials, consumer groups, and
environmental groups. The Regulatory Negotiation (Reg. Neg.) Committee had as one of its
major goals to develop an approach that would reduce the level of exposure from disinfectants
and DBFs without undermining the control of microbial pathogens. The Committee's intention
was to ensure that drinking water is microbiologically safe at the limits set for disinfectants and
DBFs and that these chemicals do not pose an unacceptable health risk at these limits. EPA
subsequently established the Microbial and Disinfectants/Disinfection Byproducts (M-DBP)
Advisory Committee which resulted in the collection, development, evaluation, and presentation
of substantial new data related to key elements of this proposed rule.
The Safe Drinking Water Act (SDWA) requires EPA to publish a MCLG for each contaminant
which, in the judgement of the EPA Administrator, "may have any adverse effect on the health of
persons and which is known or anticipated to occur in public water systems" (Section
1412(b)(3)(A). MCLGs are to be set at a level at which "no known or anticipated adverse effect
on the health of persons occur and which allows an adequate margin of safety" (Section
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1412(b)(4). The Act also requires that at the same time EPA publishes an MCLG, which is a
non-enforceable health goal, it also must publish a National Primary Drinking Water Regulation
(NPDWR) that specifies either a MCL or treatment technique. The final Stage 1 rule applied to
community water systems and nontransient noncommunity water systems that treat their water
with a chemical disinfectant for either primary or residual treatment. Certain requirements for
chlorine dioxide applied to transient noncommunity water systems.
Brief description of science input to the rule
To prepare the rule, EPA needed information on the national occurrence in drinking water of (1)
the chemical byproducts that form when disinfectants used for microbial control react with the
naturally occurring compounds present in source water and (2) disease-causing microorganisms.
EPA also needed information on how to minimize the risk from DBF's and, at the same time, still
maintain adequate control over microbial contaminants. In addition, EPA needed to assess risks
associated with DBF occurrence levels and to evaluate best available technologies for reducing
such risks to feasible levels (while not compromising microbial protection). Using scientific and
technological information gathered, EPA defined best available technologies, criteria by which
total organic carbon (naturally occurring organic precursors to DBF formation) should be
removed, and how various DBFs and disinfectants should be measured and monitored.
Description of critical documents
As stated earlier, this rule required extensive data gathering and analysis by EPA. An information
collection rule was established after the Reg. Neg. Committee determined that a rule for DBFs
was necessary. The rule evolved from many Federal Register notices, public comments, and
Advisory Committee meetings from which EPA established MCLs and MRDLs based on
scientific research. [See References 1-3]. Occurrence and exposure data was needed to
understand the extent of DBFs in drinking water and to determine the extent of the population
that is exposed to DBFs. Various studies and research documents detailed the occurrence and
exposure data and EPA analyzed and compiled the information in an occurrence assessment
document. [See References 4, 8, 13, 15]. Toxicity and epidemiological studies were key to
establishing MCLs and MRDLs. [See References 5, 6, 7, 9, 10, 11, 12, 14, 16-22, 58].
Treatment technology information and methods and standards documents were used for reviewing
drinking water and wastewater and the relationship between DBFs and organic compounds. [See
References 23-34]. MCLGs and MRDLGs were established based on criteria and assessment
documents. EPA compiled criteria information on the various DBFs in a series of health criteria
documents. [See References 44-45, 49-57, 59]. The final rule also contained a detailed discussion
for chloroform, DCA, chlorite, chloride dioxide, and bromate because significant new data was
received after the proposal. The final rule also contained a summary of the major public
comments on the MCLGs and MRDLGs. [See Rule Preamble]. Treatment technologies and best
available technologies documents were used to determine treatment requirements and alternative
treatments for meeting the new effluent guidelines. [See References 46-48]
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EPA used numerous scientific articles and reports for occurrence and exposure information and
criteria and assessment information. [See References 35-44].
Table of critical documents
Ref. i Document/Study
1 'US EPA 1994 National Primary
i Drinking Water Regulations:
j Disinfectants and Disinfection
I Byproducts. Proposed Rule. 59 FR
J38668. July 29, 1994.
2 jU.S.E.P.A. 1997. National Primary
I Drinking Water regulations;
i Disinfectants and Disinfection
j Byproducts; Notice of Data Availability;
I Proposed Rule. 62 FR 59388.
jNovemberS, 1997.
3 iUSEPA 1998 National Primary
j Drinking Water Regulations;
i Disinfectants and Disinfection
j Byproducts; Notice of Data Availability;
I Proposed Rule. 61 FR 15606. March
J31.1998.
4 jU.S.E.P.A. 1998. Occurrence As-
jsessment for Disinfectants and
i Disinfection Byproducts in Public
j Drinking Water Supplies. Office of
JGroundwater and Drinking Water. EPA
1815-6-98-004
5 'U S E P A 1998 Quantification of
i Cancer Risk from Exposure to
jChlorinated Water. Office of Science
land Technology, Office of Water.
jNovember9, 1998.
6 iCantor, K.P., etal. 1987. Bladder
jcancer, drinking water source and tap
jwater consumption: a case control
istudy. J. National Cancer Inst. 79:
i 1269-1 279
7 JDeAngelo, A.B., et al. 1991. The
jcarcinogenicity of dichloroacetic acid in
ithe male B6C3F1 mouse. Fund. Appl.
iToxicol. 16:337-347.
8 jKrasner, S.W., et al. 1989. The
joccurrence of disinfection by-products
jin U.S. drinking water. Journal AWWAj
9 jKurokawa et al. 1986. Dose-response
jstudies on the carcinogenicity of
I potassium bromate in F344 rats after
i long-term oral administration. J.
j National Cancer Inst. 77: 977-982.
Who Performed
..J.Upatego.ryl ..,
IP
IP
IP
PS
IP IO
OF
IO
OG, PS
OG
Who Funded
^(Category) H
PO
PO
PO
PO
PO
PO, ORD,
OF
ORD
PO, O
0
Funding
Mechanism
I
I
I
C
I
O
I
CA
0
Peer
Review?
OEP
OEP
OEP
ENP
ENP
ENP
ENP
ENP
ENP
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Ref. j Document/Study
10 I Morris, R.D., etal. 1992. Chlorination,
jchlorination by-products, and cancer: a
imeta- analysis. Am. J. Public Health.
!82: 955-963
11 j National Toxicology Program 1987.
JToxicology and carcinogenesis studies
jof bromodichlorommethane in F344/N
jrats and B6C3F1 mice (gavage
istudies). Technical Report Series No.
1321. NIEHS.
12 j Stevens, et al. 1989. Formation and
jcontrol of non-trihalomethane
idisinfection by-products. Journal
iAWWA. Aug:55-60
13 jBellar, et al. 1974. The occurrence of
jorganohalides in chlorinated drinking
jwater. Journal AWWA, Dec:703-706.
14 JCMA. 1996. Sodium chlorite: drinking
jwater rat two-generation reproductive
itoxicity study. Quintiles Report Ref.
iCMA/17/96.
15 jCantor, et al. 1998. Drinking water
jsource and Chlorination byproducts. I.
JRisk of bladder cancer. Epidemiology.
19:21-28
16 JDeAngelo, et al. 1998. Carcinogenicity
jof potassium bromate administered in
jthe drinking water to male B6C3f1
jmice and F344/N rats. Toxicologic
j Pathology, (draft in press)
17 JFreedman, M., et al. 1997. Bladder
icancer and drinking water: a
j population-based case-control study in
JWashington County, Maryland. Cancer
iCauses and Control. 8:738-744.
18 JKing, W.D., and Marrett, L.D. 1996.
j Case-control study of bladder cancer
land Chlorination by-products in treated
jwater (Ontario, Canada). Cancer
iCauses and Control. 7:596-604.
19 JMcGeehin, M.A. etal. 1993. Case-
j control study of bladder cancer and
jwater disinfection methods in Colorado.
JAm. Jour. Epidemiology. 138:492-501. j
20 JBull, R.J. and Cupflower, F.C. 1991.
j Health Effects of Disinfectants and
JDisinfection Byproducts. Prepared for
jthe American Water Works Research
jFoundation.
Who Performed
..J.Upatego.ryl ...
AC
OF
10
IO
PS
OF
IO
OF
AC
OG, AC
AC
Who Funded
^(Category),
0
OF
ORD
ORD
0
OF
ORD
OF
0
O
0
Funding
Mechanism
U
O
I
I
0
c, o
I
o
0
o
U
Peer
Review?
ENP
OEP
ENP
ENP
ENP
ENP
U
ENP
ENP
ENP
U
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Ref. i Document/Study
21 j Waller, et al. 1998. Trihalomethanes
Jin drinking water and spontaneous
jabortion. Epidemiology 9:134-140.
22 JReif, etal. 1996. Reproductive and
i developmental effects of disinfection
j by-products in drinking water.
I Environmental Health Perspectives
! 104:1 056-1 061.
23 jAmy, et al. 1987. Developing models
jfor predicting trihalomethane formation
I potential and kinetics. Journal AWWA.
jJuly: 89-97.
24 JGIaze, etal. 1993. Evaluating the
jformation of brominated DBFs during
iozonation. Journal AWWA. Jan. Ce-
llos
25 JKrasner, S.W., etal. 1993. Formation
land control of bromate during
iozonation of waters containing bro-
imide. Journal AWWA. Jan: 73-81
26 j Harrington, et al. 1992. Developing a
jcomputer model to simulate DBP
jformation during water treatment.
iJournal AWWA. Nov: 78-87.
27 jOwen, et al. 1993. Characterization of
j Natural Organic Matter and Its
j Relationship to Treatability. AWWA
i Research Foundation
28 jSummers, R.S., etal. 1997. Analyzing
jthe Impacts of Predisinfection Through
jJar Testing, Proceedings, AWWA
JWater Quality Technology Conference,
j Denver, CO.
29 JAPHA. 1995. Method 4500-C102 E for
jchlorite daily monitoring; Method
J6251B for HAA5 monitoring. Std.
i Methods for the Examination of Water
land Wastewater, 19th Ed. American
I Public Health Association, Washington,
JD.C.
30 JAPHA. 1996. Methods 531 OB, 531 OC,
land 531 OD -for TOC monitoring. Std.
i Methods for the Examination of Water
land Wastewater, 19th Ed. Supplement.
JAmerican Public Health Association,
jWashington, D.C.
31 iU.S.E.P.A. 1992. Methods 524.2,
j 552.1 . Methods for the Determination
iof Organic Compounds in Drinking
jWater-Supplement II. EPA/R-92/129. ,
Who Performed
..J.Upatego.ryl ...
OG
OG, AC
AC
AC
OG
AC
PS
AC
PS
PS
IO
Who Funded
^.(Category) ^
PO
ORD
ORD
O
0
PO, O
0
O, PO
0
O
ORD
Funding
Mechanism
CA
CA
G
O
C
O
0
U
U
U
C
Peer
Review?
ENP
ENP
ENP
ENP
ENP
ENP
U
U
ENP
ENP
II
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Ref. I Document/Study
32 iUSEPA 1993 Method 300 0
j Methods for the Determination of
I Inorganic Substances in Environmental
I Samples. EPA/600/R/93/1 00.
33 JU.S.E.P.A. 1995. Methods forthe
j Determination of Organic Compounds
Jin Drinking Water. Supplement III.
IEPA-600/R-95/131.
34 iUSEPA 1997 Method 300 1
j Determination of Inorganic Anions in
j Drinking Water by Ion
jChromatography. Revision 1.0. US
JEPA Nat. Exposure Research
iLaboratory, Cincinnati, OH.
35 JAmy, et al. 1993. National Survey of
j Bromide Ion in Drinking Water
jSources. Progress reports to AWWA
JResearch Foundation, U. of Colorado
jat Boulder, Dept. of Civil,
j Environmental, and Architectural
JEngineering, Boulder, Colo. 1992-
11993.
36 JMcGuire, M.J., Meadow, R.G. 1988.
jAWWA Research Foundation trihalo-
j methane survey. Journal AWWA.
iJan:61-68
37 jShorney, et al. 1996. The influence of
j raw water quality on enhanced
I coagulation and softening forthe
j removal of nom and DBP formation
jpotential. Proc. 1996 AWWA Annual
JConference, Toronto, Ontario, Canada.
38 jSinger, P.C., et. al. 1996. Enhanced
jCoagulation and Enhanced Softening
jforthe Removal of Disinfection By-
j Product Precursors: An Evaluation,
j Report to AWWA Disinfec-
jtants/Disinfection By-Products
JTechnical Advisory Workgroup of the
j Water Utility Council. December 1 996. j
39 jWestrick, et. al. 1983. The Ground
jWater Supply Survey Summary of
jVolatile Organic Contaminant
jOccurrence Data. Technical Support
JDivision, Office of Drinking Water, U.S.
jEPA., Cincinnati, OH
40 JEdwards, M.. 1997. Predicting DOC
i removal during enhanced coagulation.
jJournal AWWA. 89:78-89
Who Performed
..J.Upatego.ryl ...
IO
IO
IP IO
AC
PS
AC
AC
IP
AC
Who Funded
^(Category),
ORD
ORD
ORD
O
0
O
O
PO
ORD
Funding
Mechanism
C
C
C
O
G
O
O
I
G
Peer
Review?
II
II
II
U
ENP
U
U
U
ENP
A-80
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Ref. i Document/Study
41 JEdzwald, J.K., et. al. 1990. Aluminum
jcoagulation of natural organic matter.
jProc. Fourth Int'l. Gothenberg
I Symposium on Chemical Treatment,
jMadrid, Spain.
42 jRandtke, S.J., et. al. 1994.
I Comprehensive assessments of DBP
i precursor removal by enhanced
jcoagulation and softening. Proc.
JAWWA Ann. Conf. (Water Quality),
j New York, NY.
43 jSinger, P.C., et al. 1995. Enhanced
jCoagulation and Enhanced Softening
jforthe Removal of Disinfection By-Pro-
jduct Precursors: An Evaluation.
I Report prepared for the AWWA
jGovernment Affairs Office,
jWashington, D.C., Dept. of
I Environmental Sciences and
jEngineering, UNC, Chapel Hill, NC.
44 j White, M.C., et al. 1997. Evaluating
I criteria for enhanced coagulation com-
jpliance. Journal AWWA.
45 jCromwell, J.E., etal. 1992. Analysis of
j potential tradeoffs in regulation of
jdisinfection by-products. Office of
jGround Water and Drinking Water
I Resource Center. Washington, D.C.,
IEPA-811-R-92-008.
46 JU.S.E.P.A. 1994. Regulatory Impact
jAnalysis for NPDWR: Disinfec-
jtant/Disinfection By-Products
^Regulations. Washington, D.C.
47 'USE PA 1998 Technologies and
jCost for Control of Disinfectant and
j Disinfection By-products. Office of
JGround Water and Drinking Water
j Resource Center. Washington, D.C.
48 JU.S.E.P.A. 1998. Regulatory Impact
j Analysis for the Stage 1 Disinfec-
jtant/Disinfection By-Products
JRegulations. Washington, D.C. EPA
J815-B-98-002.
49 JU.S. EPA 1993. Draft Drinking Water
j Health Criteria Document for Bromate.
I Office of Science and Technology,
i Office of Water.
50 JU.S. EPA 1994. Final Draft Drinking
jWater Health Criteria Document for
JChlorine Dioxide, Chlorite and
jChlorate. Office of Science and
jTechnologv, Office of Water.
Who Performed
..J.Upatego.ryl ..,
AC
AC
AC
PS
PS&IP
PS
PS
PS
PS
PS
Who Funded
^(Category) H
U
O
0
O
PO
PO
PO
PO
PO
PO
Funding
Mechanism
0
O
0
O
C
C
C
C
C
C
Peer
Review?
U
U
U
ENP
U
U
ENP
ENP
U
U
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Ref. i Document/Study
51 JU.S. EPA 1994. Draft Drinking Water
i Health Criteria Document for Chlorine,
jHypochlorous Acid and Hypochlorite
lion. NCEA Office and Research and
j Development.
52 JU.S. EPA 1994. Final Draft for the
j Drinking Water Criteria Document on
JTrihalomethanes. Health and
jEcological Criteria Div., OST.
53 jU.S. EPA 1994. Draft Drinking Water
j Health Criteria Document for
jChlorinated Acetic Acids /Alcohols
j/Aldehydes and Ketones. Office of
JScience and Technology, Office of
i Water.
54 JU.S. EPA 1994. Draft Drinking Water
j Health Criteria Document for
jChloramines. ECAO. Office of
j Research and Development.
55 JU. S. EPA 1998. Dichloroacetic acid:
jCarcinogenicity Identification
j Characterization Summary. NCEA.
I Office of Research and Development.
IEPA815-B-98-010
56 JU.S. EPA 1998. Health Risk
j Assessment /Characterization of the
j Drinking Water Disinfection Byproduct
jChlorine Dioxide and the Degradation
jByproduct Chlorite. Office of Science
land Technology, Office of Water.
IEPA815-B-98-008.
57 JU.S. EPA 1998. Health Risk
j Assessment /Characterization of the
i Drinking Water Disinfection Byproduct
jBromate. Office of Science and
JTechnology, Office of Water. EPA
J815-B-98-007.
58 jU.S. EPA 1998. Panel Report and
j Recommendation for Conducting
JEpidemiological Research on Possible
i Reproductive and Developmental
j Effects Exposure to Disinfected
j Drinking Water. Office of Research
jand Development.
59 JU.S. EPA 1998. Health Risk
j Assessment/ Characterization of the
j Drinking Water Disinfection Byproduct
jChloroform. Office of Science and
JTechnology, Office of Water. EPA
J815-B-98-006.
Who Performed
..J.Upatego.ryl ..,
U
PS
PS
IO
10
PS
PS
U
PS
Who Funded
^(Category) H
ORD
PO
PO
ORD
ORD
PO
PO
ORD
PO
Funding
Mechanism
I
C
C
I
I
o
0
U
C
Peer
Review?
ENP
U
U
ENP
ENP
ENP
ENP
U
ENP
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Methodology
The program scientist and ORD scientist sent e-mails identifying, either specifically or generally,
science documents they considered critical. Using this information, we went to the docket and
pulled the documents identified. We also selected additional critical documents from the preamble
references. In addition, we met and talked on the phone with the program scientist about the rule
and the critical documents.
Agency Comments and OIG Response
In commenting on the draft report, the Office of Water's Office of Ground Water and Drinking
Water suggested specific changes related to disinfectants and by-products. Because these
changes improved the factual accuracy of the report, we changed Case 11 as suggested. The
Office of Ground Water and Drinking Water also recommended that we reassess the peer review
status of critical documents that appeared in scientific journals, and believed that certain
document should have been categorized as primary documents instead of as secondary
documents. We did reassess the peer review category for journal articles related to all the cases,
and changed the category as appropriate. Finally, we removed all references to primary
documents and secondary documents throughout the report and addendum.
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Case 12
Polychlorinated Biphenyls
Rule Title: Disposal of poly chlorinated biphenyls (PCB)
Citation for Final Rule: 63 Federal Register 35383 (June 29, 1998)
EPA Start Action Notice: 2878
Brief description of the rule
EPA amended its rules under the Toxic Substances Control Act (TSCA) that address PCB. The
changes were intended to: simplify the disposal options; make clean-ups more like those of the
Resource Conservation and Recovery Act and Superfund programs; and make the regulations as
self-implementing and flexible as possible since the PCB program did not have much funding.
The specific areas of change addressed in the amendments covered all of the key TSCA compo-
nents of use, manufacture, processing, distribution in commerce, and treatment/storage/disposal.
The following are some of the more significant changes found in the amendments:
• Addition of provisions authorizing certain uses of PCBs.
• Authorizing the manufacture, distribution, and use of PCBs for research and development
activities.
• Authorizing additional options for PCB cleanup and disposal.
• Establishing standards and procedures for managing "PCB remediation waste" (resulting
largely from spill cleanup) and "PCB bulk product waste" (derived from manufactured
products).
• Establishing methods for determining PCB concentration and equating surface and bulk
concentration for non-porous materials.
• Specifying management controls for PCB items destined for reuse.
• Establishing a mechanism for coordinating PCB management approvals among federal
programs.
Numerous other changes and clarifications apply to PCB analysis, marking, record-keeping,
reporting, and requesting exemptions.
Brief description of science input to the rule
In amending the disposal rule, EPA considered more recent health-risk information and additional
sources of contamination. Testing methods were also updated. Otherwise, EPA used the
knowledge it had gained from years of monitoring PCB disposal practices across the country to
increase the options available in resolving PCB problems.
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Description of critical documents
In the major supporting document for the rule, EPA determined the cost impact of the changes,
which was needed because the options must be cost-effective and environmentally protective.
See Reference 1.
Since the rule must protect against unreasonable risk, evaluating risk was an important part of the
process. Reference 2 is the overall risk assessment. It evaluated risk in terms of lifetime cancer
probability, so the updated cancer dose-response assessment (Reference 3) was used. Other risk-
related information was also available. For example, Reference 4 addressed exposures from one
pound or less of PCBs. One pound was the minimum at which a spill must be reported, and the
maximum amount that may be manufactured in a year without a permit. Reference 5 addressed
exposure from PCB-contaminated fluff in a landfill. Fluff is the nonmetallic waste output of a
shredder operation and is often contaminated by PCB.
Measuring the extent of contamination was important to disposal because the options vary with
both the amount of PCB involved and whether it is integrated into a product. Reference 6
concerned testing methods.
References 7 and 8 identified two specific contamination problems for which the requirements
were changed. The first concerned fluff, which was discussed above, and the second concerned
natural gas pipelines. Since 1981 EPA had monitored efforts by the natural gas industry to reduce
PCB contamination of it pipeline distribution system. Based on this experience, the requirement
pertaining to natural gas pipelines were changed in the rule.
Because the effectiveness of clean-up affects disposal options, EPA certifies clean-up methods
that can be used. Reference 9 offered an approach using kerosene to remove PCB from a surface,
and Reference 10 offered an approach using less hazardous, aqueous-based cleaners for the same
purpose.
Table of critical documents
Ref. i Document/Study
1 JU.S. EPA, April 1 998, "Cost Impacts of
jthe Final Regulation Amending the
JPCB Disposal Regulations at 40 CFR
|Part761"
2 jVersar, Inc., May 1998, "Assessment of
JRisks Associated with the PCB Dis-
jposal Amendments", Springfield, VA
3 JU.S. EPA, September 1996, "PCBs
jCancer Dose-Response Assessment
jand Application to Environmental
JMixtures", EPA/600/P-96/001 F,
jWashington, DC
Who Performed
It (Category)
PS
PS
IO
Who Funded
Jt (Category)
PO
PO
ORD
Funding
Mechanism
C
C
I
Peer
Review?
N
N
OEP
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Ref. i Document/Study
4 jU.S. EPA, October 24, 1986,
jMemorandum from Gregg Schweer,
jExposure Assessment Branch, to Jane
jKim, Chemical Regulation Branch, Re:
j"Conservative Estimates of Potential
jExposures of PCBs Resulting from
jSpills of One Pound of PCBs in Mineral
jOil or Askaral Fluid"
5 JU.S. EPA, August 16, 1988,
jMemorandum from Pat Jennings,
jExposure Assessment Branch, to
jDenise Keehner, Chief, Chemical
jRegulation Branch, Re: "Estimates of
jExposure of Humans to PCBs from
jDisposal of Fluff
6 JU.S. EPA, September 1986, "Test
jMethods for Evaluating Solid Waste",
JThird Edition. SW-846, Method
jNumber 9095 "Paint Filter Liquids Test"
7 jU.S. EPA, April 1 991 , "Project
jSummary-PCB, Lead and Cadmium
jLevels in Shredder Waste Materials: A
JRilot Study", EPA 560/5-90-008A,
jWashington, DC
8 JU.S. EPA, February 1991, "Technical
jGuidance for the Declassification of
interstate Natural Gas Pipeline
jSystems"
9 jMidwest Research Institute June 25,
J1992, Letter from K. Boggess to J.
jSmith, Chemical Regulations Branch,
JEED, OPTS, USEPA, Re: PCB
jsurface decontamination experiments
jusing kerosene"
10 jBattelle, undated, Final Report for
jWork Assignment 1-9, Technical
jSupport for PCB Disposal
jRulemaking", Columbus, OH
Who Performed
It (Category)
IP
IP
IP
PS
IP
PS
PS
Who Funded
Jt (Category)
PO
PO
PO
PO
PO
PO
PO
Funding
Mechanism
I
I
I
C
I
C
C
Peer
Review?
N
N
U
N
N
N
N
Methodology
The primary contact, via two e-mails, described some of the critical documents. All of them were
in the docket, according to him. We went to the docket (OPPT 66009A) and identified and
pulled the documents we could based on the primary contact's descriptions. In addition, we
identified and pulled some documents we thought might be critical. The primary contact later
disagreed with some of those we identified as critical, so we removed them from the summary.
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Miscellaneous Other Information
The preamble included a list of references considered by EPA in developing the final rule.
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n i s-v
Regional Ozone
Rule Title: Finding of Significant Contribution and Rulemaking for Certain States in the Ozone
Transport Assessment Group (OTAG) Region for Purposes of Reducing Regional Transport of
Ozone
Citation for Final Rule: 63 Federal Register 57355 (October 27, 1998)
EPA Start Action Notice: 3945
Brief description of the rule
States are required under section 110 of the Clean Air Act Amendments of 1990 to develop State
Implementation Plans (SIPs) that assure control of pollution sources sufficient to attain or
maintain compliance with National Ambient Air Quality Standards. Section 1 10(a)(2)(d))
requires that a SIP contain provisions prohibiting its sources from emitting air pollutants in
amounts that would contribute significantly to non-attainment, or interfere with maintenance of
NAAQS, in one or more downwind States, and Section 1 10(k)(5) authorizes EPA to find that a
SIP is substantially inadequate to meet any CAA requirement. If EPA makes such a finding, it
must require the State to submit, within a specified period, a SIP revision to correct the
inadequacy. Section 184 delineates a multi-state ozone transport region (OTR) in the Northeast
and requires specific additional controls for all areas (not only non-attainment areas) in that
region, and established the Ozone Transport Commission (OTC) for the purpose of
recommending to EPA, controls for all areas in that region.
In 1994 (the due date for serious ozone non-attainment areas to submit a demonstration of
attainment of the NAAQS), it became clear that many of the Eastern Seaboard States could not
achieve their 1-hour NAAQS for ozone because of upwind sources of ozone and its precursors,
nitrogen oxides (NOx) and volatile organic compounds (VOCs). Together with the Ozone
Transport Assessment Group (OTAG), established under the Environmental Council of States
(ECOS), EPA worked with the 37 eastern-most States and the District of Columbia, industry, and
environmental groups to gather technical information and identify and evaluate strategies for
reducing long-range transport of ozone and its precursors. Following two years of analysis, in
1997 the OTAG States voted 32-5 to recommend that EPA reduce NOx emissions from utilities
and other major sources. Reductions ranged from those already required by the Clean Air Act, up
to an 85% reduction in emissions rate from 1990 utility levels in a number of States in the OTAG
region.
In this rule EPA made a finding that 22 of the 37 States and the District of Columbia made
significant contributions to exceedences in the NAAQS for ozone in at least one downwind State,
and required them to submit SIPs that require NOx emission reductions to significantly reduce
such contributions (EPA did not claim that meeting these targets would result in NAAQS being
met in downwind States, but that meeting them would significantly reduce the impact on
downwind States in the most cost-effective manner). The rule set NOx emissions caps for each
State reflecting those reductions. The rule did not mandate which sources must reduce pollution,
but utilities and large non-utility point sources were identified as highly cost-effective targets.
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The final rule includes a NOx Budget Trading Program that will allow States to achieve the
required emissions reductions in a cost-effective way.
EPA also proposed Federal Implementation Plans (FIPs) to reduce regional ozone transport, in
the event that any of the 22 States or the District of Columbia did not submit the required State
implementation plan provisions in response to the NOx State implementation plan call (NOx SIP
call) or failed to submit an approvable plan. The FIPs include NOx reduction requirements for
utilities and large non-utility point sources, including large industrial boilers and turbines, large
internal combustion engines, and cement manufacturing.
Brief description of science input to the rule
Section 110(a)(2)(d) of the Clean Air Act Amendments likely owes its existence to scientific
studies began in the late 1960s that identified ozone as a "regional" pollutant. Papers presented at
a major international symposium sponsored by EPA in 1977 (the year Section 110(a)(2)(d) was
added to the Clean Air Act) indicted that there was strong empirical evidence for ozone and its
precursors to be transported aloft and transported for hundreds of miles in overlapping urban
plumes during sustained high pressure events, resulting in high ozone concentrations downwind.
The Clean Air Act Amendments of 1990 further strengthened section 110, and directed EPA to
contract an expert review of the ozone problem to the National Research Council of the National
Academy of Sciences, who concluded in their 1992 report, Rethinking the ozone problem in
urban and regional air pollution, that "Given the regional nature of the ozone problem in the
United States, a regional model is needed to develop the control strategies for individual urban
areas." OTAG was formed three years later to develop this regional model.
The rulemaking early on relied heavily on the scientific consensus-building process in OTAG,
which established technical working groups co-chaired by EPA and a representative of a State
environmental agency or the regulated community. One group tested the results of an air quality
model, UAM-V, against real world ozone data collected during four episodes (periods of elevated
ozone concentrations over large parts of the eastern U.S.), and modified the model chemistry to
bring the results into better agreement with the observations. The models were tested against
each other and found to provide similar results (although the models share some of the same
features, they are different in several respects, including the fact UAM-V does not actually
apportion the sources of ozone explicitly to upwind sources, but must be run with and without the
upwind sources included to calculate unwind contributions by difference). The group also
developed consistent NOx and VOC emissions inventories for the OTAG states, which were used
to drive the models. Analyses also were done using observations of air quality data during
episodes to lend independent confirmatory support to the model runs, including the conclusion
that upwind controls of VOC emissions would not have a significant impact on downwind air
quality. OTAG work groups developed and evaluated alternative control strategies, including
market trading schemes (see below). The OTAG research led to a number of voted
recommendations to EPA in 1997.
The critical culmination of the scientific input to the rule itself is found in the Air Quality
Modeling Technical Support Document for the NOx SIP Call. This report documents the results
of a series of analyses employing UAM-V and CAMx, that provide quantitative estimates of the
impacts of upwind sources of NOx on downwind exceedences of the 1-hour and 8-hour ozone
NAAQS, under a 2007 base case, as well as under the various control options. The models
simulated the meteorological conditions characteristic of four historical "episodes" in the Eastern
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U.S. (extended periods of weather conducive to the regional transport and formation of ozone),
using emissions estimated for the year 2007, with and without several control scenarios. These
model runs differed from the OTAG runs mainly in that the emissions inventory was modified by
EPA to include more recent utility emissions data for 1994-96 based on continuous emissions
monitors instead of less accurate emissions factors, and the fact that the models were run for all
the States in the OTAG area for all four episodes. The 2007 inventories included projected NOx
and VOC emissions from stationary sources, road and non-road mobile sources, and biogenic
emissions (trees produce VOC), using several EPA planning models (IPM, MOBILES, and
BEIS2, respectively), which project emissions for 2007 based on economic factors and the effects
of regulatory programs expected to be in effect in that year. EPA also updated the OTAG data
on the economics and feasibility of various control strategies. The results of the model runs and
the underlying inventories and control strategies are the critical science link in the rule, in that they
are the basis for identifying certain upwind States as significant contributors to downwind States
and demonstrating that a control strategy deemed cost-effective by EPA would reduce such
exceedences, thus providing justifications for the emissions caps for each State under the SIP call.
The rule ran into a legal challenge, including the allegation that projected state-by-state fossil fuel
heat input data were considerably different than those subsequently observed, apparently due to
utility deregulation and energy trading.
The models required development of comparable emissions inventories for each State, both to
drive the models and to serve as the base against which the NOx emissions cap for each State in
the SIP call was calculated. The base case emissions inventory was a hypothetical inventory for
the year 2007, assuming that all other regulations affecting NOx and other ozone precursors not
associated with the rulemaking were having their intended result. Also critical was the
determination of which controls on various emissions sources were "highly cost-effective,"
defined in the rulemaking as costing less than $2000/ton of NOx reduced. Several emissions
scenarios (0.25, 0.20, 0.15, and 0.12 Ib NOx/mm BTU for large electric generating units and 60%
reductions from baseline for large non-electricity-generating industrial boilers and turbines, 90%
reduction from large internal combustion engines, and 30% reduction from cement manufacturing
sources, along with both intrastate and interstate emissions trading) were evaluated in the
modeling technical support document to determine that such reductions would significantly
reduce upwind contributions to downwind exceedences.
EPA determined that an emissions reduction of 0.15 NOx/mm BTU for large electric generating
units with interstate emissions trading and a 60% reduction in the other sources cited above were
both highly cost-effective and technically feasible by 2003, and that such a reduction would
"eliminate the significant amount of contribution" of the upwind states to exceedences in
downwind states. The expected emissions reductions were used to set State-by-State caps for the
NOx SIP call2. The States were allowed to meet these caps by means other than the controls used
in the IPM models to set the caps. Because the air quality models represent only the
meteorological conditions during the four historical episodes, and not the entire ozone season, it
is not possible to forecast the probable frequency with which each State would exceed its ozone
NAAQS or contribute significantly to exceedence in a downwind State after implementation of
the rule.
2 Even though 0.12 Ib/ mm BTU feel below the $2000/ton threshold, and would further reduce excedeences, EPA
was not sure that the technology could be implemented by 2003
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Description of critical documents
Although there were no formal responses to the questionnaires, the OIG team member responsible
for this rule was able to delve more deeply into the science behind this rule, by being co-located
with a team of air quality modelers familiar with the history of air quality modeling. Therefore,
some of the critical science was found in the reference section of other critical documents, which
had been identified in turn among the references of still other supporting documents. Some of the
key science documents cited in the preamble (the numbers reference the attached table) included
the:
• Air Quality Modeling Technical Support Document for the NOx SIP Call [Reference 1], or
TSD, which bears the weight for identifying States as significant contributors to exceedences
in downwind States and recognizing that technologies recognized by EPA as cost-effective
would significantly reduce these contributions.
• Development of Modeling Inventory and Budgets for the Ozone Transport SIP Call
[Reference 2], which describes the development of the 2007 emissions inventory.
• Regulatory Impact Analysis of the NOx SIP Call., [Reference 3] which contains the analyses
that establish the cost-effectiveness of the various control technologies, including the
emissions trading options.
• Response to Significant Comments on the Finding of Significant Contribution and
Rulemaking for Certain States in the OTAG Region for Purposes of Reducing Regional
Transport of Ozone [Reference 4], which reiterates and explains the science behind the three
documents cited above.
The only other potentially key documents were published as part of the OTAG effort. The
preamble clearly stated that, "The OTAG's air quality modeling and recommendations formed
basis for today's action" (see preamble p. 57361). The proposed rule relied heavily on the
scientific consensus-building process in OTAG underpinning the development and testing of the
air quality models, development of the emissions inventory that underlies the model runs, and the
analysis of air quality data that lends confirmatory support to the model runs, including the
conclusion that upwind controls of VOC emissions would not have a significant impact on
downwind air quality. The preamble directs the reader to the OTAG webpages on the Internet.
However, citation of specific OTAG results in the preamble of the final rule are limited (see
below).
The modeling TSD [Reference 1] reference list is short, but most of the references appear critical.
It cites the manuals for the two models (UAM-V [Reference 5] and CAMx [References 6, 7, 8]);
the studies conducted by OTAG testing the models against real world data in the episodes
[References 9, 10, 11]; the chemical mechanism used in the models and an update to this
mechanism required to bring the modeled results into better agreement with the observed data
[References 12 and 13]; documents associated with the emissions inventory [References 2, 14];
the Regulatory Impact Analysis [Reference 3], and the OTAG Technical Support Document
[Reference 15], which identified the four episodes used in the modeling study and set the initial
conditions and boundary conditions; meteorological data; grid configurations; fine grid/coarse
grid definition; and vertical layer structures for the modeling. Both UAM-V and CAMx were
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developed using private funding by Systems Applications International, Inc. (SAI) and
ENVIRON, Inc., respectively.
The manuals for the models [References 5, 6, 7, 8] apparently are the only comprehensive
descriptions, since no peer reviewed literature was cited. UAM-V is an enhancement of UAM-
IV, the model that is recommended by EPA's Office of Air Quality Planning and Standards
(OAQPS) for development of SIPs. None of the UAM models have source-apportionment
capability, and several of the UAM-V developers left SAI to form ENVIRON and develop
CAMx, which does have source apportionment capability. The two models are considered
otherwise very similar. Each manual has a lengthy citation list, with many citations in common.
Generally, we looked through the citations for references that seemed to represent important
subroutines that would have been difficult to duplicate de novo. Interviews with modelers
suggested that much of the modeling effort is a mathematical exercise, and can be done de novo.
The performance of the models was reviewed in the open OTAG scientific meeting process
(which we listed as Other External in Table 1).
Of the critical science cited in the model user manuals, a report by Reynolds et al. (1973)
[Reference 16] reflects the birth of the UAM series of models. Early development of UAM was
funded under contract to SAI by ORD. The gray literature reports documenting further model
development are difficult to track, but looking at Reynolds (1977) pp795-802 In Dimitriades
[Reference 25] and the UAM-V users manual [Reference 5], it is clear that UAM was developed
through a combination of contracts and co-operative agreements between SAI, Inc. and ORD and
later OAQPS between 1970 and 1990. Arguably, SAI, and thus UAM-V and CAMx, owe their
existence to early research and development funding by EPA's Office of Air and Radiation (OAR)
and ORD.
Three critical papers provided the scientific underpinning for the ozone chemistry (CB-4)
mechanism. Gery, et al. (1989) [Reference 12] was cited in both manuals and in the TSD. This
paper represents the culmination of a series of projects funded by ORD under contract to SAI to
develop the CB-IV mechanism, the most widely used mechanism in ozone models (Dodge 2001)3.
Whitten et al. (1996) [Reference 13] was cited in the manuals as the modification of the CB-4
mechanism to better deal with isoprene emissions from vegetation. The underlying research cited
in the manuals was conducted by Carter, W. (1996) [Reference 17] working at the California Air
Resource Board under a contract with ORD.
Late in the project we discovered a summary of the OTAG process by Keating and Ferrell
(1999)4. They explained that OTAG had switched from the Biological Emissions Inventory
System (BEIS), the model used to estimate emissions of VOC and NOx from vegetation and
soils, to a new version, BEIS2. The newer model (Geron et al. 1994) [Reference 39] according
to Keating and Ferrell,
resulted in a 500% increase in the estimates of isoprene emissions and a 400% increase
in the estimates of soil NOx emissions as compared to the estimates produced by BEIS.
3 Dodge, M. 2000. Chemical oxidant mechanisms for air quality modeling. Atmospheric Environment: 34:
2103-2030
4 Transboundary Environmental Assessment: Lessons from the Ozone Transport Assessment Group. Technical
Report, NCEDR/99-02. National Center for Environmental Decision-making Research: Knoxville, TN.
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These changes had a significant effect on the overall emissions inventory, the relative
performance of air quality models, and the policy recommendations implied by air
quality model's predictions.
BEIS2 was felt to be more accurate, but resulted in overestimation of the ozone levels when run
with either UAM-V or CAMx. The addition of the Carter chemistry to the UAM-V code by
Whitten et al. yielded better results, but when a researcher at one of the centers tried to use the
new chemistry in a new model, it performed poorly (Jang 1997) [Reference 40]. Timin et al.
(1997) [Reference 41] subsequently discovered that some of the reactivity data in UAM-V had
been altered when the new isoprene code was added, and this was subsequently fixed in both
UAM-V and CAMx. Without these latter papers, the modeling results could have contained
substantial errors.
Two other papers cited in the CAMx manual appear critical. Sillman, S. (1995) [Reference 18],
developed the mechanism used in CAMx to delineate between NOx and VOC control of ozone
formation. This research was funded under a competitive cooperative agreement with the
University of Michigan funded by ORD/AREAL. Wesley, M.L. (1989) [Reference 19] developed
the mechanism in CAMx used to deposit ozone to vegetation surfaces, and important "sink" for
atmospheric ozone. This research was conducted by Argonne National Labs under an IAG
funded by ORD.
The tests of the models against real world data collected during four episodes were conducted by
the four OTAG modeling centers. They were reported in Alpine Geophysics, LLC (1998)
Modeled Effects of Indiana Point Source NOx Emissions Reductions on Local and Regional 1-
HR and 8-HR Ground Level Ozone Concentrations in 1995 and 2007 Using Two OTAG Oxidant
Episodes [Reference 9]; Sonoma Technology, Inc., (1997a); Evaluation of the UAM-V Model
Performance in OTAG Simulations, Phase I: Summary of Performance Against Surface
Observations," STI-996120-1605-FR [Reference 10]; Sonoma Technology, Inc.(STI), (1997b).
Comparison of CAMx and UAM-V Model Performance for Two Ozone episodes in the Eastern
United States. STI-996203-1733-FR [Reference 11]. The contracts to assemble and report on
the results of the modeling studies were funded by OAQPS. Peer review was limited to OTAG
process.
The data that supported the modeling evaluations included the 1988 episode in the Northeast
studied intensively using EPA's Regional Oxidant Model, the 1991 LMOS episode funded by the
Great Lakes States (LADCO 1995); SOS in the 1993 episode in the Southeast (e.g., Chameides
and Cowling 1995); the and the 1995 NARSTO-NE study in the Northeast (Roberts et al. 1995)
[References 35-38]. These references are included because they indicate who performed the
research and the funding sources and mechanisms, but were not cited in the model reports.
In summary, ORD and later OAR funded under contract the majority of the research that led to
development of UAM model and it's critical components, although not the final development of
UAM-V and CAMx. That was done primarily with venture capital from the SAI and ENVIRON.
Model testing and evaluation was funded by OTAG, using episode data that owe their existence
to a number of field studies funded by ORD, the States, and industry under the SOS, LADCO,
and NARSTO programs.
The critical reports cited in the Modeling TSD are: EPA (1996) Forecast of Average Daily NOx
Emissions in July by Electric Generation Units Using OTAG 2007 Base Case and the Integrated
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Planning Model (IPM), [Reference 20], and EPA (1998a) Development of Modeling Inventory
and Budgets for the Ozone Transport SIP Call [Reference 2]. These reports were developed by
OAQPS with support from in-house contracts. These reports in turn build on reports prepared
for OAQPS by E.H. Pechan & Associates, Inc: Pechan (1997a) Ozone Transport Assessment
Group (OTAG) Emissions Inventory Development Report - Volume I: 1990 Base Year
Development (revised draft) [Reference 21]; Pechan (1997b) Ozone Transport Assessment Group
(OTAG) Emissions Inventory Development Report - Volume III: Projections and Controls
(draft); [Reference 22] and Pechan (1997c) The Acid Rain Data Base for 1996 (ARDB96)
Technical Support Document (draft) [Reference 22]. Pechan had prepared earlier versions of the
first two reports under contract to OTAG.
The final NOx emissions caps were heavily influenced by EPA's determination that an emissions
cap of 0.15 Ib/mm BTU for large electric generating units was both cost-effective and technically
achievable by 2003 (preamble, p. 57401). The three most critical sources cited appear to be EPA,
1998b. Regulatory Impact Analysis of the NOx SIP Call Docket A-96-56, VI-B-09, September
1998 [Reference 3]; Analyzing Electric Power Generation under the CAAA, March 1998. Docket
V-C-3 [Reference 24]; and Performance of Selective Catalytic Reduction on Coal-Fired Steam
Generating Units (cited on p. 57413 of the preamble) [Reference 42].
There is a fairly clear link back to the early science that established ozone as a regional air quality
problem (i.e., high-ozone episodes were not caused entirely by local sources and plumes from one
upwind urban area), which led to the inclusion of Section 110(a)(2)(d) into the 1977 Clean Air
Act Amendments. A major international symposium sponsored by ORD and attended by more
than 1000 scientists represented a key milestone in the regional ozone transport debate.
Dimitriades, B. [Ed.] International Conference on photochemical oxidant pollution and its control.
Proceedings v.l&2. EPA-600/3-77-001 a&b [Reference 25]. The symposium was organized by
an EPA scientist. None of the papers were peer-reviewed [B. Dimitreades, pers. com.].
Although the papers covered a wide range of topics involving photochemistry, methods, etc., two
papers stand out as critical for this rule.
In the first paper, Ripperton, et al. (1977) [Reference 26] cited six Research Triangle Institute
(RTI) studies conducted from 1970-1976 that led to the hypothesis that ozone and its precursors
were transported aloft, and that new ozone was created with each diurnal cycle, and thus rural
background ozone was the result of precursors transported for hundreds of miles in overlapping
urban plumes during sustained high pressure events. These studies also are described by
Vukovitch (1977) [Reference 27]. These studies, cited in NRC (1992) (see below) as seminal,
were funded under contracts with ORD and later OAR. In the second paper, Wolff, et al. (1977)
[Reference 28] reported on a high pressure episode over New England, and showed that the
precursors must have been built up in the Midwest and moved to the east. Wolff was working at
the Interstate Sanitation Commission, which received its funding from three NE States. Wolff et
al cited two other works that used similar approaches: Coffey and Stasiuk (1975), [Reference 29]
which received rigorous journal peer review, and Bach (1975) [Reference 30], which was funded
under contract to OAR.
NRC (1992) Rethinking the ozone problem in urban and regional air pollution. [Reference 31],
cited in the modeling TSD, represents the results of the deliberations of an expert panel formed by
the National Research Council (NRC) under directions from Congress. Performed under contract
to OAR (and rigorously peer reviewed under NRC guidelines), the report concluded that a
regional model was needed to develop the control strategies for individual urban areas. It cited
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Ripperton, et al. (1977), Vukovitch et al. (1977), and Logan (1989), as providing critical
supporting evidence.
Logan (1989) [Reference 32], analyzed two years of data from the SURE/ERAQS monitoring
network covering the states between IN, MA, and NC. The NRC report said that Logan's
analysis strengthened the conclusions of the case studies cited above. Logan's work was funded
by a grant to Harvard from the National Science Foundation (or NSF). The NRC report also
cited Sillman et al. (1990) [Reference 33] as evidence of the necessity to treat urban ozone plumes
explicitly in regional-scale air quality models. This work also was funded as a grant to Harvard
from NSF.
OTAG continued to pursue the analysis of air quality data (as opposed to simulation modeling) to
provide independent support for the modeling results. These results are summarized in Guinnup,
D. and R. Collom, (1997) Final Report, Volume II: Summary and Integration of Results OTAG
Air Quality Analysis Workgroup [Reference 34]. The impact of the work is summed up
(although not explicitly cited) in pp. 57381-57386 of the preamble. One paragraph sums it up as
follows (p. 57382):
The EPA relied on OTAG data to develop the information necessary to evaluate the
weight-of-evidence factors identified above. These data include emissions (tons) and
emission density (tons per square mile), air quality analyses, trajectory, wind vector,
and "ozone cloud" analyses, and subregional zero-out modeling. In brief, EPA 's
proposed approach was as follows: the OTAG transport distance scale was applied to
identify, based on the meteorological potential for transport, which States may
contribute to ozone in downwind States.^"
These references are deemed critical, even though their role is limited to their confirmatory value
of the modeling. The references in the OTAG report were funded by OTAG, published on the
OTAG Air Quality Analysis subgroup webpage, and subject to OTAG review as noted above.
In summary, ORD and OAR funded a significant amount of the research that established ozone as
a regional air quality problem under contract to Research Triangle Institute, an independent
research organization. The Interstate Sanitation Commission funded Wolffs work, and grants
from NSF to Harvard also proved important, as did the availability of monitoring data from the
EPRI monitoring network. OTAG funding was invested in additional work that had largely only
confirmative impact on the science behind the rule itself.
Table of critical documents
Ref JDocument/Study
1 JAir Quality Modeling Technical Support
jDocument for the NOx SIP Call, U.S.
jEnvironmental Protection Agency,
jOffice of Air and Radiation,
{September 23, 1998.
Who Performed
It (Category)
IP
Who Funded
It (Category)
PO
Funding
Mechanism
C
Peer
Review?
N
5 Only the items in italics (added) refer to the air quality analysis.
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Ref jDocument/Study
2 JEPA(1998a) U.S. Environmental
jProtection Agency, "Development of
jModeling Inventory and Budgets for the
jOzone Transport SIP Call," Docket
JA-96-56, V-E-06, March 23, 1998.
3 JEPA (1998b) Regulatory Impact
jAnalysis of the NOx SIP Call Docket
JA-96-56, VI-B-09, September 1 998
4 jEPA(1998c) Response to Significant
jComments on the Finding of
jSignificant Contribution...
5 jSystem Application International (SAI),
1(1995) "User's Guide to the Variable
JGrid Urban Airshed Model (UAM-V),"
{April 1995, San Rafael, CA 94903.
6 j ENVIRON International (1997a) User's
jGuide to the Ozone Tool: Ozone
jSource Apportionment Technology for
JUAM-IV, ENVIRON: Novato, CA
7 JENVIRON International (1997b) User's
jGuide to the Comprehensive Air
JQuality Model with Extensions (CAMx),
JENVIRON:Novato, CA
8 JENVIRON International (1997c)
jAssessment of the Contribution of
jEmissions from Northern OTAG States
ion Elevated Ozone Concentrations,
JDecember 1997, ENVIRON, Novato,
JCA.
9 jAlpine Geophysics, LLC (1998)
jModeled Effects of Indiana Point
jSource NOx Emissions Reductions on
jLocal and Regional 1-HR and 8-HR
jGround Level Ozone Concentrations in
J1995 and 2007 Using Two OTAG
jOxidant Episodes, AGLCovington, KY
J41017
10 jSonoma Technology, Inc. (1997a)
j"Evaluation of the UAM-V Model
jPerformance in OTAG Simulations,
jPhase I: Summary of Performance
JAgainst Surface Observations,"
JSTI-996120-1605-FR, Santa Rosa, CA
Who Performed
It (Category)
IP
IP
IP
PS
PS
PS
PS
PS
PS
Who Funded
t It (Category) j
PO
PO
PO
0
0
0
0
O
PO
Funding
Mechanism
C
C
C, I
0
0
0
C
C
C
Peer
Review?
U
U
U
OEP
OEP
OEP
OEP
OEP
OEP
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Ref jDocument/Study
11 jSonoma Technology, Inc. (STI),
j(1997b) Comparison of CAMxand
JUAM-V Model Performance for Two
jOzone episodes in the Eastern United
jstates. STI-996203-1733-FR, Santa
JRosa, CA.
12 iGery, M.W., G.Z. Whitten, J.P. Killus
land M.C. Dodge (1989) "A
jphotochemical kinetics mechanism for
jurban and regional scale computer
jmodeling," J. Geophysical Research,
J94, 12925-12956,
13 jWhitten G.Z., H.P. Deuel, C.S. Burton
land J.L. Haney (1996) "Overview of
jthe implementation of an updated
jisoprene chemistry mechanism in
JCB4/UAM-V," Report of SAI, San
JRafael, CA
14 JEPA(1996) U.S. Environmental
jProtection Agency, "Forecast of
jAverage Daily NOx Emissions in July
jby Electric Generation Units Using
JOTAG 2007 Base Case and the
integrated Planning Model (IPM),"
JDecember 1996.
15 JOTAG Technical Support Document,
jJune 1997
16 j Reynolds, S., M. Liu, T. Hecht, P.
JRoth, and J. Seinfeld (1973) Urban
jAirshed Photochemical Simulation
jStudy: volume 1 - Development and
JEvaluation. EPA -R4-73-020a-e
17 iCarter, W. (1996) Condensed
jatmospheric photooxidation
jmechanisms for isoprene. Atmospheric
JEnvironment 30: 4275-4290
18 jSillman, S. (1995) TheuseofNOy,
|H2O2, and HNO3 as indicators for
jozone- NOx- hydrocarbon sensitivity in
jurban locations, J. Geophys. Res. 100:
114,175-14,188
Who Performed
It (Category)
PS
PS
PS
IP
PS
PS
AC
AC
Who Funded
t It (Category) j
PO
ORD
ORD
PO
O
ORD
ORD, 0
ORD
Funding
Mechanism
C
C
C
C
O
C
CA, C
CA
Peer
Review?
OEP
ENP
OEP
U
OEP
U
ENP
ENP
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Ref jDocument/Study
:
19 jWesley, M.L (1989) Parameterization
jof surface resistances to gaseous dry
jdeposition in regional-scale numeric
jmodels. Atmospheric Environment 23:
h 293-1 304
20 JEPA (1996) U.S. Environmental
jProtection Agency, "Forecast of
jAverage Daily NOx Emissions in July
jby Electric Generation Units Using
JOTAG 2007 Base Case and the
integrated Planning Model (IPM),"
jDecember 1996
21 jPechan (1997a) Ozone Transport
jAssessment Group (OTAG) Emissions
jlnventory Development Report -
jVolume I: 1990 Base Year
jDevelopment (revised draft) prepared
jfor U.S. EPA, OAQPS by E.H. Pechan
j& Associates, Inc. February, 1997;
22 jPechan (1997b) Ozone Transport
jAssessment Group (OTAG) Emissions
jlnventory Development Report -
jVolume III: Projections and Controls
j(draft) prepared for U.S. EPA, OAQPS
jby E.H. Pechan & Associates,
line., June, 1997
23 jPechan (1997c) The Acid Rain Data
JBase for 1996 (ARDB96) Technical
jSupport Document (draft)
24 i Analyzing Electric Power Generation
junderthe CAAA, March 1998 .
42 jPerformance of Selective Catalytic
JReduction on Coal-Fired Steam
JGenerating Units
25 jDimitriades, B. [Ed.] International
jConference on photochemical oxidant
jpollution and its control. Proceedings
JV.1&2. EPA-600/3-77-001 a&b
26 JRipperton, L.A., J.B. Worth, F.M
jVukovitch, and C.E. Decker. 1977.
jResearch Triangle Institute Studies of
jHigh Ozone Concentrations in Urban
iAreas. pp. 413-424 In Dimitriades
ki?zz)
Who Performed
It (Category)
OF
IP
PS
PS
PS
IP
IP
IO
PS
Who Funded
t It (Category) j
ORD
PO
O
PO
PO
PO
PO
ORD
ORD, PO
Funding
Mechanism
IAG
C
C
C
C
C
C
I
U
Peer
Review?
ENP
U
OEP
U
U
U
N
N
N
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Ref jDocument/Study
27 jVukovitch (1977) On the relationship
jbetween high ozone in the rural surface
jlayer and high pressure systems.
jAtmospheric Environment 1 1 :967-983
28 jWolff, G.T. Lioy, P., Wright, G.D.,
jMeyers, R.E., and R.T. Cederwell
1(1977) An investigation of long-range
jtransport of ozone across the
I Midwestern and Eastern United States.
jln Dimitriades (1977)
29 jCoffey, P.E., and W. Stasiuk (1975)
jEvidence of atmospheric transport of
jozone into urban areas. ES&T 9(1):
J59-62
30 jBach, Jr., W. (1975) Investigation of
jozone and ozone precursor
jconcentration in non urban locations in
jthe eastern U.S. EPA 450-3-74-034-a
31 JNRC (1991) Rethinking the ozone
jproblem in urban and regional air
jpollution. National Research Council,
jNational Academy Press, Washington,
JDC
32 jLogan, J.A. (1989) Ozone in the rural
jareas of the United States. Journal of
JGeophysical Research 94:851 1-8532
33 jSillman, S., J. Logan, and S. Wofsy
1(1990) A regional scale model for
jozone in the United States with subgrid
jrepresentation of urban and power
jplant plumes. JGR 95:5731
34 jGuinnup, D. and R. Collom (1997)
jFinal Report, Volume II: Summary and
integration of Results OTAG Air
jQuality Analysis Workgroup
35 JDennis, R. (1990) Eulerian Model
jEvaluation Program, pp. 5-83 to 5-102
jln R. Dennis et al. Evaluation of
jRegional Acid Deposition Models (Part
|1) National Acid Precipitation
jAssessment Program.
Who Performed
It (Category)
PS
OG
OG
PS
OG
AC
AC
OG, IP
IO, PS, OF, OG
Who Funded
t It (Category) j
PO
0
0
PO
PO, OF, 0
OF
OF, ORD
O
ORD, O
Funding
Mechanism
C
0
0
C
G
G
G
O
C, I
Peer
Review?
ENP
N
ENP
U
ENP
ENP
ENP
OEP
FACA
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Ref jDocument/Study
36 jChameides, W. L. and E. B. Cowling
1(1995) The state of the Southern
jOxidants Study (SOS): N.C State
jUniversity
37 JLADCO (1995) Lake Michigan Ozone
jStudy: Lake Michigan Ozone Control
jProgram. Lake Michigan Air Directors
jConsortium, Des Plains, IL.
38 JRoberts, et al. NARSTO-Northeast -
J1995 Summer Ozone Study. NARSTO
JNovember 1995
39 'Geron, C. D., A. B. Guenther, and T. E.
jPierce (1994) "An improved model for
jestimating emissions of volatile organic
jcompounds from forests in the eastern
jUnited States". Journal of Geophysical
JResearch, 99:12773
40 jJang, C. J., S. C. Y. Lo, J. Vukovich, P.
jKasibhatla, R. T. Tang, and L. Bender
1(1 997) "Sensitivity of Ozone
jPredictions to Biogenic Hydrocarbon
jChemistry and Emissions in Air Quality
JModels." (97-RA94.05). Proceedings of
jthe 90th Annual Air and Waste
JManagement Association Meeting and
JExhibition, Pittsburgh, PA
41 jTimin, B., J. Lawrimore, C. Jang, and
JH. Jeffries (1997) The Effect of the
jUpdated Isoprene Chemistry on Ozone
^Concentrations in OTAG, Draft Version
J1.5. Raleigh, NC: North Carolina
jDivision of Air Quality
Who Performed
It (Category)
AC
OG
10, IP, PS, AC,
OF
IO
PS
OG
Who Funded
t It (Category) j
ORD
0
ORD, OF, 0
ORD
O
O
Funding
Mechanism
CA
U
C
I
C
O
Peer
Review?
U
U
II
ENP
N
N
Methodology
We received no responses to questionnaires. We were given a broad introduction to the rule by
the primary contact, who directed us to the OTAG homepage on the web and to the program
scientist who led the modeling technical workgroup. That program scientist led us to the
appropriate manuals and the report of the modeling group, and suggested some additional
contacts. The OIG team member is co-located with ORD's air quality modeling division, so he
was able to get some additional scientific background on modeling issues, even though no ORD
scientists were involved in the rule-making per se. OIG also was able to interview one of the
scientists who oversaw one of the OTAG modeling centers, who provided some additional
insight. Primarily, however, this summary was put together by going to the key documents and
working back through the reference sections in those papers to their referenced documents, and
from there back to even earlier references. The OTAG references were generally available on the
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web, but it was very difficult to navigate among the references, as each center has it's own
webpage. The OTAG review paper by Keating and Ferrell (1999) would have been more helpful
if we had been introduced to it earlier in the process.
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Case 14
Nonroad Diesel Engines
Rule Title: Control of Emissions of Air Pollution from Nonroad Diesel Engines
Citation for Final Rule: 63 Federal Register 56967 (October 23, 1998)
EPA Start Action Notice: 3645
Brief description of the rule
This rule established (or revised) emission standards and emission guidelines for combined
paniculate matter (PM), carbon monoxide (CO), non-methane hydrocarbons (NMHC), and
nitrogen oxides (NOx) from nonroad diesel engines. Under section 213(a)(2) of the Clean Air
Act, the Administrator had previously determined that nonroad engine emissions were significant
contributors to ambient ozone and carbon monoxide in more than one nonattainment area, and
under section 213(a)(4) determined that emissions of PM and smoke from compression-ignition
(i.e., diesel) nonroad engines caused or contributed to air pollution caused a range of adverse
health effects for humans. NOx and PM were the emission components of the most concern for
this rule.
Covered nonroad equipment and engines included: agriculture and logging, construction, general
industrial, lawn and garden, utility, and material handling. The emission limits were technology
based, and relied somewhat on the science used to develop on-highway heavy-duty engine
emission standards. Because the standards were intended to reduce emissions by up to two-thirds
from previous standards, engine manufacturers would have to build and maintain new (or rebuilt)
nonroad engines that adhered to the new, stringent emissions standards. The manufacturers
believed they could achieve these goals and, with the California Air Resources Board and EPA,
signed a statement of principles to that effect.
The emission standards varied depending on the rated power of the engine and when the engine
was built (or rebuilt). Engines were divided into five categories, engines rated under 37 kW;
between 37 and 75 kW; between 75 and 130 kW; between 130 and 450 kW, and above 450 kW.
Within each engine power category, the initial standards were set as tier 1; for the larger power
categories, the tier 1 standards were set in a 1994 rule. For this 1998 rule, the tier 1 standards
were set for the engine power category under 37kW. Tier 2 and 3 standards (more stringent
standards) were also set to be effective in future years, dependent on the engine power category.
Smoke standards promulgated under a previous rule for nonroad diesel engines rated at or above
37 kW were extended to cover nonroad diesel engines rated under 37 kW, except 1-cylinder
engines and marine propulsion engines, and constant speed engines. The rule revised the existing
nonroad engine averaging, banking, and trading program that (because of the technological
feasibility, lead time, and cost) EPA believed was an important element in reaching the new
emissions standards.
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Brief description of science input to the rule
To prepare the rule, EPA needed information about: the large number of engine manufacturers;
the broad range of engine sizes; installation of nonroad diesel engines into the vast array of
construction, industrial, agricultural, electrical generation applications; what the engines emit and
how much; the effect of the emissions; the control techniques that addressed unique
characteristics of nonroad applications (special engine cooling needs, dusty operating
environments, etc.) and the similarities with highway heavy-duty engines; and the costs associated
with controlling the emissions. In addition, a Nonroad Emissions Model (computer program) was
also developed for this rule to project emissions inventories from nonroad sources.
Description of critical documents
A Report to Congress that confirmed and quantified air pollutants from nonroad engine sources
was the basis for the decision that a rule was needed. [See Reference 1.] EPA, the California Air
Resources Board, and engine manufacturers established a joint Nonroad Diesel Engines Statement
of Principles that formed the basis for the stringent emissions standards in the rule. [See
References 5 and 6.] The proposed rule was supported by two regulatory impact analyses and an
economic impact analysis. These analyses considered engine technology alternatives and related
costs. [See References 3, 4, and 6.]
Obtaining emission data and developing the model were important to the rule [See References 1
and 8.] The data on which the model was based included such information as: source population,
annual hours of use, horsepower, engine load factor, estimated average emissions. [See
References 2 and 6.] Additional information on the rebuilt engine industry and challenges in
varying organizational learning rates was also collected. [See References 2 and 7.] An additional
report analyzed NOx reduction benefits and health and environmental effects. [See Reference 8.]
Table of critical documents
Refj Document/Study
1 jNonroad Engine and Vehicle Emission
JStudy-Report and Appendices,
JEPA-21A-201, November 1991
2 jlCF Incorporated, Industry
jCharacterization: Nonroad Heavy
JDuty Diesel Engine Rebuilders,
jJanuary 3, 1997
3 jFinal Regulatory Impact Analysis:
jControl of Emissions of Air Pollution
ifrom Highway Heavy-Duty Engines,
lu.S.E.P.A., September 16, 1997
Who Performed
It (Category)
IP, PS
PS
IP
Who Funded
It (Category) j
PO
PO
PO
Funding
Mechanism
I, C
C
I
Peer
Review?
OEP
U
U
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Ref. j Document/Study
4 jEstimated Economic Impact of New
jEmission Standards for Heavy-Duty
jOn-Highway Engines, Acurex
jEnvironmental Corporation Final
jReport (FR-97-03), March 31, 1997,
jpage 4-1 1
5 jNonroad Compression-Ignition Engine
jStatement of Principles (see 60 FR
I45580, August 31 , 1995, Appendix)
6 jFinal Regulatory Impact Analysis:
jControl of Emissions from Nonroad
jDiesel Engines
7 jLearning Curves in Manufacturing, L.
jArgote and D. Epple, Science,
JFebruary 1990, Vol. 247, page 920
8 jBenefits of Reducing Mobile Source
iNOx Emissions, ICF Inc., Draft Final,
iSeptemberSO, 1996
Who Performed
It (Category)
PS
IP, OG, PS
IP
AC
PS
Who Funded
Jt (Category) j
PO
PO
PO
0
PO
Funding
Mechanism
C
0
I
G
C
Peer
Review?
U
U
U
ENP
U
Methodology
The program scientist sent an e-mail identifying, either specifically or generally, science
documents he considered critical. Using this information, we went to the docket and pulled the
documents identified, as well as a few others we believed critical. We also talked on the phone
with the primary contact about locating one of the older critical documents and he referred us to a
website that contained the document.
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Case 15
Plant-Incorporated Protectants
Rule Title: Regulations Under the Federal Insecticide, Fungicide, and Rodenticide Act for Plant-
Incorporated Protectants (Formerly Plant-Pesticides)
Citation for Final Rule: 66 Federal Register 37771 (July 19, 2001)
EPA Start Action Notice: Unknown
Brief description of the rule
Plants have evolved, and thus naturally possess, various mechanisms to resist pests. More
recently, scientific techniques have been developed by which pest resistance traits from diverse
living organisms can be introduced into plants to prevent, destroy, repel or mitigate pests. Under
the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), the genetic material required to
produce such pesticidal traits, and the substances produced as a result of the introduced genetic
materials, are each pesticides, and thus subject to regulation under FIFRA. The pesticidal
substances, along with the genetic materials necessary to produce them, are designated "plant-
incorporated protectants" by EPA.
FIFRA section 3(a) provides, with some exceptions, that no person may distribute or sell in the
United States any pesticide that is not registered. Section 25(b)(2) of FIFRA allows EPA to
exempt, by regulation, any pesticide from some or all of the requirements of FIFRA. With one
exception, under this rule EPA requires registration of plant-incorporated protectants. Thus, as
with other pesticides, the applicant must show that the protectant "when used in accordance with
widespread and commonly recognized practice, . . . will not generally cause unreasonable adverse
effects on the environment". The exception is for protectants derived through conventional
breeding from sexually compatible plants. Excluding the requirement for reporting adverse
effects, requirements of FIFRA and the Federal Food, Drug and Cosmetics Act do not apply to
these protectants.
In addition, the rule establishes a new part in the Code of Federal Regulations (CFR) specifically
for plant-incorporated protectants, i.e., 40 CFR 174. Procedures are also set forth for
Confidential Business Information (CBI); any claim of confidentiality must be substantiated when
the claim is made. The rule also requires, for exempted plant-incorporated protectants, that any
person who produces, for sale or distribution, a plant-incorporated protectant about which there
is any information regarding adverse effects on human health or the environment alleged to have
been caused by the plant-incorporated protectant, the producer must submit such information to
EPA within 30 days.
Brief description of science input to the rule
The rule was a legal mechanism to confirm that plant-incorporated protectants were covered by
FIFRA. The science aspects concerned the exemption for protectants derived through
conventional breeding from sexually compatible plants. To comply with FIFRA, such protectants
may not generally cause unreasonable adverse effects on the environment. EPA
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supported this conclusion by showing that the adverse effects of naturally-occurring protectants
were already known and unlikely to get worse.
Description of critical documents
To shape the regulation, EPA (sometimes with other Federal agencies) held conferences in 1987,
1988 and 1990 dealing with plant related issues, and posed several questions about different
aspects of the proposed rule to science panels; these panels had public meetings in 1992, 1993,
and 1994 to discuss the questions and provided a report on their conclusions. See References 1
through 6.
In preparing the rule, EPA drew on a large body of information developed through systemic
scientific study available in public literature, such as References 7 and 8. From this information,
staff from the EPA program office prepared five issue papers with extensive bibliographies. Most
of the cited scientific studies justified the exemption, i.e., that plant-incorporated protectants
derived through conventional breeding from sexually compatible plants should be exempt from
FIFRA. See References 9 through 13.
Two other major supporting documents underlying the rule were the economic analysis and
summary of comments on the proposed rule. These were critical because, respectively, they
summarized the options considered by the EPA (including costs and benefits) and how the rule
was changed because of the comments. See References 14 and 15.
Table of critical documents
Ref. jDocument/Study
1 jOn October 1 9-21 , 1 987, a meeting on
j"Genetically Engineered Plants:
jRegulatory Considerations" at Cornell
JDniversity, Ithaca, New York
2 jDoebley, J, 1988, In: "Transgenic Plant
jConference." Proceedings of a meeting
jheld September 7-9, 1988, in
JAnnapolis, Maryland, Frisco, Colorado:
jKeystone Center, Pages 137-145
3 jOn November 6-7, 1990, a conference
jon "Pesticidal Transgenic Plants:
jProduct Development, Risk
jAssessment, and Data Needs" in
jAnnapolis, Maryland
4 JU.S. EPA, FIFRA Scientific Advisory
jPanel meeting in Arlington, VA on
JDecember18, 1992
5 jU.S. EPA, Biotechnology Science
JAdvisory Committee meeting on July
i13, 1993
Who Performed
It (Category)
IP
AC, PS, IP
IP
AC
AC, PS
Who Funded
Jt (Category)
PO
PO
PO
PO
PO
Funding
Mechanism
I
I
I
I
I
Peer
Review?
U
U
U
FACA
FACA
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Ref. jDocument/Study
6 JU.S. EPA, joint meeting of science
jadvisors in Arlington, VA on January
121, 1994
7 'International Food Biotechnology
jCouncil, 1990, "Biotechnologies and
jfood; Assuring the safety of foods
jproduced by genetic modification", In:
jRegulatory Toxicology and
jPharmacology, Vol. 12, New York,
JNew York: Academic Press
8 jNational Research Council, 1999,
j"Hormonally Active Agents in the
JEnvironment", National Academy
jPress, Washington DC
9 JU.S. EPA, 1994, "FIFRA: Benefit and
jenvironmental risk considerations for
jinherent plant-pesticides" (issue paper)
10 JU.S. EPA, 1994, "Risk considerations
jfor outcrossing and hybridization" (
jissue paper)
11 JU.S. EPA, 2000, "Dermal and
jinhalation exposure to plant
jsubstances" (issue paper)
12 JU.S. EPA, 2000, "Natural toxicants in
jfood" (issue paper)
13 JU.S. EPA, 2000, "The glycoalkaloid
jclass; solanine and chaconine: Mech-
janisms of action" (issue paper)
14 JU.S. EPA, 2000, "Economic analysis of
jthe plant-incorporated protectant
jregulations under the Federal
jlnsecticide, Fungicide, and Rodenticide
JAct"
15 JU.S. EPA, December 2000, "Summary
jof public comments and EPA's
jresponse on issues associated with
jplant-incorporated protectants (formerly
jplant-pesticides)
Who Performed
It (Category)
AC
PS
OG
IP
IP
IP
IP
IP
IP
IP
Who Funded
Jt (Category)
PO
0
PO, OF
PO
PO
PO
PO
PO
PO
PO
Funding
Mechanism
I
U
CA
I
I
I
I
I
I
I
Peer
Review?
FACA
ENP
ENP
U
U
U
U
U
U
U
Methodology
The ORD scientist identified by the primary contact sent a detailed list of critical documents.
However, we could not find any these documents in the docket. Therefore, we concluded they
had not affected the rule so we did not include them among the critical documents. The primary
contact did not identify any critical documents, but sent us several documents.
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The preamble referenced various documents during the explanation of the rulemaking process.
Members of the pilot study team reviewed this list and picked some items we believed might be
critical. We pulled these from the docket. When the primary contact and ORD scientist reviewed
the initial summary, the primary contact suggested some changes to the list, which we made.
Miscellaneous Other Information
The preamble for the final rule was written like a scientific paper in that the references were cited
as the key points were made in the narrative.
The Office of Research and Development had programs pertaining to biogenics at its laboratories
in Gulf Breeze and Corvallis. Staff from the Corvallis laboratory was on the work group for this
rule and reviewed it before it was promulgated. However, the work done by ORD was not
specifically cited to support the rule.
The 1994 proposed rule offered three categorical exemptions, of which only one was included in
the 2001 rule. The other two proposed exemptions were: from FIFRA and FFDCA 408, all plant-
incorporated protectants based on viral coat proteins; and from FIFRA, all plant-incorporated
protectants that acted by primarily affecting the plant (e.g., thicker wax cuticle). These were
omitted from the final rule because such a wide range of comments were received and because
more scientific information became available since proposal. The science gaps identified related
particularly to these two proposed exemptions.
Agency Comments and OIG Response
In commenting on the draft report, the Office of Prevention, Pesticides and Toxic Substances
suggested changes related to plant-incorporated protectants. Because these changes improved
the factual accuracy of the report, we changed Case 15 as suggested.
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