[Federal Register Volume 64, Number 22 (Wednesday, February 3, 1999)]
[Rules and Regulations]
[Pages 5574-5580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-2545]
[[Page 5573]]
_______________________________________________________________________
Part VII
Environmental Protection Agency
_______________________________________________________________________
40 CFR Part 61
National Emission Standard for Hazardous Air Pollutants: National
Emission Standards for Radon Emissions From Phosphogypsum Stacks; Final
Rule
Federal Register / Vol. 64, No. 22 / Wednesday, February 3, 1999 /
Rules and Regulations
[[Page 5574]]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 61
[FRL-6229-4]
RIN 2060-AF04
National Emission Standard for Hazardous Air Pollutants; National
Emission Standards for Radon Emissions From Phosphogypsum Stacks
AGENCY: Environmental Protection Agency.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA) is promulgating
revisions to the National Emission Standard for Hazardous Air
Pollutants (NESHAP) that sets limits on radon emissions from
phosphogypsum stacks, codified as subpart R of 40 CFR part 61. The
Agency is taking today's action in response to a petition for
reconsideration from The Fertilizer Institute (TFI), which critiqued
the risk assessment EPA performed in support of the version of subpart
R promulgated in 1992. Today's action raises the limit on the quantity
of phosphogypsum that may be used for indoor research and development
from 700 to 7,000 pounds, eliminates current sampling requirements for
phosphogypsum used in indoor research and development, and clarifies
sampling procedures for phosphogypsum removed from stacks for other
purposes.
DATES: These regulations are effective April 5, 1999. Petitions for
judicial review of this final action must be filed no later than April
5, 1999.
ADDRESSES: Copies of the two documents entitled ``Risk Assessment for
Research and Development Uses of Phosphogypsum'' and ``Statistical
Procedures for Certifying Phosphogypsum for Entry into Commerce'' may
be obtained by writing to this address. A summary of comments received
on the proposed rule accompanied by the Agency's responses may be
obtained by requesting the response to comment document entitled
``Comments and Response to Comments--NESHAPS; National Emission
Standards of for Radon Emissions from Phosphogypsum Stacks on
Amendments to Subpart R.''
FOR FURTHER INFORMATION CONTACT: Pat Tilson; telephone number (202)
564-9762; address: Radiation Protection Division, Mail Code 6602J, U.S.
Environmental Protection Agency, Washington, DC 20460; email address:
tilson.pat@epa.gov.
SUPPLEMENTARY INFORMATION:
Docket
Docket No. A-79-11 contains the public record supporting the final
rule revising 40 CFR Part 61, Subpart R, which EPA issued in 1992 (57
FR 23305, June 3, 1992). It also contains the August 3, 1992, TFI
petition, and the EPA response partially granting and partially denying
the TFI petition (59 FR 14040, March 24, 1994). Docket No. A-94-57
contains certain documents which led to the May 8, 1996, proposal and
this final rulemaking. These dockets are available for public
inspection between the hours of 8 a.m. and 5 p.m., Monday through
Friday, in room M1500 of Waterside Mall, 401 M Street, SW, Washington,
DC 20460. A reasonable fee may be charged for copies of documents.
Introduction
Purpose of Today's Action and Summary of Changes to Subpart R
The Agency is promulgating revisions to those portions of Subpart R
of 40 CFR part 61 which concern: (1) the distribution and use of the
substance, phosphogypsum, for indoor research and development purposes;
(2) the sampling and measurement of radium-226 in phosphogypsum; and
(3) use of phosphogypsum for outdoor agricultural purposes. The
Environmental Protection Agency is taking today's action in response to
issues raised in a petition for reconsideration from The Fertilizer
Institute which questioned aspects of the risk assessment EPA performed
in support of the rulemaking that revised Subpart R in 1992. The risk
assessment was an evaluation of the risk to persons who perform
research and development activities in a laboratory using
phosphogypsum. Phosphogypsum--a byproduct of the wet-acid process of
producing phosphoric acid from phosphate rock--contains naturally
occurring radiation emitted by uranium-238 and its decay products such
as radium-226 and radon-222. Exposure to the radiation emitted by these
and other radionuclides in phosphogypsum can increase an individual's
probability of developing cancer. If present in quantities above
certain limits, the radionuclides in phosphogypsum could cause
unacceptable risks of incurring fatal cancer.
Specifically, today's action revises Sec. 61.205 to conform to the
technical findings EPA made when it re-evaluated the risk assessment
used to promulgate Subpart R in 1992. See 57 FR 23305, June 3, 1992.
EPA found that the risk assessment contained errors in the calculation
of the quantity of the radioactive gas, radon-222, that would be
present in a laboratory in which phosphogypsum was used for indoor
research and development purposes. Today's action revises the limit set
by Subpart R on the amount of phosphogypsum that may be used in indoor
research and development from 700 pounds upward to 7,000 pounds. In
addition, today's action provides clarification on how to determine
compliance with the new, 7,000-pound limit, such as whether this limit
should be applied on a facility-by-facility or on an experiment-by-
experiment basis.
In addition, the Agency is removing the requirement to sample and
measure the radium-226 in phosphogypsum that is used for indoor
research and development activities because Subpart R does not contain
a corresponding limit on the concentration of radium-226 in
phosphogypsum when it is used for these activities. Sampling of radium-
226 concentrations must still be performed when phosphogypsum is used
for outdoor agricultural purposes, as set forth in Sec. 61.204, and
when application is made to EPA for approval to use phosphogypsum for
other purposes pursuant to Sec. 61.206. Today's action makes minor
changes to Secs. 61.204 and 61.205 to draw the distinction more sharply
between the uses of phosphogypsum which are covered by the respective
sections.
In addition, the Agency is revising section 61.207 to establish the
level of statistical uncertainty that is allowed in measurements of
radium-226 in phosphogypsum. These measurements are performed in
connection with outdoor agricultural uses of phosphogypsum and those
other uses of phosphogypsum that the Agency approves on a case-by-case
basis.
History of the NESHAP for Phosphogypsum and TFI's Petition for
Reconsideration
EPA first promulgated the NESHAP for phosphogypsum stacks on
December 15, 1989. At that time, the standard required that all
phosphogypsum be disposed of in stacks. Phosphogypsum stacks are large,
on-site disposal piles composed of the excess phosphogypsum formed
during the wet-acid process. Unlike subsequent versions of Subpart R,
the 1989 standard did not permit alternate uses of phosphogypsum such
as for indoor research and development.
EPA subsequently received several petitions requesting that it
reconsider setting standards that would permit alternatives to disposal
of phosphogypsum in stacks. Petitioners argued that EPA had not
considered the
[[Page 5575]]
implications of these alternatives when it set the 1989 rule. EPA
agreed to convene a rulemaking to evaluate the attendant risks of these
alternatives to disposal and establish standards under which these
alternatives might be permissible. See 55 FR 13480, April 10, 1990. EPA
promulgated revisions to Subpart R after analyzing the associated risks
of alternate uses and evaluating the comments received on the proposed
rule. See 57 FR 23305, June 3, 1992. The revised Subpart R permitted
uses of phosphogypsum that fall into three categories: (1) Outdoor
agricultural uses, for example as a conditioner for soils containing
high quantities of salt or low quantities of calcium and other
nutrients; (2) indoor research and development activities, for example
to study the production of road-base and building materials using
phosphogypsum; and (3) other alternate uses that are approved by EPA on
a case-by-case basis.
Subsequently, TFI sought judicial review of the 1992 rule in The
Fertilizer Institute v. Environmental Protection Agency, No. 92-1320
(D.C. Cir.). TFI also filed a petition with EPA on August 3, 1992,
requesting EPA to reconsider the 1992 rule pursuant to section
307(d)(7)(B). A second suit was brought against the Agency by ManaSota-
88 in ManaSota-88 v. Browner, No. 92-1330 (D.C. Circuit). EPA entered
settlement discussions with TFI and ManaSota-88, and agreed jointly to
move the D.C. Circuit Court of Appeals to stay judicial review of the
1992 rule. The Court granted the motion. As part of that agreement, EPA
agreed to make a final decision whether to grant or deny TFI's petition
for reconsideration. EPA decided to partially deny and partially grant
the petition after careful review of all the objections to the 1992
rule set forth in the petition for reconsideration. See 59 FR 14040,
March 24, 1994. The principal purpose of the present rulemaking is to
effectuate the decision by EPA to partially grant the TFI petition.
Statutory Basis and the Benzene Policy
EPA initially promulgated the NESHAP for phosphogypsum stacks on
December 15, 1989 pursuant to Section 112 of the Clean Air Act (CAA).
In 1990, Section 112 was amended by the Clean Air Act Amendments of
1990. Section 112(q)(2) of the CAA, as amended, specifically provides
that Section 112 of the CAA shall remain in effect for, inter alia,
radionuclide emissions from phosphogypsum stacks.
Under the CAA, as in effect prior to enactment of the Clean Air Act
Amendments of 1990, the Agency, in establishing risk-based standards,
must follow the method specified in the ``Vinyl Chloride decision.''
Natural Resources Defense Council v. EPA, 824 F.2d 1146 (D.C. Cir.
1987). The Vinyl Chloride decision requires that these Section 112
standards be established in two steps. In the first step, the Agency
determines a ``safe'' or ``acceptable'' level of risk by considering
only health-related factors. Next, the Agency may make the standard
more protective considering costs and technological feasibility. The
resulting standard must protect public health with an ample margin of
safety.
EPA implemented the Vinyl Chloride decision in 1989 with the
promulgation of the NESHAP for benzene. This rulemaking established the
``Benzene Policy'' by which EPA sets standards under Section 112 of the
Clean Air Act, as in effect prior to enactment of the Clean Air Act
Amendments of 1990. See 54 FR 38044 (September 14, 1989). The Benzene
Policy sets forth the specific criteria EPA uses when determining the
safe level of risk set by NESHAPs. Any amendments or revisions to the
existing NESHAP for phosphogypsum would have to meet these criteria for
the Agency to consider it adequately protective of public health with
an ample margin of safety. Included among these criteria is the
requirement that NESHAPs protect the individual receiving the highest
lifetime risk to a level of 1 in 10,000.
Description of the Final Rule
Today's action affects those portions of Subpart R which cover the
use of phosphogypsum in indoor research and development found at
Sec. 61.205 and the procedures for sampling and measurement of radium-
226 in phosphogypsum found at Sec. 61.207. In addition, today's
rulemaking revises Sec. 61.204 to clarify that agricultural uses that
occur in an indoor laboratory must comply with Sec. 61.205, while
outdoor agricultural uses of phosphogypsum must comply with
Sec. 61.204.
The New 7,000 Pound Limit on Indoor Research and Development Uses
Today's action raises the limit set by Sec. 61.205(b)(2) on the
amount of phosphogypsum that may be used in indoor research and
development from 700 pounds to 7,000 pounds. The Agency is revising the
limit to conform to the technical findings it made when it re-evaluated
the risk assessment used to promulgate Subpart R in 1992. Specifically,
EPA found that the risk assessment contained errors in the calculation
of the quantity of the radioactive gas, radon-222, that would be
present in a laboratory in which phosphogypsum was being used for
research and development purposes. EPA has revised three of the key
assumptions used in these calculations. A complete discussion of the
changed parameters and the effect of these changes on the presence of
radon-222 are contained in the document, ``Risk Assessment of Research
and Development Uses of Phosphogypsum.'' First, EPA revised the
assumption made regarding the number of drums of phosphogypsum that
would be opened at any one time and from which radon-222 could
therefore escape to the ambient air in the laboratory. During the 1992
rulemaking, EPA's risk assessment assumed that five such drums would be
open. EPA changed this assumption to reflect that at most only one
single drum would be open under actual conditions in laboratories.
Public comments on the notice of proposed rulemaking noted that
laboratories typically use phosphogypsum a few pounds at a time, making
it unnecessary to have several drums open simultaneously.
Second, EPA changed the assumption regarding how much of the radon-
222 that is present in the phosphogypsum actually emanates into the
ambient air of the laboratory. When setting the 1992 rule, EPA had
assumed that all the radon-222 generated by the radium-226 in
phosphogypsum would be released. EPA's new risk assessment reconsiders
such factors as the rate at which air is ventilated from a laboratory,
the size of the laboratory and the effect of moisture on the rate of
emanation of radon-222 from the phosphogypsum.
Third, EPA revised the assumption on the number of hours a
researcher spends in the laboratory from 4,000 hours down to 1,000
hours per year. The value of 4,000 hours that was used in the 1992
rulemaking exceeded by 100 percent the typical occupational year of
2,000 hours. The value of 1,000 hours was judged to be a more realistic
estimate.
By making these three changes and re-calculating the risk, EPA
found that the use of 7,000 pounds of phosphogypsum for indoor research
and development purposes would cause a risk that was just slightly
higher than 1 in 100,000. It was apparent that revising the regulation
so as to permit 7,000 pounds of phosphogypsum would still meet the
presumptively safe risk level of 1 in 10,000 that EPA established with
the Benzene Policy.
EPA requested public comment on what practical advantages a higher
limit of 7,000 pounds would provide in the Notice of Proposed
Rulemaking (61 FR 20775, May 8, 1996). The comments received by the
Agency indicated that
[[Page 5576]]
the higher limit would permit larger scale experiments yielding results
which can be applied more accurately to real uses of phosphogypsum.
Comments also stated that the higher limit would permit a facility to
keep phosphogypsum in one large, 7,000-pound storage area rather than
in several smaller separate storage areas associated with each
individual experiment or activity. (For more on how to apply the 7,000-
pound limit, see discussion below on how regulated parties should
determine if individual laboratories and experiments are in
compliance.) Further comments stated that the health risk corresponding
to 7,000 pounds of phosphogypsum was acceptable, especially given the
view that EPA's conservative choice of parameter values (e.g., hours
spent inside a laboratory) led to over-estimates of the risk to persons
doing research. Other comments expressed concern, however, that doses
to persons performing radium extraction might be higher than in routine
handling in other indoor research and development. EPA's revised risk
assessment nonetheless shows that even handling the large amounts of
phosphogypsum required for extracting radium would not cause risks in
excess of the 1 in 10,000 level set by the Benzene Policy, provided
that the 7,000-pound limit was not exceeded. Based on the public
comments received and the findings of EPA's revised risk assessment,
EPA is amending the limit on the amount of phosphogypsum to 7,000
pounds. For further discussion of the revised risk assessment, see the
document, ``Risk Assessment of Research and Development Uses of
Phosphogypsum.''
How to Determine Compliance With the 7,000-Pound Limit
Today's action revises Sec. 61.205(b)(2) to clarify how compliance
is determined with the 7,000 pound limit. Both TFI's petition and many
public comments on the notice of proposed rulemaking (61 FR 20775, May
8, 1996) expressed confusion over whether this limit applies to one
room (i.e., a ``laboratory''), an entire building, etc. In other words,
is the correct method for determining compliance to add up the total
pounds of phosphogypsum in use, everywhere for all experiments and
rooms in a facility, and testing this total against the 7,000-pound
limit? Or should compliance be determined by separately comparing the
phosphogypsum used in each experiment and/or room to the 7,000-pound
limit?
The Agency first evaluated the health risk implied by each of the
above two methods of determining compliance. The risk assessment
examined whether a person working in a facility that had several
ongoing projects of 7,000 pounds would experience greater risk than a
person working in a facility having only one such project. The risk
breaks down to the sum of two types of radiation risks: (1) the risk
from direct gamma radiation; and (2) the risk from inhaled radon which
is generated by the presence of radium-226. With respect to gamma
radiation, the risk assessment assumes that the researcher is exposed
to 10 drums (7,000 pounds) in the same room for 1,000 hours, at a
distance of one meter. A researcher might receive additional gamma
radiation if any other experiments were taking place elsewhere in the
building. EPA's risk assessment considered this latter possibility. The
effect of gamma radiation from these additional rooms would, however,
be substantially decreased the further away a person is located from
the source. Hence, EPA's risk assessment found that the researcher
would for the most part only be affected by the gamma radiation from
the drums in the room he is standing in. The risk due to gamma
radiation would effectively remain unchanged with either way of
determining compliance with the 7,000-pound limit.
The second component of risk, the inhalation of radon-222, would
not increase if additional experiments took place in nearby rooms
within the same building. This results from the fact that the air in
rooms where separate experiments occur would effectively remain
isolated; the radon-222 in one room would not migrate to other rooms
and increase the radon-222 concentration found within the other rooms.
The combined risk from gamma radiation and inhaled radon-222
effectively would be the same whether the limit applied separately to
the different projects within a facility or if it limited the total
phosphogypsum from all research activities within a research complex to
7,000 pounds. A more in-depth discussion is contained in ``Risk
Assessment for Research and Development Uses of Phosphogypsum.''
Based on the findings of the risk assessment and public comments
received on the notice of proposed rulemaking, EPA revised
Sec. 61.205(b)(2) of Subpart R so that the 7,000-pound limit applies
separately to each individual research and development activity. In
addition, no more than 7,000 pounds may be stored in any room at a
research and development facility. Thus, a particular facility may
purchase or possess more than 7,000 pounds of phosphogypsum for use in
multiple research activities, so long as it does not exceed this limit
for any individual research activity and no one room within the
facility contains more than this limit.
Difference in Applicability Between Sections 61.204 and 61.205
EPA is revising Sec. 61.205(b)(5) to clarify that research and
development activities authorized by this section must occur indoors in
a controlled laboratory setting that the public cannot enter freely,
except on an infrequent basis for tours of the facility. In addition,
EPA is revising the title of Sec. 61.205 to indicate that this section
applies to indoor research and development. EPA is making these
revisions in response to both TFI's petition and public comments. These
parties expressed uncertainty as to which section of Subpart R would
apply to agricultural uses of phosphogypsum that are conducted for the
purpose of research and development. To this end, EPA has added
clarifying language to Sec. 61.205(b)(5) of the final rule that
specifies that outdoor agricultural research and development must
comply with Sec. 61.204, on outdoor agricultural uses. As a compliment
to this new language, EPA has added language to Sec. 61.204 to specify
that agricultural research and development that occurs indoors, in a
laboratory, must comply with Sec. 61.205, on indoor research and
development in a laboratory.
To summarize, outdoor uses of phosphogypsum must comply with either
Sec. 61.204, ``Distribution and use of phosphogypsum for outdoor
agricultural purposes'' or Sec. 61.206, ``Distribution and use of
phosphogypsum for other purposes.'' Section 21.206 allows EPA to
authorize, on a case-by-case basis, indoor and outdoor uses not covered
or authorized by Secs. 61.204 and 61.205. Phosphogypsum that remains
in outdoor stacks must comply with the numerical limits of Sec. 61.202.
Situations in Which Sampling of Radium-226 is Required
Today's action removes the portions of Secs. 61.205(a) and
61.207(a) requiring sampling of phosphogypsum that is to be used for
indoor research and development activities. TFI's petition and many
public comments on the notice of proposed rulemaking noted that Subpart
R does not establish any limit on the concentration of radium-226 in
phosphogypsum used pursuant to Sec. 61.205, only on the number of
pounds that are used. Hence, these parties noted that the existing
requirement on sampling would merely add hundreds of dollars of cost
without
[[Page 5577]]
increasing the assurance that public health is being protected with an
ample margin of safety.
By removing this requirement, EPA will not change the level of
protection afforded to persons who perform indoor research and
development. The risk assessment EPA performed on indoor research and
development assumed that the phosphogypsum would have a very high
concentration of radium-226 (equal to 26 pCi/g) and set a pound limit
appropriate to this assumption. This high level of radium-226
represents the radium concentration found in the most radioactive
phosphogypsum stacks, which are in Florida. The 7,000-pound limit
controls the radiological cancer risk because it has the effect of
limiting the total quantity of radium-226 that is present.
Sampling of radium-226 concentrations must nonetheless still be
performed when phosphogypsum is used for outdoor agricultural purposes,
as set forth in Sec. 61.204, and when application is made to EPA under
Sec. 61.206 for approval of phosphogypsum use for other purposes.
Procedures for Sampling and Measurement of Radium-226
The Agency is substantially revising Sec. 61.207, on sampling and
measurement of phosphogypsum, to clarify what levels of statistical
uncertainty are allowable in measurements of radium-226 in
phosphogypsum. The 1992 rule established the requirement for
measurement and sampling of phosphogypsum used for outdoor agricultural
uses under Sec. 61.204 and for ``other uses'' under Sec. 61.206. TFI's
petition and the public comments on the notice of proposed rulemaking
noted that the 1992 rule did not specify the allowable uncertainties.
Today's action provides clarification on the statistical method that
must be followed to establish this statistical uncertainty.
The following discussion relies on several statistical terms.
Critical value means the percentile value, , of a probability
distribution above or below which only per cent of the
probability lies. Thus there is a .05 probability that a normally
distributed variable will have a value above the upper 5% critical
value, which is calculated by summing the product of 1.64 times the
standard deviation of the distribution to the mean of the distribution.
When testing an hypothesis, is the level of significance, and
determines the critical value.
Hypothesis testing means a procedure for the statistical
determination of the validity of an hypothesis. A test statistic, such
as the standard normal variable, is calculated for the purpose of
discriminating between a null hypothesis and an alternative.
Level of significance means the probability, of rejecting
the null hypothesis in a test of an hypothesis.
Sampling distribution means a probability distribution assumed by a
statistic such as the sample mean, calculated from a sample drawn from
a population.
Under this final rule, the procedure for certifying an area of a
phosphogypsum stack for entry into commerce requires the collection of
samples of phosphogypsum and the measurement of their radium-226
content. The samples must be collected from regularly spaced locations
across the area of the stack being considered for entry into commerce.
After the radium-226 concentration in each sample is measured, the mean
and standard deviation of the collected samples must be calculated.
A decision rule, based on the sampling distribution for the sample
mean, must be used to determine if the phosphogypsum is acceptable for
entry into commerce. This rule requires the determination of the
critical value for a 5% level of significance in the upper, or right
hand, tail of the sampling distribution. The critical value is the 95th
percentile of the sampling distribution.
The decision rule has three outcomes. If the critical value is less
than or equal to 10 pico-curies per gram (pCi/g), phosphogypsum from
this area of the stack can be entered into commerce. (By definition,
one curie of a given radionuclide experiences 37 billion nuclear decays
per second. A pico-curie (pCi) is one trillionth of one curie.) If the
mean of the collected samples is greater than or equal to10 pCi/g,
phosphogypsum from this area of the stack cannot be entered into
commerce. If the sample mean is less than 10 pCi/g and the critical
value is greater than 10 pCi/g, the phosphogypsum cannot be entered
into commerce unless further testing is undertaken. The sample size
must be increased, and the sample mean and standard deviation
recalculated. The increased sample size reduces the standard deviation
of the sampling distribution of the mean, thereby, reducing the
interval between the mean of the sampling distribution and the critical
value. This increases the ability of the decision rule to distinguish
between the mean of the sample and the 10 pCi/g concentration limit,
thereby improving the chance that the radium-226 concentration can be
shown to be less than 10 pCi/g.
The reason for determining the critical value for the upper, or
right hand, tail of the sampling distribution is the concern that the
radium-226 concentration in the phosphogypsum not be greater than 10
pCi/g.
If a larger sample size is needed to demonstrate that the sample
mean is less than 10 pCi/g, the number of additional samples required
increases rapidly as the mean approaches 10 pCi/g, and can be quite
large in cases where the sample mean is only slightly less than 10 pCi/
g. In such cases the additional cost of certification may become a
factor in the decision to continue with the attempt to enter the
phosphogypsum from this area of the stack into commerce.
Any required additional samples must also be taken from regularly
spaced locations across the area of the phosphogypsum stack being
considered for entry into commerce. Once the required number of
additional samples have been collected, the radium-226 concentrations
in each additional sample must be measured. The mean and standard
deviation of the radium-226 concentrations for the entire set of sample
concentrations (including those previously measured) must be
recalculated and a new sampling distribution established. The critical
value for a 5% level of significance in the upper tail is established
once again. The decision rule must then be revisited. As before,
phosphogypsum from this area of the stack can be entered into commerce
only if the critical value is less than or equal to 10 pCi/g.
Although acceptance for entry into commerce is the objective of
increasing the sample size and establishing the new sampling
distribution and critical value, and is the expected outcome of the
reconsideration, it is possible the recalculated critical value will
not be less than or equal 10 pCi/g. This is because random variation in
the new sample concentrations, which can result from nonuniformity in
the distribution of radium-226 in the phosphogypsum and the random
nature of radioactive decay, may cause an increased sample mean or
standard deviation. Either or both of these increases can change the
critical value so that it is not less than 10 pCi/g. If this is the
case, either the sample size must be increased once again, and a new
sampling distribution and critical value determined, or the attempt to
certify that area of the stack for entry into commerce must be
abandoned.
[[Page 5578]]
Judicial Review
This rulemaking action promulgates revisions of a national standard
issued under Clean Air Act Section 112, 42 U.S.C. 7412. Any petition
for judicial review of this action must be filed no later than April 5,
1999 in the United States Court of Appeals for the District of Columbia
Circuit. Under Section 307(d)(7)(B) of the Clean Air Act, only those
objections to this rule which were raised with reasonable specificity
during the period for public comment or at the public hearing may be
raised as part of such judicial review.
Regulatory Analyses
Regulatory Flexibility Act
EPA has determined that it is not necessary to prepare a regulatory
flexibility analysis in connection with this rule under section 605(b)
of the Regulatory Flexibility Act, 5 U.S.C. 605(b). EPA has further
determined that this final rule will not have a significant economic
impact on a substantial number of small entities. Small entities
include small businesses, small not-for-profit enterprises, and small
governmental jurisdictions. Today's rule will have a positive economic
impact on the great majority of entities regulated by subpart R,
including small businesses. Specifically, this rule will allow greater
quantities of phosphogypsum to be used and reduce costs of
demonstrating compliance by removing certain regulatory requirements.
No new restrictions, exclusions or limitations are being added. As
such, this rule will lessen the regulatory burden on regulated
entities, including small entities, which existed prior to today's
action.
Unfunded Mandates Reform Act
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Pub.
L. 104-4, establishes requirements for Federal agencies to assess the
effects of their regulatory actions on State, local and tribal
governments and the private sector. Today's final action contains no
Federal mandates (under the regulatory provisions of Title II of UMRA)
for State, local or tribal governments or the private sector.
Paperwork Reduction Act
There are no information collection requirements in this final
rule.
Review Under Executive Order 12866
Under Executive Order 12866, 58 FR 51736 (October 4, 1993), EPA
must determine whether a regulation is ``significant'' and therefore
subject to review by the Office of Management and Budget. The Order
defines ``significant regulatory action'' as one that is likely to
result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more or
adversely affect in a material way the economy, a sector of the
economy, productivity, competition, jobs, the environment, public
health or safety, or State, local, or tribal governments or
communities;
(2) Create a serious inconsistency or otherwise interfere with an
action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants,
user fees, or loan programs or the rights and obligations of recipients
thereof; or
(4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
the Executive Order.
EPA has determined that this action does not meet any of the
criteria enumerated above, and therefore does not constitute a
``significant regulatory action'' under the terms of the Order.
Executive Order 13045: Protection of Children From Environmental Health
Risks and Safety Risks
Executive Order 13045 applies to any rule that: (1) is determined
to be ``economically significant'' as defined under E.O. 12866, and (2)
concerns an environmental health or safety risk that EPA has reason to
believe may have a disproportionate effect on children. If the
regulatory action meets both criteria, the Agency must evaluate the
environmental health or safety effects of the planned rule on children,
and explain why the planned regulation is preferable to other
potentially effective and reasonably feasible alternatives considered
by the Agency.
This rule is not subject to E.O. 13045 because it is not an
economically significant rule as defined by E.O. 12866, and because it
does not involve decisions on environmental health or safety risks that
may disproportionately affect children.
Executive Order 12875: Enhancing the Intergovernmental Partnership
Under Executive Order 12875, EPA may not issue a regulation that is
not required by statute and that creates a mandate upon a State, local
or tribal government, unless the Federal government provides the funds
necessary to pay the direct compliance costs incurred by those
governments, or EPA consults with those governments. If EPA complies by
consulting, Executive Order 12875 requires EPA to provide to the Office
of Management and Budget a description of the extent of EPA's prior
consultation with representatives of affected State, local and tribal
governments, the nature of their concerns, copies of any written
communications from the governments, and a statement supporting the
need to issue the regulation. In addition, Executive Order 12875
requires EPA to develop an effective process permitting elected
officials and other representatives of State, local and tribal
governments ``to provide meaningful and timely input in the development
of regulatory proposals containing significant unfunded mandates.''
Today's rule does not create a mandate on State, local or tribal
governments. The rule does not impose any enforceable duties on these
entities. Accordingly, the requirements of section 1(a) of Executive
Order 12875 do not apply to this rule.
Executive Order 13084: Consultation and Coordination With Indian Tribal
Governments
Under Executive Order 13084, EPA may not issue a regulation that is
not required by statute, that significantly or uniquely affects the
communities of Indian tribal governments, and that imposes substantial
direct compliance costs on those communities, unless the Federal
government provides the funds necessary to pay the direct compliance
costs incurred by the tribal governments, or EPA consults with those
governments. If EPA complies by consulting, Executive Order 13084
requires EPA to provide to the Office of Management and Budget, in a
separately identified section of the preamble to the rule, a
description of the extent of EPA's prior consultation with
representatives of affected tribal governments, a summary of the nature
of their concerns, and a statement supporting the need to issue the
regulation. In addition, Executive Order 13084 requires EPA to develop
an effective process permitting elected and other representatives of
Indian tribal governments ``to provide meaningful and timely input in
the development of regulatory policies on matters that significantly or
uniquely affect their communities.''
Today's rule does not significantly or uniquely affect the
communities of Indian tribal governments. Accordingly, the requirements
of section 3(b) of Executive Order 13084 do not apply to this rule.
The National Technology Transfer and Advancement Act 2 of 1995 (NTTAA)
The National Technology Transfer and Advancement Act of 1995
(NTTAA), Section 12(d) of Pub L. No. 104-113, is designed to encourage
the
[[Page 5579]]
adoption of standards developed by ``voluntary consensus bodies'' in
regulatory activities unless to do so would be inconsistent with
applicable law or otherwise impractical. Voluntary consensus standards
are technical standards (e.g., materials specifications, test methods,
sampling procedures, and business practices) that are developed or
adopted by voluntary consensus standards bodies. The NTTAA directs
agencies to provide Congress, through OMB, explanations when a decision
is made not to use available and applicable voluntary consensus
standards.
This action does not involve technical standards. Therefore, EPA
did not consider the use of any voluntary consensus standards.
The Congressional Review Act (CRA)
The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, U.S. House of Representatives,
and the Comptroller General of the United States prior to publication
of the rule in the Federal Register. A major rule cannot take effect
until 60 days after it is published in the Federal Register. This
action is not a ``major rule'' as defined by 5 U.S.C. 804(2). This rule
will be effective April 5, 1999.
List of Subjects in 40 CFR Part 61
Environmental protection, Air pollution control, Phosphogypsum,
Radon, Radium.
Dated: January 27, 1999.
Carol Browner,
Administrator.
For the reasons set forth in the preamble, the Environmental
Protection Agency amends 40 CFR part 61 as follows:
PART 61--[AMENDED]
1. The authority citation for part 61 continues to read as follows:
Authority: 42 U.S.C. 7401, 7412, 7413, 7416, 7601 and 7602.
Subpart R--National Emission Standards for Radon Emissions From
Phosphogypsum Stacks
2. Amend Sec. 61.204 by revising the section title, introductory
text, paragraph (c), paragraph (d), and adding paragraph (e) to read as
follows:
Sec. 61.204 Distribution and use of phosphogypsum for outdoor
agricultural purposes.
Phosphogypsum may be lawfully removed from a stack and distributed
in commerce for use in outdoor agricultural research and development
and agricultural field use if each of the following requirements is
satisfied:
* * * * *
(c) All phosphogypsum distributed in commerce for use pursuant to
this section by the owner or operator of a phosphogypsum stack shall be
accompanied by a certification document which conforms to the
requirements of Sec. 61.208(a).
(d) Each distributor, retailer, or reseller who distributes
phosphogypsum for use pursuant to this section shall prepare
certification documents which conform to the requirements of
Sec. 61.208(b).
(e) Use of phosphogypsum for indoor research and development in a
laboratory must comply with Sec. 61.205.
3. Amend Sec. 61.205 by revising the section title and paragraphs
(a) and (b) to read as follows:
Sec. 61.205 Distribution and use of phosphogypsum for indoor research
and development.
(a) Phosphogypsum may be lawfully removed from a stack and
distributed in commerce for use in indoor research and development
activities, provided that it is accompanied at all times by
certification documents which conform to the requirements of
Sec. 61.208. In addition, before distributing phosphogypsum to any
person for use in indoor research and development activities, the owner
or operator of a phosphogypsum stack shall obtain from that person
written confirmation that the research facility will comply with all of
the limitations set forth in Sec. 61.206(b).
(b) Any person who purchases and uses phosphogypsum for indoor
research and development purposes shall comply with all of the
following limitations. Any use of phosphogypsum for indoor research and
development purposes not consistent with the limitations set forth in
this section shall be construed as unauthorized distribution of
phosphogypsum.
(1) Each quantity of phosphogypsum purchased by a facility for a
particular research and development activity shall be accompanied by
certification documents which conform to the requirements of
Sec. 61.208.
(2) No facility shall purchase or possess more than 7,000 pounds of
phosphogypsum for a particular indoor research and development
activity. The total quantity of all phosphogypsum at a facility, as
determined by summing the individual quantities purchased or possessed
for each individual research and development activity conducted by that
facility, may exceed 7,000 pounds, provided that no single room in
which research and development activities are conducted shall contain
more than 7,000 pounds.
(3) Containers of phosphogypsum used in indoor research and
development activities shall be labeled with the following warning:
Caution: Phosphogypsum Contains Elevated Levels of Naturally Occurring
Radioactivity.
(4) For each indoor research and development activity in which
phosphogypsum is used, the facility shall maintain records which
conform to the requirements of Sec. 61.209(c).
(5) Indoor research and development activities must be performed in
a controlled laboratory setting which the general public cannot enter
except on an infrequent basis for tours of the facility. Uses of
phosphogypsum for outdoor agricultural research and development and
agricultural field use must comply with Sec. 61.204.
* * * * *
4. Section 61.207 is revised to read as follows:
Sec. 61.207 Radium-226 sampling and measurement procedures.
(a) Before removing phosphogypsum from a stack for distribution in
commerce pursuant to Sec. 61.204, or Sec. 61.206, the owner or operator
of a phosphogypsum stack shall measure the average radium-226
concentration at the location in the stack from which phosphogypsum
will be removed. Measurements shall be performed for each such location
prior to the initial distribution in commerce of phosphogypsum removed
from that location and at least once during each calendar year while
distribution of phosphogypsum removed from the location continues.
(1) A minimum of 30 phosphogypsum samples shall be taken at
regularly spaced intervals across the surface of the location on the
stack from which the phosphogypsum will be removed. Let n1
represent the number of samples taken.
(2) Measure the radium-226 concentration of each of the
n1 samples in accordance with the analytical procedures
described in 40 CFR part 61, appendix B, Method 114.
(3) Calculate the mean, x1, and the standard deviation,
s1, of the n1 radium-226 concentrations:
[[Page 5580]]
[GRAPHIC] [TIFF OMITTED] TR03FE99.054
Where x1 and s1 are expressed in pCi/g.
(4) Calculate the 95th percentile for the distribution,
x*, using the following equation:
[GRAPHIC] [TIFF OMITTED] TR03FE99.055
Where x* is expressed in pCi/g.
(5) If the purpose for removing phosphogypsum from a stack is for
distribution to commerce pursuant to Sec. 61.206, the owner or operator
of a phosphogypsum stack shall report the mean, standard deviation,
95th percentile and sample size. If the purpose for removing
phosphogypsum from a stack is for distribution to commerce pursuant to
Sec. 61.204, the additional sampling procedures set forth in paragraphs
(b) and (c) of this section shall apply.
(b) Based on the values for x1 and x*
calculated in paragraphs paragraphs (a)(3) and (4) of this section,
determine which of the following conditions will be met:
(1) If x1 < 10="" pci/g="" and="" x*=""> 10 pCi/g;
phosphogypsum may be removed from this area of the stack for
distribution in commerce pursuant to Sec. 61.204.
(2) If x1, < 10="" pci/g="" and="" x*=""> 10 pCi/g, the owner or
operator may elect to follow the procedures for further sampling set
forth in paragraph (c) of this section:
(3) If x1 10 pCi/g; phosphogypsum shall not
be removed from this area of the stack for distribution in commerce
pursuant to Sec. 61.204.
(c) If the owner or operator elects to conduct further sampling to
determine if phosphogypsum can be removed from this area of the stack,
the following procedure shall apply. The objective of the following
procedure is to demonstrate, with a 95% probability, that the
phosphogypsum from this area of the stack has a radium-226
concentration no greater than 10 pCi/g. The procedure is iterative, the
sample size may have to be increased more than one time; otherwise the
phosphogypsum cannot be removed from this area of the stack for
distribution to commerce pursuant to Sec. 61.204.
(1)(i) Solve the following equation for the total number of samples
required:
[GRAPHIC] [TIFF OMITTED] TR03FE99.056
(ii) The sample size n2 shall be rounded upwards to the
next whole number. The number of additional samples needed is
nA = n2-n1.
(2) Obtain the necessary number of additional samples,
nA, which shall also be taken at regularly spaced intervals
across the surface of the location on the stack from which
phosphogypsum will be removed.
(3) Measure the radium-226 concentration of each of the
nA additional samples in accordance with the analytical
procedures described in 40 CFR part 61, appendix B, Method 114.
(4) Recalculate the mean and standard deviation of the entire set
of n2 radium-226 concentrations by joining this set of
nA concentrations with the n1 concentrations
previously measured. Use the formulas in paragraph (a)(3) of this
section, substituting the entire set of n2 samples in place
of the n1 samples called for in paragraph (a)(3) of this
section, thereby determining the mean, x2, and standard
deviation, s2, for the entire set of n2
concentrations.
(5) Repeat the procedure described in paragraph (a)(4) of this
section, substituting the recalculated mean, x2, for
x1, the recalculated standard deviation, s2, for
s1, and total sample size, n2, for n1.
(6) Repeat the procedure described in paragraph (b) of this
section, substituting the recalculated mean, x2 for
x1.
[FR Doc. 99-2545 Filed 2-2-99; 8:45 am]
BILLING CODE 6560-50-P
