Pesticide Chemicals Category, Formulating, Packaging and Repackaging Effluent Limitations Guidelines, Pretreatment Standards, and New Source Performance Standards
Federal RegisterNov 6, 1996
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SUMMARY: This final regulation limits the discharge of pollutants into
navigable waters of the United States and into publicly owned treatment
works (POTWs) by existing and new facilities that formulate, package
and repackage pesticide products. This regulation covers two
subcategories of the Pesticide Chemicals Point Source Category--
Subcategory C: Pesticide Formulating, Packaging and Repackaging (PFPR)
which includes PFPR facilities that also manufacture pesticide active
ingredients (PFPR/Manufacturers) and Subcategory E: Agricultural
Refilling Establishments. EPA estimates that there are approximately
2,600 facilities in the industry. This regulation establishes effluent
limitations guidelines and standards under the Clean Water Act
including ``best conventional pollutant control technology (BCT), and
``best available technology economically achievable (BAT)'' for
existing direct dischargers, ``new source performance standards
(NSPS)'' for new direct dischargers and ``pretreatment standards for
existing and new indirect dischargers (PSES and PSNS)''. This
regulation also amends and clarifies the limitations based on ``best
practicable control technology (BPT)'' for direct discharging
facilities.
Under the final rule refilling establishments (Subcategory E) will
be required to achieve zero discharge of wastewater pollutants. The
final regulation provides Subcategory C facilities (herein referred to
as ``PFPR facilities'') a choice between zero discharge and the
``Pollution Prevention Alternative.'' This compliance alternative was
developed in response to comments on the proposed rule from the
industry and has received a large amount of industry support in
comments on the supplemental notice. This structure provides a
compliance option to facilities who agree to implement certain
pollution prevention, recycle and reuse practices. Facilities choosing
and implementing the pollution prevention alternative will receive a
discharge allowance.
The final rule will benefit the environment by removing toxic
pollutants (pesticide active ingredients and priority pollutants) from
water discharges that have adverse effects on human health and aquatic
life. EPA has estimated the compliance costs and economic impacts
expected to result from the Zero Discharge/Pollution Prevention
Alternative (i.e., Zero/P2 Alternative). The Agency has determined that
the Zero/P2 Alternative will result in a similar removal of toxic pound
equivalents per year (approximately 7.6 million toxic pound
equivalents) as the zero discharge option alone. At the same time, the
Zero/P2 Alternative is expected to result in a reduced annualized cost
($29.9 million in 1995), no facility closures and 150 moderate impacts.
EPA has determined that both Zero Discharge and the Zero/P2 Alternative
are economically achievable. However, EPA's addition of the pollution
prevention alternative to achieving zero discharge provides benefits to
the environment by minimizing the potential cross-media impacts that
would otherwise occur from hauling and incinerating the non-reusable
portion of PFPR wastewaters. The provision of an alternative compliance
method also provides flexibility to industry in meeting the effluent
limitations guidelines and standards.
DATES: This regulation shall become effective January 6, 1997. The
information collection requirements contained in this rule are included
in two separate Information Collection Request (ICR) documents. The
NPDES/Compliance Assessment/Certification ICR (No. 1427.05) and the
National Pretreatment Program (40 CFR part 403) ICR (No. 0002.08). OMB
has not yet approved these ICRs; therefore, the information collection
requirements contained in this rule are not effective until OMB has
approved them. Once OMB has approved the ICRs, EPA will publish another
notice in the Federal Register to announce OMB's approval and to amend
40 CFR Part 9 to indicate the OMB approval number. The compliance date
for Secs. 455.46 and 455.66 (PSES) is as soon as possible, but no later
than November 6, 1999. The compliance dates for Secs. 455.45 and 455.65
(NSPS) and Secs. 455.47 and 455.67 (PSNS) are the dates the new sources
commence discharging. Deadlines or compliance with Secs. 455.42 and
455.62 (BPT), Secs. 455.43 and 455.63 (BCT), and Secs. 455.44 and
455.64 (BAT) are established in the National Pollutant Discharge
Elimination System (NPDES) permits.
ADDRESSES: For additional technical information write to Ms. Shari H.
Zuskin, Engineering & Analysis Division (4303), U.S. EPA, 401 M Street
SW, Washington, D.C. 20460 or send e-mail to:
[email protected] or call at (202) 260-7130. For additional
economic information contact Dr. Lynne Tudor at the address above or by
calling (202) 260-5834.
The complete record (excluding confidential business information)
for this rulemaking is available for review at EPA's Water Docket; 401
M Street, SW, Washington, DC 20460. For access to Docket materials,
call (202) 260-3027 between 9 a.m. and 3:30 p.m. for an appointment.
The EPA public information regulation (40 CFR part 2) provides that a
reasonable fee may be charged for copying.
The Technical Development Document [EPA-821-R-96-019], Economic
Analysis [EPA-821-R-96-017] and Cost-Effectiveness Analysis [EPA-821-R-
96-018] supporting today's final rule may be obtained by writing to the
EPA Office of Water Resource Center (RC-4100), 401 M Street SW.,
Washington, DC 20460, or calling (202) 260-7786.
FOR FURTHER INFORMATION CONTACT: For additional technical information
write or call Ms. Zuskin at (202) 260-7130. For additional information
on the economic impact analyses contact Dr. Lynne G. Tudor at the above
address or by calling (202) 260-5834.
EPA is preparing a PFPR Pollution Prevention Alternative Guidance
Manual and a series of regional workshops to aid industry, permit
writers and control authorities in implementing the final rule. A
public announcement will be published in Federal Register regarding
availability of the guidance manual and the dates and locations of the
regional workshops.
SUPPLEMENTARY INFORMATION:
Regulated Entities
Entities potentially regulated by this action are: (1) Those which
generate process wastewater from the formulation, packaging and/or
repackaging of pesticide products (excluding those pesticide active
ingredients not covered by the rule); or (2) those which are
agricultural refilling establishments. Regulated categories and
entities include:
[[Page 57519]]
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Category Examples of regulated entities
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Industry............................ Pesticide formulating,
packaging and repackaging (PFPR)
facilities;
PFPR facilities that also
manufacture pesticide active
ingredients;
Agricultural refilling
establishments.
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This table is not intended to be exhaustive, but rather provides a
guide for readers regarding entities likely to be regulated by this
action. This table lists the types of entities that EPA is now aware
could potentially be regulated by this action. Other types of entities
not listed in the table could also be regulated. To determine whether
your facility is regulated by this action, you should carefully examine
the applicability criteria in Sec. 455.40 and Sec. 455.60 of the rule.
If you have questions regarding the applicability of this action to a
particular entity, consult the person listed in the preceding FOR
FURTHER INFORMATION CONTACT section.
Preamble Outline
I. Legal Authority
II. Background
A. Clean Water Act
B. Pollution Prevention Act
C. Updated Industry Overview
D. Final Rule
E. The Proposed Rule
F. The Supplemental Notice
III. Summary of Most Significant Changes from Proposal
A. Scope
1. Pesticide Active Ingredients (PAIs)
a. Sanitizer Active Ingredients and Pool Chemicals
b. Other Pesticide Active Ingredients
c. Liquid Chemical Sterilants
2. Wastewater Sources
B. Zero Discharge/Pollution Prevention Alternative Option
1. Cross Media Impacts and Incineration Issues
2. Cross-Contamination Policy
3. Request for De Minimis Discharge
4. Pollution Prevention Alternative
C. Applicability to On-Site and Stand-alone Research &
Development (R&D) Laboratories
D. Clarification of Issues Concerning PFPR/Manufacturers
1. Stabilizing versus Formulating
2. On-site Incineration as Zero Discharge
3. Amending and Clarifying of BPT
E. Clarification of Refilling Establishments
F. RCRA Issues
IV. The Final Regulation
A. Pretreatment Standards for Existing Sources (PSES)
1. Pesticide Formulating, Packaging and Repackaging (Subcategory
C)
2. Refilling Establishments (Subcategory E)
B. Best Practicable Control Technology Currently Available (BPT)
1. Pesticide Formulating, Packaging and Repackaging (Subcategory
C)
2. Refilling Establishments (Subcategory E)
C. Best Available Technology Economically Achievable (BAT)
1. Pesticide Formulating, Packaging and Repackaging (Subcategory
C)
2. Refilling Establishments (Subcategory E)
D. New Source Performance Standards (NSPS)
1. Pesticide Formulating, Packaging and Repackaging (Subcategory
C)
2. Refilling Establishments (Subcategory E)
E. Pretreatment Standards for New Sources (PSNS)
1. Pesticide Formulating, Packaging and Repackaging (Subcategory
C)
2. Refilling Establishments (Subcategory E)
F. Best Conventional Pollutant Control Technology (BCT)
1. Pesticide Formulating, Packaging and Repackaging (Subcategory
C)
2. Refilling Establishments (Subcategory E)
V. Economic Considerations
A. Introduction
B. Review of the Proposed Regulation
1. Subcategory C: PFPR and PFPR/Manufacturers
2. Subcategory E: Refilling Establishments
C. Changes to the EIA Since Proposal: Issuance of the June 1995
Supplemental Notice
D. Assessment of Costs and Impacts for the Final PFPR
Regulations
1. Summary of Economic Impact Analysis Methodology and Data
2. Estimated Facility Economic Impacts
a. Subcategory C: PFPR and PFPR/Manufacturers
b. Subcategory E: Refilling Establishments
4. Regulatory Effects Not Re-Estimated
5. Impacts of Pretreatment Standards for New Sources (PSNS) and
New Source Performance Standards (NSPS)
a. Subcategory C: PFPR and PFPR/Manufacturers
(1) PSNS
(2) NSPS
b. Subcategory E: Refilling Establishments
6. Cost-Effectiveness Analysis
a. Subcategory C: PFPR and PFPR/Manufacturers
b. Subcategory E: Refilling Establishments
E. Regulatory Flexibility Act
1. Analysis of Impacts on Small Business Entities
2. Analysis of Impacts on Other Small Entities
VI. Unfunded Mandates Reform Act
VII. Executive Order 12866
VIII. Small Business Regulatory Enforcement Fairness Act of 1996
(SBREFA)
IX. Paperwork Reduction Act
X. Water Quality Analysis
XI. Non-Water Quality Environmental Impacts
A. Air Pollution
B. Solid Waste
C. Energy Requirements
XII. Regulatory Implementation
A. Implementation of the Limitations and Standards
1. Pesticide Formulating, Packaging and Repackaging (Subcategory
C)
2. Refilling Establishments (Subcategory E)
B. Upset and Bypass Provisions
C. Variances and Modifications
1. Fundamentally Different Factors Variances
2. Removal Credits
D. Analytical Methods
Appendix A--List of Abbreviations, Acronyms and Other Terms Used In
This Document
I. Legal Authority
This final regulation establishes effluent guidelines and standards
of performance for the Pesticide Formulating, Packaging and Repackaging
Subcategories of the Pesticide Chemicals Point Source Category under
the authorities of sections 301, 304, 306, 307, and 501 of the Clean
Water Act (``the Act''), 33 U.S.C. 1311, 1314, 1316, 1317, and 1361.
In accordance with 40 CFR part 23, this regulation shall be
considered promulgated for purposes of judicial review at 1 p.m.
Eastern time on November 20, 1996. Under section 509(b)(1) of the Act,
judicial review of this regulation can be had only by filing a petition
for review in the United States Court of Appeals within 120 days after
the regulation is considered promulgated for purposes of judicial
review. Under section 509 (b)(2) of the Act, the requirements in this
regulation may not be challenged later in civil or criminal proceedings
brought by EPA to enforce these requirements.
II. Background
A. Clean Water Act
The Federal Water Pollution Control Act Amendments of 1972
established a comprehensive program to ``restore and maintain the
chemical, physical, and biological integrity of the Nation's waters,''
(section 101(a)). To implement the Act, EPA is to issue effluent
limitations guidelines, pretreatment standards and new source
performance standards for industrial dischargers. These guidelines and
standards are summarized in the proposed regulation at 59 FR 17850,
17851-52 (April 14, 1994).
Section 304(m) of the Clean Water Act (33 U.S.C. 1314(m)), added by
the Water Quality Act of 1987, requires EPA to establish schedules for
(1) reviewing and revising existing effluent limitations guidelines and
standards (``effluent guidelines''), and (2) promulgating new effluent
guidelines. On January 2, 1990, EPA published an Effluent Guidelines
Plan (55 FR 80), in which schedules were established for developing new
and revised effluent guidelines for several industry categories. One of
the industries for which the Agency established a schedule was the
Pesticide Chemicals Point Source Category.
Natural Resources Defense Council, Inc. (NRDC) and Public Citizen,
Inc.,
[[Page 57520]]
challenged the Effluent Guidelines Plan in a suit filed in U.S.
District Court for the District of Columbia (NRDC et al v. Reilly, Civ.
No. 89-2980). The plaintiffs charged that EPA's plan did not meet the
requirements of sec. 304(m). A Consent Decree in this litigation was
entered by the Court on January 31, 1992. The terms of the Consent
Decree are reflected in the Effluent Guidelines Plan published on
September 8, 1992 (57 FR 41000). This plan states, among other things,
that EPA will propose and take final action on effluent guidelines for
the formulating, packaging and repackaging subcategories of the
pesticide chemicals category by dates certain.
B. The Pollution Prevention Act
The Pollution Prevention Act of 1990 (PPA) (42 U.S.C. 13101 et
seq., Pub. L. 101-508, November 5, 1990) ``declares it to be the
national policy of the United States that pollution should be prevented
or reduced whenever feasible; pollution that cannot be prevented should
be recycled in an environmentally safe manner, whenever feasible;
pollution that cannot be prevented or recycled should be treated in an
environmentally safe manner whenever feasible; and disposal or release
into the environment should be employed only as a last resort* * * ''
(Sec. 6602; 42 U.S.C. 13101(b). In short, preventing pollution before
it is created is preferable to trying to manage, treat or dispose of it
after it is created. This effluent guideline was reviewed for its
incorporation of pollution prevention as part of this Agency effort.
According to the PPA, source reduction reduces the generation and
release of hazardous substances, pollutants, wastes, contaminants or
residuals at the source, usually within a process. The term source
reduction ``include[s] equipment or technology modifications, process
or procedure modifications, reformulation or redesign of products,
substitution of raw materials, and improvements in housekeeping,
maintenance, training, or inventory control.'' The term ``source
reduction'' does not include any practice which alters the physical,
chemical, or biological characteristics or the volume of a hazardous
substance, pollutant, or contaminant through a process or activity
which itself is not integral to or necessary for the production of a
product or the providing of a service.'' 42 U.S.C. 13102(5). In effect,
source reduction means reducing the amount of a pollutant that enters a
waste stream or that is otherwise released into the environment prior
to out-of-process recycling, treatment, or disposal.
The PPA directs the Agency to, among other things, ``review
regulations of the Agency prior and subsequent to their proposal to
determine their effect on source reduction'' (Sec. 6604; 42 U.S.C.
13103(b)(2). This directive led the Agency to implement a pilot project
called the Source Reduction Review Project that would facilitate the
integration of source reduction in the Agency's regulations, including
the technology-based effluent guidelines and standards.
C. Updated Industry Overview
The pesticide formulating, packaging and repackaging industry is
made up of two distinct types of activities. These activities result in
subcategorization for purposes of this rulemaking. The two
subcategories are referred to as:
Subcategory C: Pesticides formulating, packaging and
repackaging (PFPR) including pesticides formulating, packaging and
repackaging occurring at pesticides manufacturing facilities (PFPR/
Manufacturer) and at stand-alone PFPR facilities; and
Subcategory E: Repackaging of agricultural chemicals at
refilling establishments (Refilling Establishments).
The pesticide formulating, packaging and repackaging industry
covered by this rulemaking is made up of an estimated 2,631 in-scope
facilities. These facilities are located throughout the country, with
greater concentrations of refilling establishments located in the
Midwestern and southeastern states to serve the agricultural market.
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
requires that any substance intended to prevent, destroy, repel or
mitigate any pest must be registered with EPA and bear a label
directing the safe use of the product. 7 U.S.C. 136a. In addition,
production of all pesticide products must be reported annually to EPA.
7 U.S.C. 136e. Thus, EPA has extensive data on the contents of
pesticide products, their annual production, who formulates, packages
or repackages these products and the uses for which these products are
registered. EPA's Office of Water made extensive use of this data in
its analysis of the pesticide formulating, packaging and repackaging
industry.
Based on 1988 FIFRA establishment registration data, EPA identified
the pesticide formulating, packaging, and repackaging facilities in the
United States that were using one or more of the active ingredients
that were the focus of the Pesticide Manufacturing rulemaking. These
pesticide active ingredients are referred to as the ``272 PAIs'' and
were the focus of the survey questionnaire for the PFPR rule 1988 data
collection.1 EPA sent out approximately 700 questionnaires using a
stratified random sample of these facilities. Based on these survey
results, EPA estimates that for all of the PAIs covered by the final
rule (in-scope 272 and non-272 PAIs), that in 1988 there were
approximately 1,497 facilities involved in formulating, packaging and
repackaging pesticide products (of which 413 facilities processed non-
272 PAIs only) and approximately 1,134 refilling establishments.2
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\1\ All remaining pesticide active ingredients are referred to
in today's notice as the ``non-272 PAIs.'' In addition, not all non-
272 PAIs are in the scope of this rulemaking.
\2\ EPA has not re-estimated the number of refilling
establishments based on both 272 PAIs and non-272 PAIs because EPA
believes that there would not be any refilling establishments that
use only non-272 PAIs.
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Included in the 1,497 PFPR facilities, there were 48 pesticide
manufacturing facilities in the pesticide chemicals manufacturing
rulemaking survey database (58 FR 50637, September 28, 1993) that also
formulated and packaged pesticide products containing any of the 272
PAIs which were the focus of that rulemaking. A detailed description of
the development of this profile is contained in Section 3 of the
Technical Development Document [EPA-821-R-96-019] for this final rule.
Pesticide formulating is the mixing/diluting of one or more PAIs
with active or inert ingredients, without a chemical reaction, to
obtain a manufacturing use or end use product (see Sec. 455.10 of the
final regulation for the definitions of formulating, packaging,
repackaging and refilling establishment). Pesticide formulations take
all forms: Water-based liquid; organic solvent-based liquid; dry
products in granular, powder, solid forms; pressurized gases; and
aerosols. The formulations can be in a concentrated form requiring
dilution before application or can be ready to apply. The packaging of
the formulated pesticide product is dependent on the type of
formulation. Liquids generally are packaged into jugs, cans, or drums;
dry formulations generally are packaged into bags, boxes, drums, or
jugs. Pressurized gases are packaged into cylinders. Some formulations
are packaged into aerosol cans.
As described above, the formulating, packaging and repackaging
industry produces products in different forms. EPA has observed
formulating, packaging or repackaging performed a number of different
ways ranging from very sophisticated and automated
[[Page 57521]]
formulation and packaging lines to completely manual lines. In general,
for liquid products the process involves mixing the active ingredient
with liquid inert ingredients in a tank and then transferring the
product to containers. For dry products, the active ingredient may be
sprayed in liquid form onto a dry substrate or it may be mixed in dry
form. Dry products may undergo processes for mixing, grinding, sifting
and finally packaging. The formulating process for aerosol products is
the same as for liquid products, but the packaging is more complex and
involves filling the container, capping it, drawing a vacuum on the
container, adding propellant under pressure, and sealing the container.
Some other types of pesticide products include collars to repel and
kill fleas and ticks; pesticides that are micro-encapsulated; and
pesticides that are formed into solid shapes.
The pesticide industry is changing and efforts are being made to
improve products to meet demands of consumers for less toxic and safer
pesticides. For example, water-based solutions are gradually replacing
organic solvents in liquid pesticide formulations. Developments in
packaging also are underway. For example, the growing use of water
soluble packages can reduce worker exposure to pesticides and minimize
problems with disposal of packaging.
The refilling establishments represent a newer population of
facilities that was identified in the Agency's Survey of Pesticide
Producing Establishments. EPA discovered a significant population of
facilities that reported repackaging only. These facilities are retail
and wholesale dealers of agricultural chemicals and farm supplies.
These facilities repackage pesticides, usually herbicides, into
refillable containers which are used to transport the pesticide to the
site where it is applied.
The use of refillable containers began to grow during the 1980's
(and became widespread in the 1990's) to reduce the number of empty
pesticide containers needing to be disposed of by farmers. In general,
registrants distribute large undivided quantities of pesticides to
dealerships (refilling establishments) where the products are stored in
large bulk tanks. The dealer then repackages the pesticide from the
bulk storage tanks to portable minibulk containers that generally have
capacities of about 110 gallons. The increased use of refillable
containers led to an increased amount of herbicide stored in bulk
quantities and the need to have a secondary containment system built
around the bulk storage tanks. Separate from this rulemaking, EPA has
proposed a regulation under FIFRA that sets standards for such
secondary containment structures (59 FR 6712; February 11, 1994). In
addition, many states (22 have/are developing secondary containment
regulations) now require secondary containment for bulk pesticide
storage and dispensing operations.
D. Final Rule
Today's final rule sets forth an innovative and flexible, yet
environmentally protective, approach for the establishment of effluent
limitations and pretreatment standards under the Act. For Subcategory
C--facilities that formulate, package, or repackage pesticides--EPA is
establishing effluent limitations and pretreatment standards which
allow each facility to choose to meet a zero discharge limitation or
comply with a pollution prevention alternative that authorizes
discharge of PAI and priority pollutants after various pollution
prevention practices are followed and treatment is conducted as needed
(now characterized as the Zero/P2 Alternative option). This rule also
establishes a zero discharge limitation and pretreatment standard for
agricultural pesticide refilling establishments (Subcategory E).
EPA had originally proposed a zero discharge limitation and
pretreatment standard for PFPR facilities. 59 FR 17850 (April 14,
1994). EPA received comment which argued that the proposed zero
discharge limitation and pretreatment standard would result in adverse
non-water quality environmental impacts and that the scope of the
proposed rule should be refined in a variety of ways. Various members
of the PFPR community commented that the Agency should adopt a final
rule which would require facilities to engage in pollution prevention
practices and thereafter discharge de minimis levels of PAI and
priority pollutants in the process wastewaters. Upon receiving these
comments, EPA published a Supplemental Notice which described the Zero/
P2 alternative option in addition to some potential changes in the
scope of the rule. 60 FR 30217 (June 8, 1995).
Today's rule adopts the Zero/P2 alternative option for PFPR
facilities and changes the scope by reducing the number of PAIs and
wastewater sources which are addressed. Under the Zero/P2 option each
owner or operator of a PFPR facility in Subcategory C will make an
initial choice of whether the facility will meet zero discharge or
comply with the P2 Alternative. This choice can be made on a product
family/process line/process unit basis rather than a facility wide
basis. If the zero discharge option is chosen, the facility owner/
operator will need to do whatever is necessary, e.g., wastewater reuse
or recycle, either with or without treatment, incineration on-site or
haul the wastewater for incineration off-site or underground injection,
so that zero discharge of PAIs and priority pollutants in the
wastewater is achieved.
If the P2 Alternative portion of the option is chosen for a
particular PAI product family/process line/process unit, then the
owner/operator of the facility must agree to comply with the P2
practices identified in Table 8 to Part 455 of today's rule for that
PFPR family/line/unit. This agreement to comply with the P2 practices
and any necessary treatment would be contained in the NPDES permit for
direct discharging PFPR facilities or in an individual control
mechanism with the control authority, i.e., the POTW, for indirect
discharging PFPR facilities (see 403.12(a) for the definition of
control authority). In general, PFPR facilities choosing the P2
Alternative need only to submit a small portion of the paperwork to a
permitting or control authority (e.g., initial and periodic
certification statements). The on-site compliance paperwork is
described in Part XII.A.1 of today's notice.
Today's rule changes the scope of the proposed rule in the
following ways. First, the rule does not cover PAIs which are
sanitizers, including pool chemicals. Also certain liquid chemical
sterilants that are used on critical or semi-critical medical devices
are not covered. Second, the rule does not apply to PAIs that are
microorganisms, such as Bacillus thuringiensis (B.t.). Third, the rule
does not apply to two groups of PAIs that are mixtures--Group 1
Mixtures include substances which pose no risks and Group 2 Mixtures
include substances whose treatment technology has not been identified.
Fourth, the pretreatment standards portion of the rule does not apply
to one PAI and three priority pollutants which EPA has determined will
not pass through or interfere with POTWs. Today's rule also does not
cover inorganic wastewater treatment chemicals. With regard to
wastewater sources, EPA has decided not to cover storm water at PFPR
facilities or at refilling establishments through this rule. In
addition, there are a few other wastewater sources such employee
showers, on-site laundries, fire equipment test water, eye washes and
safety showers, certain Department of Transportation (DOT) aerosol leak
test
[[Page 57522]]
bath water and laboratory water that are not considered process
wastewater under the final rule.
EPA believes that this rule is an important example of how the
Agency is re-inventing environmental regulation. The Zero/P2
alternative option being promulgated today is cheaper for the regulated
community to comply with than the proposed zero discharge standard. The
Zero/P2 alternative option is smarter than the proposed zero discharge
standard because it incorporates flexibility in choosing which option
is best for a particular product line. The Zero/P2 alternative option
is cleaner than the proposed zero discharge standard because the P2
Alternative reduces cross-media impacts to the environment while still
achieving, virtually, the same level of pollutant removal from
discharges of PFPR process wastewaters (see Section XI for a discussion
on the non-water quality impacts associated with the final rule).
E. The Proposed Rule
On April 14, 1994 (59 FR 17850), EPA proposed effluent limitations
guidelines and standards for the control of wastewater pollutants from
the Pesticide Formulating, Packaging and Repackaging (PFPR) Industry.
The proposed rulemaking covered two subcategories. Subcategory C
included stand-alone PFPR facilities as well as formulating, packaging
and repackaging at pesticide manufacturing facilities (PFPR/
Manufacturers). Subcategory E, as proposed, included repackagers of
agricultural pesticides at refilling establishments (``refilling
establishments''). These proposed guidelines were not intended to apply
to the production of pesticide products through an intended chemical
reaction (i.e., pesticide manufacturing). (For definitions used in the
final rule, see Sec. 455.10 of the final regulation of this notice.)
Furthermore, as discussed in Section 1 of the proposal Technical
Development Document [EPA-821-R-94-002], Subcategory E (refilling
establishments) of these guidelines was not intended to apply to
wastewaters generated by custom blending or custom application
operations when performed independently or at refilling establishments.
The proposed rulemaking would have established a zero discharge
limitation for wastewater pollutants from the formulating, packaging
and repackaging of almost all pesticide active ingredients for both
subcategories covered by this regulation. Only a small number of PAIs
were not completely covered by the proposed zero discharge, as a result
of disproportionate economic impacts to small facilities.
Due to these impacts, EPA proposed a partial exemption from these
guidelines for the exterior wastewaters \3\ from small sanitizer
facilities. Small sanitizer facilities were defined as those facilities
which formulate, package or repackage 265,000 lbs/yr or less of all
registered products containing one or more sanitizer active ingredients
(listed in Table 8 of the proposed regulation) on sanitizer-only
production lines. The production cutoff of 265,000 lbs/yr represents
the production level (of these sanitizer products) at the largest
facility that would experience economic impacts if there was no
exemption for non-interior wastewater sources. (See Section III.A.1 of
this notice for a description of revisions made to this exemption).
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\3\ At the time of proposal, exterior wastewaters included:
Exterior equipment cleaning water, floor wash, leak and spill
cleanup water, safety equipment cleaning water, DOT (Department of
Transportation) aerosol test bath water, air pollution control
scrubber water, laboratory rinsate and contaminated precipitation
runoff.
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In addition to the partial exemption given to ``small sanitizers,''
EPA proposed to exempt sodium hypochlorite from coverage under the
pretreatment standards for new and existing sources (PSES and PSNS).
(See Section III.A.1 of this notice for a description of revisions made
to this exemption). EPA also proposed to exempt wastewater generated by
on-site employee showers and laundries and from the testing of fire
protection equipment from the applicability of these effluent
guidelines and standards. In general, these wastewater sources were
excluded from the proposed regulation because of worker health and
safety concerns. (See Section IX.A of the proposed rule or Section 5 of
the Final Technical Development Document (TDD) [EPA-821-R-96-019] for a
more detailed discussion of wastewater sources excluded from
regulation).
EPA based the proposed zero discharge limitation for Subcategory C
on pollution prevention, recycle/reuse and, when necessary, treatment
through the Universal Treatment System (UTS) for reuse. EPA visualized
the UTS as a flexible system consisting of a variety of treatment
technologies that have been determined to be effective for treating
PFPR wastewaters. In calculating compliance costs, EPA included costs
for various combinations of treatment technologies consisting of
emulsion breaking, hydrolysis, chemical oxidation, metals precipitation
and carbon adsorption. EPA also included costs for contract hauling
treatment residuals (sludges) from the UTS for incineration. Because of
the estimates of reduced wastewater volumes based on the increase in
reuse/recycle practices, the overall volume of wastewaters being
contract hauled off-site for incineration was not expected to increase.
Thus, EPA did not include additional costs for contract hauling of PFPR
wastewaters in the original proposal. Based on comments, revised costs
for the proposed zero discharge option were estimated for the
Supplemental Notice (60 FR 30217; June 8, 1995). (See the Final Cost
and Loadings Report (September 1996) in the public record for a
discussion on the changes to the costing methodology).
EPA based the zero discharge limitation for Subcategory E on reuse
of wastewater as makeup water for application to fields, in accordance
with the product label.
The subject of the comments on the proposed rule spanned a variety
of topics, including changes to the scope of the regulation, EPA's
pesticide cross-contamination policy and its effect on the industry's
ability to meet zero discharge, increased cross-media impacts due to
contract hauling of wastewater for incineration to meet zero discharge,
perceived conflicts with the Resource Conservation and Recovery Act
(RCRA) requirements, and requests for a discharge allowance when
following specific pollution prevention practices. See Section III of
today's notice for a summary of the changes that were made to the
proposal in response to comment.
F. The Supplemental Notice
In response to many of the comments on the proposed rule, EPA
published a supplemental notice (60 FR 30217) in the Federal Register
on June 8, 1995. EPA published the Supplemental Notice to obtain public
comment on two major topics and several smaller issues. The first major
topic for which EPA requested comments was related to the scope and
applicability of the rulemaking. Commenters on the proposed rule had
requested that EPA exempt certain pesticide active ingredients (PAIs)
and certain wastewater sources from the scope of the final rule.
EPA requested comment on expansion of the ``sanitizer exemption''
to exempt additional sanitizer active ingredients, remove the
exemption's production limit, and to include both interior and exterior
wastewater sources in the revised exemption. EPA also requested comment
on the exclusion of some other chemicals including pool chemicals,
microorganisms, mixtures
[[Page 57523]]
and pollutants that have been determined to not pass through a POTW.
(See Section III.A.1 of today's notice for a discussion of these
exemptions; also see Comment Response Document in the public record).
In addition to the exclusion of certain pesticide active
ingredients, EPA solicited comment on the partial or full exclusion of
certain wastewater sources. These wastewater sources included aerosol
leak test bath water, safety equipment cleaning water, laboratory
equipment rinse water, and storm water.
The second major topic for which EPA solicited comments was a
regulatory option comprised of two alternatives between which industry
could choose: (1) Achieving zero discharge or (2) incorporating
specific pollution prevention practices and treatment technologies at
the facility and allowing a discharge of very small quantities of
pollutants. This combined regulatory approach is referred to as the
Zero Discharge/Pollution Prevention Alternative (Zero/P2 Alternative).
In particular, the supplemental notice requested comments on the
structure of the Zero/P2 Alternative, the extent of best professional
judgement (BPJ) allowed, the specific practices included, the
modifications allowed and the details of regulatory implementation.
Overall, the comments received on the Supplemental Notice were
overwhelmingly supportive of the Zero/P2 Alternative. Furthermore, EPA
has incorporated many of the suggestions offered in the comments into
the Zero/P2 Alternative found in today's notice (see Section XII of
today's notice for a discussion of regulatory implementation).
The other issues for which EPA solicited comments in the
supplemental notice included: the applicability of the rule to PFPR
research and development facilities and stand alone direct discharging
facilities, the concentrations found in second and third rinses of a
triple rinse, and the expected burden to the permitting authorities.
III. Summary of Most Significant Changes from Proposal
This section describes the most significant changes to the rule
since proposal. Many of these changes have resulted from the comments
that are discussed in more detail in the Comment Response Document
which is contained in the record for this rulemaking. This section will
summarize the changes in the rule concerning: The scope of the rule,
the addition of the Zero/P2 Alternative, applicability of the rule to
research and development facilities, clarification of issues for PFPR/
Manufacturers, modification of the existing BPT for direct dischargers,
clarification of the definition and applicability for refilling
establishments, and RCRA issues.
The major comments received on the supplemental notice are
described in detail in the Comment Response Document in the public
record. Those comments included: Support for the pollution prevention
alternative, requests for self-certification as the method of
implementation for the final rule, comments on the specific practices
listed in the P2 Alternative, and support for the use of Best
Professional or Engineering Judgement (BPJ or BEJ) by the permitting or
control authority, respectively.
A. Scope
At the time of proposal, the scope of the rule would have included
the formulating, packaging and repackaging of all pesticide active
ingredients (with the exception of sodium hypochlorite and the partial
exemption of small sanitizers) and a wide variety of associated
wastewater sources. Since the proposal, EPA has refined the scope
concerning pesticide active ingredients (PAIs) and wastewater sources
in response to comments on both the proposed rule and the supplemental
notice. The following discussion summarizes these revisions. See the
Comment Response Document in the rulemaking record for a more detailed
discussion on the changes.
1. Pesticide Active Ingredients (PAIs)
a. Sanitizer Active Ingredients and Pool Chemicals
Several changes have been made to the original ``sanitizer
exemption,'' as proposed. In the proposed rule EPA placed small
sanitizer facilities in their own subgroup within Subcategory C.
However, for the final rule, most sanitizer products have been excluded
from Subcategory C (see Sec. 455.10 of the final regulation of today's
rule for the definition of sanitizer products). This exclusion is based
on a number of factors. The partial exemption for small sanitizer
facilities that was included in the proposal was largely based on
disproportionate economic impacts. However, based on comments EPA has
expanded the sanitizer exemption to include additional chemicals for
the following reasons: (1) Sanitizer products are formulated for the
purposes of their labeled end use to ``go down the drain;'' (2)
sanitizer active ingredients are more likely to be sent to POTWs in
greater concentrations and volumes from their labeled end use than from
rinsing formulating equipment at the PFPR facility; (3) biodegradation
data received with comments on some of these sanitizer active
ingredients supports the hypothesis that they do not pass through
POTWs; (4) these sanitizer active ingredients represent a large portion
of the low toxicity PAIs considered for regulation at the time of
proposal; and (5) many sanitizer solutions containing these active
ingredients are cleared by the Food & Drug Administration (FDA) as
indirect food additives under 21 CFR 178.1010.
The exemption now covers both interior and exterior wastewater
sources. In addition, the proposed list of 28 sanitizer active
ingredients has been expanded to incorporate the pool chemicals
exemption as well as to include home use, institutional and most
commercial antimicrobial active ingredients, with the exception of
liquid chemical sterilants (including sporicidals), industrial
preservatives and water treatment micro biocides other than pool
chemicals (as defined in Sec. 455.10 of today's regulation). Certain
liquid chemical sterilant products are exempt from today's rule, as
discussed in Section III.A.1.c. Furthermore, based on comments, EPA has
eliminated the use of a list to define the exempted sanitizer active
ingredients and is employing a written definition (see Sec. 455.10 of
the final regulation for the definition used in today's final rule).
As mentioned above, EPA has combined the pool chemicals exemption
into the sanitizer exemption. This was based on comments on the
Supplemental Notice and information gathered in post-proposal site
visits (60 FR 30219). EPA believes that a large portion of the pool
chemicals that were being reviewed for exemption can and should also be
classified as sanitizer active ingredients. In order to avoid possible
confusion, EPA has decided to combine these two groups and has
incorporated pool chemicals into the definition for sanitizer active
ingredients. In addition to this change, the pool chemicals exemption
has undergone another refinement. Under the proposed rule, the only
pool chemical that was exempt was sodium hypochlorite. Under the final
rule, EPA has added several other chemicals to the exemption. These
chemicals include calcium hypochlorite, lithium hypochlorite, potassium
hypochlorite, chlorinated isocyanurate compounds and halogenated
hydantoins. As with the sanitizer chemicals, these chemicals are not
exempted via a list, but are instead exempted by definition. See
Sec. 455.10 of the final regulation.
[[Page 57524]]
b. Other Pesticide Active Ingredients
EPA has excluded several other groups of active ingredients from
the final regulation. As discussed in the Supplemental Notice and in
the Comment Response Document, microorganisms that are considered PAIs
under FIFRA will not be covered by this regulation and will be excluded
by definition. Based on the available information on the formulation,
packaging and repackaging of such microorganisms and the generation and
characteristics of wastewaters from such operations, EPA believes these
pesticides are not formulated in a similar fashion as other PAIs
covered by this rule. Microorganisms which have registered pesticidal
uses are generally created through a fermentation process, similar to
those found in some food processing or pharmaceutical plants.
Fermentation is a biological process, whereas other pesticides are
manufactured and formulated through chemical and physical processes.
In addition, almost all the microorganisms registered as pesticide
products are exempt from the requirement of obtaining a (residue)
tolerance for pesticides in or on raw agricultural commodities (40 CFR
180.1001). Under Part 180 Subpart D--Exemptions From Tolerance--it
states that ``an exemption from a tolerance shall be granted when it
appears that the total quantity of the pesticide chemical in or on all
raw agricultural commodities for which it is useful under conditions of
use currently prevailing or proposed will involve no hazard to the
public health.''
EPA has also excluded a group of chemicals, referred to in today's
notice as ``Group 1 mixtures.'' This group includes many herbs and
spices (e.g., rosemary, thyme, peppermint, cloves...), foods/food
constituents, plants/plant extracts (excluding pyrethrins) and many
chemicals that are considered to be GRAS (generally recognized as safe)
by the Food and Drug Administration as well as those products exempt
from FIFRA under 40 CFR 152.25 (61 FR 8876; March 6, 1996)(see Sec.
455.10 of the final regulation of today's notice for the definition of
Group 1 mixtures).
There is a second group of mixtures, ``Group 2 mixtures,'' that are
being excluded from the regulation. EPA has not been able to transfer
treatability data for many of these mixtures because the
characteristics that EPA uses for technology transfer are not easily
identified (e.g., molecular weights, solubilities and aromaticity). For
example, within a given structural group, PAIs that are aromatic, have
high molecular weights or low solubility in water have been found to be
amenable to activated carbon adsorption. However, when such
characteristics cannot be identified, EPA cannot transfer treatability
data for carbon adsorption.
EPA previously considered reserving this group of chemicals for
regulation at a later time; however, after further research EPA has
decided to exclude these chemicals from the scope of the final rule.
One reason, as mentioned above, is that the treatability data is
insufficient and to obtain treatment performance data on these mixtures
would be very difficult due to the inability to transfer data. Also,
most of these chemicals in pesticide products are used as inert
ingredients rather than active ingredients and the total volume of
these mixtures in use in pesticide products is very small (i.e., Group
2 Mixture PAIs only represent approximately eight percent of all of
pesticide products). EPA was not able to develop a definition to cover
all the chemicals in this group due to the lack of homogeneity between
the chemicals. Therefore, Group 2 mixtures will be excluded from the
scope of the final rule by list as opposed to definition (see Table 9
to Part 455 of the final regulation).
There are two other groups of chemicals that are being excluded
from the final rule: Inorganic wastewater treatment chemicals and
chemicals that do not pass through POTWS. Based on comments and data
collected for the Treatability Database Report and its Addendum (see
the public record for the rulemaking), EPA has decided to exclude, from
the scope of the final regulation, inorganic chemicals that are
commonly used as wastewater treatment chemicals (e.g., ferric sulfate,
potassium permanganate, sulfuric acid, carbon, chlorine, etc...). See
Comment Response Document for a discussion on the rationale behind this
exclusion. Many of these chemicals are also excluded under the
sanitizer/pool chemicals exemption. Again, the use of a definition will
be employed to exclude these chemicals. (See Sec. 455.10 of today's
final rule for the definition). The four chemicals which are excluded
from the pretreatment standards because EPA determined that they do not
pass through POTWs are phenol, 2-chlorophenol, 2,4-dichlorophenol and
2,4-dimethylphenol. Phenol, as a constituent in sanitizer products, is
excluded from the rule as it was excluded under the proposed sanitizer
exemption due to disproportionate economic impacts. See the Comment
Response Document in the rulemaking record for a further discussion on
the decision to exclude these wastewater treatment chemicals and the
chemicals that do not pass through.
c. Liquid Chemical Sterilants
Section 221 of the Food Quality Protection Act of 1996 (Pub. L.
104-170) amended the definition of ``pesticide'' in FIFRA to exclude
liquid chemical sterilant products (including any sterilant or
subordinate disinfectant claims on such products) which are used on a
critical or semi-critical device (as defined in section 201 of the
Federal Food, Drug, and Cosmetic Act (``FFDCA'') (21 U.S.C. 321). See 7
U.S.C. 136(u), as amended. Because Congress has chosen to exclude such
sterilant products from the definition of ``pesticide'', EPA has
modified the applicability provisions of this rule so that the effluent
limitations and pretreatment standards do not cover the wastewater
discharges from the formulation, packaging, and/or repackaging of
liquid chemical sterilants for use on critical devices or semi-critical
devices as these terms are now defined in FFDCA section 201 and FIFRA
section 2(u). See 40 CFR 455.40(f). However, facilities which
formulate, package, or repackage products containing liquid chemical
sterilants into other types of products, e.g., pesticide products which
are not used on critical or semi-critical devices introduced directly
into the human body, should be aware that the wastewaters resulting
from the formulating, packaging, and repackaging activities are covered
by this rule.
2. Wastewater Sources
In the proposal, EPA excluded water from on-site employee showers,
laundries and testing of fire protection equipment (59 FR 17903). EPA
has added several other wastewater sources to the exclusion. These
include: Storm water,4 water used for testing and emergency
operation of safety showers and eye washes; DOT leak test bath water
from non-continuous overflow baths (i.e., batch baths) where no cans
have burst from the time of the last water change out; and water used
for cleaning analytical equipment and glassware and for rinsing the
retain sample container in on-site laboratories. However, the initial
rinse of the retain sample container is considered a process wastewater
source for the final regulation. (See the Comment Response
[[Page 57525]]
Document for a discussion on the exclusion of these wastewaters).
---------------------------------------------------------------------------
\4\ Storm water at PFPR facilities and Refilling Establishments
is covered by the Storm water Regulations Phase I and II,
respectively.
---------------------------------------------------------------------------
B. The Zero Discharge/Pollution Prevention Alternative Option
Commenters submitted a variety of comments which prompted the
Agency to consider the Zero/P2 Alternative option. The most significant
are summarized below. (See the Comment Response Document in the public
record for additional summary of comment responses and responses to
individual comments.)
1. Cross Media Impacts and Incineration Issues
Commenters on the proposed rule believe that the zero discharge
standard, as proposed, would lead to a large increase in cross-media
impacts because the majority of facilities would be forced to contract
haul dilute non-reusable wastewaters off-site for incineration (or
other off-site disposal). Commenters questioned the goal of achieving
zero discharge when it leads to an increase in cross-media impacts.
At the time of the proposed rule, EPA believed that the proposed
approach to achieving ``zero discharge'' of wastewater pollutants from
PFPR facilities would result in increasing the recycling, reuse and
recovery of wastewater pollutants. In addition, EPA based the
requirements on the best practices observed at PFPR facilities studied
as part of the development of the rule. However, based on the concerns
raised by commenters about the potential cross-media impacts EPA
decided to seek comment on the pollution prevention (P2) alternative to
zero discharge in order to reduce these impacts (60 FR 30217). The P2
Alternative to the zero discharge standard will allow a discharge of
wastewater after waste discharge reductions are achieved using certain
flow conservation, recycle or reuse and, under certain circumstances,
wastewater treatment practices. Should a facility choose to comply with
the regulation through the P2 Alternative the need for off-site
disposal is reduced; thus, the cross-media effects are reduced.
For those facilities that choose to comply with the final rule by
achieving zero discharge, EPA has revised the cost model. The revisions
add costs to account for increased volumes of non-reusable wastewaters
being contract hauled for off-site incineration (see the Final Cost and
Loadings Report (September 1996) for a discussion on changes to the
costing methodology). The revised cost estimates for the industry to
achieve zero discharge of wastewater pollutants, including the
additional contract hauling costs, are still found to be economically
achievable for the industry. (See Section V of today's notice for a
discussion on the economic achievability of the final regulation.)
Commenters also commented that a significant decrease in
incineration capacity and an increased cost would result from EPA's
combustion policy which may limit the permitting of new incinerators or
the expansion of capacity of existing incinerators. EPA has addressed
this concern in two ways. First, through the use of the P2 Alternative
to zero discharge, this final rule will allow for the discharge of much
of the non-reusable PFPR wastewaters that might otherwise be contract
hauled for incineration. Second, as mentioned above, EPA has revised
its costing methodology for the zero discharge option to include off-
site incineration of these additional non-reusable wastewaters and has
still found the rule to be economically achievable by the industry. In
addition, EPA does not believe an additional burden will be placed on
incineration capacity. This is supported by a survey, ``Hazardous Waste
Incineration 1994,'' published in the EI Digest, June 1994 which showed
that while there is increasing demand for incineration there is still
great untapped capacity. The surveyed commercial incinerators believe
that market saturation, competition with cement kilns and successful
waste minimization efforts by industry account for the unused capacity
and the decline in the average price for incineration. [See the memo in
the record entitled Incineration Costs for PFP Facilities, September
30, 1994.]
2. Cross-Contamination Policy
Commenters also stated that complete reuse, as proposed, is not
achievable because of EPA's existing policy on cross-contamination of
pesticide products. At the time of proposal EPA was using a standard of
zero for cross-contamination. This meant that an active ingredient may
not be present at any concentration in a FIFRA registered product where
it is not listed on the confidential statement of formula (CSF) of that
product or reported to EPA as an impurity. During the study phase for
the development of the proposal, the industry practice was to triple
rinse containers and equipment. Because of recent EPA enforcement
actions, industry commented that additional rinsing is being used to
comply with the cross-contamination policy.
Commenters believe that more aggressive enforcement of a zero-
standard cross-contamination policy would increase wastewater volumes
to the point that it would not be feasible to reuse these volumes. The
commenters also believe that these factors were not taken into account
when the proposed zero discharge regulation was developed. According to
commenters, a facility that performs a triple rinse of the equipment
interiors when changing from formulating one product to another, may
have to perform additional rinses (e.g., a five times rinse) to ensure
a level of zero cross-contamination. Commenters stated that even in
cases where the rinsate from the ``triple rinse'' could be stored for
use in a future formulation, the additional rinses create more
rinsewater than could be reused and that these very dilute wastewaters
would have to be contract hauled for off-site disposal to achieve zero
discharge. Commenters believe this additional contract hauling of
wastewater not only makes the proposed regulation economically
unachievable, but increases the opportunity for cross-media impacts.
At the time of the supplemental notice EPA was reviewing the
pesticide cross-contamination policy. EPA has since published a Notice
of Availability on a more risk-based draft policy in the Federal
Register for public comment (61 FR 1928; January 24, 1996) and expects
publication of the final policy by the end of 1996. In addition, EPA
has created the P2 Alternative to zero discharge in this rulemaking
which would allow formulators, packagers and repackagers to discharge
these dilute non-reusable rinses following the use of specified
pollution prevention practices.
3. Request for De Minimis Discharge
Due to the concerns described above, many commenters requested a
discharge allowance for these excess or non-reusable wastewaters.
Commenters suggested that they would be willing to agree to use
specified pollution prevention practices and pointed to the pollution
prevention, recycle and reuse practices described in the preamble to
the proposal (59 FR 17866) and the technical development document for
the proposal [EPA #821-R-94-002]. In some cases commenters provided
examples of possible additional practices they would be willing to
agree to use. EPA believes that a discharge allowance (``pollution
prevention allowable discharge'') may provide an added incentive to
increase the use of pollution prevention and recycle practices, while
ensuring that facilities are maximizing pollutant reductions in the
wastewater while minimizing cross-media effects. Therefore, in response
to the request for
[[Page 57526]]
a ``de minimis'' discharge alternative, EPA has incorporated the P2
Alternative into the zero discharge standard for the final regulation.
4. Pollution Prevention Alternative
Several changes have been made to the P2 Alternative since it was
first presented in the Supplemental Notice. The most significant
revision is that a facility will be able to choose between achieving
zero discharge or an allowable discharge (using the P2 Alternative) on
a product family/process line/process unit basis.
In the supplemental notice, this choice was to be made on a
facility wide basis. However, based on comments, EPA believes that the
zero/P2 alternative option will be most practical if facilities can
choose zero discharge for those processes/process units at their
facility that are most amenable to zero discharge, while choosing the
P2 Alternative for other portions of the facility for which the
pollution prevention practices are most suited. EPA believes that this
change will also reduce burden.
In addition, EPA has made some changes to the listed pollution
prevention practices. First, the two tables of listed practices, as
found in Appendix B of the Supplemental Notice, have been combined into
one table. In addition, based on comments, revisions have been made to
the language used on the table of listed practices. Under the final
rule, any practice may be modified with an adequate justification. When
no justification is listed for the specific practice it can be modified
via best professional or engineering judgement (BPJ or BEJ,
respectively). EPA believes this is appropriate due to the unique and
individual situations that may arise at a particular facility (see the
Comment Response Document in the rulemaking record or the P2 Guidance
Manual for the PFPR Industry for examples of such situations). However,
for listed practices where no justification is listed on the table, a
facility will initially have to submit a request for a modification to
the permitting/control authority for review and approval. The
permitting/control authority is expected to use BPJ or BEJ to decide if
the justification provided is adequate. In addition, the permitting/
control authority will be able to add or replace practices specified by
the rule with new or innovative practices that are more effective at
reducing the pollutant loadings from a specific facility to the
environment.
EPA has also added some additional justifications to the table of
listed practices based on comments. For example, EPA will allow
facilities to modify the practice of reusing and/or storing and reusing
rinsates generated by rinsing of drums containing only inerts when a
facility can demonstrate that the large concentration of the inert in
the formulation creates more volume, after using water conservation
practices, than could feasibly be reused or when the concentration of
the inert is so small (i.e., perfumes) that the reuse would cause a
formulation to exceed the ranges allowed in the Confidential Statement
of Formula (CSF).
Based on comment, EPA has also combined, added and removed other
practices. For example, EPA has added a practice concerning dry
formulation interior equipment cleaning that specifies that facilities
must cleanout such interiors with dry carrier prior to any water rinse
and that this carrier material should preferably be stored and reused
in future formulation of the same or compatible product (or, as a last
resort, properly disposed of as solid waste). EPA has combined many of
the water conservation practices, such as use of flow reduction on
hoses, use of low volume/high pressure rinsing equipment and floor
scrubbing machines, into one listed practice. Finally, EPA has removed
the provision for dedicated equipment that was contingent on the
inability to reuse interior rinsates. Instead, this practice will be
discussed in the P2 Guidance Manual for the PFPR Industry. (See Table 8
to Part 455 of the final regulation, for the listed practices and
listed justifications).
Furthermore, EPA has refined the definition of P2 allowable
discharge. In response to comment, this definition states that
``appropriate pollution control technologies'' include not only those
technologies listed on Table 10 of the regulation, but also include a
pesticide manufacturer's treatment system or an equivalent system, used
individually or in any combination to achieve the level of pollutant
reduction determined by the permitting authority or control authority.
An equivalent system is a wastewater treatment system that is
demonstrated in literature, treatability tests or self-monitoring data
to remove a similar level of pesticide active ingredient (PAI) or
priority pollutants as the applicable treatment technology listed in
Table 10 to part 455 of the final regulation.
Finally, EPA has decided to allow the control authority to use best
engineering judgement to waive pretreatment at the PFPR facility prior
to discharge to the POTW under certain circumstances. Under the final
P2 Alternative to zero discharge, an indirect discharger must pretreat
the portion of their allowable P2 discharge that includes interior
equipment rinsates (including drum rinsates), leak and spill cleanup
water and floor wash prior to discharge to the POTW. However, EPA will
allow the control authority to waive the pretreatment requirements for
floor wash and the final interior rinse of a triple rinse that has been
demonstrated to be non-reusable when the facility demonstrates that the
level of PAIs and priority pollutants in such wastewaters are at a
level that is too low to be effectively pretreated at the facility and
have been shown to neither pass through or interfere with the
operations of the POTW. The control authority should also take into
account whether or not the facility has employed water conservation
when generating such a non-reusable wastewater.
C. Applicability to On-Site and Stand-alone Research & Development
(R&D) Laboratories
EPA has clarified the applicability of the final PFPR regulations
to on-site and stand-alone R&D laboratories (i.e., no PFPR on-site).
The final PFPR effluent guidelines and standards do not apply to
wastewater generated from the development of new formulations of
pesticide products and the associated efficacy and field testing (where
resulting product is not manufactured for sale). This includes such
wastewaters generated at stand-alone R&D laboratories as well as at R&D
laboratories located on-site at PFPR facilities. EPA received many
comments describing the operations at both on-site and stand-alone R&D
facilities. Commenters believe that wastewaters generated at these R&D
laboratories have extremely limited reuse potential due to their
experimental nature, as such formulations may only be produced once or,
at most, for one set of trials. Therefore, commenters believe that the
pollution prevention practices listed in the Supplemental Notice (for
example, reuse of interior rinsates in future formulation) are not
amenable to these one-time wastewaters. In addition, experiments
require the use of experimental controls. According to commenters, the
addition of rinsates into the ``experimental design could alter the
results of the experiment and render the data obtained useless.'' EPA
has taken the above information into account, in addition to the
typically low quantities discharged from these operations and believes
that the wastewaters generated by experimental formulation, efficacy
and field testing can be adequately addressed in permits
[[Page 57527]]
and pretreatment agreements through BPJ and BEJ, respectively.
D. Clarification of Issues Concerning PFPR/Manufacturers
Pesticide Manufacturing is covered by 40 CFR part 455 subparts A
and B. However, close to 50 pesticide manufacturers also perform
pesticide formulating, packaging and repackaging at their facility
(called ``PFPR/Manufacturers''). EPA has included a discussion, below,
to aid in clarifying how the final rule applies to the PFPR/
Manufacturers in regard to three specific issues. First, EPA will
clarify the difference between adding a solvent to stabilize an active
ingredient and adding a solvent (or other inert ingredients) to
formulate a pesticide product, and which practice constitutes
manufacturing and which constitutes formulation. Second, EPA will
discuss whether on-site incineration can be considered as achieving
zero discharge under the PFPR final rule. Finally, EPA will amend and
clarify the interpretation of the 1978 zero discharge BPT rule for
direct discharging PFPR/Manufacturers and PFPR stand-alone facilities.
1. Stabilizing versus Formulating
Pesticide manufacturers may sometimes add a solvent (organic or
aqueous) to a manufactured PAI or intermediate for the purpose of
stabilizing the product (e.g., for transport or storage). The Pesticide
Manufacturing Final Technical Development Document [EPA-821-R-93-016;
page 1-9] states that dilution of the manufactured active ingredient is
only covered by the Pesticide Manufacturing rule when it is ``a
necessary step following a chemical reaction to stabilize the
product.'' Thus, EPA would like to clarify that manufacturers can
perform such operations without being subject to the PFPR effluent
guidelines as long as it is a necessary step to stabilize the product
following a chemical reaction. Typically, such operations are performed
without placing the pesticide in a marketable container (i.e., they are
shipped in bulk via tank truck, rail car or tote tank). However, PFPR
facilities should not conclude that they can receive PAIs (that they do
not manufacture), even in bulk quantities, and dilute it with solvent
or other carrier without being subject to the PFPR effluent guidelines,
as this would be considered formulating under Sec. 455.10.
2. On-site Incineration as Zero Discharge
Although EPA proposed zero discharge limitations based on pollution
prevention, recycle/reuse and treatment for reuse, facilities may meet
this zero discharge requirement through a number of other practices.
These practices include hauling wastewater to off-site destinations,
such as sites which have incineration, deep well injection disposal and
centralized (commercial) wastewater treatment and subsequent discharge.
In some cases, wastewaters are returned to the registrant or
manufacturer. In a few instances, on-site incineration of PFPR
wastewaters is being conducted.
EPA received comment requesting clarification of whether on-site
incineration is an acceptable means of achieving zero discharge. For
purposes of this rule, EPA considers on-site incineration a valid
option for achieving zero discharge of PFPR process wastewaters. Wet
scrubbing devices used for air pollution control on existing on-site
incinerators at PFPR facilities are not subject to the PFPR effluent
guidelines. The only existing on-site incinerators at facilities
covered by the PFPR regulation are at facilities which also manufacture
pesticide active ingredients (PFPR/Manufacturers). Scrubber wastewater
discharges from these incineration activities are currently regulated
under the pesticide manufacturing effluent guidelines (40 CFR part 455,
subparts A and B; see 58 FR 50638, September 28, 1993) for the PAIs
manufactured at these facilities.
On-site incineration at new sources (i.e., NSPS and PSNS), would
also qualify as meeting zero discharge under the PFPR regulation and
scrubber water discharges from these on-site incinerators would be
covered by the pesticide manufacturing new source standards. However,
scrubber wastewater discharges from the on-site incineration of PAIs
not regulated by the pesticide manufacturing rule would have to be
controlled using a BPJ or BEJ basis.
3. Amending and Clarifying of BPT
The 1978 BPT regulation (43 FR 44846; September 29, 1978)
established a zero discharge limitation for direct discharges from
pesticide formulating and packaging 5 facilities. This included
pesticide formulating, packaging and repackaging that occurred at
direct discharge pesticide manufacturing facilities as well as stand-
alone PFPR facilities.6 The basis for the 1978 zero discharge BPT
limitation was water conservation, reuse and recycle practices, with
any residual water being evaporated or hauled off-site to a landfill.
However, many facilities that were direct dischargers in 1978 switched
to indirect discharge of wastewaters through POTWs instead of achieving
zero discharge via recycle and land filling or evaporation. Due to the
1978 BPT regulation, presently, there should be no direct discharging
PFPR facilities. However, the zero discharge limitation was not
interpreted or implemented in the same way for PFPR/Manufacturers as it
was for stand-alone PFPR facilities.
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\5\ In 1978 repackaging was not included in the title of
Subcategory C, but was covered by the BPT regulation and, therefore,
will be included in the title for the final rule.
\6\ A stand-alone PFPR facility is a PFPR facility where either:
(1) No pesticide manufacturing occurs; or (2) where pesticide
manufacturing process wastewaters are not commingled with PFPR
process wastewaters. Such facilities may formulate, package or
repackage or manufacture other non-pesticide chemical products and
be considered a ``stand-alone'' PFPR facility.
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It is EPA's understanding that permitting authorities incorporated
the BPT zero discharge standard for PFPR wastewaters into the pesticide
manufacturers' NPDES permits as a ``zero allowance.'' A zero allowance
would let a PFPR/Manufacturer discharge PFPR wastewaters along with
their pesticide manufacturing wastewaters as long as they did not
exceed the pesticide limitations in the Pesticide Manufacturing rule.
The 1978 pesticide manufacturing BPT limitations were presented as a
total pesticides limit for 49 specific PAIs. However, the more recent
BAT and NSPS limitations (58 FR 50638; September 28, 1993) do not set a
total pesticides limit but, instead set individual production-based
limitations. Since the pesticide manufacturing limits are based solely
on the manufacturing production and do not include the PFPR production,
permits could still use a zero allowance approach to allow discharges
of PFPR wastewater from these combined facilities.
At the time of proposal, EPA did not believe it was necessary to
amend the 1978 BPT because the zero discharge limitation was comparable
to the proposed standard of zero discharge.7 EPA recognized that
the bases for the 1978 BPT and proposed rule were not identical and
that land filling and evaporation were no longer the best options for
achieving zero discharge (59 FR 17870). However, EPA believed that
[[Page 57528]]
since both the 1978 BPT and the proposed rule were largely based on
water conservation, recycle and reuse practices, facilities could meet
BPT in a manner similar to the proposed rule.
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\7\ EPA proposed a zero discharge standard for PSES based on
pollution prevention, recycle/reuse and, when necessary, treatment
and reuse and expected it to be implemented via ``no flow'' of
process wastewater.
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Following proposal, EPA received many comments on and requests for
revision of the BPT regulation from the PFPR/Manufacturing facilities
and trade associations. Commenters raised issues related to the
technical feasibility of zero discharge for both the proposed rule and
the 1978 BPT rule.
Commenters believed that, because not all wastewaters were reusable
as EPA had assumed, the potential increase in cross-media impacts
associated with a zero discharge regulation in addition to the large
costs associated with contract hauling for incineration made any zero
discharge regulation infeasible. The commenters requested numeric
discharge limitations and/or a ``de minimis'' discharge allowance
(associated with pollution prevention practices) for their PFPR
wastewaters and that BPT be revised accordingly. Based on these and
other comments on the proposed rule, EPA developed the Zero/P2
Alternative for PSES and BAT (for Subcategory C facilities) which was
discussed in the Supplemental Notice and revised based on additional
comment for today's final rule.
Commenters also specifically commented on the need for revision of
the 1978 BPT due to: (1) Certain practices on which the 1978 BPT was
based (for example, land filling and evaporation) are no longer
desirable because they may cause cross-media impacts or may no longer
be available; and (2) the changes in PAIs and pesticide formulation
chemistries since 1978. For example, many pesticide products have been
reformulated from an organic solvent-based product to a water-based
product to avoid the generation of volatile organic compounds (VOCs).
This has, in many cases, caused an increase in the volume of wastewater
generated by this industry. In addition, many facilities are switching
to safer, more ``environmentally friendly'' pesticide active
ingredients which would change the characteristics of the wastewaters
from those determined in 1978. Commenters believe that EPA must revise
BPT or account for the additional costs associated with the current
practices that would be utilized to meet the zero discharge limitation
(i.e., off-site incineration).
Based on the comments discussed above, EPA has decided to amend BPT
for both the existing direct discharging PFPR/Manufacturers and stand-
alone PFPR facilities to allow them to choose between zero discharge
and the P2 Alternative. EPA believes that although the stand-alone PFPR
facilities are already achieving zero discharge, in compliance with the
1978 BPT, the methods they are employing may potentially result in
cross-media impacts that the use of the P2 Alternative would
potentially reduce.
Also, these changes will make BPT consistent with BAT (and PSES)
while essentially achieving the same pollutant removals and potentially
decreasing cross-media impacts associated with various off-site
disposal methods. In addition, the change to the BPT limitation that is
being promulgated today for PFPR/Manufacturers will clarify that the
method by which the zero discharge limitation has been implemented
(i.e., use of a zero allowance) is appropriate.
The final PFPR rule will allow discharge of PFPR wastewaters from
PFPR/Manufacturing facilities in two specific ways. For those
facilities choosing to comply with zero discharge (as opposed to the P2
Alternative), their permits should incorporate the ``zero allowance''
approach for the PFPR portion of their operations for the PAIs that
they manufacture. For those PAIs formulated and not manufactured at the
facility, the permit should apply a strict zero discharge. In part,
this is because their pesticide manufacturing wastewater treatment
system may not consist of the appropriate treatment technologies for
such PAIs or the treatment system may not be designed to treat the
additional volumes and/or concentrations of the ``non-manufactured''
PAIs.
However, PFPR/Manufacturers can choose the P2 Alternative to zero
discharge. Such facilities would not have to achieve zero discharge or
zero allowance of their PFPR wastewaters. Instead, these facilities
would comply with the practices specified in the P2 Alternative and
would receive a ``P2 discharge allowance'' following treatment (see
Sec. 455.41 of the final regulation for the definition of P2 allowable
discharge). The P2 discharge allowance can be applied to both
pesticides that are formulated/packaged/repackaged and manufactured as
well as those that are not manufactured on-site. [Note: Facilities can
choose between zero discharge and the P2 Alternative on a product
family/process line/process unit basis.]
The treatment system used to treat the combined PFPR and pesticide
manufacturing wastewaters must incorporate treatment that is
appropriate for those PAIs which are not also manufactured on-site
(i.e., those PAIs for which individual pesticide manufacturing
production-based limitations are not contained in the NPDES permit).
Treatment is deemed appropriate through the use of: treatability
studies found in literature or performed by the facility; long-term
monitoring data; or Table 10 of the final rule.
As discussed above, EPA is also amending BPT for stand-alone PFPR
facilities. Stand-alone facilities that do not send their wastewaters
to POTWs can choose to comply with the P2 Alternative or can remain as
zero discharge. Facilities choosing the P2 Alternative may have to
apply for an NPDES permit if they do not already have a permit.
E. Clarification of Refilling Establishments
EPA has decided to use the same general definition for ``refilling
establishment'' as in the proposed effluent guideline and the proposed
FIFRA Standards for Pesticide Containers and Containment rule (i.e., an
establishment where the activity of repackaging pesticide product into
refillable containers occurs). However, EPA will use different
applicability statements in each of the regulations to further define
the term as appropriate for the particular regulation. (See the Comment
Response Document for additional discussion). The limitations and
standards of Subpart E of the PFPR final rule apply to the repackaging
of pesticide products performed by refilling establishments: (a) That
repackage agricultural pesticides; (b) whose primary business is
wholesale or retail sales; and (c) where no pesticide manufacturing,
formulating or packaging occurs. Subpart E (Refilling Establishments)
is not applicable to wastewater generated from custom application or
custom blending.
F. RCRA Issues
A number of commenters requested clarification concerning the
potential for conflict between the proposed zero discharge effluent
guidelines limitations and standards and certain requirements under the
Resource Conservation and Recovery Act (RCRA). Specifically, commenters
requested that EPA explain, in the final rule, its interpretation of
the wastewater treatment unit exemption under RCRA (40 CFR 264.1(g)(6),
265.1(c)(10)) with respect to facilities regulated by a national
effluent guideline requirement of zero discharge and how such an
exemption would apply to the Universal Treatment System (UTS). They
also requested
[[Page 57529]]
clarification on the 90-day RCRA hazardous waste storage limitation.
In general, owners and operators of hazardous waste treatment,
storage, and disposal (TSD) facilities must meet the standards outlined
in 40 CFR part 264 (and part 265 for interim status). However, the
wastewater treatment unit exemption (40 CFR 264.1(g)(6), 40 CFR
265.1(c)(10)) is intended to exempt, from certain RCRA requirements,
wastewater treatment units at facilities that are subject to the NPDES
or pretreatment requirements under the Clean Water Act 8 (for
example, PFPR facilities). The specific definition of wastewater
treatment units that are exempt from certain RCRA requirements is found
in 40 CFR 260.10. The RCRA wastewater treatment unit exemption does not
exempt hazardous wastewaters at these facilities from RCRA
requirements, but does exempt the facilities from obtaining a TSD
permit for wastewater treatment systems treating, storing, or
generating listed (40 CFR 261.30-33) or characteristic (40 CFR 261.20-
24) hazardous wastes. EPA points out that many pesticide active
ingredients are not RCRA listed hazardous wastes and most PFPR
wastewaters do not exhibit hazardous waste characteristics; therefore,
such non-hazardous wastewaters would not be covered by the RCRA
Subtitle C requirements.
---------------------------------------------------------------------------
\8\ Section 402 of the Clean Water Act addresses the NPDES
requirements, while Section 307(b) addresses the pretreatment
standards.
---------------------------------------------------------------------------
As mentioned above, many commenters requested that EPA clarify
whether or not the wastewater treatment unit exemption can be applied
to facilities that are not discharging their treated wastewater
effluent due to a zero discharge limitation in a national effluent
guideline. Facilities subject to an effluent guideline which sets a
zero discharge or other limitations or standards (such as the P2
Alternative) can, in fact, be eligible for the RCRA wastewater
treatment unit exemption, assuming that they also satisfy the
exemption's other criteria.
Commenters also requested clarification on how the RCRA 90-day
limit on the storage of hazardous wastes (40 CFR 262.34) applies to
rinsates being stored for subsequent reuse in accordance with the PFPR
effluent guidelines. Generally, RCRA TSD permits (or interim status)
are required for facilities that store hazardous waste on site.
However, the RCRA regulations allow facilities that generate hazardous
waste to store the waste without a permit or interim status provided
that certain criteria, including a 90-day limit on storage for large
quantity generators, are satisfied (these criteria are outlined in 40
CFR 262.34). As mentioned earlier in this section, most PFPR
wastewaters would not be defined as RCRA hazardous waste, either
because the wastewater does not meet a RCRA listing, or does not
exhibit any hazardous characteristic; of course, generators are still
required to make this determination with respect to their own wastes
(40 CFR 262.11). If a material is not a hazardous waste, the RCRA
regulations, including storage requirements, do not apply.
For any rinsewaters that potentially meet a RCRA listing or exhibit
a RCRA characteristic, such rinsewaters being stored for direct reuse
as outlined under today's final PFPR effluent guidelines and standards
would not be considered wastes by the Agency (see 40 CFR 261.2(e)(1)).
As described elsewhere in today's rulemaking, these rinsewaters do not
require treatment prior to reuse and, due to stringent product
specifications, do not contain constituents that are not needed in the
product being formulated. In these situations where the rinsewaters are
not classified as a waste, the RCRA regulations (including the
generator requirements and storage requirements) do not apply. However,
the RCRA regulations do require that materials being stored for reuse
not be accumulated speculatively (speculatively accumulated materials
are classified as wastes). A material is not accumulated speculatively
if the person accumulating it shows that the material is recyclable,
has a feasible means of being recycled, and that during the calendar
year, the amount of material recycled equals at least 75 percent by
weight or volume of the amount of that material accumulated at the
beginning of the period. See 40 CFR 261.1(c)(8) and 261.2(e)(2)(iii).
IV. The Final Regulation
A. Pretreatment Standards for Existing Sources (PSES)
1. Pesticide Formulating, Packaging and Repackaging (Subcategory C)
Under the final rule, EPA is establishing a zero discharge
pretreatment standard with a P2 Alternative which allows a discharge to
POTWs. The zero discharge standard is based on pollution prevention,
recycle and reuse practices and, when necessary, treatment (through the
Universal Treatment System) for reuse. The basis also includes some
amount of contract hauling for off-site incineration which may be
necessary to achieve zero discharge. Compliance with the alternative
(P2 Alternative) is based on performing specific pollution prevention,
recycle, reuse and water conservation practices (as listed in Table 8
to part 455 of the final rule) followed by a P2 allowable discharge
which requires treatment of interior wastewater sources (including drum
rinsates), leak/spill cleanup water and floor wash prior to discharge
to a POTW. 9
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\9\ In individual cases the requirement of wastewater
pretreatment prior to discharge to the POTW may be removed for floor
wash or the final rinse of a non-reusable triple rinse by the
control authority when the facility has demonstrated that the levels
of PAIs and priority pollutants in such wastewaters are at a level
that is too low to be effectively pretreated at the facility and
have been shown to neither pass through or interfere with the
operations of the POTW.
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EPA visualized the Universal Treatment System (UTS) as a flexible
system consisting of a variety of treatment technologies that have been
determined to be effective for treating PFPR wastewaters. The UTS can
include various combinations of treatment technologies consisting of
emulsion breaking, hydrolysis, chemical oxidation, metals precipitation
and carbon adsorption. See Section 7 of the Final Technical Development
Document [EPA-821-R-96-019] for the PFPR effluent guideline and the
proposal (59 FR 17873) for a detail description of the UTS.
EPA determines which pollutants to regulate in PSES on the basis of
whether or not they pass through, interfere with, or are incompatible
with the operation of POTWs (including interference with sludge
practices). A pollutant is deemed to pass through when the average
percentage removed nationwide by well-operated POTWs (those meeting
secondary treatment requirements) is less than the percentage removed
by directly discharging facilities applying BAT for that pollutant. In
the pesticide chemical manufacturing final rule, phenol, 2-
chlorophenol, 2,4-dichlorophenol and 2,4-dimethylphenol were found to
not pass through POTWs (58 FR 50649; September 28 1993). Phenol is a
PAI that is exempted from this final rule under the sanitizer exemption
while the remaining three chemicals are priority pollutants.
As discussed in Section III.A.1, based on comments and the addition
of the pollution prevention alternative to the zero discharge standard
for the final rule, EPA believes it is appropriate to exempt phenol
from the final PFPR effluent guidelines and standards, and to exclude
2-chlorophenol, 2,4-dichlorophenol and 2,4-dimethylphenol from
regulation in the final categorical pretreatment standards (PSES and
[[Page 57530]]
PSNS) because these three pollutants have been determined not to pass
through POTWs.
EPA has estimated the compliance cost for the industry to achieve
the pretreatment standards (PSES) contained in the final rule at $29.9
million annually ($1995). The current PAI pollutant loading to POTWs is
estimated at 192,789 pounds with PAI removals achieved by the final
regulation estimated at 189,908 pounds (assuming zero removals by POTWs
currently--see Cost-Effectiveness Analysis in Section V.D.6). This
means that compliance with the final rule would remove almost 99% of
the current pollutant loading. Due to the toxic nature of the majority
of PAIs, the equivalent toxic weighted pollutant removals are 7.6
million pound equivalents 10.
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\10\ The toxic weighted pollutant removals (in pound-
equivalents) for the final rule are not directly comparable to the
toxic weighted pollutant removals presented in the proposal or
supplemental notice. This is because: (1) The method used to convert
acute toxicity values to chronic value was revised from a 1:100
ratio to a 1:10 ratio and reduces the toxic weighting factor for
many PAIs; (2) the toxic weighting factor for the pyrethrins was
revised; and (3) EPA is using an average non-272 PAI toxic weighting
factor based on values for 91 non-272 PAIs instead of using the
current loading-weighted average of the toxic weighting factors for
the 272 PAIs.
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2. Refilling Establishments (Subcategory E)
EPA is establishing pretreatment standards for existing refilling
establishments at zero discharge of pollutants in process wastewaters
to POTWs. This standard is based on collection and storage of process
wastewaters followed by reuse of the wastewaters as make-up water for
application to fields in accordance with the product label. Based on
the PFPR 1988 questionnaire survey, 98 percent of the existing
refilling establishments achieve zero discharge.
Only a small number of refilling establishments are indirect
dischargers and EPA has estimated that they can comply with the final
pretreatment standards at nearly zero cost. EPA has estimated that only
19 facilities (of the 1134) do not achieve zero discharge and they
currently discharge to POTWs. EPA estimates a capital cost of only $500
(i.e., the approximate cost of a minibulk tank to store water for
reuse) for each the 19 facilities to meet the zero discharge PSES
standard.
B. Best Practicable Control Technology Currently Available (BPT)
1. Pesticide Formulating, Packaging and Repackaging (Subcategory C)
As discussed in Section III.D.3. of today's notice, EPA has amended
and clarified the BPT limitations for the PFPR/Manufacturers and
established BPT limitations for the stand-alone PFPR facilities (ie.,
PFPR facilities where no pesticide manufacturing occurs or where
pesticide manufacturing process wastewaters are not commingled with
PFPR process wastewaters). In addition to clarifying the use of ``zero
allowance'' for zero discharge for PFPR/Manufacturers, EPA is providing
both the PFPR/Manufacturers and the stand-alone PFPRs with the
opportunity to use the P2 Alternative.
Under the final rule, EPA is amending the 1978 BPT standard by
establishing a zero discharge limitation with a compliance alternative
which provides for P2 allowable discharge to surface waters. EPA is
also establishing a zero discharge limitation (without the use of a
``zero allowance'' permitting mechanism) with a compliance alternative
for a P2 allowable discharge for the stand-alone PFPR facilities. (See
Section III.D.3. for additional discussion.)
The zero discharge limitation is based on pollution prevention,
recycle and reuse practices and, when necessary, treatment and reuse
for those PAIs that are formulated, packaged and/or repackaged but are
not also manufactured at the facility. The basis also includes some
amount of contract hauling for off-site incineration.
Zero allowance is established for PFPR/Manufacturers for those
pesticides that are formulated, packaged and/or repackaged and
manufactured at the facility. Zero allowance is based on pollution
prevention, recycle and reuse practices and treatment and discharge
through the manufacturer's wastewater treatment system within the
pesticide manufacturing production-based numeric limitations (i.e.,
giving no allowance for the PFPR wastewater or its production). This is
consistent with how the existing 1978 BPT zero discharge requirements
have been implemented by permit writers.
The compliance alternative (P2 Alternative) is based on performing
specific pollution prevention, recycle, reuse and water conservation
practices (as listed in Table 8 to part 455 of the final rule) followed
by a P2 allowable discharge which requires treatment of all process
wastewaters prior to direct discharge to surface waters.
EPA has estimated that there are no additional costs or pollutant
removals associated with the BPT limitation for the PFPR/Manufacturers,
as these costs have already been absorbed by the industry over the past
18 years as a result of the 1978 BPT regulation. (See Section IV.C.1.
for a discussion on BAT and the associated costs of compliance).
EPA has not assigned any additional costs to the stand-alone PFPR
facilities as they are also currently achieving zero discharge.
However, facilities may choose to take advantage of the P2 Alternative
in order to achieve a decrease in cross-media impacts. Depending on the
current means of achieving zero discharge, a facility's costs may
increase or decrease when switching to the P2 Alternative. The costs
may increase initially due to the cost of installing a wastewater
treatment system due to the associated capitol costs; however, EPA
believes that over the long term, the annual costs for those facilities
which select the P2 Alternative would be lower. EPA assumes that
facilities will make the choice, to continue to comply with zero
discharge or to move to the P2 Alternative based, in significant part,
on economic considerations. Therefore, EPA believes that if the costs
associated with the P2 Alternative were significantly higher, the
facility would not alter their current means of compliance.
Accordingly, EPA has assumed no incremental costs as a result of the
addition of the P2 Alternative to BPT for stand-alone PFPR facilities.
2. Refilling Establishments (Subcategory E)
The existing BPT regulations did not cover refilling
establishments. As discussed in the proposal (59 FR 17870), the
practice of refilling minibulks did not begin until the late 1980's,
i.e., after the original BPT regulation was promulgated in 1978. Based
on the PFPR survey, 98 percent of the existing refilling establishments
achieve zero discharge. EPA proposed zero discharge of process
wastewater pollutants as the BPT limitations for refilling
establishments.
In the final regulation EPA is establishing a BPT limitation for
existing refilling establishments at zero discharge of pollutants in
process wastewaters to waters of the U.S. This limitation is based on
collection and storage of process wastewaters, including rinsates from
cleaning minibulk containers and their ancillary equipment; and
wastewaters from secondary containment and loading pads. The collected
process wastewater would be reused as make-up water for
[[Page 57531]]
application to fields in accordance with the product label. Since
greater the 98% of these facilities already achieve zero discharge and
the remaining facilities discharge to POTWs, the costs associated for
BPT have been estimated to be nearly zero.
C. Best Available Technology Economically Achievable (BAT)
1. Pesticide Formulating, Packaging and Repackaging (Subcategory C)
EPA has established BAT limitations that are equivalent to the
limitations established for BPT for PFPR/Manufacturers and stand-alone
PFPR facilities (see Section IV.B.1 for discussion of BPT limitations).
Under the proposal, existing direct discharge PFPR/Manufacturers
were expected to treat (for reuse) their PFPR wastewaters in a separate
treatment system from their pesticide manufacturing wastewater
treatment systems. EPA estimated the compliance costs for these
facilities by costing them for separate PFPR universal treatment
systems.
Under the final rule, existing direct discharging Subcategory C
facilities will have a choice of either complying with a zero discharge
limitation or the P2 Alternative (see Section III.D.3. for a discussion
on amending and clarifying BPT). However, the rule clarifies that in
meeting the zero discharge limitation, permitting authorities may
authorize the commingling of pesticide manufacturing and PFPR process
wastewaters to meet the pertinent BAT limitations for pesticide
manufacturers with a zero allowance for PAIs in PFPR wastewaters. EPA
has revised the cost model to account for changes in the final rule due
to updated analytical data, changes in scope and the addition of the P2
Alternative. However, EPA believes that an overestimate of the costs
would result if EPA included costs for separate UTS systems when the
facilities' current controls, used for treating PFPR wastewaters (i.e.,
prior to commingling with pesticide manufacturing wastewater) and/or
treating commingled wastewater (i.e., their pesticide manufacturing
treatment systems), already achieve the BAT limitation of zero
discharge or ``zero allowance.''
Thus, EPA is not including these costs and removals in the total
industry estimate. However, EPA has made a determination of economic
achievability even if these costs would be incurred, and is presenting
the costs and pollutant removals associated with the (17) direct
discharging PFPR/Manufacturers for informational purposes. When current
treatment in place is not accounted for, the estimated compliance cost
for the PFPR/Manufacturers to comply with BAT is $2.8 million ($1995)
and is estimated to remove greater than 99% of the pollutants. This
equals 50,248 lbs (or 71.6 million lb-eq.11) of PAIs. Again, EPA
believes this cost is economically achievable.
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\11\ The large number of toxic weighted pound equivalents is
driven by a large PFPR production value reported from a single PFPR/
Manufacturer using coumaphos with a toxic weighting factor = 5.6 x
10\3\.
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2. Refilling Establishments (Subcategory E)
EPA is establishing BAT limitations for this subcategory that are
equivalent to the limitations established for BPT. Since BPT requires
zero discharge of process wastewater pollutants and 98 percent of the
existing refilling establishments already achieve zero discharge, EPA
believes the same technology basis and discharge prohibition is
appropriate and economically achievable for BAT.
D. New Source Performance Standards (NSPS)
1. Pesticide Formulating, Packaging and Repackaging (Subcategory C)
EPA has set the new source performance standards for PFPR/
Manufacturers and stand-alone PFPRs the same as BPT and BAT. The new
source standards are established as follows:
EPA has established NSPS limitations equivalent to the limitations
that are established for BPT and BAT. Since EPA found the Zero/P2
alternative to be economically achievable for existing facilities under
BPT and BAT on a facility basis and since new facilities will be able
to choose between zero discharge and the P2 Alternative on a product
family/process line/process unit basis, EPA believes that this NSPS
standard does not create a barrier to entry.
2. Refilling Establishments (Subcategory E)
EPA is establishing NSPS standards for this subcategory that are
equivalent to the limitation established for BPT and BAT. Since BPT
requires zero discharge of process wastewater pollutants and 98 percent
of the existing refilling establishments already achieve zero
discharge, EPA believes an equivalent technology basis is appropriate
for NSPS and will not create a barrier to entry.
E. Pretreatment Standards for New Sources (PSNS)
1. Pesticide Formulating, Packaging and Repackaging (Subcategory C)
EPA is establishing PSNS standards for this subcategory that are
equivalent to the standards established for PSES (i.e., zero discharge
with a compliance alternative for a P2 allowable discharge). EPA
believes that the standards established for PSNS will not create a
barrier to entry as they are equivalent to PSES which were found to be
economically achievable.
EPA did not propose to set PSNS (or NSPS) equal to PSES (or BAT).
Although the PSNS Zero/P2 Alternative standard discussed above is a
change from the proposed PSNS, it is consistent with the Supplemental
Notice and comments submitted. At proposal, PSES included a partial
exemption for exterior wastewater sources from small sanitizer
facilities (see Section II.E of today's notice for a discussion of the
proposed partial sanitizer exemption); however, the proposed PSNS did
not include such an exemption and was found not to create a barrier to
entry for new facilities. The partial sanitizer exemption no longer
effects the economic achievability of the standards because in response
to comments, sanitizer products are no longer included in the scope of
the PFPR effluent guidelines. Based on the addition of the P2
Alternative option to these effluent guidelines and standards and the
associated estimated reductions in cross-media impacts, EPA believes
that it is appropriate to give new facilities the opportunity to use
the P2 Alternative to meet PSNS.
2. Refilling Establishments (Subcategory E)
EPA is establishing PSNS standards for this subcategory that are
equivalent to the limitations established for PSES (i.e., zero
discharge). In addition, BPT, BAT and NSPS also require zero discharge
of process wastewater pollutants, and 98 percent of the existing
refilling establishments already achieve zero discharge; thus, EPA
believes an equivalent technology basis is appropriate for PSNS and
will not create a barrier to entry.
F. Best Conventional Pollutant Control Technology (BCT)
1. Pesticide Formulating, Packaging and Repackaging (Subcategory C)
EPA has established BCT limitations that are equivalent to the
limitations established for BPT. This is because BPT and BAT establish
zero discharge
[[Page 57532]]
with a compliance alternative for a P2 allowable discharge and BCT can
be no less stringent than BPT and no more stringent that BAT. EPA
believes there are no additional costs associated with these
limitations.
2. Refilling Establishments (Subcategory E)
EPA is establishing BCT limitations for this subcategory that are
equivalent to the limitations established for BPT. Since BPT requires
zero discharge of process wastewater pollutants and 98 percent of the
existing refilling establishments already achieve zero discharge, EPA
believes an equivalent technology basis is appropriate for BCT.
V. Economic Considerations
A. Introduction
Promulgation of the final PFPR rule requires that the discharge
limitations be both technically and economically achievable. This
section of today's notice reviews EPA's analysis of the economic
impacts of the regulation and presents EPA's finding that the
limitations are economically achievable.
EPA's detailed economic impact assessment can be found in the
report titled ``Economic Analysis of Final Effluent Limitations
Guidelines and Standards for the Pesticide Formulating, Packaging, and
Repackaging Industry'' (hereafter ``final EA'') [EPA-821-R-96-017]. The
report estimates the economic effect on the industry of compliance with
the regulation in terms of facility closures (severe impacts), and
conversions of production lines to alternate activities and/or
compliance costs exceeding five percent of facility revenues (moderate
impacts). The report also includes: Analysis of the effects of the
regulation on new pesticide formulating, packaging, and repackaging
facilities and a Regulatory Flexibility Analysis detailing impacts on
small businesses and small entities. A separate report, ``Cost-
Effectiveness Analysis of Final Effluent Limitations Guidelines and
Standards for the Pesticide Formulating, Packaging, and Repackaging
Industry,'' presents an analysis of the cost-effectiveness of the final
regulation. All of these analyses support the conclusion that the
effluent limitations guidelines and standards contained in the final
PFPR regulation are economically achievable by the PFPR industry.
The discussion of economic achievability is organized in three
sections, as follows. Section V.B. summarizes the economic findings for
the regulation as proposed in April 1994. Section V.C. reviews certain
changes in the regulation since proposal that were the basis of a
supplemental notice issued in June 1995; and Section V.D. presents the
economic analysis of the final regulation, as delineated in the
preceding sections of this preamble.
B. Review of the Proposed Regulation
The April 14, 1994 notice of proposed rulemaking (59 FR 17850)
included a description of the anticipated economic impacts of proposed
effluent limitations guidelines and standards for the PFPR industry.
These economic impacts are briefly reviewed below. (See Section II.E.
for a review of the proposed regulation.)
At proposal, BCT and BAT requirements were proposed to be
equivalent to the 1978 BPT requirements; therefore, no additional costs
were expected for compliance with the BCT and BAT limitations.
Accordingly, the EIA focused on analyzing alternative PSES options for
the two industry subcategories.
1. Subcategory C: PFPR and PFPR/Manufacturers
Since completion of the proposal EIA, EPA has continued to review
its information regarding the structure of the PFPR industry and has
increased its estimates of the numbers of facilities using only non-272
PAIs that would potentially be subject to the Subcategory C regulation.
As a result, EPA's estimates of the number of affected facilities and
the impacts and costs of the proposed regulation are higher than those
presented at proposal. For example, at proposal, EPA estimated that
Subcategory C included 1,479 water-using facilities that were
potentially subject to regulation. Using the newer population
estimates, EPA now estimates that under the proposal a total of 2,018
water-using facilities would have been potentially subject to
regulation. The increase in this estimate comes entirely from the
increased estimate of the number of facilities using only non-272
PAIs.12 The following discussion of the proposed Subcategory C
regulation reflects these updated estimates of the numbers of
facilities, costs, and impacts.
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\12\ Due to changes in scope for the final regulation, 1,411
water using facilities will be potentially subject to the final
regulation.
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For the re-estimated proposed rule, EPA estimates that 2,018
Subcategory C, water-using facilities were potentially subject to
regulation. Of these 2,018 facilities, 943 used the 272 PAIs that EPA
originally considered for regulation 13 and 1,075 used only the
additional non-272 PAIs. EPA estimates that 1,142 of these facilities
would incur total annualized compliance costs of $71.9 million in 1995
dollars 14 under the proposed rule of zero discharge.
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\13\ Many of these facilities also used non-272 PAIs in addition
to the 272 PAIs.
\14\ The costs of regulatory compliance are all reported in 1995
dollars. In the EIA and the Federal Register Notice for the
regulation at proposal and in the Supplemental Notice, regulatory
compliance were reported in 1988 dollars, the base year of the PFPR
industry survey. All cost estimates, including the proposal and the
supplemental notice have been brought forward to 1995.
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The EIA for the proposed regulation used three primary impact
measures:
Severe impacts, which were defined as facility closures;
Moderate impacts or facility impacts short of closure,
which were defined as line conversions or incurrence of annualized
compliance costs exceeding five percent of facility revenue; and
Employment losses, which, for the impact analysis, were
assumed to accompany facility closures and line conversions (but not
incurrence of annualized compliance costs exceeding 5 percent of
facility revenue).
Under the proposed PSES requirements and using the updated estimate
for the number of non-272 PAI-using facilities, EPA estimates that
three facilities would close as a result of proposed regulation, while
327 facilities would incur moderate impacts. In addition, under the
proposed zero discharge rule, EPA conservatively estimates total job
losses at facilities incurring impacts at 890 full-time employment
positions. EPA judges the proposed regulation as economically
achievable using these updated impact values that are based on the
higher number of non-272 PAI-using facilities.
In addition to the facility impact analysis, EPA analyzed the cost-
effectiveness of the proposed regulation for Subcategory C facilities.
Cost-effectiveness is calculated as the ratio of the incremental annual
costs in 1981 dollars to the incremental pounds-equivalent of
pollutants removed for each option. Using the updated estimates of
costs and removals for the proposed regulation, EPA estimates total
pollutant removals of 505,235 pounds, or 38.9 million pounds-equivalent
on a toxic weighted basis, and an average cost-effectiveness value of
$1.65 per pound-equivalent.\15\ \16\ EPA considers the proposed option
to be cost-effective.
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\15\ The toxicity of the non-272 PAIs used in generating this
cost-effectiveness value was estimated as the average pre-compliance
loading-weighted average toxicity of the 272 PAIs.
\16\ At proposal, EPA reported an average cost-effectiveness, or
the cost-effectiveness value calculated relative to the baseline of
no regulation, and an incremental cost-effectiveness, or the cost-
effectiveness relative to the next less stringent regulatory option
considered. However, the incremental calculation and the comparison
are no longer relevant as the alternative options at proposal are no
longer under consideration. For this reason, in the current
discussion, EPA is reporting only the cost-effectiveness value
calculated relative to the baseline of no regulation.
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[[Page 57533]]
For analysis of the final regulation, EPA revised the toxic
weighting factors to reflect additional information on the toxicity of
the PAIs. In general, the revisions reduced the estimated toxicity of
the PAIs subject to regulation (see Section V.D.6, below, which
contains the discussion of the cost-effectiveness analysis for the
final regulation). Using these revised toxic weighting factors and also
taking into account the updated estimates of costs and pollutant
removals for non-272 PAI-using facilities, EPA estimates that the
proposed regulation would remove an estimated 23.2 million pounds-
equivalent, yielding a cost-effectiveness value of $2.77 per pound-
equivalent ($1981).
2. Subcategory E: Refilling Establishments
At proposal, an estimated 1,134 refilling establishments
(Subcategory E PFPR facilities) were potentially subject to regulation.
EPA estimates that 98 percent of these facilities, were already in
compliance with the proposed Subcategory E limitations and pretreatment
standards. All but 19 of the 1,134 existing facilities were expected to
incur no costs to comply with the proposed option. The remaining 19
facilities were expected to achieve compliance with no significant
additional cost\17\ (See Section VI.B.2). No economic impacts were
estimated to occur due to compliance with the proposed rule.
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\17\ A capital investment of approximately $500 was estimated
for each of these facilities.
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C. Changes to the EIA Since Proposal: Issuance of the June 1995
Supplemental Notice
In response to public comments on the regulation, EPA issued a
Supplemental Notice (60 FR 30217) on June 8, 1995 that solicited
comment on proposed changes in the scope of the PFPR regulation for
Subcategory C facilities and on the Zero/P2 Alternative. In addition,
EPA revised the cost estimating methodology and economic impact
estimates.
As discussed in Section III.B.4. of today's notice, EPA estimated
compliance costs for each facility to comply with the Zero/P2
Alternative option. Each facility was assumed to choose either zero
discharge or the P2 Alternative for compliance, depending on which
alternative would impose the lower annualized costs on the facility.
For the Supplemental Notice, EPA estimated total annualized compliance
costs for facilities covered under PSES at $43.4 million, in 1995
dollars, or 40 percent less than the costs for the proposed regulation.
Under the Zero/P2 Alternative option, no facilities were assessed as
closures as the result of the compliance requirements, while 208
facilities were assessed as incurring moderate impacts.\18\ The
comparable values for the regulation for the proposal (re-estimated
using the revised cost previously discussed) are 3 facility closures
and 327 facilities with moderate impacts.
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\18\ The cost and impact values for the Supplemental Notice
regulation reflect updating of the estimates of non-272 PAI-using
facilities.
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D. Assessment of Costs and Impacts for the Final PFPR Regulations
This section describes the impact measures used in the Economic
Analysis, the estimated impacts associated with the final rule, impacts
on new sources, and the cost-effectiveness analysis. As discussed
below, EPA is promulgating the regulation for Subcategory E facilities
as presented at proposal with storm water now exempted, but the
analysis of costs and impacts for the Subcategory E regulation remain
the same as presented at proposal. Accordingly, the following
discussion focuses on the Pretreatment Standards for Existing Sources
(PSES) regulation for Subcategory C facilities.
1. Summary of Economic Analysis Methodology and Data
The data sources and methodology for analyzing economic impacts
remain the same as used at proposal and for the Supplemental Notice.
For a more detailed discussion of the methodology used in the economic
impact analysis, see the preamble for the PFPR regulation at proposal
(59 FR 17850), the proposal EIA report and final EA report.
The economic impact analysis measures three types of primary
impacts: severe impacts (facility closures), moderate impacts (facility
impacts short of closure), and job losses. Each impact analysis measure
is reviewed briefly below.
Severe Impacts. Severe impacts, defined as facility
closures, were assessed on the finding that the regulation would be
expected to cause a facility to incur, on average, negative after-tax
cash flow over the three-year period of analysis. This analysis was
performed for PFPR/Manufacturers and for facilities that do not
manufacture PAIs, but receive at least 25 percent of their revenue from
PFPR activities. Facilities with relatively low reliance on PFPR
activities as a source of revenue (i.e., less than 25 percent of
revenue) were excluded from this analysis because EPA does not
anticipate that such facilities would close in entirety because of
costs of regulatory compliance associated with PFPR activities. EPA
also did not include PFPR facilities from Subcategory E (refilling
establishments) in this analysis largely because of their relatively
low reliance on PFPR activities as a source of revenue (an average of
15 percent).
Moderate Impacts. Moderate impacts were defined as a
financial impact short of entire facility closure and were analyzed in
two ways. First, PFPR facilities subject to the Subcategory C
regulation and with less than 25 percent of revenue from PFPR
activities were assessed for line conversions by comparing the after-
tax return on assets (ROA) from PFPR activities after regulation with
the ROA estimated to be achievable in an alternative line of business.
Facilities for which the post-compliance ROA for PFPR activities was
found to be less than the return achievable in an alternative line of
business were assumed to switch out of PFPR operations. Second, all
Subcategory C and E facilities, regardless of PFPR revenue reliance,
were assessed for the incurrence of total annualized compliance costs
exceeding five percent of facility revenue.
Employment losses. Possible employment losses were
assessed for facilities estimated to close as a result of regulation
and for facilities estimated to convert PFPR lines to an alternative
business activity. EPA believes that the estimates of employment loss
resulting from this analysis are highly conservative because of the
assumption that line conversions would result in loss of employment for
a facility's PFPR-related employment. More realistically, EPA expects
that line conversions will not generally lead to full loss of PFPR-
related employment.
As in the economic impact analysis for the proposed PFPR
regulation, these analyses for the final regulation assume that PFPR
facilities would not be able to pass the costs of compliance on to
their customers through price increases. Analysis of pesticide product
markets and the likely response of pesticide product customers to price
increases (as discussed in the proposal EIA), indicates that a
substantial number of facilities should recover some part of their
compliance costs through price
[[Page 57534]]
increases. Thus, the analyses of compliance cost and impacts overstate
the severity of the regulation's financial burden on the PFPR industry.
EPA extrapolated information on compliance costs, pollutant
loadings, and the frequency of facility-level compliance impacts from
data on facilities in the original PFPR industry survey to analyze the
technical and economic impacts of regulating the additional non-272
PAIs.\19\ In the following discussion, EPA has not separated the
estimated costs or impacts according to which set of PAIs facilities
are estimated to use. Additional details of the analysis of costs and
impacts for the facilities using the different sets of PAIs may be
found in the final EA.
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\19\ Although the PFPR industry survey focused on facilities
using the original 272 PAIs, some of these facilities were also
found to use one or more of the additional non-272 PAIs in their
PFPR activities. During site visits, EPA also observed PFPR
operations at several facilities that process both original 272 and
non-272 PAIs. Thus, the set of facilities used for extrapolating
financial and technical information to facilities using the non-272
PAI chemicals and the impacts of bringing these additional PAIs
under regulation also includes information on facilities that use
these non-272 PAIs.
---------------------------------------------------------------------------
Although the impact analysis methodology for the final regulation
is unchanged from proposal (see the Proposal EIA), its application has
been changed for analyzing the Zero/P2 Alternative. This regulatory
option was analyzed for each sample facility as part of two separate
compliance approaches: (1) Zero discharge and (2) pollution prevention
in combination with treatment followed by discharge (see Section
IV.A.1). Facilities were assumed to adopt the compliance approach with
the lower total annualized compliance cost including both annual
operating and maintenance costs and an annual allowance for capital
outlays. Although most facilities were estimated to achieve compliance
by pollution prevention and treatment, some were estimated to comply by
zero discharge. Thus, the combination of the analyses for the two
separate compliance approaches yields the aggregate analysis for the
final regulation for Subcategory C facilities. EPA believes this
methodology provides a realistic appraisal of the costs and impacts of
the final regulation as it embodies the compliance decision that
facility management is expected to face in deciding whether to comply
by zero discharge or by pollution prevention in combination with
treatment followed by discharge. In addition, because EPA's analysis
considers both capital and operating costs, EPA believes that the
findings from the compliance decision analysis will reasonably
approximate facility managements' findings regarding choice of the less
financially burdensome compliance approach. In addition, under the
final rule, facilities will be able to make the choice between zero
discharge and the P2 Alternative on a product family/process line/
process unit basis, which will give them even more flexibility in their
compliance choice.
2. Estimated Facility Economic Impacts
a. Subcategory C: PFPR and PFPR/Manufacturers
The costs and impacts for the final regulation applicable to PSES
Subcategory C facilities are discussed in this section and are compared
with the values estimated for the proposed and supplemental notice
regulations. In addition, the cost and impacts for the final regulation
are compared with those that EPA estimates would occur if facilities
were not provided the flexibility to choose the preferred compliance
approach from the zero discharge and pollution prevention allowable
discharge alternatives. These comparisons show that the final
regulation provides a more economical and less financially burdensome
approach to achieving desired discharge reductions than the proposed,
and otherwise previously noticed, requirements considered.
The following comparisons with the proposed regulation are relative
to the cost and impact values based on the new estimates of the number
of facilities using only non-272 PAIs. As noted previously, these
revisions increased the costs and impacts estimated for the proposed
regulation. The following discussion will show that the costs and
impacts for the final regulation are substantially less than the
updated estimates for the proposed regulation. Although this discussion
will not include comparisons with the values for the proposed
regulation as originally published, EPA points out that the costs and
impacts for the final regulation are also markedly less than the
original estimates of costs and impacts for the proposed regulation.
Of the 2,018 water-using Subcategory C facilities re-estimated to
be subject to the regulation at proposal, EPA estimates that 506
facilities, or 25 percent, including baseline failures, will incur
costs in complying with the final Subcategory C PSES regulation. Total
annualized compliance costs for these facilities are estimated at $29.9
million, in 1995 dollars (see Table 1, below). Excluding baseline
closures from the cost analysis reduces the number of facilities
expected to incur costs to 421 facilities and total annual costs to
$24.2 million, in 1995 dollars. In estimating the costs of the final
regulation, facilities were assigned to the compliance option--zero
discharge or the pollution prevention alternative--with the lower total
annualized compliance cost. From this analysis, 69 percent of the cost-
incurring facilities (including baseline failures) were expected to
select the P2 Alternative with the remaining 31 percent selecting zero
discharge.
No facilities are projected to close under the final regulation. A
total of 150 possible line conversions (a moderate impact) are
estimated. EPA does not generally expect that line conversions will
result in employment losses. However, to be conservative in its
analysis, EPA estimated the maximum potential employment loss
associated with the regulation by assuming that all PFPR employment
would be lost in facilities with line conversions. From this
assumption, the upper bound employment loss for the final regulation is
estimated at 458 full-time employment positions (FTEs).
[[Page 57535]]
Table 1.--Estimated Costs and Impacts of the Final, Proposed and Supplemental Notice PSES Regulation for Subcategory C Facilities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of annualized Maximum potential
facilities compliance Severe impacts Moderate employment loss
incurring cost ($1995, impacts *
costs millions)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Proposed Regulation.............................................. 1,142 $71.9 3 327 890
Supplemental Notice.............................................. 709 43.4 0 208 634
Final Regulation--Costs Including Baseline Closures.............. 506 29.9 0 150 458
Final Regulation--Costs Excluding Baseline Closures.............. 421 24.2
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Severe impacts are defined as facility closures. All facility employment is assumed to be lost as the result of a facility closure.
* Moderate impacts are defined as line conversions and/or total annual compliance costs exceeding 5 percent of total facility revenue. EPA does not
expect that employment losses would generally accompany line conversions; however, for this analysis, EPA assessed the maximum potential loss based on
the assumption that all employment associated with PFPR activities would be lost as a result of a line conversion.
Employment loss for the proposed regulation includes the estimated employment loss in facility closures and the worst case estimate of
employment loss in facilities with line conversions. The reported employment loss for the Supplemental Notice and Final Regulation reflects no
facility closures and includes only the worst case employment loss in facilities with line conversions.
In addition to presenting the estimated costs and impacts for the
final regulation, Table 1 also presents the comparable values for the
proposal (re-estimated) and the supplemental notice. As shown in the
table, the expected burden of the regulation has fallen considerably
from proposal through supplemental notice to the final regulation. From
proposal (re-estimated) to final, the number of Subcategory C
facilities expected to incur costs has fallen from 1,142 to 506
facilities, or 56 percent 20. This can be attributed to the
reduction in scope of certain PAIs and wastewater sources as well as to
the addition of the P2 Alternative as a compliance option to zero
discharge. The estimated drop in total annual compliance cost, from
$71.9 million to $29.9 million ($1995), represents an even greater
reduction from proposal, at 58 percent. As noted above, no severe
impacts are assessed for the final regulation while 3 facility closures
were estimated for the proposed regulation. Finally, the number of
moderate impacts and potential employment losses are also substantially
reduced from proposal, falling by 54 percent and 49 percent,
respectively. In summary, under the final regulation, the number of
facilities estimated to incur costs, the expected cost, and the
facility impacts are considerably less than estimated for the proposed
regulation.
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\20\ All comparisons with the proposed regulation and
supplemental notice are based on the analyses including baseline
closures.
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EPA also believes that the final regulation is superior to the
other options considered because of the flexibility it provides to
facilities in deciding how to achieve compliance. In particular, by
allowing facilities to choose the less expensive compliance approach--
the pollution prevention alternative or zero discharge--the regulation
achieves substantial pollution reductions but at substantially lower
costs and economic impacts than would occur if the regulation allowed
compliance by only one of the possible approaches.21 Moreover, EPA
notes that, by encouraging consideration and use of pollution
prevention as a compliance approach, the final regulation will reduce
the potential for cross-media impacts that would occur under a strict
zero discharge requirement. The regulation achieves these benefits with
only a very modest reduction in the expected pollutant removals that
would be achieved under a zero discharge regulation. Specifically, EPA
estimates that the final regulation will remove 189,908 pounds or 98.5
percent, of the estimated 192,789 pounds of pollutant discharges
subject to control by the final regulation (assuming zero removals by
POTWs currently--see Cost-Effectiveness Analysis in Section V.D.6). EPA
estimates that only 2,881 pounds, or about 1.5 percent of the pollutant
loadings subject to the final regulation will continue to be discharged
to POTWs.
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\21\ EPA has worded the final regulation to allow facilities to
make the choice between zero discharge and the pollution prevention
alternative on a product family/process unit/process line basis (as
opposed to a full facility basis). However, EPA could not estimate
costs on this basis.
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Finding of Economic Achievability
The final regulation achieves substantial reductions in harmful
pollutant discharges at very modest economic burden to the PFPR
industry. Under a conservative assumption that facilities will recover
none of their compliance costs through price increases, the regulation
is estimated to impose no severe impacts (i.e., facility closures), 150
moderate impacts (i.e., line conversion or annualized compliance cost
exceeding 5 percent of facility revenue), and a worst-case employment
loss of 458 FTEs. In addition, the final regulation provides industry
with considerable latitude in deciding how to comply with the
regulation--that is, by zero discharge or pollution prevention and
treatment. In this regard, EPA's analyses of the selected compliance
approach may overstate compliance costs because the analyses assume
application of one approach throughout the facility instead of a more
customized choice of compliance approach by PFPR line. Also, EPA
estimates that a relatively small fraction--25 percent--of the
facilities potentially subject to the proposed regulation are likely to
incur costs in complying with the final regulation. That such a small
fraction of the industry is expected to incur costs reflects in large
part EPA's decision to exclude additional PAIs and wastestreams from
coverage under the final regulation. Finally, EPA notes that the
aggregate costs and impacts estimated for the final regulation are
substantially less than those estimated for the proposed regulation,
both as analyzed for the original proposal and as analyzed on the basis
of the higher estimate of non-272 PAI-using facilities. In light of
these very modest impacts estimated for the final regulation, EPA finds
that the final PSES regulation for Subcategory C facilities is
economically achievable.
b. Subcategory E: Refilling Establishments
The regulatory approach and costing methodology for Subcategory E
facilities is unchanged from that presented at proposal with the
exception that storm water is no longer considered a process wastewater
subject to this regulation. The analysis of costs, loadings, and
economic methodology at proposal stands as previously presented.
[[Page 57536]]
EPA is establishing BPT and BAT regulations for Subcategory E
facilities set to zero discharge (equivalent to PSES). EPA's survey of
the PFPR industry indicated that no Subcategory E facilities are direct
dischargers. Accordingly, EPA estimates that the Subcategory E portion
of the PFPR industry will incur no costs for complying with the BPT or
BAT requirements.
4. Regulatory Effects Not Re-Estimated
Because the aggregate compliance costs and facility impacts
estimated under the final regulation are substantially less than those
estimated for the regulation as presented at proposal, EPA did not re-
evaluate the following economic measures for the final regulation:
community impacts, foreign trade effects, impacts on firms owning PFPR
facilities, the direct economic benefits to facilities of pollution
prevention practices, and the labor requirements. The analysis of these
additional impact categories depends on the estimated aggregate costs
for the regulation and on the results of the facility impact analysis.
With the final regulation estimated to impose aggregate compliance
costs that are 56 percent less than originally estimated for the
proposed regulation and to cause no facility closures (compared to the
2 closures originally estimated at proposal), EPA concluded that the
analysis for these additional impact categories under the final
regulation would find less consequential effects than had been
originally estimated at proposal. Because EPA had judged the slight
impacts estimated at proposal for the additional impact categories to
be consistent with an economically achievable regulation, EPA,
therefore, concluded that the impacts under the final regulation for
these additional impact categories would also be found consistent with
an economically achievable regulation. As a result, EPA decided not to
expend the resources that would be necessary to re-estimate and re-
document the lower impact levels for these additional impact
categories.
5. Impacts of Pretreatment Standards for New Sources (PSNS) and New
Source Performance Standards (NSPS)
a. Subcategory C: PFPR and PFPR/Manufacturers
(1) PSNS
EPA is setting PSNS (Pretreatment Standards for New Sources) for
Subcategory C facilities equal to PSES limitations for existing
sources. In general, EPA believes that new sources will be able to
comply at costs that are similar to or less than the costs for existing
sources, because new sources can apply control technologies and P2
practices (including dedicated lines and pressurized hoses for
equipment cleaning) more efficiently than sources that need to retrofit
for those technologies and P2 practices. As a result, given EPA's
finding of economic achievability for the final PSES regulation for
Subcategory C facilities, EPA also finds that the PSNS regulation will
be economically achievable and will not constitute a barrier to entry
for new sources.
(2) NSPS
EPA has established NSPS limitations equivalent to the limitations
that are established for BPT and BAT. BPT and BAT limitations allow
facilities to use the Zero/P2 Alternative and were found to be
economically achievable; therefore, NSPS limitations will not present a
barrier to entry for new facilities.
b. Subcategory E: Refilling Establishments
EPA is setting NSPS/PSNS for Subcategory E facilities equal to BAT/
PSES limitations for existing sources. EPA estimates that compliance
with BAT/PSES will impose no costs on existing facilities. Likewise,
new facilities are not expected to incur additional annual costs due to
the regulation. Because EPA found compliance with the final regulation
to be economically achievable for existing facilities, EPA determined
that compliance with NSPS/PSNS will also be economically achievable and
not a barrier to entry for new sources.
6. Cost-Effectiveness Analysis
EPA also performed a cost-effectiveness analysis of the final PSES
regulation for Subcategory C facilities. (A more detailed discussion
can be found in the final Cost-Effectiveness Analysis (September 1996)
[EPA-821-R-96-018]. The cost-effectiveness analysis compares the total
annualized cost incurred for a regulatory option to the corresponding
effectiveness of that option in reducing the discharge of pollutants.
Cost-effectiveness calculations are used during the development of
effluent limitations guidelines and standards to compare the efficiency
of one regulatory option in removing pollutants to another regulatory
option. Cost-effectiveness is defined as the incremental annual cost of
a pollution control option in an industry subcategory per incremental
pollutant removal. The increments are considered relative to another
option or to a benchmark, such as existing treatment. In cost-
effectiveness analysis, pollutant removals are measured in toxicity
normalized units called ``pounds-equivalent.'' The cost-effectiveness
value, therefore, represents the unit cost of removing an additional
pound-equivalent (lb eq.) of pollutants. In general, the lower the
cost-effectiveness value, the more cost-efficient the regulation will
be in removing pollutants, taking into account their toxicity. While
not required by the Clean Water Act, cost-effectiveness analysis is a
useful tool for evaluating regulatory options for the removal of toxic
pollutants. Cost-effectiveness analysis does not analyze the removal of
conventional pollutants (e.g., oil and grease, bio-chemical oxygen
demand, and total suspended solids).
For the cost-effectiveness analysis, the estimated pounds-
equivalent of pollutants removed were calculated by multiplying the
number of pounds of each pollutant removed by the toxic weighting
factor for each pollutant. The more toxic the pollutant, the higher
will be the pollutant's toxic weighting factor; accordingly, the use of
pounds-equivalent gives correspondingly more weight to pollutants with
higher toxicity. Thus, for a given expenditure and pounds of pollutants
removed, the cost per pound-equivalent removed would be lower when more
highly toxic pollutants are removed than if pollutants of lesser
toxicity are removed. Annual costs for all cost-effectiveness analyses
are reported in 1981 dollars so that comparisons of cost-effectiveness
may be made with regulations for other industries that were issued at
different times.
a. Subcategory C: PFPR and PFPR/Manufacturers
Table 2 provides estimates of the total annualized compliance
costs, in 1981 dollars, the total pollutant removals in pounds and
pounds-equivalent, and the cost-effectiveness of the final PSES
regulation for Subcategory C facilities with estimates of various POTW
removals. EPA has estimated the pollutant removals and the cost-
effectiveness value for the final rule using the same methodology as
used in the proposed rule and supplemental notice (and the Pesticide
Manufacturing effluent guideline). This methodology assumes that all
PAIs pass through the POTW (i.e., no removal by the POTW), as there is
little field data on the effectiveness of POTWs removing PAIs.
However, EPA has developed laboratory estimates for the percent
[[Page 57537]]
removals of a large number of pollutants (including some PAIs) which
were published in the Domestic Sewage Study (DSS), February 1986 [EPA/
530-SW-86-004]. For each pollutant studied, two estimates were
developed, an ``acclimated'' removal percentage, which might be
achieved by a well-run treatment facility with a constant flow rate of
the pollutant in question, and an ``unacclimated'' removal percentage,
adjusted to account for the slug loadings and batch discharges which
POTWs experience in everyday operation. While the unacclimated removals
were intended to more accurately reflect real world operating
conditions, a limited amount of test data on non-PAI pollutants
indicates that POTWs may achieve or even exceed the acclimated removal
estimates in practice. Thus it is not clear whether the acclimated or
unacclimated estimates more accurately represent the removal
percentages achieved in practice for PAIs. EPA has thus developed a
range of cost-effectiveness and total removals using three different
assumptions about the removal efficiency of POTWs: zero removals (this
most conservative estimate is included because of the lack of actual
data), unacclimated removals (which range from 30% to 90% and average
48%), and acclimated removals (which range from 80% to 95%).
Using this range of POTW removals, EPA has estimated the range of
removal to be between 18,991 and 189,908 pounds of pollutants, or
760,000 to 7.6 million toxic pounds-equivalent with cost-effectiveness
ranging from $2.74 to $27.35 per pound-equivalent when compliance costs
are held constant at $20.9 million 22 in 1981 dollars. EPA
considers even the high end of this range to be cost effective. In
order to be consistent with the proposed rule and supplemental notice
(and because of the lack of actual POTW removal data for PAIs), EPA is
presenting the cost-effectiveness and total removals for the final rule
as $2.74 per pound-equivalent and 189,908 pounds or 7.6 million pounds-
equivalent, respectively.
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\22\ EPA believes that if POTWs are removing PAIs, the cost of
compliance of the industry would be lower than $20.9 million ($1981)
due to the reduction in operating and maintenance costs associated
with the treatment system used to pretreat PFPR wastewaters prior to
discharge to the POTW.
Table 2.--National Estimates of Total Annualized Costs, Removals and Cost-Effectiveness Values for Subcategory C
PSES Facilities Under the Final Regulation
----------------------------------------------------------------------------------------------------------------
Total
annualized
compliance Pollutant Pollutant removals, (pounds- Cost-
POTW removal assumption used costs removals, equivalent) effectiveness
(millions of pounds ($/lb.-eq.)
$, 1981)
----------------------------------------------------------------------------------------------------------------
No POTW Removals.................. $20.9 189,908 7.6 million................. $2.74
POTW Removals per DSS............. 20.9 165,460 5.8 million................. 3.60
90 Percent Removal Efficiency..... 20.9 18,991 760,000..................... 27.35
----------------------------------------------------------------------------------------------------------------
Notes:
1. Includes estimated baseline failures.
2. Toxic weighting factors used in the analyses reflect more recent toxicological information and are generally
lower than the factors used at proposal and supplemental.
EPA has also estimated the removals, annual compliance cost, and
cost-effectiveness excluding baseline closures (when zero removal at
POTWs is assumed). Excluding estimated baseline failures lowers the
costs and removals to $17.1 million ($1981) and 156,592 pounds (5.8
million pounds-equivalent). The cost-effectiveness value excluding
baseline failures is $2.93 per pound-equivalent, which EPA considers to
be cost-effective.
The cost-effectiveness value (assuming no POTW removal) for the
final regulation is not directly comparable to the values presented in
the previous Federal Register notices for the proposed regulation and
the supplemental notice for two reasons. First, the scope of the
regulation has changed with fewer PAIs and waste streams covered under
the final regulation. As a result, the baseline pollutant discharges
and pollutant removals estimated for the final regulation are lower
than the values estimated for the proposed regulation. Second, the
toxic weighting factors (TWFs) used by EPA for calculating the cost-
effectiveness of the final regulation reflect more recent toxicological
data and, in general, are lower than the values used for the proposal
and supplemental notice analyses. To provide a consistent comparison of
the proposed, supplemental, and final regulations, EPA re-calculated
the toxic-weighted baseline discharges, pollutant removals, and cost-
effectiveness values for the proposed and supplemental notice
regulations using the more recent toxic weighting factors (see Table
3).23 The calculations for the final regulation also embody the
changes in regulatory scope.
---------------------------------------------------------------------------
\23\ The re-calculated cost-effectiveness values for the
proposed regulation also reflect the updated estimates of the number
of facilities using non-272 PAIs.
Table 3.--Estimated Cost-Effectiveness of the Final PSES Regulation for Subcategory C Facilities Compared with
the Proposed and Supplemental Notice Regulations
[All toxic-weighted values based on toxic weighting factors developed for the Final Regulation]
----------------------------------------------------------------------------------------------------------------
Proposed regulation: Zero Supplemental notice: Zero Final regulation: Zero
discharge with sanitizer discharge/pollution discharge/pollution
exemption (Option 3/S.1) prevention alternative prevention alternative
----------------------------------------------------------------------------------------------------------------
Total Annualized Cost, $1981 $64.1 million............. $32.7 million............. $20.9 million.
Pollutant Discharges Subject 505,235................... 337,995................... 192,789.
to Regulation, pounds.
Pollutant Loadings Subject 23.2 million.............. 15.4 million.............. 7.7 million.
to Regulation, pounds-
equivalent.
Pollutant Removals, pounds.. 503,114................... 333,731................... 189,908.
[[Page 57538]]
Pollutant Removals, pounds- 23.2 million.............. 15.3 million.............. 7.6 million.
equivalent.
Cost-Effectiveness.......... $2.77/lb-eq............... $2.14/lb-eq............... $2.74/lb-eq.
----------------------------------------------------------------------------------------------------------------
AAACost-effectiveness analysis is conventionally calculated on an incremental basis: that is, the costs and
removals of a given option are calculated as the differences from the values for the next less stringent
option. At proposal, the cost-effectiveness of Option 3/S.1 was calculated on an incremental basis relative to
the next less stringent option, Option 3/S. However, the cost-effectiveness values for the supplemental notice
and final regulations are relative to a next less stringent option of no regulation. To permit consistent
comparison of the three regulations, the cost-effectiveness of the proposed regulation has been restated
relative to a no-regulation baseline.
The effect of the regulation's reduced scope is seen by the
reductions in pollutant loadings subject to regulation in pounds and
pounds-equivalent (see Table 3, lines 2 and 3). These results show the
pollutant loadings subject to the rule at proposal to be 505,235
pounds, and on a toxic-weighted basis, 23.2 million pounds-equivalent;
under the final regulation, the pollutant loadings within the scope of
the regulation fall to 192,789 pounds and 7.7 million pounds-equivalent
on a toxic-weighted basis. The cost-effectiveness values of the
regulations using the current set of weighting factors are: $2.77 per
pound-equivalent for the proposed regulation, $2.14 per pound-
equivalent for the supplemental notice, and $2.74 per pound-equivalent
for the final regulation. The cost-effectiveness value for the final
regulation is low in relation to the values calculated for other
effluent limitations guidelines and standards recently promulgated by
EPA.
b. Subcategory E: Refilling Establishments
Estimates of compliance costs and pollutant removals associated
with Subcategory E facilities have not changed since the proposed
regulation. EPA believes that the final regulation can be implemented
at a minimal cost (i.e., a capital investment of approximately $500 for
a mini-bulk tank to store water for reuse) at the 19 facilities not
currently in compliance. Therefore, EPA determines the final regulation
to be cost-effective for Subcategory E facilities.
E. Regulatory Flexibility Act
Pursuant to section 605(b) of the Regulatory Flexibility Act, 5
U.S.C. 605(b), the Administrator certifies that this rule will not have
a significant economic impact on a substantial number of small
entities. EPA analyzed the potential impact of the rule on both small
businesses and small local governments.
Under the Regulatory Flexibility Act, an agency is not required to
prepare a regulatory flexibility analysis for a rule that the agency
head certifies will not have a significant economic impact on a
substantial number of small entities. While the Administrator has so
certified today's rule, the Agency nonetheless prepared a regulatory
flexibility assessment equivalent to that required by the Regulatory
Flexibility Act as modified by the Small Business Regulatory
Enforcement Fairness Act of 1996. The assessment for this rule is
detailed in the ``Economic Analysis of Final Effluent Limitations
Guidelines and Standards for the Pesticide Formulating, Packaging, and
Repackaging Industry'' [EPA-821-R-96-017].
EPA received many comments regarding the rule (see Section 15.6 of
the technical record and Section IV in the economic record for the
rulemaking). A number of commenters raised issues concerning small
business impacts and the need to reduce the regulation's burden on
small businesses. Specifically, as a way of reducing possible adverse
impacts on smaller businesses, some commenters requested that EPA
broaden its exemption from the regulation to include all small
businesses. In addition, some commenters argued that EPA did not need
to regulate the discharges of small PFPR businesses because the
pollutant discharges of such facilities were not likely to have a
consequential environmental impact.
EPA disagrees with this claim and believes it is inappropriate to
set small-business and/or small-production exemptions for all small
businesses and/or production volumes because of the substantial
toxicity of many of the PAIs. The size of the business and/or the
volume of PAIs processed annually are not a sufficient basis for
determining that a facility should be exempted from regulation. Because
of the high toxicity of many of the PAIs, the processing of even very
small quantities of such PAIs can result in pollutant discharges of
substantial toxicity. In addition, small business size does not
necessarily equate with small pesticide production volume, particularly
in terms of toxicity. Some small-business PFPR facilities process a
substantial volume of PAIs and have the potential to discharge
substantial volumes of toxic pollutants unless discharges are limited
by the PFPR regulation. (see the Comment Response Documents in the
rulemaking record for more information on these comments and EPA's
response to them.)
Taking into account commenters'' concerns regarding possible
impacts on small entities, EPA introduced the Zero/P2 Alternative
Option and made numerous changes to the rule designed to reduce the
burden upon all PFPR facilities, particularly small business entities.
As previously discussed, the final rule expands the sanitizer exemption
to exempt additional lower toxicity PAIs from regulatory coverage and
gives facilities a Zero/P2 compliance choice on a line by line or
process by process basis.
The factual analysis and basis for the ``no significant impact''
certification is contained in Chapter 4 of the final EA report
referenced previously and is summarized below.
1. Analysis of Impacts on Small Business Entities
To gauge the impact of the final regulation on small business, EPA
analyzed the impact of the final regulation on Subcategory C facilities
according to the business size of the owning firms and compared the
findings for the final regulation with those for the proposed
regulation. Given the large presence of small business-owned entities
in the PFPR industry, EPA exercised substantial care at proposal and
throughout development of the final regulation, to ensure that the
[[Page 57539]]
final regulation would not impose a significant impact on a substantial
number of small business-owned facilities. This effort results in the
modest incurrence of both costs and impacts by small business entities
under the final regulation.
EPA estimates that 1,513 (75.0 percent) of the 2,018 PFPR
facilities potentially subject to a Subcategory C PSES regulation are
owned by small entities. Of the 506 facilities estimated to potentially
incur compliance costs under the final rule (including baseline
failures), 357 (70.6 percent) are estimated to be owned by small
entities. Excluding projected baseline failures, 421 facilities are
expected to incur costs, of which 274, or 65.1 percent are small
business-owned facilities.
No small business-owned facilities are estimated to close as a
result of regulation. Less than 10 percent of small business-owned
facilities (137 facilities) are estimated to incur a moderate impact ``
that is, a line conversion or annualized compliance cost exceeding 5
percent of facility revenue. The average compliance cost burden among
small business-owned facilities is also small in relation to facility
revenue: on average, annualized compliance costs amount to 2.7 percent
of facility revenue for small business-owned facilities.
Finally, the number of small business-facilities incurring costs,
and the numbers of small business-facilities incurring severe or
moderate impacts are substantially less than estimated for the proposed
regulation. For the proposed regulation (re-estimated), 859 small
business-facilities were estimated to incur costs, 3 facilities were
assessed as potential closures (severe impacts), and 275 facilities
were assessed as moderate impacts; the comparable values for the final
regulation are 357 small-business facilities incurring costs, zero
severe impacts, and 137 moderate impacts. The substantial reduction in
impacts among small business-owned facilities from proposed to final
regulation reflects EPA's efforts to moderate the burden of the
regulation by introducing a new option which gives facilities the two
compliance alternatives, by reducing the PAIs and wastestreams subject
to the regulation, and by providing facilities with greater flexibility
in deciding how to achieve regulatory compliance. In light of these
findings, EPA certifies that the final regulation does not impose
significant impacts on a substantial number of small business-owned
facilities.
2. Analysis of Impacts on Other Small Entities
In addition to considering the impact of the final regulation on
small business-owned facilities, EPA also considered the regulation's
likely effects on two other categories of small entities that will be
affected by the regulation: (1) Publicly Owned Treatment Works operated
by small governments, which may be responsible for implementing the
regulation at the local level; and (2) small communities, which may
contain businesses that are adversely affected by the regulation. EPA
concluded that the final regulation would not impose significant
impacts on either of these additional small entity categories.
In the course of developing the final regulation, EPA solicited
comments on regulatory implementation issues from over 76 POTWs that
had been identified as receiving PFPR facility discharges. Fifteen of
these are POTWs are considered small--that is, POTWs that are located
in smaller jurisdictions (less than 50,000 population) or that are
small POTWs on the basis of daily treatment volume (less than or equal
to 1 million gallons per day). Comments were requested on such matters
as the burden of implementing the pollution prevention/treatment
alternative element of the regulation. Although small entity POTWs were
afforded the opportunity to comment on the implementation requirements
of the proposed regulation, none chose to do so. However, in response
to the request for comment on the supplemental notice, EPA received
responses from eight POTWs. Sev
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