United States
Environmental
Protection Agency
Office of the
Administrator
EPA100-R-97-005
May 1997
A REPORT ON REGULATORY REINVENTION
Getting Back to Basics
Reinventing Environmental Regulations
Of all the opportunities that
exist for reinventing envi-
ronmental protection,
perhaps none is more basic than the task
of reinventing environmental regulations.
As Congress has passed laws over the
years, EPA has responded with regulations
to protect people and the environment
from a multitude of risks. These regula-
tions have made a tremendous difference
in the quality of life here in the United
States, and yet, in some cases, they are not
always as effective as they might be.
In order to achieve greater results and
to reduce unnecessary costs and regulatory
burden on communities and the private
sector, EPA is working to improve envi-
ronmental regulations in a number of
ways. Basic enhancements include consol-
idating similar requirements for certain
industries; eliminating requirements that
are duplicative, obsolete, or unnecessary;
and writing in "plain English" to ensure
better comprehension of what is required.
inside
Air
Pesticides
Hazardous Waste
Water
"Plain English" Regulations
Reaffirming Reinvention
2
3
4
6
7
7
At the same time, the Agency is work-
ing to develop fundamentally new regula-
tory approaches as a way of moving envi-
ronmental protection beyond the com-
mand and control regulatory approach of
the past. By offering certain features, such
as more operational flexibility in exchange
for greater public accountability or
extended compliance schedules for those
willing to invest in innovative new tech-
nologies, EPA is helping to redefine the
traditional regulatory framework. Over
time, these efforts could create a whole
new mind-set about environmental regu-
lation. Rather than burdens requiring
compliance, the environmental regula-
tions of tomorrow may very well be rec-
ognized as a simple, straightforward
means to achieving multiple objectives,
including recognition for environmental
stewardship, long-term sustainability, less
waste and liability, and higher profits.
In the summaries that follow, EPAs
four national environmental program
managers — Mary Nichols (Air), Lynn
Goldman (Pesticides), Tim Fields (Solid
Waste—Acting) and Robert Perciasepe
(Water).— provide an overview of how
environmental regulations are being
reformed and what those reforms may
mean for environmental and public health
protection.
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•. I'UI mmmi Ill i!
Iecognizing the challenge
that industries face in
dealing with multiple air
emissions requirements, EPA is working
on a proposal that would consolidate 16
different air rules into a single set for
the synthetic organic chemical manufac-
turing industry. Known as the
Consolidated Air Rule, EPA expects
this action will significantly reduce the
regulatory burden for industry and for
state and local air quality agencies as a
result of streamlined monitoring, data
handling, reporting and recordkeeping
requirements. EPA also expects the rule
to help reduce overall emissions by
improving understanding of what is
required and by allowing the manufac-
turers to focus on emissions control
rather than the administrative intricacies
of each individual requirement. This
new rule, scheduled for proposal later
this year, could serve as a model for
consolidating air requirements for other
industry sectors.
Flexible, facility-wide air permit-
ting is another reform effort underway.
Under Title V of the Clean Air Act, facil-
ities obtain permits that include all
applicable Clean Air Act requirements,
and any change in operational status can
trigger the need for permit modification
or review. This permit review process can
hamper a facility's ability to quickly meet
changing market demands. To address
this problem, last year EPA initiated the
pollution prevention permitting pilot
(P4) to test ways of providing more oper-
ational flexibility within the existing regu-
latory structure and of achieving better
environmental protection through
improved pollution prevention tech-
niques. Through a series of pilot projects,
EPA is working with states and industry
to develop innovative permits that
include facility-wide emissions caps and
pre-approvals of certain control technolo-
gies. These permits allow certain opera-
tional changes to occur over the 5-year
life of a permit, using a streamlined
review process, as long as emissions stay
below the overall facility cap.
EPA expects the P4 program to pro-
duce several important benefits. First,
promotion of pollution prevention
the added operational flexibility helped
save up to $1 million per day. Finally,
streamlining the review process is
expected to lower workload burdens for
air emissions sources and permitting
authorities, allowing each to focus on
higher priority issues.
Recognizing that permit revisions
will always be necessary in some cir-
cumstances, EPA is working with states
and industry to streamline the Title V
permitting revision process. The pur-
pose is to reduce the cost and delay asso-
ciated with these revisions as well as the
duplication that exists with state air
emission permitting programs. EPA
expects to issue its final permit revision
procedures early next year. When imple-
mented, these provisions will improve
compliance and provide public review of
environmentally significant permit
changes without being unnecessarily
burdensome to the affected industry.
Finally, EPA is proceeding with
reforms to streamline and simplify
New Source Review permitting
requirements. Under the New Source
In one pilot project involving a pharmaceutical
plant in Georgia, the company—Searle
Corporation—estimated that the added opera-
tional flexibility helped save up to $1 million per day.
opportunities and overall net reductions
in emission levels will improve environ-
mental protection. Second, the experi-
ence of developing these innovative per-
mits on a pilot basis will help lay the
framework for potential broader appli-
cations to other sources. Third, opera-
tional flexibility may help companies
avoid unnecessary financial losses that
can occur as a result of regulatory delay.
In one pilot project involving a pharma-
ceutical plant in Georgia, the company
— Searle Corporation — estimated that
Review program, large industrial facili-
ties planning to build or expand pro-
duction capacity are required to obtain a
permit. A final rule, expected early next
year, will provide industry with greater
flexibility, reduce time delays in issuing
permits, and create incentives for use of
innovative technology. EPA expects this
move will reduce the number of per-
mitting actions that would otherwise
occur for new sources by one-halE
— Mary Nichols
REPORT ON REINVENTION
May 1997
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f esticide registration is
another area of EPA regula-
tory reform. Before any new
pesticide becomes available in the com-
mercial marketplace, it first goes through
a thorough EPA review and approval
process under the Federal Insecticide,
Fungicide and Rodenticide Act (FIFRA),
as amended by the Food Quality
Protection Act (FQPA). Every year, EPA
receives thousands of applications to reg-
ister or amend products. Over the past 3
years, EPA has worked to make the regis-
tration process faster and easier while still
providing strong protection for public
health and the environment.
Based on new risk-related informa-
tion indicating that the ingredients
would pose no unreasonable adverse
effects, in May 1996, EPA exempted 31
low-risk pesticide active ingredients
from regulation. This exemption
Acute toxicity
testing results
Minor, low risk
formulation changes
relieves pesticide manufacturers from
unnecessary regulation and helps the
Agency direct its resources to higher
risk priorities. At present, EPA is con-
sidering similar exemptions for other
chemicals and chemical uses.
As a result of changes to its internal
review process, EPA has cut average
review times for pesticide product
acute toxicity studies by more than
80 percent. The pesticide registration
process requires applicants to submit
acute toxicity testing results to EPA for
review, and on average, the
Agency receives about 900
submissions per year. Over
time, a backlog of more
than 400 studies accumulat-
ed, slowing the rate at
which new submissions
received attention. "Without
a change in practices or
resources, this backlog was
projected to grow while the
average time a company
waited for review stood at
about 24 months. As a
result of its reinvention
efforts, EPA eliminated this
backlog — despite a reduc-
tion in staff and a 6-week
government shutdown that
occurred during the latter
part of 1996. Perhaps more
importantly, the amount of
time that applicants spend
waiting for an EPA
response has dropped from about 24 to
4 months.
EPA has also offered self-certifica-
tion procedures for certain circum-
stances which allow pesticide applicants
to proceed with registration activities as
long as they notify the Agency first.
This option, which includes random
audits by EPA to ensure the process is
working properly, helps applicants avoid
unnecessary delays waiting for EPA
review. In May 1995, EPA expanded
self-certifications for certain low-risk,
minor product labeling changes.
Since that time, the number of labeling
changes handled in this manner has
doubled, saving time and resources for
both EPA and industry. EPA is proceed-
ing with self-certification initiatives to
cover other steps as well. In February
1997, this option was proposed as away
to better manage more than 2,000 sub-
missioSis'for product chemistry test-
ing data thatcome to EPA for review
everyLyear. Self-certification would be r*-
offereH for simple straightforward
determinations, such as color, odor, or
pH results, that do not require stringent
oversight. About one-third of product
rcherriistry testing submissions fall into
: this category. Because each self-certified
action would cut EPA review time by
about one-fourth, about 15 extra weeks
of staff time~wbuld be freed up each
year to focus on higher priorities. A
final decision on this issue is expected
later this summer.
May 1997
REPORT ON REINVENTION
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Another improvement effort focuses
on reviewing deficient (or unacceptable)
pesticide applications. By conducting an
in-depth rejection rate analysis of
applications that have not been
approved, EPA expects to reveal addi-
tional opportunities for improving reg-
istration in the future. Applications may
be found to be deficient for any number
of reasons, such as missing data or
incomplete labelling. Newly developed
and tested computer software may solve
the latter problem by standardizing
"precautionary" labelling. This
labelling, determined based on results
from acute toxicity studies, provides
consumers and workers with important
safety information. EPA stafFhope to
make the software available soon for
widespread use within the industry.
More recently, EPA has established
new divisions to focus specifically on
improving registration of biological
pesticides, which can provide a safer
pest control alternative, and of antimi-
crobial pesticides, which are critical to
public health and controlling human
disease. During the last 3 years, EPA has
registered over 40 new biological pesti-
cides, including the first pesticides pro-
duced by genetically engineered crop
plants. As part of an overall effort to
speed registration of microbial pesti-
cides, the Agency committed to elimi-
nate a backlog of applications waiting
for review. During the past 6 months,
the backlog has been slashed by 40 per-
cent, and staff expect it to be completely
eliminated by the end of the year.
Last November EPA's efforts to
improve pesticide registration were rec-
ognized through the Administration's
highest award for reinventing govern-
ment •— a "Hammer Award" under the
Vice President's National Performance
Review The award ceremony was host-
ed by NYCO Products, a pesticide man-
ufacturer outside Chicago. Company
President Bob Stahurski described some
of the benefits that small-and medium-
sized microbial manufacturers were
realizing as a result of the reinvented
registration process, including an ability
to get products to market faster. Similar
acknowledgments have come from
other sources. In a letter offering con-
gratulations on the Hammer Award,
Ciba-Geigy Corporation stated, irVbu
and others who worked on removing
the logjam on acute toxicity reviews are
to be commended for your dedication
to this project and for implementing
creative solutions to make the review
process more efficient."
— Lynn Goldman
ne of the first reinven-
tion efforts undertaken
in the hazardous waste
area focused on making it easier for
consumers and businesses to recycle
commonly used items, such as batteries,
pesticides, and mercury-containing
thermostats. In May 1995, EPA issued a
final regulation, known as the univer-
sal hazardous waste rule, designed to
reduce hazardous waste items in the
municipal solid waste stream, encourage
recycling and proper disposal of certain
common hazardous wastes, and reduce
the regulatory burden on businesses
that generate these wastes. The new
rule addresses a number of burdens and
deficiencies in the old system. For
example, it eliminates manifest require-
ments for universal wastes, allowing.
businesses to transport these materials
using common carriers rather than haz-
ardous waste transporters, and_itallows
businesses to store universal,;w,aste.,oja
site for up to one year, elimfhatihg.. the „„„.:,
need for more frequent collection and
disposal arrangements. In addition to M^
streamlining a number of administrative
A~~'--^
requirements, the rule alsB includes
incentives to encourag^iM'niiScfurers
to "take back" certajjTproducts. All
totalled, EPA estin^ates the new rule ^_
will save $70 million per year while still
ensuring safe &>llection, recycling, han-
dling, and treatment of low-rislytems.
Several other common sense
improvements have been made to _
improve hazardous waste management.
Epx example, in November 1995, EPA
REPORT ON REINVENTION
May 1997
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proposed changes that would promote
the environmentally sound recy-
cling of petroleum residuals. This
rule, scheduled for completion by May
1998, would streamline regulatory
requirements and increase petroleum
recycling opportunities. In
fact, if all oil-bearing
sludges currently being
generated were recycled,
the total volume of petro-
leum residuals now requir-
ing disposal could be
cut by approximately
one million metric
tons per year.
In February
,. 1997, EPA
.. •"' addressed a hazardous
waste transportation diffi-
culty for generators with
several locations separat-
? ed by public or private
rights-of-way, such as
: • universities with buildings
7 scattered across several city
blocks. EPA exempted haz-
ardous waste transport between
these locations from extensive
tracking, packaging, labelling, mark-
ing, and placarding requirements. This
action would allow hazardous waste
generators to consolidate hazardous
material from multiple facilities and
proceed with appropriate treatment
; and disposal actions more efficiently.
In addition to reducing regulatory
burden, allowing consolidation should
help prevent potential exposure
,; from multiple small collection sites.
'••_,. In April 1997, a common sense
,, '" improvement to EPA's land dis-
posal restriction regulations signifi-
cantly cut paperwork require-
,^-"™ ments. Under the old system,
hazardous waste generators
were required to complete
detailed paperwork on each hazardous
waste shipment even if the quantity and
quality of the material were the same
each time. The new rule allows genera-
tors to file the necessary records with
the land disposal facility, and as long as
the shipments do not change, no addi-
tional paperwork is required. EPA
expects this change will reduce total
paperwork burden associated with land
disposal by 1.6 million hours — a one-
third reduction overall.
Currently, EPA is working on a
number of other changes to provide
equally protective, but more cost-effec-
tive, hazardous waste management
alternatives for businesses and commu-
nities. Early next year, EPA will propose
several new approaches to the defini-
tion of solid waste that could substan-
tially reduce the number and types of
operations subject to hazardous waste
regulation. It would also remove regula-
tory disincentives that currently lead
companies to choose incineration or
land disposal over safe recycling. For
example, under the current system,
companies that generate and recycle
hazardous waste are subject to full haz-
ardous -waste treatment requirements.
The new rule would allow some haz-
ardous waste recycling to occur without
imposing the burden of hazardous
waste regulation.
Another action underway is re-
proposing the hazardous waste iden-
tification rule. Under the current sys-
tem, once a waste is listed as hazardous,
it is always considered hazardous —
even if the toxic chemicals have been
removed. This approach, while protec-
tive of human health and the environ-
ment, has the disadvantage of discour-
aging innovative treatment and pollu-
tion prevention — why would a compa-
ny invest in detoxifying its waste if the
detoxified product was still subject to
hazardous waste requirements? In 1995,
EPA proposed a rule that would allow
companies to test their waste, and if all
potentially hazardous chemicals were at
or below safe levels, then it would no
longer be federally regulated as haz-
ardous waste. Instead it would be man-
aged under alternative, but protective,
state programs. This rule will provide
relief by allowing low-risk waste, his-
torically considered to be hazardous, to
be managed under alternative or less
costly means. Because of the extensive
comments received by the public and
EPA's Science Advisory Board, the
Agency requested a multi-year exten-
sion to revise the underlying risk assess-
ment used in establishing safe levels. As
of April 11, EPA received a new court-
ordered deadline to complete a proposal
of this rule by October 31, 1999, and a
final rule by April 30, 2001.
Finally, EPA is completing a conta-
minated media rule to establish a new
regulatory framework for managing
remediation wastes generated during
hazardous waste cleanups. Now, these
wastes are subject to management,
treatment, and disposal requirements
under Resource Conservation and
Recovery Act (RCRA). In April 1996,
EPA proposed a rule with options to
exempt some remediation wastes and
allow for more site-specific manage-
ment, treatment, and disposal alterna-
tives. The final rule, which would also
simplify and streamline RCRA permit
requirements, is scheduled for issuance
in June 1998. EPA expects the changes
will significantly reduce the amount of
material subject to hazardous waste
treatment requirements. While the
actual cost-savings will depend on the
particular approach taken in the final
rule, EPA estimated total savings rang-
ing from $1.2 to $1.5 billion per year.
— Tim Fields
May 1997
REPORT ON REINVENTION
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To achieve higher levels
of water quality on a
broad, national scale,
EPA is promoting greater use of
watershed management approach-
es as a way of better addressing a
more diverse range of issues.
Building on the water quality
improvements of the past, EPA is
developing tools — regulatory and
nonregulatory—to help communi-
ties address water quality issues on a
watershed basis. In June 1996, EPA
released die Watershed Protection Framework
document that describes how diese more
comprehensive, integrated strategies can
be developed and oudines actions EPA is
taking to encourage use of watershed
approaches by states.
Over die past few years, EPA has
focused on reinventing one of the most
critical tools for watershed management
— die National Pollutant Discharge
Elimination System (NPDES). Under
diis program, industries and municipali-
ties obtain permits before discharging
wastewater to rivers, lakes, coastal waters,
or die open ocean. At present, more man
61,000 NPDES wastewater discharge
permits are in effect to protect water
quality throughout die country. In the
first of a series of actions aimed at
improving the effectiveness and efficiency
of die NPDES program, EPA issued
guidance in June 1996 to reduce the reg-
ulatory burden associated widi water
quality monitoring and reporting. The
guidance allows facilities with excellent
performance records to signficicantly
reduce monitoring and reporting activi-
ties, and it provides incentives for volun-
tary pollutant reductions tiirough such
nlcan< as riiuse 4nd recycling. If fully
Implemented, EPA estimates diis perfor-
mance-based approach would cut the
Average facility's NPDES monitoring and
reporting burden by about 25 percent.
More significantly, it could improve
water quality by allowing facilities to
direct their attention and resources to
higher water quality priorities.
A second round of reforms, proposed
in December 1996 and scheduled for
completion this July, streamlines the
NPDES permitting appeals process.
Under the current system, facilities can
file for an evidentiary hearing in order
to appeal permitting decisions, a process
that usually takes about 18 to 21 months
to resolve. The proposed reform would
eliminate these hearings and allow more
timely appeals to EPA's Environmental
Appeals Board where decisions are
reached in about 9 months. In addition
to helping facilities save costs associated
with appeals actions, this move could
help communities realize water quality
improvements more quickly as new
permit conditions go into effect.
The second round of reforms would
also allow greater use of general permits
for certain industries. General permits,
which cover multiple facilities and elimi-
nate the need to develop individual per-
mits, would provide a regulatory option
for controlling pollution from sources
that are not permitted under the current
system. EPA is considering proposing a
third round of administrative reforms
that would include expanding the types
of permitting actions that can be consid-
ered "minor" and processed by the
Agency more quickly.
Other NPDES improvements
.g are aimed at biosolids manage-
< ment and industrial pretreat-
•J ment. At present, only Utah and
& Oklahoma manage biosolids per-
mitting. As a result, in the remain-
ing 48 states, facilities are required
3 to interact with two levels of gov-
.§ ernment — their state agency and
£ EPA. In March 1997, EPA pro-
posed a rule easing state program adop-
tion. In addition, EPA is working on a
final rule that will allow community
sewage treatment plants to make certain
minor, low-risk changes to industrial
pretreatment programs without having to
go through public notice procedures.
Another significant reform effort is
focused on one of the biggest challenges
for protecting water quality: urban
storm water runoff. Ten years ago,
Congress passed amendments to the
Clean Water Act that required EPA to
issue NPDES permits in two phases to
better control stormwater. Phase I
addresses large industries and municipali-
ties of more than 100,000 people, while
Phase II addresses the remaining smaller
municipalities, industries, and commer-
cial establishments. Phase II represents an
enormous potential increase in the num-
ber of facilities subject to NPDES per-
mitting requirements — millions of new
permits could be needed. In an effort to
obtain the greatest possible environmen-
tal benefit at a reasonable cost to the reg-
ulated community, EPA proposed a more
targeted, risk-based approach for Phase II
that would only require permits for facili-
ties deemed highly likely to cause pollu-
tion due to runofE EPA expects this
approach would reduce the number of
facilities subject to stormwater regulation
by as much as 80 percent while still
ensuring water quality protection. The
final rule is expected this September.
— Robert Perciasepe
6 REPORT ON REINVENTION • May 1997
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nglish
Ml
I What To Expect...
I Sample Language from Hazardous Waste Rulemaking
ions
he difficulty in understanding.,
federal.regulations has been a
longstanding criticism .of .fed- .
feral, agencies, including EPA. In. order to
ggduce. regulatory burden on our stake-..,.
Hiolders.and Improve ..regulatory compli-
ice, EPA has established a pilot pro-
Egram aimed, at improving, both the. clari-
ty; and comprehension of regulatory
language. Under the, pilot, 13 regul.a- .
POTIS cutting across' all program areas
Mag written or revised .usjng more
jglttcise/language,. In addition,, they are ,
lEeing restructured to. a|lovy users to
pirMJnformation more, quickly. Results.
SJTom this effort .should become visible, .
tffiis.summer when EPA begins issuing
£ejirst of these regulations-for public
kjcomment. .... :. , _
Exemption for listed hazardous
waste containing low concentra-
tions of hazardous constituents
and managed in landfills and
monofills.
(a) Any hazardous waste listed
under this subpart, any mixture of
such a listed waste with a solid
waste, or any waste derived from the
treatment, storage or disposal of such
a listed waste is exempt from regula-
tion as a hazardous waste under parts
262-266 and 270 of this chapter if it
meets the requirements in 261.37(b)
and (d) (including the requirement
that all hazardous constituents pre-
sent in the waste be at or below the
levels listed in appendix XT to this
part and that the waste be disposed
in a landfill or monofill, but not a
land application unit). To maintain
the exemption, the waste must satis-
fy the conditions in 261.37(e). Any
such waste which also meets the
requirements of 261.37(f) is also
exempt from the requirements of
part 268 of this chapter.
What waste is eligible for this
exemption?
(a) Three types of waste are eligible
for exemption from the require-
ments in parts 262-266 and 270
of this chapter.
(1) Any hazardous waste listed in
this subpart.
(2) Any mixture of such a listed
waste with a solid waste.
(3) Any waste derived from treating,
storing or disposing of a listed
waste.
(b) To be exempt, the waste must
meet the requirements in
261.37(b) and (d).
(c) To remain exempt, the waste
must meet the requirements in
261.37 (e).
(d) If the waste also meets the
requirements of 261.37(f), it also
is exempt from the requirements
of part 268 of this chapter.
Reaffirming
Reinvention
In an effort to better coordinate and provide a more
consistent focus on EPA's reinvention activities, on
February 27, Administrator Carol Browner announced
that a new Office of Reinvention (OR) would be established
within the Agency. She also announced that J. Charles Fox will
serve as its new Associate Administrator. Mr. Fox will bring
valuable insights from the state perspective as he served, most
recently, as the Deputy Secretary for the Maryland Department
of the Environment. Prior to that position, he served in EPAs
Office of the Administrator and Office of Water.
In her announcement, the Administrator stated that "the
real power of reinvention lies in incorporating reinvention
principles into the way we do business — using performance-
based approaches, trying new ways of achieving compliance,
redefining our relationship with state environmental pro-
grams, using incentives and voluntary programs to achieve
environmental objectives, adopting community-based
approaches to achieve sustainable communities, or new ways
to monitor the progress of protecting public health and the
(CONTINUED ON PAGE 8)
May 1997
REPORT ON REINVENTION
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Reaffirming
Reinvention
PAGE 7)
environment These are large tasks, and
they merit a prominent place in our
organization."
The new office will ensure progress
towards EPA's reinvention commit-
ments laid out in the "Reinventing
Environmental Protection" agenda
issued by President Clinton and Vice
President Gore in March 1995. Other
responsibilities for the new office will
include:
* Managing Agency-wide reinvention
initiatives, such as the Common
Sense Initiative and Project XL.
• Helping businesses and communities
interested in pursuing more flexible
and innovative new ways of meeting
strong environmental standards.
• Coordinating with the new Center
for Environmental Information and
Statistics to improve the quality,
accessibility, and use of vital envi-
ronmental data.
A complete description of OR
responsibilities will be provided in a
future issue, once the details of the new
organization have been fully developed
and approved. Final clearance on the
new organization is expected this sum-
mer. In the meantime, EPA's
Reinvention Team, now reporting to
Mr. Fox, will continue to serve as a
&EPA
United States
Environmental Protection Agency
Washington, DC 20460
(1102)
Official Business
Penalty for Private Use
$300
* -^
For IVIore
Information
have questions about EPA's
l/oyId you jjge
fat****
s? yvo
cppjes of thTs report? If so,
ig Regu|afory^Reinvention^^
~~"' 260-4261 or by e-mail at
a.gov*Also, look
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