Withdrawal of Proposed Rules; Discontinuing Several Rulemaking Efforts Listed in the Semiannual Regulatory Agenda, 20004-20008 [2018-09206]
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Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules
Regulatory Review. This action is not a
significant regulatory action and was
therefore not submitted to the Office of
Management and Budget (OMB) for
review.
• Paperwork Reduction Act (PRA).
This action does not impose an
information collection burden under the
PRA. Therefore, its recordkeeping and
reporting provisions do not constitute a
‘‘collection of information’’ as defined
under 44 U.S.C. 3502(3) and 5 CFR
1320.3(c).
• Regulatory Flexibility Act (RFA).
This action will not have a significant
economic impact on a substantial
number of small entities under the RFA.
This action will not impose any
requirements on small entities.
• Unfunded Mandates Reform Act
(UMRA). This action does not contain
an unfunded mandate of $100 million or
more as described in UMRA, 2 U.S.C.
1531–1538, and does not significantly or
uniquely affect small governments.
• Executive Order 13132: Federalism.
This action does not have federalism
implications. It will not have substantial
direct effects on the states, on the
relationship between the national
government and the states, or on the
distribution of power and
responsibilities among the various
levels of government.
• Executive Order 13175:
Consultation and Coordination with
Indian Tribal Governments. This action
does not have tribal implications, as
specified in Executive Order 13175. It
will not have substantial direct effects
on any Indian tribes, on the relationship
between the federal government and
Indian tribes, or on the distribution of
power and responsibilities between the
federal government and Indian tribes.
Thus, Executive Order 13175 does not
apply to this action.
• Executive Order 13045: Protection
of Children from Environmental Health
Risks and Safety Risks. EPA interprets
Executive Order 13045 as applying only
to those regulatory actions that concern
health or safety risks that EPA has
reason to believe may
disproportionately affect children, per
the definition of ‘‘covered regulatory
action’’ in section 2–202 of the
Executive Order. This action is not an
economically significant regulatory
action based on health or safety risks
subject to Executive Order 13045.
The SIP is not approved to apply on
any Indian reservation land as defined
in 18 U.S.C. 1151 or in any other area
where EPA or an Indian tribe has
demonstrated that a tribe has
jurisdiction. In those areas of Indian
country, the rule does not have tribal
implications and will not impose
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substantial direct costs on tribal
governments or preempt tribal law as
specified by Executive Order 13175 (65
FR 67249, November 9, 2000).
In addition, pursuant to CAA section
307(d)(1)(B), EPA proposes to determine
that this action is subject to the
provisions of section 307(d). Section
307(d) establishes procedural
requirements specific to certain
rulemaking actions under the CAA.
Pursuant to CAA section 307(d)(1)(B),
the withdrawal of the provisions of the
Virginia regional haze regional FIP that
apply to changing reliance on CAIR to
reliance on CSAPR to address certain
deficient regional haze requirements is
subject to the requirements of CAA
section 307(d), as it constitutes a
revision to a FIP under section 110(c) of
the CAA. Furthermore, section
307(d)(1)(V) of the CAA provides that
the provisions of section 307(d) apply to
‘‘such other actions as the Administrator
may determine.’’ EPA proposes that the
provisions of 307(d) apply to EPA’s
action on the Virginia SIP revision.
List of Subjects in 40 CFR Part 52
Environmental protection, Air
pollution control, Incorporation by
reference, Intergovernmental relations,
Nitrogen dioxide, Ozone, Particulate
matter, Reporting and recordkeeping
requirements, Sulfur oxides.
Authority: 42 U.S.C. 7401 et seq.
Dated: April 19, 2018.
Cosmo Servidio,
Regional Administrator, Region III.
[FR Doc. 2018–09653 Filed 5–4–18; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 152, 156, 174 and 180
[EPA–HQ–OPPT–2012–0423; FRL–9977–08]
Withdrawal of Proposed Rules;
Discontinuing Several Rulemaking
Efforts Listed in the Semiannual
Regulatory Agenda
Environmental Protection
Agency (EPA).
ACTION: Withdrawal of proposed rules.
AGENCY:
EPA is withdrawing several
proposed regulatory requirements
described in the proposed rules
identified in this document for which
the Agency no longer intends to issue a
final regulatory action. This document
identifies the proposed rules and
provides a brief explanation for the
Agency’s decision not to pursue a final
action. The withdrawal of these
SUMMARY:
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proposed rules does not preclude the
Agency from initiating the same or a
similar rulemaking at a future date. It
does, however, close out the entry for
these rulemakings in EPA’s Semiannual
Regulatory Agenda. Should the Agency
decide at some future date to initiate the
same or similar rulemaking, it will add
an appropriate new entry to EPA’s
Semiannual Regulatory Agenda to
reflect the initiation of the action, and
EPA will issue a new notice of proposed
rulemaking.
DATES: As of May 7, 2018, the proposed
rules published on November 23, 1994,
at 59 FR 60519; November 23, 1994, at
59 FR 60525; June 26, 1996, at 61 FR
33260; and September 17, 1999, at 64
FR 50671, are withdrawn.
ADDRESSES: The docket for this action,
identified under docket identification
(ID) number EPA–HQ–OPPT–2012–
0423, is available at https://
www.regulations.gov or at the EPA
Docket Center (EPA/DC), 1301
Constitution Ave. NW, Washington, DC.
The Public Reading Room is open from
8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The
telephone number for the Public
Reading Room is (202) 566–1744, for the
OPP Docket it is (703) 305–5805, and
the telephone number for the OPPT
Docket is (202) 566–0280. For more
information about the docket and
instructions about visiting the EPA/DC,
go to https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Angela Hofmann, Director, Regulatory
Coordination Staff (7101M), Office of
Chemical Safety and Pollution
Prevention, 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001;
telephone number: (202) 564–0258;
email address: hofmann.angela@
epa.gov.
SUPPLEMENTARY INFORMATION:
I. Does this action apply to me?
This action is directed to the public
in general, and may be of particular
interest to those persons who follow
proposed rules issued under the Toxic
Substances Control Act (TSCA), the
Federal Food, Drug, and Cosmetic Act
(FFDCA), or the Federal Insecticide,
Fungicide, and Rodenticide Act
(FIFRA). Since others may also be
interested, the Agency has not
attempted to describe all the specific
entities potentially interested.
II. Why is EPA issuing this withdrawal
of proposed rules?
This document serves two purposes:
1. It announces to the public that EPA
is withdrawing certain proposed rules
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for which the Agency no longer intends
to issue a final rule.
2. It officially terminates the ongoing
rulemaking activities, which allows the
Agency to close out the individual
rulemaking entries for these actions that
appear in EPA’s Semiannual Regulatory
Agenda.
All agencies publish Semiannual
Regulatory Agendas describing
regulatory actions they are developing
or have recently completed. These
agendas are published in the Federal
Register, usually during the spring and
fall of each year, as part of the Unified
Agenda of Federal Regulatory and
Deregulatory Actions (Semiannual
Regulatory Agenda). The Agency
publishes the EPA Semiannual
Regulatory Agenda to update the public
about: Regulations and major policies
currently under development, reviews
of existing regulations and major
policies, and rules and major policies
completed or canceled since the last
Semiannual Regulatory Agenda.
The Semiannual Regulatory Agenda is
often used as a tool to solicit interest
and participation from stakeholders. As
such, EPA believes that the public is
best served by a Semiannual Regulatory
Agenda that reflects active rulemaking
efforts. The withdrawal of these inactive
rulemaking efforts will streamline EPA’s
Semiannual Regulatory Agenda and
allow the public to better identify and
focus on those rulemaking activities that
are active.
For the individual reasons described
in this document, the Agency has
decided not to complete these actions at
this time. By withdrawing the proposed
rules, the Agency is eliminating the
pending nature of that regulatory action.
Should the Agency determine to pursue
anything in these areas in the future, it
will create a new entry in EPA’s
Semiannual Regulatory Agenda and
issue a new proposed rule.
III. Which proposed rules are being
withdrawn?
This Unit identifies the proposed
regulatory actions that are being
withdrawn, provides a summary of what
was proposed, and a brief explanation
for the Agency’s withdrawal. The ‘‘RIN’’
refers to the regulatory identification
number assigned to the rulemaking
effort in the Semiannual Regulatory
Agenda.
A. Groundwater and Pesticide
Management Plan Rule (PMP); RIN
2070–AC46
1. What was proposed? On June 26,
1996 (61 FR 33260; FRL–4981–9), EPA
issued a proposed rule to implement a
key component of the Agency’s 1991
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Pesticides and Ground Water Strategy,
and it reflected many years of
discussions and input from States and
other stakeholders. Through the
development and use of State
Management Plans (SMPs), EPA
proposed to restrict the use of certain
pesticides by providing States with the
flexibility to protect the ground water in
the most appropriate way for local
conditions. This approach capitalized
on the most effective and efficient roles
for State and Federal Government to
collaborate in the protection of the
nation’s ground water resources. Using
the proposed SMP approach, EPA
proposed to restrict the legal sale and
use of five pesticides that have been
identified as either ‘‘probable’’ or
‘‘possible’’ human carcinogens—
alachlor, atrazine, cyanazine,
metolachlor, and simazine. Because of
their potential to contaminate ground
water, EPA had determined that these
pesticides may cause unreasonable
adverse effects on the environment in
the absence of effective management
measures provided by a SMP. The
proposed rule announced that the labels
of these pesticides would be changed to
require use in accordance with an EPAapproved SMP, after a period of time
allowed for development and approval
of these SMPs. The proposed rule also
contained proposed revisions to
pesticide labeling regulations, in order
to clarify general labeling requirements.
On February 23, 2000 (65 FR 8925;
FRL–6491–1), EPA solicited public
comments on additional information
about metolachlor, which was one of the
four pesticides in the proposed rule. In
the proposed PMP rule, the Agency
proposed, as a condition of continued
use, that States and Tribes prepare
chemical-specific management plans for
four herbicides that have been shown to
persist in the environment and leach to
ground water, creating a potential
unreasonable adverse effect on human
health and the environment.
Specifically, EPA sought comment on
data provided to EPA pertaining to the
products containing metolachlor, Smetolachlor, and R-metolachlor.
2. Why is it being withdrawn? Action
on the proposal was delayed while the
scope of the program described in the
proposed rule was reconsidered to
determine whether the program could
be expanded to address water quality
issues in addition to ground water, and
to determine the best partnership
approach to implementation. More
important, the risk level associated with
the named pesticides in the proposed
rule was also reexamined as part of the
FIFRA reregistration process concluded
in 2006. As part of that process, EPA
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determined that all five of the chemicals
identified in the SMP proposal met the
‘‘no unreasonable adverse effects on the
environment’’ standard for FIFRA
registration without the steps identified
in the proposed rule. These
reregistration determinations
necessarily mean that the rule is
unnecessary to prevent unreasonable
adverse effects on the environment, and
EPA is therefore withdrawing its
proposed rule.
3. Where can I get more information
about this action? The docket for this
action is available under docket ID
number OPP–36190.
B. Pesticides; Registration Requirements
for Antimicrobial Pesticide Products;
RIN 2070–AD14
1. What was proposed? On September
17, 1999, (64 FR 50671; FRL–5570–6),
EPA issued a proposed rule to establish
procedures for the registration of
antimicrobial products, as well as
implement certain new provisions of
FIFRA, as amended by the Food Quality
Protection Act (FQPA). In addition to
registration procedures for antimicrobial
products, EPA also proposed to
establish labeling standards for
antimicrobial public health products,
which would ensure that these products
are appropriately labeled for the level of
antimicrobial activity they demonstrate;
to modify its notification process for
antimicrobial products to conform to the
statutorily prescribed process; and to
exempt certain antimicrobial products
from FIFRA regulation. EPA proposed
new procedures and provisions to
streamline and improve the registration
process, increase consistency and
certainty for antimicrobial producers,
reduce the timeframes for EPA decisions
on antimicrobial registrations, increase
public health protection by ensuring the
continued efficacy of antimicrobial
public health pesticides, and promote
international harmonization efforts. EPA
proposed to interpret the applicability
of the new FIFRA definition of
‘‘pesticide’’ that excludes liquid
chemical sterilants from FIFRA
regulation and includes nitrogen
stabilizers, and to describe requirements
pertaining to use dilution labeling. EPA
anticipated the proposed rule would
provide technical, conforming and
organizational changes to portions of its
regulations on pesticide registration and
labeling for clarity and understanding.
On November 16, 1999, (64 FR 62145;
FRL–6393–8), EPA extended the
comment period for the original
proposed rule.
2. Why is it being withdrawn? On
December 14, 2001 (66 FR 64759; FRL–
6752–1) EPA issued a final rule, entitled
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‘‘Pesticide Labeling and Other
Regulatory Revisions,’’ effective
February 12, 2002, revising certain
labeling regulations for pesticide
products for clarity and published an
interpretation of the FIFRA as it applies
to nitrogen stabilizers. The final rule
also revised regulations that contain
statutory provisions excluding certain
types of products from regulation as
pesticides.
The Pesticide Registration
Improvement Act (PRIA), which was
enacted in 2003, reauthorized October 1,
2007, by the Pesticide Registration
Improvement Renewal Act (PRIA 2),
and reauthorized again on October 1,
2012 by the Pesticide Registration
Improvement Act (PRIA 3), established
deadlines and pesticide registration
service fees for registration actions. The
category of action, the amount of the
pesticide registration service fee, and
the corresponding decision review
periods by year are prescribed in these
statutes. These statutory enactments
were intended to create a more
predictable evaluation process for
affected pesticide decisions, and couple
the collection of individual fees with
specific decision review periods. They
also promote shorter decision review
periods for reduced-risk applications.
EPA now actively provides guidance for
PRIA-driven streamlined regulatory
determinations for most major pesticide
registration actions that is applicable to
all pesticide registration types, not just
antimicrobial products. (see PRIA
guidance https://www.epa.gov/
pesticides/regulating/fees/index.htm).
The passage and implementation of
PRIA and the implementation of the
Agency’s final rule regarding pesticide
labeling and other regulatory revisions
of December 14, 2001, have rendered
the remainder of what was proposed in
the proposed rule moot. For these
reasons, EPA is withdrawing the
remainder of what was proposed in its
proposed rule.
3. Where can I get more information
about this action? The docket for this
action is available under docket ID
number OPP–36190.
C. Plant-Incorporated Protectants (PIPs);
Exemption for Those Derived Through
Genetic Engineering From Sexually
Compatible Plants; RIN 2070–AD55
1. What was proposed? On November
23, 1994 (59 FR 60519; FRL–4755–3)
(when proposed, the RIN was 2070–
AC02), EPA proposed to exempt from
FIFRA regulation those plantincorporated protectants (then called
plant-pesticides) that are not likely to
present new exposures to non-target
organisms. This exemption was
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proposed based on the assumption that
if a plant normally produces a pesticidal
substance, organisms that normally
come into contact with the plant have
likely been exposed to the substance in
the past, perhaps over long periods of
time. No new exposures would be likely
to occur, and based on long experience
with plants in conventional agriculture,
such PIPs would meet the FIFRA
section 25(b)(2) exemption standard. In
defining, for regulatory purposes, those
substances for which no new exposures
would occur, the Agency proposed to
base its approach on the concept of
sexual compatibility. Sexually
compatible plants are more likely to
share common traits than are unrelated
plants. If the donor of the genetic
material is sexually compatible with the
recipient plant, it can be assumed that
the genetic material is already present in
the sexually compatible plant
population and there would be no novel
exposures. In the 1994 proposal, the
proposed regulatory text did not specify
how the genetic material of a plantincorporated protectant or ‘‘PIP’’ could
be moved from the donor to the sexually
compatible recipient plant, whether
through conventional breeding or
genetic engineering techniques.
On July 19, 2001 (66 FR 37855; FRL–
6760–4), EPA finalized part of its 1994
proposal thereby exempting certain
plant-incorporated protectants moved
among plants in a sexually compatible
population. The 2001 rule defined
sexually compatible as meaning a viable
zygote is formed only through the union
of two gametes through conventional
breeding. EPA did not in 2001 finalize
that part of the proposal dealing with
PIPs moved among plants in a sexually
compatible population through genetic
engineering but rather requested
additional public comment on the
issues raised by scientific information
discovered between 1994 in 2001, in
1994 in public comment, and by issues
raised by the 2000 report of the National
Academies of Science (NAS) National
Research Council (NRC).
2. Why is it being withdrawn? EPA is
withdrawing this proposed action
because as the Agency’s experience with
PIPs and greater scientific knowledge
have increased, it has become evident to
the Agency that were EPA to pursue an
exemption for certain PIPs moved
among plants in sexually compatible
populations through genetic
engineering, more appropriate,
scientifically current criteria for
describing the exempted PIPs should be
developed rather than relying on the
criteria proposed in 1994.
In 2001, EPA concluded that a high
probability exists that PIPs moved
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between plants in sexually compatible
populations through conventional
breeding would not present novel
exposures to nontarget organisms.
Notwithstanding that conclusion, EPA
could not (with the same level of
confidence) draw the same conclusion
for PIPs moved between plants in
sexually compatible plant populations
through genetic engineering given the
limitations of the modification
techniques available at that time. In
addition, EPA came to agree with the
2000 NRC report that recommended that
‘‘[g]iven that transfer and manipulation
of genes between sexually compatible
plants could potentially result in
adverse effects in some cases . . . EPA
should reconsider its categorical
exemption of transgenic [plantincorporated protectants] derived from
sexually compatible plants.’’ (NRC 2000
at p. 131, emphasis in original). The
NRC report pointed out for example that
the Agency’s proposed language would
exempt genetic material moved among
plants in sexually compatible
populations through genetic engineering
without taking into consideration
whether the moved genetic material
would be expressed in the same pattern
and at the same levels as occurs
naturally in the plant (NRC 2000 at p.
129). The proposal is not supported by
a sufficient basis to finalize the
proposed exemption, especially in light
of the scientific developments that have
taken place in the last decade.
Recently, newer, more precise
techniques of genetic engineering have
been developed based on scientific
discoveries in genetics and molecular
biology since the 1994 proposal and the
2001 rule were issued. These
developments will allow the Agency to
craft criteria that are scientifically more
current and that more accurately
describe the PIPs that would be
exempted as well as procedures to better
ensure that all the PIPs in an exempted
category meet the FIFRA section
25(b)(2) exemption standard.
Consequently, if EPA were to pursue
such an exemption today, the Agency
would issue a new proposed rule, based
on knowledge of the types of products
possible with the newest technology
rather than issuing a final rule based on
the previous proposals. Withdrawing
the 1994 proposal does not preclude the
Agency from initiating the same or
similar regulatory action in the future.
At that time, the Agency will initiate a
new regulatory action and create a new
entry for the Semiannual Regulatory
Agenda. It is also worth noting that the
Agency’s proposal to exempt certain
types of pesticide products from
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regulation under FIFRA is entirely a
discretionary action; there is no
requirement in FIFRA that the Agency
promulgate a regulation to exempt
products that might satisfy the
exemption standard in FIFRA section
25(b)(2). EPA is therefore withdrawing
the remainder of this proposal.
3. Where can I get more information
about this action? The docket for this
action is available under docket ID
number OPP–300369.
D. Plant-Incorporated Protectants (PIPs);
Exemption for PIPs That Act by
Primarily Affecting the Plant; RIN 2070–
AD56
1. What was proposed? On November
23, 1994 (59 FR 60519; FRL–4755–3)
(when proposed, the RIN was 2070–
AC02), EPA proposed, under FIFRA
section 25(b)(2), to exempt from most of
the requirements of FIFRA those PlantIncorporated Protectants (PIPs) (in 1994,
PIPs were called plant-pesticides (see 59
FR 60525; November 23, 1994)) that act
primarily by affecting the plant under
the assumption that such PIPs are less
likely to be directly toxic to either target
pests or to nontarget organisms. The
criteria proposed at 40 CFR 174.5(b)(2)
describe PIPs that act primarily by
affecting the plant as a pesticidal
substance so that the target pest is
inhibited from attaching to the plant,
penetrating the plant, or invading the
plant’s tissue in at least one of three
ways: (a) The pesticidal substance acts
as a structural barrier to attachment of
the pest to the host plant, a structural
barrier to penetration of the pest into the
host plant, or a structural barrier to
spread of the pest in the host plant, for
example, through the production of wax
or lignin, or length of trichomes (plant
hairs); (b) The pesticidal substance acts
in the host plant to inactivate or resist
toxins or other disease-causing
substances produced by the target pest;
or (c) The pesticidal substance acts by
creating a deficiency of a plant nutrient
or chemical component essential for
pest growth on/in the host plant.
EPA also indicated in 1994 that it was
considering whether to extend this
exemption to include substances such
as plant hormones, because plant
hormones act within the plant to
‘‘primarily affect the plant’’ and do not
act directly on a target pest.
On July 19, 2001 (66 FR 37855; FRL–
6760–4), EPA reopened the comment
period on the proposed exemption to
allow the public an opportunity to
comment on the information, analyses,
and conclusions pertaining to PIPs that
act primarily by affecting the plant in
the report issued in 2000 by the NRC of
the NAS entitled ‘‘Genetically Modified
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Pest-Protected Plants: Science and
Regulation’’ (National Research Council.
2000. National Academies Press,
Washington, DC), and to comment on
several risk issues received in public
comment on the 1994 proposal (59 FR
60525, November 23, 1994).
2. Why is it being withdrawn? Because
of new scientific discoveries in the area
of genetics and molecular biology the
Agency has concluded that neither the
original 1994 proposal nor the
subsequent 2001 supplemental proposal
present a sufficient basis for making the
statutory finding required under FIFRA
section 25(b)(2) to exempt this class of
PIPs. Given the current state of genetic
technology, it is possible that the
exemption criteria set out in 1994 could
exempt PIP products available today
that pose different risks than the Agency
envisioned when it initially proposed
the criteria. In essence, the more limited
technological capabilities and
understanding of science in 1994 led
EPA to propose criteria for a generic
exemption that current technologies and
scientific understanding have rendered
inappropriate. While there may be some
PIPs that act primarily by affecting the
plant that would meet the FIFRA
section 25(b)(2) standard for exemption,
the Agency no longer considers its
proposed criteria for a generic
exemption to fairly restrict available
products to only those that ‘‘are of a
character which is unnecessary to be
subject to’’ regulation under FIFRA. 7
U.S.C. 136w(b)(2). EPA is therefore
withdrawing this proposal.
The decision to exempt pesticides
under section 25(b) of FIFRA is entirely
discretionary; there is no requirement
that EPA promulgate pesticide
exemptions. Withdrawing the proposal
does not preclude the Agency from
initiating regulatory action in the future
for PIPs that act primarily by affecting
the plant, e.g., exempting on a case-bycase basis a PIP that acts primarily by
affecting the plant when that PIP can be
shown to meet the FIFRA section
25(b)(2) exemption standard. At that
time, the Agency would initiate a new
regulatory action and create a new entry
for EPA’s Semiannual Regulatory
Agenda.
i. Why the Proposed Exemption
Criteria Would Exempt Pesticides that
Do Not Meet FIFRA Section 25(b)(2)
Safety Standard. A number of advances
in scientific knowledge accumulated
since publication of the 1994 proposal
to exempt PIPs that act primarily by
affecting the plant have contributed to
an understanding of how the proposed
criteria would exempt from FIFRA
requirements PIPs that do not meet the
FIFRA 25(b)(2) exemption standard. For
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20007
example, recent research into plant
regulatory mechanisms, e.g., the
discovery of, and elucidation of the role
of interfering RNAs (RNAi), in gene
expression, not available at the time the
1994 proposal was published,
contributed to the Agency’s
determination that the proposed
exemption categories were constructed
such that there are PIPs in the exempted
categories that would not meet the
FIFRA section 25(b)(2) standard. RNAi
plays a key role in directing
development of an organism, as well as
controlling the various biological
functions necessary to maintaining the
life of an organism. RNAi is triggered by
dsRNA, and while dsRNA can be native
to the cell it can also be introduced from
an external source. At the time the
exemption was proposed, the role of
dsRNA in controlling biological
functions in the cell was unknown and
the possibility that dsRNA could be
introduced into the plant to affect the
plant’s behavior was not taken into
consideration. Had such knowledge
been available, the proposed criteria
would have been based on substantively
different logic.
ii. Consideration of the points made
in the 2000 NRC Report. In withdrawing
this proposal, EPA has also taken into
consideration the points the 2000 NRC
report made on the Agency’s 1994
proposal to exempt from FIFRA
requirements PIPs that act primarily by
affecting the plant. The NRC report
noted that the Agency’s analysis did not
consider all of the potential impacts on
non-target species of all of the PIPs
proposed for exemption, including the
possibility that in some instances
secondary metabolites affecting nontarget organisms could be a by-product
of a modification to create a PIP that
acts primarily by affecting the plant.
The NRC report concluded that based
on its considerations a ‘‘[C]ategorical
exemption under FIFRA might not be
scientifically justifiable’’ (NRC 2000 at
p. 133). Finally, the NRC report also
cautioned the Agency that ‘‘genetic
changes that result in production of a
specific plant protectant can result in
production of biologically active
compounds other than the intended
plant protectants’’ and cautioned that
‘‘EPA should be aware of those
unintended changes’’ (NRC 2000 at p.
134). Upon further analysis, EPA has
concluded that the generic criteria
proposed in 1994 to allow exemption of
PIPs, did not meet the FIFRA section
25(b)(2) exemption standard.
Given the large number of potential
PIPs displaying a wide range of modes
of action in the categories circumscribed
by each of the proposed exemption
E:\FR\FM\07MYP1.SGM
07MYP1
20008
Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules
criteria, and advances in knowledge
showing scientific concerns with the
logic underpinning the criteria as
constructed in 1994, the Agency cannot
utilize the proposed criteria as a basis
for this rulemaking. EPA is therefore
withdrawing this proposal.
3. Where can I get more information
about this action? The docket for this
action is available under docket ID
number OPP–300369. See also related
dockets identified by the docket ID
numbers OPP–300370 and OPP–300371.
Authority: 7 U.S.C. 136 et seq., 21 U.S.C.
346.
Dated: April 25, 2018.
Charlotte Bertrand,
Acting Principal Deputy Assistant
Administrator, Office of Chemical Safety and
Pollution Prevention.
[FR Doc. 2018–09206 Filed 5–4–18; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 180
[EPA–HQ–OPP–2017–0291; FRL–9976–34]
Receipt of a Pesticide Petition Filed for
Residues of Diquat in or on Crop
Group 6C, Dried Shelled Pea and Bean
(Except Soybean); Correction
Environmental Protection
Agency (EPA).
ACTION: Notice; correction.
AGENCY:
EPA issued a notice in the
Federal Register of September 15, 2017,
announcing the initial filing of a
pesticide petition requesting the
establishment or modification of
regulations for residues of pesticide
chemicals in or on various commodities.
DATES: Comments must be received on
or before June 6, 2018.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPP–2017–0291, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute.
• Mail: OPP Docket, Environmental
Protection Agency Docket Center (EPA/
DC), (28221T), 1200 Pennsylvania Ave.
NW, Washington, DC 20460–0001.
• Hand Delivery: To make special
arrangements for hand delivery or
delivery of boxed information, please
follow the instructions at https://
www.epa.gov/dockets/contacts.html.
daltland on DSKBBV9HB2PROD with PROPOSALS
SUMMARY:
VerDate Sep<11>2014
16:45 May 04, 2018
Jkt 244001
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Michael Goodis, Director, Registration
Division (RD) (7505P), Office of
Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460–0001;
main telephone number: (703) 305–
7090; email address: RDFRNotices@
epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you are an agricultural
producer, food manufacturer, or
pesticide manufacturer. The following
list of North American Industrial
Classification System (NAICS) codes is
not intended to be exhaustive, but rather
provides a guide to help readers
determine whether this document
applies to them. Potentially affected
entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code
112).
• Food manufacturing (NAICS code
311).
• Pesticide manufacturing (NAICS
code 32532).
B. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or email. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD–ROM that
you mail to EPA, mark the outside of the
disk or CD–ROM as CBI and then
identify electronically within the disk or
CD–ROM the specific information that
is claimed as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments.
When preparing and submitting your
comments, see the commenting tips at
https://www.epa.gov/dockets/
comments.html.
3. Environmental justice. EPA seeks to
achieve environmental justice, the fair
treatment and meaningful involvement
of any group, including minority and/or
PO 00000
Frm 00026
Fmt 4702
Sfmt 4702
low-income populations, in the
development, implementation, and
enforcement of environmental laws,
regulations, and policies. To help
address potential environmental justice
issues, the Agency seeks information on
any groups or segments of the
population who, as a result of their
location, cultural practices, or other
factors, may have atypical or
disproportionately high and adverse
human health impacts or environmental
effects from exposure to the pesticides
discussed in this document, compared
to the general population.
II. What Does this Correction Do?
This notice is being issued to correct
PP 7E8571. (EPA–HQ–OPP–2017–0291)
in FR Doc. 2017–19692, published in
the Federal Register of September 15,
2017 (82 FR 43352) (FRL–9965–43) is
corrected as follows:
PP 7E8571. (EPA–HQ–OPP–2017–
0291). Syngenta Crop Protection, LLC,
P.O. Box 18300, Greensboro, NC 27419,
requests to establish a tolerance in 40
CFR 180.226 for residues of the
herbicide, diquat (6,7-dihydrodipyrido
[1,2-a:2′1′-c] pyrazinediium), and its
metabolites in or on Crop Group 6C,
dried shelled pea and bean (except
soybean) at 0.9 parts per million (ppm).
The Method GRM012.03A is used to
measure and evaluate the chemical
residues of diquat dibromide in
commodities. Contact: RD.
Authority: 21 U.S.C. 346a.
Dated: April 26, 2018.
Michael Goodis,
Director, Registration Division, Office of
Pesticide Programs.
[FR Doc. 2018–09648 Filed 5–4–18; 8:45 am]
BILLING CODE 6560–50–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 10
RIN 0906–AB18
340B Drug Pricing Program Ceiling
Price and Manufacturer Civil Monetary
Penalties Regulation
Health Resources and Services
Administration, HHS.
ACTION: Notice of proposed rulemaking;
further delay of effective date.
AGENCY:
The Health Resources and
Services Administration (HRSA)
administers section 340B of the Public
Health Service Act, referred to as the
‘‘340B Drug Pricing Program’’ or the
‘‘340B Program.’’ HHS is soliciting
comments on further delaying the
SUMMARY:
E:\FR\FM\07MYP1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 88 (Monday, May 7, 2018)]
[Proposed Rules]
[Pages 20004-20008]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-09206]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 152, 156, 174 and 180
[EPA-HQ-OPPT-2012-0423; FRL-9977-08]
Withdrawal of Proposed Rules; Discontinuing Several Rulemaking
Efforts Listed in the Semiannual Regulatory Agenda
AGENCY: Environmental Protection Agency (EPA).
ACTION: Withdrawal of proposed rules.
-----------------------------------------------------------------------
SUMMARY: EPA is withdrawing several proposed regulatory requirements
described in the proposed rules identified in this document for which
the Agency no longer intends to issue a final regulatory action. This
document identifies the proposed rules and provides a brief explanation
for the Agency's decision not to pursue a final action. The withdrawal
of these proposed rules does not preclude the Agency from initiating
the same or a similar rulemaking at a future date. It does, however,
close out the entry for these rulemakings in EPA's Semiannual
Regulatory Agenda. Should the Agency decide at some future date to
initiate the same or similar rulemaking, it will add an appropriate new
entry to EPA's Semiannual Regulatory Agenda to reflect the initiation
of the action, and EPA will issue a new notice of proposed rulemaking.
DATES: As of May 7, 2018, the proposed rules published on November 23,
1994, at 59 FR 60519; November 23, 1994, at 59 FR 60525; June 26, 1996,
at 61 FR 33260; and September 17, 1999, at 64 FR 50671, are withdrawn.
ADDRESSES: The docket for this action, identified under docket
identification (ID) number EPA-HQ-OPPT-2012-0423, is available at
https://www.regulations.gov or at the EPA Docket Center (EPA/DC), 1301
Constitution Ave. NW, Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, for the OPP Docket it is (703) 305-5805, and the telephone
number for the OPPT Docket is (202) 566-0280. For more information
about the docket and instructions about visiting the EPA/DC, go to
https://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Angela Hofmann, Director, Regulatory
Coordination Staff (7101M), Office of Chemical Safety and Pollution
Prevention, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001;
telephone number: (202) 564-0258; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Does this action apply to me?
This action is directed to the public in general, and may be of
particular interest to those persons who follow proposed rules issued
under the Toxic Substances Control Act (TSCA), the Federal Food, Drug,
and Cosmetic Act (FFDCA), or the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA). Since others may also be interested, the
Agency has not attempted to describe all the specific entities
potentially interested.
II. Why is EPA issuing this withdrawal of proposed rules?
This document serves two purposes:
1. It announces to the public that EPA is withdrawing certain
proposed rules
[[Page 20005]]
for which the Agency no longer intends to issue a final rule.
2. It officially terminates the ongoing rulemaking activities,
which allows the Agency to close out the individual rulemaking entries
for these actions that appear in EPA's Semiannual Regulatory Agenda.
All agencies publish Semiannual Regulatory Agendas describing
regulatory actions they are developing or have recently completed.
These agendas are published in the Federal Register, usually during the
spring and fall of each year, as part of the Unified Agenda of Federal
Regulatory and Deregulatory Actions (Semiannual Regulatory Agenda). The
Agency publishes the EPA Semiannual Regulatory Agenda to update the
public about: Regulations and major policies currently under
development, reviews of existing regulations and major policies, and
rules and major policies completed or canceled since the last
Semiannual Regulatory Agenda.
The Semiannual Regulatory Agenda is often used as a tool to solicit
interest and participation from stakeholders. As such, EPA believes
that the public is best served by a Semiannual Regulatory Agenda that
reflects active rulemaking efforts. The withdrawal of these inactive
rulemaking efforts will streamline EPA's Semiannual Regulatory Agenda
and allow the public to better identify and focus on those rulemaking
activities that are active.
For the individual reasons described in this document, the Agency
has decided not to complete these actions at this time. By withdrawing
the proposed rules, the Agency is eliminating the pending nature of
that regulatory action. Should the Agency determine to pursue anything
in these areas in the future, it will create a new entry in EPA's
Semiannual Regulatory Agenda and issue a new proposed rule.
III. Which proposed rules are being withdrawn?
This Unit identifies the proposed regulatory actions that are being
withdrawn, provides a summary of what was proposed, and a brief
explanation for the Agency's withdrawal. The ``RIN'' refers to the
regulatory identification number assigned to the rulemaking effort in
the Semiannual Regulatory Agenda.
A. Groundwater and Pesticide Management Plan Rule (PMP); RIN 2070-AC46
1. What was proposed? On June 26, 1996 (61 FR 33260; FRL-4981-9),
EPA issued a proposed rule to implement a key component of the Agency's
1991 Pesticides and Ground Water Strategy, and it reflected many years
of discussions and input from States and other stakeholders. Through
the development and use of State Management Plans (SMPs), EPA proposed
to restrict the use of certain pesticides by providing States with the
flexibility to protect the ground water in the most appropriate way for
local conditions. This approach capitalized on the most effective and
efficient roles for State and Federal Government to collaborate in the
protection of the nation's ground water resources. Using the proposed
SMP approach, EPA proposed to restrict the legal sale and use of five
pesticides that have been identified as either ``probable'' or
``possible'' human carcinogens--alachlor, atrazine, cyanazine,
metolachlor, and simazine. Because of their potential to contaminate
ground water, EPA had determined that these pesticides may cause
unreasonable adverse effects on the environment in the absence of
effective management measures provided by a SMP. The proposed rule
announced that the labels of these pesticides would be changed to
require use in accordance with an EPA-approved SMP, after a period of
time allowed for development and approval of these SMPs. The proposed
rule also contained proposed revisions to pesticide labeling
regulations, in order to clarify general labeling requirements.
On February 23, 2000 (65 FR 8925; FRL-6491-1), EPA solicited public
comments on additional information about metolachlor, which was one of
the four pesticides in the proposed rule. In the proposed PMP rule, the
Agency proposed, as a condition of continued use, that States and
Tribes prepare chemical-specific management plans for four herbicides
that have been shown to persist in the environment and leach to ground
water, creating a potential unreasonable adverse effect on human health
and the environment. Specifically, EPA sought comment on data provided
to EPA pertaining to the products containing metolachlor, S-
metolachlor, and R-metolachlor.
2. Why is it being withdrawn? Action on the proposal was delayed
while the scope of the program described in the proposed rule was
reconsidered to determine whether the program could be expanded to
address water quality issues in addition to ground water, and to
determine the best partnership approach to implementation. More
important, the risk level associated with the named pesticides in the
proposed rule was also reexamined as part of the FIFRA reregistration
process concluded in 2006. As part of that process, EPA determined that
all five of the chemicals identified in the SMP proposal met the ``no
unreasonable adverse effects on the environment'' standard for FIFRA
registration without the steps identified in the proposed rule. These
reregistration determinations necessarily mean that the rule is
unnecessary to prevent unreasonable adverse effects on the environment,
and EPA is therefore withdrawing its proposed rule.
3. Where can I get more information about this action? The docket
for this action is available under docket ID number OPP-36190.
B. Pesticides; Registration Requirements for Antimicrobial Pesticide
Products; RIN 2070-AD14
1. What was proposed? On September 17, 1999, (64 FR 50671; FRL-
5570-6), EPA issued a proposed rule to establish procedures for the
registration of antimicrobial products, as well as implement certain
new provisions of FIFRA, as amended by the Food Quality Protection Act
(FQPA). In addition to registration procedures for antimicrobial
products, EPA also proposed to establish labeling standards for
antimicrobial public health products, which would ensure that these
products are appropriately labeled for the level of antimicrobial
activity they demonstrate; to modify its notification process for
antimicrobial products to conform to the statutorily prescribed
process; and to exempt certain antimicrobial products from FIFRA
regulation. EPA proposed new procedures and provisions to streamline
and improve the registration process, increase consistency and
certainty for antimicrobial producers, reduce the timeframes for EPA
decisions on antimicrobial registrations, increase public health
protection by ensuring the continued efficacy of antimicrobial public
health pesticides, and promote international harmonization efforts. EPA
proposed to interpret the applicability of the new FIFRA definition of
``pesticide'' that excludes liquid chemical sterilants from FIFRA
regulation and includes nitrogen stabilizers, and to describe
requirements pertaining to use dilution labeling. EPA anticipated the
proposed rule would provide technical, conforming and organizational
changes to portions of its regulations on pesticide registration and
labeling for clarity and understanding. On November 16, 1999, (64 FR
62145; FRL-6393-8), EPA extended the comment period for the original
proposed rule.
2. Why is it being withdrawn? On December 14, 2001 (66 FR 64759;
FRL-6752-1) EPA issued a final rule, entitled
[[Page 20006]]
``Pesticide Labeling and Other Regulatory Revisions,'' effective
February 12, 2002, revising certain labeling regulations for pesticide
products for clarity and published an interpretation of the FIFRA as it
applies to nitrogen stabilizers. The final rule also revised
regulations that contain statutory provisions excluding certain types
of products from regulation as pesticides.
The Pesticide Registration Improvement Act (PRIA), which was
enacted in 2003, reauthorized October 1, 2007, by the Pesticide
Registration Improvement Renewal Act (PRIA 2), and reauthorized again
on October 1, 2012 by the Pesticide Registration Improvement Act (PRIA
3), established deadlines and pesticide registration service fees for
registration actions. The category of action, the amount of the
pesticide registration service fee, and the corresponding decision
review periods by year are prescribed in these statutes. These
statutory enactments were intended to create a more predictable
evaluation process for affected pesticide decisions, and couple the
collection of individual fees with specific decision review periods.
They also promote shorter decision review periods for reduced-risk
applications. EPA now actively provides guidance for PRIA-driven
streamlined regulatory determinations for most major pesticide
registration actions that is applicable to all pesticide registration
types, not just antimicrobial products. (see PRIA guidance https://www.epa.gov/pesticides/regulating/fees/index.htm).
The passage and implementation of PRIA and the implementation of
the Agency's final rule regarding pesticide labeling and other
regulatory revisions of December 14, 2001, have rendered the remainder
of what was proposed in the proposed rule moot. For these reasons, EPA
is withdrawing the remainder of what was proposed in its proposed rule.
3. Where can I get more information about this action? The docket
for this action is available under docket ID number OPP-36190.
C. Plant-Incorporated Protectants (PIPs); Exemption for Those Derived
Through Genetic Engineering From Sexually Compatible Plants; RIN 2070-
AD55
1. What was proposed? On November 23, 1994 (59 FR 60519; FRL-4755-
3) (when proposed, the RIN was 2070-AC02), EPA proposed to exempt from
FIFRA regulation those plant-incorporated protectants (then called
plant-pesticides) that are not likely to present new exposures to non-
target organisms. This exemption was proposed based on the assumption
that if a plant normally produces a pesticidal substance, organisms
that normally come into contact with the plant have likely been exposed
to the substance in the past, perhaps over long periods of time. No new
exposures would be likely to occur, and based on long experience with
plants in conventional agriculture, such PIPs would meet the FIFRA
section 25(b)(2) exemption standard. In defining, for regulatory
purposes, those substances for which no new exposures would occur, the
Agency proposed to base its approach on the concept of sexual
compatibility. Sexually compatible plants are more likely to share
common traits than are unrelated plants. If the donor of the genetic
material is sexually compatible with the recipient plant, it can be
assumed that the genetic material is already present in the sexually
compatible plant population and there would be no novel exposures. In
the 1994 proposal, the proposed regulatory text did not specify how the
genetic material of a plant-incorporated protectant or ``PIP'' could be
moved from the donor to the sexually compatible recipient plant,
whether through conventional breeding or genetic engineering
techniques.
On July 19, 2001 (66 FR 37855; FRL-6760-4), EPA finalized part of
its 1994 proposal thereby exempting certain plant-incorporated
protectants moved among plants in a sexually compatible population. The
2001 rule defined sexually compatible as meaning a viable zygote is
formed only through the union of two gametes through conventional
breeding. EPA did not in 2001 finalize that part of the proposal
dealing with PIPs moved among plants in a sexually compatible
population through genetic engineering but rather requested additional
public comment on the issues raised by scientific information
discovered between 1994 in 2001, in 1994 in public comment, and by
issues raised by the 2000 report of the National Academies of Science
(NAS) National Research Council (NRC).
2. Why is it being withdrawn? EPA is withdrawing this proposed
action because as the Agency's experience with PIPs and greater
scientific knowledge have increased, it has become evident to the
Agency that were EPA to pursue an exemption for certain PIPs moved
among plants in sexually compatible populations through genetic
engineering, more appropriate, scientifically current criteria for
describing the exempted PIPs should be developed rather than relying on
the criteria proposed in 1994.
In 2001, EPA concluded that a high probability exists that PIPs
moved between plants in sexually compatible populations through
conventional breeding would not present novel exposures to nontarget
organisms. Notwithstanding that conclusion, EPA could not (with the
same level of confidence) draw the same conclusion for PIPs moved
between plants in sexually compatible plant populations through genetic
engineering given the limitations of the modification techniques
available at that time. In addition, EPA came to agree with the 2000
NRC report that recommended that ``[g]iven that transfer and
manipulation of genes between sexually compatible plants could
potentially result in adverse effects in some cases . . . EPA should
reconsider its categorical exemption of transgenic [plant-incorporated
protectants] derived from sexually compatible plants.'' (NRC 2000 at p.
131, emphasis in original). The NRC report pointed out for example that
the Agency's proposed language would exempt genetic material moved
among plants in sexually compatible populations through genetic
engineering without taking into consideration whether the moved genetic
material would be expressed in the same pattern and at the same levels
as occurs naturally in the plant (NRC 2000 at p. 129). The proposal is
not supported by a sufficient basis to finalize the proposed exemption,
especially in light of the scientific developments that have taken
place in the last decade.
Recently, newer, more precise techniques of genetic engineering
have been developed based on scientific discoveries in genetics and
molecular biology since the 1994 proposal and the 2001 rule were
issued. These developments will allow the Agency to craft criteria that
are scientifically more current and that more accurately describe the
PIPs that would be exempted as well as procedures to better ensure that
all the PIPs in an exempted category meet the FIFRA section 25(b)(2)
exemption standard. Consequently, if EPA were to pursue such an
exemption today, the Agency would issue a new proposed rule, based on
knowledge of the types of products possible with the newest technology
rather than issuing a final rule based on the previous proposals.
Withdrawing the 1994 proposal does not preclude the Agency from
initiating the same or similar regulatory action in the future. At that
time, the Agency will initiate a new regulatory action and create a new
entry for the Semiannual Regulatory Agenda. It is also worth noting
that the Agency's proposal to exempt certain types of pesticide
products from
[[Page 20007]]
regulation under FIFRA is entirely a discretionary action; there is no
requirement in FIFRA that the Agency promulgate a regulation to exempt
products that might satisfy the exemption standard in FIFRA section
25(b)(2). EPA is therefore withdrawing the remainder of this proposal.
3. Where can I get more information about this action? The docket
for this action is available under docket ID number OPP-300369.
D. Plant-Incorporated Protectants (PIPs); Exemption for PIPs That Act
by Primarily Affecting the Plant; RIN 2070-AD56
1. What was proposed? On November 23, 1994 (59 FR 60519; FRL-4755-
3) (when proposed, the RIN was 2070-AC02), EPA proposed, under FIFRA
section 25(b)(2), to exempt from most of the requirements of FIFRA
those Plant-Incorporated Protectants (PIPs) (in 1994, PIPs were called
plant-pesticides (see 59 FR 60525; November 23, 1994)) that act
primarily by affecting the plant under the assumption that such PIPs
are less likely to be directly toxic to either target pests or to
nontarget organisms. The criteria proposed at 40 CFR 174.5(b)(2)
describe PIPs that act primarily by affecting the plant as a pesticidal
substance so that the target pest is inhibited from attaching to the
plant, penetrating the plant, or invading the plant's tissue in at
least one of three ways: (a) The pesticidal substance acts as a
structural barrier to attachment of the pest to the host plant, a
structural barrier to penetration of the pest into the host plant, or a
structural barrier to spread of the pest in the host plant, for
example, through the production of wax or lignin, or length of
trichomes (plant hairs); (b) The pesticidal substance acts in the host
plant to inactivate or resist toxins or other disease-causing
substances produced by the target pest; or (c) The pesticidal substance
acts by creating a deficiency of a plant nutrient or chemical component
essential for pest growth on/in the host plant.
EPA also indicated in 1994 that it was considering whether to
extend this exemption to include substances such as plant hormones,
because plant hormones act within the plant to ``primarily affect the
plant'' and do not act directly on a target pest.
On July 19, 2001 (66 FR 37855; FRL-6760-4), EPA reopened the
comment period on the proposed exemption to allow the public an
opportunity to comment on the information, analyses, and conclusions
pertaining to PIPs that act primarily by affecting the plant in the
report issued in 2000 by the NRC of the NAS entitled ``Genetically
Modified Pest-Protected Plants: Science and Regulation'' (National
Research Council. 2000. National Academies Press, Washington, DC), and
to comment on several risk issues received in public comment on the
1994 proposal (59 FR 60525, November 23, 1994).
2. Why is it being withdrawn? Because of new scientific discoveries
in the area of genetics and molecular biology the Agency has concluded
that neither the original 1994 proposal nor the subsequent 2001
supplemental proposal present a sufficient basis for making the
statutory finding required under FIFRA section 25(b)(2) to exempt this
class of PIPs. Given the current state of genetic technology, it is
possible that the exemption criteria set out in 1994 could exempt PIP
products available today that pose different risks than the Agency
envisioned when it initially proposed the criteria. In essence, the
more limited technological capabilities and understanding of science in
1994 led EPA to propose criteria for a generic exemption that current
technologies and scientific understanding have rendered inappropriate.
While there may be some PIPs that act primarily by affecting the plant
that would meet the FIFRA section 25(b)(2) standard for exemption, the
Agency no longer considers its proposed criteria for a generic
exemption to fairly restrict available products to only those that
``are of a character which is unnecessary to be subject to'' regulation
under FIFRA. 7 U.S.C. 136w(b)(2). EPA is therefore withdrawing this
proposal.
The decision to exempt pesticides under section 25(b) of FIFRA is
entirely discretionary; there is no requirement that EPA promulgate
pesticide exemptions. Withdrawing the proposal does not preclude the
Agency from initiating regulatory action in the future for PIPs that
act primarily by affecting the plant, e.g., exempting on a case-by-case
basis a PIP that acts primarily by affecting the plant when that PIP
can be shown to meet the FIFRA section 25(b)(2) exemption standard. At
that time, the Agency would initiate a new regulatory action and create
a new entry for EPA's Semiannual Regulatory Agenda.
i. Why the Proposed Exemption Criteria Would Exempt Pesticides that
Do Not Meet FIFRA Section 25(b)(2) Safety Standard. A number of
advances in scientific knowledge accumulated since publication of the
1994 proposal to exempt PIPs that act primarily by affecting the plant
have contributed to an understanding of how the proposed criteria would
exempt from FIFRA requirements PIPs that do not meet the FIFRA 25(b)(2)
exemption standard. For example, recent research into plant regulatory
mechanisms, e.g., the discovery of, and elucidation of the role of
interfering RNAs (RNAi), in gene expression, not available at the time
the 1994 proposal was published, contributed to the Agency's
determination that the proposed exemption categories were constructed
such that there are PIPs in the exempted categories that would not meet
the FIFRA section 25(b)(2) standard. RNAi plays a key role in directing
development of an organism, as well as controlling the various
biological functions necessary to maintaining the life of an organism.
RNAi is triggered by dsRNA, and while dsRNA can be native to the cell
it can also be introduced from an external source. At the time the
exemption was proposed, the role of dsRNA in controlling biological
functions in the cell was unknown and the possibility that dsRNA could
be introduced into the plant to affect the plant's behavior was not
taken into consideration. Had such knowledge been available, the
proposed criteria would have been based on substantively different
logic.
ii. Consideration of the points made in the 2000 NRC Report. In
withdrawing this proposal, EPA has also taken into consideration the
points the 2000 NRC report made on the Agency's 1994 proposal to exempt
from FIFRA requirements PIPs that act primarily by affecting the plant.
The NRC report noted that the Agency's analysis did not consider all of
the potential impacts on non-target species of all of the PIPs proposed
for exemption, including the possibility that in some instances
secondary metabolites affecting non-target organisms could be a by-
product of a modification to create a PIP that acts primarily by
affecting the plant. The NRC report concluded that based on its
considerations a ``[C]ategorical exemption under FIFRA might not be
scientifically justifiable'' (NRC 2000 at p. 133). Finally, the NRC
report also cautioned the Agency that ``genetic changes that result in
production of a specific plant protectant can result in production of
biologically active compounds other than the intended plant
protectants'' and cautioned that ``EPA should be aware of those
unintended changes'' (NRC 2000 at p. 134). Upon further analysis, EPA
has concluded that the generic criteria proposed in 1994 to allow
exemption of PIPs, did not meet the FIFRA section 25(b)(2) exemption
standard.
Given the large number of potential PIPs displaying a wide range of
modes of action in the categories circumscribed by each of the proposed
exemption
[[Page 20008]]
criteria, and advances in knowledge showing scientific concerns with
the logic underpinning the criteria as constructed in 1994, the Agency
cannot utilize the proposed criteria as a basis for this rulemaking.
EPA is therefore withdrawing this proposal.
3. Where can I get more information about this action? The docket
for this action is available under docket ID number OPP-300369. See
also related dockets identified by the docket ID numbers OPP-300370 and
OPP-300371.
Authority: 7 U.S.C. 136 et seq., 21 U.S.C. 346.
Dated: April 25, 2018.
Charlotte Bertrand,
Acting Principal Deputy Assistant Administrator, Office of Chemical
Safety and Pollution Prevention.
[FR Doc. 2018-09206 Filed 5-4-18; 8:45 am]
BILLING CODE 6560-50-P
