83 FR 20004 - Withdrawal of Proposed Rules; Discontinuing Several Rulemaking Efforts Listed in the Semiannual Regulatory Agenda

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 88 (May 7, 2018)

Page Range		20004-20008
FR Document		2018-09206

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.

Federal Register, Volume 83 Issue 88 (Monday, May 7, 2018)

[Federal Register Volume 83, Number 88 (Monday, May 7, 2018)]
[Proposed Rules]
[Pages 20004-20008]
From the Federal Register Online [www.thefederalregister.org]
[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.

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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
http://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
http://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

[[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 http://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

Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules 20007

regulation under FIFRA is entirely a Pest-Protected Plants: Science and example, recent research into plant
discretionary action; there is no Regulation’’ (National Research Council. regulatory mechanisms, e.g., the
requirement in FIFRA that the Agency 2000. National Academies Press, discovery of, and elucidation of the role
promulgate a regulation to exempt Washington, DC), and to comment on of interfering RNAs (RNAi), in gene
products that might satisfy the several risk issues received in public expression, not available at the time the
exemption standard in FIFRA section comment on the 1994 proposal (59 FR 1994 proposal was published,
25(b)(2). EPA is therefore withdrawing 60525, November 23, 1994). contributed to the Agency’s
the remainder of this proposal. 2. Why is it being withdrawn? Because determination that the proposed
3. Where can I get more information of new scientific discoveries in the area exemption categories were constructed
about this action? The docket for this of genetics and molecular biology the such that there are PIPs in the exempted
action is available under docket ID Agency has concluded that neither the categories that would not meet the
number OPP–300369. original 1994 proposal nor the FIFRA section 25(b)(2) standard. RNAi
subsequent 2001 supplemental proposal plays a key role in directing
D. Plant-Incorporated Protectants (PIPs);
present a sufficient basis for making the development of an organism, as well as
Exemption for PIPs That Act by
statutory finding required under FIFRA controlling the various biological
Primarily Affecting the Plant; RIN 2070–
section 25(b)(2) to exempt this class of functions necessary to maintaining the
AD56
PIPs. Given the current state of genetic life of an organism. RNAi is triggered by
1. What was proposed? On November technology, it is possible that the dsRNA, and while dsRNA can be native
23, 1994 (59 FR 60519; FRL–4755–3) exemption criteria set out in 1994 could to the cell it can also be introduced from
(when proposed, the RIN was 2070– exempt PIP products available today an external source. At the time the
AC02), EPA proposed, under FIFRA that pose different risks than the Agency exemption was proposed, the role of
section 25(b)(2), to exempt from most of envisioned when it initially proposed dsRNA in controlling biological
the requirements of FIFRA those Plant- the criteria. In essence, the more limited functions in the cell was unknown and
Incorporated Protectants (PIPs) (in 1994, technological capabilities and the possibility that dsRNA could be
PIPs were called plant-pesticides (see 59 understanding of science in 1994 led introduced into the plant to affect the
FR 60525; November 23, 1994)) that act EPA to propose criteria for a generic plant’s behavior was not taken into
primarily by affecting the plant under exemption that current technologies and consideration. Had such knowledge
the assumption that such PIPs are less scientific understanding have rendered been available, the proposed criteria
likely to be directly toxic to either target inappropriate. While there may be some would have been based on substantively
pests or to nontarget organisms. The PIPs that act primarily by affecting the different logic.
criteria proposed at 40 CFR 174.5(b)(2) plant that would meet the FIFRA ii. Consideration of the points made
describe PIPs that act primarily by section 25(b)(2) standard for exemption, in the 2000 NRC Report. In withdrawing
affecting the plant as a pesticidal the Agency no longer considers its this proposal, EPA has also taken into
substance so that the target pest is proposed criteria for a generic consideration the points the 2000 NRC
inhibited from attaching to the plant, exemption to fairly restrict available report made on the Agency’s 1994
penetrating the plant, or invading the products to only those that ‘‘are of a proposal to exempt from FIFRA
plant’s tissue in at least one of three character which is unnecessary to be requirements PIPs that act primarily by
ways: (a) The pesticidal substance acts subject to’’ regulation under FIFRA. 7 affecting the plant. The NRC report
as a structural barrier to attachment of U.S.C. 136w(b)(2). EPA is therefore noted that the Agency’s analysis did not
the pest to the host plant, a structural withdrawing this proposal. consider all of the potential impacts on
barrier to penetration of the pest into the The decision to exempt pesticides non-target species of all of the PIPs
host plant, or a structural barrier to under section 25(b) of FIFRA is entirely proposed for exemption, including the
spread of the pest in the host plant, for discretionary; there is no requirement possibility that in some instances
example, through the production of wax that EPA promulgate pesticide secondary metabolites affecting non-
or lignin, or length of trichomes (plant exemptions. Withdrawing the proposal target organisms could be a by-product
hairs); (b) The pesticidal substance acts does not preclude the Agency from of a modification to create a PIP that
in the host plant to inactivate or resist initiating regulatory action in the future acts primarily by affecting the plant.
toxins or other disease-causing for PIPs that act primarily by affecting The NRC report concluded that based
substances produced by the target pest; the plant, e.g., exempting on a case-by- on its considerations a ‘‘[C]ategorical
or (c) The pesticidal substance acts by case basis a PIP that acts primarily by exemption under FIFRA might not be
creating a deficiency of a plant nutrient affecting the plant when that PIP can be scientifically justifiable’’ (NRC 2000 at
or chemical component essential for shown to meet the FIFRA section p. 133). Finally, the NRC report also
pest growth on/in the host plant. 25(b)(2) exemption standard. At that cautioned the Agency that ‘‘genetic
EPA also indicated in 1994 that it was time, the Agency would initiate a new changes that result in production of a
considering whether to extend this regulatory action and create a new entry specific plant protectant can result in
exemption to include substances such for EPA’s Semiannual Regulatory production of biologically active
as plant hormones, because plant Agenda. compounds other than the intended
hormones act within the plant to i. Why the Proposed Exemption plant protectants’’ and cautioned that
‘‘primarily affect the plant’’ and do not Criteria Would Exempt Pesticides that ‘‘EPA should be aware of those
act directly on a target pest. Do Not Meet FIFRA Section 25(b)(2) unintended changes’’ (NRC 2000 at p.
On July 19, 2001 (66 FR 37855; FRL– Safety Standard. A number of advances 134). Upon further analysis, EPA has
daltland on DSKBBV9HB2PROD with PROPOSALS

6760–4), EPA reopened the comment in scientific knowledge accumulated concluded that the generic criteria
period on the proposed exemption to since publication of the 1994 proposal proposed in 1994 to allow exemption of
allow the public an opportunity to to exempt PIPs that act primarily by PIPs, did not meet the FIFRA section
comment on the information, analyses, affecting the plant have contributed to 25(b)(2) exemption standard.
and conclusions pertaining to PIPs that an understanding of how the proposed Given the large number of potential
act primarily by affecting the plant in criteria would exempt from FIFRA PIPs displaying a wide range of modes
the report issued in 2000 by the NRC of requirements PIPs that do not meet the of action in the categories circumscribed
the NAS entitled ‘‘Genetically Modified FIFRA 25(b)(2) exemption standard. For by each of the proposed exemption

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20008 Federal Register / Vol. 83, No. 88 / Monday, May 7, 2018 / Proposed Rules

criteria, and advances in knowledge Additional instructions on low-income populations, in the
showing scientific concerns with the commenting or visiting the docket, development, implementation, and
logic underpinning the criteria as along with more information about enforcement of environmental laws,
constructed in 1994, the Agency cannot dockets generally, is available at http:// regulations, and policies. To help
utilize the proposed criteria as a basis www.epa.gov/dockets. address potential environmental justice
for this rulemaking. EPA is therefore FOR FURTHER INFORMATION CONTACT: issues, the Agency seeks information on
withdrawing this proposal. Michael Goodis, Director, Registration any groups or segments of the
3. Where can I get more information Division (RD) (7505P), Office of population who, as a result of their
about this action? The docket for this Pesticide Programs, Environmental location, cultural practices, or other
action is available under docket ID Protection Agency, 1200 Pennsylvania factors, may have atypical or
number OPP–300369. See also related Ave. NW, Washington, DC 20460–0001; disproportionately high and adverse
dockets identified by the docket ID main telephone number: (703) 305– human health impacts or environmental
numbers OPP–300370 and OPP–300371. 7090; email address: RDFRNotices@ effects from exposure to the pesticides
Authority: 7 U.S.C. 136 et seq., 21 U.S.C. epa.gov. discussed in this document, compared
346. to the general population.
SUPPLEMENTARY INFORMATION:
Dated: April 25, 2018. II. What Does this Correction Do?
Charlotte Bertrand, I. General Information
This notice is being issued to correct
Acting Principal Deputy Assistant A. Does this action apply to me? PP 7E8571. (EPA–HQ–OPP–2017–0291)
Administrator, Office of Chemical Safety and
Pollution Prevention. You may be potentially affected by in FR Doc. 2017–19692, published in
this action if you are an agricultural the Federal Register of September 15,
[FR Doc. 2018–09206 Filed 5–4–18; 8:45 am]
producer, food manufacturer, or 2017 (82 FR 43352) (FRL–9965–43) is
BILLING CODE 6560–50–P
pesticide manufacturer. The following corrected as follows:
list of North American Industrial PP 7E8571. (EPA–HQ–OPP–2017–
ENVIRONMENTAL PROTECTION Classification System (NAICS) codes is 0291). Syngenta Crop Protection, LLC,
AGENCY not intended to be exhaustive, but rather P.O. Box 18300, Greensboro, NC 27419,
provides a guide to help readers requests to establish a tolerance in 40
40 CFR Part 180 determine whether this document CFR 180.226 for residues of the
applies to them. Potentially affected herbicide, diquat (6,7-dihydrodipyrido
[EPA–HQ–OPP–2017–0291; FRL–9976–34] entities may include: [1,2-a:2′1′-c] pyrazinediium), and its
• Crop production (NAICS code 111). metabolites in or on Crop Group 6C,
Receipt of a Pesticide Petition Filed for
• Animal production (NAICS code dried shelled pea and bean (except
Residues of Diquat in or on Crop
112). soybean) at 0.9 parts per million (ppm).
Group 6C, Dried Shelled Pea and Bean • Food manufacturing (NAICS code
(Except Soybean); Correction The Method GRM012.03A is used to
311). measure and evaluate the chemical
AGENCY: Environmental Protection • Pesticide manufacturing (NAICS residues of diquat dibromide in
Agency (EPA). code 32532). commodities. Contact: RD.
ACTION: Notice; correction. B. What should I consider as I prepare Authority: 21 U.S.C. 346a.
SUMMARY: EPA issued a notice in the my comments for EPA? Dated: April 26, 2018.
Federal Register of September 15, 2017, 1. Submitting CBI. Do not submit this Michael Goodis,
announcing the initial filing of a information to EPA through Director, Registration Division, Office of
pesticide petition requesting the regulations.gov or email. Clearly mark Pesticide Programs.
establishment or modification of the part or all of the information that [FR Doc. 2018–09648 Filed 5–4–18; 8:45 am]
regulations for residues of pesticide you claim to be CBI. For CBI BILLING CODE 6560–50–P
chemicals in or on various commodities. information in a disk or CD–ROM that
DATES: Comments must be received on you mail to EPA, mark the outside of the
or before June 6, 2018. disk or CD–ROM as CBI and then DEPARTMENT OF HEALTH AND
ADDRESSES: Submit your comments, identify electronically within the disk or HUMAN SERVICES
identified by docket identification (ID) CD–ROM the specific information that
number EPA–HQ–OPP–2017–0291, by is claimed as CBI. In addition to one 42 CFR Part 10
one of the following methods: complete version of the comment that
RIN 0906–AB18
• Federal eRulemaking Portal: http:// includes information claimed as CBI, a
www.regulations.gov. Follow the online copy of the comment that does not
340B Drug Pricing Program Ceiling
instructions for submitting comments. contain the information claimed as CBI
Price and Manufacturer Civil Monetary
Do not submit electronically any must be submitted for inclusion in the
Penalties Regulation
information you consider to be public docket. Information so marked
Confidential Business Information (CBI) will not be disclosed except in AGENCY: Health Resources and Services
or other information whose disclosure is accordance with procedures set forth in Administration, HHS.
restricted by statute. 40 CFR part 2. ACTION: Notice of proposed rulemaking;
• Mail: OPP Docket, Environmental 2. Tips for preparing your comments. further delay of effective date.
daltland on DSKBBV9HB2PROD with PROPOSALS

Protection Agency Docket Center (EPA/ When preparing and submitting your
DC), (28221T), 1200 Pennsylvania Ave. comments, see the commenting tips at SUMMARY: The Health Resources and
NW, Washington, DC 20460–0001. http://www.epa.gov/dockets/ Services Administration (HRSA)
• Hand Delivery: To make special comments.html. administers section 340B of the Public
arrangements for hand delivery or 3. Environmental justice. EPA seeks to Health Service Act, referred to as the
delivery of boxed information, please achieve environmental justice, the fair ‘‘340B Drug Pricing Program’’ or the
follow the instructions at http:// treatment and meaningful involvement ‘‘340B Program.’’ HHS is soliciting
www.epa.gov/dockets/contacts.html. of any group, including minority and/or comments on further delaying the

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Document Created: 2018-05-05 02:48:20
Document Modified: 2018-05-05 02:48:20

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Proposed Rules
Action		Withdrawal of proposed rules.
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.
Contact		Angela Hofmann, Director, Regulatory Coordination Staff (7101M), Office of Chemical Safety and Pollution Prevention, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001;
FR Citation		83 FR 20004
CFR Citation		40 CFR 152 40 CFR 156 40 CFR 174 40 CFR 180