[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.

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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at 61 FR 33260; and September 17, 1999, at 64 FR 50671, are withdrawn.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: 
[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 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


