[Federal Register Volume 84, Number 244 (Thursday, December 19, 2019)]
[Rules and Regulations]
[Pages 69620-69626]
[FR Doc No: 2019-27173]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2018-C-4464]

Listing of Color Additives Exempt From Certification; Soy
Leghemoglobin

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; response to objections and denial of public hearing
requests; removal of administrative stay.

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SUMMARY: The Food and Drug Administration (FDA or we) is responding to
objections that it received from the Center for Food Safety on the
final rule entitled ``Listing of Color Additives Exempt from
Certification; Soy Leghemoglobin,'' which published on August 1, 2019.
The final rule amended the color additive regulations to provide for
the safe use of soy leghemoglobin as a color additive in ground beef
analogue products. After reviewing the objections, FDA has

concluded that the objections do not raise issues of material fact that
justify a hearing or otherwise provide a basis for revoking the
amendment to the regulations. We are also providing notice that the
administrative stay of the effective date for this color additive
regulation is now lifted.

DATES: The final rule that published in the Federal Register of August
1, 2019 (84 FR 37573) with an effective date of September 4, 2019, was
administratively stayed by the filing of objections under section
701(e)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 371(e)(2)) as of September 3, 2019. FDA lifts the administrative
stay as of December 19, 2019.

ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this final rule into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Ellen Anderson, Center for Food Safety
and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In a notification published in the Federal Register of December 13,
2018 (83 FR 64045), we announced that we filed a color additive
petition (CAP 9C0314) submitted by Impossible Foods, Inc., c/o
Exponent, Inc., 1150 Connecticut Avenue NW, Suite 1100, Washington, DC
20036. The petition proposed to amend the color additive regulations in
part 73 (21 CFR part 73), ``Listing of Color Additives Exempt from
Certification,'' to provide for the safe use of soy leghemoglobin as a
color additive in ground beef analogue products such that the amount of
soy leghemoglobin protein does not exceed 0.8 percent by weight of the
uncooked ground beef analogue product.
    Additionally, in the Federal Register of August 1, 2019 (84 FR
37573), FDA issued a final rule entitled ``Listing of Color Additives
Exempt from Certification; Soy Leghemoglobin,'' amending the color
additive regulations to provide for the safe use of soy leghemoglobin
in ground beef analogue products. Specifically, the final rule added
Sec.  73.520 (21 CFR 73.520), entitled ``Soy leghemoglobin,'' which set
forth the identity, specifications, uses and restrictions, labeling,
and exemption from batch certification for the color additive. We gave
interested persons until September 3, 2019, to file objections and
requests for a hearing on the final rule.

II. Objections and Requests for Hearings

    Sections 701(e)(2) and 721(d) of the FD&C Act (21 U.S.C. 371(e)(2)
and 379e(d)) collectively provide that, within 30 days after
publication of an order relating to a color additive regulation, any
person adversely affected by such an order may file objections,
specifying with particularity the provisions of the order deemed
objectionable, stating the grounds therefor, and requesting a public
hearing upon such objections. FDA may deny a hearing request if the
objections to the regulation do not raise genuine and substantial
issues of fact that can be resolved at a hearing (see Sec.  12.24(b)(1)
(21 CFR 12.24(b)(1)); see also Community Nutrition Institute v. Young,
773 F.2d 1356, 1364 (D.C. Cir. 1985)).
    Objections and requests for a hearing are governed by part 12 (21
CFR part 12) of FDA's regulations. Under Sec.  12.22(a) (21 CFR
12.22(a)), each objection must meet the following conditions: (1) Must
be submitted on or before the 30th day after the date of publication of
the final rule; (2) must be separately numbered; (3) must specify with
particularity the provision of the regulation or proposed order
objected to; (4) must specifically state the provision of the
regulation or proposed order on which a hearing is requested (failure
to request a hearing on an objection constitutes a waiver of the right
to a hearing on that objection); and (5) must include a detailed
description and analysis of the factual information to be presented in
support of the objection if a hearing is requested (failure to include
a description and analysis for an objection constitutes a waiver of the
right to a hearing on that objection).
    Following the publication of the final rule for the safe use of soy
leghemoglobin as a color additive in ground beef analogue products, we
received a submission from the Center for Food Safety providing
objections and requesting a hearing on each objection. The objections
are as follows:
    Objection 1: FDA should not have approved this product to be used
in ground beef analogues that are not plant-based without additional
safety testing and public comment.
    Objection 2: FDA should require labeling of this color additive as
``soy leghemoglobin/P[ichia] pastoris yeast protein.'' \1\
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    \1\ Pichia pastoris (P. pastoris) is a non-pathogenic and non-
toxicogenic strain of yeast that is genetically engineered to
express soy leghemoglobin and P. pastoris yeast proteins. Soy
leghemoglobin protein is the principal coloring agent in the color
additive. (See 84 FR 37573 at 37574.)
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    Objection 3: FDA should have required additional testing of the raw
product.
    Objection 4: FDA improperly relied on Impossible Foods' Generally
Recognized As Safe (GRAS) Notice 737 instead of independently verifying
the safety of soy leghemoglobin for use as a color additive.
    Objection 5: FDA should have required separate testing of P.
pastoris because it is genetically engineered.
    Objection 6: FDA violated the National Environmental Policy Act
(NEPA) by failing to prepare an environmental assessment or
environmental impact statement.
    See submission from Jaydee Hanson, Policy Director, and Ryan
Talbot, Staff Attorney, Center for Food Safety, to the Dockets
Management Staff, Food and Drug Administration, dated September 3,
2019, at pages 1-2, 6-12 (referred to hereinafter as the
``submission'').

III. Standards for Granting a Hearing

    Specific criteria for determining whether to grant or deny a
request for a hearing are set out in Sec.  12.24(b). Under that
regulation, a hearing will be granted if the material submitted by the
requester shows, among other things, that: (1) There is a genuine and
substantial factual issue for resolution at a hearing (a hearing will
not be granted on issues of policy or law); (2) the factual issue can
be resolved by available and specifically identified reliable evidence
(a hearing will not be granted on the basis of mere allegations or
denials or general descriptions of positions and contentions); (3) the
data and information submitted, if established at a hearing, would be
adequate to justify resolution of the factual issue in the way sought
by the requester (a hearing will be denied if the data and information
submitted are insufficient to justify the factual determination urged,
even if accurate); (4) resolution of the factual issue in the way
sought by the person is adequate to justify the action requested (a
hearing will not be granted on factual issues that are not
determinative with respect to the action requested, e.g., if the action
would be the same even if the factual issue were resolved in the way
sought); (5) the action requested is not inconsistent with any
provision in the

FD&C Act or any regulation particularizing statutory standards (the
proper procedure in those circumstances is for the person requesting
the hearing to petition for an amendment or waiver of the regulation
involved); and (6) the requirements in other applicable regulations,
e.g., 21 CFR 10.20, 12.21, 12.22, 314.200, 514.200, and 601.7(a), and
in the notice issuing the final regulation or the notice of opportunity
for a hearing are met.
    A party seeking a hearing must meet a ``threshold burden of
tendering evidence suggesting the need for a hearing'' (Costle v.
Pacific Legal Foundation, 445 U.S. 198, 214-215 (1980), citing
Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 620-621
(1973)). An allegation that a hearing is necessary to ``sharpen the
issues'' or to ``fully develop the facts'' does not meet this test
(Georgia Pacific Corp. v. EPA, 671 F.2d 1235, 1241 (9th Cir. 1982)). If
a hearing request fails to identify any factual evidence that would be
the subject of a hearing, there is no point in holding one. In judicial
proceedings, a court is authorized to issue summary judgment without an
evidentiary hearing whenever it finds that there are no genuine issues
of material fact in dispute, and a party is entitled to judgment as a
matter of law (see Rule 56, Federal Rules of Civil Procedure). The same
principle applies to administrative proceedings (see Sec.  12.28).
    A hearing request must not only contain evidence, but that evidence
should raise a material issue of fact ``concerning which a meaningful
hearing might be held'' (Pineapple Growers Ass'n v. FDA, 673 F.2d 1083,
1085 (9th Cir. 1982)). Where the issues raised in the objection are,
even if true, legally insufficient to alter the decision, an Agency
need not grant a hearing (see Dyestuffs and Chemicals, Inc. v.
Flemming, 271 F.2d 281, 286 (8th Cir. 1959)). A hearing is justified
only if the objections are made in good faith and if they ``draw in
question in a material way the underpinnings of the regulation at
issue'' (Pactra Industries v. CPSC, 555 F.2d 677, 684 (9th Cir. 1977)).
A hearing need not be held to resolve questions of law or policy (see
Citizens for Allegan County., Inc. v. FPC, 414 F.2d 1125, 1128 (D.C.
Cir. 1969); Sun Oil Co. v. FPC, 256 F.2d 233, 240 (5th Cir. 1958)).
    Even if the objections raise material issues of fact, FDA need not
grant a hearing if those same issues were adequately raised and
considered in an earlier proceeding. Once an issue has been so raised
and considered, a party is estopped from raising that same issue in a
later proceeding without new evidence. The various judicial doctrines
dealing with finality, such as collateral estoppel, can be validly
applied to the administrative process (see Pacific Seafarers, Inc. v.
Pacific Far East Line, Inc., 404 F.2d 804, 809 (D.C. Cir. 1968)). In
explaining why these principles ought to apply to an Agency proceeding,
the U.S. Court of Appeals for the District of Columbia Circuit wrote:
``The underlying concept is as simple as this: justice requires that a
party have a fair chance to present his position. But overall interests
of administration do not require or generally contemplate that he will
be given more than a fair opportunity'' (Retail Clerks Union, Local
1401 v. NLRB, 463 F.2d 316, 322 (D.C. Cir. 1972); see also Costle v.
Pacific Legal Foundation, 445 U.S. at 215-17).

IV. Analysis of Objections and Response to Hearing Requests

    The submission from the Center for Food Safety contains six
numbered objections and requests a hearing on each of them. We address
each objection below, as well as the evidence and information filed in
support of each, comparing each objection and the information submitted
in support of it to the standards for granting a hearing in Sec.
12.24(b).

A. Objection 1

    The first objection asserts that FDA should not have approved soy
leghemoglobin as a color additive to be used in ``. . . all ground beef
analogue products, not just in plant-based ground beef analogue
products'' without additional safety testing and public comment.\2\ The
objection asserts that Impossible Foods' safety testing of soy
leghemoglobin ``was based on its use with the company's soy-based
ground beef analogue and that is the extent to which FDA's review and
approval should go.'' (See page 6 of the submission.) Moreover, the
objection claims that the use of soy leghemoglobin in ``all ground beef
analogue products requires additional testing for allergenicity.'' (See
page 6 of the submission.) The Center for Food Safety provided no
scientific data to support its objection.
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    \2\ We note that we specifically stated in the final rule, ``For
the purposes of this final rule, the term ``ground beef analogue
products'' refers to plant-based or other non-animal derived ground
beef-like food products.'' See 84 FR 37573. Therefore, if a firm
wanted to use soy leghemoglobin as a color additive in animal-
derived products, that use would require authorization through the
color additive petition process.
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    We clarify that the safety testing conducted by Impossible Foods
and described in CAP 9C0314 was not based on the use of the color
additive with a soy-based ground beef analogue, as claimed in the
objection. The petitioner used a weight-of-evidence approach to address
the safety of soy leghemoglobin protein and P. pastoris proteins that
comprise the color additive. The weight-of-evidence approach, which is
a widely used method for assessing protein safety by experts in the
scientific community, is based on several elements such as the known
function of the protein and its history of exposure, whether the
protein is from a toxigenic or allergenic source, the digestibility of
the protein, and bioinformatic analysis of the protein to determine if
it is structurally similar to known allergens or toxins (i.e., amino
acid sequence homology) (Ref 1). In our review of CAP 9C0314, we
confirmed that Impossible Foods thoroughly addressed the safety of soy
leghemoglobin, including any potential allergenicity, using the weight-
of-evidence approach.
    Furthermore, we are not aware of any scientific evidence that
suggests a food matrix, whether plant-based or animal-based, would
modify the structure, function, or safety of soy leghemoglobin under
the conditions of its intended use.
    The objection failed to include any new information or data that
would refute our findings about the safety of soy leghemoglobin in food
matrices other than plant-based products. The objection merely alleges
that there is a potential for harm, without providing any scientific
basis. A hearing will not be granted on the basis of mere allegations
or general descriptions of positions and contentions (Sec.
12.24(b)(2)). The objector must, at a minimum, raise a material issue
concerning which a meaningful hearing might be held. Therefore, we are
denying the request for a hearing on this objection.

B. Objection 2

    The second objection asserts that FDA should require labeling of
this color additive as ``soy leghemoglobin/P. pastoris yeast protein.''
(See page 6 of the submission.) The Center for Food Safety alleges that
the ``labeling approved by FDA does not provide `sufficient
information' about Impossible Foods' product.'' (See page 6 of the
submission.) Additionally, the objection states that both soy
leghemoglobin and P. pastoris proteins should be identified in labeling
for consumers who ``believe that they have allergies to either soy
products or yeast products.'' (See page 7 of the submission.)
    FDA acknowledges that the color additive soy leghemoglobin contains
residual amounts of P. pastoris yeast

protein in addition to the principal coloring component, soy
leghemoglobin protein. The allergenicity of soy leghemoglobin protein
and residual yeast proteins was addressed in safety studies that
included digestibility assays in simulated gastric fluid, bioinformatic
analyses, and animal feeding studies. The totality of evidence
presented in the color additive petition indicated that there is a
reasonable certainty that soy leghemoglobin protein and P. pastoris
yeast proteins do not pose any unique allergenicity risks when
consumed.
    Furthermore, under the Food Allergen Labeling and Consumer
Protection Act of 2004 (FALCPA), which added section 403(w) to the FD&C
Act (21 U.S.C. 343(w)), the label of a food that contains an ingredient
that is or contains protein from a ``major food allergen'' must declare
the presence of the allergen in the manner described by the law. As
stated in the findings of FALCPA in section 202(2)(A), the major food
allergens identified in the FD&C Act account for over 90 percent of all
documented food allergies in the United States and represent foods that
are likely to result in life-threatening reactions. Because soybeans
are identified as a major food allergen, foods that contain soy
leghemoglobin must be labeled accordingly. Yeast protein has not been
identified as a major food allergen. The objection provided no
scientific data on the prevalence or severity of yeast protein allergy
to support its objection.
    The Center for Food Safety failed to provide any new information or
data that would refute our findings about the potential for
allergenicity to yeast proteins. The objection merely alleges that
there is a potential for harm, without providing any evidence that we
have not considered previously. A hearing will not be granted on the
basis of mere allegations or general descriptions of positions and
contentions (Sec.  12.24(b)(2)). The objection must, at a minimum,
raise a material issue concerning which a meaningful hearing might be
held. Therefore, we are denying the request for a hearing on this
objection.

C. Objection 3

    The third objection asserts that FDA should have required
additional testing of the raw color additive product. The objection
states, ``[s]ince it is reasonably foreseeable that many consumers will
not fully cook this analogue product, FDA should have required
additional allergenicity testing of preparation as present in the rare
or raw product.'' (See page 7 of the submission.) The objection failed
to include any new information or data to support this assertion.
    We note that the safety studies submitted in support of Impossible
Foods' color additive petition for soy leghemoglobin were conducted
using ``raw'' soy leghemoglobin preparation. This fact is indicated in
the color additive petition as well as in the supporting publications.
(See pages 32, 34, and 37 of CAP 9C0314). The Center for Food Safety
failed to include any new information or data that would refute our
findings about the safety of the ``raw'' soy leghemoglobin preparation,
which was considered in our evaluation. A hearing will not be granted
on the basis of mere allegations or general descriptions of positions
and contentions (Sec.  12.24(b)(2)). The objector must, at a minimum,
raise a material issue concerning which a meaningful hearing might be
held. Therefore, we are denying the request for a hearing on this
objection.

D. Objection 4

    The fourth objection asserts that FDA's reliance on Impossible
Foods' GRAS Notice 737 violates the definition of ``safe'' in Sec.
70.3(i) (21 CFR. 70.3(i)). The objection claims ``that FDA relied
heavily on Impossible Foods' GRAS Notice filed in a separate proceeding
(and under a separate statutory provision) instead of independently
verifying the safety of SLH [soy leghemoglobin] for use as a color
additive.'' (See page 7 of the submission.) Furthermore, the objection
asserts that FDA's reliance on safety studies conducted by Impossible
Foods' employees or consultants ``undermines the integrity of the color
additive petition process.'' (See page 8 of the submission.)
    FDA disagrees with the Center for Food Safety's assertion that our
approval of soy leghemoglobin as a color additive in ground beef
analogue products is in violation of Sec.  70.3(i), which defines
``safe'' to mean there is convincing evidence that establishes with
reasonably certainty that no harm will result from the intended use of
the color additive. Impossible Foods submitted CAP 9C0314, a regulatory
submission for a color additive petition distinct from GRAS notice 737,
seeking approval for the use of soy leghemoglobin as a color additive
in ground beef analogue products. FDA acknowledges that the subject of
GRAS notice 737, soy leghemoglobin preparation, is the same substance
that is the subject of CAP 9C0314. FDA also acknowledges that the
safety studies conducted in support of GRAS notice 737 were submitted
in support of CAP 9C0314. In addition to evaluating the safety of soy
leghemoglobin in response to GRAS notice 737, FDA specifically
evaluated its safety as a color additive in response to CAP 9C0314.
Furthermore, although the regulatory programs are distinct, the
standard of safety--a reasonable certainty of no harm from the intended
use--is the same for food additives, color additives, and GRAS
substances.
    As we stated in the final rule (84 FR 37573 at 37574), our safety
evaluation for a color additive considers the additive's manufacturing;
its stability; the projected human dietary exposure to the additive and
any impurities resulting from the petitioned use of the additive; the
additive's toxicological data; and other relevant information (such as
published literature) available to us. In establishing that soy
leghemoglobin is safe for use as a color additive, we considered the
petitioner's weight-of-evidence approach based on: (1) The history of
consumption of soy, soy leghemoglobin protein, and P. pastoris; (2) the
safety of the genetically engineered P. pastoris production strain; (3)
14-day and 28-day feeding studies of soy leghemoglobin preparation in
rats; (4) mutagenicity and genotoxicity studies of soy leghemoglobin
preparation; and (5) an allergenicity assessment of soy leghemoglobin
and P. pastoris proteins present in the soy leghemoglobin preparation.
The objection did not contain any additional information that we did
not already consider in our evaluation of the color additive petition,
nor did the Center for Food Safety identify any reliable evidence that
contradicts FDA's safety determination.
    We disagree with the Center for Food Safety's assertion that we
must conduct our own safety studies rather than rely on studies
conducted or funded by the petitioner to adequately evaluate the safe
use of soy leghemoglobin. Studies needed to demonstrate the safety of
food ingredients are mostly conducted by the manufacturer or their paid
contract laboratories. The FD&C Act and our implementing regulations in
21 CFR parts 70 and 71 do not require us to perform safety studies
related to color additives; rather, the burden is on petitioners to
provide safety data as part of their petition (21 CFR 71.1). FDA's
responsibility is to evaluate the data contained in the petition, as
well as other information available to us, to determine if the
petitioned use is safe. FDA provides guidance documents (Ref. 2) that
specifically describe the type of data that we expect petitioners to
generate or rely upon for safety decisions on food ingredients.
    We note that the objection criticized two peer-reviewed studies
published in

scientific journals because they are co-authored by Impossible Foods'
employees and/or their consultants. The utility of such publications is
that the journal's peer review process can promote scientific rigor and
the entire scientific community can review the studies. This
transparency allows others to conduct further studies to test and
verify the results and conclusions, if warranted.
    FDA disagrees with the Center for Food Safety's assertion that a
90-day feeding study, rather than a 28-day feeding study, with soy
leghemoglobin was appropriate because the digestibility studies in
simulated gastric fluid showed that the soy leghemoglobin protein and
P. pastoris proteins were mostly digested in 0.5 minutes and could not
be detected beyond 2 minutes under the conditions of the study. These
data indicate that both soy leghemoglobin protein and P. pastoris
proteins are expected to be rapidly digested in the stomach, and these
proteins would no longer be available intact following oral
administration in either a 28-day or 90-day study. Moreover, sequence
analysis of the soy leghemoglobin protein and P. pastoris proteins and
their known functions suggest that the intact proteins or any fragments
thereof are not likely to cause any adverse effects. Therefore, a 90-
day study, compared to a 28-day study, has no added utility for
demonstrating the safety of this ingredient, as the proteins will be
digested rapidly in the stomach just like any other consumed proteins.
    Regarding the statistical differences noted in the study and that
the objection quotes as ``potentially adverse effects'' (see page 9 of
the submission), observed effects that are deemed statistically
significant are not necessarily toxicologically relevant. For an
observed effect to be toxicologically relevant (i.e., potentially
adverse), a clear dose-response should be seen (e.g., increasing the
dose of a test substance causes an increase in the observed effect in
the test subjects), and the observed effect should occur in both sexes
of test species. If the structure and metabolism of the test substance
is known, it may be possible to develop a hypothesis on the potential
mechanism of adverse effects or lack thereof. The available information
on the structure and function of soy leghemoglobin and its fate in the
body following consumption do not lend support to the Center for Food
Safety's claim that the statistically significant differences reported
in the study are indicative of potentially adverse effects in humans.
    The objection cites an online report by Robinson and Antoniou
(2019) \3\ asserting that feeding soy leghemoglobin to rats resulted in
statistically significant changes in some clinical chemistry parameters
compared to controls. The examples cited are changes in blood
chemistry, blood clotting ability, and blood globulin values. The
Center for Food Safety surmises that such statistically significant
differences could mean potentially adverse effects and are reason for
concern. However, differences in observed clinical chemistry
parameters, even if statistically significant, do not necessarily mean
that treatment-related differences exist. There are numerous accounts
of historical control data that demonstrate the extent of inter-animal
variability observed in rat strains commonly used in toxicological
studies (Refs. 3 to 8). These data show that certain clinical chemistry
parameters may have a wide range of normal values in experimental
control animals, such that statistical differences seen between control
animals and treatment animals due to small changes in the value of the
parameter are not likely to be of biological or toxicological
significance. Importantly, the changes observed for these parameters in
Impossible Food's 28-day study were within historical ranges of control
values, did not show a dose-response relationship, and did not occur in
both sexes, indicating that the statistically significant differences
were incidental and not treatment-related. The objection is based
purely on statistical significance and not biological significance or
toxicological relevance.
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    \3\ Available at: https://www.gmoscience.org/rat-feeding-studies-suggest-the-impossible-burger-may-not-be-safe-to-eat/.
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    The objection failed to include any new information or data that
would refute our conclusion that the data provided in the petition was
adequate to establish safety. A hearing will not be granted on the
basis of general descriptions of positions and contentions (Sec.
12.24(b)(2)). The objector must, at a minimum, raise a material issue
concerning which a meaningful hearing might be held. Therefore, we are
denying the request for a hearing on this objection.

E. Objection 5

    The fifth objection asserts that FDA should have required separate
testing of P. pastoris because it is genetically engineered. The
objection states that the use of P. pastoris should ``require separate
testing for allergenicity as the genetically-engineered yeast proteins
are present in the final `soy leghemoglobin/P. pastoris preparation.'
'' (See page 9 of the submission.)
    Soy leghemoglobin was produced by genetic engineering of P.
pastoris to express specific and targeted proteins with known
functions. The fermentation process used to produce soy leghemoglobin
is performed under controlled conditions and good manufacturing
practices. Quality control tests are in place to ensure there is no
residual P. pastoris production strain in the final product. The P.
pastoris proteins and the soy leghemoglobin protein comprise the final
soy leghemoglobin color additive that is the subject of this
rulemaking. All safety studies were conducted using the soy
leghemoglobin preparation that contained both the soy leghemoglobin
protein and the P. pastoris proteins. Therefore, the safety of both the
soy leghemoglobin protein and the P. pastoris proteins were considered
in FDA's evaluation. Consequently, there is no scientific basis to
conduct additional testing of a P. pastoris strain simply because of
the methods used to develop the strain. In any event, as previously
stated, the studies contained in the color additive petition
demonstrated both types of proteins were safe. The objection provided
no scientific evidence to support its claim that separate safety
testing of the genetically engineered P. pastoris yeast is warranted.
    The objection failed to include any new information or data to
support their contention that separate allergenicity testing is needed
for P. Pastoris yeast. A hearing will not be granted on the basis of
general descriptions of positions and contentions (Sec.  12.24(b)(2)).
The objector must, at a minimum, raise a material issue concerning
which a meaningful hearing might be held. Therefore, we are denying the
request for a hearing on this objection.

F. Objection 6

    The sixth and last objection asserts that FDA violated NEPA by
failing to prepare an environmental assessment or environmental impact
statement. The objection states that ``FDA failed to consider whether
there may be indirect and cumulative adverse effects to threatened and
endangered species or their critical habitat as a result of its
approval of Impossible Foods' petition.'' (See page 10 of the
submission.) The objection alleges that the use of genetically
engineered soybeans as a source of soy protein to formulate ground beef
analogues may increase the

use of soybeans derived from genetically engineered soy varieties and
compete with the livestock industry for feedstock. (See page 11 of the
submission.) Furthermore, the Center for Food Safety suggests that the
use of dicamba, a pesticide commonly used on certain crops engineered
to be resistant to the pesticide, will increase due to increased
reliance on soy protein as an ingredient in the ground beef analogue
products. As such, the objection claims that FDA should have considered
the potential indirect and cumulative effects of increased pesticide
application on genetically engineered soybean crops and should have
required an environmental assessment or an environmental impact
statement related to CAP 9C0314.
    We do not agree that we violated NEPA by failing to prepare an
environmental assessment or an environmental impact statement.
Furthermore, we do not agree that we failed to consider whether there
may be indirect or cumulative adverse effects to threatened and
endangered species or their critical habitat resulting from the
approval of Impossible Foods' color additive petition that would
constitute extraordinary circumstances within the meaning of Sec.
25.21(b) (21 CFR 25.21(b)).
    As discussed in the filing notice for the petition (83 FR 64045;
December 13, 2018), Impossible Foods claimed that the categorical
exclusion in Sec.  25.32(k) (21 CFR 25.32(k)) applied to the proposed
use of soy leghemoglobin because the substance would be added directly
to food and is intended to remain in food through ingestion by
consumers and is not intended to replace macronutrients in food. Under
Sec.  25.21, FDA requires at least an environmental assessment for any
specific action that ordinarily would be excluded if extraordinary
circumstances indicate that the specific proposed action may
significantly affect the quality of the human environment. As discussed
in the filing notice published in the Federal Register of December 13,
2018, Impossible Foods stated that, to their knowledge, no
extraordinary circumstances exist regarding the proposed use of soy
leghemoglobin. In our analysis of the applicability of the categorical
exclusion under Sec.  25.32(k), we focused on soy leghemoglobin
production and potential waste products (i.e., food waste and/or
excretion products) and identified no extraordinary circumstances
related to production, use, or disposal of soy leghemoglobin. In the
final rule (84 FR 37573), we stated that we did not receive any new
information or comments regarding this claim of categorical exclusion,
and therefore determined that the proposed action is categorically
excluded under Sec.  25.32(k).
    No data or information was provided to support the Center for Food
Safety's contention that the approval of soy leghemoglobin as a color
additive would result in an increase in the cultivation of genetically
engineered soybeans, that such cultivation would lead to an increase in
pesticide use such as dicamba, or that such cultivation would result in
significant adverse impacts to threatened or endangered species or
their critical habitat, requiring the preparation of an environmental
assessment or an environmental impact statement. Furthermore, the
objection focuses on increased cultivation of genetically engineered
soybeans and use of pesticides such as dicamba. The objection does not
consider that Impossible Foods' soy leghemoglobin ingredient, the
substance that is the subject of the color additive petition, is not
grown or derived from genetically engineered soybean plants. Instead,
the substance is produced by a strain of genetically engineered yeast;
production occurs in vats rather than on a farm and does not require
the use of pesticides such as dicamba.
    The objection cites a 2019 Forbes article \4\ as support for the
assertion that Impossible Foods ``switch[ed] from wheat to GM soy.''
(See page 11 of the submission.) However, the Forbes article discusses
the plant-based raw material that forms the burger itself, not the
ingredient soy leghemoglobin that is the subject of FDA's action. Thus,
the Center for Food Safety's reliance on this article for the
proposition that FDA approval of soy leghemoglobin for use as a color
additive will lead to an increase in genetically engineered soybean
cultivation is misplaced. Because Impossible Foods' soy leghemoglobin
ingredient is not derived from genetically engineered soybeans, there
is no basis on which to conclude that FDA's approval of soy
leghemoglobin for use as a color additive will result in increased
cultivation of genetically engineered soybeans and/or an increased use
of pesticides in domestic agriculture.\5\ To the extent the Center for
Food Safety is arguing that FDA's approval of the petition may have an
indirect effect on the production of genetically engineered soy by
facilitating an overall increase in Impossible Foods' burger
production, we note that this argument is speculative and the Center
for Food Safety has not identified any evidence that FDA's approval of
the petition will have a meaningful effect of this nature.
---------------------------------------------------------------------------

    \4\ Available at: https://www.forbes.com/sites/louisaburwoodtaylor/2019/07/31/impossible-in-full-scale-up-mode-with-new-burger-manufacturing-deal--fda-approval/.
    \5\ We note that, based on publicly available information from
the United States Department of Agriculture, approximately 94
percent of the soybean acres planted in 2019 in the United States
were genetically engineered varieties (https://www.ers.usda.gov/topics/farm-practices-management/biotechnology/).
---------------------------------------------------------------------------

    The objection failed to include any new information or data that
would change our findings with respect to the applicability of the
categorical exclusion in Sec.  25.32(k). The request for a hearing does
not provide any evidence to support its claims. A hearing will not be
granted on the basis of mere allegations or general descriptions of
positions and contentions (Sec.  12.24(b)(2)). The objections must, at
a minimum, raise a material issue concerning which a meaningful hearing
might be held. Therefore, we are denying the request for a hearing on
this objection.

V. Summary and Conclusions

    Section 721 of the FD&C Act requires that a color additive be shown
to be safe prior to marketing. Under Sec.  70.3(i), a color additive is
safe if there is a reasonable certainty in the minds of competent
scientists that the substance is not harmful under the intended
conditions of use. In the final rule authorizing the use of soy
leghemoglobin, we concluded that the data presented by the petitioner
demonstrate that soy leghemoglobin is safe for its intended use in
ground beef analogue products.
    The petitioner has the burden to demonstrate the safety of the
additive to gain FDA approval. Once we make a finding of safety, the
burden shifts to an objector, who must come forward with evidence that
calls into question our conclusion (see section 701(e)(2) of the FD&C
Act).
    Despite its allegations, the Center for Food Safety has not
established that we have overlooked significant information contained
within the record in reaching our conclusion that the use of soy
leghemoglobin in ground beef analogue products is safe. In such
circumstances, we have determined that the objections do not raise any
genuine and substantial issue of fact that can be resolved by an
evidentiary hearing (Sec.  12.24(b)). Accordingly, we are denying the
requests for a hearing. Furthermore, after evaluating the objections,
we have concluded that the objections do not provide any basis for us
to reconsider our decision to issue the final rule authorizing the use
of soy leghemoglobin in ground beef analogue products. Accordingly, we
are not

making any changes in response to the objections.
    The filing of the objections served to stay automatically the
effectiveness of Sec.  [thinsp]73.520. Section 701(e)(2) of the FD&C
Act states that, until final action upon such objections is taken by
the Secretary, the filing of such objections operates to stay the
effectiveness of those provisions of the order to which the objections
are made. Section 701(e)(3) of the FD&C Act further stipulates that, as
soon as practicable, the Secretary shall by order act upon such
objections and make such order public. We have completed our evaluation
of the objections and conclude that a continuation of the stay of Sec.
[thinsp]73.520 is not warranted.
    In the absence of any other objections and requests for a hearing,
we conclude that this document constitutes final action on the
objections received in response to the regulation as prescribed in
section 701(e)(2) of the FD&C Act. Therefore, we are ending the
administrative stay of the regulation as of December 19, 2019 for the
Sec.  73.520 listing soy leghemoglobin as a color additive for use in
ground beef analogue products.

VI. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

1. Ladics, G.S., ``Current Codex Guidelines for Assessment of
Potential Protein Allergenicity.'' Food and Chemical Toxicology, 46:
S20-S23, 2008.
2. *FDA. ``Redbook 2000 Guidance for Industry and Other
Stakeholders; Toxicological Principles for the Safety Assessment of
Food Ingredients,'' 2007. Retrieved from https://www.fda.gov/media/79074/download.
3. Giknis, M.L.A. and C.B. Clifford, ``Clinical Laboratory
Parameters for Crl:CD(SD) Rats,'' 2006. Retrieved from https://www.crj.co.jp/cms/pdf/info_common/50/8250933/rm_rm_r_clinical_parameters_cd_rat_06.pdf.
4. Giknis, M.L.A. and C.B. Clifford, ``Clinical Laboratory
Parameters for Crl:WI(Han),'' 2008. Retrieved from https://www.criver.com/sites/default/files/resources/rm_rm_r_Wistar_Han_clin_lab_parameters_08.pdf.
5. Matsuzawa, T., M. Nomura, and T. Unno, ``Clinical Pathology
Reference Ranges of Laboratory Animals. Working Group II,
Nonclinical Safety Evaluation Subcommittee of the Japan
Pharmaceutical Manufacturers Association.'' Journal of Veterinary
Medical Science, 55(3): 351-362, 1993.
6. Pettersen, J.C., R.L. Morrissey, D. R. Saunders, et al., ``A 2-
Year Comparison Study of Crl:CD BR and Hsd:Sprague-Dawley SD Rats.''
Fundamental and Applied Toxicology, 33: 196-211, 1996.
7. Petterino, C. and A. Argentino-Storino, ``Clinical Chemistry and
Haematology Historical Data in Control Sprague-Dawley Rats From Pre-
clinical Toxicity Studies.'' Experimental and Toxicologic Pathology,
57: 213-219, 2006.
8. Seibel, J., K. Bodi[eacute], S. Weber, et al., ``Comparison of
Haematology, Coagulation and Clinical Chemistry Parameters in Blood
Samples From the Sublingual Vein and Vena Cava in Sprague-Dawley
Rats.'' Laboratory Animals, 44: 344-351, 2010.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Foods, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e) and
under authority delegated to the Commissioner of Food and Drugs
(section 1410.10 of the FDA Staff Manual Guide), notice is given that
the objections and requests for hearings were filed in response to the
August 1, 2019, final rule. Notice is also given that FDA is denying
these objections and requests for hearings. Accordingly, the
administrative stay on the effective date of the amendments is lifted
as of December 19, 2019.

    Dated: December 12, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-27173 Filed 12-17-19; 11:15 am]
BILLING CODE 4164-01-P


[Federal Register Volume 85, Number 54 (Thursday, March 19, 2020)]
[Rules and Regulations]
[Pages 15713-15714]
[FR Doc No: 2020-05339]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.

========================================================================

Federal Register / Vol. 85, No. 54 / Thursday, March 19, 2020 / Rules
and Regulations

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

18 CFR Part 157

[Docket No. RM81-19-000]

Natural Gas Pipelines; Project Cost and Annual Limits

AGENCY: Federal Energy Regulatory Commission, Energy.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: Pursuant to the authority delegated by the Commission's
regulations, the Director of the Office of Energy Projects (OEP)
computes and publishes the project cost and annual limits for natural
gas pipelines blanket construction certificates for each calendar year.

DATES: This final rule is effective March 19, 2020 and establishes cost
limits applicable from January 1, 2020 through December 31, 2020.

FOR FURTHER INFORMATION CONTACT: Richard W. Foley, Chief, Certificates
Branch 1 Division of Pipeline Certificates,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Section 157.208(d) of the Commission's
Regulations provides for project cost limits applicable to
construction, acquisition, operation and miscellaneous rearrangement of
facilities (Table I) authorized under the blanket certificate procedure
(Order No. 234, 19 FERC ] 61,216). Section 157.215(a) specifies the
calendar year dollar limit which may be expended on underground storage
testing and development (Table II) authorized under the blanket
certificate. Section 157.208(d) requires that the ``limits specified in
Tables I and II shall be adjusted each calendar year to reflect the
'GDP implicit price deflator' published by the Department of Commerce
for the previous calendar year.''
    Pursuant to Sec.  375.308(x)(1) of the Commission's Regulations,
the authority for the publication of such cost limits, as adjusted for
inflation, is delegated to the Director of the Office of Energy
Projects. The cost limits for calendar year 2020, as published in Table
I of Sec.  157.208(d) and Table II of Sec.  157.215(a), are hereby
issued.

Effective Date

    This final rule is effective March 19, 2020. The provisions of 5
U.S.C. 804 regarding Congressional review of final rules does not apply
to the final rule because the rule concerns agency procedure and
practice and will not substantially affect the rights or obligations of
non-agency parties. The final rule merely updates amounts published in
the Code of Federal Regulations to reflect the Department of Commerce's
latest annual determination of the Gross Domestic Product (GDP)
implicit price deflator, a mathematical updating required by the
Commission's existing regulations.

List of Subjects in 18 CFR Part 157

    Administrative practice and procedure, Natural gas, Reporting and
recordkeeping requirements.

    Issued: March 10, 2020.
Terry L. Turpin,
Director, Office of Energy Projects.

    Accordingly, 18 CFR part 157 is amended as follows:

PART 157--[AMENDED]

0
1. The authority citation for part 157 continues to read as follows:

    Authority: 15 U.S.C. 717-717w, 3301-3432; 42 U.S.C. 7101-7352.

0
2. In Sec.  157.208(d), Table I is amended by adding an entry for
``2020'' at the end of the table to read as follows:

Sec.  157.208  Construction, acquisition, operation, replacement, and
miscellaneous rearrangement of facilities.

* * * * *
    (d) * * *

                           Table I to Part 157
------------------------------------------------------------------------
                                                    Limit
                                   -------------------------------------
               Year                                       Prior notice
                                    Auto. proj.  cost   proj. cost limit
                                      limit (Col.1)         (Col.2)
------------------------------------------------------------------------

                              * * * * * * *
2020..............................        $12,500,000        $35,200,000
------------------------------------------------------------------------

* * * * *

0
3. In Sec.  157.215(a)(5), Table II is amended by adding an entry for
``2020'' at the end of the table to read as follows:

Sec.  157.215  Underground storage testing and development.

    (a) * * *
    (5) * * *

                          Table II to Part 157
------------------------------------------------------------------------
                         Year                                Limit
------------------------------------------------------------------------

                                * * * * *
2020.................................................         $6,700,000
------------------------------------------------------------------------

* * * * *
[FR Doc. 2020-05339 Filed 3-18-20; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 143 (Friday, July 25, 2014)]
[Rules and Regulations]
[Pages 43250-43255]
[FR Doc No: 2014-17600]

-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2013-0705]
RIN 1625 AA00; 1625-AA11

Regulated Navigation Area and Safety Zone: Tappan Zee Bridge
Construction Project, Hudson River; South Nyack and Tarrytown, NY

AGENCY: Coast Guard, DHS.

ACTION: Temporary interim rule with request for comments.

-----------------------------------------------------------------------

SUMMARY: The Coast Guard is revising the current regulated navigation
area (RNA) for the navigable waters of the Hudson River surrounding the
Tappan Zee Bridge. First, the Coast Guard is establishing a new safety
zone surrounding commercial mooring buoys installed for the ongoing
Tappan Zee Bridge replacement project. The safety zone will prohibit
all vessel traffic that could pose an imminent hazard to persons and
vessels that will be transiting to and from the bridge site and
maneuvering in close quarters between other construction vessels and
large mooring buoys. Second, the Coast Guard is expanding the size of
the current RNA and designating two areas within the RNA, the Eastern
RNA and the Western RNA, based upon their respective locations in
relation to the new safety zone. This rule is necessary to provide for
the safety of life in the RNA and safety zone during the construction
of the New NY Bridge and demolition of the existing Tappan Zee Bridge.

DATES: This rule is effective without actual notice from July 25, 2014
until December 31, 2018. For the purposes of enforcement, actual notice
will be used from the date the rule was signed, July 3, 2014 until July
25, 2014.
    Comments and related material will be accepted and reviewed by the
Coast Guard through September 23, 2014.

ADDRESSES: Documents mentioned in this preamble are part of Docket
Number USCG-2013-0705. To view documents mentioned in this preamble as
being available in the docket, go to http://www.regulations.gov, type
the docket number in the ``SEARCH'' box and click ``SEARCH.'' Click on
``Open Docket Folder'' on the line associated with this rulemaking. You
may also visit the Docket Management Facility in Room W12-140 on the
ground floor of the Department of Transportation West Building, 1200
New Jersey Avenue SE.,

Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    You may submit comments, identified by docket number, using any one
of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail or Delivery: Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590-0001. Deliveries
accepted between 9 a.m. and 5 p.m., Monday through Friday, except
federal holidays. The telephone number is<PHONE_NUMBER>.
    See the ``Public Participation and Request for Comments'' portion
of the SUPPLEMENTARY INFORMATION section below for further instructions
on submitting comments. To avoid duplication, please use only one of
these three methods.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Chief Craig Lapiejko, Waterways Management at Coast Guard
First District, telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>or, Mr. Jeff Yunker, Coast Guard Sector New York Waterways Management
Division, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on viewing or submitting
material to the docket, call Cheryl Collins, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
NYSTA New York State Thruway Authority
RNA Regulated Navigation Area
TIR Temporary Interim Rule

A. Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

1. Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation. You may submit your comments and material online at
http://www.regulations.gov, or by fax, mail, or hand delivery, but
please use only one of these means. If you submit a comment online, it
will be considered received by the Coast Guard when you successfully
transmit the comment. If you fax, hand deliver, or mail your comment,
it will be considered as having been received by the Coast Guard when
it is received at the Docket Management Facility. We recommend that you
include your name and a mailing address, an email address, or a
telephone number in the body of your document so that we can contact
you if we have questions regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
type the docket number in the ``SEARCH'' box and click ``SEARCH.''
Click on ``Submit a Comment'' on the line associated with this
rulemaking.
    If you submit your comments by mail or hand delivery, submit them
in an unbound format, no larger than 8\1/2\ by 11 inches, suitable for
copying and electronic filing. If you submit comments by mail and would
like to know that they reached the Facility, please enclose a stamped,
self-addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change the rule
based on your comments.

2. Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
type the docket number in the ``SEARCH'' box and click ``SEARCH.''
Click on Open Docket Folder on the line associated with this
rulemaking. You may also visit the Docket Management Facility in Room
W12-140 on the ground floor of the Department of Transportation West
Building, 1200 New Jersey Avenue SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

3. Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

4. Public Meeting

    We currently do not plan to hold a public meeting. But you may
submit a request for one, using one of the methods specified under
ADDRESSES. Please explain why you believe a public meeting would be
beneficial. If we determine that one would aid this rulemaking, we will
hold one at a time and place announced by a later notice in the Federal
Register.

B. Regulatory History and Information

    On September 26, 2013, the Coast Guard published a temporary
interim rule (TIR) establishing a regulated navigation area (RNA) at 33
CFR 165.T01-0705 for the Tappan Zee Bridge replacement project in that
waterway (78 FR 59231). We received no comments on the September 26,
2013 TIR. No public meeting was requested, and none was held. Today's
TIR revises the September 26, 2013 RNA on the Hudson River due to
changed circumstances in the construction project discussed below.
    The Coast Guard is issuing this TIR without prior notice and
opportunity to comment pursuant to authority under section 4(a) of the
Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision
authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because publishing an NPRM would be
impracticable and contrary to the public interest. Construction on the
Tappan Zee Bridge replacement project began on October 1, 2013. The
construction project has grown to include the installation of 16
commercial mooring buoys and an increase in the number of construction
vessels to 100 or more vessels. These changes present new safety
hazards and risks. It would be impracticable to delay promulgating this
rule, as the RNA and safety zone are necessary to protect the safety of
both the construction crew and the waterway users operating in the
vicinity of the bridge construction zone. A delay or cancellation of
the currently ongoing bridge rehabilitation project in order to
accommodate a full notice and comment period would delay necessary
operations, result in increased costs, and delay the date when the
bridge is expected to reopen for normal operations. For these reasons,
the Coast Guard believes it is impracticable and

contrary to the public interest to delay this regulation. At any time,
the Coast Guard may publish an amended rule if necessary to address
public concerns.
    For the same reasons mentioned above, under 5 U.S.C. 553(d)(3), the
Coast Guard finds that good cause exists for making this rule effective
less than 30 days after publication in the Federal Register.

C. Basis and Purpose

    Under the Ports and Waterways Safety Act, 33 U.S.C. 1221 et. seq.,
and Department of Homeland Security Delegation No. 0170.1, the Coast
Guard has the authority to establish RNAs and safety zones.
    This rule is prompted by the navigation safety situation created by
the construction of the New NY Bridge to replace the existing Tappan
Zee Bridge. Construction on the project began on October 1, 2013, and
is expected to run through December 31, 2018.
    The Coast Guard has discussed this project with the New York State
Thruway Authority (NYSTA) and Tappan Zee Constructors, LLC, to
determine whether the project can be completed without channel closures
or waterway restrictions. While the majority of construction activities
during the span of this project will not require waterway closures,
there are certain tasks that can only be completed in the channel or
surrounding installed commercial mooring buoys and will require closing
the waterway. The construction of the bridge will be extremely complex
and presents many safety hazards including overhead crane operations,
overhead cutting operations, potential falling debris, construction
vessels maneuvering and transiting between the bridge site and
commercial mooring buoys installed upstream and downstream from the
construction site, and barges positioned in the channel with a
restricted ability to maneuver. In addition to regular construction
activities, at present, NYSTA and Tappan Zee Constructors, LLC expect
to request waterway closures of the Federal Channel between March 2015
and October 2016. The channel closures will be necessary during heavy
lift operations conducted over the channel and are expected to be
conducted during daylight hours. These closures will be closely
coordinated with mariners in advance so they can alter their transit
schedules. Mariners that may safely navigate outside the Federal
channel would still be able to transit through the RNAs, during these
heavy lift operations.

D. Discussion of the Interim Rule

    The Coast Guard is revising the existing Regulated Navigation Area
surrounding the Tappan Zee Bridge construction project to expand the
size of the RNA to all waters of the Hudson River within 500 yards of
the existing Tappan Zee Bridge. (The existing RNA includes all waters
of the Hudson River within 200 yards south, and 300 yards north, of the
existing Tappan Zee Bridge.) The expansion is necessary due to
installation of 16 commercial mooring buoys, and the increase in the
number of construction vessels operating within the RNA and safety zone
to 100 or more vessels. Additionally, the RNA will be divided into the
Western RNA and Eastern RNA, based upon their respective locations in
relation to the safety zone. This is intended to reduce public
confusion that may be created with establishing the NYSTA requested
safety zone and Eastern and Western RNA areas in the same area of the
Hudson River. As requested by the NYSTA, the RNA and safety zone would
have overlapped and would have established different operating
restrictions on vessels not involved with the project. This would have
likely led to confusion among mariners when determining which
regulations apply to them if they were within the area where the RNA
and safety zone overlapped.
    Additionally, the Coast Guard is establishing a new safety zone on
the navigable waters of the Hudson River on the western side of the
Hudson River, north and south of the Tappan Zee Bridge, NY. Entry into,
anchoring, or movement within this safety zone is prohibited by all
vessels not working on the Tappan Zee Bridge construction project. The
safety zone surrounds 16 mooring buoys that are being installed for
this project. These moorings will be used as a staging site for barges
holding material used to build the New NY Bridge and demolish the
existing Tappan Zee Bridge. During peak operations, 100 or more vessels
may be within the RNAs, safety zone, or transiting to, or from, the
RNAs and safety zone.
    The Coast Guard is making these revisions to maintain safe
navigation in the project area, and to prevent accidental or
intentional damage to persons or property on the work site. The ongoing
operations, increase in the number of construction vessels on site, and
installation of the 16 mooring buoys within the RNA and safety zone,
are by their nature, hazardous and pose risks both to recreational and
commercial traffic as well as to the construction crew. In order to
mitigate the inherent risks involved with the removal of a bridge, and
installation of the New NY Bridge, it is necessary to control vessel
movement through the area. The purpose of this TIR is to ensure the
safety of waterway users, the public, and construction workers for the
duration of the New NY Bridge construction and Tappan Zee Bridge
demolition.
    Heavy-lift operations are sensitive to water movement, and wake
from passing vessels could pose significant risk of injury or death to
construction workers. In order to minimize such unexpected or
uncontrolled movement of water, any vessel transiting through the
Western RNA must make a direct and expeditious passage. No vessel may
stop, moor, anchor or loiter within the RNA at any time unless they are
working on the bridge construction operations.
    Similarly, any vessel transiting through the Eastern RNA must make
a direct and expeditious passage. No vessel may stop, moor, anchor or
loiter within the RNA at any time unless they are working on the bridge
construction operations or they are anchoring within the special
anchorage area codified in 33 CFR 110.60(c)(8) located on the eastern
shoreline at Tarrytown, NY and within the boundaries of the Eastern
RNA.
    If the project is completed before December 31, 2018, the COTP will
suspend enforcement of the Eastern or Western RNA and safety zone. The
COTP will notify the affected segments of the public of any suspension
of enforcement by appropriate means. Such means of notification could
include, but would not be limited to, Broadcast Notice to Mariners and
Local Notice to Mariners.
    The COTP maintains a telephone line that is staffed 24 hours a day,
seven days a week. The public can obtain information concerning
enforcement of the regulated navigation area and safety zone by
contacting the Coast Guard Sector New York Command Center at (718) 354-
4353.

E. Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on these statutes and executive orders.

1. Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented

by Executive Order 13563, Improving Regulation and Regulatory Review,
and does not require an assessment of potential costs and benefits
under section 6(a)(3) of Executive Order 12866 or under section 1 of
Executive Order 13563. The Office of Management and Budget has not
reviewed it under those Orders.
    The Coast Guard determined that this rulemaking would not be a
significant regulatory action for the following reasons: Vessel traffic
would only be restricted from the Eastern RNA for limited durations.
The Eastern RNA covers only a small portion of the navigable waterway
which includes the Federal navigation channel. Furthermore, while the
Federal navigation channel is closed, vessels that can safely navigate
outside the Federal navigation channel would still be able to transit
through the Western RNA or the portion of the Eastern RNA which does
not encompass the Federal navigable channel.
    Advance public notifications will also be made to local mariners
through appropriate means, which may include but are not limited to,
Local Notice to Mariners and Broadcast Notice to Mariners.

2. Impact on Small Entities

    The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as
amended, requires federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The Coast Guard
received no comments from the Small Business Administration on the
September 26, 2013 TIR. The Coast Guard certifies under 5 U.S.C. 605(b)
that this rule will not have a significant economic impact on a
substantial number of small entities.
    This rule would affect the following entities, some of which might
be small entities: The owners or operators of vessels intending to
transit or anchor or moor within the Eastern or Western RNA or safety
zone.
    The Eastern and Western RNA and safety zone will not have a
significant economic impact on a substantial number of small entities
for the following reasons. The Eastern and Western RNAs and safety zone
will be of limited size and any closures of the Federal navigation
channel will be of short duration. Mariners that can safely navigate
outside the Federal navigation channel would still be able to transit
through the Western RNA and that portion of the Eastern RNA which does
not encompass the Federal Restricted channel. Before the effective
period of a waterway closure, advanced public notifications may be made
to local mariners through appropriate means, which could include, but
would not be limited to, Local Notice to Mariners, Broadcast Notice to
Mariners, and the Boater Safety Information section of the project Web
site at http://www.newnybridge.com. Individuals may also subscribe for
email updates for the project in the ``contact us'' section of the
project Web site.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

3. Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT,
above.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

4. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

5. Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect 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. We have analyzed this rule under that Order and determined
that this rule does not have implications for federalism.

6. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

7. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such expenditure, we do discuss the effects of this rule elsewhere in
this preamble.

8. Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children From Environmental Health Risks

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
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.

12. Energy Effects

    This action is not a ``significant energy action'' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions that do not
individually or cumulatively have a significant effect on the human
environment. This rule involves restricting vessel movement within a
regulated navigation area and safety zone. This rule is categorically
excluded from further review under paragraph 34(g) of Figure 2-1 of the
Commandant Instruction. An environmental analysis checklist supporting
this determination and a Categorical Exclusion Determination are
available in the docket where indicated under ADDRESSES. We seek any
comments or information that may lead to the discovery of a significant
environmental impact from this rule.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.
    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR Part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. Revise Sec.  165.T01-0174 to read as follows:

Sec.  165.T01-0174  Regulated Navigation Areas and Safety Zone Tappan
Zee Bridge Construction Project, Hudson River; South Nyack and
Tarrytown, NY.

    (a) Regulated Navigation Area Boundaries. The following are
regulated navigation areas:
    (1) Western RNA: all waters bound by the following approximate
positions: 41[deg]04'39.16'' N, 073[deg]55'00.68'' W on the western
shoreline; thence to 41[deg]04'28.34'' N, 073[deg]54'47.18'' W; thence
to 41[deg]04'11.28'' N, 073[deg]54'48.00'' W; thence to
41[deg]03'57.26'' N, 073[deg]54'40.73'' W; thence to 41[deg]03'57.36''
N, 073[deg]54'47.38'' W; thence to 41[deg]03'58.66'' N,
073[deg]54'56.14'' W; thence to 41[deg]04'03.00'' N, 073[deg]55'07.60''
W; thence to a point on the western shoreline at 41[deg]04'06.69'' N,
073[deg]55'14.10'' W; thence northerly along the shoreline to the point
of origin (NAD 83).
    (2) Eastern RNA: all waters bound by the following approximate
positions: 41[deg]04'21.96'' N, 073[deg]52'03.25'' W on the eastern
shoreline; thence to 41[deg]04'26.27'' N, 073[deg]52'19.82'' W; thence
to 41[deg]04'26.53'' N, 073[deg]53'20.07'' W; thence to
41[deg]03'56.92'' N, 073[deg]53'18.84'' W; thence to 41[deg]03'56.69''
N, 073[deg]52'24.75'' W; thence to a point on the eastern shoreline at
41[deg]03'46.91'' N, 073[deg]52'05.89'' W; thence northerly along the
shoreline to the point of origin (NAD 83).
    (b) Safety Zone Boundaries. The following is a Safety Zone: all
waters bound by the following approximate positions: 41[deg]04'59.70''
N, 073[deg]54'45.54'' W; thence to 41[deg]05'00.18'' N,
073[deg]53'21.48'' W; thence to 41[deg]03'09.24'' N, 073[deg]53'16.86''
W; thence to 41[deg]03'07.08'' N, 073[deg]54'14.70'' W; thence to
41[deg]04'11.28'' N, 073[deg]54'48.00'' W; thence to the point of
origin (NAD 83).
    (c) Regulations. (1) The general regulations contained in 33 CFR
165.10, 165.11, and 165.13, 165.20 and 165.23 apply.
    (2) Any vessel transiting through the Western RNA must make a
direct and expeditious passage. No vessel may stop, moor, anchor or
loiter within the RNA at any time unless they are working on the bridge
construction operations.
    (3) Any vessel transiting through the Eastern RNA must make a
direct and expeditious passage. No vessel may stop, moor, anchor or
loiter within the RNA at any time unless they are working on the bridge
construction operations or they are transiting to, or from, the special
anchorage area codified in 33 CFR 110.60(c)(8) located on the eastern
shoreline at Tarrytown, NY and within the boundaries of the RNA.
    (4) Entry and movement within the Eastern RNA or Western RNA is
subject to a ``Slow-No Wake'' speed limit. All vessels may not produce
a wake and may not attain speeds greater than five knots unless a
higher minimum speed is necessary to maintain steerageway. All vessels
must proceed through the Eastern RNA and Western RNA with caution and
operate in such a manner as to produce no wake.
    (5) Entry into, anchoring, loitering, or movement within the Safety
Zone is prohibited unless the vessel is working on the bridge
construction operations or authorized by the Captain of the Port New
York (COTP) or his designated representative.
    (6) All persons and vessels must comply with all orders and
directions from the COTP or the COTP's designated representative. The
``designated representative'' of the COTP is any Coast Guard
commissioned, warrant or petty officer who has been designated by the
COTP to act on the COTP's behalf. The designated representative may be
on a Coast Guard vessel or New York State Police, Westchester County
Police, Rockland County Police, or other designated craft; or may be on
shore and will communicate with vessels via VHF-FM radio or loudhailer.
Members of the Coast Guard Auxiliary may be present to inform vessel
operators of this regulation.
    (7) Upon being hailed by a Coast Guard vessel by siren, radio,
flashing light or other means, the operator of the vessel must proceed
as directed.
    (8) For the purpose of this regulation, the Federal navigation
channel, located in the Eastern RNA is marked by the red and green
navigation lights on the existing Tappan Zee Bridge, and the New NY
Bridge. As the project progresses, the Federal navigation channel will
be intermittently closed, or partially restricted, to all vessel
transits. While the Federal navigation channel is closed, vessels that
can safely navigate outside the Federal navigation channel would still
be able to transit through the Eastern RNA. These closures or partial
restrictions are tentatively scheduled to take place between March 2015
and October 2016. The COTP will cause a notice of the channel closure
or restrictions by appropriate means to the affected segments of the
public. Such means of notification may include, but are not limited to,
Broadcast Notice to Mariners and Local Notice to Mariners.
    (9) Notwithstanding anything contained in this section, the Rules
of the Road (33 CFR part 84--Subchapter E, inland navigational rules)
are still in

effect and must be strictly adhered to at all times.
    (d) Enforcement periods. This regulation will be enforced 24 hours
a day from 5:00 a.m. on July 3, 2014 until 11:59 p.m. on December 31,
2018.
    (1) Notice of suspension of enforcement: If enforcement is
suspended, the COTP will cause a notice of the suspension of
enforcement by appropriate means to the affected segments of the
public. Such means of notification may include, but are not limited to,
Broadcast Notice to Mariners and Local Notice to Mariners. Such
notification will include the date and time that enforcement will be
suspended as well as the date and time that enforcement will resume.
    (2) Violations of this regulation may be reported to the COTP at
718-354-4353 or on VHF-Channel 16.

    Dated: July 3, 2014.
L.L. Fagan,
Rear Admiral, U.S. Coast Guard, Commander, First Coast Guard District.
[FR Doc. 2014-17600 Filed 7-24-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 76, Number 251 (Friday, December 30, 2011)]
[Proposed Rules]
[Pages 82238-82240]
[FR Doc No: 2011-33440]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-0082; FRL-9331-1]

Receipt of Several Pesticide Petitions Filed for Residues of
Pesticide Chemicals in or on Various Commodities

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of filing of petitions and request for comment.

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SUMMARY: This document announces the Agency's receipt of several
initial filings of pesticide petitions 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 January 30, 2012.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number and the pesticide petition number (PP) of interest as shown
in the body of this document, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to the docket ID number and the
pesticide petition number of interest as shown in the body of this
document. EPA's policy is that all comments received will be included
in the docket without change and may be made available on-line at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or
email. The regulations.gov Web site is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an email
comment directly to EPA without going through regulations.gov, your
email address will be automatically captured and included as part of
the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the electronic
docket at http://www.regulations.gov, or, if only available in hard
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of
operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays. The Docket Facility telephone
number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: A contact person, with telephone
number and email address, is listed at the end of each pesticide
petition summary. You may also reach each contact person by mail at
Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, DC 20460-0001.

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.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to

certain entities. If you have any questions regarding the applicability
of this action to a particular entity, consult the person listed at the
end of the pesticide petition summary of interest.

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 submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or 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 action is the agency taking?

    EPA is announcing its receipt of several pesticide petitions filed
under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA),
21 U.S.C. 346a, requesting the establishment or modification of
regulations in 40 CFR part 174 or part 180 for residues of pesticide
chemicals in or on various food commodities. The Agency is taking
public comment on the requests before responding to the petitioners.
EPA is not proposing any particular action at this time. EPA has
determined that the pesticide petitions described in this document
contain the data or information prescribed in FFDCA section 408(d)(2);
however, EPA has not fully evaluated the sufficiency of the submitted
data at this time or whether the data support granting of the pesticide
petitions. After considering the public comments, EPA intends to
evaluate whether and what action may be warranted. Additional data may
be needed before EPA can make a final determination on these pesticide
petitions.
    Pursuant to 40 CFR 180.7(f), a summary of each of the petitions
that are the subject of this document, prepared by the petitioner, is
included in a docket EPA has created for each rulemaking. The docket
for each of the petitions is available on-line at http://www.regulations.gov.
    As specified in FFDCA section 408(d)(3), (21 U.S.C. 346a(d)(3)),
EPA is publishing notice of the petition so that the public has an
opportunity to comment on this request for the establishment or
modification of regulations for residues of pesticides in or on food
commodities. Further information on the petition may be obtained
through the petition summary referenced in this unit.

New Tolerances

    1. PP 0E7789. (EPA-HQ-OPP-2011-0138). Bayer CropScience, 2 T.W.
Alexander Dr., P.O. Box 12014, Research Triangle Park, NC 27709,
requests to establish an import tolerance in 40 CFR part 180 for
residues of the fungicide trifloxystrobin (benzeneacetic acid, (E,E)-
[alpha]-(methoxyimino)-2-[[[[1-[3-(trifluoromethyl) phenyl]
ethylidene]amino]oxy]methyl]-methyl ester) and the free form of its
acid metabolite CGA-321113 ((E,E)-methoxyimino-[2-[1-(3-
trifluoromethyl-phenyl)-ethylideneaminooxymethyl]-phenyl]acetic acid),
in or on imported coffee, bean, green at 0.02 parts per million (ppm).
A practical analytical methodology for detecting and measuring levels
of trifloxystrobin in or on raw agricultural commodities has been
submitted to the Agency. The method is based on crop specific
procedures and determination by gas chromatography with nitrogen-
phosphorus detection. A newer analytical method is available employing
liquid chromatography/tandem mass spectrometry (LC/MS/MS) with an
electrospray interface, operated in a positive ion mode. Contact: Rose
Mary Kearns,<PHONE_NUMBER>, email address<EMAIL_ADDRESS>    2. PP 1F7928. (EPA-HQ-OPP-2011-0962). Dow AgroSciences, LLC., 9330
Zionsville Road, Indianapolis, IN 46268, requests to establish
tolerances in 40 CFR part 180 for combined residues of fluroxypyr 1-
methylheptyl ester [1-methylheptyl ((4-amino-3,5-dichloro-6-fluoro-2-
pyridinyl)oxy)acetate] and its metabolite fluroxypyr [((4-amino-3,5-
dichloro-6-fluoro-2-pyridinyl)oxy)acetic acid] in or on crop group 15
(cereal grains) including: Barley, buckwheat, millet, oats, rye,
teosinte, triticale, and wheat at 0.5 ppm; corn, popcorn, and sorghum
grain at 0.02 ppm; rice and wild rice at 1.5 ppm; rice, bran at 3.0
ppm; crop group 16 including forage, fodder and straw of cereal grains
at 12 ppm; hay of cereal grains at 20 ppm; and stover of cereal grains
at 4 ppm. Adequate enforcement method for the combined residues of
total fluroxypyr is available to enforce the tolerance expression in or
on food. The analytical method uses high performance liquid
chromatography with tandem mass spectrometry (HPLC/MS/MS) with limits
of quantitation (LOQ) of 0.01 ppm. Contact: Bethany Benbow, (703) 347-
8072, email address<EMAIL_ADDRESS>
New Tolerance Exemption

    PP 1E7932. (EPA-HQ-OPP-2011-0975). Clariant Corp., 625 E. Catawba
Ave., Mt. Holly, NC 28120, requests to establish an exemption from the
requirement of a tolerance for residues of 2-Propenoic acid, 2-methyl-,
2-ethylhexyl ester, telomere with 1-dodecanethiol, ethenylbenzene and
2-methyloxirane polymer with oxirane monoether with 1,2-propanediol
mono(2-methyl-2-propenoate), hydrogen 2-sulfobutanedioate, sodium salt,
2,2'-(1,2-diazenediyl)bis[2-methylpropanenitrile]-initiated (CAS

No. 1283712-50-4) under 40 CFR 180.960 when used as a pesticide inert
ingredient in pesticide formulations as a dispersing agent. The
petitioner believes no analytical method is needed because 2-Propenoic
acid, 2-methyl-, 2-ethylhexyl ester, telomere with 1-dodecanethiol,
ethenylbenzene and 2-methyloxirane polymer with oxirane monoether with
1,2-propanediol mono(2-methyl-2-propenoate), hydrogen 2-
sulfobutanedioate, sodium salt, 2,2'-(1,2-diazenediyl)bis[2-
methylpropanenitrile]-initiated is exempt from the requirement of a
tolerance based upon the definition of a low-risk polymer under 40 CFR
723.250. Therefore, an analytical method to determine residues on
treated crops is not relevant. Contact: Alganesh Debesai, (703) 308-
8353, email address<EMAIL_ADDRESS>
List of Subjects

    Environmental protection, Agricultural commodities, Feed additives,
Food additives, Pesticides and pests, Reporting and recordkeeping
requirements.

    Dated: December 21, 2011.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
[FR Doc. 2011-33440 Filed 12-29-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 47 (Friday, March 9, 2018)]
[Notices]
[Pages 10547-10548]
[FR Doc No: 2018-04751]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

Reports, Forms, and Record Keeping Requirements: Agency
Information Collection Activity Under OMB Review

AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.

ACTION: Notice of the OMB review of information collection and
solicitation of public comment.

-----------------------------------------------------------------------

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, this
notice announces that the Information Collection Request (ICR)
abstracted below will be submitted to the Office of Management and
Budget (OMB) for review. The ICR describes the nature of the
information collection and its expected burden. A Federal Register
Notice with a 60-day comment period soliciting public comments on the
following information collection was published on July 27, 2017.

DATES: Submit comments to the Office of Management and Budget (OMB) on
or before April 9, 2018.

FOR FURTHER INFORMATION CONTACT: Randolph Atkins at the National
Highway Traffic Safety Administration, Office of Behavioral Safety
Research (NTI-131), W46-500, Department of Transportation, 1200 New
Jersey Avenue SE, Washington, DC 20590. Dr. Atkins' phone number is
202-366-5597 and his email address is [email protected]

SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2127--New.
    Title: Effectiveness of State Law Enforcement Liaison Programs.
    Form No.: NHTSA Form 1408 and NHTSA Form 1409.
    Type of Review: Regular.
    Respondents: NHTSA proposes to conduct two one-time surveys. The
first survey will include all the State Law Enforcement Liaisons (LELs)
across the country. The second survey will include the LELs'
supervisors from their sponsoring agencies in the 49 States that use
LELs, either State Highway Safety Office (SHSO) or other sponsoring
agency personnel.
    Estimated Number of Respondents: There are approximately 240 State
LELs and 49 staff from the sponsoring agencies that supervise the
LELs--a total of 289 respondents.
    Estimated Time per Response: There are two survey questionnaires of
equal length, one for LELs and one for their supervisors. The average
amount of time for each respondent to complete the on-line information
collection is estimated at 45 minutes. This includes any time needed to
retrieve information.
    Total Estimated Annual Burden Hours: 217 hours.
    Frequency of Collection: The information collection will be
administered a single time.
    Abstract: State Law Enforcement Liaisons (LELs) promote NHTSA's
traffic safety programs and initiatives. The way LELs are organized and
carry out their mission varies widely across States. NHTSA proposes to
collect information from LELs and their State and/or sponsoring
agencies to improve NHTSA's understanding of LEL programs in the United
States and to evaluate the programmatic and cost effectiveness of
existing LEL approaches. The study will use online website-based
surveys designed to identify their program characteristics, costs, and
State-recommended program practices. The following data will be
collected: Number of LELs, program structure and organization, job
description, program objectives, reporting requirements, performance
monitoring practices, program costs, communication networks, reported
usefulness of specific program practices, site and conference
attendance practices, and public outreach activities. Study outcomes
will be used to inform funding agencies and LEL programs about LEL best
practices and what is required to maintain maximum LEL program
effectiveness. The information will support States and other agencies
and organizations in their efforts to reduce and prevent injuries among
the motoring public using traffic safety programs promoted by the LELs.

ADDRESSES: Send comments regarding the burden estimate, including
suggestions for reducing the burden, to the Office of Information and
Regulatory Affairs, Office of Management and Budget, 725 17th Street
NW, Washington, DC 20503, Attention: Desk Officer for Department of
Transportation, National Highway Traffic Safety Administration, or by
email at [email protected], or fax:<PHONE_NUMBER>.
    Comments are Invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department of Transportation, including whether the information
will have practical utility; the accuracy of the Department's estimate
of the burden of the proposed information collection; ways to enhance
the quality, utility and clarity of the information to be collected;
and ways to minimize the burden of the collection of information on
respondents, including

the use of automated collection techniques or other forms of
information technology.
    A comment to OMB is most effective if OMB receives it within 30
days of publication of this notice.

    Authority: 44 U.S.C. Section 3506(c)(2)(A).

    Issued in Washington, DC, on March 6, 2018.
Jeff Michael,
Associate Administrator, Research and Program Development.
[FR Doc. 2018-04751 Filed 3-8-18; 8:45 am]
 BILLING CODE 4910-59-P