Document ID: EPA-HQ-OPP-2015-0019-0003
Agency: epa
Document Type: Rule
Title: Exemption from the Requirement of a Tolerance: Salicylaldehyde
Posted Date: 2016-03-30T04:00Z

[Federal Register Volume 81, Number 61 (Wednesday, March 30, 2016)]
[Rules and Regulations]
[Pages 17611-17615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07085]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0019; FRL-9944-12]

Salicylaldehyde; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of salicylaldehyde (2-hydroxybenzaldehyde, 
CAS Reg. No. 90-02-8) when used as an inert ingredient (penetration 
aid) in pesticide formulations applied to growing crops and raw 
agricultural commodities under 40 CFR 180.910 at a concentration not to 
exceed 14% by weight of the pesticide formulation. Ag-Chem Consulting 
LLC, on behalf of Omex Agrifluids submitted a petition to EPA under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment 
of an exemption from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of salicylaldehyde.

DATES: This regulation is effective March 30, 2016. Objections and 
requests for hearings must be received on or before May 31, 2016, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2015-0019, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone 
number: (703) 305-7090; email address: RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2015-0019 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
May 31, 2016. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-

[[Page 17612]]

2015-0019, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html. Additional 
instructions on commenting or visiting the docket, along with more 
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of April 6, 2015 (80 FR 18327) (FRL-9924-
00), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-10777) by 
Ag-Chem Consulting LLC, 12208 Quinque Lane, Clifton, VA 20124 on behalf 
of Omex Agrifluids, 24730 Avenue 13, Madera, CA 93637. The petition 
requested that 40 CFR 180.910 be amended by establishing an exemption 
from the requirement of a tolerance for residues of salicylaldehyde 
(CAS Reg. No. 90-02-8) when used as an inert ingredient (penetration 
aid) in pesticide formulations applied to growing crops or to raw 
agricultural commodities after harvest at a concentration not to exceed 
14% by weight of the pesticide formulation. That document referenced a 
summary of the petition prepared by Ag-Chem Consulting LLC, on behalf 
of Omex Agrifluids, the petitioner, which is available in the docket, 
http://www.regulations.gov. There were no comments received in response 
to the notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to 
give special consideration to exposure of infants and children to the 
pesticide chemical residue and to ``ensure that there is a reasonable 
certainty that no harm will result to infants and children from 
aggregate exposure to the pesticide chemical residue . . . .''
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings. If EPA 
is able to determine that a finite tolerance is not necessary to ensure 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the inert ingredient, an exemption from the 
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors 
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for salicylaldehyde including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with salicylaldehyde 
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the adverse effects caused by salicylaldehyde as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in this 
unit.
    The acute oral toxicity of salicylaldehyde was examined in male 
rats and mice. The general oral lethal amount of salicylaldehyde is 
estimated to be 500 mg/kg in mice. The dermal LD50 for 
salicylaldehyde was determined to be greater than 23,000 mg/kg. Dermal 
irritation studies found salicylaldehyde to be irritating, with eschar 
formation and scarring 14 days after administration.
    No adverse effects attributable to a single exposure to 
salicylaldehyde were seen in the toxicity databases. In a combined 
repeated dose toxicity study with the reproduction/developmental 
toxicity screening test, toxicity was not observed in parental animals 
nor in reproductive parameters at doses up to 160 mg/kg/day, the 
highest dose tested. Fetal susceptibility was observed. Reduced 
bodyweight and offspring mortality after 4 days of nursing were 
observed at 160 mg/kg/day. The NOAEL was 40 mg/kg/day. There was no 
evidence of neurotoxicity or immunotoxicity in the combined repeated 
dose toxicity with the reproduction/developmental toxicity screening 
test.
    Salicylaldehyde was negative for mutagenicity in the Ames test and 
gave a positive response in the chromosome aberrations test using 
Chinese hamster cells (in vitro). An in vivo micronucleus assay was 
negative. Since the in vivo study is more reliable than the in vitro 
assays, the weight of evidence suggests that salicylaldehyde is 
unlikely to be mutagenic.
    There are no cancer studies available for salicylaldehyde. 
According to a DEREK (Nexus) (structural activity relationship) report, 
there are no structural alerts for carcinogenicity.

[[Page 17613]]

Based on predicted rapid metabolism and excretion, lack of specific 
target organ toxicity in the repeat dose toxicity study, lack of 
mutagenicity concerns, and lack of any structural alerts for 
carcinogenicity, salicylaldehyde is not expected to be carcinogenic to 
humans at anticipated dietary concentrations.
    The metabolism of salicylaldehyde in rabbits demonstrated that 75% 
of single dose of salicylaldehyde was excreted in the urine as 
glucuronic acid and sulfate conjugates of vanillic acid.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    No acute toxicological endpoint of concern has been identified for 
salicylaldehyde. On the basis of the repeated dose and reproductive/
developmental toxicity screening study, a no observed adverse effect 
level (NOAEL) for offspring toxicity for salicylaldehyde was 40 mg/kg 
bw/day based on reduced body weight and increased mortality in pups at 
160 mg/kg/day. The standard 10X factors for intra- and inter-species 
were applied in establishing he chronic reference dose (cRfD) of 0.4 
mg/kg/day (40 mg/kg/day/100). Based on the reduced FQPA Safety Factor 
for salicylaldehyde of 1X, the chronic population adjusted dose (cPAD) 
is equivalent to the chronic reference dose (cRfD) at 0.4 mg/kg//day. 
The chronic oral NOAEL is also applicable to the short- and 
intermediate-term dermal and inhalation exposure routes.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to salicylaldehyde, EPA considered exposure under the proposed 
exemption from the requirement of a tolerance. EPA assessed dietary 
exposures from salicylaldehyde in food as follows:
    Acute dietary assessments take into account exposure estimates from 
dietary consumption of food and drinking water. Chronic dietary 
assessments take into account dietary food and drinking water. The 
Agency assessed the dietary exposures to salicylaldehyde as an inert 
ingredient used in pesticide formulations applied to growing crops and 
livestock.
    No adverse effects attributable to a single exposure to 
salicylaldehyde were seen in the toxicity databases; therefore, an 
acute dietary risk assessment is not appropriate.
    In conducting the chronic dietary exposure assessment to 
salicylaldehyde an inert ingredient used in pesticide formulations 
applied to growing crops, raw agricultural commodities, and livestock, 
the Dietary Exposure Evaluation Model/Food Commodity Intake Database 
(DEEM-FCID) TM, Version 3.16 was used. EPA used food consumption 
information from the U.S. Department of Agriculture's National Health 
and Nutrition Examination Survey, What We Eat in America, (USDA/NHANES/
WWEIA). This dietary survey was conducted from 2003 to 2008. As to 
residue levels in food, no residue data were submitted for 
salicylaldehyde. In the absence of specific residue data, EPA has 
developed an approach that uses surrogate information to derive upper 
bound exposure estimates for the subject inert ingredient. Upper bound 
exposure estimates are based on the highest tolerance for a given 
commodity from a list of high-use insecticides, herbicides, and 
fungicides. A complete description of the general approach taken to 
assess inert ingredient risks in the absence of residue data is 
contained in the memorandum entitled ``Alkyl Amines Polyalkoxylates 
(Cluster 4): Acute and Chronic Aggregate (Food and Drinking Water) 
Dietary Exposure and Risk Assessments for the Inerts.'' (D361707, S. 
Piper, 2/25/09) and can be found at http://www.regulations.gov in 
docket ID number EPA-HQ-OPP-2008-0738.
    2. Dietary exposure from drinking water. For the purpose of the 
screening level dietary risk assessment to support this request for an 
exemption from the requirement of a tolerance for salicylaldehyde, a 
conservative drinking water concentration value of 100 ppb based on 
screening level modeling was used to assess the contribution to 
drinking water for the chronic dietary risk assessments for parent 
compound. These values were directly entered into the dietary exposure 
model.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., textiles (clothing and diapers), carpets, swimming 
pools, and hard surface disinfection on walls, floors, tables).
    There are no current or proposed residential uses for 
salicylaldehyde; however, it is possible that salicylaldehyde may be 
used as an inert ingredient in pesticide products. A highly 
conservative residential exposure assessment was performed in which it 
was assumed that all residential use pesticide products would contain 
salicylaldehyde as an inert ingredient. A complete description of the 
approach used to assess possible residential exposures from 
salicylaldehyde can be found in http://www.regulations.gov in document 
``Salicylaldehyde; Human Health Risk Assessment and Ecological Effects 
Assessment to Support Proposed Exemption from the Requirement of a 
Tolerance When Used as an Inert Ingredient in Pesticide Formulations,'' 
pp. 15 in docket ID number EPA-HQ-OPP-2015-0019.
    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance or 
exemption from a tolerance, the Agency consider ``available 
information'' concerning the cumulative effects of a particular 
pesticide's residues and ``other substances that have a common 
mechanism of toxicity.''
    EPA has not found salicylaldehyde to share a common mechanism of 
toxicity with any other substances, and salicylaldehyde does not appear 
to produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
salicylaldehyde does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's Web site at

[[Page 17614]]

http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA 
shall apply an additional tenfold (10X) margin of safety for infants 
and children in the case of threshold effects to account for prenatal 
and postnatal toxicity and the completeness of the database on toxicity 
and exposure unless EPA determines based on reliable data that a 
different margin of safety will be safe for infants and children. This 
additional margin of safety is commonly referred to as the FQPA Safety 
Factor (SF). In applying this provision, EPA either retains the default 
value of 10X, or uses a different additional safety factor when 
reliable data available to EPA support the choice of a different 
factor.
    2. Prenatal and postnatal sensitivity. There is evidence of 
increased susceptibility of infants and children due to exposure to 
salicylaldehyde. In a combined repeated dose toxicity study with the 
reproduction/developmental toxicity screening test, offspring toxicity 
was manifested as decreased body weights and increased mortality in the 
absence of maternal toxicity at doses up to 160 mg/kg/day. The 
offspring toxicity NOAEL was 40 mg/kg/day. However, there are no to low 
concerns for this susceptibility since there is a clear, well defined 
offspring toxicity NOAEL and this study is being used to establish the 
cRfD.
    3. Conclusion. EPA has determined that reliable data show the 
safety of infants and children would be adequately protected if the 
FQPA SF were reduced to 1X. That decision is based on the following 
findings:
    i. The toxicity database for salicylaldehyde includes the battery 
of acute studies, mutagenicity studies and a combined repeated dose 
toxicity study with the reproduction/developmental toxicity screening 
test.
    ii. There is no evidence of neurotoxicity in the available studies, 
therefore there is no need for a developmental neurotoxicity study.
    iii. There is no evidence of immunotoxicity in the available 
database, therefore there is no need for an immunotoxicity study.
    iv. There are low to no concerns for the increased susceptibility 
seen in the combined repeated dose toxicity study with the 
reproduction/developmental toxicity screening test.
    v. There are no residual uncertainties identified in the exposure 
databases. The dietary food exposure assessments were performed based 
on 14% by weight in the formulation (the maximum allowable use rate) 
and tolerance-level residues.
    EPA made conservative (protective) assumptions in the ground and 
surface water modeling used to assess exposure to salicylaldehyde in 
drinking water. EPA used similarly conservative assumptions to assess 
post application exposure of children as well as incidental oral 
exposure of toddlers. These assessments will not underestimate the 
exposure and risks posed by salicylaldehyde.

E. Aggregate Risks and Determination of Safety

    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
salicylaldehyde is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
salicylaldehyde from food and water will utilize 13% of the cPAD for 
the U.S. population and 49% of the cPAD for children 1-2 years old, the 
population group receiving the greatest exposure.
    3. Short- and intermediate-term risk. Short- and intermediate-term 
aggregate exposure takes into account short-term residential exposure 
plus chronic exposure to food and water (considered to be a background 
exposure level).
    Salicylaldehyde may be used as inert ingredients in pesticide 
products that could result in short-term residential exposure and the 
Agency has determined that it is appropriate to aggregate chronic 
exposure through food and water with short-term residential exposures 
to salicylaldehyde. Using the exposure assumptions described in this 
unit, EPA has concluded the combined short- and intermediate-term food, 
water, and residential exposures result in short- and intermediate-term 
aggregate MOEs of 430 for adults and 170 for children (1-2 years old). 
Because EPA's level of concern for salicylaldehyde is a MOE of 100 or 
below, these MOEs are not of concern.
    4. Aggregate cancer risk for U.S. population. Based on a DEREK 
structural alert analysis and the lack of mutagenicity, salicylaldehyde 
not expected to pose a cancer risk to humans.
    5. Determination of safety section. Based on these risk 
assessments, EPA concludes that there is reasonable certainty that no 
harm will result to the general population, or to infants and children 
from aggregate exposure to salicylaldehyde residues.

V. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation. EPA is establishing a 
limitation on the amount of salicylaldehyde that may be used in 
pesticide formulations applied to growing crops. That limitation will 
be enforced through the pesticide registration process under the 
Federal Insecticide, Fungicide, and Rodenticide Act (``FIFRA''), 7 
U.S.C. 136 et seq. EPA will not register any pesticide formulation for 
use on growing crops for sale or distribution that exceed 14% of 
salicylaldehyde.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.910 for residues salicylaldehyde (CAS Reg. 
No. 90-02-8) when used as an inert ingredient (penetration aid) in 
pesticide formulations applied to growing crops and raw agricultural 
commodities after harvest at a concentration not to exceed crops at no 
more than 14% by weight of the pesticide formulation.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a 
tolerance under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, 
October 4, 1993). Because this action has been exempted from review 
under Executive Order 12866, this action is not subject to Executive 
Order 13211, entitled ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997). This action does not contain any information 
collections subject to OMB approval under the Paperwork Reduction Act 
(PRA) (44 U.S.C. 3501 et seq.), nor does it require any special 
considerations under Executive Order 12898, entitled ``Federal Actions 
to Address Environmental Justice in Minority Populations and Low-Income

[[Page 17615]]

Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the exemption in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the national government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: March 22, 2016.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.910, add alphabetically the inert ingredient 
``Salicylaldehyde'' to the table to read as follows:

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

----------------------------------------------------------------------------------------------------------------
           Inert ingredients                          Limits                              Uses
---------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Salicylaldehyde (CAS Reg. No. 90-02-8).  Not to exceed 14% by weight of   Penetration aid.....................
                                          pesticide formulation.
 
                                                  * * * * * * *
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[FR Doc. 2016-07085 Filed 3-29-16; 8:45 a.m.]
 BILLING CODE 6560-50-P