[Federal Register Volume 81, Number 180 (Friday, September 16, 2016)]
[Rules and Regulations]
[Pages 63710-63714]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22366]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2013-0237; FRL-9951-08]
Ammonium Persulfate; Exemption From the Requirement of a
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of ammonium persulfate (CAS Reg. No.7727-
54-0) when used as an inert ingredient (preservative) in pesticide
formulations applied to growing crops and raw agricultural commodities
after harvest, etc.) at a concentration not to exceed 0.05% by weight.
Exponent, Inc., on behalf of Becker Underwood, Inc. 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 ammonium persulfate under the
approved conditions.
DATES: This regulation is effective September 16, 2016. Objections and
requests for hearings must be received on or before November 15, 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-2013-0237, 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: Michael Goodis, 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: [email protected].
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-2013-0237 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
November 15, 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-2013-0237, 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 June 5, 2013 (78 FR 33785) (FRL-9386-2),
EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a,
announcing the filing of a pesticide petition (PP 2E8096) by Exponent,
Inc., 1150 Connecticut Ave., Suite 1100, Washington, DC 20036, on
behalf of Becker Underwood, Inc., 801 Dayton Avenue, Ames, IA 50010.
The petition requested that 40 CFR 180.910 be amended by establishing
an exemption from the requirement of a tolerance for residues of
ammonium persulfate (CAS Reg. No. 7727-54-0) when used as an inert
ingredient (preservative) in pesticide formulations applied to growing
crops or raw agricultural commodities after harvest at a concentration
not to exceed 0.05% by weight in pesticide formulations. That document
referenced a summary of the petition prepared by Exponent, Inc., the
[[Page 63711]]
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 tolerance is ``safe.'' Section 408(b)(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 in establishing a tolerance 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 ammonium persulfate including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with ammonium persulfate
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 ammonium persulfate as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies
The acute oral and dermal rat lethal dose (LD)50s are
495 milligram/kilogram body weight (mg/kg bw) and >2,000 mg/kg bw,
respectively. The inhalation lethal concentration (LC)50 for
ammonium persulfate in rats is >2,950 mg/cubic meter (m\3\). It is
irritating to the eyes but not the skin. It is not a dermal sensitizer.
Several subchronic studies were available for review for the
sodium, potassium and ammonium salts of persulfate. In a 28 day oral
(diet) toxicity study in rats, toxicity was manifested as decreased
relative adrenal weight at 600 parts per million (ppm) (82 mg/kg/day).
The NOAEL was 300 ppm; equal to 41 mg/kg/day. In a 3 months oral (diet)
toxicity study in dogs, toxicity was not observed at doses up to 333
mg/kg/day, the highest dose tested. In a toxicity study in rats,
ammonium persulfate was administered via inhalation for 13 weeks then
allowed a 6-week recovery period. Toxicity was manifested as rales,
increased respiratory rate, inflammation of the trachea and bronchi/
bronchioles, decreased body weight, and increased lung weight at 25 mg/
m\3\. The NOAEL was 10.3 mg/m\3\.
The reproductive and developmental toxicity of ammonium persulfate
has been tested in rats. Parental, offspring and reproduction toxicity
was not observed at doses up to 250 mg/kg/day, the highest dose tested.
Available mutagenicity and genotoxicity studies included the Ames
test, gene mutation and chromosomal aberration assays. Ammonium
persulfate produced negative results in all of these studies.
Oral and inhalation studies of the carcinogenic and promoting
potential of ammonium persulfate do not exist; however, the
carcinogenic and promoting potential of ammonium persulfate was tested
in a non-guideline study via the dermal route of exposure. In a tumor
promotion study, mice were treated dermally with ammonium persulfate
biweekly for 51 weeks. In another study, mice were treated topically
with a solution of 200 mg/milliliter (mL) ammonium persulfate for 51
weeks. The incidence of tumors did not increase in either study.
Neurotoxicity and immunotoxicity studies were not available for
review. However, evidence of neurotoxicity and immunotoxicity of
ammonium persulfate was not observed in the submitted studies.
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
[[Page 63712]]
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.
There was no hazard attributable to a single exposure seen in the
toxicity database for ammonium persulfate. Therefore, ammonium
persulfate is not expected to pose an acute risk.
The NOAEL for ammonium persulfate was established at 300 ppm; equal
to 41 mg/kg/day based on the 28-day repeat dose oral toxicity study in
rats based on decreased relative adrenal weight at 600 ppm (82 mg/kg/
day). The chronic risk assessment for ammonium persulfate is based on
this endpoint and the chronic reference dose (cRfD) is 0.41 mg/kg/day.
The additional Food Quality Protection Act (FQPA) uncertainty factor of
3X is applied for use of short-term study for a long-term risk
assessment. EPA concluded that the uncertainty factor of 3X is adequate
because the end point selected for the risk assessment is very
conservative since no effects on absolute adrenal weight was observed;
relative weight could be due to slight decrease in body weight; no
other systemic toxicity was seen at this dose level and there were no
systemic toxicity observed in a 90-day toxicity study in dogs which
considered as long term study. Since the FQPA safety factor (SF) has
been reduced to 3X, the cPAD is 0.14 mg/kg/day. The NOAEL for
inhalation exposure has been established as 10.3 mg/m\3\ (3 mg/kg/day)
based on reversible rales and respiratory rate increases in rats. For
dermal exposures, the NOAEL for ammonium persulfate is based on the
chronic oral NOAEL with an assumption of 100% dermal adsorption.
C. Exposure Assessment
1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to ammonium persulfate, EPA considered exposure under the
proposed exemption from the requirement of a tolerance. EPA assessed
dietary exposures from ammonium persulfate in food as follows:
An acute dietary risk assessment was not conducted because no
endpoint of concern following a single exposure was identified in the
available studies. A chronic dietary exposure assessment was completed
and performed using the Dietary Exposure Evaluation Model DEEM-
FCID\TM\, Version 3.16.which includes food consumption information from
the U.S. Department of Agriculture's National Health and Nutrition
Examination Survey, ``What We Eat In America'', (NHANES/WWEIA). This
dietary survey was conducted from 2003 to 2008. In the absence of
actual residue data, the inert ingredient evaluation is based on a
highly conservative model that assumes that the residue level of the
inert ingredient would be no higher than the highest established
tolerance for an active ingredient on a given commodity. Implicit in
this assumption is that there would be similar rates of degradation
between the active and inert ingredient (if any) and that the
concentration of inert ingredient in the scenarios leading to these
highest of tolerances would be no higher than the concentration of the
active ingredient. The model assumes 100 percent crop treated (PCT) for
all crops and that every food eaten by a person each day has tolerance-
level residues. 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 ammonium persulfate,
a conservative drinking water concentration value of 100 parts per
billion (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).
While there are no current or proposed residential uses for
ammonium persulfate, it is possible that ammonium persulfate may be
used as an inert ingredient in pesticide products for which short-term
and intermediate-term residential exposures may result. In the absence
of specific residential exposure scenarios, risk estimates for
residential exposures to ammonium persulfate can be modeled based on
occupational exposure assessments. Occupational exposure assessments
for ammonium persulfate for occupational mixer/loader/applicator
exposure and occupational post-application exposure for comparable use
scenarios (e.g., low pressure handwand turf application) with only
baseline personal protective equipment result in MOEs of 10,000 or
greater (i.e., exposures are not of concern). Given the larger
treatment areas and higher concentrations used in these occupational
use pesticide products than would be seen in residential uses, MOEs for
residential use scenarios would exceed 1,000 or more and therefore
there are no concerns for residential exposures to ammonium sulfate.
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, 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 ammonium persulfate to share a common mechanism
of toxicity with any other substances, and ammonium persulfate does not
appear to produce a toxic metabolite produced by other substances. For
the purposes of this tolerance action, therefore, EPA has assumed that
ammonium persulfate 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 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 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.
[[Page 63713]]
2. Prenatal and postnatal sensitivity. There is no evidence of
increased susceptibility of infants and children following exposure to
ammonium persulfate. In the reproductive and developmental toxicity
study of ammonium persulfate in rats, parental, offspring and
reproduction toxicity was not observed at doses up to 250 mg/kg/day,
the highest dose tested.
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 3X. That decision is based on the following
findings:
i. The toxicity database for ammonium persulfate is partially
complete. The additional uncertainty FQPA factor of 3X is applied for
use of short-term study for long term risk assessment.
ii. There is no indication that ammonium persulfate is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional UFs to account for neurotoxicity.
iii. There is no evidence that ammonium persulfate results in
increased susceptibility in rats in utero or in young in the
reproductive and developmental screening study.
iv. There is no evidence of any triggers for immunotoxicity in the
available database, therefore there is no need for an immunotoxicity
study at this time or an additional UF factor to account for lack of an
immunotoxicity study.
v. There are no residual uncertainties identified in the exposure
databases. The dietary food exposure assessments were performed based
on 100% CT and tolerance-level residues. EPA made conservative
(protective) assumptions in the ground and surface water modeling used
to assess exposure to ammonium persulfate in drinking water. EPA used
similarly conservative assumptions to assess postapplication exposure
of children as well as incidental oral exposure of toddlers. These
assessments will not underestimate the exposure and risks posed by
ammonium persulfate.
E. Aggregate Risks and Determination of Safety
EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
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,
ammonium persulfate 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
ammonium persulfate from food and water will utilize <1% of the cPAD
for children 1-2 years old, the population group receiving the greatest
exposure.
3. Short- and Intermediate-term risk. A short- & intermediate-term
adverse effect was identified for ammonium persulfate. Short- and
intermediate-term risk is assessed based on short- and intermediate-
term residential exposure plus chronic dietary exposure. While there
are no current or proposed residential uses for ammonium persulfate, it
is possible that ammonium persulfate may be used as an inert ingredient
in pesticide products for which short- and intermediate-term
residential exposures may result. Margins of exposure (MOEs) for short-
and intermediate-term residential use scenarios have been calculated
and exceed 10,000 or more and therefore, since the level of concern is
for MOEs of 300 or less, there are no concerns for residential
exposures to ammonium persulfate.
4. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of mutagenicity and lack of evidence of tumors in the tumor
promoting studies via dermal route, and lack of carcinogenicity for
sulfates and ammonia (break down products), ammonium persulfate is not
expected to pose a cancer risk to humans.
5. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to ammonium persulfate residues.
V. Other Considerations
A. Analytical Enforcement Methodology
Although EPA is establishing a limitation on the amount of ammonium
persulfate that may be used in pesticide formulations, an analytical
enforcement methodology is not necessary for this exemption from the
requirement of tolerance. The 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 for sale or distribution for use on growing
crops with concentrations of ammonium persulfate exceeding 0.05% by
weight of the formulation.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
The Codex has not established a MRL for ammonium persulfate.
VI. Conclusions
Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.910 for ammonium persulfate (CAS Reg. No.
7727-54-0) when used as an inert ingredient (preservative) in pesticide
formulations applied to growing crops and raw agricultural commodities
after harvest at a concentration not to exceed 0.05% by weight.
VII. Statutory and Executive Order Reviews
This action establishes 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
[[Page 63714]]
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
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 tolerance 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: September 1, 2016.
Daniel J. Rosenblatt,
Acting 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 following inert ingredient
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
------------------------------------------------------------------------
* * * * * * *
Ammonium persulfate (CAS Reg.No. 0.05% Preservative
7727-54-0).
* * * * * * *
------------------------------------------------------------------------
[FR Doc. 2016-22366 Filed 9-15-16; 8:45 am]
BILLING CODE 6560-50-P