80 FR 79705 - Ammonium Acetate; Exemption From the Requirement of a Tolerance

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 246 (December 23, 2015)

This regulation establishes an exemption from the requirement of a tolerance for residues of ammonium acetate (CAS No. 631-61-8) when used as an inert ingredient (buffering agent) limited to 15% in pesticide formulations applied to pre-harvested crops. Exponent Inc., 1150 Connecticut Ave., Suite 1100, Washington, DC 20036 on behalf of the Gowan Company LLC., 370 South Main Street, Yuma, AZ 85364 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 acetate.

[Federal Register Volume 80, Number 246 (Wednesday, December 23, 2015)]
[Rules and Regulations]
[Pages 79705-79708]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-32170]


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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2013-0700; FRL-9939-39]


Ammonium Acetate; 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 acetate (CAS No. 631-61-8) when 
used as an inert ingredient (buffering agent) limited to 15% in 
pesticide formulations applied to pre-harvested crops. Exponent Inc., 
1150 Connecticut Ave., Suite 1100, Washington, DC 20036 on behalf of 
the Gowan Company LLC., 370 South Main Street, Yuma, AZ 85364 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 acetate.

DATES: This regulation is effective December 23, 2015. Objections and 
requests for hearings must be received on or before February 22, 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-2013-0700, 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), 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-2013-0700 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 
February 22, 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-2013-0700, 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 December 30, 2013 (78 FR79359) (FRL-
9903-69), EPA issued a document pursuant to FFDCA section 408, 21 
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
10604) by Exponent Inc., 1150 Connecticut Ave., Suite 1100, Washington, 
DC 20036, on behalf of the Gowan Company LLC., 370 South Main Street, 
Yuma, AZ 85364. The petition requested that 40 CFR 180.920 be amended 
by establishing an exemption from the requirement of a tolerance for 
residues of ammonium acetate (CAS No. 631-61-8) when used as an inert 
ingredient in pesticide formulations applied to crops pre-harvest and 
limited to 15% in pesticide formulations. That document referenced a 
summary of the petition prepared by Exponent Inc., on behalf of the 
Gowan Company LLC, the petitioner, which is available in the docket, 
http://www.regulations.gov. No comments were received on the notice of 
filing. EPA's response to these comments is discussed in Unit V.C.

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

[[Page 79706]]

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 acetate including 
exposure resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with ammonium acetate 
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 acetate as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies.
    Ammonium acetate is an ammonium salt of acetic acid. In aqueous 
solutions acetic acid and its salt ammonium acetate dissociate into the 
acetate anion (CH3COO-) and the respective cations (H+ and NH4+). The 
cations and ammonia (also a human metabolite) are physiological 
components of the human body. The chemical structures, physical-
chemical properties, environmental fate behavior, and aquatic and 
mammalian toxicity of ammonium acetate and acetic acid are similar. 
Since limited data are available on ammonium acetate, toxicity data on 
acetic acid were used to represent toxicity due to exposure to ammonium 
acetate.
    Acetic acid is of low acute dermal and inhalation toxicity in rats. 
It causes dermal irritation in mice and is corrosive in rabbits. It was 
also irritating in the eyes of rabbits. Although reduced body weight 
was observed at 390 mg/kg/day in a 90-day oral toxicity study in the 
rat, the reduction in weight gain was likely attributed to reduced 
appetite and food consumption observed in the study. Therefore, this is 
not considered an adverse effect. Although increased spleen weight was 
observed at 23-31 ppm (equivalent to 15-19 mg/kg/day) of acetic acid in 
a toxicity study in rats via the inhalation route of exposure, there is 
no concern for potential immunotoxicity. The Agency considers that this 
effect is due to red blood cell destruction rather than an immunotoxic 
response. Fetal susceptibility was not observed in several 
developmental studies in rats, mice and rabbits. Neither maternal nor 
developmental toxicity was not observed up to 1,600 mg/kg/day. It is 
not mutagenic in an Ames test nor is it clastogenic in a cytogenetic 
assay with Chinese hamster ovary K1 cells. It is not carcinogenic. In 
an eight month cancer study, tumors were not observed in rats at 60 mg/
kg/day. While evidence of potential neurotoxicity was observed in a 
literature study in rats conducted by Sapute et al.\1\, a second study 
in rats showed no indication of systemic toxicity, neurotoxicity, 
neuropathological or histological lesions at the same dose that was 
previously tested, 100 mg/kg/day. Since the second study (MRID 
49703201) \2\ was conducted according to the Organization for Economic 
Co-operation and Development (OECD) and good laboratory practice (GLP) 
guidelines, it was considered to accurately represent the neurotoxic 
potential for ammonium acetate.
---------------------------------------------------------------------------

    \1\ Satpute, R.M., Lomash, V., Hariharakrishnan, J., Roa, P., 
Singh, P., Gujar, N., and Bhattacharya, R. (2014). Oxidative Stress 
and Tissue Pathology Caused By Subacute Exposure To Ammonium Acetate 
In Rats And Their Response To Treatments With Alpha-Ketoglutarate 
And N-Acetyl Cysteine. Toxicology and Industrial Health: 30(1) 12-
14. MRID. 49507001.
    \2\ Barnett, Jr., John F. (2015). A 28-Day Oral (Gavage) 
Repeated Dose Study of Ammonium Acetate in Adult Rats. Laboratory 
Project ID 20073669. Unpublished study prepared by Charles River 
Laboratories. MRID 49703201.
---------------------------------------------------------------------------

    As noted above, acetic acid undergoes dissociation to the acetate 
anion and the H+ cations in aqueous media at pHs commonly found in the 
environment. Also, it is a naturally-occurring substance in plants and 
animals. In aerobic metabolism, acetic acid (as acetate) is a 
metabolite that combines with Co-enzyme A to form acetyl Co-A which 
subsequently enters into the Citric Acid Cycle, a common metabolic 
pathway in which food molecules are broken down to form energy. A major 
function of the Citric Acid Cycle is the oxidation of acetate. In 
animals, acetate is obtained from the breakdown of glucose molecules.
    Specific information on the studies received and the nature of the 
adverse effects caused by acetic acid as well as the no observed 
adverse effect level (NOAEL) and the lowest observed adverse effect 
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document ``Ammonium Acetate; Human Health 
Risk Assessment and Ecological Effects Assessment to Support Proposed 
Exemption from the Requirement of a Tolerance When Used as Inert 
Ingredients in Pesticide Formulations'' in docket ID number EPA-HQ-OPP-
2013-0700.

[[Page 79707]]

B. Toxicological Points of Departure/Levels of Concern

    In an aqueous environment, ammonium acetate dissociates to acetic 
acid and its salt. Therefore, it is appropriate to expect toxicity due 
to exposure to ammonium acetate to be similar to that of acetic acid. 
Therefore, based on the absence of a toxicological endpoint of concern 
via dietary route of exposure for acetic acid, its regulatory history, 
and no new toxicological data to indicate concern regarding previous 
decisions, a qualitative assessment was appropriate for ammonium 
acetate for all pathways of human exposure (food, drinking water, and 
residential). A potential endpoint of concern for the inhalation route 
of exposure was identified in a toxicity study. Increased spleen weight 
due to red blood cell destruction was observed at 23-31 ppm (equivalent 
to 15-19 mg/kg/day) of acetic acid in rats. However, according to the 
American Conference of Governmental Industrial Hygenists, Inc. (ACGIH), 
the threshold limit value (TLV) for occupational exposure to acetic 
acid is 10 ppm via inhalation. Residential exposure to the proposed use 
of ammonium acetate via inhalation is not expected to exceed the TLV 
limit of 10 ppm because the residential use pattern would result in 
drastically lower opportunities for inhalation exposure than allowed 
occupational use patterns, which are limited to 10 ppm. In addition, 
residential exposure will be much lower because exposure is expected to 
occur for shorter periods to diluted acetic acid as compared to workers 
who are exposed for 8 hours continuously, to more concentrated acetic 
acid. Therefore, a qualitative assessment was conducted with regard to 
inhalation exposure.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to ammonium acetate, EPA considered exposure under the 
proposed exemption from the requirement of a tolerance. EPA assessed 
dietary exposures from ammonium acetate in food as follows:
    Under this exemption from the requirement of a tolerance, residues 
of this ammonium acetate may be found on foods from crops that were 
treated with pesticide formulations containing ammonium acetate. 
However, a quantitative dietary exposure assessment was not conducted 
since an endpoint for risk assessment was not identified.
    2. Dietary exposure from drinking water. Since a hazard endpoint of 
concern was not identified for the acute and chronic dietary 
assessment, a quantitative dietary exposure risk assessment for 
drinking water was not conducted, although exposures may be expected 
from use on food crops.
    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).
    Ammonium acetate may be used in pesticide products and non-
pesticide products that may be used around the home. Based on the 
discussion in Unit IV.B., a quantitative residential exposure 
assessment for ammonium acetate was not conducted.
    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 acetate to share a common mechanism of 
toxicity with any other substances, and ammonium acetate 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 acetate 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 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.
    As part of its qualitative assessment, the Agency did not use 
safety factors for assessing risk, and no additional safety factor is 
needed for assessing risk to infants and children. Based on an 
assessment of ammonium acetate and its chemical properties, EPA has 
concluded that there are no toxicological endpoints of concern for the 
U.S. population, including infants and children.

E. Aggregate Risks and Determination of Safety

    Because no toxicological endpoints of concern were identified, EPA 
concludes that aggregate exposure to residues of ammonium acetate will 
not pose a risk to the U.S. population, including infants and children, 
and 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 acetate 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. EPA is establishing a limitation on the amount of ammonium 
acetate that may be used in pesticide formulations. 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 formulation used on 
crops for sale or distribution containing ammonium acetate at ready for 
use end-use concentrations exceeding 15%.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.920 for ammonium acetate (CAS No. 631-61-
8) when used as an inert ingredient (buffering agent) in pesticide 
formulations applied to crops pre-harvest and limited to 15% in the end 
use formulation.

VII. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption 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

[[Page 79708]]

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 
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 
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: December 11, 2015.
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.  180.920, add alphabetically the following inert ingredient 
to the table to read as follows:


Sec.  180.920  Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

* * * * *

------------------------------------------------------------------------
         Inert ingredients              Limits              Uses
------------------------------------------------------------------------
 
                              * * * * * * *
Ammonium acetate (CAS No. 631-61-              15%  Buffering Agent.
 8).
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2015-32170 Filed 12-22-15; 8:45 am]
 BILLING CODE 6560-50-P