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[Federal Register Volume 80, Number 200 (Friday, October 16, 2015)]
[Rules and Regulations]
[Pages 62462-62466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26297]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0363; FRL-9933-98]

2-Propen-1-Aminium, N,N-Dimethyl-N-Propenyl-, Chloride, 
Homopolymer; 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

[[Page 62463]]

tolerance for residues of 2-propen-1-aminium, N,N-dimethyl-N-propenyl-, 
chloride, homopolymer (PolyDADMAC, CAS No. 26062-79-3) when used as an 
inert ingredient under 40 CFR 180.940(a) as a dispersing aid in food 
contact surface sanitizing solutions at less than 0.6% by weight in the 
final product. Scientific & Regulatory Solutions, L.L.C., on behalf of 
SNF, 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 PolyDADMAC.

DATES: This regulation is effective October 16, 2015. Objections and 
requests for hearings must be received on or before December 15, 2015, 
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-2015-0363, 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-2015-0363 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 
December 15, 2015. 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-2015-0363, 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 July 17, 2015 (80 FR 42462) (FRL-9929-
13), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-10750) by 
Scientific & Regulatory Solutions, L.L.C., 3450 Old Washington Rd #303, 
Waldorf, MD 20602 on behalf of SNF, Inc., 1 Chemical Plant Road, 
Riceboro, GA 31321. The petition requested that 40 CFR 180.940(a) be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of PolyDADMAC, (CAS No. 26062-79-3) when used as 
an inert ingredient as a dispersing aid in pesticide formulations at 
less than 0.6% by weight. That document referenced a summary of the 
petition prepared by Scientific & Regulatory Solutions, L.L.C., on 
behalf of SNF, Inc., 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.''

[[Page 62464]]

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 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 PolyDADMAC including exposure 
resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with PolyDADMAC 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 PolyDADMAC 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.
    A single dose feeding study with rats classified PolyDADMAC as 
``slightly toxic'' at a dose level of 5 milliliter/kilogram (mL/kg) 
(approx. 2,000 milligram/kilogram (mg/kg)). The results of two skin 
irritation studies performed with rabbits indicate that PolyDADMAC is 
not a skin irritant. In two eye irritation studies performed with 
PolyDADMAC on rabbits, the results indicate that the product was 
slightly irritating to the eyes and that the effects were totally 
reversed within 72 hours following exposure. In an eye study performed 
with PolyDADMAC on cultured fibroblasts, the results indicate that 
PolyDADMAC is slightly irritating. In a teratology study performed with 
Sprague-Dawley rats, the administration of 600 milligram/kilogram/day 
(mg/kg/day) of PolyDADMAC, and to a lesser extent, at the 450 and 150 
mg/kg/day test groups, elicited a significant reduction in maternal 
food consumption during the first half of the dosing period. The NOAEL 
for PolyDADMAC on embryonic development is 600 mg/kg/day. A multi-
generational study performed with PolyDADMAC using Sprague-Dawley rats 
dosed with 0.375, 12.5, and 125 mg/kg/day (oral gavage) showed no 
increase in reproductive failure, nor were there any effects upon the 
fertility index or any other F1 or F2 generation parameters. The 
inferred NOAEL from the study was 125 mg/kg/day. The two genotoxicity 
studies performed with PolyDADMAC were negative in both an Ames test 
and in a mouse micronucleus assay. There are no carcinogenicity studies 
available for PolyDADMAC. However, no significant systemic toxicity was 
observed in the teratology, multi-generational and mutagenicity 
toxicity studies. In the absence of significant systemic toxicity, and 
lack of mutagenicity concerns, PolyDADMAC is not likely to be 
carcinogenic.

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 the NOAEL and the LOAEL are identified. 
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.
    PolyDADMAC is a large molecular weight chemical which satisfies all 
of the TSCA Polymer Exemption Rule except for its cationic properties. 
Generally, high molecular weight polymers are unlikely to be absorbed 
significantly through any route of exposure. In the case of PolyDADMAC, 
this is evidenced by: No systemic toxicity up to 600 mg/kg/day in the 
teratology study, no systemic toxicity in the multi-generational 
reproduction study up to 125 mg/kg/day, and low acute toxicity. 
Therefore, no adverse effect level endpoints have been selected for 
PolyDADMAC, and EPA concludes that it is not necessary to assess 
quantitative dietary risk or risk from exposure via dermal or 
inhalation.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to PolyDADMAC, EPA considered exposure under the proposed 
exemption from the requirement of a tolerance. EPA assessed dietary 
exposures from PolyDADMAC 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 as well as food contact surface 
sanitation uses. In the case of PolyDADMAC, there are no current or 
proposed crop pesticidal uses; therefore oral exposures from that route 
(including exposure through drinking water) are not expected. Dietary 
exposure to PolyDADMAC can occur through its use in food contact 
sanitizing solutions. However, PolyDADMAC is a large molecular weight 
chemical which is unlikely to be absorbed significantly through any 
route of exposure and no endpoints have been

[[Page 62465]]

selected for it. The Agency has not identified any concerns for 
carcinogenicity relating to PolyDADMAC; therefore, a cancer dietary 
exposure assessment was not performed.
    2. Dietary exposure from drinking water. PolyDADMAC residues may be 
found in drinking water. However, since an endpoint of concern was not 
identified for the dietary assessment (food and drinking water), a 
quantitative dietary exposure risk assessment was not conducted.
    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 
PolyDADMAC, it is possible that PolyDADMAC may be used as an inert 
ingredient in pesticide products for which residential exposures may 
result. However, in the case of PolyDADMAC no applicable endpoints of 
concern for residential exposures have been identified and a 
quantitative exposure assessment from residential exposures was not 
performed.
    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 PolyDADMAC to share a common mechanism of 
toxicity with any other substances, and PolyDADMAC does not appear to 
produce a toxic metabolite produced by other substances. For the 
purposes of this tolerance action, therefore, EPA has assumed that 
PolyDADMAC 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 Food Quality 
Protection Act Safety Factor (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.
    2. Prenatal and postnatal sensitivity. Teratology and multi-
generational studies in laboratory animals indicate that PolyDADMAC 
caused no increase in reproductive failure nor were there any 
PolyDADMAC related effects upon the fertility index or any other F1 or 
F2 generation parameters (e.g., litter size, pup weight, fertility and 
parturition, reproductive indices such as mating index, fecundity 
index, male or female fertility indices, etc.). Finally, there was no 
remarkable pathology noted upon necropsy of any of the test animals. 
Neurotoxicity was not observed in a reproduction/developmental 
screening study in rats where neurotoxicity parameters were evaluated.
    3. Conclusion. Based on an assessment of PolyDADMAC, EPA has 
concluded that there are no toxicological endpoints of concern for the 
U.S. population, including infants and children, and has conducted a 
qualitative assessment. 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.

E. Aggregate Risks and Determination of Safety

    Determination of safety section. 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.
    Based on the lack of any endpoints of concern, 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 
PolyDADMAC residues.

V. Other Considerations

A. 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.

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 Nation 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 PolyDADMAC.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.940(a) for PolyDADMAC (CAS No. 26062-79-3) 
when used as an inert ingredient as a dispersing aid in food contact 
surface sanitizing solutions at less than 0.6% by weight in the final 
product.

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 Children from Environmental Health Risks and Safety 
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any 
information collections

[[Page 62466]]

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: October 7, 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.  180.940(a), add alphabetically the inert ingredient ``2-
propen-1-aminium, N,N-dimethyl-N-propenyl-, chloride, homopolymer (CAS 
No. 26062-79-3)'' to the table to read as follows:

Sec.  180.940  Tolerance exemptions for active and inert ingredients 
for use in antimicrobial formulations (Food-contact surface sanitizing 
solutions).

* * * * *
    (a) * * *

------------------------------------------------------------------------
       Pesticide chemical         CAS Reg. No.            Limits
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                              * * * * * * *
------------------------------------------------------------------------
2-propen-1-aminium, N,N-             26062-79-3  When ready for use, the
 dimethyl-N-propenyl-,                            end-use concentration
 chloride, homopolymer.                           is not to exceed 0.6%.
------------------------------------------------------------------------
 
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[FR Doc. 2015-26297 Filed 10-15-15; 8:45 am]
BILLING CODE 6560-50-P
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