Document ID: EPA-HQ-OPP-2011-1033-0003
Agency: epa
Document Type: Rule
Title: Tolerance Exemptions: 1,3-dibromo-5,5-dimethylhydantoin
Posted Date: 2017-12-05T05:00Z

[Federal Register Volume 82, Number 232 (Tuesday, December 5, 2017)]
[Rules and Regulations]
[Pages 57367-57370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-25842]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2011-1033; FRL-9968-30]

1,3-dibromo-5,5-dimethylhydantoin; 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 1,3-dibromo-5,5-dimethylhydantoin in or 
on food when used in antimicrobial pesticide formulations applied to 
food contact surfaces in public eating places, dairy processing 
equipment, and/or food processing equipment and utensils. In addition, 
this regulation establishes an exemption from the requirement of a 
tolerance for residues of 1,3-dibromo-5,5-dimethylhydantoin when used 
as an antimicrobial pesticide treatment solution. Albemarle Corporation 
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic 
Act (FFDCA), requesting exemptions from the requirement of a tolerance 
for residues of 1,3-dibromo-5,5-dimethylhydantoin in end-use products 
applied to food contact surfaces and used for washing raw agricultural 
commodities. This regulation eliminates the need to establish a maximum 
permissible level of residues of 1,3-dibromo-5,5-dimethylhydantoin 
resulting from uses consistent with the terms of these exemptions.

DATES: This regulation is effective December 5, 2017. Objections and 
requests for hearings must be received on or before February 5, 2018, 
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-2011-1033, 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: Steven H. Weiss, Antimicrobials 
Division (7510P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; main telephone number: (703) 308-6411; 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), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers; greenhouse, nursery, and floriculture workers; 
ranchers; pesticide applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers; greenhouse, 
nursery, and floriculture workers; residential users.

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. To access the OSCPP test guidelines referenced in this 
document electronically, please go to http://www.epa.gov/ocspp and 
select ``Test Methods and Guidelines.''

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-2011-1033 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 5, 2018. 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-2011-1033, by one of 
the following methods:

[[Page 57368]]

     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. Summary of Petitioned-For Exemption

    In the Federal Register of March 14, 2012 (77 FR 15012) (FRL-9335-
9), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance 
petition (PP 1F7914) by Albemarle Corporation, 451 Florida Street, 
Baton Rouge, LA 70801. The petition requested that 40 CFR 180.940(a) be 
amended by establishing an exemption from the requirement of a 
tolerance for residues of the antimicrobial 1,3-dibromo-5,5-
dimethylhydantoin resulting from the use of this antimicrobial in food 
contact surface sanitizing solutions applied to food contact surfaces 
in public eating places, dairy processing equipment, and food-
processing equipment and utensils at concentrations not to exceed 500 
parts per million (ppm) of total bromine. The petition also requested 
establishment of an exemption from the requirement of a tolerance for 
residues of the antimicrobial 1,3-dibromo-5,5-dimethylhydantoin in or 
on all raw agricultural commodities resulting from the use of 1,3-
dibromo-5,5-dimethylhydantoin as an antimicrobial treatment in 
solutions containing a diluted end-use concentration of all bromide-
producing chemicals in the solution not to exceed 900 ppm of total 
bromine. That document referenced a summary of the petition prepared by 
Albemarle Corporation, 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. 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. Pursuant to FFDCA section 408(c)(2)(B), in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
FFDCA section 408(b)(2)(C), which 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 . . 
. .''
    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 1,3-dibromo-5,5-
dimethylhydantoin including exposure resulting from the exemption 
established by this action. EPA's assessment of exposures and risks 
associated with 1,3-dibromo-5,5-dimethylhydantoin follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
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.
    Exposures to 1,3-dibromo-5,5-dimethylhydantoin (DBDMH) only occur 
during the mixing of the treatment solution. These exposures would only 
be associated with the occupational handling/applying when pouring and 
mixing with water. When mixed with water, DBDMH rapidly hydrolyzes to 
5,5-dimethylhydantion (DMH). DMH is stable in water and is the residue 
available for dietary exposure.
    Most of the toxicology studies submitted to the Agency in support 
of registration of DBDMH were conducted on DMH (including subchronic 
oral toxicity in the rat and dog; subchronic dermal toxicity in the 
rat; chronic toxicity in the dog; combined chronic/oncogenicity in the 
rat and mouse; oncogenicity in the mouse; developmental toxicity in the 
rat and rabbit; 2-generation reproductive toxicity in the rat; 
genotoxicity battery; and general metabolism in the rat). These studies 
generally show lack of systemic toxicity up to the limit dose. No 
specific target organs were identified in adult animals tested. No 
developmental or maternal toxicity was observed. There was no evidence 
of carcinogenicity. There is also no indication of neurotoxicity or 
immunotoxicity in the database.
    The formation of the bromide ion is also present during the 
degradation of DBDMH. Based on available data, the Agency has 
previously determined that bromine does not present adverse systemic 
effects and therefore no endpoints were identified. See Bromine Final 
Registration Review Decision, Case 4015, which is document number 10 in 
docket number EPA-HQ-OPP-2009-0167, in www.regulations.gov. Based on 
its previous assessment, which remains valid, the Agency has determined 
that there are no risks of concern from exposures to bromine.
    Specific information on the studies received from the toxicity 
studies can be found at http://www.regulations.gov in document 1,3-
dibromo-5,5-dimethylhydantoin (DBDMH), Human health and ecological risk 
assessment for the new use as a Fruit and Vegetable Wash and Food 
Contact Surface Sanitizer in docket ID number EPA-HQ-OPP-2011-1033.

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

[[Page 57369]]

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 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.
    The Agency did not identify any toxicological points of departure 
because the available data indicate a lack of toxicity for DBDMH and 
its degradates (DMH and the bromide ion).

C. Exposure Assessment

    1. Dietary exposure from food uses and drinking water. Based on the 
use patterns for DBDMH, residues of the degradate DMH may be present in 
or on food as a result of exposure to the substance in treatment 
solutions or on treated food contact surfaces. DMH residues are 
unlikely to be in drinking water because the product is intended to be 
used in treatment solutions in RAC treatment facilities and on food 
contact surfaces in public eating places or processing. Nevertheless, 
because of the lack of toxicological endpoints, quantitative dietary 
food and drinking water exposure and risk assessments were not 
conducted.
    2. 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). 1,3-
dibromo-5,5-dimethylhydantoin is not registered for use on any sites 
that would result in residential exposure. Further information 
regarding EPA standard assumptions and generic inputs for residential 
exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    3. 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 1,3-dibromo-5,5-dimethylhydantoin to share a 
common mechanism of toxicity with any other substances, and 1,3-
dibromo-5,5-dimethylhydantoin does not appear to produce a toxic 
metabolite produced by other substances. Based on the lack of toxicity 
for DBDMH and its metabolites and degradates, therefore, EPA concludes 
that 1,3-dibromo-5,5-dimethylhydantoin 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 chemical, see 
EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    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 
(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.
    There are adequate pre- and/or post-natal toxicity studies for DMH 
that show no qualitative or quantitative susceptibility from exposure 
to DMH. As a result, the Agency has conducted a qualitative assessment 
in which safety factors were not relevant. Moreover, because of the 
lack of any threshold effects, the requirement to retain an additional 
10X safety factor does not apply.

E. Aggregate Risks and Determination of Safety

    Based on the toxicological profile of DBDMH, EPA concludes that 
exposures to the antimicrobial 1,3-dibromo-5,5-dimethylhydantoin will 
not pose a risk under reasonably foreseeable circumstances. In order to 
use this substance as antimicrobial treatment in process water and as a 
food contact surface sanitizer, the substance must be mixed with water, 
necessarily resulting in the conversion of DMDBH into DMH and bromine, 
for which the Agency has not identified any toxicological endpoints of 
concern. Therefore, the Agency concludes that reasonably foreseeable 
uses of this substance are safe. Accordingly, EPA finds that there is a 
reasonable certainty of no harm will result to the general population, 
or to infants and children from aggregate exposure to 1,3-dibromo-5,5-
dimethylhydantoin residues.

IV. 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. Revisions to Petitioned-For Exemption

    Although the petitioner requested exemptions for residues of 1,3-
dibromo-5,5-dimethylhydantoin with limitations on the amount of DBDMH 
in sanitizing and antimicrobial treatment solutions, EPA is 
establishing exemptions, without the requested limitations, for 
residues of 1,3-dibromo-5,5-dimethylhydantoin, because of the lack of 
toxicity of DMDBH and its metabolites and degradates.

V. Conclusion

    Therefore, exemptions from the requirement of a tolerance are 
established for residues of 1,3-dibromo-5,5-dimethylhydantoin as 
follows: When used in food contact surface sanitizing solutions applied 
to food contact surfaces in public eating places, dairy-processing 
equipment, and food-processing equipment and utensils and when used as 
an antimicrobial treatment in solutions applied to raw agricultural 
commodities in treatment facilities.

VI. Statutory and Executive Order Reviews

    This action establishes exemptions from 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

[[Page 57370]]

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).

VII. 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: November 15, 2017.
Steven Weiss,
Acting Director, Antimicrobials 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, add alphabetically the pesticide chemical ``1,3-
dibromo-5,5-dimethylhydantoin'' to the table in paragraph (a) 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) * * *

------------------------------------------------------------------------
                                         CAS Reg.
          Pesticide chemical                No.            Limits
------------------------------------------------------------------------
 
                                * * * * *
1,3-dibromo-5,5-dimethylhydantoin.....    77-48-5   None.
 
                                * * * * *
------------------------------------------------------------------------

0
3. Add Sec.  180.1346 to subpart D to read as follows:

Sec.  180.1346  1,3-Dibromo-5,5-Dimethylhydantoin; exemption from the 
requirement of a tolerance.

    Residues of 1,3-dibromo-5,5-dimethylhydantoin, including its 
metabolites and degradates, resulting from the use of 1,3-dibromo-5,5-
dimethylhydantoin in antimicrobial treatment solutions of raw 
agricultural commodities in treatment facilities are exempt from the 
requirement of a tolerance.

[FR Doc. 2017-25842 Filed 12-4-17; 8:45 am]
 BILLING CODE 6560-50-P