Document ID: EPA-HQ-OPP-2014-0374-0066
Agency: epa
Document Type: Rule
Title: Exemption from the Requirement of a Tolerance: Potassium Salts of Hops Beta Acids
Posted Date: 2015-10-21T04:00Z

[Federal Register Volume 80, Number 203 (Wednesday, October 21, 2015)]
[Rules and Regulations]
[Pages 63680-63683]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-26600]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0374; FRL-9933-73]

Potassium Salts of Hops Beta Acids; 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 the biochemical pesticide potassium 
salts of hops beta acids in or on honey and honeycomb for the control 
of Varroa mites in accordance with label directions and good 
agricultural practices. Interregional Research Project Number 4, on 
behalf of Beta Tec Hop Products, Inc., submitted a petition to EPA 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an 
exemption from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of potassium salts of hops beta acids in or on honey and 
honeycomb.

DATES: This regulation is effective October 21, 2015. Objections and 
requests for hearings must be received on or before December 21, 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-2014-0374, 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: Robert McNally, Biopesticides and 
Pollution Prevention Division (7511P), Office of Pesticide Programs, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, DC 20460-0001; main telephone number: (703) 305-7090; email 
address: BPPDFRNotices@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-2014-0374 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 21, 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-2014-0374, 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. Background and Statutory Findings

    In the Federal Register of September 5, 2014 (79 FR 53009) (FRL-
9914-98), 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 3E8217) by Interregional Research Project Number 4, 500 
College Road East, Suite 201W, Princeton, NJ 08540, on behalf of 
BetaTec Hop Products, Inc. (the

[[Page 63681]]

petitioner). The petition requested that 40 CFR part 180 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of potassium salts of hop beta acids (K-HBAs) in or on honey 
and honeycomb resulting from the control of Varroa mites. That document 
referenced a summary of the petition prepared by the petitioner, which 
is available in the docket, http://www.regulations.gov. There were 63 
comments received in response to the batched notice of filing but none 
were relevant to the establishment of a tolerance for potassium salts 
of hops beta acids.
    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 require 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. . . 
.'' Additionally, EPA is required to take into account the factors set 
forth in FFDCA section 408(b)(2)(D).
    EPA performs a number of analyses to determine the risks from 
aggregate exposure to pesticide residues. First, EPA determines the 
toxicity of pesticides. Second, EPA examines exposure to the pesticide 
through food, drinking water, and through other exposures that occur as 
a result of pesticide use in residential settings.

III. Toxicological Profile

    Consistent with FFDCA section 408(b)(2)(D), EPA has reviewed the 
available scientific data and other relevant information in support of 
this action and considered its validity, completeness and reliability, 
and the relationship of this information 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.

A. Overview of Potassium Salts of Hops Beta Acids

    K-HBAs are derived from the resin components of the cones of female 
hop plants Humulus lupulus. The three major components of K-HBAs are 
Lupulone (30-55% with an isopropyl side chain), Colupulone (20-55% with 
an isobutyl side chain), and Adlupulone (5-10% with a secbutyl side 
chain); the components differ only in the R-side chain attached. K-HBA 
is classified as a biochemical pesticide because it is naturally 
occurring (found in Humulus lupulus plant), has a non-toxic mode of 
action against the target pest, and has a history of exposure to humans 
and the environment demonstrating minimal toxicity. There is a long 
history of safe use of HBAs via the oral and dietary exposure to humans 
from its use as a preservative on meats (estimated range 4.4 
milligrams/kilograms (mg/kg) of cooked meat--5.5 mg/kg of frankfurter) 
and its presence in the beer brewing process. Due to its long history 
of exposure, K-HBAs are considered to be generally recognized as safe 
(GRAS) by FDA.

B. Biochemical Pesticide Toxicology Data Requirements

    All applicable mammalian toxicology data requirements supporting 
the petition to establish an exemption from the requirement of a 
tolerance for the use of potassium salts of hops beta acids as an 
active ingredient for use to control Varroa mites in or on honey and 
honeycomb have been fulfilled. No significant toxicological effects 
were observed in the acute toxicity study or other information from the 
literature that was used to address the toxicity data requirements. For 
the Tier I subchronic toxicity studies, data and information from 
scientific literature were used in support of acceptable rationales to 
address the data requirements, focusing on the long history of exposure 
to K-HBAs in food preservation and in the production of beer, which is 
commonly consumed in the United States. K-HBAs are not structurally-
related to known mutagens, nor are they in a chemical class known to 
contain a known mutagen. Further, from the available toxicity 
information, there were no systemic effects of potassium salts of hops 
beta acids via the oral, dermal, or inhalation routes of exposure. For 
a summary of the data upon which EPA relied, and its human health risk 
assessment based on that data, please refer to the document entitled, 
``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for 
Potassium Salts of Hops Beta acids'' (July 15, 2015), available in the 
docket for this action.

IV. Aggregate Exposures

    In examining aggregate exposure, FFDCA section 408 directs EPA to 
consider available information concerning exposures from the pesticide 
residue in food and all other non-occupational exposures, including 
drinking water from ground water or surface water and exposure through 
pesticide use in gardens, lawns, or buildings (residential and other 
indoor uses).

A. Dietary Exposure

    Human dietary exposure through food to residues of K-HBAs already 
occurs via its use as a preservative in meats and its natural presence 
in beer brewing production. EPA does not expect much residue of 
potassium salts of hops beta acids in honey from its use as a pesticide 
in hives based on residue studies. In three different studies conducted 
over 3 years, only one honey sample from one honey super was shown to 
have residues of hops beta acids (0.44 part per million (ppm)), and the 
residue level was only slightly above the analytical limits of 
detection (0.41 ppm) and well below the Limit of Quantitation (1.2 
ppm).
    No significant exposure via drinking water is expected from its use 
as an active ingredient as a pesticide. K-HBAs are non-volatile and are 
expected to degrade rapidly, with 100% degradation in 36 hours in the 
light and 4 days in the dark. Furthermore, as an insecticide, K-HBAs 
are formulated into a viscous liquid and coated on fiber strips which 
are placed inside the beehive such that the product is not sprayed or 
applied in any way that it would be expected to contact any source of 
drinking water.
    Should exposure occur, however, minimal to no risk is expected for 
the general population, including infants and children, due to the long 
history of dietary exposure to K-HBAs.

B. Other Non-Occupational Exposure

    Non-occupational exposure to potasium salts of hops beta acids is 
not expected because potassium salts of hops beta acids is formulated 
into a viscous liquid and coated on fiber strips which are placed 
inside the beehive. There are no residential proposed uses. However, 
minimal to no risk is expected for the general population, including 
infants and children, due to the minimal toxicity of this chemical as

[[Page 63682]]

demonstrated in the data submitted and evaluated by the Agency, as 
fully explained in the document entitled, ``Federal Food, Drug, and 
Cosmetic Act (FFDCA) Considerations for Potassium Salts of Hops Beta 
acids'' (July 15, 2015), available in the docket for this action.

V. 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 potassium salts of hops beta acids to share a 
common mechanism of toxicity with any other substances, and potassium 
salts of hops beta acids does not appear to produce a toxic metabolite 
produced by other substances. For the purposes of this tolerance 
action, therefore, EPA has assumed that potassium salts of hops beta 
acids 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.

VI. Determination of Safety for U.S. Population, Infants and Children

    FFDCA section 408(b)(2)(C) provides that, in considering the 
establishment of a tolerance or tolerance exemption for a pesticide 
chemical residue, EPA shall assess the available information about 
consumption patterns among infants and children, special susceptibility 
of infants and children to pesticide chemical residues, and the 
cumulative effects on infants and children of the residues and other 
substances with a common mechanism of toxicity. In addition, FFDCA 
section 408(b)(2)(C) 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 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. In applying 
this provision, EPA either retains the default value of 10X, or uses a 
different additional or no safety factor when reliable data are 
available to support a different additional or no safety factor.
    As part of its qualitative assessment, EPA evaluated the available 
toxicity and exposure data on potassium salts of hops beta acids and 
considered its validity, completeness, and reliability, as well as the 
relationship of this information to human risk. EPA considers the 
toxicity database to be complete and has identified no residual 
uncertainty with regard to prenatal and postnatal toxicity or exposure. 
No hazard was identified based on the available studies; therefore, EPA 
concludes that there are no threshold effects of concern to infants, 
children, or adults from potassium salts of hops beta acids. As a 
result, EPA concludes that no additional margin of exposure (safety) is 
necessary.

 VII. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes 
because EPA is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

VIII. Conclusion

    Based on its assessment of potassium salts of hops beta acids, 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 potassium salts of hops beta acids. EPA is therefore 
establishing an exemption from the requirement of a tolerance for 
residues of potassium salts of hops beta acids for the control of 
Varroa mites in or on honey and honeycomb, in accordance with label 
directions and good agricultural practices.

IX. Statutory and Executive Order Reviews

    This final rule establishes an exemption from the requirement of a 
tolerance under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, 
October 4, 1993). Because this final rule has been exempted from review 
under Executive Order 12866, this final rule 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 final rule 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 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 final rule 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 final rule. In addition, 
this final rule does not impose any enforceable duty or contain any 
unfunded mandate as described under Title II of the Unfunded Mandates 
Reform Act of 1995 (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 of 1995 (NTTAA) (15 U.S.C. 272 note).

X. 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).

[[Page 63683]]

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 29, 2015.
Jack E. Housenger,
Director, 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. Add section 180.1333 to subpart D to read as follows:

Sec.  180.1333  Potassium Salts of Hops Beta acids; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues of the biochemical potassium salts of hops beta acids in or on 
honey and honeycomb, when used for the control of Varroa mites in 
accordance with label directions and good agricultural practices.

[FR Doc. 2015-26600 Filed 10-20-15; 8:45 am]
 BILLING CODE 6560-50-P