[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)]
[Rules and Regulations]
[Pages 7616-7619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03671]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0314; FRL-9972-04]


Methyl-alpha-D-mannopyranoside (Alpha Methyl Mannoside); 
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 methyl-alpha-D-
mannopyranoside (alpha methyl mannoside) in or on all raw agricultural 
commodities when applied/used as a plant growth regulator. BRANDT 
iHammer 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 alpha methyl mannoside.

DATES: This regulation is effective February 22, 2018. Objections and 
requests for hearings must be received on or before April 23, 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-2017-0314, 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. To access the OCSPP 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-2017-0314 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 
April 23, 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-2017-0314, 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.

[[Page 7617]]

     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 December 4, 2017 (82 FR 57193) (FRL-
9970-76), 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 6F8506) by BRANDT iHammer, 479 Village Park Drive, Powell 
OH, 43065. The petition requested that 40 CFR part 180 be amended by 
establishing an exemption from the requirement of a tolerance for 
residues of alpha methyl mannoside. That document referenced a summary 
of the petition prepared by the petitioner, BRANDT iHammer, which is 
available in the docket, EPA-HQ-OPP-2017-0314, at http://www.regulations.gov. There were no comments received in response to the 
notice of filing.
    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, FFDCA section 408(b)(2)(D) requires that 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 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. Given that no 
toxic endpoints were identified for alpha methyl mannoside, 
consideration of the variability of the sensitivities of major 
identifiable subgroups of consumers, including infants and children is 
not necessary for this biochemical pesticide.

A. Overview of Methyl-alpha-D-mannopyranoside (alpha methyl mannoside)

    Methyl-alpha-D-mannopyranoside (alpha methyl mannoside) is a 
naturally occurring monosaccharide (simple sugar), that is ubiquitous 
in plant tissue in the form of mannose polymers. Alpha methyl mannoside 
exposure occurs naturally via diet from the breakdown of mannose 
polymers present in a variety of plant-based foods, with the highest 
concentrations found in guar gum, a common food additive of thickening 
and texture in baked goods, dairy items, meats and condiments, and in 
coffee. Alpha methyl mannoside appears to have a low toxicity profile 
and is not mutagenic. Alpha methyl mannoside has been recently found to 
regulate plant growth by modulating glycoconjugation to lectins in 
plants. As a pesticide, alpha methyl mannoside appears to stimulates 
the growth and development of a range of crops including vegetables 
(leafy, Brassica leafy, cucurbit, fruiting), alfalfa, blueberries, 
cherries, corn, cotton, grapes, onions, peanuts, potatoes, sweet 
potatoes, and nonfood crops such as bedding plants cut flowers, 
ornamentals, and turf. Submitted information/data show that when 
applied to the root, shoot or seed of targeted plants, alpha methyl 
mannoside functions by displacing glucose bond to lectin. The data/
information further show that release of glucose in the plant results 
in increased plant growth including increased yields of fruit, flower 
growth and turgidity in turf. In pesticide products, proposed 
application of alpha methyl mannoside is at rates ranging from 6 to 20 
fl. oz. per acre for food crops and 0.1 to 1.13% for nonfood crops. At 
these rates, the use of alpha methyl mannoside should not likely result 
in significant residues, environmental persistence or bioaccumulation.

B. Biochemical Pesticide Toxicology Data Review for Methyl-alpha-D-
mannopyranoside

    All applicable toxicology data requirements supporting the petition 
to establish an exemption from the requirement of a tolerance for the 
use of alpha methyl mannoside as an active ingredient in or on food 
commodities, when used in accordance with label direction and good 
agricultural practices, have been fulfilled. Based on the submitted 
data and the results of the Agency-developed dietary exposure modeling 
database DEEM-FCID (version 3.16), dietary exposure to alpha methyl 
mannoside is not anticipated and there are no human health risks of 
concern associated with alpha methyl mannoside. Acute studies on alpha 
methyl mannoside show that this naturally occurring monosaccharide 
falls within Toxicology Category IV for: Acute oral toxicity, Acute 
dermal toxicity, Primary eye irritation, and Primary dermal irritation. 
Alpha methyl mannoside is not a dermal sensitizer. Waivers were granted 
for subchronic toxicology studies including the 90-day Dermal study, 
90-day Inhalation study and Developmental toxicity study. For a more 
detailed summary of the data upon which EPA relied, please refer to the 
document entitled, ``Federal Food, Drug, and Cosmetic Act (FFDCA) 
Considerations for Methyl-alpha-D-mannopyranoside (Alpha Methyl 
Mannoside)'' December 5, 2017, available in the docket for this action 
(EPA-HQ-OPP-2017-0314).

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

    An aggregate risk assessment for alpha methyl mannoside for dietary 
(food and drinking water) exposures was not

[[Page 7618]]

conducted as no toxicological endpoints have been identified in the 
toxicity database.

B. Other Non-Occupational Exposure

    Other non-occupational exposure to alpha methyl mannoside from 
pesticidal use is not expected to occur as alpha methyl mannoside 
biodegrades rapidly once applied which would preclude significant post-
application exposure. Exposure is further minimized by the relatively 
low application rates proposed for this biochemical. There are no 
residential uses for Methyl-alpha-D-mannopyranoside. This biochemical 
is intended for agricultural, ornamental and turf crop use only. 
Therefore, the Agency does not anticipate residential exposure.

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 pesticide's residues and ``other substances that have a common 
mechanism of toxicity.''
    EPA has not found alpha methyl mannoside to share a common 
mechanism of toxicity with any other substances, and alpha methyl 
mannoside does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has assumed that alpha methyl mannoside 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 website 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 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 alpha methyl mannoside 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 
in the available studies; therefore, EPA concludes that there are no 
threshold effects of concern to infants, children, or adults from alpha 
methyl mannoside. As a result, EPA concludes that no additional margin 
of exposure (safety) is necessary.

VII. 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 Nations 
Food and Agriculture Organization/World Health Organization food 
standards program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level.
    The Codex has not established a MRL for alpha methyl mannoside.

VIII. Conclusions

    Based on its assessment of Methyl-alpha-D-mannopyranoside (alpha 
methyl mannoside or alpha methyl mannoside), 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 
alpha methyl mannoside. Therefore, an exemption is established for 
residues of alpha methyl mannoside on all raw agricultural commodities 
when used in accordance with label directions and good agricultural 
practices.

IX. 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 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

[[Page 7619]]

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).

X. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA has submitted 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: February 2, 2018.
Richard P. Keigwin, Jr.,
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 Sec.  180.1352 to subpart D to read as follows:


Sec.  180.1352  Methyl-alpha-D-mannopyranoside (Alpha methyl 
mannoside); exemption from the requirement of a tolerance.

    Residues of the biochemical pesticide Methyl-alpha-D-
mannopyranoside (alpha methyl mannoside) are exempt from the 
requirement of a tolerance in or on all raw agricultural commodities.

[FR Doc. 2018-03671 Filed 2-21-18; 8:45 am]
 BILLING CODE 6560-50-P