[Federal Register Volume 81, Number 165 (Thursday, August 25, 2016)]
[Rules and Regulations]
[Pages 58407-58410]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20409]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0811; FRL-9949-03]


Natamycin; 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 natamycin 
[6,11,28-Trioxatricyclo [22.3.1.05'7 ]octacosa-8,14,16,18,20-pentaene-
25-carboxylic acid, 22-[(3-amino-3,6-dideoxy-p-Dmannopyranosyl)oxy]-
1,3,26-trihydroxy-12-methyl-10-oxo-, 
(1R,3S,5R,7R,8E,12R,14E,16E,18E,20E, 22R,24S,25R,26S)-] in or on 
citrus, pome, stone fruit crop groups, avocado, kiwi, mango and 
pomegranates when used in accordance with label directions and good 
agricultural practices. DSM Food Specialties, B.V., P.O. Box 1, 2600 MA 
Delft, The Netherlands (c/o Keller and Heckman, LLP, 1001 G St. NW., 
Washington, DC 20001) 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 natamycin in or 
on citrus, pome, stone fruit crop groups, avocado, kiwi, mango and 
pomegranate when used in accordance with label directions and good 
agricultural practices.

DATES: This regulation is effective August 25, 2016. Objections and 
requests for hearings must be received on or before October 24, 2016, 
and must be filed in accordance with the instructions provided in 40 
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2015-0811, 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: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2015-0811 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 
October 24, 2016. Addresses for mail and hand delivery of objections 
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2015-0811 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 April 25, 2016 (81 FR 24044) (FRL-9944-
86), 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 5F8407) by Keller and Heckman, LLP, 1001 G St. NW., 
Washington, DC 2001 on behalf of

[[Page 58408]]

DSM Food Specialties, B.V., P.O. Box 1, 2600 MA Delft, The Netherlands. 
The petition requested that 40 CFR part 180 be amended by establishing 
an exemption from the requirement of a tolerance for residues of 
natamycin in or on citrus, pome, stone fruit crop groups, avocado, 
kiwi, mango, and pomegranates, when used in facilities as a post-
harvest fungistat to control certain fungal diseases. That document 
referenced a summary of the petition prepared by the petitioner, DSM 
Food Specialties, which is available in the docket, 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. 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 Natamycin

    Natamycin is a naturally occurring compound derived from the common 
soil microorganisms Streptomyces natalensis, Streptomyces lydicus, and 
Streptomyces chattanoogensis. Natamycin was originally discovered in 
Streptomyces natalensis in South Africa in the early 1950s, and was 
subsequently discovered to also occur naturally in North America in 
Streptomyces lydicus and Streptomyces chattanoogensis. It is 
commercially produced by a submerged oxygen-based fermentation of 
Streptomyces natalensis, Streptomyces lydicus, or Streptomyces 
chattanoogensis. Natamycin has been used as a food preservative 
worldwide for over 40 years and is approved as a food additive/
preservative by the European Union, the World Health Organization, and 
individual countries including New Zealand and Australia for use as a 
fungistat to suppress mold on cheese, meats and sausage. In the United 
States, natamycin is approved by the Food and Drug Administration (FDA) 
as a direct food additive/preservative for the inhibition of mold and 
yeast on the surface of cheeses (21 CFR 172.155) and as an additive to 
the feed and drinking water of broiler chickens to retard the growth of 
specific molds (21 CFR 573.685). Natamycin is also FDA approved for use 
as a treatment to suppress fungal eye infections such as blepharitis, 
conjunctivitis, and keratitis.
    As a biochemical pesticide active ingredient, natamycin is already 
approved for use as a fungistat to prevent and control the germination 
of mold and yeast spores in the growth media of mushrooms produced in 
enclosed mushroom production facilities (77 FR 29543), and to control 
fungal growth post-harvest on pineapples treated indoors (79 FR 75068). 
Natamycin has a non-toxic mode of action, has no effects on fungal 
mycelia, and development of antibiotic resistance to natamycin has not 
been reported during its entire history of use. See the document 
entitled, ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations 
for Natamycin'' (June 16, 2016), available in the docket for this 
action.

B. Biochemical Pesticide Toxicology Data Requirements

    All applicable mammalian toxicology data requirements supporting 
the petition to amend the existing tolerance exemption by adding use as 
a fungicide post-harvest, indoors, on citrus, pome, stone fruit crop 
groups, avocado, kiwi, mango, and pomegranates have been fulfilled. No 
toxic endpoints were established, and no significant toxicological 
effects were observed in any of the acute toxicity studies. In 
addition, studies submitted indicate that natamycin is not genotoxic, 
has no subchronic toxic effects, and is not a developmental toxicant. 
There are no known effects on endocrine systems via 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 Natamycin'' (June 16, 2016). This document, 
as well as other relevant information, is available in the docket for 
this action as described under ADDRESSES.

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

    The proposed use patterns may results in dietary exposure to 
natamycin, however, exposure is expected to be insignificant (see 
document entitled, ``Federal Food, Drug, and Cosmetic Act (FFDCA) 
Considerations for Natamycin'' (June 16, 2016), available in the docket 
for this action. No significant exposure via drinking water is 
expected; natamycin is applied indoors only. Some dietary exposure to 
natamycin might occur through other nonpesticidal sources as a result 
of its use as a food additive/preservative. Should exposure occur, 
however, minimal to no risk is expected for the general population, 
including infants and children, due to the low toxicity of natamycin as 
demonstrated in the data submitted and evaluated by the Agency, as 
fully explained in the document entitled, ``Federal Food, Drug, and 
Cosmetic Act (FFDCA)

[[Page 58409]]

Considerations for Natamycin'' (June 16, 2016), available in the docket 
for this action.

B. Other Non-Occupational Exposure

    Other non-occupational exposure (other than dietary) from 
pesticidal use is not expected because natamycin is not approved for 
residential uses. The active ingredient is applied directly to 
commodities and degrades rapidly. There may be some exposure to 
natamycin as a result of its use as treatment of infections, but 
minimal to no risk is expected for the general population, including 
infants and children, due to the low toxicity of natamycin as 
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 Natamycin'' (June 16, 2016), 
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 natamycin to share a common mechanism of toxicity 
with any other substances, and natamycin does not appear to produce a 
toxic metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that natamycin 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 susceptibly 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 for natamycin and considered it 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, as fully explained in the document 
entitled, ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations 
for Natamycin'' (June 16, 2016), available in the docket for this 
action. Based upon its evaluation, EPA concludes that there are no 
threshold effects of concern to infants, children, or adults when 
natamycin is applied to mushrooms, in enclosed mushroom production 
facilities, and on pineapples, citrus, pome, stone fruit crop groups, 
avocado, kiwi, mango and pomegranates when used in accordance with 
label directions and good agricultural practices. As a result, EPA 
concludes that no additional margin of exposure (safety) is necessary.

VII. Other Considerations

    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. Further, residues are not 
expected on any other crops because natamycin will only be applied 
indoors to these particular crops.

VIII. Conclusions

    Based on its assessment of natamycin, 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 
natamycin. Therefore, an amendment to the exemption of a tolerance is 
established for residues of natamycin in or on citrus, pome, stone 
fruit crop groups, avocado, kiwi, mango and pomegranates.
    The Agency is issuing the exemption for residues of natamycin in or 
on citrus, pome, stone fruit crop groups, avocado, kiwi, mango and 
pomegranates instead of limiting this exemption to post-harvest indoor 
applications to citrus, pome, stone fruit crop groups, avocado, kiwi, 
mango and pomegranates because the restrictions are not relevant to the 
FFDCA safety finding for natamycin. Those limitations are related to 
the use of the pesticide and regulated under FIFRA.

IX. Statutory and Executive Order Reviews

    This final rule 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 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

[[Page 58410]]

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 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: July 19, 2016.
Robert C. McNally,
Director, Biopesticides and Pollution Prevention 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. Revise Sec.  180.1315 to read as follows:


Sec.  180.1315  Natamycin; exemption from the requirement of a 
tolerance.

    An exemption from the requirement of a tolerance is established for 
the residues of natamycin in or on mushrooms, pineapples, citrus, pome, 
stone fruit crop groups, avocado, kiwi, mango, and pomegranates when 
used in accordance with label directions and good agricultural 
practices.

[FR Doc. 2016-20409 Filed 8-24-16; 8:45 am]
BILLING CODE 6560-50-P