Natamycin; Amendment to an Exemption From the Requirement of a Tolerance, 75065-75068 [2014-29306]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 79, Number 242 (Wednesday, December 17, 2014)]
[Rules and Regulations]
[Pages 75065-75068]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29306]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0352; FRL-9919-35]


Natamycin; Amendment to an 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 in 
or on pineapples. DSM Food Specialties B.V. submitted a petition to EPA 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an 
amendment to the 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 pineapple.

DATES: This regulation is effective December 17, 2014. Objections and 
requests for hearings must be received on or before February 17, 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-2014-0352, is available at https://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 https://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,

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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 https://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 https://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-2014-0352 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 17, 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-2014-0352, by one of 
the following methods:
     Federal eRulemaking Portal: https://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 https://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at https://www.epa.gov/dockets.

II. Background and Statutory Findings

    In the Federal Register of August 1, 2014 (79 FR 44729) (FRL-9911-
67), 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 4F8233) by DSM Food Specialties B.V. (the Petitioner), 
Alexander Fleminglaan 1, 2613 AX 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 for post-
harvest indoor use on pineapples. That document referenced a summary of 
the petition prepared by the Petitioner, which is available in the 
docket, https://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

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Drug Administration (FDA) as a direct food additive/preservative for 
the inhibition of mold and yeast on the surface of cheeses (21CFR 
172.155) and as an additive to the feed and drinking water of broiler 
chickens to retard the growth of specific molds (21CFR 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). Additional 
potential uses of natamycin include controlling fungal growth post-
harvest on pineapples treated indoors. 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'' (November 7, 
2014), 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 pineapples 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'' (November 7, 2014). 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'' (November 7, 2014), 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) Considerations for Natamycin'' (November 7, 2014), 
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'' (November 7, 2014), 
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 https://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 (FQPA SF). 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 natamycin 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, as fully explained in the document 
entitled, ``Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations 
for Natamycin'' (November 7, 2014), 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

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enclosed mushroom production facilities and on pineapples 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. 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. Further, residues are not 
expected on any other crops because natamycin will only be applied 
indoors to these particular crops.

VIII. Conclusion

    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 pineapple.
    The Agency is issuing the exemption for residues on pineapple 
instead of limiting this exemption to post-harvest indoor applications 
to pineapple 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 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).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: December 1, 2014.
Robert 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 
residues of natamycin in or on mushrooms when applied as a fungistat to 
prevent the germination of fungal spores on mushrooms produced in 
enclosed mushroom production facilities, and in or on pineapples when 
applied as a fungistat in accordance with label directions and good 
agricultural practices.

[FR Doc. 2014-29306 Filed 12-16-14; 8:45 am]
BILLING CODE 6560-50-P