Document ID: EPA-HQ-OPP-2017-0351-0004
Agency: epa
Document Type: Rule
Title: Tolerance Exemption: Deoxyribonucleic Acid Sequences
Posted Date: 2020-09-03T04:00Z

[Federal Register Volume 85, Number 172 (Thursday, September 3, 2020)]
[Rules and Regulations]
[Pages 54927-54931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19491]

-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0351; FRL-10013-43]

Deoxyribonucleic Acid (DNA) Sequences; Exemption From the 
Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of deoxyribonucleic acid sequences 
consisting solely of adenine, cytosine, guanine, and thymine, of 300 or 
fewer base pairs, and which do not contain start codons or regulatory 
sequences necessary for the initiation of transcription or translation 
when used as an inert ingredient (product identifier) in pesticide 
formulations applied to growing crops and to raw agricultural 
commodities after harvest at a concentration not to exceed 1.0 parts 
per million (ppm). InvisiDex Inc. submitted a petition to EPA under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment 
of an exemption from the requirement of a tolerance. This regulation 
eliminates the need to establish a maximum permissible level for 
residues of deoxyribonucleic acid that satisfy the terms of the 
exemption.

DATES: This regulation is effective September 3, 2020. Objections and 
requests for hearings must be received on or before November 2, 2020, 
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-2017-0351, 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.
    Due to the public health concerns related to COVID-19, the EPA 
Docket Center (EPA/DC) and Reading Room is closed to visitors with 
limited exceptions. The staff continues to provide remote customer 
service via email, phone, and webform. For the latest status 
information on EPA/DC services and docket access, visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Marietta Echeverria, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address: 
RDFRNotices@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:

[[Page 54928]]

     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-2017-0351 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 
November 2, 2020. 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-2017-0351, 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.
    For the latest status information on EPA/DC services and docket 
access, visit https://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of September 15, 2017 (82 FR 43352) (FRL-
9965-43), EPA issued a document pursuant to FFDCA section 408, 21 
U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-
11062) by InvisiDex Inc., 1129 Maricopa Hwy. #217, Ojai, CA 93023. The 
petition requested that 40 CFR 180.910 be amended by establishing an 
exemption from the requirement of a tolerance for residues of 
deoxyribonucleic acid (CAS Reg. No. 9006-49-2) when used as an inert 
ingredient (product identifier) in pesticide formulations applied to 
growing crops and to raw agricultural commodities after harvest at a 
concentration not to exceed 1.0 parts per million (ppm). That document 
referenced a summary of the petition prepared by InvisiDex Inc., the 
petitioner, which is available in the docket, http://www.regulations.gov. One comment was received on the notice of filing. 
EPA's response to this comment is discussed in Unit V.B.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. 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 tolerance 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. Section 408(b)(2)(C) of FFDCA 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 . . . .''
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that occur as a result of pesticide use in residential settings. If EPA 
is able to determine that a finite tolerance is not necessary to ensure 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the inert ingredient, an exemption from the 
requirement of a tolerance may be established.
    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 deoxyribonucleic acid sequences 
including exposure resulting from the exemption established by this 
action. EPA's assessment of exposures and risks associated with 
deoxyribonucleic acid sequences follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
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. Specific information on the studies received and the nature 
of the adverse effects caused

[[Page 54929]]

by deoxyribonucleic acid sequences as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies are discussed in this unit.
    Deoxyribonucleic acid (DNA) is routinely synthesized and degraded 
by almost all living cells. DNA breakdown into constituent nucleic 
acids continuously occurs in living cells. Purine and pyrimidine 
nucleosides can either be degraded to waste products and excreted or 
can be salvaged as nucleotide components. Therefore, metabolites of DNA 
do not pose a toxicological risk.
    DNA sequences used as product identifiers contain the same nucleic 
acids as DNA present in the environment, and humans routinely consume 
DNA as a component of food.
    All humans are exposed to DNA throughout their lives as part of 
their diet, in which DNA is metabolized to its component nucleic acids, 
which are then further used by the body for essential metabolic 
processes. Consumption of nucleic acids in food has not been associated 
with any toxic effects. Thus, because the DNA sequences that are used 
as product identifier contain the same nucleic acids, (adenine, 
cytosine, guanine and thymine) as found in DNA, consumption of food 
containing residues of DNA sequences that are used as product 
identifiers are not expected to present a toxic effect.
    There is a potential for extracellular or exogenous DNA to interact 
with microorganisms in the environment such as bacteria. This 
interaction could result in the formation of exogenous proteins or 
other materials that could potentially be harmful to humans. However, 
the DNA sequences proposed for use by the petitioner lack start codons 
or regulatory sequences necessary for the initiation of transcription 
or translation. They cannot encode a protein nor integrate with other 
genetic sequences and, as such, cannot lead to the formation of 
exogenous proteins or other materials. Moreover, the restriction of 
exempted DNA to be comprised of 300 base pairs or less will also limit 
the ability of DNA to replicate in the environment. Finally, the DNA 
sequence's ability to cause replication are further limited by lack of 
stability and integrity of extracellular DNA in the environment. 
Extracellular DNA routinely degrades in the environment when it is 
exposed to harsh environmental conditions such as mechanical shearing 
and UV degradation.

B. Toxicological Points of Departure/Levels of Concern

    As no human health toxicity endpoints have been selected, a 
quantitative assessment is not being conducted.

C. Exposure Assessment

    All humans are exposed to DNA throughout their lives as part of 
diet. As an inert ingredient in pesticide products, DNA sequences may 
result in residues in or on food. DNA sequences may be used as an inert 
ingredient (product identifiers) in pesticide formulations that are 
used in residential setting, however because DNA sequences are unlikely 
to cross the skin barrier or be available via inhalation. Therefore, 
inhalation and dermal exposure are not of concern.
    Due to the lack of toxicity, EPA does not expect these exposures to 
pose any risk of harm. DNA sequences used as product identifiers will 
also be limited to 1 ppm in pesticide formulations, with any resultant 
exposure to humans resulting from such use being negligible.

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 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.
    Due to the lack of toxicity or any threshold effects, an FQPA SF is 
not needed to protect the safety of infants and children.

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on 
deoxyribonucleic acid sequences consisting solely of adenine, cytosine, 
guanine and thymine, of 300 or fewer base pairs, and which do not 
contain start codons or regulatory sequences necessary for the 
initiation of transcription or translation when used as an inert 
ingredient (product identifier), EPA has determined that there is a 
reasonable certainty that no harm to any population subgroup will 
result from aggregate exposure to deoxyribonucleic acid sequences under 
reasonably foreseeable circumstances. Therefore, the establishment of 
an exemption from tolerance under 40 CFR 180.910 for residues of 
deoxyribonucleic acid sequences as described in the exemption when used 
as an inert ingredient in pesticide formulations applied to growing 
crops and to raw agricultural commodities after harvest at a 
concentration not to exceed 1.0 ppm, is safe under FFDCA section 408.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is not establishing a numerical tolerance for residues of 
DNA sequences in or on any food commodities. EPA is establishing 
limitations on the amount of DNA sequences that may be used in 
pesticide formulations applied pre- and post-harvest. These limitations 
will be enforced through the pesticide registration process under the 
Federal Insecticide, Fungicide, and Rodenticide Act (``FIFRA''), 7 
U.S.C. 136 et seq. EPA will not register any pesticide formulation for 
food use that exceeds 1 ppm by weight of DNA sequences in the final 
pesticide formulation.

B. Response to Comments

    One comment generally asserting that pesticides are toxic and 
should not be allowed on food was received in response to the notice of 
filing. Although the Agency recognizes that some individuals believe 
that pesticides should be banned on agricultural crops, the existing 
legal framework provided by section 408 of the Federal Food, Drug and 
Cosmetic Act (FFDCA) authorizes EPA to establish tolerances when it 
determines that the tolerance is safe. Upon consideration of the 
validity, completeness, and reliability of the available data as well 
as other factors the FFDCA requires EPA to consider, EPA has determined 
that this exemption is safe. The commenter has provided no information 
to indicate that the exemption would not be safe.

C. Revisions to Petitioned-for Tolerances

    Based on clarification as to the composition of the DNA that would 
be utilized as a product identifier, the petitioner provided additional 
descriptive criteria that have been incorporated by the Agency into the 
tolerance exemption expression to ensure that the DNA sequences used as 
product identifiers would not be taken up by organisms in the 
environment and

[[Page 54930]]

used for the production of proteins that could be harmful to human 
health.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.910 for deoxyribonucleic acid sequences 
consisting solely of adenine, cytosine, guanine and thymine, of 300 or 
fewer base pairs, and which do not contain start codons or regulatory 
sequences necessary for the initiation of transcription or translation 
when used as an inert ingredient (product identifier) in pesticide 
formulations applied to growing crops and to raw agricultural 
commodities after harvest at a concentration not to exceed 1.0 ppm.

VII. Statutory and Executive Order Reviews

    This action 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 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), nor is it considered a regulatory action under 
Executive Order 13771, entitled ``Reducing Regulations and Controlling 
Regulatory Costs'' (82 FR 9339, February 3, 2017). 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 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).

VIII. 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: August 27, 2020.
Marietta Echeverria,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES 
IN FOOD

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.  180.910, add alphabetically the inert ingredient 
``Deoxyribonucleic acid (DNA) sequences consisting solely of adenine, 
cytosine, guanine and thymine, of 300 or fewer base pairs, and which do 
not contain start codons or regulatory sequences necessary for the 
initiation of transcription or translation'' to Table 1 to read as 
follows:

Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

                           Table 1 to 180.910
------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
 
                              * * * * * * *
Deoxyribonucleic acid (DNA)       No more than 1 ppm  Product
 sequences consisting solely of    in pesticide        identifier.
 adenine, cytosine, guanine and    formulation.
 thymine, of 300 or fewer base
 pairs, and which do not contain
 start codons or regulatory
 sequences necessary for the
 initiation of transcription or
 translation.
 
                              * * * * * * *
------------------------------------------------------------------------

[[Page 54931]]

[FR Doc. 2020-19491 Filed 9-2-20; 8:45 am]
BILLING CODE 6560-50-P