Document ID: EPA-HQ-OPP-2018-0613-0003
Agency: epa
Document Type: Rule
Title: Tolerance Exemption: 2-Hydroxypropyl Starch
Posted Date: 2019-04-05T04:00Z

[Federal Register Volume 84, Number 66 (Friday, April 5, 2019)]
[Rules and Regulations]
[Pages 13551-13554]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-06689]

[[Page 13551]]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2018-0613; FRL-9991-13]

2-Hydroxypropyl Starch; 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 2-hydroxypropyl starch (CAS Reg. No. 
9049-76-7) when used as an inert ingredient (adjuvant) on growing crops 
only under 40 CFR 180.920. SciReg., Inc., on behalf of Bayer 
CropScience Biologics GmbH, submitted a petition to EPA under the 
Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an 
establishment of an exemption from the requirement of a tolerance. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of 2-hydroxypropyl starch when used in accordance with the 
terms of 40 CFR 180.920.

DATES: This regulation is effective April 5, 2019. Objections and 
requests for hearings must be received on or before June 4, 2019, 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-2018-0613, 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: Michael L. Goodis, 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: 
[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-2018-0613 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 
June 4, 2019. 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-2018-0613, 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. Petition for Exemption

    In the Federal Register of February 6, 2019 (84 FR 2115) (FRL-9987-
08), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (IN-11130) by 
SciReg., Inc. (12733 Director's Loop Woodbridge, VA 22192) on behalf of 
Bayer CropScience Biologics GmbH (Lukaswiese 4, 23970 Wismar Germany). 
The petition requested that 40 CFR 180.920 be amended by establishing 
an exemption from the requirement of a tolerance for residues of 2-
hydroxypropyl starch (CAS Reg. No. 9049-76-7) when used as an inert 
ingredient (adjuvant) in pesticide formulations applied to growing 
crops only. That document referenced a summary of the petition prepared 
by SciReg., Inc. on behalf of Bayer CropScience Biologics GmbH, the 
petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the 
notice of filing.

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;

[[Page 13552]]

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. In making this safety determination, EPA is 
directed to consider the factors contained in section 408(b)(2)(C) and 
(D). In particular, 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 2-hydroxypropyl starch 
including exposure resulting from the exemption established by this 
action. EPA's assessment of exposures and risks associated with 2-
hydroxypropyl starch 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 by 2-hydroxypropyl starch 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.
    Starches for commercial use are generally produced from potatoes, 
cereals, or other sources. They are composed of about 20-25% amylose 
and 75-80% amylopectin. High-amylose starches typically consist of 50-
80% amylose and 20-50% amylopectin. In modified starches, the chemical 
and physical characteristics of the native substances are altered to 
improve the functional properties for particular food applications.
    2-Hydroxypropyl starch is made by modifying starch derived from 
potatoes, cereals, or other sources with propylene oxide. Subchronic 
toxicity studies are available with 2-hydroxypropyl starch. The 
remaining studies used to evaluate the toxicity of 2-hydroxypropyl 
starch are conducted with various other modified starches similar to 2-
hydroxypropyl starch in structural, physicochemical, and biological 
properties. These data are considered appropriate to characterize 
potential toxicity due to exposure to 2-hydroxypropyl starch.
    The acute oral toxicity of 2-hydroxypropyl starch is low in various 
species such as mice, rats, guinea pigs, rabbits, and cats; the lethal 
dose, LD50 is >7,000 milligrams/kilogram (mg/kg). No studies 
are available on acute dermal and inhalation toxicity, skin and eye 
irritation and dermal sensitization.
    No toxicity is observed at doses as high as 9,000 mg/kg/day 
following 90 days of exposure in oral toxicity studies conducted with 
2-hydroxypropyl starch in rats.
    Three-generation reproduction toxicity studies conducted with 
surrogate modified starches in rats are available for review. Fetal 
susceptibility is not observed. No parental, offspring or reproduction 
toxicity is seen up to 62% (equivalent to 31,000 mg/kg/day) in rats 
treated with modified starches.
    Chronic toxicity and carcinogenicity studies were also conducted 
with surrogate modified starches. Reduced body weight is observed at 
30% (15,000 mg/kg/day) in a chronic/carcinogenicity study in rats. No 
other treatment-related effects or tumors were observed at doses <5,000 
mg/kg/day in rats and mice.
    Mutagenicity studies with a surrogate modified starch were 
negative. No revertant colonies were observed in an Ames test and no 
DNA exchange was observed in a sister chromatid exchange assay.
    Neurotoxicity and immunotoxicity studies are not available for 
review; however, no evidence of neurotoxicity or immunotoxicity is 
observed in the submitted studies.
    Metabolism studies conducted with a surrogate modified starch, 
sodium octenyl succinate (OSA) in rats via oral and intravenous 
administration show that these materials are metabolized and excreted 
primarily in the urine and feces. Approximately, 10% of unmodified OSA 
and 30% tricarboxylic acid of OSA are identified metabolites. In a 
metabolism study with puppy and adult dogs treated orally with \14\C-
labelled OSA, the material is metabolized and excreted primarily in the 
urine and feces. Unmodified OSA (55.7% and 59.5%) represents the main 
metabolite in adult dogs with tricarboxylic acid of OSA representing a 
small portion (4.4% and 3.6%). 3.8% and 4.7% of other OSA metabolites 
were recovered from the urine. In puppies, OSA (41.8%) and 
tricarboxylic acid (10.7%) were identified metabolites. Several in 
vitro studies show that many strains of bacteria found in the human 
colon can ferment starches.

B. Toxicological Points of Departure/Levels of Concern

    The available toxicity studies indicate that 2-hydroxypropyl starch 
has very low overall toxicity. Acute oral toxicity studies show 
LD50s above 7,000 mg/kg/day in multiple species. Repeated 
dose studies show no toxicity at doses as high as 4,500 mg/kg/day, 4.5 
times the limit dose of 1,000 mg/kg/day. Since no toxicity is observed, 
an endpoint of concern for risk assessment purposes was not identified.

[[Page 13553]]

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to 2-hydroxypropyl starch, EPA considered exposure under the 
proposed exemption from the requirement of a tolerance. EPA assessed 
dietary exposures from 2-hydroxypropyl starch in food as follows:
    Dietary exposure (food and drinking water) to 2-hydroxypropyl 
starch may occur following ingestion of foods with residues from 
treated crops. However, a quantitative dietary exposure assessment was 
not conducted since a toxicological endpoint for risk assessment was 
not identified.
    2. Dietary exposure from drinking water. Since a hazard endpoint of 
concern was not identified for the acute and chronic dietary 
assessment, a quantitative dietary exposure risk assessment for 
drinking water was not conducted, although exposures may be expected 
from use on food crops.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., textiles (clothing and diapers), carpets, swimming 
pools, and hard surface disinfection on walls, floors, tables).
    2-hydroxypropyl starch may be used in pesticide products and non-
pesticide products that may be used in and around the home. Based on 
the discussion above, a quantitative residential exposure assessment 
for 2-hydroxypropyl starch was not conducted.
    4. 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.''
    Based on the available data, 2-hydroxypropyl starch does not have a 
toxic mechanism; therefore, section 408(b)(2)(D)(v) does not apply.

D. Safety Factor for Infants and Children

    Based on the lack of threshold effects, EPA has not identified any 
toxicological endpoints of concern and is conducting a qualitative 
assessment of 2-hydroxypropyl starch. That qualitative assessment does 
not use safety factors for assessing risk, and no additional safety 
factor is needed for assessing risk to infants and children. Based on 
an assessment of 2-hydroxypropyl starch, EPA has concluded that there 
are no toxicological endpoints of concern for the U.S. population, 
including infants and children.

E. Aggregate Risks and Determination of Safety

    Because no toxicological endpoints of concern were identified, EPA 
concludes that aggregate exposure to residues of 2-hydroxypropyl starch 
will not pose a risk to the U.S. population, including infants and 
children, and that there is a reasonable certainty that no harm will 
result to the general population, or to infants and children from 
aggregate exposure to 2-hydroxypropyl starch residues.

V. Other Considerations

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.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.920 for 2-hydroxypropyl starch (CAS Reg. 
No. 9049-76-7) when used as an inert ingredient (adjuvant) in pesticide 
formulations applied to growing crops only.

VII. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption 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 
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 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

[[Page 13554]]

and pests, Reporting and recordkeeping requirements.

    Dated: March 21, 2019.
Donna Davis,
Acting Director, Registration 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. In Sec.  180.920, add alphanumerically the inert ingredient ``2-
hydroxypropyl starch (CAS Reg. No. 9049-76-7)'' to the table to read as 
follows:

Sec.  180.920   Inert ingredients used pre-harvest; exemptions from the 
requirement of a tolerance.

------------------------------------------------------------------------
       Inert ingredients                Limits               Uses
------------------------------------------------------------------------
 
                              * * * * * * *
2-Hydroxypropyl starch (CAS      ...................  Adjuvant.
 Reg. No. 9049-76-7).
 
                              * * * * * * *
------------------------------------------------------------------------

[FR Doc. 2019-06689 Filed 4-4-19; 8:45 am]
 BILLING CODE 6560-50-P