Document ID: EPA-HQ-OPP-2009-0996-0010
Agency: epa
Document Type: Rule
Title: Exemption from the Requirement of a Tolerance: Potassium hypochlorite
Posted Date: 2011-03-02T05:00Z

[Federal Register Volume 76, Number 41 (Wednesday, March 2, 2011)]
[Rules and Regulations]
[Pages 11340-11344]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-4534]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2009-0996; FRL-8859-5]

Potassium Hypochlorite; Exemption From the Requirement of a 
Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes the exemption from the requirement 
of a tolerance for residues of Potassium hypochlorite. Enviro Tech 
Chemical Services, Inc. submitted a petition to EPA under the Federal 
Food, Drug, and Cosmetic Act (FFDCA), requesting that Potassium 
hypochlorite in end-use products be eligible for the exemption from the 
requirement of a tolerance.

[[Page 11341]]

DATES: This regulation is effective March 2, 2011. Objections and 
requests for hearings must be received on or before May 2, 2011, 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: EPA has established a docket for this action under docket 
identification (ID) number EPA-HQ-OPP-2009-0996. All documents in the 
docket are listed in the docket index available at http://www.regulations.gov. Although listed in the index, some information is 
not publicly available, e.g., Confidential Business Information (CBI) 
or other information whose disclosure is restricted by statute. Certain 
other material, such as copyrighted material, is not placed on the 
Internet and will be publicly available only in hard copy form. 
Publicly available docket materials are available in the electronic 
docket at http://www.regulations.gov, or, if only available in hard 
copy, at the OPP Regulatory Public Docket in Rm. S-4400, One Potomac 
Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket 
Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The Docket Facility telephone number is (703) 
305-5805.

FOR FURTHER INFORMATION CONTACT: Wanda Henson, Antimicrobials Division 
(7510P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., 
Washington, DC 20460-0001; telephone number: (703) 308-6345; e-mail 
address: henson.wanda@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 a dairy 
cattle milk producer, food manufacturer, or beverage manufacturer. 
Potentially affected entities may include, but are not limited to:
     Dairy Cattle Milk Production (NAICS code 11212).
     Food manufacturing (NAICS code 311).
     Beverage Manufacturing (NAICS code 31212).
    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed in this unit could also be 
affected. The North American Industrial Classification System (NAICS) 
codes have been provided to assist you and others in determining 
whether this action might apply to certain entities. If you have any 
questions regarding the applicability of this action to a particular 
entity, consult the person listed under FOR FURTHER INFORMATION 
CONTACT.

 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.gpoaccess.gov/ecfr.

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-2009-0996 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 
May 2, 2011. 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 that does not contain any 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 a copy of 
your non-CBI objection or hearing request, identified by docket ID 
number EPA-HQ-OPP-2009-0996, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public 
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania 
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P), 
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South 
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only 
accepted during the Docket Facility's normal hours of operation (8:30 
a.m. to 4 p.m., Monday through Friday, excluding legal holidays). 
Special arrangements should be made for deliveries of boxed 
information. The Docket Facility telephone number is (703) 305-5805.

II. Summary of Petitioned-For Exemption

    In the Federal Register of Wednesday, January 12, 2011 (76 FR 2110) 
(FRL-8860-9), EPA issued a notice pursuant to section 408(d)(3) of 
FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide 
tolerance petition (PP 0F7767) by Enviro Tech Chemical Services, Inc, 
Modesto, CA 95358. The petition requested that 40 CFR part 180 be 
amended to establish an exemption from the requirement of a tolerance 
for potassium hypochlorite in or on apple; artichoke; asparagus; 
brussel sprouts; carrot; cauliflower; celery; cherry; cabbage; lettuce; 
fruits, citrus; cucumber; onion, green; melon; peach; nectarine; plum; 
pear; pepper, bell; potato; radish; fruit, stone; and tomato. That 
notice referenced a summary of the petition prepared by Enviro Tech 
Chemical Services, Inc., the registrant, which is available in the 
docket, http://www.regulations.gov. There were no comments received in 
response to the notice of filing.

III. 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 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 section 408(c)(2)(B) of FFDCA, in 
establishing or maintaining in effect an exemption from the requirement 
of a tolerance, EPA must take into account the factors set forth in 
section 408(b)(2)(C) of FFDCA, which 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 . * 
* *''
    Consistent with section 408(c)(2)(A) of FFDCA, and the factors 
specified in section 408(c)(2)(B) of FFDCA, EPA has reviewed the 
available scientific data and other relevant information in

[[Page 11342]]

support of this action. EPA has sufficient data to assess the hazards 
of and to make a determination on aggregate exposure for Potassium 
hypochlorite, including exposure resulting from the exemption 
established by this action. EPA's assessment of exposures and risks 
associated with potassium hypochlorite follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its 
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 potassium hypochlorite is available in 
the docket, http://www.regulations.gov.
    The Agency conducted an in-depth review of the similarities between 
potassium hypochlorite and the existing registered active ingredients, 
sodium hypochlorite and calcium hypochlorite. Based upon this review, 
the Agency determined that the data available to support the 
registrations of these active ingredients are also applicable to 
potassium hypochlorite. No additional generic or product-specific 
acute, chronic or subchronic toxicological studies were required to be 
submitted in support of this application. All toxicology data were 
bridged from studies on sodium and calcium hypochlorite based on their 
chemical similarity.
    Potassium hypochlorite is corrosive and can cause severe damage to 
the eyes and skin. Potassium hypochlorite has been assigned a Toxicity 
Category I, indicating the highest degree of toxicity for these acute 
effects. In the presence of oxygen, however, these compounds react 
easily with organic matter and convert readily into potassium chloride 
due to their simple chemical nature and structure. Exemptions from the 
requirement of a tolerance have been established for sodium and calcium 
hypochlorite used both as food contact surface sanitizers (40 CFR 
180.940) and as antimicrobials used on raw agricultural commodities (40 
CFR 180.1054 and 180.1235). Widely used in disinfecting water supplies 
for nearly a century, the hypochlorite class of chemicals has proven 
safe and practical to use provided that necessary precautions are taken 
by the user to prevent the eye and skin irritation which are inherent 
to all strong oxidizing agents. All documents related to this case can 
be found at http://www.regulations.gov in the document ``Antimicrobial 
Pesticide Products; Registration Applications'' page 16110 in docket ID 
number EPA-HQ-OPP-2009-0996.

B. Toxicological Points of Departure/Levels of Concern for Potassium 
Hypochlorite

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect in a lifetime. For more information on the general 
principles EPA uses in risk characterization and a complete description 
of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to potassium hypochlorite, EPA considered exposure under the 
petitioned-for exemption. EPA assessed dietary exposures from potassium 
hypochlorite in food as follows:
    Residues of potassium hypochlorite may remain on certain food crops 
as a result of their disinfectant uses. However, these residues pose no 
dietary risks of concern to human health based on data bridged from 
sodium hypochlorite. Therefore, a dietary risk assessment for potential 
exposures to residues in food is unwarranted.
    2. Dietary exposure from drinking water. Residues of potassium 
hypochlorite that may remain in drinking water as a result of the use 
of this chemical are not expected to pose dietary risks of concern to 
human health based on data bridged from sodium hypochlorite.
    3. 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). Potassium 
hypochlorite is currently registered for the following residential non-
dietary sites: Swimming pools, spa and hot tubs, hard, non-porous and 
porous surfaces, and laundry.
    Although residential exposure to mixer/loader/applicators is likely 
from the proposed uses of potassium hypochlorite, a quantitative risk 
assessment is not required because adverse systemic effects 
attributable to the dermal and inhalation routes of exposure to 
potassium hypochlorite are not expected based on toxicity data bridged 
from sodium hypochlorite.
    Label precautionary statements and the requirement that applicators 
wear certain personal protective equipment (goggles or face shield and 
rubber gloves) are sufficient to protect users from the localized, 
irritation effects of exposure to potassium hypochlorite. In addition, 
the label states that users of swimming pools may not enter treated 
water until the residual chlorine is measured to be between 1 ppm and 3 
ppm in order to prevent acute irritation effects.
    Further information regarding EPA standard assumptions and generic 
inputs for residential exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    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.''
    EPA has not found potassium hypochlorite to share a common 
mechanism of toxicity with any other substances, and potassium 
hypochlorite does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has assumed that Potassium hypochlorite 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

[[Page 11343]]

chemical, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    Because potassium hypochlorite was of very low systemic toxicity, 
EPA did not use a safety factor analysis for assessing risk. For 
similar reasons, the additional safety factor for the protection of 
infants and children is not necessary.

 E. Aggregate Risks and Determination of Safety

    Based on the toxicity profile and exposure scenarios for potassium 
hypochlorite, EPA believes that the risks from dietary exposures to 
this pesticide would be minimal and without consequence to human 
health. Although residential use of potassium hypochlorite poses 
potential risks for acute eye and skin injury, it is not appropriate to 
aggregate the exposure related to these surface irritation effects with 
systemic exposure from dietary ingestion. In any event, the Agency 
believes that these acute risks will be sufficiently mitigated by 
precautionary labeling requiring protection of eyes and skin while 
using this pesticide.
    Based on the toxicological and exposure data discussed in this 
preamble, EPA concludes that potassium hypochlorite will not pose a 
risk under reasonably foreseeable circumstances. Accordingly, EPA finds 
that there is a reasonable certainty of no harm will result to the 
general population, or to infants and children, from aggregate exposure 
to potassium hypochlorite residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is establishing an exemption from the requirement of a 
tolerance without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S. 
tolerances with international standards whenever possible, consistent 
with U.S. food safety standards and agricultural practices. EPA 
considers the international maximum residue limits (MRLs) established 
by the Codex Alimentarius Commission (Codex), as required by FFDCA 
section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and 
Agriculture Organization/World Health Organization food standards 
program, and it is recognized as an international food safety 
standards-setting organization in trade agreements to which the United 
States is a party. EPA may establish a tolerance that is different from 
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain 
the reasons for departing from the Codex level. The Codex has not 
established a MRL for potassium hypochlorite.

V. Conclusion

    Therefore, an exemption is established for residues of potassium 
hypochlorite.

VI. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under section 408(d) of 
FFDCA 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 section 408(d) of FFDCA, 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 section 408(n)(4) of FFDCA. 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) (Pub. L. 104-4).
    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), Pub. L. 104-113, section 12(d) (15 U.S.C. 272 
note).

VII. Congressional Review Act

    The Congressional Review Act, 5 U.S.C. 801 et seq., generally 
provides that before a rule may take effect, the agency promulgating 
the rule must submit a rule report to each House of the Congress and to 
the Comptroller General of the United States. 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 this final rule in the Federal 
Register. This final rule 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, Potassium hypochlorite.

    Dated: February 23, 2011.
Joan Harrigan Farrelly,
Director, Antimicrobials 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. Section 180.1300 is added to subpart D to read as follows:

Sec.  [emsp14]180.1300  Potassium hypochlorite; exemption from the 
requirement of a tolerance.

    An exemption from the requirement of a tolerance is established for 
residues

[[Page 11344]]

of potassium hypochlorite in or on all commodities.

[FR Doc. 2011-4534 Filed 3-1-11; 8:45 am]
BILLING CODE 6560-50-P