Document ID: EPA-HQ-OPP-2008-0093-0003
Agency: epa
Document Type: Rule
Title: Calcium Lactate Pentahydrate; Exemption from the Requirement of a Tolerance
Posted Date: 2009-05-13T04:00Z

[Federal Register: May 13, 2009 (Volume 74, Number 91)]
[Rules and Regulations]               
[Page 22456-22460]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13my09-9]                         

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0093; FRL-8412-5]

 
Calcium Lactate Pentahydrate; 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 calcium lactate pentahydrate (CAS Reg. 
No. 5743-47-5) when used as an inert ingredient in pesticide 
formulations applied to growing crops or to raw agricultural 
commodities after harvest. SynTech Global LLC, on behalf of BioNext 
sprl submitted a petition to EPA under the Federal Food, Drug, and 
Cosmetic Act (FFDCA), as amended by the Federal Quality Protection Act 
of 1996 (FQPA), requesting an exemption from the requirement of a 
tolerance. This regulation eliminates the need to establish a maximum 
permissible level for residues of calcium lactate pentahydrate.

DATES: This regulation is effective May 13, 2009. Objections and 
requests for hearings must be received on or before July 13, 2009, 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-2008-0093. 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: Karen Samek, Registration Division 
(7505P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone 
number: (703) 347-8825; e-mail address: samek.karen@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. 
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    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 Access Electronic Copies of this Document?

    In addition to accessing electronically available documents at 
http://www.regulations.gov, you may access this Federal Register 
document electronically through the EPA Internet under the ``Federal 
Register'' listings at http://www.epa.gov/fedrgstr. You may also access 
a frequently updated electronic version of 40 CFR part 180 through the 
Government Printing Office's e-CFR cite at http://www.gpoaccess.gov/
ecfr.

C. Can I File an Objection or Hearing Request?

    Under section 408(g) of FFDCA, 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. The EPA procedural regulations which 
govern the submission of objections and requests for hearings appear in 
40 CFR part 178. 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-2008-0093 in the subject line on the first page of 
your submission. All requests must be in writing, and must be mailed or 
delivered to the Hearing Clerk on or before July 13, 2009.
    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 that is described in ADDRESSES. Information not marked 
confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA 
without prior notice. Submit your copies, identified by docket ID 
number EPA-HQ-OPP-2008-0093, 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

[[Page 22457]]

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. Background and Statutory Findings

    In the Federal Register of June 4, 2008 (73 FR 31862) (FRL-8365-3), 
EPA issued a notice pursuant to section 408 of FFDCA, 21 U.S.C. 346a, 
as amended by FQPA (Public Law 104-170), announcing the filing of a 
pesticide petition (PP 7F7311) by SynTech Global LLC on behalf of 
BioNext sprl, Passage des deportes, 2, B-5030 Gembloux, Belgium. The 
petition requested that 40 CFR 180.910 be amended by establishing an 
exemption from the requirement of a tolerance for residues of calcium 
lactate pentahydrate when used as an inert ingredient in pesticide 
formulations with the active ingredient Candida oleophila strain O as a 
post- harvest treatment on stored apples and pears to control Botrytis 
cinerea (grey mold) and Penicillium expansum (blue mold). That notice 
included a summary of the petition prepared by the petitioner. There 
were no comments received in response to the notice of filing.
    Based upon review of the data supporting the petition, EPA has 
modified the exemption requested to include an exemption from the 
requirement of a tolerance for residues of calcium lactate pentahydrate 
(CAS Reg. No. 5743-47-5) under 40 CFR 180.910 when used as an inert 
ingredient in pesticide formulations applied to growing crops or to raw 
agricultural commodities after harvest. The reason for these changes 
are explained in Unit IV.
    Section 408(b)(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(b)(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 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. 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 ploymers 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. Toxicological Profile

    Consistent with section 408(b)(2)(D) of FFDCA, 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. The nature of the toxic effects caused by calcium 
lactate pentahydrate are discussed in this unit.
    The Agency has reviewed the data submitted by the petitioner. The 
data submitted includes data on lactic acid, as well as data on calcium 
lactate. Because it is likely that calcium lactate readily 
disassociates to lactic acid and calcium in the body, the Agency has 
concluded that the data on lactic acid can be used in conjunction with 
the data on calcium lactate and that these data are adequate to 
characterize the toxicity of calcium lactate pentahydrate.
    Acute oral and inhalation toxicity of lactic acid to rats and acute 
dermal toxicity of lactic acid to rabbits are low. L(+)-Lactic acid is 
severely irritating and corrosive to rabbit skin. It is expected to be 
severely irritating to the eyes. Dilute solutions are irritating to the 
eyes of rabbits. L(+)-Lactic acid is not a dermal sensitizer in guinea 
pigs. Repeat oral exposure of rats to calcium lactate for 90 days 
produced no toxicity at doses up to 5,000 milligrams/kilograms/day (mg/
kg/day). No neurotoxicity studies are available; however, no signs of 
neurotoxicity were observed in any of the available studies. Based on 
the results of the mutagenicity studies, calcium lactate pentahydrate 
is not likely to be mutagenic. A 2-year bioassay of calcium lactate in 
rats showed no evidence of carcinogenicity or any systemic toxicity at 
doses up to 5,000 mg/kg/day.
    No developmental or reproductive toxicity studies are available for 
calcium lactate pentahydrate, however, the Agency concluded that no 
developmental or reproductive studies are needed because there is no 
systemic toxicity identified at doses up to 5,000 mg/kg/day in a 2-year 
chronic toxicity study. In addition, a developmental toxicity study for 
lactic acid resulted in no maternal or developmental effects and none 
of the reproductive parameters were affected in mice at 570 mg/kg/day 
(only dose tested).

V. Aggregate Exposures

    In examining aggregate exposure, section 408 of FFDCA 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).
    Calcium lactate is used as a food additive and is a normal 
constituent of the human diet. It is used as a firming agent in canned 
fruits and can be found in jellies and preserves. It can be found 
naturally in aged cheese and is used medically to treat calcium 
deficiencies. Food and Drug Administration allows the use of calcium 
lactate as a direct human food ingredient and has granted calcium 
lactate generally recognized as safe (GRAS) status for use as a firming 
agent, flavor enhancer, leavening agent, nutrient supplement, 
stabilizer, and thickener.
    The primary route of exposure to calcium lactate pentahydrate from 
its

[[Page 22458]]

use as an inert ingredient in pesticide products would most likely be 
through consumption of food to which pesticide products containing it 
have been applied, and possibly through drinking water (from runoff). 
Residential (dermal and inhalation) exposures from home garden uses are 
possible.
    No hazard was identified for the acute and chronic dietary 
assessment (food and drinking water), or for the short-, intermediate-, 
and long-term residential assessments, and therefore no aggregate risk 
assessments were performed.

VI. Cumulative Effects

    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.''
    Unlike other pesticide ingredients for which EPA has followed a 
cumulative risk approach based on a common mechanism of toxicity, EPA 
has not made a common mechanism of toxicity finding as to calcium 
lactate pentahydrate and any other substances and calcium lactate 
pentahydrate does not appear to produce a toxic metabolite produced by 
other substances. For the purposes of this tolerance action, therefore, 
EPA has not assumed that calcium lactate pentahydrate 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 
the policy statements released by EPA's Office of Pesticide Programs 
concerning common mechanism determinations and procedures for 
cumulating effects from substances found to have a common mechanism on 
EPA's website at http://www.epa.gov/pesticides/cumulative.

VII. Determination of Safety 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.
    The toxicity database for calcium lactate is adequate for FQPA 
assessement and the potential exposure is adequately characterized 
given the low toxicity of the chemical. No acute or subchronic 
neurotoxicity studies are available, but there were no clinical signs 
of neurotoxicity observed in the available database at doses up to 
5,000 mg/kg/day. Therefore, the Agency concluded that these studies are 
not required. No developmental or reproductive toxicity studies are 
available for calcium lactate pentahydrate, however, the Agency 
concluded that no developmental or reproductive studies are needed 
because there is no systemic toxicity identified at doses up to 5,000 
mg/kg/day in a two-year chronic toxicity study. In addition, a 
developmental toxicity study for lactic acid resulted in no maternal or 
developmental effects and none of the reproductive parameters were 
affected in mice at 570 mg/kg/day (only dose tested).
    In 1973, World Health Organization (WHO) evaluated lactic acid as 
well as its ammonium, calcium, potassium, and sodium slats and stated 
that ``There is some evidence that babies in their first three months 
of life have difficulties in utilizing small amounts of DL and D(-) 
lactic acids.'' (INCHEM. (1974). Seventeenth Report of the Joint FAO/
WHO Expert Committee on Food Additives, Lactic acid and its ammonium, 
calcium, potassium and sodium salts. WHO Technical Report Series, No. 
539; FAO Nutrition Meetings Report Series, 1974, No. 53. http://
www.inchem.org/documents/jecfa/jecmono/v05je86.htm). EPA believes that 
exposure of premature or very young infants to lactic acid is unlikely. 
As stated in the Agency's reassessment document for lactic acid, 
``First, premature or very young infants ingest only formula or breast 
milk. (It is generally recommended that infants not consume solid food 
until 4 to 6 months of age). Regulation of infant formulas is under the 
purview of FDA. (www.fda.gov/fdac/features/596_baby.html).'' (Stehlin, 
I; (1996). Infant Formula: Second Best but Good Enough. FDA Consumer 
Magazine. 30 (5)). To carry out their regulation of infant foods and 
infant formulas, FDA published in 21 CFR 184.1207(c)(2) a very specific 
limitation that calcium lactate cannot be used in infant foods and 
infant formulas. Therefore, infants consuming only infant formula or 
breast milk are not exposed to calcium lactate. Once past this initial 
time-period, there is no longer a concern for potential sensitivity to 
infants and children. Older infants, like adults, process calcium 
lactate through well understood metabolic pathways.
    Based on this information, there is no concern, at this time, for 
increased sensitivity to infants and children to calcium lactate 
pentahydrate when used as an inert ingredient in pesticide formulations 
applied to growing crops or to raw agricultural commodities after 
harvest and a safety factor analysis has not been used to assess risk. 
For the same reason, EPA has determined that an additional safety 
factor is not needed to protect the safety of infants and children.

VIII. Determination of Safety for U.S. Population

    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be 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.
    Residues of concern are not anticipated for dietary exposure (food 
and drinking water) or for residential exposure from the use of calcium 
lactate pentahydrate for the proposed use pattern as an inert 
ingredient in pesticide products. As discussed in Unit VIII., EPA 
expects aggregate exposure to calcium lactate to pose no appreciable 
dietary risk given that the data on calcium lactate show a lack of any 
systemic toxicity at doses of up 5,000 mg/kg/day and a lack of any 
apparent developmental effects and that lactic acid is a normal 
component of human intermediary metabolism Furthermore, according to 
the FDA website http://www.cfsan.fda.gov/~dms/opascogd.html ``the 
Select committee concluded that: There is no evidence in the available 
information on L(+) calcium lactate that demonstrates or suggests 
reasonable grounds to suspect a hazard to the public when they are

[[Page 22459]]

used at levels that are now current or that might reasonably be 
expected in the future. There is no evidence in the available 
information on either of the isomers of lactic acid, their calcium 
slats, and their racemates that demonstrates or suggests reasonable 
grounds to suspect a hazard to individuals beyond infancy when they are 
used at levels that are now current or that might reasonable be 
expected in the future.''
    Taking into consideration all available information on calcium 
lactate pentahydrate, 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 calcium lactate 
pentahydrate. Therefore, the establishment of an exemption from 
tolerance under 40 CFR 180.910 for residues of calcium lactate 
pentahydrate when used as an inert ingredient in pesticide formulations 
applied to growing crops or to raw agricultural commodities after 
harvest can be considered safe under section 408 of FFDCA.

IX. Other Considerations

A. Endocrine Disruptors

    EPA is required under FFDCA, as amended by FQPA, to develop a 
screening program to determine whether certain substances (including 
all pesticide active and other ingredients) ``may have an effect in 
humans that is similar to an effect produced by a naturally occurring 
estrogen, or other such endocrine effects as the Administrator may 
designate.'' Following recommendations of its Endocrine Disruptor and 
Testing Advisory Committee (EDSTAC), EPA determined that there was a 
scientific basis for including, as part of the program, the androgen 
and thyroid hormone systems, in addition to the estrogen hormone 
system. EPA also adopted EDSTAC's recommendation that the program 
include evaluations of potential effects in wildlife. For pesticide 
chemicals, EPA will use the Federal Insecticide, Fungicide, and 
Rodenticide Act (FIFRA), as amended, and to the extent that effects in 
wildlife may help determine whether a substance may have an effect in 
humans, FFDCA authority to require the wildlife evaluations. As the 
science develops and resources allow, screening of additional hormone 
systems may be added to the Endocrine Disruptor Screening Program 
(EDSP).
    When additional appropriate screening and/or testing protocols 
being considered under the Agency's EDSP have been developed, calcium 
lactate pentahydrate may be subjected to further screening and/or 
testing to better characterize effects related to endocrine disruption.

B. Analytical Method

    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.

C. International Tolerances

    The Agency is not aware of any country requiring a tolerance for 
calcium lactate pentahydrate nor have any CODEX Maximum Residue Levels 
been established for any food crops at this time.

D. Revisions to Petitioned-For Exemption

    Based upon review of the data supporting the petition, EPA has 
modified the exemption requested to include an exemption from the 
requirement of a tolerance for residues of calcium lactate pentahydrate 
(CAS Reg. No. 5743-47-5) under 40 CFR 180.910 when used as an inert 
ingredient in pesticide formulations applied to growing crops or to raw 
agricultural commodities after harvest because no hazard was identified 
and therefore, no limitations are necessary.

X. Conclusions

    Based on the information in this preamble, EPA concludes that there 
is a reasonable certainty of no harm from aggregate exposure to 
residues of calcium lactate pentahydrate. Accordingly, EPA finds that 
exempting calcium lactate pentahydrate from the requirement of a 
tolerance when used as an inert ingredient in pesticide formulations 
applied to growing crops or to raw agricultural commodities after 
harvest will be safe.

XI. 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) (Public Law 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), Public Law 104-113, section 12(d) (15 U.S.C. 272 
note).

XII. 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

[[Page 22460]]

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.

    Dated: April 29, 2009.
Meredith F. Laws,
Acting Director, Registration Division, Office of Pesticide Programs.

0
Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
Therefore, 40 CFR chapter I is amended as follows:

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, the table is amended by adding alphabetically the 
following inert ingredient to read as follows:

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

* * * * *

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                                * * * * *
Calcium lactate pentahydrate      ..................  Nutrient,
 (CAS Reg. No. 5743-47-5).                             stabilizer
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E9-10769 Filed 5-12-09; 8:45 am]

BILLING CODE 6560-50-S