[Federal Register: January 6, 2010 (Volume 75, Number 3)]
[Rules and Regulations]
[Page 760-763]
[DOCID:fr06ja10-9]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2008-0671; FRL-8802-4]

Choline chloride; 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 choline chloride (CAS Reg. No. 67-48-1)
applied pre-harvest on all raw agricultural commodities when applied/
used as a solvent. Loveland Products, Inc., submitted a petition to EPA
under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of choline chloride.

DATES: This regulation is effective January 6, 2010. Objections and
requests for hearings must be received on or before March 8, 2010, 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-2008-0671. 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: Deirdre Sunderland, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>
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-2008-0671 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 March 8, 2010.
    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-2008-0671, 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<PHONE_NUMBER>.

II. Background and Statutory Findings

    In the Federal Register of December 3, 2008 (73 FR 73648) (FRL-
8391-3), 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 8E7387 ) by Loveland Products, Inc.,
P.O. Box 1286, Greeley, CO 80632-1286. The petition requested that 40
CFR 180.920 be amended by establishing an exemption from the
requirement of a tolerance for residues of choline chloride when used
as an inert ingredient in pesticide formulations applied pre-harvest.
That notice included a summary of the petition prepared by the
petitioner. There were no comments received in response to the notice
of filing.
    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 choline
chloride are discussed in this unit. The following provides a brief
summary of the risk assessment and conclusions from the Agency's review
of choline chloride. The Agency's full decision document for this
action is available in the Agency's electronic docket (regulations.gov)
under the docket number EPA-HQ-OPP-2008-0671.
    Choline chloride is a quaternary ammonium salt which dissociates in
water resulting in a positively charged quaternary hydroxyl
alkylammonium ion and a negatively charged chloride ion. Choline is an
essential component of the human diet and acts as a precursor to
acetylcholine, phospholipids, and the methyl donor betaine. It is
important for the structural integrity of cell membranes, cholinergic
neurotransmission, transmembrane signaling, methyl metabolism, and
lipid and cholesterol transport and metabolism.
    Choline was officially made an ``essential nutrient'' in 1998 and
adequate intake (AI) levels were established (women-425 milligram/day
(mg/day), pregnant women-450 mg/day, men and lactating women-550 mg/
day). The Daily Upper Intake Level for choline is 3.5 grams for adults.
Research indicates that many individuals are not getting enough
choline, with daily intake levels far below the AI.
    Chloride is a binary compound of chlorine; a salt of hydrochloric
acid. Chloride is the major extracellular anion and contributes to many
body functions including the maintenance of osmotic pressure, acid-base
balance, muscular activity, and the movement of water between fluid
compartments. The World Health Organization has performed two
assessments which determined that from a toxicological point of view,
there were no concerns for the chloride ion. It was considered to be
naturally-occurring and a normal participant of animal and human
metabolism.
    Choline chloride has demonstrated a low acute oral toxicity with
LD50 values for rats ranging from 3,150 to >= 6,000
milligram/kilogram (mg/kg) and LD50 for mice in the range of
3,900 to 6,000 mg/kg. Although appropriate animal studies are lacking
for acute dermal toxicity, an in vitro percutaneous absorption study
performed under occluded and unoccluded conditions showed that choline
chloride is expected to have a low potential for percutaneous
absorption. Acceptable acute inhalation studies are not available.
Studies conducted in the early 1960's showed only slight transient
irritation of the skin and eye.
    Repeat dose animal studies on choline chloride are limited. One
study in mice evaluated the impact of 200 mg/kg/day choline chloride
given orally or intranasally for 28 days. No adverse effects were
observed with regards to body weight, food and water consumption,
hematology, clinical biochemistry, or histopathology of various organs
(lung, heart, liver, spleen, and kidney). Results from intranasal
exposure to choline chloride were comparable with their respective
controls and to other treatment groups. The no adverse effects are
observed (NOAEL) for oral and intranasally administered choline
chloride is >= 200 mg/kg/day.
    A 72-week feeding study in rats administered 500 mg/kg/day of
choline chloride and observed the animals for 30 weeks post exposure.
There were no significant difference between the control and treated
group in relation to body weights, relative liver weight, survival
rates, and the number of neoplastic liver nodules, hepatocellular
carcinomas, lung tumors, leukemia, or other tumors. This study resulted
in a NOAEL of 500 mg/kg/day (the highest dose tested).
    Choline is a precursor to the vital neurotransmitter acetylcholine.
Studies show that choline has beneficial effects on the nervous system
and memory. Choline is necessary to promote proper development in the
fetus and infant and prevent cognitive problems. Choline chloride is
not expected to cause neurotoxicity and it is not a known endocrine
disruptor nor are its metabolites related to any class of known
endocrine disruptors. Based on the results of the in vitro and in vivo
studies the Agency concluded that choline chloride is not expected to
be carcinogenic or mutagenic.
    Since the 1930's choline chloride has been used as a widespread
nutrient in animal feed without adverse effects reported on fertility
or teratogenicity. The Food and Drug Administration (FDA) requires
choline be added to non-milk based infant formulas at a minimum
concentration of 7 mg for every 100 kilocalories (21 CFR 107.100).
Although one study did show developmental effects, they were only seen
at very high doses (>=4,160 mg/kg/day) and only in the presence of
maternal toxicity. There were no observed adverse effects for both
mothers and pups exposed to 1,250 mg/kg/day. Based on this information
the Agency concluded that choline chloride, when used as an inert
ingredient, will not cause reproductive or developmental toxicity and
therefore, does not anticipate an increased risk to infants and
children.

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).
    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.
     Exposure from the use of choline chloride is expected through the
oral route via food and drinking water. Exposure via the dermal route
may occur for those individuals applying the product both
occupationally and residentially. Due to the rapid degradation of the
chemical and the natural presence of choline and chloride in the
environment, exposure from the use of choline chloride as an inert
ingredient in pesticide products is not expected to increase the
aggregate exposure to all subpopulation including infants and children
and therefore a quantitative exposure assessment has not been
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 pesticides 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 choline chloride and any
other substances, and these chemicals do not appear to produce a toxic
metabolite produced by other substances. For the purposes of this
tolerance action, therefore, EPA has not assumed that these chemicals
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. Additional Safety Factor for the Protection of Infants and
Children.

    Section 408 of FFDCA provides that EPA shall apply an additional
tenfold margin of safety for infants and children in the case of
threshold effects to account for prenatal and postnatal toxicity and
the completeness of the database on toxicity and exposure unless EPA
determines that a different margin of safety will be safe for infants
and children. EPA concluded that the FQPA safety factor for choline
chloride should be reduced to 1X.
    The database for choline chloride is adequate to make a
determination of safety for infants and children. Choline is a natural
component of a variety of commonly consumed foods. It has been added as
a supplement to infant formula in the United States for decades. In
addition to dietary consumption of choline and chloride, choline is
made endogenously in the human body. Choline is a precursor to the
vital neurotransmitter acetylcholine. Studies show that choline has
beneficial effects on the nervous system and memory. Choline is
necessary to promote proper development in the fetus and infant and
prevent cognitive problems. Choline chloride is not expected to cause
neurotoxicity.
    Chloride is also important for many biological functions. It helps
to maintain the fluid balance of cells, proper blood volume, blood
pressure, and the pH of body fluids. The World Health Organization has
performed two assessments which determined that from a toxicological
point of view, there were no concerns for the chloride ion. It was
considered to be naturally-occurring and a normal participant of animal
and human metabolism.
    Choline chloride has been used as a widespread nutrient in animal
feed since the 1930's without adverse effects reported on fertility or
teratogenicity. Although one study in mice did show developmental
effects, they were only seen at very high doses (>=4,160 mg/kg/day) and
only in the presence of maternal toxicity. There were no observed
adverse effects for both mothers and pups exposed to 1,250 mg/kg/day.
    Exposure to choline chloride is not expected to significantly
increase the pre-existing levels found in commonly eaten foods. Due to
the negligible anticipated crop residues and subsequent exposure, the
low toxicity of the chemical and its metabolites, the bodies need for
choline from a dietary source, and the beneficial role choline plays in
fetal development and memory; the safety factor has been reduced to 1
X.

VIII. Determination of Safety for U.S. Population

    In addition to its low toxicity, exposure to choline chloride will
be limited. The expected exposure pathway is via the oral and the
dermal routes. Humans are currently exposed to choline and chloride on
a daily basis through commonly eaten foods (both naturally occurring
and when added as a nutrient) and through the bodies natural ability to
synthesize the nutrient. It is unlikely that the exposure from choline
chloride, when used as an inert ingredient applied pre-harvest to food
commodities, will significantly increase the natural concentration of
choline and chloride in foods. Choline and chloride are also found
naturally in the environment. Choline chloride is readily biodegradable
and because of its high water solubility it is expected that most of
the inert will be washed from the plant prior to consumption. Once in
water, its preferred media, it will be broken into a quaternary
hydroxyl alkylammonium ion and a chloride ion.
    Taking into consideration all available information on choline
chloride, it has been determined that there is a reasonable certainty
that no harm to any population subgroup, including infants and
children, will result from aggregate exposure to this chemical.
Therefore, the exemption from the requirement of a tolerance for
residues of choline chloride (CAS Reg. No. 67-48-1), when used as an
inert ingredient in pre-harvest applications, under 40 CFR 180.920 can
be considered safe under section 408(q) of the FFDCA.

IX. Other Considerations

A. Analytical Method(s)

    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 Tolerances

    The Agency is not aware of any country requiring a tolerance for
choline chloride nor have any CODEX Maximum Residue Levels (MRLs) been
established for any food crops at this time.

X. Conclusions

    Therefore, a tolerance exemption is established for choline
chloride (CAS Reg. No. 67-48-1) when used as inert ingredient in
pesticide formulations applied to growing crops only.

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 exemption in
this final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.) do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of 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 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: December 24, 2009.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

0
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, the table is amended by adding alphabetically the
following inert ingredients:

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

------------------------------------------------------------------------
        Inert ingredients               Limits               Uses
------------------------------------------------------------------------
                                * * * * *
Choline chloride (CAS Reg. No.    ------------------  As a solvent
 67-48-1)
                                * * * * *
------------------------------------------------------------------------

[FR Doc. E9-31280 Filed 1-5-10; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 78, Number 84 (Wednesday, May 1, 2013)]
[Notices]
[Pages 25431-25432]
[FR Doc No: 2013-10258]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. RM07-16-000 and RM01-5-000]

Revised Information Collection Activities (FERC-545, FERC-549,
and FERC-550); Comment Request

AGENCY: Federal Energy Regulatory Commission, DOE.

ACTION: Request for comment.

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

SUMMARY: The Federal Energy Regulatory Commission (Commission or FERC)
is submitting three information collections to the Office of Management
and Budget (OMB) for review of the changes to the information
collection requirements relating to the application of the Commission's
revised Company Registration procedures to interstate and intrastate
natural gas pipelines and interstate oil pipelines. The Commission
issued a Notice in the Federal Register, 78 FR 10,614 (February 14,
2013), requesting public comments by April 15, 2013. FERC received no
comments and is making this notation in its submittal to OMB.

DATES: Comments regarding the revised information collections must be
received on or before May 31, 2013.

ADDRESSES: Comments filed with OMB should be identified with the OMB
Control Nos. 1902-0154 (FERC-545), 1902-0086 (FERC-549), and 1902-0089
(FERC-550) and should be sent via email to the Office of Information
and Regulatory Affairs<EMAIL_ADDRESS>Attention: Federal
Energy Regulatory Commission Desk Officer. The Desk Officer may also be
reached via telephone at<PHONE_NUMBER>. A copy of the comments should
also be sent to the Federal Energy Regulatory Commission, identified by
the Docket Nos. RM07-16 and RM01-5, by either of the following methods:
     eFiling at Commission's Web site: http://www.ferc.gov/docs-filing/efiling.asp.
     Mail/Hand Delivery/Courier: Federal Energy Regulatory
Commission, Secretary of the Commission, 888 First Street NE.,
Washington, DC 20426.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov/help/submission-guide.asp. For user assistance contact FERC Online Support
by email at<EMAIL_ADDRESS>or by phone at:<PHONE_NUMBER>
(toll-free), or<PHONE_NUMBER> for TTY.

FOR FURTHER INFORMATION CONTACT: Ellen Brown, by email at
<EMAIL_ADDRESS>telephone at<PHONE_NUMBER>, and fax at (202)
273-0873.

SUPPLEMENTARY INFORMATION: The revisions to these collections of
information relate to the application of the Commission's revised
Company Registration procedures to interstate and intrastate natural
gas pipelines and interstate oil pipelines.
    These procedures will replace the use of random-number generated
passwords to authenticate access to a company registration account with
a superior method of authentication. Under the revised procedures, each
regulated natural gas pipeline and oil pipeline will be able to
maintain a list of eRegistered agents whom the pipeline has authorized
to submit a particular type of filing. Implementation of these changes
will provide increased flexibility for regulated entities to manage
their company registration accounts and to designate agents to make
filings at the Commission. These changes also will reduce the need for
pipelines to institute measures to protect password integrity,
including the need to request new passwords if existing passwords are
compromised.\1\ At the conference on April 16, 2013, Commission staff
made a presentation on the proposed changes. The Staff presentation and
instructional video, are available on the Commission's Web site.\2\ The
first filings under the revised company registration system are
scheduled to be made beginning no sooner than 7/12/2013.
---------------------------------------------------------------------------

    \1\ A general description of the procedures can be found in the
Commission's order in Filing Via the Internet, Docket Nos. RM07-16-
000 and RM01-5-000, 142 FERC ] 61,097 (2013) (http://elibrary.ferc.gov/idmws/common/OpenNat.asp?fileID=13174100) and in
Revisions to Electric Quarterly Report Filing Process, Order No.
770, 77 Fed. Reg. 71,288 (Nov. 30, 2012), FERC Stats. & Regs. ]
31,338, at PP 30 and 33-36 (2012) (Docket No. RM12-3-000). On March
8, 2013, the Commission issued a Notice of Technical Conference in
this proceeding, available at http://elibrary.ferc.gov/idmws/common/opennat.asp?fileID=13199806.
    \2\ See http://www.ferc.gov/EventCalendar/Files/20130412144329-CompanyRegistrationPresentation.pdf and http://www.ferc.gov/docs-filing/etariff/company-reg/company-reg-04-16-13.htm.
---------------------------------------------------------------------------

    OMB's regulations \3\ require approval of certain information
collection requirements that impose identical reporting or
recordkeeping requirements on ten or more persons. Without
consideration of potential cost savings in reduced password management
and requests for new passwords, the one-time burden on interstate and
intrastate natural gas and oil pipelines to transition to the revised
system is

estimated to be one hour per respondent at a cost of $35.99/hour for
support staff.\4\
---------------------------------------------------------------------------

    \3\ 5 CFR 1320 (2012).
    \4\ The estimated burden on electric utilities for compliance
with this requirement was included in Order No. 770, 77 FR 71,288
(Nov. 30, 2012), FERC Stats. & Regs. ] 31,338, at PP 58-62 (2012)
(Docket No. RM12-3-000) and is incorporated in FERC-920, Electric
Quarterly Report, OMB Control No. 1902-0255. Those reporting
requirements are currently pending review at OMB in ICR No. 201302-
1902-003.
---------------------------------------------------------------------------

    Information Collection Costs: The Commission estimates the average
annual burden and cost of compliance with these regulations to be the
following: \5\
---------------------------------------------------------------------------

    \5\ The estimated number of respondents and related totals for
hours and cost have been updated since the Notice issued on 2/8/2013
(at http://elibrary.ferc.gov/idmws/common/opennat.asp?fileID=13174410).

----------------------------------------------------------------------------------------------------------------
                                                                     Hours per
                                                     Number of      response (1
                 Data collection                    respondents    response per     Total hours   Total cost \7\
                                                        \6\         respondent)
----------------------------------------------------------------------------------------------------------------
FERC-545--NGA Pipelines.........................             169               1             169          $6,082
FERC-549--NGPA Pipelines........................             107               1             107           3,851
FERC-550--Oil Pipelines.........................             193               1             193           6,946
----------------------------------------------------------------------------------------------------------------

    We estimate \\that pipelines will have the initial implementation
burden of one hour and may annually review or make revisions to their
list of designated agents. The total annual burden and cost for all of
the 469 respondents (for FERC-545, -549, and -550) for this requirement
are: 469 hours or $16,879.
---------------------------------------------------------------------------

    \6\ As of April 5, 2013.
    \7\ Hourly average cost ($35.99/hour) was calculated using
Bureau of Labor Statistics (BLS), Occupational Employment Statistics
data for May 2011 (for NAICS 221100--Electric Power Generation,
Transmission and Distribution, at http://bls.gov/oes/current/naics4_221100.htm#00-0000) for the support staff.
---------------------------------------------------------------------------

    Title: FERC-545, Gas Pipeline Rates: Rate Change (Non-Formal), OMB
Control No. 1902-0154; FERC-549, Gas Pipeline Rates: NGPA Title III
Transactions and Part 341, OMB Control No. 1902-0086; and FERC-550, Oil
Pipeline Rates: Tariff Filings, OMB Control No. 1902-0089.
    Action: Revised and new company registration information
requirements.
    Respondents: Interstate and intrastate natural gas pipelines and
interstate oil pipelines.
    Frequency of Responses: One-time initial implementation and
periodic updates as needed.
    Need for Information: The changes are being implemented to enhance
the security of natural gas and oil pipelines' company registration
accounts and to provide pipelines with an enhanced ability to manage
filing permissions.
    Internal Review: We have reviewed the changes and determined that
the changes are necessary, conforming to the Commission's need for
efficient information collection, communication, and management within
the energy industry. We have assured ourselves, by means of internal
review, that there is specific, objective support for the burden
estimates associated with the information collection requirements.
    Comments: Comments are invited on: (1) Whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.

    Dated: April 25, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-10258 Filed 4-30-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 121 (Friday, June 22, 2012)]
[Rules and Regulations]
[Pages 37573-37576]
[FR Doc No: 2012-15244]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2011-N-0522]

Effective Date of Requirement for Premarket Approval for an
Implantable Pacemaker Pulse Generator

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule
to require the filing of a premarket approval application (PMA) or a
notice of completion of a product development protocol (PDP) for
implantable pacemaker pulse generators. The Agency has summarized its
findings regarding the degree of risk of illness or injury designed to
be eliminated or reduced by requiring this device to meet the statute's
approval requirements and the benefits to the public from the use of
the devices. This action implements certain statutory requirements.

DATES: This rule is effective September 20, 2012.

FOR FURTHER INFORMATION CONTACT: Melissa Burns, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1646, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended
by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L.
94-295), the Safe Medical Devices Act of 1990 (SMDA) (Pub. L. 101-629),
the Food and Drug Administration Modernization Act of 1997 (FDAMA)
(Pub. L. 105-115), the Medical Device User Fee and Modernization Act of
2002 (Pub. L. 107-250), and the Food and Drug Administration Amendments
Act of 2007 (Pub. L. 110-85), among other amendments, established a
comprehensive system for the regulation of medical devices intended for
human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established
three categories (classes) of devices, depending on the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
    Under section 513 of the FD&C Act, devices that were in commercial
distribution before the enactment of the 1976 amendments, May 28, 1976
(generally referred to as preamendments

devices), are classified after FDA has: (1) Received a recommendation
from a device classification panel (an FDA advisory committee); (2)
published the panel's recommendation for comment, along with a proposed
regulation classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices) are
automatically classified by section 513(f) of the FD&C Act into class
III without any FDA rulemaking process. Those devices remain in class
III and require premarket approval unless, and until, the device is
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807).
    A preamendments device that has been classified into class III may
be marketed by means of premarket notification procedures (510(k)
process) without submission of a PMA until FDA issues a final
regulation under section 515(b) of the FD&C Act (21 U.S.C. 360e(b))
requiring premarket approval. Section 515(b)(1) of the FD&C Act
establishes the requirement that a preamendments device that FDA has
classified into class III is subject to premarket approval. A
preamendments class III device may be commercially distributed without
an approved PMA or a notice of completion of a PDP until 90 days after
FDA issues a final rule requiring premarket approval for the device, or
30 months after final classification of the device under section 513 of
the FD&C Act, whichever is later. Also, a preamendments device subject
to the rulemaking procedure under section 515(b) is not required to
have an approved investigational device exemption (IDE) (see part 812
(21 CFR part 812)) contemporaneous with its interstate distribution
until the date identified by FDA in the final rule requiring the
submission of a PMA for the device. At that time, an IDE is required
only if a PMA has not been submitted or a PDP completed.
    Section 515(b)(2)(A) of the FD&C Act provides that a proceeding to
issue a final rule to require premarket approval shall be initiated by
publication of a notice of proposed rulemaking containing: (1) The
regulation; (2) proposed findings with respect to the degree of risk of
illness or injury designed to be eliminated or reduced by requiring the
device to have an approved PMA or a declared completed PDP and the
benefit to the public from the use of the device; (3) an opportunity
for the submission of comments on the proposed rule and the proposed
findings; and (4) an opportunity to request a change in the
classification of the device based on new information relevant to the
classification of the device.
    Section 515(b)(2)(B) of the FD&C Act provides that if FDA receives
a request for a change in the classification of the device within 15
days of the publication of the notice, FDA shall, within 60 days of the
publication of the notice, consult with the appropriate FDA advisory
committee and publish a notice denying the request for change in
reclassification or announcing its intent to initiate a proceeding to
reclassify the device under section 513(e) of the FD&C Act. Section
515(b)(3) of the FD&C Act provides that FDA shall, after the close of
the comment period on the proposed rule and consideration of any
comments received, issue a final rule to require premarket approval or
publish a document terminating the proceeding together with the reasons
for such termination. If FDA terminates the proceeding, FDA is required
to initiate reclassification of the device under section 513(e) of the
FD&C Act, unless the reason for termination is that the device is a
banned device under section 516 of the FD&C Act (21 U.S.C. 360f).
    When a rule to require premarket approval for a preamendments
device is finalized, section 501(f)(2)(B) of the FD&C Act (21 U.S.C.
351(f)(2)(B)) requires that a PMA or notice of completion of a PDP for
any such device be filed within 90 days of the date of issuance of the
final rule or 30 months after the final classification of the device
under section 513 of the FD&C Act, whichever is later. If a PMA or
notice of completion of a PDP is not filed by the latter of the two
dates, commercial distribution of the device must cease because the
device would be deemed adulterated under section 501(f).
    The device may, however, be distributed for investigational use if
the manufacturer, importer, or other sponsor of the device complies
with the IDE regulations. If a PMA or notice of completion of a PDP is
not filed by the latter of the two dates, and no IDE is in effect, the
device is deemed to be adulterated within the meaning of section
501(f)(1)(A) of the FD&C Act, and subject to seizure and condemnation
under section 304 of the FD&C Act (21 U.S.C. 334), if its distribution
continues. Shipment of devices in interstate commerce will be subject
to injunction under section 302 of the FD&C Act (21 U.S.C. 332), and
the individuals responsible for such shipment will be subject to
prosecution under section 303 of the FD&C Act (21 U.S.C. 333). In the
past, FDA has requested that manufacturers take action to prevent the
further use of devices for which no PMA has been filed and may
determine that such a request is appropriate for the class III device
that is the subject of this regulation.
    The FD&C Act does not permit an extension of the 90-day period
after issuance of a final rule within which an application or notice is
required to be filed. The House Report on the 1976 amendments states
that ``* * * [t]he thirty month `grace period' afforded after
classification of a device into class III * * * is sufficient time for
manufacturers and importers to develop the data and conduct the
investigations necessary to support an application of premarket
approval'' (H. Rept. 94-853, 94th Cong., 2d sess. 42 (1976)).
    The SMDA added section 515(i) to the FD&C Act requiring FDA to
review the classification of preamendments class III devices for which
no final rule requiring the submission of PMAs has been issued, and to
determine whether or not each device should be reclassified into class
I or class II or remain in class III. For devices remaining in class
III, the SMDA directed FDA to develop a schedule for issuing
regulations to require premarket approval. The SMDA does not, however,
prevent FDA from proceeding immediately to rulemaking under section
515(b) of the FD&C Act on specific devices, in the interest of public
health, independent of the procedures of section 515(i). Proceeding
directly to rulemaking under section 515(b) of the FD&C Act is
consistent with Congress' objective in enacting section 515(i), i.e.,
that preamendments class III devices for which PMAs have not been
previously required either be reclassified to class I or class II or be
subject to the requirements of premarket approval.
    In the Federal Register of May 6, 1994 (59 FR 23731) (the May 6,
1994, notice), FDA issued a notice of availability of a preamendments
class III devices strategy document. The strategy document set forth
FDA's plans for implementing the provisions of section 515(i) of the
FD&C Act for preamendments class III devices for which FDA had not yet
required premarket approval.

    In the Federal Register of July 27, 2011 (76 FR 44872) (the July
27, 2011, proposed rule), FDA published a proposed rule to require the
filing under section 515(b) of the FD&C Act of a PMA or notice of
completion of a PDP for the implantable pacemaker pulse generator. In
accordance with section 515(b)(2)(A) of the FD&C Act, FDA included in
the preamble of the proposed rule the Agency's tentative findings with
respect to the degree of risk of illness or injury designed to be
eliminated or reduced by requiring the devices to meet the premarket
approval requirements of the FD&C Act, and the benefits to the public
from use of the device. The July 27, 2011, proposed rule also provided
an opportunity for interested persons to submit comments on the
proposed rule and the Agency's findings. Under section 515(b)(2)(B) of
the FD&C Act, FDA provided an opportunity for interested persons to
request a change in the classification of the devices based on new
information relevant to its classification. Any petition requesting a
change in classification of the implantable pacemaker pulse generator
was required to be submitted by August 11, 2011. The comment period for
the implantable pacemaker pulse generator closed October 25, 2011.
    FDA received one comment on the proposed rule for the implanted
pacemaker pulse generator. The comment was a general statement
supporting the requirements for filing of a PMA for this device. The
comment did not recommend any changes to the proposed rule. FDA
received no petitions requesting a change in the classification of the
device.

II. Findings With Respect to Risks and Benefits

    As required by section 515(b) of the FD&C Act, FDA published its
findings regarding: (1) The degree of risk of illness or injury
designed to be eliminated or reduced by requiring that this device have
an approved PMA or a declared completed PDP and (2) the benefits to the
public from the use of the device. These findings were published in the
July 27, 2011, proposed rule.
    These findings are based on the reports and recommendations of the
advisory committees (panels) for the classification of these devices
along with information submitted in response to the 515(i) Order,
(April 9, 2009 (74 FR 16214)), and any additional information that FDA
has encountered. Additional information regarding the risks as well as
classification associated with the implantable pacemaker pulse
generator can be found in the following proposed and final rules
published in the Federal Register on these dates: March 9, 1979 (44 FR
13373); February 5, 1980 (45 FR 7940); and May 11, 1987 (52 FR 17732 at
17736).

III. The Final Rule

    Under section 515(b)(3) of the FD&C Act, FDA is adopting its
findings as published in the preamble to the proposed rule. FDA is
issuing this final rule to require premarket approval of these generic
types of devices for class III preamendments devices by revising part
870 (21 CFR part 870).
    Under the final rule, a PMA or a notice of completion of a PDP is
required to be filed on or before 90 days after the date of publication
of the final rule in the Federal Register, for any of these class III
preamendments devices that were in commercial distribution before May
28, 1976, or that has been found by FDA to be substantially equivalent
to such a device on or before 90 days after the date of publication of
the final rule in the Federal Register. An approved PMA or a declared
completed PDP is required to be in effect for any such devices on or
before 180 days after FDA files the application. Any other class III
preamendments device subject to this rule that was not in commercial
distribution before May 28, 1976, is required to have an approved PMA
or a declared completed PDP in effect before it may be marketed.
    If a PMA or a notice of completion of a PDP for any of the class
III preamendments devices is not filed on or before the 90th day past
the effective date of this regulation, that device will be deemed
adulterated under section 501(f)(1)(A) of the FD&C Act, and commercial
distribution of the device must cease immediately. The device may,
however, be distributed for investigational use, if the requirements of
the IDE regulations (part 812) are met.

IV. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

V. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this final rule is not a significant
regulatory action under Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. There have been no 510(k) submissions for
implantable pacemaker pulse generators since 1999, and there is no
record of pacemaker batteries ever being marketed. Accordingly, it has
been determined that all of these devices are in a state of disuse, and
FDA has concluded that there is little or no interest in marketing
these devices in the future. Therefore, the Agency certifies that the
final rule will not have a significant economic impact on a substantial
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $139 million, using the most current (2011) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
    FDA has concluded that this final rule will not have a significant
impact. We base this determination on an analysis of our Registration
and Listing, 510(k) and PMA database information.
    There have been no 510(k) submissions for implantable pacemaker
pulse generators since 1999, with the exception of one 510(k)
submission cleared in 2001 that was erroneously coded as an implantable
pacemaker pulse generator (product code DXY), but is actually for an
external pacemaker. This record has been corrected. Current pacemakers
have newer features and capabilities that have rendered them not
substantially equivalent to the devices cleared under 510(k) prior to
1999, which are obsolete. Current pacemakers are marketed under a PMA;
in some cases the product code DXY has been erroneously applied. In
addition, there have been no valid 510(k) submissions

for pacemaker batteries for implantable pacemakers, which also fall
under the product code DSZ also under Sec.  870.3610. Two 510(k)
submissions have been received for DSZ devices since 1976, but they
were miscoded, which has been corrected. The Agency has no record of
pacemaker batteries ever being marketed.
    This information is summarized in table 1 of this document as
follows:

                       Table 1--Summary of Electronic Registration and Listing Information
----------------------------------------------------------------------------------------------------------------
                                                                                Replaced by
          Device name               Product code         Last listed     Last valid  510(k)        approved
                                                                               cleared           technology?
----------------------------------------------------------------------------------------------------------------
Implantable Pacemaker Pulse      DXY...............  2012..............  1999..............  Yes.\1\
 Generator.
Pacemaker Battery..............  DSZ...............  No Record.........  No Record.........  No.\2\
----------------------------------------------------------------------------------------------------------------
\1\ Implantable pacemaker pulse generators have been submitted as PMAs since the early 1980s. The product code
  DXY has been erroneously applied to many of these PMA products.
\2\ Pacemaker batteries are not separately marketed products. They are internal to implantable pacemakers.

    Based on our review of electronic product registration and listing
and other data, FDA concludes that there is currently little or no
interest in marketing the affected devices and that the final rule
would not have a significant economic impact.

VI. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the Agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.

VII. Paperwork Reduction Act of 1995

    This final rule refers to currently approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in part 812 have been approved under OMB
control number 0910-0078; the collections of information in part 807,
subpart E, have been approved under OMB control number 0910-0120; the
collections of information in 21 CFR part 814, subpart B, have been
approved under OMB control number 0910-0231; and the collections of
information under 21 CFR part 801 have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 870

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
870 is amended as follows:

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for 21 CFR part 870 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Section 870.3610 is amended by revising paragraphs (a) and (c) to
read as follows:

Sec.  870.3610  Implantable pacemaker pulse generator.

    (a) Identification. An implantable pacemaker pulse generator is a
device that has a power supply and electronic circuits that produce a
periodic electrical pulse to stimulate the heart. This device is used
as a substitute for the heart's intrinsic pacing system to correct both
intermittent and continuous cardiac rhythm disorders. This device may
include triggered, inhibited, and asynchronous modes and is implanted
in the human body.
* * * * *
    (c) Date PMA or notice of completion of PDP is required. A PMA or
notice of completion of a PDP is required to be filed with the Food and
Drug Administration on or before September 20, 2012, for any
implantable pacemaker pulse generator device that was in commercial
distribution before May 28, 1976, or that has, on or before September
20, 2012, been found to be substantially equivalent to any implantable
pacemaker pulse generator device that was in commercial distribution
before May 28, 1976. Any other implantable pacemaker pulse generator
device shall have an approved PMA or declared completed PDP in effect
before being placed in commercial distribution.

    Dated: June 18, 2012.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2012-15244 Filed 6-21-12; 8:45 am]
BILLING CODE 4160-01-P


enclosed truck cab) 0.007 ( single layer,

no gloves,

enclosed truck cab) 3 3 300 25 No. Exposure Scenario Unit Exposures from Pesticide Surrogate Exposure Guide ( 8/ 98) Application Parameters Baselinea Additional PPEb Engineering Controlsc Dermal (

g/ lb ai) Inhalation (

g/ lb ai) Dermal (

g/ lb ai) Inhalation (

g/ lb ai) Dermal (

g/ lb ai) Inhalation (

g/ lb ai) Application Rate ( lb ai/ A) d Area Treated ( acre/ day) e Application Days/ year Maximum Typical 51 Ground Applications  Granulars:

8 loading granulars for ground based applications 6.9 ( single layer,

gloves, open mixing) 1.7 ( single layer,

gloves, open mixing) 3.4 ( additional layer, gloves) 0.085 ( full face resp) NF NF 5 4 80 30 9 applying granulars using ground based equipment 7.2 ( single layer,

gloves, open cab) 1.2 ( single layer,

gloves, open cab) 4.18 ( additional layer, gloves) 0.06 ( full face resp) 2.0 ( single layer,

gloves, enclosed truck cab) 0.220 ( single layer,

gloves, enclosed truck cab) 5 4 80 30 Ground Applications Liquids:

10 mixing/ loading liquids for ground based applications 23 ( single layer,

gloves, open mixing) 1.2 ( single layer,

gloves, open mixing) 17.5 ( additional layer, gloves) 0.06 ( full face resp) 8.6 ( single layer,

gloves,

closed mixing system) 0.083 ( single layer,

gloves,

closed mixing system) 3 3 80 30 11 applying liquids using ground based equipment 14 ( single layer,

gloves, open cab) 0.74 ( single layer,

gloves, open cab) 11.0 ( additional layer, gloves) 0.037 ( full face resp) 5.1 ( single layer,

gloves,

closed cab) 0.43 ( single layer,

gloves,

closed cab) 3 3 80 30 " No Data" or '" na" indicates that no appropriate data are available for incorporation into this cell. " N/ F" indicates that this exposure scenario is not considered feasible by HED due to engineering or other practical considerations ( e. g., an open cockpit aerial application scenario is not considered feasible as aircraft appropriate for this use are not manufactured 52 with open cockpits).

a Baseline clothing and PPE scenario: Workers wearing single layer clothing, chemical resistant gloves, and no respirator. Also open cab for applicators and flaggers.

Exceptions are noted on an individual basis.

b PPE: Workers typically wear double layer of clothing, chemical resistant gloves, and respirator. Exceptions are noted on an individual basis.

c Engineering controls: Workers wearing single layer clothing and no gloves while using an appropriate engineering control system ( e. g., closed mixing, enclosed cabs).

d See Section 3.2.3. for derivation of application rates.

e HED believes these values represent a reasonable estimation of the median to upper percentile of what can be treated in a single day based on the exposure scenario of concern. Users of this table are cautioned to note that these values are based on professional judgement when appropriate data are not available. 53 Table 5. Non Cancer Risks For Occupational Molinate Handlers at Baseline Clothing Scenario ( Unit Exposures from PHED)

No. Exposure Scenario Absorbed Daily Dose using Max Application Rate ( mg/ kg/ day) Short Term Risk ( MOE) Intermediate

Term Risk ( MOE)

Dermal a Inhalation b Dermal c Inhalation d Combined e Dermal f Inhalation g Combined h Aerial Applications  Granulars:

3 pilots applying granulars using aerial equipment 4 flagging during aerial application of granulars 0.0236 0.0032 76 6500 25 8 24 6 Aerial Applications Liquids:

6 pilots applying liquids using aerial equipment 7 flagging during aerial application of liquids 0.0566 0.0045 32 4600 11 4 17 3 Ground Applications  Granulars:

8 loading granulars for ground based applications 0.0158 0.0097 110 2200 38 13 8 5 9 applying granulars using ground based equipment 0.0165 0.0069 110 3000 36 12 11 6 Ground Applications Liquids:

10 mixing/ loading liquids for ground based applications 0.0315 0.0041 57 5100 19 6 19 5 11 applying liquids using ground based equipment 0.0192 0.0025 94 8200 31 10 31 8 " No Data" indicates that no appropriate data are available for incorporation into this cell. " N/ F" indicates that this exposure scenario is not considered feasible by HED due to engineering or other practical considerations ( e. g., an open cockpit aerial application scenario is not considered feasible as aircraft appropriate for this use are not manufactured with open cockpits). N/ A indicates that an appropriate risk level has been obtained and there is no need for imposition of a more protective level of risk mitigation.

a Absorbed daily dermal dose ( mg/ kg/ day) = unit exposure (

g/ lb ai)*( 1E 3 mg/ ug) unit conversion * application rate ( lb ai/ A) * acres treated ( acres/ day) * dermal absorption ( 40%)

body weight ( 70 kg)

b Absorbed daily inhalation dose ( mg/ kg/ day) = unit exposure (

g/ lb ai) * 1E 3 mg/ ug * application rate ( lb ai/ A) * acres treated ( acres/ day) * inhalation absorption ( 100%)

body weight ( 70 kg)

c Short Term Dermal MOE = [ LOAEL ( 1.8 mg/ kg/ day)] / absorbed daily dose ( mg/ kg/ day). MOEs < 300 indicate a risk concern 54 d Short Term Inhalation MOE = NOAEL ( 20.9 mg/ kg/ day)/ absorbed daily dose ( mg/ kg/ day). MOEs < 100 indicate a risk concern e Combined MOE = 1 1 + 1 ( Dermal MOE) ( Inhalation MOE)

3 f Intermediate Term Dermal MOE = NOAEL ( 0.2 mg/ kg/ day)/ absorbed daily dose ( mg/ kg/ day). MOEs < 100 indicate a risk concern.

g Intermediate Term Inhalation MOE = NOAEL ( 0.078 mg/ kg/ day)/ absorbed daily dose ( mg/ kg/ day). MOEs < 100 indicate a risk concern.

h Combined MOE = 1 ÷ ( 1/ Dermal MOE) + ( 1/ Inhalation MOE) 55 Table 6. Non Cancer Risks For Occupational Molinate Handlers at Additional Protective Clothing and PPE to Mitigate Exposures ( Unit Exposures from PHED)

No. Exposure Scenario Absorbed Daily Dose using Max Application Rate ( mg/ kg/ day) Short Term Risk ( MOE) Intermediate

Term Risk ( MOE)

Dermal a Inhalation b Dermal c Inhalation d Combined e Dermal f Inhalation g Combined h Aerial Applications  Granulars:

3 pilots applying granulars using aerial equipment 4 flagging during aerial application of granulars 0.010 0.00016 180 130,000 60 20 490 19 Aerial Applications Liquids:

6 pilots applying liquids using aerial equipment 7 flagging during aerial application of liquids 0.0526 0.00023 34 90,000 11 4 340 4 Ground Applications  Granulars:

8 loading granulars for ground based applications 0.0078 0.00049 230 43,000 77 26 160 22 9 applying granulars using ground based equipment 0.0096 0.00034 190 61,000 63 21 230 19 Ground Applications Liquids:

10 mixing/ loading liquids for ground based applications 0.0240 0.00021 75 100,000 25 8 380 8 11 applying liquids using ground based equipment 0.0151 0.00013 120 160,000 40 13 620 13 " No Data" indicates that no appropriate data are available for incorporation into this cell. " N/ F" indicates that this exposure scenario is not considered feasible by HED due to engineering or other practical considerations ( e. g., an open cockpit aerial application scenario is not considered feasible as aircraft appropriate for this use are not manufactured with open cockpits). N/ A indicates that an appropriate risk level has been obtained and there is no need for imposition of a more protective level of risk mitigation.

a Absorbed daily dermal dose ( mg/ kg/ day) = unit exposure (

g/ lb ai)*( 1E 3 mg/ ug) unit conversion * application rate ( lb ai/ A) * acres treated ( acres/ day) * dermal absorption ( 40%) body weight ( 70 kg)

b Absorbed daily inhalation dose ( mg/ kg/ day) = unit exposure (

g/ lb ai) * 1E 3 mg/ ug * application rate ( lb ai/ A) * acres treated ( acres/ day) * inhalation absorption ( 100%)

body weight ( 70 kg) 56 c. Short Term Dermal MOE = [ LOAEL ( 1.8 mg/ kg/ day)] / absorbed daily dose ( mg/ kg/ day) MOEs < 100 indicate a risk concern d Short Term Inhalation MOE = NOAEL ( 20.9 mg/ kg/ day)/ absorbed daily dose ( mg/ kg/ day). MOEs < 100 indicate a risk concern e Combined MOE = 1 1 + 1 ( Dermal MOE) ( Inhalation MOE)

3 f Intermediate Term Dermal MOE = NOAEL ( 0.2 mg/ kg/ day)/ absorbed daily dose ( mg/ kg/ day). MOEs < 100 indicate a risk concern.

g Intermediate Term Inhalation MOE = NOAEL ( 0.078 mg/ kg/ day)/ absorbed daily dose ( mg/ kg/ day). MOEs < 100 indicate a risk concern.

h Combined MOE = 1 ÷ ( 1/ Dermal MOE) + ( 1/ Inhalation MOE) 57 Table 7. Non Cancer Risks For Occupational Molinate Handlers at Engineering Controls to Mitigate Exposures ( Unit Exposures from PHED)

No. Exposure Scenario Absorbed Daily Dose using Max Application Rate ( mg/ kg/ day) Short Term Risk ( MOE) Intermediate

Term Risk ( MOE)

Dermal a Inhalation b Dermal c Inhalation d Combined e Dermal f Inhalation g Combined h Aerial Applications  Granulars:

3 pilots applying granulars using aerial equipment 0.0146 0.0279 120 750 39 14 3 2 4 flagging during aerial application of granulars 0.00040 0.000064 4500 330,000 1,500 500 1,200 360 Aerial Applications Liquids:

6 pilots applying liquids using aerial equipment 0.0257 0.00087 70 24,000 23 8 89 7 7 flagging during aerial application of liquids 0.0011 0.000090 1600 230,000 530 180 870 150 Ground Applications  Granulars:

8 loading granulars for ground based applications N/ F 9 applying granulars using ground based equipment 0.0046 0.0013 390 17,000 130 44 62 26 Ground Applications Liquids:

10 mixing/ loading liquids for ground based applications 0.0118 0.00028 150 73,000 51 17 270 16 11 applying liquids using ground based equipment 0.0070 0.0015 260 14,000 86 29 53 19 " No Data" indicates that no appropriate data are available for incorporation into this cell. " N/ F" indicates that this exposure scenario is not considered feasible by HED due to engineering or other practical considerations ( e. g., an open cockpit aerial application scenario is not considered feasible as aircraft appropriate for this use are not manufactured with open cockpits). N/ A indicates that an appropriate risk level has been obtained and there is no need for imposition of a more protective level of risk mitigation.

a Absorbed daily dermal dose ( mg/ kg/ day) = unit exposure (

g/ lb ai)*( 1E 3 mg/ ug) unit conversion * application rate ( lb ai/ A) * acres treated ( acres/ day) * dermal absorption ( 40%) body weight ( 70 kg)

b Absorbed daily inhalation dose ( mg/ kg/ day) = unit exposure (

g/ lb ai) * 1E 3 mg/ ug * application rate ( lb ai/ A) * acres treated ( acres/ day) * inhalation absorption ( 100%) 58 body weight ( 70 kg)

c Short Term Dermal MOE = [ LOAEL ( 1.8 mg/ kg/ day)] / absorbed daily dose ( mg/ kg/ day). MOEs < 100 indicate a risk concern d Short Term Inhalation MOE = NOAEL ( 20.9 mg/ kg/ day)/ absorbed daily dose ( mg/ kg/ day). MOEs < 100 indicate a risk concern e Combined MOE = 1 1 + 1 ( Dermal MOE) ( Inhalation MOE)

3 f Intermediate Term Dermal MOE = NOAEL ( 0.2 mg/ kg/ day)/ absorbed daily dose ( mg/ kg/ day). MOEs < 100 indicate a risk concern.

g Intermediate Term Inhalation MOE = NOAEL ( 0.078 mg/ kg/ day)/ absorbed daily dose ( mg/ kg/ day). MOEs < 100 indicate a risk concern.

h Combined MOE = 1 ÷ ( 1/ Dermal MOE) + ( 1/ Inhalation MOE)