Federal Food, Drug, and Cosmetic Act (FFDCA) Considerations for Choline Chloride

                    Docket ID Number: EPA-HQ-OPP-2015-0023
                             Date: August 11, 2015

Section 408(c)(2)(A)(i) of FFDCA allows the U.S. Environmental Protection Agency (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 the EPA determines that the exemption is "safe." Section 408(c)(2)(A)(ii) of FFDCA defines "safe" to mean that "there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information." This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, the EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require the EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance or tolerance exemption, 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 . . . ." Additionally, FFDCA section 408(b)(2)(D) requires that the EPA consider "available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity."
The EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, the EPA determines the toxicity of the pesticide. Second, the EPA examines exposure to the pesticide through food, drinking water, and other exposures that occur as a result of pesticide use in residential settings.
I.  Summary of Petitioned-for Tolerance Exemption
In the Federal Register of March 4, 2015 (Volume 80, Number 42, FR page numbers 11611 -11614), the EPA issued a notice pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance petition (PP 4F8287) by CP Bio, Inc.; 4802 Murrieta Street, Chino, CA 91710. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues of Choline Chloride in or on all food commodities (when applied preharvest). That document referenced a summary of the petition prepared by the petitioner CP Bio, Inc., which is available in Docket ID Number EPA-HQ-OPP-2015-0023 via http://www.regulations.gov.
II.  Toxicological Profile
Consistent with FFDCA section 408(b)(2)(D), the EPA reviewed the available scientific data and other relevant information on Choline Chloride, and considered its validity, completeness, and reliability, as well as the relationship of this information to human risk. The EPA also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
A.  Overview of Choline Chloride

Choline Chloride is a quaternary ammonium salt consisting of a choline cation with a chloride anion. As with many salts, it presents as a white crystalline solid that is odorless. It can readily dissociate into two constituents  -  Choline and Chloride  -  particularly in water. Each constituent is ubiquitous in the environment, constitutes a regular part of the human diet, and serves many critical functions in the human body. Choline is an essential human dietary component and is found in foods such as egg yolk, vegetables and animal fat as free Choline and as phophatidylcholines, such as lecithin. Choline is a precursor for the production of the neurotransmitter acetylcholine, and is important for the structural integrity of cell membranes and various physiological pathways such as methylation metabolism, transmembrane signaling, and lipid and cholesterol transport and metabolism. Choline is also endogenously produced in the pancreas. Chloride is also a regular part of the human diet, particularly as a constituent of edible salt, and serves many functions in human biology. Chiefly, Chloride is an essential electrolyte located in all body fluids and is responsible for maintaining acid/base balance, transmitting nerve impulses and regulating fluid in and out of cells.

Choline Chloride is designated as GRAS (Generally Recognized as Safe) and is approved by the Food and Drug Administration (FDA) as a human nutrient under 21 CFR 182.8252. It is also considered a GRAS substance as a nutrient and or dietary supplement in animal feeds under 21 CFR 582.5252. It has been used as a food additive in animal feed since the early 1930s (OECD, 2004).

As a biopesticide, Choline Chloride is considered a plant growth regulator (PGR) and is intended for use to increase growth and decrease stress in growing crops. (The crops listed in the End-use Product (EP) associated with this new active ingredient include fruiting vegetables, cereal grains, stone fruit, tree nuts and cotton.)  The product is to be applied at application rates ranging from 0.0004 to 0.282 lb ai/A to foliage.  The most active constituent of the active ingredient is considered to be Choline but the Chloride Salt of Choline compound (Choline Chloride) provides joint activity as the salt compound is more stable and effective as a delivery vehicle. As with most PGRs, Choline Chloride is necessarily applied at low concentrations because use at high concentrations results in detrimental effects to the plant. Choline Chloride is already approved for use by EPA as an inert ingredient in pesticide products without numerical limitation for pre-harvest food (as a solvent under 40 CFR 180.920) and nonfood uses.

Based on the data submitted in support of this petition (summarized in Unit II. B., below) and the comprehensive risk assessment conducted by the Agency (References 1-3, below), EPA concludes that there is a reasonable certainty of no harm from aggregate exposures to Choline Chloride, including the consumption of food treated with this active ingredient in accordance with label directions and good agricultural practices. EPA has made this determination because available toxicology data indicate that the active ingredient is of low acute toxicity and is not a developmental toxicant, a mutagen, or toxic via repeat oral exposure.

1. Acute Toxicity

Choline Chloride is not considered to be acutely toxic based on the available data. The chemical is classified into toxicity category III for acute oral toxicity and into toxicity category IV for dermal and inhalation toxicity and dermal and eye irritation. The substance is not considered to be a dermal sensitizer.

All Tier I mammalian acute "6-pack" toxicology data requirements were all conducted according to the OCSPP guidelines, and were found to be acceptable. The results are summarized in Table 1 below.

Table 1. Acute Mammalian Toxicology Data for Choline Chloride (40 CFR § 158.2050)
Study/OCSPP Guideline No.
Results
Toxicity Category
MRID
Acute oral toxicity (UDP method)
(870.1100)
LD50  > 1,750 mg/kg (rat)
LD50  = 3,129 mg/kg estimated

III
49403804
Acute dermal toxicity
(870.1200)
LD50 > 5,050 mg/kg (rat)
IV
49403805
Acute inhalation toxicity
(870.1300)

LC50 > 2.03 mg/L (rat)

IV
49403807
Primary eye irritation
(870.2400)
Minimally irritating (rabbit): minimal irritation observed at one hour post instillation of the test substance with clearance by 24 hours
IV
49403806
Primary dermal irritation
(870.2500)
Nonirritating (rabbit): no irritation noted at any point throughout the 72-hour study.
IV
49403808
Dermal sensitization (Buehler)
(870.2600)
Not a sensitizer (guinea pig)
N/A
49403809

2. Subchronic Toxicity

90-Day Oral

In MRID 49403810 and in the unassigned MRID associated with the subchronic toxicity requirement, data were cited from the open scientific literature to satisfy the data requirement. Two studies (21-day and 28 day oral toxicity) were assessed and found adequate for use in the risk assessment. Both studies confirm a lack of adverse effects through the oral exposure. While neither of these studies individually satisfy the 90-day oral toxicity data requirement, the collective results of these studies are sufficient to satisfy the data requirement along with the fact that Choline is an important component of the human diet and is endogenously produced in humans (as discussed previously in this document). Likewise, adverse effects are also not anticipated from the Chloride portion of the substance as Chloride is regularly consumed and is present in the human body as an electrolyte (as discussed previously in this document). Summaries of the two studies are provided below. Based on the available information, adverse effects are not anticipated from exposure to Choline Chloride as a biopesticide.

21-day Oral Toxicity Study in the Rat: In a study to evaluate the effects of Choline on microsomal liver enzymes in males versus females, rats were administered choline by gavage twice daily for 21 days at doses of 0 and 500 mg/kg/day (daily dose of 1,000 mg/kg/day). Body weights, food consumption, liver weights and several microsomal enzymes were evaluated. Body weight and food consumption were unaffected in the test animals when compared to the control animals. In the female test animals, relative liver weights were increased (4%) and microsomal liver enzyme activities related to the smooth endoplasmic reticulum were increased (3%). This effect was not observed in males. The effects were considered to be beneficial in that the increase is related to generation of membranous phospholipids. Therefore, the no-observed-adverse-effect-level (NOAEL) for the study is 1,000 mg/kg, the highest dose tested.

28-day Oral Toxicity Study in the Mouse: In a 28-day oral toxicity study, female and male mice were administered Choline Chloride by gavage daily at doses of 0 and 200 mg/kg/day. As part of the study, other groups of mice were dosed via intranasal and intraperitoneal routes as well; however, for the purposes of this subchronic oral toxicity assessment, only the part of the study involving gavage dosing of mice will be discussed as it is the route relevant to the anticipated exposure. Body weight, food and water consumption, skin, eye and mucous membranes and behavior of mice were observed daily. At study termination, hematology, clinical chemistry, gross pathology and histopathology were assessed. The results of the study indicated no adverse effects for any of the parameters tested. The NOAEL for the study is 200 mg/kg/day, which was the highest dose tested.

90-Day Dermal

The 90-day dermal data requirement is `conditionally required' (CR) to support the proposed use of Choline Chloride. The Agency has waived this data requirement at this time. This decision is based in accordance with 40 CFR 158.2050, which states that data is required when application of a product involves purposeful application to the human skin or uses that would result in prolonged dermal exposure, or if the active ingredient is known or expected to be metabolized differently by the dermal route of exposure than by the oral route and the metabolite is of toxicological concern. Although purposeful application and prolonged exposure to the human skin is not anticipated the proposed use will result in potential short-term dermal exposure to occupational mixer/loaders and applicators using aerial and ground equipment. However, Choline Chloride is a PGR and will, therefore, be used at low concentrations with an application rate ranging from 0.00044 to 0.282 lb ai/acre on agricultural crops. Appropriate Personal Protective Equipment (PPE) on end-use product labels will sufficiently mitigate any dermal exposure.

90-Day Inhalation

In accordance with 40 CFR 158.2050, the 90-day inhalation data requirement is `conditionally required' if there is a likelihood of significant levels of repeated inhalation exposure to the pesticide as a gas, vapor or aerosol. The Agency has waived this data requirement at this time based on the use pattern provided in the proposed products. First, Choline Chloride is applied as a liquid, and has a low vapor pressure and volatility (6.57-8 Pa (4.73-10 mmHg) at 25°C). Second, as a PGR, Choline Chloride will be applied at low concentrations (0.0004 to 0.282 lb ai/A) approximately 2-4 times per season. Significant inhalation exposure is not anticipated based on the character of this PGR and the proposed use pattern.

3. Mutagenicity

Mutagenicity data from the open scientific literature from the open scientific literature (MRID 49403810) satisfy the mutagenicity data requirement and support food uses for Choline Chloride. Three separate Ames assays, strains of Salmonella typhimurium were exposed to Choline Chloride at up to 10,000 ug/plate with or without metabolic activation. Choline Chloride was not considered mutagenic in any of the assays. In an in vitro chromosomal aberration assay using Chinese hamster ovary (CHO) cells, cells were exposed to Choline Chloride at up to 5,000 ug/ml with or without metabolic activation. The substance was not considered mutagenic in the assay. Ambiguous results were observed in a sister chromatid exchange (SCE) assay consisting of two parallel studies where CHO cells were exposed to Choline Chloride at concentrations of up to 5,000 ug/ml with or without metabolic activation. An increase in SCEs were observed with metabolic activation in one of the studies; however, the increase was sporadic, not dose related and not reproduced in the second parallel study. In a separate SCE study with CHO cells exposed to concentrations of choline chloride at up to 5,000 ug/ml no increase in the number of SCEs was observed. The available data indicate that that Choline Chloride is not mutagenic.

4.  Developmental Toxicity

A developmental toxicity study on mice from the open scientific literature (MRID 49403810) satisfy the data requirement and support the proposed food uses of Choline Chloride. In the study, mice were exposed every other day from gestation day 1 to 18 to Choline Chloride in feed in doses of 1250, 4160, 10800 and 20000 mg/kg/day. Historical control data from 414 pregnant mice served as the control. All mice were sacrificed on gestation day 19. Observations were made for body weight gain, resorptions, fetal survival, fetal weight and fetal external, visceral and skeletal abnormalities. Maternal body weight gain was reduced in all but the lowest dose group. All fetuses were resorbed in the highest dose group. No resorptions occurred in the low dose group. Fetal lethality occurred in the 4160 (35% lethality) and 10800 (69% lethality) dose groups. No statistically significant fetal malformations were observed. The NOAEL for maternal and developmental toxicity was 1250 mg/kg. Although adverse effects were observed in this study, the effects were at extremely high doses. These are doses to which humans are extremely unlikely to be exposed. All of the doses employed in the study were above OCSPP's currently recommended top dose, or limit dose of 1,000 mg/kg, for toxicity testing. No adverse effects were observed at the dose of 1250 mg/kg which is above the limit dose. The top dose used in the study was 20 times that recommended in the current OCSPP and OECD test guidelines.

III.  Aggregate Exposure

In examining aggregate exposure, FFDCA section 408 directs the 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).

Food Exposure: Dietary exposure to the pesticidal residues of Choline Chloride is expected to be negligible. One, Choline Chloride is a PGR and is necessarily applied at low concentrations. (As with most PGRs, use of high concentrations can result in detrimental effects to the plant.) Two, Choline Chloride biodegrades rapidly, once applied. A MITI-I test demonstrated that Choline Chloride is 93% degraded within 14 days. Three, as a salt, Choline Chloride dissociates readily when in contact with water, making its persistence as a residue even more unlikely. (OECD, 2004) Altogether, the pesticidal use of Choline Chloride is not likely to contribute significantly to human dietary exposure.
Notably, humans are already dietarily exposed to Choline Chloride. It is produced endogenously; and it is found naturally in foods in the human diet. Indeed, it is considered an essential human dietary component, serving critical functions in nerve transmission, cell membrane integrity and lipid metabolism. (OECD, 2004)
Drinking Water Exposure: No significant residues of choline chloride are expected in drinking water when products are used according to label instructions. The active ingredient is applied terrestrially at low concentrations; it is very soluble in water; and it biodegrades rapidly, once applied. As such, any residues of choline chloride in drinking water are anticipated to be negligible.
It should be additionally noted that both choline and chloride, the constituents of choline chloride, are ubiquitous in the environment; and there is a long history of incidental, but minor, exposure through drinking water. For the reasons discussed above  -  namely, high solubility and biodegradability, the pesticidal use of choline chloride is not anticipated to contribute significantly to human exposure beyond existing background levels.
Other Non-occupational Exposure:  Non-occupational exposure to Choline Chloride residues are not expected. Choline Chloride is not intended for use in residential settings; it is intended for agricultural use only.

IV.  Cumulative Effects from Substances with a Common Mechanism of Toxicity

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the EPA consider "available information concerning the cumulative effects of [a particular pesticide's] . . . residues and other substances that have a common mechanism of toxicity."

The EPA has not found Choline Chloride to share a common mechanism of toxicity with any other substances, and Choline Chloride does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, the EPA has assumed that Choline Chloride does not have a common mechanism of toxicity with other substances.

For information regarding the EPA's efforts to determine chemicals that have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the EPA's website at http://www.epa.gov/pesticides/cumulative.

V.  Determination of Safety for the U.S. Population, Infants and Children

FFDCA section 408(b)(2)(C) provides that, in considering the establishment of a tolerance or tolerance exemption for a pesticide chemical residue, the EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) provides that the 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 the EPA determines that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factor. In applying this provision, the EPA either retains the default value of 10X, or uses a different additional or no safety factor when reliable data are available to support a different additional or no safety factor.

Because there are no threshold effects associated with this biochemical, an additional margin of safety for infants and children is not necessary.

EPA has determined that there are no foreseeable dietary risks to the U.S. population, including infants and children, from the pesticidal use of Choline Chloride. Exposure to the residues of Choline Chloride are expected to be negligible due to the low concentrations associated with its use as a PGR and its high solubility and rapid biodegradability. Moreover, any exposure to Choline Chloride residues are not expected to pose a risk. No toxic endpoints have been established for Choline Chloride. There has been a long history of significant human dietary and endogenous exposure without documented incident. And the constituents of Choline Chloride are known to be readily metabolized.
VI.  Conclusions
The EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues of Choline Chloride. Therefore, an exemption from the requirement of a tolerance is established for residues of Choline Chloride in or on all food commodities when applied preharvest and used in accordance with label directions and good agricultural practices.

VII.  References

OECD (2004) SIDS Initial Assessment Report for SIAM 19: Choline Chloride. October 19-22.
	< http://www.inchem.org/documents/sids/sids/67481.pdf>

Ottenstein, B., Boncoddo, N., Walker, A. and Thurmon, F. (1952) Experiments on the choline content of the skin and sebum. J. Invest. Dermatol. 19:105-108.


[Federal Register Volume 81, Number 117 (Friday, June 17, 2016)]
[Proposed Rules]
[Pages 39604-39605]
[FR Doc No: 2016-14281]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2016-0280; FRL-9947-80-Region 7]

Approval of Iowa's State Implementation Plan (SIP); Definition of
Greenhouse Gas and Prevention of Significant Deterioration (PSD)
Plantwide Applicability Limits (PALs) Revisions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve two SIP revisions submitted by the State of Iowa. First, EPA is
proposing to approve the definition of greenhouse gas, which will make
the state's definition consistent with the Federal definition, and add
greenhouse gases to emission inventory requirements. Second, EPA is
proposing to approve Iowa's revision to its Prevention of Significant
Deterioration (PSD) program, specifically to the definition of
``subject to regulation,'' and adopt by reference the most recent
Federal plantwide applicability limitations (PALs) provisions.

DATES: Written comments must be received by July 18, 2016.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R07-
OAR-2016-0280, to http://www.regulations.gov. Follow the online
instructions for submitting comments. Once submitted, comments cannot
be

edited or removed from Regulations.gov. The EPA may publish any comment
received to its public docket. Do not submit electronically any
information you consider to be Confidential Business Information (CBI)
or other information whose disclosure is restricted by statute.
Multimedia submissions (audio, video, etc.) must be accompanied by a
written comment. The written comment is considered the official comment
and should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, the full EPA public comment
policy, information about CBI or multimedia submissions, and general
guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Heather Hamilton, Environmental
Protection Agency, Air Planning and Development Branch, 11201 Renner
Boulevard, Lenexa, Kansas 66219 at<PHONE_NUMBER>, or by email at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This document proposes to take action to
approve the definition of greenhouse gas, and add greenhouse gases to
emission inventory requirements. We have published a direct final rule
approving the State's SIP revision (s) in the ``Rules and Regulations''
section of this Federal Register, because we view this as a
noncontroversial action and anticipate no relevant adverse comment. We
have explained our reasons for this action in the preamble to the
direct final rule. If we receive no adverse comment, we will not take
further action on this proposed rule. If we receive adverse comment, we
will withdraw the direct final rule and it will not take effect. We
would address all public comments in any subsequent final rule based on
this proposed rule. We do not intend to institute a second comment
period on this action. Any parties interested in commenting must do so
at this time. For further information, please see the information
provided in the ADDRESSES section of this document.

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Greenhouse gases,
Incorporation by reference, Reporting and recordkeeping requirements.

    Dated: June 3, 2016.
Mark Hague,
Regional Administrator, Region 7.
[FR Doc. 2016-14281 Filed 6-16-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: July 5, 2007 (Volume 72, Number 128)]
[Notices]
[Page 36698-36699]
[DOCID:fr05jy07-64]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12805-000]

Pacific Gas and Electric Company; Notice of Application Accepted
for Filing and Soliciting Motions To Intervene, Protests, and Comments

June 28, 2007.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 12805-000.
    c. Date filed: June 11, 2007.
    d. Applicant: Pacific Gas and Electric Company.
    e. Name of Project: Pit 3 Dam Streamflow Incremental Generation
Project.
    f. Location: The project would be located in the Pit River upstream
of Shasta Lake, near the towns of Burney, Fall River Mills, and
McArthur, in Shasta County, California.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)--825(r).
    h. Applicant Contact: Mr. Alan Soneda, Pacific Gas and Electric
Company, 245 Market Street, MS N11E, P.O. Box 770000, San Francisco, CA
94177-0001, phone<PHONE_NUMBER>.
    i. FERC Contact: Sonali Dohale,<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. Description of Project: The proposed project would consist of
one powerhouse with a turbine and generator to be constructed on the
right abutment at the downstream side of the existing Pit 3 Dam. The
proposed Project will be run-of-river; the minimum required instream
flow below Pit 3 Dam will be passed through the proposed powerhouse
without change in volume or timing. The project is estimated to have an
annual generation of 18.3 gigawatt-hours per-year.
    l. Locations of Applications: A copy of the application is
available for inspection and reproduction at the Commission in the
Public Reference Room, located at 888 First Street NE, Room 2A,
Washington DC 20426, or by calling<PHONE_NUMBER>. This filing may also
be viewed on the Commission's Web site at http://www.ferc.gov using the

``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy is

also available for inspection and reproduction at the address in item h
above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Competing Preliminary Permit: Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice

of intent to file such an application, to the Commission on or before
the specified comment date for the particular application (see 18 CFR
4.36). Submission of a timely notice of intent allows an interested
person to file the competing preliminary permit application no later
than 30 days after the specified comment date for the particular
application. A competing preliminary permit application must conform
with 18 CFR 4.30(b) and 4.36.
    o. Competing Development Application: Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30(b) and 4.36.
    p. Notice of Intent: A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    q. Proposed Scope of Studies under Permit: A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    r. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210,
385.211, 385.214. In determining the appropriate action to take, the
Commission will consider all protests or other comments filed, but only
those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any comments,
protests, or motions to intervene must be received on or before the
specified comment date for the particular application.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper; See 18 CFR 385.2001 (a)(1)(iii) and
the instructions on the Commission's Web site under ``e-filing'' link.
The Commission strongly encourages electronic filing.
    s. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``RECOMMENDATIONS
FOR TERMS AND CONDITIONS'', ``PROTEST'', ``COMPETING APPLICATION'' OR
``MOTION TO INTERVENE'', as applicable, and the Project Number of the
particular application to which the filing refers. Any of the above-
named documents must be filed by providing the original and the number
of copies provided by the Commission's regulations to: The Secretary,
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. A copy of any motion to intervene must also be
served upon each representative of the Applicant specified in the
particular application.
    t. Agency Comments: Federal, state, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-12928 Filed 7-3-07; 8:45 am]

BILLING CODE 6717-01-P


ATTACHMENT 3 Premanufacture Notice ( PMN) Form and Instructions EPA Form 7710 15 [ For electronic copies of the PMN Form and Instructions, see http:// www. epa. gov/ opptintr/ newchems/ pmnforms. htm and follow the appropriate links.] ATTACHMENT 4 Calculation of Hourly Wage Rates ( Excerpt from Economic Impact Analysis) 1U. S. Department of Labor, Bureau of Labor Statistics. Occupational Compensation Survey, National Summary 1996.

2Managerial labor is assumed to be composed of operational labor, including engineers or chemists at the plant manager, facility research manager, or higher levels, legal managers, and financial managers.

3Technical labor is assumed to be composed of operational labor, including senior engineers or chemists equivalent to head process or project engineer, and financial labor, such as accountants. It is assumed that operational labor is used at a five to one ratio with financial labor.

4The methodology used for the CAIR analysis also used wage information for chemists in estimating the managerial and technical wage rates. The current methodology does not include chemists in estimating the composite wage rates because updated information on wage levels for chemists was not available from BLS. The Engineer salary information is expected to be similar to Chemist salary information. In addition, BLS data for Level VI attorneys in goods producing industries were not available, so wages for all private industry level VI attorneys were used instead.

5U. S. Department of Labor, Bureau of Labor Statistics. Employment Cost Index  March 1998, U. S. Department of Labor, Washington, D. C., U. S. Department of Labor News Release 01 236, June 2001, Table 6.

6U. S. Department of Labor, Bureau of Labor Statistics. Employer Costs for Employee Compensation  March 2001, www. bls. gov, Table 11. Calculation of Hourly Wage Rates Wage data used in developing the basic wage rates for this analysis were derived from 1996 wage information published by the Bureau of Labor Statistics ( BLS) for all goods producing, private industries1. The managerial, technical, and clerical wage rates are based on wage information for four BLS occupation categories: engineers, accountants, attorneys, and secretaries. As shown in Table A 1, the managerial and technical level wage rates are composites of the BLS wage rates for several occupation categories and levels. The managerial level wage rate is a composite of the wage rates of Engineers ( levels VI VIII), Accountants ( levels V VI), and Attorneys ( levels IV VI) 2. The technical level wage is a composite of the wage rates of Engineers ( levels III VIII) and Accountants ( levels ( III VI) 3. The clerical wage rate is an average of all the clerical wage levels provided by BLS ( i. e., levels I V). The weighting factors used to develop the managerial and technical wage rates are based on information provided by the chemical industry and chemical industry trade associations on the typical fraction of total reporting effort that is accounted for by each specific BLS occupation category. 4 The 1996 composite annual salary estimates were adjusted to second quarter 2001dollars using the Employment Cost Index ( ECI) for three categories of white collar occupations in private industries5. The 2001 adjusted, composite salary for the managerial, technical, and clerical labor categories was then multiplied by benefits and overhead factors to estimate a 2001 loaded, annual salary. Detailed benefits data for white collar occupations in private, goods producing industries were used to account for the additional cost of benefits for managerial, technical, and clerical labor6. The overhead factor of 17 percent is based on information provided by the chemical industry and chemical industry trade associations. The loaded annual salary was then divided by 2,080 hours ( i. e., the average number of hours worked per year by a full time employee) to derive the loaded, hourly wage rates used in this analysis for each labor category. The hourly wage rates are $ 98.34 for managerial personnel, $ 72.89 for technical personnel and $ 29.39 for clerical personnel, all in 2001 dollars. TABLE A 1 LOADED HOURLY WAGE RATES BY LABOR CATEGORY Labor Category Occupation ( levels) June 1996 Average Salary Weighting Factor 1996 Composit e Salary* ECI Ratio 6/ 96:

12/ 01 2001 Adjusted Salary 2001 Benefits (% Salary) Overhead (% Salary) 2001 Loaded Annual Salary 2001 Loaded Hourly Rate Managerial Engineer ( VI VIII) $ 104,971 10/ 17 $ 61,748 Attorney ( IV VI) $ 116,255 5/ 17 $ 34,193 Accountant ( V VI) $ 82,030 2/ 17 $ 9,651 Composite $ 105,592 1.23 $ 129,878 40.5% 17.0% $ 204,558 $ 98.34 Technical Engineer ( III VIII) $ 83,243 5/ 6 $ 69,369 Accountant ( III VI) $ 65,780 1/ 6 $ 10,963 Composite $ 80,332 1.19 $ 95,595 41.6% 17.0% $ 151,614 $ 72.89 Clerical Secretarial ( I V) $ 31,502 1/ 1 $ 31,502 Composite $ 31,502 1.21 $ 38,117 43.4% 17.0% $ 61,140 $ 29.39 * Composite Salaries are determined by multiplying average salaries by the weighting factor and summing across occupations.

Sources: U. S. Department of Labor, Bureau of Labor Statistics. Occupational Compensation Survey, National Summary, 1996. U. S. Department of Labor, Bureau of Labor Statistics. Employment Cost Index  March 1998, U. S. Department of Labor, Washington, D. C. U. S. Department of Labor News Release 01 236, June 2001, Table 6. ATTACHMENT 5 Selection Criteria  TSCA Section 8( a) Rule vs. SNUR SELECTION CRITERIA: These criteria serve as guidelines and not as rigid standards for the regulatory selection process.

SECTION 8( a) Rules   REQUIREMENTS, TYPES OF DATA, USES:

  Statutory prerequisites: None ( i. e., no required risk findings) other than a legitimate Agency need for such data " as the Administrator may reasonably require" and the use of notice and comment rulemaking for the establishment of reporting requirements.

 Scope: EPA can require reporting by manufacturers, importers, and processors of both new ( PMN) and existing ( initial Inventory) chemical substances.

 Types of data: EPA may use section 8( a) rules to obtain a variety of health and environmental data, including data on chemical identity and structure, uses, volume of production/ importation/ processing, byproducts, health and environmental effects, exposure, and disposal.

 Data support functions: Section 8( a) rules provide background exposure related data to support chemical risk assessment; e. g., data support for section 4 testing decisions, voluntary testing decisions, section 6 rulemaking, section 9 referral actions, follow up SNURs, and chemical advisories.

 Follow up monitoring function: Section 8( a) rules can be used to monitor certain chemical activities which may cause significant new or ongoing exposures to the subject chemicals ( i. e., section 8( a) reporting rules can be triggered by the commencement of certain prescribed chemical activities or by prescribed changes in chemical activities); this type of section 8( a) rule ensures that EPA will receive notification and information concerning the chemical activities described in the rule; however, the Agency can only take follow up action through lengthy rulemaking ( via section 4, 5( a)( 2), or 6) or by civil action in cases of extreme and imminent hazard ( via section 7).

CRITERIA THAT FAVOR DEVELOPMENT OF A SECTION 8( a) RULE  A need to gather data for chemical risk assessment, with no perceived need for immediate shortterm control action: The basic data support function described above is the primary function of section 8( a) rules.

 Lesser health and environmental concerns: If EPA intends to develop a follow up/ monitoring rule for a particular chemical substance, the Agency would favor a section 8( a) rule when the level of OTS concern regarding health and environmental effects of the chemical is not sufficient to require that follow up action be immediately available ( under section 5( e) or 5( f)) once the reporting requirement is triggered and notification is received by EPA ( e. g., the substances is an eye or skin irritant; EPA lacks sufficient data on health and environmental effects for purposes of risk assessment; the substance may cause transient neurotoxic effects; the substances has moderate acute toxicity; the substance may persist in the environment; the substance may cause organ damage or reduced sperm counts; chronic exposure to the substance may result in health effects that generally are reversible).  Activities are ongoing: If EPA intends to develop a follow up/ monitoring rule for a particular chemical substance, the Agency would favor a section 8( a) rule when the chemical activities in question are ongoing at the time of rulemaking ( i. e., currently taking place or recently ceased and likely to resume) or are likely to be ongoing when the rule is proposed. By definition, a SNUR would not be possible under such circumstances.

 A need for long term monitoring: A section 8( a) rule is favored if OTS needs to monitor industrywide production and exposure trends on a long term basis, as in the following examples:

( 1) The rule may be triggered by a number of different firms over time, and the activity eventually may be considered ongoing ( thereby preventing a SNUR);

( 2) The rule may be triggered a number of times by the same firm, and the activity may be considered ongoing;

( 3) Potential increases in exposure are expected to occur gradually over time and/ or at a number of independent sites, making it necessary for the Agency to gather, aggregate, and analyze exposure related data before making a decision about the potential for unreasonable risk.

SECTION 5( a)( 2) SNURS   REQUIREMENTS, TYPES OF DATA, USES:

 Statutory prerequisites: TSCA does not require a risk finding for SNURs. The only statutory requirements are ( 1) that EPA consider " all relevant factors" ( including the four exposure related factors in section 5( a)( 2)) before designating a significant new use, and ( 2) that the use not be ongoing at the time the SNUR is promulgated ( i. e., not currently taking place or recently ceased and likely to resume).

 Scope: SNURs may be applicable to manufacturers, importers, and processors of both new and existing chemical substances.

 Types of data: EPA is authorized to require SNUR notice submitters to report the same types of data as may be required under section 8( a), plus certain types of test data in certain limited cases ( note that health and environmental data must already be in the " possession or control" of the person submitting the notice ( other health and environmental data which are known to or reasonably ascertainable by the person submitting the notice, which need only be described)); EPA generally requires SNUR respondents to complete the PMN reporting form.

 Follow up monitoring function: SNURs can serve largely the same monitoring/ notification/ information function as section 8( a) rules, with three important differences:

( 1) A significant new use must be an activity that is not ongoing at the time the SNUR is promulgated; ( 2) A SNUR respondent cannot commence the significant new use while EPA is evaluating the data in the SNUR notice; ( 3) TSCA authorizes EPA to take immediate follow up control action under either section 5( e) ( the Agency lacks data but determines that the activity may present an unreasonable risk) or section 5( f) ( the activity will present an unreasonable risk and section 6 action is necessary).

CRITERIA THAT FAVOR DEVELOPMENT OF A SECTION 5( a)( 2) SNUR:

  Greater health and environmental concerns: If the potential health and environmental hazards posed by a chemical substance are of sufficient concern to OTS that the Agency wants to be able to do the following:

( 1) Monitor potential exposure/ risk which may be caused by non ongoing activities involving the subject chemical;

( 2) Prevent these activities from occurring until OTS has completed its assessment of the activities and has determined the potential for release and exposure;

( 3) Take immediately effective control action ( if necessary) via section 5( e) or 5( f) to prevent the activities from occurring ( at least on an interim basis) after the completion of Agency review ( e. g., the substance is a possible or probably human carcinogen; the substance may cause human teratogenic or reproductive effects; the substance has high acute toxicity; the substance tends to bioaccumulate in living tissue and is slow to biodegrade; chronic exposure to the substance may result in health effects that generally are irreversible).

  Likely that small businesses engage in the activities: Section 8( a) exempts small manufacturers, importers, and processors ( as defined by EPA) from reporting requirements under that section. The Agency therefore may not receive adequate data from a section 8( a) rule in some cases if a substantial number of the firms subject to the rule qualify as " small." If EPA can determine prior to rulemaking that there is a likelihood that respondents will be small firms, the Agency may wish to ensure that it will have access to information from these key potential respondents by developing a SNUR for datagathering purposes.

OTHER CRITERIA THAT MAY AFFECT THE REGULATORY SELECTION PROCESS ( examined in every case):

 Federal regulatory action and state statutory/ regulatory action involving the subject chemical: Relevant to the current need for OTS regulatory action, the likelihood of ongoing or future activities, and past experiences involving the subject chemical.

 Know past and present activities and projected future activities involving the subject chemical ( including the size of the firms involved, the volume of production/ importation/ processing, potential releases and exposures, etc.): If available, this information is a relevant supplement to all of the section 8( a)/ SNUR criteria listed above.

 Concerns and objective of EPA and the technical staff responsible for the subject chemical: ECAD regulatory staff relies heavily on continuing input from management ( with regard to long term regulatory objectives for the subject chemical) and technical staff ( with regard to health and environmental concerns and short term regulatory objectives). ATTACHMENT 6 Selected SNUR Case History Abstracts HEXACHLORONORBORNADIENE ( CAS # 2432 99 7)

° also known as HEX BCH.

II. TOXICITY ° Extremely persistent compound with a great tendency to bioaccumulate. ° Slow biodegradation. ° Very toxic to fish. ° Possible analogue to known carcinogens.

II. REFERRING OFFICE'S CONCERNS/ NEEDS ° Monitor: its manufacture, importation, and processing; intended end uses, and potential worker exposure and environmental releases. ° Once production levels reach a certain point, EPA will reconsider its decision not to text HEX BCH.

III. USES A. Past and Ongoing ° Commercial batch manufacture and processing. ° Intermediate in the production of isodrin which is an intermediate in the production of endrin ( both pesticides).

B. Small Business ° Capable of production by a small firm.

IV. REGULATORY BACKGROUND ° Listed on the Preliminary Assessment Information Rule. ( One time reporting only). ° Listed on the section 8( d) model health and safety data reporting rule ( 40 CFR Part 716). ° Local limit on its discharge in a public treatment system. Limit based on plant's treatment capacity and not on human health or environmental risk. V. RECOMMENDATION/ RATIONALE: Section 8( a) rule for ongoing uses and significant new use rule for non ongoing uses.

° Well documented high toxicity concern. ° Small businesses potential. ° Satisfies referring office's needs. ° No federal regulation exists to provide a governmental entity with an opportunity to: evaluate potential human and environmental exposures to HEX BCH from its manufacture, importation, processing, and intended end use; and to protect human beings and the environment from potentially adverse exposures before they occur. METHYL N BUTYL KETONE ( CASE # 591 78 6)

° also known as MBK.

VII. TOXICITY ° Causes central and peripheral neuropathy in humans. Nerve damage is irreversible at concentrations as low as 50 ppm. ° Absorbed readily through the skin. ° Eye and skin irritant. ° Limited evidence suggests testicular atrophy.

II. REFERRING OFFICE'S CONCERNS/ NEEDS ° Monitor: its resumption of commercial manufacture, importation, and processing; intended end uses, and potential worker and consumer exposure.

III. USES A. Past ° Commercial manufacture, importation and processing. ° Solvent in lacquers, sealers, varnish removers, oils, fats, and waxes. ( i. e., consumer products).

B. Ongoing ° Importation for toxicological research and development.

C. Small Business ° Capable of production by a small firm.

IV. REGULATORY BACKGROUND ° Occupational Safety and Health Administration standard ( 8 hour Time Weighted Average ( TWA) 100 ppm). ° American Conference of Governmental Industrial Hygienists TWA 5 ppm. No binding effect. ° National Institute of Occupational Safety and Health TWA 5 ppm. No binding effect.

V. RECOMMENDATION/ RATIONALE: Significant new use rule.

° Well documented high toxicity concern. ° Small businesses potential. ° Satisfies referring office's needs. ° No federal regulation exists to provide a governmental entity with an opportunity to: evaluate potential human and environmental exposures to MBK from its manufacture, importation, processing, and intended end use; and to protect human beings and the environment from potentially adverse exposures before they occur. URETHANE ( CASE # 51 79 6)

° Urethane is a name commonly but improperly applied to high molecular weight polyurethanes used as foams, elastomers, and coatings. These products are not made from the urethane, and do not generate urethane upon decomposition.

X. TOXICITY ° Urethane is well established as a carcinogen. Malignant tumors have occurred in many species of animals following the administration of urethane by the oral, inhalation, topical, subcutaneous, and intraperitoneal routes. Urethane is also a transplacental carcinogen that readily traverses the placenta and affects the fetus. ° Toxic fumes when heated; liver toxin; bone marrow depressant.

II. REFERRING OFFICE'S CONCERNS/ NEEDS ° Monitor: its resumption of manufacture, importation, and processing; intended end uses, and potential worker and consumer exposure.

III. USES A. Past ° Commercial manufacture, importation and processing. ° Intermediate in the production of N hydroxymethyl derivatives, which are useful as cross linking agents for imparting wash and wear properties to fabrics. ° Human medicine: sclerosing agent for varicose veins and hemorrhoids, antineoplastic agent, hypnotic, treatment of chronic leukemia, and multiple myeloma. ° Pharmaceutical intermediate.

B. Ongoing ° Toxicological research.

C. Small Business ° Capable of production by a small firm.

IV. REGULATORY BACKGROUND ° Banned by the Food and Drug Administration as an active and inactive ingredient in drugs. FDA also prohibited the use of a food preservative that produces urethane when it is used tin acidic beverages. ° Designated by EPA as a Toxic Hazardous Waste # 238. ° Listed as a Hazardous material under the Hazardous Materials Transportation Act. V. RECOMMENDATION/ RATIONALE: Significant new use rule.

° Well documented high toxicity concern. ° Small businesses potential. ° Satisfies referring office's needs. ° No federal regulation exists to provide a governmental entity with an opportunity to: evaluate potential human and environmental exposures from urethane's manufacture, importation, processing, and intended end use; and to protect human beings and the environment from potentially adverse exposures before they occur.

The consequences of not collecting this information is to allow, without EPA review, human and environmental exposures to toxic chemical substances. PENTABROMOETHYLBENZENE ( CASE # 85 22 3)

° also known as PEB.

X. TOXICITY ° Carcinogenicity observed in other structurally related compounds having a polyhalogenated aromatic moiety. ° Persistent compound with a great tendency to bioaccumulate. ° Slow biodegradation.

II. REFERRING OFFICE'S CONCERNS/ NEEDS ° Monitor: its resumption of commercial manufacture, importation, and processing; intended end uses, and potential worker exposure and environmental release. ° If production is to be reinstated, EPA will reconsider its decision not to test HEXBCH

III. USES A. Past and Ongoing ° Has been used in the past as an additive type flame retardant. ° No known ongoing uses.

B. Small Business ° Capable of production by a small firm.

V. REGULATORY BACKGROUND ° The Interagency Testing Committee designed PEB for priority consideration in its 15th report. ° Listed on the section 8( d) model health and safety data reporting rule ( 40 CFR Part 716). ° Listed on the Preliminary Assessment Information Rule. ( 40 CFR Part 712). ° Proposed, pursuant to section 4( a)( 1)( A) findings, that chemical fate and environmental effects testing be performed. ° Proposed Test Rule withdrawn due to termination of all known manufacture and processing operations. V. RECOMMENDATION/ RATIONALE: Significant new use rule.

° Structurally analogous to substances of carcinogenic concern. ° Small businesses potential. ° Satisfies referring office's needs. ° No federal regulation exists to provide a governmental entity with an opportunity to: evaluate potential human and environmental exposures to PEB from its manufacture, importation, processing, and intended end use; and to protect human beings and the environment from potentially adverse exposures before they occur.


[Federal Register Volume 87, Number 133 (Wednesday, July 13, 2022)]
[Notices]
[Page 41857]
[FR Doc No: 2022-14855]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2002-13251]

Petition for Extension of Waiver of Compliance

    Under part 211 of title 49 Code of Federal Regulations (CFR), this
document provides the public notice that on June 1, 2022, Arizona
Eastern Railway Company (AZER) petitioned the Federal Railroad
Administration (FRA) for an extension of a waiver of compliance from
certain provisions of the Federal railroad safety regulations contained
at 49 CFR part 232, Brake System Safety Standards for Freight and Other
Non-passenger Trains and Equipment; End of Train Devices. The relevant
FRA Docket Number is FRA-2002-13251.
    Specifically, AZER seeks to extend relief that permits movement
from the Freeport-McMoRan Copper & Gold's mining facility near
Claypool, Arizona, to a location between mileposts (MPs) 1229.0 and
1227.6 on AZER trackage, where the required inspections (a pre-
departure inspection and Class 1 initial terminal air brake test and
inspection) are performed. Additionally, AZER seeks to extend relief
formerly granted in FRA Docket Number FRA-2017-0100, which permits
movement from Clifton Yard in Clifton, Arizona, to South Siding near MP
1210.0, where the required inspections are performed. FRA is combining
the requests and relief from both dockets and considering them under
the originally assigned docket number for the relief in Claypool,
Arizona, Docket Number FRA-2002-13251. In support of its request, AZER
states that railroad operations have remained the same since the
original waivers were granted, and rail traffic volumes have
continuously increased, supporting the need for this relief.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment and a public hearing, they
should notify FRA, in writing, before the end of the comment period and
specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted at http://www.regulations.gov. Follow the online instructions for submitting
comments.
    Communications received by August 29, 2022 will be considered by
FRA before final action is taken. Comments received after that date
will be considered if practicable.
    Anyone can search the electronic form of any written communications
and comments received into any of our dockets by the name of the
individual submitting the comment (or signing the document, if
submitted on behalf of an association, business, labor union, etc.).
Under 5 U.S.C. 553(c), the U.S. Department of Transportation (DOT)
solicits comments from the public to better inform its processes. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
https://www.transportation.gov/privacy. See also https://www.regulations.gov/privacy-notice for the privacy notice of
regulations.gov.

    Issued in Washington, DC.
John Karl Alexy,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2022-14855 Filed 7-12-22; 8:45 am]
BILLING CODE 4910-06-P


                  UNITED STATES ENVIRONMENTAL PROTECTION AGENCY                 NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY                              2000 TRAVERWOOD DRIVE                            ANN ARBOR, MI  48105-2498

									     OFFICE OF 									AIR AND RADIATION 6/21/16

MEMORANDUM

SUBJECT: Allison meeting on GEM related issues

FROM: Houshun Zhang

TO:  Greenhouse Gas Emissions Standards and Fuel Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles - Phase 2 - Docket EPA-HQ-OAR-2014-0827

This memo documents a conference call meeting at EPA on June 13, 2016 with Allison Transmission, Inc.  Many people from Allison attended this meeting, including Debbie Gordon, Scott Mundy, Jed Mott, Bob Meyers, and Jeff Shultz. On EPA side,  Houshun Zhang, James Sanchez, Paul Dekraker, and Kevin Newman attended meeting.

During the meeting, Allison presented their findings on GEM with many constructive comments, specifically on shifting strategy.  EPA staff will investigate their comments, and take necessary actions accordingly if needed.


(B) Chronic test. At a minimum, dissolved oxygen should be measured in each replicate at the beginning and end of the test and at weekly intervals. However, for some chronic static-renewal tests (e.g., Daphnia magna chronic toxicity, 850.1300), it is recognized that this may result in a large of samples at each sampling period. Additionally, for chronic flow-through tests that use "splitters" to deliver the test solution to more than one replicate test vessel in a consistent manner, dissolved oxygen may not need to be measured in each replicate at weekly intervals.  Refer to paragraph (e)(6)(iii) for examples regarding exceptions to measuring each test vessel.
             (C) Sediment test. Dissolved oxygen should be measured daily in at least one replicate per control and treatment level. For static-renewal tests, the measurement should be taken just before water renewal.
      (4) pH. The pH in tests should not vary by more than 1.0 units in any one test.
            (A) Acute test. pH should preferably be measured daily in each replicate. However, at a minimum, pH should be measured in each replicate at the beginning and end of the test and every 24 hours in at least one replicate each of the control(s) and highest, lowest, and middle treatment levels.
            (B) Chronic test. At a minimum, pH should be measured in each replicate at the beginning and end of the test and at weekly intervals. However, for some chronic static-renewal tests (e.g., Daphnia magna chronic toxicity, 850.1300), it is recognized that this may result in a large of samples at each sampling period. Additionally, for chronic flow-through tests that use "splitters" to deliver the test solution to more than one replicate test vessel in a consistent manner, dissolved oxygen may not need to be measured in each replicate at weekly intervals.  Refer to paragraph (e)(6)(iii) for examples regarding exceptions to measuring each test vessel.
            (C) Sediment test. pH should be measured daily in at least one replicate per control and treatment level. For static-renewal tests, the measurement should be taken just before water renewal.
      (5) Hardness (freshwater tests).
            (A) Acute test. Total water hardness should be measured in the dilution water at the beginning of the test.
            (B) Chronic test. At a minimum, total water hardness should be measured in at least one replicate in the dilution water control and highest treatment level at the beginning and end of the test and at weekly intervals.
            (C) Sediment test. Total water hardness should be measured in the overlying water in at least one replicate of each control and treatment level at the beginning and end of the test.
      (6) Salinity (saltwater tests).
            (A) Acute test. Salinity should be measured at the beginning and end of the test in at least one replicate of each control and treatment level. For a static-renewal test, salinity should be measured at the beginning of the test and at the end of the longest renewal period in at least one replicate of each control and treatment level. For flow-through tests, salinity should be measured at the beginning and end of the test in at least one replicate of each control and treatment level. In a flow-through test using natural seawater unadjusted for salinity which can fluctuate during the test, salinity should be measured at the beginning and end of the test in at least one replicate of each control and treatment level, and measuring the salinity in one replicate of each control for the other days is recommended. The specific test guideline should be consulted for further guidance.
            (B) Chronic test. For flow-through tests, salinity should be measured at a minimum at the beginning and end of the test in at least one replicate of each control and treatment level.
            (C) Sediment test. Salinity should be measured in the overlying water in at least one replicate of each control and treatment level at the beginning and end of the test.
      (7) Ammonia. Exposure to ammonia can have an adverse effect on the test organisms (see paragraphs (l)(30) and (l)(33) of this guideline). Ammonia levels are generally of a greater concern in sediment tests. Therefore, in sediment tests, the ammonia concentration should be measured in the overlying water in at least one replicate of each control and treatment level at the beginning and end of the test. In addition, ammonia should be measured in pore water at the beginning, middle, and end of the test. Total ammonia measurements are recommended.
       (8) Alkalinity and specific conductance. Alkalinity and specific conductance should be measured in the dilution water at the beginning of the test. For longer duration chronic tests (i.e., OCSPP 850.1400, Fish Early Life-stage), weekly measurements are recommended as well (see paragraph (i)(5) on dilution water hardness for details regarding where to sample).
      (9) TOC and COD. Measurement of TOC or COD in the dilution water at the beginning of the test is recommended, but at a minimum, TOC and COD should be analyzed periodically in the dilution water source to document and characterize their magnitude and variability. For tests with cationic substances, TOC or COD should be measured at the beginning of the test.
(j) Test validity elements. Test-specific validity elements can be found in each OCSPP Series 850, Group A guideline. Additional test validity elements that apply to all OCSPP Series 850, Group A guidelines are as follows:
      (1) Test substance exposure concentrations. Refer to the general discussion of replicates under paragraph (e)(6)(iii) of this guideline.
            (i) A test may be considered to be unacceptable or invalid if:
                  (A) The test substance was not stable as defined in paragraph (e)(5) of this guideline.
                  (B) Solubility was likely to have been a problem at the treatment levels tested (e.g., precipitates formed), and no analytical measurements were performed on the soluble fraction to verify dissolved exposure concentrations. See paragraph (g)(3) of this guideline for methods used to segregate out the soluble fraction.
      (2) Measured concentrations versus nominal concentrations. This section describes acceptable limits of deviation of measured concentrations from nominal concentrations. Additional information can be found in paragraph (l)(20) of this guideline.
            (i) When a laboratory test design has been specifically modified to accommodate the instability of the test substance or for other factors likely to cause variability in test concentrations, and the design is judged adequate based on sufficient preliminary information, the test will not be considered to be unacceptable or invalid solely on the grounds that measured concentrations deviated by more than 20% from nominal concentrations, provided that the following conditions are met:
                  (A) Preliminary stability information is provided with complete documentation and description of the methods used, and preliminary stability tests are conducted under test conditions essentially identical to the actual test conditions.
                  (B) A reasonable and scientific explanation is provided, and the variability of results produced by the chemical analysis method is adequately characterized.
                  (C) All test vessels exhibit a similar (but not necessarily identical) shift in concentrations. If concentrations in some test vessels increase substantially (greater than 20%), and concentrations in other test vessels decrease substantially (greater than 20%), they will not be considered to have exhibited a similar shift. The most important consideration is that concentrations do not experience a shift in "order," i.e., the highest treatment level should retain its position as the highest, and the next should remain second, and so on. If the order is shifted, the test may be considered to be unacceptable or invalid since regression analysis would not yield statistically sound median lethal concentrations and confidence intervals.
                  (D) The variability of the measured concentrations is acceptable as discussed in paragraph (e)(5) of this guideline.
                  (E) A statistically valid endpoint (e.g., LC50, EC50, NOEC, etc., or LC50, EC50, or NOEC is greater than the limit concentration) can be derived from the measured concentrations.
            (ii) Conducting flow-through or static-renewal tests with algae and cyanobacteria is not feasible with the current state of available methods. Therefore, the following are recommended for a test substance that is expected to degrade or volatilize to less than 80% of the initial-measured concentration based on preliminary stability testing and physico-chemical properties:
                  (A) The test should be conducted normally, with concentrations measured at the beginning and end of the test, as it is important to understand the behavior of the test substance during the test. If stability is expected to be a problem, measuring test concentrations midway through 96-hour tests at 48 hours may be considered to better understand the rate of dissipation.
                  (B) Based on preliminary analysis, the analytical method should have a detection limit below any anticipated decrease in test concentrations, and test concentrations should not decrease below the LOD.
                  (C) Procedural modifications may be necessary when testing algae with volatile materials or fast degrading materials. These modifications should still allow for carbon dioxide uptake sufficient for acceptable growth. Possible modifications include shortening the test period, using test flasks with ground glass stoppers, increasing the size of the test flasks to reduce the surface to volume ratio, shaking flasks twice daily instead of continuously when using a rotary shaker, and conducting testing at lower temperatures.
	(2) Test substance concentration variability.
            (i) In some cases, high variability in test substance concentrations cannot be avoided because the test concentrations are approaching the LOD or because of unavoidable binding of the test substance to the chemical analysis apparatus. When the ratio of the highest measured concentration to the lowest measured concentration for a treatment level is expected to vary by more than 1.5 or, for sediment testing, if equilibrium or steady state cannot be achieved, providing a justification for an exception to this to the Agency in advance of conducting aquatic laboratory testing is strongly advised. This exception justification should consist of:
                  (A) Documentation of preliminary analyses indicating this problem.
                  (B) The specific steps that will be taken to mitigate the problem.
                  (C) The fully developed chemical analysis method.
                  (D) The raw data, standards, quality control samples, and chromatograms from a representative analysis using the method. For each chemistry method, the MDL and LOQ should be identified.
            (ii) The Agency will decide on each exception justification on a case-by-case basis. However, if a series of aquatic tests are to be conducted with one chemical, and exceeding this limit in all of the tests is anticipated, one exception justification may cover more than one test.
(k) Reporting.
      (1) Background information. In addition to the reporting requirements prescribed in the Good Laboratory Practices Standards (40 CFR 792 and 40 CFR 160), the study report should include the following information:
            (i) Test facility (name and location), study dates, and personnel. If conducted outside of a laboratory or greenhouse, report the geographic location, and describe the relation of this location to the occurrence or culture of the test species in the surrounding area.
            (ii) The name of the sponsor, study director, principal investigator, names of other scientists or professionals, and the names of all supervisory personnel involved in the study.
            (iii) Raw data sufficient to allow independent confirmation of the study authors' conclusions. Raw data includes all measurements recorded during the study including, but not limited to, effects (mortality, growth, behavior, etc.), environmental conditions (temperature, dissolved oxygen, pH, etc.), and test substance concentrations measured as specified and are necessary for the reconstruction and evaluation of the report of that study. The absence of raw data may make the study incomplete and impossible to review for scientific soundness and thus can lead to study being considered unacceptable or invalid as scientifically unsound.
            (iv) The signed and dated reports of each of the individual scientists or other professionals involved in the study, including each person who, at the request or direction of the testing facility or sponsor, conducted an analysis or evaluation of data or specimens from the study after data generation was completed.
            (v) The locations where all raw data and the final report are stored.
            (vi) The statement prepared and signed by the quality assurance unit identifying whether or not the study was conducted in compliance with Good Laboratory Practices Standards (40 CFR 792 or 40 CFR 160). Alternatively, the statement can indicate it was conducted under OECD Principles of GLP (see paragraph (l)(22) of this guideline), in accordance with the multilateral agreement with OECD member countries.
      (2) Data elements. The test report should provide a complete and accurate description of test procedures and evaluation of test results including, but not limited to, the following:
            (i) Objectives and procedures stated in the approved protocol, including any changes or deviations or occurrences that may have influenced the results of the test.
            (ii) Identification of the test substance (including source, lot, batch number, and purity), and known physical and chemical properties that are pertinent to the test. Provide the physical state, water solubility, pH, stability, and degradation properties under test conditions and stability under storage conditions if stored prior to use or prior to sample analysis. Where appropriate, a cross-reference to OCSPP Series 830 (Product Properties Test Guidelines) guideline study results can be used to report this data.
            (iii) Source of the dilution water, its chemical characteristics (e.g., conductivity, hardness, TOC, salinity, pH), and a description of any pretreatment; description of growth medium or sediment, if applicable.
            (iv) Methods of preparation of the test substance (e.g., stock solution preparation) and the concentrations of test substance used in limit and definitive testing. If vehicles are used, provide the name, composition, and source of the vehicle, the nominal concentration of the test substance in the vehicle, and the vehicle concentration(s) used in the test.
            (v) Information about the test organisms: common name and scientific name, method of species verification, source, life stage, sex (if appropriate), preventative or disease treatments, feeding history, acclimation procedures, and culture method.
            (vi) Description of the test system used in definitive, limit, or any preliminary testing. This includes a description of the test vessels, volume of solution in the test vessels, method of test substance introduction or test substance delivery system, renewal schedule (static-renewal tests), renewal schedule for stock feeding the diluter system (flow-through tests), system flow rate expressed as volume additions per 24 hours (flow-through tests), number of test organisms per test vessel, number of replicates per control and treatment level, all environmental parameters, and description of any feeding during the test (if applicable) including type of food, source, amount given, and frequency.
            (vii) Description of all techniques used in stock solution preparation (e.g., shaking, stirring, sonication, heating, solvent, etc.) and the appearance of the stock solution.
            (vii) Methods and frequency of sampling test media for the test substance and degradates and media sampled. Report the frequency of primary stock and secondary stock solution preparation, and timing of sampling from aquaria in relationship to replacement of stock solutions feeding diluter system (flow-through tests).
            (viii) Description of all analytical chemistry methods used in preliminary trials in establishing percent purity of batches of test substance or in measuring concentrations in range-finding, limit, and definitive tests. Include a complete description of the method so that a bench chemist can independently determine the necessary equipment and perform the analysis. Also include the raw data, standards, quality control samples, and chromatograms from samples taken during either range-finding, definitive, or limit tests, not of standards or samples from recovery tests. Provide the accuracy of the method, LOD, MDL, and LOQ.
            (viii) Results of measurements of test substance. Provide a justification for, or validation of, the separation technique should be provided in the study report.
            (x) Methods, frequency, and results of environmental monitoring performed during the test (e.g., temperature, dissolved oxygen, pH, water hardness (freshwater), salinity (saltwater), lighting, photoperiod) and other records of test conditions.
            (xi) Biological observations reported in sufficient detail to allow complete independent evaluation of the results (see specific test guidelines in this group for specific measures of effect to be reported). All data developed during the study that are suggestive or predictive of toxic effects and all concomitant gross toxicological manifestations should be submitted.
            (xii) Calculated endpoints and a description of all statistical methods including: software used, handling of outlier data points, handling of non-detect or zero values, tests to validate the assumptions of the analyses, level of significance, any data transformations, a measure of the sensitivity of hypothesis tests (either the minimum significant difference or the percent change from the control that this minimum difference represents). Raw data should be reported to allow independent verification of statistical procedures.
            (xv) Methods used for test vessel and treatment randomization as well as methods for random or indiscriminate assignment of test organisms to test vessels.
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      (3) American Society for Testing and Materials. ASTM E1847-96, Standard Practice for Statistical Analysis of Toxicity Tests Conducted Under ASTM Guidelines. In Annual Book of ASTM Standards, Vol. 11.06, American Society for Testing and Materials, West Conshohocken, PA. Current edition reapproved March 1, 2013.
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