[Federal Register Volume 76, Number 244 (Tuesday, December 20, 2011)]
[Notices]
[Pages 78933-78934]
[FR Doc No: 2011-32435]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]

Food and Drug Administration Clinical Trial Requirements,
Regulations, Compliance, and Good Clinical Practice; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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    The Food and Drug Administration (FDA), Los Angeles District
Office, in cosponsorship with the Society of Clinical Research
Associates (SoCRA), is announcing a public workshop. The public
workshop on FDA's clinical trial requirements is designed to aid the
clinical research professional's understanding of the mission,
responsibilities, and authority of the FDA and to facilitate
interaction with FDA representatives. The program will focus on the
relationships among FDA and clinical trial staff, investigators, and
institutional review boards (IRB). Individual FDA representatives will
discuss the informed consent process and informed consent documents;
regulations relating to drugs, devices, and biologics; as well as
inspections of clinical investigators, of IRB, and research sponsors.
    Date and Time: The public workshop will be held on March 7 and 8,
2012, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Hyatt Regency
Newport Beach, 1107 Jamboree Rd., Newport Beach, CA 92660, 1 (949) 729-
1234.
    Attendees are responsible for their own accommodations. Please
mention SoCRA to receive the hotel room rate of $145.00 plus applicable
taxes (available until February 14, 2012, or until the SoCRA room block
is filled).
    Contact: Linda Hartley, Office of Regulatory Affairs, Food and Drug
Administration, 19701 Fairchild, Irvine, CA 92612,<PHONE_NUMBER>, FAX:
(949) 608-4417; or Society of Clinical Research Associates (SoCRA), 530
West Butler Ave., Suite 109, Chalfont, PA 18914, 1<PHONE_NUMBER> or
(215) 822-8644; FAX:<PHONE_NUMBER>, email<EMAIL_ADDRESS>Web site:
www.socra.org.
    Registration: The registration fee will cover actual expenses
including refreshments, lunch, materials, and speaker expenses. Seats
are limited; please submit your registration as soon as possible.
Workshop space will be filled in order of receipt of registration.
Those accepted into the public workshop will receive confirmation. The
cost of the registration is as follows:

                          Cost of Registration
------------------------------------------------------------------------
                                                              SoCRA
                                                             member  $575.00
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SoCRA nonmember (includes membership)............    650.00
Federal Government SoCRA member..................    450.00
Federal Government SoCRA nonmember...............    525.00
FDA Employee.....................................       [*]
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* Fee Waived.

    If you need special accommodations due to a disability, please
contact SoCRA or Linda Hartley (see Contact) at least 21 days in
advance.
    Extended periods of question and answer and discussion have been
included in the program schedule. SoCRA designates this education
activity for a maximum of 13.3 Continuing Education (CE) Credits for
SoCRA CE and continuing nurse education (CNE). SOCRA designates this
educational activity for a maximum of 13.3 American Medical Association
Physician's Recognition Award Category 1 Credit(s)\TM\. Physicians
should claim only the credit commensurate with the extent of their
participation. SoCRA is accredited by the Accreditation Council for
Continuing Medical Education to provide continuing medical education
for physicians. SoCRA is an approved provider of CNE by the
Pennsylvania State Nurses Association (PSNA), an accredited approver by
the American Nurses Credentialing Center's Commission on Accreditation
(ANCC).

ANCC/PSNA Provider Reference Number: 205-3-A-09.
    Registration Instructions: To register, please submit a
registration form with your name, affiliation, mailing address,
telephone, fax number, and email, along with a check or money order
payable to ``SoCRA''. Mail to: SoCRA (see Contact for address). To
register via the Internet, go to http://www.socra.org/html/FDA_Conference.htm. (FDA has verified the Web site addresses throughout
this document, but we are not responsible for any subsequent changes to
the Web sites after this document publishes in the Federal Register.)
    Payment by major credit card is accepted (Visa/MasterCard/AMEX
only). For more information on the meeting registration, or for
questions on the public workshop, contact SoCRA (see Contact).

SUPPLEMENTARY INFORMATION: The public workshop helps fulfill the
Department of Health and Human Services' and FDA's important mission to
protect the public health. The public workshop will provide those
engaged in FDA-regulated (human) clinical trials with information on a
number of topics concerning FDA requirements related to informed
consent, clinical investigation requirements, IRB inspections,
electronic record requirements, and investigator initiated research.
Topics for discussion include the following: (1) What FDA Expects in a
Pharmaceutical Clinical Trial; (2) Adverse Event Reporting--Science,
Regulation, Error, and Safety; (3) Part 11 Compliance--Electronic
Signatures; (4) Informed Consent Regulations; (5) IRB Regulations and
FDA Inspections; (6) Keeping Informed and Working Together; (7) FDA
Conduct of Clinical Investigator Inspections; (8) Meetings With FDA:
Why, When, and How; (9) Investigator Initiated Research; (10) Medical
Device Aspects of Clinical Research; (11) Working With FDA's Center for
Biologics Evaluation and Research; and (12) The Inspection Is Over--
What Happens Next? Possible FDA Compliance Actions.
    FDA has made education of the drug and device manufacturing
community a high priority to help ensure the quality of FDA-regulated
drugs and devices. The public workshop helps to achieve objectives set
forth in section 406 of the FDA Modernization Act of 1997 (21 U.S.C.
393), which includes working closely with stakeholders and maximizing
the availability and clarity of information to stakeholders and the
public. The public workshop also is consistent with the Small Business
Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121) as
outreach activities by Government Agencies to small businesses.

    Dated: December 14, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-32435 Filed 12-19-11; 8:45 am]
BILLING CODE 4160-01-P


Page 1 of 20 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES July 24, 2002 MEMORANDUM FROM: Kathryn Boyle, CoChair IIFG and Kerry Leifer, CoChair IIFG TO: Robert Forrest, Chief Minor Use, Inerts, and Emergency Response Branch SUBJECT: IIFG Decision Documents on Reassessing Exemptions from the Requirement of a Tolerance for the Mineral Acids (Hydrochloric, Carbonic, Phosphoric, and Sulfuric) and their Ammonium, Calcium, Ferrous, Ferric, Magnesium, Potassium, Sodium, and/ or Zinc Salts Collectively these Decision Documents cover four mineral acids and the salts of these acids. The individual Decision Documents are: (1) Hydrochloric Acid and Salts, (2) Salts of Carbonic Acid, (3) Phosphoric Acid and Salts, and (4) Sulfuric Acid and Salts. The Inert Ingredient Focus Group reassessment is based on various conclusions of the FAO/ WHO Joint Expert Committee on Food Additives, conclusions of various FDA GRAS (Generally Recognized As Safe) Assessments, information previously used by OPP as part of the reregistration process, and other information available on government websites.

In total 46 exemptions from the requirement of a tolerance in 40 CFR 180 are reassessed. This total consists of 18 in the phosphoric acid document, nine in the hydrochloric acid document, six in the carbonic acid document, and 13 in the sulfuric acid document. Page 2 of 20 INERT INGREDIENT FOCUS GROUP DECISION DOCUMENT for Hydrochloric Acid and Salts Petition No.: no Tolerance Reassessments?: yes Chemical Category/ Group: mineral acid and salts The following describes the various ways that hydrochloric acid and its salts are used.

Table 1: Use Pattern (pesticidal  inert ingredient)

Chemical Name PC Code 40 CFR 180.1001 Inert Use Pattern (Pesticidal) Current Inert List hydrochloric acid 045901 845901 (c) solvent, neutralizer 3 ammonium chloride 900327 (c) intensifer, fire suppressant 4B calcium chloride 875605 (c), (e) stabilizer 4B ferric chloride 834901 (d) limitation of 2%, suspending, dispersing agent 4B magnesium chloride 013902 813902 (c) safener 4B potassium chloride 813904 (c) solid diluent, carrier 4B sodium chloride 800012 (c) solid diluent, carrier 4A There is also a tolerance exemption for sodium chloride in 40 CFR 180.2.

Use Pattern: (pesticidal  active ingredient)

At this time, only hydrochloric acid and magnesium chloride are used as active ingredients. Page 3 of 20 Hydrochloric acid is used as a disinfectant in 48 products. Many of these products are toilet bowl cleaners, with concentrations of hydrochloric acid ranging from 9.5 to 60%. However, potable human drinking water systems, meat and poultry processing plants, and hospitals are also use sites. Magnesium chloride is used as an herbicide at iceplants in only one product. There are no longer any EPA registered active ingredient uses for any of the other above listed chloride salts.

Table 2: Use Pattern (FDA GRAS)

Chemical GRAS Citation GRAS Uses hydrochloric acid 21 CFR 182.1057 neutralizing agent ammonium chloride 21 CFR 184.1138 dough strengthener, flavor enhancer, leavening agent, processing aid calcium chloride 21 CFR 184.1193 anticaking agent, antimicrobial agent, curing or pickling agent, firming agent, flavor enhancer, humectant, nutrient supplement, pH control agent, processing aid, stabilizer and thickener, surface active agent, synergist, texturizer ferric chloride 21 CFR 184.1297 flavoring agent magnesium chloride 21 CFR 184.1426 flavoring agent and adjuvant, nutrient supplement potassium chloride 21 CFR 184.1622 flavor enhancer, flavoring agent, nutrient supplement, pH control agent, stabilizer or thickener Ammonium chloride and calcium chloride also have uses in food contact surface sanitizing solutions under 21 CFR 178.1010. Page 4 of 20 Table 3: Use Pattern (non pesticidal):

Chemical Uses hydrochloric acid in the production of chlorides; refining ore in the production of tin and tantalum; to neutralize basic systems; laboratory reagent; hydrolyzing of starch and proteins in the preparation of various food products; pickling and cleaning of metal products; as catalyst and solvent in organic synthesis; for oil and gas well treatment; in removing scale from boilers and heat exchange equipment; pharmaceutic aid (acidifier). ammonium chloride solutions for eye irrigation, fertilizer, dyeing, electroplating, safety explosives, lustering cotton, washing powders, electrolyte for dry cell batteries, soldering, metal and refinishing flux, galvanizing calcium chloride used for antifreeze and refrigerating solution, in fire extinguishers, to preserve wood and stone, ice manufacturing, glues, cements, fireproofing fabrics, automobile antifreeze mixtures, to melt ice and snow, as coagulant in rubber manufacturing, as size in admixture with starch paste, in concrete mixes to give quicker initial set and greater strength, freezeproofing of coal and ores, dust control on unpaved roads, sizing and finishing cotton fabrics, as brine for filling inflatable tires on tractors to increase traction. ferric chloride treatment of sewage and industrial wastes; etching agent for engraving, photography, and printed circuitry; condensation catalyst in Friedel crafts reactions; mordant; oxidizing, chlorinating, and condensing agent; disinfectant; pigment; feed additive; water purification. magnesium chloride source of magnesium metal, chemical intermediate for magnesium oxychloride for cement, catalyst, flocculating agent, agent in fire extinguishers, agent in textile and paper manufacturing, component for ceramics, fireproofing agent for wood, component of refrigerating brines potassium chloride fertilizer component (primary plant nutrient); chemical intermediate in production of other potassium salts; photography; medical uses both orally and intravenously for treating potassium depletion states; dietary supplement. sodium chloride In the production of chemicals (sodium hydroxide, soda ash, hydrogen chloride, chlorine, metallic sodium), ceramic glazes, metallurgy, curing hides, food preservative, food seasoning, mineral waters, soap manufacture (salting out), home water softeners, highway deicing, regeneration of ion exchange resins, photography, herbicide, fire extinguishing, nuclear reactors, mouthwash, medicine (heat exhaustion  intravenous solutions for fluid replacement), saline solutions for eye washes and contact lens solutions, salting out dyestuffs, supercooled solutions.

It should be noted that ammonium chloride and potassium chloride have uses as fertilizers. Plants need various elements (metals and non metals) for proper growth. Especially for agricultural crops, plants are supplied these elements as part of chemical fertilizers. The most important elements for plant growth are nitrogen, phosphorus, and potassium. Other metals needed in the soil for plant up take are calcium, magnesium, iron, and trace elements such as zinc. Both potassium chloride and ammonium chloride are intentionally added to growing agricultural crops as needed to promote plant growth. Page 5 of 20 Page 6 of 20 Assessment of Hydrochloric Acid and its Salts Hydrochloric acid and its ammonium, sodium, potassium, calcium, magnesium, and iron salts are being assessed as a group due to their chemical similarities. Due to its acidic nature the toxicity of hydrochloric acid will be different from those of the more neutral chloride salts. However, the chloride salts all contain the chloride ion and thus share some common chemistries. A major focus of this assessment is the work previously performed by FDA in assessing the safety of these chemicals as food additives.

1. Physical/ Chemical Properties:

The physical and chemical properties of hydrochloric acid and its various salts are described in the May 7, 2002 EFED Assessment. See attached.

2. Information Sources:

The following information was used in performing this assessment. The available information consisted of information retrieved from various websites, such as: °EPA( www. epa. gov), °NIOSH,( www. cdc. gov/ niosh/ ipcsneng/ neng1184.html), (www. cdc. gov/ niosh/ ipcsneng/ neng1051.html), (www. cdc. gov/ niosh/ ipcsneng/ neng0764.html), (www. cdc. gov/ niosh/ npg/ npgd0229.html), and (www. cdc. gov/ niosh/ npg/ npgd0346.html) ° TOXNET ( www. toxnet. nlm. nih. gov.), °WHO( www. inchem. org/ documents/ jecfa/ jecmono/ v05je83.htm) and (www. inchem. org/ documents/ jecfa/ jecmono/ 40abcj43.htm)

Various FDA GRAS Assessments were used, as well as, the FAO/ WHO Assessments.

3. NIOSH (National Institute for Occupational Safety and Health)

The NIOSH Pocket Guide for hydrogen chloride indicates that hydrogen chloride is a colorless to slightly yellow gas with a pungent, irritating odor. It is nonflammable. Additional information on the NIOSH web site included the Occupational Health Guideline for Hydrogen Chloride. Hydrogen chloride gas irritates the eyes, mucous membranes, and skin. The current OSHA standard for hydrogen chloride is a ceiling of 7 mg/ m 3 . Ingestion of hydrochloric acid can cause severe burns of the mucous membranes of the mouth, esophagus, and stomach.

The NIOSH International Chemical Safety Cards for magnesium and calcium chloride indicate that TLVs (Threshold Limit Values) have not been established. Both chemicals can irritate the skin and the respiratory tract, and when dissolved in water liberate a considerable amount of heat. Page 7 of 20 According the International Chemical Safety Card for ammonium chloride, the substance irritates the eyes, the skin and the respiratory tract. The TLV is established only for the fume.

The NIOSH International Chemical Safety Cards for iron salts (soluble, as Fe) which includes ferric chloride indicates an exposure limit of 1 mg/ m 3 (time weighted average).

4. Acid Characteristics An acid is a substance that when dissolved in water yields H + ions. The increase of the concentration of the H + ions lowers the pH. Mineral acids contain a non metal such as phosphorus, nitrogen, sulfur, or chlorine which may or may not be combined with oxygen. When combined with oxygen, these anions can be referred to as oxyanions. Strong acids are those acids that when dissolved completely transfer their H + ions to water. Hydrochloric acid is an example of a strong acid.

5. Cations: Sodium, Potassium, Calcium, Magnesium, and Iron Generally, a salt of a strong acid, such as hydrochloric acid, when dissolved in water dissociates to yield the chloride ion (an anion, which is negatively charged) and a positively charged cation. In the human body, these salts tend to dissociate and thus, for the most part, react in the body as the anion and the cation.

Metals such as calcium, sodium, magnesium, potassium, and iron are also required for proper functioning of human biological systems. For risk assessment purposes an important feature of these metals is that overall the body does have an effective means of processing them. The primary means of exposure to these cations is ingestion. Four of the most common cations required for functioning of human biology are: sodium, potassium, calcium and magnesium. Chemically, sodium and potassium belong to the same chemical family: calcium and magnesium belong to a different chemical family.

Sodium:

The average human body burden of sodium is approximately 20 grams (g) for a 70 kilogram (kg) adult. The sodium cation is necessary for the nerves and muscles to function properly. It is the principal cation of extracellular fluid, and helps to maintain the body's water balance. These electrolytes, the electrically charged ions in the body fluids, consist to a great extent of sodium and potassium. There is no Recommended Dietary Allowance (RDA) for sodium.

Potassium:

The average human body burden of potassium is approximately 140 g for a 70 kg adult. The potassium cation is important in regulating blood pressure, regulating cellular water content, Page 8 of 20 maintaining proper pH balance, and transmission of nerve impulses. It helps to regulate the electrical activity of the heart and muscles. The potassium RDA is 900 mg/ day.

Calcium:

The average human body burden of calcium is approximately 1 kg for a 70 kg adult; or 1/ 70th of our weight is calcium. The calcium cation is necessary for bone and teeth formation. It is also important for the proper functioning of nerves, enzymes, and muscles, and plays a role in blood clotting and the maintenance of cell membranes. The RDAs for calcium are 1000 mg/ day for adults aged 19 to 50 years and 1200 mg/ day for individuals older than 50 years.

Magnesium:

The average human body burden of magnesium is approximately 20 g for a 70 kg adult. The magnesium cation is also used in building bones. It plays a role in releasing energy from muscles and regulating body temperature. The RDA for magnesium is 310 to 320 mg/ day for adult females and 400 to 420 mg/ day for adult males with the RDA increasing with increasing age.

Iron:

Another common metal cation that is needed for functioning of human biology, but in smaller amounts often referred to as trace, is iron. The human body burden of iron is approximately 4.1 g for a 70 kg adult. Iron functions as a carrier of oxygen. The hemoglobin molecule in blood transports oxygen from the lungs to the cells. The myoglobin molecule supplies oxygen to muscle cells. Iron deficiency is characterized by anemia, stunted growth, fatigue, and lowered resistance to infection. The RDAs for iron are 10 mg/ day [0.14 mg/ kg/ day for an adult (70 kg) male (25 to 50 years)] and 15 mg/ day [0. 25 for an adult (60 kg) female (19 to 50 years)]. Pregnant and nursing woman have increased requirements for iron.

Dietary iron is poorly absorbed. The intestinal mucosa is a limiting factor in iron absorption. Normal absorption is about 1 mg/ day in an adult male, and about 1.4 mg/ day in an adult female. Absorption occurs in the divalent (ferrous) form, which must then be oxidized to the trivalent (ferric) form for use. Acute toxicity of iron ingested from normal dietary sources has not been reported. However, death especially in young children has resulted from ingestion of large overdoses of medicinal iron. (doses ranging from 40 to 1600 mg/ kg  average 900 mg/ kg). It is noted that the iron from ferric salts is less well absorbed than that from ferrous salts.

6. Ammonium Salt:

Ammonium chloride dissociates to the chloride anion and the positively charged ammonium cation (NH4 + ). Humans cannot convert atmospheric nitrogen to any form that can be used as part of any of the various metabolic cycles. Therefore, reduced nitrogen (NH4 + )hasto Page 9 of 20 enter the body from an outside source. These sources are the nitrogen containing amino acids in protein which are consumed daily as part of the diet. Although the human body can produce some amino acids, ten amino acids are considered "essential" amino acids, i. e., they must be consumed in the diet.

Generally the body works to maintain a balance of nitrogen intake and nitrogen excretion. The estimated daily ammonia intake through food and drinking water is 18 mg. In contrast, 4000 mg of ammonia per day are produced endogenously in the human intestine.

Ammonia and the ammonium ion are integral components of normal human metabolic processes. Ammonia is released following deamination that occurs when protein is used by the body for energy production. The liver converts ammonia via the urea cycle into urea. According to FDA in the "Evaluation of the Health Aspects of Certain Ammonium Salts as Food Ingredients" (1974), "the normal liver so readily detoxifies ammonium ion from alimentary sources that blood concentrations of ammonium salts do not rise to the levels necessary to evoke toxic response." Approximately 80% of the body's excess nitrogen is eliminated through the kidneys as urea, approximately 25 to 30 grams per day. Page 10 of 20 7.

Toxicological Profile Table With the exception of the information in IRIS (Integrated Risk Information System), the Agency has not reviewed any of the toxicological studies in the following table for hydrochloric acid or any of its salts. The reviews of these studies were obtained from Toxnet,

as well as other government websites. Table 4:

Toxicological Profile Chemical Toxicity Other Information Hydrochloric Acid Severely corrosive by all routes as 1N solution; IRIS RfC =

2 x 2 2 mg/ m 3 based on hyperplasia of nasal mucosa, larynx and trachea in rat chronic inhalation study; LOAEL =

15 mg/ m 3 (10ppm); Chemical has no systemic toxicity associated with exposure except the acute effects of corrosion/ irritation depending upon the pH of the solution.

CERCLA Reportable Quantity: greater than 10 lb (4. 54 kg); Hazardous Air Pollutant (HAP)

chemical; 1995 production 7.

33 billion lbs; Ammonium Chloride Mild skin and respiratory system irritant; Dust irritating to eyes; Ingestion of 40 to 50 g over a short period would be expected to exhaust available body buffers of the average adult and produce potentially fatal acidosis.

Mild acidosis occurs at a dose of 2 g; One sixth molar ammonium chloride was given to mice orally in the drinking water after day 7 during pregnancy and although the offspring were small sized no congenital defects were found; Absorbed almost 100%

in the gastrointestinal tract CERCLA Reportable Quantity: greater than 5000 lb (2270 kg); Page 11 of 20 Magnesium Chloride Rat oral LD50 =

2800 mg/ kg;

signs:

convulsions, changes in respiration and cardiac function; Drug use as electrolyte replenisher in hemadialysis and peritoneal dialysis fluid; Cathartic; 90 day study in rats with magnesium chloride hexahydrate doses

0,

0. 1,

0. 5,

2.

5%

in diet NOAEL =

2.

5%

(highest dose tested (HDT)); Developmental study in rats with magnesium chloride hexahydrate doses:

0,

200, 400,

800mg/ kg/ day NOAEL= 800mg/ kg/ day (HDT); Carcinogenicity study in mice with magnesium chloride hexahydrate doses 0,

0.5, 2%

in diet for 96 wks– not carcinogenic Deliquescent US production 1972 8.6 x 10 11 grams Calcium Chloride Rat oral LD50 =

1000 mg/ kg; Mouse LD50 =

1940 mg/ kg; Anhydrous form irritating to skin, eyes and mucus membranes Hygroscopic; Liberates heat during water absorption and on dissolution; US production 1993 1.4 billion lbs Ferric Chloride Rat oral LD50 =

0. 5 5 g/

kg added to bottled water; Skin, eye and mucous membrane irritant; Carcinogenicity study in rats at doses of 0,

0.

25,

0.

5%

in drinking water was negative; Excess ingestion of iron produces liver toxicity; Acute ingestion of 0. 5 g of iron produces severe toxicity Hygroscopic; CERCLA Reportable Quantity: greater than 100 lb (45. 4 kg); US production 1. 2 x 10 11 grams; iron drinking water guideline 300 ug/ L Page 12 of 20 Potassium Chloride Rat oral LD50 =

2600

3020 mg/ kg; Mild eye irritation for rabbits; Irritating to skin and mucous membranes; Commercial dietary salt substitute;

US production 1980 =

3 x 10 12 grams; OSHA PEL =

15 mg/ m 3 ,

5 mg/ m 3 for respirable particles Sodium Chloride Skin, eye and mucous membrane irritant; Affects blood pressure in humans; Average daily intake of US citizens 10 12 g/

day with 3 g occurringnaturally,3 g added incooking, 46 g inprocessed foods Common table salt, sea salt Page 13 of 20 8. OPP REDs (Reregistration Eligibility Decision Document)

Mineral Acid RED The following information on the acute toxicity of hydrochloric acid was in the 1993 RED: The oral LD50 is 1000 mg/ kg, toxicity category III. The dermal LD50 is > 2000 mg/ kg, toxicity category III. Hydrochloric acid is toxicity category I for eye and dermal irritation. No other toxicological data were required based on the use patterns at the time of the RED and the corrosiveness shown in the acute studies for dermal and eye irritation.

Inorganic Halide RED This 1993 RED included sodium chloride. The oral LD50 (rat) is 3000 mg/ kg, toxicity category III. Sodium chloride was classified as moderate, toxicity category III for eye irritation, and mild, toxicity category IV for skin irritation. Because of its abundance in the environment and low toxicity to humans, no additional toxicity data were required.

9. FDA GRAS (Generally Recognized As Safe) Assessments Hydrochloric Acid The FDA Assessment is titled "Evaluation of the Health Aspects of Hydrochloric Acid as a Food Ingredient" (1979). Hydrochloric acid has a variety of FDA approvals for food additive use. "Food stuffs to which hydrochloric acid has been added expose consumers predominantly to chloride ions and other chemical products resulting from its reaction to chloride ions and other chemical products resulting from its reaction with neutralizing agents or chemicals in the food. Free hydrochloric acid would be expected to be present in only minute amounts, if at all."

The human stomach normally contains sufficient hydrochloric acid to maintain the pH of gastric juice at 1.5 to 2. 5. The introduction of any hydrochloric acid into the stomach proportionally depresses the secretion of the acid by the stomach.

According to FDA:

"Hydrochloric acid in concentrated form is a strongly corrosive agent and the consequences of exposure to it are well known. However, as it is used in food processing, or as a food additive to adjust the pH, hydrochloric acid is neutralized or buffered by the food to which it is added. Thus, human consumption is not of the acid, but of the chloride ion in the salts formed in the neutralization process..... There is no evidence in the available information on hydrochloric acid that demonstrates or suggests reasonable grounds to suspect a hazard to the public when it is used at levels that are now current or that might reasonably be expected Page 14 of 20 in the future."

Ammonium Chloride The FDA Assessment is titled "Evaluation of the Health Aspects of Certain Ammonium Salts as Food Ingredients" (1974).

"Ammonia and ammonium ion are integral components of normal metabolic processes and play an essential role in the physiology of man. Although there have been no significant feeding studies specifically designed to ascertain the safety threshold of ammonium compounds as food ingredients, numerous metabolic studies have been reported in the scientific literature. Extrapolation of these findings to the concentrations of ammonium compounds normally present in foods does not suggest that there would be untoward effects at such levels."

Calcium Chloride The FDA Assessment is titled "Evaluation of the Health Aspects of Certain Calcium Salts as Food Ingredients" (1975). The estimated per capita daily intake of calcium chloride is 160 mg. Both the calcium and the chloride are common constituents of food and are metabolized by the normal metabolic processes in humans.

Magnesium Chloride The FDA Assessment is titled "Evaluation of the Health Aspects of Magnesium Salts as Food Ingredients" (1976). Magnesium is (1) a dietary essential, (2) involved in many metabolic reactions, (3) important in electrolyte balance, and (4) present in fruits, vegetables, grains, milk, meat and fish. No chronic toxicity data were available. The "status of magnesium as a ubiquitous and essential dietary ingredient for the maintenance of homeostatic and bioenergetic mechanisms leads to the opinion that none of the available evidence suggests any probable hazard when any of the GRAS compounds of magnesium is used as a food ingredient." The conclusion was reached that there was no available information on magnesium chloride to demonstrate, or suggest "reasonable grounds to suspect, a hazard to the public when ... used at levels that are now current and in the manner now practiced, or which might reasonably be expected in the future."

Potassium Chloride The FDA Assessment is titled "Evaluation of the Health Aspects of Sodium Chloride and Potassium Chloride as Food Ingredients" (1979). The concentration of potassium in blood serum is maintained normally between 3. 5 and 5 meq/ L.

"The available evidence indicates that in normal individuals potassium chloride is well tolerated, and that metabolism quickly and efficiently adjusts potassium in the Page 15 of 20 body to narrow homeostatic levels. Certain health conditions are known to affect the normal homeostatic control of sodium and potassium in the body to narrow homeostatic levels. Certain health conditions are known to affect the normal homeostatic control of sodium and potassium metabolism, and patients with these conditions must adjust their diets to avoid proscribed electrolyte intakes. Water intake, efficiency of the kidney, and the ratio of sodium to potassium in the diet are interrelated factors that must be evaluated in considering the health aspects of changing the relative intakes of sodium chloride and potassium chloride."

It was concluded:

"There is no evidence in the available information on potassium chloride that demonstrates or suggests reasonable grounds to suspect a hazard to the public when it is used at levels that are now current or that might reasonably be expected in the future."

Sodium Chloride The FDA Assessment is titled "Evaluation of the Health Aspects of Sodium Chloride and Potassium Chloride as Food Ingredients" (1979). Sodium chloride, commonly known as table salt, occurs abundantly in nature, in sea water and mineral springs, and in large underground deposits. The mineral form is called halite. It is a food ingredient and has historically been considered an essential part of the diet. The body must have some sodium. The human body has a homoeostatic control to maintain the proper balance of sodium, potassium. and chlorine in the human body. The concentration of sodium in blood serum is maintained normally between 136 to 145 meq/ L. That of chlorine is 96 to 106 meq/ L.

The American diet is considered to contain an abundance of salt which if consumed in excess, may have adverse health consequences. In fact, treatment of certain diseases such as hypertension can require restriction of salt intake. Acute and chronic toxic effects, including death, can occur when salt is ingested in excessive amounts. There is no daily requirement for salt, as it would be a level highly dependent all dietary sources, the level of potassium and the sodium to potassium ratio in the diet, and health conditions such as sweating.

The Assessment considers that the consumption of sodium chloride in the aggregate should be lowered in the United States. The Assessment concluded: "The evidence on sodium chloride is insufficient to determine that the adverse effects reported are not deleterious to the health of a significant proportion of the public when it is used at levels that are now current and in the manner now practiced."

10. FAO/ WHO Expert Committee on Food Additives Page 16 of 20 WHO has performed two assessments: hydrochloric acid in 1966 and calcium acetate, chloride, gluconate, and sulfate in 1973.

Both assessments discussed 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.

11. Human Health Hazard Characterization:

Hydrochloric acid in its concentrated form is highly corrosive. Due to this property toxicity testing can only be performed on dilute concentrations or on neutralized forms of the acid such as a salt. The consequences of acute exposure to hydrochloric acid are well understood. Dermal exposure can lead to burns. Exposure to the gas can cause severe irritation of the upper respiratory tract.

Exposure to hydrochloric acid in pesticide products as an inert ingredient would be in the role of a pH adjuster. This is indicative of the use of small amounts of hydrochloric acid that are incorporated in a pesticide product to lower the pH . After the pH adjustment is performed, the hydrochloric acid would be neutralized. As an active ingredient hydrochloric acid is subject to FIFRA (Federal Insecticide, Fungicide, and Rodenticide Act) registration requirements and various labeling language as specified in the RED. Hydrochloric acid, whether used as an inert or an active ingredient, must be used and applied according to good manufacturing or good agricultural practices. However, there are no significant adverse effects, to the general public or any population subgroup from consumption of residues of hydrochloric acid resulting from pesticide product uses.

As a group salts of hydrochloric acid constitute a group of chemicals with many uses including direct use in the food supply. In particular sodium chloride, common table salt, can be purchased and used by the public in the amounts specifically chosen for their individual wants and desires. According to the information available to the Agency, sodium chloride used in food processing results in consumption of 4 to 6 grams of sodium chloride in the average diet per day. The average individual adds up to another 3 grams of sodium chloride during cooking and at the table.

The available toxicity data indicates that the human body metabolizes chloride, ammonium, calcium, iron, magnesium, potassium, and sodium ions through well understood pathways. In fact, all are necessary human nutrients. Various salts of hydrochloric acid have been used in the food supply for a number of years. There are no available data to indicate any significant adverse effects to the general public or any population subgroup from consumption of residues of the ammonium, calcium, iron, magnesium, potassium, and sodium salts of hydrochloric acid resulting from pesticide product uses. Page 17 of 20 Given the long history of safe use, the available toxicity data, an understanding of the human body's ability to metabolize these chemicals, and the evaluations by FDA and WHO, the IIFG believes that ammonium, sodium, potassium, magnesium, calcium and iron chloride are of low oral toxicity.

12. Type of Risk Assessment/ Risk Characterization:

The toxicity of these chemicals derives from the irritation and caustic effects; therefore, a qualitative assessment for all pathways of human exposure (food, drinking water, and residential) is appropriate.

Given the widespread occurrence of hydrochloric acid and its ammonium, calcium, iron, magnesium, potassium, and sodium salts in the existing food supply, the amounts that may be present in food as a result of the use of these chemicals in a pesticide product would not be expected to significantly increase the existing amounts in the food supply. There is no available information on any of the salts of hydrochloric acid considered in this document indicative of a human health hazard resulting from the EPA regulated uses as well as the FDA GRAS uses to the general public or any population subgroup. No additional information are needed to assess the safety of hydrochloric acid and its salts.

13. Sensitivity of Infants and Children:

Due to its acidic nature, its corrosive potential, there is high acute toxicity for hydrochloric acid. Hydrochloric acid must be used in pesticide products according to good manufacturing or good agricultural practices. The ammonium, calcium, iron, magnesium, potassium, and sodium salts of hydrochloric acid have low toxic potential. At this time, there is no concern for potential sensitivity to infants and children. A safety factor analysis has not been used to assess the risk. For the same reasons the additional tenfold safety factor is unnecessary.

14. Environmental Fate and Ecotoxicity Assessment/ Characterization:

In general, the constituents of the mineral acids, such as hydrochloric acid, are commonly found in soil and water in the environment suggesting that releasing low levels of these chemicals would not normally be expected to adversely effect wildlife or water resources. Large releases may adversely affect wildlife and water resources either directly or indirectly. Direct effects may result from exceeding toxicity thresholds of specific chemicals. Indirect effects may be manifested through disrupting ecosystems through altering pH or increasing availability of algal nutrients.

Hydrochloric acid is a strong acid. The magnitude of the pH changes, and thus the magnitude of effects, would depend on a number of factors including the amount of material released and the buffering capacity of the exposed soil or water. Normal aquatic pHs range from Page 18 of 20 5 to 9. EPA's Office of Water recommended water quality criteria for pH are 6. 5 to 9 for freshwater and 6. 5 to 8.5 for saltwater. At higher or lower pH aquatic life is expected to be adversely impacted. In addition, rapid changes in pH can also be detrimental to aquatic life. Hydrochloric acid is not expected to be persistent in the environment. Instead it is expected to dissociate, react with organic or inorganic materials, and complex with ionic substrates.

Hydrochloric acid salts dissociate in water resulting in a positively charged (cationic) metal in solution. Dissociation is frequently dependent on pH, with lower (more acidic) pHs resulting in higher levels of dissociation and greater solubility. Aquatic toxicity of metals varies with the species of metal and its concentration. EPA's freshwater water quality criteria for iron is 1 ppm implying relatively low toxicity. Metals do not degrade and thus are permanent in the environment. They are likely to dissipate by being sequestered in soil, sediment, and plants.

15. Cumulative Exposure:

Section 408( b)( 2)( D)( v) 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 chemical's residues and "other substances that have a common mechanism of toxicity." The chemicals considered in this document are structurally related; however, all of the salts are low toxicity chemicals. Therefore, the resultant risks separately and/ or combined should also be low. EPA does not have, at this time, available data to determine whether these pesticide chemicals have a common mechanism of toxicity with other substances or how to include these pesticide chemicals in a cumulative risk assessment.

16. Determination of Safety:

Based on its review and evaluation of the available information, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to residues of hydrochloric acid and its ammonium, sodium, potassium, calcium, magnesium, and iron salts. Therefore, the following exemptions from the requirement of a tolerance are reassessed: In 40 CFR 180.2 sodium chloride. In 40 CFR 180.1001 (c) ammonium chloride, calcium chloride, hydrochloric acid, magnesium chloride, potassium chloride, and sodium chloride. In 40 CFR 180.1001 (d) ferric chloride. In 40 CFR 180.1001 (e) calcium chloride.

17. List Reclassifications:

The following List reclassifications are made or confirmed:

Hydrochloric acid: List 4B. With the restriction of use as a solvent, pH adjuster, neutralizing agent. Ammonium chloride: List 4B Page 19 of 20 Calcium chloride: List 4B Ferric chloride: List 4B, current limitation remains in place. Magnesium chloride: List 4B Potassium chloride: List 4A considering its use as a salt substitute Sodium chloride: List 4A considering its use as common table salt The following table lists the various chemical names, CAS Reg. No., and CAS Index Names that will be used for listing in 40 CFR. 180. Note that both the anhydrous and the hydrated forms are included. The Agency sees no reason to distinguish between these chemicals given that the only difference is the attachment of the water molecules.

Chemical Name CAS Reg. No. Chemical Abstracts Index Name Hydrochloric acid 7647 01 0 Hydrochloric acid (6CI, 7CI, 8CI, 9CI)

Ammonium chloride 12125 02 9 Ammonium chloride (( NH4) Cl) (9CI)

Calcium chloride 10043 52 4 Calcium chloride (CaCl2) (9CI)

Calcium chloride hydrate (CaCl2. 1/ 3H2O) 56073 24 6 Calcium chloride (CaCl2), hydrate (3: 1) (9CI)

Calcium chloride, hydrate (8CI) 22691 02 7 Calcium chloride (CaCl2), hydrate (9CI)

Calcium chloride dihydrate 10035 04 8 Calcium chloride (CaCl2), dihydrate (9CI)

Calcium chloride hexahydrate 7774 34 7 Calcium chloride (CaCl2), hexahydrate (9CI)

Calcium chloride monohydrate 13477 29 7 Calcium chloride (CaCl2), monohydrate (9CI)

Ferric chloride 7705 08 0 Iron chloride (FeCl3) (8CI, 9CI)

Ferric chloride monohydrate 60684 13 1 Iron chloride (FeCl3), monohydrate (9CI)

Ferric chloride dihydrate 54862 84 9 Iron chloride (FeCl3), dihydrate (9CI)

Iron III chloride hexahydrate 10025 77 1 Iron chloride (FeCl3), hexahydrate Ferric chloride dodecahydrate 58694 80 7 Iron chloride (FeCl3), dodecahydrate (9CI)

Ferric chloride nonahydrate 58694 79 4 Iron chloride (FeCl3), nonahydrate (9CI)

Ferric chloride sesquihydrate 115321 78 3 Iron chloride (FeCl3), hydrate (2: 3) (9CI)

Ferric chloride trihydrate 58694 75 0 Iron chloride (FeCl3), trihydrate (9CI)

Magnesium chloride 7786 30 3 Magnesium chloride (MgCl2) (9CI)

Magnesium chloride hexahydrate 7791 18 6 Magnesium chloride (MgCl2), hexahydrate (9CI)

Potassium chloride 7447 40 7 Potassium chloride (KCl) (9CI) Page 20 of 20 Sodium chloride 7647 14 5 Sodium chloride (NaCl) (9CI)

Attachment:

EFED Review of Mineral Acids (Birchfield; May 7, 2002)


[Federal Register Volume 86, Number 66 (Thursday, April 8, 2021)]
[Notices]
[Pages 18279-18283]
[FR Doc No: 2021-07226]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC21-13-000]

Commission Information Collection Activities (FERC-725l); Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission.

ACTION: Notice of information collection and request for comments.

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SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995, the Federal Energy Regulatory Commission (Commission or
FERC) is soliciting public comment on the currently approved
information collection, FERC 725L (Mandatory Reliability Standards for
the Bulk-Power System: MOD Reliability Standards).

DATES: Comments on the collection of information are due June 7, 2021.

ADDRESSES: You may submit copies of your comments (identified by Docket
No. IC21-13-000) by one of the following methods:
    Electronic filing through http://www.ferc.gov, is preferred.
     Electronic Filing: Documents must be filed in acceptable
native applications and print-to-PDF, but not in scanned or picture
format.
     For those unable to file electronically, comments may be
filed by USPS mail or by hand (including courier) delivery:
    [cir] Mail via U.S. Postal Service Only: Addressed to: Federal
Energy Regulatory Commission, Secretary of the

Commission, 888 First Street NE, Washington, DC 20426.
    [cir] Hand (Including Courier) Delivery: Deliver to: Federal Energy
Regulatory Commission, 12225 Wilkins Avenue, Rockville, MD 20852.
    Instructions: All submissions must be formatted and filed in
accordance with submission guidelines at: http://www.ferc.gov. For user
assistance, contact FERC Online Support by email at
<EMAIL_ADDRESS>or by phone at<PHONE_NUMBER> (toll-free).
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at http://www.ferc.gov.

FOR FURTHER INFORMATION CONTACT:  Ellen Brown may be reached by email
at<EMAIL_ADDRESS>telephone at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Title: FERC-725L, Mandatory Reliability Standards for the Bulk-
Power System: MOD Reliability Standards.
    OMB Control No.: 1902-0261.
    Type of Request: Three-year extension of the FERC-725L information
collection requirements with no changes to the reporting requirements.
    Abstract: MOD Reliability Standards ensure that generators remain
in operation during specified voltage and frequency excursions,
properly coordinate protective relays and generator voltage regulator
controls, and ensure that generator models accurately reflect the
generator's capabilities and equipment performance.
    On May 30, 2013, the North American Electric Reliability
Corporation (NERC) filed a petition explaining that the reliability of
the Bulk-Power System benefits from ``good quality simulation models of
power system equipment,'' \2\ and that ``model validation ensures the
proper performance of the control systems and validates the computer
models used for stability analysis.'' NERC further stated that the
Reliability Standards will enhance reliability because the tests
performed to obtain model data may reveal latent defects that could
cause ``inappropriate unit response during system disturbances.'' \2\
Subsequently, on March 20, 2014,\1\ the Commission approved Reliability
Standards MOD-025-2, MOD-026-1, and MOD-027-1. These Standards were
intended to address generator verifications needed to support Bulk-
Power System reliability that would also ensure that accurate data is
verified and made available for planning simulations.\2\
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    \1\ Final Rule in Docket No. RM13-16-000.
    \2\ NERC Petition for Approval of Five Proposed Reliability
Standards MOD-025-2, MOD-026-1, MOD-027-1, PRC-019-1, and PRC-024-1
submitted to FERC on 5/30/2013.
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    On May 1, 2014,\3\ the Commission approved Reliability Standards
MOD-032-1 and MOD-033-2. These Standards were to address ``system-level
modeling data and validation requirements necessary for developing
planning models and the Interconnection-wide cases that are integral to
analyzing the reliability of the Bulk-Power System''.
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    \3\ Order in Docket No. RD14-5-000.
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    MOD-025-2, MOD-026-1, MOD-027-1, MOD-031-3, MOD-032-1 and MOD-033-2
are all currently approved within the FERC-725L information collection.
The reporting requirements associated with each standard will not
change as a result of this extension request.
    Type of Respondents: NERC-registered entities including generator
owners, transmission planners, planning authorities, balancing
authorities, resource planners, transmission service providers,
reliability coordinators, and transmission operators.\4\
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    \4\ In subsequent portions of this notice, the following
acronyms will be used: PA = Planning Authority, GO = Generator
Owner, TP = Transmission Planner, BA = Balancing Authority, RP =
Resource Planner, TSP = Transmission Service Provider, RC =
Reliability Coordinator, TOP = Transmission Operator.
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    Estimate of Annual Burden: \5\ The Commission estimates the annual
public reporting burden \6\ and cost for the information collection as:
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    \5\ ``Burden'' is defined as the total time, effort, or
financial resources expended by persons to generate, maintain,
retain, or disclose or provide information to or for a Federal
agency. For further explanation of what is included in the
information collection burden, reference 5 Code of Federal
Regulations 1320.3.
    \6\ Each of the five MOD standards in the FERC-725L information
collection previously contained ``one-time'' components to their
respondent burden. These one-time burden categories consisted
primarily of activities related to establishing industry practices
and developing data validation procedures tailored toward these
reliability standards and their reporting requirements. None of the
one-time burdens apply any longer, so they are being removed from
the FERC-725L information collection.
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RD20-4

     Elimination of the burden associated with the load-serving
entity (LSE) function in Requirement R1 of proposed Reliability
Standard MOD-031-3.\7\ The NERC petition states as the load-serving
entity is no longer a NERC registration category, NERC proposes to
remove this entity from the applicability section of proposed
Reliability Standard MOD-031-3 and remove reference to this entity in
Requirement R1, Part 1.1, where it is listed as an ``Applicable
Entity'' for purposes of Requirements R2 and R4.\8\ Additionally, NERC
proposes to strike the term ``Planning Authority'' from the
applicability section of the standard and the explanatory text that
follows. The preferred terminology for the responsible entity that
coordinates and integrates transmission facilities and service plans,
resource plans, and protection systems is ``Planning Coordinator.'' \9\
This is a terminology change and will not result in a change in burden.
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    \7\ The burden associated with the current version of this
standard, MOD-031-2, is included in FERC-725L.
    \8\ Standards Alignment with Registration Petition at 10.
    \9\ Standards Alignment with Registration Petition at 10.
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     Modification of the term ``Planning Authority'' to
``Planning Coordinator'' in proposed Reliability Standard MOD-033-
2.\10\ In the petition, NERC proposes to strike the term ``Planning
Authority'' from the applicability section of the standard and the
explanatory text that follows. The proposed change is intended to
promote consistent use of ``Planning Coordinator'' throughout the
Reliability Standards.\11\ This is a terminology change and will not
result in a change in burden.
---------------------------------------------------------------------------

    \10\ The burden associated with the current version of this
standard, MOD-033-1, is included in FERC-725L.
    \11\ Standards Alignment with Registration Petition at 11.
---------------------------------------------------------------------------

     Reliability Standard MOD-031-3 (Demand and Energy Data).
     Reliability Standard MOD-033-2 (Steady-State and Dynamic
System Model Validation).

                               Proposed Changes to Burden Due to Docket No. RD20-4-000 Adjustments and Clarifications \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Annual number of                             Average burden
  Reliability standard & requirements    Number of respondents &    responses per       Annual number of          hrs. per         Total annual burden
                                             type of entity          respondent             responses             response                hours
                                        (1).....................               (2)  (1) * (2) = (3).........               (4)  (3) * (4) = (5)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                               RD20-4 Net Changes to FERC-725L, OMB Control No. 1902-0261
--------------------------------------------------------------------------------------------------------------------------------------------------------
MOD-031-3 (Demand and Energy Data)      -561 (DP, LSE, TP & BA).                 1  -561....................                 8  -4,488
 Develop summary in accordance w/R1,
 Subparts 1.5.4 and 1.5.5.--program
 decrease & adjustment/clarification
 \12\.
MOD-031-3 (Demand and Energy Data)      113 (PC & BA)...........                 1  113.....................                 8  904
 Develop data request in accordance w/
 R1 and R3 & Evidence Retention--
 adjustment/clarification \13\.
MOD-031-3 (Demand and Energy Data)      381 (TP, BA & DP).......                 1  381.....................                 8  3,048
 Develop and provide data in
 accordance w/R2 and R4 & Evidence
 Retention--adjustment/clarification
 \12\.
MOD-033-2 (Steady-State Dynamic System  -14 (RC & TOP) \14\.....                 1  -14.....................                 8  -112
 Model Validation) R2 Data Submittal
 [for R2]--adjustment.
MOD-033-2 (Steady-State Dynamic System  -14 (PC, RC & TOP) \15\.                 1  -14.....................                 1  -14
 Model Validation), R1-R2, Evidence
 Retention, adjustment.
                                       -----------------------------------------------------------------------------------------------------------------
    Net Changes for FERC-725L due to    ........................  ................  -95 (net reduction).....  ................  -662 (net reduction).
     RD20-4.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The adjustments, due to normal industry fluctuations, are based on figures in the NERC registry as of April 10, 2020.

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

    \12\ The estimates reflect a program decrease of 63 de-
registered LSEs (and corresponding program decrease of 504 hrs.)
related to Docket No. RD20-4-000, and an adjustment/clarification
(decrease) of 498 DPs, TPs, and BAs (and corresponding decrease of
3,984 hrs.), not related to Docket No. RD20-4-000. The updated
number of 381 DPs, TPs and BAs is listed in a new row clarifying
their applicability with Requirements R2 and R4. Requirement R2
requires applicable entities to develop and provide data pursuant
with Requirement R1.
    \13\ The 113 PCs and BAs were originally estimated in FERC-725A
due to Order No. 693. However, the estimates and descriptions were
not clearly spelled out, so we are clarifying them. [Some of this
burden may still be in FERC-725A (and double counted temporarily).]
    \14\ The estimate is changing to 174 (from 188) due to normal
industry fluctuation.
    \15\ The estimate is changing to 188 (from 194) due to normal
industry fluctuation.

     MOD-025-2 (Verification and Data Reporting of Generator Real and Reactive Power Capability and Synchronous Condenser Reactive Power Capability)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Annual  number
                                           Number of         of  responses   Total number   Average burden & cost   Total annual burden      Cost per
                                        respondents \16\          per        of responses        per response       hours & total annual  respondent ($)
                                                              respondent                                                    cost
                                     (1)..................             (2)     (1) * (2) =  (4)..................  (3) * (4) = (5)......       (5) / (1)
                                                                                (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Attachment 2.......................  1003 (GO)............               1            1003  6 hrs.; $502.02 \17\.  6,018 hrs.;                    502.02
                                                                                $503,526.06.
Evidence Retention.................  1003 (GO)............               1            1003  1 hr.; $34.79 \18\...  1003 hrs.; $34,894.07           34.79
                                    --------------------------------------------------------------------------------------------------------------------
    Total..........................  .....................  ..............  ..............  .....................  7,021 hrs.;
                                                                                $538,420.07.
--------------------------------------------------------------------------------------------------------------------------------------------------------

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    \16\ The number of respondents for MOD-025-2/MOD-026-1/MOD-027-
1/MOD-31-3/MOD-032-/MOD-033-2 are from the NERC compliance registry
February 5, 2021.
    \17\ This wage figure uses the average hourly wage (plus
benefits) for electrical engineers (Occupation Code: 17-2071,
$70.19/hour) and managers (Occupation Code: 11-0000, $97.15/hour)
obtained from the Bureau of Labor Statistics (BLS) (from https://www.bls.gov/oes/current/naics2_22.htm). The average used the
following calculation: [$70.19/hour + $97.15/hour] / 2 = $83.67/
hour.
    \18\ The estimate uses the hourly average wage (plus benefits)
for file clerks obtained from the Bureau of Labor Statistics:
$34.79/hour (BLS Occupation Code: 43-4071).

              MOD-026-1 (Verification of Models and Data for Generator Excitation Control System or Plant Volt/Variance Control Functions)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Annual  number
                                           Number of         of  responses   Total number   Average burden & cost   Total annual burden      Cost per
                                          respondents             per        of responses        per response       hours & total annual  respondent ($)
                                                              respondent                                                    cost
                                     (1)..................             (2)     (1) * (2) =  (4)..................  (3) * (4) = (5)......       (5) / (1)
                                                                                (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Instructions for obtaining           201 (TP).............               1             201  8 hrs.; $669.36 \17\.  1,608 hrs.;                    669.36
 excitation control system or plant                                                                                $134,541.36.
 voltage/variance control function
 model.

Documentation on generator           501 (GO) \i\.........               1             501  8 hrs.; $669.36 \17\.  4,008 hrs.;                    669.36
 verification.                                                                                $335,349.36.
Evidence Retention.................  668 (GO and TOP).....               1             668  1 hr.; $34.79 \18\...  668 hrs.; $23,239.72.           34.79
                                    --------------------------------------------------------------------------------------------------------------------
    Total..........................  .....................  ..............  ..............  .....................  6,284 hrs.;
                                                                                $493,130.44.
--------------------------------------------------------------------------------------------------------------------------------------------------------

              MOD-027-1 (Verification of Models and Data for Turbine/Governor and Load Control or Active Power/Frequency Control Functions)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Annual  number
                                           Number of         of  responses   Total number   Average burden & cost   Total annual burden      Cost per
                                          respondents             per        of responses        per response       hours & total annual  respondent ($)
                                                              respondent                                                    cost
                                     (1)..................             (2)     (1) * (2) =  (4)..................  (3) * (4) = (5)......       (5) / (1)
                                                                                (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Instructions for obtaining           201 (TP).............               1             201  8 hrs.; $669.36 \17\.  1,608 hrs.;                    669.36
 excitation control system or plant                                                                                $134,541.36.
 voltage/variance control function
 model.
Documentation on generator           501 (GO) \19\........               1             501  8 hrs.; $669.36 \17\.  4,008 hrs.;                    669.36
 verification.                                                                                $335,349.36.
Evidence Retention.................  668 (GO and TP)......               1             668  1 hr.; $34.79 \18\...  668 hrs.; $23,239.72.           34.79
                                    --------------------------------------------------------------------------------------------------------------------
    Total..........................  .....................  ..............  ..............  .....................  6,284 hrs.;
                                                                                $493,130.44.
--------------------------------------------------------------------------------------------------------------------------------------------------------

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    \19\ It is estimated that the applicable numbers of generator
owner respondents used to calculate the public reporting burden for
these standards MOD-026-1, MOD-027-1, MOD-032-1 and MOD-033-1 is
half of total numbers of GO (501=1003/2) due to the higher
applicability threshold for those Reliability Standards.

                                     MOD-031-3 (formerly MOD-031-2) (Demand and Energy Data), included in FERC-725L
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Annual  number
                                       Number and type of    of  responses   Total number     Avg. burden & cost    Total annual burden      Cost per
   Reliability standard MOD-031-3         respondents             per        of responses     per response \20\     hours & total annual    respondent
                                                              respondent                                                    cost
                                     (1)..................             (2)     (1) * (2) =  (4)..................  (3) * (4) = (5)......       (5) / (1)
                                                                                (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
(On-going) Develop summary in        616 (DP, TP and/or                  1             616  8 hrs.; $561.52......  4,928 hrs.;                    561.52
 accordance with Requirement R1,      BA).                                                                          $345,896.32.
 Subparts 1.5.4 and 1.5.5.
MOD-031-3 Net Changes in RD20-4 (in  .....................  ..............             -67  .....................  -536 hrs.; $37,621.84
 the first table above).
                                    --------------------------------------------------------------------------------------------------------------------
    New Total for MOD-031-3 for      .....................  ..............             549  .....................  4,392 hrs.;
     Renewal.                                                                                $308,274.48.
--------------------------------------------------------------------------------------------------------------------------------------------------------

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    \20\ The estimate uses the average hourly wage (plus benefits)
of $70.19/hour for electrical engineers (Occupation Code: 17-2071)
from the Bureau of Labor Statistics.

              MOD-032-1 (Verification of Models and Data for Turbine/Governor and Load Control or Active Power/Frequency Control Functions)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Annual  number
                                           Number of         of  responses   Total number   Average burden & cost   Total annual burden      Cost per
                                          respondents             per        of responses        per response       hours & total annual  respondent ($)
                                                              respondent                                                    cost
                                     (1)..................             (2)     (1) * (2) =  (4)..................  (3) * (4) = (5)......       (5) / (1)
                                                                                (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Data Submittal.....................  1,418 (BA, GO, PA/PC,               1           1,418  8 hrs.; $561.52 \20\.  11,344 hrs.;                   561.52
                                      RP, TO, TP, and TSP).                                                         $796,235.36.

Evidence Retention.................  1,418 (BA, GO, PA/PC,               1           1,418  1 hr.; $34.79 \18\...  1,418 hrs.;                     34.79
                                      RP, TO, TP, and TSP).                                                         $49,332.22.
                                    --------------------------------------------------------------------------------------------------------------------
    Total..........................  .....................  ..............  ..............  .....................  12,762 hrs.;
                                                                                $998,484.70.
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                   MOD-033-2 (formerly MOD-033-1) (Steady-State and Dynamics System Model Validation)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Annual  number
                                           Number of         of  responses   Total number   Average burden & cost   Total annual burden      Cost per
                                          respondents             per        of responses        per response       hours & total annual  respondent ($)
                                                              respondent                                                    cost
                                     (1)..................             (2)     (1) * (2) =  (4)..................  (3) * (4) = (5)......       (5) / (1)
                                                                                (3)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Data Submittal.....................  178 (RC and TOP).....               1             178  8 hrs.; $669.36......  1,424 hrs.;                    669.36
                                                                                $119,146.08.
Evidence Retention.................  243 (PA/PC, RC, and                 1             243  1 hr.; $34.79 \18\...  243 hrs.; $8,453.97..           34.79
                                      TOP).
MOD-033-2 Net Changes in RD20-4 (in  .....................  ..............             -28  .....................  -126.................
 the first table above).
                                    --------------------------------------------------------------------------------------------------------------------
    New Total for MOD-033-2 Renewal  .....................  ..............             393  .....................  1,541 hrs.;
                                                                                $128,935.47.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The total annual estimated burden and cost for the FERC-725L
information collection is 38,724 hours and $2,960,375.60 respectively.
    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 4, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-07226 Filed 4-7-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 148 (Thursday, August 3, 2017)]
[Notices]
[Page 36132]
[FR Doc No: 2017-16350]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 3267-016]

Chasm Hydro, Inc.; ECOsponsible, LLC; Notice of Application for
Transfer of License and Soliciting Comments, Motions To Intervene, and
Protests

    On July 10, 2017, Chasm Hydro, Inc. (transferor) and ECOsponsible,
LLC (transferee) filed an application for the transfer of license for
the Ballard Mill Project No. 3267, from the transferor to the
transferee. The project is located on the Salmon River in Franklin
County, New York. The project does not occupy Federal lands.
    The applicants seek Commission approval to transfer the license for
the Ballard Mills Project from the transferor to the transferee.
    Applicant's Contacts: For Transferor: Mr. John Dowd, President,
Chasm Hydro, Inc., P.O. Box 265, Chateaugay, NY 12920.
    For Transferee: Mr. Dennis Ryan, Manager, ECOsponsible, LLC, P.O.
Box 114, West Falls, NY 14170.
    FERC Contact: Patricia W. Gillis,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    Deadline for filing comments, motions to intervene, and protests:
30 days from the date that the Commission issues this notice. The
Commission strongly encourages electronic filing. Please file comments,
motions to intervene, and protests using the Commission's eFiling
system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support at<EMAIL_ADDRESS>(866) 208-3676 (toll free), or
(202) 502-8659 (TTY). In lieu of electronic filing, please send a paper
copy to: Secretary, Federal Energy Regulatory Commission, 888 First
Street NE., Washington, DC 20426. The first page of any filing should
include docket number P-3267-016.

    Dated: July 28, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-16350 Filed 8-2-17; 8:45 am]
BILLING CODE 6717-01-P


----- Forwarded by Richard Keigwin/DC/USEPA/US on 06/03/2010 03:17 PM
-----

From:	"Roy Olson"<EMAIL_ADDRESS>
To:	Richard Keigwin/DC/USEPA/US@EPA

Cc:	"Bob Shockey"<EMAIL_ADDRESS>"Leigh Shockey"
<EMAIL_ADDRESS>
 "Stanley Bernard"<EMAIL_ADDRESS>"Steve Kay"
<EMAIL_ADDRESS>
Date:	06/03/2010 03:07 PM

Subject:	Endangered Species Data for Maleic Hydrazide

June 3, 2010

Mr. Richard P. Keigwin, Jr.

Director, Pesticide Re-evaluation Division

Ref:  Endangered Species Data for Maleic Hydrazide

Dear Mr. Keigwin:

According to the Maleic Hydrazide Final Work Plan Registration Review
January 2010 Case 0381, there was only one public comment submitted and
that by the Federal Endangered Species Task Force (FESTF) requesting
that any technical registrant for maleic hydrazide who is not a member
of the FESTF (or a company having met its data compensation obligations)
be asked to provide a formal offer-to-pay to the FESTF for reliance on
their data.

This comment raises significant concerns for us.  Since no DCI has been
issued for endangered species data for maleic hydrazide, no requirement
exists for making offers-to-pay to the FESTF at this time and when that
DCI does finally issue, there are procedures under FIFRA for responding
that do not include having to make such offers.  We deem it wholly
inappropriate for the FESTF to lobby the Agency to make a proforma
decision as to what endangered species data it will accept for maleic
hydrazide.  It is rather unseemly for a task force consisting of
reputable companies in the pesticide industry to make a formal comment,
such as the one above, to a public docket.

Drexel intends to fulfill endangered species data requirements for
maleic hydrazide by citing new data, not by relying on the FESTF data
and we do not feel obligated to rely on  FESTF data just because they
request the Agency to tell us to.  We are a founding member of the
Generic Endangered Species Task Force (GESTF), a consortium consisting
of eleven registrants, which is generating its own endangered species
data set.  Over the last several years, the GESTF has been engaged in
technical discussions with EPA regarding its ongoing data development
activities and has been encouraged by EPA's responses to our efforts and
progress thus far.

The purpose of this letter is to inform EPA that Drexel Chemical
Company, as a member in good standing of the GESTF, will rely on data
submitted by that task force to satisfy the endangered species data
requirements for our technical maleic hydrazide registrations.  Our
response to the maleic hydrazide DCI, when issued, will note that we are
part of an agreement to share in the cost to develop endangered species
data and based on the GESTF progress to-date, should be able to cite
that data well within the time frame called for under the DCI.

Thank you for your attention to this matter.

Sincerely,

Roy W. Olson

Business Development Manager

Drexel Chemical Company


[Federal Register Volume 76, Number 23 (Thursday, February 3, 2011)]
[Notices]
[Pages 6180-6181]
[FR Doc No: 2011-2296]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Summary Notice No. PE-2011-04]

Petitions for Exemption; Summary of Petitions Received

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of petitions for exemption received.

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

SUMMARY: This notice contains a summary of a petition seeking relief
from specified requirements of 14 CFR. The purpose of this notice is to
improve the public's awareness of, and participation in, this aspect of
FAA's regulatory activities. Neither publication of this notice nor the
inclusion or omission of information in the summary is intended to
affect the legal status of any petition or its final disposition.

DATES: Comments on petitions received must identify the petition docket
number involved and must be received on or before February 23, 2011.

ADDRESSES: You may send comments identified by Docket Number FAA-2010-
0990 using any of the following methods:
     Government-wide rulemaking Web site: Go to http://www.regulations.gov and follow the instructions for sending your
comments electronically.
     Mail: Send comments to the Docket Management Facility;
U.S. Department of Transportation, 1200 New Jersey Avenue, SE., West
Building Ground Floor, Room W12-140, Washington, DC 20590.
     Fax: Fax comments to the Docket Management Facility at
202-493-2251.
     Hand Delivery: Bring comments to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For more information on the rulemaking process, see the
SUPPLEMENTARY INFORMATION section of this document.
    Privacy: We will post all comments we receive, without change, to
http://www.regulations.gov, including any personal information you
provide. Using the search function of our docket Web site, anyone can
find and read the comments received into any of our dockets, including
the name of the individual sending the comment (or signing the comment
for an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78).
    Docket: To read background documents or comments received, go to
http://www.regulations.gov at any time or to the Docket Management
Facility in Room W12-140 of the West Building Ground Floor at 1200 New
Jersey Avenue, SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: Jan Thor,<PHONE_NUMBER>),
Standardization Branch, ANM-113, Federal Aviation Administration, 1601
Lind Avenue, SW., Renton, WA 98057-3356, or Fran Shaver, (202) 267-
4059, Office of Rulemaking, ARM-207, Federal Aviation Administration,
800 Independence Avenue, SW., Washington, DC 20591.
    This notice is published pursuant to 14 CFR 11.85.

    Issued in Washington, DC, on January 28, 2011.
Pamela Hamilton-Powell,
Director, Office of Rulemaking.

Petitions for Exemption

    Docket No.: FAA-2010-0990.
    Petitioner: The Boeing Company.
    Section of 14 CFR Affected: Sec.  25.809(a).
    Description of Relief Sought: To provide relief from the ``all
lighting conditions'' element of Sec.  25.809(a), at Amendment 25-116,
for a limited number of the Boeing Model 787-8 airplanes delivered on
or before December 31, 2013. If granted, this exemption would allow
sufficient time for Boeing to develop, certify, and incorporate into
production a new exterior lighting system that is compliant with Sec.
25.809(a).

[FR Doc. 2011-2296 Filed 2-2-11; 8:45 am]
BILLING CODE 4910-13-P