UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES January 14, 2004 MEMORANDUM SUBJECT: Review of 2,4 D Incident Reports DP Barcode D297233, Chemical# 030001 81 ( includes all salts, esters)

FROM: Jerome Blondell, Ph. D., Health Statistician Chemistry and Exposure Branch Health Effects Division ( 7509C)

Monica S. Hawkins, M. P. H., Environmental Health Scientist Chemistry and Exposure Branch Health Effects Division ( 7509C)

THRU: Francis B. Suhre, Chief Chemistry and Exposure Branch Health Effects Division ( 7509C)

TO: Timothy Dole, Industrial Hygienist Reregistration Branch 1 Health Effects Division ( 7509C)

BACKGROUND The following data bases have been consulted for the poisoning incident data on the active ingredient 2,4 D ( PC Code: 030001):

1) OPP Incident Data System ( IDS)  reports of incidents from various sources, including registrants, other federal and state health and environmental agencies and individual consumers, submitted to OPP since 1992. Reports submitted to the Incident Data System represent anecdotal reports or allegations only, unless otherwise stated. Typically no conclusions can be drawn implicating the pesticide as a cause of any of the reported health effects. Nevertheless, sometimes with enough cases and/ or enough documentation risk mitigation measures may be suggested. 2) Poison Control Centers  as the result of a data purchase by EPA, OPP received Poison Control Center data covering the years 1993 through 1998 for all pesticides. Most of the national 2 Poison Control Centers ( PCCs) participate in a national data collection system, the Toxic Exposure Surveillance System which obtains data from about 65 70 centers at hospitals and universities. PCCs provide telephone consultation for individuals and health care providers on suspected poisonings, involving drugs, household products, pesticides, etc.

3) California Department of Pesticide Regulation  California has collected uniform data on suspected pesticide poisonings since 1982. Physicians are required, by statute, to report to their local health officer all occurrences of illness suspected of being related to exposure to pesticides. The majority of the incidents involve workers. Information on exposure ( worker activity), type of illness ( systemic, eye, skin, eye/ skin and respiratory), likelihood of a causal relationship, and number of days off work and in the hospital are provided.

4) National Pesticide Telecommunications Network ( NPTN)  NPTN is a toll free information service supported by OPP. A ranking of the top 200 active ingredients for which telephone calls were received during calendar years 1984 1991, inclusive has been prepared. The total number of calls was tabulated for the categories human incidents, animal incidents, calls for information, and others.

2,4 D REVIEW I. Incident Data System Incident# 1317 1 A pesticide incident occurred in 1994, when a male pesticide applicator applied herbicides that contained the product for nine years. The man reported sinus problems and a pre existing tremor condition that worsened after eight years. No further information on the disposition of the case was reported.

Incident# 1332 1 A pesticide incident occurred in 1973, after a man applied herbicides containing the product for about 15 years. After 13 years, he reported psoriasis and dermatitis. No further information on the disposition of the case was reported.

Incident# 1534 1 A pesticide incident occurred in 1994, when a seaman used herbicides that contained the product. Fifteen years later, he reported damage to end organs and respiratory system, nervous system disorders, neurological damage, the inability to heal properly, skin problems, skin rash, and chloracne. No further information on the disposition of the case was reported.

Incident# 2796 67 A pesticide incident occurred in 1994, when an organic grower's neighbor applied the 3 product that drifted toward his nursery. The man reported a sore throat. No further information on the disposition of the case was reported.

Incident# 2796 99 A pesticide incident occurred in 1994, when an individual reported watery eyes, nausea, vomiting, grogginess, and a headache that lasted for two days after the product was applied to crops. No further information on the disposition of the case was reported.

Incident# 3258 1 A pesticide incident occurred in 1996, when an aerial applicator treated a large field with the product. The applicator passed over a house that was adjacent to the field and apparently did not shut off the spray. Two men were standing in the yard at the same time. One of the men returned home and immediately showered. The second man reported skin irritation and a burning sensation on his face, neck, head, and chest, and a sore throat. He was treated by a physician and released from the hospital and referred to a dermatologist. No further information on the disposition of the case was reported.

Incident# 3965 16 A pesticide incident occurred in 1994, when the product was applied in the right of way. Specific symptoms were not mentioned. No further information on the disposition of the case was reported.

Incident# 3965 34 A pesticide incident occurred in 1996, when the product was applied to the lawn. An individual, who has severe asthma, was exposed to the product. Specific symptoms were not mentioned. No further information on the disposition of the case was reported.

Incident# 4426 1 A pesticide incident occurred in 1996, when a woman applied the product that spilled on her legs and feet. She reported thrombocytopenia. No further information on the disposition of the case was reported.

Incident# 6167 1 A pesticide incident occurred in 1997, when an individual, who did not wear personal protective equipment, applied the product regularly. The individual's face, legs, and arms are usually soaked with the product. The individual reported tremors and facial fasciculation for eight months and was treated by a physician. No further information on the disposition of the case was reported.

Incident# 7096 1 A pesticide incident occurred in 1998, when an individual reported nausea, vomiting, respiratory problems, coughing, and a fever of 102 degrees. After reviewing the label and the 4 MSDS, a physician, who treated the individual, stated that the symptoms may have been caused by something other than exposure to the product. No further information on the disposition of the case was reported.

Incident# 7587 72 A pesticide incident occurred in 1996, when a fifty seven year old woman applied the product to control blackberries on her property. She accidentally wiped her eyes with her hands and reported eye irritation. The woman was treated in the emergency room. No further information on the disposition of the case was reported.

Incident# 7587 98 A pesticide incident occurred in 1996, when a forty three year old man, who is a nursery employee, reported dizziness after mowing the grass in an area that was sprayed with the product. The product was applied the previous day. No further information on the disposition of the case was reported.

Incident# 7587 131 A pesticide incident occurred in 1996, when a fifty three and forty seven year old woman reported malaise. The two women noticed an odor after the product was applied near their home. No further information on the disposition of the case was reported.

Incident# 8376 1 A pesticide incident occurred in 1998, when a man reported burning and red skin after the product soaked through his clothes to his skin. The man was treated by a physician. No further information on the disposition of the case was reported.

Incident# 8766 1 A pesticide incident occurred in 1999, when a 17 year old female reported hives on her neck. Five days earlier, the lawn at her school was treated with the product. The female was treated by a physician. No further information on the disposition of the case was reported.

Incident# 8766 2 A pesticide incident occurred in 1999, when an adult developed a rash 4 5 days after application. No further information on the disposition of the case was reported.

Incident# 9057 1 A pesticide incident occurred in 1999, when a seventy two year old woman hoed an area in her yard after her grandson sprayed thistles in the yard. She reported leg and stomach pain three weeks later and was later treated by a physician. No further information on the disposition of the case was reported.

Incident# 9694 1 A pesticide incident occurred in 1999, when a thirty six year old man reported second and third degree burns, edema, erythema, and respiratory irritation. The product was applied to an 5 area adjacent to the man who was exposed to the drift. He was admitted to the hospital for six days. No further information on the disposition of the case was reported.

Incident# 10075 2 A pesticide incident occurred in 2000, when a sixty three year old man reported ocular irritation and pain while mixing and loading the product. He was treated in an emergency room and diagnosed with corneal abrasion. No further information on the disposition of the case was reported.

Incident# 10112 1 A pesticide incident occurred in 2000, when a sixty nine year old man reported dizziness. He was mixing and loading the product that splashed in his face. No further information on the disposition of the case was reported.

Incident# 10621 1 A pesticide incident occurred in 1999, when a sixty nine year old man, who did not wear personal protective equipment, reported coughing up blood and choking four days after after he applied the product. He was treated by a physician and was diagnosed with pneumonia. No further information on the disposition of the case was reported.

Incident# 10629 1 A pesticide incident occurred in 2000, when a man sprayed his lawn and became dizzy the following day and again four days later. No further information on the disposition of the case was reported.

Incident# 10831 17 A pesticide incident occurred in 2000, when a man, who was doing a line opening procedure, reported skin irritation on his neck. No further information on the disposition of the case was reported.

Incident# 11251 7 A pesticide incident occurred in 2001, when a woman was working in a building packaging the herbicide and reported coughing, lightheadedness, dry heaves, vomiting, headache, and a burning sensation on her left lateral thigh. She was treated by a physician. No further information on the disposition of the case was reported.

Incident# 11251 8 In 2000, a news article reported a suspicious case in New Zealand where a man was exposed to 2,4 D drift and later developed Parkinsonism. Details of the exposure and documentation are not provided in this new article.

Incident# 11633 2 A pesticide incident occurred in 2001, when a sprayer was exposed after their back pack leaked the product. The sprayer reported skin irritation. No further information on the 6 disposition of the case was reported.

Incident# 11639 1 A pesticide incident occurred in 2001, when a forty three year old man reported nausea, myalgia, and a fever after the hose unhooked and the product got on his clothes. An hour later, he removed his clothes and then showered. No further information on the disposition of the case was reported.

Incident# 11639 2 A pesticide incident occurred in 2001, when a sixty seven year old man reported malaise, anorexia, and weight loss. The man used the product the previous week. He also had major surgery about the same time. No further information on the disposition of the case was reported.

Incident# 11987 1 A pesticide incident occurred in 2001, when a thirty nine year old man reported nausea, abdominal pain, and weight loss after he applied the product to his lawn. He was treated by a physician. No further information on the disposition of the case was reported.

Incident# 12120 1 A pesticide incident occurred in 2001, when a man reported anorexia, nausea, muscle weakness, chills, and sweating after he applied the product while working for three consecutive days. He was treated by his physician who reportedly diagnosed an infection. No further information on the disposition of the case was reported.

Incident# 12399 1 A pesticide incident occurred in 2000, when a forty four year old woman reported a miscarriage, chest tightness and pain, headache, and prolonged bleeding. The product was applied to a pasture. No further information on the disposition of the case was reported.

Incident# 12771 4 A pesticide incident occurred in 2002, when a man got some of the product on his foot and reported skin irritation. He was treated by a physician. No further information on the disposition of the case was reported.

Incident# 12887 1 A pesticide incident occurred in 2002, when a eight year old boy reported vomiting and strep throat. The boy drove his off road wheeler in a pasture that was treated with the product. Significant exposure from the pasture is very unlikely and symptoms are not consistent with exposure. He was treated by a physician. No further information on the disposition of the case was reported.

Incident# 12936 1 A pesticide incident occurred in 2002, when a fifty nine year old man reported lightheadedness, chest pain, hypertension, dizziness, hypertension, and other cardiovascular 7 symptoms similar to a heart attack. No further information on the disposition of the case was reported.

Incident# 12991 1 A pesticide incident occurred in 2002, when a man reported nausea and diarrhea after spraying the diluted product two days earlier. The product accidentally got on his skin. Symptoms are considered inconsistent with short term skin contact. No further information on the disposition of the case was reported.

Incident# 13109 1 A pesticide incident occurred in 2002, when a neighbor was accused of maliciously using the product to poison the water supply of another neighbor. The individual drank contaminated water for about a week and reported abdominal and kidney pain. No further information on the disposition of the case was reported.

Incident# 13251 1 A pesticide incident occurred in 2002, when a woman, who did not wear personal protective equipment, reported skin irritation, pain, and a rash after the diluted product spilled on her hands. She did not wash her hands for three hours after the exposure. The woman was treated by a physician. No further information on the disposition of the case was reported.

Incident# 13281 14 A pesticide incident occurred in 2002, when a fifty one year old man, who is a truck driver, reported difficulty breathing, vomiting, nausea, and a headache. The product was on the inside of his truck and a strong odor was present. No further information on the disposition of the case was reported.

Incident# 13578 1 A pesticide incident occurred in 2002, when an individual ingested approximately 150 ml of a 640 g/ l solution ( 96 grams swallowed) of the product in a suicide attempt. The individual was transported to the hospital and later died of multiple organ failure. No further information on the disposition of the case was reported.

Incident# 13883 14 A pesticide incident occurred in 1997, when the product was applied and drifted onto a person, car, and a garden. Specific symptoms were not mentioned. No further information on the disposition of the case was reported.

Incident# 14150 1 A pesticide incident occurred in 2002, when a seventy eight year old woman reported nausea, dizziness, fatigue, and difficulty sleeping. She sprayed crops with a backpack sprayer and did not wear personal protective equipment. The woman was treated by a physician. No further 8 information on the disposition of the case was reported.

Incident# 14167 1 A pesticide incident occurred in 2003, when a thirty two year old man reported melena, weight loss, and bleeding ulcers. He used the product at work at unknown concentrations for several hours at a time. He was treated by a physician. No further information on the disposition of the case was reported.

Incident# 14318 5 A pesticide incident occurred in 2002, when the product was applied to the lawn by an individual's neighbor. The individual reported coughing, a sore and swollen throat, and chest pain. The individual was treated by a physician and diagnosed with severe respiratory distress and chemical inhalation injury. A few days later, the individual was admitted to the hospital overnight with dehydration, nausea, and muscle cramps. No further information on the disposition of the case was reported.

Incident# 14457 2 A pesticide incident occurred in 2003, when a seventy three year old man reported pruritis on his hands, feet, legs, and arms which persisted for 3 weeks. The man was treated by a physician. No further information on the disposition of the case was reported.

II. Poison Control Center Data  1993 through 1998 Results for the years 1993 through 1998 are presented below for occupational cases, nonoccupational involving adults and older children, and for children under age six. Cases involving exposures to multiple products and cases with unrelated medical outcome are excluded. Tables 1 4 present the hazard information for 2,4 D compared with all other pesticides on six measures: percent with symptoms, percent with moderate, major, or fatal outcome, percent with major or fatal outcome, percent of exposed cases seen in a health care facility, and percent hospitalized and percent seen in a critical care facility. Table 1 reports the number of cases on which the data derived in Tables 2 4 are based. Table 2 presents this information for occupational cases, Table 3 for non occupational cases involving adults and older children ( six years or older), and Table 4 for children under age six.

Table 1. Number of 2,4 D exposures reported to the Toxic Exposure Surveillance System ( AAPCC), number with determined outcome, number seen in a health care facility for occupational and non occupational cases ( adults and children six years and older) and for children under six years of age only, 1993 1998 . 9 Subgroup Exposures Outcome determined Seen in Health Care Facility Occupational: adults and older children 273 171 102 Non occupational: adults and older children 3150 1561 355 Children under age six 1341 602 63 Table 2. Comparison between 2,4 D and all pesticides for percent cases with symptomatic outcome ( SYM), moderate or more severe outcome ( MOD), life threatening or fatal outcome ( LIFE TH), seen in a health care facility ( HCF), hospitalized ( HOSP), or seen in an intensive care unit ( ICU) reported to Poison Control Centers, 1993 1998 for occupational cases only.

Pesticide SYM* MOD* LIFE TH* HCF* HOSP* ICU*

2,4 D 81.9% 14.6% 0.585% 37.4% 7.84% 2.94%

All Pesticides 86.0% 18.8% 0.621% 47.0% 6.08% 2.36%

Ratio 0.95 0.78 0.94 0.80 1.29 1.24 * Symptomatic cases based on those cases with a minor, moderate, major, or fatal medical outcome. Denominator for SYM, MOD, and LIFE TH is the total cases where medical outcome was determined. Denominator for HCF is all exposures. Denominator for HOSP and ICU is all cases seen in a health care facility.

Table 3. Comparison between 2,4 D and all pesticides for percent cases with symptomatic outcome ( SYM), moderate or more severe outcome ( MOD), life threatening or fatal outcome ( LIFE TH), seen in a health care facility ( HCF), hospitalized ( HOSP), or seen in an intensive care unit ( ICU) reported to Poison Control Centers, 1993 1998 for non occupational cases involving adults and older children.

Pesticide SYM* MOD* LIFE TH* HCF* HOSP* ICU*

2,4 D 65.8% 9.67% 0.128% 11.3% 5.35% 1.69%

All Pesticides 68.5% 10.5% 0.359% 16.5% 6.24% 2.67%

Ratio 0.96 0.92 0.36 0.68 0.86 0.63 * Symptomatic cases based on those cases with a minor, moderate, major, or fatal medical outcome. Denominator for SYM, MOD, and LIFE TH is the total cases where medical outcome was determined. Denominator for HCF is all exposures. Denominator for HOSP and ICU is all cases seen in a health care facility. 10 Table 4. Comparison between 2,4 D and all pesticides for percent cases with symptomatic outcome ( SYM), moderate or more severe outcome ( MOD), life threatening or fatal outcome ( LIFE TH), seen in a health care facility ( HCF), hospitalized ( HOSP), or seen in an intensive care unit ( ICU) for adults and children six years and older reported to Poison Control Centers, 1993 1998 for children under six years old..

Pesticide SYM* MOD* LIFE TH* HCF* HOSP* ICU*

2,4 D 23.1% 1.33% 0.166% 4.70% 3.17% 1.59%

All Pesticides 21.8% 1.40% 0.120% 16.4% 4.78% 1.36%

Ratio 1.06 0.95 1.38 0.29 0.66 1.17 * Symptomatic cases based on those cases with a minor, moderate, major, or fatal medical outcome. Denominator for SYM, MOD, and LIFE TH is the total cases where medical outcome was determined. Denominator for HCF is all exposures. Denominator for HOSP and ICU is all cases seen in a health care facility.

In general, 2,4 D is less likely to cause minor, moderate, or life threatening symptoms than other pesticides and less likely to cause effects which would require medical treatment, hospitalization, or critical care. There was a slightly elevated requirement for hospitalization or critical care among occupational cases seen in a health care facility, but this was based on eight cases ( 3 of the 8 were seen in an ICU). Among children less than six years old, the percentage with life threatening symptoms and attention in a critical care unit was higher, but this was based on a single case. Therefore, one should be cautious about over interpreting the results for children on these two measures. In all three groups, the most common symptoms were ocular and dermal, accounting for over 400 symptomatic ( minor, moderate, or major medical outcome) each. Primary symptoms included irritation, rash, erythema, and itching. There were more complaints of eye problems than dermal problems suggesting that getting sprayed in the eye was a leading cause of symptomatic illness. A total of 53 cases reported edema or hives, suggesting an allergic type reaction. Gastrointestinal, neurological, and respiratory effects were also reported, primarily nausea, vomiting, throat irritation, headache, dizziness, coughing, and difficulty breathing.

III. California Data  1982 through 2001 Detailed descriptions of 127 cases submitted to the California Pesticide Illness Surveillance Program ( 1982 2001) were reviewed. In 33 of these cases, 2,4 D was used alone or was judged to be responsible for the health effects. Only cases with a definite, probable or possible 11 relationship were reviewed. 2,4 D ranked 74th as a cause of systemic poisoning in California based on data for 1982 through 2001. Table 1 presents the types of illnesses reported by year. Table 2 gives the total number of workers that took time off work as a result of their illness and how many were hospitalized and for how long.

Table 1. Cases Due to 2,4 D in California Reported by Type of Illness and Year, 1982 2001.

Year Illness Type Systemica Eye Skin Respiratoryb Combinationc Total 1982 1  1   2 1983   3   3 1984  2 1   3 1985  2    2 1986  1 1   1 1987 1     1 1988   1   1 1989 7     7 1990  2    2 1991   1   1 1992 1 1    2 1993   1   1 1994  1    1 1995

1996 1     1 1997

1998 1   1  2 1999 1    1 2 2000       12 Year Illness Type Systemica Eye Skin Respiratoryb Combinationc Total 2001

Total 13 9 9 1 1 33 a Category includes cases where skin, eye, or respiratory effects were also reported. b Category not used until 1990. Prior respiratory cases classified as systemic. c Category includes combined irritative effects to eye, skin, and respiratory system.

Table 2. Number of Persons Disabled ( taking time off work) or Hospitalized for Indicated Number of Days After 2,4 D Exposure in California, 1982 2001.

Time period Number of Persons Disabled Number of Persons Hospitalized One day 4

Two days 1

3 5 days 3

6 10 days

more than 10 days

Unknown 3

Indefinite

Note that no cases were hospitalized and only a few workers took time off work for a relatively short period of time. A variety of worker activities were associated with exposure to 2,4 D as illustrated in Table 3 below.

Table 3. Illnesses by Activity Categories for 2,4 D Exposure in California, 1982 2001 13 Activity Category Illness Category Systemica Eye Skin Respiratoryb Combinationc Total Applicator 3 5 7 15 Mixer/ loader 1 4 5 Storage/ disposal 1 1 2 Drift 7 7 Field worker 1 1 Other 1 1 1 3 Total 13 9 9 1 1 33 a Category includes cases where skin, eye, or respiratory effects were also reported. b Category not used until 1990. Prior respiratory cases classified as systemic. c Category includes combined irritative effects to eye, skin, and respiratory system.

According to the above activity categories, handlers ( applicators and mixer/ loaders) were associated with the majority ( 61%) of illnesses. Nearly half of these cases occurred during cleaning or repair operations or when a hose broke. One of the drift incidents involved six workers who experienced drift from a helicopter application. These illnesses included symptoms of rash, eye irritation and pain, headache, muscle twitching, numbness, corneal abrasion, eye irritation, nausea, weakness, and vomiting. Two cases, classified as possibly related to 2,4 D mentioned extreme sensitivity to a nearby application. A third case mentioned allergic reaction in an applicator on the upper extremities.

IV. National Pesticide Information Center On the list of the top 200 chemicals for which NPIC received calls from 1984 1991 inclusively, 2,4 D was ranked 8th with 429 incidents in humans reported and 108 in animals ( mostly pets).

V. Scientific Literature 14 The World Health Organization ( WHO) sponsored a review of 2,4 D by the International Programme on Chemical Safety that was published in Environmental Health Criteria in 1984. This comprehensive review includes a chapter on the " effect on man, clinical and epidemiological studies". Pertinent sections of this review are quoted below:

Signs and symptoms of acute over exposure to 2,4 D or its derivatives occurred after ingestion or absorption of large amounts, or where poor occupational hygiene was practiced leading to pronounced dermal absorption of the material. It is unlikely that, with good agricultural practice, good personal protection, and occupational hygiene, resulting in exposures to low concentrations of 2,4 D, any of the acute symptoms and signs reported below would be expected to occur.

From the point of view of occupational and bystander safety, it is reassuring that no reports were found of fatal poisonings following dermal exposure or inhalation, though temporary unconsciousness and other severe acute effects have been attributed to massive combined dermal and inhalation exposures to 2,4 D herbicides.

In addition to subjective symptoms of the central nervous system, impaired coordination, impaired responses to external stimuli, unconsciousness, coma, and death have been observed in human beings mainly after absorption of lethal or nearly lethal doses of 2,4 D.

Long lasting flaccid paraparesis or quadriparesis following skin contact with 2,4 D herbicides was reported . . . Cases of sensory neuropathy attributed to the ingestion of, or dermal exposure to, 2,4 D herbicides have also been reported.

Herbicide ingredients other than 2,4 D and related compounds might be at least partly responsible for the observed neurotoxic effects. In particular, organic solvents, emulsifiers, and ethylene glycol present in herbicide formulations have been mentioned in this connection.

Muscle fibrillations, myotonia, myoglobinuria, muscular weakness and other indications of a myotoxic effect of 2,4 D have been reported in patients treated with large doses of purified 2,4 D products . . . as well as in cases of suicidal or accidental ingestion of 2,4 D herbicides or following occupational over exposure . . . In human beings, the threshold dose for gross myotoxic effects certainly exceeds 5 mg/ kg body weight per day, and may be above 36 mg/ kg body weight per day.

Dyspnea or respiratory tract irritation were occasionally reported following occupational over exposure of 2,4 D production workers or herbicide sprayers.

Degeneration of, or fatty changes in kidney tubules, or proteinuria, increased blood urea levels, and other indications of a nephrotoxic effects were observed in cases of fatal or nearly fatal herbicide ingestion. 15 Vomiting, diarrhea, nausea, and other indications of toxic effects on the digestive tract were observed . . . after ingestion of large doses of 2,4 D herbicides, or combined inhalation and dermal over exposure. . . However, no gastrointestinal symptoms were reported by volunteers who ingested a single dose of 5 mg pure 2,4 D/ kg body weight. . . Thus, an intake of more than 300 mg 2,4 D per adult appears to be required to induce acute toxic effects on the gastrointestinal tract.

Chronic tonsillitis and paranasal sinusitis were reported in workers packaging 2,4 D sodium salt.

Based on clinical studies in which 2,4 D was injected into patients as a drug, the noobserved adverse effect level for signs and symptoms of acute 2,4 D poisoning in children and adults appears to be at or near 36 mg/ kg body weight.

A more recent review of the potential for chlorophenoxy herbicides to cause poisoning was completed by Reigart and Roberts in 1999 ( Recognition and Management of Pesticide Poisonings, Fifth Edition, EPA publication 735 R 98 003). Key passages related to symptoms and dose are quoted below:

Some of the chlorophenoxy acids, salts, and esters are moderately irritating to skin, eyes, and respiratory and gastrointestinal linings. In a few individuals, local depigmentation has apparently resulted from protracted dermal contact with chlorophenoxy compounds.

Ingestion of large amounts of chlorophenoxy acids has resulted in severe metabolic acidosis in humans. Such cases have been associated with electrocardiographic changes, myotonia, muscle weakness, myoglobinuria, and elevated serum creatine phophokinase, all reflecting injury to striated muscle.

The medical literature contains reports of peripheral neuropathy following what seemed to be minor dermal exposures to 2,4 D. It is not certain that exposures to other neurotoxicants were entirely excluded in these cases. Single doses of 5 mg/ kg body weight of 2,4 D and 2,4,5 T have been administered to human subjects without any adverse effects. One subject consumed 500 mg of 2,4 D per day for 3 weeks without experiencing symptoms or signs of illness.

Chlorophenoxy compounds are moderately irritating to skin and mucous membranes. Inhalation of sprays may cause burning sensations in the nasopharynx and chest, and coughing may result. Prolonged inhalation sometimes causes dizziness. Adjuvant chemicals added to enhance foliage penetration might account for the irritant effects of some formulations.

Manifestations of systemic toxicity of chlorophenoxy compounds are known mainly from clinical experience with cases of deliberate suicidal ingestion of large quantities. Most reports of fatal outcomes involves renal failure, acidosis, electrolyte imbalance, and a 16 resultant multiple organ failure.

Patients will present within a few hours of ingestion with vomiting, diarrhea, headache, confusion, and bizarre or aggressive behavior. Mental status changes occur with progression to coma in severe cases. . . Muscle weakness and peripheral neuropathy have been reported after occupational exposure.

Myotonia and muscle weakness may persist for months after acute poisoning. Electromyographic and nerve conduction studies in some recovering patients have demonstrated a mild proximal neuropathy and myopathy.

In a study of asymptomatic herbicide applicators, their urinary excretion of chlorophenoxy compounds rarely exceeded 1 2 mg/ L.

The following studies provide additional insight into the relationship between poisoning and route of exposure and the dose that can be fatal in the case of ingestions. Friesen et al. ( 1990) reported on a 61 year old woman who ingested 2,4 D and was treated successfully with alkaline diuresis. Their review of earlier cases noted fatalities had been reported following ingestions of amounts ranging from 250 mg/ kg to 1,200 mg/ kg body weight.

Flanagan et al. ( 1990) reported prospectively on 41 patients acutely poisoned by chlorophenoxy herbicides and ioxynil during 1984 87. Of these 41 patients, 30 were reported to have ingested chlorophenoxy compounds alone, of whom six died. How many of the 30 patients ingested 2,4 D alone was not reported. Lack of information about the patients who were exposed only to 2,4 D make this report of limited value for the purposes of this review.

Durakovic et al. ( 1992) reported on four suicides, each involving ingestion of a 40% solution of 2,4 D alone as the active ingredient. The quantity of 2,4 D ranged from 250 to 2,000 mg/ kg body weight. Signs of poisoning with 2,4 D were listed as pain in the tongue and pharnyx, erythema, vomiting, pain and weakness in muscles, lethargy, stupor, increased or lowered body temperature, weakness or respiratory muscle paralysis, coma, convulsions, and cardiac arrhythmias. The lowest dose reported to cause death, 40 grams occurred in an agricultural worker aged 80 years. A second case, involving an accidental ingestion of 40 80 grams of 2,4 D in a 50 year old miner who mistook the product for an alcoholic drink.

Keller et al. ( 1994) reported on an ingestion of an unknown quantity of relatively pure 2,4 D by a 49 year old man in a suicide attempt. His symptoms included vomiting, blood in diarrhea, disorientation, rapid pulse, pain in abdomen, deterioration of respiration, and massive hemorrhage of stomach mucosa. Based on serum concentrations in various tissues, the authors concluded that at least 25 35 grams of 2,4 D were ingested.

Jorens et al. ( 1995) also reported on the fatal case of a 60 year old farmer who ingested only 2,4 D at an estimated dose of 3,000 mg/ kg and in addition to the other symptoms had profuse gastrointestinal bleeding and metabolic acidosis due to the caustic effects of the acid. 17 Leonard et al. ( 1997) reported on an unusual case of a 65 year old man who developed lethargy over a period of two months, and then dark urine and upper abdominal discomfort. He was diagnosed with hepatitis and it was considered due to his habit of licking his golf ball to clean it, particularly on the greens where the herbicide was applied. The patient was skeptical of the diagnosis and it's relationship to licking his golf ball and later resumed the practice. He then requested repeat testing a month afterwards, which confirmed renewed altered liver function and convinced the patient that his exposure was affecting his liver. In a letter to the editor, Leonard et al. ( 1998) reported a similar case in a 23 year old man who had hepatitis and evidence of cirrhosis despite only moderate alcohol consumption.

Bradberry et al. ( 2000) reviewed the mechanisms of poisoning and clinical features of chlorophenoxy poisoning. Between 1962 and 1999, 66 cases of chlorophenoxy poisoning following ingestion were identified. Symptoms and signs of ingestion included vomiting, gastrointestinal pain, diarrhea, coma, hypertonia, ataxia, miosis, convulsions, fasciculation, and paralysis. Myopathic symptoms included limb muscle weakness, loss of tendon reflexes, and myotonia. Other symptoms included metabolic acidosis, rhabdomyolysis, and renal failure. Twenty two of the 66 patients died. The authors noted that it was not possible to determine a dose/ response relationship among these cases because the dose was rarely known with accuracy. Dermal and inhalation exposure, on the other hand, only occasionally led to systemic poisoning. The authors noted five cases of systemic toxicity reported between 1959 and 1963 which involved inadvertent spillage of 2,4 D on the limbs with little or no protective clothing. One such case was a 39 year old farmer who complained of paresthesia in the fingers and toes and myalgia. Over the next two weeks, he developed weakness and incoordination of the hands with reduced reflexes. Symptoms resolved almost completely over the next 9 months. In each of the other four cases of peripheral neuropathy after dermal exposure, there was typically a latent period of several days before the onset of nausea and vomiting, sometimes with anorexia or diarrhea. " Pain, paresthesiae, and weakness affecting mainly the lower limbs followed. Clinical findings were of a flaccid paralysis ( in 2 cases so severe that the patients could not walk) with impaired light touch, pain and temperature sensation, and reduced or absent reflexes. There was EMG evidence of denervation in 2 cases, described as ` minimal' in one of these." These other four cases all eventually recovered though mild weakness was present at the 2 3 year follow up examination in 3 of the cases. Inhalation exposure has been reported to lead to gastrointestinal and peripheral neuromuscular symptoms including nausea, vomiting, constipation, abdominal pain, limb paresthesia and pain, myalgia, weakness, and hypertonia. In some cases these symptoms persisted several weeks after a single exposure.

Reproductive effects Schreinemachers ( 2003) compared 43,500 birth outcomes compiled by the National Center for Health Statistics in selected counties of Minnesota, North Dakota, South Dakota and Montana with high wheat and low wheat acreage in those states. She found that in high wheat counties, combined circulatory and respiratory malformations increased by more than two fold, and musculoskeletal malformations increased by 50% relative to low wheat counties. Death rates 18 from birth malformations among male infants in high wheat counties were more than twice the rates in low wheat counties. This study suggests a possible association between rates of birth malformations and indirect measures of human exposure to chlorophenoxy herbicides, a common weed killer sold commercially and used in agriculture.

Since this study used wheat acreage rather than actual measurements of human exposure to determine associations with birth malformations, it is not known whether birth malformations occurred among families with actual exposure to the herbicides in question in the selected counties. Such epidemiologic studies are used to generate hypotheses. Then they must be followed up with studies that measure exposure in individuals rather than just on a county basis to determine whether the suggested relationship still holds. Although individual exposures cannot be determined from this research, the results may be indicative of potential hazards in connection with environmental exposures to chlorophenoxy herbicides. The author concluded " The purpose of this exploratory study is to identify a potential regional hazard. Results should be viewed in this light".

One strong point for this study was the apparent restriction to rural farm counties so that factors affecting urban counties would not confound results. Information on percent people living in rural farm and rural nonfarm areas should have been provided to confirm this result rather than just relying on 50% of the population being rural ( criteria for a counties' inclusion in the study).

The weakest aspect of the study is the grouping of counties into high and low exposure based on percent wheat acreage. A large percent of the population in many of these counties may not have resided on a farm at all. Their exposure to wheat versus corn and soybeans meant that over factors including exposure to fungal, viral and bacterial flora was likely very different and a potential confounder. Most importantantly, you don't know if the birth defects actually involve persons exposed to 2,4 D; just that they resided in counties where relatively larger amounts of 2,4 D were likely to be used. This is known as aggregation bias and such studies are referred to as having an ecologic design and subject to the ecologic fallacy.

Carcinogenicity A Science Advisory Board/ Scientific Advisory Panel Special Joint Committee reviewed available data on 2,4 D in 1994 and concluded that " the data are not sufficient to conclude that there is a cause and effect relationship between exposure to 2,4 D and non Hodgkin's lymphoma" and 2,4 D has been classified in Group D, not classifiable as to human carcinogenicity ( EPA, 1994). In 1996, HED reviewed the following five additional studies:

1. Waterhouse D, Carman WJ, Schottenfeld D, Gridley G, McLean S. Cancer incidence in the rural community of Tecumseh, Michigan: A pattern of increased lymphopoietic neoplasms. Cancer 77: 763 770, 1996.

2. Zahm SH, Babbit PA, Weisenburger DD, Blair A, Saal RC, Vaught JB. The role of agricultural pesticide use in the 19 development of non Hodgkin's lymphoma in women. Archives of Environmental Health 48: 353 358, 1993.

3. Morrison HI, Semenciw RM, Wilkins K, Mao Y, Wigle DT. Non Hodgkin's lymphoma and agricultural practices in the prairie provinces of Canada. Scandinavian Journal of Work, Environment and Health 20: 42 47, 1994.

4. Persson B, Fredriksson M, Olsen K, Beoryd B, Axelson O. Some occupational exposures as risk factors for malignant lymphomas. Cancer 72: 1173 1778, 1993.

5. Kogevinas M, Kauppinen T, Winkelmann R, et al. Soft tissue sarcoma and non Hodgkin's lymphoma in workers exposed to phenoxy herbicides, chlorophenols, and dioxins: two nested case control studies. Epidemiology 6: 396 402, 1995.

HED concluded after reviewing these five studies that: These studies are not sufficient to change the conclusions drawn by the Science Advisory Panel/ Scientific Advisory Board. Only two studies, Zahm et al. 1993 and Kogevinas et al. 1995 looked specifically at exposure to 2,4 D and even in these studies, there were problems with correlation with exposure to other pesticides. Statistical significance was achieved for two types of cancer ( Hodgkin's disease and soft tissue sarcoma). However, the earlier evidence for these two sites was generally much less supportive than it was for non Hodgkin's lymphoma.

Since the 1996 review, very few new studies have examined the relationship between exposure to 2,4 D and cancer. The most recent review was in Critical Reviews in Toxicology by Garabrant and Philbert at the University of Michigan School of Public Health ( 2002). Their conclusion was " Overall, the available evidence from epidemiologic studies is not adequate to conclude that any form of cancer is causally associated with 2,4 D exposure." This review was conducted at the request of the Industry Task Force II on 2,4 D Research. Many of the studies reviewed by Garabrant and Philbert measured cancer risk among workers exposed to a variety of herbicides. For example, studies of licensed pesticide applicators included a number of exposures in addition to 2,4 D, in such a manner, that 2,4 D relative contribution to risk could not be determined. These studies are excluded from this review unless there was information on risks specific to 2,4 D or just 2,4 D and 2,4,5 T. Only five studies, four cohort and one case control study, were identified that specifically assess the carcinogenicity of 2,4 D ( Kogevinas et al. 1997, Zahm 1997, Lynge 1998, Burns et al. 2001, and Hardell et al. 1999).

Investigators at IARC updated an earlier study ( Kogevinas et al. 1995) of a multinational cohort of primarily manufacturing workers exposed to chlorophenoxy herbicides ( Kogevinas et al. 1997). There was no significant associations between 2,4 D exposure and soft tissue sarcoma ( STS), NHL, and Hodgkin's disease among those not exposed to TCDD dioxin contaminants. The Odds ratio for STS was 1.35 ( 95% CI 0.16  4.88) based on two observed cases. The Odds 20 ratio for NHL was 1.00 ( 95% CI 0.46 to 1.90) based on nine observed cases. The Odds ratio for Hodgkin's disease was 0.27 ( 95% CI 0.01 to 1.51) based on one observed case.

Zahm ( 1997) reported on a cohort of pesticide applicators potentially exposed to 2,4 D up to 90 120 days per year. There were no cases of STS or Hodgkin's disease. The estimated odds ratio for NHL was 1.63 ( 95% CI 0.33 to 4.77) based on three cases. However, all three cases had potential exposure to DCPA, MCPP, dicamba, and organophosphate insecticides as well as 2,4 D. Therefore, the risk from exposure to 2,4 D alone cannot be specified.

Lynge ( 1998) examined cancer incidence in a cohort of 2,119 Danish phenoxy herbicide workers exposed between 1947 and 1993. However, most of these workers were exposed to MCPA rather than 2,4 D. No odds ratios were calculated for those workers primarily exposed to 2,4 D.

Burns et al. ( 2001) updated earlier studies of a cohort of 1,517 chemical workers who manufactured or formulated 2,4 D between 1945 and 1994. The odds ratio for NHL was 1.00 ( 95% CI 0.21 to 2.92) based on three cases. These three cases had relatively low exposures based on cumulative dose estimates compared to other workers in the cohort. There was one case of Hodgkin's disease compared to 0.6 expected which was not significant. Soft tissue sarcomas were not measured in this study. Burns et al. concluded there was " no evidence of an increased risk of death due to all causes or total malignant neoplasms. No significant risk of NHL was found".

The case control study by Hardell et al. ( 1999) examined 404 cases of non Hodgkin's lymphoma and 741 controls. None of the subjects had exposure to 2,4 D alone and exposure to 2,4 D and 2,4,5 T were not significantly associated with NHL ( Odds Ratio = 1.3, 95% CI 0.7 to 2.3). A higher estimated odds ratio was found for those with less than 30 days exposure than for those with more than 30 days exposure, a finding that does not support dose response.

Two additional studies that should be mentioned used an ecologic study design to determine whether chlorophenoxy herbicides were associated with cancer. One study examined cancer rates in four northern wheat producing states in the U. S. ( Schreinemachers 2000). This study used wheat acreage as a surrogate for exposure to chlorophenoxy herbicides and determined cancer rates for grouped counties or individual counties based on tertiles of wheat acreage. As the author points out, this study " will generate hypotheses for more resourceintensive and definitive cohort and case control studies where exposure information can be determined for individual subjects, thereby avoiding ecologic fallacies." Although a number of possible associations between high wheat acreage and cancer were identified, it is not possible to determine which cancer sites were due to chance, confounding, and other factors without further studies.

A second study in northern Italy examined incidence rates of lymphomas in rice growing areas where chlorophenoxy herbicides were used ( Fontana et al. 1998). This study identified cases of Hodgkin's disease and non Hodgkin's lymphoma in two provinces in both men and 21 women for the time periods 1985 88 and 1991 93. Results of soil and water analyses performed in 1974 75 were used to classify 13 municipalities as having high exposure to 2,4 D and 2,4,5 TP. Levels of water contamination were similar for 2,4 D and 2,4,5 TP and there were no measurements of tetrachlorodibenzodioxin ( TCDD). Although there was a significant association between non Hodgkin's lymphoma in men and the high exposure area, it was not possible to say whether 2,4 D, 2,4,5 TP or TCDD was responsible for the association. Other confounding factors might also account for the observed association. A supplemental case control study examined hematolymphopoietic cancers ( NHL, Hodgkin's disease, and leukemias) and found some evidence for elevated risk among those with occupations in rice fields, but the odds ratios were not statistically significant and, as before, the association could not be tied, specifically to 2,4 D.

Based on the above reviews of the above studies, HED concludes there is no additional evidence that would implicate 2,4 D as a cause of cancer.

VI. Conclusion A number of effects reported in humans were associated with a specific dose. These reports are summarized below:

In human beings, the threshold dose for gross myotoxic effects certainly exceeds 5 mg/ kg body weight per day, and may be above 36 mg/ kg body weight per day ( WHO 1984).

no gastrointestinal symptoms were reported by volunteers who ingested a single dose of 5 mg pure 2,4 D/ kg body weight. . . Thus, an intake of more than 300 mg 2,4 D per adult appears to be required to induce acute toxic effects on the gastrointestinal tract ( WHO 1984).

Based on clinical studies in which 2,4 D was injected into patients as a drug, the noobserved adverse effect level for signs and symptoms of acute 2,4 D poisoning in children and adults appears to be at or near 36 mg/ kg body weight ( WHO 1984).

Single doses of 5 mg/ kg body weight of 2,4 D and 2,4,5 T have been administered to human subjects without any adverse effects. One subject consumed 500 mg of 2,4 D per day for 3 weeks without experiencing symptoms or signs of illness ( Reigart and Roberts 1999).

In a study of asymptomatic herbicide applicators, their urinary excretion of chlorophenoxy compounds rarely exceeded 1 2 mg/ L ( Reigart and Roberts 1999).

fatalities had been reported following ingestions of amounts ranging from 250 mg/ kg to 1,200 mg/ kg body weight ( Friesen et al. 1990 ).

Durakovic et al. ( 1992) reported on four suicides, each involving ingestion of a 40% 22 solution of 2,4 D alone as the active ingredient. The quantity of 2,4 D ranged from 250 to 2,000 mg/ kg body weight. . . The lowest dose reported to cause death, 40 grams occurred in an agricultural worker aged 80 years. A second case, involving an accidental ingestion of 40 80 grams of 2,4 D in a 50 year old miner who mistook the product for an alcoholic drink ( Durakovic et al. 1992).

The information above suggests a no observed effect level in humans of around 5 10 mg/ kg body weight. Low observed lethal dose by ingestion appears to be around 250 500 mg/ kg body weight.

Based on California data, the majority of illnesses and injury due to 2,4 D occur among handlers and not among bystanders exposed to drift or residue. One drift case did occur when six person exposed to drift from a helicopter application experienced nausea, headache, throat and eye irritation. This particular application violated label directions. Handler associated cases often occur due to equipment failure or during repair and maintenance of application equipment.

Of particular concern are the observations by Bradberry et al. ( 2000) that found five cases of systemic toxicity reported between 1959 and 1963 which involved inadvertent spillage of 2,4 D on the limbs with little or no protective clothing. One such case was a 39 year old farmer who complained of paresthesia in the fingers and toes and myalgia. Over the next two weeks, he developed weakness and incoordination of the hands with reduced reflexes. Symptoms resolved almost completely over the next 9 months. In each of the other four cases of peripheral neuropathy after dermal exposure, there was typically a latent period of several days before the onset of nausea and vomiting, sometimes with anorexia or diarrhea. " Pain, paresthesiae, and weakness affecting mainly the lower limbs followed. Clinical findings were of a flaccid paralysis ( in 2 cases so severe that the patients could not walk) with impaired light touch, pain and temperature sensation, and reduced or absent reflexes. There was EMG evidence of denervation in 2 cases, described as ` minimal' in one of these." These other four cases all eventually recovered though mild weakness was present at the 2 3 year follow up examination in 3 of the cases. Inhalation exposure has been reported to lead to gastrointestinal and peripheral neuromuscular symptoms including nausea, vomiting, constipation, abdominal pain, limb paresthesia and pain, myalgia, weakness, and hypertonia. In some cases these symptoms persisted several weeks after a single exposure. Bradberry et al. ( 2000) noted that no such cases have been reported in the past 20 years which may suggest that impurities or differences in formulation may be responsible for the earlier reported cases. Nevertheless, the potential for 2,4 D to cause relatively long term ( 9 months in one case) serious effects ( two cases unable to walk) from just dermal or inhalation exposure, though rare, suggests a very serious hazard.

VII. Recommendations Personal protective equipment to prevent excessive dermal exposure may be important not only to prevent minor irritant effects, but also long term effects to the muscles. Labels should clearly warn that significant amounts of 2,4 D spilled on the skin should be rinsed off with copious amounts of soap and water immediately after exposure. 23 A large number of problems have occurred among workers and residential users who got 2,4 D in their eyes. Thus, eye protection for both occupational and residential users is warranted.

References Bradberry SM, Watt BE, Proudfoot AT, Vale JA. 2000. Mechanisms of toxicity, clinical features, and management of acute chlorophenoxy herbicide poisoning: a review. J Toxicol Clin Toxicol. 38( 2): 111 22.

Burns CJ, Beard KK, Cartmill JB. 2001. Mortality in chemical workers potentially exposed to 2,4 dichlorophenoxyacetic acid ( 2,4 D) 1945 94: an update. Occup Environ Med. 58( 1): 24 30.

Durakovic Z, Durakovic A, Durakovic S, Ivanovic D. 1992. Poisoning with 2,4 dichlorophenoxyacetic acid treated by hemodialysis. Arch Toxicol. 66( 7): 518 21.

EPA ( U. S. Environmental Protection Agency). 1994. An SAB Report: Assessment of Potential 2,4 D Carcinogencity. Review of the Epidemiological and Other Data on Potential Carcinogencity of 2,4 D. U. S. Environmental Protection Agency Science Advisory Board ( SAB), Washington, D. C.

Faustini A, Settimi L, Pacifici R, Fano V, Zuccaro P, Forastiere F. 1996. Immunological changes among farmers exposed to phenoxy herbicides: preliminary observations. Occup Environ Med. 53( 9): 583 5.

Flanagan RJ, Meredith TJ, Ruprah M, Onyon LJ, Liddle A. 1990. Alkaline diuresis for acute poisoning with chlorophenoxy herbicides and ioxynil. Lancet. Feb 24; 335( 8687): 454 8.

Fontana A, Picoco C, Masala G, Prastaro C, Vineis P. 1998. Incidence rates of lymphomas and environmental measurements of phenoxy herbicides: ecological analysis and case control study. Archives of Environmental Health 53: 384 387.

Friesen EG, Jones GR, Vaughan D. 1990. Clinical presentation and management of acute 2,4_ D oral ingestion. Drug Saf. 5( 2): 155 9.

Garabrant DH, Philbert MA. 2002. Review of 2,4 dichlorophenoxyacetic acid ( 2,4 D) epidemiology and toxicology. Critical Reviews in Toxicology 32( 4): 233 257.

Hardell L, Eriksson M. 1999. A case control study of non Hodgkin's lymphoma and exposure to pesticides. Cancer 85: 1353 1360.

Jorens PG, Heytens L, De Paep RJ, Bossaert L, Selala MI, Schepens PJ. 1995. A 2,4 dichlorophenoxyacetic acid induced fatality. Eur J Emerg Med. 2( 1): 52 5. 24 Keller T, Skopp G, Wu M, Aderjan R. 1994. Fatal overdose of 2,4 dichlorophenoxyacetic acid ( 2,4 D). Forensic Sci Int. 65( 1): 13 8.

Kogevinas M, Becher H, Benn T, Bertazzi PA, Boffetta P. 1997. Cancer mortality in workers exposed to phenoxy herbicides, chlorophenols, and dioxins. Am J Epidemiol. 145: 1061 1075.

Leonard C, Burke CM, O'Keane C, Doyle JS. 1997. " Golf ball liver": agent orange hepatitis. Gut. 40( 5): 687 8. and comment in: Gut. 42( 1): 143, 1998.

Lynge E. 1998. Cancer incidence in Danish phenoxy herbicide workers, 1947 1993. Environ Health Perspect. 106: 683 688.

Reigart JR, Roberts JR. 1999. Recognition and Management of Pesticide Poisonings, Fifth Edition. EPA 735 R 98 003. U. S. Environmental Protection Agency, Washington, D. C.

Schreinemachers DM. 2000. Cancer mortality in four northern wheat producing states. Environ Health Perspect. 108: 873 881.

Schreinemachers DM. 2003. Birth malformations and other adverse perinatal outcomes in four wheat producing states. Environ Health Perspect. 111: 1259 1264. ( and two comments and response by Kirby RS and Salihu HM and by Burns CJ and Leonard RC. 2003. Environ Health Perspect. 111: A868 A870).

World Health Organization ( WHO) 1984. 2,4 Dichlorophenoxyacetic acid ( 2,4 D). Environmental Health Criteria 29: 83 101.

Zahm SH. 1997. Mortality study of pesticide applicators and other employees of a lawn service company. JOEM 39: 1055 1067.

cc: 2,4 D file ( 030001) William Hazel, HED ( 7509C) Mark Seaton, SRRD ( 7508C) 25


[Federal Register: January 23, 2009 (Volume 74, Number 14)]
[Notices]
[Page 4178]
[DOCID:fr23ja09-43]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER09-504-000]

AC Landfill Energy, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

January 14, 2009.
    This is a supplemental notice in the above-referenced proceeding of
AC Landfill Energy, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR Part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426, in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure(18 CFR 385.211 and
385.214). Anyone filing a motion to intervene or protest must serve a
copy of that document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR Part 34, of future issuances of securities and assumptions of
liability, is February 3, 2009.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://
www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First St., NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list.
    They are also available for review in the Commission's Public
Reference Room in Washington, DC. There is an eSubscription link on the
Web site that enables subscribers to receive e-mail notification when a
document is added to a subscribed docket(s). For assistance with any
FERC Online service, please e-mail<EMAIL_ADDRESS>or call
(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
 [FR Doc. E9-1351 Filed 1-22-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 238 (Thursday, December 11, 2014)]
[Notices]
[Pages 73577-73581]
[FR Doc No: 2014-29155]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9920-28-OAR]

Fuels and Fuel Additives: Request for Substantiations of Claims
of Confidential Business Information (CBI) From Businesses That Have
Submitted Reports and Transactional Information Under the Renewable
Fuel Standard (RFS) Program

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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SUMMARY: The U.S. Environmental Protection Agency (EPA or Agency) has
received a request under the Freedom of Information Act (FOIA) for
certain records submitted to EPA under the Renewable Fuel Standard
(RFS) program between January 1, 2011 and November 2014. These records
were submitted to EPA pursuant to the RFS program's annual reporting,
quarterly reporting and transactional information reporting within
EPA's Moderated Transaction System (EMTS). This notice is a request for
substantiations of confidentiality claims from businesses that have
submitted any or all of the information listed in this notice and are
claiming the information as confidential business information (CBI).
The procedures by which businesses may voluntarily substantiate claims
of CBI in regard to the information at issue in the FOIA request are
provided in this notice, which is referenced in the parties' joint
briefing schedule in the case, Perkins Coie LLP v. McCarthy, Case 1:13-
cv-01799 (D.D.C filed Nov. 11, 2013). EPA's Office of General Counsel
(OGC) will review comments received in response to this notice in
preparing a Final Confidentiality Determination under 40 CFR part 2,
subpart B, to determine whether the information at issue should be
released publicly in response to the FOIA request at issue in the
above-referenced litigation. If OGC determines after reviewing the
substantiations that some or all of the documents responsive to the
FOIA request are not entitled to confidential treatment under 40 CFR
part 2, and therefore should be released, EPA will provide notice of
this determination by letter, prior to release, to businesses who have
submitted the information, allowing such businesses 10 working days to
respond, pursuant to 40 CFR 2.205(f).

DATES: Written comments must be postmarked or hand delivered to the
address listed below, or emailed to the person listed in the FOR
FURTHER INFORMATION CONTACT section, by January 9, 2015.

ADDRESSES: You \1\ may submit your comments by any of the following
methods: Email<EMAIL_ADDRESS>---------------------------------------------------------------------------

    \1\ By ``you,'' EPA is referencing here and throughout this
notice an authorized representative of a business that has submitted
to EPA the information at issue in this notice.
---------------------------------------------------------------------------

U.S. Mail:
U.S. Environmental Protection Agency,
ATTN: Ben Larson,
Mail Code 6405A,
1200 Pennsylvania Ave. NW.,
Washington, DC 20460.

Commercial Delivery:
U.S. Environmental Protection Agency,
William Jefferson Clinton Building--North,
ATTN: Ben Larson,
Mail Code 6405A, Room 6520W,
1200 Pennsylvania Ave. NW.,
Washington, DC 20004.

    Instructions: Address all comments to the person listed in the FOR
FURTHER INFORMATION CONTACT section, postmarked, hand delivered or
emailed by January 9, 2015.

FOR FURTHER INFORMATION CONTACT: Ben Larson, Compliance Division,
Office of Transportation and Air Quality (MC-6405A), U.S. Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington DC 20460;
telephone number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Worldwide Web (WWW). In addition to being
available in the Federal Register, an electronic copy of today's notice
will also be available through the WWW. A copy of this notice will be
posted on EPA's Renewable Fuel Standard notification Web site at:
http://www.epa.gov/otaq/fuels/renewablefuels/notices.htm.
    This request for substantiation is covered under OMB's Information
Collection Request number 2020-0003.
    Organization of this Document: The following outline is provided to
aid in location information in this preamble.

I. General Information
    A. Does this notice apply to me?
    B. What should I consider as I prepare my comments to the EPA?
II. Background and Purpose of Notice
III. Description of Data Elements Requested by Category
    A. Annual Compliance Report
    B. Ownership of Renewable Identification Numbers Generated in
Years 2012 and 2013
    C. Transactional Information Contained in EPA's Moderated
Transaction System
IV. Request for Comments

I. General Information

A. Does this notice apply to me?

    This notice is directed to businesses that have submitted
information under 40 CFR part 80 subpart M. If you have further
questions regarding the applicability of this action to a particular
party, after reviewing the remainder of this notice, please contact the
person listed in the FOR FURTHER INFORMATION CONTACT section. The FOIA
request does not identify by name any single company in its request for
RFS documents.

B. What should I consider as I prepare my comments to the EPA?

1. Submitting Information Claimed as CBI in Response to This Notice
    Clearly mark as ``CONFIDENTIAL'' any or all of the comments or
information that you claim to be CBI that you submit in response to
this notice. For CBI saved on a computer disc or CD ROM that you mail
to the EPA, mark the outside of the disk or CD ROM as ``CONFIDENTIAL''
and then identify electronically within the disk or CD ROM the specific
information that is claimed as CBI. Information marked as CBI will not
be disclosed except in accordance with procedures set forth in 40 CFR
part 2.
    Do not submit information through email that you consider to be CBI
or otherwise protected. Only send or deliver information identified as
CBI to the mail or hand/courier delivery address listed within this
notice.
    Alternatively, businesses can submit example reports with example
data filled in within each field. The business can use the example data
as a tool for explaining its reasoning.
    If you have any questions about CBI or the procedures for claiming
CBI, please consult the person identified in the section within this
notice marked FOR FURTHER INFORMATION CONTACT.
2. Tips for Preparing Your Comments
    Follow all instructions in this notice and, if you are claiming
information as CBI, please respond to each of the eleven questions
listed within the ``Request for Comments'' section below. As necessary,
please provide specific examples to illustrate your concerns and
suggest alternatives, making any necessary references to applicable
statutes, case law or regulations. Explain your views as clearly as
possible,

avoiding the use of profanity or personal threats.
    Make sure to submit your information and comments by the comment
period deadline identified in the preceding section titled DATES. You
may also provide the name, date, and Federal Register citation.

II. Background and Purpose of Notice

    Background. The EPA's Office of Transportation and Air Quality
(OTAQ) has responsibility for protecting public health and the
environment by regulating air pollution from vehicles, engines, and the
fuels used to operate them, and by encouraging travel choices that
minimize emissions. To promote the use of fuels derived from renewable
sources, Congress established the Renewable Fuel Standards (RFS)
program in Section 211(o) of the Clean Air Act (the CAA or the Act).
The CAA specifies increasing annual ``applicable volumes'' of four
categories of renewable fuel--total renewable fuel, cellulosic biofuel,
biomass-based diesel, and advanced biofuel--to be used in the
transportation sector.\2\ For purposes of the RFS program, renewable
fuel must be derived from ``renewable biomass'' and meet other
definitional requirements, including specified lifecycle greenhouse gas
emissions reductions as compared to baseline petroleum fuel. The Act
directs EPA to establish a compliance program and annual percentage
standards to ensure that the applicable volumes of renewable fuel are
used.
---------------------------------------------------------------------------

    \2\ Section 211(o)(7) provides EPA with authority to waive the
statutory applicable volumes in whole or in part in certain
specified circumstances.
---------------------------------------------------------------------------

    EPA implements the RFS through regulations established in 40 CFR
part 80 subpart M. EPA requires the submission of compliance reporting
information under Sec. Sec.  80.1451 and 80.1452. Certain additional
information must be submitted to EPA for facility registration, and for
other purposes. See Sec. Sec.  80.1449, 1450, 1464, 1465, 1466, 1467,
1469.
    Purpose. EPA OTAQ has received a request under the Freedom of
Information Act (FOIA), 5 U.S.C. 552, for certain records submitted to
EPA under the RFS reporting requirements, including the Annual
Compliance reports submitted by Obligated Parties; RIN Activity or
Ownership by Quarter; and transactional information entered into the
EPA's Moderated Transaction System (EMTS). The FOIA request does not
identify by name any single company in its request for RFS documents.
The specific data elements in these reports are defined further below
under the section, ``Description of Data Elements Requested by
Category.'' Companies submitting reports under the RFS program have
claimed all or some of this information as confidential business
information (CBI). In accordance with applicable EPA regulations, 40
CFR part 2, subpart B, the EPA has determined that some companies have
asserted CBI claims, and that others might be expected to assert CBI
claims, for some or all of the information sought through the FOIA
request. Under EPA regulations at 40 CFR part 2, subpart B, the FOIA
request has been initially denied to afford companies an opportunity to
provide comments and information to substantiate a claim as described
below. The FOIA request and corresponding CBI issues are the subject of
litigation in federal district court in the District of Columbia,
Perkins Coie LLP v. McCarthy, Case 1:13-cv-01799 (D.D.C filed Nov. 11,
2013).
    In light of the large number of businesses involved that have made
CBI claims or are expected to make CBI claims, EPA is proceeding using
a multi-step process as described in the joint proposed briefing
schedule in the above-noted case. First, a certain number of businesses
have recently received formal requests by certified letter for
substantiations, pursuant to 40 CFR 2.204(e). Second, this Federal
Register notice is to provide the remaining businesses that supplied
the information described in this notice with an opportunity to provide
information in support of each respective business's confidentiality
claims, as further directed below. This submission is not required and
a business will not waive any claim by not submitting information in
response to this Federal Register notice. The EPA's Office of General
Counsel (OGC) will consider the responses received from all of the
businesses that were contacted by direct letter and through this
Federal Register notice and issue a final confidentiality determination
that covers the information described in this notice. EPA anticipates
that the final confidentiality determination for each business will be
the same. As to those businesses that have submitted RFS information to
EPA but did not receive one of the request letters for substantiation
discussed above and chose not to provide information in response to
this notice, the EPA anticipates providing determinations pursuant to
40 CFR 2.204(d)(2) and 2.205(f) to those businesses based on the
determinations made for the businesses that provide substantiations.
Each business will receive 10 working days' notice prior to release of
any information that is not found to be confidential.
    Therefore, EPA is providing you the opportunity to make the
showings described below, with specific references to those portions of
the information you consider to be CBI. Please note that each affected
business need only substantiate its claims of confidentiality once
during this process. EPA will not be sending out additional letters
requesting substantiation following the publication of this notice. By
the conclusion of this process, EPA will provide: (1) final
confidentiality determinations to the businesses that have submitted
responses to this notice or to any directly mailed substantiation
request letters, and (2) notice, under 40 CFR 2.204(d)(2) and 2.205(f),
to the other businesses on record who have submitted types of RFS
information, if any, that EPA determines not to be confidential.

III. Description of Data Elements Requested by Category

    EPA OGC will make a final confidentiality determination on the
categories of information described under this section. The categories
list the different data elements that an affected business may have
submitted to EPA under the RFS program. Certain data elements listed
below may not be relevant to every affected business.

A. Annual Compliance Report

    Any obligated party described in Sec.  80.1406 (refiners and
importers of gasoline/diesel) or exporter of renewable fuel described
in Sec.  80.1430 must submit to EPA reports on an annual basis as
described in Sec.  80.1451(a)(1). The time period for the reports,
which are responsive to the pending FOIA request, include those
submitted from 2011 through November 2014. The format and exact data
elements of the annual compliance report has varied between compliance
years, but they include the information required by Sec.
80.1451(a)(1), and the following general types of data elements:
    Report Information
    a. Report Name (RFS0303, RFS0302, etc)--Form ID for the RFS2 Annual
Compliance Report;
    b. Report Type (original or resubmission)--Indicates whether this
is an original report or resubmission;
    c. CBI (yes or no)--Specifies if the data contained within the
report is being claimed as Confidential Business Information (CBI)
under 40 CFR part 2, subpart B;

    d. Report Date--Date of report submission;
    e. Compliance Year--Compliance period of the report.
    Compliance Elements
    f. Renewable Volume Obligation (RVO) Name--Indicates to which RVO
types (Cellulosic Biofuel, Biomass-Based Diesel, Advanced Biofuel,
Renewable Fuel) the reported compliance information is related;
    g. Renewable Fuel Standard Value/Equivalence Value--The renewable
fuel standards are defined at Sec.  80.1405. For exporters of renewable
fuel, the equivalence value for the exported renewable fuel is found at
Sec.  80.1415;
    h. Cellulosic biofuel waiver credits payment method--The method by
which payment has been submitted for cellulosic biofuel waiver credits,
including pay.gov, fedwire, or U.S. Mail;
    i. Cellulosic biofuel waiver credits ID--Transaction reference ID
provided by the U.S. Treasury for purchase of the cellulosic biofuel
waiver credits.
    Compliance Activity and Status
    j. Compliance Basis--How obligated parties indicate the compliance
level, including as an Aggregated Importer, Aggregated Refiner,
Exporter, or facility by facility;
    k. If ``Refinery by Refinery'' selected for compliance basis, then
each facility ID listed out in a separate row;
    l. Renewable Fuel Export Type--For renewable fuel exporters, the
type of renewable fuel exported;
    m. Total volume of gasoline and diesel production and Renewable
Fuel Exported;
    n. Prior year deficit--Renewable Volume Obligation deficit from
prior compliance year;
    o. Current year deficit--Renewable Volume Obligation deficit to be
carried into the next compliance year;
    p. Renewable Volume Obligation--Total, in gallons, calculated by
combining the non-renewable gasoline, non-renewable diesel, multiplying
it by the annual standards, and combining the result with any prior-
year deficit as described in Sec.  80.1407;
    q. Current year/Prior year RINs used for compliance (aggregated by
D-code, RVO name, and compliance level);
    r. Cellulosic biofuel waiver credits used.

B. Ownership of Renewable Identification Numbers Generated in Years
2012 and 2013

    Producers and importers of renewable fuel generate renewable
identification numbers, or ``RINs,'' for each gallon of renewable fuel
they import or produce for use in the United States. RINs are assigned
to batches of renewable fuel by producers and importers of such fuel,
and typically separated from those batches by an obligated party or
other entity that blends the renewable fuel into conventional fuel.
Once separated, RINs may be kept for compliance or sold. Obligated
parties comply with their renewable volume obligations by accumulating
RINs and then retiring them to demonstrate annual compliance.
    RIN ownership is tracked through EPA's Moderated Transaction System
(EMTS). EMTS is a high-volume transaction system that tracks the full
RIN lifecycle, including RIN generation, buy/sell, separation, and
retirement. RIN ownership totals are continuously captured and
maintained within this system.
    In addition, companies also report RIN ownership totals through the
quarterly compliance ``RIN Activity Report'' as required in Sec.
80.1451(c)(1). The RIN Activity Report contains RINs owned at the start
and end of each quarter for ``prior-year'' and ``current-year'' RINs.
    This FOIA request seeks ownership information by company for RINs
that were generated in years 2012 and 2013.

C. Transactional Information Contained in EPA's Moderated Transaction
System

    As described in the previous section, RFS transactions are entered
into EMTS as required under Sec.  80.1451(c)(1)(ii). Elements listed
are referenced as they appear in the EMTS users guide posted at http://www.epa.gov/otaq/fuels/renewablefuels/emtshtml/emtsdocuments.htm. The
time period for the reports, which are responsive to the pending FOIA
request, include those submitted from 2011 through November 2014. The
following list contains the data elements responsive to this FOIA.
    RIN trades (data elements within a ``buy'' and ``sell''
transaction)--EMTS system records specific to RINs transferring from
one trading partner to another, including specific data elements about
the trade.
Company Identifying Information
    a. Submitting Company Identifying Info--Company entering the RIN
buy/sell transaction into EMTS;
    b. EMTS Transaction Date--The date EMTS processed the transaction;
Trading Partner Identifying Information
    c. Trading partner ID--The four digit EPA assigned ID of the
company identified as the trading partner;
    d. Trading partner Name--The name of the company identified as the
trading partner.
Optional Information Provided to Trading Partner
    e. PTD number [optional]--Number on the Product Transfer Document
(used for transactions);
    f. Matching Transaction Identifier [optional]--User-specified ID
that can be used to match specific transactions (entering the EMTS
Transaction ID of the received trade to be matched);
    g. Public Supporting Document [optional]--Any public supporting
text used by the company to share with its trading partner;
    h. Public Supporting Document Number [optional]--Tracking/
identification numbers that are associated with the public supporting
document text;
    i. Public Supporting Document [optional]--Any public supporting
text used by the company to share with its trading partner;
    j. Public Supporting Document Number [optional]--Tracking/
identification numbers that are associated with the public supporting
document text.
Compliance Activity
    k. RIN quantity--Amount of RINs involved in the transaction;
    l. Batch volume [conditional--required for assigned RINs]--Volume
of batch fuel, in gallons, involved in the transaction;
    m. Fuel Code/''D'' Code--Identifies the type of Fuel produced
involved in the transaction;
    n. Assignment Code--Status of the RINs (Assigned or Separated);
    o. RIN Year--Generation year of the RINs;
    p. [QAP Service Type Code]--** New in 4Q 2014--Indicates the
Quality Assurance Provider (QAP) service associated with the RINs;
    q. Buy/Sell Reason code--The reason the buy/sell transaction is
taking place;
    r. Price per RIN [conditional--required if Price per Gallon is not
reported]--Price per individual RIN;
    s. Price per Gallon [conditional--required if Price per RIN is not
reported]--Price per individual gallon;
    t. Transaction Detail Comment [conditional]--Comment provided by
the user on the transaction;
    u. RINs Information for non-FIFO trades [multiple, conditional--
includes: Generate Organization ID, Generate Facility ID, and Batch
Number]--Information provided by buyer/seller to select specific
batches either at the producer level or down to the individual batch
level.

Other Optional Submitter Provided Information
    v. 1--Supporting Document [optional]--Information for the industry
user to create user defined data to report supporting document
identifiers;
    w. 1--Supporting Document Number [optional]--ID number associated
with the supporting document text;
    x. 2--Supporting Document [optional]--Information for the industry
user to create user defined data to report supporting document
identifiers;
    y. 2--Supporting Document Number [optional]--ID number associated
with the supporting document text.
    RIN generation transactions--EMTS system records specific to a
registered renewable fuel producer assigning RINs to a batch of
renewable fuel, including elements related to the renewable fuel
production process.
Company Identifying Information
    a. Submitting Company Identifying Info--Company entering the RIN
generation transaction into EMTS;
    b. EMTS Transaction Date--The date EMTS processed the transaction.
Compliance Activity
    c. RIN Quantity--Quantity of RINs generated for the batch;
    d. Batch volume--Total volume of the fuel batch in gallons;
    e. Fuel Code/''D'' Code--Identifying the type of renewable fuel
associated with the batch;
    f. Production Process--Process used for producing the renewable
fuel;
    g. Fuel Category--The renewable fuel (ethanol, biogas, biodiesel,
etc);
    h. Fuel Production Date--Date the renewable fuel batch was produced
    i. Denaturant Volume--The volume of non-renewable fuel added to a
volume of ethanol to create the batch volume for a given batch number
of renewable fuel;
    j. Equivalence Value--A multiplier applied to the batch volume to
determine the number of RINs that will be generated per gallon of
renewable fuel produced. The equivalence value is directly related to
fuel category code;
    k. Production Source--Originating Organization--Four digit ID of
the organization producing the renewable fuel;
    l. Production Source--Originating Facility--Five digit ID of the
production facility of the renewable fuel;
    m. Batch number--Industry user assigned identification number for
the batch of renewable fuel;
    n. Production Source--Additional information (text box);
    o. Feedstock--Feedstock used to produce the batch of renewable
fuel;
    p. Feedstock amount--Amount of feedstock used in the production of
the batch of renewable fuel;
    q. Feedstock--Additional Information (text box);
    r. Co-product--Co-products created from the renewable fuel
production process;
    s. Co-product additional information--Comment provided by the
industry user on the co-products produced;
    t. [QAP Service Type Code]--** New in 4Q 2014--Quality Assurance
Provider service type associated with the RINs;
    u. Transaction Detail Comment--Comments provided by the industry
user on the EMTS transaction.
Other Optional Submitter Provided Information
    v. 1--Supporting Document [optional]--Information for the industry
user to create user defined data to report supporting document
identifiers;
    w. 1--Supporting Document Number [optional]--ID number associated
with the supporting document text;
    x. 2--Supporting Document [optional]--Information for the industry
user to create user defined data to report supporting document
identifiers;
    y. 2--Supporting Document Number [optional]--ID number associated
with the supporting document text.
    RIN separation transaction--EMTS system records specific to a RFS
registered party separating RINs from renewable fuel, including
elements related to the RIN quantity and why the party is separating
RINs.
Company Identifying Information
    a. Submitting Company Identifying Info--Company entering the RIN
separation transaction into EMTS;
    b. EMTS Transaction Date--The date EMTS processed the transaction;
Compliance Activity
    c. RIN quantity--Quantity of RINs separated from the fuel;
    d. Batch volume--Volume of renewable fuel involved in the
transaction;
    e. Fuel Code/''D'' Code--Identifying the type of renewable fuel;
    f. Separate Reason Code--Reason for separating RINs from the
renewable fuel;
    g. Transaction Date--Date EMTS processes the transaction;
    h. RIN Year--Year the RINs involved in the transaction were
generated;
    i. [QAP Service Type Code]--** New in 4Q 2014--Quality Assurance
Provider service type associated with the RINs;
    j. Blender Organization Identifier [conditional]--Company ID for
upstream delegation for blending;
    k. Blender Organization Name [conditional]--Company name for
upstream delegation for blending;
    l. Transaction Detail Comment [conditional]--User provided comments
on the transaction;
    m. RINs Information for non-FIFO trades [multiple, conditional--
includes: Generate Organization ID, Generate Facility ID, and Batch
Number]--Information provided by the Organization involved in the
transaction to select specific batches either at the producer level or
down to the individual batch level.
Other Optional Submitter Provided Information
    n. 1--Supporting Document [optional]--Information for the industry
user to create user defined data to report supporting document
identifiers;
    o. 1--Supporting Document Number [optional]--ID number associated
with the supporting document text;
    p. 2--Supporting Document [optional]--Information for the industry
user to create user defined data to report supporting document
identifiers;
    q. 2--Supporting Document Number [optional]--ID number associated
with the supporting document text.
    RIN retirement transaction--EMTS system records specific to a RFS
registered party using RINs for compliance or removing RINs from the
RFS marketplace for other reasons, including elements related to the
RIN quantity and why the party is retiring RINs.
Company Identifying Information
    a. Submitting Company Identifying Info--Company entering the RIN
retirement transaction into EMTS;
    b. EMTS Transaction Date--The date EMTS processed the transaction.
Compliance Activity
    c. RIN quantity--Amount of RINs retired;
    d. Batch volume [conditional]--Amount of fuel in gallons involved
in the retire transaction;
    e. Fuel Code/''D'' Code--Identifying the type of renewable fuel;
    f. Assignment Code--Status of RINs (assigned or separated);
    g. RIN Year--Year RINs involved in the transaction were generated;
    h. [QAP Service Type Code]--** New in 4Q 2014--Quality Assurance
Provider service type associated with the RINs;
    i. Retire Reason code--Reason for retiring the RINs;

    j. Transaction Date--Date the EMTS system processes the
transaction;
    k. Compliance Year [conditional]--If retiring for annual
compliance, the compliance year;
    l. Compliance Level Code [conditional]--If retiring for annual
compliance, the compliance level such as Refiner, Importer, or
Exporter;
    m. Compliance Facility Identifier [conditional]--If retiring for
annual compliance and choosing to comply facility by facility, the five
digit facility ID the RINs are being retired under;
    n. Transaction Detail Comment [conditional]--Comments provided by
the industry user on the EMTS transaction;
    o. RINs Information for non-FIFO trades [multiple, conditional--
includes: Generate Organization ID, Generate Facility ID, and Batch
Number]--Information provided by the Organization involved in the
transaction to select specific batches either at the producer level or
down to the individual batch level.
Other Optional Submitter Provided Information
    p. 1--Supporting Document [optional]--Information for the industry
user to create user defined data to report supporting document
identifiers;
    q. 1--Supporting Document Number [optional]--ID number associated
with the supporting document text;
    r. 2--Supporting Document [optional]--Information for the industry
user to create user defined data to report supporting document
identifiers;
    s. 2--Supporting Document Number [optional]--ID number associated
with the supporting document text.

IV. Request for Comments

    The purpose of this notice is to notify you, as an authorized
representative of a business that has submitted information to the RFS
program, that the EPA OGC will be making a final confidentiality
determination concerning the information described within this notice
that you have claimed or might be expected to claim as CBI. If you feel
that some or all of the information is entitled to confidential
treatment, you must make the showings below with specific reference to
those portions of the information you consider confidential.
    Please be specific when identifying and substantiating the
information subject to your claim. Where your claim, as originally made
at the time of submission to the Agency or as modified by your response
to this letter, does not include all information on a page, please
attach a copy of each such page with brackets around the text that you
claim to be CBI. Any information not specifically identified as subject
to a confidentiality claim and substantiated as such in your response
to this letter may be disclosed to the requester without further notice
to you. Please note that if a page, document, group, or class of
documents claimed by you to be CBI contains a significant amount of
information which the EPA OGC determines is not CBI, your CBI claim
regarding that page, document, group, or class of documents may be
denied.
    For each item or class of information that you claim as CBI, please
answer the following questions, giving as much detail as possible. Your
comments in response to these questions will be used by the EPA to
determine whether the information has been shown to be entitled to
confidential treatment:
    1. For what period of time do you request that the information be
maintained as confidential, e.g., until a certain date, until the
occurrence of a specified event, or permanently? If the occurrence of a
specific event will eliminate the need for confidentiality, please
specify that event.
    2. Information submitted to the EPA becomes stale over time. Why
should the information you claim as confidential be protected for the
time period specified in your answer to question #1?
    3. What measures have you taken to protect the information claimed
as confidential? Have you disclosed the information to anyone other
than a governmental body or someone who is bound by an agreement not to
disclose the information further? If so, why should the information be
considered confidential?
    4. Is the information contained in any publicly available material
such as the Internet, publicly available databases, promotional
publications, annual reports, or articles? If so, specify which.
    5. Is there any means by which a member of the public could obtain
access to the information? Is the information of a kind that you would
customarily not release to the public?
    6. Has any governmental body made a determination as to the
confidentiality of the information? If so, please attach a copy of the
determination.
    7. For each item or category of information claimed as
confidential, explain with specificity why release of the information
is likely to cause substantial harm to your competitive position.
Explain the specific nature of those harmful effects, why they should
be viewed as substantial, and the causal relationship between
disclosure and such harmful effects. How could your competitors make
use of this information to your detriment?
    8. Do you assert that the information is submitted on a voluntary
or a mandatory basis? Please explain the reason for your assertion. If
you assert that the information is voluntarily submitted information,
please explain whether the information is the kind that would
customarily not be released to the public.
    9. Whether you assert the information as voluntary or involuntary,
please address why disclosure of the information would tend to lessen
the availability to the EPA of similar information in the future.
    10. If you believe any information to be (a) trade secret(s),
please so state and explain the reason for your belief. Please attach
copies of those pages containing such information with brackets around
the text that you claim to be (a) trade secret(s).
    11. Explain any other issue you deem relevant (including, if
pertinent, reasons why you believe that the information you claim to be
CBI is not emission data or effluent data).
    Please note that you bear the burden of substantiating your
confidentiality claim(s). Generalized or conclusory statements will be
given little or no weight in EPA's determination on the confidentiality
of the information you claim to be CBI. Your comments must be
postmarked or hand delivered to this office, or emailed to the person
listed in the FOR FURTHER INFORMATION CONTACT section, by January 9,
2015.
    If you wish to claim any information that you provide in your
response to this letter to itself be confidential, you must mark the
response ``CONFIDENTIAL'' or with a similar designation, and must
bracket all text in the response that you so claim. Information so
designated will be disclosed by the EPA only to the extent allowed by,
and by means of the procedures set forth in, 40 CFR part 2, subpart B.
If you fail to claim the information provided in your response as
confidential, it may be made available to the public without further
notice to you.
    Should you have any questions concerning this matter, contact the
person listed in the FOR FURTHER INFORMATION CONTACT section.

    Authority: 40 CFR 2.204 et. al

    Dated: December 4, 2014.
Byron Bunker,
Director, Compliance Division, Office of Transportation and Air
Quality.
[FR Doc. 2014-29155 Filed 12-10-14; 8:45 am]
BILLING CODE 6560-50-P