[Federal Register Volume 83, Number 142 (Tuesday, July 24, 2018)]
[Rules and Regulations]
[Page 34948]
[FR Doc No: 2018-15759]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2018-0695]

Security Zone; Seattle's Seafair Fleet Week Moving Vessels, 2018,
Puget Sound, WA

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce Seattle's Seafair Fleet Week
Moving Vessels security zones from 10 a.m. on July 31, 2018, through 6
p.m. on August 6, 2018. These security zones are necessary to help
ensure the security of the vessels from sabotage or other subversive
acts during Seafair Fleet Week Parade of Ships. The designated
participating vessels are: HMCS YELLOWKNIFE (MM 706), HMCS WHITEHORSE
(MM 705), and USCGC MELLON (WHEC 717). During the enforcement period,
no person or vessel may enter or remain in the security zones without
the permission of the Captain of the Port (COTP), Puget Sound or her
designated representative. The COTP has granted general permission for
vessels to enter the outer 400 yards of the security zones as long as
those vessels within the outer 400 yards of the security zones operate
at the minimum speed necessary to maintain course unless required to
maintain speed by the navigation rules.

DATES: The regulations in 33 CFR 165.1333 will be enforced from 10 a.m.
July 31, 2018, through 6 p.m. on August 6, 2018, unless cancelled
sooner by the Captain of the Port Puget Sound or her designated
representative.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email Petty Officer Zachary Spence,
Sector Puget Sound Waterways Management Division, Coast Guard;
telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the security
zones for Seattle's Seafair Fleet Week Moving Vessels in 33 CFR
165.1333 from 10 a.m. on July 31, 2018, through 6 p.m. on August 6,
2018.
    In accordance with the general regulations in 33 CFR part 165,
subpart D, no person or vessel may enter or remain in the security
zones without the permission of the Captain of the Port, Puget Sound or
her designated representative. For 2018, the following areas are Sec.
165.1333 security zones: All navigable waters within 500 yards of HMCS
YELLOWKNIFE (MM 706), HMCS WHITEHORSE (MM 705), and USCGC MELLON (WHEC
717) while each such vessel is in the Sector Puget Sound COTP Zone.
    The COTP has granted general permission for vessels to enter the
outer 400 yards of the security zones as long as those vessels within
the outer 400 yards of the security zones operate at the minimum speed
necessary to maintain course unless required to maintain speed by the
navigation rules. The COTP may be assisted by other federal, state or
local agencies with the enforcement of the security zones.
    All vessel operators who desire to enter the inner 100 yards of the
security zones or transit the outer 400 yards at greater than minimum
speed necessary to maintain course must obtain permission from the COTP
or her designated representative by contacting the on-scene patrol
craft on VHF Ch 13 or Ch 16. Requests must include the reason why
movement within this area is necessary. Vessel operators granted
permission to enter the security zones will be escorted by the on-scene
patrol craft until they are outside of the security zones.
    This notice of enforcement is issued under authority of 33 CFR
165.1333 and 5 U.S.C. 552(a). In addition to this notice of
enforcement, the Coast Guard will provide the maritime community with
advanced notification of the security zones via the Local Notice to
Mariners and marine information broadcasts on the day of the event. In
the event that there are changes to the participating vessels, due to
operational requirements, the Coast Guard will provide actual notice
for any additional designated participating vessels not covered in this
notice. In addition, members of the public may contact Sector Puget
Sound COTP at<PHONE_NUMBER> for an up-to-date list of designated
participating vessels. For a pending amendment to Sec.  165.1333(a)
related to possible changes in participating vessels after the notice
of enforcement is published, see final rule published June 28, 2018 (83
FR 30345). That rule will become effective July 30, 2018. If the COTP
determines that the security zones need not be enforced for the full
duration stated in this notice of enforcement, a Broadcast Notice to
Mariners may be used to grant general permission to enter all portions
of the regulated areas.

    Dated: July 18, 2018.
M.M. Balding,
Captain, U.S. Coast Guard, Acting Captain of the Port Puget Sound.
[FR Doc. 2018-15759 Filed 7-23-18; 8:45 am]
 BILLING CODE 9110-04-P


TABLE OF CONTENTS Page No.

14. BREAST MILK INTAKE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 14.1. BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 14.2. KEY STUDIES ON BREAST MILK INTAKE . . . . . . . . . . . . . . . . . . . . . . . . . 1 14.3. RELEVANT STUDIES ON BREAST MILK INTAKE . . . . . . . . . . . . . . . . . . . 4 14.4. KEY STUDIES ON LIPID CONTENT AND FAT INTAKE FROM BREAST MILK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 14.5. OTHER FACTORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 14.6. RECOMMENDATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 14.7 REFERENCES FOR CHAPTER 14 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 LIST OF TABLES Table 14 1. Daily Intakes of Breast Milk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Table 14 2. Breast Milk Intake for Infants Aged 1 to 6 Months . . . . . . . . . . . . . . . . . . . . . . . . 2 Table 14 3. Breast Milk Intake Among Exclusively Breast fed Infants During the First 4 Months of Life . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Table 14 4. Breast Milk Intake During a 24 Hour Period . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Table 14 5. Breast Milk Intake Estimated by the DARLING Study . . . . . . . . . . . . . . . . . . . . . . 4 Table 14 6. Milk Intake for Bottle and Breast fed Infants by Age Group . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Table 14 7. Milk Intake for Boys and Girls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Table 14 8. Intake of Breast Milk and Formula . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Table 14 9. Lipid Content of Human Milk and Estimated Lipid Intake Among Exclusively Breast fed Infants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Table 14 10. Predicted Lipid Intakes for Breast fed Infants Under 12 Months of Age . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Table 14 11. Number of Meals Per Day . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Table 14 12. Percentage of Mothers Breast feeding Newborn Infants in the Hospital and Infants at 5 or 6 Months of Age in the United States in 1989 , by Ethnic Background and Selected Demographic a Variables . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 b Table 14 13. Breast Milk Intake Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 Table 14 14. Confidence in Breast Milk Intake Recommendations . . . . . . . . . . . . . . . . . . . . . 13 Table 14 15. Breast Milk Intake Rates Derived From Key Studies . . . . . . . . . . . . . . . . . . . . . 14 Table 14 16. Summary of Recommended Breast Milk and Lipid Intake Rates . . . . . . . . . . . . 15 Volume II  Food Ingestion Factors Chapter 14  Breast Milk Intake Exposure Factors Handbook Page August 1997 14 1 14. BREAST MILK INTAKE 14.1. BACKGROUND Breast milk is a potential source of exposure to toxic The available studies on breast milk intake are substances for nursing infants. Lipid soluble chemical summarized in the following sections. Studies on breast compounds accumulate in body fat and may be transferred milk intake rates have been classified as either key studies to breast fed infants in the lipid portion of breast milk. or relevant studies based on the criteria described in the Because nursing infants obtain most ( if not all) of their Introduction ( Volume I, Section 1.3.1). Recommended dietary intake from breast milk, they are especially intake rates are based on the results of key studies, but vulnerable to exposures to these compounds. Estimating relevant studies are also presented to provide the reader the magnitude of the potential dose to infants from breast with added perspective on the current state of knowledge milk requires information on the quantity of breast milk pertaining to breast milk intake. consumed per day and the duration ( months) over which Relevant data on lipid content and fat intake, breast feeding occurs. Information on the fat content of breast feeding duration and frequency, and the estimated breast milk is also needed for estimating dose from breast percentage of the U. S. population that breast feeds are also milk residue concentrations that have been indexed to lipid presented. content. Several studies have generated data on breast milk intake. Typically, breast milk intake has been measured over a 24 hour period by weighing the infant before and after each feeding without changing its clothing ( test weighing). The sum of the difference between the measured weights over the 24 hour period is assumed to be equivalent to the amount of breast milk consumed daily. Intakes measured using this procedure are often corrected for evaporative water losses ( insensible water losses) between infant weighings ( NAS, 1991). Neville et al. ( 1988) evaluated the validity of the test weight approach among bottle fed infants by comparing the weights of milk taken from bottles with the differences between the infants' weights before and after feeding. When test weight data were corrected for insensible water loss, they were not significantly different from bottle weights. Conversions between weight and volume of breast milk consumed are made using the density of human milk ( approximately 1.03 g/ mL) ( NAS, 1991). Recently, techniques for measuring breast milk intake using stable isotopes have been developed. However, few data based on this new technique have been published ( NAS, 1991). Studies among nursing mothers in industrialized countries have shown that intakes among infants average approximately 750 to 800 g/ day ( 728 to 777 mL/ day) during the first 4 to 5 months of life with a range of 450 to 1,200 g/ day ( 437 to 1,165 mL/ day) ( NAS, 1991). Similar intakes have also been reported for developing countries ( NAS, 1991). Infant birth weight and nursing frequency have been shown to influence the rate of intake ( NAS, 1991). Infants who are larger at birth and/ or nurse more frequently have been shown to have higher intake rates. Also, breast milk production among nursing mothers has been reported to be somewhat higher than the amount actually consumed by the infant ( NAS, 1991).

14.2. KEY STUDIES ON BREAST MILK INTAKE Pao et al. ( 1980)  Milk Intakes and Feeding Patterns of Breast fed Infants  Pao et al. ( 1980) conducted a study of 22 healthy breast fed infants to estimate breast milk intake rates. Infants were categorized as completely breast fed or partially breast fed. Breast feeding mothers were recruited through LaLeche League groups. Except for one black infant, all other infants were from white middleclass families in southwestern Ohio. The goal of the study was to enroll infants as close to one month of age as possible and to obtain records near one, three, six, and nine months of age ( Pao et al., 1980). However, not all mother/ infant pairs participated at each time interval. Data were collected for these 22 infants using the test weighing method. Records were collected for three consecutive 24 hour periods at each test interval. The weight of breast milk was converted to volume by assuming a density of 1.03 g/ mL. Daily intake rates were calculated for each infant based on the mean of the three 24 hour periods. Mean daily breast milk intake rates for the infants surveyed at each time interval are presented in Table 14 1. For completely breast fed infants, the mean intake rates were 600 mL/ day at 1 month of age and 833 mL/ day at 3 months of age. Partially breast fed infants had mean intake rates of 485 mL/ day, 467 mL/ day, 395 mL/ day, and 554 mL/ day at 1, 3, 6, and 9 months of age, respectively. Pao et al. ( 1980) also noted that intake rates for boys in both groups were slightly higher than for girls. Volume II  Food Ingestion Factors Chapter 14  Breast Milk Intake Page Exposure Factors Handbook 14 2 August 1997 Table 14 1. Daily Intakes of Breast Milk Age Period ( mL/ day) ( mL/ day) Number of Infants Surveyed at Mean Range of ( months) of Infants ( mL/ day) ( mL/ day) ( mL/ day) Each Time Intake Daily Intake a Completely Breast fed 1 month 11 600 ± 159 426  989 3 months 2 833 645  1,000 6 months 1 682 616  786 Partially Breast fed 1 month 4 485 ± 79 398  655 3 months 11 467 ± 100 242  698 6 months 6 395 ± 175 147  684 9 months 3 < 554 451  732 Data expressed as mean ± standard deviation. a Source: Pao et al., 1980.

The advantage of this study is that data for both exclusively and partially breast fed infants were collected for multiple time periods. Also, data for individual infants were collected over 3 consecutive days which would account for some individual variability. However, the number of infants in the study was relatively small and may not be entirely representative of the U. S. population, based on race and socioeconomic status, which may introduce some bias in the results. In addition, this study did not account for insensible water loss which may underestimate the amount of breast milk ingested. Dewey and Lönnerdal ( 1983)  Milk and Nutrient Intakes of Breast fed Infants from 1 to 6 Months  Dewey and Lönnerdal ( 1983) monitored the dietary intake of 20 breast fed infants between the ages of 1 and 6 months. Most of the infants in the study were exclusively breast fed ( five were given some formula, and several were given small amounts of solid foods after 3 months of age). According to Dewey and Lönnerdal ( 1983), the mothers were all well educated and recruited through Lamaze childbirth classes in the Davis area of California. Breast milk intake volume was estimated based on two 24 hour test weighings per month. Breast milk intake rates for the various age groups are presented in Table 14 2. Breast milk intake averaged 673, 782, and 896 mL/ day at 1, 3, and 6 months of age, respectively. The advantage of this study is that it evaluated breastfed infants for a period of 6 months based on two 24 hour observations per infant per month. Corrections for insensible water loss apparently were not made. Also, the number of infants in the study was relatively small and may not be representative of U. S. population, based on race and socioeconomic status. Table 14 2. Breast Milk Intake for Infants Aged 1 to 6 Months Age Number Mean SD Range a 1 16 673 192 341 1,003 2 19 756 170 449 1,055 3 16 782 172 492 1,053 4 13 810 142 593 1,045 5 11 805 117 554 1,045 6 11 896 122 675 1,096 Standard deviation. a Source: Dewey and Lönnerdal, 1983.

Butte et al. ( 1984)  Human Milk Intake and Growth in Exclusively Breast fed Infants  Breast milk intake was studied in exclusively breast fed infants during the first 4 months of life ( Butte et al., 1984). Breastfeeding mothers were recruited through the Baylor Milk Bank Program in Texas. Forty five mother/ infant pairs participated in the study. However, data for some time periods ( i. e., 1, 2, 3, or 4 months) were missing for some mothers as a result of illness or other factors. The mothers were from the middleto upper socioeconomic stratum and had a mean age of 28.0 ± 3.1 years. A total of 41 mothers were white, 2 were Hispanic, 1 was Asian, and 1 was West Indian. Infant growth progressed satisfactorily over the course of the study. The amount of milk ingested over a 24 hour period was determined using the test weighing procedure. Test weighing occurred over a 24 hour period for most participants, but intake among several infants was studied over longer periods ( 48 to 96 hours) to assess individual variation in intake. The study did not indicate whether the data were corrected for insensible water loss. Mean breast milk intake ranged from 723 g/ day ( 702 mL/ day) at 3 months to 751 g/ day ( 729 mL/ day) at 1 month, with an overall mean of 733 g/ day ( 712 mL/ day) for the entire study period ( Table 14 3). Intakes were also calculated on the basis of body weight ( Table 14 3). Based on the results of test weighings conducted over 48 to 96 hours, the mean variation in individual daily intake was estimated to be 7.9 ± 3.6 percent. Volume II  Food Ingestion Factors Chapter 14  Breast Milk Intake Exposure Factors Handbook Page August 1997 14 3 Table 14 3. Breast Milk Intake Among Exclusively Breast fed Infants During the First 4 Months of Life Age of Intake Intake Weight ( months) Infants ( g/ day) ( g/ kg day) ( kg) Number Breast Milk Breast Milk Body a a b 1 37 751.0 ± 130.0 159.0 ± 24.0 4.7 2 40 725.0 ± 131.0 129.0 ± 19.0 5.6 3 37 723.0 ± 114.0 117.0 ± 20.0 6.2 4 41 740.0 ± 128.0 111.0 ± 17.0 6.7 Data expressed as mean ± standard deviation. a Calculated by dividing breast milk intake ( g/ day) by breast milk intake ( g/ kg b day). Source: Butte et al., 1984.

The advantage of this study is that data for a larger number of exclusively breast fed infants were collected than were collected by Pao et al. ( 1980). However, data were collected over a shorter time period ( i. e., 4 months compared to 6 months) and day to day variability was not characterized for all infants. In addition, the population studied may not be representative of the U. S. population based on race and socioeconomic status. Neville et al. ( 1988)  Studies on Human Lactation  Neville et al. ( 1988) studied breast milk intake among 13 infants during the first year of life. The mothers were all multiparous, nonsmoking, Caucasian women of middle to upper socioeconomic status living in Denver, Colorado ( Neville et al., 1988). All women in the study practiced exclusive breast feeding for at least 5 months. Solid foods were introduced at mean age of 7 months. Daily milk intake was estimated by the test weighing method with corrections for insensible weight loss. Data were collected daily from birth to 14 days, weekly from weeks 3 through 8, and monthly until the study period ended at 1 year after inception. The estimated breast milk intakes for this study are listed in Table 14 4. Mean breast milk intakes were 770 g/ day ( 748 mL/ day), 734 g/ day ( 713 mL/ day), 766 g/ day ( 744 mL/ day), and 403 g/ day ( 391 mL/ day) at 1, 3, 6, and 12 months of age, respectively. In comparison to the previously described studies, Neville et al. ( 1988) collected data on numerous days over a relatively long time period ( 12 months) and they were corrected for insensible weight loss. However, the intake rates presented in Table 14 4 are estimated based on intake during only a 24 hour period. Consequently, these intake rates are based on short term data that do not account for day to day variability among individual infants. Also, a smaller number of subjects was included than in the previous studies, and the population studied may not be representative of the U. S. population, based on race and socioeconomic status.

Table 14 4. Breast Milk Intake During a 24 Hour Period Standard Age Number Mean Deviation Range ( days) of Infants ( g/ day) ( g/ day) ( g/ day)

1 7 44 71  31 149 2 10 182 86 44 355 3 11 371 153 209 688 4 11 451 176 164 694 5 12 498 129 323 736 6 10 508 167 315 861 7 8 573 167 406 842 8 9 581 159 410 923 9 10 580 76 470 720 10 10 589 132 366 866 11 8 615 168 398 934 14 10 653 154 416 922 21 10 651 84 554 786 28 13 770 179 495 1144 35 12 668 117 465 930 42 12 711 111 554 896 49 10 709 115 559 922 56 13 694 98 556 859 90 12 734 114 613 942 120 13 711 100 570 847 150 13 838 134 688 1173 180 13 766 121 508 936 210 12 721 154 486 963 240 10 622 210 288 1002 270 12 618 220 223 871 300 11 551 234 129 894 330 9 554 240 120 860 360 9 403 250 65 770 a Negative value due to insensible water loss correction. a Source: Neville et al., 1988.

Dewey et al. ( 1991a; 1991b)  The DARLING Study  The Davis Area Research on Lactation, Infant Nutrition and Growth ( DARLING) study was conducted in 1986 to evaluate growth patterns, nutrient intake, morbidity, and activity levels in infants who were breast fed for at least the first 12 months of life ( Dewey et al., 1991a; 1991b). Seventy three infants aged 3 months were included in the study. The number of infants included in the study at subsequent time intervals was somewhat lower as a result of attrition. All infants in the study were healthy and of normal gestational age and weight at birth, and did not consume solid foods until after the first 4 months of age. The mothers were highly educated and of " relatively high socioeconomic status" from the Davis area of California ( Dewey et al., 1991a; 1991b). Breast milk intake was Volume II  Food Ingestion Factors Chapter 14  Breast Milk Intake Page Exposure Factors Handbook 14 4 August 1997 estimated by weighing the infants before and after each ( Table 14 7). Breast milk intake was estimated to be 656 feeding and correcting for insensible water loss. Test g/ day ( 637 mL/ day) at 1 month and 776 g/ day ( 753 mL/ day) weighings were conducted over a 4 day period every 3 at 3 months. months. The results of the study indicate that breast milk intake declines over the first 12 months of life. Mean breast milk intake was estimated to be 812 g/ day ( 788 mL/ day) at 3 months and 448 g/ day ( 435 mL/ day) at 12 months ( Table 14 5). Based on the estimated intakes at 3 months of age, variability between individuals ( coefficient of variation ( CV) = 16.3 percent) was higher than individual day to day variability ( CV = 5.4 percent) for the infants in the study ( Dewey et al., 1991a).

Table 14 5. Breast Milk Intake Estimated by the DARLING Study Age Number of Mean Intake Standard Deviation ( months) Infants ( g/ day) ( g/ day)

3 73 812 133 6 60 769 171 9 50 646 217 12 42 448 251 Source: Dewey et al. ( 1991b).

The advantages of this study are that data were collected over a relatively long time ( 4 days) period at each test interval which would account for some day to day infant variability, and corrections for insensible water loss were made. However, the population studied may not be representative of the U. S. population, based on race and socioeconomic status.

14.3. RELEVANT STUDIES ON BREAST MILK INTAKE Hofvander et al. ( 1982)  The Amount of Milk Consumed by 1 to 3 Month Old Breast or Bottle Fed Infants  Hofvander et al. ( 1982) compared milk intake among breast fed and bottle fed infants at ages 1, 2, and 3 months of age. Intake of breast milk and breast milk substitutes was tabulated for 25 Swedish infants in each age group. Daily intake among breast fed infants was estimated using the test weighing method. Test weighings were conducted over a 24 hour time period at each time interval. Daily milk intake among bottle fed infants was estimated by measuring the volumetric differences in milk contained in bottles at the beginning and end of all feeding sessions in a 24 hour period. The mean intake rates for bottle fed infants were slightly higher than for breast fed infants for all age groups ( Table 14 6). Also, boys consumed breast milk or breast milk substitutes at a slightly higher rate than girls Table 14 6. Milk Intake for Bottle and Breast fed Infants by Age Group Age Breast Milk Substitutes Breast Milk ( months) Mean ( g/ day) Mean ( g/ day) a a 1 713 656 2 811 773 3 853 776 ( 500 1,000) ( 360 860)

( 670 1,180) ( 575 985)

( 655 1,065) ( 600 930)

Range given in parentheses. a Source: Hofvander et al., 1982.

Table 14 7. Milk Intake for Boys and Girls Boys Girls Age ( g/ day) N ( g/ day) N Mean Mean Breast milk 1 663 12 649 13 2 791 14 750 11 3 811 12 743 13 Breast milk substitute 1 753 10 687 15 2 863 13 753 12 3 862 13 843 12 Source: Hofvander et al., 1982.

This study was conducted among a small number of Swedish infants, but the results are similar to those summarized previously for U. S. studies. Insensible water losses were apparently not considered in this study, and only short term data were collected. Köhler et al. ( 1984)  Food Intake and Growth of Infants Between Six and Twenty six Weeks of Age on Breast Milk, Cow's Milk, Formula, and Soy Formula  Köhler et al. ( 1984) evaluated breast milk and formula intake among normal infants between the ages of 6 and 26 weeks. The study included 25 fully breast fed and 34 formula fed infants from suburban communities in Sweden. Intake among breast fed infants was estimated using the test weighing method over a 48 hour test period. Intake among formula fed infants was estimated by feeding infants from Volume II  Food Ingestion Factors Chapter 14  Breast Milk Intake Exposure Factors Handbook Page August 1997 14 5 Table 14 8. Intake of Breast Milk and Formula Breast Milk Cow's Formula Soy Formula Age ( wks) N Mean ( g/ day) SD ( g/ day) N Mean ( g/ day) SD ( g/ day) N Mean ( g/ day) SD ( g/ day)

6 14 22 26 26 21 13 12 746 726 722 689 101 143 114 120 20 19 18 18 823 921 818 722 111 95 201 209 13 13 13 12 792 942 861 776 127 78 196 159 Source: Köhler et al., 1984. bottles with known volumes of formula and recording the the length of time that an infant nurses. Lipid content amount consumed over a 48 hour period. Table 14 8 increases from the beginning to the end of a single nursing presents the mean breast milk and formula intake rates for session ( NAS, 1991). The lipid portion accounts for the infants studied. Data were collected for both cow's approximately 4 percent of human breast milk ( 39 ± 4.0 milk based formula and soy based formula. The results g/ L) ( NAS, 1991). This value is supported by various indicated that the daily intake for bottle fed infants was studies that evaluated lipid content from human breast milk. greater than for breast fed infants. Several studies also estimated the quantity of lipid The advantages of this study are that it compares breast consumed by breast feeding infants. These values are milk intake to formula intake and that test weightings were appropriate for performing exposure assessments for conducted over 2 consecutive days to account for variability nursing infants when the contaminant( s) have residue in individual intake. Although the population studied was concentrations that are indexed to the fat portion of human not representative of the U. S. population, similar intake breast milk. rates were observed in the studies that were previously summarized. Axelsson et al. ( 1987)  Protein and Energy Intake During Weaning  Axelsson et al. ( 1987) measured food women who participated in a study of breast milk intake consumption and energy intake in 30 healthy Swedish among exclusively breast fed infants. The study was infants between the ages of 4 and 6 months. Both formula conducted with over 40 women during a 4 month period. fed and breast fed infants were studied. All infants were fed The mean lipid content of breast milk at various infants' supplemental foods ( i. e., pureed fruits and vegetables after ages is presented in Table 14 9. The overall lipid content 4 months, and pureed meats and fish after 5 months). Milk for the 4 month study period was 34.3 ± 6.9 mg/ g ( 3.4 intake among breast fed infants was estimated by weighing percent). Butte et al. ( 1984) also calculated lipid intakes the infants before and after each feeding over a 2 day period from 24 hour breast milk intakes and the lipid content of the at each sampling interval. Breast milk intake averaged 765 human milk samples. Lipid intake was estimated to range mL/ day at 4.5 months of age, and 715 mL/ day at 5.5 months from 23.6 g/ day ( 3.8 g/ kg day) to 28.0 g/ day ( 5.9 g/ kg day). of age. The number of women included in this study was small, This study is based on short term data, a small number and these women were selected primarily from middle to of infants, and may not be representative of the U. S. upper socioeconomic classes. Thus, data on breast milk population. However, the intake rates estimated by this lipid content from this study may not be entirely study are similar to those generated by the U. S. studies that representative of breast milk lipid content among were summarized previously.

14.4. KEY STUDIES ON LIPID CONTENT AND FAT INTAKE FROM BREAST MILK Human milk contains over 200 constituents including lipids, various proteins, carbohydrates, vitamins, minerals, and trace elements as well as enzymes and hormones ( NAS, 1991). The lipid content of breast milk varies according to Butte et al. ( 1984)  Human Milk Intake and Growth in Exclusively Breast fed Infants  Butte et al., ( 1984) analyzed the lipid content of breast milk samples taken from Volume II  Food Ingestion Factors Chapter 14  Breast Milk Intake Page Exposure Factors Handbook 14 6 August 1997 Table 14 9. Lipid Content of Human Milk and Estimated Lipid Intake Among Exclusively Breast fed Infants Age ( months) Number Lipid Lipid Lipid Lipid of Content Content Intake Intake Observations ( mg/ g) ( percent) ( g/ day) ( g/ kg day) a b a a 1 37 36.2 ± 7.5 3.6 28.0 ± 8.5 5.9 ± 1.7 2 40 34.4 ± 6.8 3.4 25.2 ± 7.1 4.4 ± 1.2 3 37 32.2 ± 7.8 3.2 23.6 ± 7.2 3.8 ± 1.2 4 41 34.8 ± 10.8 3.5 25.6 ± 8.6 3.8 ± 1.3 Data expressed as means ± standard deviations. a Percents calculated from lipid content reported in mg/ g. b Source: Butte, et al., 1984.

the U. S. population. Also, these estimates are based on specified ( i. e., 3 months or 6 months). Also, because intake short term data and day to day variability was not rates are indexed to the lipid portion of the breast milk, they characterized. may be used in conjunction with residue concentrations Maxwell and Burmaster ( 1993)  A Simulation Model to Estimate a Distribution of Lipid Intake from Breast Milk Intake During the First Year of Life  Maxwell and Burmaster ( 1993) used a hypothetical population of 5,000 infants between birth and 1 year of age to simulate a distribution of daily lipid intake from breast milk. The hypothetical population represented both bottle fed and breast fed infants aged 1 to 365 days. A distribution of daily lipid intake was developed based on data in Dewey et al. ( 1991b) on breast milk intake for infants at 3, 6, 9, and 12 months and breast milk lipid content, and survey data in Ryan et al. ( 1991) on the percentage of breast fed infants under the age of 12 months ( i. e., approximately 22 percent). A model was used to simulate intake among 1,113 of the 5,000 infants that were expected to be breast fed. The results of the model indicated that lipid intake among nursing infants under 12 months of age can be characterized by a normal distribution with a mean of 26.8 g/ day and a standard deviation of 7.4 g/ day ( Table 14 10). The model assumes that nursing infants are completely breast fed and does not account for infants who are breast fed longer than 1 year. Based on data collected by Dewey et al. ( 1991b), Maxwell and Burmaster ( 1993) estimated the lipid content of breast milk to be 36.7 g/ L at 3 months ( 35.6 mg/ g or 3.6%) and 40.2 g/ L ( 39.0 mg/ g or 3.9%) at 12 months. The advantage of this study is that it provides a " snapshot" of daily lipid intake from breast milk for breastfed infants. These results are, however, based on a simulation model and there are uncertainties associated with the assumptions made. The estimated mean lipid intake rate represents the average daily intake for nursing infants under 12 months of age. These data are useful for performing exposure assessments when the age of the infant cannot be indexed to fat content.

Table 14 10. Predicted Lipid Intakes for Breast fed Infants Under 12 Months of Age Statistic Value Number of Observations in Simulation 1,113 Minimum Lipid Intake 1.0 g/ day Maximum Lipid Intake 51.5 g/ day Arithmetic Mean Lipid Intake 26.8 g/ day Standard Deviation Lipid Intake 7.4 g/ day Source: Maxwell and Burmaster, 1993.

14.5. OTHER FACTORS Other factors associated with breast milk intake include: the frequency of breast feeding sessions per day, the duration of breast feeding per event, the duration of breast feeding during childhood, and the magnitude and nature of the population that breast feeds. Frequency and Duration of Feeding  Hofvander et al. ( 1982) reported on the frequency of feeding among 25 bottle fed and 25 breast fed infants at ages 1, 2, and 3 months. The mean number of meals for these age groups was approximately 5 meals/ day ( Table 14 11). Neville et al. ( 1988) reported slightly higher mean feeding frequencies. The mean number of meals per day for exclusively breast fed infants was 7.3 at ages 2 to 5 months and 8.2 at ages 2 weeks to 1 month. Neville et al. ( 1988) reported that, for infants between the ages of 1 week and 5 months, the average duration of a breast feeding session is 16 18 minutes. Volume II  Food Ingestion Factors Chapter 14  Breast Milk Intake Exposure Factors Handbook Page August 1997 14 7 Table 14 11. Number of Meals Per Day Age ( months) Bottle fed Infants Breast fed ( meals/ day) ( meals/ day) a a 1 5.4 ( 4 7) 5.8 ( 5 7)

2 4.8 ( 4 6) 5.3 ( 5 7)

3 4.7 ( 3 6) 5.1 ( 4 8)

Data expressed as mean with range in parentheses. a Source: Hofvander et al., 1982.

Population of Nursing Infants and Duration of Breast Feeding During Infancy  According to NAS ( 1991), the percentage of breast feeding women has changed dramatically over the years. Between 1936 and 1940, approximately 77 percent of infants were breast fed, but the incidence of breast feeding fell to approximately 22 percent in 1972. The duration of breast feeding also dropped from about 4 months in the early 1930s to 2 months in the late 1950s. After 1972, the incidence of breast feeding began to rise again, reaching its peak at approximately 61 percent in 1982. The duration of breast feeding also increased between 1972 and 1982. Approximately 10 percent of the mothers who initiated breast feeding continued for at least 3 months in 1972; however, in 1984, 37 percent continued breast feeding beyond 3 months. In 1989, breast feeding was initiated among 52.2 percent of newborn infants, and 40 percent continued for 3 months or longer ( NAS, 1991). Based on the data for 1989, only about 20 percent of infants were still breast fed by age 5 to 6 months ( NAS, 1991). Data on the actual length of time that infants continue to breast feed beyond 5 or 6 months are limited ( NAS, 1991). However, Maxwell and Burmaster ( 1993) estimated that approximately 22 percent of infants under 1 year of age are breast fed. This estimate is based on a reanalysis of survey data in Ryan et al. ( 1991) collected by Ross Laboratories ( Maxwell and Burmaster, 1993). Studies have also indicated that breast feeding practices may differ among ethnic and socioeconomic groups and among regions of the United States. The percentages of mothers who breast feed, based on ethnic background and demographic variables, are presented in Table 14 12 ( NAS, 1991). Intake Rates Based on Nutritional Status  Information on differences in the quality and quantity of breast milk consumed based on ethnic or socioeconomic characteristics of the population is limited. Lönnerdal et al. ( 1976) studied breast milk volume and composition ( nitrogen, lactose, proteins) among underprivileged and privileged Ethiopian mothers. No significant differences were observed between the data for these two groups; and similar data for wellnourished Swedish mothers were observed. Lönnerdal et al. ( 1976) stated that these results indicate that breast milk quality and quantity are not affected by maternal malnutrition. However, Brown et al. ( 1986a; 1986b) noted that the lactational capacity and energy concentration of marginally nourished women in Bangladesh were " modestly less than in better nourished mothers." Breast milk intake rates for infants of marginally nourished women in this study were 690 ± 122 g/ day at 3 months, 722 ± 105 g/ day at 6 months, and 719 ± 119 g/ day at 9 months of age ( Brown et al., 1986a). Brown et al. ( 1986a) observed that breast milk from women with larger measurements of arm circumference and triceps skinfold thickness had higher concentrations of fat and energy than mothers with less body fat. Positive correlations between maternal weight and milk fat concentrations were also observed. These results suggest that milk composition may be affected by maternal nutritional status.

14.6. RECOMMENDATIONS The key studies described in this section were used in selecting recommended values for breast milk intake, fat content and fat intake, and other related factors. Although different survey designs, testing periods, and populations were utilized by the key and relevant studies to estimate intake, the mean and standard deviation estimates reported in these studies are relatively consistent. There are, however, limitations with the data. Data are not available for infants under 1 month of age. This subpopulation may be of particular concern since a larger number of newborns are totally breast fed. In addition, with the exception of Butte ( 1984), data were not presented on a body weight basis. This is particularly important since intake rates may be higher on a body weight basis for younger infants. Also, the data used to derive the recommendations are over 10 years old and the sample size of the studies was small. Other subpopulations of concern such as mothers highly committed to breast feeding, sometimes for periods longer than 1 year, may not be captured by the studies presented in this chapter. Further research is needed to identify these subgroups and to get better estimates of breast milk intake rates. The general designs of both key and relevant studies and their limitations are summarized in Table 14 13. Table 14 14 presents the confidence rating for breast milk intake recommendations. Volume II  Food Ingestion Factors Chapter 14  Breast Milk Intake Page Exposure Factors Handbook 14 8 August 1997 Breast Milk Intake  The breast milk intake rates for nursing infants that have been reported in the key studies described in this section are summarized in Table 14 15. Based on the combined results of these studies, 742 mL/ day is recommended to represent an average breast milk intake rate, and 1,033 mL/ day represents an upper percentile intake rate ( based on the middle range of the mean plus 2 standard deviations) for infants between the ages of 1 and 6 months of age. The average value is the mean of the average intakes at 1, 3, and 6 months from the key studies listed in Table 14 15. It is consistent with the average intake rate of 718 to 777 mL/ day estimated by NAS ( 1991) for infants during the first 4 to 5 months of life. Intake among older infants is somewhat lower, averaging 413 mL/ day for 12 month olds ( Neville et al. 1988; Dewey et al. 1991a; 1991b). When a time weighted average is calculated for the 12 month period, average breast milk intake is approximately 688 mL/ day, and upper percentile intake is approximately 980 mL/ day. Table 14 16 summarizes these recommended intake rates. Lipid Content and Lipid Intake  Recommended lipid intake rates are based on data from Butte et al. ( 1984) and Maxwell and Burmaster ( 1993). Butte et al. ( 1984) estimated that average lipid intake ranges from 23.6 ± 7.2 g/ day ( 22.9 ± 7.0 mL/ day) to 28.0 ± 8.5 g/ day ( 27.2 ± 8.3 mL/ day) between 1 and 4 months of age. These intake rates are consistent with those observed by Burmaster and Maxwell ( 1993) for infants under 1 year of age [( 26.8 ± 7.4 g/ day ( 26.0 ± 7.2 mL/ day)]. Therefore, the recommended breast milk lipid intake rate for infants under 1 year of age is 26.0 mL/ day and the upper percentile value is 40.4 mL/ day ( based on the mean plus 2 standard deviations). The recommended value for breast milk fat content is 4.0 percent based on data from NAS ( 1991), Butte et al. ( 1984), and Maxwell and Burmaster ( 1993).

14.7. REFERENCES FOR CHAPTER 14 Axelsson, I.; Borulf, S.; Righard, L.; Räihä, N. ( 1987) Protein and energy intake during weaning: effects and growth. Acta Paediatr. Scand. 76: 321 327. Brown, K. H.; Akhtar, N. A.; Robertson, A. D.; Ahmed, M. G. ( 1986a) Lactational capacity of marginally nourished mothers: relationships between maternal nutritional status and quantity and proximate composition of milk. Pediatrics. 78: 909 919. Brown, K. H.; Robertson, A. D.; Akhtar, N. A. ( 1986b) Lactational capacity of marginally nourished mothers: infants' milk nutrient consumption and patterns of growth. Pediatrics. 78: 920 927. Butte, N. F.; Garza, C.; Smith, E. O.; Nichols, B. L. ( 1984) Human milk intake and growth in exclusively breastfed infants. Journal of Pediatrics. 104: 187 195. Dewey, K. G.; Lönnerdal, B. ( 1983) Milk and nutrient intake of breast fed infants from 1 to 6 months: relation to growth and fatness. Journal of Pediatric Gastroenterology and Nutrition. 2: 497 506. Dewey, K. G.; Heinig, J.; Nommsen, L. A.; Lönnerdal, B. ( 1991a) Maternal versus infant factors related to breast milk intake and residual volume: the DARLING study. Pediatrics. 87: 829 837. Dewey, K. G.; Heinig, J.; Nommsen, L.; Lönnerdal, B. ( 1991b) Adequacy of energy intake among breastfed infants in the DARLING study: relationships to growth, velocity, morbidity, and activity levels. The Journal of Pediatrics. 119: 538 547. Hofvander, Y.; Hagman, U.; Hillervik, C.; Sjolin, S. ( 1982) The amount of milk consumed by 1 3 months old breast or bottle fed infants. Acta Paediatr. Scand. 71: 953 958. Köhler, L.; Meeuwisse, G.; Mortensson, W. ( 1984) Food intake and growth of infants between six and twenty six weeks of age on breast milk, cow's milk formula, and soy formula. Acta Paediatr. Scand. 73: 40 48. Lönnerdal, B.; Forsum, E.; Gebre Medhim, M.; Hombraes, L. ( 1976) Breast milk composition in Ethiopian and Swedish mothers: lactose, nitrogen, and protein contents. The American Journal of Clinical Nutrition. 29: 1134 1141. Maxwell, N. I.; Burmaster, D. E. ( 1993) A simulation model to estimate a distribution of lipid intake from breast milk during the first year of life. Journal of Exposure Analysis and Environmental Epidemiology. 3: 383 406. National Academy of Sciences ( NAS). ( 1991) Nutrition during lactation. Washington, DC. National Academy Press. Neville, M. C.; Keller, R.; Seacat, J.; Lutes, V.; Neifert, M.; et al. ( 1988) Studies in human lactation: milk volumes in lactating women during the onset of lactation and full lactation. American Journal of Clinical Nutrition. 48: 1375 1386. Pao, E. M.; Hines, J. M.; Roche, A. F. ( 1980) Milk intakes and feeding patterns of breast fed infants. Volume II  Food Ingestion Factors Chapter 14  Breast Milk Intake Exposure Factors Handbook Page August 1997 14 9 Journal of the American Dietetic Association. Ryan, A. S.; Rush, D.; Krieger, F. W.; Lewandowski, G. E. 77: 540 545. ( 1991) Recent declines in breastfeeding in the United States, 1984 1989. Pediatrics. 88: 719 727. Volume II  Food Ingestion Factors Chapter 14  Breast Milk Intake Page Exposure Factors Handbook 14 10 August 1997 Table 14 12. Percentage of Mothers Breast feeding Newborn Infants in the Hospital and Infants at 5 or 6 Months of Age in the United States in 1989 , by Ethnic Background and Selected Demographic Variables a b Total White Black Hispanicc Category Newborns 5 6 Mo Newborns 5 6 Mo Newborns 5 6 Mo Newborns 5 6 Mo Infants Infants Infants Infants All mothers 52.2 19.6 58.5 22.7 23.0 7.0 48.4 15.0 Parity Primiparous 52.6 16.6 58.3 18.9 23.1 5.9 49.9 13.2 Multiparous 51.7 22.7 58.7 26.8 23.0 7.9 47.2 16.5 Marital status Married 59.8 24.0 61.9 25.3 35.8 12.3 55.3 18.8 Unmarried 30.8 7.7 40.3 9.8 17.2 4.6 37.5 8.6 Maternal age < 20 yr 30.2 6.2 36.8 7.2 13.5 3.6 35.3 6.9 20 24 yr 45.2 12.7 50.8 14.5 19.4 4.7 46.9 12.6 25 29 yr 58.8 22.9 63.1 25.0 29.9 9.4 56.2 19.5 30 34 yr 65.5 31.4 70.1 34.8 35.4 13.6 57.6 23.4 $ 35 yr 66.5 36.2 71.9 40.5 35.6 14.3 53.9 24.4 Maternal education No college 42.1 13.4 48.3 15.6 17.6 5.5 42.6 12.2 College 70.7 31.1 74.7 34.1 41.1 12.2 66.5 23.4 d Family income <$ 7,000 28.8 7.9 36.7 9.4 14.5 4.3 35.3 10.3 $ 7,000$ 14,999 44.0 13.5 49.0 15.2 23.5 7.3 47.2 13.0 $ 15,000$ 24,999 54.7 20.4 57.7 22.3 31.7 8.7 52.6 16.5 $ $ 25,000 66.3 27.6 67.8 28.7 42.8 14.5 65.4 23.0 Maternal employment Full time 50.8 10.2 54.8 10.8 30.6 6.9 50.4 9.5 Part time 59.4 23.0 63.8 25.5 26.0 6.6 59.4 17.7 Not employed 51.0 23.1 58.7 27.5 19.3 7.2 46.0 16.7 U. S. census region New England 52.2 20.3 53.2 21.4 35.6 5.0 47.6 14.9 Middle Atlantic 47.4 18.4 52.4 21.8 30.6 9.7 41.4 10.8 East North Central 47.6 18.1 53.2 20.7 21.0 7.2 46.2 12.6 West North Central 55.9 19.9 58.2 20.7 27.7 7.9 50.8 22.8 South Atlantic 43.8 14.8 53.8 18.7 19.6 5.7 48.0 13.8 East South Central 37.9 12.4 45.1 15.0 14.2 3.7 23.5 5.0 West South Central 46.0 14.7 56.2 18.4 14.5 3.8 39.2 11.4 Mountain 70.2 30.4 74.9 33.0 31.5 11.0 53.9 18.2 Pacific 70.3 28.7 76.7 33.4 43.9 15.0 58.5 19.7 Mothers were surveyed when their infants were 6 months of age. They were asked to recall the method of feeding the infant when in the a hospital, at age 1 week, at months 1 through 5, and on the day preceding completion of the survey. Numbers in the columns labeled " 5 6 Mo Infants" are an average of the 5 month and previous day responses. Based on data from Ross Laboratories. b Hispanic is not exclusive of white or black. c College includes all women who reported completing at least 1 year of college. d Source: NAS, 1991. Volume II  Food Ingestion Factors Chapter 14  Breast Milk Intake Exposure Factors Handbook Page August 1997 14 11 Table 14 13. Breast Milk Intake Studies Study Number of Individuals Type of Feeding Sampling Time and Interval Population Studied Comments KEY STUDIES Butte et al., 1984 45 Exclusively breast fed for first 4 months Most infants studied over 1 day only, at 1, 2, 3, 4 months some studied over 48 to 96 hours to study individual variability Mid to uppersocioeconomic stratum Estimated breast milk intake;

corrected for insensible water loss Dewey et al.,

1991a; 1991b 73 Breast fed for 12 months;

exclusively breast fed for at least first 4 months Test weighing over 4 day period every 3 months for 1 year Highly educated,

highsocioeconomic class from Davis area of California Estimated breast milk intake;

corrected for insensible water loss Dewey and Lönnerdal, 1983 20 Most infants exclusively breast fed Two test weighings per month for 6 months Mid to upper class from Davis area of California Estimated breast milk intake; did not correct for insensible water loss Neville et al., 1988 13 Exclusively breast fed infants Infants studied over 24 hour period at each sampling interval;

numerous sampling intervals over first year of life Nonsmoking Caucasian mothers; middle to uppersocioeconomic status Estimated breast milk intake and lipid intake; corrected for insensible water loss; estimated frequency and duration of feeding Pao et al., 1980 22 Completely or partially breast fed infants Three consecutive days at 1, 3,

6, and 9 months White middle class from southeastern Ohio Estimated breast milk intake; did not correct for insensible water loss Volume II  Food Ingestion Factors Chapter 14  Breast Milk Intake Page Exposure Factors Handbook 14 12 August 1997 Table 14 13. Breast Milk Intake Studies ( continued)

Study Number of Individuals Type of Feeding Sampling Time and Interval Population Studied Comments RELEVANT STUDIES Axelsson et al., 1987 30 Breast fed infants and infants fed formula with two different energy contents Studied over 2 day periods at 4.5 and 5.5 months of age Swedish infants Measured intake rates; not corrected for insensible water loss Brown et al., 1986a;

1986b 58, 60 Breast fed infants Studied over 3 days at each interval Bangledeshi infants;

marginally nourished mothers Measured milk and nutrient intake based on nutritional status; not corrected for insensible water loss Hofvander et al.,

1982 50 25 breast fed and 25 formula fed infants Studied 24 hour period at 1, 2,

and 3 months Swedish infants Estimated breast milk and formula intake; no corrections for insensible water loss among breast fed infants;

estimated frequency of feeding Köhler et al., 1984 59 25 fully breast fed and 34 formula fed infants Studied over 48 hour periods at 6, 14, 22, and 26 weeks of age Swedish infants Estimated breast milk and formula intake based on nutritional status; no corrections for insensible water loss among breast fed infants Maxwell and Burmaster, 1993 1,113 Population of 1,113 breastfed infants based on a hypothetical population of 5,000 breast fed and bottlefed infants NA NA Simulated distribution of breast milk intake based on data from Dewey 1991a; estimated percent of breast fed infants under 12 months of age NAS, 1991 NA Breast fed infants NA NA Summarizes current state of knowledge on breast milk volume, composition and breast feeding populations Volume II  Food Ingestion Factors Chapter 14  Breast Milk Intake Exposure Factors Handbook Page August 1997 14 13 Table 14 14. Confidence in Breast Milk Intake Recommendations Considerations Rationale Rating Study Elements C Level of peer review All key studies are from peer review literature. High C Accessibility Papers are widely available from peer review journals. High C Reproducibility Methodology used was clearly presented. High C Focus on factor of interest The focus of the studies was on estimating breast milk intake. High C Data pertinent to U. S. Subpopulations of the U. S. were the focus of all the key studies. High C Primary data All the studies were based on primary data. High C Currency Studies were conducted between 1980 1986. Although incidence of breast Medium feeding may change with time, breast milk intake among breastfed infants may not.

C Adequacy of data collection period Infants were not studied long enough to fully characterize day to day Medium variability.

C Validity of approach Methodology uses changes in body weight as a surrogate for total ingestion. Medium This is the best methodology there is to estimate breast milk ingestion. Mothers were instructed in the use of infant scales to minimize measurement errors. Three out of the 5 studies corrected data for insensible water loss.

C Study size The sample sizes used in the key studies were fairly small ( range 13 73).

C Representativeness of the population Population is not representative of the U. S.; only mid upper class, well Low nourished mothers were studied. Socioeconomic factors may affect the incidence of breastfeeding. Mother's nourishment may affect milk production.

C Characterization of variability Not very well characterized. Infants under 1 month not captured, mothers Low committed to breast feeding over 1 year not captured.

C Lack of bias in study design ( high Bias in the studies was not characterized. Three out of 5 studies corrected for Low rating is desirable) insensible water loss. Not correcting for insensible water loss may underestimate intake. Mothers selected for the studies were volunteers; therefore response rate does not apply. Population studied may introduce some bias in the results ( see above).

C Measurement error All mothers were well educated and trained in the use of the scale which Medium helped minimize measurement error.

Other Elements C Number of studies There are 5 key studies. High C Agreement between researchers There is good agreement among researchers. High Overall Rating Studies were well designed. Results were consistent. Sample size was fairly Medium low and not representative of U. S. population or population of nursing mothers. Variability cannot be characterized due to limitations in data collection period. Volume II  Food Ingestion Factors Chapter 14  Breast Milk Intake Page Exposure Factors Handbook 14 14 August 1997 Table 14 15. Breast Milk Intake Rates Derived From Key Studies Mean ( mL/ day) N ( mean plus 2 standard Reference Upper Percentile ( mL/ day)

deviations)

Age: 1 Month 600 729 747 673 weighted avg = 702 11 918 Pao et al., 1980 37 981 Butte et al., 1984 13 1,095 Neville et al., 1988 16 1,057 Dewey and Lönnerdal, 1983 1,007a Age: 3 Months 833 702 712 782 788 weighted avg = 759 2  Pao et al., 1980 37 923 Butte et al., 1984 12 934 Neville et al., 1988 16 1,126 Dewey and Lönnerdal, 1983 73 1,046 Dewey et al., 1991b 1,025a Age: 6 Months 682 744 896 747 weighted avg = 765 1  Pao et al., 1980 13 978 Neville et al., 1988 11 1,140 Dewey and Lönnerdal, 1983 60 1,079 Dewey et al., 1991b 1,059a Age: 9 Months 600 627 avg = 622 12 1,027 Neville et al., 1988 50 1,049 Dewey et al., 1991b 1,038 Age: 12 Months 391 435 weighted avg = 427 9 877 Neville et al., 1988 42 923 Dewey et al., 1991a; 1991b 900 12 MONTH TIME WEIGHTED AVERAGE 688 Range 900 1,059 ( middle of the range 980)

Middle of the range. a Volume II  Food Ingestion Factors Chapter 14  Breast Milk Intake Exposure Factors Handbook Page August 1997 14 15 Table 14 16. Summary of Recommended Breast Milk and Lipid Intake Rates Age Mean Upper Percentile Breast Milk 1 6 Months 742 mL/ day 1,033 mL/ day 12 Month Average 688 mL/ day 980 mL/ day Lipidsa < 1 Year 26.0 mL/ day 40.4 mL/ day The recommended value for the lipid content of breastmilk is 4.0 percent. a


[Federal Register Volume 79, Number 37 (Tuesday, February 25, 2014)]
[Notices]
[Pages 10578-10581]
[FR Doc No: 2014-03973]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-71574; File No. SR-ICEEU-2014-04]

Self-Regulatory Organizations; ICE Clear Europe Limited; Notice
of Filing of Proposed Rule Change To Clear New Sovereign Contracts

February 19, 2014.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder \2\ notice is hereby given that
on February 11, 2014, ICE Clear Europe Limited (``ICE Clear Europe'')
filed with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared primarily by ICE Clear Europe. The Commission
is publishing this notice to solicit comments on the proposed rule
change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The principal purpose of the change is to provide for the clearance
of new CDS contracts that are Western European Sovereign CDS contracts
referencing the Republic of Ireland, Italian Republic, Portuguese
Republic, and Kingdom of Spain (the ``New Sovereign Contracts'').

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, ICE Clear Europe included
statements concerning the purpose of and basis for the proposed rule
change and discussed any comments it received on the proposed rule
change. The text of these statements may be examined at the places
specified in Item IV below. ICE Clear Europe has prepared summaries,
set forth in sections A, B, and C below, of the most significant
aspects of these statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the additional CDS products is to allow ICE Clear
Europe Clearing Members the ability to clear additional European CDS
products through ICE Clear Europe's platform.
    ICE Clear Europe has identified Western European Sovereign CDS
Contracts as a product that has become increasingly important for
market participants to manage risk and express views with respect to
the European sovereign credit markets. ICE Clear Europe believes
clearance of the New Sovereign Contracts will benefit the markets for
credit default swaps on Western European sovereigns by offering to
market participants the benefits of clearing, including reduction in
counterparty risk and safeguarding of margin assets pursuant to
clearing house rules. The terms of the New Sovereign Contracts will be
governed by Paragraph 12 of the CDS Procedures. Clearing of the New
Sovereign Contracts will not require any changes to ICE Clear Europe's
existing Clearing Rules and CDS Procedures (although ICE Clear Europe
has updated its risk management

framework (including relevant policies) and margin model as discussed
herein).
    ICE Clear Europe's CDS risk management framework, including the
margin methodology (the ``CDS Model''),\3\ has been enhanced to include
several features designed to address particular risks of the New
Sovereign Contracts. To address so-called general wrong way risk
(``General Wrong Way Risk'') involving correlation between the risk of
default of an underlying sovereign and the risk of default of a
clearing member that has written credit protection through a New
Sovereign Contract on such sovereign, additional jump-to-default
requirements for initial margin are established for portfolios that
present such risk.
---------------------------------------------------------------------------

    \3\ ICE Clear Europe has performed a variety of empirical
analyses related to clearing of the New Sovereign Contracts under
its margin methodology, including back tests and stress tests.
---------------------------------------------------------------------------

    ICE Clear Europe proposes to adopt a combination of qualitative and
quantitative approaches to capture General Wrong Way Risk. Under the
enhanced CDS Model, an additional contribution to initial margin will
be required when the seller of protection exhibits a high degree of
association with an underlying Western European Sovereign reference
entity by virtue of domicile (qualitative approach) or high spread
return correlation (quantitative approach). To address General Wrong
Way Risk arising from clearing member domicile, ICE Clear Europe will
require full collateralization of the jump-to-default loss for a
protection seller under a contract referencing the sovereign where the
protection seller is domiciled.
    Under the quantitative approach, which applies where the protection
seller is not domiciled in the jurisdiction of the underlying
sovereign, two types of thresholds are introduced: A loss threshold and
a correlation threshold. Additional General Wrong Way Risk
collateralization will be collected if both thresholds are exceeded. If
the spread return correlation between the member and the sovereign is
above the correlation threshold and the sovereign CDS jump-to-default
loss is above the loss threshold, General Wrong Way Risk
collateralization is assessed as a function of the spread return
correlation and amount by which the loss threshold is exceeded. The
charge becomes more conservative as the spread return correlation
increases. The application of additional initial margin requirements
under the quantitative approach is not subject to discretion, although
the thresholds are subject to review by the CDS Risk Committee as part
of its periodic review of ICE Clear Europe's margin methodology.
    Other forms of wrong way risk arising from currency risk are also
addressed. To mitigate the currency risk between a sovereign reference
entity and a New Sovereign Contract involving that entity, and to
facilitate greater market liquidity, the New Sovereign Contracts (and
related margin and guaranty fund requirements) are denominated in U.S.
dollars, rather than Euro. In addition, the rules contain prohibitions
on self-referencing trades (i.e., trades where the clearing member is
an affiliate of the underlying sovereign reference entity). Such trades
may not be submitted for clearing, and if a clearing member
subsequently becomes affiliated with the underlying reference entity,
the rules applicable to New Sovereign Contracts provide for the
termination of relevant positions.
    The ICE Clear Europe CDS Risk Policy, the CDS Risk Model
Description methodology document and CDS Wrong Way Risk Policy have
been updated to account for these additional features of the risk model
for the New Sovereign Contracts.
2. Statutory Basis
    ICE Clear Europe believes that clearing of the proposed New
Sovereign Contracts is consistent with the requirements of Section 17A
of the Act \4\ and regulations thereunder applicable to it, including
the standards under Rule 17Ad-22.\5\ The amendments will provide for
clearing of New Sovereign Contracts by ICE Clear Europe, consistent
with ICE Clear Europe's existing clearing arrangements and related
financial safeguards, protections and risk management procedures. ICE
Clear Europe has adopted enhancements to the existing CDS Model to
address the clearing of the New Sovereign Contracts, including the
additional initial margin requirements under the qualitative and
quantitative approaches to General Wrong Way Risk discussed above. The
New Sovereign Contracts that will be cleared are Western European
Sovereign CDS contracts substantially similar to other CDS contracts
currently cleared by ICE Clear Europe. Acceptance of New Sovereign
Contracts for clearing, on the terms and conditions set out in the ICE
Clear Europe Rules and the enhanced CDS Model, is consistent with the
prompt and accurate clearance of and settlement of securities
transactions and derivative agreements, contracts and transactions
cleared by ICE Clear Europe, the safeguarding of securities and funds
in the custody or control of ICE Clear Europe and the protection of
investors and the public interest, within the meaning of Section
17A(b)(3)(F) of the Act.\6\ Clearing of the New Sovereign Contracts
will also satisfy the relevant requirements of Rule 17Ad-22,\7\ as
discussed below.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78q-1.
    \5\ 17 CFR 240.17Ad-22.
    \6\ 15 U.S.C. 78q-1(b)(3)(F).
    \7\ 17 CFR 240.17Ad-22.
---------------------------------------------------------------------------

    Financial Resources. ICE Clear Europe will apply its existing
margin methodology to the New Sovereign Contracts, with the
enhancements to address General Wrong Way Risk discussed above. ICE
Clear Europe believes that this model, including the additional initial
margin that may be required to address General Wrong Way Risk, will
provide sufficient margin to cover its credit exposure to its clearing
members from clearing such contracts, consistent with the requirements
of Rule 17Ad-22(b)(2) and Rule 17Ad-22(d)(14).\8\ In addition, ICE
Clear Europe believes the CDS Guaranty Fund, under its existing
methodology, will, together with the required margin, provide
sufficient financial resources to support the clearing of New Sovereign
Contracts consistent with the requirements of Rule 17Ad-22(b)(3).\9\
---------------------------------------------------------------------------

    \8\ 17 CFR 240.17Ad-22(b)(2), (d)(14).
    \9\ 17 CFR 240.17Ad-22(b)(3).
---------------------------------------------------------------------------

    Operational Resources. ICE Clear Europe will have the operational
and managerial capacity to clear the New Sovereign Contracts as of the
commencement of clearing, consistent with the requirements of Rule
17Ad-22(d)(4).\10\ ICE Clear Europe believes that its existing systems
are appropriately scalable to handle the additional New Sovereign
Contracts, which are generally similar from an operational perspective
to the CDS contracts currently cleared by ICE Clear Europe.
---------------------------------------------------------------------------

    \10\ 17 CFR 240.17Ad-22(d)(4).
---------------------------------------------------------------------------

    Settlement. ICE Clear Europe believes that the rule changes will be
consistent with the requirements of Rule 17Ad-22(d)(5), (12) and (15)
\11\ as to the finality and accuracy of its daily settlement process
and avoidance of the risk to ICE Clear Europe of settlement failures.
ICE Clear Europe will use its existing settlement procedures, account
structures and approved financial institutions as used in other CDS
clearing for the New Sovereign Contracts. ICE Clear Europe believes
that its Rules and procedures related to settlements (including
physical settlements), appropriately identify and manage the risks
associated with

settlements under New Sovereign Contracts.
---------------------------------------------------------------------------

    \11\ 17 CFR 240.17Ad-22(d)(5), (12) and (15).
---------------------------------------------------------------------------

    Default Procedures. ICE Clear Europe's existing Rules and default
management policies and procedures for CDS will apply to the New
Sovereign Contracts as well. ICE Clear Europe believes that the Rules
and procedures allow for it to take timely action to contain losses and
liquidity pressures and to continue meeting its obligations in the
event of clearing member insolvencies or defaults, including in respect
of New Sovereign Contracts, in accordance with Rule 17Ad-22(d)(11).\12\
---------------------------------------------------------------------------

    \12\ 17 CFR 240.17Ad-22(d)(11).
---------------------------------------------------------------------------

    Governance. ICE Clear Europe has determined to accept the New
Sovereign Contracts for clearing in accordance with its governance
process, including review of the contracts and related risk management
considerations (and the enhancements to the margin methodology for
General Wrong Way Risk discussed herein) by the CDS Risk Committee and
approval by its Board. These arrangements are consistent with the
requirements of Rule 17Ad-22(d)(8).\13\ Although the General Wrong Way
Risk approaches, when applied to all clearing members who clear the New
Sovereign Contracts, may result in clearing members being subject to
different margin charges based on their domicile and correlation with
the underlying sovereign for a contract, ICE Clear Europe believes that
the policy properly aligns the margin requirements to the risks
presented by clearing members in this regard. The policy on General
Wrong Way Risk has been established with well-defined, objective
parameters and is applicable to all clearing members that choose to
clear the New Sovereign Contracts. Further, ICE Clear Europe does not
believe the revised margin methodology creates a conflict of interest
between ICE Clear Europe and its clearing members or among clearing
members. The revised margin methodology operates without the need for
the CDS Risk Committee, ICE Clear Europe Board or management to
exercise discretion concerning particular clearing members or the
margin levels applicable to them. The qualitative and quantitative
components to the methodology do not contain discretionary elements,
and once the relevant threshold is exceeded, the clearing house is
required under the policy to assess an additional initial margin charge
based on the margin methodology. This approach should minimize any
potential conflicts of interest. As noted above, the CDS Risk Committee
and ICE Clear Europe management will regularly review the
appropriateness of the quantitative threshold. Accordingly, the policy
does not, in ICE Clear Europe's view, result in unfair discrimination
among clearing members within the meaning of Section 17A(b)(3)(F) of
the Act and Rule 17Ad-22(d)(8).\14\ ICE Clear Europe further notes that
it has extensively consulted with its CDS Risk Committee as to this
aspect of the clearing of the New Sovereign Contracts.
---------------------------------------------------------------------------

    \13\ 17 CFR 240.17Ad-22(d)(8).
    \14\ 15 U.S.C. 78q-1(b)(3)(F); 17 CFR 240.17Ad-22(d)(8).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    ICE Clear Europe does not believe the proposed New Sovereign
Contracts would have any impact, or impose any burden, on competition
not necessary or appropriate in furtherance of the purpose of the Act.
ICE Clear Europe does not anticipate that its commencement of clearing
for the New Sovereign Contracts will adversely affect the trading
market for those contracts or for CDS more generally. Specifically,
allowing clearing of the New Sovereign Contracts will provide market
participants with the additional choice to have their transactions in
these types of contracts cleared, and should generally promote the
further development of the market for these contracts. Moreover, ICE
Clear Europe has established fair and objective criteria for
eligibility to clear the New Sovereign Contracts, consistent with its
criteria for other cleared CDS. Although clearance of New Sovereign
Contracts may result in an increase in margin requirements for some
clearing members as a result of the General Wrong Way Risk
requirements, ICE Clear Europe believes that these changes will
properly align margin requirements to the risks presented by such
clearing members with respect to the New Sovereign Contracts. As a
result, ICE Clear Europe is of the view that these changes are
necessary and appropriate in furtherance of the purpose of the Act and
the Commission's regulations thereunder, including the financial
resources and risk management requirements of Rule 17Ad-22.\15\
Furthermore, ICE Clear Europe does not believe that any such increase
in margin requirements would significantly affect the ability of
clearing members or other market participants to continue to clear CDS,
consistent with the risk management requirements of the clearing house,
or otherwise limit market participants' choices for selecting clearing
services. Accordingly ICE Clear Europe does not believe that clearance
of the New Sovereign Contracts will impose any burden on competition
among clearing members not necessary or appropriate in furtherance of
the purposes of the Act.
---------------------------------------------------------------------------

    \15\ 17 CFR 240.17Ad-22.
---------------------------------------------------------------------------

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    Written comments relating to the current proposal for acceptance of
the New Sovereign Contracts for clearing have not been solicited or
received. One comment letter was received in connection with ICE Clear
Europe's prior filing with respect thereto (File No. 2012-08), which
suggested, in relevant part, consideration of additional wrong way risk
raised by credit exposures of protection sellers to underlying
sovereign reference entities. (The letter raised other issues
concerning the disclosure of risk management processes generally and
the effectiveness of market-standard sovereign CDS contracts as a
hedge, which ICE Clear Europe believes are outside the scope of this
rule change). ICE Clear Europe believes that the combination of the
qualitative and quantitative approaches discussed herein provides
appropriate initial margin protection for General Wrong Way Risk, and
notes that ICE Clear Europe management and the CDS Risk Committee
regularly review the appropriateness of the margin methodology. ICE
Clear Europe will notify the Commission of any written comments
received by ICE Clear Europe.
    The CDS Risk Committee raised no objection to the clearing of the
New Sovereign Contracts on the terms described herein on December 10,
2013. The clearing of the New Sovereign Contracts was approved by the
ICE Clear Europe board on August 1, 2012.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period up to 90 days (i) as the
Commission may designate if it finds such longer period to be
appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) by order approve or disapprove the proposed rule change or
    (B) institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml) or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ICEEU-2014-04 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-ICEEU-2014-04. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of such filings will also be available
for inspection and copying at the principal office of ICE Clear Europe
and on ICE Clear Europe's Web site at https://www.theice.com/notices/Notices.shtml?regulatoryFilings.
    All comments received will be posted without change; the Commission
does not edit personal identifying information from submissions. You
should submit only information that you wish to make available
publicly. All submissions should refer to File Number SR-ICEEU-2014-04
and should be submitted on or before March 18, 2014.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-03973 Filed 2-24-14; 8:45 am]
BILLING CODE 8011-01-P


MEMORANDUM From: BART Project Team, EPA Office of Air Quality Planning and Standards To: Docket for BART Guidelines, OAR 2002 0076 Subject: Fine Particles: Overview of Source Testing Approaches Date: April 1, 2005 A. Background Most stationary source test methods specified in State rules do not adequately quantify either total PM emissions or PM2.5 emissions. Additionally, some of the current stationary source test methods will not adequately provide a uniform indication of the sources' performance in controlling PM2.5 emissions. Most source test methods referenced in SIPs provide a measurement of the particulate matter that is solid or liquid at a temperature specified in the method or applicable standard. Filtration temperatures of 250" F and 320" F are typical although other temperatures may be specified in a few test methods or applicable standards. Generally, these filterable particulate matter test methods are either identical or very similar to one of the ten Federal test methods published in Appendix A of 40 CFR Part 60 and used to determine compliance with New Source Performance Standards ( NSPS). These test methods are adequate to evaluate the compliance status of a source for emissions of that component of particulate matter evaluated when the applicable rule was developed. However, these test methods do not provide a measurement of total particulate matter emissions, or PM2.5 emissions. The test method proposed to determine compliance with the first group of NSPS ( 36 FR 15713) determined the sum of the mass of material collected on or prior to the filters maintained at 250" F and the material collected in the cooled impingers that followed the filter. While the material collected prior to the filter provided a measure of the filterable particulate material, the material collected in the impingers was stated to measure vapors in the stack that would become particulate matter at 70" F ( 36 FR 15495). When combined, the method provided a measurement of the total particulate matter emissions from the facility tested. The promulgated test method ( 36 FR 24888) did not include the analysis of the impinger portion of the sampling train. To accommodate the change in the test method, EPA made adjustments in the promulgated emission limits to reflect the change in the test method. The EPA made adjustments of up to 50 percent in the promulgated emission limitations to reflect the measurement of only the filterable portion of the emissions. EPA recognized in setting several subsequent NSPS that the source test method used to determine compliance with the particulate matter emissions limits measured only part of the total particulate matter emitted by the applicable sources. This recognition was published on October 6, 1975, in the promulgated Revisions to Performance Testing Methods ( 40 FR 46250). Similarly, EPA acknowledged this in the proposal preamble to Subpart CC Standards of Performance for Glass Manufacturing Plants ( 6/ 15/ 79) in the section " Selection of Performance Test Methods: The use of EPA Reference Method 5  Determination of Particulate Emissions from Stationary Sources." In developing the NSPS emission limitations, it is evident that only a portion of the particulate matter emissions were considered. As a result, the test methods that EPA selected for determining compliance with these emission limitations measured only that same portion of the particulate matter emissions. It was recognized that these test methods were not suitable for quantifying the total emissions to the atmosphere and that the impinger portion of the sampling train contained the missing portion of the particulate matter emissions. On December 17, 1990, EPA promulgated Method 202 in Appendix M of 40 CFR Part 51 ( 56 FR 65433) to provide a method for States to use to analyze the impinger ( or " back half") content of PM emissions and provide a measure of the condensable particulate emissions. The principal procedures in Method 202 improved upon the original Method 5 back half analysis proposed in 1971. In developing this measurement method, EPA consulted with several State and local agencies and incorporated several options to simplify or accommodate existing policies and source testing methodologies for condensable particulate matter. We believe that by excluding the optional components, the use of EPA Method 202, combined with EPA Method 5 or EPA Method 17, provides a reasonable indication of total particulate matter emissions for the majority of stationary emission sources. However, the combination of EPA Method 5 and Method 202 measures particulate matter that is larger than 2.5 micrometers in aerodynamic diameter, and will not provide a reasonable measurement of the emissions of PM2.5. Methods are available that can separate particulate matter by aerodynamic size. On April 17, 1990, EPA promulgated EPA Method 201 and Method 201A to provide a source test method that separated filterable particulate matter greater than 10 micrometers from filterable particulate matter equal or smaller than 10 micrometers. The single cyclone used in these methods replaced the nozzle of EPA Method 17 to separate the two size classes of filterable particulate. This method allows sources to determine their emissions of filterable PM10 when there are size specific emission limits or when there is a need for size specific emission inventories. With the addition of a second smaller cyclone following the single cyclone of EPA Method 201A, the filterable particulate can be separated into three size classifications. These classifications include filterable particulate matter greater than 10 micrometers, filterable particulate matter equal or smaller than 10 micrometers but greater than 2.5 micrometers, and filterable particulate matter equal or smaller than 2.5 micrometers. This method is posted as Conditional Method 40 ( CTM 40) on EPA's Emission Measurement Centers web page at http:// www. epa. gov/ ttn/ emc/ ctm. htm. Of the methods mentioned previously, the most reliable measurement of total direct PM2.5 emissions would combine the use of Conditional Method 40 with EPA Method 202. The acceptability of a source using the existing SIP test methods for filterable particulate matter as an indication of the source's relative performance in controlling PM2.5 emissions would depend on the source's level of condensable particulate matter emissions in relation to filterable PM emissions, the proportion of filterable particulate matter that is smaller than 2.5 micrometers, the add on PM control device effectiveness, and the need to consider limiting the emissions of the condensable material.

B. The existing PM test methods and the emission limits based upon these methods have been acceptable since 1971, why do they need to be changed for PM2.5? Several changes have occurred over the last 30 years that have gradually eroded the predictive capabilities of particulate matter source test methods used in most SIPs to evaluate the sources performance in controlling the pollutant measured by the ambient air quality test method. In the 1970' s and early 1980' s, the ambient air quality test method quantified the total particulate matter suspended in the ambient air. At the beginning of this period, particulate matter control measures were relatively poor. Additionally, most of particulate matter control measures applied over the last 30 years have focused on filterable particulate matter. While some control measures for other air pollutants also resulted in collateral reductions in condensable particulate and particulate precursor emissions, these reductions were relatively small. As a result, the relative amount of sulfates, nitrates and condensed organic matter in the ambient air particulate matter was proportionally greater in the 1980' s than it was in the 1970' s. The promulgation of the PM10 NAAQS in 1987 resulted in further reductions in filterable PM from sources, but there were few nonattainment areas where control of the condensable constituents of PM10 was required in order to achieve attainment. As a result, stationary source control measures that addressed only the filterable component of particulate matter were generally adequate to achieve the PM10 NAAQS. With the promulgation of the PM2.5 NAAQS in 1997 and associated ambient air quality monitoring, speciation analyses of PM2.5 show that a substantial portion of PM2.5 consists of sulfates, nitrates and organic carbon. These constituents are also a substantial portion of the condensable particulate matter collected from stationary sources. With the increased application of increasingly efficient filterable particulate matter control measures, condensable emissions have become a larger percentage of overall PM2.5 emissions for several stationary source categories. Based upon the particle size distribution presented in Table 1.1 6 of AP 42, 29 percent of the total filterable particulate matter is filterable PM2.5. As a result, 71 percent of the total PM2.5 emissions would be condensable PM. Since filterable particulate matter emissions controls have improved since 1971 and since most sources achieve substantially lower emissions than required by State and Federal emissions limitations, and condensable emissions have generally not been significantly reduced, the significance of the condensable emissions as a proportion of direct PM2.5 emissions may be greater than indicated above. A test method that measures total filterable particulate matter, commonly including mostly particles larger than PM2.5 and yet excluding condensable emissions, is a poor indicator of source performance at reducing PM2.5 emissions.

C. What methods are available for measuring PM size and condensable PM from stationary sources? EPA has adopted one of several methods that are available for classifying particulate matter by aerodynamic diameter. The method adopted is based upon the use of centrifugal forces created in cyclones to separate particulate matter into two aerodynamic size classifications. The cyclone specified in EPA Method 201 and 201A separates particulate matter with a nominal aerodynamic diameter greater than 10 micrometers from the remaining particulate matter. The addition of a second smaller cyclone following the EPA Method 201A cyclone as is specified in EPA Method CTM 40 separates the particulate matter that has an aerodynamic diameter greater than 2.5 micrometers from the remaining particulate matter. A filter follows the final cyclone of these particle sizing methods to collect the smaller material. Under EPA's source test methods to separate PM based on particle size, both of the cyclones and the filter are maintained at the flue gas temperature. Therefore, any material that is in a vapor state in the flue gas but would be condensed as a result of dilution and cooling when released to the ambient air will not be measured by these particle sizing methods. Vapors that would condense to form particulate matter in the ambient air can be quantified by EPA Method 202. The EPA Method 202 is intended for use in conjunction with a filterable particulate matter test method such as Method 201A or CTM 40. Impingers containing cold water are used by most methods to condense water vapor for determining the flue gas moisture content. Besides condensing water vapor in the flue gas, organic and inorganic chemical vapors are also condensed in these impingers. In EPA Method 202, the organic and inorganic vapors condensed in the impingers are separated with an organic solvent and weighed after evaporating the water and organic solvent used for separation. As recommended by the National Academy of Sciences, EPA and others are developing dilution based source test methods for collecting and analyzing PM2.5. Rather than condensing vapors in chilled water, cool filtered dilution air condenses the vapors prior to collection on filters. In the new method under development by EPA, particulate matter is sized using the same cyclones used in CTM 40. However, the in stack filter used in CTM 40 is removed so that all of the PM2.5 particulate matter is collected at near ambient temperature on the filters.

D. Why is a new dilution based test method being developed by EPA? The use of dilution based particulate matter sampling offers several advantages over the combination of EPA Method CTM 40 and Method 202. One advantage is that the vapors are condensed and chemical reactions occur in a manner similar to when stack gas is released to the atmosphere. As a result, the potential for particulate matter formation that may occur in water but would not occur in air is eliminated. Another advantage is that the potential for losing particulate matter during the evaporation of the impinger water is eliminated. With the use of multiple filter types, the use of dilution sampling methods will allow for the speciation of the collected PM2.5 by the same methods used for speciation of ambient air particulate matter. Additionally, dilution based methods allow for the measurement of the particle size distribution of the particulate matter smaller than 2.5 micrometers. This can be accomplished by modifying the hardware of the sampling equipment to extend the residence time of the sampled particulate matter. The extra residence time allows the ultrafine particulate matter initially formed during vapor condensation to grow toward its ultimate particle size distribution.

E. What types of sources should use the new dilution based test method? The new dilution based test method would be appropriate for most sources. Sources with very complex flue gas characteristics ( e. g., having several acidic and alkali gases with semi volatile organic matter) and those sources that want to generate a speciation profile specific to their facility should use the new dilution test method. Sources with very low PM2.5 emission concentrations and low SO2 and NOX emission concentrations also may wish to use the new dilution method. However, the more complex operation and increased size of the equipment associated with the new method may persuade some sources to use an alternative method. Sources where the flue gas is near ambient temperature or where the sampled gas can be cooled to near ambient temperature could use CTM 40 or its equivalent to quantify PM2.5 emissions. Sources with less complex flue gas characteristics may want to use CTM 40 combined with EPA Method 202.

F. What are the main features of the new test method? The main features of the new test method are in the areas of sample extraction, particle sizing, sample flow rate measurement, dilution air conditioning, dilution air flow rate measurement, sample mixing with dilution air and sample filtration. An additional major feature, where particulate speciation is desired, is the method of extracting an aliquot of the diluted sample. Flue gas is extracted isokinetically at a flow rate that produces particulate matter sizing at 10 and 2.5 micrometers by the two in stack cyclones. The sampled flue gas and the PM2.5 particulate matter is extracted from the stack prior to dilution and cooling with ambient air that has been conditioned by removing excess moisture and ambient particulate matter with a HEPA filter. The objective of all the methods is to achieve complete mixing prior to filtration and to minimize sample losses on the internal surfaces of the hardware. The PM2.5 is removed from the diluted sample gas by a Teflon filter. The PM2.5 deposited on the internal surfaces of the hardware is quantitatively recovered with acetone. Both the Teflon filter and the PM2.5 recovered from the internal surfaces of the sampler are weighed. When speciation of the PM2.5 is desired, aliquots of the diluted sample gas are extracted for collection on filters. The ambient air speciation criteria are followed with respect to the filter media used and analytical finish of the three filters.

G. What is the schedule for finalization of the new test method? We have posted the dilution based PM2.5 source test method on the TTN web as " Conditional Test Method 39" and expect that this method will provide the basis for a 40 CFR Part 51, Appendix M method to be proposed at a later date. Beyond proposing the EPAdeveloped dilution test method, we may identify the use of a source test method developed by a national voluntary consensus standard setting organization. Public Law 104 113, also known as the National Technology Transfer and Advancement Act ( NTTAA), requires that we use technical standards that are developed or adopted by voluntary consensus standards bodies as a means to carry out policy objectives where appropriate. The law also requires us to consult with such bodies when it is in the public interest to participate with them in the development of technical standards. On April 23, 2003 the ASTM Source and Ambient Atmospheres Committee started Work Item WK752 to develop a PM2.5 source test method similar to the method we are developing. EPA is an active participant in this committees activities for this work item. We believe that it is in the interest of the public and the Agency to participate in the ASTM process of developing a PM2.5 source test method. While we cannot predict when an ASTM standard will be available and whether it will be a suitable test method for EPA to specify for use in SIPs, we expect to make a decision on the final test method by December 2004.


[Federal Register: February 24, 2009 (Volume 74, Number 35)]
[Rules and Regulations]
[Page 8169-8170]
[DOCID:fr24fe09-12]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2008-1291; Airspace Docket No. 08-AGL-20]

Amendment of Class E Airspace; Milwaukee, WI

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E airspace at Milwaukee, WI.
Additional controlled airspace is necessary to accommodate Area
Navigation (RNAV) Standard Instrument Approach Procedures (SIAP) at
Waukesha County Airport, Waukesha, WI. Also, this rule changes an
airport name from John H. Batten Field to John H. Batten Airport,
Racine, WI. The FAA is taking this action to enhance the safety and
management of Instrument Flight Rule (IFR) operations at Waukesha
County Airport.

DATES: Effective Date: 0901 UTC, May 7, 2009. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR Part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd., Fort Worth, TX 76193-0530; telephone (817)
321-7716.

SUPPLEMENTARY INFORMATION:

History

    On December 18, 2008, the FAA published in the Federal Register a
notice of proposed rulemaking to amend Class E airspace at Milwaukee,
WI, adding additional controlled airspace at Waukesha County Airport,
Waukesha, WI (73 FR 76981, Docket No. FAA-2008-1291). Interested
parties were invited to participate in this rulemaking effort by
submitting written comments on the proposal to the FAA. No comments
were received. Class E airspace designations are published in paragraph
6005 of FAA Order 7400.9S signed October 3, 2008, and effective October
31, 2008, which is incorporated by reference in 14 CFR Part 71.1. The
Class E airspace designations listed in this document will be published
subsequently in that Order.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by amending Class E airspace at Milwaukee, WI, adding
additional controlled airspace at Waukesha County Airport, Waukesha,
WI, to accommodate SIAPs. This action also changes the name of John H.
Batten Field to John H. Batten Airport, Racine, WI.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it adds additional controlled airspace in the Milwaukee, WI,
airspace area, at Waukesha County Airport, Waukesha, WI.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR Part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

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1. The authority citation for 14 CFR Part 71 continues to read as
follows:

    Authority: 49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24
FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

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2. The incorporation by reference in 14 CFR Part 71.1 of the Federal
Aviation Administration Order 7400.9S, Airspace Designations and
Reporting Points, signed October 3, 2008, and effective October 31,
2008, is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700
feet or more above the surface.

* * * * *

AGL WI E5 Milwaukee, WI [Amended]

Milwaukee, General Mitchell International Airport, WI
    (Lat. 42[deg]56'50'' N., long. 87[deg]53'48'' W.)
Racine, John H. Batten Airport, WI
    (Lat. 42[deg]45'40'' N., long. 87[deg]48'50'' W.)
Waukesha, Waukesha County Airport, WI
    (Lat. 43[deg]02'28'' N., long. 88[deg]14'13'' W.)

Milwaukee, Lawrence J. Timmerman Airport, WI
    (Lat. 43[deg]06'37'' N., long. 88[deg]02'04'' W.)

    That airspace extending upward from 700 feet above the surface
within a 8.4-mile radius of General Mitchell International Airport,
and within an 8.1-mile radius of John H. Batten Airport, and within
a 7.5-mile radius of the Waukesha County Airport, and within 2 miles
each side of the 282[deg] bearing from the Waukesha County Airport
extending from the 7.5-mile radius to 10.5 miles west of the
Waukesha County Airport, and within an 8.9-mile radius of Lawrence
J. Timmerman Airport.
* * * * *

    Issued in Fort Worth, TX, on February 12, 2009.
Roger M. Trevino,
Acting Manager, Operations Support Group, Central Service Center.
 [FR Doc. E9-3818 Filed 2-23-09; 8:45 am]

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