80 FR 57629 - Notice of Issuance of Final Determination Concerning Certain Analytical-Grade Acetonitrile
DEPARTMENT OF HOMELAND SECURITY
U.S. Customs and Border Protection Federal Register Volume 80, Issue 185 (September 24, 2015)
U.S. Customs and Border Protection
Federal Register Volume 80, Issue 185 (September 24, 2015)
| Page Range | 57629-57631 | |
| FR Document | 2015-24288 |
[Federal Register Volume 80, Number 185 (Thursday, September 24, 2015)] [Notices] [Pages 57629-57631] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-24288] ----------------------------------------------------------------------- DEPARTMENT OF HOMELAND SECURITY U.S. Customs and Border Protection Notice of Issuance of Final Determination Concerning Certain Analytical-Grade Acetonitrile AGENCY: U.S. Customs and Border Protection, Department of Homeland Security. ACTION: Notice of final determination. ----------------------------------------------------------------------- SUMMARY: This document provides notice that U.S. Customs and Border Protection (``CBP'') has issued a final determination concerning the country of origin of certain analytical-grade acetonitrile. Based upon the facts presented, CBP has concluded that the country of origin of the analytical-grade acetonitrile is the country of origin of the crude acetonitrile for purposes of U.S. Government procurement. DATES: The final determination was issued on September 18, 2015. A copy of the final determination is attached. Any party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial review of this final determination within October 26, 2015. FOR FURTHER INFORMATION CONTACT: Ross Cunningham, Valuation and Special Programs Branch, Regulations and Rulings, Office of International Trade (202) 325-0034. SUPPLEMENTARY INFORMATION: Notice is hereby given that on September 18, 2015 pursuant to subpart B of Part 177, U.S. Customs and Border Protection Regulations (19 CFR part 177, subpart B), CBP issued a final determination concerning the country of origin of certain analytical- grade acetonitrile, which may be offered to the U.S. Government under an undesignated government procurement contract. This final determination, HQ H265712, was issued under procedures set forth at 19 CFR part 177, subpart B, which implements Title III of the Trade Agreements Act of 1979, as amended (19 U.S.C. 2511-18). In the final determination, CBP concluded that the processing in the United States does not result in a substantial transformation. Therefore, the country of origin of the analytical-grade acetonitrile is the country of origin of the crude acetonitrile for purposes of U.S. Government procurement. Section 177.29, CBP Regulations (19 CFR 177.29), provides that a notice of final determination shall be published in the Federal Register within 60 days of the date the final determination is issued. Section 177.30, CBP Regulations (19 CFR 177.30), provides that any party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial review of a final determination within 30 days of publication of such determination in the Federal Register. Dated: September 18, 2015. Harold Singer, Acting Executive Director, Regulations and Rulings, Office of International Trade. HQ H265712 September 18, 2015 OT:RR:CTF:VS H265712 RMC CATEGORY: Country of Origin David R. Stepp Bryan Cave LLP 120 Broadway, Suite 300, Santa Monica, CA 90401-2386 Re: U.S. Government Procurement; Country of Origin of Acetonitrile; Substantial Transformation Dear Mr. Stepp: This is in response to your letter dated April 1, 2015, requesting a country-of-origin determination on behalf of the Sigma-Aldrich Corporation (``Sigma-Aldrich''). You state that Sigma- Aldrich wishes to sell ``analytical-grade acetonitrile'' to the U.S. Government and thus seeks a determination that the country of origin of its product will be the United States. [[Page 57630]] We note that Sigma-Aldrich is a party-at-interest within the meaning of 19 CFR 177.22(d)(1) and is entitled to request this final determination. A meeting was held by teleconference on August 15, 2015. FACTS: Analytical-grade acetonitrile is a purified chemical that Sigma- Aldrich plans to manufacture in the United States from crude, commercial-grade acetonitrile imported from China and other countries. You state that commercial-grade acetonitrile is most useful as an industrial-grade solvent. Because it is produced as a byproduct of other industrial processes, you state that it contains a relatively low level of ``pure acetonitrile.'' You state that commercial-grade acetonitrile ``can be less than 95%'' and that it contains contaminants such as water. As its name suggests, purified analytical-grade acetonitrile contains fewer contaminants and may be up to 99.5% pure. In its purified, analytical grades, acetonitrile is suitable for use in chemical testing instruments such as Liquid Chromatography-Mass Spectrometry and Ultra-Performance Liquid Chromatography. These instruments are used for analyzing chemicals for pharmaceutical drug development and production, food safety, medical clinical testing, and environmental testing. You state that commercial-grade acetonitrile is unsuitable for these applications because its impurities would cause false readings and damage the testing equipment. Sigma-Aldrich produces several analytical grades of purified acetonitrile, including CHROMASOLV[supreg] Plus for HPLC; MC-MS CHROMASOLV[supreg]; LC-MS Ultra CHROMASOLV[supreg], tested for UHPLC- MS; and CHROMASOLV[supreg] Plus, for HPLC. Sigma-Aldrich will purify the imported commercial-grade acetonitrile using the following processes. The steps are set forth in general terms in accordance with your request to exclude confidential information: 1. Freezing the crude product; 2. Extracting the pure acetonitrile from the frozen mass; 3. Analyzing the purified acetonitrile output product and the correct purity level for the grade being produced; 4. Packaging the purified acetonitrile, which requires: a. Special glass bottles b. Rinsing the bottles c. Filling the bottles You state that the process is lengthy and requires sophisticated, expensive equipment and highly educated personnel. The steps described above take about four days for a ``typical batch'' of 20,000 liters. Scientists, all of whom possess at least a Bachelor of Science degree, perform or oversee the production process which uses a specialized unit and precision testing equipment. ISSUE: Whether the purification process described above will ``substantially transform'' the product such that the country of origin of the finished analytical-grade acetonitrile will be the United States for U.S. Government procurement purposes. LAW AND ANALYSIS: Pursuant to Subpart B of Part 177, 19 CFR 177.21 et seq., which implements Title III of the Trade Agreements Act of 1979, as amended (19 U.S.C. 2511 et seq.), CBP issues country-of-origin advisory rulings and final determinations as to whether an article is a product of a designated country for the purpose of granting waivers of certain ``Buy American'' restrictions on U.S. Government procurement. In rendering final determinations for purposes of U.S. Government procurement, CBP applies the provisions of Subpart B of Part 177 consistent with the Federal Procurement Regulations. See 19 CFR 177.21. In this regard, CBP recognizes that the Federal Acquisition Regulations restrict the U.S. Government's purchase of products to U.S.-made or designated country end products for acquisitions subject to the Trade Agreements Act. See 48 CFR 25.403(c)(1). The Federal Acquisition Regulations define ``U.S.-made end product'' as ``an article that is mined, produced, or manufactured in the United States or that is substantially transformed in the United States into a new and different article of commerce with name, character, or use distinct from that of the article or articles from which it was transformed.'' See 48 C.F.R Sec. 25.003. You argue that the imported commercial-grade acetonitrile will be substantially transformed when Sigma-Aldrich purifies it into analytical-grade acetonitrile. Therefore, in your view, the finished product will be eligible for U.S. Government procurement because its country of origin will be the United States. A substantial transformation occurs when an article is used in a manufacturing process that results in a new article that has a new name, character or use different from that of the original imported article. In previous rulings, ``CBP has consistently held that refining or purification of a crude substance does not generally effect a substantial transformation that results in a different article of commerce with a new name, character, or use''. Headquarters Ruling Letter (``HQ'') H113256, dated December 27, 2010. For example, CBP has held that refining linseed oil, in H554664, dated October 29, 1987, and Octamine (an aviation lubricant), in HQ 556143, dated March 2, 1992, did not result in an article with a new name, use, or character. You argue that the acetonitrile purification processes will result in a substantial transformation because the finished product will have a new name, character, and use. Although a change in a product's name is the weakest evidence of a substantial transformation, as noted in Uniroyal, Inc. v. United States, 3 CIT 220 (1982), aff'd 702 F.2d 1022 (Fed. Cir. 1983), you point that ``[t]he imported product is referred to as `crude' or `commercial grade,' whereas the processed product is referred to as `purified' and `analytical grade.''' In both cases, however, the name of the product remains acetonitrile. The adjectives ``crude,'' ``commercial grade,'' ``purified,'' and ``analytical'' qualify the noun ``acetonitrile.'' As we have previously noted, the addition of an adjective in front of a product name is generally not persuasive. See HQ 731731, dated February 23, 1989. We therefore find that the purification process does not result in an article with a new name. You also argue that the processed acetonitrile has a new character compared to the crude acetonitrile. You state that the imported crude acetonitrile has the character of an industrial manufacturing byproduct, whereas the purified product has the character of a laboratory reagent. CBP's examination of character, however, focuses on the chemical and physical properties of the product itself. See HQ 571975, dated April 3, 2002. CBP's Laboratories and Scientific Services Directorate informed us that no chemical reactions or physical changes occur in Sigma-Aldrich's processing. Instead, the processing only removes impurities in the acetonitrile. We therefore find that the purification process does not result in an article with a different character. While the finished product will not have a different name or character, it will have a different use. The imported crude product can be used as a solvent for industrial processes but not in precision testing applications because impurities can damage the testing equipment or produce measurement errors. Although the finished product could also be used as a solvent, you [[Page 57631]] state that this is unlikely because it would be ``cost prohibitive.'' Therefore, you state that its likely use is confined to analytical testing. In support of your argument that a substantial transformation will take place when the crude acetonitrile is purified into analytical- grade acetonitrile, you analogize to rulings HQ 563301, dated August 26, 2005 and HQ 731731, dated February 23, 1989. In HQ 731731, we found that a substantial transformation occurred when raw powdered vancomycin hydrochloride was processed into a finished antibiotic drug capable of intravenous use. As imported, the raw chemical was unfit for medical use. Applying the three substantial transformation factors, we found that the name changed to ``sterile'' vancomycin hydrochloride, the use changed to an injectable antibiotic, and the character changed to a purified solution of uniform potency levels. Accordingly, we found that the chemical was substantially transformed. Similarly, in HQ 563301 we found that a substantial transformation occurred when bulk parathormone was processed into finished parathormone cartridges. We held that the ``extensive processing transforms the raw parathormone from an unstable, non-sterile, frozen material unsuitable for human use into a pharmaceutical agent ready for human use.'' A common theme in HQ 563301 and HQ 731731 is the production of a medicine from chemicals that were previously unfit for human consumption. In both cases, we found that--along with the required change in name and character--this conversion from raw chemicals to medication represented a significant change in use. Here, aside from the fact that no change in name or character will occur, the production of analytical-grade acetonitrile results in a less significant change in use, namely, from one type of industrial use to another. We believe that this case is more analogous to cases involving the refining and purification of chemicals than to those involving the production of medicine. As noted above, CBP has consistently held that refining or purification of a crude substance does not generally effect a substantial transformation. You attempt to distinguish one of these cases, H566143, dated March 2, 1992, by pointing out that there was no substantial transformation because ``both the precursor and purified substances had the same essential character as aviation lubricants of merely different grades and were therefore not different articles of commerce, and both substances had the same chemical structures.'' Yet here too the crude and purified acetonitrile will have the same essential character as acetonitrile and you have provided no evidence that the substances will have a different chemical structure. Therefore, we are ``bound to follow the well-settled principle of Customs law that the mere refining of a chemical does not result in a substantial transformation of the imported chemicals into a new and different article of commerce with a new name, character, and use.'' HQ 556143, dated March 2, 1992. HOLDING: The purification process described above will not substantially transform the acetonitrile, and the country of origin of the finished analytical-grade acetonitrile will not be the United States for U.S. Government procurement purposes. Sincerely, Harold Singer, Acting Executive Director, Regulations & Rulings, Office of International Trade. [FR Doc. 2015-24288 Filed 9-23-15; 8:45 am] BILLING CODE P
![Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices 57629
API chapters Title AmSpec Services, LLC is accredited by the U.S. Customs and Border
for the following laboratory analysis Protection Laboratory Methods (CBPL)
17 ................. Maritime Measurement. procedures and methods for petroleum and American Society for Testing and
and certain petroleum products set forth Materials (ASTM):
CBPL No. ASTM Title
27–01 .............. D287 Standard Test Method for API Gravity of crude Petroleum and Petroleum Products.
27–02 .............. D1298 Standard Practice for Density, Relative Density (Specific Gravity), or API Gravity of Crude Petroleum and Liq-
uid Petroleum Products by Hydrometer Meter.
27–04 .............. D95 Standard Test Method for Water in Petroleum Products and Bituminous Materials by Distillation.
27–05 .............. D4928 Standard Test Method for Water in Crude Oils by Coulometric Karl Fischer Titration.
27–06 .............. D473 Standard Test Method for Sediment in Crude Oils and Fuel Oils by the Extraction Method.
27–08 .............. D86 Standard Test Method for Distillation of Petroleum Products.
27–11 .............. D445 Standard Test Method for Kinematic Viscosity of Transparent and Opaque Liquids.
27–13 .............. D4294 Standard Test Method for Sulfur in Petroleum and Petroleum Products by Energy-Dispersive X-ray Fluores-
cence Spectrometry
27–20 .............. D4057 Standard Practice for Manual Sampling of Petroleum and Petroleum Products.
27–48 .............. D4052 Standard Test Method for Density and Relative Density of Liquids by Digital Density Meter.
27–50 .............. D93 Standard Test Methods for Flash-Point by Pensky-Martens Closed Cup Tester.
27–53 .............. D2709 Standard Test Method for Water and Sediment in Middle Distillate Fuels by Centrifuge.
27–54 .............. D1796 Standard Test Method for Water and Sediment in Fuel Oils by the Centrifuge Method.
27–58 .............. D5191 Standard Test Method For Vapor Pressure of Petroleum Products.
Pending ........... D97 Standard Test Method for Pour Point of Petroleum Products.
Pending ........... D2500 Standard Test Method for Cloud Point of Petroleum Products.
Anyone wishing to employ this entity SUMMARY: This document provides Therefore, the country of origin of the
to conduct laboratory analyses and notice that U.S. Customs and Border analytical-grade acetonitrile is the
gauger services should request and Protection (‘‘CBP’’) has issued a final country of origin of the crude
receive written assurances from the determination concerning the country of acetonitrile for purposes of U.S.
entity that it is accredited or approved origin of certain analytical-grade Government procurement.
by the U.S. Customs and Border acetonitrile. Based upon the facts Section 177.29, CBP Regulations (19
Protection to conduct the specific test or presented, CBP has concluded that the CFR 177.29), provides that a notice of
gauger service requested. Alternatively, country of origin of the analytical-grade final determination shall be published
inquiries regarding the specific test or acetonitrile is the country of origin of in the Federal Register within 60 days
gauger service this entity is accredited the crude acetonitrile for purposes of of the date the final determination is
or approved to perform may be directed U.S. Government procurement. issued. Section 177.30, CBP Regulations
to the U.S. Customs and Border DATES: The final determination was (19 CFR 177.30), provides that any
Protection by calling (202) 344–1060. issued on September 18, 2015. A copy party-at-interest, as defined in 19 CFR
The inquiry may also be sent to of the final determination is attached. 177.22(d), may seek judicial review of a
CBPGaugersLabs@cbp.dhs.gov. Please Any party-at-interest, as defined in 19 final determination within 30 days of
reference the Web site listed below for CFR 177.22(d), may seek judicial review publication of such determination in the
a complete listing of CBP approved of this final determination within Federal Register.
gaugers and accredited laboratories. October 26, 2015. Dated: September 18, 2015.
http://www.cbp.gov/about/labs- FOR FURTHER INFORMATION CONTACT: Ross Harold Singer,
scientific/commercial-gaugers-and- Cunningham, Valuation and Special Acting Executive Director, Regulations and
laboratories Programs Branch, Regulations and Rulings, Office of International Trade.
Rulings, Office of International Trade HQ H265712
Dated: September 10, 2015.
(202) 325–0034. September 18, 2015
Ira S. Reese,
SUPPLEMENTARY INFORMATION: Notice is OT:RR:CTF:VS H265712 RMC
Executive Director, Laboratories and hereby given that on September 18,
Scientific Services Directorate. CATEGORY: Country of Origin
2015 pursuant to subpart B of Part 177,
[FR Doc. 2015–24229 Filed 9–23–15; 8:45 am] U.S. Customs and Border Protection David R. Stepp
BILLING CODE 9111–14–P Regulations (19 CFR part 177, subpart Bryan Cave LLP
B), CBP issued a final determination 120 Broadway, Suite 300, Santa Monica,
concerning the country of origin of CA 90401–2386
DEPARTMENT OF HOMELAND certain analytical-grade acetonitrile, Re: U.S. Government Procurement;
SECURITY which may be offered to the U.S. Country of Origin of Acetonitrile;
Government under an undesignated Substantial Transformation
U.S. Customs and Border Protection Dear Mr. Stepp: This is in response to
government procurement contract. This
Notice of Issuance of Final final determination, HQ H265712, was your letter dated April 1, 2015,
Determination Concerning Certain issued under procedures set forth at 19 requesting a country-of-origin
tkelley on DSK3SPTVN1PROD with NOTICES
Analytical-Grade Acetonitrile CFR part 177, subpart B, which determination on behalf of the Sigma-
implements Title III of the Trade Aldrich Corporation (‘‘Sigma-Aldrich’’).
AGENCY: U.S. Customs and Border Agreements Act of 1979, as amended You state that Sigma-Aldrich wishes to
Protection, Department of Homeland (19 U.S.C. 2511–18). In the final sell ‘‘analytical-grade acetonitrile’’ to
Security. determination, CBP concluded that the the U.S. Government and thus seeks a
processing in the United States does not determination that the country of origin
ACTION: Notice of final determination.
result in a substantial transformation. of its product will be the United States.
VerDate Sep<11>2014 16:45 Sep 23, 2015 Jkt 235001 PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 E:\FR\FM\24SEN1.SGM 24SEN1](https://thefederalregister.org/doc/80_FR_57814/page/1.svg)
![57630 Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices
We note that Sigma-Aldrich is a party- take about four days for a ‘‘typical crude substance does not generally
at-interest within the meaning of 19 CFR batch’’ of 20,000 liters. Scientists, all of effect a substantial transformation that
177.22(d)(1) and is entitled to request whom possess at least a Bachelor of results in a different article of commerce
this final determination. A meeting was Science degree, perform or oversee the with a new name, character, or use’’.
held by teleconference on August 15, production process which uses a Headquarters Ruling Letter (‘‘HQ’’)
2015. specialized unit and precision testing H113256, dated December 27, 2010. For
equipment. example, CBP has held that refining
FACTS: linseed oil, in H554664, dated October
Analytical-grade acetonitrile is a ISSUE:
29, 1987, and Octamine (an aviation
purified chemical that Sigma-Aldrich Whether the purification process lubricant), in HQ 556143, dated March
plans to manufacture in the United described above will ‘‘substantially 2, 1992, did not result in an article with
States from crude, commercial-grade transform’’ the product such that the a new name, use, or character.
acetonitrile imported from China and country of origin of the finished You argue that the acetonitrile
other countries. You state that analytical-grade acetonitrile will be the purification processes will result in a
commercial-grade acetonitrile is most United States for U.S. Government substantial transformation because the
useful as an industrial-grade solvent. procurement purposes. finished product will have a new name,
Because it is produced as a byproduct LAW AND ANALYSIS: character, and use. Although a change
of other industrial processes, you state in a product’s name is the weakest
that it contains a relatively low level of Pursuant to Subpart B of Part 177, 19 evidence of a substantial transformation,
‘‘pure acetonitrile.’’ You state that CFR 177.21 et seq., which implements as noted in Uniroyal, Inc. v. United
commercial-grade acetonitrile ‘‘can be Title III of the Trade Agreements Act of States, 3 CIT 220 (1982), aff’d 702 F.2d
less than 95%’’ and that it contains 1979, as amended (19 U.S.C. 2511 et 1022 (Fed. Cir. 1983), you point that
contaminants such as water. seq.), CBP issues country-of-origin ‘‘[t]he imported product is referred to as
As its name suggests, purified advisory rulings and final ‘crude’ or ‘commercial grade,’ whereas
analytical-grade acetonitrile contains determinations as to whether an article the processed product is referred to as
fewer contaminants and may be up to is a product of a designated country for ‘purified’ and ‘analytical grade.’’’ In
99.5% pure. In its purified, analytical the purpose of granting waivers of both cases, however, the name of the
grades, acetonitrile is suitable for use in certain ‘‘Buy American’’ restrictions on product remains acetonitrile. The
chemical testing instruments such as U.S. Government procurement. adjectives ‘‘crude,’’ ‘‘commercial grade,’’
Liquid Chromatography-Mass In rendering final determinations for ‘‘purified,’’ and ‘‘analytical’’ qualify the
Spectrometry and Ultra-Performance purposes of U.S. Government noun ‘‘acetonitrile.’’ As we have
Liquid Chromatography. These procurement, CBP applies the previously noted, the addition of an
instruments are used for analyzing provisions of Subpart B of Part 177 adjective in front of a product name is
chemicals for pharmaceutical drug consistent with the Federal Procurement generally not persuasive. See HQ
development and production, food Regulations. See 19 CFR 177.21. In this 731731, dated February 23, 1989. We
safety, medical clinical testing, and regard, CBP recognizes that the Federal therefore find that the purification
environmental testing. You state that Acquisition Regulations restrict the U.S. process does not result in an article with
commercial-grade acetonitrile is Government’s purchase of products to a new name.
unsuitable for these applications U.S.-made or designated country end You also argue that the processed
because its impurities would cause false products for acquisitions subject to the acetonitrile has a new character
readings and damage the testing Trade Agreements Act. See 48 CFR compared to the crude acetonitrile. You
equipment. 25.403(c)(1). The Federal Acquisition state that the imported crude
Sigma-Aldrich produces several Regulations define ‘‘U.S.-made end acetonitrile has the character of an
analytical grades of purified acetonitrile, product’’ as ‘‘an article that is mined, industrial manufacturing byproduct,
including CHROMASOLV® Plus for produced, or manufactured in the whereas the purified product has the
HPLC; MC–MS CHROMASOLV®; LC– United States or that is substantially character of a laboratory reagent. CBP’s
MS Ultra CHROMASOLV®, tested for transformed in the United States into a examination of character, however,
UHPLC–MS; and CHROMASOLV® Plus, new and different article of commerce focuses on the chemical and physical
for HPLC. Sigma-Aldrich will purify the with name, character, or use distinct properties of the product itself. See HQ
imported commercial-grade acetonitrile from that of the article or articles from 571975, dated April 3, 2002. CBP’s
using the following processes. The steps which it was transformed.’’ See 48 C.F.R Laboratories and Scientific Services
are set forth in general terms in § 25.003. Directorate informed us that no
accordance with your request to exclude You argue that the imported chemical reactions or physical changes
confidential information: commercial-grade acetonitrile will be occur in Sigma-Aldrich’s processing.
1. Freezing the crude product; substantially transformed when Sigma- Instead, the processing only removes
2. Extracting the pure acetonitrile Aldrich purifies it into analytical-grade impurities in the acetonitrile. We
from the frozen mass; acetonitrile. Therefore, in your view, the therefore find that the purification
3. Analyzing the purified acetonitrile finished product will be eligible for U.S. process does not result in an article with
output product and the correct purity Government procurement because its a different character.
level for the grade being produced; country of origin will be the United While the finished product will not
4. Packaging the purified acetonitrile, States. have a different name or character, it
which requires: A substantial transformation occurs will have a different use. The imported
tkelley on DSK3SPTVN1PROD with NOTICES
a. Special glass bottles when an article is used in a crude product can be used as a solvent
b. Rinsing the bottles manufacturing process that results in a for industrial processes but not in
c. Filling the bottles new article that has a new name, precision testing applications because
You state that the process is lengthy character or use different from that of impurities can damage the testing
and requires sophisticated, expensive the original imported article. In equipment or produce measurement
equipment and highly educated previous rulings, ‘‘CBP has consistently errors. Although the finished product
personnel. The steps described above held that refining or purification of a could also be used as a solvent, you
VerDate Sep<11>2014 16:45 Sep 23, 2015 Jkt 235001 PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 E:\FR\FM\24SEN1.SGM 24SEN1](https://thefederalregister.org/doc/80_FR_57814/page/2.svg)
![Federal Register / Vol. 80, No. 185 / Thursday, September 24, 2015 / Notices 57631
state that this is unlikely because it not generally effect a substantial SUMMARY: Notice is hereby given,
would be ‘‘cost prohibitive.’’ Therefore, transformation. You attempt to pursuant to CBP regulations, that
you state that its likely use is confined distinguish one of these cases, H566143, Saybolt LP has been approved to gauge
to analytical testing. dated March 2, 1992, by pointing out petroleum and certain petroleum
In support of your argument that a that there was no substantial products and accredited to test
substantial transformation will take transformation because ‘‘both the petroleum and certain petroleum
place when the crude acetonitrile is precursor and purified substances had products for customs purposes for the
purified into analytical-grade the same essential character as aviation next three years as of May 20, 2015.
acetonitrile, you analogize to rulings HQ lubricants of merely different grades and
563301, dated August 26, 2005 and HQ were therefore not different articles of DATES: Effective Dates: The
731731, dated February 23, 1989. In HQ commerce, and both substances had the accreditation and approval of Saybolt
731731, we found that a substantial same chemical structures.’’ Yet here too LP as commercial gauger and laboratory
transformation occurred when raw the crude and purified acetonitrile will became effective on May 20, 2015. The
powdered vancomycin hydrochloride have the same essential character as next triennial inspection date will be
was processed into a finished antibiotic acetonitrile and you have provided no scheduled for May 2018.
drug capable of intravenous use. As evidence that the substances will have
FOR FURTHER INFORMATION CONTACT:
imported, the raw chemical was unfit a different chemical structure.
for medical use. Applying the three Therefore, we are ‘‘bound to follow the Approved Gauger and Accredited
substantial transformation factors, we well-settled principle of Customs law Laboratories Manager, Laboratories and
found that the name changed to that the mere refining of a chemical Scientific Services Directorate, U.S.
‘‘sterile’’ vancomycin hydrochloride, the does not result in a substantial Customs and Border Protection, 1300
use changed to an injectable antibiotic, transformation of the imported Pennsylvania Avenue NW., Suite
and the character changed to a purified chemicals into a new and different 1500N, Washington, DC 20229, tel. 202–
solution of uniform potency levels. article of commerce with a new name, 344–1060.
Accordingly, we found that the character, and use.’’ HQ 556143, dated SUPPLEMENTARY INFORMATION: Notice is
chemical was substantially transformed. March 2, 1992. hereby given pursuant to 19 CFR 151.12
Similarly, in HQ 563301 we found that and 19 CFR 151.13, that Saybolt LP, 220
a substantial transformation occurred HOLDING:
The purification process described Texas Ave., Texas City, TX 77590, has
when bulk parathormone was processed
above will not substantially transform been approved to gauge petroleum and
into finished parathormone cartridges.
the acetonitrile, and the country of certain petroleum products and
We held that the ‘‘extensive processing
origin of the finished analytical-grade accredited to test petroleum and certain
transforms the raw parathormone from
an unstable, non-sterile, frozen material acetonitrile will not be the United States petroleum products for customs
unsuitable for human use into a for U.S. Government procurement purposes, in accordance with the
pharmaceutical agent ready for human purposes. provisions of 19 CFR 151.12 and 19 CFR
use.’’ 151.13. Saybolt LP is approved for the
Sincerely,
A common theme in HQ 563301 and following gauging procedures for
Harold Singer,
HQ 731731 is the production of a petroleum and certain petroleum
Acting Executive Director, Regulations & products from the American Petroleum
medicine from chemicals that were Rulings, Office of International Trade.
previously unfit for human Institute (API):
[FR Doc. 2015–24288 Filed 9–23–15; 8:45 am]
consumption. In both cases, we found
BILLING CODE P API Chapters Title
that—along with the required change in
name and character—this conversion
3 ................... Tank Gauging.
from raw chemicals to medication DEPARTMENT OF HOMELAND 5 ................... Metering.
represented a significant change in use. SECURITY 7 ................... Temperature Determination.
Here, aside from the fact that no change
8 ................... Sampling.
in name or character will occur, the U.S. Customs and Border Protection 12 ................. Calculations.
production of analytical-grade
Accreditation and Approval of Saybolt 17 ................. Maritime Measurement.
acetonitrile results in a less significant
change in use, namely, from one type of LP as a Commercial Gauger and
industrial use to another. Laboratory Saybolt LP is accredited for the
We believe that this case is more following laboratory analysis
AGENCY: U.S. Customs and Border
analogous to cases involving the procedures and methods for petroleum
Protection, Department of Homeland
refining and purification of chemicals and certain petroleum products set forth
Security.
than to those involving the production by the U.S. Customs and Border
ACTION: Notice of accreditation and
of medicine. As noted above, CBP has Protection Laboratory Methods (CBPL)
approval of Saybolt LP as a commercial and American Society for Testing and
consistently held that refining or
gauger and laboratory.
purification of a crude substance does Materials (ASTM):
CBPL No. ASTM Title
27–02 .............. D1298 Standard Practice for Density, Relative Density (Specific Gravity), or API Gravity of Crude Petroleum and Liq-
tkelley on DSK3SPTVN1PROD with NOTICES
uid Petroleum Products by Hydrometer Meter.
27–03 .............. D4006 Standard Test Method for Water in Crude Oil by Distillation.
27–04 .............. D95 Standard Test Method for Water in Petroleum Products and Bituminous Materials by Distillation.
27–05 .............. D4928 Standard Test Method for Water in Crude Oils by Coulometric Karl Fischer Titration.
27–06 .............. D473 Standard Test Method for Sediment in Crude Oils and Fuel Oils by the Extraction Method.
27–13 .............. D4294 Standard Test Method for Sulfur in Petroleum and Petroleum Products by Energy-Dispersive X-ray Fluores-
cence Spectrometry.
VerDate Sep<11>2014 16:45 Sep 23, 2015 Jkt 235001 PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 E:\FR\FM\24SEN1.SGM 24SEN1](https://thefederalregister.org/doc/80_FR_57814/page/3.svg)
Document Created: 2018-02-26 10:18:14
Document Modified: 2018-02-26 10:18:14
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of final determination. | |
| Dates | The final determination was issued on September 18, 2015. A copy of the final determination is attached. Any party-at-interest, as defined in 19 CFR 177.22(d), may seek judicial review of this final determination within October 26, 2015. | |
| Contact | Ross Cunningham, Valuation and Special Programs Branch, Regulations and Rulings, Office of International Trade (202) 325-0034. | |
| FR Citation | 80 FR 57629 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR