美国豁免香气成分残留限量要求（Fragrance Components; Exemption From the Requirement of a Tolerance)

　　ACTION

 

　　Final Rule.

 

　　SUMMARY

 

　　This regulation establishes an exemption from the requirement of a tolerance for residues of various fragrance component substances when used as inert ingredients in antimicrobial pesticide formulations for use on food contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils. This regulation eliminates the need to establish a maximum permissible level for residues of these various fragrance component substances

 

　　TABLE OF CONTENTS

 

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　　DATES:

 

　　ADDRESSES:

 

　　FOR FURTHER INFORMATION CONTACT:

 

　　SUPPLEMENTARY INFORMATION:

 

　　I. General Information

 

　　A. Does this action apply to me?

 

　　B. How can I get electronic access to other related information?

 

　　C. How can I file an objection or hearing request?

 

　　II. Today's Action

 

　　A. What is the authority for this action?

 

　　B. What action is the Agency taking?

 

　　III. EPA's Proposal

 

　　IV. Public Comments

 

　　V. Final Rule and Determination of Safety

 

　　VI. Other Considerations

 

　　A. Analytical Enforcement Methodology

 

　　B. International Residue Limits

 

　　VII. Conclusion

 

　　VIII. Statutory and Executive Order Reviews

 

　　X. Congressional Review Act

 

　　List of Subjects in 40 CFR Part 180

 

　　PART 180—[AMENDED]

 

　　DATES:

 

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　　This regulation is effective May 20, 2015. Objections and requests for hearings must be received on or before July 20, 2015, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

 

　　ADDRESSES:

 

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　　The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2013-0821, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566-1744, and the telephone number for the OPP Docket is (703) 305-5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets.

 

　　FOR FURTHER INFORMATION CONTACT:

 

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　　Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address: RDFRNotices@epa.gov.

 

　　SUPPLEMENTARY INFORMATION:

 

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　　I. General Information

 

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　　A. Does this action apply to me?

 

　　You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

 

　　Crop production (NAICS code 111).

 

　　Animal production (NAICS code 112).

 

　　Food manufacturing (NAICS code 311).

 

　　Pesticide manufacturing (NAICS code 32532).

 

　　B. How can I get electronic access to other related information?

 

　　You may access a frequently updated electronic version of 40 CFR part 180 through the Government Publishing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

 

　　C. How can I file an objection or hearing request?

 

　　Under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2013-0821 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must bereceived by the Hearing Clerk on or before July 20, 2015. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

 

　　In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2013-0821, by one of the following methods:

 

　　Federal eRulemaking Portal: http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

 

　　Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.

 

　　Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at http://www.epa.gov/dockets/contacts.html.

 

　　Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at http://www.epa.gov/dockets.

 

　　II. Today's Action

 

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　　A. What is the authority for this action?

 

　　EPA is taking this action under section 408(e) the FFDCA, 21 U.S.C. 346a(e), which allows EPA to establish a tolerance exemption under FFDCA section 408, 21 U.S.C. 346a et se. Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . . ”

 

　　EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of FFDCA section 408 and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/regulating/tolerances.htm.

 

　　B. What action is the Agency taking?

 

　　EPA, on its own initiative under FFDCA section 408(e), is establishing exemptions from the requirement of a tolerance for residues of various fragrance component substances identified at the end of this document.

 

　　III. EPA's Proposal

 

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　　In the Federal Register of July 25, 2014 (79 FR 43350) (FRL-9910-53), EPA proposed, on its own initiative under FFDCA section 408(e), 21 U.S.C. 346a(e), to establish exemptions from the requirement of a tolerance for residues of acetaldehyde (CAS Reg. No. 75-07-0), acetic acid (CAS Reg. No. 64-19-7), allyl cyclohexyl propionate (CAS Reg. No. 2705-87-5), butryic acid (CAS Reg. No. 107-92-6), butyl alcohol (CAS Reg. No. 71-36-3), citral (CAS Reg. No. 5392-40-5), citronellol (CAS Reg. No. 106-22-9), citronellyl acetate (CAS Reg. No. 150-84-5), β-damascone, (Z)-(CAS Reg. No. 23726-92-3), decanal (CAS Reg. No. 112-31-2), (E)-4-decenal (CAS Reg. No. 65405-70-1), decanoic acid (CAS Reg. No. 334-48-5), 1-decanol (CAS Reg. No. 112-30-1), 2,6-dimethyl-5-heptanal (CAS Reg. No. 106-72-9), 2-dodecanol, (2E)- (CAS Reg. No. 20407-84-5), d-limonene (CAS Reg. No. 5989-27-5), ethyl 2-methylbutyrate (CAS Reg. No. 452-79-1), (E)-geraniol (CAS Reg. No. 106-24-1), (E)-geraniol acetate (CAS Reg. No. 105-87-3), heptanal (CAS Reg. No. 111-71-7), heptanoic acid (CAS Reg. No. 111-14-8), heptyl alcohol (CAS Reg. No. 111-70-6), hexanal (CAS Reg. No. 66-25-1), hexanoic acid (CAS Reg. No. 142-62-1), (Z)-3-hexenol (CAS Reg. No. 928-96-1), (Z)-3-hexenol acetate (CAS Reg. No. 3681-71-8), hexyl acetate (CAS Reg. No. 142-92-7), hexyl alcohol (CAS Reg. No. 111-27-3), lauric acid (CAS Reg. No.143-07-7), lauric aldehyde (CAS Reg. No. 112-54-9), lauryl alcohol (CAS Reg. No. 112-53-8), methyl-α-ionone (CAS Reg. No. 127-42-4), 3-methyl-2-butenyl acetate (CAS Reg. No. 1191-16-8), 2-methylundecanal (CAS Reg. No. 110-41-8), myristaldehyde (CAS Reg. No. 124-25-4), myristic acid (CAS Reg. No. 544-63-8), neryl acetate (CAS Reg. No. 141-12-8), n-hexanol (CAS Reg. No. 111-27-3), nonanal (CAS Reg. No. 124-19-6), nonanoic acid (CAS Reg. No. 112-05-0), nonyl alcohol (CAS Reg. No. 143-08-8), octanal (CAS Reg. No. 124-13-0), octanoic acid (CAS Reg. No. 124-07-2), 1-octanol (CAS Reg. No. 111-87-5), palmitic acid (CAS Reg. No. 57-10-3), propionic acid (CAS Reg. No. 79-09-4), stearic acid (CAS Reg. No. 57-11-4), 2-tridecanal (CAS Reg. No. 7774-82-5), 3,5,5-trimethylhexanal (CAS Reg. No. 5435-64-3), undecanal (CAS Reg. No. 112-44-7), undecyl alcohol (CAS Reg. No. 112-42-5), valeraldehyde (CAS Reg. No. 110-62-3), and valeric acid (CAS Reg. No. 109-52-4) when used as fragrance components (i.e., inert ingredients) in antimicrobial pesticide formulations for use on food-contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils at end-use concentrations not to exceed 100 parts per million (ppm).

 

　　As discussed in that document, EPA has reviewed the available scientific data and other relevant information in support of this action, consistent with FFDCA section 408(c)(2), and the factors specified in FFDCA section 408(b)(2)(C and D). EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for these various fragrance components including exposure resulting from the exemptions from the requirement of a tolerance established by this action. For a detailed discussion of the aggregate risk assessments and determination of safety that support the establishment of these exemptions from the requirement of a tolerance, please refer to the July 25, 2014 Federal Register final rule and its supporting documents, available at http://regulations.gov.

 

　　IV. Public Comments

 

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　　EPA received nine comments to the proposed rule. Six of the comments were fully supportive of the proposed rule. One comment made specific reference to the fragrance component acetaldehyde and stated that the risk assessment of acetaldehyde should reconsider the compound's cancer risk. The comment noted that part of the safety finding for the fragrance components was based on no structural alerts for genotoxicity or carcinogenicity but in the case of acetaldehyde EPA had previously considered acetaldehyde tobe a probable human carcinogen based on inadequate human cancer studies and animal studies that have shown increased incidence of nasal tumors in rats and laryngeal tumors in hamsters after inhalation exposure. The Agency agrees with the commenter that the safety analysis provided in the proposed rule, which relies on human exposure threshold values for non-cancer risks, is not applicable to acetaldehyde and therefore, cannot be used to support an exemption for acetaldehyde. As such, EPA is not establishing in this final rule an exemption from the requirement of a tolerance for acetaldehyde as a fragrance component for use in antimicrobial pesticide formulations for use on food-contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils at end-use concentrations not to exceed 100 ppm.

 

　　Two comments made reference to fragrance sensitivity among certain individuals. The Agency understands the commenter's concerns, however the legal framework provided by FFDCA section 408 states that tolerances may be set when the pesticide chemical meets the safety standard imposed by that statute. The Agency is required by FFDCA section 408 to estimate the risk of the potential exposure to these residues. Neither the supporting information cited by the commenters or other reliable data demonstrate the occurrence of specific adverse effects directly attributable to exposures to the substances listed in Unit III and EPA has concluded that there is a reasonable certainty that no harm will result to the general population and to infants and children from aggregate exposure to the fragrance components listed in Unit III when used as inert ingredients in antimicrobial formulations for use on food contact surfaces in public eating places, dairy processing equipment, and food processing equipment and utensils at end-use concentrations not to exceed 100 ppm.

 

　　V. Final Rule and Determination of Safety

 

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　　Except for the exclusion of acetaldehyde, EPA is not making any changes to the risk assessment or final rule text that was proposed in July 25, 2014 Federal Register. Therefore, EPA concludes that there is a reasonable certainty that no harm will result to the general population and to infants and children from aggregate exposure to acetic acid; allyl cylcohexylpropionate; butryic acid; butyl alcohol; citral; citronellol; citronellyl acetate; β-damascone, (Z)-; decanal; (E)-4-decenal; decanoic acid; 1-decanol; 2,6-dimethyl-5-heptanal; 2-dodecanol, (2E)-; d-limonene; ethyl 2-methylbutyrate; (E)-geraniol; (E)-geraniol acetate; heptanal; heptanoic acid; heptyl alcohol; hexanal; hexanoic acid; (Z)-3-hexenol; (Z)-3-hexenol acetate; hexyl acetate; hexyl alcohol; lauric acid; lauric aldehyde; lauryl alcohol; methyl-α-ionone; 3-methyl-2-butenyl acetate; 2-methylundecanal; myristaldehyde; myristic acid; neryl acetate; n-hexanol; nonanal; nonanoic acid; nonyl alcohol; octanal; octanoic acid; 1-octanol; palmitic acid; propionic acid; stearic acid; 2-tridecanal; 3,5,5-trimethylhexanal; undecanal; undecyl alcohol; valeraldehyde; and valeric acid residues when used as when used as fragrance components (i.e., inert ingredients) in antimicrobial pesticide formulations for use on food-contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils at end-use concentrations not to exceed 100 ppm.

 

　　VI. Other Considerations

 

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　　A. Analytical Enforcement Methodology

 

　　An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

 

　　B. International Residue Limits

 

　　In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

 

　　The Codex has not established a MRL for the fragrance components listed in Unit II above.

 

　　VII. Conclusion

 

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　　Therefore, exemptions from the requirement of a tolerance are established for residues of acetic acid (CAS Reg. No. 64-19-7), allyl cyclohexyl propionate (CAS Reg. No. 2705-87-5), butryic acid (CAS Reg. No. 107-92-6), butyl alcohol (CAS Reg. No. 71-36-3), citral (CAS Reg. No. 5392-40-5), citronellol (CAS Reg. No. 106-22-9), citronellyl acetate (CAS Reg. No. 150-84-5), β-damascone, (Z)- (CAS Reg. No. 23726-92-3), decanal (CAS Reg. No. 112-31-2), (E)-4-decenal (CAS Reg. No. 65405-70-1), decanoic acid (CAS Reg. No. 334-48-5), 1-decanol (CAS Reg. No. 112-30-1), 2,6-dimethyl-5-heptanal (CAS Reg. No. 106-72-9), 2-dodecanol, (2E)- (CAS Reg. No. 20407-84-5), d-limonene (CAS Reg. No. 5989-27-5), ethyl 2-methylbutyrate (CAS Reg. No. 452-79-1), (E)-geraniol (CAS Reg. No. 106-24-1), (E)-geraniol acetate (CAS Reg. No. 105-87-3), heptanal (CAS Reg. No. 111-71-7), heptanoic acid (CAS Reg. No. 111-14-8), heptyl alcohol (CAS Reg. No. 111-70-6), hexanal (CAS Reg. No. 66-25-1), hexanoic acid (CAS Reg. No. 142-62-1), (Z)-3-hexenol (CAS Reg. No. 928-96-1), (Z)-3-hexenol acetate (CAS Reg. No. 3681-71-8), hexyl acetate (CAS Reg. No. 142-92-7), hexyl alcohol (CAS Reg. No. 111-27-3), lauric acid (CAS Reg. No. 143-07-7), lauric aldehyde (CAS Reg. No. 112-54-9), lauryl alcohol (CAS Reg. No. 112-53-8), methyl-α-ionone (CAS Reg. No. 127-42-4), 3-methyl-2-butenyl acetate (CAS Reg. No. 1191-16-8), 2-methylundecanal (CAS Reg. No. 110-41-8), myristaldehyde (CAS Reg. No. 124-25-4), myristic acid (CAS Reg. No. 544-63-8), neryl acetate (CAS Reg. No. 141-12-8), n-hexanol (CAS Reg. No. 111-27-3), nonanal (CAS Reg. No. 124-19-6), nonanoic acid (CAS Reg. No. 112-05-0), nonyl alcohol (CAS Reg. No. 143-08-8), octanal (CAS Reg. No. 124-13-0), octanoic acid (CAS Reg. No. 124-07-2), 1-octanol (CAS Reg. No. 111-87-5), palmitic acid (CAS Reg. No. 57-10-3), propionic acid (CAS Reg. No. 79-09-4), stearic acid (CAS Reg. No. 57-11-4), 2-tridecanal (CAS Reg. No. 7774-82-5), 3,5,5-trimethylhexanal (CAS Reg. No. 5435-64-3), undecanal (CAS Reg. No. 112-44-7), undecyl alcohol (CAS Reg. No. 112-42-5), valeraldehyde (CAS Reg. No. 110-62-3), and valeric acid (CAS Reg. No. 109-52-4) when used as fragrance components (i.e., inert ingredients) in antimicrobial pesticide formulations for use on food-contact surfaces in public eating places, dairy-processing equipment, and food-processing equipment and utensils at end-use concentrations not to exceed 100 ppm.

 

　　VIII. Statutory and Executive Order Reviews

 

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　　This action establishes exemptions from the requirement of a tolerance under FFDCA section 408(e). The Officeof Management and Budget (OMB) has exempted tolerance actions from review under Executive Orders 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993) and 13563, entitled Improving Regulation and Regulatory Review (76 FR 3821, January 21, 2011). As a result, this action is not subject to Executive Order 13211, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001). Nor does it require OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997).

 

　　This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.); does not require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994); and does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).

 

　　This action directly regulates growers, food processors, food handlers, and food retailers, but it does not regulate State or tribal governments. Nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). Therefore, the Agency has determined that Executive Orders 13132, entitled Federalism (64 FR 43255, August 10, 1999) and 13175, entitled Consultation and Coordination with Indian Tribal Governments (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty, contain any unfunded mandate, or otherwise significantly or uniquely affect small governments as described in the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501 et seq.).

 

　　Under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.), the Agency hereby certifies that this action will not have significant negative economic impact on a substantial number of small entities. Establishing an exemption from the requirement of a pesticide tolerance is, in effect, the removal of a regulatory restriction on pesticide residues in food and thus such an action will not have any negative economic impact on any entities, including small entities.

 

　　X. Congressional Review Act

 

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　　Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

 

　　List of Subjects in 40 CFR Part 180

 

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　　Environmental protection

 

　　Administrative practice and procedure

 

　　Agricultural commodities

 

　　Pesticides and pests

 

　　Reporting and recordkeeping requirements

 

　　Dated: May 8, 2015.

 

　　G. Jeffrey Herndon,

 

　　Director, Registration Division, Office of Pesticide Programs.

 

　　Therefore, 40 CFR chapter I is amended as follows:

 

　　begin regulatory text

 

　　PART 180—[AMENDED]

 

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　　1.The authority citation for part 180 continues to read as follows:

 

　　Authority:

 

　　21 U.S.C. 321(q), 346a and 371.

 

　　2.In § 180.940, revise the entry for “Acetic acid” and alphabetically add the following inert ingredients to the table in paragraph (a) to read as follows:

 

　　§ 180.940 Tolerance exemptions for active and inert ingredients for use in antimicrobial formulations (Food-contact surface sanitizing solutions).

 

　　* * * * *

 

　　(a) * * *

(a) * * *